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FIELD OF THE INVENTION [0001] This invention relates to novel calcium phosphate-coated implantable medical devices and processes of making same. The unique calcium-phosphate coated implantable medical devices minimize immune response to the implant. The coated implantable devices have the capability to store and release one or more medicinally active agents into the body in a controlled manner. BACKGROUND OF THE INVENTION [0002] Cardiovascular stents are widely used in coronary angioplasty procedures to enlarge coronary arteries and thereby allow better blood circulation. Typically this is accomplished by a balloon angioplasty procedure wherein a contracted stent, usually in the form of a metallic mesh tube, is moved in to the site of blood vessel narrowing along a guide wire. Once the stent is in place an internally situated balloon expands it radially. After expansion the balloon is deflated and removed from vessel while the stent remains expanded in place. The stent thus provides a scaffold support for the walls of the blood vessel, enlarging the vessels aperture and increasing blood flow. This operation saves millions of lives annually around the world. Unfortunately the placement of metallic stents often leads to harmful side effects. A relatively large proportion of patients (up to half of the population, according to some statistics) experience an immune response to the implanted stent called inflammatory restenosis, and other negative effects, which lead to a re-narrowing of the vessel. This typically requires repeat surgical treatment within 1-2 years of the original balloon angioplasty operation. [0003] The mechanisms that lead to restenosis and other immune responses associated with the implantation of a medical device are initiated by damage to the vessel lining during the surgical procedure. Such damage is very difficult to avoid entirely, but its effects, i.e. inflammation and/or infection, may be diminished through modifications to the surface of metallic implantable medical devices. The most common surface modification of implanted medical devices is the application of a thin polymer film coating. These coatings are frequently impregnated with medically active agent(s) such as antibiotics, anti-inflammatory agents and other, more complex drugs. These medically active agents are released from the coating through leaching to the arterial wall and the blood stream, often aided by dissolution of the carrier film. Typically, biodegradable polymers such as polylactic acid, polyglycolic acid, and others, frequently in combination with heparin and other anti-thrombogenic agents, are selected in such drug delivery systems. A particular advantage of the polymer coatings on stents is that the coatings are flexible and generally non-thrombogenic. [0004] In the past, polymeric materials have been used for drug delivery control and have enjoyed substantial clinical success for certain drug systems. Unfortunately, even biodegradable polymers, although more bio-friendly than the native metallic surface, are still recognized by living tissue as foreign objects. Therefore the bio-degradation process is frequently accompanied by inflammatory response of the tissue. In some critical applications, such as cardiovascular stents, it has been determined that polymer coated stents do not perform according to expectations in longer term (in excess of 1 year) of use. Furthermore, in many instances relatively rapidly resorbing polymer coatings are quickly depleted, from the stent surface with concomitant loss of the long-term affects of the drug and harmful exposure of the bare metal surface to contact tissue. This may result in an adverse response of the tissue, leading to inflammation, restenosis (in the case of stents), and requiring repetitive surgical intervention. [0005] There is therefore a strong need to discover materials for coating implantable medical devices that are entirely biocompatible and thus do not cause any adverse effects in the tissue. Furthermore, ideally this coating material will be able to deliver one or more pharmaceutically active agents to a targeted site. Studies have shown that porous coatings may accept the required load of drugs through adsorption and then release the drugs in a controlled manner. The drug release process is dependant on surface properties of the coating-material and the adsorption properties, molecular size, and other characteristics of the drug. [0006] One group of materials exhibiting desired characteristics has been known for a long time, and is used extensively for the surface modification of large rigid implants such as artificial hips in the human body. These materials are members of the family of calcium phosphates (CaP) and include hydroxyapatite (HA), di- and tri-calcium phosphates, as well as partially or fully amorphous calcium phosphates. These materials are mineral components of hard tissue and as such are fully bio-compatible and bio-resorbable with no side effects. Calcium phosphate, in particular hydroxyapatite (HA), is a principal inorganic component of bone, and thus offers entirely new perspectives for coating-based drug encapsulation and drug delivery systems. [0007] Hydroxyapatite ceramics, Ca 10 (PO 4 ) 6 (OH) 2 , belong to the class of calcium phosphate (CaP) based bioactive materials that are used for a variety of biomedical applications, including matrices for drug release control [M. Itokazu et al., Biomaterials, 19, 817-819, 1998; F. Minguez et al Drugs Exp. Clin. Res., 16[5], 231-235, 1990; W. Paul and C. P. Sharma, J. Mater. Sci. Mater. Med., 10, 383-388, 1999]. Other members of the CaP family, such as dicalcium phosphate (CaHPO 4 .2H 2 O) or tricalcium phosphate (Ca 3 (PO 4 ) 2 ), have also been used for similar purposes. The CaP family of materials has been long recognized as having a high degree of biocompatibility with human tissue. [0008] The use of calcium phosphate coatings, including HA coatings, thermally deposited on implantable devices has been limited by the fact that such coatings used to date have had thicknesses of >0.01 mm and have exhibited brittle behaviour when in bulk form. This characteristic has limited their use to applications where a solid support structure, such as dental or hip implant, does not allow for much deformation of the structure. In such cases, the potential for coating damage is limited and osseo-integration with the tissue occurs in an improved manner. HA coated implants in particular have been shown to possess excellent biocompatibility and provide accelerated integration of the implant with the surrounding tissue. The bio-resorption rate of such coatings can be controlled through adjustment of their crystallinity and chemical composition, e.g. by the incorporation of carbonate groups and other methods known to those skilled in the art. [0009] A method alternative to thermal coating is the biomimetic deposition of HA films at room temperature (BM-HA). This technique has been used for a variety of biomedical applications, for example drug delivery [H. B. Wen et al, J. Biomed. Mater. Res., 41, 227-36, 1998; S. Lin and A. A. Campbell, U.S. Pat. No. 5,958,430, 1999; D. M. Liu et al J. Mater. Sci. Mater. Med., 5, 147-153, 1994; K. de Groot et al, J. Biomed. Mater. Res., 21, 1375-1381, 1987). This forming mechanism is driven by supersaturation of Ca 2+ and PO 4 3− , under appropriate solution pH, where HA is the most stable phase. As the process proceeds at or near room temperature, the apatitic crystals which form through nucleation and growth may incorporate biologically active species, such as antibiotics, anti-cancer drugs, anti-inflammatory agents, etc. The deposition rates for BM-HA are in the range of 0.05-0.5 μm/h. [0010] This relatively low deposition rate may be enhanced significantly if electric field is applied to the metallic substrate being coated, e.g. stent, in a solution containing proper concentration of calcium and phosphorous ions. This variant of coating is usually referred to as Electro-Chemical Deposition (ECD), and the resulting film termed as ECD-HA. As ECD also proceeds at (or near) room temperature, drug encapsulation is also possible in ECD-HA. The physiological solutions for BM-HA formation are naturally water-based, which makes it impossible to encapsulate hydrophobic bioactive agents into BM-HA coatings. The biomimetic HA films (both BM-HA and ECD-HA) may be deposited on implantable medical devices at room temperature, which is of great advantage for drug encapsulation during deposition. [0011] Unfortunately, the bonding strength BM-HA and ECD-HA to metallic surfaces is generally significantly lower than that of sol-gel HA (termed here SG-HA). At the same time, bonding strength of BM-HA or ECD-HA to previously consolidated hydroxyapatite is high, generally in excess of 40 MPa. In this respect building additional BM-HA or ECD-HA film on top of the already existing, well-bonded to the metallic substrate film of SG-HA provides a novel and inventive route to achieve high bonding strength, controlled porosity, and drug encapsulation capability of the films deposited at room temperature, [0012] Another alternative for room (or near-room) temperature deposition of porous calcium phosphate films, in particular hydroxyapatite, for drug impregnation and encapsulation, is so-called calcium phosphate cement (CPC) route. In this previously disclosed process (refer to U.S. Patent Application No. US2002/0155144 A1 “Bifunctional Hydroxyapatite Coatings and Microspheres for in-situ Drug Encapsulation”, by T. Troczynski, D. Liu, and Q. Yang), fine particles of calcium phosphate precursor Ca(OH)2 and calcium phosphate salt monocalcium phosphate anhydrate, are milled and mixed in ethanol, followed by film deposition and impregnation by sodium phosphate solution (refer to the Example 4 below for details of this procedure). As a result of this process, microporous, semi-amorphous CPC-HA results, suitable for delivering drugs through leaching and during film resorption. Similarly as above, CPC-HA film bonds poorly to metallic surfaces, such as those of implants or stents. However, CPC-HA film deposited on previously consolidated surface of HA, such as SG-HA, achieves high bonding strength, generally in excess of 40 MPa. In this respect building additional CPC-HA film on top of the already existing, well-bonded to the metallic substrate film of SG-HA provides a novel and inventive route to achieve high bonding strength, controlled porosity, and drug encapsulation capability of the films deposited at room temperature. [0013] Electric field-assisted thin film deposition technologies have the great advantage of the resulting film uniformity, especially for complex substrates such as stents. One such technology termed Electro-Phoretic Deposition (EPD) is well known method in ceramic processing. In this method fine particles of a ceramic (generally about a micrometer or less in size) suspended in a liquid attain electric charge through interaction with the liquid or through addition to the suspension of surface-active species. The simplest example of such EPD system is oxide (or hydroxide, such as hydroxyapatite) ceramic powder suspended in water and acid (such as nitric acid) mixture. In such environment protons will have a tendency to absorb on surface of the ceramic particles, providing positive charge to the particles. Upon application of electric field, such charged particles would migrate to the negative electrode (cathode). Exactly opposite would happen in basic environment, i.e. negatively charged particles of ceramic would migrate to the positive electrode (anode). EPD is an excellent technique for deposition of ceramic films, including calcium phosphate films, as disclosed in U.S. Pat. No. 5,258,044, dated Nov. 2, 1993 (“Electro-phoretic Deposition of Calcium Phosphate Material on Implants”, by D. D. Lee). Unfortunately, EPD films must be sintered at relatively high temperature to gain sufficient structural integrity. For example, the EPD films of calcium phosphate disclosed in U.S. Pat. No. 5,258,044, had to be sintered at between 600° C. and 1350° C. These temperatures are high enough to induce substantial change to the metallic substrate, e.g. in terms of surface oxidation or microstructural changes (e.g. grain growth). [0014] Drug encapsulation in HA has been achieved in the past by simple post-impregnation of a sintered, porous HA ceramic [K. Yamamura et al, J. Biomed. Mater. Res., 26, 1053-64, 1992]. In this process, the drug molecules simply adsorb onto the surface of the porous ceramic. The drug release is accomplished through desorption and leaching of the drug to the surrounding tissue after exposure to physiological fluid. Unfortunately, most of the adsorbed drug molecules release from such system in a relatively short period of time. Impregnation of drug material into porous sintered calcium phosphate microspheres has been reported in the patent literature. “Slow release” porous granules are claimed in U.S. Pat. No. 5,055,307 [S. Tsuru et al, 1991], wherein the granule is sintered at 200-1400° C. and the drug component impregnated into its porosity. “Calcium phosphate microcarriers and microspheres” are claimed in WO 98/43558 by B. Starling et al [1998], wherein hollow microspheres are sintered and impregnated with drugs for slow release. D. Lee et al. [WO98/16209] claim poorly crystalline apatite wherein macro-shapes harden and may simultaneously encapsulate drug material for slow release. It has been suggested to use porous, composite HA as a carrier for gentamicin sulfate (GS), an aminoglycoside antibiotic to treat bacterial infections at infected osseous sites [J. M. Rogers-Foy et al, J. Inv. Surgery 12 (1997) 263-275]. The presence of proteins in HA coatings did not affect the dissolution properties of either calcium or phosphorus ions and that it was solely dependent on the media [Bender S. A. et al. Biomaterials 21 (2000) 299-305]. [0015] Stents are disclosed in several patent publications. U.S. patent publication No. 2002/0007209 A1, published Jan. 17, 2002, de Sheerder et al., discloses an expandable metal tube prosthesis with laser cuts in the walls. The prosthesis can be coated with titanium nitride (TiN) for bio-compatibility. The holes in the walls of the prosthesis can be used to locally administer medicines and the like. [0016] U.S. Pat. No. 6,387,121 B1, issued May 14, 2002, Alt, assigned to Inflow Dynamics Inc., discloses a stent constructed with a tubular metal base. The stent can be constructed to have three layers (see FIG. 2 ). The first layer 15 is typically 316L stainless steel. The intermediate layer 50 is formed of a noble metal or an alloy thereof, preferably selected from a group consisting of niobium, zirconium, titanium and tantalum (see column 7, lines 58-61). The third or outer layer 80 is preferably composed of a ceramic-like metal material such as oxide, hydroxide or nitrate of metal, preferably iridium oxide or titanium nitrate, as a bio-compatible layer that serves as a primary purpose to avoid tissue irritation and thrombus formation. [0017] EP 0 950 386 A2, published Oct. 20, 1999, Wright et al., assigned to Cordis Corporation, discloses a thin walled stent which is formed as a cylinder with a plurality of struts. The struts have channels formed therein. Therapeutic agents can be deposited in the channels. Rapamycin specifically is mentioned as a therapeutic agent which can be deposited in the channels to prevent restenosis (re-narrowing) of an artery. SUMMARY OF THE INVENTION [0018] The invention is directed to an implantable medical device with a calcium phosphate coating comprising: (a) substrate; and (b) calcium phosphate coating on the substrate, said coating having desired bonding and porosity characteristics. [0019] The calcium phosphate coating of the device can be hydroxyapatite. The thickness of the calcium phosphate coating can be between about 0.00001 mm and 0.01 mm, and preferably about 0.001 mm to 0.0001 mm. The tensile bond strength between the substrate and the calcium phosphate coating can be greater than about 20 MPa. The calcium phosphate coating can be deposited on the device as particles having a diameter between about 1 μm and 100 μm and a thickness of between about 1 μm to 10 μm. The particles can cover about 20% to about 90% of the surface of the substrate. [0020] The implantable medical device can be constructed of stainless steel, cobalt alloy, titanium cobalt-chromium or metallic alloy. The calcium phosphate coating can be porous and the pores can retain a drug. The rate of release of the drug from the pores can be controlled in an engineered manner. [0021] The substrate can have a first calcium phosphate coating and a second calcium phosphate coating and the drug can be contained in both the first and the second coating or only in one coating. The drug can be one which inhibits restenosis. The calcium phosphate coating can be dicalcium phosphate, tricalcium phosphate or tetracalcium phosphate. The device can be a human or animal tissue implantable device. The device can be a stent which is coated with calcium phosphate. [0022] The invention is also directed to a process of coating an implantable medical device with a calcium phosphate coating comprising: (a) hydrolyzing a phosphor precursor in a water or alcohol based medium; (b) adding a calcium salt precursor to the medium after the phosphite has been hydrolyzed to obtain a calcium phospate gel; (c) depositing the calcium phosphate gel as a coating on the surface of a substrate; and (d) calcining the calcium phosphate coating at a suitable elevated temperature and for pre-determined time to obtain a crystallized calcium phosphate having desired crystallinity, bonding and porosity characteristics. [0023] The deposition of the coating on the substrate can be performed by aerosol deposition, dip-coating, spin-coating, electrophospate coating or electrochemical coating. The calcium phosphate coating can be calcined at a temperature of at least about 350° C. The calcium phospate gel can be hydroxyapatite gel. [0024] The porosity of the calcium phosphate coating can be controlled and can retain a drug. The rate of release of drug can be controlled. The calcium phosphate coating can be hydroxyapatite, dicalcium phosphate, tricalcium phosphate or tetracalcium phospate. [0025] The phosphate precursor can be an alkyl phosphite or a triethyl phosphate. The calcium precursor can be a water-soluble calcium salt. The water soluble calcium salt can be calcium nitrate. [0026] The invention is also directed to a process of coating a soft tissue implantable device with a calcium phosphate coating comprising: (a) providing a soft tissue implantable substrate; (b) depositing a calcium phosphate coating on the substrate utilizing a biomimetic deposition process; or (c) depositing the calcium coating on the substrate utilizing a calcium phosphate cement deposition process; or (d) depositing the calcium phosphate coating on the substrate utilizing an electro-phoretic deposition process; or (e) depositing a calcium phosphate coating on the substrate utilizing an electrochemical deposition process. [0027] The device can be a calcium phosphate coated stent. The calcium phosphate coating can be hydroxyapatite. The calcium phosphate coating can be deposited discontinuously on the substrate as discrete particles. [0028] A first calcium phosphate coating can be deposited on the substrate utilizing an aerosol-gel process, a sol-gel process or an electro-phoretic deposition process or an electro-chemical deposition process and a second calcium phosphate coating can be deposited on the first coating or the substrate utilizing an aerosol-gel process, a sol-gel process, a biomimetic process, a calcium phosphate cement process, an electro-phoretic deposition process or an electrochemical deposition process. [0029] The calcium phosphate coating can contain and elude a drug. The calcium phosphate coating can be coated with a hydrogel film. The calcium phosphate can be deposited on the substrate as discontinuous non-equiaxial particles. The non-equiaxial particles can have an average size of about 0.1 μm and a thickness up to about 0.01 mm. The first and second coatings can contain a drug. [0030] The ratio of calcium to phosphate in the sol-gel precursor can be engineered to enable various phosphate phases to be obtained. The calcium phosphate phase can be hydroxyapatite, dicalcium phosphate, tricalcium phosphate or tetracalcium phospate. DRAWINGS [0031] In drawings which illustrate specific embodiments of the invention, but which should not be construed as restricting the spirit or scope of the invention in any way: [0032] FIG. 1A is a micrograph of a stainless steel (316L) stent coated with discontinuous ASG-HA thin film. [0033] FIG. 1B is a magnification of the sector indicated by the rectangle of FIG. 1A . [0034] FIG. 2A is a micrograph of a stainless steel stent (316L) coated with discontinuous ASG-HA thin film and crimpled, with no damage to the coating. [0035] FIG. 2B is a micrograph of the same stent as shown in FIG. 2A after expansion showing no damage to the coating. [0036] FIG. 3A is a micrograph of a stainless steel (316L) stent coated with continuous EPD-HA thin film. [0037] FIG. 3B is an about 4×6 μm magnification of the sector indicated by the rectangle of FIG. 3A . [0038] FIG. 4A is a micrograph of a stainless steel (316L) stent coated with continuous ECD-HA thin film. [0039] FIG. 4B is an about 65×88 μm magnification of the sector indicated by the rectangle of FIG. 4A . DETAILED DESCRIPTION OF THE INVENTION [0040] Throughout the following description specific details are set forth in order to provide a more thorough understanding of the invention. However, the invention may be practiced without these particulars. In other instances, well known elements have not been shown or described in detail to avoid unnecessarily obscuring the present invention. Accordingly, the specification and drawings are to be regarded in an illustrative, rather than a restrictive, sense. [0041] The invention in one embodiment is directed to implantable medical devices with a flexible thin film calcium phosphate bio-compatible and bio-resorbable coating that has the ability to act as a high capacity drug carrier. Such CaP coatings have no side-effects during coating dissolution into body fluids, and can be designed with a high level of control of coating dissolution rate and microstructure, which also determine the drug retention and release characteristics. [0042] Of all the types of implantable medical devices that exist, the coronary stents utilized in balloon angioplasty procedures provide a useful model for testing the effectiveness of sol-gel deposited thin flexible CaP coatings on such stents due to the fact that such stents are designed to be flexible. The use of such stents in the examples below should not, however, be considered as limiting the application of the CaP coatings described only to stents. The invention has broad application to virtually any type of body implantable device. [0043] We have determined unexpectedly that the intrinsic brittle behaviour of CaP ceases to limit the system strain capability if the strongly bonded coating is sol-gel deposited and is thinner than approximately 0.001 mm. Experiments involving repeated contraction/expansion of such thin CaP sol-gel coated stents reveal that there is no separation of the coating from the stent, nor visible damage to the coating, if the coating is thinner than about 0.001 mm and is strongly bonded to the substrate (the tensile bond strength should be larger than about 40 MPa, as measured in model strength experiments according to ASTM C-633 standard). [0044] In addition, we have discovered that if the novel sol-gel process for deposition of calcium phosphates, in particular hydroxyapatite (HA) synthesis (as previously disclosed in our U.S. Pat. No. 6,426,114 B1, Jul. 30, 2002, “Sol-Gel Calcium Phosphate Ceramic Coatings and Method of Making Same”, by T. Troczynski and D. Liu) is used, the resulting thin flexible coating has controlled porosity which may be utilized to retain drugs within the coating, and release the drugs at a controlled rate. [0045] The invention pertains to a sol-gel (SG) process for synthesis of calcium phosphate, in particular, hydroxyapatite (HA), thin film coatings on implantable medical devices. The process allows the HA to be obtained in a controlled crystallized form, at a relatively low temperatures, i.e. starting at ≈350° C. This is an unexpectedly low crystallization temperature for HA sol-gel synthesis. The process provides excellent chemical and physical homogeneity, and bonding strength of HA coatings to substrates. The low process temperature avoids substrate metal degradation due to thermally-induced phase transformation, microstructure deterioration, or oxidation. [0046] Disclosed herein is a method wherein uniform films of hydroxyapatite by the electro-phoretic deposition (EPD) method (EPD-HA) are deposited on complex stent surface, and there is no need to pursue sintering in excess of 500° C. to achieve substantial structural integrity of the film and its high bonding strength to the metallic substrate. In this method, the first step is the well-known EPD of the HA film, for example as disclosed in U.S. Pat. No. 5,258,044, using suspension of sub-micrometer particles of HA in water. This film is dried and then heat treated at 500° C. for 10-60 minutes to initiate sintering of HA. The film is still too weak and too poorly bonded for practical use as a coating on stent or other medical device or implant, but is sufficiently strong to survive the subsequent processing step comprising impregnation by aero-sol-gel HA droplets. The droplets penetrate porosity of the previously deposited EPD-HA, strongly aided by the capillary suction. Thus, majority of the pores of the EPD-HA film are penetrated by the sol-gel precursor of HA, all the way to the metallic substrate. This composite film can be now dried and sintered at a relatively low temperature or 400-500° C., due to the very high activity of the sol-gel component of the film. The sol-gel film bonds the particles of HA deposited by EPD, and bonds well to the metallic substrate during the heat treatment Thus, both the film uniformity (due to EPD process) and low-temperature sinterability (due to sol-gel process) have been achieved. This novel and inventive hybrid technology for uniform HA coatings on stents has the ability to produce films in thickness range from about 1 micron to above 100 microns, with porosity in the range from about 10 vol % to about 70 vol %. Such porous thick HA films are excellent carriers for drugs loaded through impregnation into open porosity of the film. Details of such hybrid process, and its several variants, for preparation of HA films on stents, are given in the examples below. [0047] Problems with drug delivery in vivo are frequently related to the toxicity of the carrier agent, the generally low loading capacity for drugs, and the aim to control drug delivery resulting in self-regulated, timed release. With the exception of colloidal carrier systems, which support relatively high loading capacity for drugs, most organic systems deliver inadequate levels of bioactive drugs. Sol-gel films heat-treated at relatively low temperatures closely resemble the properties of colloidal films, in terms of accessible surface area and porosity size. [0048] The sol-gel process according to the invention allows the calcium phosphate to be obtained in a crystallized form, at relatively low temperature, i.e. approximately 350-500° C. Variation of the heat treatment temperature and time provides for control of coating crystallinity (i.e. a more amorphous, more easily resorbable coating can be processed at lower temperatures) as well as coating porosity (higher porosity and smaller average pore size at lower temperatures). Variation of Ca/P ratio in the sol-gel precursor mix allows one to obtain various calcium phosphate phases, for example, hydroxyapatite, dicalcium phosphate, tricalcium phosphate or tetracalcium phosphate. [0049] The invention in one embodiment is directed to a sol-gel process for preparing calcium phosphate, such as hydroxyapatite, which comprises: (a) hydrolysing a phosphor precursor in a water or alcohol based medium; (b) adding a calcium salt precursor to the medium after the phosphite has been hydrolysed to obtain a calcium phosphate gel such as a hydroxyapatite gel; (c) depositing the gel on the surface of an implantable medical device; and (d) calcining the calcium phosphate, such as hydroxyapatite, at a suitable elevated temperature and for pre-determined time to achieve desired crystallinity, bonding and porosity characteristics for the coating on the device. The deposition of the gel can be done by any number of methods, such as aero-sol deposition, dip-coating, spin-coating, electrophoretic deposition. [0050] In a preferred embodiment, the phosphor precursor can be an alkyl phosphite and the alkyl phosphite can be triethyl phosphite. Further the calcium precursor can be a water-soluble calcium salt and the water soluble calcium salt can be calcium nitrate. The crystallized calcium phosphate can be calcined at a temperature of at about 350° C. or higher. The metallic implantable medical device can be stainless steel, cobalt alloy, a titanium substrate or other metallic alloy substrate. [0051] We have discovered that if certain specific characteristics of the calcium phosphate coatings are maintained, the coatings become highly flexible while maintaining their chemistry, high bio-compatibility, and bio-resorbability. The most important characteristics are (a) coating thickness, and (b) the strength of the coating bonding to the metallic substrate. We have repeatedly demonstrated (refer to the examples below) that if CaP coating thickness is maintained below about 0.001 mm, and its bonding strength to the metallic substrate is above approximately 40 MPa, the substrate-coating system retains the strain capabilities of the substrate alone, i.e. the system maintains its integrity during deformation. [0052] Furthermore, we have discovered that thicker CaP coatings deposited discontinuously on metallic substrate, i.e. in the form of separate “islands” and “patches” approximately 1-100 μm in diameter, retain high resistance against substrate deformation. Our experiments have shown that stents coated with such 1-100 μm patches, about 1-10 μm thick, can be crimped and then expanded without damage to the patches of ceramic. These patches can be deposited on the substrate through a variety of methods discussed above, such as BM-HA, ECD-HA, CPC-HA (all at room or near-room temperature), or EPD-HA, SG-HA and combinations thereof (these two techniques including heat treatment at elevated temperatures). These coating deposition techniques are illustrated in the following examples. The discontinuous CaP film coated medical implant may have some fraction of an area of the metallic substrate exposed to living tissue, which may again lead to the adverse tissue reaction described above. This problem can be avoided by combining discontinuous CaP films with a continuous bio-compatible and non-thrombogenic polymer. Thus, a composite CaP-polymer coating on medical implant is the result. Furthermore, a thin (<0.001 mm) continuous CaP coating can be combined with a thicker discontinuous CaP coating. [0053] The effects of this process (described in detail in the Examples) are shown in the representative FIGS. 1 and 2 . FIG. 1A illustrates stainless steel (316L) stent coated with discontinuous ASG-HA thin film; FIG. 1B is a magnification of the sector of (A) indicated by the rectangle. FIG. 2A illustrates a stainless steel (316L) stent coated with discontinuous ASG-HA thin film and crimped, with no damage to the coating. FIG. 2B is the same stent after expansion, showing no damage to the coating. [0054] Our discovery of flexible continuous/discontinuous CaP films or CaP/polymer films opens up a range of new applications of highly biocompatible Cap coatings for medical implants, particularly, but not limited to those that require deformation capability such as coronary stents. [0055] A sol-gel (SG) process provides superior chemical and physical homogeneity of the final ceramic product compared to other routes, such as solid-state synthesis, wet precipitation, or hydrothermal formation. The SG process allows the desired ceramic phase, e.g. thin film CaP coating, to be synthesized at temperatures much lower than some of the alternate processes. In the SG coating process substrate metal degradation due to thermally induced phase transformations and microstructure modification or oxidation, is avoided. SG widens green-shaping capability, for example, and it is a very convenient method for deposition of thin ceramic coatings. [0056] Sol-Gel deposition of HA (SG-HA) films at elevated temperatures (350-500° C.) was disclosed previously in U.S. Pat. No. 6,426,114 B1. Sol-gel (SG) processing of HA allows molecular-level mixing of the calcium and phosphor precursors, which improves the chemical homogeneity of the resulting calcium phosphate. The crystallinity of the calcium phosphate phase can be enhanced by appropriate use of water treatment during processing. Variation of Ca/P ratio in the sol-gel precursor mix allows one to obtain any of a number of calcium phosphate phases, for example, hydroxyapatite, dicalcium phosphate, tricalcium phosphate or tetracalcium phosphate. The versatility of the SG method provides an opportunity to form thin film coatings, either continuous or discontinuous, in a rather simple process of dip-coating, spin-coating or aero-sol deposition. [0057] A high degree of HA crystallinity is frequently required for longer-term bioactive applications, because partially crystalline, or amorphous calcium phosphate, such as HA, coatings are rapidly resorbed by living tissue. For the presently disclosed application of thin HA films on implantable medical devices, control of crystallinity of the HA coating is possible through variation of the time/temperature history during processing. This allows control of the coating resorption rate and thus rate of release of the drugs impregnated into microporosity of the coating. [0058] Ceramics produced by sol-gel processing can be designed to include high fraction of pores, with well-defined (narrowly distributed) pore size. This is a consequence of the chemical route to the final oxide ceramic produced through SG. Only a small fraction of the original precursor mass is finally converted to the ceramic oxide, the remaining fraction being released during heat treatment, usually in the form of gas, is usually as a combination of water and carbon dioxide. Thus, the released gases leave behind a large fraction of porosity, up to 90% in some instances, depending on the drying conditions and heat treatment time and temperature. These pores can be as small as several nm in diameter, again depending on the drying conditions and heat treatment time and temperature. Effectively, the accessible surface area of such sol-gel derived oxide ceramics can reach several hundred square meters per gram of the oxide, making it an excellent absorbent of gas or liquid substances, or solutions. For example, the average pore size in sol-gel HA treated at relatively low temperature of 400° C. is about 5 nm in diameter, with 90% of pore diameters falling within the range of 1-30 nm. This unique porosity characteristic is widely utilized to produce desiccants, filters and membranes of sol-gel derived ceramic. In this respect sol-gel derived ceramic oxides have a great advantage over polymers, which are in general difficult to process to possess high porosity and high accessible surface area. In the present invention, we utilize this unique property of sol-gel derived CaP coatings on medical implants, especially stents, possessing high accessible surface area to make it a high-capacity drug carrier. [0059] In the text of this application, it is understood that when appropriate, the term “calcium phosphate” (CaP) is used generically and includes minerals such as hydroxyapatite, dicalcium phosphate, tricalcium phosphate, tetracalcium phosphate and amorphous or partially amorphous calcium phosphate. Studies on the sol-gel route to thin film calcium phosphate coatings on implantable medical devices, particularly stents, performed by the inventors have led to an unexpected break-through in process development. The method according to the invention has produced CaP coatings after heat treatment in air, starting at about 350° C. We have unexpectedly discovered that the film is highly flexible if it is thinner than about 0.001 mm, thereby allowing damage-free manipulation of a CaP coated deformable implantable medical device, for example the contraction and expansion of a CaP coated stent. Preferably, the coating has a thickness between about 0.0001 and 0.001 mm. Furthermore, in this application, we have discovered that the film can accept drugs into its fine porosity, thereby allowing it to address the adverse phenomena related to common medically implanted devices, i.e. the restenosis that occurs after placement of a coronary stent in a blood vessel. [0060] The calcium phosphate coating according to the invention has been deposited on stents and other metallic surfaces using variety of techniques, including dip-coating, spin-coating, aero-sol deposition electrophoretic deposition. The coatings were deposited on stents made of 316L stainless steel and tubes, and on other metallic substrates including cobalt-iron alloy and titanium. EXAMPLES [0061] To demonstrate the feasibility of the unique processing concepts outlined above, the following examples are described below for stainless steel substrate and coronary stents. The procedures outlined below can be applied to other implantable medical devices. Example 1 [0062] In the first stage of the process, phosphite sol was hydrolysed in a water-ethanol mixture (a concentration of 3M) in a sealed beaker until the phosphite was completely hydrolysed (which is easily recognized by loss of a characteristic phosphite odour), at ambient environment. A Ca salt (2M) was then dissolved in anhydrous ethanol, and the solution was then rapidly added into the hydrolysed phosphite sol. The sol was left at ambient environment for 8 hours, followed by drying in an oven at 60° C. As a result of this process, a white gel was obtained. For the sol containing Ca/P ratio required to produce HA, the gel showed a pure (single phase) apatitic structure with a Ca/P ratio of 1.666, identical to stoichiometric HA, after calcining at a temperature as low as 350° C. Varying the Ca/P ratio allows other calcium phosphates, such as dicalcium phosphate (Ca/P=1) or tricalcium phosphate (Ca/P=1.5), to be obtained. A coating produced using this process, and applied to 316 SS substrate, showed adhesive strength of about 40 MPa after curing at a temperature<450° C. The coating was crack-free and porous. Example 2 [0063] In another variant of the process, a pure water-based environment was used. The aqueous-based sols were prepared in the same manner as described above in Example 1 for the ethanol-based system. A higher rate of hydrolysis of the phosphite sol was observed. The mixed sol was dried while stirring. After 8 hours aging, a white gel appeared. For the sol containing a Ca/P ratio required to produce HA an apatitic structure with Ca/P ratio of 1.663, close to stoichiometric HA, resulted after calcining the gel at a temperature of 350° C. Both the ethanol-based and aqueous-based gels showed essentially the same apatitic structure at relatively low temperatures. This invention provides a method of synthesizing the HA ceramics via an aqueous-based sol-gel process. Example 3 [0064] A CaP coating was deposited on the surfaces of a group of electropolished stainless steel stents through aerosol-gel processing. The stents were first treated in 2.4 N phosphoric acid solution for 10 minutes at 70° C. to clean the surface and produce microroughness for increased bonding of the coating. The treated stents were ultrasonically cleaned and dried. The CaP sol was prepared by (a) hydrolysing a phosphor precursor (phosphite); (b) adding a calcium salt precursor to the medium after the phosphite has been hydrolysed to obtain a calcium phosphate sol such as a hydroxyapatite sol. The sol was atomized into ˜ 4 μm large particles using ultrasonically assisted atomizer, and the resulting aerosol fed into a coating chamber. This specific deposition technique is referred to as Aero-Sol-Gels (ASG) deposition and the resulting hydroxyapatite film as ASG-HA. [0065] The clean stent was inserted into the coating chamber filled with flowing CaP aerosol-gel for a period of 30 seconds, while maintaining the aerosol flow at 0.1 liter/min and chamber temperature at 50° C. The temperature of the coating chamber affects the deposition mode of the coating, producing a uniform, film like coverage of the surface as evidenced by SEM. The coating was dried at 60° C. and heat treated at 450° C. for 15 min to crystallize CaP to form hydroxyapatite thin film. The procedure produces a thin coating covering uniformly the surface of the stent. The thickness of the coating is measured using ellipsometry in the range of 50-150 nm. The subsequent SEM studies on the crimped and expanded coated stents show no evidence of cracking or delamination of the coating. This proves the reliability of the uniform, thin continuous CaP coating during the deployment and implantation of the stent into the coronary artery. Example 4 [0066] CaP coating has been deposited on the surface of an electropolished stainless steel stents through aerosol-gel processing (ASG), as described in Example 3. The chamber temperature was maintained at 25° C. The coating was dried at 60° C. and heat treated at 450° C. for 15 min to crystallize CaP to form hydroxyapatite thin film. The procedure explained above produces a coating comprising of isolated island of approximately 2-6 μm in size and 0.1-2 μm in thickness, scattered uniformly on the surface of the stent, and covering about 70% of the surface of the stent, as shown in FIGS. 1A and 1B . Subsequent SEM studies on the crimped and expanded coated stents showed no evidence of cracking or delamination of the coating, as shown in FIGS. 2A and 2B . This proves the reliability of the discontinuous CaP coating of variable thickness during the deployment and implantation of the stent into the coronary artery. Example 5 [0067] Stainless steel metallic substrates (316L) were coated with a 0.6-0.8 μm thin layer of apatite (ASG-HA) as described in Example 3. One group of samples was annealed at 400° C. for 20 min to achieve crystalline SG-HA(C) film and another group at 375° C. for 60 min to achieve amorphous SG-HA(A) film. These films were used as nucleation site for precipitation of BM-HA film. The SG-HA coated samples were immersed into “simulated body fluid” (SBF) of ionic composition (in units of mmol/l) 142 Na + , 5.0 K + , 2.5 C 2+ , 1.5 Mg 2+ , 103 Cl − , 25 HCO 3 − , 1.4 HPO 4 2− , and 0.5 SO 4 2− . The SBF was buffered at pH 7 . 4 with tris(hydroxymethyl)-aminomethane and HCl. This in-vitro static deposition (i.e. the SBF was not renewed during the deposition period) at ˜24° C. produced good quality, dense 3-5 μm thick BM-HA film deposits on flat SG-HA substrates. The crystalline SG-HA(C) film is coated with dense BM-HA, whereas amorphous SG-HA(A) film is coated with porous BM-HA. The properties of the underlying SG-HA surface modification film can be used to vary the properties, e.g. porosity, of the nucleated and deposited top BM-HA film for drug encapsulation. Example 6 [0068] Stainless steel metallic stents (316L) were coated with −0.1 μm thin CaP coatings as described in Example 3. An inorganic colloidal slurry containing calcium phosphate precursor Ca(OH) 2 and calcium phosphate salt monocalcium phosphate anhydrate, was ball milled in ethanol. The two starting inorganic ingredients had particle size 0.3-2 μm and 0.5-4 μm, respectively. The initial Ca/P ratio in the slurry was kept at 1.5. As dissolution and precipitation are the principal mechanisms for apatite development in such system, 5 wt % of submicron, crystalline hydroxyapatite powder was used as seeds for heterogeneous nucleation of CPC-HA. The thin CaP film surface-modified sample was dip coated in the ethanol suspension of the precursors. After single dip coating, an approximately 10 μm thick layer of porous precursor powder mixture developed on the substrate due to rapid evaporation of ethanol. Due to the colloidal nature of the precursors slurry, this film develops sufficient structural integrity (i.e. strength and hardness) to accept the next processing step. In this step, the film is exposed to sodium phosphate water-based solution (0.25 M), which is allowed to soak into the open pores of the film, and then placed in an incubator at 37° C., 100% relative humidity, for 24 h. During incubation, the colloidal precursors react with the phosphate liquid and precipitate HA. In order to assess the possibility of using this double-coating route for controlled drug release, amethopterin (Sigma Chemicals, USA) was employed as a model drug, in an amount of 5% based on solid phase content of CPC-HA precursors. The drug was mixed with the colloidal suspension of the precursors, before dip coating was performed. During incubation period, 20 μm thick CPC-HA coating precipitated encapsulating the drug molecules within the nanopores of the crystallizing HA. After encapsulation, a drug release study was conducted by immersion of the substrates into 20 ml of phosphate buffer saline (PBS, pH=7.4) at constant ratio of (CPC coating weight)/(volume of PBS) of 1 mg/ml. A reference sample coated with hydrogel film was also tested for drug release kinetics. The hydrogel film was prepared by dipping the CPC-HA layer containing the drug into a polymer solution containing 3% polyvinyl alcohol. After drying, the weight gain of the ˜20 mg CPC-HA layer due to the additional hydrogel coating was ˜0.5 mg, corresponding to the content of polymer film in the CPC-HA matrix of about 2.5%. The samples of PBS liquid with released drug were periodically taken out (i.e. entire liquid was emptied) and refilled with the same amount of 20 ml of PBS. The drug concentration in the supernatant was determined via an UV-Visible spectroscopy. Although a burst effect was detected for both coatings over the initial period of about 8 h, a slower release is evident for the sample post-coated with hydrogel. A linear relationship was obtained between the amount of drug released and (time) 1/2 for the release time greater than 8 h. Example 7 [0069] The stent was submerged into water-based, diluted suspension of sub-micron particles of hydroxyapatite, containing approximately 2 wt % of HA in the suspension. DC voltage of 5V was applied to the stent, for times varying from 5 seconds, to 10 minutes. As the particles of HA naturally attain positive charge in such solution, they are attracted to the stent surface which is also a negative electrode (cathode) in this system. The buildup of HA particles attracted to the stent (cathode) allows to produce an extremely uniformly coated surface, thickness of the coating varying as a function of time of application of voltage. The film uniformity is the biggest advantage of such Electro-Phoretic Deposition (EPD) processing, which is difficult to reproduce using other methods such as sol-gel processing. For the short time of 10 sec., the EPD-HA coating thickness is about 1 micrometer. This type of EPD-HA coating on 316L stainless steel stent is illustrated in FIG. 3 . For the longer times of several minutes, the coating thickness may exceed 10 micrometers. Thus, in this EPD process, a controlled thickness, uniform HA film may be produced. The as deposited film constitutes loosely bonded particles of HA, of porosity generally in excess of 50 vol %. In order to increase structural integrity and bonding strength to the substrate of such EPD film, heat treatment is necessary at temperatures at least 500° C., for times at least 10 minutes. The heat treatment of EPD films proceeds at higher temperatures and longer times than sol-gel films, because HA particles deposited in the EPD process are less reactive than those deposited in the sol-gel process. The goal of such heat treatment is to increase interparticle bonding, while providing sufficient residual porosity to maintain low stiffness and flexibility of the film, and to provide room for drug impregnation. The need for higher temperature and longer times heat treatment of EPD films is a disadvantage, as the heat treatment process may adversely affect properties of the metallic substrate of the stent. Example 8 [0070] The HA was deposited on a 316L stainless steel stent surface through EPD process as described in the Example 7. The uniformly deposited EPD film was heat treated at 500° C. for 10 minutes to achieve minimal structural integrity of the film, sufficient to survive handling and preventing re-fluxing of the film upon contact with liquid medium. Such EPD-coated stent was exposed to droplets of sol in the aero-sol-gel process described in Example 3. The sol droplets have penetrated open porosity of the EPD film, and, by capillary attraction, located themselves mostly within negative curvature of the necks between EPD deposited HA particles. Such composite coating was heat treated again at 500° C. for 10 minutes. Now the active sol-gel component of the coating allowed achieving high structural integrity of the film, while EPD component of the coating allowed achieving high uniformity of coverage by the film. A uniform, porous HA film was achieved in this novel combined process. Example 9 [0071] The electrochemical deposition (ECD) of hydroxyapatite HA has been conducted in the mixed aqueous solution of Ca(NO 3 ) 2 4H 2 O and NH 4 —H 2 PO 4 . In this process HA is deposited on the cathodic (negatively biased) surface of stent or implant by the following reaction: 10Ca 2+ +6PO 4 3− +2OH→Ca 10 (PO 4 ) 6 (OH) 2 ECD was conducted in the mixed aqueous solution of 0.02329 M Ca(NO 3 ) 2 4H 2 O and 0.04347 M NH 4 H 2 PO 4 . The stainless steel specimen, i.e. stent, was the cathode, and platinum was used as the anode. The pH was controlled at 4.0 with the addition of sodium hydroxide. The environment temperature was controlled at 40° C.±1° C. The coating morphology deposited at low current density (1 mA/cm 2 ) was a thin uniform porous structure, 1-2 micrometers thick for deposition time of 0.5-1 minute, as illustrated in FIG. 4 . Example 10 [0072] The HA was deposited on a 316L stainless steel stent surface through ASG-HA process as described in the Example 4. The discontinuous network of HA patches left some of the stent surface uncoated. 5V DC bias voltage was applied to such pre-coated stent, and the stent submerged into suspension of submicron HA particles. The uncoated metallic surface of the stent preferentially attracted HA particles leading to preferential electrophoretic deposition (EPD) of HA in these areas, to build the coating about 1 micrometer thick in about 10 seconds. The coated stent was heat treated at 500 C for 10 minutes. The EPD-HA coated areas show increased porosity as compared to ASG-HA coated areas, suitable for impregnation with drug carrying liquid. Such composite engineered HA coating shows unique properties regarding mechanical performance and drug release properties. Example 11 [0073] The HA was deposited on a 316L stainless steel stent surface through ASG-HA process as described in the Example 3, followed by the process of ECD-HA deposition as described in Example 9, but on top of the already heat treated ASG-HA. Such composite engineered coating allowed to achieve substantially higher bonding strength (as compared to ECD-HA deposited directly on metallic surface), and capability of drug encapsulation during deposition of ECD-HA on top of ASG-HA. Example 12 [0074] The HA was deposited on two 316L stainless steel stents surface through ASG-HA process as described in the Example 4. The coated stents were evaluated in the standard thromboresistance test in dogs. Minimal thrombosis with a grade of 1 (defined as thrombus found at one location only) was observed in one out of two test sites. In the second test site, no thrombosis (grade 0) was observed. [0075] The process for coating of calcium phosphate, in particular HA, bioactive ceramics, on implantable medical devices disclosed herein offers the following advantages in comparison to other processes and other coating materials on implantable medical devices: (1) The coating process, including CaP sol synthesis, can be completed in ambient environment (i.e. air), in less than 24 hours. (2) The thin (<0.001 mm) adhesive CaP coatings exhibit sufficient flexibility to survive substantial strain, e.g. during crimping and expanding of a coated stent, without coating damage or spallation (3) Porous CaP coatings can be produced, with controlled amount and size of the pores, which allows design flexibility in choice and absorption/release characteristics for the drug impregnated into the coating (4) The synthesis requires low temperature (˜350° C.) and short time (<1 hour) of calcination for formation of high quality, highly adhesive CaP coating. Low temperature calcination of the novel CaP coatings on metals permits thermal treatment in an air environment without the risk of metal oxidation and possible property degradation due to microstructural deterioration or phase transformations. [0080] It will be clear for the person skilled in the art of sol-gel processing that coating deposition parameters, such as time, the flow rate of the aerosol, temperature of the coating chamber or the concentration of the sol-gel solution can be customized for different implantable medical device materials and applications producing various degree of coverage on the surface. Similar manipulation and optimization of process parameters may be applied to other coating methods disclosed, i.e. dip- and spin-coating and electrophoresis, biomimetic coating, electrochemical deposition coating, calcium phosphate cement coating, electrophoretic deposition coating, as well as coating porosity distribution and ratio of the inorganic phase (CaP) to organic phase (biodegradable polymer). These parameters were optimized for the particular CaP coatings on the implantable medical devices described in the foregoing examples. [0081] It is well known that crystallinity and microporosity of hydroxyapatite directly affects its dissolution rate in body fluids. Different heat treatment regimes and temperatures can be adopted to produce various degrees of crystallinity and microporosity to control the degradation of the coating into the body environment. This advantage is of a great importance where drug delivery capabilities are added to the implantable medical device surface coated with sol-gel derived CaP. Similar deposition process can be applied to coating other metallic surfaces, such as Ti substrates or other alloys, such as Cobalt-Chromium-Nickel-Molybdenum-Iron. A thin uniform thin HA coating is obtained. The results of this experiment provide basic evidence of the feasibility of the as described coating on implantable medical devices composed of non-metallic materials such as polymers. [0082] The nature of the process for CaP coatings deposition according to the invention is such that it can be easily incorporated into the current production practice of metallic implantable medical devices. The water-based liquid precursors to CaP ceramic coatings, simple deposition technique (e.g. dipping or spin-coating or aerosol deposition or electrophoretic deposition, and others) and low-temperature heat treatment in air make the process not unlike simple painting-curing operation which can be commercialized with relatively small effort. [0083] As will be apparent to those skilled in the art in the light of the foregoing disclosure, many alterations and modifications are possible in the practice of this invention without departing from the scope thereof. Accordingly, the scope of the invention is to be construed in accordance with the substance defined by the following claims.

This invention relates to novel calcium phosphate-coated implantable medical devices and processes of making same. The calcium-phosphate coatings are designed to minimize the immune response to the implant (e.g. restenosis in stenting procedures) and can be used to store and release a medicinally active agent in a controlled manner. Such coatings can be applied to any implantable medical devices and are useful for a number of medical procedures including (but not limited to) balloon angioplasty in cardiovascular stenting, ureteral stenting and catheterisation. The calcium phosphate coatings can be applied to a substrate as one or more coatings by a sol-gel deposition process, an aerosol-gel deposition process, a biomimetic deposition process, a calcium phosphate cement deposition process, an electro-phoretic deposition process or an electrochemical deposition process. The coating can contain and elude a drug in an engineered manner.

This is a division of application Ser. No. 465,354 filed Feb. 9, 1983 now U.S. Pat. No. 4,523,695. BACKGROUND OF THE INVENTION The present invention relates to a surgical stapler for applying staples to suture or close a wound or incision, particularly a surgical skin stapler for implanting skin staples in or through the skin to suture an exterior wound or incision. Surgical staplers are used for closing or connecting conformed wound edges of tissue by implanting metal staples in the tissue. By actuation of a lever, the staple is pressed by a ram or driver against an anvil surface provided at the tip of the stapler tool and is thereby deformed, so that the parts of the staple protruding from the stapler tip are moved toward each other and penetrate into the tissue. U.S. Pat. No. 4,179,057 discloses a surgical stapler comprising a staple magazine containing a supply of staples, a spring for advancing the staples in the staple magazine, an anvil surface provided at the stapler tip, and a driver displaceable relative to the anvil surface in a staple channel which deforms a staple supported on the anvil surface. In a stapler of the type disclosed in the aforementioned patent, the staples are advanced along a straight feed path in the staple magazine. The forwardmost staple lies in the path of movement of the driver which extends at an angle which appears to be about 50° with respect to the longitudinal axis of the staple magazine. The stapler is actuated in plier fashion to advance the driver which presses the forwardmost staple protruding from the stapler tip against the anvil surface and deforms it to close the staple side portions. At this point, the staple has been implanted and it is necessary to remove from the staple the anvil surface which is fixed to the stapler tip. However, if the stapler has been improperly positioned, it is possible to pull the closed staple out of the tissue when disengaging the anvil surface from the implanted staple. U.S. Pat. No. 4,202,480 discloses a surgical stapler which also comprises a staple magazine having a straight staple feed path. The staple channel in the stapler in which the driver is displaceable and the staple magazine meet at almost a right angle. The forwardmost staple is advanced by the driver to the anvil surface on which it is deformed with its side portions protruding forwardly of the stapler tip. The anvil surface is transversely disposed at the forward end of the staple channel. It is also difficult to pull the anvil surface of this stapler out of an implanted staple. U.S. Pat. No. 3,819,100 discloses a surgical stapler comprising a removable staple cartridge which is inserted into and locked to the stapler. The staple cartridge has a straight staple feed path. Staples are advanced by a driver moved by a stepping mechanism. The forward housing portion of the stapler, into which the staple cartridge is inserted, is rotatable relative to the rear housing portion. The anvil surface is fixed at the front end of the staple cartridge. Prior art surgical staplers have the disadvantage that they did not afford a good view of the work area because the driver moved transversely to the straight staple magazine. Therefore when the stapler was positioned for use, a considerable portion of the work area was obscured. While it is possible to arrange and feed the staples laying flat one behind the other in order provide a slim tool tip affording a better view of the work area, the cost of manufacturing the parts required to accomplish this is high. Moreover, the number of staples that can be accommodated in a staple magazine if the staples lie flat one behind the other is relatively small. OBJECTS AND SUMMARY OF THE INVENTION It is an object of the present invention to provide a surgical stapler, particularly a skin stapler, which eliminates the possiblity of tearing an implanted staple out of the tissue or substantially disturbing it when the anvil is separated from the staple, particularly if the stapler was improperly positioned. The above and other objects are achieved according to the invention disclosed herein which provides a surgical stapler having an anvil surface or nose movable transversely with respect to a staple channel between an operating position and a retracted position, and in which movement of the anvil surface is controlled as a function of the position of a driver in the staple channel which cooperates with the anvil surface to deform a staple. According to the invention, movement of the anvil surface is coupled with that of the driver. When the die is moved into its operating position, the anvil surface is also automatically brought into its operating position in which it protrudes into the staple channel in which the driver moves. Advancement of the staple in the channel is stopped by the anvil surface, and deformation of the staple takes place between the anvil surface and the driver. When the die is subsequently retracted, the anvil surface moves automatically into its retracted position, so that the closed staple does not interfere with removal of the stapler instrument. According to the invention, the anvil surface and the driver are brought into their operating positions together, the driver moving longitudinally in the staple channel while the anvil moves transversely to the staple channel. Further objects of the present invention are to provide a stapler, particularly a skin stapler, whose tool tip is narrow and in which the staples are arranged and fed upright one against the other so that the staple magazine including the advancing mechanism can be relatively simple and yet the tool tip can be narrow, thereby covering up as little of the work area as possible. These and other objects are achieved in accordance with the invention by providing a staple magazine which extends essentially parallel to the staple channel and having at its forward end a curved section opening into the staple channel. According to the invention, the staples are disposed in the magazine parallel to each other standing upright so that the side and the base or crown portions of adjacent staples are in contact, and are advanced by a spring. Since the forward end of the staple magazine is curved where the staple magazine opens into the staple channel, the forwardmost staple enters the staple channel in which the driver moves lying flat in the staple channel. When the die is moved to its operating position, it blocks the opening of the magazine into the staple channel so that the next staple can be advanced into the channel only after the driver has been brought back into its retracted position. Therefore, only the forwardmost staple in the magazine can be engaged by the driver as the driver is moved past the magazine opening. According to a preferred embodiment of the invention, the anvil surface is fastened to a leaf spring which extends in the staple channel and includes an inclined surface. The driver includes a projection which cooperates with the inclined surface so that when the projection strikes the inclined surface, the leaf spring is deformed in such a way that the anvil surface is brought into its operating position. Upon release of the driver, the tension of the deformed leaf spring is released to automatically return the anvil surface into its retracted position. For skin staplers precise guiding of the staple during the staple closing process is very important because the staple is closed as it emerges from the staple channel at the tip of the tool. According to a preferred embodiment of the invention, a notch or slot for retaining the base or crown portion of the staple during the deformation process is disposed in the anvil surface. In the initial phase of deformation, a projection or bulge in the base of the staple penetrates into the notch or slot, so that the staple is prevented from turning or pivoting. Preferably the notch or slot is located in the center of the anvil surface and the projection or bulge is symmetrically disposed in the staple. The notch or slot edges preferably dig into the staple and bring about an interlocking of the staple and the anvil surface in the central portion of the base region of the staple. According to a preferred embodiment of the invention, the staple channel comprises side, upper and lower guide surfaces which limit movement of the forwardmost staple as it is advanced lying flat in the staple channel. The guide surfaces extend forwardly to beyond the anvil surface. An embossment positions the forwardmost staple in the staple channel upon being advanced from the magazine. From there, as the driver is advanced towards its operating position, the staple is transported to the anvil surface and feeding of additional staples from the magazine is blocked. The guide surfaces provide a well-defined advance of a staple in the channel. Preferably the guide surfaces are extended in projections of relatively small dimensions protruding forwardly beyond the anvil surface. A two-part housing comprising a rear housing portion and a front housing portion which is rotatable relative to the rear housing portion facilitates use of the stapler. The rear housing portion contains the actuating mechanism for the driver and the front housing portion contains the driver and anvil surface which are rotatable together with the front housing portion relative to the rear housing portion. By making the front housing portion rotatable relative to the rear housing portion, the orientation of the staple relative to the actuating mechanism can be selected freely. Hence the physician need not align the actuating mechanism transversely to the wound or incision seam but can hold the instrument in the position most favorable for working the instrument. It is important that the stapler be actuated with little effort since the instrument can only be held steady and firmly, which is required for precise setting of the staples, if the staples can be deformed and implanted with little physical force. To achieve this, the actuating element of the actuating mechanism and a lever in the rear housing portion, and the driver are coupled in such a way that the effective leverage of the lever increases as the actuating element moves further away from its inoperative position while at the same time the advancing force transmitted to the driver increases for a constant actuating force at the actuating element. In the first phase of actuation of the actuating element, the forwardmost staple of the staple magazine is simply advanced in the staple channel until it reaches the anvil surface. In this first phase the force required is relatively low. However, the maximum force that is available is required when the staple is being deformed and this maximum force occurs when the actuating element reaches its maximum travel. The amount of force required to deform the staple is reduced by the actuating mechanism disclosed herein so that it is possible to deform the staple simply by moving the actuating element with one's index finger. Compared with known staplers, the actuating force required to operate the stapler disclosed herein is reduced by about one half. It is possible to positively couple the movement of the driver with the lengthwise movement of a slide coupled to the actuating element. However such coupling of the driver to the actuating element would be disadvantageous because the driver would follow every movement of the slide and it is possible that a second staple could enter the channel without the first staple having been deformed and released if the driver is not fully advanced to its operating position. To avoid this, according to the invention, the driver and slide are not positively coupled. Instead means are provided so that the driver is not retracted by the slide unless the driver has been advanced to its operating position. According to a preferred embodiment of the invention, a slide coupled to the actuating element is provided which includes a tongue loaded with a transverse spring action which cooperates with a control cam disposed in the housing. The tongue includes a surface which is positioned against a transverse edge of the driver and permits the driver to be retracted only after the driver has been advanced fully into its operating position. Only then can the driver be retracted and the opening of the staple magazine into the channel cleared so that the next staple can be advanced. According to a preferred embodiment of the invention, a counting mechanism is provided which is advanced by a projection on the tongue of the slide. The counting mechanism indicates the number of staples used or the number of staples remaining in the magazine. The above and other objects, features, aspects and advantages of the invention will be more readily perceived from the following description of the preferred embodiments thereof when considered with the accompanying drawings and appended claims. BRIEF DESCRIPTION OF THE DRAWINGS The present invention is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like numerals indicate similar parts and in which: FIG. 1 is a schematic, longitudinal section view taken through a stapler according to the invention; FIG. 2 is a longitudinal section view taken through the tip portion of the stapler of FIG. 1 depicting the anvil surface in its retracted position; FIG. 3 is a view similar to that of FIG. 2 depicting the anvil surface in its operating position; FIG. 4 is a section taken along line IV--IV of FIG. 2; FIG. 5 is a section along line V--V of FIG. 3; FIG. 6 is a vertical section view taken through the magazine portion of the stapler of FIG. 1; FIG. 7 is a side schematic view of a portion of the stapler of FIG. 1 illustrating the cooperation of the slide of the actuating mechanism and the driver as the driver is advanced; FIG. 8 is a side schematic view similar to that of FIG. 7 illustrating the cooperation of the slide and the driver of the stapler of FIG. 1 shortly before the driver is retracted; FIG. 9 is a plan schematic view of structure depicted in FIG. 8; FIG. 10 is a vertical section view of a stapler tip including a counting mechanism according to another embodiment of the invention; FIG. 11 is a vertical section view of a part of the rear housing of a stapler according to another embodiment of the invention depicting the actuating mechanism thereof in the retracted position of the slide; and FIG. 12 is a view similar to that of FIG. 11 depicting the actuating mechanism in the feed position of the slide. DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the invention are illustrated and described in connection with a stapler for applying staples to an exterior wound or incision across a layer of skin, although the invention is not limited to such a surgical stapler. The embodiment of the stapler illustrated in FIGS. 1-9 comprises as depicted in FIG. 1 a rear housing portion 10 and a front housing portion 11. The front housing portion 11 is mounted to the rear housing position for rotation of the front housing portion about its longitudinal axis. The mechanism 12 for actuating the stapler is contained in the rear housing portion 11. A slide 13 which advances a driver 15 is guided in the front housing portion 10 for longitudinal displacement but is prevented from rotating. The slide 13 comprises a forwardly projecting flexible tongue 14 which also cooperates with the driver 15, as described more fully below. The driver 15 comprises an elongated rigid strip of material which is displaceable in its longitudinal direction in a channel or duct 16. The strip has a central recess 17 (FIG. 4) at the forward end of which is disposed a bent-up section 18 having an enlarged head. A leaf spring 19 extends in the channel 16 substantially parallel to the driver 15. The leaf spring 19 has an inclined surface 20 (FIG. 2) and is provided with a central slot 21 (FIG. 4) closed on all sides which extends forwardly and rearwardly of the region of the inclined surface 20. The enlarged head of the bent section 18 of the driver 15 protrudes through the slot 21 and is pressed against the upper side of the leaf spring 19. The forward end of the leaf spring 19 is bent downwardly to form the anvil surface 22. The rear end of leaf spring 19 is fixed to the front housing portion 11. When the driver 15 is in its retracted position, as depicted in FIG. 2, the bent section 18 is positioned at the base of the inclined surface 20. Due to the inherent tension in the front region of the leaf spring 19, the leaf spring positions itself in the channel 16 as depicted in FIG. 2. Since the height of the channel 16 is greater than the height of the anvil 22, there is a clearance between the anvil 22 in its retracted position and the lower region 16' at the front of the channel 16. A staple magazine 26 (FIGS. 1 and 6) extends parallel to the channel 16 in the front housing portion 11. Staples 24 are arranged in the magazine standing upright side by side and extending along the feed passage of the magazine parallel to the channel 16. A helical spring 25 braced against the housing contacts the rearmost staple and urges the rearmost staple and with it the entire stack of staples forward under constant tension. The forward section 26' of the staple magazine 26 is curved upwardly at an angle of 90° and opens into the channel 16. The staples are urged into the curved section 26' of the magazine and extend along the arc of the curve as depicted in FIG. 6, with the forwardmost staple 24' being disposed lying flat in the channel 16. The lower region 16' in the forward portion of the channel 16 in which the leaf spring 19 can move vertically is of greater width than the region above it. The height of the wider, lower channel portion 16' is only slightly greater than the thickness of the staples 24 so that channel portion 16' forms a guide channel for the advance of the forwardmost staple 24' and for the driver 15. This guide channel is defined by the lower guide face 16a, the two upper guide faces 16b, (FIG. 6), and by the lateral guide faces 16c (FIG. 4). The staples 24, whose undeformed configuration is depicted in broken lines by the staple 24' in FIG. 5, have arcuate side portions 24a connected via a straight leg region 24b to a central base or crown portion 24c. The straight leg regions 24b extend obliquely outwardly from the base portion to the side portions 24a. The base portion 24c is semicircular with the circumference of the semicircle facing in the direction of the side portions. The base portion is engaged by the anvil surface 22 during forward motion of the staple. In order to insure centering of the staple 24, the anvil surface 22 is provided with a vertical slot 22'. In the arcuate section 26' of the staple magazine 26, the side portions 24a of adjacent staples 24 are spaced apart while the straight leg regions 24b are in contact with adjacent leg regions due to the difference in radii of the curves for the upper and lower surfaces of the arcuate section 26'. Thus, the force of the spring 25 can be transmitted through the staples in the arcuate section 26' to the forwardmost staple 24'. At the opening 27 (FIG. 5) of the magazine 26 into the channel 16, the underside of the upper guide face 16b is embossed (not shown) to hold the forwardmost staple 24' in a well-defined position. As the driver 15 is advanced from retracted position shown in FIG. 2; its front end abuts the forwardmost staple 24' and pushes it forward in the channel section 16'. At the same time, the bent section 18 moves along the inclined surface 20 of the leaf spring 19 so that the anvil surface 22 at the forward end of the leaf spring is brought from its retracted position into the operative position shown in FIG. 3. The staple designated 24" in FIGS. 3 and 4 is now situated between the forward end of driver 15 and the anvil surface 22 in a position in which the tips of the staple side portions protrude slightly forwardly from the instrument. As the driver 15 is advanced further, the staple side portions emerge from the front end of the instrument, with staple 24" being deformed and closed to the solid line configuration depicted in FIG. 5 in which the base 24c of the staple has been bent flat on the inner side of the anvil surface 22. To obtain as long a guide path as possible during deformation of staple 24", the guide faces 16a, 16b and 16c extend into projections 28 which define the exit gap of channel 16 out of the housing and which protrude slightly beyond the anvil surface 22. As soon as the driver 15 has carried the forwardmost staple 24' away from the opening 27 of the magazine into the channel, the opening 27 is closed by the driver so that the next staple cannot be advanced into the channel 16. The next staple can only be advanced into the channel after the driver 15 has returned to its retracted position where it is clear of the opening 27. FIGS. 7-9 illustrate control of the driver 15 by the slide 13. Slide 13, which is supported to the front housing portion 11 for longitudinal displacement but is prevented from rotating, comprises at its forward end a forwardly projecting, flexible tongue 14 which is vertically springloaded. A laterally projecting guide wing or cam surface 30 is disposed at the end of the tongue 14 and cooperates with a control cam 31 fixed to the housing portion 11. When the slide 13 is advanced by the actuating mechanism 12, its front face strikes driver 15, pushing it in the direction of the tool tip. A bevel formed on wing 30 causes wing 30 to abut on a rearward bevel of the control cam 31. The tongue 14 then flexes upwardly and wing 30 slides on the upper cam surface 32. If the slide 13 is retracted before its forward end position is reached corresponding to the operating position of the driver, the wing 30 slides back on to the upper cam surface 32, which maintains the slide and correspondingly the driver in the advanced position they assumed. Only after the slide 13 reaches the position shown in FIG. 8 and the wing 30 has gone beyond the front end of the control cam 31 is the stamping operating completed and staple 24" closed. As the slide 13 is thereafter being moved back, the rear surface of the wing 30, which is inclined, contacts the correspondingly inclined forward surface of the control cam 31. As a result, the tongue 14 is forced downward, and a projection of the tongue 14 enters into the slot 17 of the driver 15. As the slide 13 is further retracted, the wing 30 is pulled beneath the control cam 31, and the driver 15 is drawn rearward. Referring to FIG. 7, after the wing 30 has passed along the underside of the control cam 31, the tongue 14 springs upward, releasing the driver 15 at its starting position. Until the driver 15 is pulled back to its starting position, it does not clear the opening 27 of the staple magazine 26 into the channel 16. FIG. 10 depicts an embodiment in which a counting mechanism 33 is secured to the front housing portion 11. The counting mechanism is stepped by movement of the tongue 14 of the slide 13. The counting mechanism 33 comprises a hollow cylinder 34 fixed in the housing portion 11 in which is rotatably mounted a cylinder 35 having ratchet teeth 36 disposed about the periphery of the lower end thereof. A projection 37 disposed at the front end of tongue 14 engages the teeth 36 when the wing 30 is raised by the guide cam 31 during a feed movement. In this manner the cylinder 35 is rotated towards the forward end of the instrument by a predetermined angle with each feed movement of the driver 15. The top of the cylinder 35 is provided with a mark and the periphery of the hollow cylinder 34 is provided with a scale so that the mark indicates on the scale the number of staples 24 remaining in the magazine 26. At the rear end of the front housing portion 11 is disposed a cylindrical bushing 40 (FIG. 1) in which slide 13 is coaxially mounted. The cylindrical bushing 40 can be removed from the rear housing portion 10 so that the magazine can be loaded with staples. The rear end of the slide 13 is coupled to a part 39 slidably movable along a track 42 in the interior of the rear housing portion 10. The sliding part 39 includes a sleeve 43 disposed about a shank 44 of the slide 13 which is bounded on both sides by flanges. The sliding part 39 is provided with a rack 45 having teeth or serrations which are engaged by corresponding serrations on a toothed disc segment 46. The toothed disc segment 46 forms one lever arm of a two-armed lever which pivots about a pivot pin 47 in the housing portion 10. The other lever arm 48 is engaged by a pin 49 disposed in a transverse slot 50 of a trigger lever 51. The trigger 51 is guided in a recess 52 of the handle 53 extending approximately parallel to channel 16, and is urged outwardly of the handle by a spring 54. Trigger 51 is dimensioned so that it can be actuated with the index finger when the handle 53 is gripped. The trigger, upon being pushed into the handle 53, causes the lever 46, 48 to be pivoted about the pivot pin 47 so that the sliding part 39 is advanced forwardly, and with it slide 13. Near the end position of the lever 46, 48 where it extends almost at right angles with the slide 13, leverage is the greatest, and corresponds to the stamping action of the driver. Thus, for a constant actuating force, the maximum force applied to the driver occurs during stamping. An actuating mechanism 12' similar to mechanism 12 of FIG. 1 is illustrated in FIGS. 11 and 12. FIG. 11 depicts the retracted position of the slide 13 and FIG. 12 its advanced position. Spring 54 urges the trigger 51 out of the handle 53 and at the same time brings the sliding part 39, and with it the slide 13, into the retracted position. In the embodiment of FIG. 1 the transverse slot 50 of the trigger 51 has an angular shape, while in the embodiment of FIGS. 11 and 12, the transverse slot 50 is straight. Certain changes and modifications of the embodiments of the invention disclosed herein will be readily apparent to those skilled in the art. It is the applicants' intention to cover by their claims all those changes and modifications which could be made to the embodiments of the invention herein chosen for the purpose of disclosure without department from the spirit and scope of the invention.

A stapler, particularly for suturing skin wounds or incisions, is disclosed which comprises a channel in which a driver is advanced by a slide in the direction of an anvil surface. A staple magazine which extends substantially parallel with the driver includes a curved section which opens into the channel to deliver staples into the channel for engagement by the driver. During forward displacement of the driver, a projection on the driver presses a leaf spring to which the anvil surface is connected. The anvil surface at the forward end of the leaf spring is thereby brought into its operating position and is automatically moved back into its retracted position upon release of the spring after the driver is retracted. The curved section in the staple magazine enables the stapler to have a slim profile which does not obscure the working area during a stapling operation. After completion of a stapling operation, the anvil surface is automatically retracted from a closed, implanted staple.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application claims the benefit of U.S. Provisional Patent Application No. 61/838,553, which was filed on Jun. 24, 2013, and which is incorporated by reference herein. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH [0002] The present invention was supported in part by funds from the U.S. government (i.e., NIH Grant No. RO3NS058595, NIH Grant No. R15 NS074404, and the Office of the Assistant Secretary of Defense for Health Affairs through the Peer Reviewed Orthopaedic Research Program under Award No. W81XWH-13-02301), and the U.S. government may therefore have certain rights in the invention. FIELD OF THE INVENTION OR TECHNICAL FIELD [0003] The present invention relates to the field of nerve regeneration, in particular to nerve conduits for the regeneration of peripheral nerves. BACKGROUND OF THE INVENTION [0004] In the United States, each year more than 700,000 people suffer from peripheral nerve injuries (PNI) that can lead to a lifelong disability, such as paralysis. The most frequent causes include motor vehicle accidents, gunshot wounds, stabbings, and birth trauma. [0005] Currently, there are two gold standard treatments for nerve repair, which are end-to-end suturing and application of autograft or allograft biological tissue. However, each strategy suffers from a number of limitations. For example, end-to-end suturing cannot be performed when the nerve gap is larger than 1 cm. The use of autograft results in potential donor site morbidity for the patient and can potentially exacerbate the condition. The use of allograft tissue has an associated risk of immunogenicity. [0006] Recent advances in tissue engineering and biomaterials suggest that there may be other approaches to nerve repair and regeneration that may overcome the limitations associated with harvesting natural tissues. One such approach would be the use of biomaterials to produce natural or synthetic nerve guidance conduits (NGCs). These NGCs may overcome some of the limitations of nerve autograft and allograft methods. The NGCs act as an essential precursor for nerve repair, since they can reduce tension at the suture line, can protect the regenerating axons from the infiltrating scar tissue, and can exhibit a low immune response. Although FDA-approved tissue engineered nerve devices have been available in the market for several years, these implant devices do not possess the proper physical topography or chemical cues for nerve repair and regeneration. Also, most of them are currently limited to a critical nerve gap of approximately 4 cm. To design an optimal NGC for enhancing PNR still remains a challenge. [0007] Current laboratorial NGCs developed using haptotactic strategies alone are not yet comparable to autograft. For example, multichannel NGCs may have an insufficient cross sectional area and or inhibit cell-cell interaction between each of the individual channels. This may lead to functional mismatches and an insufficient level of regeneration. Controlling the position of inner filament bundles within NGCs has yet to be achieved, despite the fact that the presence of microfilaments has been demonstrated to enhance axonal regeneration and provide contact guidance for the regenerating axons in rats. Alternatively, microfilaments can mislead cell migration which can result in uneven distribution of cells within the NGC. These failures in NGCs may be attributed to the inadequate design of intra-luminal guidance channels/filament, forming incomplete fibrin cables during the initial stages of regeneration. Without the formation of this aligned bridge of extracellular material (ECM), further mechanisms for nerve repair are limited. Therefore, it still remains a challenge to design an optimal NGC for enhancing PNR, when compared to the use of autografts. SUMMARY OF THE INVENTION [0008] An embodiment of the present invention provides a fabricated implantable NGC. In some embodiments, the NGC comprises an inner spiral structured porous sheet. Such conduits have the potential to serve as medical devices to treat PNI and restore function to the site of the injury. This may be achieved by the spiral structure's ability to facilitate regeneration of nerve tissues. [0009] In another embodiment of the present invention, the NGC has an integrated spiral structured porous sheet decorated with surface channels. Such a structure increases the surface area available for cell migration and attachment, and may reduce the length of time needed for recovery. Additionally, such a structure can reduce the wear and tear that is often observed with single lumen tubular NGCs. A highly-aligned set of electrospun fibers are present within the surface channels and on the backs thereof. The presence of aligned fibers in such areas ensures that the regenerating nerve will come into contact with aligned fibers. In order to place and suture the nerve tissue without tension, there are two reserved chambers at the proximal and distal end of the conduit. The chambers allow for nerve stumps to be sutured without tension due to the fact that the chambers provide space to house the nerve in place with an optimal grip. A dense layer of randomly-oriented fibers on the outside of the spiral structure can greatly improve the mechanical properties of the NGC and provides integrated structural support for nerve regeneration. The spiral conduit is tunable such that its length and diameter can be varied controllably depending on how it is to be used. The length and the outer diameter of the conduit depend on the size of its intermediate sheet, which is the spiral structured porous layer of the NGC. The method of fabricating the conduit does not limit its length, thus enabling the application for longer gap repair/regeneration for PNI. BRIEF DESCRIPTION OF FIGURES [0010] FIG. 1 is a schematic illustration in cutaway view of a nerve guidance conduit (NGC) according to an embodiment of the present invention bridging the stumps of a damaged nerve; [0011] FIG. 2 is a schematic end-on cross-sectional view of the NGC of FIG. 1 ; [0012] FIG. 3 is a scanning electomicrograph (SEM) image of a first side of a portion of a porous polymeric sheet of a type used to fabricate NGCs according to an embodiment of the present invention; [0013] FIG. 4 is an SEM image of the side opposite the first side of the porous polymeric sheet of FIG. 3 ; [0014] FIG. 5 is an SEM image of a porous polymeric sheet having aligned nanofibers thereupon according to an embodiment of the present invention; [0015] FIG. 6 is an SEM image of a porous polymeric sheet having randomly-distributed nanofibers thereupon; [0016] FIG. 7 is a stereomicroscopic image of the exterior of a second NGC; [0017] FIG. 8 is stereomicroscopic image of the NGC of FIG. 7 after being sectioned longitudinally; [0018] FIG. 9 is a stereomicroscopic image of an end-on view of the NGC of FIG. 7 ; [0019] FIG. 10 is an SEM image of surface channels on a polymer sheet of a type used to fabricate an NGC according to an embodiment of the present invention; [0020] FIG. 11 is a schematic diagram of a polymer sheet of the type shown in FIG. 10 ; [0021] FIG. 12 is a group of stress-strain plots generated from tests performed on various NGCs which are embodiments of the present invention; [0022] FIG. 13 is a bar chart comparing cell proliferation on various NGCs which are embodiments of the present invention; [0023] FIG. 14 is a plot showing changes in sciatic functional index (SFI) over time for rats having implanted NGCs according to embodiments of the present invention; [0024] FIG. 15 is a bar chart of compound muscle action potentials (CMAP) for rats having implanted NGCs according to embodiments of the present invention; [0025] FIG. 16 is a bar chart of nerve conduction velocities (NCV) for rats having implanted NGCs according to embodiments of the present invention; [0026] FIG. 17 is a bar chart of percent of neural tissue regenerated in sciatic nerves bridged by NGCs according to embodiments of the present invention; [0027] FIG. 18 is a bar chart comparing muscle weight ratios for the gastrocnemius muscle of rats for which the sciatic nerve was bridged by NGCs according to embodiments of the present invention; [0028] FIG. 19 is a bar chart comparing muscle fiber diameter for the gastrocnemius muscle of rats for which the sciatic nerve was bridged by NGCs according to embodiments of the present invention; and [0029] FIG. 20 is a bar chart comparing muscle fiber coverage for the gastrocnemius muscle of rats for which the sciatic nerve was bridged by NGCs according to embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0030] Embodiments of the present invention provide NGCs with integrated spiral structured porous sheets decorated with surface channels and electrospun fibers. Such NGCs provide superior mechanical strength compared to NGCs in the prior art, along with integrated multiple channels, stable aligned fibrous layers, good inter-cell communication, and high surface/volume ratios within the NGCs. Chambers at the distal and proximal ends of the NGC provide additional space for fitting nerve stumps in order to reduce the tension at the suture line between the NGC and the nerve stump. A dense outer fibrous tube on the outside of the spiral structured porous sheet can prevent the infiltration of scar tissue while the regeneration process takes place. One embodiment of the NGC of the present invention comprises a three-dimensional (3-D) spiral structured porous sheet having two chambers at the ends thereof. The spiral structure includes a highly porous polycaprolactone (PCL) sheet, which may be formed as a spiral-wound sheet using known methods and decorated with surface channels on a surface of the spiral wound sheet, coated with a thin layer of aligned electrospun fibers on the surface channels, and a dense randomly-oriented fibrous tube on the outside of the NGC. Other bioresorbable materials known for use in the biomedical arts may be used in place of PCL for the sheet and fibers (e.g., collagen/PCL blends for the fibers). [0031] Other embodiments of the present invention provide a process for fabricating an implantable NGC, such as the embodiment of an NGC described above, which can be used as a medical device for facilitating the repair and regeneration of nerve tissues. [0032] Several features of NGCs according to embodiments of the present invention are discussed herein below. [0000] 1. Three-Dimensional (3-D) Integrated Spiral Structured Porous Sheet with Proximal and Distal Reserved Chambers [0033] Collagen tubes, which have been approved by the FDA, lack sufficient mechanical strength to support nerve regeneration. As for multi-channel NGCs, the major drawback is that cells/axons in each channel do not interact well with those in the other channels, which adversely affects nerve regeneration and would affect nerve function recovery even if the nerve gap were bridged. In comparison, the integrated spiral structure makes the NGC of the present invention superior to those in the prior art in that mechanical properties are greatly improved and favorable for inter-cellular interaction and neural myelination. This is important for nerve regeneration because of the time required for nerve regeneration to bridge large nerve gaps. Further, a NGC should have enough mechanical strength to provide structural support to the nerve during regeneration. Also, the proximal and distal chambers in the ends of the NGC provide an optimal initial environment for nerve ingrowth. These chambers can prevent stress from accruing when the nerve tissue is sutured with the conduit in an end-to-end fashion. Moreover, the increased surface/volume ratio and the highly porous intermediate layers of the PCL sheet are preferred for cell attachment and nutrient transportation during nerve regeneration. [0000] 2. Decorated Surface Channels on the Spiral Porous Sheet with Additional Electrospun Aligned Fibers and and an Outer Fibrous Tube [0034] Electrospinning is an approach for polymer biomaterial processing that provides an opportunity to control morphology, porosity and composition of an NGC using relatively unsophisticated equipment. Unlike conventional fiber spinning processes that produce fibers with diameters in the micrometer range, electrospinning is capable of producing fibers in the nanometer diameter range, which are typically deposited in the form of nonwoven fabrics. Nanofibers provide a connection between the nanoscale and the macroscale world, since, although their diameters are in the nanometer range, the fibers are very long, sometimes having lengths of the order of kilometers. A major problem of all hollow tubes is misdirection of cellular migration: since transected axons produce axon sprouts proceeding in a distal direction, a neuroma is always formed which consists of minifascicles proceeding in an abnormal manner, proliferating Schwann cells (SCs), fibroblasts and capillaries. If there is a directional factor of any kind (e.g., an artificial nerve tube which usually provides no endoneurial structure), the neuroma proceeds in the desired direction. This phenomenon has been called “neuromateous neurotization”. In consequence, only a few dispersed axons are able to enter the right fascicle and endoneurial tube in the distal nerve stump once they have reached the end of the conduit in the interior of the NGC. [0035] One successful tissue engineering strategy for nerve repair is to create aligned features on the conduit to provide guidance for cell migration and directional axonal regeneration across the glial scar and lesion site in both central nervous system and peripheral nervous system injuries. Such features may include aligned surface channels and electrospun fiber-based conduits for nerve repair, according to embodiments of the present invention. [0036] Consequently, the construction of a spiral structure conduit with highly aligned surface channels and nano-fibers is very helpful for nerve proliferation and neurite extension. Meanwhile, the intricate aligned structure can also influence the growth and distribution of seeded SCs, which further directs the longitudinal extension of the neural axons. Further, there is a wide range of polymers available that are suitable for deposition on the spiral sheet to meet the individualized specifications for the NGC (e.g., collagen/PCL copolymer nanofibers, rather than pure PCL sheets). [0037] Fibers spun along the outside of the NGC not only assist in stabilizing the spiral structure, but also inhibit infiltration of scar tissue through the inter-connective pores. By increasing the mechanical strength of the NGC, the risk of structural failure can be minimized, promoting more uniform and natural regeneration of nerve tissue. Tunable Features of the NGC [0038] In order to solve the conflict between optimizing the mechanical properties of the NGC and maximizing its length, many techniques may be used to reinforce the NGC. In a method according to an embodiment of the present invention, a spiral conduit (e.g., a spiral structured porous sheet) is placed onto a rotator and a nanofiber is spun in random orientations along the spiral structure to form an outer fibrous tube. The thickness of the outer fibrous tube can be controlled. This dense layer of randomly-oriented fibers deposited on the outside of the spiral conduit can improve the mechanical properties of the entire structure, and meanwhile provide a stable structural support during nerve regeneration. In a method according to an embodiment of the present invention, depositing the outside layer of fibers on the spiral conduit is the final and separate step of fabricating the NGC, so it is practical to modify the polymers used to form the fibers before the electrospinning step. The outer fibrous tube can be made from polymers that are different from that of the spiral sheet or the aligned fibers. [0039] In another aspect, the process of the present invention is tunable in that the sizes of the spiral conduit are controllable, and both the length and the outside diameter are dependent on the size of the spiral-wound sheet. Therefore, in order to fabricate a spiral conduit with a particular size, (e.g., a length larger than 15 mm, which is the maximum length of nerve regeneration achieved with silicone tubes in rats), it is only necessary to cut a polymer sheet to the appropriate size. Embodiments of the Present Invention [0040] FIG. 1 is a schematic illustration in cutaway view of a nerve guidance conduit (NGC) 10 according to an embodiment of the present invention bridging the stumps 12 , 14 of damaged nerve 16 . The stumps 12 , 14 are received in reserved chambers 18 , 20 at the proximal and distal ends 22 , 24 of the NGC 10 , and held in place with sutures 26 , 28 , or by other means known in the art. The reserved chambers 18 , 20 allow the nerve stumps 12 , 14 to be placed in the NGC 10 and sutured without tension by housing the nerve stumps 12 , 14 in place with an optimal grip. [0041] FIG. 2 is a schematic cross-sectional view of the NGC 10 showing that the NGC 10 includes an outer fibrous tube 30 surrounding one or more spiral wound sheets 32 The fibrous tube 30 includes a dense structure of randomly oriented polymer fibers (not shown). The spiral wound sheets 32 define a lumen 34 inside the NGC 10 . The lumen 34 is bounded by an inner surface 36 of the spiral wound sheets 32 . The NGC 10 further includes an integrated guidance spiral 38 having a plurality of surface channels 40 . The guidance spiral 38 is are composed of multiple layers (e.g., layers 42 , 44 ), and together define a spiral guidance channel 46 within the lumen 34 . In some embodiments of the present invention, the surface channels 40 are arranged such that they are substantially parallel to each other and to a longitudinal axis (not shown) of the NGC 10 . The layers 42 , 44 may be extensions of the spiral-wound sheets 32 , or may be formed separately therefrom, then integrated with the spiral-wound sheets 32 . The plurality of surface channels 40 increases the surface area of the guidance spiral 38 that is available for cell migration and may reduce the length of time needed for nerve regeneration. Additionally, the integrated layers 42 , 44 may reduce the wear and tear that can occur in NGCs known in the art. Such wear and tear is often observed with single lumen tubular NGCs. [0042] In some embodiments of the present invention, a highly aligned orientation of electrospun nanofibers (not shown) are provided as coats on the surface channels 40 , and on both layers 42 , 44 of the spiral sheet 38 , and dense randomly-oriented fibers are provided on an outer surface 48 of the NGC 10 , which greatly improves the mechanical properties of the NGC 10 , as discussed above. In some embodiments, the aligned fibers are substantially parallel to each other. In some embodiments, the aligned fibers are substantially parallel to a longitudinal axis of the NGC 10 . The presence of aligned fibers ensures that all areas of the regenerating axon will come into contact with aligned fibers. [0043] The NGC 10 is tunable such that its size can be varied in a controlled fashion depending on how it is to be used. The length and the outer diameter of the NGC 10 are dependent on the size of guidance spiral 38 . An NGC 10 according to the present invention may have any length, thus enabling it to be used to repair long gaps in the axon for the repair or regeneration of peripheral nerves. [0044] FIGS. 3 and 4 are scanning electromicrograph (SEM) images a first side and a second side opposite the first side of a portion of a porous polymeric sheet 50 of a type that may be used to fabricate the spiral-wound sheets 32 or guidance spiral 38 of an NGC of the same type as NGC 10 , before the application of electrospun nanofibers. Interconnected pores (e.g., pores 52 ) are present throughout the polymeric sheet 50 . FIG. 5 is an SEM image of a porous polymeric sheet 54 of the same type as polymeric sheet 50 , showing aligned nanofibers 56 that have been deposited on the polymeric sheet 54 by electrospinning. FIG. 6 is an SEM image of a porous polymeric sheet 58 of the same type as polymeric sheets 50 , 54 showing randomly-distributed nanofibers 60 that have been deposited on the polymeric sheet 58 by electrospinning. [0045] FIGS. 7-9 are stereomicroscopic images of an NGC 62 according to an embodiment of the present invention. NGC 62 is of the same general type as the NGC 10 discussed with respect to FIGS. 1 and 2 . FIG. 7 is an image of the intact NGC 62 showing its outer fibrous tube 64 . FIG. 8 is an image of the interior of the NGC 62 after it has been cut lengthwise, showing an interior surface 66 of the outer fibrous tube 64 , the guidance spiral 66 , and the reserved chambers 68 , 70 . FIG. 9 is an end view of the NGC 62 showing the outer spiral wall 64 , the guidance spiral 66 and the channels 72 of the guidance spiral 66 . FIG. 10 is a SEM image of a portion of polymer sheet 74 , which is of a type for making an NGC according to an embodiment of the present invention, showing the substantially parallel alignment of channels 76 , which are separated by ridges 78 . Exemplary Fabrication Method [0046] In a method of fabricating an NGC according to an embodiment of the present invention, a polycaprolactone (PCL) sheet was fabricated using a combination of the solvent evaporation method and the salt-leaching method. An 8% (w/v) PCL solution was poured onto a glass petri dish, and acupuncture needles having a diameter of 150 μm were placed on top of the PCL solution to form multi-channels having widths of about 180 μm. The dish was moved to a hood to let it air dry. After an hour, the resulting PCL sheet was immersed into deionized water so that the salt was dissolved, producing pores in the PCL sheet. The needles were also removed, having formed multi-channels on the PCL sheet with widths of about 180 μm. After 30 minutes, the PCL sheet was taken out and dried on a paper towel. Subsequently, 2 hours later, the fully dried PCL sheet was cut into a rectangular shape having dimensions of about 12 mm by 10.5 mm to bridge a 10 mm nerve gap in an animal study. [0047] Referring to FIG. 11 , in an exemplary embodiment of the method, the cut PCL sheet 80 had opposite longer edges 82 , 84 (i.e., the 12 mm edges), and opposite shorter edges 86 , 88 (i.e., the 10.5 mm edges). It may be noted that the channels 90 are substantially parallel to the longer edges 82 , 84 . Two rectangular areas 92 , 94 were cut out from the opposite corners 96 , 98 of the edge 82 , such that edge 82 was then shorter than edge 84 . [0048] PCL aligned nanofibers were spun on the cut PCL sheet 80 using a conductible rotation disk method known in the art. A 16% (w/v) solution of PCL in 1,1,1,3,3,3 Hexafluoroisopropanol (HFIP) (Oakwood Products, Inc) was prepared for electrospinning. Aligned fibers were deposited on the 12 mm×10.5 mm PCL sheet longitudinally on the edge of the rotating disk such that the fibers were substantially parallel to channels 90 . The fibers were deposited such that they would be substantially longer than the cut PCL sheet 80 . The sheet was carefully removed from the disk to ensure the fibers deposited remained aligned. The excess lengths of fiber (i.e., the portions of the fibers that extended beyond the edges of the cut PCL sheet 80 were collected and folded onto the back of the cut PCL sheet 80 . [0049] Turning back to FIG. 11 , the cut PCL sheet 80 with the aligned nanofibers thereon was then wound in a spiral fashion from the edge 82 to the edge 84 , such that the edge 82 was in the interior of the resulting spiral NGC and the channels 90 were substantially parallel to a longitudinal axis of the spiral NGC. In the spiral NGC, the cutaway areas 92 , 94 become reserved chambers (e.g. reserved chambers 68 , 70 of spiral NGC 64 of FIGS. 7-9 , or reserved chambers 18 , 20 of spiral NGC 10 of FIG. 1 ). [0050] Random nanofibers were then spun onto the outside of the spiral NGC to form an outer fibrous tube on the spiral NGC. The thickness of the outer fibrous tube was approximately 150 μm. The outer fibrous tube is intended to secure the entire spiral structure, enhance the mechanical strength, and prevent tissue infiltration during nerve regeneration. The resulting spiral NGC with its outer fibrous tube was 1.8 mm in diameter and 12 mm in length, suitable for bridging a 10 mm nerve gap. Tensile Properties of the NGCs of the Present Invention [0051] FIG. 12 is a plot of stress versus strain for several NGCs fabricated according to a method of the present invention: an outer fiber tube comprising a dense layer of randomly-oriented nanofibers; the outer fiber tube with a spiral sheet therein, and the outer fiber tube with the spiral sheet and aligned nanofibers (“AF”). The following tensile properties were measured: Young's Modulus, percent elongation to failure, and tensile strength of the different NGCs. The Young's Modulus, calculated through the stress-strain curve shown FIG. 12 , ranged between 0.262-0.7625 Mpa. All three of the NGCs yielded a Young's Modulus that can stand force stretching and be applicable for in vivo use. The values reported for the outer fibrous tube and the other NGCs all in a useful range for use in nerve regeneration and repair. High tensile strength will provide a mechanically strong NGC that can be sutured well during coaptation of the nerve stump and NGC, and preserve the suture after surgery. The measured physical properties of the NGCs of FIG. 11 are summarized in Table 1, below. [0000] TABLE 1 Tensile Properties of Nerve Guidance Conduits Young's Tensile Modulus (MPa) % Elongation Strength (MPa) Outer Fibrous Tube 0.7625 296.4 8.98 Outer Fibrous Tube + 0.33766 171 2.08 Spiral Outer Fibrous Tube + 0.32766 301 1.78 Spiral + AF Porosities of the NGCs [0052] The measured porosity values for the outer fibrous tube (hereinafter, NGC-T), outer fibrous tube+spiral (hereinafter, NGC-T-S), and outer fibrous tube+spiral+AF (hereinafter, NGC-T-S-AF) were respectively 71.98±1.22%, 75.01±2.69%, and 78.41±3.64%. The differences in porosities for these three types of NGCs are not statistically significant (p<0.05). Cell Proliferation [0053] Schwann cells were adopted as the model for evaluation of cellular response on the fiber-based spiral NGCs. At day 4, NGC-T-S-AF showed significantly greater cell proliferation than NGC-T and NGC-T-S. The cell numbers for each type of NGC are shown in FIG. 13 . The degrees of cell proliferation for the NGC-T and NGC-T-S are significantly lower (p<0.05) than for the NGC-T-S-AF. Implantation of NGCs [0054] The NGCs were tested in a 10 mm Sprague Dawley (SD) rat sciatic nerve defect to evaluate the effect of nanofibers on peripheral nerve regeneration through porous spiral NGCs. The sciatic nerve of each rat was cut, then bridged with one of the NGCs. One group received an autograft rather than a NGC. One group received no grafts. All rats were in good condition during the survival weeks. There were no obvious signs of systemic or regional inflammation and surgical complications after implantation [0055] The recovery of motor function was assessed based on the walking track evaluation Referring to FIG. 14 , normal sciatic functional index (SFI) value of −9.4±1.4 was measured from all healthy rats (n=30) before surgery. All experimental animals had decreased SFI of values between −85.6 and −94.5 (n=30) by week 2 after surgery. During the initial 4 weeks, there was no significant improvement in any of the groups. At 6 weeks after surgery, the overall SFI reached the levels between −72.2 and −91.7, which was equivalent to an improvement of 2.8-13.4 index points from week 2. Each group's 6-week SFI value was recorded as follows: autograft (−72.2±6.6), T-S-AF (−81.5±3.2), T-S(−88.4±4.9), and T (−91.7±4.2). The autograft SFI revealed a significant difference (p<0.05) as compared to the T-S and T groups. The SFI in the T-S-AF group was significantly higher than for the T groups (p<0.05). [0056] Functional recovery was further evaluated with electrophysiological assessment to determine whether functional recovery occurred through the NGCs. Six weeks post-surgery, compound muscle action potentials (CMAP) were evoked by stimulation at the surgical limbs and recorded from gastrocnemius muscle following by measurements of amplitude and nerve conduction velocity (NCV). Signals were absent and no muscle contractions were observed in the non-grafted group. Referring to FIG. 15 , for the amplitude measurements, each group's value was recorded as follows: autograft (5.25±1.51 mV), T-S-AF (4.96±1.58 mV), T-S(3.6±1.39 mV), and T (2.0±0.64 my). Significant differences in amplitude were observed in the T group as compared to the autograft and T-S-AF groups (p<0.05). However, the difference between the autograft, T-S-AF, and T-S groups (p>0.05) was not statistically significant. Similar results were found in NCV measurement: autograft (31.57±4.13 m/s), T-S-AF (26.47±6.87 m/s), T-S (18.28±4.16 m/s), and T (13.3±5.65 m/s) (See FIG. 16 ). Significant differences in NCV were observed in the autograft group as compared to the T-S and T groups (p<0.05). The NCV result in the T group also showed a significant difference as compared to autograft and T-S-AF groups (p<0.05). However, there were no significant differences when the NCV values of the autograft group were compared to those of the T-S-AF group, which may indicate that nanofibers can accelerate the level of muscle reinnervation as well as autograft. [0057] After 6 weeks post-surgery, the distal nerve segment from each group was explored and carefully isolated from the surrounding tissues. A pinch reflex test was performed distally. A reflex movement of the back muscles indicates that the sensory fibers are positively regenerated through the NGCs, while no movement was considered as lack of sensory fibers in the NGCs. The results are presented in Table 2, below. [0000] TABLE 2 Pinch Test Results Number of rats responding to pinch test (n = 5) Autograft 5/5 T-S-AF 5/5 T-S 4/5 T 3/5 [0058] Further histological evaluations of nerve regeneration behavior with NGCs were investigated under a light microscope. The results clearly demonstrated the potential of the NGCs of the present invention to house a large number of supportive cells, both with and without nanofibers to enhance the surface area of the channel. The NGCs possessed durable mechanical strength to support the entire regeneration process. Low magnifications of micrographs showed that neural tissues, including myelinated axons and myelin sheath, were all successfully presented among the groups. Angiogenesis occurred through which new blood vessels were formed during the nerve regeneration process. Normal axons were nearly all surrounded by uniform thicknesses of myelin sheaths and presented large fiber diameters. Nevertheless, the studied groups presented premature morphologies (i.e., diverse nerve fiber sizes and thinner myelin sheaths). [0059] Quantitative analysis of the total occupied neural tissue coverage in the NGCs compared to those of normal rat nerves (70.57±3.81%) further confirmed the above findings. Referring to FIG. 17 , each group's value was recorded as follow: autograft (29.29±4.61%), T-S-AF (26.52±3.77%), T-S(17.37±2.97%), and T (5.88±1.43%). No significant differences were found among autograft and T-S-AF groups. However, the area occupied by neural tissue in T-S group showed significantly lower values than the autograft, and T-S-AF groups. High significance was observed in the T group as compared to the other groups (p<0.01). Finally, it should be noted that the cross-sectional micrograph of T group was covered with a large white area. That implied the single lumen repair limited the nerve regeneration. [0060] When severe nerve injury occurs, the muscle is denervated and the balance of muscle metabolism could be shifted from protein synthesis toward protein degradation. As a consequence, the target muscle presents a decreased muscle cell size, muscle weight loss, hyperplasia of connective tissues, and new blood vessel formation. To evaluate the reinnervation of the gastrocnemius muscle, Masson trichrome staining was applied to the section followed by measurements of muscle weight ratio, diameter of muscle fibers, and muscle fiber coverage per cross section. Referring to FIG. 18 , for comparisons of muscle weight ratio, each group's value was recorded as follows: autograft (39.73±4.19%), T-S-AF (25.64±3.01%), T-S(22.31±2.18%), and T (19.2±2.03%). The muscle weight ratio of the autograft group was greater than that of the other groups by a statistically significant amount (p<0.05). However, there were no significant differences between the T-S-AF and T-S groups (p>0.05). The T group revealed a significant lower ratio than the T-S-AF group. [0061] Referring to FIG. 19 , for comparisons of muscle fiber diameter, each group's value was recorded as follows: autograft (34.62±1.05 μm), T-S-AF (31.81±2.18 μm), T-S(25.5±6 μm), and T (21.56±2.98 μm). Although the autograft group showed a significant difference from the T-S and T groups, it was not significantly higher than the T-S-AF group. Also, there were no significant differences between the T-S and T groups (p>0.05). Further findings showed that the value for the T group was significantly lower than that for the autograft, and T-S-AF groups. [0062] Referring to FIG. 20 , for comparisons of muscle fiber coverage, each group's value was recorded as follows: autograft (96.84±4.1%), T-S-AF (93.72±4.63%), T-S (86.99±10.31%), and T (58.42±4.69%). There were no significant differences between the values for the autograft, T-S-AF, and T-S groups (p>0.05); however, they were all significantly greater than the value for the T group (p<0.05). [0063] From qualitative analyses and histological observations discussed above, spiral NGCs of the present invention, with or without nanofibers, revealed the potential to prevent muscle atrophy as well as the effect of autograft. Both the surface channels and the aligned fibers provide good topographical cues for nerve regeneration, and thus allow muscle reinnervation faster than single lumen NGCs, thus suggesting that the surface channels and nanofibers further assisted NGC structures in promoting nerve regeneration. [0064] It should be understood that the embodiments described herein are merely exemplary in nature and that a person skilled in the art may make many variations and modifications thereto without departing from the scope of the present invention. All such variations and modifications, including those discussed above, are intended to be included within the scope of the invention, as defined by the appended claims.

A nerve guidance conduit includes a spiral structured porous sheet decorated with channels on its surface and electrospun nanofibers in a parallel alignment with the channels and an outer tubular structure including randomly-oriented nanofibers. Such a structure provides augmented surface areas for providing directional guidance and augmented surfaces for enhancing and peripheral nerve regeneration. The structure also has the mechanical and nutrient transport requirements required over long regeneration periods. To prepare a nerve guidance conduit, porous polymer sheet is prepared by a solvent casting method while using a template of thin rods to form parallel channels on a surface of the sheet. Aligned nanofibers are deposited on the sheet parallel to the channels. The polymer sheet is then wound to form a spiral structure. A dense layer of randomly-oriented nanofibers may be deposited on the outside of the spiral.

FIELD OF THE INVENTION This invention is in the field of seat base support assemblies. It relates to seat base support assemblies for furniture or the like wherein the support assemblies employed are of the non-coil spring type; i.e., they comprise sinuous spring bands, wire grids or chord-rubber webbing, or are made up of flexible steel bands. The invention finds particularly advantageous application to sinuous band seat spring assemblies, however, and is discussed initially in that context. BACKGROUND OF THE INVENTION Over the past ten to twelve years furniture seat spring torsioning devices such as disclosed in U.S. Pat. No. 3,210,064, No. 3,388,904, and No. 3,525,514, met the industry's long sought need for deep-drop uplift at the back rail and also contributed in other ways to the luxury seat which evolved during that time frame. As eleven (11) gauge helical spring connectors became disproportionally more expensive during this period these devices have been used almost exclusively with SWING ANCHOR connecting links and radius links such as disclosed in U.S Pat. No. 3,790,149, and depended upon kinetic energy stored in the arced sinuous spring itself to produce all upward resilience. The upholstered furniture styles most widely sold at the time developed all the back rail uplift considered desirable using such connecting links. During the past three to four years, however, there has been a move toward the use of thicker and thicker cushions. Attractive new and thicker cushion materials, including foam rubber laminates, have necessitated the lowering of seat frame heights dramatically. As a result, an urgent need was created in such constructions for more upward resilience of a strong dynamic nature in the spring base. SUMMARY OF THE INVENTION An object of the present invention is to provide a new and improved rail connector for sinuous spring bands, wire grids, chord-rubber webbing, and flexible steel bands. Another object is to provide a rail connector which embodies the salutary features of conventional helical spring connectors while retaining essentially none of the undesirable features thereof. Still another object is to provide a rail connector which produces spring torsioning and dynamic uplift at the back rail through kinetic energy which it itself stores, and which then cooperates with any spring action in the seat base support assembly, which might be sinuous, arced, or de-arced, a wire grid, chord-rubber webbing, or flexible steel bands. Yet another object is to provide such rail connectors which give varying degrees of dynamic uplift resilience obtained by offering alternative spring action modes within themselves. The foregoing and other objects are realized in accord with the present invention by producing two related forms of rail connector. A first form uses pre-stressed, close wound coil spring with attachment arms. In one alternative the coil spring is wound on an axis transverse to the axis of spring expansion and contraction while in another alternative the coil spring is wound on an axis longitudinally arranged relative thereto. In either alternative the connector may selectively have a leverage-amplified torsioning capability. A second form uses a pre-stressed, cantilever spring configuration. This connector may selectively be used with a sinuous spring band having leverage-amplified torsioning incorporated therein. The invention for the first time provides seat spring-enhancing connectors that in themselves combine the four essential seat-force-generators; i.e., (1) torsioning; (2) dynamic uplift; (3) expansion-contraction; and (4) leverage-amplification. These, in turn, produce to the greatest degree the four most desired seat-performance characteristics; i.e., (1) initial-drop; (2) deep-drop; (3) softness without "oil canning", "bucketing", "jack-knifing", or "bottoming"; and (4) resilient uplift proportionate to load. BRIEF DESCRIPTION OF THE DRAWINGS The invention, including its construction and modes of operation, together with additional objects and advantages thereof, is illustrated more or less diagrammatically in the drawings, in which: FIG. 1 is a vertical sectional view through a portion of the back end of a furniture seat spring base, illustrating a spring band assembly including a first form of rail connector embodying features of the present invention; FIG. 2 is a view taken along line 2--2 of FIG. 1; FIG. 3 is a view similar to FIG. 1 illustrating one modification of the first form of rail connector embodying features of the invention; FIG. 4 is a view similar to FIG. 1 illustrating another modification of the first form of rail connector embodying features of the invention; FIG. 5 is an enlarged view of a portion of an alternative first form of rail connector embodying features of the invention; FIG. 6 is a view similar to FIG. 1 illustrating a second form of rail connector in a spring band assembly embodying features of the invention; FIG. 7 is a view taken along line 7--7 of FIG. 6; FIG. 8 is a view similar to FIG. 7 illustrating the second form of rail connector in a sinuous spring band assembly embodying features of the invention; and FIG. 9 is a view similar to FIG. 7 illustrating the second form of rail connector in another sinuous spring band assembly. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings, and particularly to FIGS. 1 and 2, a portion of the back end of a furniture seat base is illustrated generally at 10. The seat base 10 comprises spring band assemblies 15, only one of which is shown, extending in parallel relationship between the front rail (not shown) and back rail 16 of the base frame. Each assembly 15 includes a normally arced sinuous spring band 20 of standard loop size; i.e., a seven-eighths (2/3) inch interval between linear segments 25 and semi-circular segments 26 of the band. Each band 20 is connected to the back frame rail 16 by a first form of rail connector 30 embodying features of the invention. The rail connector 30 is fabricated of eleven (11) gauge wire, similar to standard helicals. It comprises a section 35 of three coils tightly wound on an axis transverse to that of the band 20 and the axis of expansion and contraction of the connector 30. Extending from the coil section 35, at their uppermost extremity, tangent to the arc of the coils and in opposite directions, are a rail-attachment leg 38 and a spring-attachment leg 39. The rail-attachment leg 38 terminates in a transversely disposed anchor section 40 which seats in a conventional "G" clip 41, while the spring-attachment leg 39 seats on and grips the spring band 20. The spring attachment leg 39 is inclined slightly upwardly from the horizontal, in contrast to the rail-attachment leg 38, and includes an upwardly formed shoulder 45 and a terminal hook 46. The shoulder is formed approximately mid-way between the hook 46 and tangency with the coil 35, seven-eighths (2/3) inches each way in the case where the band 20 is regular sinuous. As seen best in FIG. 1, the downwardly opening hook 46 is designed to seat over the penultimate linear segment 25b in the spring band 20, while the ultimate linear segment 25a seats against the shoulder 45. The result is to lock the end of the band 20 and the connector 30 together. In operation, the attachment-arm 39 reaching up into the band 20 sets up a torsioning effect in the back of the band. The arm 39 is spring loaded upwardly by the strength of the coil section 35 and produces dynamic uplift. At the same time the coil section 35 permits of longitudinal expansion-contraction of the connector 30. The coil section 35 and rail-attachment leg 38 extending outwardly of the band 20 end amplify the leverage induced torque. In an alternative construction of the first form of the invention, as seen in FIG. 3, the rail connector 130 is attached to the rail 116 through a gang bore 142. The rail-attachment leg 138 of the connector has a shorter anchor section 140 which can pass through the bore 142 from front to back of the rail 116 and then seats against the back of the rail to lock the connector 130 to the rail. The spring-attachment leg 139 in this form of the connector is much shorter and has an upwardly formed hook 146 at its inner end. The hook 146 is so formed that when it seats upwardly, onto the ultimate linear segment 125a of the spring band 120, it cannot slip off during seat base operation. The connector 130 provides both dynamic uplift and resilient expansion-contraction at the band end. It does not induce torsion or leverage amplification. The connector 130 can also be connected to the ultimate linear segment 125a of the band 120 by a conventional VLE clip, as seen at 150 in FIG. 4. As such, the single spring attachment leg 139 obtains a wider purchase area on the band 120 end. The effect is to enhance lateral stability of the spring band assembly. Turning now to FIG. 5, a modified coil section for a connector otherwise identical to that hereinbefore discussed is illustrated at 235. As illustrated, the coil section 235 is tightly wound in five (5) coils on an axis longitudinally aligned with the sinuous spring band span (not shown). This form of the connector 130 produces the same salutary effects, the dynamic uplift being produced by a torquing expansion-contraction of the coil section 235 in contrast to the loop compression-expansion of the coil section 35, however. FIGS. 6 and 7 illustrate a portion of a furniture seat base 310 comprising spring band assemblies 315 (only one shown) in which a second form of spring band 320 connector is illustrated at 330. The connector 330 uses a cantilever principle to provide dynamic uplift to the band 320 at the back rail 316. The rail connector 330 is fabricated of spring steel wire of relatively heavy gauge; i.e., eight (8) gauge or heavier. As best illustrated in FIG. 7, it includes a pair of identical connector arms 331 extending parallel to each other between the rail 316 and the band 320. As seen once again in FIG. 6, each connector arm 331 includes a generally V-shaped body 335 made up of a rail-attachment leg 338 and a spring-attachment leg 339. The legs 338 are vertically oriented and preferably four (4) inches long. The legs 338 are joined at their upper ends by a base leg 340 which seats in a conventional EKS clip 341 stapled to the top of the rail 316. Curving upwardly and inwardly from the lower end of each rail-attachment leg 338 is a corresponding spring-attachment leg 339. The spring-attachment legs 339 are approximately eight (8) inches long. Formed on the free ends of the legs 339 are attachment hooks 346 identical to the hooks 146 hereinbefore discussed. The connector 330 is a variation of the second form of the invention wherein the hooks 346 receive and seat on the ultimate linear segment 325a of the spring band 320. In operation the legs 338 are braced against the rail 316 with the spring-attachment legs 339 extending inwardly and upwardly therefrom to the hooks 346. In unloaded position the hooks are disposed approximately one (1) inch above the level of the EKS clip 341. The connector 330 thus is effective to dynamically urge the spring band 320 end upwardly when a subject is seated. At the same time longitudinal resilient expansion-contraction can and does take place in the connector 330, enhancing seat base softness. FIG. 8 illustrates a sinuous spring band assembly 415 which incorporates a connector 430 identical to the connector 330 hereinbefore discussed. In the spring band assembly 415 the connector hooks 446 are seated on a linear segment 425f of the band 420 which is sixth from the end of the band; i.e., the ultimate linear segment 425a. The linear segment 425a is connected to the rail by a SWING ANCHOR connector clip 460 such as illustrated in FIG. 1 of the aforementioned U.S. Pat. No. 3,790,149. The base of the clip 460 is seated, together with the base leg 440 of the connector 430, in the conventional EKS clip stapled to the top of the rail 416. The spring band 420 immediately inwardly of its ultimate linear segment 425a, at the penultimate linear segment, is bent upwardly for the length of one semi-circular band segment 426a and then bent back into the normal arc of the band. This creates a torsion inducing moment arm configuration in the end of the band as illustrated at FIG. 12 in the aforementioned U.S. Pat. No. 3,525,514. In operation of this spring band assembly 415 the connector 430 performs the same functions as previously ascribed to the connector 330. Further, however, its dynamic uplift is effected inwardly of the band end. This uplift, coupled with the torsion inducing band 420 configuration and the articulate connection provided by the clip 460 produces a highly sophisticated and luxurious seat base. FIG. 9 illustrates a sinuous spring band assembly 515 which also incorporates a connector 530 identical to the connector 330 hereinbefore discussed. In the assembly 515 the sinuous band 520 is a de-arced band, however; i.e., it has very little inherent upward resilience. In this assembly the connector 530 pre-loads the band 520 upwardly at the fourth linear segment 525d from the ultimate linear segment 525a. The ultimate linear segment 525a is seated in the EKS clip 540 on the rail 516, together with the base leg 540 of the connector 530. The connector leg 539 thus preloads the band 520 upwardly with the seat base 10 in its relaxed state as a subject is seated and rises, the connector provides a dynamic uplift which would otherwise not be present. All of the connectors hereinbefore discussed are also used to connect other forms of seat base support means to the frame rails. As will readily be understood, wire grids such as manufactured under the trademark PERMA-MESH by Flexolators, Inc., chord-rubber webbing such as manufactured by the Pirelli, s.p.a., of Italy, and flat steel bands, for example, do not have stored upward resilience in the sense that arced sinuous spring bands do. When connected to the back frame rail by connectors embodying the inventions disclosed herein, however, they are provided with a dynamic uplift adjacent the back rail. In this sense they are similar to a de-arced sinuous spring band. While several embodiments described herein are at present considered to be preferred, it is understood that various modifications and improvements may be made therein, and it is intended to cover in the appended claims all such modification and improvements as fall within the true spirit and scope of the invention.

A rail connector and improvement in seat base support assembly. The connector takes two basic forms. In the first a pre-stressed, close wound coil, disposed either transversely or longitudinally of the connector, is effective to continuously bias the seat base support means upwardly. In the second a cantilevered, curved spring arm serves the same purpose. The connector may be configured to reach into the body of a sinuous spring band, for example, and define a torque arm in the band, at the back rail. All forms are applicable to wire mesh, chord rubber webbing, flat steel bands and sinuous, both arced and dearced.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62/352,683 filed Jun. 21, 2016, the entire disclosure of which is incorporated by reference herein. BACKGROUND 1. Technical Description [0002] The present disclosure is directed to an anvil assembly for use with a surgical stapling device. More particularly, the present disclosure is directed to an anvil assembly for a circular surgical stapling device including a stabilizing collet positioned to prevent damage to the anvil assembly. 2. Background of Related Art [0003] Circular staplers are commonly used to perform a variety of surgical procedures including anastomosis procedures for joining ends of tubular tissue sections and hemorrhoidectomy procedures for treating hemorrhoids. Typically, circular staplers include a stapling device and an anvil assembly. The stapling device includes a handle assembly, a body portion extending from the handle assembly, a shell assembly including a staple cartridge, and a trocar extending from the shell assembly. The anvil assembly is releasably secured to the trocar of the stapling device and includes an anvil assembly having an anvil shaft and an anvil head assembly. The shell assembly includes a circular knife. When the circular stapler is fired, the circular knife is advanced from the shell assembly and cuts tissue as staples are ejected from the staple cartridge and formed against the anvil head assembly. In use, the stapling device and the anvil assembly are delivered to a surgical site within a patient separately and coupled to each other prior to use. [0004] Typically, the stapling device and the anvil assembly are coupled together at the surgical site by a clinician using a grasper. More particularly, the clinician grasps the anvil shaft of the anvil assembly with the grasper and positions the anvil shaft about the trocar of the stapling device to couple the trocar to the anvil shaft. This coupling procedure takes place within a body lumen or orifice where visibility is limited. [0005] When a clinician applies too much pressure on the anvil shaft, the anvil shaft can be damaged, e.g., crushed or deformed, such that the anvil shaft cannot be properly coupled to the stapling device. This problem is exacerbated because due to the poor visibility at the surgical site, the clinician may be unaware that the anvil shaft has been damaged and is not properly coupled to the stapling device. As such, when circular stapler is fired, the anvil assembly may become disengaged from the stapling device such that the staples are not formed in cut tissue. [0006] Accordingly, a need exists in the surgical arts for an anvil assembly that is less susceptible to damage during attachment of the anvil assembly to the stapling device to facilitate reliable attachment of the anvil assembly to a stapling device. SUMMARY [0007] In one aspect of the disclosure, an anvil assembly includes an anvil shaft defining a first longitudinal bore and an anvil head assembly. The anvil shaft has a proximal portion and a distal portion. The proximal portion includes a plurality of flexible legs that define the first longitudinal bore. The anvil head assembly is secured to the distal portion of the anvil shaft and supports an anvil plate that defines a plurality of staple deforming pockets. A stabilizing collet defines a second longitudinal bore. The collet is supported within the first longitudinal bore and is positioned to prevent damage to the plurality of flexible legs. [0008] In another aspect of the disclosure, a surgical stapler includes a stapling device and an anvil assembly. The stapling device includes a handle assembly, a body portion that extends distally from the handle assembly, a shell assembly including a staple cartridge having a plurality of staples, and a trocar extending from the shell assembly. The anvil assembly includes an anvil shaft and an anvil head assembly. The anvil shaft has a proximal portion and a distal portion and defines a first longitudinal bore configured to receive the trocar of the stapling device. The proximal portion includes a plurality of flexible legs that defines the first longitudinal bore. The anvil head assembly is secured to the distal portion of the anvil shaft and supports an anvil plate that defines a plurality of staple deforming pockets. A stabilizing collet defines a second longitudinal bore configured to receive the trocar. The collet is supported within the first longitudinal bore and is positioned to prevent damage to the plurality of flexible legs. [0009] In embodiments, the collet is cylindrical. [0010] In certain embodiments, the collet is substantially rigid. [0011] In some embodiments, the collet has a distal end including a plurality of cantilevered fingers, wherein each of the plurality of cantilevered fingers has a protrusion configured to secure the collet within the first longitudinal bore of the anvil shaft. [0012] In certain embodiments, each of the plurality of flexible legs defines a longitudinal channel with an adjacent one of the plurality of flexible legs. [0013] In embodiments, the anvil shaft defines a hole positioned adjacent the distal end of each of the longitudinal channels. Each of the holes is configured to receive a respective one of the protrusions. [0014] In some embodiments, each of the holes is circular. [0015] In certain embodiments, the anvil head assembly is pivotally secured to the anvil shaft. [0016] In embodiments, the anvil plate is annular. BRIEF DESCRIPTION OF THE DRAWINGS [0017] Various embodiments of the presently disclosed crush resistant anvil assembly are described herein below with reference to the drawings, wherein: [0018] FIG. 1 is a side perspective view of a surgical stapler including an exemplary embodiment of the presently disclosed crush resistant anvil assembly; [0019] FIG. 2 is an enlarged view of the indicted area of detail shown in FIG. 1 ; [0020] FIG. 3 is a cross-sectional view taken along section line 3 - 3 of FIG. 2 ; [0021] FIG. 4 is a side perspective view of the anvil assembly shown in FIG. 2 ; [0022] FIG. 5 is an enlarged view of the indicated area of detail shown in FIG. 4 ; [0023] FIG. 6 is a side perspective view of a collet of the anvil assembly shown in FIG. 4 ; [0024] FIG. 7 is a side cross-sectional view of the collet shown in FIG. 6 and the anvil shaft of the anvil assembly shown in FIG. 4 with parts separated; [0025] FIG. 8 is a side cross-sectional view of the collet and anvil shaft shown in FIG. 7 as the collet is slid into the anvil shaft; [0026] FIG. 9 is a side cross-sectional view of the collet and anvil shaft shown in FIG. 8 with the collet secured within the anvil shaft; and [0027] FIG. 10 is a side cross-sectional view of the collet and anvil shaft shown in FIG. 9 as a trocar of the stapling device is positioned within the anvil shaft. DETAILED DESCRIPTION OF EMBODIMENTS [0028] Exemplary embodiments of the presently disclosed damage resistant anvil assembly will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. In this description, the term “proximal” is used generally to refer to that portion of the stapler that is closer to a clinician, while the term “distal” is used generally to refer to that portion of the stapler that is farther from the clinician. In addition, the term “endoscopic” is used generally to refer to procedures performed through a small incision or a cannula inserted into a patient's body including endoscopic, laparoscopic, and arthroscopic procedures. Finally, the term clinician is used generally to refer to medical personnel including doctors, nurses, and support personnel. [0029] The presently disclosed anvil assembly includes an anvil head assembly, an anvil shaft, and a stabilizing collet. In embodiments, the stabilizing collet may be formed of a substantially rigid material. Alternately, other materials of construction that provide support to the anvil shaft are envisioned. The anvil shaft includes a plurality of flexible legs that flex outwardly in response to insertion of a trocar of a surgical stapling device into the anvil shaft to releasably couple the anvil shaft to the trocar. The collet is received within a longitudinal bore defined by the flexible legs of the anvil shaft at a location to support the flexible legs and minimize the likelihood of damage to the anvil shaft caused by engagement of the anvil shaft with a grasper. The collet is also positioned in a location not to interfere with flexing of the legs during coupling of the anvil shaft to the trocar of the stapling device. [0030] FIG. 1 illustrates a manually powered surgical stapler 10 including a stapling device 12 supporting an exemplary embodiment of anvil assembly 100 . The stapling device 12 includes a handle assembly 14 , a body portion 16 that extends distally from the handle portion 14 , and a shell assembly 18 that supports a staple cartridge 20 . The staple cartridge 20 supports a plurality of staples (not shown) that are arranged in an annular configuration within the shell assembly 18 . The stapling device 12 also includes a trocar 22 that extends from the distal end of the body portion 16 through the shell assembly 18 . The trocar 22 is configured to releasably engage the anvil assembly 100 as described in further detail below. For a more detailed description of a suitable stapling device, see U.S. Pat. Nos. 7,234,624, 7,364,060 and 7,857,187 (“the incorporated patents”) which are incorporated herein by reference in their entirety. [0031] Referring also to FIGS. 2-4 , the anvil assembly 100 includes an anvil head assembly 102 and an anvil shaft 104 . Although not specifically described in this application, the anvil head assembly 102 can be pivotally or fixedly attached to the anvil shaft 104 . Examples of pivotally attached anvil head assemblies are described in the incorporated patents. [0032] The anvil head assembly 102 includes a housing 106 that supports an anvil plate 108 ( FIG. 2 ) and a cut ring assembly 110 . The housing 106 has a smoothly curved distal surface 112 that facilitates atraumatic entry of the anvil assembly 100 into and through a body orifice or lumen. A proximal side of the housing 106 defines a cavity (not shown) that is configured to receive the anvil plate 108 and the cut ring assembly 110 . For a more detailed description of the components of the anvil head assembly 102 , see the incorporated patents. [0033] The anvil shaft 104 includes a longitudinal body portion 116 that includes a tubular portion 118 and a plurality of flexible legs 120 that extend proximally from the tubular portion 118 . Each of the flexible legs 120 has a semi-cylindrical configuration such that the legs 120 cooperate to define a longitudinal bore 122 ( FIG. 3 ) that is dimensioned to receive the trocar 22 of the stapling device 12 ( FIG. 1 ) when the anvil assembly 100 is secured to the stapling device 12 . The bore 122 extends from the proximal end of the flexible legs 120 at least partially into the tubular portion 118 of the anvil shaft 104 . [0034] In embodiments, the anvil shaft 104 may include a plurality of splines 126 positioned about the anvil shaft 104 . As is known in the art, the splines 126 mate with recesses (not shown) defined within the shell assembly 16 FIG. 2 ) of the surgical stapling device 12 to properly orient the staple cartridge 20 in relation to the anvil plate 108 of the anvil assembly 100 when the anvil assembly 100 and the shell assembly 18 are approximated. The anvil shaft 104 may also include one or more stabilization rings 130 (only one is shown) positioned about the anvil shaft 104 at a position to engage the shell assembly 16 when the anvil assembly 100 and the shell assembly 18 are approximated to provide added stability to the anvil assembly 100 . For a more detailed description of an anvil assembly including a stabilization ring, see U.S. Pat. No. 8,424,535 which is incorporated herein by reference in its entirety. Although the splines 126 and the stabilization ring 130 are shown to be formed integrally with the anvil shaft 104 , it is contemplated the either or both could be formed separately from the anvil shaft 104 and secured to the anvil shaft 104 using any known fastening technique including welding, crimping gluing or the like. [0035] Referring to FIGS. 4 and 5 , each of the flexible legs 120 of the anvil shaft 104 defines a longitudinal channel 134 with an adjacent leg 120 . Each longitudinal channel 134 includes an enlarged cutout or hole 136 formed at the distal end of the longitudinal channel 134 . The holes 136 are configured to secure a collet 150 within the longitudinal bore 122 of the anvil shaft 104 . In embodiments, the hole 136 is substantially circular although other configurations are envisioned. One or more of the flexible legs 120 may also include a bore 140 which is configured to receive a suture or the like (not shown). The suture can be used to allow a clinician to retrieve or position the anvil assembly 100 from or within a surgical site. The proximal end of each of the flexible legs 120 has an inner surface that defines a recess 160 ( FIG. 7 ) such that the recesses 160 collectively define an annular recess 160 a ( FIG. 9 ). The annular recess 160 a facilitates releasable engagement of the anvil assembly 100 to the stapling device 12 . [0036] Referring also to FIG. 6 , the collet 150 may be substantially rigid and is positioned within the longitudinal bore 122 defined by the anvil shaft 104 . The collet 150 is substantially cylindrical and defines a longitudinal bore 152 ( FIG. 7 ) that is dimensioned to receive the trocar 22 ( FIG. 10 ). A distal portion 154 of the collet 150 includes a plurality of cantilevered fingers 156 . Each of the fingers 156 includes a protrusion 158 that is dimensioned and configured to be received in a respective one of the holes 136 ( FIG. 5 ) formed in the anvil shaft 104 as described in further detail below. [0037] Referring to FIGS. 7-9 , in order to assemble the collet 150 within the anvil shaft 104 , the distal end of the collet 150 is inserted into the proximal end of the longitudinal bore 122 of the anvil shaft 104 and slid distally in the direction indicated by arrow “A” in FIGS. 7 and 8 . The collet 150 is positioned to align the protrusions 158 with the longitudinal channels 134 positioned between the flexible legs 120 . When the protrusions 158 engage an inner wall of the flexible legs 120 , the fingers 156 are deflected inwardly in the direction indicated by arrow “B” in FIG. 8 to facilitate passage of the collet 150 through the longitudinal bore 122 . When the protrusions 158 are moved into alignment with the holes 136 , the fingers 156 spring outwardly in the direction indicated by arrow “C” in FIG. 9 to move the protrusions 158 into the holes 136 to secure the collet 150 within the longitudinal bore 122 . [0038] Referring to FIG. 10 , the trocar 22 includes a pointed distal end 30 and an enlarged proximal portion 32 that defines a shoulder 32 a . As known in the art, the proximal end of the trocar 22 is secured to an approximation mechanism (not shown) of the stapling device 12 ( FIG. 1 ) to facilitate movement of the trocar 22 between retracted and advanced positions. When the trocar 22 is inserted into the longitudinal bore 122 of the anvil shaft 104 and the longitudinal bore 152 of the collet 150 in the direction indicated by arrow “D” in FIG. 10 , the enlarged proximal portion 32 of the trocar 22 engages a proximal end of the flexible legs 120 of the anvil shaft 104 to urge the flexible legs 120 outwardly in the direction indicated by arrows “E”. When the enlarged proximal portion 32 of the trocar 22 is moved distally in the direction indicated by arrow “D” into alignment with the recess 160 defined at the proximal end of the flexible legs 120 , the flexible legs 120 return to their undeformed configuration to receive the enlarged proximal portion 32 of the trocar 22 . When the enlarged proximal portion 32 is received within the recess 160 , the shoulder 32 a on the enlarged proximal portion 32 of the trocar 32 engages a proximal wall 161 defining the recess 160 to secure the anvil shaft 104 to the trocar 22 . [0039] During an endoscopic surgical procedure, the anvil assembly 100 is grasped with a grasper (not shown) that is inserted through a small incision in the skin to position the trocar 22 within the longitudinal bore 122 of the anvil shaft 104 and secure the anvil assembly 100 to the trocar 22 of the surgical stapling device 12 . The collet 150 is positioned within the longitudinal bore 122 of the anvil shaft 104 and extends from a distal end of the flexible legs 120 towards the proximal end of the flexible legs 120 to support the flexible legs 120 and inhibit radial compression or other deformation of the flexible legs 120 that may result from pressure applied to the flexible legs 120 by a manipulating instrument (not shown). Collet 150 may be formed from any suitable, medical grade material having a stiffness to perform the functions described herein. Suitable materials include, for example, stainless steel or nylon. The collet 150 is secured within the longitudinal bore 122 of the anvil shaft 104 in a position that does not interfere with outward flexing of the flexible legs 120 and, thus, allows the anvil assembly 100 to be readily connected to the trocar 22 . [0040] Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. It is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another without departing from the scope of the present disclosure. As well, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described embodiments. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

An anvil assembly is disclosed that includes an anvil shaft including a proximal portion and a distal portion and defining a first longitudinal bore. The proximal portion includes a plurality of flexible legs that define the first longitudinal bore dimensioned to receive a trocar of a stapling device. An anvil head assembly is secured to the distal portion of the anvil shaft and supports an annular anvil plate that a plurality of staple deforming pockets. The anvil assembly also includes a rigid collet defining a second longitudinal bore that is configured to receive the trocar of the stapling device. The rigid collet is supported within the first longitudinal bore and is positioned to prevent crushing of the plurality of flexible legs when the anvil assembly is manipulated with a grasper.

FIELD OF THE INVENTION The present invention relates to a method and apparatus for the destruction of the inner lining of body organs, and, more particularly, to a method and apparatus for the selective destruction of the endometrium. BACKGROUND OF THE INVENTION In certain circumstances it may be advantageous to destroy one or more layers of the inner lining of various body organs. Such destruction may be advantageous in the treatment or prevention of certain diseases or other physical conditions. In particular, dysfunctional uterine bleeding (DUB) which can be a problem for many women, and particularly for postmenopausal women. Various methods and apparatus have been used to destroy layers of living tissue without damaging the underlying layers. Some of the apparatus include devices for heating the layer to be destroyed using, for example, radio frequency energy and microwave energy. Alternatively, other thermal techniques for destroying the inner lining of various body organs include chemical treatments, cryotherapy, laser therapy and electrosurgery. U.S. Pat. No. 5,277,201 describes a method and apparatus for endometrial ablation utilizing an electrically conductive balloon adapted to supply Monopolar RF energy to the endometrial layer when the balloon is expanded within the body organ. U.S. Pat. No. 5,277,201 further illustrates a balloon device for use in endometrial ablation wherein the balloon surface includes a plurality of selectively excitable RF electrodes along with a plurality of selectable temperature sensors adapted to measure the temperature of the endometrium during the ablation process. U.S. Pat. No. 4,979,948 describes thermal ablation of the mucosal layer of a gallbladder by resistive heating with an RF balloon electrode. Electric current is delivered via a conductive expansion liquid which fills the balloon. Balloon catheters supplied with a heated fluid have also been used for thermal ablation of hollow body organs as described in U.S. Pat. No. 5,045,056. Application of microwave and high frequency RF energy to destroy tissue, using electrodes enclosed in expanded balloons have been described in, for example, U.S. Pat. Nos. 4,662,383 and 4,676,258. SUMMARY OF THE INVENTION According to the present invention, an apparatus for heating tissue in the interior of a body organ, for example the uterus, comprises an expandable element adapted to fit within the body organ wherein the expandable element is covered with a web of optically conductive material arranged to conduct light to the interior surface of the body organ. In this embodiment, the expandable element may include a reflective surface which reflects light from the optically conductive material to the interior surface of the body organ. In one embodiment of the present invention, the web of optically conductive material may be, for example, a web of optical fibers connected to one or more light sources, for example high intensity lamps or lasers, which generate the light energy transmitted by the optically conductive material. In a further embodiment of the present invention, temperature detection devices, for example thermocouples, are attached to the expandable element to measure the temperature of the lining of the body organ as it is being heated by the light energy transmitted by the optically conductive material. The present invention further includes a method of selectively heating the lining of a body organ utilizing the apparatus of the present invention including the steps of inflating the expandable element to fit within the body organ, heating the interior surface of the body organ by passing light energy from the light source through the optically conductive material to the lining. In addition, a method according to the present invention may include the step of measuring the temperature of the lining and selectively turning the light sources on and off to control the temperature of the lining. BRIEF DESCRIPTION OF THE DRAWINGS The novel features of the invention are set forth with particularity in the appended claims. The invention itself, however, both as to organization and methods of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which: FIG. 1 illustrates an optical ablation system according to the present invention including an ablation instrument and an electro-optic generator. FIG. 2 is a cross sectional view of the ablation instrument illustrated in FIG. 1 along view line 2--2. FIG. 3. illustrates an optical ablation system according to the present invention including an ablation instrument and an alternative embodiment of an electro-optic generator. FIG. 4 is a cutaway view of a cross section of an expandable diffusing web according to the present invention. FIG. 5 is a cutaway side view of the distal end of the ablation instrument according to the present invention prior to deployment of the expandable diffusing web. FIG. 6 is a cutaway side view if the distal end of the ablation instrument according to the present invention after deployment of the expandable diffusing web. FIG. 7 is a side view of a balloon for use in the present invention. FIG. 8 is a side view of the distal end of the ablation instrument according to present invention illustrating a first optical fiber mesh with a first thermocouple. FIG. 9 is a side view of the distal end of an ablation instrument according to the present invention illustrating first and second heating element segments including first and second thermocouples. FIG. 10 is a side view of the distal end of an ablation instrument according to the present invention illustrating first, second and third heating element segments including first, second and third thermocouples. FIG. 11 is a flow diagram illustrating one embodiment of the control flow for the electro-optic circuitry for an ablation instrument according to the present invention. FIG. 12 is a flow diagram illustrating one embodiment of the control flow for the electro-optic circuitry for an ablation instrument according to the present invention. DETAILED DESCRIPTION OF THE INVENTION FIG. 1 illustrates an optical ablation system 15 according to the present invention including an ablation instrument 10 and an electro-optic generator 11. In FIG. 1, Optical Energy in the form of light is supplied to ablation instrument 10 by electro-optical generator 11. As used herein, the term "optical" is intended to include that portion of the electromagnetic spectrum including radiation in the ultraviolet, visible and infrared wavelengths. Electro-optical generator 11 includes an optical energy source 12, one or more energy coupling devices 14, one or more optical filters 16, one or more variable attenuators 18 which may also comprise a variable neutral density filter, one or more fiber optic bundles 20, one or more thermocouple inputs 24 and control circuitry 22. Optical energy source 12 may be, for example, a laser, a halogen lamp, a conventional incandescent lamp or other optical energy source. Optical energy source 12 may be a single source which provides light which is white or spectrally pure at a specific wavelength. Alternatively, Optical energy source 12 may include a plurality of light sources having any combination of wavelengths and power levels. Optical energy source 12 is coupled to fiber optic bundle 20 by energy coupling lens 14, optical filter 16 and variable attenuator 18. Energy coupling lens 14 focuses optical energy from optical energy source 12 through optical filter 16 and variable attenuator 18 onto the proximal end of fiber optic bundle 20. The intensity and/or wavelength of optical energy source 12 may be controlled by, for example, signals from control circuit 22 transmitted through control line 72. Optical filter 16 may be a single frequency filter adapted to filter out all but one of the wavelengths generated by optical energy source 12. Alternatively, Optical filter 16 may be a plurality of selectable filters from which a filter effective at one or more wavelengths may be chosen to selectively filter optical energy generated by optical energy source 12. Optical filter 16 may also be a spectral filter adapted to pass energy within a band of wavelengths. Optical filter 16 may also be a filter wheel which contains a number of band pass filters. The wavelength of light filtered by optical filter 16 may be controlled by, for example, signals from control circuit 22 transmitted through control line(s) 70. After passing through optical filter 16, energy from optical energy source 12 passes through variable attenuator 18. Variable attenuator 18 may also be referred to as a variable neutral density filter. Variable attenuator 18 is adapted to control the energy level of the light which is focused on to the proximal end of fiber optic bundle 20. The setting of variable attenuator 18 may be controlled by, for example, signals from control circuit 22 transmitted through control line(s) 74. The energy passed by variable attenuator 18 may be controlled by signals from control circuit 22 to ensure that the appropriate energy level is input to the proximal end of fiber optic bundle 20. Energy coupling lens 14 may include a plurality of energy coupling lenses, for example the three energy coupling lenses 14a, 14b and 14c illustrated in FIG. 1. Optical filter 16 may include a plurality of optical filters, for example, the three optical filters 16a, 16b and 16c illustrated in FIG. 1. Variable attenuator 18 may include a plurality of variable attenuators, for example, the three variable attenuators 18a, 18b and 18c illustrated in FIG. 1. In addition, fiber optic bundle 20 may include a plurality of fiber optic bundles, for example, the three fiber optic bundles illustrated in FIG. 1. The number of energy coupling lenses, optical filters, variable attenuators and fiber optic bundles will depend upon the design of the ablation system 15, however, the number of coupling lenses, optical filters, variable attenuators and fiber optic bundles will generally correspond to the number of regions the ablation instrument is designed to separately heat within the body cavity being treated. Electro-optic generator 22 includes temperature signal wires 24 which are adapted to relay signals representative of the temperature at selected points at the distal end of ablation instrument 10 to control circuit 22. The number of temperature signal wires 24 will depend upon the design of ablation system 15, however, the number of thermocouple inputs will generally correspond to a multiple of the number of regions the ablation instrument is designed to separately heat. In the embodiment of the ablation instrument illustrated in FIG. 1, the electro-optic generator includes three temperature signal wires 24a, 24b and 24c. In one embodiment of the present invention, temperature signal wires 24 comprise a pair of wires which are connected through ablation instrument 10 to a thermocouple at a distal end of the ablation instrument. Fiber optic bundles 20 and temperature signal wires 24 terminate at generator connector 19 which is adapted to mate with instrument connector 26. In FIG. 1, instrument connector 26 is shown in cutaway view to show fiber optic bundles 21a, 21b and 21c and to show thermocouple inputs 25a, 25b and 25c which are positioned within instrument connector 26 and flexible sleeve 27. Fiber optic bundles 20 exit electro-optic generator 11 at generator connector 19 where each fiber optic bundle 20a, 20b and 20c is butt-coupled to a corresponding fiber optic bundle 21a, 21b and 21c such that optical energy is transmitted from fiber optic bundles 20a, 20b and 20c to fiber optic bundles 21a, 21b and 21c, respectively. Temperature signal wires 24 also exit electro-optic generator 11 at generator connector 19 where temperature signal wires 24a, 24b and 24c are connected to temperature signal wires 25a, 25b and 25c, respectively. Fiber optic bundles 21 and temperature signal wires 25 pass through flexible sleeve 27 to instrument handle 28 and through instrument handle 28 to rigid sleeve 34. Instrument handle 28 includes connector 35, fluid source connector 29, sleeve retractor 32, sleeve retractor stop 33 and fluid line 36. Flexible sleeve 27, terminates at connector 35 while fiber optic bundles 21 and temperature signal wires 25 pass through connector support 27 and the central portion of instrument handle 28 to the central annulus of rigid sleeve 34. Fluid source connector 29, which is adapted to receive a fluid source such as, for example, syringe 30, is connected to fluid line 36. In the embodiment of FIG. 1, syringe 30 includes plunger 31 which is adapted to force fluid, for example air, through fluid line 36. Fluid line 36 extends from fluid source connector 29 to the annulus of rigid sleeve 34. In instrument handle 28 as illustrated in FIG. 1, sleeve retractor 32 is connected to sleeve collar 37 which is connected to rigid sleeve 34 such that rigid sleeve 34 may be retracted in the proximal direction by moving sleeve retractor 32 in the proximal direction. The travel of sleeve retractor 32 is limited by sleeve retractor stop 33, thus limiting the proximal travel of rigid sleeve 34. As rigid sleeve 34 is retracted, expandable sleeve tip 40 at the distal end of rigid sleeve 34 opens, releasing the balloon or other device positioned in the central annulus of rigid sleeve 34 at the distal end of sleeve 34. FIG. 2 is a cross sectional view of the ablation instrument illustrated in FIG. 1 along view line 2--2. In FIG. 2, fluid line 36 is surrounded by fiber optic bundles 21a, 21b and 21c and by temperature signal wires 25a, 25b and 25c. As illustrated in FIG. 2, fiber optic bundles 21a, 21b and 21c each include one or more fiber optic fibers 38 which are adapted to transmit optical energy. Temperature signal wires 25 are adapted to transmit signals representative of temperature. Fluid line 36 is adapted to transmit fluid such as, for example, air. FIG. 3 illustrates an optical ablation system according to the present invention including an ablation instrument and an alternative embodiment of an electro-optic generator. In the embodiment of electro-optic generator 11 illustrated in FIG. 3, optical energy source 12 of FIG. 1 is divided into a plurality of controllable optical energy sources 12a, 12b and 12c. In one embodiment of the present invention, the intensity of optical energy sources 12 is controllable and the energy from optical energy sources 12a, 12b and 12c is controlled by energy control signals from control circuit 22 which are transmitted through, for example, control lines 72. Each of energy sources 12a, 12b and 12c pass optical energy through energy coupling lenses 14a, 14b and 14c respectively. Energy coupling lenses 14a, 14b and 14c focus optical energy on fiber optic bundles 20a, 20b and 20c through optical filters 16a, 16b and 16c respectively. In one embodiment of the present invention, optical filters 16 may include a plurality of selectable optical filters which may be selected by filter selection signals from control circuit 22 which are transmitted through, for example, control lines 70. The number of energy coupling lenses, optical filters and fiber optic bundles will depend upon the design of ablation system 15, however, the number of coupling lenses, optical filters and fiber optic bundles will generally correspond to the number of regions the ablation instrument is designed to separately heat within the body cavity being treated. In all other respects, the ablation system 15 illustrated in FIG. 3 is substantially identical to the ablation system 15 illustrated in FIG. 1. FIG. 4 is a cutaway view of a cross section of an expandable diffusing web 46 according to the present invention. In FIG. 3 expandable defusing web 46 includes reflective coating 42, balloon 44, optical fiber mesh 47 and an adhesive layer 50 for attaching the fiber optic mesh to the balloon. Reflective coating 42 may be, for example, a coating of silver or other reflective material which covers the outer surface of Balloon 44. Balloon 44 may be constructed of, for example, mylar or other expandable balloon material. Optical fiber mesh 47 may include optical fibers 48, reflective fiber terminator 52 and fill threads 49. Fill threads 49 may be solid as illustrated in FIG. 4. Alternatively, fill threads 49 may be made of an optically conductive material. Optical fiber mesh 47 may be, for example, a light emitting woven light emitting panel which is manufactured by Ploy-Optic or by Lumitex. Reflective fiber terminator 52 is located at the end of optical fiber 48 to reflect any optical energy which reaches the end of optical fiber 48 without being diffused. FIG. 5 is a cutaway side view of the distal end of ablation instrument 10 according to the present invention prior to deployment of expandable diffusing web 46. In FIG. 5, the distal end of rigid sleeve 34, including expandable diffusing web 46 is disposed within uterus 56. Expandable diffusing web 46 is folded to fit within rigid sleeve 34. The interior of uterus 56 is covered by an endometrial layer 58. As rigid sleeve 34 is withdrawn, by, for example moving sleeve retractor 32, expandable diffusing web 46 forces expandable sleeve tip 40 open, exposing expandable diffusing web 46. Fluid line 36 is connected to the proximal end of expandable diffusing web 46 such that a fluid, such as air, supplied at fluid source connector 29 fills the interior of expandable diffusing web 46, forcing expandable diffusing web 46 to expand. FIG. 6 is a cutaway side view if the distal end of ablation instrument 10 according to the present invention after deployment of expandable diffusing web 46. In FIG. 6, rigid sleeve 34 has been retracted, exposing expandable diffusing web 46. Expandable diffusing web 46, which includes balloon 44 and optical fiber mesh 47 is expanded to fit against endometrial lining 58 of uterus 56 by filling balloon interior 60 with a fluid such as air. Fluid line 46 connects balloon interior 60 to fluid source connector 29. FIG. 7 is a side view of a balloon 44 for use in the present invention. It will be recognized that balloon 44 may be shaped to fit within any body cavity, however, in the embodiment of the invention described herein, expandable diffusing web 46 is designed to be used within the uterus to destroy the endometrial lining. Thus, balloon 44 illustrated in FIG. 7 is shaped to fit within the uterus and to hold the optical fiber mesh firmly against at least a substantial portion of the endometrial lining. Nor is it necessary that the invention be limited to the use of a balloon as an expandable element since any means of expanding expandable diffusing web 46 to position optical fiber mesh near or adjacent the interior lining (e.g. the endometrium) of the body cavity to be treated is within the scope of the present invention. In FIG. 7, balloon 44 has been expand ed by filling interior 60 with an appropriate fluid, such as air, and the expanded balloon 44 takes on the shape of the interior of a uterus. FIG. 8 is a side view of the distal end of ablation instrument 10 according to the present invention illustrating a portion of expandable diffusing web 46 which includes a first optical fiber mesh 47a. The embodiment of the invention illustrated in FIG. 8 further includes a first thermocouple 62a. In FIG. 8, optical fiber mesh 47a is disposed on the distal end of balloon 44. In FIG. 8, optical fiber mesh 47a includes optical fibers 48a which are interwoven with fill threads 49a. At their proximal end, optical fibers 48a of optical fiber mesh 47a are connected to the distal end of one of fiber optic bundles 21 which extend through rigid sleeve 34, alternatively, optical fibers 48a of optical fiber mesh 47a may be a continuation of one of the optic fiber bundles 21. For example, the proximal ends of fiber optics 48a may be gathered together to form an optical fiber bundle 51a which is connected to, for example, the distal end of fiber optic bundle 21a using, for example a butt-connector such as the one used to connect fiber optic bundle 20a with fiber optic bundle 21a, alternatively, fiber bundle 51a may be a continuation of the distal end of fiber optic bundle 21a. Fiber optic bundle 21a is joined to or disperses to form optical fibers 48a such that optical energy is passed from fiber optic bundle 21a to optical fibers 48a, thus optical energy generated at optical energy source 12 may be transmitted through fiber optic bundle 20a to fiber optic bundle 21a and through fiber optic bundle 21a to optical fibers 48a of optical fiber mesh 47a. Thermocouple 62a is positioned to detect the temperature of tissue adjacent optical fiber mesh 47a. Temperature signal wires 25a, being connected to thermocouple 62a, relay a signal representative of the temperature at thermocouple 62a to temperature signal wires 24a which, in turn relay the signal to control circuit 22. Optical fiber mesh 47a, being positioned on balloon 44, is held in place against the tissue to be treated by the expansion of balloon 44 as a result of the fluid supplied through fluid line 36. FIG. 9 is a side view of the distal end of ablation instrument 10 according to the present invention illustrating a portion of expandable diffusing web 46 which includes a first optical fiber mesh 47a and a second optical fiber mesh 47b. The embodiment of the invention illustrated in FIG. 9 further includes a first thermocouple 62a and a second thermocouple 62b. In FIG. 9, a second optical fiber mesh 47b has been wrapped around the distal end of the balloon illustrated in FIG. 8 to increase the surface area of balloon 44 covered by optical fiber mesh 47. Thus, the previous description of the instrument with respect to FIG. 8 is applicable with respect to like elements of FIG. 9. In addition to the elements described with respect to FIG. 8, FIG. 9 illustrates optical fiber mesh 47b which includes optical fibers 48b which are interwoven with fill threads 49b. At their proximal end, optical fibers 48b of optical fiber mesh 47b are connected to the distal end of one of fiber optic bundles 21 which extend through rigid sleeve 34. For example, the proximal ends of fiber optics 48b may be gathered together to form an optical fiber bundle 51b which is connected to, for example, the distal end of fiber optic bundle 21b using, for example, a butt-connector such as the one used to connect fiber optic bundle 20b with fiber optic bundle 21b, alternatively, fiber bundle 51b may be a continuation of the distal end of fiber optic bundle 21b. Fiber optic bundle 21b is joined to optical fibers 48b such that optical energy is passed from fiber optic bundle 21b to optical fibers 48b, thus optical energy generated at optical energy source 12 may be transmitted through fiber optic bundle 20b to fiber optic bundle 21b and through fiber optic bundle 21b to optical fibers 48b of optical fiber mesh 47b. Thermocouple 62b is positioned on balloon 44 to detect the temperature of tissue adjacent optical fiber mesh 47b. Temperature signal wires 25b, being connected to thermocouple 62b, relay a signal representative of the temperature at thermocouple 62b to temperature signal wires 24b which, in turn, relay the signal to control circuit 22. Optical fiber mesh 47b, being positioned on balloon 44, is held in place against the tissue to be treated by the expansion of balloon 44 as a result of the fluid supplied through fluid line 36. FIG. 10 is a side view of the distal end of ablation instrument 10 according to the present invention illustrating a portion of expandable diffusing web 46 which includes a first and optical fiber mesh 47a, a second optical fiber mesh 47b and a third optical fiber mesh 47c. The embodiment of the invention illustrated in FIG. 10 further includes a first thermocouple 62a, a second thermocouple 62b and a third thermocouple 62c. In FIG. 10, a third optical fiber mesh 47c has been wrapped around the distal end of the balloon illustrated in FIG. 8 and FIG. 9 to increase the surface area of balloon 44 covered by optical fiber mesh 47. Thus, the previous description of the instrument with respect to FIG. 8 and FIG. 9 is applicable with respect to like elements of FIG. 10. In addition to the elements described with respect to FIG. 8 and FIG. 9, FIG. 10 illustrates an optical fiber mesh 47c which includes optical fibers 48c which are interwoven with fill threads 49c. At their proximal end, optical fibers 48c of optical fiber mesh 47c are connected to the distal end of one of fiber optic bundles 21 which extend through rigid sleeve 34. For example, the proximal ends of fiber optics 48c may be gathered together to form an optical fiber bundle 51c which is connected to, for example, the distal end of fiber optic bundle 21c using, for example, a butt-connector such as the one used to connect fiber optic bundle 20c with fiber optic bundle 21c, alternatively fiber bundle 51c may be a continuation of the distal end of fiber optic bundle 21c. Fiber optic bundle 21c is joined to optical fibers 48c such that optical energy is passed from fiber optic bundle 21c to optical fibers 48c, thus optical energy generated at optical energy source 12 may be transmitted through fiber optic bundle 20c to fiber optic bundle 21c and through fiber optic bundle 21c to optical fibers 48c of optical fiber mesh 47c. Thermocouple 62c is positioned on balloon 44 to detect the temperature of tissue adjacent optical fiber mesh 47c. Temperature signal wires 25c, being connected to thermocouple 62c, relay a signal representative of the temperature at thermocouple 62c to temperature signal wires 24c which, in turn, relay the signal to control circuit 22. Optical fiber mesh 47c, being positioned on balloon 44, is held in place against the tissue to be treated by the expansion of balloon 44 as a result of the fluid supplied through fluid line 36. The embodiment of the invention illustrated in FIG. 1 is adapted to controllably heat three separate regions within the uterus of a human patient to selectively destroy the endometrial layer within those regions. The energy and depth of penetration of the optical energy may be controlled by controlling the energy level and wavelength of the energy transmitted to the proximal end of each fiber optic bundle 20a, 20b and 20c. Longer wavelengths penetrate deeper into tissue. Shorter wavelengths, for example, blues and greens, may be used to achieve surface heating. Thus, depending on the effect that is desired, different wavelength of optical energy may be selected. Optical energy is transmitted through optical bundles 20 to optical bundles 21 and optical bundles 51. Optical energy which passes through optical bundles 51 is diffused by optical fiber mesh 47 of expandable diffusing web 46. Reflective coating 42 acts to reflect optical energy away from balloon 44 and into tissue surrounding expandable diffusing web 46. The depth of penetration of the optical energy into surrounding tissue will be a function of a number of factors, including the wavelength of the optical energy radiated by expandable diffusion web 46 and the distance from the expandable diffusion web 46 to the tissue to be treated. The rate at which the tissue is heated will also depend upon a number of factors, including the output energy generated by optical energy source 12, the losses in electro-optic generator 11 and ablation instrument 10, the distance from the expandable diffusion web 46 to the tissue to be treated and the wavelength of the optical energy. However, by monitoring the tissue as it is treated using, for example, thermocouples 62, the surgeon may control the temperature of the tissue being treated with relative accuracy. In use a surgeon will introduce the distal end of ablation instrument 10 into the body cavity of a patient such that expandable sleeve tip 40 is positioned at a predetermined depth within the body cavity. For the purposes of this discussion, the body cavity to be treated will be the uterus of a female human being. It will be recognized that, with slight modification, the present invention may be used to treat other body cavities. Once sleeve tip 40 is inserted into the uterus 56 as illustrated in FIG. 5, sleeve retractor 32 may be used to slide rigid sleeve 34 back away from expandable diffusing web 46. As rigid sleeve 34 is retracted, expandable diffusing web 46 forces expandable sleeve tip 40 open. Once sleeve retractor 32 reaches its proximal most travel point it is stopped by sleeve retractor stop 33 which prevents rigid sleeve 34 from retracting further. Once rigid sleeve 34 is retracted, expandable diffusing web 34 may be expanded to contact the interior of the uterus by, for example inflating balloon 44 by injecting an appropriate fluid, such as, for example air into balloon interior 60. Fluid is introduced into balloon 44 through fluid line 36 which is connected to fluid source connector 29 which, in the embodiment illustrated in FIG. 1, is connected to a syringe and plunger which may be used to inflate or deflate balloon 44. Expandable diffusing web 46, being shaped to fit the body cavity, e.g. the uterus, being treated, is designed to force optical fiber mesh 47 against a substantial portion of the interior surface of the body cavity. Thus, when expandable diffusing web 46 is fully expanded, optical fiber mesh 47 is positioned directly adjacent or in direct contact with endometrium 58 of uterus 56. Once expandable diffusing web 46 is positioned within uterus 56, optical energy may be supplied to optical fiber mesh 47 by turning on optical energy source 12. Once optical energy source 12 is turned on, the light radiated by optical energy source 12 is focused on the proximal end of optical fiber bundle 20 by energy coupling lens 14. As optical energy passes through optical filter 16, it is filtered to remove unwanted wavelengths. As optical energy passes through variable attenuator 18 the energy level is attenuated. Therefore, the optical energy focused upon fiber optic bundle 20 is filtered and attenuated such that it is optical energy of a selected wavelength and energy level. Optical energy focused upon the proximal end of fiber optic bundle 20 is transmitted through fiber optic bundle 20 to fiber optic bundle 21 and from fiber optic bundle 21 to expandable diffusing web 46 where it is radiated into the endometrial layer from optical fiber mesh 47. Where different optical energy levels or wavelengths are to be transmitted to different regions of the endometrium, a plurality of energy coupling lenses 14a-14c, optical filters 16a-16c and variable attenuators 18a-18c may be used to focus filtered optical energy onto a plurality of fiber optic bundles 20a-20c as illustrated in FIG. 1. Alternatively, where different optical energy levels or wavelengths are to be transmitted to different regions of the endometrium, a plurality of optical energy sources 12a-12c, energy coupling lenses 14a-14c and optical filters 16a-16c may be used to focus filtered optical energy onto a plurality of fiber optic bundles 20a-20c as illustrated in FIG. 2. The optical energy focused on optical bundles 20a-20c may then be transmitted through optical fiber bundles 21a-21c to each optical fiber mesh 47a-47c. Once the optical energy reaches expandable diffusing web 46, it is radiated by optical fibers 48 which are woven with fill threads 49 to form optical fiber mesh 47. Radiation from optical fibers 48 which is not directed into the tissue adjacent optical fiber mesh 47 is reflected by reflective coating 42 as illustrated in FIG. 4. Thus, both the energy radiated toward the tissue and the reflected energy is absorbed by the tissue adjacent to fiber optic mesh 47. Further, since the energy is transmitted optically, it is not necessary for the tissue to be directly adjacent fiber optic mesh 47 as the radiated energy will be absorbed by any tissue illuminated by the energy from the mesh. This arrangement provides for uniform escape or emission of energy focused on the fiber optic bundles 20 in fiber optic generator 11. Further, in an arrangement according to the present invention, energy is evenly radiated from the outside of the expandable diffusing web, and is, therefore absorbed by the endometrial lining of the uterus causing temperature of the tissue to rise. The control sequence for control circuit 22 of the electro-optic generator illustrated in FIG. 1 is illustrated in FIG. 11. Once expandable diffusing web 46 has been positioned and inflated as described previously, optical energy may be supplied to expandable web 46 to heat endometrial lining 58. The first step in supplying optical energy to endometrial lining 58 is to select an appropriate wavelength. In particular, red and near infrared wavelengths would be selected for heating deep (e.g. 0-10 millimeters) into uterine tissue. Ultraviolet, blue or green wavelengths would be used for heating uterine tissue to a depth of, for example, (0-3 millimeters). Once the appropriate optical energy wavelength has been selected by, for example, adjustment of optical filter 16 or by appropriate selection of optical energy source 12, optical energy may be supplied to expandable web 46. The energy level or intensity of the optical energy supplied to expandable web 46 may be controlled by controlling the attenuation of variable attenuators 18 or by controlling the intensity of optical energy source 12. Temperature feedback from thermocouple 62 may be used to adjust the energy level supplied to fiber optic bundles 20. Thus, the temperature of the body lining being treated is controlled by controlling the energy level supplied to expandable web 18 while the depth of penetration of the energy supplied to expandable web 46 is controlled by controlling the wavelength of the optical energy supplied to fiber optic bundles 20. The flow diagram of FIG. 11 illustrates the control sequence for the electro-optic generator illustrated in FIG. 1. The temperature of endometrial lining 58 is sensed by, for example, thermocouple 62 which provides a signal to control circuit 22 through temperature signal wires 24 and 25. As illustrated in FIG. 11, control circuit 22, in step 67, senses the temperature at thermocouple 62 and produces a signal 100 which is representative of the temperature measured at thermocouple 62. In step 68, signal 100 is compared to a predetermined set point temperature such as, for example, any temperature between 42° C. and 100° C. for a time sufficient to destroy the inner lining of the organ in question. If the temperature represented by signal 100 is lower than the set point temperature, control circuit 22 generates a signal 103. In step 71, signal 103 causes control circuit 22 to decrease the attenuation of the optical energy focused on optical fiber bundle 20, thus increasing the optical energy supplied to expandable web 46. Once the attenuation has been reduced, control circuit 22 generates a signal 105 which causes control circuit 22 to return to step 67 where the temperature is measured again and a new signal 100 is generated. Once the temperature represented by signal 100 reaches the set point temperature control circuit 22, in step 69, generates a signal 106 which is representative of the time the endometrium has been at the desired temperature. The time represented by signal 106 is compared, in step 72 to a predetermined set time and if the time represented by signal 106 is less than the predetermined set time, control circuit 22 generates signal 107 which returns control circuit 22 to step 67. If during the control cycle, the signal 100 rises above the set point temperature, then signal 102 is generated, causing control circuit 22 to increase attenuation at variable attenuators 18, thus decreasing the optical energy delivered to expandable diffusing web 46. Once the actual time at the desired temperature, represented by signal 106, reaches the predetermined set time in step 72, signal 108 is generated indicating, in step 73, that the procedure is complete and generating signal 109 which turns off optical energy source 12 in step 74. The flow diagram of FIG. 12 illustrates the control sequence for the electro-optic generator illustrated in FIG. 2. The temperature of endometrial lining 58 is sensed by, for example, thermocouple 62 which provides a signal to control circuit 22 through temperature signal wires 24 and 25. As illustrated in FIG. 12, control circuit 22, in step 80, senses the temperature at thermocouple 62 and produces a signal 200 which is representative of the temperature measured at thermocouple 62. In step 81, signal 200 is compared to a predetermined set point temperature. If the temperature represented by signal 200 is lower than the set point temperature, control circuit 22 generates a signal 203. In step 84, signal 203 causes control circuit 22 to increase the optical energy from optical energy source 12 which increases the intensity of the optical energy focused on optical fiber bundle 20, thus increasing the optical energy supplied to expandable web 46. Once optical energy has been increased, control circuit 22 generates a signal 205 which causes control circuit 22 to return to step 80 where the temperature is measured again and a new signal 200 is generated. Once the temperature represented by signal 200 reaches the set point, temperature control circuit 22, in step 82, generates a signal 206 which is representative of the time the endometrium has been at the desired temperature. The time represented by signal 206 is compared, in step 85 to a predetermined set time and, if the time represented by signal 206 is less than the predetermined set time, control circuit 22 generates signal 207 which returns control circuit 22 to step 80. If during the control cycle, the signal 200 rises above the set point temperature, then signal 202 is generated, causing control circuit 22 to decrease the optical energy from optical energy source 12, which decreases the intensity of the optical energy focused on optical fiber 20, decreasing the energy delivered to expandable diffusing web 46. Once the actual time at the desired temperature, represented by signal 206, reaches the predetermined set time in step 85, signal 208 is generated indicating, in step 86, that the procedure is complete and generating signal 209 which turns off optical energy source 12 in step 87. In operation, ablation instrument 10 would be connected to electro-optic generator 11 and the distal end of instrument 10 would be inserted into the appropriate body organ, for example, into the uterus 56. Rigid sleeve 34 would then be retracted using sleeve retractor 32, thereby exposing expandable diffusing web 46 which includes balloon 44. Balloon 44 is inflated using, for example, balloon inflator syringe 30 which includes plunger 30. Once balloon 44 is inflated forcing expandable diffusing web 46 to conform to the interior of uterus 56, electro-optic generator 11 is activated, thus delivering optical energy to optical fibers 48 of optical fiber mesh 47 on expandable diffusing web 46. Control circuit 22 is then used to monitor the heating of endometrial layer 58 of uterus 56 through thermocouple(s) 62. Control circuit 22 acts to bring endometrial layer 58 up to a desired temperature, hold endometrial layer 58 at that temperature for a predetermined length of time and then turn off optical energy to the endometrial layer. Expandable diffusing web 46 may then be collapsed by deflating balloon 44 using, for example syringe 30. Once expandable diffusing web 46 is deflated, it may be retracted from uterus 56. Use of an ablation instrument according to the present invention may be advantageous, when compared to electrosurgical or other apparatus for use in endometrial ablation, for example: Light energy may be less likely to interfere with the operation of the thermocouples; a light diffusing fiber-optic web may be more adaptable to expansion than RF electrodes; contact with the uterine wall is not required as it may be in an RF device; it is possible to control the depth of heating by controlling the wavelength of the optical energy applied to the endometrial lining. According to one embodiment of the present invention, light energy from optical energy source 12, which may be, for example, common projection lamps, may be used to uniformly heat the endometrium 58° to 70° C. and thereby ablate the endometrium. The array of fiber-optic mesh or webs 47 are connected individually to an array of high intensity lamps 12 via fiber-optic cables 20 and 21. Fiber optic mesh 47 may Heating of the endometrium 58 is achieved through absorption of the optical radiation transmitted through fiber optic cables 20 and 21. The temperature of each fiber optic web, for example fiber optic webs 47a-47c, is monitored by a thermocouple, for example 62a-62c, which, through a feedback loop including temperature signal wires 24 and 25 which are connected to control circuitry 22, controls the intensity of its associated lamp 12. In this embodiment, fiber-optic mesh 47 and thermocouples 62 cover the outside of an inflatable silvered mylar pouch or balloon 44. Balloon 44 is inserted into the uterus and then inflated. Inflation brings fiber-optic webs 47 and thermocouples 62 into contact with the endometrium or endometrial layer 58. Lamps 12 are then turned on and the temperature of the endometrium is monitored intensity of the optical energy supplied to fiber optic webs 47 is controlled by monitoring feedback from thermocouples 62 until therapy is complete. The silvered surface of mylar balloon 44 directs all the optical radiation into the endometrium for heating. While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.

A method of performing endometrial ablation comprising heating entire surface of the endometrium to a temperature of between 45° C. and 70° C. to destroy the cells of the endometrial lining while maintaining the average temperature of the myometrium at a temperature below approximately 42° C. An apparatus for performing an endometrial ablation comprising an expandable membrane such as a balloon adapted to fit within the uterus and contact the endometrial lining when expanded. A web of light diffusing fiber-optic cables arranged on the outer surface the balloon such that the web contacts the endometrial lining of the uterus when the balloon is expanded. The fiber-optic web is connected to an array of high intensity lamps via a series of fiber-optic cables. The temperature of the endometrium is monitored by a of a series of temperature sensors arranged upon the surface of the balloon.

BACKGROUND OF THE INVENTION 1. Field of the Invention The invention concerns a highly concentrated mineralised natural complex and the method for its production, with respect to the integration of mineral oligoelements in pharmaceutical, cosmetic and herbal field, for human and animal usage, and for the care of the flora in general. 2. Description of Related Art Currently, elements obtained by the purification of inorganic material, or, for example, through operations of synthesis, hemi-synthesis, chelation, complexation are being used as integrators of minerals oligoelements. The so obtained inorganic formulations present considerable problems of absorption and side effects. The ingested substances are thereby absorbed in a very little amount, consequently inducing the user to ingest considerable quantities, so that the absorbed ones can quantitatively satisfy the individual need. Another disadvantage of the products obtained with the known technique is the one due to the undesired side effects, for example, after the ingestion of substances used for integrating iron gastric disturbances may occur. On the other hand, it is known that some organic substances, such as some vegetable and/or animal products, contain oligominerals that are effective for man's health and simultaneously do not have negative side effects. However, those elements useful for man's health are contained in the above mentioned organic substances in very small percentages, hence they have poor therapeutic qualities. SUMMARY OF THE INVENTION The aim of the present invention is on the one hand to produce mineralised natural complexes of one or more mineral elements at a high concentration, which together predispose the human organism to their high absorption without producing negative side effects, on the other hand, the aim is to determine a process through which the mentioned complexes are realised. The process, related to this invention, which allows to reach such results, consists in resorting to natural substances, like vegetable and/or animal products, then, usually, in the carrying out of their mixing in definite proportions, therefore in their treatment until the inorganic part is separated from the organic one, and finally, in the transformation of the produced minerals blend into an easily administrated product, like capsules and tablets. For the consumer their intake is the equivalent to the intake of a quantity of minerals comparable in a qualitative and quantitative way to the ones that would be taken, in favourable cases, with the ingestion of an initial high quantity of vegetable or animal material. Moreover, the elaboration of organic natural products, among those containing an oligomineral mixture as close as possible to the wanted optimum, allows to obtain a mineral formulation that has a high biological affinity for man, with a greater bio-availability and compared with those that are nowadays on the market less harmful side effects. These formulation which for the complexity of the elements contained even in traces, cannot absolutely be chemically reconstructed. The invention through which such results have been reached, is realised on the one hand with natural mineralised complexes with a high concentration of one or more main elements of vegetable and/or animal origin and a plurality of other elements equally useful to the human organism, and on the other hand with a process for their production realised through the mixing, in definite proportions, of the vegetal or animal products to be mineralised, and also with their mineralization through the elimination of the organic portion. Such process is, therefore, characterised by the treatment of natural organic products in order to obtain a mineralised complex containing all the mineral substances originally contained in the raw material treated first in form of oxides and other salts. Such mineralised complexes will be titrated in each element by considering those that are contained in a larger quantity, for example calcium, iron, zinc, potassium, copper, magnesium and manganese, and the aforesaid mineralised complexes will be finally checked to ascertain the absence of elements recognised as toxic, such as lead, cadmium and mercury. The mineralised natural complexes so produced permit to reach advantageous results, as described here below, unlike the use of single mineral elements obtained with methods known nowadays. In particular, they allow the organism to be integrated not only with the single primary elements, prevailing in the mineralised complex, but also with an innumerable series of other useful minerals that the mineralised complex contains in a composition which is formulated in nature. For instance, instead of assuming only "Gluconate Iron" as with the existing technique, the mineralised complex is taken as obtained from a mixture of vegetal products such as Capsella bursa pastoris, of which the upper part is used, Cynara of which the leaves are used, Salvia offinalis, of which the leaves are used. Such complex allows to intake iron in form of oxide and salts together with many other oligoelements, such as calcium, zinc, magnesium, potassium, sodium, copper and manganese, besides other ones in tiny traces, which aid the assimilation of iron without creating harmful side effects. The elaboration of natural organic products allows, that is to say, to produce a mineralised complex from which the human organism perfectly absorbs most of the various oligomineral elements contained in the same complex. The natural formula, possessing precise qualitative and quantitative relations of the single elements--probably due to biological affinity--determines a much greater absorption than the one obtained by ingesting the single elements presently used. Both the ratios between the single elements and the association between the single substances can be the cause of the considerable absorption of these last ones by the organism. In fact, many of the substances present in minimum doses, even if untraceable, act as catalysts, therefore helping the absorption of the primary element needed for the desired integration. Another advantage is due to the minor side effects resulting from the nature of the formulation more compatible with man. BRIEF DESCRIPTION OF THE DRAWING More characteristics of the invention will be evident from the following detailed description with reference to the process illustrated on the block diagram, provided only as example, in the enclosed drawing, which shows in schematic form a flow diagram of the apparatus elements associated with performing the invention, and the steps of the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS In the process exemplified in the drawing figure: 1 indicates the tank containing the mixture of vegetable and/or animal natural products, each one in a clean and fragmented state, containing one or more primary mineral elements in addition to those in smaller quantities, combined with organic substances to be eliminated; 2 indicates the heated cell, normally at a temperature included between 200° and 900° C., in which the mixture coming from container 1 is mineralised, therefore the organic portion is normally separated in vapours and fumes. The mineralised complex in container 3 is a mineral complex characterised by a qualitative and quantitative composition of the chosen primary mineral elements, each one combined with a plurality of mineral elements already present, sometimes in minimum measures, on the vegetal and/or animal products from which they are originally produced and contained. The product coming out from group 3 is in one case conveyed directly to chamber 6, and in the other case conveyed to mixer 4 in which it is mixed with other active principles coming from container 5 in order to originate in chamber 6 the mixture that is to be transformed into capsules or tablets, then to be packed and after distributed on the market. In the general formulation the production process of a mineral complex first foresees the quantitative determination of the metals that one wishes to integrate, hence a selection of the vegetal and/or animal raw materials that present a particularly high content of the above-mentioned metals. After having accomplished the choice of the organic raw materials to be used, the process through which the wanted mineral complex is obtained, can be described in a detailed way as follows: The chosen raw materials are analysed to make sure that the element is to be integrated is constant in them. The selected raw materials are dried, then individually cut and sieved until obtaining a uniform granulometry that is adapted for being mineralised. The previously processed raw materials as described above, are eventually mixed between them in the right proportion in order to obtain in the final complex the content of principal elements as wanted in the ratio. The aforesaid mixture is distributed on trays of stainless steel until reaching a layer of 5 cm. for each tray. The trays are stacked in a muffle one on top of the others, with some space between them for combustion fumes to escape. The normally methane operating muffle is programmed in such a way to reach within it a temperature of approximately 200-400° C. for 1-3 hours, then it is raised to a temperature of about 500-900° C. for 3-5 more hours, or anyway until the complete removal of the organic portion from the mixture of drugs introduced. The first period of time, at a temperature of 200-400° C., is essential in order to obtain a perfect light coloured mineralised product, without any carbonised organic products. The mineralised product obtained from the muffle is subjected to a quantitative analysis for being titrated, at least in its main elements, and to a control in order to verify the absence of elements recognised as toxic. It can be conveyed in the packaging division, or first mixed with additional chosen active principles, and hence sent to the packaging. However, the invention is illustrated here as follows with reference to two applications for the production of different highly concentrated mineralised natural complexes. EXAMPLE 1 A Mineral Complex Particularly Rich in Iron Drugs used: Capsella bursa pastoris, of which the upper part is used; Cynara scolymus, of which the leaves are used; Salvia officinalis, of which the leaves are used The proportion for the mixing has been chosen according to the content of iron in the single drugs above-indicated, in particular: Capsella bursa pastoris: 20% Cynara scolymus: 70% Salvia officinalis: 10% The selected vegetal drugs have been cut until reaching a uniform granulometry that is adequate to be mineralised. The optimal granulomethy is the following: Capsella bursa pastoris: 1.5-2.0 mm. Cynara scolymus: 1.5-2.0 mm. Salvia officinalis: 1.5-2.0 mm. The aforesaid fragmented mixture has been distributed on the stainless steel trays until reaching a layer of about 5 cm. of drug for each tray. The trays are stacked one on top of the other, with some space between them for the combustion fumes to escape. The methane operating muffle is programmed to reach within it a temperature of approximately 300° C. for a time of 2 hours at first, then it is raised and kept at a temperature of approximately 700° C. for 4 more hours. The first step at 300° C. is essential in order to obtain a perfect white coloured final product completely inorganic. The mineralised product is encapsulated in gelatine capsules with a final weight of about 500 mg. In this process the obtained mineralised complex contains all the mineral substances originally contained in the raw materials in form of oxides and other salts. The composition of the mineralised complex is the following: ______________________________________Element Concentration in the complex in mg/g______________________________________Iron 7.73 Calcium 109.8 Zinc 0.19 Magnesium 21.75 Potassium 85.0 Sodium 9.3 Copper 0.03 Manganese 0.49______________________________________ Due to the high concentration of iron and the relatively high specific weight of the mineralised complex, only four capsules a day are sufficient to obtain a good daily integration of such element (the daily recommended ration of iron is 14 mg. according to the Italian Law). As a matter of fact, the solubility, and therefore the bio-availability with a pH: 1, is extremely high: in fact 2 g. of product are 93.05% soluble in one litre of hydrochloric acid with a pH: 1 at 37° C. (liquid simulating gastric juice). EXAMPLE 2 A Mineral Complex Particularly Rich in Calcium Drugs used: Paretaria officinalis, of which the upper part is used; Urtica dioica, of which the leaves are used; Eucalyptus globulus, of which the leaves are used; Ginkgo biloba, of which the leaves are used. The proportions for the mixing have been chosen according to the calcium content in the single above-mentioned drugs, in particular: Paretaria officinalis: 10% Uttica dioica: 50% Eucalyptus globulus: 30% Ginkgo biloba: 10% The selected vegetable drugs have been cut until reaching a uniform granulometiy, adequate for being mineralised. The optimal granulometry for each drug is the following: Paretaria officinalis: 1.5-2.0 mm. Urtica dioica: 1.5-2.0 mm. Eucalyptus globulus: 1.5-2.0 mm. Ginkgo biloba: 1.5-2.0 mm. After having mixed the drugs, separately chopped up by following the above-mentioned granulometry, the mixture is distributed on steel trays until reaching a layer of 5 cm. of drug for each tray. The trays are stacked one on top of each other, with some space between them for the combustion fumes to escape. The muffle, normally heated with methane, is programmed in such a way to reach within it a temperature of approximately 300° C. for 2 hours, then it is raised and kept at a temperature of about 700° C. for 4 more hours. The first step at 300° C. is essential in order to obtain a perfect white coloured final product and completely inorganic. The mineralised product is encapsulated in gelatine capsules with a final weight of about 500 mg. In this process the obtained mineralised complex contains all the mineral substances originally contained in the raw materials in form of oxides and other salts. The composition of the obtained mineralised complex is the following: ______________________________________Element Concentration in the complex in mg/g.______________________________________Iron 1.9 Calcium 299.5 Zinc 0.46 Magnesium 33.74 Potassium 94.6 Sodium 8.5 Copper 2.5 Manganese 4.08______________________________________ Due to the high concentration of calcium and the relatively high specific weight of the mineralised complex, only five capsules per day are sufficient to obtain a good daily integration of calcium (in Italy the recommended daily ration of calcium is of 800 mg.). In fact, the solubility, and so the bio-availability with a pH: 1, is extremely high: 2 g. of product are 77.15% soluble in a little of hydrochloric acid with a pH: 1 at 37° C. (liquid simulating gastric juice). The process is repeated for any other individually chosen vegetal and/or animal product, or in combination with other organic products characterised by a high content of metal or metals, through which the integration of mineral oligoelements in humans, animals or plants is intended to be operated.

The invention concerns a highly concentrated mineralised natural complex, characterised by at least one main mineral element quantified with nutritional and/or dietetic integrator properties and by other mineral elements obtained in the complex from the mineralization of vegetal and/or animal products. Moreover, it concerns the method for its production consisting in using vegetal and/or animal organic substances, having a high content of oligominerals, in carrying out their fragmentation, their mixing and the mineralization until the inorganic part is completely separated from the organic part, and then in transforming the aforesaid inorganic part in forms of easy commercialization.

BACKGROUND OF THE INVENTION The field of the invention pertains to electric devices to open and close draperies or curtains, and in particular, to devices that automatically control the position of the draperies or curtains in response to light or heat. A light actuated electric drapery drive is disclosed in U.S. Pat. No. 4,471,275 wherein the circuit provides overload protection in addition to providing opening and closing of the draperies by manual switches or the light sensor. The light sensor actuates the circuit to operate the drive motor upon sufficient lighting level. U.S. Pat. No. 3,675,023 discloses combined heat and light sensors for mounting atop a building. The combined heat and light sensors are mounted for electro-mechanically driven movement to follow the sun during the day. In response to the heat and light striking the sensors with changing levels and direction throughout the day, the sensors control the opening and closing of draperies or Venetian blinds progressively about the building as the sun progresses about the building. Of more general interest is U.S. Pat. No. 3,529,214 which discloses light responsive systems to automatically control street lamps. The systems include means in the circuit to ignore sudden flashes of light so that the street lamps will not be extinguished in response to a sudden and momentary flash of light. SUMMARY OF THE INVENTION In response to the need for a simple and very compact electric drive for draperies or curtains that is automatically actuated in response to changed light level, applicant has invented the very compact and unobtrusive curtain puller disclosed below. The curtain puller is meant to replace the conventional spring loaded tensioner which typically includes a freely rotatable pulley for engagement with the loop of drapery cord and means to attach to the floor or wall. The new light actuated curtain puller externally appears much like the above tensioner with a pulley adjacent the top and spring tensioned means extending from the bottom for attachment to a floor or wall adjacent the draperies or curtains. Atop the new puller is a light sensing means with a cap to control the direction from which light may enter the light sensing means. As with the tensioner the new puller is preferably positioned behind or adjacent the edge of the drapery or curtain near the side of the window. In this location the cap can shield the light sensing means from the interior lighting and permit light to enter from the window and behind the drapery or curtain. Inside the new puller is a miniature high torque electric motor having the drive shaft attached to the external pulley. In the preferred embodiment the motor is a reversible alternating current motor optically isolated from a direct current control circuit. The direct current control includes means triggered by the light sensing means to cause a first timing circuit to begin a timing cycle. If the first timing cycle is completed a second timing cycle begins with the start of a motor operate signal. A flip flop circuit retains the current state of the motor and draperies and permits operation of the motor only for a change of the draperies. Alternatively, optional configurations can use a direct current reversible electric motor and motor drive or a digital decoder can be substituted for the light sensing means to receive and decode control signals passed through the building wiring. DESCRIPTION OF THE DRAWINGS FIG. 1 is a front exterior view of the curtain puller; FIG. 2 is a side exterior view of the curtain puller; FIG. 3 is a top view of the curtain puller; FIG. 4A is an electric schematic for the photoelectric cell circuit; FIG. 4B is an electric schematic for the timing and status circuit; and FIG. 4C is an electric schematic for the power supply and motor drive circuit. DESCRIPTION OF THE PREFERRED EMBODIMENT Illustrated in FIGS. 1, 2 and 3 is the exterior box or container 10 for the curtain puller. The box 10 may be constructed of metal or plastic halves that merely snap together or are fastened together with mechanical fasteners. Adjacent to the top of the box is a separate cover piece 12 open at the top and affixed to the front of the box 10. Within the cover 12 is a drive pulley 14 mounted on a motor drive shaft extending from a small electric motor 16 within the box 10. The pulley 14 engages the drapery or curtain cord 18 in turn extending downwardly about the pulley 14 and upwardly to the curtain rod (not shown). Thus, the electric motor 16 drives the curtain cord 18 to open or close the curtains or drapes. In other words, the motor 16 moves the object or curtains from an open first position to a closed second position or vice versa. Below the box is a bracket 20 that may be attached to the wall of a house adjacent a window with mechanical fasteners through the holes 22 in the bracket. Within the bracket 20 is a transverse rod 24 to which a pair of springs 26 are attached at their lower end. The upper ends of the springs 26 are attached to a second transverse rod 28 in turn affixed to the inside of the back of the box 10. The springs 26 provide suitable tensioning for the curtain cord 18. Atop the box 10 is a small shield 30 which may be manually rotated about a vertical axis. The shield 30 has an opening 32 to permit light to enter therein. Inside the shield is a photocell connected to the internal circuitry of the curtain puller. A 110 volt AC power supply cord as indicated at 34 extends into the box 10 and is attached to a rectifier and motor power circuit indicated at 36. Also inside the box 10 is a printed circuit board 38 to which are attached the electric elements comprising the control circuit for the curtain puller. As shown the box 10 encloses the entire electric control and power supply for the curtain puller. The box 10 is not substantially larger than a conventional spring tensioner for a curtain cord loop. FIGS. 4A, 4B, and 4C illustrate the control and power circuitry for the curtain puller. With the exception of the 110 volt AC power supply cord 34 and plug for the electrical power to the curtain puller, the control and power circuitry is entirely contained within the box 10. Referring in particular to FIG. 4C, a fuse F1 and transformer T1 in the 110 volt AC supply provide power to a regulator circuit comprising a diode bridge 40 and an integrated circuit regulator REG-1. The regulator circuit provides 12 volts DC power to the control circuit illustrated in FIGS. 4A and 4B and to the isolator circuit including opto-isolators IC1 and IC2 shown in FIG. 4C. The transformer T1 also provides AC power at reduced voltage to the pulley drive motor 16 through the triacs Q1 and Q2. Triacs Q1 and Q2 are in turn triggered by signals respectively from opto-isolators IC1 and IC2. In other words, the transformer and regulator circuit act as a power supply means for supplying power from the 110 AC power source to the control circuit and motor. A suitable motor 16 is a reversible 24 volt 60 cycle AC motor. A reversible DC motor might be substituted for motor 16 with suitable changes in the power supply to provide DC current and solid state switching means in substitution for triacs Q1 and Q2. The opto-isolators or optical couplers IC1 and IC2 provide electrical isolation between the AC power for the motor 16 and the low voltage substantially DC control signals in the control circuit shown in FIGS. 4A and 4B. The signal through the opto-isolators IC1 and IC2 is provided by a 12 volt DC signal in turn controlled by a pair of transistors Q3 and Q4. The pair of optically isolated connection circuits is between transistor Q4 and triac Q1 and between transistor Q3 and triac Q2. Thus, the control of rotational direction of the motor 16 is determined by a signal from opto-isolator IC1 to triac Q1, or for the other direction, by the signal from opto-isolator IC2 to triac Q2. The control circuit identified by the reference 38 to a printed circuit board within the box 10 comprises in FIGS. 4A and 4B a photo-electric cell Q5 which is contained within the hooded cover 30 at the top of the box 10. In response to a sufficient increase or decrease in light the photo cell Q5 provides an input to an integrated circuit IC3 which in turn provides an output at pin 7 of a sudden up or down voltage change as indicated by arrows 42 and 44. In other words, the photoelectric cell Q5 is a light sensing means for detecting changes in levels of light, i.e., presence or absence of light in the daytime and nighttime, respectively. The sudden change in voltage up 42 or down 44 is provided as an input to pin 4 of integrated circuit IC4 which in turn massages the signal to provide through integrated circuit IC7 a reset and start signal illustrated by the "one shot" 46 at pin 4 of integrated circuit IC7. The reset and start "one shot" 46 in turn is provided to pin 6 of a dual timer integrated circuit IC5. A suitable integrated circuit IC4 is a Motorola Monostable Multivibrator MC14538B or equivalent. Integrated circuit IC5 is a National Semiconductor Dual Timer LM556 or equivalent. The reset and start "one shot" 46 is also provided through integrated circuit IC8 from pin 3 to the base of transistor Q6, which with the associated circuitry and dual timer IC5 provides a ramp function timing signal that increases in voltage continuously from the moment that the "one shot" reset and start signal is received. Typically, this ramp function, as indicated schematically by arrow 48 on the XY plot adjacent transistor Q6, constantly increases the charge on capacitor C6 until a prespecified voltage is reached. Each time the signal from the photocell Q5 passes a threshold of increasing light or decreasing light an up or down voltage change is generated by integrated circuit IC3 and sensed at the base of transistor Q6 to reset the ramp function output 48 by discharging capacitor C6. Typically the ramp function circuit elements connected between transistor Q6 and pins 1, 2 and 3 of integrated circuit IC5 are specified to provide about a 15 minute time period from start or reset until a specified voltage is reached. Thus, short term changes in light level sensed by the photo electric cell Q5 do not result in actuation of the control circuit beyond resetting the ramp function output 48. Once the specified ramp function voltage is reached, the second timer of integrated circuit IC5 is actuated by the output 1 at pin 5 to T2 pin 8. The second timer includes the circuit elements connected to pins 7, 11, 12 and 13 of integrated circuit IC5. The potentiometer P1 provides adjustable means for setting the length of time the motor 16 operates by setting the specified ramp function maximum voltage for the second timer. With actuation of the second timer an output 2 signal at pin 9 is provided to pin 3 of integrated circuit IC6 which acts as a flip-flop or latch to determine the current state or position of the motor 16 and thereby determine the current position of the curtain. A suitable integrated circuit IC6 is Motorola Dual Flip-Flop MC14013B or equivalent. The flip-flop integrated circuit IC6 thereby permits or does not permit the motor to operate depending upon the direction of operation of the motor the previous time the motor was actuated to move the curtain. In other words, the flip-flop or latch acts as a latching means for determining the current position of the motor in either of the first and second positions and for actuating the motor to move the object or curtain to the position opposite the current position of the object or curtain. The status of the integrated circuit IC6 can be easily determined by the light emitting diode D8 which is connected to pin 9 of integrated circuit IC6 and illuminated when the curtain is in the closed position. A by-pass or a manual switch S2 is also provided so that the curtain can be conveniently opened or closed as desired during the night or during the day. The manual closure or opening of the curtain is sensed through the connection to pins 2 and 5 of integrated circuit IC6. The output from integrated circuit IC6 pins 1 and 2 respectively provide one-half of the control to the base of transistor Q4 or the base of transistor Q3 thereby determining the direction of rotation. The other half of the control is provided by the output at pin 9 of the dual timer IC5. Once actuated by the output at pin 9 of integrated circuit IC5 the motor operates for a period of time necessary to move the curtain as set by the exterior circuitry and potentiometer P1 of the second timer of dual timer IC5. The second timer circuit is also actuated by engaging the manual switch S2 to also start the motor running with the second timer. In either case the motor runs for a set period of time sufficient to open or close the curtain. In summary, the flip-flop circuitry only permits the motor to operate when either the signal from integrated circuit IC3 or from the manual switch S2, if thrown, provides for movement of the curtain opposite to that of the previous movement of the curtain.

An automatic electro-mechanical device for opening and closing a curtain or drapery in response to changed light striking a photoelectric cell on the device. The device comprises a miniature high torque reversible electric motor and control packaged in a container of substantially the same size as a conventional cord tensioner of curtains or draperies. To close the drapes at sun-down and open the drapes at sun-up automatically without actuation if the lighting changes for short periods of time, the device comprises a dual timer circuit with individual ramping circuits. One timer circuit monitors the sustained presence or absence of light for a predetermined amount of time. The other timer regulates the motor drive run time. A flip flop circuit signals the current state of the curtains or drapes by providing memory of the last directional movement of the motor.

FIELD OF THE INVENTION [0001] The present invention relates to the container of the blender, particularly to a set of high-speed blades mounted inside the lower portion of the container. GROUND OF THE INVENTION [0002] The usage of blender become popular today; the configuration structure of a blender is mainly a set of rotatable blades disposed inside the container to mix the ice cubes, vegetables and fruits until they become liquid. [0003] In early phases, the container of the blender was made of glass. The user began to operate with a glass container, somehow a glass break detector, if any, was needed by manufacturers to know whether the glass container was broken a little or not, in view of the fractures or cracks happened to occur on the glassware due to impacts or collisions. Density-dependent factors such as to expand when hot to shrink when cold also caused the glass surfaces to expand or shrink disproportionately and then cracks began to occur. Persons skilled in the art provided reinforced plastic such as acrylic resin to manufacture the container of the blender instead of the glassware. Because the reinforced plastic was not only light weight but also cost efficient, durable and rigid, they were attractive raw materials cherished by the manufacturers and consumers. But the containers made of reinforced plastic, during longer time period usage, the inner wall was impacted or collided intermittently by the stirred objects, eventually it resulted in nicks. Debris of the scraped acrylic resin was possibly mixed into the liquid. Once the debris remained in the liquid got drunk by consumers led to a poor hygiene condition. In fact the manufacturers provided a container made simply from a reinforced plastic hardly complied with all hygienic rules. The inventors of the present invention encounter the problems as mentioned above, provide a metal lining (cylindrical member) to shield the inner wall of the receptacle, which is known by their patent document 1. [0004] Patent Document 1: TW580,899 entitled “container for blender” assigned to the inventors Kou-I Ling and Rong-Yuan Tseng of the present invention on 21 Mar. 2004, the same is also patented in the USA assigned patent number as U.S. Pat. No. 6,786,440 on 7 Sep. 2004. DISCUSSION ABOUT PRIOR ARTS [0005] As shown in FIG. 1 , a conventional blender having a cup ( 1 ), a set of blades ( 3 ) installed within the base of cup ( 1 ). When blades ( 3 ) are rotated in high speed, the vegetable and fruit will be grated until they become liquid as well as a whirlpool is formed in the receptacle, which is illustrated and indicated by spiral arrows as shown in FIG. 2 . But the whirlpool ( 4 ) in usual brings the rough and long fibers ( 41 ) to the outer circle in contact with the inner wall by centrifugal force. In other words, by centrifugation the rough and long fibers ( 41 ) is not swirl into the center of the whirlpool ( 4 ) but whirl around the outer circle thereof. Some rough and long fibers ( 41 ) are neither brought to the lower portion of the cup ( 1 ) by whirlpool ( 4 ) nor further being grated by the blades ( 3 ). It could not catch one's sense when drinking juice with rough and long fibers are not liquefied efficiently. A spoon may be inserted into the whirlpool ( 4 ) or the stirring time is prolonged to grate the rough and long fibers. As a result, for a longer time period, the grated fibers immersed in the liquid are stirred to a foam with bubbles, this “oxidization” activity exposed in the air is going to influence the bright color and luster of the juice. The nutrition will be lost; the active fiber basis vitamins will be destroyed. The same problems happened to occur in the cited patent document 1. Accordingly, a metal lining combined to the inner wall of the cup ( 1 ) as a shield reduces the stirring time for promptly providing juice catches the user's sense. That is the key point of the present invention. SUMMARY OF THE INVENTION [0006] Accordingly, the present invention is aimed to provide a container of the blender comprises a cup ( 1 ) and a lining ( 2 ) disposed inside the cup ( 1 ) characterized in that the lining ( 2 ) is formed as a shield inside the cup ( 1 ), a number of teeth ( 21 ) projected from the inner wall of the lining ( 2 ) for grinding the fibers of vegetable and fruit. [0007] The lining ( 2 ) is selected from one of the following: metal lining, glass lining, lining has approximately the same hardness. [0008] Several vertical ribs ( 11 ) projected from the inner wall of the cup ( 1 ), several vertical stopper members ( 22 ) formed on the inner wall of the lining ( 2 ) which are corresponding to the vertical ribs ( 11 ), the ribs ( 11 ) are received into the hollowed trough of the stopper members ( 22 ). [0009] A number of teeth ( 21 ′) are arranged on and projected up from the top end of the stopper members. [0010] The rib ( 11 ) has a vertical facet ( 111 ), and the stopper member 22 has a vertical facet ( 221 ). [0011] The lining ( 2 ) is selected from one of the following: half-mask, whole mask. [0012] The half-mask lining is combined to the cup ( 1 ) by injection modeling. [0013] The half-mask lining is mounted inside the cup ( 1 ), the top rim of the lining ( 2 ) has lip ( 26 ). [0014] The half-mask lining is mounted inside the cup ( 1 ), several prop stands ( 24 ) extended from the top rim of the lining ( 2 ), a horizontal ring is connected to the top portion of the prop stands ( 24 ). [0015] The half-mask lining is mounted inside the cup ( 1 ), the top rim of the lining ( 2 ) has horizontal ring extended radially outwardly. [0016] The lining ( 2 ) is selected from one of the following: integrally formed as a whole annular lining, a number of lining pieces ( 2 a ), or ( 2 b ) combined to form an annular lining. [0017] The first facet of the stopper member ( 22 ) is bended inward to form a buckled piece ( 222 ), the buckled piece ( 222 ) leads into a groove ( 113 ) defined on the first facet of the rib ( 11 ), the second facet of the lining pieces ( 22 ) is a flat facet directly leads into a trench ( 112 ) defined on the second facet of the rib ( 11 ) of the cup ( 1 ). EFFECTS AND MECHANISMS OF THE PRESENT INVENTION [0018] The advantages can be achieved from practicing of the present invention as following: [0019] The rigid lining ( 2 ) shields the inner wall of the receptacle from collision of rigid material, but the fibers remained in the teeth ( 21 ) on the inner wall of the lining can be ground and cut into pieces. Therefore, the duration of grating fruit and vegetable can be reduced, the related “oxidization” activity of the juice exposed in air will also be decreased; rather, the bright color and luster of the juice can be kept vividly. The nutrition will not be lost, further the active fiber basis vitamins and sense of smell is kept as a freshener. BRIEF DESCRIPTION OF THE DRAWINGS [0020] FIG. 1 : a cross sectional view of the prior art, a conventional container of the blender; [0021] FIG. 2 : a top plan view of FIG. 1 ; [0022] FIG. 3 : an exploded view of the receptacle of the juicer according to the first embodiment of the present invention; [0023] FIG. 4 : an assembled view of the container of FIG. 3 ; [0024] FIG. 5 : a cross sectional view of FIG. 3 ; [0025] FIG. 6 : a top plan view of FIG. 3 ; [0026] FIG. 7 : a schematic view of FIG. 3 ; [0027] FIG. 8 : an exploded view of the container of the blender according to the second embodiment of the present invention; [0028] FIG. 9 : an assembled view of FIG. 8 ; [0029] FIG. 10 : an exploded view of the container of the third embodiment of the present invention; [0030] FIG. 11 : an assembled view of FIG. 10 ; [0031] FIG. 12 : an exploded view of the container of the fourth embodiment of the present invention; and [0032] FIG. 13 : an assembled view of FIG. 12 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT First Embodiment [0033] As shown in FIG. 3 , the present invention is a container includes a cup ( 1 ), a rigid lining ( 2 ) mounted inside the cup ( 1 ). The lining ( 2 ) is a prefabricated component combined to the cup ( 1 ) by injection molding. In other words, the lining ( 2 ) is first placed in the mode and then a transparent or translucent acrylic cup ( 1 ) is formed to wrap over the circumference of the lining ( 2 ) integrally as a whole by injection molding; finally, they are never detached from each other. [0034] Lining ( 2 ) is shaped as a half-mask, that is, the lining ( 2 ) only shields the lower half portion of the cup ( 1 ) but the upper half portion of the cup ( 1 ) is not shielded by the lining ( 2 ). Users can see vegetable or fruit cubes are whipped or thrashed in the cup ( 1 ). If the lining ( 2 ) is shaped as a whole-mask (as shown in FIG. 13 ), the upper and lower half portions of the cup are shielded by the lining ( 2 ). Users only look down on the vegetable or fruit cubes whipped or thrashed in the cup ( 1 ). [0035] Lining ( 2 ) is combined to the inner wall of the cup ( 1 ) to form a shield screen characterized in that a number of teeth ( 21 ) projected from the inner wall of the lining ( 2 ) applied to grate fibers of vegetable and fruit. Teeth ( 21 ) can be arranged in parallel with one another, but they are all arrayed in alignment with each other finally to form a crossed or columned shape of teeth array. Rather, the lining ( 2 ) can be made of metal, glass, alloy, or non-alloy material, which is with a hardness rather rigid than the acrylic cup ( 1 ). Lining ( 2 ) is an annular member formed integrally as a whole one, but which is preferred in the shape of polygon. A lining base ( 21 ) can be added to the bottom of the cap ( 1 ) as a shield screen thereof. The top end of the lining ( 2 ) has an L type wall ( 25 a ) bended outward and upward, the bottom end of the lining ( 2 ) has an L type wall ( 25 b ) bended inward and downward respectively. Both L type walls ( 25 a , 25 b ) are embedded into the inner wall of the cup ( 1 ) to eliminate the permeation of liquid through a chink on the wall. [0036] Cup ( 1 ) has a handle ( 12 ) and a spout ( 13 ). Several vertical ribs ( 11 ) are protruded from the inner wall of the cup ( 1 ); several vertical stopper members ( 22 ) corresponding to the ribs ( 11 ) are also formed on the obverse side of the wall of the lining ( 2 ), hollowed troughs opposed to the stopper members ( 22 ) are formed on the reverse side of the wall of the lining ( 2 ), the hollowed troughs are suitable for matching up and receiving the vertical rib ( 11 ). [0037] As shown in FIG. 6 , look down on the cup ( 1 ), and the lining ( 2 ), a facet ( 111 ) of the rib ( 11 ) and a facet ( 221 ) of the stopper members ( 22 ) can be formed as perpendicular spoilers which dampen vibration of the vegetable and fruit fibers (as shown in FIG. 7 ) but sweep them in the whirlpool ( 4 ) as much as possible to the center thereof; and then to the lower half portion of the cup ( 1 ) being crumbled by the straight blades. But only a few rough and long fibers ( 41 ) are forced into the center of the whirlpool, most of them still left outside the inner circle of the whirlpool ( 4 ). [0038] As shown in FIG. 7 , when the straight blades (not shown) is rotated in high speed, rough and long fibers ( 41 ) in the whirlpool ( 4 ) remained in the teeth ( 21 ) on the surrounding inner wall of the lining ( 2 ) will soon be grated and chopped into pieces. Possibility of the rough and long fibers being grated is greatly improved. Though the fibers all are not easily forced into the whirlpool center at once, they can be chopped into pieces by the teeth ( 21 ) as well. Therefore, the duration for the blender stirring the chopped fibers is reduced; meanwhile, possibility of oxidization of the stirred juice is also reduced. Rather, the top end of the stopper members ( 22 ) has a number of teeth ( 21 ′) projected up thereof, by means of the projected teeth ( 21 ′), the fibers of vegetable and fruit can be further grated and chopped into pieces. The teeth ( 21 ′) projected up from the top end of the stopper members ( 22 ) are advantageous to the grinding. Second Embodiment [0039] As shown in FIG. 8 , the container of the blender includes a cup ( 1 ), and a rigid lining ( 2 ) mounted inside the cup ( 1 ). First, each of the cup ( 1 ) and lining ( 2 ) are prefabricated components, and then the lining ( 2 ) is mounted inside the cup ( 1 ) and combined to the cup ( 1 ) integrally as a whole. After combination, the assembled view of the container is illustrated as shown in FIG. 9 . [0040] The lining ( 2 ) is shaped as a half-mask. But several prop stands ( 23 ) extended from the top rim of the hood ( 2 ) to a height adjacent to the top rim of the cup ( 1 ), a horizontal ring ( 24 ) is connected to the top ends of the prop stands ( 23 ). The horizontal ring ( 24 ) is convenient for the users to hold, and when the lining ( 2 ) is mounted inside the cup ( 1 ), the horizontal ring ( 24 ) placed on the L-shape (i.e. like a top step of a ladder) top rim of the container which is suitable for a lid (not shown) capped over the container, then the horizontal ring ( 24 ) is sandwiched between the container and the lid. Therefore the lining ( 2 ) can be mounted inside the container without any movements. Third Embodiment [0041] As shown in FIG. 10 , the container of the blender includes a cup ( 1 ), and a rigid lining ( 2 ) mounted inside the cup ( 1 ). The cup ( 1 ) and the lining ( 2 ) are prefabricated separately, and then the lining ( 2 ) is embedded into the cup ( 1 ) and combined to the cup ( 1 ) integrally as a whole. After combination, the assembled view is illustrated as shown in FIG. 11 . [0042] The lining ( 2 ) is shaped as a half mask, which is composed of a number of lining pieces ( 2 a ). A stopper member ( 22 ) is formed on the obverse side of the lining piece ( 2 a ) as well as the teeth ( 21 ) are arrayed on the same side. The first facet of the stopper member ( 22 ) is bended inward to form a buckled piece ( 222 ). A groove ( 113 ) is defined on the first facet of the rib ( 11 ) of the cup ( 1 ), the buckled piece ( 222 ) can be led into the groove ( 113 ) in place and then the rib ( 11 ) enclosed inside the hollowed trough formed on the reverse side of the stopper member ( 22 ). The second facet of the lining pieces ( 22 ) is a flat facet directly leads into a trench ( 112 ) defined on the second facet of the rib ( 11 ) of the cup ( 1 ). A number of teeth ( 21 ′) can also be arranged on the top end of stopper member ( 22 ). Rather, the lip ( 26 ) is extended radially outwardly from the top rim of the lining pieces ( 2 a ) is convenient for the user to hold when the lining pieces ( 2 a ) are assembled or disassembled with each other. Fourth Embodiment [0043] As shown in FIG. 12 , the container of the blender includes a cup ( 1 ), and a rigid lining ( 2 ) mounted inside the cup ( 1 ). The cup ( 1 ) and the lining ( 2 ) are prefabricated components. The lining ( 2 ) is embedded into the cup ( 1 ) and then combined to the cup ( 1 ) integrally as a whole. After combination, the assembled view is illustrated as shown in FIG. 13 . [0044] The lining ( 2 ) is shaped as a whole mask. The lining ( 2 ) is composed of a number of lining pieces ( 2 b ), but the top rim of the lining ( 2 ) is bended outward to form a horizontal ring ( 27 ). The horizontal ring ( 27 ) is not only convenient for the user to hold to assemble or disassemble the lining pieces ( 2 b ), but the horizontal ring ( 27 ) can be placed on the top step of the ladder like top rim of the container so as the horizontal ring ( 27 ) can be sandwiched between the cup ( 1 ) and the lid (not shown) without any movements.

The present invention is aimed to provide a container of the blender. It can prevent the inner wall of the container from abrasions and blemishes. Further, the time-consuming for fibers of the fruit and vegetable being grated and chopped can be reduced. The container of the blender includes a cup, a lining mounted inside the cup characterized in that the lining as a shield screen on the inner wall of the cup, the inner wall of the lining has a number of teeth projected thereof for grating the fibers of the vegetable and fruit.

RELATED APPLICATIONS Co-pending application Ser. No. 060,408, filed July 25, 1979, now U.S. Pat. No. 4,271,839 for Dilatation Catheter Method and Apparatus shows a dilatation catheter in which dilatation is accomplished by everting a balloon from the end of a catheter, blowing the balloon up to dilate an occluded blood vessel, deflating the balloon, and re-inverting the balloon within the catheter. Co-pending application Ser. No. 114,979 filed Jan. 24, 1980 for Flexible Calibrator shows a catheter having a calibrator bead at the distal end thereof which is used to measure the diameter of the lumen in a stenotic segment of blood vessel. The present invention comprises a calibrator bead in trailing relation to a dilatation balloon. The combination of these two elements enables the calibrator element to measure the lumen of the dilated artery rather than, as in the co-pending application, being used to measure the lumen of an occluded passage in a pre-dilated artery. BACKGROUND OF THE INVENTION The present invention relates to a method and apparatus for use in dilating occluded blood vessels and for measuring the degree of dilation of the occlusions within these vessels. Prior to the present invention these two objectives were attainable, as a result of the teachings set forth in the above-identified copending patent applications, by the use of two catheters, one having a balloon element to dilate the occlusion and the other having a calibrator element to measure the widened lumen of the occluded segment of artery. This could result in the repeated insertion and removal of catheters into and out of arteries until the sizes of the enlarged passages of the occluded segments of the arteries were of acceptable dimensions. The heavier the traffic of catheters within blood vessels the greater is the risk that material may be accidentally dislodged therefrom with possible consequent blockage elsewhere in the blood circulation system. SUMMARY OF THE INVENTION The present invention combines in a single catheter a dilatation balloon element and a calibrator bead element. Following dilatation of an occlusion the calibrator bead may be moved into the dilated lumen of the occlusion in order to determine whether the occlusion has been sufficiently dilated. The two objects are thereby achieved without the need of indulging in the time-consuming and hazardous activities of repeatedly removing and replacing catheters. The principal object of the invention is to combine in a single catheter instrument dilatation balloon means which can be inflated and deflated and calibrator bead means to measure the lumen of the dilated occlusion in the artery. This and other objects and advantages of the invention will be apparent from the following description taken in conjunction with the drawings forming part of this specification. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a semi-schematic view of the present catheter positioned adjacent an occlusion. FIG. 2 is a similar view showing the occlusion being dilated. FIG. 3 is a similar view showing the balloon element reinverted. FIG. 4 is a similar view showing the catheter during the course of movement through the same artery to the next occlusion to be treated. FIG. 5 is a view showing in elevation and longitudinal cross-section the details and construction of the present catheter with the balloon element everted. FIG. 6 is a view like that of FIG. 5 showing the balloon element in inverted condition. DESCRIPTION OF THE PREFERRED EMBODIMENT The catheter comprises a calibrator oval 10, a flexible shaft 12, a manifold 14 which serves for the connection of a syringe 16 to the instrument, a balloon 18 which is longitudinally extensible from the oval 10 under the fluid pressure applied by syringe 16 and thereafter laterally expansible under increased fluid pressure, and a guide wire 20 to be pulled to re-invert the balloon 18 within the oval 10. A blood vessel 22 partially occluded by occlusion 24 is provided with an incision 26 for the introduction into the vessel of the catheter. The catheter is moved along the vessel until the oval 10 bears against the end of occlusion 24, as shown in FIG. 1. The syringe 16 is then attached to manifold 14 and actuated to evert the balloon 18 and extend it into the restricted lumen of occlusion 24. The fluid pressure is then increased to radially expand the balloon and compress the occlusion. The fluid pressure is then reduced by reverse operation of the syringe and the syringe is removed from manifold 14. Wire 20 is then manually pulled to re-invert the balloon within the oval. The oval is then moved within the compressed occlusion 24. Ready movability of the oval through the occlusion indicates that the occlusion has been adequately compressed. If the oval is not readily movable through the occlusion the instrument is used to further compress the occlusion. Once the occlusion has been suitably compressed the instrument may be moved further along the vessel 22, as indicated in FIG. 4, if there is a further occlusion to be treated. The details of construction of the instrument are shown in FIGS. 5-6. The oval 10 and shaft 12 are formed by a tightly wound helical spring 28 which provides the catheter with sufficient flexibility to enable its movement through tortuous arteries. The oval and shaft are provided with an overcoating 30 of silicone, heat-shrink tubing, Teflon, or the like. The balloon element 18 is made of an elastomeric material such as latex. One end of the balloon is attached to the end of the oval 10 and the other end of the balloon is attached with suture 32 to guide wire 20. The wire 20 is small in diameter relative to the internal diameter of spring 28 to provide an annular fluid passage between the syringe 16 and balloon 18. Expansion of the balloon element out of the end of the catheter takes place in anisotropic fashion, with the balloon element first everting out of the catheter in advance of substantial lateral expansion, and then, after eversion, laterally expanding in response to the continued exertion of fluid pressure internally of the catheter. Optimal dimensional data for the catheter and the balloon element are set forth in my co-pending application Ser. No. 060,408. While the invert-evert form of balloon is preferred, other types and forms of balloons may be used as long as they do not impede the movability of the catheters through the arteries and as long as they do not interfere with the use of the calibrator ovals to measure or calibrate the inside diameters of the arterial lumens.

A catheter is provided with an inflatable-deflatable balloon element to radially enlarge a partially occluded artery lumen and the catheter is provided with a calibrator oval to internally gauge the enlarged lumen.

TECHNICAL FIELD This invention relates generally to a header of an agricultural cutting machine, such as a combine, windrower or other crop harvesting machine, or a mower, and more particularly, to a guard for a sickle of a header, integrally incorporating an air discharge system including streamlined, non-obstructive air outlets operable for effectively directing pressurized air rearwardly over the sickle and toward a floor or pan of a header, for blowing cut plant material, particularly loose grain and the like, onto a floor or pan of the header, so as to avoid loss of the material, without interfering with the cutting action or plant flow over the guard. BACKGROUND ART Sickles typically including cutter bars supporting a row of knives, have been used to cut plants, including, but not limited to, hay, grasses, small grains and the like, for many years. The knives are composed of a plurality of knife or sickle sections which are mounted in side by side relation forming an elongate metal knife assembly. The elongate knife assembly is normally supported so as to slide longitudinally through slots in, or over, forwardly projecting, spaced apart guards. The knife assembly moves back and forth in a reciprocating movement to move the knives relative to the guards so that the leading knife edges of the knives cross over the guards or through the slots in the guards. This produces a shearing or cutting action which severs plant stems and stalks or other material which flows into and is captured in the spaces between the knives and the guards. In operation, as the crop cutting machine moves forwardly over a field, it is desirable for the plant stems and stalks to flow smoothly and uninterruptedly into the spaces between the guards, so as to be cleanly severed by the knives. It is also desired for the cut plant material to flow smoothly and largely uninterruptedly over the sickle, not bunch up thereon, and flow or fall onto a floor or pan of the header, particularly when the cutting machine is a harvester. Often, harvesters also include a rotary reel disposed over the sickle to facilitate the induction of the plants into the sickle, clear cut plant material from the sickle, and help move the cut crops onto the header floor. On the header, the cut crop material is typically conveyed sidewardly toward the center of the header, by an auger or belt, for induction into a feeder of the machine or other apparatus. A problem that can occur, however, when cutting crops in the above manner, is that sometimes as a result of the cutting action, crops will not be inducted into the header, but instead will be lost. For instance, as a result of a dull or worn sickle, the crop stalks or stems may be jerked, bent, and/or torn instead of cleanly cut, which can shake grain loose from the crop before it enters the header, such that some of the loose grain can fall to the ground in front of the header. The bats or tines of reel can also strike the crops and shatter pods, etc., to loosen or thresh the grain so as to be lost, particularly under dry conditions. Still further, the augers for conveying the cut crops toward the center of the header can include fingers that operate to pull the cut crops into the auger, which can unintentionally thresh some of the grain from the crop. As a result, a significant amount of loose grain can be present in the forward region of a header, on and above the sickle and guards, which is at risk of loss if not conveyed or inducted onto the header. Numerous devices and systems have been developed over many years, in attempts to blow loose grain toward the header. Reference in this regard, the system utilizing pressurized air directed through nozzles or jets on or in connection with the sickle guards disclosed in McDonnell U.S. Pat. No. 6,085,510, issued Jul. 11, 2000. However, an observed shortcoming of the embodiment of the system of the McDonnell patent illustrated in FIGS. 1-3 of that patent, is that the air nozzles or outlets are located in the slots of the guards in which the sickle knives move. In a second embodiment shown in FIG. 4 and subsequent Figures of the McDonnell patent, nozzles project sidewardly from the guards into the spaces between the adjacent guards, so as to be located in the crop flow paths along and between the guards. Reference also, Phillips U.S. Pat. No. 2,718,744, issued Sep. 27, 1955; and Klinger U.S. Pat. No. 2,737,006, issued Feb. 26, 1954. The Phillips and Klinger patents also utilize pressurized air nozzles, but located on structures on the guards or extending forwardly therefrom (Phillips massively so), and which also extend sidewardly into the crop flow path (more so in Klinger) so as to possibly interfere with crop flow to the cutting region between the sickle knife and side of the guard. Any outward projection of a nozzle into the crop flow path can result in contact with crop plants forwardly of the front edge of the header pan that can jar the plants, to cause them to drop grain, which can fall between the guards so as to be lost. The air flow ducts of Phillips and Klinger are also significantly larger than the guards and extend beneath the guards, so as to limit the positioning options of the guards and the header relative to the ground, particularly the closeness to the ground and the ability to orient the guards toward the ground. The Phillips and Klinger air flow ducts are also exposed to damage from contact with the ground. Thus, what is sought is an air discharge system for guards of a sickle of a header of an agricultural plant cutting machine, that is effective for discharging flows of air rearwardly, for directing loose grain and other crop elements toward the header, yet which is unobtrusive and overcomes one or more of the problems, disadvantages, and shortcomings referenced above. SUMMARY OF THE INVENTION What is disclosed is an integral air discharge system for guards of a sickle of a header of an agricultural plant cutting machine, such as, but not limited to, a combine, windrower, or the like, that is effective for discharging flows of air rearwardly, for directing loose grain and other crop elements toward the header, yet which is unobtrusive and overcomes one or more of the problems, disadvantages, and shortcomings referenced above. According to a preferred aspect of the invention, a guard for a sickle of an agricultural plant cutting machine includes a base configured for mounting to a header of a plant cutting machine adjacent to a forward edge of an upwardly facing floor of the header, and an elongate finger attached to the base and oriented relative thereto so as to extend forwardly therefrom when mounted to a header. The finger includes a forward tip portion opposite the base, the finger including a slot extending sidewardly therethrough intermediate the base and the tip portion and configured for cooperatively receiving a sickle knife for reciprocating sideward movement relative to the finger. The finger includes opposite side surfaces adjacent to opposite ends of the slot and against which the sickle knife will cut plants when reciprocated sidewardly relative to the finger, and the finger including a longitudinally extending, upwardly facing surface extending from the base to the forward tip portion. The upwardly facing surface includes a rearwardly facing air discharge nozzle therein, and the finger includes an air flow passage extending internally therethrough from an air inlet adjacent the base to the nozzle for delivering a flow of pressurized air thereto, the nozzle being at least mostly flush with or recessed into the upwardly facing surface. As a result, the nozzle is operable for discharging the flow of air rearwardly over the finger without obstructing plant material flow thereover. Preferably, the pressure of the air will be sufficient to blow at least a substantial amount of loose grain and other plant material located forwardly of the front edge of the header floor, onto the header floor for collection by a conveyor of the header for processing. According to another preferred aspect of the invention, the air inlet is disposed beside the base, and is connected to a suitable source of pressurized air, which can be, for instance, an air compressor located on the plant cutting machine, or on the header itself. According to another preferred aspect, the guard is configured in side by side spaced apart relation with one or more additional guards, so as to be conveniently jointly mountable to a header. And, a joint air inlet or separate inlets can be provided in connection with the air flow passages, as desired or required for a particular application. According to still another preferred aspect of the invention, the nozzle is integrated into the upwardly facing surface of the finger forwardly of or above the slot containing the sickle knife, so as to be positioned just forwardly of, or over a forward region of, the cutting region of the sickle, such that the air flow discharged from the nozzle will be strongest at the location where the most loose grain is anticipated to be present. To facilitate this positioning, the air passage will preferably include a lower portion which extends forwardly under the slot, and an upper portion in connection with the lower portion and extending upwardly and possibly rearwardly to the nozzle. Optional aspects of the invention include a shallow concave channel or recess rearwardly of the nozzle, wherein the nozzle is oriented to discharge the flow of air through the channel, thereby facilitating the desired smooth, uninterrupted flow of plant material over the nozzle, while providing a desired airflow pattern. Alternatively, the nozzle can be flush with the surface of the finger. As another option, one or more additional nozzles can be incorporated into the upper surface of the finger, arranged in a predetermined array, and the nozzle or nozzles can be configured to discharge the flows of air therefrom in a predetermined pattern, such as a tightly focused rearwardly directed pattern, or a broader fan pattern, as determined at least in part by the effect sought to be achieved. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top view of a combine including a header having an air discharge system for the sickle thereof, including air discharge nozzles incorporated into guards of the sickle, according to the present invention; FIG. 2 is an enlarged fragmentary side view of the header of FIG. 1 , showing a representative sickle guard and a preferred manner of incorporation of the air discharge system of the invention into the guard, and illustrating discharge of air from a nozzle of the system and the effect thereof on loose grain above the sickle; FIG. 3 is a simplified fragmentary top view of a representative sickle guard, illustrating a manner of incorporation of a nozzle of the system of the invention incorporated into an upwardly facing surface of the guard; FIG. 4 is a fragmentary perspective view of a pair of guards for a sickle, showing elements of the air discharge system of the invention incorporated therein; FIG. 5 is a fragmentary top view of the header, showing another embodiment of an air discharge nozzle usable with the system of the invention, and illustrating different air discharge patterns that can be achieved using different nozzles with the invention; FIG. 6 is a top view of a pair of guards illustrating still another embodiment of air discharge nozzles usable with the system of the invention, and illustrating still different air discharge patterns achievable with the different nozzles; FIG. 7 is an enlarged fragmentary partial sectional side view of a guard, illustrating a manner of incorporation of air flow passages and a nozzle of the system of the invention therein; FIG. 8 is an enlarged fragmentary sectional side view of a guard, showing a nozzle, and illustrating discharge of a flow of air therefrom; and FIG. 9 is a fragmentary top view of the guard of FIG. 8 , in partial section. DETAILED DESCRIPTION OF THE INVENTION Turning now to the drawings wherein several preferred embodiments of the invention are shown, in FIG. 1 , a conventional, well known agricultural cutting machine, which is a combine 20 , is shown including a header 22 . Header 22 is shown supported in the conventional, well-known manner on a forward end 24 of combine 20 , and is operable for cutting or severing crops such as, but not limited to, small grains such as wheat and soybeans, and inducting the severed crops into a feeder 26 for conveyance into combine 20 for threshing and cleaning, in the well known manner, as combine 20 moves forwardly over a field, as denoted by arrow F. Referring also to FIG. 2 , which is a side view of header 22 , header 22 includes a pan or floor 28 which is supported in desired proximity to the surface of the field during the harvesting operation, and an elongate, sidewardly extending sickle 30 along a forward edge portion 32 of floor 28 , sickle 30 being operable for severing the crop for induction into header 22 , as will be explained. Header 22 additionally includes an elongate, sidewardly extending reel 34 (shown in outline form in FIG. 1 ) disposed above sickle 30 and rotatable in a direction for facilitating induction of the severed crops into header 22 . An elongate, rotatable auger 36 (also shown in outline form in FIG. 1 ) that extends in close proximity to a top surface 38 of floor 28 and has helical flights therearound is operable in cooperation with reel 34 for conveying the severed crops toward an inlet opening of feeder 26 for induction into combine 20 , in the well-known manner. Referring more particularly to FIG. 1 , sickle 30 extends in a sideward direction along the width of floor 28 , between a first side edge portion 40 of the floor, and an opposite second side edge portion 42 . Sickle 30 includes an elongate, sidewardly extending cutter bar assembly 44 supported in substantially longitudinally aligned relation adjacent to forward edge portion 32 of floor 28 , along the length thereof. Referring also to FIGS. 3 , 4 and 5 , cutter bar assembly 44 includes a plurality of forwardly extending, elongate guards 46 arranged in a sidewardly extending, spaced apart array, along the forward edge portion of header 22 . Each guard 46 is preferably of cast metal and includes a rearwardly located base 48 , which is suitably attached, here by a bolt 50 and a nut 52 , to a fixed bar 54 or other fixed structure of assembly 44 . Here, it can be observed that guards 46 are provided in pairs connected together by a crossmember, although it should be understood that, alternatively, they could be provided individually, or connected together in a greater number, with equal utility for the purposes of the present invention. Each guard 46 additionally includes a forwardly extending finger 56 attached to base 54 , finger 56 having a forwardly located forward tip 58 . Each finger 56 includes oppositely facing side surfaces 60 and 62 which extend forwardly from adjacent base 48 to tip 58 , and which taper convergingly as they approach tip 58 . Each finger 56 also includes an upwardly facing surface 64 which extends from base 48 to tip 58 . Each finger 56 includes a slot 66 extending therethrough between side surfaces 60 and 62 , intermediate base 48 and tip 58 , slots 66 of the respective fingers 56 being aligned along the length of sickle 30 . Referring more particularly to FIGS. 2 and 5 , cutter bar assembly 44 supports an elongate sickle knife 68 for reciprocating longitudinal movement within slots 66 , knife 68 including a row of knife sections 70 including oppositely facing, angularly related knife edges 72 which, in conjunction with site surface 60 or 62 of adjacent guards 50 , respectively, effect a shearing or cutting action which severs plant stems and stalks or other material captured between the knives and the guards as the knife sections are reciprocatingly moved sidewardly, as denoted by arrow A in FIG. 5 . Guards 46 will typically extend beyond sickle knife 68 by no more than 12 inches, as it may be desired under some conditions to have a capability to point the guards downwardly at a small acute angle to the ground, for instance, with the sickle close to the ground, for harvesting downed crops, without the guard tips entering the ground. It is also desirable for the guards to have a smooth streamlined shape, which is relatively narrow, so as to smoothly guide the crops into the spaces therebetween, for cutting. As noted above under the Background Art heading, as combine 20 is moved forwardly over a field containing crops, sickle knife 68 will be moved reciprocatingly sidewardly relative to guards 46 , to sever the crops which enter the spaces between guards 46 . Knife edges 72 will capture and cut the stems or stalks of the crop plants against the side surface 60 or 62 of the adjacent guard, in an area denoted as a cutting zone 74 illustrated in relation to the leftmost guard 46 in FIG. 5 . As a result of the cutting action, and particularly if the crop is dry and/or knife edges 72 are dull, and/or the side edge of the slot is worn and rounded, and also as a result of being batted by reel 34 , grain can be loosened from the crop plants, e.g., pods shattered, such that the loose grain will fall onto sickle 30 , and onto any plant material thereon, so as to be in danger of falling to the ground and being lost. Grain can also be shaken loose if the guards are large, or are not sufficiently streamlined for smooth crop flow therepast, or have obstructions that extend into the crop flow path, so as to shake or jar the crops as they are inducted into the sickle. This can be particularly problematic in drilled crops which lack defined rows and thus increase the possibility of guards 46 being propelled directly into plants during the cutting operation. Referring more particularly to FIG. 2 , loose soybeans 76 are depicted in the area above sickle 30 , as would be typically present during the harvesting of crops such as soybeans or other legumes, as well as other small grains. If not captured, at least some of loose grains 76 would typically be lost, for instance by falling through the spaces between knife sections 70 and guards 46 , or by falling forwardly over the front edge of the sickle. To avoid or reduce the occurrence of grain loss in the above described manner, an air discharge system 78 is incorporated into some and preferably all of guards 46 of sickle 30 , according to the present invention. Air discharge system 78 includes at least one rearwardly facing air discharge nozzle 80 incorporated into upwardly facing surface 64 of each finger 56 , and an air flow passage 82 extending internally through each finger 56 from an air inlet 84 located adjacent to base 48 , to nozzle 80 , for delivering a flow of pressurized air thereto. The pressurized air is provided by a suitable source thereof, such as, but not limited to, an air pump or air compressor 86 disposed at a suitable location, such as on header 22 , and which is suitably powered, for instance, by a fluid motor, belt, shaft, chain, or the like, in the well-known manner. Compressor 86 is connected to air inlets 84 , for delivering pressurized air thereto, via an air distribution system which will preferably include a main air manifold 88 extending sidewardly beneath floor 28 of header 22 , and including a plurality of nipples or small air distribution tubes 90 emanating therefrom at appropriately spaced locations therealong corresponding to the locations of air inlets 84 . Smaller air distribution tubes 90 are shown extending from manifold 88 individually to air inlets 84 . Alternatively, it should be recognized that a variety of different air distribution system configurations can be utilized according to the present invention. The configuration and location of air discharge nozzles 80 on surfaces 64 of respective fingers 56 can be varied according to the preferences and/or requirements for a particular application. Generally, it will be an objective of the invention for nozzles 80 to be minimally if at all obstructive to crop and plant flow over and passed fingers 56 , such that little or no resultant additional jarring or disturbing of the plants passing over the nozzle occurs so as to result in additional loosening of grain from the plants. Additionally according to the invention, an objective will be to generate rearwardly directed pressurized air flows that will be effective in blowing and directing loose grain on to floor 28 to capture the loose grain and prevent loss thereof. Further according to the invention, it will be an objective to minimize susceptibility of plugging of nozzles 80 by plant material and the like. Still further, it will be an objective when incorporating nozzles 80 and air flow passages 82 into fingers 56 , to maintain and not significantly degrade the structural integrity of the fingers, or to materially change the operability thereof. In accordance with the above objectives, several embodiments of nozzle configurations of the invention are illustrated in FIGS. 2 through 9 . Referring more particularly to FIGS. 2 , 4 , 5 , and 7 through 9 , nozzles 80 are illustrated as rearwardly directed and recessed into upwardly facing surface 64 of fingers 56 . Of these, nozzles 80 of FIGS. 2 , 4 , 5 and 8 are circular shaped, and nozzles 80 of FIGS. 8 and 9 are diamond shaped. This represents a range of acceptable nozzles and is thus not intended to be limiting. Each nozzle 80 is also illustrated disposed at a forward end of a rearwardly extending recessed channel 92 , which, in cooperation with the nozzle configuration, facilitates and guides the pressurized air flow in a desired pattern, without significantly disrupting crop flow over upwardly facing surface 64 of the finger. However, it should be noted that other locations, including a more forward location, can be utilized according to the invention. Referring more particularly to FIG. 2 , the pressurized air flow, denoted by arrows 94 , is illustrated as flowing along a relatively low, rearwardly directed trajectory over sickle 30 and forward edge portion 32 of floor 28 . Referring in particular also to FIG. 5 , FIGS. 5 and 6 , Air flow 94 is also illustrated from the side in FIG. 8 . Here, it should be recognized that the configuration, including, but not limited to, size, shape, and angular orientation, of nozzles 80 can be determined for a particular application, as can the configuration, e.g., size, shape and angular orientation of the channel 92 if used. FIG. 5 illustrates possible air flow patterns that can be achieved with the nozzles of the invention, including a narrower pattern that generally extends over the base region of the guard in which the nozzle is located, as defined by lines 96 emanating from the respective nozzles, and a wider fan shape pattern that extends over a greater portion of the sickle knives also, as defined generally be lines 98 . Referring in particular to FIG. 3 , a nozzle 80 which is substantially flush with surface 64 is shown, the nozzle having a generally oval or tear drop sectional shape when viewed from above. Again, this illustrates the variety of nozzle configurations that can be used according to the invention. Referring more particularly to FIG. 6 , still another nozzle configuration is illustrated, which is a multiple nozzle arrangement including an array of three nozzles 80 disposed in surface 64 , facing in slightly offset directions, and configured to discharge streams of pressurized air in a wide ranging fan pattern, illustrated again by lines 98 emanating from each of the nozzles. Here, it should be noted that the number of nozzles, positions, and orientations, on a finger can be varied, as desired or required for a particular application. In the fore and aft direction, nozzles 80 are preferably disposed so as to most advantageously direct the pressurized air for recovering or protecting from the loss of loose grain, without degrading the integrity and strength of the fingers. In the embodiments shown, nozzles 80 are generally located above a forward region of slot 66 through which the sickle knife reciprocates. To achieve this location, air flow passage 82 has a generally V shape, including a lower portion 100 which is routed forwardly through the finger below slot 66 , and an upper portion 102 which connects with lower portion 100 and extends rearwardly therefrom to the nozzle, or nozzles, as variously shown in the FIGS. Air flow passage 82 can be cast in place in the finger. Essentially, the fore and aft location selected here has been found to be advantageous as it places the nozzles close to the cutting zone where the largest portion of the loose grain has been typically found to be present, such that the air will be at its greatest pressure where the grain is found, and will be less likely to be dissipated by intervening plant material such as leaves, stems and the like which will be passing through the cutting zone also. It will be understood that changes in the details, materials, steps, and arrangements of parts which have been described and illustrated to explain the nature of the invention will occur to and may be made by those skilled in the art upon a reading of this disclosure within the principles and scope of the invention. The foregoing description illustrates the preferred embodiment of the invention; however, concepts, as based upon the description, may be employed in other embodiments without departing from the scope of the invention. Accordingly, the following claims are intended to protect the invention broadly as well as in the specific form shown.

A guard for a sickle of an agricultural plant cutting machine includes a forwardly extending finger including a longitudinally extending, upwardly facing surface extending over the sickle, which includes a rearwardly facing air discharge nozzle therein located above and/or forwardly of the sickle, and the finger includes an air flow passage extending internally therethrough from an air inlet adjacent to a base of the finger to the nozzle, for delivering a flow of pressurized air thereto, the nozzle being at least mostly flush with or recessed into the upwardly facing surface. As a result, the nozzle is operable for discharging the flow of air rearwardly over the finger without obstructing plant material flow thereover, the air flow being sufficient to blow at least a substantial amount of loose grain and other plant material located forwardly of the front edge of a header floor of the machine, onto the floor for collection by a conveyor of the header for processing.

FIELD OF THE INVENTION This invention relates to an improved, multi-tiered, storage and/or display stand for displaying to customers, on store counters or the like, a plurality of pre-packaged boxed goods, such as candy bars or the like, packaged in boxes of different sizes. BRIEF DESCRIPTION OF PROBLEMS ASSOCIATED WITH PRIOR ART It is known to tier displays of goods, such as pre-packaged, boxed articles, on counters in stores, or shops, where display counter space is at a premium. The prior art discloses that tiered displays normally provide support shelves, of preselected and uniform size, for supporting articles on vertically spaced, horizontal or inclined, shelves. The construction of prior tiered stands normally positions shelves of the same size in vertical arrays. The use of uniform width tiers, or shelves, frequently prevents lack of flexibility, such as where it is desired to display, on the multiple tiers of the same display device, goods that have been pre-packaged, by their manufacturers or packers, in boxes of different width. OBJECTS OF THIS INVENTION It is one object of this invention, to provide an attractive stacking display of support shelves, or tiers, that provide improved viewing of boxed goods, that are located on the shelves or tiers at different levels, or on vertically spaced tiers, of a stacking display. Another object of this invention is to provide flexibility in a stacking display for goods, by providing shelves whose width dimension may be selectively varied to accommodate boxes of different width that contain articles, such as individually wrapped chocolate bars or candy bars, that are to be displayed on a store counter, or the like, while permitting customer-selection of goods from any and all of the tiers of the display. It is another object of this invention to provide a new and improved stacking display that is characterized by simplicity of construction, ease of assembly, increased viewing attractiveness, being of knockdown construction to permit shipping the parts thereof in a compact arrangement, and which stacking display, when assembled, providing for display of boxes of goods, of different lateral sizes, on selected vertically spaced tiers of the display. Further objects and advantages of my invention will become apparent to one skilled in the art from the following description of the invention disclosed herein. BRIEF DESCRIPTION OF PRIOR ART It is known to provide an array of trays for carrying articles thereon, wherein the trays are vertically spaced apart, or tiered. See U.S. Pat. Nos. 2,575,919; 2,901,120; and 3,095,093. In said tiered tray arrays, the support shelf for articles carried in the tray are positioned either horizontal or nearly horizontal, and a plurality of spaced upright sides are provided, that are formed integral with the support wall or are attached to the support wall, to form basket-like units for receiving articles into or onto the trays. Tiering of any two similar trays usually is accomplished by using multiple vertical rod-like supports, or spacers, which extend between corresponding walls or the tiered tray arrays. U.S. Pat. No. 2,901,120, discloses use of tiered trays whose support shelves are of different size, and wherein the difference in size extends from back to front, but with the width sizes of the tiered trays being the same. Stacks, or tiers, of trays that display goods, for customer selection therefrom, are also known, such as disclosed in U.S. Pat. No. 2,916,293 which discloses the inclining of all tiers of trays so that articles therewithin will move, by gravity, downwardly and forwardly toward the forward upright edge of the tray, as articles are removed from a forward portion of the tray. After the topmost tray has been emptied, the emptied tray must be removed to permite access to goods in the tray tier below the emptied tray. A stand, made up of laterally spaced pairs of inclined, upwardly converging, tubular support leg frames, with transverse wire tier supports, whose transverse ends telescope into apertures provided in the tubular supports, and with straps for limiting the front-to-rear length of the tiers of the stand, and with a plurality of inclined, tier bottoms formed of longitudinal wires, that have vertical, front end, plate-like panels located at the forward end of each tier, is illustrated, but not described as to structure or use, in U.S. Design Pat. No. 162,990. SUMMARY OF THIS INVENTION A stacking, tiered, display stand is disclosed herein which provides multiple, vertically spaced, planar support tiers each of which is adapted to support thereon boxed articles, such as boxed chocolate bars or candy bars. The multiple tiered display stand disclosed herein has its tiers horizontal, for being mounted on a horizontal countertop. However, it will be understood, by one skilled in the art, that the stacked display tiers may also be mounted on inclined support means, so that the display tiers will be inclined forwardly on a supporting horizontal countertop. The stacking, tiered, display of this invention may be easily assembled at or adjacent the point of usage by store personnel, and is preferably made up of a plurality of clear plastic parts to provide an attractive display stand which permits customer viewing, from different aspects, of the goods being offered for sale. The stacking, tiered, display that is disclosed herein has knock-down character, to provide for compact volume in shipping, and provides for simple assembly at, or adjacent, the point of use. Each tier of the display tray has a pair of selectively adjustable lateral rails for varying the operative width of the support shelf of each tier, to accommodate boxes of different widths on the respective tiers of the display, thereby providing a flexible use display, and an attractive vending apparatus for counter-displayed goods. Each pair of vertically spaced shelves have pairs of laterally spaced rails which cooperate with vertically spaced rails of a higher or lower tier, so as to provide vertical supports between pairs of vertically spaced tiers. Simple, plate-like spacers serve as load transmitting columns that are used for spacing and supporting one tier above a support tier therebelow. In the display rack disclosed herein, each tray, or tier, of a multiple-tiered rack includes a pair of rails positioned adjacent each of the two longitudinal edges of each tray. The two rails each include an upper rail positioned to bound one of the spaced longitudinal edges of the region that supports the box of goods positioned on the tier. Each pair of vertically aligned rails, use columnar members which extend between the pair of rails to provide vertical support for one tier positioned above a tier that is located therebelow. BRIEF DESCRIPTIONS OF THE DRAWINGS FIG. 1 is a perspective view of an assembled two-tiered display rack embodying the features of this invention and illustrating in full lines part of the construction of one pair of adjacent upper and lower edge rails of the two tiers of the display tray; FIG. 2 is an enlarged, fragmentary, cross-sectional view, taken substantially on line 2--2 of FIG. 1, which is located in a plane about midway between the innermost and outermost side walls of the pair of abutting upper and lower rails along the left-hand edge of lower shelf 12, and shows details of a pair of abutting side rails located along one lateral edge of a support shelf of the lower tier of the two-tiered display rack shown in FIG. 1, FIG. 3 is a fragmentary cross-sectional view taken substantially on line 3--3 of FIG. 1 and showing additional details of a typical edge rail construction for one shelf of the tiered display rack, and by means of which the effective width of a horizontal support tier may be selectively set, and also illustrating, in fragment, the use of vertically oriented, planar spacers cooperating with the construction of the side rails for spacing pairs of tiers vertically and for supporting an upper tier by the next adjacent lower tier of the stand; FIG. 4 is a fragmentary cross-sectional view taken on line 4--4 of FIG. 3, showing the assemblage of a pair of tongues extending from the pair of side rails located along one edge of one tier of the display rack of FIG. 1; and FIG. 5 is an exploded view showing details of one support tier shelf of the display rack shown in FIG. 1, with an illustration of details of the spaced slide holders that are provided on the underside of a tier plate and are adapted for receiving thereinto pairs of adjacent tongues that extend from the pair of side rails that are provided along each side edge of a tier shelf, and also illustrating in exploded, or separated, relationship the spacer plates that extend vertically between rails adjacent the edges of each tier plate, to provide the means for vertical spacing of a pair of support tiers of the display rack, with the upper tier being supported by the lower tier through use of columnar-like plate supports. DETAILED DESCRIPTION OF THE INVENTION Referring now to the drawings, and particularly to FIG. 1, a two-level storage and display rack, adapted for mounting on a store counter, is shown generally at 10. The storage rack shown in FIG. 1 has only two tiers, but more tiers may be provided using vertical spacers, as shown in FIGS. 3 and 5, to space the additional tiers apart. Each shelf, or tier, of the two-tiered display rack example of FIG. 1 may be provided of a size, to have supported thereon, the goods-containing portion of a box of counter goods, such as chocolate bars, chewing gum, or other goods that the store keeper may be offering for sale. A five-tiered rack, using structural elements as disclosed hereinafter, has been constructed and has been demonstrated to be of stable construction. The horizontally elongated shelf of the lowermost tier of display rack 10 is generally indicated by numeral 12, with an upper, second, horizontally elongated tier shelf 14 spaced above said lowermost tier shelf 12. Each of the tier shelves 12 and 14 has associated, elongated, edge rails that are similarly constructed, so that a detailed description of the edge rail elements, and other features of construction of the lower tier shelf 12 will operate to provide a description of similar elements shown associated with the second tier shelf 14. Some elements, such as the specific vertical, columnar, side spacers 16, that are positioned to extend between side rails associated with the two shelves 12 and 14 are shown assembled only in FIGS. 1-3, in position on vertically aligned side rails to serve as a spacer and a support. The exploded view of FIG. 5 illustrates how these vertical spacers may be used either above or below a tier that includes one horizontal tier shelf for supporting another tier shelf, and these spacers may, for example, be used below the tier shelf 12 shown in FIG. 5, or between a pair of tier shelves 12 and 14, to serve to either support the lowermost tier above a counter, or to space a next higher tier above a next lower tier. In the specific illustrations in the Figures, the lower tier includes a flat, planar, horizontal support shelf member 12. The forwardmost end of shelf member 12 is provided with a transverse abutment wall 20 that lies in a plane transverse to the plane of shelf member 12, and is secured to shelf member 18 by any means, such as by being glued or melded thereto. The portion of the transverse, forward abutment wall 20 that extends above the upper surface of shelf 12, is positioned to serve as an abutment against which a wall of a body, or box, that is supported on shelf 12 may abut. The rear end of the storage and display rack 10, that is opposite forward wall 20, is open, so that an attendant may easily withdraw an empty box supported on the shelf 12, and insert onto the shelf 12, from rearwardly of the rack 10, a fresh, or replacement, box with goods therein. The lower tier shelf 12 is provided, along each of its longitudinal edges, with associated, elongated, upper and lower rail members, respectively 22 and 24, whose assembled structural portions are best seen in FIGS. 1-4, and whose overall shape may be seen in perspective in FIG. 5. An upper rail member 22, located adjacent to the left edge of shelf member 12, as viewed in FIGS. 1 and 3, includes an elongated, upper side rail, or body, that is provided with an elongated upwardly-opening groove means 25 in the upper edge of rail member 22 that is bounded by spaced, upright, inner and outer, longitudinal side walls, 28 and 30, that are spaced by transverse end walls 32 and 33. The upper side rail along the right hand longitudinal edge of shelf 12 is of similar construction and is designated 22', and with the parts thereof using the same identifying numeral with a prime (') mark. As seen in FIG. 3, when a shelf, such as shelf 12, and its side rails are assembled, only a portion of the total height of upper rails 22 and 22' extend above the upper surface of shelf 12. The lower rails 24 and 24' each are of mirror image construction relative to its adjacent upper side rails 22 and 22'. But while upper rails 22 and 22' have only portions thereof located vertically above the plane of adjacent shelf 12, the lower edge rails 24 and 24' have all portions thereof located below the plane of shelf 12. The lower edge rails 24 and 24' each also include a downwardly opening elongated recess or groove 27 that is located in a mirror-image relation to the similar structures provided in upper rails 22 and 22', but as seen in FIG. 3, all portions of lower side rails 24 and 24' are located below the plane in which shelf 18 is located. One purpose of having a pair of laterally spaced upper rails 22 located adjacent the two longitudinal edges of shelf 12 is to provide a pair of longitudinal elements that may be moved toward or away from each other to engage, or accommodate, the width of the box that rests on shelf 12, where the box is at least as wide as, or or wider than, the shelf 12. If the width of a rectangular box on shelf 12 is less than the width of shelf 12, then, at most, only one side wall of the box might be engaged by the innermost side of one of the two upper rails 22 or 22'. Since each of the two upper rails 22 and 22' are mirror images of each other, the similar elements on rail 22' carry the same identifying numeral as appears on rail 22, but with a prime mark (') added. It will now be seen, from FIGS. 1, 3 and 5 together, that the upper and lower rail members adjacent the side edges of shelf 12 have an exterior shape that is essentially the same. It will be understood that, if desired or necessary, the rail members themselves may be provided with selected interior shapes and walls for receiving and cooperating with spacer members of different size as may be necessary, or desired. However, for purposes of the description herein, it is to be understood that all rail members will be fundamentally of the same shape and size, except as may be needed to provide a modification. FIGS. 1 and 3 illustrate how a pair of upper, side rail members, 22 and 22', are each assembled alongside the two longitudinal edges of both lower shelf 12 and upper shelf 14. The underside of each shelf, 12 and 14, includes the same structure as shown on the underside of shelf 22 in the exploded perspective view of FIG. 5. Thus, the underside of each tier shelf, 12 and 14, is provided with two pairs of spaced angle sections 26a and 26b that are secured, or otherwise adhered to, or melded with, the undersurface of said shelves to make an integral structure adjacent each of the two lateral edges of the shelf. Also, and so that shelf 12 will not tilt, or slope, from front to back, the rear end of shelf 12 is provided with a rail 20', seen in exploded FIG. 5, which extends below shelf 12 the same distance that the lower portion 20a, of transverse abutment wall 20, extends below shelf 12. As best seen in FIG. 5, a shelf, such as either the planar support shelf 12 or 14, has affixed to the underside thereof, such as by gluing, or melding, two sets of socket angle sections, 26a and 26b, that lie respectively adjacent the lateral shelf edges 12a and 12b. Although aligned sets of separated socket angle sections 26a and 26b are shown, elongated angle-shaped sections, of the cross-section seen in FIG. 4, could be used instead, and then the end portions of said elongated sections would be the equivalent of the structures shown. The said socket angle sections, together with the underside of the shelf 12 to which the socket angle sections attach, provide generally socket-like, or generally rectangular, tubular-like, sockets, or tongue-holding means, indicated at 26c, for slidably receiving thereinto, or therethrough, lateral extensions, or tongues, 22a and 22b, that extend from an upper rail 22. The same sockets, or tongue-holding means, also receive lateral extensions 24a and 24b that extend from a lower rail 24, as is seen in FIG. 3. As best seen in FIG. 3, when a shelf 12 or 14 has its rails 22 or 24 assembled thereon, the socket angle sections 26a and 26b are of a size and spacing from the underside of the associated shelf 12, so that the two adjacent tongues, 22a and 24a, or 22'a and 24'a, of the two rails 22 and 24 are held by the tongue-holding means against the undersurface of a planar support, such as 12 or 14, in each socket space 26c provided between spaced, angled, flange sections 26a and 26b. The cross-sectional view of FIG. 3 shows the upper rails 22 and 22', when moved to their closest spacing, which is controlled or dictated, by the fact that upper rails 22 and 22', as seen in FIGS. 1 and 3, abut opposite lateral edges of shelf 12, with rail 22 abutting shelf edge 12a while rail 22' abuts an opposite shelf edge 12b, as seen in FIG. 3. The lower rails 24 and 24' are not so constrained, but lower rails 24 and 24', are preferably to be selectively moved into a position of vertical alignment with a set of upper rails 22 and 22', as best seen in FIG. 1. Alternatively, lower rails 24 and 24', may be selectively moved laterally inwardly until said rails abut the edges of angle flange sections 26a and 26b, or may be moved laterally outwardly of the position shown in FIG. 3, provided that some portion of tongues 24a and 24'a are not moved outwardly to a position where all portions of tongues 24a and 24'a escape the tongue holding means provided by socket angle sections 26a and/or 26b. Considering the structure shown in FIG. 3, the lower rails, 24 and 24', could be moved inwardly toward each other until an innermost portion of those rails abut an edge of the socket angle sections 26a and 26b. Referring now to the manner of effecting selective vertical spacing between the support shelves 12 and 14, or between shelf 12 and the top of a counter upon which the tiered display of FIG. 1 is supported, or between upper shelf 14 and a third shelf thereabove, the means for effecting such spacing utilizes the fact that each rail member 22, 24, 22' and 24' is provided with an interior groove means, such as the upwardly opening groove means 26 of rail 22, that is bounded longitudinally, such as by side walls 28 and 30 as described above, and as seen in FIGS. 1-3 and 5. More specifically, the groove means 26 does not provide a continuous slot along the length of its rail. Instead, each rail, such as rail 22 seen in FIGS. 2, 3 and 4, and rail 24 as seen in FIGS. 3 and 5, includes, in the groove means for the rail, one or more transverse ribs such as 40 and 42, that are clearly shown in FIG. 2. To cooperate with such groove means and its transverse ribs 40 and/or 42, there are provided vertical spacers, or columnar spacer means, in the form of planar, spacer plates 16, referred to earlier above. These planar spacer plates 16 are of a thickness to slidably fit into the longitundinal space between spaced side walls 28 and 30 of a rail member 22 or 24. Within the longitundinal space between the spaced side walls 28 and 30 of the rail member, there are provided one or more transverse ribs 40 and 42 as seen in FIG. 2. The shape of spacer plates 16 are most clearly seen in FIGS. 1, 2 and 5. Spacer plates 16 are rectangular in elevation as seen in FIG. 5 with their length edges 46 being greater than their height edges 48. As will appear from the following description, the rectangular spacer plates provide for two alternative spacings between shelves 12 and 14. A pair of opposed notches, 44, extending from the length edges of spacer plate 16, are provided in alignment with each other and extend toward each other from the long edges 46 of the rectangular plate 16. The length of the short edges 48 and 48' of plate 16 provides an effective measure of one spacing between an aligned upper rail 22, associated with lower shelf 12, and a lower rail 24, associated with upper shelf 14, spaced thereabove as seen in FIG. 1. The notches 44 are of a size and shape to permit a spacer plate 16 to fit over a transverse rib 40 or 42, here shown, in FIG. 2, to be rectangular in cross section. The spacing of notch 44 from the distal short edge 48' is selected so that when a notch 44 receives therein a rib 40, as seen in FIG. 2, the distal short edge 48' of plate 16 will slide against, and engage the closest edge 42' of rib 42, as shown in FIG. 2. Similar ribs provided in an opposite rail member, such as rail members 24 or 24' (seen in FIG. 5) permits the spacer plate to provide for firm engagement and interconnection between a pair of oppositely facing rail members, such as between one lower rail 22 and an opposed upper rail 24, as seen in FIG. 1. If a greater spacing is desired between a pair of shelves 12 and 14, the spacer plates 16 are to be rotated ninety degrees (90°) from their length position seen in FIG. 1 to a width position where edges 48 and 48' take the positions shown for long edges 46 as seen in FIG. 5. The length of edges 48 and 48' are selected so that long edges 46 of a spacer plate 16 will slidingly fit between ribs 40 and 42. In this latter arrangement, since a shorter edge of spacer plate 16 is captured in a groove, the spacing between a pair of spaced shelves 12 and 14 will be greater. The spacer plates may also be used as a pair of free legs to support lower rail members 24 and 24' upon the surface of a flat counter, as suggested by the lower truncated spacer plates shown extending downwardly in FIG. 3. By inclining, or beveling the lower edges, of a pair of laterally spaced support legs extending downwardly from lower rail members 24 and 24', the tiered display stand may be converted to a stand wherein the goods supported thereon are displayed at an inclined attitude, with the goods on a shelf, such as shelf 12, engaging the upper front flange 20 located at the forward end of a support shelf plate 12 or 14. The material used in making the various parts shown in the Figures of the drawings are a transparent plastic, thereby creating a tiered display stand that is eye-catching and attractive, while at the same time providing the rigidity and strength needed to serve the purpose as a display stand. The nature of the plastic material permits ease in forming and assembly, yet provides for inexpensiveness of construction and strength for the intended purposes. While a particular embodiment of this invention has been shown and described, it will be obvious to those skilled in the art that various changes and modifications may be made therein without departing from the spirit and scope of the invention and, therefore, it is intended in the appended claims to cover all such changes and modifications which fall within the true spirit and scope of the invention.

A variable width tiered display stand, which may be supplied in knocked-down condition, and which may be readily assembled at the site of use, is disclosed. The stand provides multiple tiers, each adapted for support of a box of boxed goods thereon, to provide an attractive means for display, and offer, of goods to prospective customers, while permitting the shopkeeper to easily withdraw empty boxes of goods from the tiers and to insert fresh boxed goods on the tiers as may be required or desired. The stands are preferably made of transparent plastic parts which may be easily fit together, and which do not require additional fastener means for keeping the tiered display stand assembled.

RELATED APPLICATIONS [0001] This application is a continuation of my pending application, Ser. No. 11/980,986, filed Dec. 31, 2007, which application is a divisional of my pending application Ser. No. 11/545,328, filed Oct. 10, 2006, which application is a continuation of my earlier filed pending patent applications, Ser. No. 10/686,948, filed on Oct. 15, 2003, which is a continuation-in-part of application Ser. No. 10/431,839 filed May 7, 2003 and Ser. No. 09/939,376 filed Aug. 24, 2001, which both disclose in part subject matter disclosed in my earlier filed patent application filed under Ser. No. 09/745,116 filed Dec. 21, 2000. This application is also a continuation of my application, Ser. No. 12/387,175 filed Apr. 28, 2009, which application is a continuation in part of my pending application, Ser. No. 11/705,396, filed Feb. 12, 2007, which application is a continuation of my pending application Ser. No. 11/396,158, filed Mar. 31, 2006, which application in part discloses and claims subject matter disclosed in my earlier filed pending patent applications, Ser. No. 10/686,948, filed on Oct. 15, 2003, which is a continuation-in-part of application Ser. No. 10/431,839 filed May 7, 2003 and Ser. no. 09/939,376 filed Aug. 24, 2001, which both disclose in part subject matter disclosed in my earlier filed patent application filed under Ser. No. 09/745,116 filed Dec. 21, 2000. FIELD OF THE INVENTION [0002] The present invention relates to a mission adaptable set of components for a multiple-purpose collapsible portable cart, which may convert to a utility table, for use in camping, hunting, search and rescue, and other outdoors activities. The cart can be easily assembled in a number of uses, and disassembled for easy transporting of the cart in a movable storage bin, a backpack or a hand-carried bag. BACKGROUND OF THE INVENTION [0003] Various single use carts exist for carrying canoes and small boats by hand. Other outdoors-oriented carts exist for carrying game. In addition, wheelbarrows and small carts are used for transporting gear at outdoors locations. However, none of the existing carts can be converted to a versatile portable cart which can interchangeably function as a rescue cart with a carrier for injured persons and be converted to a stationary utility table, as a portable canoe or boat cart which can be folded down and transported within the canoe or boat, as a game cart for transporting game over long, rough terrain, or as a gear cart, all of which can broken down into a carrying position, by hand or by back. OBJECTS OF THE INVENTION [0004] It is therefore an object of the present invention to provide a mission-adaptable set of interchangeable components forming movable and stationary load supports and work surfaces. [0005] It is an object of the present invention to provide a versatile multi-purpose cart, which is quickly assembled or disassembled. [0006] It is also an object to provide a multi-purpose cart, which quickly converts from one use to another. [0007] It is further an object to provide a cart which as a stable, flat platform for supporting cooking devices, machinery, camera tripods and the like. [0008] It is yet another object to provide a caravan of components for a load support system, which is stable during transport over rough terrain. [0009] It is yet another object to provide a portable collapsible cart/utility table with minimal fasteners. [0010] It is yet another object to provide a portable collapsible cart/utility table, which can be stabilized in a position of rest. [0011] It is also an object of the present invention to provide a universally adaptable carrier cart/utility table. [0012] It is yet another object of the present invention to provide a cart for carrying medical rescue stretchers, canoes and small boats by hand, which converts to a utility table for triage and emergency medical response. [0013] It is yet another object to provide a portable search and rescue cart/utility table adapted to carry a stretcher or other carrier for an injured person. [0014] It is also an object of the present invention to provide an outdoors-oriented cart for carrying game or injured parties. [0015] It is yet another object of the present invention to provide a small cart with a well for transporting gear at outdoor locations, which can be converted to a stable utility table with a work surface. [0016] It is also an object of the present invention to provide a versatile portable cart which can interchangeably function as a stationary work surface table, as a portable canoe or boat cart which can be folded down and transported within the canoe or boat, as a rescue cart for injured persons, as a game cart for transporting game over long, rough terrain, or as a gear cart, all of which can be broken down into a carrying position, by hand or by back. [0017] It is yet another object to provide a portable cart/utility table which is either backpackable or which can be carried by hand. [0018] It is yet another object to provide a carrier for transporting military equipment and ordnance. [0019] It is yet another object to provide a cart-hauling clamp for pulling the portable cart/utility table behind a bicycle or motorized all terrain vehicle while resisting tipping over of the cart during directional change of the cart-hauling bicycle or all terrain vehicle. [0020] It is yet another object to provide a portable cart/utility table, which can be used as a wheeled cart on terrain or as a ski cart on snow. [0021] It is also an object of the present invention to improve over the disadvantages of the prior art. SUMMARY OF THE INVENTION [0022] In keeping with these objects and others, which may be apparent, the present invention relates to a universal mission-adaptable set of structural components forming a myriad of useful movable support carts or stationary utility tables, which can be rapidly and accurately deployed in the field with minimal or no tool assembly. The cart may be a convertible, multi-purpose portable cart, for use in camping, hunting, emergency response, search and rescue operations and other outdoors activities, such as for carrying canoes and small boats by hand. It may also carry game, injured parties or be used for transporting gear at outdoors locations. It is a versatile portable cart which can interchangeably function as a movable or stationary medical rescue carrier, cargo carrier, portable canoe or boat cart, which can be assembled with interfitting parts and with minimal fasteners. It can be folded down and transported within the canoe or boat, as a carry cart for transporting game or injured parties over long, rough terrain or snow, or as a gear cart, all of which can be broken down into a carrying position, by hand or by back. [0023] The cart/utility table is moved by manual pushing or pulling force applied to activate vehicle movement actuators, such as wheels upon terrain or skis upon snow or ice, wherein upon the exertion of force the wheels or skis cause forward or rearward movement of the portable cart. [0024] The cart/utility table is easily assembled or disassembled by connecting its parts together, or optionally assembled from a pre-set storage configuration in a carry pack to an assembled structure. [0025] The cart/utility table easily changes from one use to the other. For example, in one embodiment, a hollow cargo well may contain a second loose layer, which turns into a rescue stretcher when the second layer becomes taut when zipped up from a loose, relaxed state within the cargo well to a taut rescue stretcher for carrying injured persons thereon. [0026] In an alternate rescue embodiment, clamps can be provided on shortened horizontal support members to hold rails to hold medical rescue stretcher rails, and optional handles or pivotable kickstands can be further attached by clamps to the stretcher rails. [0027] In military applications, the height of the vertical struts can be lowered to keep the injured person on a low profile stretcher close to the ground, to avoid visible detection. In such a case, the handles can optionally easily rotate from a handle carry position to a stationary kickstand mode. [0028] The portable cart is preferably under thirty (30) pounds, preferably twenty two (22) to twenty eight (28) pounds, so that it can be carried by hand or within a backpack over rough terrain. It is collapsible, so that it can be disassembled and carried in a canoe or small boat, and then reassembled with minimal assembly steps and parts, at another destination along the canoe or boat's journey. [0029] To prevent flat tires, its wheels are preferably solid core tires, which cannot get flat, or made of cellular materials, such as medium density, micro-cellular urethane, with stainless steel bearings, over which the wheels rotate. A typical wheel has two press fit bearings adjacent to an integrally molded hub. While the typical wheel is about 2-3 inches wide, for transporting cargo or game on sand or granular terrain, the wheels may be wider, such as 4-6 inches in width. [0030] For maneuverability in snow-filled winter scenes, optional ski members, including skis, are attached to vertical braces having a length corresponding to the radius of the cart's wheels. The vertical ski braces are attached to the vertical struts where the wheel axles attach. [0031] For hardiness, the material of the structural frame components is preferably a lightweight but resilient and strong material, such as, for example, 60-61 T6 fully anodized aluminum, or stainless steel. In a substantially pre-assembled optional embodiment, in a storage position within a carry bag, the vertical struts are connected to horizontal supports, which are further engaged with rails to hold a cargo well or rescue stretcher. Pivoting of the horizontal supports about each respective longitudinal axis to a position of rest biases the resiliently engaged rails to return to their natural position of use when released from the storage position. [0032] These pivotable support and strut assemblies can be further strengthened by optional V-shaped braces, which are positioned where each vertical strut meets each corresponding horizontal support member. [0033] The portable cart/utility table can hold up to 500 pounds, and for manual pulling easily pulls 300 pounds. The portable cart/utility table is durable to carry heavy weight over rough terrain, such as rock-strewn dirt trails or sloping riverbank surfaces. [0034] To carry a canoe or boat, two horizontal load supports optionally include support cushions upon which the canoe or boat rests. The position of the horizontal load supports can be varied to accommodate various widths of the canoe or boat. [0035] To function as a game or rescue cart, the frame, such as a pair of U-shaped rails which are joined end to end, is provided upon the horizontal load supports to form a rounded rectangular frame, over which a taunt, but slightly stretchable, bed of fabric is placed, such as canvas or other flexible material, i.e., plastic or netting. The bed includes sewn loops through which portions of the U-shaped rails of the frame are inserted. Other fabric fasteners such as clips, zippers or eyelets can be also used. [0036] In an alternate embodiment, the boat support cushions are removable from the horizontal load supports and are replaced by a two-piece clamp, which attaches by at least one fastener, such as a pair of screws, to the horizontal load supports of the cart. Conventional stretchers or personal rescue carriers, such as Stokes-type baskets, are clamped to the cart within the clamps on each respective horizontal load support. In this embodiment, the boat support cushions are attached to a thin plate, such as of ⅛ inch aluminum or otherwise, which has at least one fastener such as a pair of threaded studs, insertable with the respective hole or holes in the horizontal load supports, so that the boat support cushions can be removed and replaced by the stretcher-bearing clamps. [0037] To function as a wagon cart with a well for carrying gear, a hollow fabric well, such as of canvas, is draped between the horizontal load members and over and around the front and rear U-shaped brackets. A cover may be provided to cover the gear therein. The well and cover can also be made of other suitable flexible materials, such as plastic, netting or canvas. An optional removable hard bottom substrate floor layer may be provided within the cargo well. While this floor layer may be of any hard material, materials such as lightweight aluminum, wood or marine polymer plastics are preferred. [0038] Furthermore, the cargo cart may have an optional handle from which may be draped a further optional accessory cargo bag. In the stretcher embodiment, where the upper layer is fastened taut, the handle may have a removable headrest pillow. [0039] Kickstands may be optionally provided to stabilize the portable cart/utility table during rest or during loading of contents thereon. [0040] In yet another embodiment, an anti-tipping bicycle attachment is provided to attach the cart to a bicycle while preventing the cart from turning over during transportation. In one embodiment, the cart/utility table has two wheels for cargoes weighing from 300-500 pounds. However, for heavier loads, such as for 600-1,000 pounds, an optional double axle version includes two pairs of overlapping wheels for heavier cargo. In this embodiment, the portable cart/utility table uses four wheels in the overlapped configuration, with an optional hard molded canister. In this overlapping, wheeled version, a long axle attaches a pair of front wheels and a short axle attaches a pair of rear wheels through the respective vertical supports, although the length of the axles can be reversed. Using four wheels doubles the carrying capacity of the cart/utility table, and the overlapped positioning of the pairs of wheels maintains a short wheelbase for compactness, for maneuverability and for climbing slopes or ledges. [0041] In the four-wheeled embodiment, double parallel rails may be provided for additional structural strength. The overlapping, dual axle, four-wheel version gives the user extra pivot points on rough terrain. For example, pushing down upon the optional handle enables the user to lift the further away distal wheels off the ground. Furthermore, pulling upon the handle enables the user to lift the nearer, proximal wheels off the ground. [0042] The accessory which is placed upon the vertical supports of either the two wheeled or four wheeled cart/utility table, such as the rescue stretcher, the boat cushion, the cargo cart, etc., can be attached permanently or by fasteners to each horizontal load support member of the portable cart/utility table. However, in an alternate embodiment, the horizontal supports have longitudinally extending channels to slide the accessories in on top of the horizontal supports. Furthermore, the accessory, such as a railed rescue stretcher, can be carried by a clamp which itself is attached to the horizontal support by insertion in such a channel, or the stretcher can be dropped in and clamped to a pair of rails forming the horizontal support. [0043] This clamp upon each horizontal support member may be a one-piece clamp with a full width top section and short end pieces, which mate with and slip into a T-shaped slot channel of the horizontal support member. Alternatively, the clamp may have a full width bottom member which mates with and slides into a T-slot of the horizontal support. In yet another embodiment, two short identical clamp members are inserted into the T-slots of the horizontal member at the two ends. Moreover, the clamping sections can have spring-like gripping action to be retained upon tubular members, such as medical rescue stretcher rails, or the clamps can use fasteners such as fasteners, such as thumbscrews or ball plungers for retention. [0044] In yet another embodiment, a covered canister can be held in place over the rails of the frame of the cart, in a stable position, by virtue of its weight being held in place upon the rails of the cart, wherein a concave, downward facing channel engages the linear, upper convex support surface of each rail. [0045] Furthermore, the cart of the present invention can be disassembled and broken down for hand held or backpack transport and it can easily be assembled for its varied uses. Moreover, when a boat or canoe is carried, the cart has a precision balance feature that rotates the wheels to maintain the cart in a horizontal stable position. [0046] The convertible cart/utility table of the present invention is just one of many modular embodiments which may be made of the present invention. Because of the interchangeability of the parts, the components of the convertible cart/utility table can also be used for assembling a boat hauling cart, a game hauling cart, a wheelbarrow-type hauling cart, a low profile stretcher, a high profile stretcher and a component of a mobile emergency response system. [0047] Furthermore, in the rescue mode, the convertible cart/utility table allows for one person to transport an injured person instead of two on a stretcher. Because of the convertibility of the cart, when the person is brought to a triage situation for treatment and assessment, the wheels of the cart can be easily removed without tools and replaced by one or more kickstands to stabilize the cart. [0048] Therefore, in its broadest sense, the present invention is a movable support, such as a convertible cart/utility table, which is collapsible for storage and transport and is able to be assembled and dis-assembled for use in carrying a load, and alternatively functioning as a stationary utility table having stationary legs instead of wheels. [0049] In one embodiment, the convertible cart/utility table includes a pair of modular load support members which each includes at least one carrying strut extending downward therefrom and a carrier. [0050] The convertible cart/utility table is preferably carried by handles, which may be extensions of parallel rails constituting the load support member, or the handles may be separate handles having handle extension members nesting in a receiving member of the load support for receiving an adjustably removable handle extension member, such as a tube. The handles may be single grips extending coaxial to the first or the second horizontal frame rails of the movable support. [0051] In an alternate embodiment, the handles in a pivotable rectangular brace configuration, including a first set of manual grips extending between parallel connectors, which are further connected by a rotatable transverse bar, to enable the handles to be rotated up to a carrying position, or down to a storage position. [0052] These optional pivotable handles lock in an upper position for hauling the cart, and reverse to a lower position for storage, or in a low profile use, contact the ground surface for operating as a kickstand. [0053] In addition, the handles may optionally also pivot about their longitudinal axis downward to reach ground level to function as a kickstand for a low profile table cart, or may swing out of the way in a high profile cart when stored during travel or during the stationary utility table mode. [0054] By “low profile use” it is meant that the movable load support is positioned low to the ground to avoid detection, such as in military rescues. By “high profile use” it is meant that the movable load support is positioned higher up from the ground, such as for example, between 30 and 36 inches, more or less, to allow for access to the load. For example, if the load is an injured person in a rescue operation, the height is high enough to allow medical treatment personnel to conveniently treat the injured person. If the load is cargo, then the height of the high profile movable support, such as a cart, is convenient for stowing and removing the cargo being transported. [0055] These axially pivotable handles may slide within a hollow support rail, and be locked in place by fasteners, such as spring pins extending through respective holes in an outer wall of the hollow support rail. [0056] Preferably, the handle includes a first hand grip located coaxially to the handle shaft or tube and an outer second handle grip, which is located parallel to the handle shaft or tube, which is in rigid connection with the coaxial handle grip. Both parallel hand grips are connected by parallel brace members laid perpendicular to the hand grips. The handle member is lockable in at least two positions, such as an upward position for hauling the convertible cart/utility table and a downward position for using the handle as a kickstand in a low profile embodiment, or for storage in a high profile embodiment. [0057] These handles may be locked in place with a spring pin. [0058] The longitudinally extending structural frame rails of the movable support can each accommodate a handle extending therefrom, each frame rail having a connecting end and a handle attachment end, and a plurality of spring pin apertures for attachment of additional members. [0059] In a preferred embodiment, there are at least two spring pins, wherein a spring pin of the plurality of spring pins reversibly protrudes a spring pin aperture of the plurality of spring pin apertures located on each respective frame rail, such as a first horizontal tube. [0060] Preferably, for knockdown transport, each frame rail may be made of several components, such as a longitudinally extending mid section joined at each opposite end to longitudinally extending first and second connecting end portions. A first spring pin aperture is located on each lateral side of the connecting ends of the first horizontal tube and the second horizontal tube; and a second spring pin aperture is located on each top side of the connecting ends of the first horizontal tube and the second horizontal tube, a distance farther from the connecting end than of the first spring pin aperture. Other pin locations are applicable. [0061] These assembled frame rails together accommodate optionally one or more clamps, with at least one clamp in communication with a first horizontal tube and at least one other clamp in communication with the second horizontal tube, with both tubes forming the frame rails of the movable load support. [0062] In a further alternate embodiment, one or more transverse support bars, preferable at least two transverse support bars, are substantially perpendicular to the pair of longitudinally extending frame rail tubes, and may optionally be in communication with a clamp holding a carrier in removable communication with the clamp or clamps. The carrier may be a rescue stretcher, Stokes carrier, cargo bin, open cargo hauling well, rack or other load support means. [0063] The clamp may be attached to a strut through which accommodates axles therethrough for movement actuators, such as wheels. [0064] Optionally the clamp may be at least one clamp, reversible for accommodating a range of sizes of carriers, including a bottom surface, an opposing top surface, and a inside surface, a clamp front surface and an opposing clamp rear surface. The bottom surface includes a plurality of grooves for optionally receiving one of the horizontal support tubes of the frame rails, with the reverse top surface including at least one groove for optionally receiving a horizontal support tube. This reversible clamp has a first bore extending from its top surface to its bottom surface, for allowing a bolt to pass therethrough. The reversible clamp also includes a rail-accommodating aperture extending from the clamp's front surface to the clamp's rear surface for receiving a horizontal support tube of a frame rail, and the reversible clamp has a tightening knob for securely attaching the clamp to each respective horizontal support tube; [0065] The clamp also includes a latch to tighten a load support, such as a stretcher or other rail in place. So that the latch does not become loose, the threaded securing bolt of the latch, which is threaded into a threaded bore of the body of the reversible clamp, includes a bottom flange wider than the threaded bore, which includes a reciprocal flange recess to accommodate the flange of the threaded securing bolt. An optional fixed nut or flange is located at the end of the bolt, for preventing the separation of the joinable latch and main body parts of the reversible clamp and the bolt from the clamp. [0066] In a preferable embodiment, the clamp may be a heavy-duty clamp having a lower portion having a first concavity for insertion above the horizontal support tubes and a second concavity for slidable and removable insertion of a carrier or a second carrier, a top surface and a guide boss for removable attachment of an upper portion. The upper portion has a third concavity for slidable and removable insertion of a carrier and a guide recess for removable attachment to the lower portion. The heavy duty clamp includes a first latch rigidly connected to the clamp's lower portion, in communication with the first concavity for gripping the horizontal support tube of a frame rail of the load support carrier securely. [0067] The heavy duty clamp also preferably has a second latch, preferably at an upper end, which second latch is rigidly connected to an upper portion of the heavy duty clamp in communication with the third concavity for gripping the load support carrier securely. [0068] The heavy duty clamp may optionally support one or more rails holding a fluid catch under the load support carrier, to catch blood and other body fluids if the load support carrier holds an injured person being medically treated thereon. [0069] This second latch includes a lever latch for manual securing of the load support carrier and a clamping jaw for forming a frictional contact force between the latch and the frame rail of the carrier. [0070] When the carrier is a stretcher secured to the convertible cart/utility table, the pitch of the stretcher can be adjusted, such as for example, to raise or lower the head of the person being treated. In this case, the stretcher carrier has a front end and a rear end, wherein the front end of each rail is secured to a respective upper hook receptacle portion of the clamp and the rear end of each frame rail of the carrier is secured to a respective lower hook portions of the clamp, resulting in an elevation differential between the front end and the rear end of the second carrier. The clamps come in pairs so that the front and rear clamps on each side are equidistant from each other in length, with each secured to opposing horizontal support tubes of each frame rail. [0071] In such a case of the head portion of a medical stretcher or other carrier being raised higher than an opposite foot end, the height of the respective head and foot portions can be varied by placing the foot end in the lower hook portions of the foot clamps and the head end in the higher hook portion of the heavy duty clamp. Optionally, the height can be further varied by varying the height of each kickstand, wherein the rear kickstand is in a position of the clearance being a minimum, and the front kickstand is in a position of the clearance being a maximum, resulting in maximum height differential between the front end of the carrier and the rear end of the carrier. [0072] Additionally, the diameter of the upper latch jaw is effectively less then the inside diameter of the rail support concavity of the clamp for allowing the jaw to accommodate a change in pitch of the carrier, in case the carrier has to be tilted, such as for raising the head of an injured person being treated upon the load support carrier. This latch jaw includes cylindrical portions and a contact portion including a concave surface for evenly contacting the convex surface of the carrier's frame rail. [0073] Optionally, the kickstand may be a pair of kickstands, namely a front kickstand and a rear kickstand, adjustable in width and insertable through the clamping means and clamped onto each end of each horizontal support frame rail and extending substantially vertically therefrom. [0074] For further strength of the movable support in a stationary position of use as a utility table, the kickstand may include a substantially vertical left leg, substantially vertical right leg, and a kickstand connecting bar detachably extending horizontally between the left and right legs. Each of the left and right legs of the kickstand may include a lower end and a height adjustable member insertable to the legs by means of a swivel joint for allowing the legs to rotate freely. [0075] The height adjustable members adjust the height of each leg, preferably by insertion of a first pin, such as a locking pin or a spring pin, insertable within a selected aperture of a plurality of pin apertures in substantially vertical orientation, wherein the height adjustment member is removably insertable into each leg for a predetermined incremental height interval, such as about one inch. [0076] Besides this macroadjustment of the kickstand leg by selective insertion of the pin into a selected aperture, the height can be adjusted by a microadjustment means, including the kickstand having a screw end and the lower end of the leg includes a receptacle, for the screw end, for fine adjustment of the height of the movable support, where the distance between the edge of the leg of the kickstand and the lower edge of the height adjustment member is a clearance distance. [0077] The heavy duty clamp also includes an optional outside surface having a hinge for removably attaching at least one rotatable swivelable accessory therefrom, wherein the accessory is an examination or surgical lamp having a flexible or hinged neck, an instrument tray, an arm or leg limb platform support or a gravity or pump fed intravenous (IV) pouch support having an insertable vertical rod and a component for insertion into the vertical rod into the hinge. [0078] The hinge accessory may include a splitting attachment having an insertion pin for removable and rotatable communication with the hinge, and at least two hinges extending substantially vertically for additional components in a stacking arrangement, such as, for example, one instrument tray being elevated above another instrument tray. [0079] If there is a person with blood loss during surgery in the field, this convertible cart/utility table can also have an auxiliary fluid catch draining fluids into a closed shallow bucket. [0080] In addition, medical accessories and a power pack for lighting and for instrument power can be attached to the cart. [0081] In the basic cart mode a transverse member connecting the load support members is not necessary, as the downwardly extending struts accommodate the axles for one or more pairs of wheels, which act as transverse support members for the cart in its basic transportable cart embodiment. [0082] The load support member itself may be a) a resting member supporting a load thereon or, b) it may be a clamp. The clamp may be adjustable by a handle, which may have a stop to prevent complete unscrewing of the stud of the handle so that the clamp cannot come apart. The clamp can be a pair of jaws, or it can be a longitudinally extending slider clamp where the load support slides into a recess between two overhanging cantilevered members extending upward from the base. [0083] The convertible cart/utility table is also useful in military and emergency situations. For example, in addition to rescue of injured military or civilian personnel, the cart may be used in areas contaminated by toxic substances or weather related disasters. Besides moving an injured party in a triage situation to a treatment area in a detoxification environment caused by a weapon of mass destruction such as gas, smoke or other noxious particles, there may be a necessity for a wash of the persons so the contaminated persons can be brought by the convertible cart/utility table to a wash area where they are first immediately washed of surface contaminants. In this weapons of mass destruction treatment facility there can be any one of these pieces of equipment to wheel the injured persons to decontaminate them. If they are not ambulatory, for any further treatment they can be brought to the medical facility. [0084] The medical facility can set up as a fully operational ten (10) or more bed field hospital treatment facility with ten (10) or more sets of bins carried on ten or more carts, wherein each upper most bin shell container of each set of containers for each bin can be tilted and moved can be moved from a horizontal carrying position to a vertical stand upright position with drawers extending outward therefrom. A mobile hospital is modular in its design. If there is a need for more than ten (10) beds, then increment units of ten can be provided and deployed to a site. For rapid deployment, the convertible cart/utility table with cargo hauling bins can be hauled by all terrain vehicles in a rapid manner. [0085] In addition, the convertible cart/utility table easily converts without tools from either a wheeled embodiment to a fixed table embodiment wherein the wheels are replaced by one or more kickstands. When in the utility table mode, the cart can have extending therefrom, by clamps, one or more swivelable platforms supporting injured limbs of a person or medical supplies such as an instrument tray, a light, an I.V. tube pole, etc. In this case, the platform is pivotable, but not removable. It pivots like a hinge to any desired position. [0086] Auxiliary transverse bars can be added when in the fixed table embodiment. Additionally, there are micro and macro adjustments of the height of the cart depending on the need for access to the injured person on the cart. For example, there are macro adjustments in one-inch (1″) increments to raise the cart up and there is also a micro adjustment by a threaded member for up to a one-inch (1″) of micro adjustment. [0087] To hold rescue stretchers or other carrier rails, a heavy-duty utility clamp has a concave hook portion for dropping in a stretcher rail and a lower concave portion for dropping in a rail holding an auxiliary fluid catch basin or sling. However, one end of the stretcher can be put in a lower concave hook of the heavy-duty utility clamp to slant the position of the stretcher. Furthermore, by adjusting the transverse bars and/or the axles, the width of the utility table can be widened, so it is totally adjustable to fit any size carrier or stretcher. [0088] In addition, in order to raise the head of an injured party, raising one end and lowering the other end can slant the table portion. A preferable ten-degree)(10°) adjustment can be done with the adjustable foot height and then there is an additional five degrees)(5°) by adjusting the heavy-duty clamp and raising or lowering one end of the stretcher on the utility table. [0089] Hinged platform arm or leg board platforms may extend from a clamp attached to the frame rail of the utility table. The platforms swing out radially in a horizontal plane, to provide maximum adjustability for the position of the limbs of a victim or for the positioning of medical/surgical accessories, such as intravenous stands, instrument trays or examination lamps. It is further noted that attached to the auxiliary arm board platforms may be poles for supporting an intravenous fluid pack or a tent to repel insects from the treatment environment. While other suitable measurements may be used, these arm board platforms are preferably six inches (6″) wide and the leg boards approximately eight inches (8″) wide. [0090] The convertible cart/utility table also optionally includes a clamping means, which may be a latch, a pair of clamping jaws, a longitudinally extending slotted extrusion or a receptacle. [0091] The axle-carrying struts each have a lower end with an axle mounting means at the lower end and at least one axle extending through each axle-carrying vertical strut. Each axle has at least one vehicle movement actuator, such as a wheel or a ski, of a pair of vehicle movement actuators attached at opposite sides of the convertible cart/utility table, which also has a carrier attachable to the load support member, wherein when the carrier supports a load thereupon. Such a carrier may be a hollow well, a bin, a pair of rails, a rescue stretcher or Stokes carrier or other support surface or container. Optionally the carrier may be rotatable from a horizontal position of travel to an upright position as a shelved cabinet. [0092] The parts are easily assembled and disassembled without the necessity of tools. For example, the parts can be held together by clamps or receiving receptacles including a spring pin aperture for receiving a push pin for secure interconnecting of a component of the convertible cart/utility table, such as the handle tube within the receiving member of the load support member. The components can also be held in place by pins or other fasteners positioned within diametrically opposed transverse holes for allowing a through pin to extend therethrough. PINS [0093] While in simple embodiments the convertible cart/utility table includes a single pair of wheels attached by struts extending down from the load support members, in other embodiments the convertible cart/utility table includes two pairs of axle load supports and four vehicle movement actuators, such as wheels. [0094] To convert from a movable support, such as a convertible cart to a stationary utility table, the downwardly extending axle-supporting struts are detached by their clamping means from the load support members, and replaced by stationary kickstands, which contact the ground to maintain the utility table in a stationary position. [0095] One kickstand may be used with the wheeled struts still in place, although for maximum stability all wheeled struts are replaced by kickstands. [0096] The kickstand may be a single rod extending from the load support member to the ground, or it may be an H-shaped or U-shaped pair of downwardly extending rods connected by a widenable transverse member, to vary the width of the convertible cart/utility table. [0097] The convertible cart/utility table may also include at least one cargo bin removably connected to the load support member. [0098] Each of the cargo bins preferably includes a top shell container of a plurality of shells, each having a top outer surface and an opposing top inner surface; a bottom shell having a bottom outer surface and an opposing bottom inner surface. The top outer surface includes a boss arrangement and the bottom outer surface includes a recess arrangement corresponding with the boss arrangement, for aligning a plurality of the cargo bins to be vertically stacked one on top of each other in a caravan of bin-hauling carts. There may also be one or more intermediate shell containers. [0099] The bin of the convertible cart/utility table has one or more latches for removably connecting the top shell to the bottom or intermediate shell, wherein the latch is optionally lockable. Preferably, each bin is made of a sturdy, lightweight material, such as fiberglass. [0100] A top shell can be removed from the stack of bins and stood upright as a medical or other supply cabinet, which includes slidable drawers, anchored to and within the top shell of the cargo bin. Preferably, the top inside surface and the bottom inside surface of the shells of the bin each includes a foam lining for limiting the movement of contents within the cargo bins. Additionally, the shells further include one or more optional removable interior containers. [0101] The mission-adaptable components may therefore deploy a portable cargo bin having a cabinet system and at least one locking latch, and be secured to the collapsible cart/utility table, in a method including: [0102] i) in the case of the collapsible cart/utility table having vehicle movement actuators, such as wheels, securing the wheels in place to prevent movement, [0103] ii) applying force to tilt the collapsible cart/utility table about a first axis until a first rest position is reached, wherein the force is optionally applied to a pair of handles in connection with the collapsible cart/utility table, and the first axis of tilt being the vertex formed of the intersection between the bottom outer surface and a bottom front surface; [0104] iii) unlatching the straps holding the shells of the bin; [0105] iv) applying force to tilt the collapsible cart/utility table about a second axis until a second rest position is reached, wherein the second axis of tilt is the vertex formed of the intersection between the top outer surface and the top front surface; [0106] v) disengaging the latch or latches; and [0107] vi) separating the top shell from the bottom shell and the portable cart/utility table, allowing it to return to the first rest position or optionally to return fully to the initial standing position. [0108] The convertible cart/utility table may also include a modular load support member which includes at least one axle-carrying strut extending downward therefrom, a receiving member for receiving an adjustably removable handle tube and optionally a clamping means. [0109] The clamping means may be an extrusion slider clamp rigidly attached to the modular load support member, having a top clamp surface, an inside edge and an outside edge. The top clamp surface further includes a groove formation aligned with the inside edge and the outside edge for horizontally receiving a carrier therein. [0110] In this case, the axle carrying struts have a lower end with an axle mounting means at the lower end, at least one axle extending through each axle-carrying strut. Each axle has at least one vehicle movement actuator of a pair of vehicle movement actuators attached at opposite sides of the cart and a carrier attachable to the clamp, wherein when the carrier supports a load thereupon. [0111] The axle carrying struts may each includes a lower end with an axle mounting means at the lower end, at least one axle extending through each vertical strut and a plurality of transverse holes for resisting impact. A carrier is attachable to the load support member, wherein when the carrier supports a load thereupon. Additionally, each axle carrying strut may have a pair of support trusses for increased load support, the trusses being rigidly connecting the axle carrying support and the extrusion clamp. [0112] As a result, the convertible cart/utility table is mission adaptable for a variety of missions, and is not mission specific, such as for one particular task. The components break down into interchangeable parts, and are easily transported or stored for adaptability to a myriad of tasks in both friendly and hostile environments. DESCRIPTION OF THE DRAWINGS [0113] The present invention can best be described in connection with the accompanying drawings, in which: [0114] FIG. 1 is an exploded perspective view of the components of the basic cart embodiment broken down for transport within and on the storage backpack; [0115] FIG. 2 is a perspective view of the backpack on a user, with the cart contained therein; [0116] FIG. 3 is an exploded inverted perspective view of the basic cart embodiment components, disassembled from their original transport configuration; [0117] FIG. 3A is a perspective view of an alternate simplified embodiment where the vertical strut is permanently attached to a horizontal member in a “T” configuration; [0118] FIG. 3B is a perspective view of an embodiment where the horizontal support is permanently affixed to the vertical strut by welding or other means; [0119] FIG. 3C is an alternate embodiment where the vertical strut fits within a hole in the horizontal support and is fastened by a fastener. [0120] FIG. 4 is a perspective view of the assembled boat cart; [0121] FIG. 5 is a perspective view of the assembled cart with a boat fastened for transport; [0122] FIG. 6 is an exploded perspective view, inverted, of the components required to assemble the boat cart; [0123] FIG. 7 is an exploded perspective of a typical wheel, showing two press fit bearings adjacent an integrally molded hub; [0124] FIG. 8 is a perspective view of an axle-locking member, installed on the assembled axle; [0125] FIG. 9 is a sectional elevation view, taken through lines 9 - 9 of FIG. 8 , showing the locking member compressing and locking the axle joint; [0126] FIG. 10 is a diagrammatic side elevation view of the boat cart in its resting position, with a boat hull contacting the raised edge; [0127] FIG. 11 is a diagrammatic side elevation view of the boat cart with the boat hull positioned and fully installed, illustrating the precision balancing feature of the cart; [0128] FIG. 12 is a perspective view of the assembled alternate embodiment cart, for hunting/gaming applications; [0129] FIG. 13 is an exploded perspective view of the inverted gaming cart, illustrating the framework fastening method; [0130] FIG. 14 is an exploded perspective view, inverted, of the gaming cart, illustrating the attachment of the stretcher canvas material to the framework components; [0131] FIG. 15 is an exploded perspective view of the attachment of the handlebar component to the locking receptacles on the framework; [0132] FIG. 16 is a sectional elevation view, taken through lines 16 - 16 of FIG. 15 , showing the locking receptacles acting on the installed leg of the handlebar; [0133] FIG. 17 is a perspective view of the gaming cart, with a deer fastened for transport; [0134] FIG. 18 is a perspective view of a further embodiment, a cart for transporting cargo, equipped with optional wide tires and axle for use on sand or granular terrain; [0135] FIG. 19 is a perspective view of a fully loaded cargo cart, with the cover material partially cutaway to reveal its contents; [0136] FIG. 20 is an exploded perspective view, inverted, of the cargo cart, illustrating the attachment of the canvas material to the framework components; [0137] FIG. 21 is another exploded perspective detail view of the components for a stretcher-hauling clamp of an alternate embodiment for a search and rescue cart; [0138] FIG. 22 is a perspective view of the clamp embodiment shown in FIG. 21 , showing the sliding action of the clamp therein, for quick removal of the stretcher therefrom; [0139] FIG. 23 is a perspective view of the portable cart of the present invention, showing the clamp as in FIGS. 21 and 22 carrying a rescue stretcher; [0140] FIG. 24 is a perspective view of the portable cart carrying a Stokes-type personal rescue carrier; [0141] FIG. 25 is an exploded view of components of a further alternate embodiment for a support for removal of a boat support cushion therefrom; [0142] FIG. 26 is a perspective view of an alternate embodiment for a hunting cart with an accessory racking system for transport of hunting gear, such as a tree stand chair, archery implements and firearms thereon; [0143] FIG. 27 is an exploded detail view of a quick release clamp for rail fastening to the cart shown in FIG. 26 ; [0144] FIG. 28 is an assembled elevational view of the clamp of FIG. 27 attached to a rail; [0145] FIG. 29 is an exploded perspective view of a typical clamp for gear support for the cart as in FIG. 26 ; [0146] FIG. 30 is a perspective view of an anti-tipping attachment for connecting a bicycle to the portable cart of the present invention; [0147] FIG. 31 is an exploded perspective view of the components of FIG. 30 ; [0148] FIG. 32 is a side elevational view of an alternate embodiment of the portable cart of this invention with four wheels, shown with a covered cargo-hauling bin; [0149] FIG. 32A is a top plan view of the cover for a bin used with the cart as in FIG. 32 ; [0150] FIG. 32B is a top plan view of the bin used with the cart as in FIG. 32 ; [0151] FIG. 32C is an exploded view of the cover and bin as in FIG. 32 ; [0152] FIG. 32D is a side elevational view of the cover and bin as in FIG. 32 ; [0153] FIG. 32E is a front elevational view of the cover and bin as in FIG. 32 ; [0154] FIG. 32F is a front cross-sectional view thereof, taken along lines “ 32 F- 32 F” of FIG. 32D ; [0155] FIG. 32G is an exploded perspective view thereof; [0156] FIG. 32H is an exploded perspective view of an alternate embodiment of a load support has a plurality of spaced apart, downwardly extending axle carrying struts and a receiving member for a handle tube, has an upper pushpin aperture and a pair of opposite holes for a through pin to extend therethrough, showing two axles accommodating a pair of dual wheels in coaxial orientation; [0157] FIG. 32I is a close-up perspective view of the receiving member and handle spring pin engaged in the receiving member as in FIG. 32H ; [0158] FIG. 32J is a side elevational view of an alternate embodiment of a four-wheel cargo bin hauling cart showing stacked cargo hauling bins held in place in a boss and recess engagement; further showing a kickstand engaged to the handle; [0159] FIGS. 32K , 32 L and 32 M are side elevational views of the sequence of the disassembly of one of the cargo hauling bins to a deployed standing position with operable sliding draws; [0160] FIG. 32N is a front elevational view of the standing bin as in FIG. 32M ; [0161] FIG. 32O is a local perspective view of an optional trailer hitch assembly; [0162] FIG. 32P is a side elevational view of an all-terrain vehicle pulling the four-wheel cargo bin-hauling cart with the trailer hitch as in FIG. 32O . [0163] FIG. 33 is a perspective view of one embodiment for an assembled frame of a portable cart with four wheels; [0164] FIG. 33A is a bottom perspective view of the chassis and wheel portions thereof; [0165] FIG. 34 is a perspective view of an alternate embodiment of a channeled horizontal load support member with an integral T-slot; [0166] FIG. 35 is a perspective view of the channeled horizontal load support member as in FIG. 34 , shown with an extruded support cushion installed in a T-slot; [0167] FIG. 36 is a perspective view of the embodiment for an assembled cart with four wheels further incorporating horizontal support members with a T-slot; [0168] FIG. 37 is a perspective view of a horizontal support member with a clamp member having two short T-slot engaging members and a full-length top section; [0169] FIG. 38 is a perspective view of a horizontal support member with a clamp member having a full-length T-slot engaging bottom member and two short clamping top members; [0170] FIG. 39 is a perspective view of a horizontal support member with two short identical clamping members installed in the T-slots at the extreme ends; [0171] FIG. 40 is a side elevational view of an alternate embodiment for a rescue carrier cart with shortened horizontal supports and with a pivotable kickstand; [0172] FIG. 41 is a front elevational view of the kickstand portion of the rescue carrier cart as in FIG. 40 ; [0173] FIG. 42 is a side elevational view of the rescue carrier cart as in FIG. 40 , shown with the kickstand pivoted in a transportable position of rest; [0174] FIG. 43 is a side elevational view of a low profile military rescue carrier cart, shown with a handle; [0175] FIG. 44 is a front elevational view of the handle as in FIG. 43 ; [0176] FIG. 43A is a perspective view of a low profile rescue carrier cart shown with an alternate embodiment for a stretcher bearing assembly having a reversible handle/cart support; [0177] FIG. 43B is an exploded perspective view of the stretcher-bearing tube components of the stretcher-bearing assembly of FIG. 43A , showing interlocking spring-loaded pin and receptacle fasteners; [0178] FIG. 43C is a detail view of the spring-loaded pin as in FIG. 43B ; [0179] FIG. 43D is a side elevational view of the assembled components of a low profile rescue carrier cart as in FIGS. 43A , 43 B and 43 C; [0180] FIG. 43E shows the low profile rescue carrier cart, in a side elevational view; [0181] FIG. 45 is a side elevational view of an alternate embodiment for a four wheeled rescue carrier cart, shown with stretcher rails and with stabilizing tie rods, for use as a temporary stationary medical gurney; [0182] FIG. 46 is a top plan view thereof; shown without the stretcher rails; [0183] FIGS. 47 , 47 A, 47 B, 48 and 49 show respective isometric, left side, top, front and right side views of the clamp used in the embodiments shown in FIGS. 40-46 ; [0184] FIG. 50 is an isometric view of a half piece thereof, shown with spring pins; [0185] FIG. 51 is an isometric perspective view of a further embodiment for a disassembled, single axle cart, stored in a carry bag; [0186] FIG. 51A is a further perspective view thereof; [0187] FIG. 52 is an exploded perspective view of the cart as in FIG. 51 , shown during assembly, wherein arrows indicate directional movement of rotation about the axis of the rails shown therein; [0188] FIG. 52A is a perspective view thereof showing one wheel in place upon an axle; [0189] FIG. 53 is a close-up cutaway view of the spring stop member regulating outward movement of the optional rails of the cart of the present invention from a storage position to a position of use; [0190] FIG. 54 is an overall perspective view in partial cutaway of the cart showing the wagon portion in its cargo-carrying configuration; [0191] FIG. 55 is an overall perspective view of the cart of FIG. 54 , shown in its rescue stretcher configuration; [0192] FIG. 56 shows a detail view of an optional ski attachment instead of wheels, for use in snow and winter environments; [0193] FIG. 57 shows a detail view of an optional platform base for supporting objects thereon; [0194] FIG. 58 is a perspective view of portable cart frame configured as a multi-victim stretcher; [0195] FIG. 59 is a perspective view of multi-victim stretcher using single fabric top surface cover; [0196] FIG. 60 is a perspective view of multi-victim cart frame reconfigured to accept separate stretchers; [0197] FIG. 61 is a perspective view of multi-victim stretcher using separate stretchers; [0198] FIG. 62 is an end view of wheel subassembly attachment mechanism in engaged position; [0199] FIG. 63 is an end view of wheel subassembly attachment mechanism in disengaged position; [0200] FIG. 64 is an end view of attachment clamp for tubular overhead bar; [0201] FIG. 65 is a perspective view of portable cart frame configured as an operating room table/gurney; [0202] FIG. 66 is a perspective view of operating room table/gurney; [0203] FIG. 67 is an end view of wheel brake mechanism in applied position; [0204] FIG. 68 is an end view of wheel brake in an off position; [0205] FIG. 69 is an end view of side rail adjustable clamp; and, [0206] FIG. 70 is a perspective view of adjustable clamp assembly. [0207] FIG. 71 is a diagrammatic flow chart of use of the convertible cart/utility table of the present invention in a medical emergency response triage environment; [0208] FIG. 72 is an exploded perspective view of the basic components of the convertible cart/utility table of the present invention, showing removable kickstand and wheel support components; [0209] FIG. 73 is an exploded view of the tubular frame component of the convertible cart/utility table of the present invention, with an alternate embodiment for a kickstand holding sleeve; [0210] FIG. 74 is an exploded perspective view of an assembled convertible cart/utility table in the utility table mode, showing an auxiliary power pack attached thereto and a medical stretcher above; [0211] FIG. 75 is a side elevational view of the convertible cart/utility table in the utility table mode as in FIG. 74 , shown in a tilting feature with one portion of the utility table being raised higher than a higher opposite lower end proportion, and showing an optional body fluid captive collector; [0212] FIG. 76 is a detailed view of the height adjustable foot portion of the convertible cart/utility table as in FIGS. 74 and 75 , as shown in the ellipse “ 76 ” in FIG. 74 ; [0213] FIG. 77 is a detailed perspective view of a reversible clamp of the convertible cart/utility table as in FIG. 43A ; shown in the detail callout “ 78 ” of FIG. 43A ; [0214] FIG. 78 is a close-up rear elevational detail view of the clamp as in FIG. 77 , shown in a reversed position, as shown in the detail callout “ 78 ” in FIG. 43A ; [0215] FIG. 79 is a front elevational view of an optional heavy-duty clamp for the convertible cart/utility table as in FIG. 72 , as shown in detail callout “ 79 ” in FIG. 72 ; [0216] FIG. 80 is a detailed front elevational view showing a hook of the heavy-duty clamp as in FIG. 79 showing the retraction of a stretcher rail support, allowing the stretcher rail to drop thereby selectively tilting the head or foot of the stretcher; [0217] FIG. 81 is a perspective view of the stretcher clamp for the tilted stretcher effected by the clamp retractor as in FIG. 80 , which stretcher clamp allows for the tilting rotation of the stretcher rod; [0218] FIG. 82 is a perspective view taken at detail callout “ 82 ” in FIG. 81 , showing the rotation thereof effectuating tilting of the latch; [0219] FIG. 83 is an exploded perspective view of a claim for an auxiliary limb appendage support used in connection with the convertible cart/utility table as in FIG. 72 or FIG. 74 ; [0220] FIG. 84 is an exploded perspective view of the clamp as in FIG. 83 showing intravenous support stanchion and a medical instrument tray. [0221] FIG. 85 is an exploded perspective view of the clamp of FIG. 83 sharing a means for mounting a medical clamp and, [0222] FIG. 86 is a perspective view illustrating an instrument tray set-up used in connection with the clamp as in FIG. 83 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0223] As shown in the drawing FIGS. 1-70 , the present invention is directed to a mission-adaptable set of components forming a convertible cart/utility table. For example, the present invention may include foldable cart 1 , having a load support for carrying a load, such as a boat, such as a canoe, which can also function as a game cart or a wagon for carrying gear in outdoor field applications. [0224] FIG. 1 shows cart 1 in a disassembled storage position with a pair of horizontal load support members 10 laid parallel adjacent to each other, supporting wheels 30 thereon. Wheels 30 are secured in place by a transverse connecting rod 31 through wheel hubs 30 a and by one or more load securing straps 50 . Disassembled storage cart 1 is inserted within carry bag 120 , which includes ledge 121 and fabric loops 122 for holding bracket members 60 , 70 and handle 80 outside of carry bag 120 . [0225] To transport portable cart 1 by hand carry straps 124 are attached to carry bag 120 . Conversely as shown in FIG. 2 , to transport portable cart 1 upon the back of a user, carry straps 124 are attached to carry bag 120 , which supports portable cart 1 in a weight bearing manner, or else horizontal support members 10 are inverted to support portable cart 1 in a weight bearing manner, and carry bag 120 covers portable cart 1 in a non-weight bearing manner. [0226] To be disassembled in a carry position, U-shaped bracket rails 60 , 70 , wheels 30 and axle members 32 are inversely attached to horizontal load supports 10 to comprise a folded manually transportable cart. [0227] As shown in the exploded view of FIG. 3 , in the storage position, in a preferred embodiment, cart 1 includes a pair of parallel, spaced apart inverted horizontal load support members 10 . Support members 10 each have a front-end 10 a and a rear end 10 b. The front and rear ends 10 a, 10 b each have at least one axially placed receptacle aperture 12 extending longitudinally within each load support member 10 , for holding structural components therethrough in a storage position, such as axle members 32 for wheels 30 . In this storage position, axle members 32 are also inserted within aperture of 33 of axle connector 34 . [0228] FIG. 3 also shows horizontal load support members 10 having preferably a generally upside down U-shaped configuration when viewed in cross-section, wherein a generally flat member 10 c has downwardly extending flanges 10 d, 10 e including one or more linearly extending slots 10 f for insertion of holding straps 50 therein. [0229] Although apertures 12 are shown in the drawings, it is contemplated that other configurations may be applicable to horizontal load support members 10 , so long as other members, such as rails 60 , 70 and so forth, may be attached thereto by fasteners, preferably in an axis parallel to the axis of horizontal support members 10 . [0230] While size may vary, support member 10 is preferably sixteen (16) inches long and two and a quarter (2.25) inches wide. Each flange 10 d, 10 e extends down about one (1) inch from flat member 10 c. Slots 10 f are preferably 2.125 inches wide and 0.1875 inches high, to accommodate straps 50 , such as, for example, standard 2-inch wide fabric straps. [0231] FIG. 3 also shows vertical struts 20 optionally having at least one small hole 22 , such as kickstand receptacle aperture 22 , for insertion of optional kickstand 40 therein. [0232] FIG. 3 also shows horizontal load support members 10 being respectively demountably attached to a pair of vertical struts 20 , having apertures 21 and 22 . In one embodiment, horizontal load support members 10 can be demountably attached to vertical struts 20 , but in an alternate embodiment they can be permanently affixed to each other, such as in the alternate embodiments shown in FIGS. 3A and 3B . [0233] Moreover, while preferably horizontal struts are U-shaped, as in FIG. 3 , in alternate embodiments other configurations can be used, as long as vertical strut 20 can be attached to horizontal support member 10 . [0234] For example, in FIG. 3A vertical strut 20 ′ is in a unified T-shaped member with horizontal support member 10 ′. In FIG. 3B , vertical struts 20 ′ and horizontal support members 10 ′ are attached by weldment 20 ″. In FIG. 3C , vertical strut 20 ′ is inserted in hole 10 ″ of horizontal support member 10 ′, and attached by fastener 10 ′″, such as a screw or other fastener. In these alternate embodiments shown in FIGS. 3A , 3 B or 3 C, horizontal load support members 10 ′ may be solid in cross sectional configuration. One such configuration shown in FIGS. 3A , 3 B and 3 C is that of a parallelepiped, namely a solid form, all of whose sides are parallelograms, such as rectangles, and whose opposite sides are parallel to one another. [0235] In another embodiment vertical strut 20 may be adjustable in length with a sleeve containing a telescopic shaft (not shown) and with a spring urging the shaft in and out of the sleeve, with a lock provided. [0000] Kickstand 40 is shown deployed in FIG. 4 . Kickstand 40 is secured in place by a fastener, such as nylon set screw 37 . Setscrews 37 also hold axle members 32 in the storage position through vertical struts 20 . [0236] Vertical struts 20 are preferably made from 1½×2-inch solid bar stock anodized aluminum, or stainless steel. Vertical struts 20 are preferably about 10.25 inches long, 2 inches wide and 1½ inches in depth. Also shown in FIG. 3 , the plurality of optional larger holes 21 , such as holes, which are 0.765 or 1.625 inches in diameter, are located on a front side of vertical strut 20 . Smaller hole 22 on the bottom accommodates kickstand 40 , which is preferably a hollow aluminum tube of 0.75-inch diameter and 16 inches in length. [0237] Optional larger holes 21 within vertical strut 20 are provided for weight reduction of portable cart 1 . [0238] On a side 23 transverse to the front 24 of each vertical strut 20 , at a lower portion 20 a thereof, is provided a further hole 25 of about 1-inch in diameter for insertion of each axle member 32 therethrough. Hole 25 has a permanently affixed, bushing 26 therein, such as a PVC (polyvinyl chloride) bushing, to prevent wear and tear of each aluminum axle member 32 by the aluminum surface of hole 25 . [0239] As also shown in FIGS. 3 , 4 and 6 , each wheel 30 is demountably attached at an end, respectively, to a pair of axle members 32 , with axle members 32 extending inwardly from and demountably attached to lower portion 20 a of the respective vertical struts 20 , wherein axle members 32 are in a transverse relationship to horizontal load support members 10 . Fasteners, 36 , such as cotter pins, hold each wheel 30 upon each axle 32 . [0240] Each axle member 32 is received within each hole 25 , of each lower portion 20 a of each vertical strut 20 . A compression groove 27 exists from the underside of vertical strut 20 to hole 25 and continues to further through hole 27 a, providing for compression of lower portion 20 a of vertical strut 20 . [0241] To accommodate narrow or wider cargo, such as watercraft of varying widths, the distance between vertical struts 20 can be varied along the axle length by loosening and tightening the tightening member 28 and moving vertical struts 20 laterally apart or towards each other along axle members 32 . [0242] Although optionally a one-piece axle may be used (not shown), preferably the pair of axle members 32 are held in opposite axial orientation by straight rigid axle connector 34 . Axle connector 34 has tightening member 35 , and a pair of receptacles 33 at the respective two ends of axle connector 34 , so that axle members 32 respectively extend outwardly from, and are demountably attached within, the axle connector receptacle bore 33 . [0243] While the axle may be optionally a one-piece axle, such as shown as reference numeral 606 in FIG. 33 herein, preferably the pair of connected oppositely extending axle members 32 form together an axle for wheels 30 . [0244] Each axle member 32 is made of solid round stock of anodized aluminum or stainless steel, approximately 0.75 inches in diameter. At the wheel-supporting end 32 a, the diameter is about 0.59 inches in diameter with shoulders 32 b of about 0.08 inches in height, transverse to the axis of axle member 32 . These shoulders 32 b provide a resting surface to prevent axial movement of wheel 30 upon axle member 32 . [0245] As shown in FIG. 7 , each wheel 30 rotates about press fit bearings 32 b, while each wheel 30 is positioned upon each respective axle member 32 of FIG. 8 . As shown in FIG. 6 , at the opposite end of one axle member 32 , there is provided a hollow, threaded recess 32 c of about 0.75 inches deep, to accommodate a connecting threaded member 32 d of other axle member 32 , to axially connect both axle members 32 together within axle connector 34 , with a wheel 30 at each end. [0246] FIGS. 8 and 9 show how axle connector 34 is compensated along groove 38 , thereby locking axle members 32 within bushing 39 , which is within receptacle bore 33 of axle connector 34 , by tightening of tightening bolt 35 a of tightening member 35 . Preferably bushing 39 is a PVC (polyvinyl chloride) bushing. Groove 38 is preferably 1/16 to ⅛ inch, in width, which allows for the compression of axle connector 34 around axle members 32 . Tightening bolt 35 a is inserted within a conventional receptacle which is a through hole at the proximal end and which is tapped with threaded grooves at the distal end, to allow for compression of axle connector 34 . [0247] FIGS. 4 and 6 also show at least one kickstand 40 , preferably a pair, respectively extending horizontally rearward from each lower portion of vertical struts 20 . Each kickstand member 40 extends rearwardly from the at least one kickstand receptacle aperture 22 of respective vertical struts 20 and each kickstand 40 is demountably attached within each respective kickstand receptacle aperture 22 . Each kickstand member 40 is preferably contoured so as to contact the ground to stabilize portable cart 1 is a parked position of rest. [0248] As shown in FIG. 5 , to hold a canoe, game or cargo in place upon cart 1 , one or more adjustable load-securing straps 50 are slidably attached to both respective horizontal load supports 10 in a transverse relationship to load supports 10 . Straps 50 are preferably reinforced flexible canvas straps of about 2 inches in width. [0249] To complete portable cart 1 as a canoe or boat cart, FIG. 4 shows support cushions 13 mounted upon respective horizontal load supports 10 . Support cushions 13 are flexible, such as of rubber or foam, to support the weight of boat 2 thereon. [0250] FIGS. 10 and 11 show the precision balancing of boat 2 upon cart 1 , wherein the placement of boat 2 upon cart 1 causes cart 1 to rotate from a position of rest in FIG. 10 to a horizontal load position of FIG. 11 , in the direction of the arrow. [0251] FIGS. 12-17 show another embodiment that converts portable cart 1 into a game cart. Alternatively, FIGS. 18-20 show how to convert cart 1 into a cargo wagon with a hollow well. First, in either situation, carry frame 55 is secured to horizontal load supports 10 . Although a one piece, generally rectangular frame (not shown) may be used, preferably frame 55 includes a pair of U-shaped brackets 60 , 70 joinable together to form frame 55 . [0252] Various fasteners may be provided to horizontal load supports 10 to carry objects, such as carriers, thereon. [0253] Alternatively, for example, a clamp maybe provided to horizontal load supports 10 to carry a frame of a discrete transportable carrier directly thereon, as disclosed hereinafter with respect to FIGS. 21-24 . In that case, instead of the frame being integrally part of the portable chart, as in FIGS. 12-17 , in FIGS. 21-24 , the frame is clamped to the horizontal load supports 10 of portable cart 1 . Other fasteners may include longitudinally extending channel slots, such as in FIGS. 33-39 described further below. [0254] Meanwhile, further with respect to FIGS. 12-17 , U-shaped front bracket 60 extends horizontally forward from front-end receptacle apertures 12 of horizontal load supports 10 , wherein front bracket 60 is demountably attached within front-end receptacle apertures 12 at one end of horizontal load supports 10 . [0255] U-shaped rear bracket 70 extends horizontally rearward from oppositely positioned rear end receptacle apertures 12 of horizontal load supports 10 and rear bracket 70 is demountably attached within each oppositely positioned rear end receptacle aperture 12 of horizontal load supports 10 . [0256] FIG. 13 shows how frame 55 is secured to cart 1 . Each distal end of U-shaped front bracket 60 is inserted through apertures in respective ends 10 b of horizontal supports 10 until each distal end engages a corresponding hole in each vertical support 20 , where they are held in place by pins 29 . Pins 29 engage lateral holes 18 in horizontal supports 10 and corresponding through holes 19 in distal ends of U shaped brackets 60 . Likewise, each distal end of U-shaped rear bracket 70 is inserted through apertures in respective ends 10 a of horizontal supports 10 until each distal end engages a corresponding hole in each vertical support 20 , where it is also held in place by a pin 29 . Pins 29 engage lateral holes 18 in horizontal supports 10 and corresponding through holes 19 in distal ends of U shaped brackets 60 , 70 of frame 55 . [0257] U-shaped brackets 60 , 70 are preferably of hollow, anodized aluminum tubing of about 0.75 inches in diameter. The length of each distally extending side member thereof is about 23.50 inches and the width of the cross bar connecting the distal side members is about 21.63 inches. About 0.75 inches from each distal end is a scoring, to accommodate a clamp thereon, to form frame 55 . [0258] As shown in FIGS. 12 and 15 for pulling or pushing game or cargo upon portable cart 1 , handle 80 extends rearwardly at an upward angle from joints 71 of either U-shaped rear bracket 70 for pushing portable cart 1 , or from front U-shaped bracket 60 for pulling portable cart 1 (not shown). Furthermore, handle 80 may be permanently attached to either U-shaped bracket 60 or 70 , or handle 80 may be removable and demountably attached to either front U-shaped bracket 60 or rear U-shaped bracket 70 . [0259] Handle 80 has preferably two aluminum tubing connecting members about 22.5 inches in length, connected by a hand accommodating transverse bar of solid aluminum, and is 17.5 inches in width. Handle 80 includes connectors 81 , having distal sleeves, such as PVC (polyvinyl chloride) sleeves 82 , permanently affixed thereto, which are insertable within joints 71 by locking member 72 , having threaded member 72 a which passes through bore 71 a of joint 71 and bore 81 a of handle 80 . Compression groove 73 exists in joint 71 , providing compression of joint 71 . [0260] Handle 80 may optionally have an auxiliary extension member and clamp (not shown), so that it can be attached to the rear frame of a bicycle (not shown), to pull portable cart 1 . [0261] To carry game 3 , as shown in FIG. 17 , or to carry an injured person in a rescue operation, FIG. 12 shows portable cart 1 having fabric stretcher 100 stretched tautly between horizontal load members 10 and preferably mounted over and around front and rear U-shaped brackets 60 and 70 of frame 55 , by threading brackets 60 , 70 through fasteners such as sewn-in loops 102 of fabric stretcher 100 , which may alternatively be made of plastic or other taut load bearing material. Other types of fasteners can be used. For example, FIG. 14 shows that loop 102 a is openable, and closed by fastener, such as zipper fastener 102 b. [0262] As also shown in FIG. 12 , handle 80 may include a pair of posts extending obliquely off of a horizontal axis of portable cart 1 , wherein a head rest cushion 85 extends between the posts to support the head and neck of an injured person being transported upon stretcher 100 . [0263] FIGS. 18-20 show that to carry cargo, hollow fabric cargo well 110 is attached in the same manner to frame 55 . Hollow cargo well 110 may also alternatively be made of plastic or other taut load bearing material, and covered by cover 112 . FIGS. 18 and 19 also show wider wheels 130 for use on sand or granular terrain. Assembly and Disassembly [0264] The various embodiments of the mission adaptable multiple-purpose portable cart/utility table can be quickly and easily assembled and disassembled. [0265] For example, for making a canoe cart from the disassembled portable cart 1 , wheel-retaining members, such as cotter pins 36 , are taken out of axle members 32 in their stored position, and wheels 30 come out. Axle members 32 are then removed from between vertical struts 20 . The axle members 32 are then clamped in a horizontal use position into receptacles 33 of rigid axle connector 34 . Axle members are inserted between vertical struts 20 and locked in place. Wheels 30 are placed upon axle members 32 and secured by cotter pins 36 . Kickstand 40 is loosened from its rest position and placed in place in receptacles within vertical struts 20 . Canoe supporting cushions 13 are installed upon horizontal load supports 10 to support a canoe or boat thereupon. Straps 50 hold the canoe or boat installed upon cushions 13 in a secure transportable position. [0266] To convert portable cart 1 into a game cart as in FIG. 17 or a rescue cart as in FIG. 12 , kickstands 40 are removed and fabric stretcher 100 is installed on U-shaped frame members 60 , 70 of frame 55 frames by fasteners such as sewn loops 102 thereof. U-shaped frame members 60 , 70 are placed on horizontal load supports 10 , and kickstand members 40 are installed as braces for fabric stretcher 100 . Straps 50 are then installed to securely hold game or an injured party upon stretcher 100 . Then handle 80 is installed upon U-shaped bracket 60 or 70 of frame 55 to pull or push portable cart 1 . [0267] To convert portable cart 1 into a wagon to haul cargo, as in FIGS. 18 and 19 , fabric stretcher 100 is removed and hollow well 110 is installed over U-shaped members 60 , 70 of frame 55 . [0268] To make the portable chart 1 portable again, the components are disassembled in reverse into bag 120 . Strap or straps 50 are used as a carry handle or for backpack shoulder loops. [0269] While the rescue stretcher shown in FIG. 12 has its own customized stretcher 100 , in another embodiment shown in FIGS. 21-24 , to convert portable cart 1 to a retrofit disabled person-bearing transportable carrier cart for search and rescue operations, using conventional railed stretcher 230 , support cushions 13 are removable from horizontal load supports 10 and replaced by clamping assembly 200 . Clamping assembly 200 includes lower jaw 202 , and upper jaw 204 . While different jaw configurations can be used, the embodiment shown in FIGS. 21-24 shows each having longitudinally extending recesses 206 and 208 therein to grip perimeter frame rails of a load supporting transportable carrier, such as conventional railed stretcher 230 therebetween, as shown in FIG. 23 . [0270] Lower jaw 202 of clamping assembly 200 includes an engaging surface 210 with threaded studs 212 which are inserted into through-holes 214 of load supports 10 , and permanently locked with nuts 216 . Upper jaw 204 is provided with a pair of oblong through-slots, 218 , to allow upper jaw 204 to slide on upper surface of lower jaw 202 , when threaded T-handles 220 are loosened. As shown by the arrows in FIG. 22 this sliding action allows for quick removal of any stretcher frame rail secured between jaw assembly 200 . [0271] FIGS. 23 and 24 are perspective views of a typical stretcher 230 , and a Stokes-type rescue basket 240 , securely clamped to portable cart 1 utilizing the previously described clamping assembly 200 . [0272] As shown in FIG. 25 in this embodiment, instead of being permanently attached to each horizontal load support 10 , removable support cushion 13 is permanently attached to removable plate 302 with an adhesive 304 . This cushion assembly is removably attachable by nuts 316 and threaded studs 312 , to each horizontal load support 10 . [0273] FIG. 26 illustrates portable cart 1 , outfitted with a plurality of racking assemblies 400 , each comprising a rail clamp 410 , an upstanding post 424 , and a hanger clamp 430 . Rack assembly 400 , when used in conjunction with additional rack assemblies 400 , allows for transportation and quick removal of essential hunting gear such as a chair stand 440 , archery equipment 441 , and rifle 442 . Other related items such as knapsacks and bedrolls may be supported by rack assembly 400 , as well. Rack assembly 400 is easily disassembled from cart 1 upon reaching a chosen destination, and the components are conveniently transported within cart 1 's storage backpack, such as carry bag 120 shown in FIG. 1 . [0274] Also illustrated in FIG. 26 are stabilizing assemblies 450 and 460 . Assembly 450 makes use of post 420 , which is friction-fit into an inverted rail clamp 410 . Assembly 460 comprises an inverted tubular sleeve 462 , optionally permanently welded to the handle assembly crosspiece. Sleeve 462 accepts kickstand post 424 in a similar fashion to rail clamp 410 . These assemblies 450 460 serve to brace the cart 1 when it is parked. [0275] Moreover, kickstand post 424 may be used with any embodiment having a handle, such as handle 80 of FIGS. 12 and 17 - 19 , or handle 81 of FIGS. 32 and 33 . [0276] Turning to FIG. 27 , which is highlighted in FIG. 26 , an exploded perspective close-up detail view of rail clamp 410 is presented. Clamping block 411 is provided with a bore 412 to receive post 424 , an attachment face 413 including a semi bore 414 , and notch 415 , and threaded bore 416 . Plate 417 includes semi bore 418 , through hole 419 , and protruding rib 420 . [0277] As shown in FIG. 28 , when threaded knob 422 is inserted into hole 419 of plate 417 and tightened into threaded bore 416 of block 411 , clamping is achieved against frame member 60 . Rib 420 is secured within notch 415 by a camming action in the direction of arrow “A”. [0278] FIG. 29 shows cantilevered hanger clamp 430 , poised to slide down upstanding post 424 . Hanger clamp 430 is provided with a bore 431 , which is notched in a similar manner to clamping receptacles 71 of the handle assembly. The notch separates the body of hanger clamp 430 into two walls. Threaded knob 422 will compress the walls surrounding the notch, thereby tightening bore 431 around post 424 . L-shaped region 432 is integrally formed with the body of the hanger clamp, and provides a strong and durable support for transporting hunting or other gear. [0279] FIG. 30 is a perspective view of an anti-tipping linkage 500 , which couples cart 1 to a bicycle. Linkage 500 counteracts cart rollover caused by centrifugal force as the bicycle negotiates turns. [0280] FIG. 31 illustrates the components of linkage 500 . Bicycle seat-stem compression clamp 510 is formed of a body portion 511 , and plate 512 , fastened by screws 513 . Bore 514 is angled so that clamp 510 remains perpendicular when installed on a typical bicycle seat-stem. Clamp 510 is provided with a bore 515 on rear face 516 , which accepts a shaft 520 . Pin 517 passes through clamp and fixes shaft 520 via a through-bore. Shaft 520 includes through-bore 522 at its distal end. Another through-bore 523 is provided slightly proximal of aperture 522 . When shaft 520 is inserted into coil spring 530 , hooked leg 531 of the spring will fit into bore 522 . A sliding collar 524 will then extend over leg 531 to prevent pull-out, and a pin 526 will be fitted into collar hole 525 , and into bore 523 of the shaft 520 , thereby securing the collar to the shaft and preventing removal of the coil spring. [0281] A shaft 540 is provided for the opposite end of coil spring 530 . Hooked leg 532 fits into bore 542 of the shaft, and collar 544 slides over and is fixed by pin 546 , fitted into collar hole 535 and shaft bore 543 . [0282] Support rails 550 and 551 are fixed to handle clamps 71 of cart 1 . The rails are bent into an inverted V configuration, and permanently affixed to block 552 . Block 552 is provided with bore 553 , into which the free end of shaft 540 is fitted. Pin 555 is inserted into through bore 554 of block 552 , and passes through bore 547 of shaft 540 , creating the continuous, secure anti-tipping linkage 500 between cart 1 and a bicycle. It is understood that during maneuvers of the bicycle, there will be no problems associated with a typical universal or pivot joint; the coil spring will absorb and disperse any rotational stresses, and will react as a 360° “living hinge”. [0283] FIGS. 32A-32G , 33 and 33 A show an alternate embodiment 600 of the portable cart using four wheels 30 in an overlapped configuration. A hard molded cover 601 is illustrated although any cover or no cover can be used as well. Cover 601 covers bin 602 with lower overlapping edge cap 601 a fitting over peripheral shoulder 602 a of bin 602 . Bin 602 also has longitudinally extending concave channels 603 , which rest upon rails 604 of cart 600 of FIG. 32 . Downward pressure of the weight of bin 602 and its contents helps stabilize bin 602 upon rails 604 , which may be optionally covered with rubber or other resilient linearly extending cushions. [0284] Although FIG. 32 illustrates portable cart 600 with covered bin 602 , portable cart 600 can be used with other embodiments, such as, for example, boat cushions 13 shown in [0285] FIG. 4 , framed rail stretchers 100 as in FIG. 12 , the game cart of FIG. 17 , the cargo cart of FIG. 18 , the conventional rescue carriers of FIGS. 23 and 24 or the gear rack of FIG. 26 , among others. [0286] FIG. 32H shows an exploded inverted view of an alternate embodiment for a ruggedized handle assembly, including handle 630 and handle shaft 626 with spring pin 628 lined up to enter the end of stanchion truss weldment 620 . Stanchion truss weldment 620 has two downward extending struts 632 , which accommodate axles 624 therethrough, which axles 624 , in-turn, attach to wheels 622 . Central bushing receptacle 634 accepts the end of handle shaft 626 . Receptacle 634 also has a lower pushpin aperture and a pair of opposite holes for a through pin to hold handle shaft in place. FIG. 32H also shows kickstand 640 stowable within handle shaft 626 . [0287] FIG. 32I shows a close-up inverted view of receptacle 634 , showing handle shaft 626 located within truss weldment 620 , and held in place by spring pin 628 of handle shaft 626 and/or through pin 629 . [0288] FIG. 32J shows a four wheel cargo hauling cart with kickstand 640 attached to kickstand attachment bracket 638 , which is part of handle 630 . Also shown are stacked cargo bin shell containers 634 held securely by straps 636 . [0289] In the sequence of FIGS. 32K , 32 M, and 32 N, straps 636 have been detached from bin shell containers 634 , and the sequence of removal of top bin 634 is shown ending with a vertically oriented bin drawer cabinet 635 with a cover panel 639 removed, thereby exposing slidably openable drawers 642 on its front surface. FIG. 32N shows drawers 642 behind drawer retaining panel 639 in a cutaway view. [0290] Lower bin 634 optionally contains related medical supplies for a field hospital, such as power packs, oxygen tanks, and other necessary medical supplies. [0291] FIG. 32O is an optional hitch assembly 644 , which replaces the handle assembly. Hitch legs 646 are received into handle 630 . [0292] Spring pins 651 also participate in this coupling. Connector 646 , with hitch tongue 652 , form a structure engagable with receiver clevis 653 attached to all terrain vehicle 656 . FIG. 32P shows hitch 644 being used to pull cart 632 by all-terrain vehicle 656 . [0293] FIG. 33 shows a perspective view of the frame of cart 600 . Long axle 606 attaches front wheels 30 while short axle 605 attaches rear wheels 30 through respective vertical support pairs 20 . The use of four wheels doubles the carrying capacity of the cart of this invention while the overlapped positioning of the wheels maintains a short wheelbase for compactness and for maneuverability such as turning with fixed axles and the ability to easily climb ledges. For durability, the rails 604 may be a double pair of parallel rails. [0294] Double axled cart 600 has increased maneuverability, since user pushing upon an optional handle 81 enables user to lift the farther away, distal pair of wheels 30 off the ground, and the user pulling upward of handle 81 raises the nearer proximal wheels 30 off the ground. [0295] FIGS. 34 through 39 are concerned with an alternate embodiment of the horizontal load support member 10 . The alternate embodiment 610 has an integral T-slot channel 611 in its top surface to facilitate easy installation and removal of a variety of attachments, such as cushions 615 shown in FIG. 35-36 , clamps 620 , 630 , 640 , shown in FIGS. 37-39 , or platform 1450 shown in FIG. 57 . Load member 610 can be conveniently extruded of aluminum or magnesium; it can be used either with the two-wheel cart 1 or the four-wheeled embodiment 600 . [0296] FIG. 35 shows a resilient cushion 615 installed in the T-slot 611 of support member 610 . This cushion 615 can be extruded of a variety of rubber or thermoplastic elastomers and serves the same purpose as cushion member 13 described above. A perspective view of FIG. 36 shows cushions 615 installed on a four-wheel cart 600 . [0297] As described above, clamp assembly 200 is used to convert portable cart 1 to a disabled person-bearing transportable carrier cart. Three separate alternate embodiments of clamp assembly 200 are presented; all are compatible with the use of horizontal support member 610 . [0298] FIG. 37 shows a one-piece clamp 620 with full width top section 622 and short end pieces 621 , which mate with, and slip into the T-slot 611 of horizontal support member 610 . [0299] FIG. 38 shows clamp 630 with a full width bottom member 631 which mates with and slides into T-slot 611 of horizontal support 610 . [0300] FIG. 39 shows another alternate embodiment consisting of two short identical clamp members 640 , which are inserted into the T-slots 611 of member 610 at the two extreme ends. [0301] In all cases, the short clamping sections can be sized to offer spring-like gripping action on the tubular members, or fasteners, such as thumbscrews or ball plungers (not shown) can be used for retention. [0302] FIGS. 40-50 show alternate embodiments for converting a conventional hand carried, railed medical rescue stretcher to a lightweight wheeled version. [0303] For example, FIGS. 40-42 show shortened horizontal support members 710 with tightening members 711 . Rails 713 are held either by clamps, such as shown in FIGS. 37-39 , or alternatively through apertures in horizontal support members 710 , as shown in FIG. 14 . Horizontal support members 710 are demountably attached to vertical struts 720 having extending therethrough transverse axles 732 supporting wheels 730 . Optional pivotable kickstand 740 is attached to rails 713 by clamp 800 . [0304] As also shown in FIGS. 47-50 , clamp 800 includes two jaws 801 , 802 having aperture recess 803 for insertion of rails 713 therethrough. Clamp 800 is closed and tightened by fastener 804 operated by rotatable knob 805 . Internal spring pins 806 , as shown in FIG. 47 , cooperate with fastener 804 and knob 805 to tighten clamp 800 about rail 713 . Internal grooves 807 , 808 accommodate kickstand 740 in the respective positions of support and rest, as shown in FIG. 40 and FIG. 42 respectively. [0305] FIG. 43 shows an alternate embodiment for a military or emergency rescue carrier cart 900 with a profile set low to the ground, including shortened horizontal members 910 with tightening fasteners 911 . Rails 913 are also held by clamps as in FIGS. 37-39 , or alternately through apertures in horizontal support members 910 , as in FIG. 14 . Horizontal support members 910 are demountably attached to shortened vertical struts 920 to keep stretcher rails 913 close to the ground. Optional bent handle 945 is connected by clamps 800 disclosed in FIGS. 47-50 , as discussed above. [0306] FIGS. 45-46 show how the stretcher version shown in FIGS. 40-42 can be converted to a stationary medical gurney 1000 . Rails 1013 are supported by horizontal support members 1010 , which hare demountably attached to vertical struts 1020 , having axles 1032 supporting wheels 1030 . To stabilize gurney 1000 , horizontally extending tie rods 1036 , 1037 are joined by threaded clamp 1038 or other fastening means. [0307] The major structural components of an alternate embodiment low profile rescue carrier are shown in FIG. 43A . Latch clamps 1800 of stretcher bearing tube assemblies 950 support stretcher 1730 and also engage handles 630 at each end. Handles 630 may be rotated into an upward locking position or downward. Tube assemblies 950 include lateral spring pins 962 and upper spring pins 963 for proper placement of wheel assemblies comprising struts 920 having rail bearing clamps 910 operable by latch handles 911 . [0308] FIG. 43B shows an exploded view of handles 630 engagable with stretcher bearing tube assemblies 950 of FIG. 43A . Handles 630 are attached to short handle shafts 956 with spring pins 958 (as in detail callout FIG. 43C ) within. Similarly, a coupling section detailed in FIG. 43C has spring pins 958 installed as shown. Spring pins 958 include bent leaf spring section 960 which tail end impinges on the inside of tube 956 or tube 952 while the other end is attached to spring pin button 962 which protrudes through a hole in the side of tube 956 or 952 . Buttons 962 couple with a tube mid sections 954 via holes near the ends of these tubes. Buttons 963 function as wheel set locators and fit into wheel set clamps for proper fixturing, as shown in FIG. 43A . [0309] The low profile rescue carrier is also shown in the side elevational view of FIG. 43D , which illustrates the feature of the handles 630 rotated to the downward position and functioning as kickstands. [0310] As shown in FIG. 43E , the low profile rescue carrier is easily converted into a low profile transport rotating handles 630 from the kickstand support position to an upright handle position which is easily grasped by medical personnel. Short handle shafts 956 are shown in the optionally extended position in FIG. 43E , to allow for clearance between the medic and the stretcher. The medic may drag the stretcher 1730 upon stretcher bearing assembly 950 as shown, or alternatively, push or pull the stretcher or other carrier bearing assembly 950 forward by reversing his orientation. [0311] FIGS. 51-53 show a further embodiment for portable cart 1101 which folds down to a disassembled storage position as in FIG. 51 and which unfolds to an assembled position of use as in FIG. 52 . Cart 1101 includes a pair of horizontal load support members 1110 laid parallel to each other, which rotate axially to move perpendicularly extending vertical struts 1120 outward from a position within a storage bag 1101 a, where vertical struts 1120 face each other's distal ends, to a position of use 90 degrees perpendicular to the storage position, where vertical struts 1120 extend in the same plane but outward from horizontal load support members 1110 . [0312] In this embodiment shown in FIGS. 51-53 , the resilient rails 1178 are engaged to horizontal supports 1110 such that when in a position of storage the rails 1178 are biased to return to their normal position of use, when released from the storage position, thus causing vertical struts 1120 attached to horizontal supports 1110 to pivot upward and bow, thus increasing the strength of the cart. [0313] The same is true with other embodiments of the present invention. For example, placing a boat 2 upon cart 1 causes horizontal support members 10 and wheel axles 31 to bow, giving it the strength of an uncollapsible Roman arch. The same is true with respect to stretcher or cargo hauling embodiments shown in FIGS. 12 , 17 - 19 , 40 - 45 and 58 - 66 , for example, wherein putting weight makes the carrier portion taut and bows the frame members into a position of strength. Also the multiple floating overlapping rails as in FIG. 14 , for example, bow the rails and strengthen the cart with a load supported thereon. [0314] Moreover, vertical struts 1120 can be further strengthened in place to horizontal supports 1110 by connecting braces, such as V-shaped braces 1121 . Wheels 1130 are held by axle 1131 , which in a storage position is placed within the storage bag 1101 a. To lengthen cart 1101 , rails 1178 move away from each other within holes 1112 within horizontal supports 1110 , and are stopped from further movement by spring stop buttons 1171 . [0315] FIGS. 54-55 show portable cart 1201 which can be converted from a cargo hauling wagon configuration with cargo well 1290 attached to frame 1255 , to a rescue stretcher with taut rescue canvas or other stretcher 1292 when stretcher 1292 , which sits loosely above hollow well 1290 during the cargo hauling configuration, but which becomes taut when peripheral fasteners, such as zippers 1296 , snaps or the like tighten stretcher 1292 in place about frame 1255 . [0316] Optional kickstand 1240 or handle 1280 may be attached to cart 1201 by joints 1271 . A further accessory arm bag 1201 b may be draped down from handle 1280 for further storage. An optional hard floor member 1294 may be provided below stretcher layer 1292 within cargo well 1290 for cargo hauling strength. [0317] FIG. 56 shows optional ski attachments 1330 for cart 1301 , wherein ski portions 1331 are attached by braces 1332 to vertical struts 1320 . The length of braces 1332 is equal to the radius of wheels 30 in previous embodiments. [0318] FIG. 57 shows optional platform base 1450 for supporting object such as camera tripods, cooking devices, ordnance, etc. upon cart 1401 . Platform base 1450 slides within channels 1411 and is secured in place by fasteners such as recessed hex nuts. [0319] FIG. 58 shows a portable cart frame of this invention configured as a cargo hauler or as a multi-victim stretcher. The cart includes two outer longitudinal horizontal parallel rigid load support frame members 1501 , which are preferably tubular. The cart also may include an optional center frame member 1502 , also preferably tubular, as well as optional transverse frame members 1503 , overhead tube frame 1505 , two vehicle actuators, such as wheels 30 and axle 32 . It is contemplated that in snow conditions the vehicle actuators can alternatively be skis, such as shown in FIG. 56 herein. [0320] Also as shown in FIG. 58 , fasteners, such as cotter pins 1504 are used to attach horizontal support members 1501 and 1502 within holes, such as circular holes for tubular shaped horizontal support members in transverse members 1503 . [0321] Also as in FIG. 58 , vertical struts having the wheel subassembly with wheel 30 are attached to outer horizontal support members 1501 , such as tubes, with mechanisms 1506 which permit quick attachment and detachment. Attachment clamps 1507 secure overhead handle 1505 to outer ends of horizontal support members 1501 . [0322] Although not shown in the drawings, any of the embodiments herein shown in all the drawing FIGS. 1-70 may have vertical length adjustment means (not shown), such as a sleeve containing a telescoping shaft, the sleeve having a spring means for urging the shaft in a selectably extendable manner out of the sleeve and a lock for locking the telescoping shaft into a selected extended position. [0323] FIG. 59 shows a single cargo or person hauling fabric top surface sheet 1512 , which can be made of canvas or similar material. Sheet 1512 preferably has sewn longitudinal pockets at the outer edges to accept horizontal support members 1501 and a central pocket 1513 to accommodate optional central frame member 1502 when inserted in direction 1514 as shown. Optional apron sections 1513 can be flipped over the side edges. [0324] FIG. 60 shows the frame of this cargo hauling or multi-victim cart readjusted to foreshorten the distance between transverse members 1503 by securing cotter pins 1504 in holes in horizontal support members 1501 and 1502 which are located farther in from the ends. [0325] As shown in FIG. 61 , this adjustment can be used to accommodate separate stretchers 1525 with locating extensions 1526 and handles 1527 . [0326] FIGS. 62 and 63 show end views of the quick disconnect/connect mechanisms 1506 (in viewing direction “ 62 - 62 ” in FIG. 58 ) with horizontal support member 1501 shown optional as tubular in cross section. Top clamping member 1532 has slot 1531 which permits it to slide from the locking position shown in FIG. 62 to the unlocked position of FIG. 63 thereby releasing side horizontal support member 1501 from the wheel 32 subassembly which continues below lower clamp jaw 1533 . [0327] In FIG. 62 , spring 1534 is compressed since the locking shaft concentric with it has been threaded downward by turning handle 1530 in a clockwise direction. [0328] In FIG. 63 , handle 1530 has been turned about 180 degrees counter-clockwise thereby permitting spring 1534 to push up on top member 1532 releasing horizontal support member 1501 . [0329] FIG. 64 is a partial end cross section (in plane “ 64 - 64 ” of FIG. 58 ) of clamp 1507 . The split 1544 in clamp body 1540 permits selective grasping of horizontal support member 1501 as per the clamping force from screw 1542 as applied through knob 1541 . Stainless steel insert 1543 prevents collapse of the end of tube 1505 of the overhead assembly. [0330] FIG. 65 shows yet another embodiment of the cart of this invention as a frame for a portable operating room table or a gurney. This portable operating room table/gurney includes side horizontal support members 1550 , such as, for example, frame tubes, auxiliary side bars 1551 , transverse frame members 1552 , vertical struts 1553 , overhead support frames 1554 , overhead rails 1555 , trolley 1556 , and attachment clamps 1557 . The portable operating room table/gurney rides on four wheels 30 with axles 32 . [0331] The fully configured gurney is shown in FIG. 66 . Additional features shown include flexible fluid capture collection sling 1562 , fluid collection tube 1563 , fluid collection tank 1564 , adjustable side clamp 1560 , side rest or surgical instrument table 1561 , wheel brakes 1558 , and overhead accessory 1569 for attaching lights or other surgical accessories. [0332] FIGS. 67 and 68 show the construction and operation of wheel brake assembly 1558 . Brake frame 1570 is rigidly attached to vertical strut 1553 . Upper pivot frame 1572 works in conjunction with handle/link 1574 , curved spring link 1573 , and plunger shaft 1575 to form an “over-center” mechanism with two stable states, clamped or unclamped. [0333] In FIG. 67 , handle 1574 is pushed down into a snap-locked position pushing tip 1576 into contact with wheel 32 tire 1571 thereby contacting the top surface and deforming it to prevent wheel 32 from rotating. [0334] FIG. 68 shows the “brake-off” position which is obtained by lifting handle 1574 past the center position thereby lifting tip 1576 out of contact with tire 1571 . [0335] FIG. 69 is an end view of adjustable side clamp 1560 with side tube 1550 and auxiliary rod 1551 in cross section (see plane “ 69 - 69 ” in FIG. 66 ). Instrument table 1561 attached to clamp body 1580 can be moved longitudinally along tube 1561 and locked in place as desired by turning knob 1581 which impinges the end of screw 1582 against horizontal support member 1550 . [0336] FIG. 70 shows an exploded view of attachment clamp 1557 used in a variety of locations on overhead frames 1554 . It includes main body 1590 with groove 1591 , outer clamp member 1593 with lip 1593 and screw 1596 with knob 1595 . In operation, lip 1593 pivots within groove 1591 ; tube 1554 is grasped by the concave surfaces of body 1590 and outer member 1593 as tightened by screw 1596 . A tube end 1594 which can represent a tube 1555 or an accessory 1568 is inserted in the hole in the end of body 1590 and locked. [0337] FIG. 71 is a flow chart showing the use of the convertible cart/utility table of the present invention in a medical emergency response triage environment. [0338] For example, in disaster medical care, triage is the medical screening of patients to determine their relative priority for treatment. Three groups are defined, the first is those casualties not expected to survive even with treatment, second is the group who will recover without treatment, and third the highest priority group who need treatment in order to survive. FIG. 71 illustrates how the convertible cart/utility table (CCUT) of this invention can be utilized in this environment. [0339] For example, as in FIG. 71 , incoming casualties 1650 arrive at triage center 1652 by ambulance, helicopter or otherwise. Here they are screened into the three categories, labeled “Type 1 ”, “Type 2 ” and “Type 3 ” and those who can be treated are then transported via exit path 1654 to field hospital unit 1656 by using a wheeled version of the Convertible cart/utility table (CCUT). After prep at a Pre-Operative Station, the patient is wheeled via path 1658 to the Operating Room (OR) where a table version of the Convertible cart/utility table (CCUT) is used in a utility table mode as an operating platform. Patient is then wheeled upon Convertible cart/utility table (CCUT) via path 1660 to the Post-Operative/Post Recovery station for monitoring, which may be done, on either a wheeled or table version of Convertible cart/utility table (CCUT). The patient may need further surgery, which would require transporting wheeled on Convertible cart/utility table (CCUT) back via path 1666 to the Pre-Operative Station. If Patient is sufficiently recovered, he or she is transported via path 1662 upon wheeled Convertible cart/utility table (CCUT) back to triage center 1652 vicinity for further transportation merging with others from triage in the outgoing exit queue path 1664 . [0340] FIG. 72 shows an exploded view of the major components of convertible cart/utility table (CCUT) 1700 for supporting stretcher 1730 thereon. These include axle support struts 1712 with rail clamps 1716 at the top ends and wheels 1718 located by axle 1715 . Kick stands 1704 , used with heavy duty rail clamps 1714 , convert convertible cart/utility table (CCUT) to the stationary utility table configuration. Adjustable feet 1710 provide a high friction surface and terrain adjustability. Macro adjustment of leveling or height is via multiple holes 1706 , in kickstand like 1704 , which accept spring pin 1713 attached near the end of foot extension 1708 . Side rails 1702 complete the basic structure. [0341] FIG. 73 shows side rails 1702 , which are mounted to kickstands 1704 by clamps 1714 , which engage tubing rails 1702 . Tubing rails 1702 have middle connecting tube 1723 and side tubes 1722 , connected by connectors, such as, for example, spring pins and holes. [0342] FIG. 74 shows convertible cart/utility table (CCUT) 1700 configured as a utility table with auxiliary power pack 1732 and stretcher 1730 . [0343] FIG. 75 shows the feature, which tilts the table top by adjusting the height of kickstands 1704 on different ends at different heights. FIG. 75 also shows an optional body fluid capture collector 1760 such as a concave sling connected to a medical waste collector 1762 . [0344] FIG. 76 shows details of kickstand foot 1710 . Threshold shaft 1752 is screwed into nut 1754 and into foot extension 1713 thereby providing a micro adjustment of height up to about one inch. High friction pad 1756 and tilt adjustment ball and socket joint 1754 complete foot 1710 . [0345] FIG. 77 shows reversible clamp 1800 , as in FIG. 43A , which is used with convertible cart/utility table (CCUT) 1700 . It includes housing block 1802 , with rail aperture 1812 , which clamps onto tubing 1722 via lever screw 1814 . Groove 1816 receives tubing rail 1730 , such as that from a stretcher, which rail 1730 is locked in place via over-center clamp 1804 with jaw 1808 , operable by actuator lever 1810 . The opposite grooves 1818 , 1820 and 1822 are spaced laterally to accommodate stretchers of different widths. These can be optionally locked via a clamp 1806 having a jaw similar to jaw 1808 , which is moved to the desired groove 1818 , 1820 or 1822 . [0346] FIG. 78 shows reversible clamp 1800 inverted to use the multiple width grooves 1818 , 1820 or 1822 . [0347] FIGS. 79 and 80 show details of heavy duty clamp 1900 , which has upper block 1902 with groove 1904 to receive a stretcher side tube 1730 . Over-center latch 1906 locks stretcher tube via jaw 1910 and actuator lever 1908 . Lower block 1912 has side rail groove 1920 , holding rail 1722 , which groove 1920 is lockable via latch 1914 with jaw 1918 and lever 1916 . Lower extension 1922 accommodates either stretcher tube or fluid drape in groove 1924 . [0348] The end view of clamp 1900 in FIG. 81 shows that upper retaining latch block 1932 can pivot to permit stretcher tube 1930 to tilt relative to side rail 1722 . [0349] In the more complete perspective view of FIG. 82 , it can be seen that the lower (foot) end of stretcher rail 1731 of stretcher 1730 is then supported by recess or groove 1924 in the lower extension 1922 of the second clamp 1900 . [0350] FIG. 83 depicts auxiliary pivotable medical support platform assembly 2000 including base 2001 , clamp insert 2002 and platform 2003 . This versatile mechanism clamps onto a side rail of the convertible cart/utility table (CCUT). Body limb member support 2004 holds a limb. Assembly 2000 has movable hinge section can swivel relative to clamp base 2016 . FIG. 84 shows medical support platform assembly 2000 with pole 2022 used to support intravenous (IV) bag 2026 with infusion line 2028 . Extension rod 2024 provides more height for proper infusion gravity head. Tray 2030 is similarly supported. [0351] FIG. 85 shows medical support assembly 2000 used to support gooseneck examination/surgical lamp 2040 attached to flexible neck conduit 2042 held in and movable arm support 2046 . [0352] FIG. 86 shows another use of medical support assembled 2000 to support multiple instrument trays 2050 . [0353] It is further noted that other modifications may be made to the present invention, without departing from the scope of the invention.

A mission adaptable multi-purpose, collapsible portable cart/utility table, for use in emergency response and disaster situations, camping, hunting and other outdoors activities, which carries medical rescue carts, canoes, small boats, game, or hauled cargo by hand. It transports one or more cargo bins over long, rough terrain and each bin can include one or more cabinet drawers therein, wherein upon tilting of a cargo bin from a horizontal transport position to a substantially vertical position the cargo bin serves as a supply cabinet. Each bin is openable to expose the supply drawers for use.

This application is a continuation-in-part of U.S. patent application Ser. No. 08/194,017 filed Feb. 9, 1994, now U.S. Pat. No. 5,496,369 the contents of which are incorporated herein by reference. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates generally to an apparatus and method for treating tinnitus, and in particular, to a human cerebral cortex neural prosthetic for delivering geometrically dispersed electrical signals to the patient's primary auditory cortex and/or to a human cerebral cortex or the patient's thalamus and to human cerebral cortex neural prosthetic for microinfusing geometrically dispersed portions of drugs to the patient's primary auditory cortex or the patient's thalamus. 2. Background of the Related Art Tinnitus is a disorder where a patient experiences a sound sensation within the head ("a ringing in the ears") in the absence of an external stimulus. This uncontrollable ringing can be extremely uncomfortable and often results in severe disability. Tinnitus is a very common disorder affecting an estimated 15% of the U.S. population according to the National Institutes for Health, 1989 National Strategic Research Plan. Hence, approximately 9 million Americans have clinically significant tinnitus with 2 million of those being severely disabled by the disorder. There are no treatments currently available that consistently eliminate tinnitus although many different types of treatments have been attempted. This wide variety of attempted treatments attests to the unsatisfactory state of current tinnitus therapy. Several more common attempts will be discussed below. One approach involves suppression of abnormal neural activity within the auditory nervous system with various anticonvulsant or local anesthetic medications. Examples of such anticonvulsant medications include xylocaine and lidocaine which are administered intravenously. In addition, since the clinical impact of tinnitus is significantly influenced by the patient's psychological state, antidepressants, sedatives, biofeedback and counseling methods are also used. None of these methods has been shown to be consistently effective. Another widely used approach to treating tinnitus involves "masking" undesirable sound perception by presenting alternative sounds to the patient using an external sound generator. In particular, an external sound generator is attached to the patient's ear (similar to a hearing aid) and the generator outputs sounds into the patient's ear. Although this approach has met with moderate success, it has several significant drawbacks. First, such an approach requires that the patient not be deaf in the ear which uses the external sound generator. That is, the external sound generator cannot effectively mask sounds to a deaf ear which subsequently developed tinnitus. Second, the external sound generator can be inconvenient to use and can actually result in loss of hearing acuity in healthy ears. Yet another approach involves surgical resection of the auditory nerve itself. This more dangerous approach is usually only attempted if the patient suffers form large acoustic neuromas and tinnitus. In this situation, the auditory nerve is not resected for the specific purpose of eliminating tinnitus but is removed as an almost inevitable complication of large tumor removal. In a wide series of patients with tinnitus who underwent this surgical procedure of acoustic nerve resection, only 40% were improved, 10% were not improved and 50% were actually worse. An alternative and somewhat more successful approach involves electrical stimulation of the cochlear. In patients who have tinnitus and have received a cochlea implant, as many as half reported some improvement in their tinnitus after implantation. Round window stimulation has also been useful in improving tinnitus in selected patients. However, the success rate of this approach has also remained relatively low. Prior to the nineteenth century, physicians and scientists believed the brain was an organ with functional properties distributed equally through its mass. Localization of specific functions within subregions of the brain was first demonstrated in the 1800s, and provided the fundamental conceptual framework for all of modern neuroscience and neurosurgery. As it became clear that brain subregions served specific functions such as movement of the extremities, and touch sensation, it was also noted that direct electrical stimulation of the surface of these brain regions could cause partial reproduction of these functions. SUMMARY OF THE INVENTION It is therefore an object of the invention to provide a prosthetic apparatus which can be placed in one of a patient's cerebral cortex or in the patient's thalamus to reduce the effects of tinnitus. Another object of the invention is to provide a prosthetic apparatus which can be positioned in the brain such that electric discharges can be accurately delivered to geometrically dispersed locations in either the cortex or thalamus. Another object of the invention is to provide a prosthetic which allows a physician to physiologically test location and function of neural prosthetic electrodes to reduce or eliminate the patient's tinnitus. Another object of the invention is to provide a prosthetic apparatus which can be positioned in the brain such that microinfusions of a drug that reduces abnormal neural activity due to tinnitus can be administered in geometrically dispersed locations in the patient's cortex or thalamus. Another object of the invention is to provide a prosthetic apparatus which can support a reservoir of the drug so that the microinfusions can be continuously administered. One advantage of the invention is that it reduces or eliminates the effects of tinnitus. Another advantage of the invention is that it can utilize a single electrode. Another advantage of the invention is that it can utilize a single catheter. Another advantage of the invention is that it penetrates the brain as opposed to resting on the brain surface, thus requiring significantly less current to stimulate localized areas of the cortex or the thalamus. Another advantage of the invention is that it penetrates the brain thus requiring significantly lower doses of the drug and hence reduces unwanted side effects related to inadvertent treatment of surrounding tissue. Another advantage of the invention is that the contacts are sufficiently closely arranged next to each other to provide high geometric resolution stimulation of the auditory cortex. One feature of the invention is that it includes a penetrating longitudinal support or electrode. Another feature of the invention is that it includes multiple contacts on the longitudinal support. Another feature of the invention is that it includes a stimulation device. Another feature of the invention is that each contact can separately introduce electrical discharges in the primary auditory cortex. Another feature of the invention is that it utilizes a catheter to administer micro-infusions of the drugs to disperse locations in the patient's cortex or thalamus. Another feature of the invention is that the catheter includes an electrode for recording discharges in the patient's cortex or thalamus. Another feature of the invention is that it utilizes a drug reservoir for containing reserve portions of the drug. Another feature of the invention is that it can include a flexible wire multicontact electrode. Another feature of the invention is that the flexible wire multicontact electrode is inserted into the brain using a rigid introducer. Another feature of the invention is that a flat plastic plate attached to the longitudinal support (electrode) at the site of skull attachment helps position the prosthetic in the auditory cortex. The flat plastic plate has a cup to receive a sphere coupled to leads which interconnect the contacts to a speech processor. These and other objects, advantages and features of the present invention will become more apparent from the following description of embodiments thereof taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIGS. 1A and 1B show the orientation of a patient's primary auditory cortex in relation to the patient's cochlea and cochlear nucleus. FIG. 2A shows a multi-contact recording/stimulating electrode system 100 for blocking and/or masking the abnormal electrical activity present in tinnitus patients according to one embodiment of the invention. FIG. 2B shows a human cerebral cortex neural prosthetic according to one embodiment of the invention. FIG. 3A shows a side view of a plane A which intersects a coronal section with a Sylvian fissure exposed, and FIGS. 3B and 3C show the coronal section before and after tissue is digitally "peeled off" the Sylvian fissure. FIG. 4 shows a neural prosthetic with a support having electrical contacts and its stimulation device. FIG. 5 shows a prosthetic which includes two longitudinal supports according to another embodiment of the invention. FIG. 6 shows a prosthetic according to yet another embodiment of the invention. FIG. 7A shows the prosthetic of FIG. 6 as looking down on the patient's brain surface, FIG. 7B shows a closer view of a stopping piece with a cup and a lid, and FIG. 7C corresponds to FIG. 7A with the support inserted. FIG. 8 shows another embodiment of the invention involving drug-infusion into regionally targeted locations within the brain according to another embodiment of the invention. FIG. 9 shows a closer view of a catheter with ports or openings. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS It is presumed that patients perceive tinnitus because neurons within the central auditory system (Auditory Cortex and/or Medial Geniculate Nucleus (MGN) of the Thalamus) are firing abnormally. By using sophisticated medical imaging and neurosurgical techniques discussed in U.S. Pat. No. 5,496,369, the contents of which are incorporated herein by reference, specific regions in the brain can be targeted and the abnormal electrical activity blocked or masked with stimulating electrodes or with drugs delivered through precisely placed brain catheters. The primary auditory region of the human brain is buried deep within the Sylvian fissure. It is not visible from the brain surface and its exact location varies slightly from one person to the next. MRI and CT scanners were not invented at the time of Dr. Dobelle's experiments so the anatomy of the patient's auditory cortex could not be studied prior to surgery, and this region could only be visualized with difficulty in the operating room after the Sylvian fissure was surgically dissected. Once the buried auditory cortex was exposed, surface stimulating electrodes were placed by hand over the area thought to be the auditory cortex and the brain was stimulated in a fashion similar to that used to generate visual phosphenes. Reproducible sound sensations were generated in the experimental subjects. Though these preliminary findings were encouraging, a range of limitations precluded further work by this group. Among the more daunting problems the Utah group faced were recruiting suitable patients for the experimental study and obtaining good stimulation characteristics from the experimental surface electrodes. The minimal stimulation threshold for eliciting sound sensations was found to be 6 milliamperes, which is too high to be tolerated chronically and is thousands of times greater than currents found subsequently to be required to generate phosphenes in visual cortex using penetrating electrodes. Recent advances in MRI and computer technology now allow detailed preoperative imaging of human auditory cortex. An important aspect of the cochlear implant technology, which is now highly refined, involves transducing sound into complex electrical stimulation sequences. This large body of technical knowledge developed over the last twenty years will be directly applicable to the treatment of tinnitus via the auditory cortex prosthetic device. Normal Hearing Mechanisms of human hearing are reviewed briefly to provide a framework for discussion of the tinnitus masking system. The auditory system is composed of many structural components that are connected extensively by bundles of nerve fibers. The system's overall function is to enable humans to extract usable information from sounds in the environment. By transducing acoustic signals into electrical signals that can then be processed in the brain, humans are able to discriminate amongst a wide range of sounds with great precision. FIGS. 1A and 1B show a side and front view of areas involved in the hearing process. In particular, the normal transduction of sound waves into electrical signals occurs in cochlea 110, a part of the inner ear located within temporal bone (not shown). Cochlea 110 is tonotopically organized, meaning different parts of cochlea 110 respond optimally to different tones; one end of cochlea 110 responds best to high frequency tones, while the other end responds best to low frequency tones. Cochlea 110 converts the tones to electrical signals which are then received by cochlear nucleus 116. This converted information is passed from cochlea 110 into brain stem 114 by way of electrical signals carried along the acoustic nerve and in particular, cranial nerve VIII (not shown). The next important auditory structure encountered is cochlear nucleus 116 in brain stem 114. As the acoustic nerve leaves the temporal bone and enters skull cavity 122, it penetrates brain stem 114 and relays coded signals to cochlear nucleus 116, which is also tonotopically organized. Through many fiber-tract interconnections and relays (not shown), sound signals are analyzed at sites throughout brain stem 114 and thalamus 126. The final signal analysis site is auditory cortex 150 situated in temporal lobe 156. The mechanisms of function of these various structures has also been extensively studied. The function of cochlea 110 is the most well-understood and the function of auditory cortex 150 is the least understood. For example, removal of the cochlea 110 results in complete deafness in ear 160, whereas removal of auditory cortex 150 from one side produces minimal deficits. Despite extensive neural connections with other components of the auditory system, auditory cortex 150 does not appear to be necessary for many auditory functions. Advanced imaging combined with an intraoperative stereotactic system now enable placement of penetrating electrodes into auditory cortex during routine epilepsy surgery without dissection of the Sylvian fissure. Primary auditory cortex 150 in FIGS. 1A and 1B is tonotopically organized, meaning stimulation in different areas is likely to cause the patient to perceive different tones. These tones form the building blocks of complex sound phenomena such as speech. Tonotopic organization is a fundamental characteristic of the cochlea and cochlear nucleus as well, as discussed above. Auditory cortex 150, however, has its tonotopic map stretched across a larger volume of tissue (greater that twice the volume of cochlear nucleus 116). Greater tissue volume enables placement of a greater number of electrical contacts for a given tonotopic zone. This results in increased signal resolution and improved clarity of auditory sensation. Finally, because of anatomical differences, auditory cortex 150 can accommodate penetrating electrode arrays. Stimulating Electrode FIG. 2A shows a multi-contact recording/stimulating electrode system 100 for blocking and/or masking the abnormal electrical activity present in tinnitus patients according to one embodiment of the invention. In particular, system 100 includes a multi-contact stimulating/recording electrode 104 connected to cables 108 via connector 112. Cables 108 enter skull 116 at burr hole opening 120 of skull 116 and are connected to a stimulation device 410 positioned in subcutaneous tissue of axial skeleton (thorax or abdomen). FIG. 2B shows a closer view of multi-contact stimulating/recording electrode 104 of electrode system 100. Electrode 104 has a first end 206a and a second end 206b which is blunt or smoothly curved. Electrode 104 has electrical contacts 220 along a longitudinal support 226. Support 226 can be anywhere from several millimeters long to several centimeters long. Electrical contacts 220 are small metal pads which can be separately electrically charged via respective wires 232a available at first end 206a. Wires 232a are coupled to stimulation device 410 (see FIGS. 2A and 4). Electrical contacts 220 are spaced approximately 10 micrometers to several millimeters apart and preferably approximately 50 to 150 micrometers apart. Application of a voltage to contacts 220 near first end 206a results in stimulating low (or high--to be determined by questioning the patient) tones in auditory cortex 150 (see FIGS. 1A and 1B), whereas application of a voltage to contacts 220 near second end 206b results in stimulation of high (or low) tones in auditory cortex 150. Electrode 104 is stereotaxically placed into the primary auditory cortex of the patient with tinnitus. This can be done using a standard stereotaxic head frame under local anesthesia. That is, the above discussed three dimensional computerized MRI reconstruction method of FIGS. 3A-3C is used to stereotaxically place electrode 104 within the targeted region of auditory cortex 150. Correct placement is confirmed by presenting a series of tones to the patient and mapping the tonotopic responses of the neurons along electrode 104. In deaf patients, this mapping procedure is not possible, but mapping can still be carried out using microstimulation currents delivered to various contacts along electrode 104. The deaf patient describes the relative pitch of the sounds he or she perceives following stimulation, whereby the electrically stimulated location and parameters which most closely match the patient's tinnitus are determined. This approach could be used in the thalamus (MGN) as well, but the preferred embodiment involves implantation in the cortex. Regardless of whether or not stimulating electrode 104 is placed into the correct region of the cortex or into the correct region of the MGN, electrode 104 is coupled to stimulation device 410 via cables 108 and in particular, wires 232a. Longitudinal support 226 can be a rigid support or a flexible wire with a rigid introducer which enables the physician to introduce electrode 104 into a patient's brain and then subsequently remove the rigid introducer thereby exposing electrical contacts 220 to auditory cortex 150. Support 226 can be one of the probes shown in FIGS. 3-5 in "Possible Multichannel Recording and Stimulating Electrode Arrays: A Catalog of Available Designs" by the Center for Integrated Sensors and Circuits, University of Michigan Ann Arbor, Mich., the contents of which are incorporated herein by reference. Alternative electrodes such as Depthalon Depth Electrodes and interconnection cables from PMT Corporation 1500 Park Road, Chanhassen, Minn., 55317 could also be used as support 226 and electrical couplers between contacts 220 and a speech processor (410 in FIG. 4). Electrical contacts 220 can operate as high impedance (megohms) contacts or low impedance (a few ohms to several thousand ohms) contacts. This enables the contacts to output a small (a few microamperes as opposed to a few milliamperes) current. High impedance contacts localize the potentials applied to the patient's primary auditory cortex to approximately a few hundred micrometers. The localization of applied electric charges corresponds to the tonotopic spacing of nerve cell pairs. Electrode 104 is arranged along a longitudinal direction of auditory cortex 150. However, auditory cortex 150 is located in the transverse temporal gyrus and is buried deep within the Sylvian fissure. Consequently, its location cannot be determined simply by looking at an exposed surface of the brain. Therefore, MRI imaging techniques must be employed to reveal the exact orientation of auditory cortex 150. A single coronal image of an individual's brain cannot reveal the exact orientation of auditory cortex 150. However, for treatment of tinnitus, a standard coronal MRI provides a fairly good estimate as to the location of the target region, whether or not the target region is the auditory cortex or the thalamus. However, if more precise targeting is desired, a series of two dimensional images must be obtained and a resulting 3-D MRI image constructed. Once such an image is constructed, the digital data making up that image can be transformed to provide a view of the Sylvian fissure. This in turn exposes auditory cortex 150 as a mole-like mound. That is, tissue on top of the digital image can be "peeled off" to expose the sylvian fissure and consequently auditory cortex 150 "pops out" of the image. This process is described in "Three-dimensional In Vivo Mapping of Brain Lesions in Humans", by Hanna Damasio, MD, Randall Frank, the contents of which are incorporated herein by reference. FIG. 3A shows a side view of a plane A which intersects a coronal section 310 as well as a view of coronal section 310 with Sylvian fissure 316 exposed. FIGS. 3B and 3C show coronal section 310 before and after tissue is digitally "peeled off" to expose auditory cortex 150. One or more resulting mounds 320 is revealed in FIG. 3C and this mound corresponds to auditory cortex 150 of FIG. 1B. Mound 320 does not appear until after tissue on the underside of Sylvian fissure 316 is reconstructed to provide the 3-D image. Once the exact location and orientation of mound 320 and consequently auditory cortex 150 have been determined using these 3-D MRI image processing techniques, electrode 104 can be accurately inserted into auditory cortex 150. FIG. 4 shows electrode 200 just prior to insertion into auditory cortex 150. In addition, FIG. 4 shows stimulation device 410 coupled to wires 238 via cable 414. Stimulation device 410 is a chronic electrical stimulation device. This stimulator device is well tested and widely available. Examples include chronic epidural stimulators made by Medtronics used for chronic back and leg pain and deep brain stimulators, as well as nearly all types of cochlear implants. The above electrical implantation technique for tinnitus is quick and safe, e.g., over 100 auditory cortex region electrode implantations have been performed in patients being evaluated for medically intractable seizures as reported by a French epilepsy surgery group. In addition, since electrode 104 is placed in the exact site of presumed abnormal neuronal electrical activity, it is much more effective in disrupting or altering abnormal neuronal electrical activity, thereby eliminating tinnitus. Moreover, preliminary testing has shown that placement of electrode 104 within the central auditory system causes patients to perceive sounds, and this will likely be the case even in patients who are deaf from causes refractory to cochlear implantation. Also, stimulation in the auditory cortex does not impair hearing in tinnitus patients who do have good hearing. FIG. 5 shows an electrode 510 which includes two longitudinal supports 226a and 226b according to another embodiment of the invention. Although two supports are shown, three or more such supports could be used. Longitudinal support 226a is connected to cable 108a containing wires 232a via connector 112a and longitudinal support 226b is connected to cable 108b containing wires 232b via connector 112b. Cables 108a and 108b are again connected to stimulation device 410 as in FIG. 4. FIG. 6 shows an electrode 610 according to yet another embodiment of the invention. In particular, FIG. 6 shows longitudinal support rod 226 with first end 606a and second end 606b. End 606a is arranged in the region of auditory cortex 150 with low tones (or high tones as previously discussed) and second end 606b is arranged in the region of auditory cortex 150 with high (or low) tones in a manner similar to first end 206a and second end 206b of FIG. 2B. Here, however, longitudinal support 226 has a sphere 616 which is stopped by a stopping piece 614. This enables the physician to insert longitudinal support 226 at a wide range of angles and yet secure electrode 610 once longitudinal support 226 has been inserted. FIG. 7A shows electrode 610 of FIG. 6 as looking down on the patient's brain surface 704. FIG. 7B shows a closer view of stopping piece 614 with a cup 708 and a lid 714 with a notch 716 for passing leads 232. FIG. 7C corresponds to FIG. 7A with support 226 inserted into surface 704 and sphere 616 resting in cup 708 "(FIG. 7B)". FIG. 7C also shows lid 714 covering sphere 616 with leads 232 extending out of notch 716. FIG. 8 shows another embodiment of the invention involving drug-infusion into regionally targeted locations within the brain. The alternative drug-infusion treatment strategy relies on the same principal of regionally targeted treatment within the brain, but employs a different effector to eliminate the abnormal neural activity causing tinnitus. Namely, a small drug infusion catheter 801 is stereotaxically placed into either the auditory cortex or thalamus (MGN) and microinfusions of various drugs that block abnormal neural activity are infused into the targeted locations. Referring in more detail to FIG. 8, a drug infusion catheter-recording device 800 is connected to an injectable (rechargeable) drug reservoir-pump 804 via connector 803 which is secured with sutures widely used in neurosurgery. Pump 804 is secured to the patient's skull 808 under the scalp and is not exposed to the external environment. Pump 804 has a valve 824 which can be accessed externally so that additional drugs can be injected via a syringe (not shown) without reopening the patient's scalp. Catheter 801 has multiple ports 814 from which the drugs are microinfused into the targeted brain regions. FIG. 9 shows a closer view of catheter 801 with ports or openings 814. Catheter 801 can be made, for example, of silastic such as the catheters sold by Radionics, Codman, and Medtronics. Catheter 801 need not have a circular cross-section 817 and instead can be flat, elliptical or any other shape which facilitates broader diffusion of the drug. Catheter 801 can include a small embedded recording-stimulating electrode 819 which can be connected to stimulation device 410 so that cathether 801 can be properly positioned. Electrophysiologic recording data from this special catheter electrode will provide physiologic confirmation of proper catheter position in auditory cortex. The diameters of ports (or openings) 814 can be approximately between 10 micrometers and several millimeters and preferably between approximately 40 micrometers and 1 millimeter. The centers of ports 814 can also be tens of micrometers apart to millimeters apart and the spacing need not be uniform. Pumps manufactured by Medtronics and Alzet can serve as injectable drug reservoir-pump 804. Examples of drugs that could be infused include anticonvulsants such as Dilantin and inhibitory neurotransmitters such as GABA and local anesthetics such as lidocaine. In high enough concentrations, these compounds should block abnormal neuronal discharges. By delivering the drugs to the specific central nervous system target, significantly higher concentrations of the drug reach their target without exposing non-targeted surrounding tissue, as compared to the concentrations which could be delivered by simply systemically administering the same drug orally or intravenously. Consequently, this strategy should result in marked improvement in efficacy while avoiding toxic side effects. The precise amount of drug infusion depends on the type of drug but can be determined at the outset of implantation. In particular, catheter 801 is initially inserted into the targeted location in the manner described above. The patient is then asked if there is any noticeable reduction in ringing due to the tinnitus as the amount of drug infusion is manually adjusted. The amount of infusion is that amount which is required to eliminate the ringing. Once the amount is determined, the appropriate chronic infusion pump 804 is connected to catheter 801 and all incisions are closed. Post-operative modifications of infusion rates can be carried out using percutaneous radio control techniques, e.g., Medtronics. As mentioned above, the alternative drug-infusion treatment strategy relies on the same electrode placement principals as described above with respect to FIGS. 3A-3C. Namely, a series of images must again be obtained and a resulting 3-D MRI image constructed. Once the image is constructed, the digital data making up that image can be transformed to provide a view of the Sylvian fissure. This in turn exposes auditory cortex 150 as a mole-like mound. Again, tissue on top of the digital image can be "peeled off" to expose the Sylvian fissure and consequently auditory cortex 150 "pops out" of the image. Numerous additional modifications and variations of the present invention are possible in light of the above teachings. It is therefore understood that the invention may be practiced otherwise than as specifically claimed.

A neural prosthetic device for reducing or eliminating the effects of tinnitus is inserted into a tinnitus patient's primary auditory cortex (or thalamus). The prosthetic device includes a stimulation device for outputting processed electrical signals and an electrode arranged in the primary auditory cortex having a plurality of electrical contacts. Each of the plurality of electrical contacts independently outputs electrical discharges in accordance with the electrical signals. In another embodiment, a catheter is inserted into the tinnitus patient's primary auditory cortex or thalamus. The catheter microinfuses drugs which suppress or eliminate abnormal neural activity into disperse geometric locations in the cortex or thalamus, thereby reducing or eliminating the effects of the patient's tinnitus.

CROSS-REFERENCE TO RELATED APPLICATION [0001] The present application claims priority to and is a continuation of U.S. patent application Ser. No. 13/080,754, titled GARNISH PICK, filed Apr. 6, 2011, which is a Non-Provisional of and claims priority to U.S. Provisional Patent Application Ser. No. 61/321,291, titled GARNISH PICK, filed Apr. 6, 2010, the entire contents of these applications are incorporated herein by reference in their entirety for all purposes. BACKGROUND [0002] A variety of garnishes may be used to add flavor and decoration to foods and beverages. For example, beverages including alcoholic cocktails may be served with a garnish of vegetables or fruits that are at least partially submerged in the beverage. Such garnishes are often served on a garnish pick in order to secure the garnish and enable the garnish to be more easily removed from the beverage. SUMMARY [0003] A garnish pick is disclosed that includes one or more appendages. In at least some embodiments, at least some of the appendages may comprise skewering shafts that are tapered and/or sharpened at an outer tip of the appendage for skewering and holding a garnish. Such appendages may project from a main shaft of the garnish pick at a variety of angles and/or orientations. In at least some embodiments, the angles and/or orientations at which such appendages project from a main shaft may be defined so that the garnish pick simulates the appearance of an organism or a portion thereof, such as a branch of a tree or an antler of an animal. In at least some embodiments, at least some of the appendages may form a hook for securing the garnish pick to a food or beverage container, such as a rim of a serving glass. An appendage that forms a hook may be used to prevent the garnish pick from becoming further submerged or entirely submerged into foods or beverages in a container. Accordingly, an appendage of the garnish pick may serve either as a shaft with which to skewer and hold a garnish, or as a hook for accepting a rim of a food or beverage container. At least some embodiments, the garnish pick may have two or more appendages, wherein at least one of the appendages may serve as a hook, while at least one of the other appendages may serve as a skewering shaft. BRIEF DESCRIPTION OF DRAWINGS [0004] Non-limiting and non-exhaustive aspects are described with reference to the following figures, wherein like reference numerals refer to like parts throughout the various figures unless otherwise specified. [0005] FIG. 1 shows an example garnish pick, according to one embodiment, in a martini glass, in which the pick has a straight main shaft and a single appendage serving as a hook for the rim of the glass. [0006] FIG. 2 shows an example garnish pick, according to one embodiment, situated in a martini glass, in which the pick has a curving main shaft and two appendages. One appendage serves as a hook, and the other as a skewering shaft. [0007] FIG. 3 shows an example garnish pick, according to one embodiment, in which the main shaft is forked, forming two skewering shafts. In this figure a single pick shown in three different views that are rotated 45 degrees relative to each other shows the relative position of the hook. [0008] FIG. 4 shows an example garnish pick, according to one embodiment, in which three appendages connect to a curved shaft resembling, for example, a deer's antler. One appendage serves as a hook and the other two as skewering shafts. [0009] FIG. 5 shows an example garnish pick, according to one embodiment, in which two appendages connect to a curved shaft, one of which serves as a hook and the other as a skewering shaft. [0010] FIG. 6 shows an example garnish pick, according to one embodiment, in which the pick is rotated approximately 90 degrees relative to each other in each figure, and in which three appendages connect to a curved main shaft, one of which serves as a hook and the others as skewering shafts. [0011] FIG. 7 shows an example garnish pick, according to one embodiment, in which there is no hooking appendage and in which main shaft forks, forming two skewering appendages. [0012] FIG. 8 shows another example garnish pick according to one embodiment. [0013] FIG. 9 shows an example garnish pick, according to one embodiment, in which two appendages emerge from opposite or opposing sides of a straight shaft, forming three skewing shafts. [0014] FIG. 10 shows an example garnish pick, according to one embodiment, in which three appendages and the main shaft are contoured to resemble, for example, a twig or branch of a tree or plant. [0015] FIG. 11 shows three example garnish picks, according to three embodiments, which are contoured to resemble twigs or branches. [0016] FIG. 12 shows another example garnish pick according to one embodiment. [0017] FIG. 13 shows the example garnish pick of FIG. 12 in an example use environment of a beverage container. DETAILED DESCRIPTION [0018] Conventional cocktail garnish picks are typically thin, straight, cylindrical pieces of wood, metal or plastic, with a sharpened end. While the typical garnish pick is formed by a single straight shaft to skewer and hold a garnish, such a design allows the entire pick to occasionally slide below the line of the liquid, potentially submerging the garnish pick. This is inconvenient for people that prefer to eat the garnish while drinking the cocktail, because it may require the person to dip his or her fingers into the cocktail to retrieve the pick and garnish, and which may be perceived as unsanitary and unappealing. In addition, when more than one garnish is skewered and stacked onto a single shaft, it may be difficult for a person to remove each garnish from the garnish pick without using his or her fingers. If, for example, three olives are stacked on a single shaft, the olive next to the sharp end of the shaft can be easily pulled off by a person using their teeth, while removing a second or third olive may require the person to use his or her fingers to remove the second or third olives because of the increased distance of the second and third olives from the sharp end of shaft. [0019] Referring now to FIG. 1 , an example garnish pick 100 is shown according to one embodiment in an example usage environment of a martini glass 114 . Specifically, FIG. 1 shows how an appendage 110 of the garnish pick may exit a main shaft 112 angling toward the skewering end of the garnish pick, and hook or otherwise secure the pick to the rim of a glass, preventing the garnish pick from sliding into the cocktail glass, or completely or further submerging the garnish pick into a beverage. In this embodiment, the main shaft 112 also serves as a skewering shaft for holding a garnish. [0020] FIG. 2 shows a garnish pick 200 in an example usage environment of a martini glass 216 . In this example embodiment, garnish pick 200 includes three appendages, wherein a first appendage 210 may serve as a hook, and a second appendage 212 and a third appendage 214 may serve as skewering shafts. FIG. 2 also shows how garnishes, e.g., in this case olives, can be held on the garnish pick, for example, by appendages 212 and 214 . [0021] FIG. 3 shows a single embodiment of a garnish pick depicted at different angles rotated 45 degrees relative to each other. FIG. 3 shows how multiple appendages can exit the primary shaft, one serving as a hook for the rim of the glass, while the others serve as skewers. [0022] In further detail, still referring to FIG. 1 , FIG. 2 and FIG. 3 , the garnish pick may be of a total length that is approximately equal to the distance from the rim of a martini glass to the center of the bottom of the glass. However, other suitable lengths may be used. Because martini glasses come in a variety of shapes and sizes, this distance may vary. In at least one non-limiting example, a total length of the garish pick does not exceed five inches and is not less than two inches in length. FIG. 9 further shows how an appendage for serving as a hook may be omitted from the garnish pick in at least some embodiments. [0023] In at least some embodiments, a total diameter or width of the garnish pick may be at its largest is 15 cm or less, with the diameter or width diminishing toward the sharp end of the skewering shafts. The portions of the garnish pick that are adapted to hold a garnish may have a diameter sufficiently small such that a garnish (e.g., an olive or other suitable garnish item) can slide onto that portion of the garnish pick without undue difficulty and/or without splitting or damaging the garnish. [0024] In at least some embodiments, the main shaft and/or appendages may curve, have abrupt bends, or be curved along at least a portion of its axis. The main shaft and/or appendages may have bumps, ridges, craters, or be otherwise unsmooth or rough (e.g., as shown by the non-limiting examples of FIGS. 10 and 11 ). The main shaft and/or appendages may have circular cross-sections, convolute cross-sections, ovular cross-sections, non-circular cross-sections, square or rectangular cross-sections, pentagonal cross-sections, hexagonal cross-sections, or irregularly shaped cross-sections, among other shapes. The main shaft and/or appendages may have twists and/or cork screws that may be expanding or narrowing (e.g., at a radius of curvature) along a longitudinal axis of the main shaft or appendage (e.g., non-regular corkscrew or twist). Such twists and/or corkscrews may be less than a full rotation, between one full rotation and two full rotations, greater than two full rotations, or comprise an even greater number of rotations. In at least some embodiments, one or more of the appendage may have smaller appendages (e.g., sub-appendages) that branch from them. [0025] The construction details of the garnish picks disclosed herein may be that such garnish picks may be made of wood or of any other sufficiently rigid, flexible, and/or strong material such as plastic, rubber, metal, glass, ceramic, and the like depending on implementation. Further, the various components of the garnish pick can be made of different materials. For example, a garnish pick may comprise two or more materials. For example, the garnish pick may comprise a first material (e.g., metal or plastic) having an outer coating comprising a second material (e.g., rubber, plastic or paint). [0026] The advantages of the disclosed embodiments may include, without limitation, that the garnish pick can be hooked to the side of a glass, preventing the pick from becoming completely or further submerged in a beverage, and can provide additional shafts (e.g., appendages) on which to hold garnishes. Such embodiments may also eliminate the need to retrieve the pick out of the beverage or beverage container (e.g., with fingers) and may make it easier to eat garnishes off of the pick (e.g., without using fingers to touch the garnishes). [0027] As previously described, a garnish pick is provided that may be used to hold garnishes with one or more appendages emerging from a main shaft, angled toward a sharp end of the main shaft, that are used either to hook the pick to the rim of the glass or to skewer garnishes, or both. In embodiments where the garnish pick comprises a plurality of appendages, such appendages may project from a main shaft of the garnish pick at the same or different angles relative to each other along a longitudinal axis and/or an orthogonal axis of the main shaft. For example, a first appendage may project from the main shaft at a greater angle relative to a longitudinal axis of the main shaft than a second appendage and/or a third appendage. Accordingly, the garnish pick may comprise two, three, four, five, or more appendages that each project from a main shaft or other base appendage (e.g., where such appendages comprise sub-appendages) at different angles relative to each other as measured relative to a longitudinal axis of the main shaft or other base appendage. As another example, a first appendage may project from the main shaft or other base appendage (e.g., for sub-appendages) at a 2 o'clock position when viewed in a plane that is orthogonal to the longitudinal axis of the main shaft or base appendage, while a second appendage may project from the main shaft at a 6 o'clock position, and/or a third appendage may project from the main shaft at an 8 o'clock position. Such examples are provided for descriptive purposes and should not be considered limiting. [0028] FIG. 12 shows another example garnish pick 1200 according to one embodiment. FIG. 13 shows the example garnish pick 1200 of FIG. 12 in an example use environment of a beverage container. Garnish pick 1200 includes a pick body 1210 . The pick body may include a first elongate body portion 1212 having a first end 1214 forming a first tapered skewer 1216 and having a second end 1218 forming a hook 1220 . The pick body may include a second elongate body portion 1230 branching outward from the first elongate body portion at an intermediate location 1232 between first end 1214 and second end 1218 . The second elongate body portion may have a distal end 1232 forming a second tapered skewer 1234 . In at least some embodiments, first elongate body portion 1212 may taper from second end 1218 toward first end 1214 , and second elongate body portion 1230 may taper from a base end 1236 toward distal end 1232 of the second elongate body portion. [0029] In at least some embodiments, a cross-sectional area of the second elongate body portion at the base end is smaller than a cross-sectional area of the first elongate body portion at the intermediate location where the second elongate body portion branches outward from the first elongate body portion. In at least some embodiments, the first elongate body portion may be curved along a length of the first elongate body portion between the first end and the second end. The curvature of the first elongate body portion may vary along at least a portion of the length of the first elongate body portion between the first end and the second end. In at least some embodiments, the first elongate body portion may be curved in one, two, or more orthogonal planes along at least a portion of the length of the first elongate body portion between the first end and the second end. The second elongate body portion may be curved in one, two, or more orthogonal planes along at least a portion of a length of the second elongate body portion between a base end and the distal end. The first and second elongate body portions may each have a different curvature. A length of the second elongate body portion may be less than, greater than, or equal to a length of the first elongate body portion between the intermediate location and the first end of the first elongate body portion. [0030] In at least some embodiments, the pick body may further include a third elongate body portion branching outward from the first elongate body portion at another intermediate location between the first end of the first elongate body portion and the intermediate location where the second elongate body branches outward from the first elongate body. The third elongate body portion may have a distal end forming a third tapered skewer. The third elongate body portion may be curved in one, two, or more orthogonal planes along at least a portion of the length of the third elongate body portion between a base end and a distal end of the third elongate body portion. The first, second, and third elongate body portions may each have different curvature a, and may each have similar or different lengths of one or more other elongate body portions of the garnish pick. [0031] In at least some embodiments, hook 1220 formed at second end 1218 of first elongate body portion 1212 may branch outward from first elongate body portion 1212 at a location that is offset 1240 from second end 1218 of first elongate body portion 1212 . The hook may taper along its length toward a distal end 1221 of the hook. The hook formed at the second end of the first elongate body portion may be adapted to receive a rim of a beverage container 1300 (e.g., as depicted in FIG. 13 ). In at least some embodiments, a remainder of the pick body including at least the first and second elongate portions may be sized to fit substantially within a beverage container when or if the rim of the beverage container is received by the hook as depicted in FIG. 13 , for example. FIG. 13 shows garnish pick 1200 with example garnish 1310 . [0032] In at least some embodiments, the pick body may be asymmetric about any plane (e.g., any or all reference planes) passing through the garnish pick. The pick body may comprise a core formed from a first material and an outer coating substantially surrounding the core, the outer coating formed from a second material that is different from the first material. [0033] As yet another alternative description of an example garnish pick, a pick body of the garnish pick may include a stem portion (e.g., the portion of pick body 1212 between 1218 and 1232 ), a first elongate body portion (e.g., the portion of pick body 1212 between 1214 and 1232 ) branching from the stem portion, and a second elongate body portion (e.g., elongate body portion 1230 branching from the stem portion or the first elongate body portion. The first elongate body portion may taper from a base end toward a distal end of the first elongate body portion to form a first tapered skewer, and the second elongate body portion may taper from a base end toward a distal end of the second elongate body portion to form a second tapered skewer. The stem portion may form a hook as previously described. [0034] While the foregoing written description enables one of ordinary skill to make and use what is considered presently to be the best mode thereof, those of ordinary skill will understand and appreciate the existence of variations, combinations, and equivalents of the specific embodiments, methods, and examples disclosed herein. Such disclosure and/or claimed subject matter should therefore not be limited by the above described embodiments, methods, and examples.

A garnish pick for food and/or beverages is disclosed. In at least some embodiments, the garnish pick includes a plurality of appendages that form skewering shafts for skewering garnishes. In at least some embodiments, at least one appendage of the garnish pick forms a hook for securing the garnish pick to a food or beverage container. In at least some embodiments, the garnish pick and its associated appendages may be shaped to simulate the appearance of organisms or portions thereof. As one example, the garnish pick may simulate the appearance of a branch of a tree or an antler of an animal.

FIELD OF THE INVENTION The present invention generally relates to cardiac assist systems, including cardiomyoplasty, for the treatment of patients needing augmented cardiac output. More specifically, the present invention relates to a device and algorithm for a combined cardiomyostimulator and cardiac pacer-cardioverter-defibrillator. BACKGROUND OF THE INVENTION Cardiac assist systems aid patients with chronically and unacceptably low cardiac output who cannot have their cardiac output raised to acceptable levels by traditional treatments, such as drug therapy. One particular type of cardiac assist system currently used is a cardiomyoplasty. Essentially a cardiomyoplasty provides a muscle-powered cardiac assist system. As seen in U.S. Pat. No. 4,813,952 of Khalafalla, incorporated herein by reference, the cardiomyoplasty is a cardiac assist system powered by a surgically-modified muscle tissue, such as the latissimus dorsi. In particular, the latissimus dorsi is wrapped around the heart. An implantable pulse generator is provided. The implantable pulse generator senses contractions of the heart via one or more sensing leads and stimulates the appropriate nerves of the muscle tissue with burst signals to cause the muscle tissue to contract in synchrony with the heart. As a result, the heart is assisted in its contractions, thereby raising the stroke volume and thus cardiac output. Besides delivering therapeutic electrical pulses to the muscle, the pulse generator is quite often also coupled so as to also provide therapeutic electrical pulses to the heart. See, for example, U.S. Pat. No. 4,735,205 of Chachques et al., incorporated herein by reference. Patients with chronic cardiac output deficiencies, although treatable through cardiomyoplasty, face an increased risk for cardiac arrhythmic episodes, such as ventricular tachycardia or fibrillation. These arrhythmic episodes may be life-threatening. In order to treat these potentially life-threatening cardiac arrhythmias, some cardiac assist systems have been proposed which combine a muscle stimulator as well as a cardiac pacer-cardioverter-defibrillator. In such a manner a patient who has had a cardiomyoplasty may, in addition to receiving musclepowered cardiac assistance, also receive various types of therapeutic cardiac electrical stimulation. One example of such a system may be seen in the U.S. Pat. No. 5,251,621 issued to Collins and entitled "Arrhythmia Control Pacer Using Skeletal Muscle Cardiac Graft Stimulation." One problem associated with devices which combine a muscle stimulator as well as a cardiac pacer-cardioverter-defibrillator is that the muscle stimulation may interfere with the reliable sensing of cardiac events. During ventricular arrhythmias, such as ventricular fibrillation or ventricular tachycardia (hereafter "VF" and "VT" respectively) the cardiac signals may have very low amplitudes. This is especially the case during VF. The stimulation of the muscle wrap at that time could thus interfere with reliably sensing the VF or VT due to post-pace polarization, cross talk, et cetera. The U.S. Pat. No. 5,251,621 issued to Collins offers one solution to this problem. The Collins patent discloses a cross channel blanking control signal to disable pacemaker sensing during generation of a skeletal muscle stimulation pulse. This is intended to prevent the pacemaker from incorrectly classifying a skeletal muscle stimulation pulse as an episode of intrinsic cardiac activity. At all times, however, muscle stimulation is continued. In fact, during arrhythmic events besides muscle stimulation continuing, Collins discloses adjusting various parameter of the muscle stimulation bursts, such as pulse amplitude, duration as well as the interval between pulses within a burst. One problem with this approach, however, is the continuation of skeletal muscle stimulation may interfere with the reliable sensing of the arrhythmia. Moreover, adjusting the various parameters of the muscle stimulation signal, such as amplitude or duration, creates an even greater likelihood that the device will not be able to reliably sense the arrhythmia. Rapid detection of a cardiac tachyarrhythmia, and especially VF, is very important. A typical cardiac pacer-cardioverter-defibrillator detection algorithm requires the detection of a certain number of tachyarrhythmic events within a specified time period. In the case of VF detection, these devices will typically initiate the charging of a cardiac output circuit. This charging period may last between 1 to 21 seconds, depending on the therapy to be delivered. Following charging, the detection algorithm would once again confirm VF and deliver the therapy. Once the therapy was delivered, the detection algorithm would remain active until the tachyarrhythmic episode termination was confirmed. At high energy levels, the period from tachyarrhythmia detection until tachyarrhythmia termination confirmation and muscle therapy reactivation could be extremely long, up to 35 seconds, or even longer. The consequence of this inhibition of the cardiac assistance during an episode of tachyarrhythmia is that cardiac output is highly compromised. In addition, while in fibrillation the threshold to achieve defibrillation through electrical shock rises exponentially. Higher defibrillation thresholds, however, mean the device must feature larger capacitors or higher voltages or both. SUMMARY OF THE INVENTION It is thus an object of the invention to provide a cardiac assist system which permits the rapid detection of a cardiac arrhythmia. It is a further object of the present invention to provide a cardiac assist system which provides cardiac assistance during a cardiac arrhythmia. These and other objects are met by the present invention which comprises a device and algorithm for a combined cardiomyostimulator and a cardiac pacer-cardioverter-defibrillator. In particular the present invention operates, in a first embodiment, to deliver stimulation to a skeletal muscle grafted about a heart; sense depolarizations of a patient's heart; measure the intervals separating successive depolarizations of the patient's heart; define first and second interval ranges; determine the number of the measured intervals falling within the first and second interval ranges; inhibit the delivery of stimulation to a skeletal muscle grafted about a heart upon the sensing of a depolarization within the first or second interval range; detect the occurrence of a first type of arrhythmia when the number of the measured intervals falling within the first interval range equals a first predetermined value; detect the occurrence of a second type of an arrhythmia when the number of the intervals falling within the second interval range equals a second predetermined value; deliver a first type of arrhythmia therapy in response to the detection of the first arrhythmia; and deliver a second type of arrhythmia therapy in response to the detection of the second arrhythmia, the second type of arrhythmia therapy having a cardiac stimulation component and a skeletal muscle component. BRIEF DESCRIPTION OF THE DRAWINGS The foregoing and other aspects of the present invention will be best appreciated with reference to the detailed description of the invention in conjunction with the accompanying drawings, wherein: FIG. 1 illustrates an example of a system for performing both long-term stimulation of skeletal muscles for cardiac assistance using systolic augmentation as well as direct electrical stimulation of a heart according to the present invention. FIG. 2 is a functional schematic diagram of an implantable pulse generator used in the system of the present invention. FIG. 3 is an illustration of detection interval ranges employed in a preferred embodiment of the present invention. FIG. 4 is an arrhythmia detection/therapy muscle state diagram of the present invention. FIG. 5 is a timing diagram showing the relationship between muscle stimulation, cardiac events, and a defibrillation charge cycle. FIG. 6 is a timing diagram showing the relationship between muscle stimulation and cardiac events of an alternate embodiment. FIG. 7 depicts an alternate muscle stimulation burst which may be used with the present system. FIG. 8 depicts an alternate embodiment of the muscle catch stimulation which may be used with the present system. FIG. 9 depicts an alternate embodiment of the muscle catch stimulation which may be used with the present system. The drawings are not necessarily to scale. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The present invention employs a sensor to monitor cardiac electrical activity and cardiac demand in a skeletal muscle-powered cardiac assist system (hereinafter referred to as "CAS"). A basic CAS may be configured in a variety of ways as described in the aforementioned patent to Khalafalla. One specific configuration is discussed herein simply as an illustration. The present invention, however, may be used in any system concerning cardiac augmentation using skeletal muscle, such as aortic counterpulsation or a skeletal muscle ventricle. Thus it should be understood the particular configuration illustrated is not intended to limit the present invention. The System of the Present Invention FIG. 1 illustrates an example of a system 1 for performing long-term stimulation of skeletal muscles for cardiac assistance using systolic augmentation as well as direct electrical stimulation of a heart 2. As seen, skeletal muscle graft 3 is positioned about the heart 2. In the preferred embodiment the latissimus dorsi muscle is used for the skeletal muscle graft, as is well known in the art. The longitudinal fibers of the muscle graft 3 are oriented generally perpendicular to the longitudinal axes of the right ventricle 4, left ventricle 5 and interventricular septum 10 of the heart. Muscle graft 3 is positioned in this manner so that when it is stimulated, muscle graft 3 compresses ventricles 4, 5 and particularly left ventricle 5, to thereby improve the force of right and left ventricular contraction. In such a manner the overall hemodynamic output of heart 2 is increased. In a preferred configuration, muscle graft 3 is wrapped around the heart 2 and fixedly attached to itself to form a cup-shaped "sling," using running sutures 12. Alternatively, muscle graft 3 may be attached to heart 2 using running sutures 13 as illustrated. As seen, electrical stimulation and sensing of heart 2 is accomplished through lead 15. In particular, lead 15 electrically couples pulse generator 6 to heart 2. Lead 15 provides cardiac pacing as well as defibrillation therapies. In the preferred embodiment lead 15 is the model 6936 tri-polar TRANSVENE lead from Medtronic Inc., Minneapolis, Minn. As seen, lead 15 is implanted in right ventricle 4 such that bipolar pacing electrode assembly 16 is in the right ventricular apex and defibrillation coil 17 is within the right ventricle 4. Although in the preferred embodiment a single lead is provided for pacing as well as defibrillation therapies, other types of lead configurations, such as multiple transvenous or subcutaneous or any combination thereof, may be used. Muscle graft 3 is electrically stimulated through a pair of leads 21, 22. In particular leads 21, 22 couple pulse generator 6 to skeletal muscle graft 3. In the preferred embodiment leads 21, 22 are the model 4750 intramuscular lead from Medtronic, Inc., Minneapolis, Minn. As seen, each lead 21, 22 extends from pulse generator 6 to latissimus dorsi muscle graft 3. The electrodes (not shown) of each lead 21, 22 are placed to cause muscle graft 3 to contract when electrically stimulated, as is well known in the art. Other types of leads or electrodes, however, may be used, such as epimysial or neuromuscular leads or nerve cuff electrodes. The Pulse Generator of the Present Invention FIG. 2 is a functional block diagram of a pulse generator 6 in which the present invention may usefully be practiced. This diagram should only be taken, however, as exemplary of the type of device in which the invention may be embodied and not as limiting. It is believed the invention may usefully be practiced in a wide variety of device implementations. For example, the invention is also believed practicable in conjunction with the implantable muscle stimulator-pacemaker-cardioverters-defibrillators disclosed in U.S. Pat. No. 5,251,621 issued to Collins entitled "Arrhythmia Control Pacer Using Skeletal Muscle Cardiac Graft Stimulation." The device is illustrated as being provided with six electrodes, 500, 502, 504, 506, 508, 572 and 574. Electrodes 500 and 502 may be a pair of electrodes located in the ventricle and mounted to a lead 15 as discussed above. Electrode 504 may correspond to a remote, indifferent electrode located on the housing of pulse generator 6. Electrodes 506 and 508 may correspond to large surface area defibrillation electrodes located within the right ventricle, coronary sinus, superior vena cava or may also be located subcutaneous, located on or part of the device housing or to the epicardium. Electrodes 572 and 574 are muscle stimulation electrodes coupled to the skeletal muscle wrap 3, as discussed above. Electrodes 500 and 502 are switchable through switch matrix 512 to the R-wave detector circuit, comprising band-pass filter circuit 514, auto threshold circuit 516 for providing an adjustable sensing threshold as a function of the measured R-wave amplitude and comparator 518. A signal is generated on R-out line 564 whenever the signal sensed between electrodes 500 and 502 exceeds the present sensing threshold defined by the auto threshold circuit 516. As illustrated, the gain on the band pass amplifier 514 is also adjustable by means of a signal from the pacer timing and control circuitry 520 on GAIN ADJ line 566. The operation of this R-wave detection circuitry may correspond to that disclosed in commonly assigned U.S. Pat. No. 5,118,824, issued to Keimel and incorporated herein by reference. However, alternative R-wave detection circuitry such as that illustrated in U.S. Pat. No. 4,819,643, issued to Menken and U.S. Pat. No. 4,880,004, issued to Baker et al., both incorporated herein by reference, may also be employed. The threshold adjustment circuit 516 sets a threshold corresponding to a predetermined percentage of the amplitude of a sensed R-wave, which threshold decays to a minimum threshold level over a period of less than three seconds thereafter, similar to the automatic sensing threshold circuitry illustrated in the article "Reliable R-Wave Detection from Ambulatory Subjects", by Thakor et al., published in Biomedical Science Instrumentation, Vol. 4, pp. 67-72, 1978. It is preferable that the threshold level not be adjusted in response to paced R-waves, but instead should continue to approach the minimum threshold level following paced R-waves to enhance sensing of low level spontaneous R-waves associated with tachyarrhythmias. The time constant of the threshold circuit is also preferably sufficiently short so that minimum sensing threshold may be reached within 1-3 seconds following adjustment of the sensing threshold equal to 70-80% of the amplitude of a detected spontaneous R-wave. The invention may also be practiced in conjunction with more traditional R-wave sensors of the type comprising a band pass amplifier and a comparator circuit to determine when the band-passed signal exceeds a predetermined, fixed sensing threshold. Switch matrix 512 is used to select which of the available electrodes are coupled to band pass amplifier 534. Under control of microprocessor 524, switch matrix directs delivery of electrical stimulation pulses to cardiac tissue and the skeletal muscle wrap. Selection of the switch matrix settings is controlled by the microprocessor 524 via data/address bus 540. Signals from the selected electrodes are passed through band-pass amplifier 534 and into multiplexer 532, where they are convened to multi-bit digital signals by A/D converter 530, for storage in random access memory 526 under control of direct memory address circuit 528. Multiplexer 532 further receives voltage from battery 537 via VBATT 536. Amplifier 534 may be a broad band pass amplifier, having a band pass extending for approximately 0.5 to 200 hertz. The filtered EGM signals from amplifier 534 are passed through multiplexer 532, and digitized in A-D converter circuitry 530. The digitized data may be stored in random access memory 526 under control of direct memory address circuitry 528. The occurrence of an R-wave detect signal on line 564 is communicated to microprocessor 524 via data/address bus 540, and microprocessor 524 notes the time of its occurrence. The remainder of the circuitry is dedicated to the provision of muscle stimulation, cardiac pacing, cardioversion and defibrillation therapies. The pacer timing/control circuitry 520 includes programmable digital counters which control the basic time intervals associated with cardiac pacing and muscle stimulation. The durations of these intervals are determined by microprocessor 524, and are communicated to the pacing circuitry 520 via address/data bus 540. Pacer timing/control circuitry also determines the amplitude of the muscle stimulation and cardiac pacing pulses and the gain of band-pass amplifier, under control of microprocessor 524. During cardiac pacing or muscle stimulation, the escape interval counter within pacer timing/control circuitry 520 is reset upon sensing of an R-wave as indicated by a signal on line 564, and on timeout triggers generation of a pacing pulse by pacer output circuitry 522, which is coupled to electrodes 500 and 502 or electrodes 572 and 574. The escape interval counter is also reset on generation of a cardiac pacing pulse, and thereby controls the basic timing of cardiac pacing functions, including anti-tachycardia pacing and subsequent muscle stimulation. The duration of the interval deemed by the escape interval timer is determined by microprocessor 524, via data/address bus 540. The value of the count present in the escape interval counter when reset by sensed R-waves may be used to measure the duration of R-R intervals, to detect the presence of tachycardia and change muscle stimulation parameters. Microprocessor 524 operates as an interrupt driven device, and responds to interrupts from pacer timing/control circuitry 520 corresponding to the occurrence of sensed R-waves and corresponding to the generation of cardiac pacing and muscle stimulation pulses. These interrupts are provided via data/address bus 540. Any necessary mathematical calculations to be performed by microprocessor 524 and any updating of the values or intervals controlled by pacer timing/control circuitry 520 and switch matrix 512 take place following such interrupts. In the event that a tachyarrhythmia is detected, and an antitachyarrhythmia pacing regimen is desired, appropriate timing intervals for controlling generation of anti-tachycardia pacing therapies are loaded from microprocessor 524 into the pacer timing/control circuitry 520 and switch matrix 512. Similarly, in the event that generation of a cardioversion or defibrillation pulse is required, microprocessor 524 employs the counters in timing and control circuitry 520 to control timing of such cardioversion and defibrillation pulses, as well as timing of associated refractory periods during which sensed R-waves are ineffective to reset the timing circuitry. Further, in the event the onset of a tachyarrhythmia is detected, but not yet confirmed, the filtered and digitized EGM available at A/D 530 will be compared by microprocessor 524 with a value from RAM 526. Measured values above set will continue detection. Values below set confirm the arrhythmia if more than 50% of the X out of Y have been detected. In the preferred embodiment X and Y are programmable counts corresponding to the VFNID and the fibrillation event buffer memory (located in the RAM 526) respectively, both of which are discussed in more detail below with regards to the VF counting mode state 34 seen in FIG. 4. Microprocessor 524 will then initiate a therapy if programmed to do so. In response to the detection of fibrillation or a tachycardia requiring a cardioversion pulse, microprocessor 524 activates cardioversion/defibrillation control circuitry 554, which initiates charging of the high voltage capacitors 556, 558, 560 and 562 via charging circuit 550, under control of high voltage charging line 552. During charging, microprocessor 524 enables pacer/timing control 520 to pace out 522 and switch matrix 512 to deliver muscle stimulation pulses until the high voltage capacitors 556 are sufficiently charged. The voltage on the high voltage capacitors is monitored via VCAP line 538, which is passed through multiplexer 532, and, in response to reaching a predetermined value set by microprocessor 524, results in generation of a logic signal on CAP FULL line 542, terminating charging. The CAP FULL line 542 signal is sent over DATA/ADDRESS 540 to the pace timer/control 520, which then inhibits delivery of the muscle stimulation pulses. Thereafter, delivery of the timing of the defibrillation or cardioversion pulse is controlled by pacer timing/control circuitry 520. One embodiment of an appropriate system for delivery and synchronization of cardioversion and defibrillation pulses, and controlling the timing functions related to them is disclosed in more detail in the commonly assigned U.S. Pat. No. 5,188,105 by Keimel, Method and Apparatus for Detecting and Treating a Tachyarrhythmia, incorporated herein by reference. Any known cardioversion or defibrillation pulse generation circuitry, however, is believed usable in conjunction with the present invention. For example, circuitry controlling the timing and generation of cardioversion and defibrillation pulses as disclosed in U.S. Pat. No. 4,384,585, issued to Zipes, in U.S. Pat. No. 4,949,719 issued to Pless et al., cited above, and in U.S. Pat. No. 4,375,817, issued to Engle et el., all incorporated herein by reference may also be employed. Similarly, known circuitry for controlling the timing and generation of anti-tachycardia pacing pulses as described in U.S. Pat. No. 4,577,633, issued to Berkovits et el., U.S. Pat. No. 4,880,005, issued to Pless et el., U.S. Pat. No. 7,726,380, issued to Vollmann et el. and U.S. Pat. No. 4,587,970, issued to Holley et el., all of which are incorporated herein by reference may also be used. In modern cardiac pulse generators, the particular anti-tachycardia and defibrillation therapies are programmed into the device ahead of time by the physician, and a menu of therapies is typically provided. For example, on initial detection of tachycardia, an anti-tachycardia pacing therapy may be selected. On re-detection of tachycardia, a more aggressive anti-tachycardia pacing therapy may be scheduled. If repeated attempts at anti-tachycardia pacing therapies fail, a higher level cardioversion pulse therapy may be selected thereafter. Prior art patents illustrating such pre-set therapy menus of antitachyarrhythmia therapies include the above-cited U.S. Pat. No. 4,830,006, issued to Haluska, et al., U.S. Pat. No. 4,727,380, issued to Vollmann et al. and U.S. Pat. No. 4,587,970, issued to Holley et al. The present invention is believed practicable in conjunction with any of the known anti-tachycardia pacing and cardioversion therapies, and it is believed most likely that the invention of the present application will be practiced in conjunction with a device in which the choice and order of delivered therapies is programmable by the physician, as in current cardiac pulse generators. In addition to varying the therapy delivered following a failed attempt to terminate a tachyarrhythmia, it is also known that adjustment of detection criteria may be appropriate. For example, adjustment may comprise reducing the number of intervals required to detect a tachyarrhythmia to allow a more rapid redetection or by changing the interval ranges to bias detection towards detection of ventricular fibrillation, for example as disclosed in U.S. Pat. No. 4,971,058, issued to Pless et al and incorporated herein by reference. In the present invention, selection of the particular electrode configuration for delivery of the cardioversion or defibrillation pulses is controlled via output circuit 548, under control of cardioversion/defibrillation control circuitry 554 via control bus 546. Output circuit 548 switches the high voltage electrodes 506 and 508 for delivery of the defibrillation or cardioversion pulse regimen, and may also be used to specify a multi-electrode, simultaneous pulse regimen or a multi-electrode sequential pulse regimen. Monophasic or biphasic pulses may be generated. One example of circuitry which may be used to perform this function is set forth in U.S. Pat. No. 5,163,427, issued to Keimel, incorporated herein by reference. However, output control circuitry as disclosed in U.S. Pat. No. 4,953,551, issued to Mehra et al. or U.S. Pat. No. 4,800,883, issued to Winstrom both incorporated herein by reference, may also be used in the context of the present invention. Alternatively single monophasic pulse regimens employing only a single electrode pair according to any of the above cited references which disclose implantable cardioverters or defibrillators may also be used. Operation of the System of the Present Invention FIG. 3 is an illustration of detection interval ranges which may be employed in a preferred embodiment of the present 'invention. The specific detection interval ranges are selected and programmed by the physician. As seen, events which occur less than 120 milliseconds (hereafter "ms") apart are not detected due to blanking. This is a fixed interval and its length is not programmable by the physician. The range of intervals between detected events taken as indicative of fibrillation are greater than 120 ms and less than 300 ms. That is the fibrillation detection interval (hereafter "FDI") extends to 300 ms. This range is programmed and is selected by the physician to suit the particular patient. The range of intervals between detected events taken as indicative of tachyarrhythmia are greater than 300 ms and less than 450 ms. That is the tachyarrhythmia detection interval (hereafter "TDI") extends to 450 ms. This range is also programmed and is selected by the physician to suit the particular patient. Events having intervals between 450 ms to 923 ms, in the preferred embodiment, are taken as indicative of normal sinus rhythm. That is the brady escape interval (hereafter "BEI") extends to 923 ms. This range is also programmed and is selected by the physician to suit the particular patient. Events which occur at intervals which would be greater than the BEI are taken as indicative of bradycardia. For example, if a first event is sensed and a second event is sensed 200 ms later, ventricular fibrillation is provisionally detected. As a second example, if a first event is sensed and second event occurs 100 ms later and a third event occurs 210 ms after the second event, then a ventricular tachycardia (hereafter "VT") is provisionally detected. This is so because the second event occurred during blanking and thus was not sensed; the third event was thereafter sensed a sum of 320 ms after the first, well within the VT zone. It should be noted that the specific times for intervals is for the preferred embodiment and thus is only illustrative of the present invention. Other interval lengths may also be used within the scope of the present invention. FIG. 4 is an arrhythmia detection/therapy muscle state diagram of the present invention. As discussed above the present invention features skeletal muscle graft stimulation as well as cardiac stimulation. One of the important requirements of such a system, however, is to accurately detect cardiac arrhythmias and respond with the appropriate therapy. As discussed above, concurrent skeletal muscle graft stimulation may interfere with the detection and diagnosis of arrhythmias. Thus, one important feature of the present invention is the manner in which it provides for skeletal muscle graft stimulation as well as cardiac stimulation while also managing the prompt detection and diagnosis of arrhythmias. In particular, the present invention temporarily stops or inhibits skeletal muscle stimulation once the onset of an arrhythmia is sensed. As seen, during normal sinus rhythm the system remains at normal sinus rhythm state 30. In state 30 device provides both skeletal muscle graft stimulation and any bradycardia stimulation required. Bradycardia stimulation may take the form of any suitable electrical stimulation therapy, and preferably is given in the form of VVI pacing, although other types of pacing therapy may be delivered, such as VOO, OVO and WT. Bradycardia stimulation is delivered, in the preferred embodiment, upon the detection of a sequence of cardiac events in which the range of intervals between detected events greater than BEI. If, however, a sequence of cardiac events is detected in which the range of intervals between detected events is less than the TDI, then the skeletal muscle stimulation is inhibited (as represented by line 31) and VT counting mode state 32 is reached. In the preferred embodiment, if only one TDI is detected, then the skeletal muscle stimulation is inhibited and VT counting mode state 32 is reached. While in the VT counting mode state 32, the skeletal muscle stimulation is re-enabled and the device returns to normal sinus rhythm state 30 if one interval greater than the TDI is detected. In addition, when a sequence of cardiac events is detected in which the range of intervals between detected events is less than the FDI, then the skeletal muscle stimulation is inhibited (as represented by line 31) and VF counting mode state 34 is reached. In the preferred embodiment, if only one FDI is detected, then the skeletal muscle stimulation is inhibited and VF counting mode state 34 is reached. While in the VF counting mode state 34, if VT detection is programmed on, the skeletal muscle stimulation is re-enabled and the device returns to normal sinus rhythm state 30 upon the detection of consecutive events with intervals greater than TDI equal to one-third of the number of intervals to detect VF (hereafter "VFNID"). If, however, VT detection is programmed off, the skeletal muscle stimulation is re-enabled and the device returns to normal sinus rhythm state 30 upon the detection of consecutive intervals greater than FDI equal to one-third of VFNID. Of course, if VT detection is programmed off, deliver VT therapy state 36 may still be reached through combined count state 38, discussed below. It should be noted because FDI is smaller than TDI, then when VF counting mode state 34 is reached, this necessarily implies VT counting mode state 32 is also reached. From an electronic circuit design perspective, however, the counting bins for each state are simultaneously active, although both not necessarily registering events at the exact same time. While in VT counting mode state 32 the device counts the number of events which meets the TDI criterion. When the cumulative VT event counter is equal to the number of intervals to detect VT, also called VTNID, then VT detection is fulfilled, deliver VT therapy state 36 is reached and VT therapy is delivered. In the preferred embodiment VTNID is programmable. As discussed in more detail below, VT detection and deliver VT therapy state 36 may also be reached through combined count state 38. While in the VF counting mode state 34 the device counts the number of events which meet the FDI criterion. When the cumulative event counter is equal to VFNID, then VF detection is fulfilled, deliver VF therapy state 40 is reached and VF therapy is delivered. In the preferred embodiment VFNID is programmable. As discussed above, VFNID essentially is the number of past events that must satisfy the FDI criteria to be detected as fibrillation. The count uses past events that have been stored in the fibrillation event buffer memory (located in the RAM 526 of FIG. 2) which include both paced and sensed events. For example, if VFNID is set to 18 and fibrillation event buffer is set to 24; then to detect VF 18 of the last 24 events must satisfy the FDI criteria. As seen, deliver VF therapy state 40 may also be reached combined count state 38. Combined count state 38 is provided to avoid excessive detection times during competing VT and VF counters. Thus combined count state 38 is reached, in the preferred embodiment, when the VF event counter reaches five and the VT event counter plus the VF event counter is greater than or equal to the combined number of intervals to detect parameter (hereafter "CNID"). In the preferred embodiment CNID is not directly programmable, but rather is equal to seven sixths of VFNID. Once the combined count state 38 is reached, then the second look criterion is applied. Second look criterion is used only after combined count state 38 is reached. Second look criterion is applied to determine whether VT or VF therapy should be delivered. In the preferred embodiment second look criterion is as follows: If all of the previous 8 intervals are greater than or equal to FDI, then the VT detected path should be followed and deliver VT therapy state 36 is reached, but if one of the previous 8 intervals is less than FDI, then the VF detected path will be followed and deliver VF therapy state 40 is reached. Once deliver VF therapy state 40 is reached, VF therapy is completed or aborted and VT/VF termination detection state 42 is reached. Similarly once deliver VT therapy state 36 is reached, VT therapy is completed or aborted and VT/VF termination detection state 42 is reached. While in VT/VF termination detection state 42, the device determines whether VT or VF is re-detected. If either VT or VF is detected, then the device returns to the relevant therapy state. If neither VT nor VF is re-detected, the device returns to normal sinus state 30. VT/VF termination detection is accomplished as follows: If VT detection is programmed "Off" and eight consecutive events having intervals greater than FDI are sensed, then VF termination is detected and the device returns to normal sinus state 30. If VT detection is programmed "On" and eight consecutive events having intervals greater than TDI (which by definition is greater than FDI) are sensed, then VT termination is detected and the device returns to normal sinus state 30. As discussed above the present invention also features skeletal muscle stimulation while charging for defibrillation. Essentially this feature provides muscle stimulation pulses to the grafted skeletal muscle while the device is charging a capacitor to deliver a defibrillation pulse. As mentioned above, because the muscle continues to contract and causes cardiac perfusion to be maintained. This cardiac perfusion, in turn, limits the increase in the overall defibrillation threshold. Because the increase in these thresholds is minimized, this permits the device to feature smaller capacitors or lower voltages or both. FIG. 5 is a timing diagram showing the relationship between muscle stimulation, cardiac events and a defibrillation charge cycle. As seen, during normal sinus rhythm, represented here by normal QRS complex 202 the device is in normal sinus state 30. As such, muscle stimulation burst 201 is delivered to stimulate the skeletal muscle graft and thereby provide cardiac assistance, as described above. At first occurrence of a VF event 204 device enters detection state 206. As explained in FIG. 4, during detection state 206 device is in VF counting mode state 34 and VT counting mode state 32. As also explained in FIG. 4 once a VF event 204 is detected all muscle stimulation is inhibited, as may be seen in the lack of any muscle bursts in the region of detection state 206. Once VF is confirmed the device then enters deliver VF therapy state 40. While in deliver VF therapy state 40, device performs several operations, including charging of the output capacitors, depicted as line 208. In addition, skeletal muscle stimulation is re-initiated and a series of asynchronous muscle stimulation bursts 210, 212 are delivered. In the preferred embodiment asynchronous bursts 210, 212 have a greater amplitude than muscle stimulation burst 201, on the order of one and a half times as large. Once charging of the output capacitors is completed, a sequence to synchronize the defibrillation discharge to a sensed R-wave is undertaken. In particular, device begins a synchronization sequence during synchronization time 216. Synchronization sequence is undertaken to synchronize defibrillation discharge to a sensed cardiac event as well as to re-confirm the presence of the arrhythmia. If the synchronization sequence is successful, then defibrillation discharge 214 is delivered synchronized to a sensed cardiac event. If the synchronization sequence is unsuccessful, then defibrillation discharge 214 is delivered at the timing out of synchronization time 216. In addition during synchronization time 216, device re-inhibits skeletal muscle stimulation in order to permit reliable sensing of any intrinsic cardiac events. FIG. 6 is a timing diagram showing the relationship between muscle stimulation and cardiac events of an alternate embodiment. In particular, in an alternate embodiment, if synchronization is unsuccessful, then the device delivers an asynchronous muscle stimulation burst 322 immediately prior to defibrillation discharge 214, as best seen in FIG. 6. Muscle stimulation burst 322 is intended to cause the heart to be squeezed by the skeletal muscle graft and achieve roughly a systolic position when defibrillation discharge 214 is delivered. Because the volume of the heart in such a position is decreased the defibrillation threshold is likewise decreased. Turning again to FIG. 5, once defibrillation discharge 214 is delivered, then device enters into VT/VF termination detection state 42 to thereby confirm heart has returned to normal sinus rhythm. FIG. 7 depicts an alternate muscle stimulation burst which may be used with the present system. These muscle stimulation bursts may be used at any suitable time within the present system, and are not limited to only use prior to delivery of the defibrillation therapy. As seen muscle stimulation burst 300 occurs after QRS 303 in the amount of a synchronization delay 305. In the preferred embodiment synchronization delay 305 is programmable and is undertaken in order to synchronize the muscle stimulation burst 300 with the ventricular contraction. Muscle stimulation burst 300 has essentially two sections, first section 301 and second section 302, often referred to as "muscle catch" and "muscle pulse train" respectively. As seen, first section 301 has a smaller interpulse interval 304 within the burst, i.e. a higher frequency. In comparison second section 302 has a relatively larger interpulse interval 304 within the burst, i.e. a relatively smaller frequency. The higher frequency first section 301 increases the velocity and force of the skeletal muscle graft contraction. In the preferred embodiment interpulse interval 304 and number of pulses in the catch may be selected by the physician. The pulse waveform, amplitude 308 and width of the muscle catch are the same for the remainder of the burst. FIG. 8 depicts an alternate embodiment of the muscle catch stimulation which may be used with the present system. As seen all parameters of the muscle stimulation burst 300 are the same as that described above with respect to FIG. 7 but for the amplitude of second section 302. FIG. 9 depicts an alternate embodiment of the muscle catch stimulation which may be used with the present system. As seen all parameters of the muscle stimulation burst 300 are the same as that described above with respect to FIG. 7 but for the amplitude of second section 302. In particular amplitude of each burst within second section 302 decreases. The rate of decrease of pulse amplitude within each burst decreases as a function of rate, i.e. the faster the rate of muscle stimulation, the greater the decrease of pulse amplitude within the pulse train. As discussed above, the mechanically induced cardiac output augmentation of the present invention during VF (which is associated with loss of cardiac output) leads to maintaining defibrillation thresholds during prolonged episodes of fibrillation, thus resulting in longer battery life or smaller device size or both. It also permits a longer charging interval without the concern of a dangerously low or temporarily lost cardiac output. While the present invention has been described in detail with particular reference to a preferred embodiment, it will be understood variations and modifications can be effected within the scope of the following claims. Such modifications may include substituting elements or components which perform substantially the same function in substantially the same way to achieve substantially the same result for those described herein.

A device and algorithm for a combined cardiomyostimulator and a cardiac pacer-cardioverter-defibrillator. In particular the present device operates, in a first embodiment, to deliver stimulation to a skeletal muscle grafted about a heart; sense depolarizations of a patient's heart; measure the intervals separating successive depolarizations of the patient's heart; define first and second interval ranges; determine the number of the measured intervals falling within the first and second interval ranges; inhibit the delivery of stimulation to a skeletal muscle grafted about a heart upon the sensing of a depolarization within the first or second interval range; detect the occurrence of a first type of arrhythmia when the number of the measured intervals falling within the first interval range equals a first predetermined value; detect the occurrence of a second type of an arrhythmia when the number of the intervals falling within the second interval range equals a second predetermined value; deliver a first type of arrhythmia therapy in response to the detection of the first arrhythmia; and deliver a second type of arrhythmia therapy in response to the detection of the second arrhythmia, the second type of arrhythmia therapy having a cardiac stimulation component and a skeletal muscle component.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of International Patent Application No. PCT/US2014/063473 filed Oct. 31, 2014, which claims the benefit of Provisional Patent Application No. 61/899,106 filed Nov. 1, 2013, both of which are hereby incorporated by reference. FIELD OF THE INVENTION [0002] The invention relates generally to an accommodating intraocular lens device and, more particularly, to an accommodating intraocular lens device configured for implantation in a lens chamber of a subject's eye. BACKGROUND [0003] Surgical procedures on the eye have been on the rise as technological advances permit for sophisticated interventions to address a wide variety of ophthalmic conditions. Patient acceptance has increased over the last twenty years as such procedures have proven to be generally safe and to produce results that significantly improve patient quality of life. [0004] Cataract surgery remains one of the most common surgical procedures, with over 16 million cataract procedures being performed worldwide. It is expected that this number will continue to increase as average life expectancies continue to rise. Cataracts are typically treated by removing the crystalline lens from the eye and implanting an intraocular lens (“IOL”) in its place. As conventional IOL devices are primarily focused for distance visions, they fail to correct for presbyopia and reading glasses are still required. Thus, while patients who undergo a standard IOL implantation no longer experience clouding from cataracts, they are unable to accommodate, or change focus from near to far, from far to near, and to distances in between. [0005] Surgeries to correct refractive errors of the eye have also become extremely common, of which LASIK enjoys substantial popularity with over 700,000 procedures being performed per year. Given the high prevalence of refractive errors and the relative safety and effectiveness of this procedure, more and more people are expected to turn to LASIK or other surgical procedures over conventional eyeglasses or contact lens. Despite the success of LASIK in treating myopia, there remains an unmet need for an effective surgical intervention to correct for presbyopia, which cannot be treated by conventional LASIK procedures. [0006] As nearly every cataract patient also suffers from presbyopia, there is convergence of market demands for the treatment of both these conditions. While there is a general acceptance among physicians and patients of having implantable intraocular lens in the treatment of cataracts, similar procedures to correct for presbyopia represent only 5% of the U.S. cataract market. There is therefore a need to address both ophthalmic cataracts and/or presbyopia in the growing aging population. BRIEF SUMMARY [0007] The intraocular lens (IOL) device described herein generally comprise two lens portions. In a preferred embodiment, a first lens portion provides most, if not all, of the accommodative power and a second base lens provides most, if not all, of the corrective refractive power that is needed by a particular patient. Because the first lens portion must provide an accommodative power, it must respond by either changing shape or by displacement along an optical axis in response to the contraction and relaxation of the ciliary muscles which control the eye's natural ability to accommodate. To that end, the first lens portion may be provided as an elastically deformable lens chamber that is filled with a fluid or gel. In contrast to the elastically deformable lens chamber, the base lens is configured to not readily deform or change its curvature in response to the radially compressive forces exerted on the circumferential edge. The transfer of the radially compressive forces onto the lens chamber may be accomplished by incorporating one or more of the following features in the IOL: (1) the opposing sides of the lens chamber having a reduced thickness as compared to the base lens, (2) a hinge disposed between the base lens and the peripheral portion, (3) the lens chamber being made of a material having a lower Young's modulus than the base lens, and/or (4) the base lens being made of a substantially rigid material. [0008] In one embodiment, an intraocular lens (IOL) device is provided. The IOL comprises a first lens comprising a pair of opposing and deformable surfaces and a cavity defined therebetween, the first lens having a first lens diameter, a second lens having a second lens diameter, and a circumferential haptic having an outer peripheral edge, the circumferential haptic coupling the first lens and the second lens. A main IOL cavity is defined by the circumferential haptic, the first lens and the second lens. The IOL device is resiliently biased to an unaccommodated state being characterized by the IOL device having a first diameter d 1 in the absence of radial compressive forces exerted on the outer peripheral edge. The IOL device actuates to an accommodated state characterized by a second diameter d 2 in response to radial compressive forces exerted on the outer peripheral edge, wherein d 1 >d 2 . [0009] In accordance with a first aspect, the first lens is a biconvex lens. [0010] In accordance with a second aspect, the cavity is fully enclosed. [0011] In accordance with a third aspect, the IOL further comprises a gel in the cavity. The gel preferably has a refractive index of 1.46 or greater, preferably 1.48 or greater and most preferably 1.55 or greater. The gel preferably has a Young's modulus of 10 psi or less, preferably 5 psi or less, and more preferably 1 psi or less. In a particularly preferred embodiment, the gel has a Young's modulus of 0.5 psi or less, preferably 0.25 psi or less, and most preferably 0.01 psi or less. The gel preferably is a highly-branched polymer, preferably cross-linked silicone. [0012] In accordance with a fourth aspect, the second lens is a one of a plano-convex lens, a bi-convex lens and a positive meniscus lens. [0013] In accordance with a fifth aspect, the second lens is substantially more rigid than the first lens. [0014] In accordance with a sixth aspect, the IOL further comprises a hinge disposed between the circumferential haptic and the second lens. In a preferred embodiment, in the presence of the compressive forces on the peripheral edge, the hinge directs a substantial portion of the compressive forces onto the first lens to cause a greater proportionate reduction in the first lens diameter to be reduced proportionately than in the second lens diameter. [0015] In accordance with a seventh aspect, each of the opposing and deformable surfaces of the first lens has a thickness that is 50% or less of the second lens, preferably 25% or less of the second lens, and more preferably, 10% or less of the second lens. [0016] In accordance with an eighth aspect, the IOL further comprises one or both of a plurality of apertures disposed on the circumferential haptic and a circumferential channel defined within the circumferential haptic. The plurality of apertures may be in fluid communication with the main IOL cavity. The plurality of apertures may be in fluid communication with both the circumferential channel and the main IOL cavity. [0017] In accordance with a ninth aspect, the IOL device further comprises a plurality of raised bumps, wherein at least one of the plurality of raised bumps is positioned adjacent to each one of the plurality of apertures. [0018] In accordance with a tenth aspect, the IOL device further comprises a plurality of troughs, at least one of the plurality of troughs extending radially inward from each one of the plurality of apertures to facilitate fluid flow into the apertures. [0019] In accordance with an eleventh aspect, the circumferential haptic comprises a plurality of radial arms coupling the second lens, the plurality of radial arms defining apertures therebetween to permit fluid communication with the main cavity. [0020] In accordance with a twelfth aspect, the circumferential haptic comprises a third circumferential cavity disposed peripherally of the main IOL cavity. [0021] In accordance with a thirteenth aspect, the opposing surfaces of the first lens are displaced away from each other upon the application of a radial force along the circumferential haptic. The opposing surfaces comprises central and peripheral regions and a gradually increasing thickness profile from the peripheral to the central regions. [0022] In another embodiment, an IOL is provided. The IOL comprises a first lens made of an elastic and deformable material having a first Young's modulus, a second lens in spaced relation to the first lens along a central optical axis and a circumferential portion encircling the first and second lens, the circumferential portion comprising an outer peripheral edge. At least one of a portion of the second lens and a portion of the circumferential portion is made of a material having a second Young's modulus. The first Young's modulus is less than the second Young's modulus. [0023] In accordance with a first aspect, only the second lens is made of the material having the second Young's modulus. [0024] In accordance with a second aspect, only the portion of the circumferential portion is made of the material having the second Young's modulus. [0025] In accordance with a third aspect, the first Young's modulus is about 100 psi or less. [0026] In accordance with a fourth aspect, the second Young's modulus is about 100 psi or greater. [0027] In accordance with a fifth aspect, the second Young's modulus is about 150 psi or greater. [0028] In accordance with a sixth aspect, the first lens comprises a pair of opposing and deformable surfaces and a cavity defined therebetween, the first lens having a first lens diameter and wherein a main IOL cavity is defined between the first lens, the second lens and the circumferential portion. [0029] In accordance with a seventh aspect, the IOL further comprises a hinge disposed on the second lens outside of the active optical area. [0030] In accordance with an eighth aspect, the first lens is comprised of two opposing surfaces which are displaced away from each other upon the application of a radial force along a peripheral edge. The two opposing surfaces each having central and peripheral regions, wherein the central region has a thickness that is at least 2 times, preferably at least three times, and most preferably at least four times greater than a thickness of the peripheral region. [0031] In a further embodiment, an IOL is provided. The IOL comprises a first lens, a second lens in spaced relation to the first lens and a circumferential haptic coupling the first and second lens. The first lens comprises opposing sides and an enclosed cavity between the opposing sides. The opposing sides each have central and peripheral regions, the central region being disposed around an optical axis, the peripheral region being disposed around the central region. The central region is at least two times thicker than the peripheral region. The second lens in spaced relation to the first lens, the second lens having a thickness that is greater than either one of the opposing sides of the first lens. A circumferential haptic has an outer peripheral edge configured for engagement with a capsular bag of an eye when the IOL is implanted. A main IOL cavity is defined by the circumferential haptic, the first lens and the second lens. [0032] In accordance with a first aspect, the central region is at least three times thicker than the peripheral region. [0033] In accordance with a second aspect, the central region is at least four times thicker than the peripheral region. [0034] In accordance with a third aspect, the enclosed cavity of the first lens comprises a gel having a first refractive index. [0035] In accordance with a fourth aspect, the opposing sides of the first lens has a second refractive index that is less than the first refractive index of the gel. [0036] In accordance with a fifth aspect, the gel is a vinyl-terminated phenyl siloxane. [0037] In accordance with a sixth aspect, the gel has a Young's modulus of 0.25 psi or less, preferably 0.01 psi or less. [0038] Other objects, features and advantages of the described preferred embodiments will become apparent to those skilled in the art from the following detailed description. It is to be understood, however, that the detailed description and specific examples, while indicating preferred embodiments of the present invention, are given by way of illustration and not limitation. Many changes and modifications within the scope of the present invention may be made without departing from the spirit thereof, and the invention includes all such modifications. BRIEF DESCRIPTION OF THE DRAWINGS [0039] Illustrative embodiments of the present disclosure are described herein with reference to the accompanying drawings, in which: [0040] FIGS. 1A-1B are perspective and side cross-sectional views, respectively, of an embodiment of a dual-cavity IOL device. [0041] FIG. 2 is a perspective cross-sectional view of another embodiment of a dual-cavity IOL device having holes disposed on the top surface. [0042] FIGS. 3A-3B are front and perspective cross-sectional views of another embodiment of a dual-cavity IOL device having through-holes disposed through the top and bottom surfaces in communication with the main cavity. [0043] FIG. 4 is a perspective cross-sectional view of another embodiment of a dual-cavity IOL device having through-holes disposed through the top and bottom surfaces and which are not in fluid communication with the main cavity. [0044] FIGS. 5A-5B are perspective cross-sectional views of another embodiment of a dual-cavity IOL device comprising arc-shaped cutouts on the bottom surface to provide a fluid communication with the main cavity. [0045] FIGS. 6A-6B are perspective cross-sectional and rear views of another embodiment of a dual-cavity IOL device comprising arch-shaped cutouts on the bottom surface and a plurality of peripheral through holes in communication with a circumferential channel. [0046] FIG. 7A-7B are top perspective and cross-sectional views of another embodiment of a dual-cavity IOL device comprising a plurality of raised protrusions adjacent through-holes which are in communication with the main cavity and circumferential channel. [0047] FIG. 8A-8B are top perspective and cross-sectional views of another embodiment of a dual-cavity IOL device comprising a plurality of troughs adjacent through-holes which are in communication with the main cavity and circumferential channel. [0048] FIG. 9 is a partial cross-sectional view of an embodiment of the IOL device, cut away along the optical axis A-A. [0049] FIGS. 10A-10B are cross-sectional views of further embodiments of the IOL device. [0050] FIG. 11A depicts the human eye with the lens material removed following a capsulorhexis. [0051] FIGS. 11B-11C depict the implanted IOL device in the unaccommodated and accommodated states, respectively. [0052] Like numerals refer to like parts throughout the several views of the drawings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0053] Specific, non-limiting embodiments of the present invention will now be described with reference to the drawings. It should be understood that such embodiments are by way of example and are merely illustrative of but a small number of embodiments within the scope of the present invention. Various changes and modifications obvious to one skilled in the art to which the present invention pertains are deemed to be within the spirit, scope and contemplation of the present invention as further defined in the appended claims. [0054] FIGS. 1A-1B depicts a basic structure of an embodiment of the accommodating intraocular lens (IOL) 100 . The IOL 100 is depicted as comprising an elastically deformable lens chamber 110 , a base lens 150 , and a lens periphery 170 coupling the lens chamber 110 and the base lens 150 . The elastically deformable lens chamber 110 provides most, if not all, of the accommodative power by deforming or changing in curvature in response to the radially compressive forces that are exerted onto the IOL 100 during accommodation. The base lens 150 provides most, if not all, of the corrective refractive power that is required by a particular patient and is not required to deform or change in shape or curvature. Thus, the lens chamber 110 and the base lens 150 cooperate to restore both a patient's vision and natural range of accommodation. [0055] The lens chamber 110 is made of an elastically deformable material and comprises opposing sides 112 and 114 that are joined together at the periphery of the lens chamber 110 to define a bi-convex exterior shape and an internal enclosed cavity 120 . Each of the opposing sides 112 and 114 comprise a central region 112 a , 114 a and a peripheral region 112 b , 114 b and a gradient of thickness that increases radially from the peripheral region 112 b , 114 b to the central region 112 a , 114 a . This thickness profile is intended to encourage deformation of the opposing sides 112 , 114 away from one another and to permit the opposing sides to bulge and increase its curvature in opposing directions along an optical axis A-A without causing the membrane to buckle about the central region 112 a , 114 a . Thus, while the conventional wisdom suggests that a greater degree of deformation and outward bulging would be achieved with the opposite thickness profile (e.g., a thickness profile that decreases radially from the peripheral region 112 b , 114 b to the central region 112 a , 114 a ), such a thickness profile is more likely to cause the lens chamber 110 to buckle or collapse inwardly about the central region 112 a , 114 a upon the application of a radially compressive force once implanted in a patient's eye. During accommodation, the application of radially compressive forces may cause an internal vacuum to develop inside the lens chamber 110 , thereby causing the opposing sides 112 , 114 to buckle inwardly. [0056] Thus, in a particularly preferred embodiment, the opposing sides have a gradually increasing thickness from the peripheral regions 112 b , 114 b , to the central region 112 a , 114 a . In a preferred embodiment, the central region 112 a , 114 a , as measured along the optical axis A-A, has a thickness that is two times or more, preferably three times or more, and most preferably four times or more than the thickness of the peripheral region 112 b , 114 b , as measured just adjacent to the area where the opposing sides 112 , 114 join at the peripheral region. In another preferred embodiment, the point of greatest thickness in the central region 112 a , 114 a and the point of least thickness in the peripheral regions 112 b , 114 b is characterized as having a thickness ratio of 2:1 or greater, preferably 3:1 or greater, and most preferably 4:1 or greater. In one embodiment, the central region 112 a , 114 a , as measured along the optical axis A-A, comprises an area of thickness that is about 100 microns, preferably about 200 microns, and the peripheral region 112 b , 114 b comprises an area of thickness that is about 50 microns as measured just adjacent to the area where the opposing sides 112 , 114 join at the peripheral region. While the thickness profile is described in relation to FIGS. 1A-1B , it is understood that the same or a substantially similar thickness profile may be provided for all of the IOL devices depicted and described herein. [0057] The base lens 150 is coupled to the lens chamber 110 via a lens periphery 170 . The base lens 150 may be a positive lens that provides convergent power, such as a bi-convex, plano-convex or a positive meniscus lens. Alternatively, the base lens 150 may be a negative lens that provides divergent power, such as a bi-concave, plano-concave or a negative meniscus lens. The base lens 150 depicted in FIGS. 1A-1B is a positive meniscus lens. [0058] The base lens 150 is preferably more rigid than the opposing sides 112 , 114 of the lens chamber 110 . The greater rigidity may be imparted by providing a base lens 150 having a thickness that is significantly greater than the thicknesses of the opposing sides 112 , 114 of the lens chamber 110 . Alternatively or in addition to providing a greater thickness, the base lens 150 may be made of a different or stiffer material having a higher elastic Young's modulus as compared to the lens chamber 110 . The base lens 150 preferably does not substantially change its shape and curvature in response to the radially-compressive accommodative force applied onto the peripheral edge 180 of the lens periphery 170 . Instead, the radially compressive accommodative forces are transferred onto the lens chamber 110 to cause the desired deforming changes. [0059] In a preferred embodiment, the base lens 150 is substantially thicker than one of the opposing sides 112 , 114 of the lens chamber 110 , as measured along the optical axis A-A. In a preferred embodiment, the thickness of each one of the opposing sides 112 , 114 of the lens chamber 110 , as along the optical axis A-A depicted in FIGS. 1A-1B and 9 , is less than ½, preferably less than ⅓, preferably less than ¼, and most preferably less than ⅕ of the thickness of the base lens 150 at the central optical axis A-A. Because the base lens 150 is substantially thicker than either one of the opposing sides 112 , 114 of the lens chamber 110 , the base lens 150 has an effective Young's modulus that is substantially greater than either one of the opposing sides 112 , 114 of the lens chamber 110 . While FIGS. 1A-1B and 9 depict the relative thickness of the opposing sides 112 , 114 of the lens chamber 110 and the base lens 150 for IOL 100 , it is understood that all of the IOL devices disclosed herein may have the same or similar thickness profile with respect to the lens chamber 110 and the base lens 150 . [0060] The lens chamber 110 and the base lens 150 are coupled together by a lens periphery 170 . The lens periphery 170 comprises a circumferential edge 180 configured to engage a circumferential region of the capsular bag of the eye. As depicted in FIGS. 11A-11C , the circumferential region 52 is where the capsular bag 40 is coupled to the zonules 50 , generally at a location where the density of the zonules 50 is the greatest. The zonules 50 , in turn, couple the capsular bag 40 to the ciliary muscles 60 which contract and relax to provide a range of accommodation. While FIGS. 11B and 11C depict a particularly preferred embodiment in which an IOL 100 is implanted with the lens chamber 110 being oriented anteriorly within the lens capsule 40 of the eye, it is understood that the IOL 100 may also be implanted with the lens chamber 110 being oriented posteriorly within the lens capsule 40 of the eye. [0061] The lens periphery 170 comprises a radial portion 172 and a circumferential hinge 174 that cooperate together to transmit a significant portion, if not most, of the radially compressive forces exerted onto the circumferential edge 180 onto the lens chamber 110 and away from the base lens 150 . Referring back to FIGS. 1A-1B , the radial portion 172 extends radially inwardly from the lens periphery 170 to the lens chamber 110 and the hinge 174 is disposed between the lens periphery 170 and the base lens 150 . Both the radial portion 172 and the hinge 174 cooperate to maximize the extent to which the radially-compressive accommodative forces applied to the peripheral edge 180 are transmitted to the lens chamber 110 . The greater the force transmitted to the lens chamber 110 , the greater the deformation and change of curvature of the opposing sides 112 , 114 of the lens chamber 110 . [0062] The lens periphery 170 may be solid and thickened as compared to the base lens 150 , as depicted in FIGS. 1A-1B and 9 . Alternatively, the lens periphery 170 may comprise a hollow space or a circumferential channel to reduce the delivery profile of the IOL, as depicted in FIGS. 2, 3A, 3B, 4, 6, 7, and 8 . Because the IOL 100 is implanted into a relatively small incision size, it must be rolled up to assume a delivery profile that is at least as small as the incision size. [0063] The circumferential hinge 174 is provided as a thinned or grooved area disposed in the lens periphery 170 and surrounding the base lens 150 . The circumferential hinge 174 permits the lens periphery 170 to pivot radially inwardly towards the lens chamber 110 such that the radially compressive forces applied to the circumferential edge 180 are directed substantially along the radial portion 172 and applied to the lens chamber 110 , as opposed to being applied to the base lens 150 , which is configured to generally resist deformation (See FIG. 11C ). Thus, the radial portion 172 is itself preferably sufficiently rigid in order to substantially transmit the radial compressive force onto the lens chamber 110 . In a preferred embodiment, the hinge 174 is provided both peripherally and circumferentially around the base lens 150 as a thinned area or as a groove. [0064] FIGS. 11B and 11C depicts the configuration of the IOL 100 in the absence of a radial compressive force applied to the circumferential peripheral edge 180 ( FIG. 11B , an unaccommodated eye) and in the presence of a radial compressive force applied to the circumferential peripheral edge 180 ( FIG. 11C , an accommodated eye) in which the peripheral edge 180 tilts in the direction C about the hinge 174 , transmitting the radial compressive forces onto the lens chamber 110 , and thereby causing the opposing sides 112 , 114 of the lens chamber 110 to be displaced apart from one another and increase in curvature. [0065] The features described herein which are intended to maximize the extent to which the radially compressive forces are transmitted to a lens chamber 110 and thus provide a large range of accommodation. The IOLs described herein may further be made of a material that does not resist deformation or is characterized as having a low Young's modulus. The IOLs may be made of a single material or, alternatively, different portions of the IOL may be made of different materials having differing Young's modulus (see FIGS. 10A-10B ). [0066] In one preferred embodiment, at least the opposing sides 112 , 114 of the lens chamber 110 is made of a material of sufficient mechanical strength to withstand physical manipulation during implantation, but is of sufficiently low Young's modulus so as to minimize its resistance to deformation. In a preferred embodiment, the opposing sides 112 , 114 of the lens chamber 110 is made of a polymer having a Young's modulus of 100 psi or less, preferably 75 psi or less, and most preferably 50 psi or less. In one preferred embodiment, the remaining portions of the IOL 100 (e.g., the base lens 150 , the peripheral portion 170 ) has a Young's modulus that is greater than the Young's modulus of the walls 112 , 114 , of the lens chamber 110 . The walls 112 , 114 of the lens chamber 110 may be a polymer, preferably a silicone polymer and, more preferably a phenyl siloxane, such as a vinyl-terminated phenyl siloxane or a vinyl-terminated diphenyl siloxane. In order to impart sufficient mechanical strength, the polymer may be crosslinked, reinforced with fillers, or both. The fillers may be a resin or silica that have been functionalized to react with the polymer. [0067] The opposing sides 112 , 114 of the lens chamber 110 defines an enclosed cavity 120 that is filled with a fluid or gel having specific physical and chemical characteristics to enhance the range of refractive power provided by the IOL during accommodation. The fluid or gel is selected such that it cooperates with the walls 112 , 114 of the lens chamber 110 in providing a sufficient range of accommodation of up to at least 3 diopters, preferably up to at least 5 diopters, preferably up to at least 10 diopters and most preferably up to at least 15 diopters. In a preferred embodiment, the enclosed cavity 120 is filled with the fluid or gel before implantation of the IOL 100 into the capsular bag 40 of the eye and, in a more preferred embodiment, the cavity 120 is filled with the fluid or gel in the manufacture of the IOL 100 . [0068] In one preferred embodiment the enclosed cavity 120 is filled with a fluid, such as a gas or a liquid, having low viscosity at room temperature and a high refractive index. In a preferred embodiment, the fluid is a liquid having a viscosity of 1,000 cP or less at 23° C. and a refractive index of at least 1.46, 1.47, 1.48, or 1.49. The fluid may be a polymer, preferably a silicone polymer, and more preferably a phenyl siloxane polymer, such as a vinyl-terminated phenyl siloxane polymer or a vinyl-terminated diphenyl siloxane polymer. Preferably, in embodiments where the fluid is made of a polymer, the polymer is preferably not crosslinked and that the polymer may be linear or branched. Where the fluid is a vinyl-terminated phenyl siloxane polymer or diphenyl siloxane polymer, the vinyl groups may be reacted to form other moieties that do not form crosslinkages. [0069] In accordance with one embodiment, fluid may be a polyphenyl ether (“PPE”), as described in U.S. Pat. No. 7,256,943, entitled “Variable Focus Liquid-Filled Lens Using Polyphenyl Ethers” to Teledyne Licensing, LLC, the entire contents of which are incorporated herein by reference as if set forth fully herein. [0070] In accordance with another embodiment, the fluid may be a fluorinated polyphenyl ether (“FPPE”). FPPE has the unique advantage of providing tunability of the refractive index while being a chemically inert, biocompatible fluid with low permeability in many polymers. The tunability is provided by the increasing or decreasing the phenyl and fluoro content of the polymer. Increasing the phenyl content will effectively increase the refractive index of the FPPE, whereas increasing the fluoro content will decrease the refractive index of the FPPE while decreasing the permeability of the FPPE fluid through the walls 112 , 114 of the lens chamber 110 . [0071] In another preferred embodiment, the enclosed cavity 120 is filled with a gel. The gel preferably has a refractive index of at least 1.46, 1.47, 1.48, or 1.49. The gel may also preferably have a young's modulus of 20 psi or less, 10 psi or less, 4 psi or less, 1 psi or less, 0.5 psi or less, 0.25 psi or less and 0.01 psi or less. In a preferred embodiment, the gel is a crosslinked polymer, preferably a crosslinked silicone polymer, and more preferably a crosslinked phenyl siloxane polymer, such a crosslinked vinyl-terminated phenyl siloxane polymer or a vinyl-terminated diphenylsiloxane polymer. Other optically clear polymer liquids or gels, in addition to siloxane polymers, may be used to fill the cavity 120 and such polymers may be branched, unbranched, crosslinked or uncrosslinked or any combination of the foregoing. [0072] A gel has the advantages of being extended in molecular weight from being crosslinked, more self-adherent and also adherent to the walls or opposing sides or walls 112 , 114 of the lens chamber 110 than most liquids. This makes a gel less likely to leak through the walls 112 , 114 of the lens chamber 110 . In order to obtain the combination of accommodative power with relatively small deformations in the curvature of the walls 112 , 114 of the lens chamber 110 , the gel is selected so as to have a high refractive index while being made of an optically clear material that is characterized as having a low Young's modulus. Thus, in a preferred embodiment, the gel has a refractive index of 1.46 or greater, preferably 1.47 or greater, 1.48 or greater and most preferably 1.49 or greater. At the same time, the gel preferably has a Young's modulus of 10 psi or less, preferably 5 psi or less, and more preferably 1 psi or less. In a particularly preferred embodiment, the gel has a Young's modulus of 0.5 psi or less, preferably 0.25 psi or less, and most preferably 0.01 psi or less. It is understood that at lower Young's modulus, the gel will present less resistance to deformation and thus the greater the deformation of the walls 112 , 114 of the lens chamber 110 for a given unit of applied force. [0073] In particularly preferred embodiment, the gel is a vinyl-terminated phenyl siloxane that is produced based on one of the four formulas provided as follows: [0074] Formula 1: 100 parts 20-25 mole % vinyl terminated diphenylsiloxane-dimethylsiloxane copolymer (Gelest PDV 2335). 3 ppm platinum complex catalyst 0.35 pph of phenyl siloxane hydride crosslinker (Nusil XL-106) Young's modulus of elasticity=0.0033 psi [0079] Formula 2: 100 parts 20-25 mole % vinyl terminated diphenylsiloxane-dimethylsiloxane copolymer (Gelest PDV 2335). 3 ppm platinum complex catalyst 0.4 pph of phenyl siloxane hydride crosslinker (Nusil XL-106) Young's modulus of elasticity=0.0086 psi [0084] Formula 3: 100 parts 20-25 mole % vinyl terminated diphenylsiloxane-dimethylsiloxane copolymer (Gelest PDV 2335). 3 ppm platinum complex catalyst 0.5 pph of phenyl siloxane hydride crosslinker (Nusil XL-106) Young's modulus of elasticity=0.0840 psi [0089] Formula 4: 100 parts 20-25 mole % vinyl terminated diphenylsiloxane-dimethylsiloxane copolymer (Gelest PDV 2335). 3 ppm platinum complex catalyst 0.6 pph of phenyl siloxane hydride crosslinker (Nusil XL-106) Young's modulus of elasticity=2.6 psi [0094] The walls 112 , 114 of the lens chamber 110 and the fluid or gel contained within the lens cavity 120 are preferably selected so as to prevent or reduce the likelihood of the fluid or gel migrating outside of the walls 112 , 114 of the lens chamber 110 . Thus, in a preferred embodiment, one or both of the walls 112 , 114 of the lens chamber 110 and the fluid or gel is/are selected from biocompatible materials that optimize the resistance to permeability of the fluid or gel across the walls 112 , 114 of the lens chamber 110 . [0095] One method of decreasing the permeability of the gel contained inside the cavity 120 across the walls 112 , 114 of the lens chamber 110 is to provide a gel that is cross-linked. The degree of cross-linking, however, must be selected and controlled such that, on the one hand, the walls 112 , 114 of the lens chamber 110 and the gel have a sufficiently low Young's modulus to minimize the resistance of the walls 112 , 114 of the lens chamber 110 to deformation and, on the other hand, to minimize the permeation of the gel across the walls 112 , 114 of the lens chamber 110 . Thus, in a preferred embodiment, longer chain polymers that are lightly cross-linked, such as those used for silicone gels, starting with monomers having molecular weights that are greater than 35,000 daltons, preferably greater than 50,000 daltons and, most preferably, at least 70,000 daltons are desired. [0096] In another preferred embodiment, a gel is used having low permeability extractables. Such gels may be formulated by using long chain polymers that are branched. [0097] In a preferred embodiment, one or both of the lens chamber walls 112 , 114 and the gel is made of homo- or co-polymers of phenyl-substituted silicones. [0098] For the lens chamber walls 112 , 114 , the crosslinked homo- or co-polymers preferably have a diphenyl content of 5-25 mol %, preferably 10-20 mol % and more preferably 15-18 mol %. Alternatively, for the lens chamber walls 112 , 114 , the homo- or co-polymers preferably have a phenyl content of 10-50 mol %, preferably 20-40 mol %, and more preferably 30-36 mol %. [0099] For the gel, the homo- or co-polymers preferably have a diphenyl content of 10-35 mol %, preferably 15-30 mol % and more preferably 20-25 mol %. Alternatively, for the gel, the homo- or co-polymers preferably have a phenyl content of 20-70 mol %, preferably 30-60 mol % and more preferably 40-50 mol %. [0100] In a particularly preferred embodiment, the lens chamber walls 112 , 114 are made of a crosslinked phenyl siloxane having a diphenyl content of about 15-18 mol % or a phenyl content of about 30-36 mol % and the gel is made of a phenyl siloxane having a diphenyl content of about 20-25 mol % or a phenyl content of about 40-50 mol %. The lens chamber walls 112 , 114 are understood to be more crosslinked than the gel. [0101] In a particularly preferred embodiment, the lens chamber walls 112 , 114 are made of a vinyl-terminated phenyl siloxane, most preferably a crosslinked vinyl-terminated phenyl siloxane. Reinforcing agents, such as silica, may also be included in a range 10-70 mol %, preferably 20-60 mol % and most preferably 30-50 mol %. [0102] The walls 112 , 114 of the lens chamber 110 and the fluid or gel contained within the lens cavity 120 are also preferably selected so as to increase the range of accommodative power that is provided by the lens chamber 110 . In one preferred embodiment, the walls 112 , 114 of the lens chamber 110 are made of a material having a lower refractive index than the fluid or gel contained in the enclosed cavity. In one preferred embodiment, the refractive index of the lens walls 112 , 114 of the chamber 110 is 1.38 and the refractive index of the gel or fluid is 1.49. [0103] The differential refractive indices provided by the lens chamber walls 112 , 114 and the gel or liquid contained within the chamber 120 may be provided by the differences in the materials or the composition of the materials used for the lens chamber walls 112 , 114 and the gel or liquid. [0104] In one embodiment, both the lens chamber walls 112 , 114 and the gel or liquid is made of a phenyl siloxane having different diphenyl or phenyl content. In a preferred embodiment, the lens chamber walls 112 , 114 has a diphenyl or phenyl content that is less than that for the gel or liquid. In another preferred embodiment, the walls 112 , 114 of the lens chamber 110 may be made of a cross-linked vinyl-terminated phenyl siloxane having a diphenyl content of 15-18 mol % or a phenyl content of 30-36 mol % and the gel contained within the walls 112 , 114 of the lens chamber 110 may be made of a vinyl-terminated phenyl-siloxane having a diphenyl content of 20-25 mol % or a phenyl content of 30-36 mol %. [0105] In another embodiment, the differential refractive indices may be provided by providing a dimethyl siloxane for the lens chamber walls 112 , 114 and the gel may be a phenyl siloxane having a high diphenyl or phenyl content. In a preferred embodiment, the diphenyl content is at least 20 mol %, at least 25 mol %, at least 30 mol %, at least 35 mol %, and at least 40 mol %. Alternatively, the phenyl content is at least 40 mol %, at least 50 mol %, at least 60 mol %, at least 70 mol %, and at least 80 mol %. [0106] In a further embodiment, the differential refractive indices may be provided by a crosslinked fluoro siloxane, such as a 3,3,3-trifluoropropylmethyl siloxane and the gel may be a phenyl siloxane having a high diphenyl or phenyl content. In a preferred embodiment, the diphenyl content is at least 20 mol %, at least 25 mol %, at least 30 mol %, at least 35 mol %, and at least 40 mol %. Alternatively, the phenyl content is at least 40 mol %, at least 50 mol %, at least 60 mol %, at least 70 mol %, and at least 80 mol %. [0107] Now turning back to FIGS. 1A-1B , a main cavity 130 is defined between the lens chamber 110 , the base lens 150 and the lens periphery 170 . The main cavity 130 is preferably filled with a fluid or gel. The fluid or gel in the main cavity 130 may be the same as the fluid or gel contained in the enclosed cavity 120 . In a preferred embodiment, the fluid is a saline solution and the main cavity 130 is filled with the saline solution after implantation of the IOL in the capsular bag of the eye. [0108] Filling the main cavity 130 after implantation of the IOL into the capsular bag will permit the IOL to take on a significantly smaller delivery profile such that the IOL may be rolled up and inserted through a relatively small incision. In a preferred embodiment, the incision size is less than 6 mm, preferably less than 5 mm, most preferably less than 4 mm and even most preferably less than 3 mm. [0109] In embodiments where the main cavity 130 is filled with a fluid or gel after implantation, a valve (not shown) is preferably disposed on the IOL to permit injection of the fluid or gel into the main cavity 130 after implantation. The valve may be a one-way valve that permits injection of fluid or gel into the main cavity 130 but prevents the fluid or gel from exiting the main cavity 130 . The valve is preferably disposed on the surface of the IOL that is facing in the anterior direction after it has been implanted in the eye. It is understood that the valve, however, is preferably not disposed on either one of the opposing sides 112 , 114 so as to avoid disrupting the integrity of the lens chamber 110 which may house the same of different fluid or gel. [0110] In a preferred embodiment, the fluids or gels in the respective enclosed cavity 120 and the main cavity 130 are completely segregated from one another. In one preferred embodiment, the enclosed cavity 120 and the main cavity 130 may have a different fluid and/or gel. In another preferred embodiment, one of the enclosed cavity 120 and the main cavity 130 may comprise one of a fluid or gel and the other one of the enclosed cavity 120 and the main cavity 130 may comprise the other one of a fluid or gel. In a preferred embodiment, there is no fluid exchanged between the enclosed cavity 120 and the main cavity 130 . [0111] The IOL 100 is intended to be implanted in a capsular bag 40 of the eye and centered about an optical axis A-A (See FIGS. 11A-11C ). The lens chamber 110 and the base lens 150 are dimensioned to extend to or beyond the effective optical zone B-B as defined about the optical axis A-A of a patient's eye. The effective optical zone B-B is generally the largest possible opening through which light can enter the eye and thus is controlled by the largest effective diameter of the pupil 30 when completely dilated. This diameter is typically about 4-9 mm. Therefore, in a preferred embodiment, the diameters of the lens chamber 110 and the base lens 150 is preferably at least 4 mm, at least 5 mm, at least 6 mm, at least 7 mm, at least 8 mm and at least 9 mm. [0112] As previously indicated, either one or both of the enclosed cavity 120 of the lens chamber 110 and/or the main cavity 130 is/are filled with a fluid or gel. The fluid may be a gas, a liquid. The fluid or gel preferably is characterized as having a sufficiently high refractive index such that the lens chamber 110 provides a range of accommodation in response to small changes in the curvature of the opposing sides 112 , 114 . [0113] Because the IOL 100 is resiliently biased such that the opposing sides 112 , 114 of the lens chamber 110 are substantially flat or have minimal curvature, small changes in the curvature of the opposing sides 112 , 114 will lead to proportionately greater changes in the refractive power of the lens. Thus, the lens chamber 110 , in combination with the base lens 150 , can provide a change in the optical power of up to at least 3 diopters, preferably up to at least 5 diopters, preferably up to at least 10 diopters and most preferably up to 15 diopters in response to the accommodative forces (e.g., radially compressive forces) exerted on the implanted IOL. [0114] FIG. 2 depicts another embodiment of the IOL 200 . The IOL 200 is similar in many respects with the IOL 100 of FIGS. 1A-1B in that it comprises a lens chamber 210 , a base lens 250 and a lens periphery 270 joining the lens chamber 210 and the base lens 250 . The lens periphery 270 further comprises a circumferential edge 280 . The IOL 200 differs from IOL 100 in that IOL 200 comprises a plurality of holes 202 disposed circumferentially along the top surface of the IOL 200 and externally around the lens chamber 210 and a circumferential channel 240 disposed within the lens periphery 270 . The holes 202 are intended to provide a fluid exchange channel between the circumferential channel 240 , the main cavity 230 and the exterior of the IOL 200 . The accommodative forces of the eye's capsular bag will cause the IOL 200 to radially expand and compress which, in turn, will cause the aqueous fluid to enter and exit the main cavity 230 through the holes 202 . In a preferred embodiment, the holes 202 are disposed symmetrically about the top surface of the IOL 200 . [0115] FIGS. 3A-3B depict another embodiment of the IOL 300 which comprises a plurality of through-holes 302 around the circumferential periphery of the IOL 300 . The through-holes 302 differ from the holes 202 in FIG. 2 in that the through-holes are provided through both sides of the IOL 300 and the IOL 300 does not comprise a circumferential channel, whereas the holes 202 of the IOL 200 of FIG. 2 are only provided on the top surface of the IOL 200 . The provision of through-holes 302 increase the efficiency with which the aqueous fluid fills and exits the main cavity 330 . [0116] Moreover, the through-holes 302 are dimensioned to be as large as can fit between the space between the circumferential edge 380 and the lens chamber 310 . One advantage in the provision of numerous large through-holes 302 about the circumferential periphery is that it reduces the material bulk of the IOL 300 and permits it to take on a smaller delivery profile when it is folded and inserted into the capsular bag of the eye during implantation surgery. Thus, the IOL 300 will require a smaller incision for implantation into the capsular bag of the eye. It is understood, however, that the spacing 301 between the through-holes 302 must be sufficient to permit the transfer of force applied to the circumferential edge 380 onto the lens chamber 310 . In a preferred embodiment, the spacing 301 is no more than ¼, preferably no more than ½, and most preferably no more than ¾ of the diameter of the through-holes 302 . [0117] FIG. 4 depicts another embodiment of the IOL 400 also comprising through-holes 402 , except that the through-holes 402 do not provide a fluid exchange between the main cavity 430 and the exterior of the IOL 400 . The IOL 400 is thus similar to the IOL 100 of FIGS. 1A-1B in that a valve is required such that the main cavity 430 of the IOL 400 may be filled after implantation into the capsular bag of the eye. The main function of the through-holes 402 in this embodiment is to reduce the bulk of the IOL 400 so as to provide a smaller delivery profile. Thus, once implanted, the fluid or gel in the lens cavity 420 and the main cavity 430 remain contained and the IOL 400 does not permit for fluid exchange between the fluid in the exterior of the IOL 400 and the fluid or gel in the main cavity 430 . FIG. 4 differs from the IOLs depicted in the preceding figures ( FIGS. 1-3 ) in that it depicts the shape of the IOL 400 when a radial force is applied to the peripheral edge so as to cause a the opposing sides of the cavity 420 to bulge apart from one another. It is noted that the IOL 400 must be dimensioned such that the lower wall of the lens cavity 420 does not contact the base lens 450 within a range of the radial force that would be expected during the accommodation of the eye. [0118] FIGS. 5A-5B depict yet a further embodiment of the IOL 500 which comprises a plurality of arc-shaped cutouts 502 . The arc-shaped cutouts 502 are configured to function to provide a fluid exchange between the main cavity 530 and the exterior of the IOL 500 . The IOL 500 comprises radial arms 504 between the arc-shaped cutouts 502 to couple and support the base lens 550 to the lens periphery 570 . In a preferred embodiment, the radial arms 504 comprise a hinge between the peripheral portion 570 and the base lens 550 that permits the radial arms 504 to bend or rock inwardly upon application of a force upon the circumferential edge 580 so that the force is transferred to radially compressing the lens chamber 510 . The hinge may simply be a groove or an area of reduced material thickness that is disposed either on the internal, external or both internal and external surfaces of the radial arms 504 . As with the other IOLs described herein, the IOL 500 returns to a radially-expanded state in the absence of a force applied upon the circumferential edge 580 . The IOL 500 is resiliently biased to a flatter configuration as shown in FIG. 5A in the absence of radially-compressive forces being exerted on the circumferential edge 580 , as when the eye is unaccommodated. The IOL 500 is radially compressible to reduce the overall diameter of the lens chamber 110 and thus cause opposing sides 512 , 514 of the lens chamber 510 to increase its curvature upon the application of a radially compressing force onto the circumferential edge 580 , as when the eye is accommodated. See, e.g., FIG. 4 . [0119] FIGS. 6A-6B depicts yet a further embodiment of the IOL 600 which comprises an internal circumferential channel 640 in addition to the enclosed cavity 620 and the main cavity 630 . The circumferential through-holes 602 permit aqueous fluid flow into and out of the circumferential channel 640 and the arc-shaped cutouts 604 permit aqueous fluid flow into and out of the main cavity 630 . Radial arms 606 couple the base lens 650 to the peripheral portion 670 and a hinge is disposed on the radial arm between the base lens 650 and the peripheral portion 670 . Again, the presence of the internal circumferential channel 640 is intended to reduce the material bulk and thus to permit insertion of the IOL 600 through relatively smaller incisions. [0120] The IOLs described herein are intended for implantation in a capsular bag of a patient's eye following performance of a capsulorhexis, in which a circular portion is removed from the anterior portion of the capsular bag. [0121] FIG. 11A depicts the eye 10 following performance of a capsulhorexis and before implantation of an IOL. The eye 10 is depicted as comprising a cornea 20 through which the surgical incision is made to access the capsular bag 40 . The diameter of the circular portion B-B removed from the capsular bag 40 depends upon each person's individual anatomy is typically in the range of from about 4 mm to about 9 mm. Here, the diameter 32 of the circular portion B-B removed from the capsular bag 40 corresponds roughly to the diameter of the pupil 30 . Preferably, as much of the capsular bag 40 and its zonular connections 50 are maintained as possible. The zonules 50 couple the capsular bag 40 with the ciliary muscle 60 and transmit the accommodative forces to effectuate the curvature or shape changes of the capsular bag 40 . Once the crystalline lens material is removed from the capsular bag 40 , the IOL may be inserted and implanted such that the circumferential edge substantially engages the zonules 50 attached to the capsular bag 40 . Additionally, the IOL is substantially centered along the optical axis A-A and engagement of the IOL with the zonules 50 is preferred to reduce the likelihood of decentration. In embodiments of the IOL comprising holes and through-holes, it is preferable that the holes and through-holes be located outside of the optical zone B-B. Moreover, the holes and through-holes should have rounded edges so as to prevent the perception of glare by the recipient. [0122] FIGS. 7A-7B and 8A-8B depict an IOL 700 which is configured with raised protrusions 790 or troughs 795 adjacent to the through-holes 702 to create a space between the capsular bag and the through-holes 702 and to thereby ensure the free flow of the aqueous fluid in and out of the main cavity 730 and the circumferential channel 740 . [0123] The IOL 700 comprises three enclosed chambers: an enclosed lens chamber 720 , a main cavity 730 and an internal circumferential channel 740 . A plurality of circumferentially disposed through-holes 702 are sized to provide fluid exchange between both the main cavity 730 and the internal circumferential channel 740 , on the one hand, and the exterior of the IOL 700 , on the other hand. The fluid or gel in the lens chamber 720 remains contained within the lens chamber 720 . [0124] The IOL 700 further comprises arc-shaped cut-outs 704 and radial arms 706 disposed to couple the base lens 750 to the peripheral portion 770 , in the same manner as depicted in FIGS. 6A-6B . The significant feature of IOL 700 is the presence of raised protrusions 790 ( FIGS. 7A-7B ) or troughs 795 ( FIGS. 8A-8B ) adjacent the through-holes 702 . The raised protrusions 790 or troughs 795 are configured to ensure that the capsular bag does not form a seal over the through-holes 702 so as to impede or prevent the aqueous fluid from flowing freely in and out of the main cavity 730 and the circumferential channel 740 . [0125] As discussed above, the IOLs described herein are configured to transmit most, if not all, of the radially compressive forces exerted on the circumferential edge onto the lens chamber. In contrast to the elastically deformable lens chamber, the base lens is not configured to deform or change its curvature in response to the radially compressive forces exerted on the circumferential edge. The transfer of the radially compressive forces onto the lens chamber may be accomplished by incorporating one or more of the following features in the IOL: (1) the opposing sides of the lens chamber having a reduced thickness as compared to the base lens, (2) a hinge disposed between the base lens and the peripheral portion, (3) utilizing materials having different elastic moduli for the lens chamber and the base lens; and (4) the variation of refractive indices provided for the opposing sides of the lens chamber and the fluid or gel contained therein. [0126] FIGS. 10A and 10B depict an IOL 800 which is constructed of at least two different elastomeric materials having different Young's modulus of elasticity, with at least the base lens 850 being made of a material having a higher Young's modulus than the lens chamber 810 . [0127] FIG. 10A depicts the IOL 800 as being constructed by assembling at least five (5) separately molded pieces, 801 A, 802 A, 803 A, 804 A, and 850 . Thus, in addition to the two halves 801 A, 803 A of the lens chamber 810 , The peripheral portion of the IOL 800 is provided in two ring portions 802 A, 804 A. The first ring portion 802 A surrounding the lens chamber 810 has a higher elastic Young's modulus than the second ring portion 804 A surrounding the base lens 850 . In a preferred embodiment, the two halves 801 A, 803 A of the lens chamber 810 and the second ring portion 803 A has a Young's modulus of 100 psi or less, preferably 75 psi or less, and most preferably 50 psi or less and the base lens 850 and the first ring portion 802 has a Young's modulus of more than 100 psi, preferably more than 250 psi, and most preferably more than 350 psi. In a particularly preferred embodiment, the Young's modulus of the first ring portion 802 A may be up to 500 psi. [0128] FIG. 10B depicts the IOL 800 as being constructed by assembling at least three (3) separately molded pieces 801 B, 802 B and 803 B. The first lens chamber 810 and the surrounding peripheral portion is provided by assembling 801 B and 802 B and the base lens portion 850 and the surrounding peripheral portion is provided by assembling 803 B to the underside of 802 B. The assembled first lens chamber 810 and surrounding peripheral portion ( 801 B, 802 B) has a lower elastic Young's modulus than the base lens portion 850 and the surrounding peripheral portion ( 803 B). In a preferred embodiment, portions 801 B, 802 B has a Young's modulus of 100 psi or less, preferably 75 psi or less, and most preferably 50 psi or less and the base lens portion 803 B has a Young's modulus of more than 100 psi, preferably more than 250 psi and, most preferably, more than 350 psi. In a particularly preferred embodiment, the Young's modulus of the base lens portion 803 B may be up to 500 psi. [0129] The invention described and claimed herein is not to be limited in scope by the specific preferred embodiments disclosed herein, as these embodiments are intended as illustrations of several aspects of the invention. Indeed, various modifications of the invention in addition to those shown and described herein will become apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the appended claims.

An intraocular lens (IOL) device comprising a first lens, a second lens and a circumferential haptic. The first lens comprises a pair of opposing and deformable surfaces and a cavity defined therebetween. The first lens has a first lens diameter. The second lens has a second lens diameter. The circumferential haptic has an outer peripheral edge and couples the first lens and the second lens. A main IOL cavity is defined by the circumferential haptic, the first lens and the second lens. The IOL device is resiliently biased to an unaccommodated state, characterized by the IOL device having a first diameter d 1 in the absence of radial compressive forces exerted on the outer peripheral edge. The IOL device actuates to an accommodated state being characterized by a second diameter d 2 in response to radial compressive forces exerted on the outer peripheral edge, wherein d 1 >d 2 .

GOVERNMENT RIGHTS This application was funded under United States Department of Agriculture Contract No. 90-34189-5014 Sub of 4501. The United States Government has certain rights under this application and any patent issuing thereon. CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of application Ser. No. 08/376,395, filed Jan. 23, 1995, now U.S. Pat. No. 5,527,959. BACKGROUND OF THE INVENTION (1) Summary of the Invention The present invention relates to table salt (sodium chloride) substitute compositions and their method of use. In particular, the present invention relates to physical mixtures of lysine monohydrochloride and potassium chloride, and optionally succinic acid which produce a salty taste and which unexpectedly closely parallels the taste of table salt. (2) Description of Related Art Numerous compositions have been described by the prior art as table salt substitutes. Illustrative are U.S. Pat. Nos. 1,874,055 to Liebrecht; 2,824,008 to Perri et al; 2,829,056 to Kemmerer; 3,015,567 to Hause et al; 3,993,795 to Mauror et al; 5,145,707 to Lee; 5,173,323 to Omari; 5,176,934 to Lee and 5,229,161 to Turk. Some of the compositions use lysine mono- or dihydrochloride and potassium chloride mixed together (Omari and Kemmerer); however, there are additional ingredients, particularly glutamates which produce allergic reactions (asthma, headaches, etc. in certain people) and do not enhance taste or sodium chloride, which is to be avoided in salt-free diets. OBJECTS It is therefore an object of the present invention to provide novel potassium chloride lysine monohydrochloride mixtures, preferably with a small amount of succinic acid which closely parallels the taste of table salt. Further, it is an object of the present invention to provide a method for using the compositions. Further, it is an object of the present invention to provide the compositions which are easily prepared as an admixtures. These and other objects will become increasingly apparent by reference to the following description. DESCRIPTION OF PREFERRED EMBODIMENTS The present invention relates to an edible composition having a salty taste which consists essentially of an admixture selected from the group consisting of (1) lysine monohydrochloride and potassium chloride, and (2) the lysine monohydrochloride, the potassium chloride and succinic acid each of which are food grade, wherein the weight ratio of the lysine monohydrochloride to potassium chloride is between about 1 to 9 and 3 to 2 and wherein the ratio of lysine monohydrochloride to succinic acid is between about 3 to 1 and 13 to 1 and the composition has a pH between about 5.5 and 6.3. The present invention also relates to a method for imparting a salty taste to a food which comprises providing an edible composition in the food which consists essentially of an admixture selected from the group consisting of (1) lysine monohydrochloride and potassium chloride, and (2) the lysine monohydrochloride, the potassium chloride and succinic acid which are food grade, wherein the ratio of the lysine monohydrochloride to potassium chloride is between about 1 to 9 and 3 to 2 and wherein the ratio of lysine monohydrochloride to succinic acid is between about 3 to 1 and 13 to 1 and the composition has a pH between about 5.5 and 6.3. The composition is easily prepared by simple mixing of the ingredients. In order to mask the bitter aftertaste of the potassium chloride there must be between 10% to 60% of the lysine monohydrochloride. When crystals of lysine monohydrochloride are physically mixed with crystals of potassium chloride, the resulting mixture has the appearance of, and taste intensity of, table salt, without the characteristic taste of the potassium ion. Lysine monohydrochloride can also be co-crystallized with potassium chloride from a solution in which they are soluble (such as water) to produce a salty crystalline mixture. The succinic acid produces a more salty taste in amounts between about 0.1 and 10 percent by weight in the composition. In the most preferred compositions the weight ratio of lysine monohydrochloride to potassium chloride is between 2 and 3 to 7. When succinic acid is present, the weight ratio of lysine monohydrochloride to potassium chloride is 2 and 2.99 to 7 and the succinic acid is included in an amount between 0.1 and 10 percent by weight of the composition. Lysine is an essential amino acid and thus is a dietary supplement. Potassium chloride is commonly used as a salt substitute to avoid sodium intake. Succinic acid is a common food acid. Thus, the composition fulfills dietary as well as taste needs. The following are illustrative Examples of the compositions of the present invention. EXAMPLE 1 Table 1 shows the results of taste tests by a taste panel of 3 people of various compositions incorporating lysine monohydrochloride (LysMhc) lysine monohydrate (Lysmh) potassium chloride (KCl) and an acid (HCl) or base (KOH). TABLE 1______________________________________Salt Molar Ratio ofname Lys/Cl/K Solution comp. Sol. pH Taste______________________________________1 2:4:2 Lysmhc + KCl 5.55 Salty+++2 2:3:1 Lysmhc + KCl 5.66 Salty-acid3 2:2:1 Lysmhc + Lysmh + KCl 9.34 Salty4 4:3:1 Lysmhc + Lysmh + KCl 9.48 Salty-sweet5 2:2:1 Lysmhc + KOH 9.50 Salty- metallic6 2:6:2 Lysmhc + KCl + HCl 1.00 Acidic______________________________________ *The salt+ tastes saltier than salty and salty- tastes less saltier than salty. ** The water used was double distilled water. A crystallized dry salt product composed of Lysmhc and KCl (1) with a molar ratio of 2:4 was found to possess the desired salty taste. EXAMPLE 2 Table 2 shows the results of taste tests by a taste panel of 3 people for various mixtures of lysine monohydrochloride (Lysmhc) and KCl mixtures as dry salts and in solution. TABLE 2______________________________________weight % Sol./2 gLysmhc/KCl Dry Mixture water pH______________________________________0/100 (25%) Irritates Irritates 7.6210/90 Salty++++* Salty++++ 6.2320/80 Salty+++ Salty++++ 6.2130/70 Salty++ Salty+++ 6.1240/60 Salty++ Salty+++ 6.0150/50 Salty+ Salty+ 5.9960/40 Salty Salty 5.9770/30 Salty- Salty+ 5.8780/20 Salty-- Salty+ 5.8390/10 Salty--- Salty-- 5.71100/0 (33%) Salty-sweet Salty-sweet 5.75100% dd** Water -- -- 5.70______________________________________ *The salt+ tastes saltier than salty and salty- tastes less saltier than salty. **double distilled water. As can be seen from Table 2 mixtures including 10 to 60% of the lysine monohydrochloride with potassium hydrochloride had the desired taste both in dry form and in solution. These mixtures also had an acid pH between about 5.5 and 6.3 depending upon the amount of lysine monohydrochloride. EXAMPLE 3 Table 3 shows different concentrations of a thirty weight percent (30%) lysine monohydrochloride to potassium chloride mixture (dry) mixed which is then dissolved in water used in taste tests by a taste panel of 3 people. As can be seen, the mixture can be used in an amount up to about 30% by weight in water to produce the desired salty taste. TABLE 3______________________________________30 wt % Lys/KClCont. in water pH Taste Comment______________________________________10 6.04 salty Clear sol.20 6.02 salty+ Clear sol.30 6.02 Salty++ Clear sol.40 5.90 Irritates Saturated25% (100% KCl) 7.62 Irritates Clear sol.25% (100% 7.11 Standard BlurredNaCl) sol.______________________________________ No other amino acid tested (including glutamic acid, glutamic acid monohydrochloride, glycine, glycine monohydrochloride, and lysine monohydrate) provided the masking of the potassium taste. The optimal concentration of lysine monohydrochloride in the mixture was about thirty percent (30%) by weight in Example 3 based upon taste tests. EXAMPLE 4 A preference test was conducted in which 38 panelists participated and tasted four dry samples in random order. The samples were: 1. 70/30 wt % potassium chloride/crystalline lysine monohydrochloride, which is the subject of the current application. 2. Commercially available MORTON SALT SUBSTITUTE (containing potassium chloride, fumaric acid, tri- and mono-calcium phosphate). 3. Example 1 of U.S. Pat. No. 2,829,056 (containing lysine dihydrochloride, mono-potassium glutamate, potassium chloride and tricalcium phosphate). 4. Regular table salt. The results of this test indicated the composition No. 1 of the invention was preferred to No. 2 and No. 3. The ranking of Samples No. 1, No. 2 and No. 3 were 61, 75, and 86, respectively, with the lowest number being preferred. The ranking was determined as follows: There was statistically difference at the 95% level between No. 1 and No. 3 (U.S. Pat. No. 2,829,056), but the difference between No. 1 and No. 2 was not statistically significant. EXAMPLE 5 Taste trials were performed to assess the intensity of the composition No. 1 of the invention in aqueous solution. In these trials a fifth sample was added to those of Example 4. 5. Same as No. 1 with 10% succinic acid added. A 4% solution was prepared of each sample and the rank scores were 16, 49, 50, 55, and 55 for samples No. 4, No. 5, No. 2, No. 3 and No. 1, respectively. This test indicates that the samples No. 1 and No. 5 were about 50% the intensity of regular table salt. EXAMPLE 6 Succinic acid (SA) was added to physical mixtures of potassium chloride (KCl) and lysine monohydrochloride (LysMhc). The results are shown in the following Table 4. TABLE 4______________________________________Wt % KCl/LysMhc/SA Dry Mixture Taste 4% Solution Taste______________________________________70/30/00 salty very mild salty70/15/15 very acidic, irritates very acidic, irritates70/20/10 very acidic acidic70/25/05 salty acidic salty acidic70/27.5/2.5 very good salty mild salty45/45/10 salty acidic very little saltiness______________________________________ These data indicate that there is a taste improvement by addition of a small amount of succinic acid. The ratio of lysine monohydrochloride to succinic acid that gives this advantage is 10:1 as in application Ser. No. 08/376,395, filed Jan. 23, 1995. Preferably between about 2.5 and 2.9 percent of the composition is succinic acid and the remainder is potassium chloride. It is intended that the foregoing description be only illustrative of the present invention and that the present invention be limited only by the hereinafter appended claims.

A physical mixture which consists essentially of compositions of lysine monohydrochloride and potassium chloride alone or admixed with small amounts of succinic acid, in particular weight ratios, and which has a salty taste comparable to table salt (sodium chloride). The mixture masks the bitter aftertaste of the potassium chloride and can provide dietary lysine which is an essential amino acid.

PRIOR APPLICATION This application is a continuation-in-part of my prior copending application Ser. No. 07/589,995filed Sep. 28, 1990 entitled ESOPHAGEAL DISPLACEMENT ELECTRODE. That application is incorporated by reference herein. FIELD OF THE INVENTION This invention relates to esophageal electrodes and, more particularly, comprises such an electrode that may be inserted down a patient's esophagus and into the stomach with a portion of the electrode in contact with the stomach wall in a position most favorable for electrically stimulating the ventricle of the heart in cooperation with an external electrode placed on the patient's chest. There are a number of medical procedures in which esophageal electrodes are used for such purposes as defibrillating and pacing the heart as well as for stimulating breathing. Examples of the use of esophageal electrodes in such procedures are shown in several United States patents and pending applications including Nos. 4,574,807, 4,683,890, 4,735,206, and 4,960,133; and Ser. Nos. 421,807 filed Oct. 16, 1989; 214,778 filed Jul. 5, 1988; and 812,015 filed Dec. 23, 1985 (now abandoned). An esophageal electrode may also be used as an ECG pickup. Those patents and applications are herein incorporated by reference. Many of these procedures may be substantially enhanced and facilitated if the electrode is capable of being moved close to the organ of the body being treated such as the ventricles of the heart. Frequently patient care in a hospital and emergency care outside a hospital require ventricular pacing. Customarily, this is an invasive procedure and must therefore be performed in a sterile atmosphere, and the procedure requires a considerable period of time to perform. Many of the patents and applications identified above disclose a method and apparatus employing an internal, noninvasive esophageal electrode in combination with an external chest electrode, which are much more convenient to use, more efficient in performing the intended function, and do not require the presence of a physician. The techniques described in the above identified patents and applications relating to pacing and/or defibrillation may be made more efficient if the electrode is positioned as close to the ventricle of the heart as possible. The closer the electrode is to the ventricle, the less electrical energy is needed to perform the pacing or defibrillating functions, and the more confident the attendant may be that the current flow between the internal and external electrodes is along the desired path. The prior application Ser. No. 07/589,995, supra is directed to an esophageal displacement electrode to achieve greater efficiency in the practice of such procedures. The device includes a semi rigid plastic tube that may be inserted either orally or nasally into the esophagus. The tube carries an electrode at its distal end and has a mechanism incorporated into it which enables the user to cause the distal end of the tube to bend and press against the wall of the esophagus. The mechanism is of sufficient strength to cause the esophagus to displace under the pushing force of the electrode. To enable the tube to bend readily under the action of the mechanism, the tube is crimped so as to define a hinge at the distal region of the tube. The mechanism for deflecting the distal end of the tube includes a rigid pin having a cord connected at each end and which is aligned generally parallel to the axis of the tube and positioned at the distal portion thereof in the vicinity of the hinge. One cord attached to the proximal end of the pin extends out the proximal end of the tube, while the other cord attached to the distal end of the pin extends through a port located distally of the hinge in the tube and reenters the tube through a second port proximal of the hinge and then extends out the proximal end of the tube. By pulling on the cord attached to the distal end of the pin, the pin may be positioned beyond the hinge adjacent the distal port, and continued pulling of the cord will cause the tube t bend at the hinge. The present invention is directed to an esophageal-stomach electrode to achieve greater efficiency in the performance of such procedures. The closer an electrode is positioned to the heart, the less electrical power is needed to control the heart and more consistent control of the heart is achieved. In accordance with the present invention a thin semi rigid plastic tube with the electrode on the distal end similar to the tube in the 07/589,995 application is used, but of sufficient length to be passed down the esophagus into the stomach. A mechanism, also similar to that in the earlier application, is incorporated into the tube which enables the user to cause the last couple of inches of the distal end of the tube to bend back on itself approximately 135 degrees from its original position. The user then withdraws the electrode until the bent back section of the distal end impacts on the stomach wall and displaces the stomach wall toward the heart. This action places the electrode in its operative position closest to the ventricle of the heart so as to cooperate with an external electrode on the chest to impress a pulse upon the heart. The bent back section of the distal end also prohibits further withdrawal of the electrode. This invention will be better understood and appreciated from the following detailed description of a preferred embodiment thereof, selected for purposes of illustration and shown in the accompanying drawings. BRIEF DESCRIPTION OF THE FIGURES FIG. 1 is a diagrammatic frontview of a patient suggesting the heart, esophagus and stomach and showing without details of esophageal-stomach displacement electrode of the present invention extending through the esophagus and into the stomach; FIG. 2 is an enlarged cross-sectional view of the distal end of displacement electrode disposed in the stomach and with the distal end in the undisplaced position; FIG. 3 is a view similar to FIG. 2 but showing the distal end of the electrode in its displaced position; FIG. 4 is a view similar to FIG. 3 and showing the electrode elevated so that its tip engages the wall of the stomach and displaces the wall so that it essentially engages the heart; FIG. 5 is a side view of the control mechanism for the electrode shown in FIGS. 1 4 and showing one of the positions for the control slide; and FIG. 6 is a cross-sectional view of the control mechanism taken along section line 6 6 in FIG. 5. DETAILED DESCRIPTION OF THE INVENTION In FIG. 1 the torso and head of a patient are shown along with the patient's heart H, esophagus E and stomach S. The stomach is located posterior and spaced from the ventricle V. The esophageal-stomach displacement electrode shown extends through the patient's mouth, through the esophagus and into the stomach with its distal end located relatively close to the ventricle V. The present invention enables the distal end of the esophageal-stomach displacement electrode to displace angularly within the stomach and subsequently be pulled slightly back out of the esophagus, or alternatively, further angularly displaced, upwardly into pressurized contact with the stomach wall to position the wall closer than normal to the heart (see FIG. 4) and thereby place the stomach displacement electrode in closer proximity to it. This is illustrated in FIGS. 2, and 3 and 4. The electrode includes a semi rigid plastic tube 10 made of nylon or other suitable material which may be approximately 20 inches long and approximately 3/16 inch in diameter. The tube should be semi rigid, much like a gastric tube, and be relatively torque free. The distal end 12 of the tube carries an electrode 14, preferably spherical in shape and having a stem 16 that fits within the distal end of the tube. The electrode may be pressed in place or suitably fastened by other means. In the preferred form, the electrode 14 is 1/4 inch in diameter, which just exceeds the diameter of the tube 10 so that the ball will make positive contact with the stomach wall when the distal end 12 of the tube 10 is displaced. The distal end 12 may be then further displaced or the complete electrode pulled back out of the esophagus to cause a bulge 50 (FIG. 4) in the stomach wall to place the wall and the electrode 14 closer to heart ventricle V. At this point, the electrode is prevented from further displacement by resistance of the stomach wall. The tube 10 is carried by a control mechanism 20 shown in FIG. 4 which is connected to a displacement mechanism 22 disposed in the tube. The control mechanism is located at the proximal end of the tube outside the mouth when the esophageal-stomach displacement electrode is placed in the stomach as shown in FIG. 1. The tube 10 is crimped as suggested at 26 in FIGS. 2, 3 and 4 so as to form a hinge 27 in the tube, which enables it to bend readily at that point. In the wall 25 of the tube 10, ports 28 and 30 are formed on opposite sides of the hinge 27, each spaced approximately an inch therefrom. While in the embodiment shown, each of the two ports is approximately one inch from the crimp 26, that dimension as well as others given may be varied to suit the particular application, as is more fully described below. A rigid pin 32 is disposed in the tube 10 and extends generally parallel to the tube axis. The pin may be made of metal, rigid plastic, or any other material having sufficient rigidity to prevent the tube 10 from bending at the crimped area 26 when the pin spans the hinge. A pair of cords 34 and 36 are connected to the proximal and distal ends 38 and 40, respectively, of pin 32 and extend proximally in the tube 10 out its proximal end 42 and into the control mechanism 20. Cord 34 extends directly from the proximal end of the pin 32 within the tube 10 to the control mechanism 20, while cord 36 extends from the distal end 40 of the pin, out the tube 10 through port 28 and from that point it extends proximally externally of the tube, spanning the crimped portion 26 to the port 30 where the cord reenters the tube 10 and extends in the tube to the control mechanism 20. As is evident from FIGS. 2, 3 and 4, the location of the pin 32 may readily be changed by pulling one or the other of the cords 34 or 36 in a proximal direction. Pin 32 is somewhat shorter than the distance between the crimped portion 26 of the tube and the lower port 28. Travel of the pin 32 in the tube 10 in a distal direction is limited by the location of port 28. The size of pin 32 is such that it cannot be drawn through port 28 and, therefore, when the pin 32 reaches its lowermost point and a continued pull is exerted on cord 36, the distal portion of the tube 10 is caused to deflect (in this example approximately 135°) from the position shown in FIG. 2 to that shown in FIG. 3. At this point the tube must still be further deflected or pulled back out of the stomach to place it into pressurized contact with the stomach wall to cause a bulge 50 as shown in FIG. 4. While the tube 10 is displaced or bent about the hinge 27 by pulling on cord 36 when pin 32 has reached its lowermost position, merely by releasing tension on the cord 36, the natural bias of the tube 10 to the configuration of FIGS. 1 and 2 will cause it to return to the shape shown therein. The control mechanism 20 shown in FIG. 5 is connected to the distal ends of the cords 34 and 36 to operate the displacement mechanism 22 by taking up one cord and playing out the other. The control mechanism 20 includes a sleeve 50, rectangular in cross section in the embodiment shown, and containing a slide 52. A bracket 54 is secured to the bottom wall 56 of sleeve 50 and retains the proximal end 42 of tube 10 in place. The bracket 54 includes a bar 62 and clamping plate 58 that sandwich the tube end, and the plate 58 is secured to the bar 62 by screws 60. The cords 34 and 36 enter the sleeve 50 through a port 64 in bottom wall 56, aligned with the proximal end 42 of the tube 10 when the tube is secured to the bracket 54. The proximal ends 66 and 68 of the cords are respectively connected to flanges 70 and 72 carried by the slide 52. In FIG. 5, slide 52 is shown in the position that places the pin 32 in the tube in the position shown in FIG. 2. When the slide is moved to the right as viewed in FIG. 5, the pin 32 moves to its lowermost position in tube 10 and the tube is deflected, as shown in FIG. 3. Because the slide 52 is generally U shaped with an opening 74 in its bottom wall 76 that rests upon the bottom wall 56 of sleeve 50, movement of the slide 52 in the sleeve 50 does not in any way interfere with the movement of the cords 34 and 36 in response to displacement of the slide. The electrode typically may be used in the following manner. Assume that the electrode is part of a pacing mechanism as shown in U.S. Pat. No. 4,735,206, supra. The tube 10 is inserted into the esophagus either through the mouth or the nasal passage to a depth wherein the electrode 14 is disposed out the lower end of the esophagus into the stomach at a depth sufficient to enable displacement of the tube's distal end 12 to approximately 135 degrees from its straighten or insertion position as shown in FIG. 3. The external electrode also forming part of the pacer is mounted on the chest of the patient and the controls, etc. are properly set. In order to reduce the amount of electrical energy required to effect pacing, the operator moves the slide 52 to the right as shown in FIG. 5 which will cause the pin 32 to move downwardly in the tube 10 so that its distal end 40 is immediately adjacent the port 28. Further movement of the slide 52 in that direction will cause the distal portion of the tube 10 to deflect and place the electrode 14 in proximity to the upper stomach wall near the heart ventricle V., as shown in FIG. 3. Further deflecting the distal end 12 or pulling back the tube 10 at its proximal portion then places the electrode 14 in pressurized displacable contact with the upper stomach wall causing a bulge that places the electrode closer to the ventricle V (FIG. 4). With the electrode in the displaced position of FIG. 4, the pacing pulses are imposed across the electrodes. When the procedure is completed, the operator may move the slide 52 back to the position of FIG. 5, which will relieve the tension on the cord 36 and allow the tube 10 to return to the position of FIG. 2. Thereafter the tube 10 may be withdrawn. From the foregoing description, those skilled in the art will appreciate that the present invention provides a very convenient means of enabling an operator to place the esophageal stomach displacement electrode very close to the heart or other organ by means of a noninvasive procedure and thereby reduce the energy required to carry out the particular procedure such as pacing or defibrillation upon the patient. It will also be appreciated that while a specific embodiment is shown in the drawings, modifications may be made thereof without departing from this invention. For example, while a pin is shown as applying the bending force to the interior of the tube, other configurations for the device may be employed. Any structure which will not pass through the lower port 28 and will not interfere with the action of the hinge 27 will cause the tube 10 to deflect when the cord attached to it and exiting the tube through the port 28 is tensioned. It should, if necessary, also stiffen the hinge portion of the tube when it is being inserted in the esophagus and stomach. The member which applies the bending force must be capable of moving freely in the tube under the operation of the control 20 so as to be readily movable in response to actuation of the control. The tube 10 could, of course, carry more than one electrode. For example, in the earlier patents, supra, a number of spaced contact rings are shown carried by the tube. Because modifications may be made of the invention without departing from its spirit, it is not intended that the scope of this invention be limited to the specific embodiment illustrated and described. Rather, the scope of this invention is to be determined by the appended claims and their equivalents.

An esophageal-stomach displacement electrode comprises a flexible tubular member designed to be inserted through the esophagus into the stomach. An electrode is carried by the tube in the region of its distal end. The tube is hinged near the distal end which enables that end of the tube to displace angularly in the stomach and displace the stomach wall. The stomach wall displacement may occur by angularly displacing the distal end or by otherwise pulling the tube partially out of the esophagus after its distal end partially displaced toward the stomach wall. A displacement mechanism is disposed in the tube in the region of the hinge and is controlled from a point externally of the body for causing the distal end of the tube to displace angularly, and to be positioned to engage and displace the stomach.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to games and, more specifically, to a board game having a lake theme. [0003] 2. Description of the Related Art [0004] A wide variety of games have a common characteristic, namely, competition among two or more players using a single set of rules. Some of these games, specifically board games, involve movement of pieces upon a board onto, in, over or though spaces that relate to each player's status and/or position. [0005] Many proposed board games have attempted to simulate the accumulation of wealth through a variety of mechanisms. For example, U.S. Pat. No. 2,026,082 to Darrow discloses a game simulating the world of real estate in which players move game pieces around a board and attempt to accumulate wealth and property at the expense of opposing players. Moreover, U.S. Pat. No. 4,140,319 discloses a game simulating the development and rezoning of real estate and accumulation of wealth involving game pieces moveable upon a board. Additionally, U.S. Pat. No. 4,189,153 simulates the accumulation and development of businesses and their employees. [0006] Several others have proposed particular designs for playing boards and/or game pieces used in games, including U.S. Design Pat. No. 262,125 (“POT LUCK” game board), U.S. Pat. No. 295,987 (“BLACK GOLD” game board), U.S. Pat. No. 340,266 (chessmen), U.S. Pat. No. 352,332 (game pieces), U.S. Pat. No. 380,781 (“ASTRONOPOLY” game board), and U.S. Pat. No. 386,798 (“UNITED STATES POSTAL MONOPOLY GAME”), and U.S. Pat. No. 5,484,157 (chess-like game with military objects as game pieces) and U.S. Pat. No. 5,492,332 (chess-like game with irregularly shaped board). [0007] Still others have proposed board games with various goals and/or themes, such as U.S. Pat. No. 4,010,957 (purchasing sports teams), U.S. Pat. No. 4,052,071 (accumulating wealth and travel across the U.S.), U.S. Pat. No. 4,062,544 (raising self “out of ghetto”), U.S. Pat. No. 4,136,881 (accumulating wealth according to two economic paradigms), U.S. Pat. No. 4,378,942 (accumulating stocks, commodities or bonds), U.S. Pat. No. 4,486,022 (buy, sell and trade sports performers), U.S. Pat. No. 4,927,156 (accumulating speculatively priced properties), U.S. Pat. No. 5,135,230 (accumulating income and maximizing baseball player quality), U.S. Pat. No. 5,292,133 (acquiring African nations), U.S. Pat. No. 5,314,188 (attempting to get family members home), and U.S. Pat. No. 5,456,473 (completing construction project), U.S. Pat. No. 5,673,915 (purchasing U.S. states, highways, airports and telephone companies), and U.S. Pat. No. 6,164,650 (“add-on” game for use with MONOPOLY™ game). [0008] Other proposals for board games have been disclosed in British Patent Specification 694,880 (get to a home space across irregularly routed path of spaces), British Patent Specification 915,550 (experiencing foreign travel), and UK Application GB 2 055 299 A (playing board with holes for score markers). [0009] Although the above proposals have no doubt supplied much entertainment, none of the above games, boards and/or game pieces have successfully simulated the ups and downs of life at a lake. Moreover, none of the above inventions and patents, taken either singularly or in combination, is seen to describe the instant invention as claimed. Thus a board game having a lake theme solving the aforementioned problems is desired. SUMMARY OF THE INVENTION [0010] The invention is a game having a lake theme. A game includes: a playing board; a plurality of tokens representing identities of players playing the game; a plurality of title deed cards; a plurality of game pieces; a source of scrip; a plurality of cards each one of which bears indicia related to one of a penalty, an award and a direction; and at least two elements operable by the players in turn for randomly determining movement of the tokens upon the board. [0011] The playing board includes a plurality of successive, contiguous spaces defining a continuous path about a periphery of the board. First, second and third sets of the spaces identify properties, such as lake areas, dams and boat dealerships, that may be purchased with scrip by a player landing upon the respective space. Each one of the title deeds is associated with a respective one of the lake areas, dams and boat dealerships, and bears indicia indicating a rental payment payable to a player acquiring the property, and payable by a player subsequently landing upon the space identifying the property. Each of the game pieces may be purchased with scrip and placed upon an acquired lake area, dam or boat in order to increase the rental payment. Preferably, a plurality of the deeds bear indicia relating to lakes. Preferably, a plurality of the spaces bear indicia related to lakes. Preferably, a plurality of the cards bear indicia related to lakes. [0012] Accordingly, it is a principal object of the invention to provide a board game simulating the ups and downs of life at a lake. [0013] It is another object of the invention to provide a board game where by the ups and downs of life at a lake may be simulated by acquiring lake properties, dams and boat dealerships. [0014] It is a further object of the invention is to provide a board game whereby the ups and downs of life may be simulated by erection of game pieces on spaces identifying the lake areas, dams and boat dealerships. [0015] It is an object of the invention to provide improved elements and arrangements thereof for the purposes described which is inexpensive, dependable and fully effective in accomplishing its intended purposes. [0016] These and other objects of the present invention will become readily apparent upon further review of the following specification and drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0017] [0017]FIG. 1A is a plan view of a game board having a lake theme according to the present invention. [0018] [0018]FIG. 1B is a plan view of portion B of the game board of FIG. 1A. [0019] [0019]FIG. 1C is a plan view of portion C of the game board of FIG. 1A. [0020] [0020]FIG. 1D is a plan view of portion D of the game board of FIG. 1A. [0021] [0021]FIG. 1D is a plan view of portion D of the game board of FIG. 1A. [0022] [0022]FIG. 1F is a plan view of portion F of the game board of FIG. 1A. [0023] [0023]FIG. 1E is a plan view of portion E of the game board of FIG. 1A [0024] [0024]FIG. 1G is a plan view of portion G of the game board of FIG. 1A. [0025] [0025]FIG. 1H is a plan view of portion H of the game board of FIG. 1A. [0026] [0026]FIG. 1I is a plan view of portion I of the game board of FIG. 1A. [0027] [0027]FIG. 2A is a profile view of a game piece resembling a boat propellar. [0028] [0028]FIG. 2B is a profile view of a game piece resembling an anchor. [0029] [0029]FIG. 2C is a profile view of a game piece resembling a speedboat. [0030] [0030]FIG. 2D is a plan view of a game piece resembling a Lake Cabin. [0031] [0031]FIG. 2E is a plan view of a game piece resembling a Marina building. [0032] [0032]FIGS. 3A, 3B, 3 C, 3 D, 3 E, 3 F, 3 G, 3 H and 3 I are plan views of a plurality of individual Makin a Wake and Sunken Chest cards. [0033] [0033]FIG. 4A is a plan view of title deed cards to the Bear Lake and Jump Off Joe Lake properties. [0034] [0034]FIG. 4B is a plan view of title deed cards to the Sun Runner Boat Dealership and Medical Lake properties. [0035] [0035]FIG. 4C is a plan view of title deed cards to the Clear Lake and Waitts Lake properties. [0036] [0036]FIG. 4D is a plan view of title deed cards to the Liberty Lake and Spokane Falls Dam properties. [0037] [0037]FIG. 4E is a plan view of title deed cards to the Marshal Lake and Rock Lake properties. [0038] [0038]FIG. 4F is a plan view of title deed cards to the SeaRay Boat Dealership and Deer Lake properties. [0039] [0039]FIG. 4G is a plan view of title deed cards to the Silver Lake and Loon Lake properties. [0040] [0040]FIG. 4H is a plan view of title deed cards to the Badger Lake and Sprague Lake properties. [0041] [0041]FIG. 4I is a plan view of title deed cards to the Thomson Lake and Bayliner Boat Dealership properties. [0042] [0042]FIG. 4J is a plan view of title deed cards to the Lake Cocolala and Spirit Lake properties. [0043] [0043]FIG. 4K is a plan view of title deed cards to the Grand Coulee Dam and Long Lake properties. [0044] [0044]FIG. 4L is a plan view of title deed cards to the Lake Sachine and Priest Lake properties. [0045] [0045]FIG. 4M is a plan view of title deed cards to the Lake Roosevelt and Donzi Boat Dealership properties. [0046] [0046]FIG. 4N is a plan view of title deed cards to the Lake Pend Oreille and Lake Couer D'Alene properties. [0047] Similar reference characters denote corresponding features consistently throughout the attached drawings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0048] The present invention is a board game intended to simulate the life at a lake. Much of the interest in the game lies in experiencing the ups and downs of life on, at, adjacent, or near a lake, and includes the acts of acquiring, selling, mortgaging and improving properties, such as lake areas, dams and boat Dealerships associated with lakes. While the preferred embodiment set forth below involves particular properties, such as lake areas, boat dealerships on, adjacent, or relating to various lakes, those skilled in the art will understand that the invention is not limited to only lake areas, boat dealerships and dams. Other types of lake-related properties are within the scope of the invention. [0049] As best illustrated in FIG. 1A, the game includes a generally square-shaped game board 10 including a total of eight portions B, C, D, E, F, G, H, I positioned about a periphery of the board. Each of the portions B, C, D, E, F, G, H, I includes five delineated, sequential spaces. As seen in FIG. 1A, each of portions B, C, D, E, F, G, H, I are contiguous with two other portions B, C, D, E, F, G, H, I, thus forming a continuous path of delineated spaces adjacent a periphery of board 10 . [0050] As best illustrated in FIGS. 2A through 2C, tokens 20 represent the identities of the players. Tokens 20 are moved across the path according to a throw of dice by the token's owner. For example, if a total of seven results from the owner's dice throw, that player moves his or her token seven spaces along the path. While only three exemplary tokens 20 are depicted, those skilled in the art will appreciate that the invention is not limited to such examples. Other examples of configurations include those in the shape of a captain's wheel, a life preserver, a boat trailer, a cigarette boat, a cabin cruiser, a drag boat, a cruise liner, a jet ski, a ski boat, a fishing boat, an open bow boat, a day cruiser, and a sailboat. Moreover, the number of players is not limited to three. While any reasonable number of players may play, a preferred number of players is four to nine. [0051] Portion B includes a GO space 100 , which serves as a starting point for the players on the board's continuous path. Portion B further includes two spaces corresponding to lake areas, namely Bear Lake 110 and Jump Off Joe Lake 130 . Sunken Chest space 120 , and Waterfront Taxes Due space 140 make up the remainder of portion B. [0052] Lake areas in the game are organized into groups. Each of the lake areas in a given group has a common color that identifies their association as a group. For example, a purple bar on each of Bear Lake 110 and Jump Off Joe Lake 130 may be used to identify them as belonging to one group of lake areas. [0053] Portion C includes three lake areas, namely, Medical Lake 160 , Clear Lake 180 , and Waitts Lake 190 . A bluish-green bar may be used to identify these areas as making up another associated group of lake areas. Portion C further includes Sun Runner Boat Dealership space 160 and Makin A Wake space 170 . [0054] Portion D includes an IN JAIL/JUST VISITING space 200 , which has a IN JAIL portion 204 and a JUST VISITING portion 205 . Portion D also includes three spaces corresponding to another group of associated lake areas, namely, Liberty Lake 210 , Marshal Lake 230 , and Rock Lake 240 . Orangish-red bars are preferably included on lake areas 210 , 230 , 240 to indicate their association. Spokane Falls Dam space 220 completes the amount of spaces in portion D. [0055] Portion E includes three spaces corresponding to yet another group of associated lake areas, namely, Deer Lake 260 , Silver Lake 280 and Loon Lake 290 . Bars colored orange may be used to indicate their association as a group. Searay Dealership space 250 and Sunken Chest space 270 complete the number of spaces in portion D. [0056] Portion F includes a FREE BOAT LAUNCH space 300 and three spaces corresponding to yet another group of associated lake areas, Badger Lake 310 , Sprague Lake 330 , and Thomson Lake 340 , each of which preferably has a red bar thereon to indicate their group association. Makin A Wake space 320 completes portion F. [0057] Portion G includes three spaces to form yet another group of associated lake areas, namely, Lake Cocolala 360 , Spirit Lake 370 , and Long Lake 390 . They preferably have yellow bars indicating their association. A Bayliner space 350 and a Grand Coulee Dam space 380 complete portion G. [0058] Portion H includes GO TO JAIL space 400 . Lake Sachine 410 , Priest Lake 420 , Lake Roosevelt 440 make up still another group of associated lake areas. They preferably have colored bars, in this case green, to indicate their association. Sunken Chest space 430 completes portion H. [0059] Finally, portion I includes two spaces corresponding to a last group of associated lake areas, namely, Lake Pend Oreille 470 and Lake Couer D'Alene 490 . An association between them as a group is preferably indicated by dark blue bars thereon. Portion I is completed by Donzi Dealership space 450 , Makin A Wake space 460 and Boat Tab Renewal space 480 . [0060] The game is played with scrip money, preferably in denominations of $1, $5, $10, $20, $50, $100, and $500. At the beginning of the game, the players should be given equal amounts of scrip, which in a preferred embodiment of the game is $1,500. If the number of players exceeds the amount of preferred $1,500 multiples of scrip in the bank, then each share of scrip may be accordingly decreased and a credit against the decreased amount be maintained for the player against the Bank. [0061] The game also utilizes a plurality of Makin A Wake cards 500 , 505 , 510 , 515 , 520 , 525 , 530 , 535 , 540 , 545 , 550 , 555 , 560 , 565 , 570 , 575 , as individually shown in FIGS. 3A through 3D, that are stacked face down and piled at space 30 , as illustrated in FIG. 1A. Similarly, a plurality of Sunken Chest cards 600 , 605 , 610 , 615 , 620 , 625 , 630 , 635 , 640 , 645 , 650 , 655 , 660 , 665 , 670 , 675 , individually illustrated in FIGS. 3E through 3I, are stacked face down and piled at space 40 , again as shown in FIG. 1A. The game also includes a predetermined amount of lake cabins 50 and marinas 60 , as shown in FIGS. 2D and 2E, respectively, for placement upon lake areas. [0062] The game may be played by two or more players, one of whom serves as Banker. The Banker handles all receipt and payment of scrip on behalf of the Bank. The Bank is the original owner of all of the lake areas, boat dealerships, and dams, as described above. [0063] Play of the game is organized into turns for each player. On each player's turn, he or she operates one or more elements for randomly determining movement of the tokens over the path. Preferably, two such elements are dice. Based upon the amount shown on the element(s), such as dice, the player moves his or her token the indicated number of spaces along the continuous path in a clockwise direction. Those skilled in the art will appreciate that the invention is not limited to the use of dice, but that any chance-determining element may be used. For example, a spinner may be used to determine the number of spaces advanced by a player's token during his or her turn. [0064] If, as a result of a player's throw of the dice, his or her token lands upon one of the lake areas, boat dealerships, or dams, he or she may purchase it from the Bank if it is not already owned. The price for the lake area, boat dealership or dam in question is preferably displayed on the associated space. Exemplary prices for the lake areas may be found in Table I, while exemplary prices for each of boat dealerships and dams may be found in Table II. As seen in Tables I and II, prices for the lake areas vary greatly, just as they do around lakes in reality. TABLE I Preferred Prices for Lake Areas LAKE AREA PRICE ($) Bear Lake 110 60 Jump Off Joe Lake 130 60 Medical Lake 160 100 Clear Lake 180 100 Waitts Lake 190 120 Liberty Lake 210 140 Marshal Lake 230 140 Rock Lake 240 160 Deer Lake 260 180 Silver Lake 280 180 Loon Lake 290 200 Badger Lake 310 220 Sprague Lake 330 220 Thomson Lake 340 240 Lake Cocolala 360 260 Spirit Lake 370 260 Long Lake 390 280 Lake Sachine 410 300 Priest Lake 420 300 Lake Roosevelt 440 320 Lake Pend Oreille 470 350 Lake Couer D'Alene 490 400 [0065] [0065] TABLE II Preferred Prices for Boat Dealerships and Dams BOAT DEALERSHIP OR DAM PRICE ($) Sun Runner Dealership, 150 200 Spokane Falls Dam, 220 150 Searay Dealership, 250 200 Bayliner Dealership, 350 200 Grand Coulee Dam, 380 150 Donzi Dealership, 450 200 [0066] As best shown in FIGS. 4A through 4N, one title deed card 113 , 133 , 163 , 183 , 193 , 213 , 233 , 243 , 263 , 283 , 293 , 313 , 333 , 343 , 363 , 373 , 393 , 413 , 423 , 443 , 473 , 493 is associated with each one lake area. Similarly, a title deed card 153 , 253 , 353 , 453 , 223 , 383 , is associated with each individual boat dealership 150 , 250 , 350 , 450 and each individual dam 220 , 380 , respectively. After payment of scrip money to the Bank, the player purchasing a property receives the associated title deed card as proof of ownership. Preferably, each of the title deed cards associated with a lake area has a colored bar displayed thereon to match the corresponding lake area on board 10 . If the player landing upon an unowned property does not wish to purchase it, the Banker, upon preagreed rules, may auction off the property to the highest bidder among the remaining players. The winning bidder receives the associated title deed card after receipt of payment to the Bank. Once a property has been sold, the associated title deed card is displayed face side up by that player in order to indicate that it is not mortgaged. [0067] Preferably, each of the boat dealership spaces 150 , 250 , 350 , 450 , and title deed cards 153 , 253 , 353 , 453 associated therewith includes a picture 154 , 254 , 354 , 454 , respectively, that is illustrative of life at a lake. For example, each of pictures 154 , 254 , 354 , 454 can be an ornamental design for a boat, such as one commonly used on a lake. Similarly, each of the dam spaces 220 , 380 , and title deed cards 223 , 383 , includes a picture 224 , 384 illustrative of life at a lake. For example, each of pictures 224 , 384 can be an ornamental design of a waterfall plunging over a dam at the edge of a lake. [0068] If the property landed upon is already owned by another player, the player landing, or “trespassing”, upon the property must pay a rental fee to the owner if the owner demands the same in a timely manner such as, for example, before the next player rolls the dice. In the case of boat dealerships or dams, the rental fee will depend upon how many boat dealerships or dams are owned by the owner of the landed upon space at the time of the trespass. If the player's token is trespassing upon a dam space, the player must throw the dice and pay a multiple of the dice throw in scrip to the owner of the dam as a rental payment. The multiple used depends upon how many dams are owned by the player owning the dam in question, and is indicated on the title deed to the dam. For example, in a preferred embodiment the player whose token lands upon a dam must pay four times the amount resulting from the dice throw if only one dam is owned, and ten times the amount if two Dams are owned. [0069] Similarly, if a player's token lands upon a boat dealership that is owned by another player, the player trespassing must also pay the owner a rental fee based upon the number of boat dealerships owned by the player whose boat dealership was landed upon. However, the rental fee is not dependent upon a throw of the dice, but is instead displayed on the associated title deed card. In a preferred embodiment, the trespasser must pay $25 if the owner owns only a single boat dealership, $50 if the owner owns two dealerships, $100 if the owner owns three dealerships and $200 if the other player owns all the dealerships. [0070] If a player's token lands upon a lake area that is already owned by another player, the rental fee due will depend upon whether all the lake areas in the group are commonly owned and whether the lake area landed upon has been improved, i.e., whether lake cabin(s) and/or a marina have been erected upon the lake area landed upon. The particular rental fee may be read from the information displayed on the associated title deed card. If one player owns all the lake areas in a given group, the rental payment is twice the amount displayed on the associated title deed card if the lake area is not improved, i.e., no lake cabins or marinas have been erected thereon. For example, the rental payment for trespassing upon the Thomson Lake area 340 (and the other lake areas 310 , 330 in the group are not commonly owned) in an unimproved condition is only $20, as best shown in FIG. 4I. The rental payment for trespassing on an unimproved Thomson Lake Area 340 increases to $40 if the owner also happens to own both the other lake areas 310 , 330 associated therewith. The rent for trespassing increases with the number of lake cabins and marinas built upon the trespassed upon lake area. For example, with reference to FIG. 4I, rent for one lake cabin on the Thomson Lake area 340 costs $100, rent for three lake cabins costs $750, and rent for one marina costs $1,100. [0071] As described above, the Lake Areas are organized into groups. If a player acquires all the Lake Areas within an associated group, the player is allowed to improve one or more of his or her lake areas in the associated group on his or her turn by erecting lake cabins and/or marinas. The player may erect up to four lake cabins on each lake area in the group. Once four lake cabins have been erected on each lake area in the group, the player may then erect up to one marina each on one or more of the lake areas in the associated group. When a marina is erected, the lake cabins must be returned to the Bank. Thus, the rental payment for trespassing on a lake area with a marina does not include any additional rent for the four lake cabins previously, i.e., the rental payment is not cumulative for all improvements. [0072] The costs for erecting lake cabins and marinas is displayed on the title deed card associated with the lake area that is being improved. For example, with reference to FIG. 4I, the erection of each lake cabin on Lake Thomson 340 costs $150, while the marina costs an additional $150. As in purchases of lake areas from the Bank, the costs for improving a lake area are payable to the Bank. Because the number of lake cabins and marinas is limited, they may not be available from the Bank at the time a player wishes to buy them. If so, that player must wait until another player sells or returns one or more of them back to the Bank, a subject that is described in greater detail below. [0073] A player improving his or her lake areas in an associated group must do so in an even manner upon the lake areas within that group. For example, while a player may erect one house at a time upon any one of the lake areas in an associated group, he or she may not erect, for example, two houses on one lake area and no houses on another lake area within the same group, or for example, three houses on one lake area and one or no houses on another lake area within the same group. [0074] The board includes several other lake-related spaces, spaces which do not have corresponding title deed cards and which may not be owned. These spaces include Waterfront Taxes Due space 140 , IN JAIL/JUST VISITING space 200 , FREE BOAT LAUNCH 300 , Boat Tab Renewal space 480 , and GO space 100 . Waterfront Taxes Due space 140 represents the relatively higher amount of taxes paid by a person owning a lot adjacent a lake shore. If a player's token lands upon Waterfront Taxes Due space 140 , that player must pay the Bank his or her choice of 10% of his or her scrip on hand, or $200. Boat Tab Renewal space 480 represents a boat owner's requirement to renew his or her boat trailer's registration, a process evidenced by a new tab. If a player's token lands upon Boat Tab Renewal space 480 , that player must pay the Bank $75 in scrip. Preferably, Waterfront Taxes Due space 140 includes a picture 144 illustrative of home on a lakefront that is subject to, of course, waterfront taxes. Desirably, Boat Tab Renewal space 480 includes a picture 484 illustrative of a boat trailer and money. FREE BOAT LAUNCH 300 space represents a boat launch open to the public without any fees. FREE BOAT LAUNCH space 300 indicates that no rental is due for any player landing his or her token upon the space. Similarly, FREE BOAT LAUNCH space 300 also includes a picture 340 , which in this case, is preferably illustrative of a boat launch site. [0075] If a player's token lands upon GO TO JAIL space 400 , that player must place his or her token in an IN JAIL portion 204 of IN JAIL/JUST VISITING space 200 . A player whose token is in the IN JAIL portion 204 must remain in that space until a dice throw on his or her next turn (or his third turn) is a “double”. If no such double is thrown by the player's third consecutive turn, he or she must pay a $50 fine to the Bank to be freed. A “double” is a dice throw in which each die results in the same number. For example, one type of “double” includes the situation when a “3” is displayed by each of two dice. Once freed from the IN JAIL portion 204 , the player moves his or her token to the JUST VISITING portion 205 of the space 200 . [0076] When a player lands upon the IN JAIL/JUST VISITING space 200 in the ordinary course of play, the player places his or her token in a JUST VISITING portion 205 of the IN JAIL/JUST VISITING space 200 to indicate that he or she is “just visiting”, and is not subject to imprisonment as described above. A player's token is also placed in the IN JAIL portion 204 if he or she rolls doubles thrice in succession during a turn or draws a “GO TO JAIL”-type Sunken Chest or Makin A Wake card, each of which is described in greater detail below. [0077] At the beginning of the game, players start moving their tokens from GO space 100 . As the continuous path wraps around and reaches GO space 100 , players will inevitably either land upon, or pass over, GO space 100 , thus completing a full circuit of the path. Because the path is continuous, there is no point along the board at which play terminates or a player wins. Instead, the termination of play is determined by other facets of the game, the details of which are discussed below. If a player's token lands upon, or passes over, GO space 100 , that player collects $200 from the Bank. [0078] The Makin A Wake spaces 170 , 320 , 460 and Sunken Chest spaces 120 , 270 , 430 represent some of the ups and downs of life on a lake. Metaphorically speaking, a wake from a boat may sometimes tip a boat over, while at other times lift a boat high up in the air. Similarly, a chest found at the bottom of a lake may hold a surprise or two for a person opening it up. [0079] If a player's token lands upon one of the Makin A Wake spaces 170 , 320 , 460 or Sunken Chest spaces 120 , 270 , 430 , he or she must draw a card from the appropriate one of two piles stacked face down at the respective spaces 30 , 40 , as illustrated in FIG. 1A. As best illustrated in FIGS. 3A through 3D, each of the Makin A Wake cards 500 , 505 , 510 , 515 , 520 , 525 , 530 , 535 , 540 , 545 , 550 , 555 , 560 , 565 , 570 , 575 has indicia thereon announcing one of a benefit, a penalty and an instruction to move the drawing player's token 20 to a particular space on the board 10 . Similarly, as best shown in FIGS. 3E through 3I, each Sunken Chest Card 600 , 605 , 610 , 615 , 620 , 625 , 630 , 635 , 640 , 645 , 650 , 655 , 660 , 665 , 670 , 675 has indicia thereon announcing one of a benefit, a penalty and an instruction to move the drawing player's token 20 to a particular space on the board 10 . Preferably, a plurality of the Makin A Wake cards 500 , 505 , 510 , 515 , 520 , 525 , 530 , 535 , 540 , 545 , 550 , 555 , 560 , 565 , 570 , 575 and/or Sunken Chest cards 600 , 605 , 610 , 615 , 620 , 625 , 630 , 635 , 640 , 645 , 650 , 655 , 660 , 665 , 670 , 675 have lake-related indicia associated with a penalty, benefit or instruction. After following the instructions indicated by the indicia printed thereon, the drawing player returns the card face down to a bottom of the appropriate pile at the respective space 30 , 40 . [0080] As best illustrated in FIGS. 1B, 1C, 1 E, 1 F, 1 H and 1 I, in a preferred embodiment, each of the Makin A Wake spaces 170 , 320 , 460 , and Sunken Chest spaces 120 , 270 , 430 includes a picture 174 , 324 , 464 and 124 , 274 , 434 , respectively, illustrative of life at a lake. For example, the Sunken Chest picture 124 , 274 , 434 can be an ornamental illustration of a treasure chest, and the Makin A Wake picture 174 , 324 , 464 can be a scene of a boat traveling fast enough to create a wake in the water. Moreover, as best illustrated in FIGS. 3A through 3I, each Makin A Wake card 500 , 505 , 510 , 515 , 520 , 525 , 530 , 535 , 540 , 545 , 550 , 555 , 560 , 565 , 570 , 575 and Sunken Chest card 600 , 605 , 610 , 615 , 620 , 625 , 630 , 635 , 640 , 645 , 650 , 655 , 660 , 665 , 670 , 675 will either grant a particular benefit, assign a particular penalty, or instruct the drawing player to move his or her token to a particular space, and a picture 501 , 506 , 511 , 516 , 521 , 526 , 531 , 536 , 541 , 546 , 551 , 556 , 561 , 566 , 571 , 576 , 601 , 606 , 611 , 616 , 621 , 626 , 631 , 636 , 641 , 646 , 651 , 656 , 661 , 666 , 671 , 676 illustrative of the benefit, penalty or instruction is also born thereon. More preferably, they are illustrative of the associated benefit, penalty or instruction. More preferably, they are illustrative of a benefit or penalty associated with life at a lake. Descriptions for preferred pictures 501 , 506 , 511 , 516 , 521 , 526 , 531 , 536 , 541 , 546 , 551 , 556 , 561 , 566 , 571 , 576 , 601 , 606 , 611 , 616 , 621 , 626 , 631 , 636 , 641 , 646 , 651 , 656 , 661 , 666 , 671 , 676 may be found in Tables III through VI. Obviously, the invention scope includes any and all illustrations, pictures, designs, schematics, etc. that represent life on a lake. TABLE III Makin A Wake cards Description of Benefit or Penalty Description of Picture “Skier down: go back Illustration of a ski boat three spaces.” speeding away from a water skier flailing in the water, 501. “Ticket for no life Illustration of a judge preserver: pay $15.” holding a gavel while sitting at a desk between two flags, 506. “Set sail to Liberty Lake. Illustration of a sailboat If you pass GO, collect $200.” sailing on a lake, 511. “Take a walk on the lakeshore: Illustration of a boardwalk advance token to beautiful Lake extending around a marina, Couer D'Alene.” 516. “Skier down: go back three Illustration of a ski boat spaces.” speeding away from a water skier flailing in the water, 521. “You overpay interest on your Illustration of a first hand boat loan: bank pays you $50.” handing over paper money to a second hand, 531. “Water ski to Thomson Lake. If Illustration of a person you pass GO, collect $200.” water skiing on a lake, 526. “Pull up anchor and race to GO: Illustration of a boat collect $200.” speeding across a lake, 536. “Go to Jail. Do not pass GO. Illustration of a Coast Guard Do not collect $200.” boat with a flasher towing a smaller boat, 541. “Make a wake to Sun Runner ™ Illustration of a Sun Runner Dealership.” boat, 551. “Get out of Jail freel!“ Illustration of birds peacefully flying across a sunlit sky, 546. “If Dealership is unowned, you Illustration of a boat on a may buy it from the Bank.” lake, 556. [0081] [0081] TABLE IV Additional Makin A Wake cards Description of Benefit or Penalty Description of Picture “Win Fishing Derby: collect Illustration of a person on a $150.” lakeshore holding up a fish larger than himself, 561. “Set sail to the nearest Dam. Illustration of a Dam, 571. If unowned, you may buy it from the Bank. If owned, throw the dice and pay the owner ten times the amount shown.” “Set sail to the nearest Illustration of a boat, 566. Dealership and pay the owner twice the rental to which he or she is entitled.” “Set sail for the nearest Illustration of a boat, 576 Dealership and pay the owner twice what he or she is entitled.” [0082] [0082] TABLE V Sunken Chest Cards Benefit or Penalty Description of Picture “Sell vintage Cris Craft ™, Illustration of one hand collect $200.” handing paper money to another hand, 606. “Your boat broke its prop: pay Illustration of a boat on a $40.” lake that has just lost its prop to the bottom of the lake, 601. “You have won second place at Illustration of a boat Lake Pend Oreille Poker Run: speeding across a lake, 611. collect $100.” “Buy new camping gear for Illustration of campsite, weekend at Lake Roosevelt: pay volleyball court and $150.” treeline adjacent a lakeshore, 616. [0083] [0083] TABLE VI Additional Sunken Chest Cards Benefit or Penalty Description of Picture “Complete boating safety course Illustration of a person and enjoy insurance discount: wearing a graduation-style collect $20.” cap and gown in front of a boat on a trailer, 626. “Restored ski boat wins 1 st Illustration of a first Prize in boat show: collect $50 place ribbon and a boat, from each player.” 631. “You won the Long Lake Poker Illustration of a boat run: collect $25 from every speeding across a lake, 636. player.” “Take a cruise to GO: collect Illustration of a cruise $200.” ship sailing on a lake, 641. “Boat needs repairs: pay $200.” Illustration of a outboard boat motor and a pipe wrench, 651. “Go to Jail. Do not pass GO. Illustration of a Coast Do not collect $200.” Guard boat with a flasher towing a smaller boat, 656. “Overcharged for boat repair: Illustration of a person collect $25.” smiling and receiving paper money from another person, 661. “Win fishing bet by catching Illustration of a person on prize steelhead in Lewiston: a lakeshore holding a fish collect $100 from the player on larger than himself and of a your right.” hand handing over paper money, 671. “Sell old boat trailer: collect Illustration of a boat $45.” trailer attached to a truck, 676. [0084] A roll of doubles allows a player, after completing any actions associated with the space their token is moved to, to roll the dice again without having to wait for a next turn. In this fashion, a player may roll doubles twice or thrice during a single turn. If, however, a player rolls doubles three times in succession during a turn, they must to jail and place their token in the IN JAIL portion 204 of the IN JAIL/JUST VISITING space 200 . [0085] The object of the game is to force all the other players to quit the game because of their inability to meet their financial obligations that develop as the game proceeds. Because each player's token will from time to time land upon a lake area, boat dealership or dams owned by another player, the trespassing player will incur rental charges. Moreover, a player's token will inevitably land upon other spaces exacting some sort of financial penalty. If unable to pay his or her obligations in scrip on hand, the player must dispose of his or her property, i.e., lake areas, boat dealerships, dams, lake cabins, and marinas. Lake areas, boat dealerships and dams may be given to the creditor in satisfaction of the rental payment, sold to any other player, auctioned to the highest bidder, or mortgaged to the Bank in order to raise enough scrip to satisfy the rental payment. Lake cabins and marinas may not be sold to other players, but may be sold back to the Bank at half the purchase price listed on the associated title deed card. [0086] As mentioned above, lake areas, boat dealerships and dams may be mortgaged to the Bank for a mortgage amount listed on the associated title deed card. Once one of the above is mortgaged, the mortgaging player must turn the title deed card face down to indicate that it is mortgaged. If the player wishes to later pay off the mortgage, he must pay back to the Bank the amount of the mortgage principal, plus, according to preferred rules of the game, ten percent interest. If a mortgaged property is transferred to another player without first lifting the mortgage, the new owner must pay ten percent interest immediately upon transfer. In order to lift the mortgage, the receiving player must pay the mortgage principal and an additional ten percent interest. According to preferred rules, no player may mortgage a Lake Area without first selling back to the Bank all of his or her Lake Cabins and Marinas erected upon that Lake Area. As a result of mortgaging a property, no rental payment may be demanded for it if another player trespasses upon that property. [0087] If the trespassing player is unable to meet his or her obligations by selling, transferring or mortgaging lake areas, boat dealerships, dams, lake cabins and marinas, he or she is declared Bankrupt and must quit the game. All of the Bankrupt player's scrip must be given to his or her creditor. All of the Bankrupt player's Lake cabins and marinas must be sold back to the Bank at half price and the scrip given to his or her creditor. All of the Bankrupt player's remaining lake areas, boat dealerships and dams must then be sold by the Bank to the highest bidder(s), or if no bid on a property is made, given to his or her creditor. The scrip resultant from the sale goes to the creditor. If the creditor receives a mortgaged property, the creditor must immediately pay a ten percent interest charge on the mortgage to the Bank as described above, and may optionally pay off the mortgage principal at that time. If the principal is not paid at that time, an additional ten percent interest will be due at the time the principal is actually paid. [0088] Play of the game continues until all but one of the players is Bankrupt. Thus, the remaining player is declared the winner. [0089] It is to be understood that the present invention is not limited to the embodiment described above, but encompasses any and all embodiments within the scope of the following claims.

A game includes: a playing board; a plurality of tokens representing identities of players playing the game; a plurality of title deed cards; a plurality of game pieces; a source of scrip; a plurality of cards each one of which bears indicia related to one of a penalty, an award and a direction; and at least two elements operable by the players in turn for randomly determining movement of the tokens upon the board. The playing board includes a plurality of successive, contiguous spaces defining a continuous path about a periphery of the board. First second and third sets of the spaces identify properties, such as lake areas, dams and boat dealerships, that may be purchased with scrip by a player landing upon the respective space. Title deeds bear indicia indicating a rental payment.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Application Ser. No. 60/828,262, filed Oct. 5, 2006, entitled “Device for Active Treatment and Regeneration of Tissues Such as Wounds,” which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION [0002] The present invention concerns a new device and method for treating tissues and open wounds and accomplishing directed tissue growth. BACKGROUND [0003] Patients with open wounds, which cannot be sutured edge to edge, constitute a major health problem. Such wounds, which may include exposed muscle, tendon or bone, tend to become chronic. Poor blood supply, infection and dehydration are causative factors. Prolonged institutional care is usually required. Non-surgical treatment is usually followed by reconstructive surgery by means of skin grafts, composite tissue transfers or tissue regeneration. [0004] Occlusive, pliable film dressings prevent dehydration and facilitate healing, but only in very superficial open wounds. In deeper wounds, “active” dressings permitting either supply of saline or therapeutic agents and/or suctioning of the wound surface improve healing by reducing tissue swelling, aiding contraction and stimulating healing. Continuously administered solutions influence the wound by diffusion processes. Therapeutic agents may constitute antibacterial substances for treating infection, enzymes for dissolution of non-viable material, growth factors or genes in tissue regeneration. Also cells may be supplied. In clean wounds, dressings combining fluid supply and drainage may facilitate adhesion of meshed skin grafts. [0005] Wound suctioning by means of fluid-absorbing dextranomer beads (range of pressure depending on the degree of saturation of the beads; maximal suction −200 mmHg, that is 200 mmHg below atmospheric) has been reported. A cellular or fibrous (polyurethane, polyester etc) dressing pad with open pores with or without capillary activity, which may comprise layers with different qualities, and which is fitted with an impermeable cover sheet, was described in U.S. Pat. No. 4,382,441 and is incorporated herein by reference. Fluid is administered to the supply port of the said pad by pressure and/or drained from a drainage port by suction, and the supply tube contains a regulator valve. Fluid may thus be supplied to the pad 1) freely without or with suctioning, 2) in a rate-limited way combined with suction at the drainage port, or the fluid supply may be closed and the pad exposed only to suctioning. Using this invention, the wound was exposed continuously both to wetting and suctioning (−150 mmHg and −40 mmHg). Devices allowing intermittent or continuous fluid supply and/or suction drainage through a “spacer” comprising of a matted polyester fiber or polyurethane foam pad placed between the wound and the covering sheet were developed. [0006] The dressing according to U.S. Pat. No. 4,382,441 may also be used for achieving tissue regeneration. An operational example in this said patent discloses that the open polymer dressing pad may be applied on a cell growth substrate (a collagen fiber scaffold, used in tissue regeneration, constitutes one such substrate). Also, growth substances may be supplied from said pad to the substrate, components of the substrate may be replaced and degradation products removed. A dressing according to the invention, used as a viability-maintaining device in vitro, i.e. a bioreactor, is described as an operational example in said patent. Functional Aspects of the Open Pore Dressings [0007] During fluid supply and suctioning through an occlusively applied open pore dressing described in U.S. Pat. No. 4,382,441, the fluid volume forced by suctioning from capillaries and wounded tissue becomes added to that administered through the supply port. Functional aspects of this treatment are demonstrated in vitro in Examples 1-3. Example 1 suggests that in the presence of an unchanged flow resistance—located either in the fluid supply to the dressing or in the tissue—drainage fluid flow rate and suction pressure are directly correlated. The direct correlation between pressures in the drainage port and pad in a wide pressure range (Example 2) confirms previous findings ( 5 ). The dressing pad (Example 3) remains partially saturated even when treatment fluid is supplied at a rate of 7,200 mL/24 h. In vivo, treatment fluid is given at an approximate maximal rate of 2,400 mL/24 h, and the average rates by which tissue fluid form may range from 50 to 1,000 mL/24 h. The combined “maximal” in vivo fluid load of 3,400 mL/24 h (2,400+1,000 mL) thus clearly suggests a partially saturated state (3,400 mL/7,200 mL). The suctioning effect on the wound becomes abolished only when fluid or gas is allowed to enter the dressing freely or when the open pores have become clogged by biological material. Malfunction and Limitations of Open Pore Dressings Used for Combined Fluid Supply and Wound Suctioning on a Continuous or Intermittent Basis [0008] Fluids may be supplied to the dressing either continuously by hydrostatic force from a drip stand, or by propulsion pump. Malfunction related to the hydrostatic pressure of the supplied fluid is at present neither recognized nor corrected for. Elevation of the fluid bag of a gravity drip for instance 68 cm or 136 cm above the dressing yields hydrostatic pressures of +50 and +100 mmHg respectively at the supply port. Dependency of the fluid bag relative to the dressing has the opposite effect. Pressure pumps expose the supply port to higher positive propulsive pressures, and may also include a significant positive or negative hydrostatic pressure component. [0009] Viscous and particulate material or clots may predispose to gradual blocking of hydrophilic, capillary-active dressing pores, in particular near the drainage port. This will reduce the rate of fluid transport and also the suctioning force exerted on the wound surface. An eventually elevated hydrostatic pressure at the supply port becomes transmitted through the dressing pores to the blockage. Once the hydrostatic pressure exceeds the resistance in the dressing, a leak may result in overflow with wetting and soiling. If such blocking events are to be detected, complex electronic controls involving both supply and drainage would be required. A pressure sensor may reproducibly detect a pressure of +100 mmHg, but in a range extending towards +20 mmHg, the rate of false positive alarms will increase and reduce treatment practicality in a resource-demanding way. A simple and reproducible apparatus and method for eliminating hydrostatic pressure and achieving reliably a standardized combination of continuous therapeutic fluid supply with warning of impending dressing pore blockage is lacking, both in clinical wound treatment and tissue regeneration. [0010] Known open pore dressings with supply and/or drainage ports (e.g., Principal AB, Malmö, Sweden; Kinetic Concepts, San Antonio, USA) lack means for reliable intermittent administration of saline or drug solution by injection during ongoing suctioning at the drainage port. Although local injection through the supply port can be accomplished with such devices, the need to leave the port open when fitting and removing a syringe or small volume fluid bag leads to immediate pressure equilibration between air and pad both before and after injection of the dosage. The first results in evacuation of the fluid representing the continuously supplied dosage from the pad, and the second in evacuation of the locally injected dose. A reliable apparatus and method for distributing treatment fluid intermittently to the wound tissue during continuous suctioning is thus lacking. [0011] Bleeding from the wound during ongoing suctioning is an infrequent but at times life-threathening complication, which manifests itself by blood or plasma being sucked from the dressing. A simple means which may allow reproducible early detection of bleeding during ongoing suctioning is lacking. SUMMARY [0012] In one or more embodiments, the use of positive hydrostatic or pump pressure as driving force for supplying fluid continuously to the open pore dressing is eliminated or minimized, and treatment fluid is sucked through the dressing pores by means of the suction pump used for distributing negative pressure to the wound. The placement of a fluid bag in bed at the level of the wound is impractical and prone to physical disturbance. Instead, the fluid reservoir (usually a pliable fluid bag) is placed on a support comprising a sloping or horizontal surface and the hydrostatic pressure is eliminated or minimized (i.e. to the level required for neutralizing flow resistance) by moving this said support vertically along a pole. This latter allows the fluid bag to be manually or automatically positioned level with the wounded tissue irrespectively of its height above the floor. The positioning may be facilitated using a horizontal level measuring device. In this apparatus and method, dependent on suctioning for function, one sensor which measures fluid supply rate will suffice for detecting malfunction. [0013] A fluid administration set, intended to be used with the said fluid bag resting on said sloping or horizontal surface, comprising a drip chamber with angulated entry channel, which allows drops to fall freely, permits visual or automatic drop count. The said set may be fitted with a horizontal level meter and an injection port. [0014] A supply port comprising of an elastic injection membrane is described. Intermittent doses of saline or drug solution can be administered against a resistance (cannula, syringe piston/wall contact, iv set rate-controlling device) from a syringe or fluid bag through this said elastic membrane to a dressing exposed to suctioning. This injection mode blocks air entry during connection and removal of the syringe, and allows the supplied fluid to distribute evenly throughout the dressing and over the wound surface as a result of vacuum and capillarity. Once fluid is detected visually in the suction tube a full intermittent dose has been given. [0015] To prevent blocking the dressing pores at the drainage port by biological material, a suction port device is disclosed which contains an open grid means interposed between the whole area of said port and the open polymer dressing. This device maximally increases the area of dressing directly exposed to suctioning, augmenting the capacity of said port to eliminate particles and debris and increasing the duration of full function of the open pore dressing. [0016] When using the dressing to supply nutrients for tissue regeneration, the rates of fluid transport and suctioning in the scaffold can be reduced to low levels to leave diffusional and cellular processes undisturbed. This is accomplished either by avoiding or minimizing hydrostatic pressure or pump head (to a level just sufficient to overcome both supply tube and open pore or tissue scaffold flow resistance) and applying concomitantly weak suction at the drainage port. In this latter situation more complex monitoring may be included. [0017] An apparatus and method of allowing detection and warning of bleeding from a wound treated by suctioning comprising a computer connected with a scale, which measures serially the weight of the fluid sucked off the wound into an immobilized canister, and gives warning when the rate of fluid formation increases beyond that measured prior to the bleeding. BRIEF DESCRIPTION OF THE DRAWINGS [0018] Embodiments of the present invention will now be described by way of example only and with reference to the accompanying drawings of which: [0019] FIG. 1 shows a schematic view of a dressing system, according to an embodiment of the invention. [0020] FIG. 2 shows two schematic cross-sections of another embodiment of the vertically movable rest including an alternative means for fixing said pole via a hook that can be clamped to the footboard of a bed. [0021] FIG. 3 shows schematically an embodiment which includes motorized means for moving and fixing said platform at the desired level relative to the wounded tissue. [0022] FIG. 4 shows a schematic cross-section of a fluid administration set for treating wounded tissue. [0023] FIG. 5 shows an embodiment of said fluid administration set which includes a level meter and an injection port. [0024] FIG. 6 shows a schematic cross-section of an open pore polymer dressing. [0025] FIG. 7 shows a schematic cross-section of a non-protruding membrane injection port allowing intermittent supply of fluid during suctioning. [0026] FIG. 8 shows a schematic perspective view of said port integrated in a dressing cover sheet used for self-assembly. [0027] FIG. 9 shows a schematic cross-section of another embodiment of a membrane injection port invention. [0028] FIG. 10 shows a schematic cross-section of a drainage port invention with open grid. [0029] FIG. 11 shows a schematic cross-section of dressing having an open pore dressing overlying a scaffold used for tissue regeneration, according to another embodiment of the invention. [0030] FIG. 12 shows a schematic cross-section of a device for detecting bleeding from the wound. DETAILED DESCRIPTION [0031] FIG. 1 shows one embodiment of the apparatus according to the invention. The dressing is sealed to the wounded tissue by means of a pliable polymer sheet. Treatment fluid contained in a pliable bag reservoir is connected to the supply port of the dressing by way of flexible tubing, while a suction pump is connected by tube to a drainage port. Fluid bag and horizontal level meter are placed on a rest which is movable along a pole in a vertical direction, and can be fixed in a position which is level with the wound. The pole is fixed on a base which holds a suction pump with canister. [0032] More specifically, patient 1 is being treated with an open polymer dressing pad 2 sealed to the wounded tissue by means of a pliable polymer sheet 3 . The means for accomplishing fluid flow comprises a pliable bag filled with treatment fluid 4 which is placed on rest 5 . This bag connects by its outlet 6 to a drip chamber 7 which is followed by a flexible supply tube 8 comprising a fluid rate controlling device 9 and injection port 10 before connecting with the supply port 11 of the dressing 2 . A rest 5 which is sloping in the area of the fluid bag is shown. The bag 4 is positioned on rest 5 with outlet 6 dependently, facilitating complete drainage and displacing eventual contained air upwards. The rest 5 can maintain fluid bag 4 in a flat or inclined plane in a range between 0° and 30°, allowing full fluid evacuation without, or with minimal, height difference between full and empty bag. A dressing drainage port 12 is connected by tube 13 to suction pump 14 . Suction pump 14 and/or its fluid canister 15 may be connected to the line of suction anywhere—including on rest 5 —where it may effectively drain fluid and prevent build-up of significant hydrostatic pressure within said tube 13 . Canister 15 may be fitted with a scale 16 to allow determination of fluid volumes. The suction pump 14 may be fixed to the base 17 , pole 18 or rest 5 by means of a screw, clamp or elastic strap. Rest 5 is movable in vertical directions along pole 18 and fixed by means of a clamp 19 in a position where the fluid surface in bag 4 and the supply port 11 of the dressing are level, i.e. the hydrostatic pressure at port 11 is at or near zero. This adjustment may be accomplished using a height indicator means 20 which may be connected with said rest 5 . The means 20 may constitute for instance a horizontal level meter fixed either to a rewindable cord or to the proximal end of tube 8 , or alternatively a telescopic pole or low energy red laser pointer connected with rest 5 . The base 17 may be fitted with wheels 21 . The rest 5 , pole 18 , and base 17 can for instance be made of aluminium, stainless steel or polycarbonate. Rest 5 can be moved along pole 18 manually, and locked at a suitable level by said clamp 19 , or the pole may be height adjustable, constituted for instance of telescoping tubular sections which can be locked by screws at required length. The disclosed base 17 with pole 18 and rest 5 may be adapted for self-assembly. [0033] FIG. 2 shows an embodiment of an apparatus according to the invention, which rids the rest 5 and its pole 18 of contact with the floor. In this device the footboard 22 of the bed is used as base. The construction minimizes the area of working-space occupied by the treatment devices and tubing. Rest 5 with U-shaped pole 18 is fastened to the footboard 22 by means of a hook-like structure 23 which may comprising elastic polymer or metal. The U-shape of pole 18 may allow positioning of rest 5 within a vertical range corresponding to the combined length of the two parallel vertical parts of pole 18 , allowing the total length of pole 18 to be minimized. Immobilization of pole 18 is achieved by means of clamps 19 and 24 . The fluid bag 4 , placed on rest 5 with its outlet 6 dependent, is kept in place by vertical bars 25 . An ultrasound distance sensor 26 is fixed to hook 23 —for instance by means of an elastic or rewindable cord 27 —and used for determining the horizontal level by measuring distances from wound and fluid bag to the roof. The device according to FIG. 2 may also be adapted for self-assembly. The straight pole 18 shown in FIG. 1 may fit in clamp 24 shown in FIG. 2 and used as an alternative to the u-shaped pole. [0034] FIG. 3 shows an embodiment of an apparatus according to the invention, which may allow automatic movement and fixation of a horizontal rest 5 at a height along said pole 18 corresponding to the level of the wounded tissue at the press of a button. This may be accomplished by means of a unit comprising a computer 28 connected electronically with ultrasound sensors 26 and 29 and an electrical motor 30 . The said motor 30 operates a cog-wheel 31 which meshes with another toothed part 32 extending along pole 18 . Wire-based or hydraulic mechanisms may also be used. Once the said computer 28 receives for instance telemetric input on the distance from the wounded tissue to the roof from sensor 26 after activation by the therapist, computer 28 activates sensor 29 and moves rest 5 vertically to the same level. The said rest 5 may maximally be moved vertically in a range from 10 cm to 200 cm above floor level, which corresponds approximately to that of a lower leg wound on a sitting or standing patient and a wound on the head of a standing patient. The range of movement may also be restricted to fit patients lying or sitting in bed, with a range from 30 cm to 150 cm above floor level. [0035] FIG. 4 shows an embodiment of an apparatus used according to the invention for administering treatment fluid from a fluid bag in a sloping or horizontal position. It comprises a transparent drip chamber 7 with an angulated entry channel 33 between the spike 34 and chamber 7 . Said angulated entry channel 33 may be rigid or elastic, bendable to a chosen angle, and preferably made of polymer material. The chamber 7 is made of rigid polymer material. Tube 8 is made of pliable polymer material whose walls may be Luer format. The tube is fitted either with a roller clamp 9 or other mechanically or electronically operated device for controlling the flow rate—accomplished either by external compression of tube 8 or another known means of lumen reduction—and finally includes a connector 35 to the dressing supply port 11 . The angulated entry channel 33 permits the chamber 7 to be approximately vertically positioned with the connected fluid bag placed on sloping or horizontal rest 5 . This allows drops to fall freely in the chamber, permitting secure reading of the drip rate. Drip chambers of interest allow 40-80 drops per ml when exposed to negative pressures as high as 150 mmHg. Standard Luer format of tube 8 , roller clamp 9 and connector 35 may be used but not obligatorily. The connector 35 to be fitted on the dressing port tube may alternatively constitute an elastic tube. [0036] FIG. 5 shows a further embodiment of apparatus according to the invention to administer treatment fluid from a fluid bag. It differs from that described in FIG. 4 by including a horizontal level meter 36 and a tubular injection port connector 37 . The latter may include tap 38 for directional control. The tubular connector 37 may be substituted by an elastic injection membrane. Said level meter 36 , comprising for example a small gas bubble enclosed in a transparent glass tube filled with liquid fluid, is connected with the tube 8 for instance by arms 39 embracing tube 8 . The level meter 36 should preferably be positioned near the drip chamber 7 to allow the meter 36 to be read while adjusting the height of the fluid bag 4 on rest 5 to match that of dressing 2 . Connector 37 may be used for adding a drug dose to pad 2 during ongoing continuous supply and suctioning. To achieve optimal drip rate readability in chamber 7 of the embodiments shown in FIGS. 4 and 5 , the combined angle of entry channel 33 and rest 5 for the fluid bag should be 90°. [0037] Both the supply tube 8 and suction tube 13 may be thick-walled and/or corrugated at the inside to withstand kinking and compression, with inner diameter of approximately 3 mm. The suction tube 13 and canister 15 may be manufactured in pliable polymer materials. The sensor which measures fluid supply rate is suitably connected with an alarm. [0038] In special situations, in particular associated with low-flow tissue culturing applications using pressure pumps, monitoring of volume rates of fluid supply and drainage may be included, as may pump head pressure and inadvertent gravity free flow. The propulsing force or head of the pressure pump should be just sufficient to achieve fluid flow. The pump should suitably be connected with a pressure sensor in the tube 8 or pad 2 to allow detection and adaption to a pump-related pressure disturbance. Computerized alarms concerning start/stop, occlusion, overflow and air-leak conditions may be applied. Known pressure and/or ultrasonic transducers or optical sensors may be used. A drip-sensing device may be attached to drip chamber 7 . A timer-activated clamp may allow the fluid supply tube of a drip set to open and close at user-defined intervals, and a timer may control the start-stop function of the suction pump. [0039] FIG. 6 shows an example of an open pore dressing with its pad 2 placed on the wound 40 and covered by a pliable, adhesive film or sheet 3 , which is adhered to the adjacent skin 41 . One supply port 11 and one drainage port 12 are adhered to the sheet 3 at a distance from each other. Each port is fitted with a tubular member, which allows the port to be connected to known supply or drainage tubes. Corresponding to these ports, apertures through the said sheet 3 allow access to pad 2 for fluid supply and suction drainage respectively. Flexible tubes are connected airtightly with the said ports 11 and 12 , for instance by means of luer lock or elastic tube being forced over a conical rigid and tubular end-piece. The said sheet 3 , ports 11 , 12 and tubing 8 , 13 provide a seal which allows the negative pressure within pad 2 and on the surface of wound 40 to be contained at a predefined level at least during operation of the suction pump. Pad 2 may comprise cell material with open pores or spatia like polyurethane or polyester foam or polyester fibers, and the latter may be matted. Pad 2 may include layers in which the pores and/or spatia have different dimensions. A thin dressing layer sandwiched between pad 2 and the wound surface may comprise knit or woven biofiber like cotton, wool or silk containing capillary functioning pores. This layer may be cut to fit sensitive areas of the wound where blood vessels and nerves are superficial or exposed. The sheet 3 may be fluid- or air-impermeable and is typically produced in polymer material (Minnesota Mining and Manufacturing, St. Paul, Minn. 55144). Pad, ports and tubes may be assembled either during fabrication, or bedside by the user. In a method according to the invention intended for treatment of wounds by means of the dressing shown in FIG. 6 , the pressure at the supply port of the dressing is typically 0 mmHg, including correction for tube friction. This level of pressure is combined with suctioning at the drainage port ranging between −20 mmHg and −200 mmHg. This treatment may be applied intermittently or continuously for variable periods of time. The maximal suction applied under these circumstances is −760 mmHg. Fluid is supplied according to the invention at rates which may vary between 100 ml/24 h and 2,000 ml/24 h and loading doses for filling the dressing with drug solution may vary between 1 ml and 500 ml. This treatment may be undertaken on a continuous or intermittent basis. [0040] An injection port device can be used for adminstering treatment fluid intermittently to the complete wound surface underneath dressing pad 2 . This administration is always accomplished during ongoing suctioning through the drainage port 12 . This apparatus, shown in FIG. 7 , comprises an elastic membrane 42 which must have qualities which allow maintainment of occlusion after being perforated repeatedly by a needle. Membrane 42 may be connected adhesively to sheet 3 , and the construction may or may not include a hole in said sheet 3 corresponding to the center of membrane 42 . In connection with injection by needle through said membrane 42 , the elastic qualities of membrane 42 should prevent formation of needle holes which could result in elimination of the vacuum in dressing pad 2 . The membrane device may also be available as a separate unit with an adhesive rim at its circumference, the latter covered by removable protective paper, whereby said device can be applied adhesively around a hole in a dressing sheet 3 in a known manner. Finally, an adhesive, reusable and pliable lid may be placed on membrane 42 to maintain sterility between injections. [0041] FIG. 8 shows an injection port apparatus according to FIG. 7 which is integrated in a pre-fabricated dressing sheet 3 intended for self-assembly, such that the dressing becomes complete by inclusion of dressing pad 2 and drainage port 12 . [0042] FIG. 9 exemplifies another embodiment of the said injection port apparatus, and comprising a rigid frame 43 which may be circular, and which is adhesively connected with the edges of a hole made in flexible sheet 3 covering the pad 2 . The frame is likewise airtightly connected with elastic membrane 42 . Frame 43 may be fitted with a lid 44 , a handle 45 , a joint 46 and a flange 47 . When the device is not in use, lid 44 is closed over membrane 42 . In this process, flange 47 enters a slit 48 in frame 43 to maintain secure occlusion. The membrane may optionally be protected by an adhesive tape patch 49 when not in use. Underneath the said membrane 42 is a rigid impermeable plate 50 which is connected by side walls 51 to said frame 43 , and said walls 51 are fitted with apertures 52 . The plate 50 may prevent the needle from inadvertently entering the wounded tissue in situations where the pad is thin. The membrane of the device according to FIG. 9 can suitably be manufactured in natural or synthetic rubber or elastic polymer including silicone. The frame, lid and plate structures may be manufactured in, for example, known, rigid polymer materials, and plate 50 may contain metal to prevent needle penetration. In operation during ongoing suctioning the lid 44 is opened by its handle 45 , the piece of tape 49 is removed. A needle connected with a fluid-filled syringe is advanced through said membrane 42 while the membrane 42 is stabilized by holding lid 44 . The fluid is slowly injected, allowing it to become distributed throughout the dressing by suction and capillary force. The supply of fluid may be terminated once fluid appears in the drainage tube. After injection the needle is removed and tape 49 and lid 44 are repositioned. [0043] FIG. 10 shows an embodiment of an apparatus according to the invention comprising a drainage port which facilitates drainage of debris through a capillary-active dressing pad. It comprises a drainage port tube 53 with flange 54 sealed to pad 2 by means of an adhesive sheet 3 . An open grid 55 adhered to the flange covers the entry to the opening 56 in the flange in order to avoid obstruction of dressing material against the edges of said opening 56 . The grid is preferably manufactured of semi-flexible or rigid cells with open pores or spatia made of polymer materials, for instance polyester, polyurethane or steel wool, all typically less compressible to suction than dressing pad 2 . [0044] FIG. 11 shows an apparatus and method according to the invention comprising an open polymer pad 2 overlying a tissue culturing scaffold 57 used for regenerating skin tissue in a wound 40 . The adhesive cover sheet 3 , the supply port 11 and suction drainage port 12 are indicated. Depending on which type of tissue is to be regenerated, the scaffold may comprise biological and/or non-biological material. A biological scaffold may comprise collagen or dermis, hyaluronic acid or fibrin. When regenerating bone the scaffold may comprise bioactive ceramics or glass. Non-biological polymer fiber scaffolds may be biodegradable and comprise, for example, poly-glycolic acid polyester (PGA) or related substances. The optimal pore size of the scaffold may vary with the phase in the growth process. Passage by diffusion of all relevant nutrients and growth substances is obligatory throughout the regenerative process, and cell and vascular structures will have to be accommodated as they develop. The scaffold may thus include a range of more narrow pores which allow passage of molecules including peptides and proteins, as well as a range of wider pores allowing passage of cells, and this pore ratio may vary with the degree of tissue development. Antibacterial substances, analgesics, enzymes, growth factors, growth media and cells, including stem cells, fetal cells and genes, may be supplied. [0045] In a method for accomplishing tissue regeneration in vivo or in vitro, see FIG. 11 , the positive and negative pressures applied to pad 2 should be minimized in order to leave diffusional and cellular processes in the growth zone of the underlying tissue scaffold undisturbed. The forces governing the passage of fluid through the scaffold should be determined mainly by diffusion and minimal suction. This is accomplished in a controlled way by combining zero hydrostatic pressure or minimal pump head pressure in the dressing with at most weak suction at the drainage port. The hydrostatic pressure in the dressing can be 0 mmHg including compensation both for tube and open pore and/or tissue scaffold resistance. The suction pressures can range, for example, from −0 mmHg to −30 mmHg. The fluid supply rates may typically vary between 20 ml/24 h and 400 ml/24 h and loading doses for filling the dressing with drug solution may vary between 1 ml and 100 ml. This treatment may be undertaken on a continuous or intermittent basis. The pad 2 may be substituted for a tissue scaffold when the porosity of the scaffold allows passage of treatment fluid under flow and pressure conditions as defined above. [0046] FIG. 12 shows an apparatus according to an embodiment of the invention for detecting bleeding from the wound during ongoing suctioning by a simple weighing technique. Canister 15 is immobilized in a tight-fitting receptacle 58 placed over load sensor 59 , which in turn is connected to computer 60 , display and control-panel 61 , loudspeaker 62 and telemetric unit 63 , all constructed according to the state of the art, and being part of the basal part 64 of the said apparatus. Elastical force or movement in suction tube 13 , or movement in the pump 14 in operation, is prevented from being propagated to canister 15 by means of tubular buffer organs 64 and 65 , each comprising a rigid and a pliable part. The rigid part constitutes in this example two closely fitting openings in the rigid receptacle wall 66 . The pliable tubular part 67 is designed to further minimize movement and elastic force. The rigid part of each buffer organ may comprise polymer or metal. The pliable tubular part can be made of elastic polymer fitted with an inner discontinuous “skeleton” of rigid material to prevent collapse and occlusion. The pump 14 is additionally isolated with regard to vibration by means of elastic layer 68 placed between the base of the pump 14 and the basal part of the apparatus containing the computer and control means. This part of the apparatus can be made of metal to avoid vibration and increase stability. [0047] The scale 59 may be operated by a load cell according to the state of the art. The computer 61 measures the weight of fluid in the canister 15 at pre-set intervals, and stores and displays the data using simple state of the art technology. The computer 61 first determines the baseline rate and variability of the therapeutic fluid formation over time based on measurements for instance at 2-5 min intervals. The smallest rate of fluid formed in addition to the therapeutic rate, which is to be considered as sign of a bleeding, is decided by the user and fed into the computer 61 . The computer 61 then subtracts incoming rates from baseline serially and gives an audible, visual and possibly telemetric alarm once bleeding is detected. A bleeding in the wound may manifest itself 1) as a stepwise increase in liquid fluid weight 2) as a linear increase or 3) as an exponential increase. In a more advanced design, such patterns may also be identified and used by the computer as additional signs of bleeding. The computer can also warn of overflow of fluid in canister 15 . EXAMPLE 1 [0048] Fluid flow rates in the dressing were studied in vitro as a function of the negative pressure applied at the suction port. The flow resistance was unchanged throughout. EXAMPLE 1 [0049] [0000] Suction Flow rate mmHg (%) ml/24 h (%) −50 (−100) 144 (100) −100 (−200) 360 (250) −200 (−400) 624 (433) [0050] Table I. Rate-limited fluid flow vs suction pressure in occlusively applied open polymer dressing with supply and drainage ports, studied in vitro. [0051] The dressing comprising polyester fibers (11×13 cm) covered occlusively by polymer film and fitted with supply and drainage ports at opposing ends. The dressing was positioned horizontally. [0052] The hydrostatic pressure at the supply port was 0 mmHg and the flow resistance in the supply was unchanged during the experiments. Fluid flow at the entry to the dressing and pump pressure were measured according to the state of the art. DISCUSSION [0053] In this situation with unchanged resistance to entry of fluid into the porous dressing, fluid flow rate and suction pressure were close to linearly related. EXAMPLE 2 [0054] The negative pressure and degree of hydration in the dressing were studied in vitro as functions of the negative pressure at the drainage port. EXAMPLE 2 [0055] [0000] Step 1 Step 2 Step 2 Step 3 Fluid flow 1440 1440 1440 1440 rate (ml/24 h) Drainage −15 −50 −100 −200 port gas pressure (mmHg) Open pore −13 −46 −93 −180 gas pressure (mmHg) Dressing 52 40 50 35 fluid saturation (Per cent) [0056] Table 2. In vitro assessment of pore gas pressure and fluid saturation during treatment according to the invention. [0057] The dressing comprising polyester fibers (11×13 cm) covered occlusively by polymer film and fitted with supply and drainage ports at opposing ends. The dressing was positioned horizontally. [0058] The hydrostatic pressure at the supply port was zero. Fluid flow was unchanged throughout the experiment. Pressure was measured in the drainage port and on the surface of the dressing pad. Dressing fluid saturation was measured by weighing, and calculated as percentage of the total saturable volume under influence of negative pressure as indicated. DISCUSSION [0059] Suction pressures at the drainage port and within the pad were correlated over a pressure range of therapeutic interest. The dressing pad was partially saturated with fluid (mean: 44 percent, range: 35-52 percent). Clinically, a wound would thus be exposed dynamically to a combination of wetting and suction. EXAMPLE 3 [0060] The drainage capacity of a dressing exposed to fluid loading was studied in vitro. EXAMPLE 3 [0061] In vitro assessment of the drainage capacity of a dressing exposed to fluid loading. [0062] The dressing comprising polyurethane foam (10×7.5 cm) covered occlusively by polymer film and fitted with supply and drainage ports at opposing ends. The dressing was positioned horizontally. [0063] Fluid supply was increased from 20 drops/min to 100 drops/min in steps of 20 drops. The hydrostatic pressure at the supply port was zero. The suction pressure applied at the drainage port was −50 mm Hg. The thickness of the dressing was used as a measure of its compressed volume, and measured at each step. Dressing fluid saturation was assessed in the last step of the experiment, and determined as the percentage between the fluid contained in the dressing (assessed by weighing) and the total saturable volume assessed volumetrically during maximal suctioning. RESULT [0064] The height of the dressing at each step of the experiment was compressed to approximately 7 mm. The dressing fluid saturation at 100 drops/min (equal to 7,200 mL/24 h) was 50/63 mL, and the maximal saturation thus 80%. DISCUSSION [0065] This small format dressing remains partially saturated even when fluid is supplied at a rate as high as 7,200 mL/24 h. The results indicate that drainage capacity and hence a local suctioning effect is functional in a wide volume range at a pressure of −50 mmHg. CONCLUSION [0066] In one embodiment, an apparatus for treating and regenerating tissues, covering a wound, combining liquid fluid supply and suction, comprises a pole, a rest, said rest being movable in vertical directions along said pole and having a clamp for securing said rest at a height corresponding to the height of the tissue, at least one fluid reservoir placed on said rest, connected to the tissue, and means for controlling the fluid supply and suction. [0067] The rest can form an angle, for example, in the range 0-30° to the horizontal. The rest can be hinged, and immobilized in any angle from horizontal to vertical. The range of vertical movement of the rest can be, for example, approximately 10-200 cm, including for example 30-150 cm. A horizontal level meter can used for securing said rest at a height corresponding to the height of the tissue. The level meter such as a telescopic pointer, laser pointer or ultrasound sensor, can be connected with said rest directly or by means of a cord. [0068] The fluid reservoir can comprise a pliable and flexible bag filled with treatment fluid. The fluid supply can be connected with the tissue by means of a tube. [0069] The controlling means can include a drip chamber and a roller clamp connected with said tube. The controlling means include a drip chamber with an angulated spike connected with said tube. The controlling means can include a level meter connected with said tube. The controlling means can include an injection port connected with said tube. The means controlling the fluid supply can comprise an electronically operated valve. The means controlling the fluid supply can comprise a kink-resistant supply tube. [0070] The apparatus can further comprise at least a drop-sensitive sensor for assessing the flow rate. The suction means can comprise a suction pump placed on the platform and connected to the tissue by means of a tube. The inner wall of said tube can be corrugated. The suction pump can be connected to a canister whose liquid fluid content can be determined by means of a scale or by weighing. The suction means can comprise a suction pump is placed on the floor. The suction means can comprise a pump is fixed to the pole by means of a clamp. [0071] The pole is, for example, u-shaped and fixed by means of a clamp to a hook which can be fastened to the footboard of a bed. The pole can be straight and fixed to a base. The pole can comprise telescoping parts which can be locked in position by means of screws, clamps or by a hydraulic mechanism. [0072] The apparatus can farther comprise a motor which moves said rest in a vertical direction and which is operable by means of a computer. The apparatus can also comprise ultrasound level meters, one fixed and one movable, and both connected to said computer. The apparatus can further comprise a pump used for administering the fluid supply. The pressure head of the said pump can be monitored by means of a sensor in the supply tube. The fluid flow can be controlled by means of timer activated clamps. [0073] In one embodiment, apparatus for treating and regenerating tissues allowing administration of a restricted amount of fluid to the supply port of an occlusively applied porous dressing pad during exposure of said pad to continuous suctioning through a separate drainage port, comprising a restricting means preventing free fluid flow, a means to prevent ingress of air through said supply port in connection with said fluid administration, and a drainage port. [0074] The supply port can comprise of an injection membrane airtightly connected with a polymer sheet. The supply port can comprise a plate at the side of the dressing pad which can prevent a needle used for injecting treatment fluid through said membrane from penetrating into the dressing and to the wound. [0075] The apparatus can further comprise a roller clamp that provides additional restricting means. The friction between piston and syringe wall can provide additional restriction means. [0076] In another embodiment, a method for treating and regenerating tissues allowing administration of a restricted amount of saline or drug solution to the supply port of an occlusively applied porous dressing pad during exposure of said pad to continuous suctioning, comprises: applying continuous suction to the drainage port in the range between 30 and 200 mmHg; applying an injection needle airtightly to a syringe or fluid bag filled with saline or drug solution; avoiding a fluid bag hydrostatic load; perforating said supply port elastic injection membrane with the needle during ongoing suction at the drainage port of said dressing pad; injecting the content of the syringe into the dressing pad in 1-5 minutes during ongoing suctioning at said drainage port; stopping the injection once injected fluid becomes visible through the suction tube wall as it exits the drainage port of the dressing pad; and withdrawing the said needle from the elastic membrane. [0077] In yet another embodiment, a method for non-regenerative tissue treatment by means of combined fluid supply and suction drainage to a porous dressing, comprises: eliminating hydrostatic pressure in the fluid supply port by positioning the fluid bag at the level required for neutralizing supply tube flow resistance; maintaining the tissue hydrostatic pressure at the supply port at 0 mmHg; maintaining the fluid flow in a range between 100 ml/24/h and 2,400 ml/24 h; providing a seal which allows negative pressure to be distributed over the tissue and to be maintained at a predetermined level at least during operation of the suction; [0000] maintaining the suction normally in a range between −20 mmHg and −200 mmHg, maximally −760 mmHg; utilizing loading doses in the range between 1 ml and 500 ml; and applying steps a-f continuously or intermittently. [0078] In yet another embodiment, a method for regenerative treatment by means of combined fluid supply and suction drainage to a tissue scaffold, comprises: eliminating hydrostatic pressure by positioning the fluid bag at a level just sufficient to overcome both supply tube and/or open pore scaffold flow resistance; maintaining the fluid flow in the range between 20 ml/24/h and 400 ml/24 h; providing a seal which allows negative pressure to be distributed over the tissue and to be maintained at a predetermined level at least during operation of the suction; maintaining the suction in the range between −0 mmHg and −30 mmHg; utilizing loading doses in the range between 1 ml and 100 ml; and applying steps a-e continuously or intermittently. [0079] In yet another embodiment, a method for regenerative treatment allowing artificial circulation to a tissue scaffold, comprises: eliminating hydrostatic pressure by positioning the fluid bag at a level just sufficient to overcome supply tube, porous pad and/or scaffold flow resistance; controlling fluid supply rate by interposing a pump in the supply line; monitoring the pressure head in the supply port; monitoring the pressure in the porous pad or scaffold; maintaining the tissue hydrostatic pressure at the supply port at 0 mmHg; maintaining the fluid flow in the range between 20 ml/24/h and 400 ml/24 h; providing a seal which allows negative pressure to be distributed over the tissue and to be maintained at a predetermined level at least during operation of the suction; maintaining the suction in the range between −0 mmHg and −30 mmHg; utilizing loading doses in the range between 1 ml and 100 ml; and applying steps a-i continuously or intermittently. [0080] In another embodiment, an apparatus for treating and regenerating tissues by means of an occlusively applied dressing pad, comprises a drainage port with means to counteract occlusion of the underlying open pores of the pad when said pad is exposed to continuous suction. The drainage port means can comprise an open grid consisting of interconnected or separate units which form a pattern covering the whole underside of the port abutting the dressing pad. The grid can include the opening in the flange. [0081] In another embodiment, an apparatus for detecting bleeding from a wound during continuous suctioning treatment comprises a receptacle, a scale, a canister, movement buffer organs, a computer, visual display, audible alarm and telemetry. [0082] In another embodiments, a method for detecting bleeding from a wound during continuous suctioning treatment, comprises: determining the baseline rate and variability of therapeutic fluid formation over time based on measurements of net weights of fluid in the canister at 2-5 min intervals; determining of the minimal rate of fluid formed in addition to said baseline rate which is to be considered as a sign of bleeding, and feeding this information to the computer; making the computer subtract incoming rates of fluid formation from baseline serially, and giving an audible, visual and telemetric alarm once bleeding is detected.

Hydrostatic pressure of aqueous solutions—supplied from reservoir under rate control through tube to port of airtightly applied open pore dressing pad—is eliminated by levelling reservoir placed on rest with pad. Dressing pad may overlie a tissue culturing scaffold. A drip chamber with angulated channel permits drops to fall freely and be counted. Injection port elastic membrane prevents air inlet to pad while suction is applied at port, permitting fluid given under rate control through membrane to distribute evenly in pad. A drainage port flange, wholly covered by an open grid, is described. Acute wound bleeding is detected by computer-controlled serial weighing of a movement-stabilized drainage fluid canister with warning of abnormal flow rate increase.

PRIORITY CLAIM In accordance with 37 C.F.R. 1.76, a claim of priority is included in an Application Data Sheet filed concurrently herewith. Accordingly, the present invention claims priority to U.S. provisional patent application Ser. No. 61/785,423, filed on Mar. 14, 2013, entitled “EXPANDABLE CORPECTOMY DEVICE”, the contents of which are hereby expressly incorporated herein by reference. FIELD OF THE INVENTION The invention generally relates to improvements to vertebral implants and, more particularly, to a longitudinally expandable vertebral implant including telescoping sections configured for incremental expansion by a ratchet expander for ease of securement at any desired increment in situ. BACKGROUND OF THE INVENTION The spine consists of vertebrae that are categorized into sections known as the cervical, thoracic and lumbar section in a flexible arranged column. The vertebrae are separated by small cartilaginous cushions known as intervertebral discs. Intervertebral discs are oblate spherical structures that maintain the space between adjacent vertebrae. Each intervertebral disc consists of an outer annulus fibrosus, which surrounds the inner nucleus pulposus. The annulus fibrosus consists of several layers of strong annular fibrocartilage to contain the nucleus pulposus and distribute pressure evenly across the disc wherein a mucoprotein gel serves to absorb shocks. Deterioration of an intervertebral disc results in limited mobility and can cause severe pain. For instance, normal aging causes the nucleus pulposus to lose fluid and contract in volume resulting in a reduction in the intervertebral space. Any reduction of space between adjacent vertebrae may put pressure on the nerves of the spinal column. Further, a reduction in volume of the nucleus pulposus reduces the disc's ability to absorb shock which can result in disc herniation. The bulge of a herniated disc may also put pressure on nearby nerve structures resulting in pain as well as diminished range of motion. Surgical options are available including laminectomy and discectomy combined with vertebral fusion and/or dynamic stabilization. However, these surgical options are highly invasive and require prolonged hospitalization and recovery. More recently, artificial disc replacement prosthetics have been used to replace or augment all or part of the removed or resected intervertebral disc. In order to reduce the pain associated with the movement of the intervertebral joint, surgical intervention is often indicated as a means to alleviate pressure upon the spinal cord while concomitantly stabilizing the associated vertebrae. This involves a surgical procedure to distract the disc and or vertebra, or portions thereof, and the insertion of bone fusing material into the cavity of the opposing vertebra. Corpectomy devices have been developed to help support the spine and maintain the normal spacing between opposing vertebrae. Some of these devices may be packed with fusing material to ensure solid bone growth between the two vertebrae. Typically, corpectomy devices are manufactured at various heights requiring that a cavity between opposing vertebrae be distracted to a dimension corresponding to the sized corpectomy device. The surgical procedure to prepare the implant site can be difficult and lengthy. Moreover, the procedure can increase risk of trauma to the tissues surrounding of the implant site. SUMMARY OF THE INVENTION The instant invention is a longitudinally adjustable corpectomy device which fits within the intervertebral distracted channel. The device includes a means for engaging an extendable member to accommodate the distracted channel. An expanding member moves in relation to a base member in accordance with a rack and pinion type operation. The ratchet mechanism prevents the two members from contracting once expanded. An objective of the instant invention to provide a corpectomy device that may be adjusted within the intervertebral cavity or adjusted in situ within the cavity. It is a further objective of the instant invention to provide an expandable corpectomy which can be expanded by use of a rack rotated by a removable shaft. Yet another objective of the instant invention is to provide vertebra engagable endplates which are arranged to pivot and self adjust. Other objectives and advantages of this invention will become apparent from the following description taken in conjunction with any accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. Any drawings contained herein constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof. BRIEF DESCRIPTION OF THE FIGURES FIG. 1 is a side view of the corpectomy device in a compressed position with the pivoting endplate angled forward; FIG. 2 is a side view of the corpectomy device in a compressed position with the pivoting endplate angled backward; FIG. 3 is a side view of the corpectomy device in a raised position with the pivoting endplate centered; backward; FIG. 4 is the opposite side view of FIG. 3 depicting the pinion driver; FIG. 5 is the perspective view illustrating the ratchet mechanism for use in locking the members in position; FIG. 6 is a pictorial view depicting the corpectomy device between vertebra in a compressed position; FIG. 7 is another pictorial view of FIG. 6 from a different perspective; FIG. 8 is view of FIG. 7 with a pinion driver; FIG. 9 is view of FIG. 8 upon rotation of the pinion driver; FIG. 10 is a pictorial view depicting the corpectomy device between vertebra in an expanded position; FIG. 11 is a pictorial view depicting the ratchet mechanism of the corpectomy device; FIG. 12 is a pictorial view depicting the corpectomy device with a top endplate; FIG. 13 is a pictorial view of the corpectomy device in position. DETAILED DESCRIPTION OF THE INVENTION Referring now to the Figures, set forth is the corpectomy device 10 in a compressed position with the pivoting endplate 12 angled forward. The corpectomy implant device 10 is defined by a base member 14 telescopingly received into an expansion member 16 . The base member 14 is formed from a housing having a lower end 15 with a first 17 and second 19 side walls extending from said lower end 15 . Said base member include end walls 21 and 23 positioned between said first and second side walls 17 , 19 each having a centrally disposed U-shaped slot 18 formed therein extending from the lower end along a length of the end walls with a first edge 20 of said slot 18 non-engaging and a second edge 22 lined with an engaging edge, preferably directional ratchet teeth 22 . Lower endplate 12 can be inserted into the open end of the base member 14 , the lower endplate having a surface 11 for use in bone engagement. The expansion member 16 is formed from housing having first and second side walls 25 and 27 and first and second end walls 29 and 31 , the four walls constructed and arranged to encompass said base member walls. Side wall 25 includes an aperture 24 sized to permit insertion of pinion tool 30 having a shoulder 32 that allows ease of rotation by bearing upon the side wall 25 with a pinion for engagement of the ratchet teeth 22 . Rotation of the pinion tool 30 provides extension of the expansion member 16 from the base member 14 as the pinion tool is limited in movement with the expansion member 16 by the size of the aperture 24 . Positioned with the base member is a spring loaded biasing ratchet assembly 36 having a pair of engagement prongs 38 and 40 that engage the ratchet teeth 22 . The biasing ratchet assembly 36 includes having a biasing member 41 that engages an inner surface of the base member 14 expanding the engagement prongs 38 and 40 against the ratchet teeth 22 wherein the spacing of the extension member from the base member is unidirectional to prohibit compression of the structure once positioned. The expansion member 16 permits the device to expand relative to the base member 14 and overall longitudinal dimension of the device. Upper endplate 42 can be inserted into the open end of the expansion member 16 , the upper endplate having a surface 44 for use in bone engagement. The endplates 12 and 42 may be interchangeably connected or permanently attached, such as laser welded, to the corpectomy device. These endplates may be of any desired shape, size or thickness. For example, the endplate 42 of FIG. 12 is substantially flat with engagement teeth 44 forming a pattern allowing bone growth material to pass through. In FIGS. 1-3 the endplate 12 can be moved at an angle that will allow the implant to restore the normal curvature of the spine after the corpectomy device is installed. Moreover, the shape may or may not correspond to the cross-sectional shape and size (foot-print) of the base. In those instances where the patient presents unusual physiology, such as curvature of the spine (lordosis or kyphosis), additional physiology compensating members may be interposed with the respective endplates. These compensating members allow the corpectomy implant device 10 to take on a more arcuate shape thereby conforming more closely with the existing spinal configuration. FIG. 2 is a side view of the corpectomy implant device 10 in a compressed position having expansion member 16 placed over the insert of base member 14 with the pivoting endplate 12 angled backward. FIG. 3 is a side view of the corpectomy implant device 10 in a raised position with the pivoting endplate 12 centered. FIG. 4 is the opposite side view of FIG. 3 depicting the pinion driver 30 inserted into aperture 24 . FIG. 5 is the reverse perspective view illustrating the biasing ratchet mechanism 36 for use in locking the base member 14 and the expansion member 16 in a raised position. FIGS. 6-8 and 13 are pictorial views depicting the corpectomy implant device 10 between vertebra 100 and 102 in a compressed position. FIGS. 9-11 depict the device in an expanded state with the pinion driver 30 used to raise the expansion member 16 over the base member 14 . Accordingly, in preferred embodiments, a corpectomy device comprises a base member, an expansion member, an upper or lower endplate. In another preferred embodiment, the base member comprises a slot having a first side wall and a second side wall, wherein the first side wall is smooth and the second side wall comprises one or more teeth, spikes or jagged edges. In another preferred embodiment, the expansion member comprises an aperture for receiving a pinion tool having a first shoulder wherein the first shoulder is smooth, and a second shoulder for engagement of the base member. In yet another preferred embodiment, the corpectomy device comprises a ratchet, the ratchet comprising at least one engagement prong, a biasing member or combinations thereof. In yet another preferred embodiment, the upper and lower endplates are interchangeable and comprise patterns, dimensions, shapes, smooth surfaces, grooved surfaces, rough surfaces, or mobility for engaging a vertebra. Embodiments of the invention are also directed to methods for manipulating the distance between vertebrae in a patient in need thereof. Accordingly, in a preferred embodiment, a method of manipulating the distance between adjacent vertebrae in a patient, comprising surgically inserting an expandable corpectomy device into an intervertebral cavity, the corpectomy device comprising an upper endplate, a lower endplate, a base member wherein the base member is telescopingly receivable into an expansion member; the base member comprising a slot having a first side wall that is smooth and a second side wall lined with teeth; the expansion member having an aperture for receiving a pinion tool for increasing longitudinal distances of the expansion member relative to the base member. In some preferred embodiments, the distances between the teeth in the second side wall of the base member aperture are sized so that the expansion can occur by desired increments. In another preferred embodiment, the corpectomy device comprises a spring loaded biasing ratchet having a pair of engagement prongs for engaging the second side wall of the aperture of the base member and a biasing member for engaging an inner surface of the base member. In other preferred embodiments, the upper endplate is insertable into an open end of the expansion member, the upper endplate having a surface for bone engagement. Preferably, the upper and lower endplates are interchangeable and comprise patterns, dimensions, shapes, smooth surfaces, grooved surfaces, rough surfaces, or mobility for engaging a vertebra. Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. Furthermore, to the extent that the terms “including”, “includes”, “having”, “has”, “with”, or variants thereof are used in either the detailed description and/or the claims, such terms are intended to be inclusive in a manner similar to the term “comprising.” It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein. One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.

The instant invention is a longitudinally adjustable corpectomy device which fits within the intervertebral distracted channel. A ratchet mechanism allows for an extendable member to adjust to a longer length to accommodate a distracted channel. The ratchet type mechanism allows the members to move in a unidirectional movement to prevent the two members from contracting once expanded.

FIELD OF THE INVENTION The present invention relates generally to medical treatment of wounds, and more particularly to an improved wound shield and irrigation dressing for treating wounds to promote the overall healing process and to discourage enteric fistula and wound infections. BACKGROUND OF THE INVENTION Wound shields for treating enteric fistula and wound infections are known. The express purpose of these prior devices is to provide an irrigation dressing for patients as a replacement for the typical gauze type dressings. It is well known that gauze type dressings are not only messy, but result in constant re-opening of the wounds when the dressings are changed, which could cause infections and delay the healing process. Further, dressing changes usually cannot be performed by the patient alone. They are often quite painful to the patient, expensive, and not conducive to providing frequent irrigation of the wound with medical solutions. One known prior art irrigation dressing proposed to alleviate the problems associated with gauze type dressings is shown in expired U.S. Pat. No. 3,026,874. The device taught in that patent provides a wound shield that forms a dam around a wound and includes a clear flexible plastic window or cover for observing the healing process. The dam is fabricated of a continuous loop of foam rubber. To facilitate flushing and air control, several holes are provided at selected locations along the perimeter of the shield. The device is held in place using belts and snap fasteners that are rigidly attached to the wound shield. Although the wound shield described above is preferred over gauze dressings, the foam rubber dam is too rigid for good sealing qualities. Further, the overall wall depth of the device is too shallow to accommodate adequate irrigation solution volumes. Lastly, the dam often comes into contact with the wound thus disrupting the healing process. A modified wound shield or irrigating dressing is shown in FIG. 1 . Wound shield 2 includes a generally oval shaped dam 20 and a window 18 attached over the top of the dam 20 . The shield is secured to a patient by a first belt 4 and a second belt 6 . The ends of the belts 4 and 6 are rigidly connected to window 18 by snap fasteners. Dam 20 includes an irrigation aperture 3 adapted to receive a tube 10 connected on a remote end to a supply of irrigation solution 12 . Dam 20 includes a drying aperture 3 adapted to receive a tube 8 connected on a remote end to a supply of oxygen, and a draining aperture 7 adapted to receive a tube 14 connected to an associated pump 16 . In use of the above device, a flow of irrigation solution constantly irrigates the wound on the patient by a timer control, patient control, or care giver control. Oxygen or air is alternately supplied into the shield to dry the wound, while pump 16 removes the irrigation solution from the enclosed area. The wound is visible through window 18 as it heals without being exposed to contaminants. The dressing can be used for about two weeks before changing is required. The dam of the wound shield described above comprises a hollow, highly flexible tube, which is inflated with air prior to or during use. The desired firmness is obtained by controlling the pressure of air within the dam. Although the wound dressing is modestly successful in treating patients, the device requires a fair amount of readjustment after it is installed on the patient because the dressing twists and bends with movement of the patient. This is primarily due to a lack of flexibility in the wound shield. Further, the device tends to buckle in the middle due to a lack of cross-sectional rigidity in the inflatable dam section. This causes leakage from under the wound shield as well as undesirable contact between the wound and the window. Therefore, it would be desirable to provide an irrigation dressing that is less rigid to prevent separation from the skin of the patient as the patient moves. The irrigation dressing should not be too soft so that it crumples with patient movement. It is also desirable to provide an irrigation dressing that can be readily used with vacuum assist closure (VAC) devices for applying a vacuum to a wound. It is further desirable to provide an irrigation dressing system that can conform to the shape of a moving patient yet retaining its fluid containment and vacuum integrity. SUMMARY OF THE INVENTION In accordance with a preferred embodiment of the invention, a wound shield and irrigation dressing system is provided to be worn on ambulatory patients for protecting and enclosing wounds. The wound shield allows for frequent irrigation of the wound with an irrigation solution and alternate frequent drying of the wound, while also providing for drainage of the irrigation solution and selective application of a vacuum to the wound. The wound shield includes a hollow inflatable tubular dam formed of an inner peripheral surface defining a central opening adapted to surround the wound of the individual, an outer peripheral surface defining the outermost extremity of the dam, a bottom body-engaging surface and a top surface connecting said inner and outer peripheral surfaces to one another. A somewhat stiff clear plastic window is provided having generally flat front and rear planar surfaces. The flat rear planar surface of the window is attached to the top surface of the dam, so that a central cavity opening is defined under the window and surrounded by the oval dam. In a preferred aspect of the invention, the wound shield includes an inner peripheral ridge extending from the inner peripheral surface beyond the bottom body-engaging surface of the dam downwardly away from the window. An outer peripheral ridge is formed on the tubular dam extending from the outer peripheral surface beyond the bottom body-engaging surface of the dam downwardly away from the window. The ridges on the bottom or rear side of the device provide an overall elongate “U-shaped” contact surface for contacting the skin, eliminating the need to apply skin adhesives to the patient, while also sealing in fluids and eliminating vacuum loss. The ridges also play an important part in improving the cross-sectional rigidity of the dam and for preventing fluid leakage. Ridges can also extend from the front or top surface of the dam aiding in the adhesion of the dam to the window, and adding to the overall cross-sectional rigidity of the dam. In another preferred aspect of the invention, the wound shield includes a plurality of connectors attached to the front planar surface of the clear plastic window. Each connector is disposed at different locations outside the central opening of the dam, and each is adapted to be releasably attached to a connecting end of a belt. The connectors are pivotable about an axis parallel to the front planar surface of the window. In yet another preferred aspect of the invention, the subject wound shield includes a resilient self-sealing plug disposed inside the dam. The plug is adapted to receive a hypodermic needle, whereby air can be forced into the dam through the hypodermic needle causing the dam to inflate. The plug is “self healing” and seals itself upon removal of the hypodermic needle, so that the fluid containment integrity of the dam is not compromised. Precise control over the pressure within the dam is thereby enabled. An object of the present invention is to provide an improved wound shield with pivoting belt connectors that allow for patient movement without the need for readjustment of the wound shield. A further object is to provide a wound shield with one or more radial ribs disposed on the perimeter of the dam to prevent fluid leakage from out of the central cavity. It is yet another object of the invention to provide a wound shield with an improved cross-sectional rigidity. A further object is to provide an airtight dam facilitating vacuum assisted closure (VAC). The irrigating dressing is particularly useful with this technique because the wound can be thoroughly cleaned with fluids and thoroughly dried with air using the device before vacuum is applied. The wound can be treated with VAC without irrigation. It is another object of the invention to provide a wound shield having an inflatable dam with an improved inflating device for precise control over the fluid pressure within the dam. Another object of the invention is to provide a wound shield that enables frequent wound cleansing, drying and drainage, while also being easy to use and maintained by care givers and patients. Another object is to make the patient ambulatory while wearing the device. These and other objects will become apparent from the following description of the preferred embodiments taken together with the accompanying drawings and appended claims. BRIEF DESCRIPTION OF THE DRAWINGS The invention may take physical form in certain parts and arrangements of parts, the preferred embodiments of which will be described in detail in this specification and illustrated in the accompanying drawings which form a part hereof, and wherein: FIG. 1 is a perspective view of a prior art wound dressing device; FIG. 2 is a top view of a preferred wound shield and a preferred belt arrangement in accordance with the present invention; FIG. 3 is a cross-sectional view taken along the line A—A of the preferred wound shield shown in FIG. 2 ; FIG. 4 is a bottom view of the preferred dam of the preferred wound shield shown in FIG. 2 ; FIG. 5 is a bottom view of an alternative embodiment of the wound shield using cut outs in the window for irrigating, drying, and draining; and, FIG. 6 is a top view of an alternative embodiment of the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawings wherein the showings are for the purpose of illustrating the preferred embodiments of the invention only, and not for purpose of limiting same, FIGS. 2-4 show a wound shield 30 including a hollow tubular inflatable dam 32 , and a clear plastic window 34 attached to the dam 32 . Dam 32 is formed of an inner peripheral surface or wall 42 which defines and surrounds a central opening 50 . Dam 32 also includes an outer peripheral surface or a wall 44 connected to inner peripheral surface 42 by a rear or bottom body-engaging surface 48 and a front or top surface 46 . Dam 32 is provided with an irrigation aperture 52 extending from outer peripheral surface 44 through inner peripheral surface 42 . Aperture 52 is adapted to receive or otherwise couple with an irrigation tube for providing communication between an irrigation system and central opening 50 . Typically, the irrigation system provides an irrigation solution with medicinal characteristics for continuous or frequent cleansing of the wound. A drying aperture 54 is provided, which is adapted to receive or otherwise couple with a drying tube connected to an associated air supply. Drying aperture 54 provides communication between the air supply and central opening 50 for continuous or selective intermittent drying of the wound after irrigation. The drying aperture is also useful for connection to an associated source of vacuum (not shown) for use with VAC devices to apply a vacuum to the wound. A drainage aperture 56 is provided, preferably on a side of the dam opposite from the irrigation and drying apertures as shown. The drainage aperture is adapted to receive or otherwise couple with a drainage tube. The drainage tube could be connected to a pump, a collecting device, or a like device, to facilitate the removal of the irrigation solution, and dead skin and blood discharged from the wound. Both apertures 52 and 56 extend through the dam 32 from outer peripheral surface 44 through inner peripheral surface 42 . These apertures can be plugged using suitable stoppers or the like when used as a VAC, when the patient is ambulatory, or as desired. It is to be appreciated that any of the apertures can be adapted for connection with an associated source of vacuum. Dam 32 is preferably manufactured using a rotational casting or a rotational molding such as slush molding. The mold is typically made of aluminum but could be made of a variety of other metals. Dam 32 is formed from a soft liquid plastic, preferably vinyl, and the apertures are formed by extending a core pin through the mold, and removing the core pin after the liquid plastic cures. Dam 32 further includes a soft self-sealing plug 40 preferably molded into the outer wall 44 . Self-sealing plug 40 is adapted to receive a hypodermic needle used to inflate the dam 32 with air. The needle is inserted through the self-sealing plug 40 and the bulb is compressed to force air into the dam until the desired firmness of the dam 32 is obtained. The needle can be withdrawn at any time from the self-sealing plug 40 without any leakage of the air after removal. The self-sealing plug also allows for addition or removal of air at any time. Self-sealing plug 40 is preferably made of nitriale rubber. Window 34 is made of a semi-hard clear plastic vinyl and has a generally flat planar bottom surface 33 and a generally flat top planar surface 35 . In the embodiment illustrated, the window has an overall generally rectangular shape. Preferably, bottom planar surface 33 is attached to front surface 46 of the dam 32 using ultra-violet curable adhesive. However, various other types of adhesives could be used. Window 34 completely encloses central opening 50 of the dam 32 so that central opening 50 can remain airtight when the wound shield 30 is placed on the body of the patient, except for apertures 52 , 54 , and 56 . It is preferred that window 34 encompass outer peripheral surface 44 of the dam 32 to increase the rigidity of the wound shield 30 . A pair of spaced apart connector assemblies 64 are disposed on top planar surface 35 of window 34 at opposite sides of the window. Connector assemblies 64 include a set of spaced apart co-axial tubes 66 holding a rod 68 that is connected to a set of eyelets 70 . Tubes 66 are preferably made of plastic and could be bonded to top planar surface 35 of the window 34 or could be formed during the molding of window. Rods 68 and eyelets 70 are placed in tubes 66 prior to bonding or molding. Rod 68 and eyelet 70 are pivotable about an axis parallel to top planar surface 35 , so that movement or twisting of the patient does not cause wound shield 30 to move from its position on the body of the patient. Further, connector assemblies are placed at a location outside central opening 50 to ensure that even pressure is applied to the entire perimeter of dam 32 when wound shield 30 is on the body of a patient. Rods 60 and eyelets 70 are preferably made of metal, but could be made of plastic or the like. The rods 68 extend completely across the face of the would shield 30 and in that way help prevent the shield from buckling in the middle during use such as along the line defined by section A—A in FIG. 2 . A pair of belts 36 and 38 are provided for holding wound shield 30 at a fixed location on the patient, so that central area 50 surrounds the wound. Belts 36 and 38 are preferably made of an elastic material, such as latex or neoprene foam, and are preferably non-absorbent and easy to clean. Each belt includes a first and a second connecting end 58 . Each connecting end 58 includes a connecting portion 60 attached to the belt, and a hook portion 62 adapted to engage eyelet 70 . It should be appreciated that in some circumstances, the wound shield may only need one belt because of the size or location of the wound. Further, the belt could be fixed at one end to a fixed connector on the wound shield, and be pivotable at the other end. It also should be appreciated that the releasable engagement of the belt and the connector assembly could employ connector types other than the preferred eye and hook arrangement. With particular reference now to FIG. 3 , dam 32 includes a ridge 72 extending angularly from inner peripheral surface 42 beyond and away from the bottom body-engaging surface 48 . Dam 32 also includes a ridge 74 extending angularly from outer peripheral surface 44 beyond and away from the bottom body-engaging surface 48 . Ridges 72 and 74 cooperate in holding wound shield 30 in a fixed position on the patient's body, even during movement and twisting of the patient. Further, ridges 72 and 74 seal central opening 50 and prevent any fluids or vacuum from escaping, and prevent contaminants from entering central area 50 . Ridges 72 and 74 also alleviate the need to apply skin adhesives to the skin of the patient prior to applying the front body-engaging surface of the wound shield, while adding substantially to the cross-sectional rigidity of the dam 32 . With continued reference to FIG. 3 , dam 32 preferably also includes a ridge 76 extending angularly from inner peripheral surface 42 beyond and away from top surface 46 and a ridge 78 extending angularly from outer peripheral surface 44 beyond and away from top surface 46 . Ridges 76 and 78 aid in the adhesion process of front surface 46 to the back surface 33 of window 34 . Additionally, ridges 76 and 78 increase the cross-sectional rigidity characteristic of dam 32 , which helps prevent the center of the wound shield 30 from buckling after securing wound shield 30 on the body of a patient. It should be appreciated that in some cases, such as in stubborn wounds, more pressure is necessary for irrigation of the wound. It also should be appreciated that it is not always necessary to place irrigation aperture, drying aperture, and drainage aperture through the dam. For example, FIG. 5 shows a wound shield 77 having a dam 79 attached to a window 81 . A first hole 75 is cut out of window 81 and covered over by a piece of adhesive tape 80 or plug. A second hole 82 is cut out of window 81 and covered by a piece of adhesive tape 84 or plug. The holes 75 , 82 are adapted to receive the tip of an asepto syringe. Adhesive tape 80 or plug can be removed and irrigation solution can be communicated to the wound through hole 75 via large syringe, or the like. Further, an air source could be used to communicate air to the wound through hole 75 for drying the wound. Adhesive tape 84 or plug can be removed to provide drainage of irrigation solution, dead skin, and blood from central area 50 . After cleansing, drying, and drainage, tape 80 and 84 or plug can be placed back over holes 75 and 82 , respectively, protecting the wound from outside dirt or bacteria. It should be noted that the shape of the wound shield could take on many forms, and the connector assemblies could be disposed on the window in a variety of different orientations. For example, FIG. 6 shows a wound shield 30 ′ having an overall smaller size than the shield 30 shown in FIGS. 2-4 . Only a single belt 36 ′ is needed to receive the shield 30 ′ to a patient. This type of wound shield could be useful for a wound near the groin area of an individual, such as one that would occur in a hernia operation or catheterization procedure. The wound shield 30 ′ is formed and functions substantially identical to the shield 30 described above. Like parts are indicated in FIG. 6 with a primed (′) suffix. The foregoing descriptions are specific embodiments of the present invention. It should be appreciated that these embodiments are described for purposes of illustration only, and that numerous alterations and modifications may be practiced by those skilled in the art without departing from the spirit and scope of the invention. It is intended that all such modifications and alterations be included insofar as they come within the scope of the invention as claimed or the equivalents thereof.

An irrigation dressing is provided including a hollow inflatable tubulardam with a central opening adapted to surround the wound of the individual. A semi-hard resilient clear plastic window is attached to the dam, such that the central opening is completely enclosed on a front surface of the dam. The dressing includes an inner peripheral ridge and an outer peripheral ridge extending beyond a bottom or back body-engaging surface of the dam which facilitates drawing a vacuum. A plurality of connectors are attached to a front planar face surface of the clear plastic window. At least one connector is pivotable about an axis parallel to the front planar surface of the window. A self-sealing plug is disposed inside the dam so that the dam can be inflated to selected pressures using an associated hypodermic needle or the like.

RELATED APPLICATIONS [0001] This patent application is a continuation of U.S. patent application Ser. No. 14/602,958, filed Jan. 22, 2015, which is a continuation of U.S. patent application Ser. No. 14/300,902, filed Jun. 10, 2014, now U.S. Pat. No. 8,986,715, issued Mar. 24, 2015, which is a continuation of U.S. patent application Ser. No. 13/937,512, filed Jul. 9, 2013, now U.S. Pat. No. 8,926,953, issued Jan. 6, 2015, which is a continuation of U.S. patent application Ser. No. 13/441,783, filed Apr. 6, 2012, now U.S. Pat. No. 8,632,760, issued Jan. 21, 2014, which is a continuation of U.S. patent application Ser. No. 13/356,284, filed Jan. 23, 2012, now U.S. Pat. No. 8,263,054, issued Sep. 11, 2011, which is a continuation of U.S. patent application Ser. No. 12/425,933, filed Apr. 17, 2009, now U.S. Pat. No. 8,298,518, issued Oct. 30, 2012, which is a continuation of U.S. patent application Ser. No. 11/943,714, filed Nov. 21, 2007, now U.S. Pat. No. 8,038,988, issued Oct. 18, 2011, which is a continuation of U.S. patent application Ser. No. 11/805,122, filed May 22, 2007, now U.S. Pat. No. 8,101,161, issued Jan. 24, 2012, which is a continuation of U.S. patent application Ser. No. 10/345,788, which was filed on Jan. 15, 2003, now U.S. Pat. No. 7,351,404, issued Apr. 1, 2008, which claims the benefit of U.S. Provisional Application No. 60/354,425, filed on Feb. 4, 2002, all of which are hereby incorporated by reference herein. FIELD OF THE INVENTION [0002] This invention relates to a method for stimulating the growth of mammalian hair comprising the application to mammalian skin of a cyclopentane heptanoic acid, 2-cycloalkyl or arylalkyl derivative or a pharmacologically acceptable acid addition salt thereof, alone, or in association with a topical pharmaceutical carrier. BACKGROUND OF THE INVENTION [0003] Dermatologists recognize many different types of hair loss, the most common by far being “alopecia” wherein human males begin losing scalp hair at the temples and on the crown of the head as they get older. While this type of hair loss is largely confined to males, hence its common name “male pattern baldness,” it is not unknown in women. No known cure has yet been found despite continuing attempts to discover one. [0004] A good deal is known about various types of human hair and its growth patterns on various parts of the body. [0005] For purposes of the present invention, it is necessary to consider various types of hair, including, terminal hairs and vellus hairs and modified terminal hairs, such as seen in eye lashes and eye brows. Terminal hairs are coarse, pigmented, long hairs in which the bulb of the hair follicle is seated deep in the dermis. Vellus hairs, on the other hand, are fine, thin, non-pigmented short hairs in which the hair bulb is located superficially in the dermis. As alopecia progresses, a transition takes place in the area of approaching baldness wherein the hairs themselves are changing from the terminal to the vellus type. [0006] Another factor that contributes to the end result is a change in the cycle of hair growth. All hair, both human and animal, passes through a life cycle that includes three phases, namely, the anagen phase, the catagen phase and the telogen phase. The anagen phase is the period of active hair growth and, insofar as scalp hair is concerned, this generally lasts from 3-5 years. The catagen phase is a short transitional phase between the anagen and telogen phases which, in the case of scalp hair, lasts only 1-2 weeks. The final phase is the telogen phase which, for all practical purposes, can be denominated a “resting phase” where all growth ceases and the hair eventually is shed preparatory to the follicle commencing to grow a new one. Scalp hair in the telogen phase is also relatively short-lived, some 3-4 months elapsing before the hair is shed and a new one begins to grow. [0007] Under normal hair growth conditions on the scalp, approximately 88% of the hairs are in the anagen phase, only 1% in catagen and the remainder in telogen. With the onset of male pattern baldness, a successively greater proportion of the hairs are in the telogen phase with correspondingly fewer in the active growth anagen phase. [0008] Alopecia is associated with the severe diminution of hair follicles. A bald human subject will average only about 306 follicles per square centimeter, whereas, a non-bald human in the same age group will have an average of 460 follicles per square centimeter. This amounts to a one-third reduction in hair follicles which, when added to the increased proportion of vellus hair follicles and the increased number of hair follicles in the telogen phase, is both significant and noticeable. Approximately 50% of the hairs must be shed to produce visible thinning of scalp hair. It is thus a combination of these factors: transition of hairs from terminal to vellus, increased number of telogen hairs—some of which have been shed, and loss of hair follicles that produces “baldness”. [0009] While a good deal is known about the results of male pattern baldness, very little is known about its cause. The cause is generally believed to be genetic and hormonal in origin although, the known prior art attempts to control it through hormone adjustment have been singularly unsuccessful. [0010] One known treatment for male pattern alopecia is hair transplantation. Plugs of skin containing hair are transplanted from areas of the scalp where hair is growing to bald areas with reasonable success; however, the procedure is a costly one in addition to being time-consuming and quite painful. Furthermore, the solution is inadequate from the standpoint that it becomes a practical, if not an economic, impossibility to replace but a tiny fraction of the hair present in a normal healthy head of hair. [0011] Other non-drug related approaches to the problem include such things as ultra-violet radiation, massage, psychiatric treatment and exercise therapy. None of these, however, has been generally accepted as being effective. Even such things as revascularization surgery and acupuncture have shown little, if any, promise. [0012] By far, the most common approach to the problem of discovering a remedy for hair loss and male pattern alopecia has been one of drug therapy. Many types of drugs ranging from vitamins to hormones have been tried and only recently has there been any indication whatsoever of even moderate success. For instance, it was felt for a long time that since an androgenic hormone was necessary for the development of male pattern baldness, that either systemic or topical application of an antiandrogenic hormone would provide the necessary inhibiting action to keep the baldness from occurring. The theory was promising but the results were uniformly disappointing. [0013] The androgenic hormone testosterone was known, for example, to stimulate hair growth when applied topically to the deltoid area as well as when injected into the beard and pubic regions. Even oral administration was found to result in an increased hair growth in the beard and pubic areas as well as upon the trunk and extremities. While topical application to the arm causes increased hair growth, it is ineffective on the scalp and some thinning may even result. Heavy doses of testosterone have even been known to cause male pattern alopecia. [0014] Certain therapeutic agents have been known to induce hair growth in extensive areas of the trunk, limbs and even occasionally on the face. Such hair is of intermediate status in that it is coarser than vellus but not as coarse as terminal hair. The hair is generally quite short with a length of 3 cm being about maximum. Once the patient ceases taking the drug, the hair reverts to whatever is normal for the particular site after six months to a year has elapsed. An example of such a drug is diphenylhydantoin which is an anticonvulsant drug widely used to control epileptic seizures. Hypertrichosis is frequently observed in epileptic children some two or three months after starting the drug and first becomes noticeable on the extensor aspects of the limbs and later on the trunk and face. (The same pattern of hypertrichosis is sometimes caused by injury to the head.) As for the hair, it is often shed when the drug is discontinued but may, in some circumstances, remain. [0015] Streptomycin is another drug that has been found to produce hypertrichosis, in much the same way as diphenylhydantoin, when administered to children suffering from tuberculous meningitis. About the same effects were observed and the onset and reversal of the hypertrichosis in relation to the period of treatment with the antibiotic leave little question but that it was the causative agent. [0016] Two treatments have been demonstrated as showing some promise in reversing male pattern alopecia. These treatments include the use of a microemulsion cream containing both estradiol and oxandrolone as its active ingredients and the use of organic silicon. [0017] In addition to the foregoing, it has been reported in U.S. Pat. Nos. 4,139,619 and 4,968,812 that the compound minoxidil is useful for the treatment of male pattern baldness. That compound, among others, has proven to have considerable therapeutic value in the treatment of severe hypertension. It is a so-called “vasodilator” which , as the name implies, functions to dilate the peripheral vascular system. Dermatologists and others have recognized that prolonged vasodilation of certain areas of the human body other than the scalp sometimes result in increased hair growth even in the absence of any vasodilating therapeutic agent. For instance, increased hair growth around surgical scars is not uncommon. Similarly, arteriovenous fistula have been known to result in increased vascularity accompanied by enhanced hair growth. Externally-induced vasodilation of the skin, such as, for example, by repeated biting of the limbs by the mentally retarded and localized stimulation of the shoulders by water carries has been known to bring on hypertrichosis in the affected areas. Be that as it may, similar techniques such as continued periodic massage of the scalp have been found to be totally ineffective as a means for restoring lost hair growth to the scalp. Scar tissue on the scalp inhibits rather than promotes hair growth. [0018] U.S. Pat. No. 6,262,105 to Johnstone suggests that prostaglandins and derivatives thereof are useful in a method of enhancing hair growth. [0019] Bimatoprost, which is sold by Allergan, Inc. of Irvine, Calif., U.S.A. as Lumigan® ophthalmic solution, for treating glaucoma now has been found as being effective to increase the growth of eyelashes when applied in the FDA approved manner. [0020] It is, therefore, a principal object of the present invention to provide a novel and effective treatment for the stimulation of hair growth and the treatment of male pattern baldness. [0021] Another object of the invention is to provide a method of stimulating hair growth in humans and non-human animals that is compatible with various types of therapeutic agents or carriers and, therefore, would appear to be combinable with those which, by themselves, demonstrate some therapeutic activity such as, for example, microemulsion creams or topical compositions containing estradiol and oxandrolone, minoxidil or agents that block the conversion of testosterone to dihydrotesterone (Procipia). [0022] Still another objective is the provision of a treatment for the stimulation of hair growth which, while effective for its intended purpose, is apparently non-toxic and relatively free of unwanted side effects. [0023] An additional object of the invention herein disclosed and claimed is to provide a method for treating hair loss in men or women which can be applied by the patient under medical supervision no more stringent than that demanded for other topically-administered therapeutic agents. [0024] Other objects of the invention are to provide a treatment for male pattern alopecia which is safe, simple, painless, cosmetic in the sense of being invisible, easy to apply and quite inexpensive when compared with hair transplants and the like. SUMMARY OF THE INVENTION [0025] This invention provides pharmaceutical compositions for topical application to enhance hair growth comprising an effective amount of a cyclopentane heptanoic acid, 2-cycloalkyl or arylalkyl compound represented by the formula I [0000] [0000] wherein the dashed bonds represent a single or double bond which can be in the cis or trans configuration, A is an alkylene or alkenylene radical having from two to six carbon atoms, which radical may be interrupted by one or more oxa radicals and substituted with one or more hydroxy, oxo, alkyloxy or alkylcarboxy groups wherein said alkyl radical comprises from one to six carbon atoms; B is a cycloalkyl radical having from three to seven carbon atoms, or an aryl radical, selected from the group consisting of hydrocarbyl aryl and heteroaryl radicals having from four to ten carbon atoms wherein the heteroatom is selected from the group consisting of nitrogen, oxygen and sulfur atoms; X is —N(R 4 ) 2 wherein R 4 is selected from the group consisting of hydrogen, a lower alkyl radical having from one to six carbon atoms, [0000] [0000] wherein R 5 is a lower alkyl radical having from one to six carbon atoms; Z is ═O; one of R 1 and R 2 is ═O, —OH or a —O(CO)R 6 group, and the other one is —OH or —O(CO)R 6 , or R 1 is ═O and R 2 is H, wherein R 6 is a saturated or unsaturated acyclic hydrocarbon group having from 1 to about 20 carbon atoms, or —(CH 2 )mR 7 wherein m is 0 or an integer of from 1 to 10, and R 7 is cycloalkyl radical, having from three to seven carbon atoms, or a hydrocarbyl aryl or heteroaryl radical, as defined above in free form or a pharmaceutically acceptable salt thereof, in association with a pharmaceutical carrier adapted for topical application to mammalian skin. [0026] Preferably, the compound is a cyclopentane heptanoic acid, 2-(phenyl alkyl or phenyloxyalkyl) represented by the formula II [0000] [0000] wherein y is 0 or 1, x is 0 or 1 and x and y are not both 1, Y is a radical selected from the group consisting of alkyl, halo, e.g. fluoro, chloro, etc., nitro, amino, thiol, hydroxy, alkyloxy, alkylcarboxy, halo substituted alkyl wherein said alkyl radical comprises from one to six carbon atoms, etc. and n is 0 or an integer of from 1 to 3 and R 3 is ═O, —OH or —O(CO)R 6 wherein R 6 is as defined above or a pharmaceutically acceptable salt thereof. [0027] More preferably the compound is a compound of formula III [0000] [0000] wherein hatched lines indicate a configuration, solid triangles are used to indicate β configuration. [0028] More preferably y is 1 and x is 0 and R 1 , R 2 and R 3 are hydroxy. [0029] Most preferably the compound is cyclopentane N-ethyl heptanamide-5-cis-2-(3α-hydroxy-5-phenyl-1-trans-pentenyl)-3,5-dihydroxy, [1 α ,2 β ,3 α ,5 α ], also known as bimatoprost. [0030] Another aspect of the invention provides methods for stimulating the rate of hair growth and for stimulating the conversion of vellus hair or intermediate hair to growth as terminal hair in a human or non-human animal by administering to the skin of the animal an effective amount of a compound wherein the compound has the formula: [0000] [0000] wherein the dashed bonds represent a single or double bond which can be in the cis or trans configuration, A is an alkylene or alkenylene radical having from two to six carbon atoms, which radical may be interrupted by one or more oxa radicals and substituted with one or more hydroxy, oxo, alkyloxy or alkylcarboxy groups wherein said alkyl radical comprises from one to six carbon atoms; B is a cycloalkyl radical having from three to seven carbon atoms, or an aryl radical, selected from the group consisting of hydrocarbyl aryl and heteroaryl radicals having from four to ten carbon atoms wherein the heteroatom is selected from the group consisting of nitrogen, oxygen and sulfur atoms; X is —N(R 4 ) 2 wherein R 4 is selected from the group consisting of hydrogen, a lower alkyl radical having from one to six carbon atoms, [0000] [0000] wherein R 5 is a lower alkyl radical having from one to six carbon atoms; Z is ═O; one of R 1 and R 2 is ═O, —OH or a —O(CO)R 6 group, and the other one is —OH or —O(CO)R 6 , or R 1 is ═O and R 2 is H, wherein R 6 is a saturated or unsaturated acyclic hydrocarbon group having from 1 to about 20 carbon atoms, or —(CH 2 )mR 7 wherein m is 0 or an integer of from 1 to 10, and R 7 is cycloalkyl radical, having from three to seven carbon atoms, or a hydrocarbyl aryl or heteroaryl radical, as defined above in free form or a pharmaceutically acceptable salt thereof. [0031] These and other aspects of the invention will become apparent from the description of the invention which follows below. BRIEF DESCRIPTION OF THE DRAWING FIGURE [0032] The FIGURE shows the effect on the eyelashes of one patient treated for glaucoma with Lumigan® bimatoprost for six months. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0033] Alopecia (baldness) a deficiency of either normal or abnormal hair, is primarily a cosmetic problem in humans. It is a deficiency of terminal hair, the broad diameter, colored hair that is readily seen. However, in the so-called bald person although there is a noticeable absence of terminal hair, the skin does contain vellus hair which is a fine colorless hair which may require microscopic examination to determine its presence. This vellus hair is a precursor to terminal hair. In accordance with the invention as described herein, compounds represented by [0000] [0000] wherein R 1 , R 2 , A, B, Z and X are defined above, can be used to stimulate, such as stimulating the conversion of vellus hair to growth as terminal hair as well as increasing the rate of growth of terminal hair. [0034] The present invention was discovered as follows: [0035] In the course of treating patients having glaucoma, treatment may only be appropriate in one eye. Within the course of daily practice it was discovered that a patient who been treated with bimatoprost has lashes that were longer, thicker and fuller in the treated eye than in the non-treated eye. On examination the difference was found to be very striking. The lashes were longer and had a more full dense appearance in the treated eye. The lash appearance on the lids of the treated eye would have appeared quite attractive if it represented a bilateral phenomenon. Because of its asymmetric nature, the long lashes on one side could be construed as disturbing from a cosmetic standpoint. Because of the very unusual appearance a systematic examination of other patients who were taking bimatoprost in only one eye was made. It soon became apparent that this altered appearance was not an isolated finding. Comparison of the lids of patients who were taking bimatoprost in only one eye revealed subtle changes in the lashes and adjacent hairs of the bimatoprost-treated side in several patients. Definite differences could be identified to varying degrees in the lashes and adjacent hairs of all patients who were taking the drug on a unilateral basis for longer than 6 months. [0036] These findings were totally unexpected and surprising. Minoxidil is thought to stimulate hair growth by its ability to cause vasodilation suggesting that agents with such a capability may be uniquely effective in stimulating hair growth. The finding that bimatoprost, which, as explained below, is not a prostaglandin derivative, such as latanoprost stimulates hair growth is especially surprising and unexpected. [0037] The changes in the lashes were apparent on gross inspection in several patients once attention was focused on the issue. In those with light colored hair and lashes, the differences were only seen easily with the aid of the high magnification and lighting capabilities of the slit lamp biomicroscope. In the course of a glaucoma follow up examination, attention is generally immediately focused on the eye itself. Because of the high power magnification needed only one eye is seen at a time and the eye is seen at a high enough power that the lashes are not in focus. At these higher powers, any lash asymmetry between the two eyes is not likely to be noticed except by careful systematic comparison of the lashes and adjacent hairs of the eyelids of the two eyes. [0038] Observed parameters leading to the conclusion that more robust hair growth occurred in the treated area following administration of bimatoprost were multiple. They included increased length of lashes, increased numbers of lashes along the normal lash line, increased thickness and luster of lashes, increased auxiliary lash-like terminal hair in transitional areas adjacent to areas of normal lash growth, increased lash-like terminal hairs at the medial and lateral canthal area, increased pigmentation of the lashes, increased numbers, increased length, as well as increased luster, and thickness of fine hair on the skin of the adjacent lid, and finally increased perpendicular angulation of lashes and lash-like terminal hairs. The conclusion that hair growth is stimulated by bimatoprost is thus supported not by evidence of a difference in a single parameter but is based on multiple parameters of hair appearance in treated vs. control areas in many subjects. This finding is entirely unexpected and represents a previously unrecognized effect of bimatoprost on stimulation of hair follicles. The modified hairs of the lashes normally turn over slowly and are in their resting phase longer than hair on, for example, the scalp. The ability to cause differences in appearance of lashes, the ability to stimulate conversion of vellus or intermediate hair to terminal hairs in transitional areas and the ability to stimulate growth of vellus hair on the skin indicates that bimatoprost is a diversely effective and efficacious agent for the stimulation of hair growth. Thus, the present invention provides a treatment by bimatoprost of hair of the scalp, eyebrows, beard and other areas that contain hair that results in increased hair growth in the corresponding areas. [0039] Patients that are treated in or around the eye with compounds of the invention, such as bimatoprost, regularly develop hypertrichosis including altered differentiation, numbers, length, thickness, curvature and pigmentation in the region of treatment. [0040] Some examples of representative compounds useful in the practice of the present invention include the compounds shown in Table 1: [0000] TABLE 1 cyclopentane heptenamide-5-cis-2-(3α-hydroxy-5-phenyl-1-trans-pentenyl)-3, 5-dihydroxy, [1 α , 2 β , 3 α , 5 6 α] cyclopentane N,N-dimethylheptenamide-5-cis-2-(3α-hydroxy-5-phenyl-1-trans-pentenyl)-3, 5- dihydroxy, [1 α , 2 β ▭, 3 α , 5 α ] cyclopentane heptenylamide-5-cis-2-(3α-hydroxy-4-meta-chlorophenoxy-1-trans-pentenyl)-3, 5- dihydroxy, [1 α ▭▭, 2 β , 3 α , 5 α ] cyclopentane heptenylamide-5-cis-2-(3α-hydroxy-4-trifluoromethylphenoxy-1-trans-pentenyl)-3, 5-dihydroxy, [1 α , 2 β ▭, 3 α , 5 α ] cyclopentane N-isopropyl heptenamide-5-cis-2-(3α-hydroxy-5-phenyl-1-trans-pentenyl)-3, 5- dihydroxy, [1 α , 2 β ▭, 3 α , 5 α ] cyclopentane N-ethyl heptenamide-5-cis-2-(3α-hydroxy-5-phenyl-1-trans-pentenyl)-3, 5 dihydroxy, [1 α , 2 β ▭, 3 α , 5 α ] cyclopentane N-methyl heptenamide-5-cis-2-(3α-hydroxy-5-phenyl-1-trans-pentenyl)-3, 5- dihydroxy, ▭ [1 α , 2 β ▭, 3 α , 5 α ] cyclopentane heptenamide-5-cis-2-(3α-hydroxy-4-meta-chlorophenoxy-1-trans-buteny;)-3, 5- dihydroxy, [1 α , 2 β ▭, 3 α , 5 α ] [0041] One presently preferred compound for use in the practice of the present invention is cyclopentane N-ethyl heptanamide-5-cis-2-(3α-hydroxy-5-phenyl-1-trans-pentenyl)-3,5-dihydroxy, [1 α ,2 β ,3 α ,5 α ], also known as bimatoprost and sold under the name of Lumigan® by Allergan, Inc., Calif., USA. This compound has the following structure: [0000] [0042] The synthesis of the above compounds described above has been disclosed in U.S. Pat. No. 5,607,978. This patent also shows, particularly in Examples 1, 2, 5 and 7 that these compounds are not prostaglandins, in that they do not behave as prostaglandins in art-recognized assays for prostaglandin activity. The invention thus relates to the use of the above compounds, or prodrugs of the active compounds, for treatment for the stimulation of hair growth. As used herein, hair growth includes hair associated with the scalp, eyebrows, eyelids, beard, and other areas of the skin of animals. [0043] In accordance with one aspect of the invention, the compound is mixed with a dermatologically compatible vehicle or carrier. The vehicle which may be employed for preparing compositions of this invention may comprise, for example, aqueous solutions such as e.g., physiological salines, oil solutions or ointments. The vehicle furthermore may contain dermatologically compatible preservatives such as e.g., benzalkonium chloride, surfactants like e.g., polysorbate 80, liposomes or polymers, for example, methyl cellulose, polyvinyl alcohol, polyvinyl pyrrolidone and hyaluronic acid; these may be used for increasing the viscosity. Furthermore, it is also possible to use soluble or insoluble drug inserts when the drug is to be administered. [0044] The invention is also related to dermatological compositions for topical treatment for the stimulation of hair growth which comprise an effective hair growth stimulating amount of one or more compounds as defined above and a dermatologically compatible carrier. Effective amounts of the active compounds may be determined by one of ordinary skill in the art but will vary depending on the compound employed, frequency of application and desired result, and the compound will generally range from about 0.0000001 to about 50%, by weight, of the dermatological composition, preferably from about 0.001 to about 50%, by weight, of total dermatological composition, more preferably from about 0.1 to about 30%, by weight of the composition. [0045] The present invention finds application in all mammalian species, including both humans and animals. In humans, the compounds of the subject invention can be applied for example, to the scalp, face, beard, head, pubic area, upper lip, eyebrows, and eyelids. In animals raised for their pelts, e.g., mink, the compounds can be applied over the entire surface of the body to improve the overall pelt for commercial reasons. The process can also be used for cosmetic reasons in animals, e.g., applied to the skin of dogs and cats having bald patches due to mange or other diseases causing a degree of alopecia. [0046] The pharmaceutical compositions contemplated by this invention include pharmaceutical compositions suited for topical and local action. [0047] The term “topical” as employed herein relates to the use of a compound, as described herein, incorporated in a suitable pharmaceutical carrier, and applied at the site of thinning hair or baldness for exertion of local action. Accordingly, such topical compositions include those pharmaceutical forms in which the compound is applied externally by direct contact with the skin surface to be treated. Conventional pharmaceutical forms for this purpose include ointments, liniments, creams, shampoos, lotions, pastes, jellies, sprays, aerosols, and the like, and may be applied in patches or impregnated dressings depending on the part of the body to be treated. The term “ointment” embraces formulations (including creams) having oleaginous, water-soluble and emulsion-type bases, e.g., petrolatum, lanolin, polyethylene glycols, as well as mixtures of these. [0048] Typically, the compounds are applied repeatedly for a sustained period of time topically on the part of the body to be treated, for example, the eyelids, eyebrows, skin or scalp. The preferred dosage regimen will generally involve regular, such as daily, administration for a period of treatment of at least one month, more preferably at least three months, and most preferably at least six months. [0049] For topical use on the eyelids or eyebrows, the active compounds can be formulated in aqueous solutions, creams, ointments or oils exhibiting physiologically acceptable osmolarity by addition of pharmacologically acceptable buffers and salts. Such formulations may or may not, depending on the dispenser, contain preservatives such as benzalkonium chloride, chlorhexidine, chlorobutanol, parahydroxybenzoic acids and phenylmercuric salts such as nitrate, chloride, acetate, and borate, or antioxidants, as well as additives like EDTA, sorbitol, boric acid etc. as additives. Furthermore, particularly aqueous solutions may contain viscosity increasing agents such as polysaccharides, e.g., methylcellulose, mucopolysaccharides, e.g., hyaluronic acid and chondroitin sulfate, or polyalcohol, e.g., polyvinylalcohol. Various slow releasing gels and matrices may also be employed as well as soluble and insoluble ocular inserts, for instance, based on substances forming in-situ gels. Depending on the actual formulation and compound to be used, various amounts of the drug and different dose regimens may be employed. Typically, the daily amount of compound for treatment of the eyelid may be about 0.1 ng to about 100 mg per eyelid. [0050] For topical use on the skin and the scalp, the compound can be advantageously formulated using ointments, creams, liniments or patches as a carrier of the active ingredient. Also, these formulations may or may not contain preservatives, depending on the dispenser and nature of use. Such preservatives include those mentioned above, and methyl-, propyl-, or butyl-parahydroxybenzoic acid, betaine, chlorhexidine, benzalkonium chloride, and the like. Various matrices for slow release delivery may also be used. Typically, the dose to be applied on the scalp is in the range of about 0.1 ng to about 100 mg per day, more preferably about 1 ng to about 10 mg per day, and most preferably about 10 ng to about 1 mg per day depending on the compound and the formulation. To achieve the daily amount of medication depending on the formulation, the compound may be administered once or several times daily with or without antioxidants. [0051] The invention is further illustrated by the following non-limiting examples: Example 1 In Vivo Treatment [0052] A study is initiated to systematically evaluate the appearance of lashes and hair around the eyes of patients who are administering bimatoprost in only one eye. The study involves 10 subjects, 5 male, 5 female, average age 70 years, (ranging from 50-94 years). All patients have glaucoma. Each subject is treated daily by the topical application of one drop of bimatoprost at a dosage of 1.5 .mu.g/ml/eye/day (0.03%, by weight, ophthalmic solution, sold under the name Lumigan® by Allergan, Irvine, Calif., U.S.A.) to the region of one eye by instilling the drop onto the surface of the eye. The region of the fellow control eye is not treated with bimatoprost and served as a control. [0053] In the course of treatment with eye drops, there is typically spontaneous tearing, and excess fluid from the drops and associated tears gathers at the lid margins. In the course of wiping the drug containing fluid from the lid margins and adjacent lid, a thin film of the fluid is routinely spread to contact the adjacent skin of the lid area. This widespread exposure of the skin around the lid to the effect of drops is regularly demonstrated in patients who develop a contact dermatitis. Typically the entire area of the upper and lower lid are involved with induration, erythema and edema demonstrating the regular extensive exposure of the ocular adnexa to the influence of topically applied drugs. [0054] The study is limited to subjects who have administered bimatoprost to one eye for more than 3 months. The mean duration of exposure to bimatoprost prior to assessing the parameter of lash growth between the control and study eye is 129 days (range 90-254 days). Observations are made under high magnification at the slit lamp biomicroscope. Documentation of differences between the control and treatment areas is accomplished using a camera specially adapted for use with the slit lamp biomicroscope. [0000] The results of the observations are as follows: [0055] Length of lashes: Increased length of eyelashes is regularly observed on the side treated with bimatoprost. The difference in length varies from approximately 10% to as much as 30%. [0056] Number of lashes: Increased numbers of lashes are observed in the treated eye of each patient. In areas where there are a large number of lashes in the control eye, the increased number of lashes in the bimatoprost-treated eye gave the lashes on the treated side a more thickly matted overall appearance. [0057] Auxiliary lash-like hair growth: Several patients have an apparent increase in lash-like hair in transitional areas adjacent to areas of normal lash distribution. These prominent robust appear lash-like hairs appeared to be of comparable length to the actual lashes. These long, thick lash-like hairs were present in the central portion of the lids of several patients in a linear arrangement just above the lash line. Hairs are present at similar locations in the control eyes but are by contrast thinner or more fine in appearance, have less luster and pigment and are more flat against the skin of the lid typical of vellus or intermediate hairs. In several patients, lash-like terminal hairs grow luxuriantly in the medial canthal area in the treated eye. In the corresponding control eye, vellus hairs are seen at the same location. Lash-like hairs are also present in the lateral canthal area of the treated eye but not the control eye in several subjects. Large lashes are not normally present at the lateral canthus and the area is generally free of all but a few occasional very fine lashes or vellus hairs. [0058] Increased growth of vellus hair on lids: Fine microscopic vellus hair is present on the skin of the lids and is easily seen with the slit lamp biomicroscope. This vellus hair is typically denser adjacent to and below the lateral portion of the lower lids. While remaining microscopic, vellus hairs are increased in number, appear more robust and are much longer and thicker in treated than in control eyes in the areas below and lateral to the lower lid. [0059] Perpendicular angulation of hairs: In areas where there are lash-like hairs above the lash line and in the medial and lateral canthal areas, the hairs are much longer, thicker and heavier. They also leave the surface of the skin at a more acute angle, as though they are stiffer or held in a more erect position by more robust follicles. This greater incline, pitch, rise or perpendicular angulation from the skin surface gives the appearance of greater density of the hairs. [0060] The foregoing observations clearly establish that bimatoprost can be used to increase the growth of hair in man. This conclusion is based on the regular and consistent finding of manifestations of increased hair growth in treated vs. control areas in human subjects. The conclusion that the drug bimatoprost is capable of inducing increased robust growth of hair is based not on a single parameter, i.e., length, but is based on multiple lines of evidence as described in the results. Detailed examination and description of multiple parameters of differences in hair is greatly facilitated by the ability to examine the hairs at high magnification under stable conditions of fixed focal length and subject position utilizing the capabilities of the slit lamp biomicroscope. [0061] The Figure shows the actual results on the eyelashes of a patient treated for glaucoma with Lumigan® bimatoprost for 6 months. Example 2 Topical Cream [0062] A topical cream is prepared as follows: Tegacid and spermaceti are melted together at a temperature of 70-80° C. Methylparaben is dissolved in about 500 gm of water and propylene glycol, polysorbate 80, and bimatoprost are added in turn, maintaining a temperature of 75-80° [0063] C. The methylparaben mixture is added slowly to the Tegacid and spermaceti melt, with constant stirring. The addition is continued for at least 30 minutes with additional stirring until the temperature has dropped to 40-45° C. Finally, sufficient water is added to bring the final weight to 1000 gm and the preparation stirred to maintain homogeneity until cooled and congealed. Example 3 Topical Cream [0064] A topical cream is prepared as follows: Tegacid and spermaceti are melted together at a temperature of 70-80° C. Methylparaben is dissolved in water and propylene glycol, polysorbate 80, and bimatoprost are added in turn, maintaining a temperature of 75-80° C. The methylparaben mixture is added slowly to the Tegacid and spermaceti melt, with constant stirring. The addition is continued for at least 30 minutes with additional stirring until the temperature has dropped to 40-45° C. Finally, sufficient water is added to bring the final weight to 1000 gm and the preparation stirred to maintain homogeneity until cooled and congealed. [0065] The composition is applied to bald human scalp once daily to stimulate the growth of hair. Example 4 Topical Ointment [0066] An ointment containing 2% by weight bimatoprost is prepared as follows: [0067] White petrolatum and wool fat are melted, strained and liquid petrolatum is added thereto. The bimatoprost, zinc oxide, and calamine are added to the remaining liquid petrolatum and the mixture milled until the powders are finely divided and uniformly dispersed. The mixture is stirred into the white petrolatum, melted and cooled with stirring until the ointment congeals. The foregoing ointment can be applied topically to mammalian skin for increased rate of hair growth, and can be prepared by omitting the zinc oxide and calamine. Example 5 Ointment [0068] A dermatological ophthalmic ointment containing 10% by weight bimatoprost is prepared by adding the active compound to light liquid petrolatum. White petrolatum is melted together with wool fat, strained, and the temperature adjusted to 45-50° C. The liquid petrolatum slurry is added and the ointment stirred until congealed. Suitably the ointment is packaged in 30 gm tubes. [0069] The foregoing ointment can be applied to the eyelid to enhance the growth of eyelashes. Similarly the composition can be applied to the brow for eyebrow growth. Example 6 Solution [0070] An aqueous solution containing 5%, by weight, bimatoprost is prepared as follows. Bimatoprost is dissolved in water and the resulting solution is sterilized by filtration. The solution is aseptically filled into sterile containers. [0071] The composition so prepared can be used in the topical treatment of baldness by application to the scalp daily. Example 7 Lotion [0072] A sample of bimatoprost is dissolved in the vehicle of N-methyl pyrrolidone and propylene glycol. The composition can be used for application to dogs or cats having hair loss due to mange or alopecia of other causes. Example 8 Aerosol [0073] An aerosol containing approximately 0.1% by weight bimatoprost is prepared by dissolving the bimatoprost in absolute alcohol. The resulting solution filtered to remove particles and lint. This solution is chilled to about minus 30° C. To the solution is added a chilled mixture of dichlorodifluoromethane and dichlorotetrafluoroethane. Thirteen ml plastic-coated amber bottles are cold filled with 11.5 gm each of the resulting solution and capped. [0074] The composition can be sprayed on the scalp daily to stimulate the growth of hair. Example 9 Dusting Powder [0075] A powder of the compound bimatoprost is prepared by mixing in dry form with talcum powder at a weight/weight ratio of 1:10. The powdered mixture is dusted on the fur of minks or other commercially valuable fur bearing animals and show animals for increased rate of hair growth. Example 10 Related Compounds [0076] Following the procedure of the preceding Examples, compositions are similarly prepared substituting an equimolar amount of a compound of Table 1 for the bimatoprost disclosed in the preceding Examples. Similar results are obtained. [0077] While the preferred embodiment of the invention has been illustrated and described, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention. [0078] The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

Methods and compositions for stimulating the growth of hair are disclosed wherein said compositions include a cyclopentane heptanoic acid, 2-cycloalkyl or arylalkyl compound represented by the formula I wherein the dashed bonds represent a single or double bond which can be in the cis or trans configuration, A, B, Z, X, R 1 and R 2 are as defined in the specification. Such compositions are used in treating the skin or scalp of a human or non-human animal. Bimatoprost is preferred for this treatment.

This application claims the benefit of U.S. Provisional Application No. 60/186,185, filed Mar. 01, 2000 U.S. Provisional Application No. 60/159,465, filed Oct. 13, 1999. This application is a continuation-in-part of U.S. application Ser. No. 09/071,523, filed May 01, 1998, U.S. Pat. 6,276,700 B1, issued Aug. 21, 2001, which application claims the benefit of U.S. Provisional Application No. 60/045,490 filed May 02, 1997. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not Applicable. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention most generally relates to gravity driven vehicles such as downhill racing carts. More particularly this invention relates to maneuverable, steerable gravity driven vehicles Most particularly, the invention relates to a stable, durable gravity driven vehicle which is steerable, has at least two wheels or two skis or a combination of wheels and skis and at least one brake, is ridden in a prone, face down, face forward position and which may be ridden on varied surface terrain such as dirt, grass or snow. Even more particularly this invention relates to the mechanism for suspension of the wheels and/or skis which is configured to provide precise control in turns especially the carving of turns, by the skis, while descending on snow cover. 2. Description of Related Art Although there are various patents disclosing embodiments for devices which permit movement over a surface, the following patents known to the inventors hereof, do not in any manner suggest or teach the Gravity Driven Steerable Wheeled or ski equipped Vehicle disclosed and claimed by applicants in the instant application for patent. U.S. Pat. No. 3,887,210 to Funke discloses a four wheeled, downhill racing cart with a steel frame and a driver's seat mounted on the frame for use on various surfaces. The rider of the cart must sit in an upright position with feet forward. The cart is steered by applying pressure with the feet to pedals attached to the front axle assembly. There is a braking mechanism which is triggered by leaning forward in the seat and engaging a braking member which is suspended from the seat frame. When the seat is leaned forward and the braking member is engaged, a plate is lowered to contact the ground surface and apply braking by frictionous contact with the ground. A rubber pad is fastened to the underside of the braking plate for braking engagement with the surface over which the cart is traveling. The cart does have handle bars, however, they are not used at all for steering control of the vehicle. The handles appear to be used for holding on and keeping the rider with the cart. The device also has carry hooks on the front handle assembly for towing of the device to the starting area. Additionally, the device can be fitted with a “roll-bar” attachment. U.S. Pat. No. 4,098,519 to Reid, Jr. device looks most like the known “flexible flyer” type of snow sled. This wheeled sled has four wheels and may be ridden on a variety of surfaces in a sitting or prone position. The body of the device is not inclined and is composed of several, separate, wooden slats. There are slots in the body of the device for gripping when riding in a seated position. However, the prone position would be preferred in order for the user to operate the two hand brakes installed on the handle bars at the front of the device. The device is steered by way of crossed steering bars pivoted to each of the rear axle brace, front axle brace, and steering handle. The steering bars are connected diagonally to opposite positions on the front and rear axles such that the axle braces are pivoted in opposite directions as the steering handle is moved—this minimizes turning radius. Springs return the steering handle to a neutral, centered position when there is no pressure on the steering handle. The hand brakes act on the front wheels. This device does not have any sort of tow hook for pulling the sled to a starting position. There is no restraining device or harness on this, or any of the previously described sleds. There is also no “roll-bar” or any sort of plate or device to prevent injury or to keep the sled from tipping over. U.S. Pat. No. Des. 331,031 to Janoff discloses a design for a land sled. Design patents cover only the look of the device depicted in the Figures and no real description of the device is included in a design patent. This particular land sled differs from the two previously described devices in several ways. It has two large roller type wheels, instead of four smaller wheels. It is capable of being steered by either the hands or feet and can be ridden sitting in an upright position (steering with the feet) or in a prone position (steering with the hands). The steering appears to be accomplished in a way similar to that of known “flexible flyer” type snow sleds—by pushing and/or pulling the large handle bar extending across the front of the device. There are also slots along the side of the sled, towards the back, for gripping when using the sled from a seated position. There does not appear to be any sort of incline to the main body of the sled, on which one would sit or lay prone, although it is difficult to determine much about the mechanics of a device from a design patent. U.S. Pat. No. 5,354,081 to Huffman et. al. discloses a stunt-riding toy for use on a variety of surfaces including snow. The device may be fitted with four wheels, or skis. This vehicle has a seat and also must be operated from a sitting position, with the feet placed on plates near the front of the device. The device is quite narrow and is steered mainly by leaning in the direction it is desired to turn. The front foot plates also serve as a brake and a means to keep the vehicle from leaning too far and tipping over. If the vehicle leans too far, the plates will contact the ground surface, apply braking pressure and prevent further tipping. The device has two handles and a rear hand cable brake which pulls a plate into contact with the wheels when the hand brake is engaged. The handles are positioned near the rear of the device, close to the seat so that the rider's arms hang down along the rider's side to grip the handles, and keep the rider in an upright position. The invention has the particular objectives, features and advantages of: 1) a steerable gravity driven vehicle; 2) that such vehicle is ridden in a prone, face forward position; 3) that such vehicle has at least one brake; 4) that such vehicle has a plurality of wheels, most preferably four (4) wheels however the sled having three (3) wheels—the single wheel preferably located between the legs of the driver—is also disclosed and is within the scope of the disclosure of the invention; 5) that such vehicle may alternatively have a combination of skis and wheels providing for enhanced performance for use on snow covered terrain; 6) that such vehicle may alternatively have at least one ski forward or in the front position of the vehicle and a slide pan toward the rear portion of the vehicle; 7) that such vehicle may alternatively have at least 3 skis, wherein either one ski is forward or in the front position of the vehicle or toward the rear portion of the vehicle; 8) that such vehicle as described in 1) though 7) above may have incorporated therein the mechanism for suspension of the wheels and/or skis which is configured to provide precise control in turns especially the carving of turns, by the skis, while descending on snow cover; and 9) that such vehicle as described in 1) through 4) above may be retrofitted with components in order to create the vehicle(s) described in 5), 6), 7) and 8) above. The patents noted herein provide considerable information regarding the developments that have taken place in this field of non-motorized vehicle technology. Clearly the instant invention provides many advantages over the prior art inventions noted above. Again it is noted that none of the prior art meets the objects of the gravity driven vehicle in a manner like that of the instant invention. None of them is as effective and as efficient as the instant Gravity Driven Steerable Vehicle for maneuvering down steep, varied surface terrain and none of them are operated from the prone face down and face forward position. SUMMARY OF THE INVENTION The most fundamental objects and advantages of the invention are: 1) a steerable gravity driven vehicle; 2) that such vehicle is ridden in a prone, face down, face forward position; 3) that such vehicle has at least one brake; 4) that such vehicle has at least two wheels or skis/slide pan or a combination thereof; 5) that such vehicle has a steering suspension mechanism which provides for the carving, by the steerable skis, of precise turns on snow covered surfaces: and 6) a kit of components which are used to retrofit a wheeled vehicle to one with wheels, skis, pan or a combination of wheels, skis or pan. It should be noted that where there are three (3) wheels on the vehicle, the third wheel may be located either at the front or the rear of the vehicle. The third wheel may be the same size as the other two wheels, or may be large or smaller. The third wheel may be independently steerable, or steerable in cooperation with the steering of the other two wheels. The vehicle may have independent mechanical, air actuated or hydraulic actuated brakes and may have independent hydraulic shock absorbers on some or all wheels. But the vehicle need not have shock absorbers at all, or may have shock absorption only for the front wheels, for example. The vehicle also may have an attachment for the picking up of the vehicle by, for example, a ski chair lift, and which may be a part of the driver/operator restraint system acting to keep the operator's legs from drifting off of the vehicle especially in a sharp turn maneuver. The attachment for picking up the vehicle may further serve to protect the rider should the vehicle roll over. However, this attachment is not fundamental to the invention. A primary object of the invention is to provide a gravity driven steerable vehicle comprising a chassis and a riding surface on which a rider is oriented in a prone, face down, face forward position, at least two wheels or skis or combination thereof, means for steering the vehicle, means for causing deceleration or halting of motion of the vehicle, and means for harnessing the rider onto and into the vehicle. Another primary object of the invention is to provide means for steering each wheel independently. A further primary object of the invention is to provide means for absorbing shock exerted on said vehicle caused by the vehicle passing over rough terrain. Another object of the invention is to provide means for towing the vehicle to the top of an incline, and means for assisting the rider in staying on the vehicle and protecting the rider if the vehicle were to roll over. Yet another object of the invention is to provide such a vehicle further comprising four wheels. Another object of the invention is to provide such a vehicle having three wheels. A still further object is to provide a safety brake which actuates upon release of the hand grips for operation and parking safety if a rider were to fall off of the vehicle during operation of the vehicle. A yet still further object is to provide a means for automatically causing the vehicle to hold a constant turn which actuates upon the occasion if a rider were to fall off of the vehicle during operation of the vehicle. A fundamental object of this invention is to provide a means or mechanism for suspension of the wheels and/or skis which means or mechanism is comprises a single a-arm pivotably attached to an axle at an axle pivot point and a shock absorber connecting end pivotably connected to one end a shock absorber and which shock absorber other end pivotably connected to said axle. The suspension system may be provided preferably independent for each wheel or ski or on only the front axle of the vehicle. The suspension system configured to provide precise control in turns especially the carving of turns, by the skis, while descending on snow covered terrain. Another fundamental object of the invention is to provide a ski assembly having front end and a ski rear end, a ski running surface and a ski upward-facing surface and having a ski brake assembly configured to cause, when said brake assembly is operator actuated, a brake blade to extend below said ski running surface at said ski rear end thereby engaging the terrain surface upon which the ski is running. There may also be provided a brake return assembly preferably using springs to return said brake blade to a non-braking position. These and further objects of the present invention will become apparent to those skilled in the art after a study of the present disclosure of the invention and with reference to the accompanying drawings which are a part hereof, wherein like numerals refer to like parts throughout, and in which: BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS FIG. 1 is a combination of a top plan view, a side plan view and a front plan view of the vehicle all of which are illustrating the body curvatures, the rider inclined riding surface/bed and the like; FIG. 2 shows a top plan view of the vehicle, showing, in shadow the axle, steering, and wheel spindles; FIG. 3 shows a top plan view of the three (3) wheeled embodiment of the vehicle; FIG. 4 is a detail view of the assembly axle with an air/oil shock used in the wheel suspension; FIG. 5 is a detail view of the assembly axle with a coil/oil shock used in the wheel suspension; FIG. 6 is a detail view of the hydraulic rear wheel brake system; FIG. 7 is a detail view showing the steering linkage in association with the prone steering position of the rider; FIG. 8 is a detail view showing the right rear wheel spindle; FIG. 9 is a detail view showing the right front wheel spindle; FIG. 10 the two views illustrate detail of the tow-bar assembly which also is a part of the rider restraint system; FIGS. 11A, 11 B and 11 C are a top plan view, and side plan view and a rear plan view respectively showing, in shadow, substantially all of the components and their relationship and which illustrates a wheeled vehicle retrofitted with skis on the front and wheels to the rear; FIGS. 12A, 12 B and 12 C are a top plan view, and side plan view and a rear plan view respectively showing, in shadow, substantially all of the components and their relationship and which illustrates a wheeled vehicle retrofitted with skis on the front and skis on the rear; FIGS. 13A, 13 B and 13 C are a top plan view, and side plan view and a rear plan view respectively showing, in shadow, substantially all of the components and their relationship and which illustrates a wheeled vehicle retrofitted with skis on the front and a slide pan to the rear which slide pan has grooves directed from front to rear which provide lateral stabilizing of the vehicle and which has a suspension system and a piston actuator which actuates braking by pressing the shovel/blade into the snow surface; FIGS. 14A and 14B is a combined and sectioned drawing of a top plan view and a rear plan view respectively showing, in shadow, substantially all of the components and their relationship and which illustrates a braking system for a vehicle having wheels in the rear; FIGS. 15A and 15B is a combined and sectioned drawing of a top plan view and a rear plan view respectively showing, in shadow, substantially all of the components and their relationship and which illustrates a braking system for a vehicle having wheels in the front; FIGS. 16A and 16B is a top plan view and a rear plan view respectively which illustrates in the partial top plan view in shadow the front skis assembled to the front a-arm and also illustrating in shadow the steering linkage, the front brake system and the front suspension system and particularly in FIG. 16B is illustrated the “canting” of the skis; FIG. 17 is a partial rear plan view of the attachment of a rear ski with brake components and showing, in shadow, the “unloaded” attitude of the ski and the relative positions of the suspension components and the fully loaded shock absorber compressed attitude of the ski and the relative positions of the suspension components; FIG. 18 is a partial top plan view of the left rear ski attached to the rear axle illustrating the a-arm attachment to the ski post, the a-arm pivot point on the axle, the connection of the a-arm to the shock absorber which is attached to the axle at the shock absorber pivot location and also showing the brake blade, brake arm, brake cylinder; FIG. 19 is a side plan view of the ski assembly of the invention, which shows, in shadow, the change in position of the brake components of the braking assembly; and FIG. 19A is a top view of section AA which illustrates the detail of the brake return spring assembly. DESCRIPTION OF THE PREFERRED EMBODIMENTS The following is a description of the preferred embodiment of the invention. It is clear that there may be variations in the size and the shape of the gravity driven wheeled vehicle, in the materials used in the construction and in the orientation of the components. Most importantly, the teaching of the wheeled version of the gravity driven vehicle is applicable to the version having skis or pans mounted in place of some or all of the wheels and which is used as a gravity driven vehicle on snow or ice covered downhill terrain. The stability in the absorbing of shock from uneven surface conditions and the stability and performance while making turns while going downhill derives from the combination of the steering and suspension geometry and the inherent shape of the skis mounted in place of the wheels and tires. A. The Wheeled Gravity Driven Vehicle: In order to most simply and clearly characterize the essential features of the invention reference is made to drawing FIGS. 1, 1 A, 1 B, 2 , 3 , 6 and 10 in which the essential elements of the invention are identified by numerals (not in a circle). FIGS. 4, 5 , 7 , 8 and 9 are details of various elements which are well known to the ordinary skilled artisan. It is also important to note that the instant vehicle invention may have one wheel in front and one wheel in the rear. It is also possible to have three wheels with the single wheel either in the front or in the rear of the vehicle. Steering may be effected by using either the front wheel(s) or the rear wheel(s) or both. Braking combinations are likewise possible—front wheel, rear wheel or both. With reference now to particularly FIGS. 1, 2 , 3 , 6 , 10 , 14 A, 14 B, 15 A and 15 B there is illustrated a four wheeled gravity driven steerable wheeled vehicle 10 . There is a chassis 12 having chassis front portion 12 A, chassis rear portion 12 B, chassis underside 12 C and chassis top side 12 D. A rider riding surface 14 is on chassis top side 12 D and is configured to cause a rider on rider riding surface 14 to be oriented in a prone, face down, face forward position. There is provided a means for attaching, 16 , a rear axle assembly 16 A substantially at chassis rear portion 12 B. There is also means for mounting, 18 , a front axle assembly 18 A substantially at chassis front portion 12 A. Provided also is a means for steering, 20 , gravity driven steerable wheeled vehicle 10 or three-wheeled vehicle 40 by the rider when the rider is positioned on rider riding surface 14 . There are rear wheel hub and spindle assemblies 22 integral with rear axle assembly 16 A. Wheels and tires 23 are normally mounted to the wheel hub. Front wheel hub and spindle assemblies 24 are integral with front axle assembly 18 A. A braking system or means for causing deceleration and halting of motion 26 of vehicle 10 when vehicle 10 (or 40 ) has motion is provided. Braking system 26 may be hydraulic, mechanical or a combination of the two and braking may be of all wheels or some of the wheels. In order to help the rider stay on vehicle 10 or 40 , there is a means for harnessing 28 the rider onto and into rider riding surface 14 when the rider is positioned on the vehicle. To provide additional comfort for the rider and to improve the stability of the vehicle while moving, there may be provided means for absorbing shock 20 exerted on each of the front wheels and tires 23 attached to each of the two front wheel hub and spindle assemblies 24 thereby damping shock caused by vehicle 10 passing over rough terrain, between front wheels and tires 23 and front axle assembly 18 A. There may also be means for absorbing shock 32 exerted on each of the rear wheels and tires 23 attached to each of the two rear wheel hub and spindle assemblies 22 thereby further damping shock. In order to get wheeled vehicle 10 or 40 or ski equipped vehicle 10 A or 40 A up a ski slope for example, there is provided a combination rear roll bar and transport bail 34 . When the rider is on the vehicle, bar 34 is in the lowered position providing the rider with a roll bar and an object against which pressure may be applied when the rider is in a sharp turn. Bar 34 is placed in a second position which permits attachment to a lift such as a ski lift. In order to discuss some of the engineering features, reference is again made to the drawings including FIGS. 4-19. The drawings show simply the preferred embodiments of the wheeled and the ski equipped vehicle which have the following preferred specifications: FIG. 1 shows a top, side, and front plan view of the vehicle, illustrating the body curvatures, the rider inclined riding surface/bed including the 11″ diameter high speed pneumatic, tubeless tires in the preferred embodiment of the vehicle, which are designed for motor vehicle racing at speeds in excess of 100 mph and which provide excellent traction and a soft but firm ride. Advanced four wheel “A” arm air spring, oil damped suspension—independent four wheel suspension with air/oil shocks or with coil/oil shocks is provided and yields a smooth, stable ride over surfaces with irregularities ranging from wash board to large bumps. However, not all four wheels need have suspension, possibly only the front wheels might have suspension. Also, the vehicle could be made in either a four-wheeled or three wheeled embodiment. In either embodiment, the suspension is not essential. FIG. 3 illustrates a three (3) wheeled embodiment of the vehicle. FIG. 4 shows a detail view of the assembly axle with an air/oil shock used in the wheel suspension, and FIG. 5 shows a detail view of the assembly axle with a coil/oil shock used in the wheel suspension. Independent hydraulic braking is provided from dual, real wheel, hydraulic disk brakes, designed for motor vehicle racing at speeds to 150 mph and operated with a single hand lever. These brakes give smooth, uniform and powerful braking capability whether with a four or three-wheeled embodiment. The braking system could be modified for a three-wheeled embodiment. FIG. 6 is a detail view of the hydraulic rear wheel brake system. For the detail of the braking system used with the ski equipped version of the vehicles 10 A or 40 A, reference is made to FIGS. 16-19. Particularly, FIGS. 16A and 16B illustrates in the partial top plan view in shadow front skis 70 A assembled to the front a-arm 32 A and also illustrating in shadow the steering linkage, the front brake system 80 including brake return system 88 and the front suspension system 30 and particularly in FIG. 16B is illustrated the “canting” of the skis 70 A; FIG. 17 shows the attachment of a rear ski assembly 70 A i.e, the ski assembly having ski brake assembly 80 as a part of ski assembly 70 and also shows, in shadow, the “unloaded” attitude of ski assembly 70 A and the relative positions of the suspension components and the fully loaded shock absorber 32 B compressed attitude of the ski and the relative positions of the suspension components, i.e., a-arm 32 A and the piston of absorber 32 B; FIG. 18 shows a left rear ski 70 A attached to means for absorbing shock 32 which is attached to the rear axle 31 , the manner of the a-arm 32 A attachment to the ski post 72 , the a-arm pivot point 32 A 3 on the axle 31 , the connection of the a-arm shock attachment end 32 A 2 to the shock absorber end 32 B 1 which shock absorber is attached to the axle at the shock absorber pivot location 32 B 2 and also showing the brake blade 84 , brake arm 82 , and the brake cylinder 81 . FIG. 19 is a view of the ski assembly 70 A of the invention, which shows, in shadow, the change in position of the brake components of the braking assembly 80 . FIG. 19A is a top view of section AA which illustrates the detail of the brake return spring assembly 88 along with return springs 88 A. There is provided a combination rear roll bar and transport bail. This bar is hinged so that locked in the folded down position, it tends to confine the legs of the rider and further resists overturning of the vehicle. When this bar is in the unfolded or up position it is useful as a tow or lift bar which may be attachable to a ski lift as an example of use. However, it is possible to have an embodiment of the vehicle without this feature. FIG. 10 illustrates detail of the tow-bar assembly which also is a part of the rider restraint system. The prone (lying down) low center of gravity design provides control and good visibility. It is also possible that this low position may add to the level of safety for the rider. The extremely low center of gravity provides a relatively stable and safe ride—overturning is nearly impossible. There is provided a safety harness which enhances control, stability and rider safety, and which is shown illustrated in FIGS. 2 and 3. The shoulder harness provides rider stability and contributes to rider safety by keeping the rider in place on the vehicle. There is also an automatic brake which actuates upon release of the hand grips for operation and parking safety. This feature is not essential to the basic embodiment of the invention, however this is an important additional feature. With this safety braking mechanism, the vehicle will be stopped if the rider were to fall off of the vehicle at some point during the operation of the vehicle. Additional to the automatic brake system there may also be a means for causing the vehicle to go into a constant tight turn mode of operation if the rider loses control or if the rider fall from the vehicle while in motion. The surface of the vehicle on which the rider lays is comprised of a closed cell body pad for rider comfort. There is an elevated chest rest and thick foam mat which provide additional rider comfort and visibility. In the preferred embodiment, the body and chassis of the vehicle is made from light weight foam core fiberglass reinforced construction. The strong, rigid, impact resistant foam filled fiberglass body with aluminum inserts provides a single framework for attachment of all components. Fiberglass body, plated steel parts, and extensive use of aluminum provide optimum protection from the elements, and from impact damage. The steering and braking mechanism is a ball bearing bicycle style steering and braking assembly which is positive, responsive and familiar to all to control, thus making learning to ride, and riding the vehicle easier and more comfortable. FIGS. 7 and 15A provide, in combination a detail view showing the prone steering linkage. Substantially the same steering system as shown is FIGS. 7 and 15A is also used in the ski equipped vehicles as shown in FIGS. 11A, 12 A, 13 A and 16 A. There are provided precision bearings on all four axles in one embodiment. Independent rear axles provide maximum maneuverability in a four wheeled embodiment. The vehicle may be provided with precision wheel hubs, with pre-lubricated ball bearings, which are maintenance free. In a preferred embodiment the suspension and steering spindle bearings are formed of woven TEFLON or NOMEX and are designed to withstand high impact forces and hostile environments, and provide long life with no maintenance. FIG. 2 shows a top, side, and front plan view of the vehicle showing, in shadow, the axle, steering, and wheel spindles. Also, FIGS. 8 and 9 show a detail view showing the right rear wheel spindle and a detail view showing the right front wheel spindle. The preferred steering post ball bearings and linkage ball rod ends provide maintenance free, smooth, zero back lash response. Each vehicle may be provided with elastomer bumper strips in the front and the rear which provide impact protection for the vehicle and rider. The preferred steering post, wheel, and front and rear axle assemblies can be removed intact should maintenance be required, thus reducing time and cost of any necessary maintenance. In a preferred embodiment, the vehicle chassis has a ramp-shaped underbody and detachable covers which offer protection for axles, steering linkage, and suspension from road obstacles. Each vehicle in the preferred embodiments has strong, impact resistant fiberglass fenders which protect the rider from track dirt and contact with the wheels or skis when riding. Following is a general description of the many technical features and the advantages achieved by the presently disclosed invention. It is material provided to further enhance the level of disclosure and present all of the presently known advantages achieved because of the technical features of the invention. General Discussion: A. The Gravity Driven Vehicle with Skis or Combination of Skis and Wheels or Slide Pan While much of the following description is presented as a description of a wheeled vehicle similar to the vehicle of the present invention as described above but which has been retrofitted or specially constructed to result in the vehicle for use on snow covered terrain. It is important to note that the vehicle basically as described above but modified for use on snow may be custom made rather than created from a wheeled version by means for retrofitting the wheeled version. All of the disclosure above is applicable to the disclosure of the ski version of the vehicle except of course that portion which relates to the specifics of the braking system and some aspects of the steering systems. 1. Retro Fit Kits/Ski Version The retrofit kit is used in conjunction with the gravity driven wheeled vehicle of the present invention or other like products to make the product easily adaptable for use in snow covered conditions. The details of the systems described below apply as a retrofit package or basically describe the components and the function when applied to a gravity driven vehicle custom designed and dedicated for use only on snow. I.e., a wheeled vehicle may be retrofitted with the combination of skis or slide pans or custom designed and built in the same manner. FIGS. 11-13 and 16 illustrate the vehicle with skis in the front and wheels to the rear, skis both front and rear, and skis in front and a slide pan with braking to the rear respectively. It should further be noted that the use of skis and slide pan or slide pans is interchangeable in that they both provide the sliding surface upon which the vehicle rides when in descent on a snow covered surface. A slide pan or ski may be used in any combination in the front in the rear or both front and rear locations of the vehicle. Front Steering System—FIGS. 11-13 and 16 A unique discovery during the course of the development efforts to create the winter or snow covered terrain version of the gravity driven vehicle occurred in the integration of the skis onto the existing single swing arm suspension design of the wheeled product. As a consequence of the advanced four wheel “A” arm air spring, oil damped suspension—independent four wheel suspension with air/oil shocks or with coil/oil shocks as illustrated in at least FIGS. 4, 5 , and the multiple views of FIGS. 11-16 there achieved a smooth, stable ride over surfaces with irregularities ranging from wash board to large bumps. With the mounting of skiis to the A-arm or the wishbone portion of the suspension system, the position or attitude of the outer edge of all skis due to the single arm geometry when there is no rider on the sled and the shocks are operating properly, causes the outer edge of all skis to be constantly engaged with the ground or snow surface. When the sled is being ridden the loading of the shocks, depending on how they are set, causes the skis to change to a more flat or level attitude relative to the snow or to the ground surface. This attitude only reaches a substantially flat attitude if there is extreme loading on the sled body and does so to absorb shock to the sled and rider. After such levels of loading and impulse types of shocks to the sled, the sled always returns to the outer edge engagement posture. Substantially because of this characteristic of ski attitude or the inward canting of the skis when the sled is being ridden, on a modest downhill terrain put in particular when travelling on steeper downhill and upon initiation of turns, the lower or downhill ski becomes more heavily loaded tending to increase the flatness orientation relative to the snow surface yet still resulting in the outer edge carving into the snow. I.e., the outer edge of the ski carves into the snow and as it becomes increasingly loaded the suspension slightly counters the digging or carving action but continues to engage the snow surface. The upper ski or uphill ski, particularly the outer edge, with the lesser loading while in the turn it is still partially canted inwardly, carves as well and even more aggressively because of this canted attitude of the uphill ski in the turn. Alternatively described, the uphill ski acts somewhat as an anchor as this engagement becomes more unloaded in an aggressive turn, the a-arm extends its full travel maintains constant engagement with the snow due to the fact the lower or downhill ski is flattening allowing the attitude of the uphill ski to remain in constant contact with the snow. This unexpected performance characteristic or functionality provides benefits such as for example: the carving action of both skis constantly counterbalancing each other provides tremendous control and maneuverability in virtually every snow condition; and under conditions of heavy loading of the downhill ski, the digging and tipping tendency of the sled is reduced dramatically. To provide further control and maneuverability a keel component may be added to the ski bottoms. A. The front ski retrofit is attached to the existing front a-arm (wishbone) assembly of the wheeled version with either a double or the single arm/linkage geometry by utilizing the existing fastening system. When fixed to the suspension linkage the ski has the ability to pivot from an axis perpendicular to the axle allowing the tip and heal to pivot in opposition to one another, upwards and downwards and is limited in its pivot by a stop mechanisms mounted to either the ski or the mounting system. The width and length of the selected skis and the forward or rearward positioning of the pivot point is established based upon the terrain and the specific performance requirements desired. The steering geometry has been designed to create a carving action when the skis are turned by the steering linkage. I.e., upon causing a turn using the steering mechanism both ski tips rise slightly, the tails sink slightly and the inner edge of the ski opposite of the direction of the turn and the outer edge of the ski in the direction of the turn tilt slightly downwards into the snow or ice surfaces. These edges can also be described as the ski edges on the inner radius of the turn. Brake System—FIGS. 13, 16 - 19 B. The independently or simultaneously actuated right and left, rear, front or rear and front, or independent rear and front combined brakes or single brake actuation unit whether one or divided mechanism is integrated in to the front ski and trailing or sliding pan or ski assemblies that are part of the vehicle/mountain sled retrofit package. The actuation of the mountain sled brake is either mechanical, hydraulic, servo-mechanical, pneumatic or a combination of these technologies. When this solution is used as a retrofit it is intended, whenever and wherever possible, that the existing actuation system or systems be utilized. Rear Tracking and Control System—FIG. 13 C. The rear brake system or systems is/are integrated into an under body pan covering a portion or all of the sled under body from approximately the middle of the sled length and some distance forward of the rear axle location mounting surfaces and is attached or nearly meets the sled underside and extends sufficiently across the width of the sled in the front in a fixed or in a limited manner with a hinge or slide like interface allowing the pan from the hinge point rearwards to move up and down or to slide or flatten out across the under face of the sled a distance equal to the translated stroke distance of an internally mounted shock system. The pan will be a complete cover with a downward sloping straight or radiused lead edge, running from the mounted or hinged or meeting leading edge and transitioning to a gliding surface that runs almost parallel to the underside of the body or sled frame. The rear pan or ski assemblies will be covering a single or double shock absorption mechanism able to operate independent of or together with each other and the braking mechanism that will be substantially a swing arm or linearly actuated arm or blade that will when actuated protrude out from the pan or ski below their running surfaces and into the snow or ice surface at a positive, negative or right angle to the pan or running surface and will be depth adjustable equal to the geometry and stroke of the actuation. This pan or ski (if chosen) as seen from behind is profiled to provide maximum lateral grip and stability when either turning or gliding. The geometries are optimized to address snow condition and terrain. Benefits D. Commercial: The winter retrofit package allows an owner of a summer mountain sled the simplified and flexible solution of utilizing at a minimum a sled body with an integral frame or a sled body with a separate frame. Additionally, depending upon the components of the winter retrofit package, many more of the basic of summer mountain sled components can be used in retrofitting the summer sled for winter recreation such as the axle, suspension, steering and braking systems. E. Technical: The retrofitted summer sled steering, braking, and rear tracking and control systems provide in the sled retrofitted for winter use all of the already known benefits of summer/wheeled sled including superior control and stability for a snow sledding experience. 2. Alternative Ski Version—Studded Tires The condition of downhill ice packed or ice covered roadways, trails, paths, etc. presents a braking, steering and control challenge for both a conventional summer mountain sled and a winter mountain sled of any form or configuration. The operational challenge is to provide a sled with a steering and braking solution that handles these conditions. The following embodiment of the invention and declared benefits address this challenge. A mountain sled equipped with four wheel or three wheel independent or simultaneous braking systems will have its standard tires replaced with slick or profiled tires that have been retrofitted or produced to order with studs, nails, screws, etc. fixed to, inserted into or imbedded in the rolling surface of the tire and protruding from the rolling face of the tire sufficiently to provide contact and grip in the existing ice or ice packed condition on the running surface. The selection of each tire profile and cleat material, cleat geometry and cleat placement and number of cleats is dependent solely on the application surface and can be changed and optimized accordingly to best suit the exact requirements of each downhill surface. Benefits Alternative Ski Version—Studded Tire Version This solution has the distinct benefit of providing exceptional control on most every downhill ice covered or ice packed roadway, trail, path, etc. running surface. I. Due to the fact that only the tires used for summer sport are replaced with tires having studs or nails (or the like) mounted to the tread portion of the tire to provide improved friction interface between the sled and the running surface. All other subsystems, steering, suspension and braking remain the same for the studded tire version as for the summer tire version. The resulting sled has substantially all of the performance advantages of the summer wheeled vehicle. I Double Arm Independent Suspension (Upper and Lower Control Arm Design) The challenge of providing superior handling and control of a gravity driven mountain sled is to offer the best technology to achieve differing optimized operating results to meet the demands of the conditions and requirements of various terrains. The integration of certain solutions in a mountain sled with tires or with winter attachments such as in various presented solutions is primarily possible due to the combination of certain existing technologies, materials and compact componentry and by integrating them into various suspension geometries. The advent of small components coming from the mountain bike industry, has permitted mountain sledding to move from being basically unsophisticated toys to sophisticated sports equipment. Integrated into the mountain sled is a suspension system that displays when viewed from the side (from sled rear to front or front to rear) a suspension geometry that is trapezoidal in form (parallelogram) with all four joints forming pivots and the two sled side, upper and lower fastening points/pivots are fixed in some manner firmly to the sled frame or uni-body or axle system or combination thereof and the spindle or the ski assembly or ski pan assembly is fixed somewhere on the fixed member connecting the outboard pivot points of the trapezoid. As part of this design and resisting loading of the trapezoidal design is an arm that extends at an angle away from one of the inboard trapezoid pivot locations and is an integral mechanical arm to which a shock absorber is attached to the end of arm and to a fixed point on the body, frame or axle system and both ends of the shock absorber can pivot. This geometry allows the upright mounting face for the spindle or ski or pan to move the spindle or ski or snow pan assembly upward and downward when the sled is pointed straight forward and when the sled itself has certain load exerted and released such that the tire, ski or pan maintains complete contact of its lower running surface with the operating surface, the running surface remains parallel with itself as it is loaded and unloaded. The longitudinal motion of the entire assembly is limited by the stroke of the shock absorber and the operating envelope of the related mechanics. This design permits minimal axial motion of the contact running surface as it is loaded and unloaded called scrubbing. This scrubbing action is considerably less than that witnessed by the solution already presented in the claim from TSI with a single arm solution. Benefits This solution gives the clear benefits of II. Maintaining constant and maximum contact of the entire running face of the tire, ski, and pan solutions with the running surface. III. Reduces scrubbing and non-uniform wear of the running surfaces of the tires, skis and pans. IV. Simplifies steering geometry compound angles allowing maximization of ski contact and carving benefits. This system is highly recommended for applications utilizing skis and sliding pan systems. II Integrated Body & Frame Solution The body design and construction for the instant vehicle represents the latest form of taking the idea of monocoque or body integral frames and eliminating the need for conventional frames and separate bodies for use in mountain sled, sleds and sled product applications. This idea utilizes the fiberglass upper and lower body components known as or halves and sandwiches them together and imbeds inserts to add strength, to bond the halves, to stiffen the body and to take maximum advantage of the collective strength of each system. This solution accommodates and allows the fiberglass to be a connecting structure through the use of adhesives and epoxies that are part of the normal fiber-glassing process of dissimilar materials. This permits the combination of a variety of materials that would not otherwise be combined in a conventional fame/body construction. The imbedded materials then are optimized for their ability to retain fasteners, to choose material that accommodates extreme variations in temperature, adequately spread load across the fiberglass surface and eliminating extra material where it is unnecessary. Benefits The benefits from such a solution are; I. Provides singular body and frame system, simplifying assembly, inventory and repair. II. Makes maximum use of the strength and stiffness of each system. III. Allow adaptability and design modifications when new materials come available without requiring the whole design be changed. There are additional subsystems which may be incorporated into the gravity driven vehicle of each of the embodiments described such as for example: Rollover protection Steering damping Accessories such as headlights, speedometer Adjustable steering ratios Prone sled body angle support system Complete braking system i.e., one system for the front and one for the rear which may use two (2) independent master cylinders and brake circuits. Detail Relative to the Suspension System, the Ski Assembly and The Braking System Suspension geometry action and performance contribution to tracking and steering control: The existing, previously disclosed single A-arm suspension geometry provides the ability to present the outer edge of four skis, when mounted to a two opposing arm axle assemblies, to the snow at an angle to the running surface which delivers significant unique, maneuvering and steering control performance in most all snow conditions. This performance results from the fact that a carving geometry of the skis to the snow occurs. This engagement with the running surface is equally as consistent improves as the sled is underway and is caused to turn through the steering linkage. In a turn or as one is traversing a downhill slope the outboard or downhill ski receives increased load and the ski engages more with the snow/ice running surface until such time that the load on this ski begins to overcome the resisting force of the shock attached to the shock anchor point on the A-arm and the axle. As the resisting force (ajustable) is gradually overcome the A-arm begins to pivot at the A-arm pivot and ski assembly begins to move toward a flatter orientation with the snow. This action helps to avoid over powering the engagement of the downhill ski downhill edge and helping to avoid overturning. Simultaneously, the uphill ski is less loaded but still has its outer edge engaged in the snow and creates a scrapping action on the adjacent downhill snow/ice as well as packing what ever loose snow is present under the underside of the ski. This uphill ski performance improves as the downhill ski continues to flatten in respect to the running surface and loading. Additionally, the underside of any and all skis can be equipped with various geometry keels to assist in linear or turn tracking of all skis as they, under suspension applied compressive loads, present more ski surface and the keels to the running surface. There are always limits to this performance resulting from excessive speed and surface conditions, etc. Ski Pivot Action and Performance Contribution: The Ski foot and post pivot allows any ski when traveling over uneven surfaces to follow the terrain contour more closely. The swing motion allowed by this feature is limited by the presence of bumpers mounted on the ski foot which contact ski post extensions when pivot travel limits are reached. This function delivers another benefit because of the ability to allow the ski to follow the terrain more closely that being it causes the brake mounted on the attached ski assembly to achieve more consistent contact with running surface. Braking Alternative A: Brake Action and Performance Contribution: The brake assembly developed by the applicants provides superior braking action in various snow and ice conditions. The brake assembly has a hydraulic piston actuated lever equipped with a brake blade. This brake is actuated through the introduction of hydraulic pressure into the input port, the pressure causes the piston shaft to extend from the cylinder in the direction of the rear of the ski, the shaft is attached to the brake lever which begins to pivot at the brake lever pivot and rotates the lever with the attached blade toward the running surface until such point that the full stroke piston and the lever has been reached. The developed solution looked to achieve maximum force, with limited space by using a short stroke cylinder and applying multiple ratio motion at the brake tip. Currently, the solution developed provides practically two inches of travel at the brake tip. The solution utilizes external extension springs to assist the brake return when no longer under hydraulic pressure. The solution is further supported by the presence of an expansion tank mounted to and on the non-pressure side of the brake actuation cylinder. The expansion cylinder is partially filled with the same fluid used to actuate the piston and then securely plugged. This expansion tank provides three benefits, closed system that does not allow air to enter the non-pressurized side of the system and contaminate the pressurized side of the system if air were to get by the piston seals, this non-pressurized side of the system could be used to introduce opposing pressure by filling it with more fluid and when compared with an open ended system where an air vent is present to relieve pressure this solution eliminates the likelihood of drawing contaminants such as water into the cylinder or by the piston seals into the pressurized fluid side of the system. Braking Alternative B: Brake Action and Performance Contribution: The brake assembly developed by the applicants provides superior braking action in various snow and ice conditions. The brake assembly depicted in print number(s) ______ shows a hydraulic piston actuated lever equipped with a brake blade. This brake is actuated through the introduction of hydraulic pressure into the input port, the pressure causes the piston shaft to retract extend from the fully extended position away from the rear end of the ski, the shaft is attached to the brake lever which begins to pivot at the brake lever pivot and rotates the lever with the attached blade upwards away from and out of the running surface until such point that the full stroke piston and the lever has been fully retracted. The developed solution looked to achieve maximum force, with limited space by using a short stroke cylinder and applying multiple ratio motion at the brake tip. Currently, the solution developed provides practically two inches of travel at the brake tip. The solution utilizes external extension springs to assist the brake return when no longer under hydraulic pressure. The solution is further supported by the presence of an expansion tank mounted to and on the non-pressure side of the brake actuation cylinder. The expansion cylinder is partially filled with the same fluid used to actuate the piston and then securely plugged. This expansion tank provides three benefits, closed system that does not allow air to enter the non-pressurized side of the system and contaminate the pressurized side of the system if air were to get by the piston seals, this non-pressurized side of the system could be used to introduce opposing pressure by filling it with more fluid and when compared with an open ended system where an air vent is present to relieve pressure this solution eliminates the likelihood of drawing contaminants such as water into the cylinder or by the piston seals into the pressurized fluid side of the system. The gap between the rear end of the ski and the brake blade is critical. The development of this ski brake determined that when braking, the disturbed running surface, snow, ice, etc. needs to find a place to release the braking loads and if this release location is readily available between the blade and the ski it will escape at that point, evidenced through the plume, rooster tail that gets larger the larger the gap and the higher the speed. Conversely, when the gap is reduced to a minimum the loads, forces, energy is then captured under the ski and greatly increases brake drag and brake performance. While these additional subsystems are not being described in detail herein, it is certainly within the skill of the ordinary artisan in the field of mechanics and mechanical design to understand and implement many types of mechanisms or systems addressing the incorporation of any or all of the above subsystems into any one of the vehicles as described as the instant invention. It is thought that the present gravity driven steerable vehicle, for use in riding or racing primarily down hill over varied terrain, and many of its attendant advantages is understood from the foregoing description and it will be apparent that various changes may be made in the form, construction and arrangement of the parts thereof without departing from the spirit and scope of the invention or sacrificing all of its material advantages, the form hereinbefore described being merely a preferred or exemplary embodiment thereof. Elements of the Invention 10 A four wheeled gravity driven steerable vehicle 10 A A four ski equipped gravity driven steerable vehicle 12 a chassis having 12 A chassis front portion, 12 B chassis rear portion, 12 C chassis underside and 12 D chassis top side; 14 a rider riding surface on said chassis top side 12 D configured to cause a rider to said ride riding surface 14 to be oriented in a prone, face down, face forward position; 16 means for attaching a rear axle assembly 16 A substantially at said chassis rear portion 12 B; 16 A a rear axle assembly 18 means for mounting a front axle assembly 18 A substantially at said chassis front portion 12 A; 18 A a front axle assembly 20 means for steering said gravity driven steerable wheeled vehicle 10 by said rider when said rider is positioned on said rider riding surface 14 ; 22 rear wheel hub and spindle assemblies integral with said rear axle assembly 16 A; 23 wheels and tires 24 front wheel hub and spindle assemblies integral with said front axle assembly 18 A. 26 braking system or means for causing deceleration and haulting of motion of said vehicle 10 when said vehicle has motion. 28 means for harnessing the rider onto and into said rider riding surface 14 when said rider is positioned on said vehicle 10 30 means for absorbing shock exerted on each said front wheels and tires 23 attached to each said two front wheel hub and spindle assemblies 24 thereby damping shock caused by said vehicle 10 passing over rough terrain, between said front wheels and tires 23 and said front axle assembly 18 A; 32 means for absorbing shock exerted on each said rear wheels and tires 23 attached to each said two rear wheel hub and spindle assemblies 22 thereby damping shock caused by said vehicle 10 passing over rough terrain, between said rear wheels and tires 23 and said rear axle assembly 16 A; 31 axle component 32 A a-arm 32 A 1 wheel and ski assembly attachment end 32 A 2 Shock absorber pivotal attachment end 32 A 3 a-arm pivot attached to axle 31 32 B shock absorber 32 B 1 shock absorber a-arm end 32 B 2 shock absorber axle pivotable attachment end 34 combination rear roll bar and transport bail 40 A three wheeled gravity driven steerable wheeled vehicle 40 A A gravity driven steeable vehicle with two skis in front and two wheels in the rear 70 ski assembly without ski braking assembly for attaching to a-arm 71 ski front end 71 A ski rear end/tail, 71 B ski running surface and 71 C ski upward-facing surface 72 ski post 74 ski foot 76 ski pivot 70 A ski assembly with ski braking assembly 80 ski braking assembly 84 brake blade 84 A gap between brake blade and ski rear end 82 brake arm 83 brake arm pivot 81 brake cylinder 85 brake cylinder mounting and pivot bracket 85 A brake cylinder pivot 86 sealed brake cylinder reservoir 88 brake return assembly 88 A brake return springs 88 B

A gravity driven steerable vehicle having wheels, or skis or a combination of wheels and skis for recreational use, most particularly on surfaces such as pavement, artificial hard-pack turf, mountain slopes, dirt roads, grass and hard-packed or non-packed snow. The vehicle has at least three (3) but preferably four (4) wheels, or skis or a combination of wheels and skis which may or may not be on independent axles one from the other and which may or may not be each independently shock suspended. There is also a steering mechanism for steering the vehicle and a driver compartment portion for containing a driver of the vehicle in a prone face-down and face-forward position. The vehicle is steerable by the driver from the prone face-down and face-forward position. The mechanism for suspension of the wheels and/or skis is configured to provide precise control in turns especially the carving of turns, by the skis, while descending on snow covered terrain. The attitude of the skis relative to the snow surface changes upon initiation of a turn and while in the turn to increase the edgeing of the skis thereby enhancing the turning characteristics of the vehicle. The vehicle may further have a braking system for slowing or stopping the vehicle and a harness apparatus for harnessing the driver onto and into the vehicle.

RELATED APPLICATION This application claims the benefit of U.S. Provisional Application No. 60/474,861, filed May 30, 2003, entitled, “Radial Reflection Diffraction Tomography,” which is incorporated herein by this reference. The United States Government has rights in this invention pursuant to Contract No. W-7405-ENG-48 between the United States Department of Energy and the University of California for the operation of Lawrence Livermore National Laboratory. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates in general to imaging, and more particularly to an imaging method and apparatus employing Radial Reflection Diffraction Tomography. 2. Description of Related Art Intravascular ultrasound (IVUS) imaging provides a method for imaging the interior of blood vessel walls. In standard acoustical techniques, a catheter with a rotating ultrasound transducer is inserted into a blood vessel. The transducer launches a pulse and collects the reflected signals from the surrounding tissue. Conventional ultrasonic imaging systems use B-mode tomography or B-scans, wherein images are formed from the envelope of the received display echoes returning to an ultrasonic transducer as brightness levels proportional to the echo amplitude and by assuming straight ray theory (i.e., geometrical optics). The brightness levels can then be used to create cross-sectional images of the object in the plane perpendicular to the transducer image. However, such images typically suffer from the consequences of ray theory of sound propagation, which does not model its wave nature. A circumferential scan can be made by either rotating a single transducer (mechanical beam steering) or by phasing an array of transducers around a circumference (electronic beam forming). Typically, one ultrasound pulse is transmitted and all echoes from the surface to the deepest range are recorded before the ultrasound beam moves on to the next scan line position where pulse transmission and echo recording are repeated. When utilizing B-scan, the vertical position, which provides depth of each bright dot is determined by the time delay from pulse transmission to return of the corresponding echo, and the horizontal position by the location of the receiving transducer element. Although B-scan IVUS images can be utilized to detect plaque and characterize its volume, the classification of plaque types by ultrasound is very difficult. Conventional B-scan images utilizes scattering, which, in turn, depends on the acoustic impedance dissimilarity of tissue types and structures. Although hard calcifications in some plaque can be detected using such a mismatch, the similarity in the acoustic properties of fibrous plaque and lipid pools prevents direct identification. Consequently, the size of the fibrous cap cannot be accurately estimated. Diffraction tomography has additionally been applied to medical imaging problems for a number of years, usually in a standard circumferential through transmission mode. Furthermore, improved vascular images have been provided by utilizing time domain diffraction tomography, a technique capable of accounting for the wave propagation of the transmitted acoustic waves in addition to redundant information from multiple angular views of the objects imaged. A related B-mode approach that incorporates spatial compounding has also been employed to provide improved vascular images through multiple look angles. Background information on rotational IVUS systems are described, for example, in U.S. Pat. No. 6,221,015 to Yock. Background information on phased-array IVUS systems are described, for example, in U.S. Pat. No. 6,283,920 to Eberle et al., as well as U.S. Pat. No. 6,283,921 to Nix et al. Multi-functional devices have been proposed in other areas of vascular intervention. For example, U.S. Pat. No. 5,906,580 to Kline-Schoder et al., describes an ultrasound transducer array that may transmit signals at multiple frequencies and may be used for both ultrasound imaging and ultrasound therapy. Therapeutic ultrasound catheters, are described, for example, in U.S. Pat. No. 5,725,494 to Brisken et al. and U.S. Pat. No. 5,581,144 to Corl et al., which describes another ultrasound transducer array that is capable of operating at multiple frequencies. However, none of the above devices and associated techniques from the above cited patents, are suited for rapid identification of objects, such as, but not limited to, vulnerable plaque or objects recessed in a bore hole, in accordance with the principles of the present invention. SUMMARY OF THE INVENTION The present invention is directed to a wave-based imaging method, which includes: directing predetermined energy waves radially outward from within an interspace and receiving scattered energy waves from one or more objects. The received data are processed to produce images of the objects, wherein the processing includes application of a wave-based algorithm that can map an angular location and a plurality of frequency parameters of the received scattered energy waves to construct images of the one or more objects. Another aspect of the present invention is directed to a wave-based imaging method that can be utilized to characterize a plaque, which includes: inserting a catheter having a longitudinal axis and a distal end into an artery, wherein the catheter further includes a single transmitter disposed about the distal end of the catheter and a receiver aperture having a plurality of receivers additionally disposed about the distal end of the catheter, wherein the transmitter and the receiver aperture is capable of rotating up to 360 degrees about the longitudinal axis of the catheter. As part of the method, one or more predetermined energy waves are directed radially outward from the single transmitter and radial scattered energy waves are received in a predetermined imaging mode by the receiver aperture. The received scattered energy waves results in collected data capable of being processed to produce images of plaque from the surrounding artery walls, wherein the processing includes application of a wave-based algorithm that can map an angular location and a plurality of frequency parameters of the received scattered energy waves to construct the images and determine the risk of rupture and/or thrombosis. Another aspect of the present invention is directed to a wave-based imaging method that can be utilized to characterize a plaque, which includes: inserting a catheter into an artery, directing one or more predetermined energy waves radially outward and receiving one or more radial scattered energy waves from a distal end of the catheter; collecting a radial scattered tomographic data baseline of the artery's tissue; measuring an applied external pressure to the artery; obtaining a deformation radial scattered tomographic data set of the artery's tissue after application of the external pressure; and processing the radial scattered tomographic data baseline and the deformation radial scattered tomographic data set to produce a final image indicating elasticity of the artery to characterize the imaged plaque, wherein the processing includes application of a wave-based algorithm that can map an angular location and a plurality of frequency parameters of the received scattered energy waves. A further aspect of the present invention is directed to a wave-based imaging apparatus, which includes a flexible substrate having a longitudinal axis and a distal region and one or more elements disposed on the distal region and capable of directing one or more predetermined energy waves radially outward and receiving one or more radial scattered energy waves from one or more objects. The received scattered energy waves are capable of producing images of one or more objects by processing a collected data set, wherein the processing includes application of a wave-based algorithm that can map an angular location and a plurality of frequency parameters of the received scattered energy waves. A final aspect of the present invention is directed to a wave-based imaging apparatus that includes a Hilbert space inverse wave (HSIW) algorithm that can map an angular location and a plurality of frequency parameters of said received reflected diffracted energy waves so as to characterize plaque within a living vessel. Accordingly, the present system and method employs desired Radial Reflection Diffraction Tomographic techniques to determine the state and location of buried wastes, to track plumes of underground contaminants of materials, to determine the state of materials residing in waste drum barrels or weapons, to evaluate nondestructively parts having existing access holes (e.g., automobile parts), and for identifying potentially life threatening vulnerable plaque buildup on living vessel walls. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 a illustrates a basic multimonostatic mode configuration that includes a single transducer rotating about a fixed center. FIG. 1 b illustrates a basic multistatic mode configuration that includes a fixed annular array of outwardly directed transducers. FIG. 1 c illustrates a basic multistatic mode configuration that includes a rotating aperture. FIG. 2 shows a conventional IVUS catheter. FIG. 3 a shows a conventional IVUS catheter inserted into a diseased artery. FIG. 3 b illustrates the RRDT geometry of the present invention when a catheter is inserted into a diseased artery. FIG. 4 illustrates RRDT non-destructive evaluation within a bore hole. DETAILED DESCRIPTION OF THE INVENTION Referring now to the following detailed information, and to incorporated materials; a detailed description of the invention, including specific embodiments, is presented. Unless otherwise indicated, numbers expressing quantities of ingredients, constituents, reaction conditions and so forth used in the specification and claims are to be understood as being modified by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the subject matter presented herein. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the subject matter presented herein are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. General Description The present invention employs inverse wave techniques to reconstruct images of a medium surrounding a physical probe in a plane perpendicular to an axis of rotation in a radial reflection configuration, i.e., in a multimonostatic or a multistatic arrangement disclosed infra, wherein one or more transmitting and receiving elements, more often at least about 15 of such elements, e.g., transducer(s), are at a fixed radius and designed to collect scattered fields, e.g., reflected and diffracted fields. Such a radial reflection diffraction tomography (RRDT) technique is based upon a linearized scattering model to form images given the disclosed physical transmitter and receiver configurations and the mathematical method, i.e., a Hilbert-based wave algorithm, utilized to invert the scattering collected fields. As example embodiments, the multimonostatic and multistatic probes can be mounted at the end of a flexible substrate, such as a catheter or snaking tube that can be inserted into a part with an existing access hole or a medium (e.g., an artery) with the purpose of forming images of the plane perpendicular to the axis of rotation. By applying the Hilbert space inverse wave (HSIW) algorithm of the present invention to the collected data of such multimonostatic and multistatic probes, radial reflected diffraction tomographic images are readily obtained. Specific Description FIG. 1( a ) shows a basic multimonostatic conceptual arrangement of the present invention, wherein a single energy source element 1 , such as a transducer, can operate as both source and receiver (as denoted by T/R, to indicate transmitter and receiver) at multiple spatial locations. At each angular location along the illustrated dashed circumference, as denoted by the directional arrow, energy source element 1 can launch a primary field wave (not shown) and receive a reflected scattered field wave (not shown). Such an arrangement often requires a spectrally wide band frequency diverse source capable of producing frequencies from about 1 kHz to about 3 THz (Electromagnetic frequencies), often from about 100 Hz to about 10 GHz (Acoustic frequencies), more often between about 20 MHz and about 60 MHz (Acoustic frequencies), to provide spatial diversity so as to form images of a surrounding medium. FIG. 1( b ) shows an example conceptual multistatic mode embodiment, wherein a plurality of fixed energy source elements 2 , e.g., transducers, are arranged as an annular array, generally designated by the reference numeral 20 . In succession, along for example, the illustrated directional arrow, each energy source element (for example, the element denoted by the letter T to indicate a transmitter) is capable of launching a primary field wave (not shown) and a backscattered field wave (not shown) is measured on all the remaining elements (as denoted by the letter R, indicating the remaining fixed elements are operating as receivers). FIG. 1( c ) illustrates a beneficial multistatic conceptual arrangement that includes a plurality of energy source elements 4 configured in a rotating sub-aperture 6 , as denoted by the bi-directional arrow, formed by a single transmitter, as denoted by the letter T to indicate a transmitter, and surrounded by multiple receivers, as denoted by the letter R. At each angular location, as denoted by the single directional arrow along the illustrated dashed circumference, transmitter T can launch a primary field (not shown) and a backscattered field (not shown) is measured on all receivers R. When operating in a reflection mode as disclosed herein, the mathematics applied to the collected data operate beneficially to image objects because the range resolution of the reconstructed image is proportional to the number of frequencies used in the reconstruction. Under the Hilbert space inverse wave algorithm, increasing the number of frequencies and transducers, increases the complexity of the reconstruction, the size of the intermediary data files, reconstruction time, and computer memory requirement. Thus, the trade-off between computer resources and resolution is a consideration. Nonetheless, the techniques employed in the present invention are beneficial even at acoustic frequencies from as low as about 100 Hz to as high as about 10 GHz. Such lower frequencies allow the disclosed embodiments to additionally be employed in borehole type of applications, such as, but not limited to, characterizing underground contamination plumes or waste in contamination barrels. For either the multimonostatic or multistatic example embodiments, the planar reconstruction of the imaged object(s) requires that the one or more collected measurements map a pair of spatial variables (i.e., angular location and incident source frequency) of a physical object into the angular location and frequency parameters of the measured field. An exemplary application of the present invention is in the characterization of vulnerable atherosclerotic plaque. Arthrosclerosis is a condition where the arteries are obstructed by the buildup of deposits, “intravascular plaque” (IVP), on the inside of arterial walls and such a buildup of deposits can lead to what is known to those of ordinary skill in the art as cerebrovascular disease, which is the third leading cause of death and the leading cause of major disability among adults. Plaque grows as a fibrous tissue encapsulating a lipid pool and as the plaque grow it may incorporate calcium. Of particular concern is vulnerable or unstable plaque because of the possibility of such plaque becoming inflamed and unexpectedly rupturing. Stable or non-vulnerable plaque, typically includes a thick layer of fibrous tissue of about 800 microns but is not life threatening and can be treated slowly. A thin fibrous cap of typically up to about 300 microns covering a pool of a soft lipid core typically characterizes vulnerable plaque. When such a cap is disrupted, the thin cap is compromised and the lipid deposited into the artery can produce adverse effects, such as thrombus formation, strokes and death. FIG. 2 shows a conventional catheter, generally designated as reference numeral 200 , for intravascular tissue characterization, such as atherosclerotic vulnerable plaque. Such a catheter 200 , typically has an elongated flexible substrate 202 with an axially extending lumen 204 through which a guide wire 206 , and/or various other devices or other instruments can be delivered to a region of interest. An ultrasonic transducer assembly 208 is provided at the distal end 210 of the catheter, with a connector 214 located at the proximal end of the catheter for transducer manipulation and processing received transducer signals. Transducer assembly 208 can comprise a plurality of transducer elements 216 arranged in a cylindrical array centered about a longitudinal axis 218 of the catheter for transmitting and receiving ultrasonic energy. Adhesive (not shown) and or an end-cap (not shown) can be applied to transducer assembly 208 , and lumen 204 to protect such elements from the surrounding environment. Transducer assembly's 208 individual elements (not shown) and conductive acoustical backing (not shown) are often mounted on the inner wall of elongated flexible body 202 operating as the flexible substrate. FIG. 3 a illustrates a typical IVUS method using such a catheter 200 , as shown in FIG. 2 a . In such a conventional application, catheter 200 , having a transducer assembly 208 that can launch an energy wave as a primary field (as denoted by the letter F) is inserted typically non-centered into a nominally circular diseased artery 302 . Around a wall 304 of artery 302 is a fibrous collagen plaque 306 . A lipid pool 308 can reside inside such a fibrous structure, wherein when a fibrous cap 310 of plaque 306 separating lipid pool 302 from the blood (not shown) within artery 302 is more than about 800 μm thick, plaque 306 is characterized as stable. However, in cases where cap 310 is less than about 300 μm thick, such a plaque is characterized as vulnerable, and is more likely to rupture and/or thrombosis. The present invention utilizes the disclosed RRDT approach for improved intravascular applications such as characterizing plaque as discussed above, and incorporates various aspects of the method of utilizing a probe, such as, but not limited to, the catheter as shown in FIG. 3 a . However, such catheters 200 and similar probes known to those of ordinary skill in the art typically show angular overlap for beam processing, which results in loss of valuable image information of one or more objects of interest within a surrounding medium. The present invention overcomes such processing by incorporating novel improvements of the transmitters and receivers, by utilizing frequencies between about 20 MHz (Acoustic) and about 60 MHz (Acoustic), and by utilizing RRDT techniques of the present invention as discussed herein. Such novel embodiments accounts for phase, amplitude, and beam diffraction, to recover not only such loss of valuable image information information but to further enhance the imaging capabilities of the invention by providing images with improved lateral resolution of the acoustic absorption and sound speed. FIG. 3 b shows the geometry incorporated by the RRDT method of the present invention. FIG. 3 b shows a cross-sectional view of a catheter 200 , having an outer diameter between about 0.25 mm and about 5 mm, being inserted into an artery 302 , having a surrounding plaque 306 that includes a cap 310 and a lipid pool 308 . Inserted into artery 302 is a non-centered catheter 200 , which includes a transducer assembly (not shown) that can be disposed about the distal end of catheter 200 , as disclosed in the present invention, with a radial location specified by r O ≡R O (cos θ O , sin θ O ), where R O is the catheter 200 probe radius, a constant. At each angular location, θ O , transducer assembly 208 , as shown in FIG. 3 a , launches a primary field F radially outward (as denoted by the letter r) into a medium, such as the blood (not shown) and surrounding tissue in this example, and the transducer arrangement, as disclosed in the present invention, can measure a reflected scattered field (not shown) having, for example, at least up to about 90 degrees of angular content from one or more objects, such as the linings of cap 310 that overlies lipid pool 308 . As another example embodiment, the RRDT method and apparatus of the present invention can be combined with elastography to gain further insight into a surrounding medium's elastic properties and provide further information in the determination of characterizing plaque as vulnerable or stable. Generally, the contrast in elastic properties between a lipid pool and a fibrous cap is evident. By utilizing elastography, the elastic properties of a vessel wall can be obtained by observing a deformation of the vessel due to an external pressure, such as the pressure produced by a heart. Such a change in the arterial pressure due to the pumping action of the heart produces a measurable deformation of the tissue surrounding the vessel. Such a deformation can be measured by tracking a motion of patterns in successive intravascular scans as disclosed by the present invention. By knowing the arterial pressure and the measured deformation, the present invention can recover elastic properties of the surrounding tissue. From such elastic properties, one can further characterize the surrounding tissue to predict plaque composition. FIG. 4 illustrates a further beneficial embodiment, wherein the present invention can be utilized for non-destructive characterization (i.e., RRDT imaging) in applications other than for intravascular RRDT imaging. As shown by the example cross-sectional underground view of a borehole 404 in FIG. 4 , a flexible substrate 400 or snake-like tube having a transducer assembly 402 similarly configured like the intravascular RRDT application discussed above, can be lowered into bore hole 404 so as to image a site using RRDT techniques. Such an arrangement can launch a primary field (denoted by the letter F) and receive diffracted energy waves having frequencies often between about 100 Hz and about 300 Hz, to determine the state of buried wastes, such as waste within a radioactive waste drum barrel 410 or a biohazardous container, and/or to track a plume 412 of underground contaminants. In a similar manner, disclosed probes herein, can be inserted into waste drum barrels 410 , or weapons (not shown) or any part having an existing access hole, such as, but not limited to, an automobile engine, and determine the state of the part or material. Hilbert Space Wave Inversion Hilbert spaces are spaces constructed using vectors. Specifically they define vector spaces where sets of vectors in the space “add up” to another vector, an analog to Euclidean space where measurements can be added to result in another valid measurement. Hilbert spaces are particularly useful when studying the Fourier expansion of a particular function. In the Fourier transform, a complex function describing a waveform is re-expressed (transformed) into the sum of many simpler wave functions. A Hilbert space describes the “universe of possible solutions” given one particular such function. The Hilbert space inverse wave (HSIW) algorithm of the present invention enables an inverse for any multistatic or multimonostatic geometry with any combination of sources, receivers, and frequencies. In a radial reflection device of the present invention, such as an intravascular ultrasound probe having an outer diameter between about 0.25 mm and about 5 mm, or a probe configured to non-destructively characterize buried wastes (e.g., tracking plumes of underground contaminants of materials), evaluating the state of materials residing in waste drum barrels or weapons, or to non-destructively evaluate parts with existing access holes (e.g., automobile parts), acquired data are collected at discrete angular locations. Such angular locations are denoted by: R n t ≡R 0 (cos θ n , sin θ n )  (1) for transmitter locations, where θ n =nΔθ src for n=0,1 . . . , N src −1, where N src 2π/Δθ, and Δθ src is the source angular increment. Similarly, receiver locations are given by: R m r ≡R o (cos θ m , sin θ m )  (2) where θ m =mΔθ rcv for m=0,1 . . . , N src −1, where N rcv 2π/Δθ rcv , and Δθ rcv is the receiver angular increment. For each source, configured receiver(s) can record a backscattered field as a time series that can be digitized for processing. Discrete Fourier transforming the time series data result in the spectrum of one or more measured wave forms at discrete frequencies. The forward scattering equation under the Born approximation with both spatial and frequency diversity is given by: ψ B scat ( R m r ,R n t ,ω l )= P (ω l ) k O 2 (ω l )∫ dr ′ G ( R m r ,r ′ ,ω l ) o ( r ′ ) G ( r ′ ,R n t ,ω l ),  (3) where ω l ,l=0,1. . . , N f −1 are the discrete frequencies and N f is the number of frequencies in the pulse band width. The HSIW as disclosed herein interprets Equation (3) as a mapping from a continuous object space to a discrete measurement space. The object space is the physical (x,y) space of the object function. The measurement space includes discrete angles and temporal frequencies at which the scattered data are collected. The scattering operator projects the object onto the measurement space. The forward propagation or projection kernel is defined as: Π*( r )≡ P (ω l ) k O 2 (ω l ) G ( R m r ,r,ω l ) G ( r,R n t ,ω l ),  (4) where Π(r) is a J≡(N src ×N rcv ×N f ) element column vector, and P(ω l ) is the incident pulse spectrum. Mathematically, the projection is represented as an inner product between the object function and the kernel via: D=∫dr Π*( r ) o ( r )≡<Π, o >,  (5) where D is a J element column vector, and where each element represents a particular source, receiver, and frequency combination. Symbolically, the forward scattering operator, K, is defined as: K[•]≡∫drΠ*( r )[•].  (6) The HSIW method of the present invention is employed to derive an inverse of the operator as shown in equation (6). The singular value decomposition (SVD) of K is given as: K=USV † ,  (7) where the columns of U form an orthonormal set of column vectors, u j , which span a measured data space, and the components of V form an orthonormal set of vectors, v j (r), which span an object space. S is a diagonal matrix of singular values, σ j . It is emphasized that the u j are complex column vectors where as the v j (r) are complex functions of r. The set of normal equations for such a singular system are: Kv j ( r )=σ j u j ,  (8) K † u j =σ j v j ( r ),  (9) KK † u j =σ j Kv j ( r )=σ j 2 u j ,  (10) K † Kv j ( r )=σ j K † u j ( r )=σ j 2 v j ( r ),  (11) The inversion method of the present invention estimates the object function of equation (5) given measured data in D. Such an inversion incorporates expanding the object function in terms of v j (r): o ^ ⁡ ( r ) = ∑ j = 0 J - 1 ⁢ α j ⁢ v j ⁡ ( r ) , ( 12 ) where the α j are constant coefficients to be determined. Substituting the object expansion into equation (5) results in: D = ∫ ⁢ ⅆ r ⁢ ⁢ Π * ⁡ ( r ) ⁢ ∑ j = 0 J - 1 ⁢ α j ⁢ v j ⁡ ( r ) = ∑ j = 0 J - 1 ⁢ α j ⁢ ∫ ⁢ ⅆ r ⁢ ⁢ Π * ⁡ ( r ) ⁢ v j ⁡ ( r ) , ( 13 ) Applying the definition of the K operator in equation (6) to equation (8) yields an expression for the integral of equation (13), Kv j =∫dr Π*( r ) v j ( r )=σ j u j ,  (14) which reduces equation (13) to: D = ∫ ∑ j = 0 J - 1 ⁢ α j ⁢ σ j ⁢ u j , ( 15 ) Using the orthogonality of the u j vectors, the unknown α j is solved as follows: u i † ⁢ D = ∑ j = 0 J - 1 ⁢ α j ⁢ σ j ⁢ u i † ⁢ u j = ∑ j = 0 J - 1 ⁢ α j ⁢ σ j ⁢ δ ij = α i ⁢ σ i , ( 16 ) resulting in: α i = u i † ⁢ D σ i , ( 17 ) The adjoint of the forward scattering operator, K † and the singular values and singular vectors, σ j , u j , and v j (r) are now required. First, the following inner product equation defines the adjoint, < u,Kv >=< K † u,v>,   (18) Using the definition of the forward scattering operator from equation (16) results in: u † ∫dr Π*( r ) v ( r )=∫ dr ( u † Π*( r )) v ( r ),  (19) By comparing the right hand sides of equations (18) and (19), the following definition of the adjoint of the forward scattering operator is obtained: K † [•]≡[•]·Π T ( r ).  (20) The σ j and u j are determined by solving the eigenvalue equation of equation (10) formed by the outer product of the forward scattering operator with its adjoint. Explicitly, the outer product is represented by: (∫ dr Π*( r )Π T ( r )) u j =σ j 2 u j ,  (21) which is a J×J eigenvalue equation of the form Ax=λx. The Π(r) vectors are known analytically and can be evaluated numerically. It follows that the elements of the outer product matrix can be computed numerically and the resulting system solved numerically for the σ j 2 and u j . Given these and using equation (19) to solve for v j (r) results in: v j ⁡ ( r ) = 1 σ j ⁢ Π T ⁡ ( r ) ⁢ u j . ( 22 ) Substituting equations (17) and (22) into equation (12) yields the final expression for the reconstruction: o ^ ⁡ ( r ) = ∑ j = 0 J - 1 ⁢ 1 σ j 2 ⁢ Π T ⁡ ( r ) ⁢ u j ⁢ u j † ⁢ D . ( 23 ) As described above, the Π(r) vectors of equation (4), and outer products and eigenvalues of equation (21) are computed numerically. The measurement system of the analytically described invention only measures part of the scattered field due to the aperture and the loss of the evanescent field information and accordingly, some of the eigenvalues, σ j 2 , are close to zero. Those eigenvalues and their corresponding eigenvectors determine the rank of the outer product matrix, and they must not be used in the reconstruction of equation (23). Thus, in the method of the present invention, a Best Rank N approximation is used to select the number of singular values/vectors. A ratio is computed as follows: R ⁡ ( N ) = ∑ j = 0 N - 1 ⁢ σ j 2 ∑ j = 0 J - 1 ⁢ σ j 2 , ( 24 ) where the singular values are assumedly arranged from smallest to largest: σ 0 2 ≦σ 1 2 ≦σ J−1 2 . Plotting R(N), the point at which the function starts to rise rapidly is graphically identified. The index of the singular value at which this occurs is labeled as J 0 . With this value determined, a final reconstruction is as follows: o ^ ⁡ ( r ) = ∑ j = J 0 J - 1 ⁢ 1 σ j 2 ⁢ Π T ⁡ ( r ) ⁢ u j ⁢ u j † ⁢ D ( 25 ) The HSIW as disclosed herein is flexible in that it allows any transducer configurations of the present invention and any number of frequencies to be used in forming such a final reconstruction. Changes and modifications in the specifically described embodiments can be carried out without departing from the scope of the invention, which is intended to be limited only by the scope of the claims.

A wave-based tomographic imaging method and apparatus based upon one or more rotating radially outward oriented transmitting and receiving elements have been developed for non-destructive evaluation. At successive angular locations at a fixed radius, a predetermined transmitting element can launch a primary field and one or more predetermined receiving elements can collect the backscattered field in a “pitch/catch” operation. A Hilbert space inverse wave (HSIW) algorithm can construct images of the received scattered energy waves using operating modes chosen for a particular application. Applications include, improved intravascular imaging, bore hole tomography, and non-destructive evaluation (NDE) of parts having existing access holes.

BACKGROUND OF THE INVENTION This invention relates to a method and apparatus for collecting poultry from poultry houses. To meet the ever increasing demand for chicken in the American diet, a mass production process has evolved wherein a centrally located processing plant is supplied with live chickens from an array of surrounding satellite chicken farms. Each chicken farm is individually operated and includes a number of poultry houses where the chickens are confined from the baby chick stage to the time they are harvested. By confining the chickens, productivity is increased while the operating costs are lowered. However, by confining the chickens in a densely populated area, careful control of air temperature, humidity and bacteria count must be maintained. While raising the chickens in a poultry house is accomplished under automated and manual process control, harvesting the chickens is still a labor intensive procedure which has not changed much over the years. The harvesting procedure begins by placing a number of chicken coops within the poultry house. A typical chicken coop is formed of 15 cages arranged in rows and columns with three cages in a row and 5 cages in a column all joined together to form a rectangular enclosure. Each cage is formed with a front opening having a pivoted door which provides access to the interior of the cage. The actual loading is accomplished by men working in pairs. Each man catches a number of chickens in each hand and thrusts them into the opening in the cage, one man following the other, until the cage is full. The door is then closed and the next cage is filled, and so on down the column. During the loading process, there are short intervals of time when the cage opening is unprotected and chickens can escape. In an attempt to thwart the escape, some chickens can be harmed, and the resultant confusion disrupts the loading process. This invention is directed to the provision of a flexible vision blocking curtain across the loading opening to prevent the escape of chickens during the loading process by interrupting their line of sight. A number of cages to thwart the escape of chickens have been invented, as typified by U.S. Pat. No. 4,285,299, issued Aug. 25, 1981 to Doverd E. Thomas; and U.S. Pat. No. 5,596,950 issued Jan. 28, 1997 to Briggs et al. The patent to Thomas shows a hinged door arranged at an angle to the horizontal so that the poultry can slide down into the cage and cannot escape. Briggs et al. show a pair of inwardly swinging gates which are biased to a closed position. When loading poultry, the gates swing inwardly to deposit the poultry within the cage and then swing to a closed position. While the above mentioned patents do teach the design of poultry cages to prevent escape during loading, the prior art does not teach the use of a vision blocking flexible curtain across the opening. SUMMARY OF THE INVENTION The overall object of the present invention is to improve upon the prior art loading gates by adding a flexible vision blocking curtain across the cage opening to lie in the vision path of chickens already in the cage to prevent them from seeing an escape opening. It is a specific object of the invention to suspend a vision blocking flexible curtain along a top portion of the cage opening so as to enable the curtain to swing inwardly when chickens are loaded and to swing outwardly when the chickens are unloaded. It is another object of the invention to form the curtain in various shapes to suit the needs of a particular application. Instead of a plastic sheet, the curtain can also be formed of a loosely woven fabric to increase ventilation. In both the sheet plastic or woven fabric construction, a hem or additional weight may be added to the sides and bottom to control flexibility and curtain restoring force after being pushed into an open position. The curtain can also be formed of overlapping strips to increase flexibility. It is yet another object of the invention to devise a novel method of loading chickens into a cage of a coop by integrating a vision blocking opening to eliminate the criticality in the timing between door opening and hand loading of a batch of chickens to prevent their escape. In so doing, the loading operation can be carried out with less disruption and less harm to chickens. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front view of an assemblage of cages forming a chicken coop with the door of the top right cage in an open position; FIG. 2 is a side perspective view of the FIG. 1 coop; FIG. 3 is an enlarged front view of the open cage shown in FIGS. 1 and 2 along with the closed cage immediately below; FIG. 4 is a part schematic view of the opaque curtain across the cage opening as viewed from inside the cage; FIG. 5 is a schematic side view illustrating the operation of the curtain; FIG. 6 shows a modified curtain formed of individual strips; and FIG. 7 shows a modified curtain formed of a loosely woven fabric. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now in general to the drawings and in particular to FIGS. 1-3, a chicken coop 10 is shown for transporting chickens from a poultry house to a processing plant. The chicken coop is formed of an assembly of cages 11, here fifteen in number, arranged in rows and columns with three cages in a row and five cages in a column. The cages are integrally joined to form a rectangular enclosure having a roof 12, five floors 13, a front wall 14, rear wall 15 and four side walls 16. The side walls 16 and rear wall 15 are formed of an open framework to confine the chickens while providing ventilation. The two interior side walls 16 form a common wall for adjacent cages. A pair of spaced tubular, rectangular beams 17 are joined to the underside of bottom floor 13 to receive a fork lift to move the coop. Each cage 11 of the coop has a frame opening 18 which collectively form the front wall 14. Each frame opening comprises a top frame member 19, a bottom frame member 20 and two side frame members 21. The frame members can be fabricated from lengths of square tubing common to multiple frame openings. Referring now to FIG. 3, a door 22 is pivotally mounted on the bottom frame member 20 to move from an open position shown in the top cage of FIG. 3 to a closed position shown in the lower cage in FIG. 3. The pivotal mounting of door 22 includes a limiting pivot position where the door remains at rest in an open position with its inside surface substantially flush with the cage floor as shown in the top cage in FIG. 3. In its closed position shown in the bottom cage in FIG. 3, the door is rotated until it engages a stop 23 where it remains until manually moved to an open position. A handle 24 is mounted on the outside surface of the door to facilitate manual opening and closing. The prior art shows numerous mechanisms for opening and closing a cage door. A simple hand latch is disclosed in U.S. Pat. No. 4,285,299 mentioned above while an over center spring mechanism 25 is employed here to hold the door closed when it is manually lifted from its at rest open position. The mechanism for opening and closing the cage door is conventional and is not part of the disclosed invention. A vision obstructing flexible curtain 26 is mounted across the opening 18 forward of the door to obstruct the opening when the door is in its open position. Applicant has discovered that when caged chickens cannot see an unobstructed escape path they will not attempt an escape. The curtain 26 in FIG. 3 is in the form of a black sheet of plastic having a hem 27. As seen in FIG. 4, the curtain is hung from the inside of the top member 19 by means of a clamping strip 28 and a number of screws 29. FIGS. 4 and 5 are part schematic views explaining the mode of operation of the vision obstructing curtain. FIG. 4 is a view of the inside of the curtain as seen by chickens confined by the remaining five sides of the cage. The inventor has discovered that chickens will not attempt flight when an open escape path is not visible to them. In this manner, the invention solves the problem of chicken escape when door 22 is in the open position during the cage loading operation. As an optional feature, a wood dowel or steel pin 34 can be inserted in hem 27 for ballast. FIG. 5 diagrammatically explains the operation of the curtain. FIG. 5 also discloses an alternative mounting for the curtain. Instead of a clamping strip and screws as shown in FIG. 4, FIG. 5 discloses a series of open hooks 30 spaced along top member 19 which supports the curtain on a matching series of grommets 31. As seen in FIG. 5, when door 22 is in the open position, chickens are pushed through the curtain, causing it to rotate in a counterclockwise direction as shown by the arrows 32 around pivots 30, 31. After the chickens are loaded, the curtain rotates back to its vertical rest position, darkening the opening. When the cage is full, door 22 is moved to a closed position. To unload all of the cages in a coop, a fork lift engages the rectangular beams 17, and rotates the coop about a quarter turn in a counterclockwise direction. The weight of the birds sliding down the floors forces the doors to open and the curtains to swing to an open position as shown by the arrows 33. After the chickens are unloaded, the coop is rotated back to a rest position and the doors are closed. FIG. 6 shows a modified curtain construction which is suspended from top frame member 19 in a manner similar to FIG. 4. However, instead of a single layer curtain, two layers 34 and 35 are employed. The front layer 34 is split at cuts shown with a solid line while the rear layer 35 is split at cuts shown with a dashed line. This construction provides for greater flexibility while still obstructing the line of sight. FIG. 7 shows a modified curtain suspended from top member 19 in the manner shown at 28 and 29 in FIG. 4 or by means of hooks and grommets as shown in FIG. 5. The curtain 35 is formed of a closely woven fabric which allows for a certain degree of ventilation while obstructing the line of sight. It is not intended to limit the present invention to the details of illustration or terms of description of the preferred embodiments shown above. It will be appreciated by those skilled in the art that various modifications and alterations therein may be made within the scope of the present invention.

Method and apparatus for loading a poultry coop. Each compartment in the coop has a rectangular frame opening which is blocked or unblocked by a pivoted door. A flexible vision blocking curtain is hung across the opening to prevent the escape of any poultry during the loading procedure.

CROSS REFERENCE TO RELATED APPLICATIONS This is a divisional application of U.S. application Ser. No. 13/130,585 filed May 23, 2011, which is a US National Stage of International application PCT/NO2010/000002 filed 4 Jan. 2010. FIELD OF INVENTION The present invention concerns a biological oil composition, formulations comprising the oil composition, and the use of the oil composition in dietary supplements, functional foods and pharmaceutical products for the prevention or treatment of cardiovascular disease. BACKGROUND OF INVENTION In the 1970s, Bang, Dyerberg and Nielsen described the plasma lipid and lipoprotein pattern of Eskimos living on the west coast of Greenland, and compared it with that of the Danish population (H. O. Bang, J. Dyerberg and A. B. Nielsen. Plasma lipid and lipoprotein pattern in Greenlandic West-coast Eskimos. Lancet 1971; 1:1143-45). Later, Dyerberg and his collaborators (J. Dyerberg, H. O. Bang and N. Hjørne. Fatty acid composition of the plasma lipids in Greenland Eskimos. American Journal of Clinical Nutrition 1975; 28:958-66) related the differences they found, to the remarkably low mortality from coronary heart disease among the Eskimos, compared to Danes. Since the dietary fat intake was almost the same in the two populations, they suggested that the striking difference in coronary heart disease could be due to the big difference in the intake of marine fats and that coronary heart disease could be associated with the chemical nature of the dietary lipids (J. Dyerberg, H. O. Bang. E. Storffersen, S. Moncada and J. R. Vane. Eicosapentaenoic acid and prevention of thrombosis and atherosclerosis? Lancet 1978; 2:117-19). After these pioneering studies, it became evident that coronary heart disease, which is still among the most serious killer diseases in Western societies, could no longer be regarded merely as a lipid storage disease caused by excessive dietary fat intake. The scientists who pioneered this research were the first to suggest that the anti-atherogenic factors in the traditional Eskimo diet were marine long chain poly unsaturated fatty acids (PUFAs). Their diet, consisting largely of seal, whale and seabirds, and, to some extent, fish, provided several grams—may be as much as 15 grams—of such fatty acids each day. This is far more than a typical “modern” Western diet contains. Research during the last 30-40 years has confirmed the classical studies by the Dyerberg group and established a firm scientific foundation for a common understanding among scientists and other professionals: The health benefits of sea-food and marine oils can first and foremost be associated with two typical marine PUFAs, namely eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). This statement is in line with the conclusions and recommendations from the symposium “Beyond Cholesterol: Prevention and Treatment of Coronary Heart Disease with n-3 Fatty Acids, published by Deckelbaum et al. ( American Journal of Clinical Nutrition 2008; 87(suppl): 2010S-2S). EPA and DHA contain, respectively, 20 and 22 carbon atoms with 5 and 6 conjugated double bonds, of which the first one is in the position 3 carbon atoms (n-3) counted from the hydrophobic (methyl) end of both these fatty acids. The abbreviation C20:5n-3 is often used as a chemical designation for EPA and C22:6n-3 for DHA. Phytoplankton in the marine environment is the primary producers of EPA and DHA, which follow the food-web from this first trophic level via zooplankton to fish and sea-mammals. Plant food oils and animal fat contain low levels, if any, of EPA and DHA. EPA and DHA are believed to be particularly important in prevention of cardiovascular disease. Even modest sea-food intake, supplying 250 mg of EPA and DHA daily, seems sufficient to reduce the risk of coronary death by 36% and to reduce mortality in the general population by 17% (U. J. Jung et al. American Journal of Clinical Nutrition 2008; 87(suppl): 2003S-9S). Physiological and molecular mechanisms proposed to explain the cardioprotective effects of EPA and DHA, include 1) lowering the levels of triacylglycerol and free fatty acids in plasma, 2) increasing high density lipoprotein (HDL) levels and decreasing low density lipoproteins (LDL) levels, 3) decreasing platelet aggregation, 4) decreasing cholesterol delivery and cholesterol deposition in arterial walls, 5) decreasing arterial inflammation. These are interactive mechanisms involving complex and diverse biochemical mechanisms, including effects of EPA and DHA as well as of their transformation products (prostaglandins, prostacycline, thromboxans, leukotrienes) on modulation of immunity and inflammation and gene expression in different cells and tissues. Although the health benefits of EPA and DHA no longer can be questioned, the mechanisms involved are too complex to be fully understood. For instance, it is still a puzzling fact that “the major mechanisms underlying the beneficial effects of n-3 fatty acids in the prevention and treatment of coronary artery disease appears to be distinct from effects on lowering plasma triacylglycerol concentrations” (Deckelbaum et al., American Journal of Clinical Nutrition 2008; 87(suppl): 2010S-2S). Preclinical and human clinical studies during the last 30-40 years have provided consistent evidence that consumption of sea-food and marine food oils is beneficial for the health, and it has become generally accepted among those skilled in the art that these health benefits are, first and foremost, associated with EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). The total evidence related to the ability of these two marine n-3 PUFAs to prevent coronary heart disease is so overwhelming that it has become part of a primary prevention strategy of health authorities in Western societies to recommend daily EPA and DHA consumption. In support of this strategy, it can be referred to the symposium “Beyond Cholesterol: Prevention and Treatment of Coronary Heart Disease with n-3 Fatty Acids” summarized and discussed by R. J. Deckelbaum et al. ( American Journal of Clinical Nutrition , 2008; 87 (suppl): 2010S-2S). Moreover, concentrates of EPA and DHA, produced as disclosed in U.S. Pat. Nos. 5,502,077, 5,656,667 and 5,698,594, have been approved by the US Food and Drug Administration (FDA) as pharmaceutical preparations that reduce the level of blood components regarded as risk factors for coronary heart disease. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a representative visual illustration of plaque formation in aortas of female mice fed a diet to which was added the biological oil composition (Diet 1) or the EPA/DHA-concentrate (Diet 2), compared to the reference diet (Diet 3). FIG. 2 illustrates the average growth of female mice (n=10) on the three experimental diets. FIG. 3 shows the average weight of different organs of female mice (n=10) fed the three experimental diets (WAT=white adipose tissue). DETAILED DESCRIPTION OF THE INVENTION In the description of the present invention below the terms biological oil composition, copepod oil, copepod oil composition, oil composition are used interchangeable. EPA and DHA are predominant fatty acids present in marine fish, whale, seal and crustaceans. Also, the oil present in the marine copepod Calanus finmarchicus is a rich source of EPA and DHA, but this oil differs from other marine oils in a number of other chemical characteristics. Compared to other marine oils, the copepod oil of the present invention is very rich in the C18:4n-3 PUFA (stearidonic acid, SDA). Unlike other common marine food oils, the PUFAs present in the copepod oil exist predominantly as monoesters with long chain monounsaturated alcohols i.e. wax esters. Compared to other common dietary marine oils, the copepod oil of the present invention contains a relatively high proportion of free fatty acids, low amounts of triglycerides, and high levels of astaxanthin and cholesterol. Based on the common understanding that EPA and DHA are the key factors responsible for the beneficial effects of marine oils in prevention and treatment of coronary artery disease, the biomedical effects of these two fatty acids have been compared with those of the copepod oil composition, as described in the present invention. The effects of the copepod oil according to the present invention have been compared with that of a concentrated EPA/DHA-preparation on atherosclerotic plaque formation and on total cholesterol level in mice, adjusted so that copepod oil provided the same total amount of EPA and DHA as the total amount of EPA and DHA in the reference preparation. In these studies, experimental animals (Apolipoprotein E (ApoE) deficient mice) feeding on an atherogenic high fat (21% w/w) diet containing 0.2% (w/w) cholesterol were used. Although there are differences in chemical composition between the copepod oil composition of the present invention and other dietary marine oils, the remarkable difference in biological activities, as described in the present invention, could not at all be predicted by anyone working on the effects of marine PUFAs on coronary heart disease. Most striking is the highly unexpected finding that the biological oil composition of the present invention, as opposed to concentrated EPA/DHA, has a statistically significant ability to inhibit formation of atherosclerotic plaques. It also differs from EPA and DHA in the way it affects the pattern of lipid deposition in the body of the experimental animals. The copepod oil described in the present invention is in itself a novel anti-atherosclerotic composition. The biological oil composition according to the present invention also shows a significant effect on blood cholesterol level. Total blood cholesterol levels are significantly lower in animals fed with a diet comprising the biological oil composition according to the present invention as compared with the levels in animals fed a diet comprising concentrated EPA/DHA The biological oil composition according to the present invention is derived from a marine copepod, preferably a copepod of the genus Calanus , such as Calanus finmarchicus , using freshly harvested, frozen/thawed or dehydrated raw material. Oil compositions according to the invention may be obtained by any method known to the person skilled in the art such as, but not limited to, conventional fish oil production technology, biotechnological methods, organic solvents or supercritical fluid extraction, or cold pressing. Independent of the procedure of obtaining the oil and the yield of oil, the typical gross composition will be as shown in Table 1. To illustrate the uniqueness of the biological oil composition according to the present invention, the corresponding compositions of conventional fish oil (cod liver oil) and krill oil are shown for comparison. It is evident from this gross chemical analysis that these oils are highly different, in particular regarding their contents of triglycerides, phospholipids, monoesters (wax esters), and of astaxanthin. It should be noted that wax esters constitute the major lipid component in the copepod oil of the present invention, unlike both cod liver oil and krill oil. TABLE 1 Typical chemical composition of three different marine oils: (A) Copepod oil from Calanus finmarchicus caught in Norwegian waters, (B) cod liver oil from Atlantic cod Gadus morhua , and (C) krill oil from Euphausia superba caught in the Southern ocean, given in mg/g oil. Lipid classes A 1 B 2 C 3 Triglycerides 60 955 260 Free fatty acids 80 14 13 Fatty alcohols 62 0 0 Saturated fatty acids 190 160 300 Monounsaturated 125 385 300 Polyunsaturated 270 475 387 n-3 fatty acids >250 395 332 n-6 fatty acids <15 50 55 Cholesterol 40 12 50 Wax esters (fatty acid/alcohol esters) 650 0 0 Polar lipids (phospholipids, free 200-260 18 670 fatty acids, free fatty alcohols) Neutral lipids (triglycerides, wax 740-800 967 310 esters, cholesterol) 1 Copepod oil produced by Calanus AS (www.calanus.no). 2 From Falch, E., Rustad, T., and Aursand, M. By-products from gadiform species as raw material for production of marine lipids as ingredients in food or feed. Process Biochemistry 2006; 41: 666-674. 3 From Phleger, C. F., Nelson, M. N., Mooney, B. D., and Nichols, P. D. Interannual and between species comparison of the lipids, fatty acids, and sterols of Antarctic krill from the US AMLR Elephant Island survey area. Comparative Biochemistry and Physiology Part B 2002; 131: 733-747. Besides the notable difference in gross chemical composition (Table 1), the three marine oils used here for illustration purposes, are highly different also in their content of individual fatty acids (Table 2). TABLE 2 Fatty acid composition of three different marine oils: (A) Copepod oil from Calanus finmarchicus caught in Norwegian waters, (B) cod liver oil from Atlantic cod Gadus morhua , and (C) krill oil from Euphausia superba caught in the Weddell Sea, given in mg/g oil. Fatty acids A 1 B 2 C 3 14:0 FA (myristic) 108 40 119 15:0 FA 6 0 0 16:0 FA (palmitic) 72 112 209 16:1 n-9 1.8 0 0 16:1 n-7 FA 16 61 0 16:1 n-5 FA 0 0 56 17:0 FA 1.7 0 0 16:2 n-4 FA 1.7 0 0 18:0 FA 4.5 27 15 16:3 n-3 0.8 0 0 18:1 n-9 FA (oleic) 23.4 167 170 16:4 n-3 2.2 0 0 18:1 n-7 FA 2.8 40 70 18:2 n-6 FA 10.2 19 25 18:3 n-3 FA 24.4 14 9 20:0 FA 0 0 0 18:4 n-3 FA (stearidonic, SDA) 109.7 21 51 20:1 n-11 FA 5.3 0 0 20:1 n-9 FA (gadoleic) 27 98 13 20:4 n-6 FA 2.0 8 7 20:4 n-3 FA 9.0 0 0 22:1 n-11 (+20:4 n-3 FA) 42.7 8.5 0 22:1 n-9 FA 2.7 0 0 20:5 n-3 FA (eicosapentaenoic, EPA) 67.0 72 128 22:4 n-6 FA 10.5 0 0 24:1 n-9 FA 2.9 0 0 22:5 n-3 FA 3.7 20 0 22:6 n-3 FA (docosahexaenoic, DHA) 54.7 188 101 Sum identified 612.7 895.5 973 1 Copepod oil produced by Calanus AS (www.calanus.no). 2 From Standal, I. B., Praël, A., McEvoy, L., Axelson, D. E., and Aursand, M. Discrimination of Cod Liver Oil According to Wild/Farmed and Geographical Origins by GC and 13C NMR. J. Am Oil Chem Soc 2008; 85: 105-112. 3 From Hagen, W., Kattner, G., Terbrüggen, A., and Van Vleet, E. S. Lipid metabolism of the Antarctic krill Euphausia superba and its ecological implications. Marine Biology 2001; 139: 95-104. The most noteworthy difference in fatty acid composition between the three oils, is the very high stearidonic acid (SDA) content in the copepod oil. In the oil composition of the present invention, SDA, EPA and DHA exist to a large extent as esters with long chain alcohols. A typical composition of wax esters and long chain alcohols in the copepod oil of the present invention is shown in Table 3. TABLE 3 Typical composition of wax esters and alcohol/fatty acid combinations (% (w/w)) in copepod oil derived from Calanus finmarchicus . 1 Major alcohol/ Minor alcohol/ Wax ester fatty acid fatty acid % (w/w) 30:1 14:0/16:1 16:1/14:0 0.8 32:1 16:0/16:1 14:0/18:1 1.9 32:2 16:1/16:1 14:0/18:2 0.6 32:4 14:0/18:4 16:0/16:4 0.9 34:1 16:0/18:1 14:0/20:1 — 20:1/14:0 17.6  34:2 16:0/18:2 16:1/18:1 0.9 34:3 16:0/18:3 16:1/18:2 — 34:4 16:0/18:4 16:1/18:3 2.7 34:5 14:0/20:5 16:1/18:4 0.4 36:1 20:1/16:0 16:0/20:1 — 22:1/14:0 21.9  36:2 20:1/16:1 16:1/20:1 2.3 36:5 16:0/20:5 20:1/16:4 1.1 36:6 16:1/20:5  14:/22:6 0.3 38:1 22:1/16:0 16:0/22:1 2.8 38:2 22:1/16:1 20:1/18:1 3.9 38:3 20:1/18:2 22:1/16:2 0.4 38:4 20:1/18:3 22:1/16:3 0.9 38:5 20:1/18:4 22:1/16:4 5.4 38:6 16:0/22:6 16:1/22:5 — 40:2 20:1/20:1 22:1/18:1 5.9 40:3 22:1/18:2 0.7 40:5 22:1/18:4 20:1/20:4 4.7 40:6 20:1/20:5 1.5 42:2 22:1/20:1 20:1/22:1 12.7  42.6 22:1/20:5 20:1/22:5 1.5 42:7 20:1/22:6 2.0 44:2 22:1/22:1 4.9 44:7 22:1/22:6 0.6 1 Compiled from Graeve, M. and Kattner, G. Species-specific differences in intact wax esters of Calanus hyperboreus and C. finmarchicus from Fram Strait - Greenland Sea. Marine Chemistry 1992; 39: 269-281. In conclusion, the copepod oil of the present invention differs markedly from typical fish oil and krill oil in both gross chemical composition and fatty acid content. However, like other marine oils it comprises EPA and DHA. In spite of its high wax-ester content, the oil composition of the present invention is a low-viscous and completely free-flowing liquid at room-temperature. One of the reasons for this is that the alcohols of the wax esters are predominated by medium-length monounsaturated alcohols, typically 80% or more (mainly C20:1 and C22:1). Depending on the analytical methods used, the typical content of wax-ester of the oil composition of the present invention is 70-90%, whereas it contains 10-20% of other components such as free fatty acids, triacylglycerols, sterols and pigments. In certain applications, it may be advantageous or even desirable to remove free fatty acids and other components by suitable methods known to those skilled in the art. Thus, in one embodiment of the preset invention the oil composition may contain up to 100% wax ester. It has been found that the copepod oil according to the present invention has markedly different biological effects than a concentrated preparation of EPA and DHA used in the same concentration as in the copepod oil. Particularly the composition according to the present invention prevents the formation of atherosclerotic plaque and thus is useful in the prevention and treatment of cardiovascular disease. The composition according to the present invention is also found to have an effect on the total blood cholesterol level and is useful in the prevention and treatment of hypercholesterolaemia and elevated blood cholesterol levels. The biological oil composition according to the present invention comprises from 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, by weight up to 75%, 80%, 85%, 86%, 87%, 88%, 89% 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, 100% by weight of wax esters. Preferably the biological oil composition comprises from 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87% 88%, 89% by weight up to 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, 99.5%, 100% by weight of wax esters. Further the biological oil composition of the present invention comprises from 5%, 6%, 7%, 8%, 9%, 10% by weight up to 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20% by weight of SDA. The content of EPA in the biological oil composition may be 3%, 4%, 5%, 6%, 7%, by weight up to 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15% by weight. The composition may comprise 2%, 3%, 4%, 5% by weight up to 6%, 7%, 8%, 9%, 10% by weight of DHA. In one embodiment, the present invention provides a biological oil composition wherein the composition comprises 20-100% by weight of wax esters, preferably 50-100% by weight of wax esters, more preferred 70-100% by weight of wax esters for use as a medicament for the prevention and treatment of cardiovascular disease. The oil composition may be isolated from a marine copepod, preferably one of the genus Calanus , and more preferably said copepod is of the species Calanus finmarchicus. In other embodiments of the invention the present invention provides a biological oil composition for the use as a medicament in the prevention and treatment of atherosclerosis, hypercholesterolaemia and elevated blood cholesterol levels. In another embodiment the present invention provides an oil composition that further comprises 5-20% by weight of SDA. In yet another embodiment the present invention provides an oil composition comprising 3-15% by weight of EPA and 2-10% by weight of DHA. In a further embodiment of the present invention an oil composition comprising 20-100% by weight of wax esters, preferably 70-100% by weight of wax esters, 5-20% by weight of SDA, 3-15% by weight of EPA and 2-10% by weight of DHA is provided. In another embodiment of the present invention an oil composition comprising fatty alcohols and SDA, DHA and EPA as monoester with fatty alcohols is provided. In a further embodiment the present invention provides an oil composition comprising 1000-4000 ppm of astaxanthin, mainly in esterified form. A dietary supplement formulation comprising an oil composition as described above is also provided by the present invention. A functional food formulation comprising an oil composition as described above is also encompassed by the present invention. In yet another embodiment of the present invention a pharmaceutical formulation comprising an oil composition as described above is provided. The formulation according to the invention comprising an oil composition as described above may be provided in capsules, tablets, emulsions or tonics and may comprise one or more pharmaceutically acceptable additive selected from the group consisting of adjuvans, antioxidants, emulsifiers, surfactants and carriers. The present invention further provides the use of an oil composition as described above for the manufacturing of a product for the prevention or treatment of a cardiovascular disease, particularly atherosclerosis, hypercholesterolaemia and elevated blood cholesterol levels. The present invention also provides a method for the prophylaxis or treatment of cardiovascular disease, particularly atherosclerosis, hypercholesterolaemia and elevated blood cholesterol levels wherein the individual in need of such prophylactic or curative treatment is orally administered with a pharmaceutical composition comprising a biological oil composition wherein the composition comprises 20-100% by weight of wax esters, preferably 50-100% by weight of wax esters, more preferred 70-100% by weight of wax esters, and wherein a daily dosage level in the range of 4-100 mg/kg body weight. In another embodiment the present invention provides a method wherein the administered pharmaceutical composition further comprises 5-20% by weight of SDA. In yet another embodiment the present invention provides a method wherein the pharmaceutical composition comprising 3-15% by weight of EPA and 2-10% by weight of DHA. In a further embodiment of the present invention a method wherein the administered pharmaceutical composition comprises 20-100% by weight of wax esters, preferably 70-100% by weight of wax esters, 5-20% by weight of SDA, 3-15% by weight of EPA and 2-10% by weight of DHA is provided. In another embodiment of the present invention a method wherein the administered pharmaceutical composition comprising fatty alcohols and SDA, DHA and EPA as monoester with fatty alcohols is provided. In a further embodiment the present invention provides a method wherein the administered pharmaceutical composition comprises 1000-4000 ppm of astaxanthin, mainly in esterified form. The following non-limiting experimental part and examples illustrate and document the present invention. EXAMPLES Experimental When studying the preventive efficacy of any drug candidate or dietary ingredient on coronary heart disease, the most reliable end-point analyses are the actual disease manifestations, such as, for instance, formation of atherosclerotic plaques. Effects on blood parameters considered to be indicative of the risk of disease development are of course important for evaluation of mode of action of new anti-atherogenic drug candidates, but it is preferable to relate such blood analyses to efficacy data on the disease manifestation itself. This has been the philosophy in the studies constituting the foundation of the present invention. The biological effects of the copepod oil of this invention were recorded in mice deficient in apolipoprotein E (ApoE). Mice of this strain are routinely used to determine effects of dietary components on development of vascular inflammation and atherosclerotic plaques, since they develop atherosclerotic lesions according to a pattern very similar to that of humans, and they are useful model animals for studies of biochemical and cellular processes involved in initiation, progression and regression of atherotrombotic disease. The studies were carried out at the Faculty of Medicine at the University of Tromsø (Norway). Three groups of ten female mice were installed at an age of 7 weeks and fed 3 different diet treatments (see below) for 13 weeks. The mice were fed ad libitum with an experimental high fat (21% w/w) and cholesterol (0.2% w/w) diet, rich in bioavailable carbohydrates (sugar/dextrin) and with a high proportion of saturated fat (sniff Spezialdiaten GmbH, sniff EF Clinton/Cybulsky (II) mod.). The composition of this diet promotes development of obesity and of atherosclerotic lesions. The diet was added either 1% (w/w) of the copepod oil of the present invention (Diet 1) or 0.1223% (w/w) of an EPA/DHA-concentrate (Diet 2), producing two experimental feeds with equal contents of EPA and DHA. The cholesterol content of these two diets and of the control diet (Diet 3) without added oil was adjusted to 0.20% by adding cholesterol, taking into account the cholesterol present in the feed ingredients and in the copepod-oil itself. The composition of the experimental diets is shown in Table 4. TABLE 4 Experimental diet for rats and mice with high fat/cholesterol content (type ssniff ® EF Clinton/Cybulsky (II) mod.) 1 with ingredient and nutritional profile for the three test groups Diet 1 Diet 2 Copepod oil EPA/DHA Diet 3 preparation concentrate Control Ingredients Sucrose, % 33.0876 33.0476 32.5867 Milk fat, % 19.9692 19.9692 19.9692 Casein (vitamin free), % 19.4700 19.4700 19.4700 Maltodextrin, % 9.9846 9.9846 9.9846 Corn starch, % 4.9923 4.9923 4.9923 Powdered cellulose, % 4.9923 4.9923 4.9923 AIN-76 Mineral Mix, % 3.4946 3.4946 3.4946 Calanus Oil-841, % 1.0000 — — Omacor Oil-842, % — 0.1223 — AIN-76A Vitamin Mix, % 0.9985 0.9985 0.9985 Corn Oil, % 0.9985 0.9985 1.9985 Calcium carbonate, % 0.3994 0.3994 0.3994 DL-Methionine, % 0.2995 0.2995 0.2995 Choline bitartrate, % 0.1997 0.1997 0.1997 Cholesterol, % 0.1498 0.1498 0.1498 Ethoxyquin, % 0.0040 0.0040 0.0040 Nutritional profile Protein, % 17.4 17.4 17.4 Fat, % 21.0 21.0 21.0 Cholesterol, ppm 2 027 2 027 2 027 Carbohydrates, % 48.9 48.9 48.4 Fiber (max), % 5.0 5.0 5.0 Energy, kcal/g 4.48 4.56 4.55 From Protein, % 15.3 15.3 15.4 Fat (ether extract), % 41.6 41.7 41.8 Carbohydrates, % 43.0 43.0 42.8 1 Produced by ssniff Spezialdiäten GmbH (www.ssniff.de). The copepod oil preparation was an experimental product provided by Calanus AS, Tromsø, Norway (www.calanus.no). The EPA/DHA concentrate used as reference test substance was the lipid lowering drug Omacor (Pronova Biopharma ASA, P.O. Box 420, NO-1327 Lysaker, Norway). According to the manufacturer (www.pronova.com) this product contains 90% omega-3-acid ethyl esters of EPA (460 mg/g) and DHA (380 mg/g) and is manufactured using fish oil as a starting material. The experimental mice were monitored daily, and weighed at regular intervals. Samples of blood serum were taken at different points for later analysis of various blood parameters including lipids and fatty acids. The mice were sacrificed at the end of the experiment, and all relevant organs were dissected out following standard procedures. Following dissection of the sacrificed mice, the aortas were isolated, cleaned and cut open longitudinally, pinned to a white cardboard and fixed in 10% formalin for at least 24 hours. The aortas were stained with Oil Red O (Sigma) before analysis. After rinsing, the aortas were mounted on microscopic slides, and images (2,700 dpi) were acquired using a SprintScan 35 scanner (Polaroid, Cambridge, Mass., USA) equipped with GeoScan Enabler (Meyer Instruments, Houston, Tex., USA). The images were analyzed for positive areas, adopting the state-of-the art calibration and image analyses methodology. The total lesion area was quantified in each group by computer-assisted quantitative morphometry as described by N. V. Guevara et al. (The absence of p53 accelerates atherosclerosis by increasing cell proliferation in vivo. Nature Medicine 1999; 5:335-339). Biological Effects i) Atherosclerosis It has been found that the copepod oil of the present invention has markedly different biological effects than a concentrated preparation of EPA and DHA used in the same concentration as in the copepod oil. This was a highly unexpected finding, considering the overwhelming consensus among the skilled in the art, that the positive health effects of marine oils are associated with their content of EPA and DHA, exclusively. The results are shown in Table 5 and in FIGS. 1-3 . The effect of the copepod oil of the present invention and of EPA/DHA-concentrate on atherosclerotic plaque formation in the aortas of female mice is shown in Table 5. The copepod oil preparation had a striking and statistically highly significant effect on reduction of plaque formation both in the aortic arch (p=0.002) and the total aorta (p=0.001) compared to control. Also the EPA/DHA-concentrate reduced plaque formation compared to control, but the effect did not meet the requirements of statistical significance. TABLE 5 The effect of a copepod oil preparation and of concentrated EPA/DHA on atherosclerotic plaque formation 1 in the ascending aortic arch, thoracal, abdominal and perirenal segments of the aorta in female mice. Diet 1 Diet 2 Copepod oil EPA/DHA Diet 3 preparation concentrate Control Target region (n = 10) (n = 10) (n = 10) Aortic arch (A) 15.1 18.0 22.0 Thoracal (B) 7.93 9.51 12.16 Abdominal (C) 1.93 2.52 3.94 Perirenal (D) 1.36 2.27 1.94 Total aorta (B-D) 4.59 5.87 7.22 1 The figures represent the average lesion area in percent of total area of each target region at time of sacrifice. See FIG. 1 for the subdivision of target regions (A-D) of the aorta. Growth of the mice is shown in FIG. 2 . Although the mice grew fastest on feed enriched with copepod oil, and thrived well on that diet, this apparent difference does not meet the requirements for statistical significance. There was no difference between the groups in feed intake and no negative effects could be observed on animals fed the experimental diets. Weight of different organs is shown in FIG. 3 . Although there was a higher level of fat deposited in the white adipose tissue (WAT) in mice fed the copepod oil, the difference was not statistically significant. However, it is a noteworthy observation indeed that the copepod oil of the present invention reduces plaque formation while more lipids are deposited in lipid storage tissues. ii) Blood Cholesterol Level The copepod oil has a notably more pronounced anti-atherosclerotic effect than purified EPA and DHA at same concentration as in this oil. The mechanisms involved in this effect of the copepod oil may accordingly be additive to the EPA- and DHA-effects or be entirely different. The results shown in Table 6 illustrate that Calanus Oil differs from EPA and DHA also regarding the effect on blood cholesterol level in the experimental animals. Whereas the cholesterol level in blood of animals fed the EPA/DHA-diet was the same as in control animals after 13 weeks of feeding, the cholesterol level in blood of the Calanus Oil group was notably lower. Both treatment groups seem to have a slight, and similar, triglyceride lowering effect compared to control. TABLE 6 Effects of the dietary supplements on bodyweight, food intake and plasma lipids in apoE-deficient female mice after 13 weeks of treatment, as mean values +− SEM. Diet 1 Diet 2 Copepod oil EPA/DHA Diet 3 Female apoE- composition concentrate Control deficient mice (n = 10) (n = 10) (n = 10) Bodyweight (g) Initial 18.4 +/− 0.3  18.7 +/− 0.3  18.6 +/− 0.4  Final 38.9 +/− 1.2  37.7 +/− 1.6  34.6 +/− 1.2  Food intake 2.72 +/− 0.05 2.72 +/− 0.07 2.77 +/− 0.04 (g/day) Total cholesterol 12.3 +/− 1.25 15.9 +/− 1.28 16.1 +/− 1.25 (mmol/L) Triacylglycerol 0.82 +/− 0.05 0.84 +/− 0.07 0.96 +/− 0.05 (mmol/L)

This invention relates to a biological oil composition, preferably obtained from a copepod, most preferably the copepod Calanus finmarchicus and the use thereof to prevent or treat formation of atherosclerotic plaques and hence development of coronary heart disease. The composition comprises the same marine n-3 polyunsaturated fatty acids (PUFAs) generally regarded as being responsible for the anti-atherosclerotic effect of marine oils, namely EPA (C20:5n-3 eicosapentaenoic acid) and DHA (C22:6n-3 docosahexaenoic acid). However, quite unexpectedly, it has been found that the oil composition of the present invention has a remarkably higher ability to prevent formation of atherosclerotic plaques than what can be attributed to EPA and DHA alone, and moreover, unlike EPA and DHA alone it has a notable blood cholesterol lowering effect.

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of application Ser. No. 08/088,581, filed Jul. 9, 1993, abandoned, which is a continuation of application Ser. No. 07/689,643, filed Apr. 23, 1991, abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to pharmacological compositions which contain polyelectrolyte complexes in microparticulate form and at least one active substance. The active substance can in this case be embedded in the matrix of the polyelectrolyte complex, itself be a partner in the polyelectrolyte complex or be bound to a partner of the polyelectrolyte complex. By active substances are meant primarily pharmacological active substances such as active peptides, proteins, enzymes, enzyme inhibitors, antigens, cytostatics, antibiotics, antiinflammatory agents or vaccines. In the particular case of ultrasonic diagnostic aids, also meant as active substances in this connection are contrast agents such as gases, for example air, oxygen or inert gases. 2. Description of the Prior Art It is known from the literature that multiple charged macromolecular compounds with ions of opposite charge form ionic compounds which may, depending on the charge distribution and the molecular weight of the final product, precipitate from aqueous solutions. In this case, low molecular weight ions of the same charge are displaced by the higher molecular weight compound. These phenomena are also collected together under the overall term "polyelectrolyte effect". State of the art are, inter alia, the formation of gels by mixing alginate solutions and Ca 2+ . Protein precipitations also take place in some cases in accordance with this principle. Polyelectrolyte complexes can in principle be composed of a macromolecular, multiply charged component of one polarity and many low molecular weight ions of the other polarity, or else of two macromolecular partners, each of which is multiply charged with different polarity. Hollow capsules which are prepared from such polyelectrolyte complexes are described, for example, in BE-A 901.704, EP-A 0 127 989, EP-A 0 188 309, EP-A 0 127 713, DE-A 32 09 127, EP-A 0 152 898, U.S. Pat. No. 4,487,758, DE-A 32 09 098, U.S. Pat. No. 4,409,331, A. Johansen and J. M. Flink, Enzyme Mikrob. Technol., 1986, vol. 8, 145-148 or C. E. Camp and S. S. Sofer, Enzyme Mikrob. Technol., 1987, vol. 9, 685-689. Formulations and active substance combinations which not only convert the active substance in a non-deleterious manner into a form which can be administered but also have a specific effect on the biodistribution, bioavailability or absorption of the pharmaceutical are becoming increasingly important in modern pharmaceutical technology. It is possible therewith to achieve both new therapeutic and diagnostic areas of use and, for example, an increase in the therapeutic index of an active substance. Particulate systems of extremely small diameter (so-called micro- or nanoparticles) in particular have suggested themselves recently as important administration form, both in the oral and in the parenteral area. Usually employed in this connection as carrier substances are biocompatible, biodegradable polymers. SUMMARY OF THE INVENTION It has now been found, surprisingly, that polyelectrolyte complexes show to a particular extent properties, both as carrier substances and as active substance components, which meet the profile of requirements of biocompatible (biodegradable) polymer systems and can be adapted to meet the various requirements. It was known of hollow capsules, including polyelectrolyte complex capsules, that active substance incorporation capacities of 90% and more can be achieved. This was not to be expected with microparticles which are composed of just such polyelectrolyte complexes, because these complexes form only at the interface (around the active substance). This particularly applies when they are prepared from purely aqueous reaction solutions into which active substances, which are soluble therein, are introduced. It was therefore all the more surprising that particulate polyelectrolyte complexes also display incorporation capacities of more than 90%. It was furthermore surprising that in the preparation of such polyelectrolyte complex matrices there was formation of fine particles in the μm range or emulsions and not, as was really to be expected, an agglomerated mass. It is possible according to the invention to prepare such colloidal systems of micro/nanoparticles especially well from polyelectrolyte complexes. There is then in vivo, via solution equilibria and charge interactions, a slow decomplexation as well as a breakdown of complexands, which results in dissolution of the complex and release of the active substance. These release conditions can, as can the consistency properties, be controlled via the composition of the complex. DESCRIPTION OF THE PREFERRED EMBODIMENTS The partners employed for the complex formation are preferably biocompatible, biodegradable polyacids and polybases which are naturally occurring or composed of natural subunits. In this case, "poly" means that the compound carries more than one charge of the same polarity, preferably a large number of such charges. The particular counterions can be composed either of low molecular weight ions or likewise of a polyionic species. Either one or both ionic partners can be either inorganic or organic in nature. In the case of organic polyions, hydrophobic substituted derivatives prove suitable and preferable. Preferred materials for the preparation of biocompatible polyelectrolyte complex/active substance combinations are, as polyacids: xylan polysulfate, partially hydrophobically esterified xylan polysulfate, polysulfates of other polysaccharides such as, for example, starch hydrolysates, inulin, hydroxyethylstarch, dextrans and the partially hydrophobically substituted derivatives thereof in each case, and poly(amino acids) such as polyaspartic acid or polyglutamic acid and the hydrophobically substituted derivatives thereof in each case. As polybases: poly-L-lysine of various defined molecular weight ranges, poly-α,β-(2-dimethylaminoethyl)-D,L-aspartamide (PDAA), copolymers of PDAA and hydrophobically esterified poly-α,β-(2-hydroxyethyl)-D,L-aspartamide (PHEA), chitosan, lysine octadecyl ester, aminated dextrans, aminated cyolodextrins, aminated cellulose ethers, aminated pectins and the partially hydrophobically substituted derivatives thereof in each case. In one preferred embodiment, the polyelectrolyte complex contains a polyacid which is selected from: xylan polysulfates, dextran sulfates, poly(amino acids) such as polyaspartic acid or polyglutamic acid, polysaccharide polysulfates such as sulfates of starch hydrolysates, inulin, hydroxyethylstarches, polysaccharide polysulfonates, polysaccharide polyphosphates, polyphosphates, and, more preferably, the polyelectrolyte complex contains a polyacid which is selected from: in each case partially hydrophobized (for example etherified, esterified) derivatives of xylan polysulfate, polysulfates of other polysaccharides such as, for example, starch hydrolysates, inulin, hydroxyethylstarches, dextrans; of poly(amino acids) such as polyaspartic acid or polyglutamic acid, and of polysaccharide polysulfonates, polysaccharide polyphosphonates, polyphosphates. In another preferred embodiment, the polyelectrolyte complex contains a polybase which is selected from: poly-L-lysine, poly-α,β-(2-dimethylaminoethyl)-D,L-aspartamide, chitosan, lysine octadecyl ester, aminated dextrans, aminated cyclodextrine, aminated cellulose ethers, aminated pectins, and, more preferably, the polyelectrolyte complex contains a polybase which is selected from: in each case (for example by partial or complete esterification and/or etherification) hydrophobized derivates of: poly-L-lysine of various molecular weight ranges, poly-α,β-(2-dimethylaminoethyl)-D,L-aspartamide, chitosan, aminated dextrans, aminated cyclodextrins, aminated cellulose ethers, aminated pectins and copolymers of poly-α,β-(2-dimethylaminoethyl)-D,L-aspartamide and hydrophobically esterified poly-α,β-(2-hydroxyethyl)-D,L-aspartamide. Microparticles composed of polyelectrolyte complexes can, depending on the requirements, be prepared in average particle sizes from a few nm up to a few hundred μm. It is also possible by definition for the microparticles to be in the form of emulsions. The breadth of the size distribution can be adjusted, for example by the stirring speed on mixing the polyelectrolytes, the drop rate, the nozzle diameter, the pH and by suitable choice of the polyelectrolyte partners. It is particularly advantageous to carry out the formation of the complexes with addition of auxiliaries such as amphiphilic molecules (for example ® Pluronic) or colloidal substances (for example adjuvants) with high incorporation capacity. These parameters can be determined in simple routine tests and adjusted to the required particle size and particle size distribution. Particles below 5 μm in diameter are suitable for intravenous injection. Particles with a diameter <15 μm, preferably <10 μm can be employed as s.c. or i.m. injectable depot forms and as a vehicle to increase the enteral absorption. The incorporation of an active substance in the polyelectrolyte complex particles/colloids can be carried out in at least 4 ways: a) incorporation by "entrapment" of the active substance, which is present in solution, on precipitation of the complex, b) incorporation by absorption of the active substance from a solution with which the already prepared polyelectrolyte complexes come into contact (especially in the case of porous materials or gels with "sponge" properties), c) precipitation of the polyelectrolyte complex, in which case the active substance is chemically bound to at least one complex partner and, d) incorporation by employing the active substance as partner in the formation of the polyelectrolyte complex. This usually requires at least one charge or polarizable group on the active substance. The invention therefore also relates to a process for preparing pharmaceutical compositions containing polyelectrolyte complexes and active substances, where a solution of an acidic and a solution of a basic substance, where at least one of these substances must be polymeric, are mixed and where a) either one of the partners is an active substance or contains the latter in chemically bound form, or b) the active substance is contained in one of the solutions, and subsequently the resulting polyelectrolyte complex is precipitated in microparticulate form or, where appropriate, converted into a microparticulate form. Polyelectrolyte complex/active substance formulations show, because the consistency properties can be widely varied on the one hand and can be very specifically adjusted on the other hand, property profiles as required for diverse pharmaceutical applications. Thus, it has emerged that the cytostatic daunorubicin and the polyacid xylan polysulfate produce macroparticles which contain daunorubicin and release the latter in buffer solution or in biological systems uniformly over a lengthy period, during which they are broken down. If polybases are also added and/or the polyacid is changed, especially by replacing xylan polysulfate by xylan polysulfate which is partially substituted with palmitoyl ester groups, it is possible to reduce the particle size to <<5 μm and the result is an i.v. injectable system with the release properties described above. The therapeutic index of the cytostatic can be drastically increased with a slow-release form of this type. The activity properties of other low molecular weight active substances such as antibiotics (for example tetracycline) or other cytostatics can also be distinctly improved in this way. If proteins are incorporated in polyelectrolyte complex microparticles, it is possible in this way both to protect them from hydrolytic attack and to achieve controlled release profiles. Thus, for example, vaccine preparations can be produced using vital proteins or similar substances suitable for vaccination and can, depending on the particle size, be injected i.m. or even administered orally, in which case there is absorption in the gastrointestinal tract of particles <5 μm, and subsequent antigen expression/immunization occurs. It is possible, with such antigen-containing polyelectrolyte complexes according to the invention, to achieve release profiles which allow a large dose of the vaccine to be delivered shortly after administration and after a period of, for example, 4 weeks (booster). The substances particularly suitable for forming polyelectrolyte complexes in this case are described in Example 3. It is also possible to convert peptide-based active substances by means of polyelectrolyte complex preparations into suitable long-term systems. These formulations are in some cases superior to the known polymeric depot systems for LHRH analogs, for example, both because the degradability is better and because the release profiles are defined. Polyelectrolyte complexes are likewise suitable for preparing wound ointment preparations which contain, for example, antibiotics or proteins as regeneration promoters. The polyelectrolyte complex microparticles according to the invention are also outstandingly suitable as air-containing echogenic contrast agents for ultrasonic diagnosis. Polyelectrolyte complex particles composed of hydrophobically esterified dextran sulfate and of a copolymer of PDAA and hydrophobically esterified PHEA (for abbreviations, see page 4) have proven particularly suitable for ultrasonic diagnosis. The invention is explained in more detail hereinafter by means of examples. The particle size has been determined by microscopic methods or by filtration through filters of defined pore size and, in some cases, by Coulter counter (from Coulter Electronics) or flow cytometer. EXAMPLES a) Preparation of polyelectrolyte complexes Example 1 Complex of xylan polysulfate and poly-L-lysine 3800 A 0.1% aqueous solution of each of xylan polysulfate sodium salt (from BENE-Chemie) and of poly-L-lysine of average molecular weight 3800 (from Sigma) is made up. Sufficient HCl is added to the poly-L-lysine solution for the pH to be 3. The xylan polysulfate solution is likewise adjusted to pH 3 (HCl) and added dropwise via a metering pipette. The polyelectrolyte complex precipitates and is separated off by centrifugation and membrane filtration. After washing with H 2 O, the microparticulate product can be freeze-dried. The particle size can be controlled by the vessel size, the stirring speed, the diameter of the dropwise addition nozzle and the dropping rate and can be adjusted from the region around 20 nm to 100 μm. EXAMPLE 2 Complex of palmitoylxylan polysulfate with 20% palmitic acid residues and chitosan 0.1% solutions are prepared as in Example 1. The procedure corresponds to that employed in Example 1, only that no pH control is carried out in this case, and polylysine is replaced by chitosan (from Protan). The palmitoylxylan polysulfate can be prepared, for example, by the process described in German Patent Application P 3921761.2. Chitosan 143 is used. The resulting particles are large agglomerates (100 μm and larger) and can be reduced to a size of 1-4 μm by grinding in a mortar. EXAMPLE 3 Polyelectrolyte complex particles composed of palmitoylxylan polysulfate with 20% palmitic acid and chitosan with incorporation of human serum albumin as model protein for vaccines. The procedure is carried out as described in Example 2, only that 0.2% human serum albumin (from Sigma), dissolved in water, is added to the palmitoylxylan polysulfate solution before the dropwise addition. Particles in the range 2-5 μm can be obtained after grinding. See Example 10 for the determination of the albumin release. EXAMPLE 4 Preparation of rabies vaccine/polyelectrolyte complex microparticles Particles in the <5 μm range can be obtained with two different preparations: I. Polyacid: Palmitoylxylan polysulfate with 20% palmitic acid Polybase: Lysine octadecyl ester Auxiliary: ®Pluronic F68 50 mg of polyacid are dissolved in 5 ml of a 0.1% strength solution of rabies vaccine from Behringwerke (the solution is aqueous and contains 40% sucrose), the pH is 6.3. 50 mg of polybase are added to 5 ml of a 0.5% strength solution of ®Pluronic F68 in water. The polyacid/vaccine solution is added dropwise to the stirred polybase solution (which has pH 5.8). After centrifugation (10 min, 2000 rpm), the clear supernatant is separated off, and the residue is made into a paste with H 2 O and freeze-dried. Yield 779.7 mg of particles. The amount of the employed vaccine incorporated can be found by resuspension and analysis of the supernatant (in H 2 O) to be 90%. II. Polyacid: Palmitoylxylan polysulfate with 20% palmitic acid Polybase: 40:60 copolymer of poly-α,β-(2-dimethylaminoethyl)-D,L-aspartamide (40%) and poly-α,β-(2-palmitoyloxyethyl)-D,L-aspartamide (60%) no auxiliary Once again, two solutions are made up, each containing 50 mg of polyacid/base. The polyacid solution is identical to that in I. The polybase solution is identical to that in I except that it contains no ®Pluronic. Both solutions are adjusted to pH 7 and, as in I, centrifuged and the residue is made into a paste and freeze-dried. The incorporation efficiency corresponds to that in I. Yield: 76.5 mg. EXAMPLE 5 Vaccination of mice against human serum albumin with polyelectrolyte complex microparticles The following microparticle preparations were employed: Sample I: Xylan sulfate esterified with about 15% palmitic acid/lysine octadecyl ester +7% Pluronic®68, 5-30 μm Sample II: Xylan sulfate esterified with about 15% palmitic acid/lysine octadecyl ester, ≦10 μm Sample III: Xylan sulfate esterified with about 15% palmitic acid/poly-L-lysine 4 kDa +7% Pluronic® F68, 2-50 μm Sample IV: Polyaspartic acid 30 kDa/poly-α,β-(2-dimethylaminoethyl)-D,L-aspartamide/poly-.alpha.,β-(2-palmitoyloxyethyl)-D,L-aspartamide copolymer (40:60), <10 μm Sample V: Xylan sulfate/lysine octadecyl ester, 10-20 μm All the samples contained about 7% by weight human serum albumin (Behringwerke). These complexes were resuspended in concentrations of 66.67 μg/ml, 6.67 μg/ml and 0.67 μg/ml in PBS (phosphate-buffered saline). 0.3 ml of each vaccine was administered s.c. to, in each case, 10 NMRI mice weighing about 20 g. 14 weeks after the vaccination, the experimental animals were revaccinated with the same dose. The antibodies directed against human serum albumin in the serum of the experimental animals were quantified in an ELISA. Used as comparison was aluminum hydroxide Al(OH) 3 which is known as a good adjuvant and is contained in various vaccines. ELISA titer after inoculation with 6.67 μg of formulation/ml (average dose), 2, 4, 8, 14 (revaccination), 16 and 21 weeks after the first vaccination: ______________________________________Sample Day 0 Day 2 Day 4 Day 8 Day 14______________________________________I <1:300 <1:300 1:300 1:900 1:900II <1:300 <1:300 1:300 <1:300 <1:300III <1:300 1:300 1:900 1:2700 1:8100IV <1:300 <1:300 <1:300 1:2700 1:8100V <1:300 1:900 1:2700 1:8100 1:24300Al(OH).sub.3 <1:300 1:900 1:900 1:900 1:900______________________________________Sample Day 16 Day 21______________________________________I 1:72900 1:72900II 1:24300 1:24300III 1:72900 1:24300IV 1:72900 1:72900V 1:72900 1:72900Al(OH).sub.3 1:8100 1:24300______________________________________ Administration of the same vaccine to guinea pigs likewise resulted in distinct seroconversion. EXAMPLE 6 Polyelectrolyte complex particles composed of polyaspartic acid and poly-α,β-(2-dimethylaminoethyl)-D,L-aspartamide (PDAA) with incorporation of tetracycline as example of a low molecular weight active substance. The procedure is as described in Example 3, except that a 0.2% solution of tetracycline in water is employed in place of human serum albumin. See Example 11 for the tetracyctine release. EXAMPLE 7 Polyelectrolyte complex particles composed of xylan polysulfate and daunoribicin. 10 mg of xylan polysulfate are dissolved in 0.5 ml of H 2 O. 100 μl of a 10% daunorubicin solution (daunorubicin from Sigma) are diluted to 0.4 ml with water. The daunorubicin solution is added dropwise to the xylan polysulfate solution. The resulting suspension contains particles whose diameter is in the 5 μm range. See Example 12 for the daunorubicin release. EXAMPLE 8 Polyelectrolyte complex particles composed of palmitoylxylan polysulfate with 20% palmitic acid, daunorubicin and lysine octadecyl ester. 1 ml of a solution which contains 1% each of daunorubicin and lysine octadecyl ester is adjusted to pH 4. A 1% solution of palmitoylxylan polysulfate, likewise 1 ml, likewise adjusted to pH 4, is added dropwise. The resulting suspension can no longer be fractionated by filtration. The particles can be adjusted by altering the concentration, the stirring speed, the dropping rate and the nozzle diameter in the range from 100 nm to 1 μm (see Table 1). TABLE 1______________________________________Particle Concen- Stirring Dropping Nozzlesize tration speed rate diameter______________________________________ 1 μm 0.1% 300 min.sup.-1 100 min.sup.-1 0.5 mm 10 μm 0.5% 300 min.sup.-1 100 min.sup.-1 0.5 mm 20 μm 1% 300 min.sup.-1 100 min.sup.-1 0.5 mm100 nm 0.1% 1000 min.sup.-1 100 min.sup.-1 0.5 mm 20 nm 0.1% 1000 min.sup.-1 100 min.sup.-1 0.2 mm 80 μm 1% 100 min.sup.-1 100 min.sup.-1 0.5 mm100 μm 1% 100 min.sup.-1 200 min.sup.-1 0.5 mm______________________________________ EXAMPLE 9 Echogenic injectable polyelectrolyte complex microparticles as ultrasonic contrast agent. The polyelectrolyte complex particles are prepared as follows: In each case a 1% strength aqueous solution at pH 7 is made up from dextran sulfate (M=6000) in which about 20% of the dextran OH groups have been esterified with caproic acid and the remaining OH groups have been sulfated ("hydrophobically esterified dextran sulfate", "polyacid ") and from a copolymer of poly-α,β-(2-dimethylaminoethyl)-D,n-aspartamide (60%) and poly-α,β-(2-palmitoyloxyethyl)-D,L-aspartamide (40%) ("polybase"). The polyacid solution is added dropwise to the polybase solution and stirred at room temperature for 10 minutes, the complex is removed by centrifugation, the solution is decanted off, and the solid is made into a paste with and freeze-dried. Test as contrast agent: Freeze-dried and resuspended microparticles with a size of the order of 1-3 μm are investigated in a phantom which represents a model of the heart and extremely small capillary vessels (lung model) for the ultrasonic contrast brought about by incorporated air. The particles pass through the capillaries unhindered. b) Release tests EXAMPLE 10 Release of albumin from the microparticles described in Example 3 A microparticle suspension in phosphate buffer is shaken continuously. After 1, 4, 7, 13, 21 add 28 days, the supernatant is removed and then the albumin content is determined by electrophoresis known from the literature. The result is a profile with 2 release maxima as is required for various vaccines: ______________________________________Release on day 1 4 7 13 21 28Albumin released 50 20 <5 <5 10 <5______________________________________ Particles are no longer present after somewhat more than one month. EXAMPLE 11 Tetracycline release from the polyelectrolyte complex particles of Example 6. The breakdown test is carried out as test 10. The active substance is determined by a UV spectroscopic method known from the literature. The results are: ______________________________________Release on day 1 4 7 13Tetracycline released 30 10 10 <5______________________________________ EXAMPLE 12 Release of daunorubicin from the polyelectrolyte particles of Example 7. The particle suspension is placed in a Soxhlet extractor and extracted with H 2 O for several days. Daunorubicin in the extract is determined by a fluorometric method known from the literature (at 472/555 nm). It emerges that the release, based on the total amount of daunorubicin weighed in, is as follows: ______________________________________after 3.5 h 11 h 20 h 29 h the releasewas: 8.5% 10.5% 15.0% 26.2% of the amount______________________________________ of active substance employed.

The invention relates to a pharmacological composition comprising a polyelectrolyte complex, in particular a polyacid with an average particle size of less than 15 μm and an active agent, among which are active peptides, proteins, enzymes, enzyme inhibitors, antigens, cytostatics, antiinflamatory agents, antibiotics and vaccines. The said composition ensures that the active agent is converted in a non-deleterious manner into a form which can be administered. In addition, the biodistribution, bioavailability and absorption of the pharmaceutical are beneficially affected.

BACKGROUND OF THE INVENTION The present invention is directed to a container, and more particularly to a container which may be used for the disposal of infectious septic articles to prevent contamination of the environment or the transmittal of disease. FIELD OF THE INVENTION It is known that the disposal of various kinds of waste must be accomplished in a manner to avoid a number of hazards, including hazards to the environment, that is, to the land, to air, and to bodies of water, including rivers, lakes, and the oceans. In recent years, the disposal of waste which is identified as being hazardous to persons or to the environment has increased, and expanded, and the disposal of chemical and medical wastes has received greater attention. Regulations have been and are being issued by Governmental bodies with regard to the disposal of ever increasing categories of waste. Among the articles disposed of as waste are sanitary napkins and tampons. These have traditionally been disposed of with waste from bathrooms, such as soiled paper towels, or by being flushed down the toilet. Formerly, it was not considered that the disposal of these articles in this manner created an environmental hazard or was otherwise undesirable. More recently, it has been recognized that the disposal of sanitary napkins might result in the transmission of the HIV virus, the cause of the AIDS disease. Mendelssohn U.S. Pat. No. 4,846,828 provides a recognition of this problem; the resulting danger has greatly increased due to the spread of AIDS to a greater number of women in the population. The proposal of this patent is to have a sanitary napkin and a disposal means connected to it, so that after the sanitary napkin has been used, the attached or "self-contained" disposal means, a wrapping, is folded over the soiled portion of the sanitary napkin. The disposal means or wrapping is intended to completely encloses the soiled napkin. There are a number of disadvantages of the product of the noted patent. The wrapping or "package" itself adds to the bulk of the product when worn, and consequently to the discomfort of the wearer. Moreover, the structure of this patent requires that it be properly manipulated in order to provide the seal. The cover or wrapping which is attached to the sanitary napkin must be very carefully handled in order to achieve a sealed wrapping of the sanitary napkin. The construction requires the adhering of an adhesive tape to a surface of the used sanitary napkin, but this can be difficult or impossible since the used sanitary napkin often contains a very substantial amount of liquid, or is otherwise made moist. The user has to grasp and move separate sections of the wrapping so as to encompass the soiled sanitary napkin while holding the sanitary napkin. Further, there is not provided a hermetic sealing by the structure disclosed in this patent. Froidh et al U.S. Pat. No. 4,735,316 discloses a sanitary napkin and a container for it in the form of a bag, the bag being usable as a disposal container after use of the sanitary napkin; the bag is neither sealed when closed with the used sanitary napkin, nor hermetically sealed. Black U.S. Pat. No. 4,182,336 provides a sanitary napkin having a sack-like container attached to it, the container being made of moisture-proof material, and the used sanitary napkin is placed in the bag, and the bag is then closed by manipulation of a flap which is secured in the closed position by adhesive. Allison U.S. Pat. No. 4,857,066 also provides a bag which is attached to a sanitary napkin, and which is used for disposal of the sanitary napkin after use, the structure including adhesive spots of pressure sensitive adhesive, in spaced relationship, to secure a flap of the bag in closed position; this construction does not provide a sealed or a hermetically sealed bag. Kadel U.S. Pat. No. 5,133,457 provides a tampon applicator and container, which provides for disposal of a tampon applicator, but not of a tampon. SUMMARY OF THE INVENTION There is provided a container for disposing of such septic potentially infectious articles as sanitary napkins, tampons and other bandages, i.e. an absorbent body to absorb body fluid. The container is made of combustible material and comprises two parts, such as a top and a bottom. The two parts, when assembled, provide an unobstructed enclosed space for readily receiving a bandage such as a sanitary napkin or tampon. One of the parts has a peripheral edge adjacent an opening into the enclosed space, or into a part of the enclosed space. One of the parts is provided with an adhesive body which extends completely about a peripheral edge, and the two parts may be initially separate, assembled, or nested, there being a removable protective covering on the adhesive so as to prevent contact of either the other part of the container or any other object with the adhesive. Upon removal of the protective cover, the used bandage such as a sanitary napkin or tampon may be readily placed into one part of the container, the protective cover of the adhesive then being removed, and the other part moved to close the container and, by engaging the adhesive, being bonded to the first part of the container. The adhesive is pressure sensitive, bonding upon contact, and providing a hermetic seal: the adhesive is sufficiently strong to prevent manual separation of the parts. Among the objects of the present invention are to provide a disposable container for septic, infectious material which will prevent contamination. Another object of the present invention is to provide such a container which may be readily disposed of, together with its contents, by suitable, conventional and inexpensive methods, such as burning. A further object of the present invention is to provide a container for the disposal of such articles which may be readily manufactured and shipped, and which is of low cost. Still another object of the present invention is the provision of a container for the disposal of such articles which may be readily and easily used, without undue manipulation, and which will enable the hermetic and strong sealing of the container after placement of an article therein. Other objects and many of the attendant advantages of the present invention will be readily understood from the accompanying specification, claims and drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded view, with parts in section, of a container and a sanitary napkin in accordance with the present invention. FIG. 1a is an enlarged view of the structure in the circle designated FIG. 1a of FIG. 1. FIG. 2 is an elevational view, with parts in section, of a sealed container and a sanitary napkin therein, in accordance with the present invention. FIG. 3 is a perspective exploded view of another embodiment of a container in accordance with the present invention. FIG. 4 is an elevational view, with parts in section, of a further embodiment of a container and sanitary napkin, in accordance with the present invention. FIG. 5 is a perspective view, with parts removed and in section, of a another embodiment of a container and sanitary napkin in accordance with the present invention. FIG. 6 is a perspective view, with parts removed and in section, of a further embodiment of a container and sanitary napkin in accordance with the present invention. FIG. 7 is a perspective view, with parts removed and in section, of still another embodiment of a container and sanitary napkin in accordance with the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings, wherein like or corresponding reference numerals are used for like or corresponding parts throughout are used, there is shown in FIG. 1 a container generally designated 10 and comprising a first part 12 which is generally in the form of the end portion of a poultry egg, extending to a large diameter circumference of such poultry egg. The part 12 encompasses an unobstructed space 14 extending inwardly from an edge 16 thereof. The second part 18 comprises a generally cylindrical wall 20 and a bottom 22 joined to it, the wall 20 having at its upper end, as shown in FIG. 1a, a shoulder 24 and, interiorly thereof, an upstanding peripherally extending ridge 26. On the shoulder 24 is a body of adhesive 30, the adhesive 30 extending entirely about the part 18, and is continuous and unbroken. The adhesive body 30 is provided with a protective covering 32 of paper, or the like, which may be readily removed from the adhesive body 30, but which protects it from engagement with another object, such as the part 12, until it is removed. The part 18 provides an open space 28 in it, which is unobstructed, and which may readily receive a part of a sanitary napkin or other absorbent body. There is shown in FIG. 1, within the container 10, occupying the spaces 14 and 34, an absorbent body 34, i.e., a bandage which is unused, i.e. aseptic. The absorbent body 34 may have a disposable cover (not shown) and is specifically a new, ready-for-use sanitary napkin. Alternatively, the bandage 34 may be a tampon, or other product of material, shape and size to absorb body fluids. When assembled, the body 34 may be placed in the part 18, and with the covering 32 in place, the part 12 is associated with the part 18, guidance for such association being provided by the upstanding ridge 26. Thus, there will be provided a container 10 with an unused aseptic, and ready-for-use absorbent body 34. The part 12 will not be bonded to the part 18, since the adhesive 30 will not be in engagement with the part 12. The container 10 with the unused and aseptic absorbent body 34 therein may be placed at convenient locations, such as in rest rooms, or medical facilities, and may be carried by a person. The container 10 with the body 34 therein is therefore readily available for use, since there will be no impediment to the disassociation of part 12 from part 18, thereby providing ready access to the sanitary body 34. After the container 10 has been separated and the new sanitary absorbent body 34 has been removed, the parts 12 and 18 are retained for re-use, to receive a used, septic and possibly infectious absorbent body, which may or may not be the absorbent body which was removed from the container 10. When a used absorbent body is to be disposed of, it is placed within one or another of the parts 12 and 18, the protective cover 32 is removed, and the parts 12 and 18 are associated together so that the adhesive 30 is in contact with both of the parts 12 and 18. The adhesive 30 provides a substantially permanent bond between these parts and is of sufficient strength to prevent the manual separation of the parts 12 and 14. The adhesive 30 also provides a hermetic seal between the container parts 12 and 42. Among the adhesives which are suitable is Adhesive 4693 of 3M Company, St. Paul, Minnesota. Container 10, and each of the containers herein disclosed, is made of material which is readily combustible, so that the container and the used and possibly infectious absorbent body within it may be disposed of by burning, in accordance with established procedures and regulations. The material of which the container is made includes combustible plastic, as well as other materials such as those which are paper-based. In FIG. 2, there is shown an egg-shaped container 40 comprising an upper part 12, and a lower part 42 having the shape of a part of a poultry egg. The part 42 will be seen to have a shoulder 24 and a ridge 26, with an adhesive body 30 on the shoulder 24. The lower portion of the part 12 engages the adhesive 30, and the adhesive 30 thereby serves to bond the parts 12 and 42. The space within the container 40 is unobstructed, so that the space readily contains a used absorbent body 44, such as a used sanitary napkin, tampon or bandage which may contain body fluids. Since such body fluids may be infectious, and therefore the body 44 may be infectious, the container 40, including the adhesive 30, seals the used absorbent body 44 therewithin and is not hazardous. In FIG. 3, there is shown another embodiment of a container in accordance with the present invention. The container 50 comprises a first part 52 having a top 54 of square configuration, and depending walls 56, the walls terminating in a peripherally extending edge 58 located at the bottoms thereof, and surrounding an opening into the unobstructed space 60 within the part 52. A similarly shaped second or bottom part 62 has a bottom 64 which is congruent with the top 54, and has walls 66 extending upwardly therefrom and which are in alignment with the walls 56. On the upper edge 68 of the walls 66 is a body of adhesive 30, shown partly covered with a protective strip 32. The total height of the container 50 is substantially equal to the height of a used septic absorbent body, such as a sanitary napkin (not shown). As will be understood, the protective strip 32 will have been removed, to expose the adhesive 30, so that the parts 52 and 62, with their substantially unobstructed spaces, may be joined at their edges to provide a butt joint. There is provided a disposable container 50 with the septic body therein, and which is both hermetically sealed and incapable of being separated by manual force. There is shown in FIG. 4 a further embodiment of the present invention, there being provided a container 70 having a first part 72 having a top 74 in the form of a flat disc, which may be provided with a depending annular flange 76. There is also provided a second part 78 shaped generally like the part 42 of FIG. 2, and having an upper edge 80 on which there is an adhesive body 30 which bonds to the underside of the top 74. Within the body 78 there is a used, septic absorbent body 44, which may be a sanitary napkin. FIG. 5 is a perspective view of a container 80 which is of generally elongate parallelepiped shape and size so as to closely encompass a sanitary napkin 84. Container 80 comprises a tray-like bottom part 82 having a length and width substantially equal to the length and width of the sanitary napkin 84 and having a height provided by the walls 86 which is somewhat less than the thickness of the sanitary napkin 84. The walls 86 include a shoulder 88 and an upstanding ridge 90; a body of adhesive 30 is on the shoulder 88. The top part 92 is of substantially the same length and width as the bottom part 82 and has depending walls 94 which have internal dimensions slightly greater than the ridge 90, so as to be guided thereby. The bottom edges of the walls 94 engage the adhesive 30, so that the container with the used septic sanitary napkin 84 is hermetically sealed, and the container 80 may not be opened by manual force. In FIG. 6, there is a generally elongate parallelepiped container 100, having a first, bottom part 102 of the same shape and size as the bottom part 82, but having a height of the walls 106 thereof substantially equal to the thickness of a used septic sanitary napkin 84. The top edge of the walls 86 is provided with a body of adhesive 30, and the second or top part 108 of the container 100 has a rectangular top 110, the bottom surface of which engages the adhesive 30, and the depending walls 112 of which telescope over a portion of the walls 106 of the first or bottom part 102. FIG. 7 discloses a container 120 in accordance with the present invention comprising a first part 122 and a second part 124, each of which has a width substantially equal to the width of a sanitary napkin 84 and a depth substantially equal to the thickness of the sanitary napkin 84. The total height of the container 120, comprised of the parts 122 and 124, is substantially equal to the length of the sanitary napkin 84; each of the parts 122 and 124 has a height which is less than the length of sanitary napkin 84. The part 124 will be seen to have a shoulder 126 with adhesive 30 thereon, and an upstanding ridge 128. Ridge 128 has an exterior size and shape slightly smaller than the interior size and shape of the part 122, and thereby serves to guide the part 122 into engagement with the adhesive 30 on the shoulder 126. There has been provided a container which may be readily used for the disposal of septic, potentially infectious bodies, such as absorbent bodies that may have body fluids in them. Such absorbent bodies or bandages include sanitary napkins, tampons, and bandages. The container herein provided has a substantially unobstructed space for receiving the septic body and is made of separable parts which are bonded together by an adhesive which provides both a hermetic seal and a bonding of such strength as to prevent manual disassembly. The insertion of a septic body, such as a used sanitary napkin, may be readily accomplished, requiring no complicated manipulation. When put in the container or container part, and after removal of the protective cover from the adhesive, a hermetically sealed container, incapable of being manually opened, results. The sealed container may be disposed of in an ecologically acceptable manner, such as by incineration, due to the fact that the container is made of combustible material. The herein disclosed container may be used to ship and/or store an aseptic, unused sanitary napkin or other absorbent body. Such an aseptic body, which can be properly packaged to maintain its aseptic condition, may be placed in the container with the parts of the container joined, but one part being separated from contact with the adhesive by a protective layer on the adhesive, so that the parts of the container are readily separable. The herein disclosed container is readily usable, both to extract a body from the container and to place a body within a container, and to provide a hermetic sealing of the container with the aseptic within it. The claims and specification describe the invention presented, and the terms that are employed in the claims draw their meaning from the use of such terms in the specification. Some terms employed in the prior art may be broader in meaning than specifically employed herein. Whenever there is a question between the broader definition of such term as used in the prior art and the more specific use of the term herein, the more specific meaning is meant.

A container of combustible material is provided for disposal, in an ecologically satisfactory manner, of septic bodies, such as a used sanitary napkin, tampon or bandage. The container comprises two parts, with at least one part providing an open, obstructed space for the reception of the septic body. One of the parts of the container has an adhesive body which completely encircles it. The adhesive body is initially protected by a removable cover. When the parts are assembled, so that both parts are in contact with the adhesive, the adhesive provides a continuous bonding of the parts of the container to hermetically seal the container. The adhesive is sufficiently strong to prevent manual separation of the parts. The container may be used to ship and store an aseptic body, prior to use, and then be used for the reception, sealing and disposal of the same or a similar body which has become septic.

[0001] This application claims priority from the provisional application U.S. serial No. 60/207,017, filed on May 25, 2000, the benefit of which is hereby claimed under 37 C.F.R. §1.78(a)(3). BACKGROUND OF THE INVENTION [0002] This invention is directed to combinations comprising a growth hormone secretagogue, a prodrug thereof or a pharmaceutically acceptable salt of said growth hormone secretagogue or said prodrug and an antidepressant, a prodrug thereof or a pharmaceutically acceptable salt of said antidepressant or said prodrug and to pharmaceutical compositions and kits comprising such combinations. This inventions is particularly directed to combinations wherein the antidepressant is a selective serotonin reuptake inhibitor. This invention is also directed to methods of improving the physical and/or psychological condition of a patient undergoing a medical procedure, to methods of treating musculoskeletal frailty, to methods of treating congestive heart failure and to methods of attenuating protein catabolic response after a major operation comprising administering such a combination. In particular, this invention relates to such compositions and kits that improve the cardiac function, metabolism, muscle tone and/or mental state of patients undergoing a medical procedure. The compositions and kits of this invention are also useful in treating central nervous system disorders of patients undergoing a medical procedure. [0003] Growth hormone (GH), which is secreted from the pituitary gland, stimulates growth of all tissues of the body that are capable of growing. In addition, GH is known to have the following basic effects on the metabolic process of the body: [0004] 1. Increased rate of protein synthesis in substantially all cells of the body; [0005] 2. Decreased rate of carbohydrate utilization in cells of the body; and [0006] 3. Increased mobilization of free fatty acids and use of fatty acids for energy. [0007] Deficiency in GH results in a variety of medical disorders. In children, it causes dwarfism. In adults, the consequences of acquired GH deficiency include profound reduction in lean body mass and concomitant increase in total body fat, particularly in the truncal region. Decreased skeletal and cardiac muscle mass and muscle strength lead to a significant reduction in exercise capacity. Bone density is also reduced. Administration of exogenous GH has been shown to reverse many of these metabolic changes. Additional benefits of GH therapy have included reduction in LDL cholesterol and improved psychological well-being. [0008] In cases where increased levels of GH were desired, the problem was generally solved by providing exogenous GH or by administering an agent which stimulated GH production and/or release. In either case the peptidyl nature of the compound necessitated that it be administered by injection. Initially the source of GH was the extraction of the pituitary glands of cadavers. This resulted in an expensive product, and carried with it the risk that a disease associated with the source of the pituitary gland could be transmitted to the recipient of the GH (e.g., Jacob-Creutzfeld disease). Recently, recombinant GH has become available which, while no longer carrying any risk of disease transmission, is still a very expensive product which must be given by injection or by a nasal spray. [0009] Most GH deficiencies are caused by defects in GH release, not primary defects in pituitary synthesis of GH. Therefore, an alternative strategy for normalizing serum GH levels is by stimulating its release from somatotrophs. Increasing GH secretion can be achieved by stimulating or inhibiting various neurotransmitter systems in the brain and hypothalamus. As a result, the development of synthetic GH-releasing agents to stimulate pituitary GH secretion are being pursued, and may have several advantages over expensive and inconvenient GH replacement therapy. By acting along physiologic regulatory pathways, the most desirable agents would stimulate pulsatile GH secretion, and excessive levels of GH that have been associated with the undesirable side effects of exogenous GH administration would be avoided by virtue of intact negative feedback loops. [0010] Physiologic and pharmacologic stimulators of GH secretion include arginine, L-3,4-dihydroxyphenylalanine (L-DOPA), glucagon, vasopressin, and insulin induced hypoglycemia, as well as activities such as sleep and exercise, and any activity which indirectly causes GH to be released from the pituitary by acting on the hypothalamus perhaps either to decrease somatostatin secretion or to increase the secretion of the known secretagogue GH releasing factor (GHRF) or an unknown endogenous GH-releasing hormone or all of these. [0011] Tang et al., Restoring and Maintaining Bone in Osteogenic Female Rat Skeleton: I. Changes in Bone Mass and Structure, J. Bone Mineral Research 7 (9), p1093-1104, 1992 discloses data for the lose, restore and maintain (LRM) concept, a practical approach for reversing existing osteoporosis. The LRM concept uses anabolic agents to restore bone mass and architecture (+ phase) and then switches to an agent with the established ability to maintain bone mass, to keep the new bone (+/− phase). The rat study described therein utilized PGE 2 and risedronate, a bisphosphonate, to show that most of the new cancellous and cortical bone induced by PGE 2 can be maintained for at least 60 days after discontinuing PGE 2 by administering risedronate. [0012] Antidepressants are agents used to treat affective or mood disorders and related conditions. Affective mood disorders are characterized by changes in mood as the primary clinical manifestation. Either extreme of mood may be associated with psychosis, manifested as disordered or delusional thinking and perceptions which are often incongruent with the predominant mood. Affective disorders include major depression and mania, including bipolar manic-depressive illness. Preferred classes of antidepressants include norepinephrine reuptake inhibitors (NERIs), including secondary and tertiary amine tricyclics; selective sertraline reuptake inhibitors; combined NERI/SSRIs; monoamine oxidase (MAO) inhibitors; and atypical antidepressants. NERIs potentiate the actions of biogenic amines by blocking their major means of physiological inactivation, which involves transport or reuptake into nerve terminals, and specifically, agents which block the reuptake of norepinephrine into said nerve terminals. The term selective serotonin reuptake inhibitor refers to a compound which inhibits the reuptake of serotonin by afferent neurons. Combined NERI/SSRIs block the reuptake of both serotonin and norepinephrine by afferent neurons. Monoamine oxidase inhibitors are compounds which inhibit monoamine oxidase, for example by blocking the metabolic deamination of a variety of monoamines by mitochondrial monoamine oxidase. SUMMARY OF THE INVENTION [0013] This invention is directed to combinations comprising a growth hormone secretagogue (GHS), a prodrug thereof or a pharmaceutically acceptable salt of said GHS or said prodrug and an antidepressant, a prodrug thereof or a pharmaceutically acceptable salt of said antidepressant or said prodrug. This invention is also directed to pharmaceutical compositions, methods and kits comprising said combination, as described below. Preferred classes of antidepressants for use in the combinations, pharmaceutical compositions, kits and methods of this invention are norepinephrine reuptake inhibitors (NERIs), selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAO inhibitors), combined NERI/SSRIs, and atypical antidepressants, prodrugs of said antidepressants and pharmaceutically acceptable salts of said antidepressants and said prodrugs. [0014] This invention is particularly directed to pharmaceutical compositions comprising a GHS, a prodrug thereof or a pharmaceutically acceptable salt of said GHS or said prodrug; a SSRI, a prodrug thereof or a pharmaceutically acceptable salt of said SSRI or said prodrug; and a pharmaceutically acceptable carrier, vehicle or diluent. [0015] NERIs are especially preferred. NERIs may be either secondary amine tricyclic compounds or tertiary amine tricyclic compounds. Particularly preferred secondary amine tricyclic NERI compounds include, but are not limited to, amoxapine, desipramine, maprotiline, nortriptyline and protriptyline, prodrugs of said secondary amine tricyclic NERIs and pharmaceutically acceptable salts of said secondary amine tricyclic NERIs and said prodrugs. Particularly preferred tertiary amine tricyclic NERI compounds include, but are not limited to, amitryptiline, clomipramine, doxepin, imipramine and trimipramine, prodrugs of said tertiary amine tricyclic NERIs and pharmaceutically acceptable salts of said tertiary amine tricyclic NERIs and said prodrugs. [0016] SSRIs are also especially preferred. Particularly preferred SSRIs include, but are not limited to, citalopram, femoxetine, fluoxetine, fluvoxamine, indalpine, indeloxazine, milnacipran, paroxetine, sertraline, sibutramine and zimeldine, prodrugs of said SSRIs and pharmaceutically acceptable salts of said SSRIs and said prodrugs. Sertraline and fluoxetine, and pharmaceutically acceptable salts thereof, are more particularly preferred. Sertraline hydrochloride is most preferred. [0017] Combined NERI/SSRIs are also especially preferred. A particularly preferred combined NERI/SSRI is venlafaxine, prodrugs thereof and pharmaceutically acceptable salts of venlafaxine and of said prodrugs. Other combined NERI/SSRIs are also within the scope of the combinations, pharmaceutical compositions, kits and methods of this invention. [0018] Monoamine oxidase (MAO) inhibitors are also especially preferred. Particularly preferred MAO inhibitors include, but are not limited to, phenelzine, tranylcypromine and selegiline, prodrugs thereof and pharmaceutically acceptable salts of said MAO inhibitors and of said prodrugs. [0019] Atypical antidepressants are also especially preferred. Particularly preferred atypical antidepressants include, but are not limited to, bupropion, nefazodone and trazodone, prodrugs thereof and pharmaceutically acceptable salts of said atypical antidepressants and of said prodrugs. [0020] In the combinations, pharmaceutical compositions, methods and kits of this invention, it is preferred that said GHS is a compound of the formula I: [0021] or a stereoisomeric mixture thereof, diastereomerically enriched, diastereomerically pure, enantiomerically enriched or enantiomerically pure isomer thereof, [0022] wherein: [0023] HET is a heterocyclic moiety selected from the group consisting of [0024] d is 0, 1 or 2; [0025] e is 1 or 2; [0026] f is 0 or 1; [0027] n and w are 0, 1 or 2, provided that n and w cannot both be 0 at the same time; [0028] Y 2 is oxygen or sulfur; [0029] A is a divalent radical, where the left hand side of the radical as shown below is connected to C″ and the right hand side of the radical as shown below is connected to C′, selected from the group consisting of [0030] —NR 2 —C(O)—NR 2 —, —NR 2 —S(O) 2 —NR 2 —, —O—C(O)—NR 2 —, —NR 2 —C(O)—O—, —C(O)—NR 2 —C(O)—, —C(O)—NR 2 —C(R 9 R 10 )—, —C(R 9 R 10 )—NR 2 —C(O)—, —C(R 9 R 10 )—C(R 9 R 10 )—C(R 9 R 10 )—, —S(O) 2 —C(R 9 R 10 )—C(R 9 R 10 )—, —C(R 9 R 10 )—O—C(O)—, —C(R 9 R 10 )—O—C(R 9 R 10 )—, —NR 2 —C(O)—C(R 9 R 10 )—, —O—C(O)—C(R 9 R 10 )—, —C(R 9 R 10 )—C(O)—NR 2 —, —C(O)—NR 2 —C(O)—, —C(R 9 R 10 )—C(O)—O—, —C(O)—NR 2 —C(R 9 R 10 )—C(R 9 R 10 )—, —C(O)—O—C(R 9 R 10 )—, —C(R 9 R 10 )—C(R 9 R 10 )—C(R 9 R 10 )—C(R 9 R 10 )—, —S(O) 2 —NR 2 —C(R 9 R 1 )—C(R 9 R 10 )—, —C(R 9 R 10 )—C(R 9 R 10 )—NR 2 —C(O)—, —C(R 9 R 10 )—C(R 9 R 10 )—O—C(O)—, —NR 2 —C(O)—C(R 9 R 10 )—C(R 9 R 10 )—, —NR 2 —S(O) 2 —C(R 9 R 10 )—C(R 9 R 10 )—, —O—C(O)—C(R 9 R 10 )—C(R 9 R 10 )—, —C(R 9 R 1 0 )—C(R 9 R 10 )—C(O)—NR 2 , —C(R 9 R 10 )—C(R 9 R 10 )—C(O)—, —C(R 9 R 10 )—NR 2 —C(O)—, —C(R 9 R 10 )—O—C(O)—NR 2 —, —C(R 9 R 10 )—NR 2 —C(O)—NR 2 —, —NR 2 —C(O)—O—C(R 9 R 10 )—, —NR2—C(O)—NR 2 —C(R 9 R 10 )—, —NR 2 —S(O) 2 —NR 2 —C(R 9 R 10 )—, —O—C(O)—NR 2 —C(R 9 R 10 )—, —C(O)—N═C(R 1 )—NR 2 —, —C(O)—NR 2 —C(R 1 1 )═N—, —C(R 9 R 10 )—NR 2 —C(R 9 R 10 )—, —NR 2 C(R 9 R 10 )—, —NR 2 —C(R 9 R 10 )—C(R 9 R 10 )—, —C(O)—O—C(R 9 R 10 )—C(R 9 R 10 )—, —NR 2 —C(R 1 1 )=N—C(O)—, —C(R 9 R 10 )—C(R 9 R 10 )—N(R 12 ) —C(R 9 R 10 )—NR 12 —, —N═C(R 1 1 )—NR 2 —C(O)—, —C(R 9 R 1 )—C(R 9 R 10 )—NR 2 —S(O) 2 —, —C(R 9 R 10 )—C(R 9 R 10 )—S(O) 2 —NR 2 —, —C(R 9 R 10 )—C(R 9 R 10 )—C(O)—O—, —C(R 9 R 10 )—S(O) 2 —C(R 9 R )—, —C(R 9 R 10 )—C(R 9 R 10 )—S(O) 2 —, —O—C(R 9 R 10 )—C(R 9 R 10 )—, —C(R 9 R 10 )—C(R 9 R 10 )—O—, —C(R 9 R 10 )—C(O)—C(R 9 R 10 )—, —C(O)—C(R 9 R)—C(R 9 R 10 )— and —C(R 9 R 10 )—NR 2 S(O) 2 —NR 2 ; [0031] Q is a covalent bond or CH 2 ; [0032] W is CH or N; [0033] X is CR 9 R 10 , C═CH 2 or C═O; [0034] Y is CR 9 R 10 , 0 or NR 2 ; [0035] Z is C═O, C═S or S(O) 2 ; [0036] G 1 is hydrogen, halo, hydroxy, nitro, amino, cyano, phenyl, carboxyl, —CONH 2 , —(C 1 -C 4 )alkyl optionally independently substituted with one or more phenyl, one or more halogens or one or more hydroxy groups, —(C 1 -C 4 )alkoxy optionally independently substituted with one or more phenyl, one or more halogens or one or more hydroxy groups, —(C 1 -C 4 )alkylthio, phenoxy, —COO(C 1 -C 4 )alkyl, N, N-di—(C 1 -C 4 )alkylamino, —(C 2 -C 6 )alkenyl optionally independently substituted with one or more phenyl, one or more halogens or one or more hydroxy groups, —(C 2 -C 6 )alkynyl optionally independently substituted with one or more phenyl, one or more halogens or one or more hydroxy groups, —(C 3 -C 6 )cycloalkyl optionally independently substituted with one or more (C 1 -C 4 )alkyl groups, one or more halogens or one or more hydroxy groups, —(C 1 -C 4 )alkylamino carbonyl or di—(C 1 -C 4 )alkylamino carbonyl; [0037] G 2 and G 3 are each independently selected from the group consisting of hydrogen, halo, hydroxy, —(C 1 -C 4 )alkyl optionally independently substituted with one to three halo groups and —(C 1 -C 4 )alkoxy optionally independently substituted with one to three halo groups; [0038] R 1 is hydrogen, —CN, —(CH 2 ) q N(X 6 )C(O)X 6 , —(CH 2 ) q N(X 6 )C(O)(CH 2 ) t -A 1 , —(CH 2 ) q N(X 6 )S(O) 2 (CH 2 ) t A 1 , (CH 2 ) q N (X 6 )S(O) 2 X 6 , (CH 2 ) q N(X 6 )C(O)N(X 6 )(CH 2 ) t A 1 , —(CH 2 ) q N(X 6 )C(O)N(X 6 )(X 6 ), (CH 2 ) q C(O)N(X 6 )(X 6 ), (CH 2 ) q C(O)N(X 6 )(CH 2 ) t A 1 , —(CH 2 ) q C(O)OX 6 , (CH 2 ) q C(O)O(CH 2 ) t -A 1 X, (CH 2 ) q OX 6 , (CH 2 ) q OC(O)X 6 , —(CH 2 ) q OC(O)(CH 2 -A 1 , —(CH 2 ) q OC(O)N(X 6 )(CH 2 ) t Al, —(CH 2 ) q OC(O)N(X 6 )(X 6 ), —(CH 2 ) q C(O)X 6 , (CH 2 ) q C(O)(CH 2 ) t A 1 X, (CH 2 ) q N(X 6 )C(O)OX 6 , —(CH 2 ) q N(X 6 )S(O) 2 N(X 6 )(X 6 ), (CH 2 ) q S(O) m X 6 , (CH 2 ) q S(O)m(CH 2 ) t A 1 , —(C 1 -C 10 )alkyl, —(CH 2 ) t -A 1 , —(CH 2 ) q —(C 3 -C 7 )cycloalkyl, (CH 2 ) q -Y 1 —(C 1 -C 6 )alkyl, —(CH 2 ) q —Y 1 —(CH 2 ) t -A 1 or —(CH 2 ) q —Y 1 —(CH 2 ) t —(C 3 -C 7 )cycloalkyl; [0039] where the alkyl and cycloalkyl groups in the definition of R 1 are optionally substituted with (C 1 -C 4 )alkyl, hydroxy, (C 1 -C 4 )alkoxy, carboxyl, —CONH 2 , —S(O) m (C 1 -C 6 )alkyl, —CO 2 (C 1 -C 4 )alkyl ester, 1 H-tetrazol-5-yl or 1, 2 or 3 fluoro groups; [0040] Y 1 is O, S(O) m , —C(O)NX 6 —, —CH═CH—, —C≡C—, —N(X 6 )C(O)—, —C(O)NX 6 —, —C(O)O—, —OC(O)N(X 6 )— or —OC(O)—; [0041] q is 0, 1, 2, 3 or 4; [0042] t is 0, 1, 2 or 3; [0043] said (CH 2 ) q group and (CH 2 ) t group in the definition of R 1 are optionally independently substituted with hydroxy, (C 1 -C 4 )alkoxy, carboxyl, —CONH 2 , —S(O) m (C 1 -C 6 )alkyl, —CO 2 (C 1 -C 4 )alkyl ester, 1H-tetrazol-5-yl, 1, 2 or 3 fluoro groups or 1 or 2 (C 1 -C 4 )alkyl groups; [0044] R 1A is selected from the group consisting of hydrogen, F, Cl, Br, I, (C 1 -C 6 )alkyl, phenyl(C 1 -C 3 )alkyl, pyridyl(C 1 -C 3 )alkyl, thiazolyl(C 1 -C 3 )alkyl and thienyl(C 1 -C 3 )alkyl, provided that R 1A is not F, Cl, Br or I when a heteroatom is vicinal to C″; [0045] R 2 is hydrogen, (C 1 -C 8 )alkyl, —(C 0 -C 3 )alkyl—(C 3 -C 8 )cycloalkyl, —(C 1 -C 4 )alkyl-A 1 or A −1 ; [0046] where the alkyl groups and the cycloalkyl groups in the definition of R 2 are optionally substituted with hydroxy, —C(O)OX 6 , —C(O)N(X 6 )(X 6 ), —N(X 6 )(X 6 ), —S(O) m (C 1 -C 6 )alkyl, —C(O)A 1 , —C(O)(X 6 ), CF 3 , CN or 1, 2 or 3 independently selected halo groups; [0047] R 3 is selected from the group consisting of A 1 , (C 1 -C 10 )alkyl, —(C 1 -C 6 )alkyl-A 1 , —(C 1 -C 6 )alkyl-(C 3 -C 7 )cycloalkyl, —(C 1 -C 5 )alkyl-X 1 -(C 1 -C 5 )alkyl, —(C 1 -C 5 )alkyl-X 1 -(C 0 -C 5 )alkyl-A 1 and —(C 1 -C 5 )alkyl-X 1 —(C 1 -C 5 )alkyl-(C 3 -C 7 )cycloalkyl; [0048] where the alkyl groups in the definition of R 3 are optionally substituted with —S(O) m (C 1 -C 6 )alkyl, —C(O)OX 3 , 1, 2, 3, 4 or 5 independently selected halo groups or 1, 2 or 3 independently selected —OX 3 groups; [0049] X 1 is O, S(O) m , —N(X 2 )C(O)—, —C(O)N(X 2 )—, —OC(O)—, —C(O)O—, —CX 2 ═CX 2 —, —N(X 2 )C(O)O—, —OC(O)N(X 2 )— or —C≡C—; [0050] R 4 is hydrogen, (C 1 -C 6 )alkyl or (C 3 -C 7 )cycloalkyl, or R 4 is taken together with R 3 and the carbon atom to which they are attached and form (C 5 -C 7 )cycloalkyl, (C 5 -C 7 )cycloalkenyl, a partially saturated or fully saturated 4- to 8-membered ring having 1 to 4 heteroatoms independently selected from the group consisting of oxygen, sulfur and nitrogen, or is a bicyclic ring system consisting of a partially saturated or fully saturated 5- or 6-membered ring, fused to a partially saturated, fully unsaturated or fully saturated 5- or 6-membered ring, optionally having 1 to 4 heteroatoms independently selected from the group consisting of nitrogen, sulfur and oxygen; [0051] X 4 is hydrogen or (C 1 -C 6 )alkyl or X 4 is taken together with R 4 and the nitrogen atom to which X 4 is attached and the carbon atom to which R 4 is attached and form a five to seven membered ring; [0052] R 6 is a bond or is [0053] X 5 and X 5a are each independently selected from the group consisting of hydrogen, CF 3 , A 1 and optionally substituted (C 1 -C 6 )alkyl; [0054] the optionally substituted (C 1 -C 6 )alkyl in the definition of X 5 and X 5a is optionally substituted with a substituent selected from the group consisting of A 1 , OX 2 , —S(O) m (C 1 -C 6 )alkyl, —C(O)OX 2 , (C 3 -C 7 )cycloalkyl, —N(X 2 )(X 2 ) and —C(O)N(X 2 )(X 2 ); [0055] or the carbon bearing X 5 or X 5a forms one or two alkylene bridges with the nitrogen atom bearing R 7 and R 8 wherein each alkylene bridge contains 1 to 5 carbon atoms, provided that when one alkylene bridge is formed then only one of X 5 or X 5a is on the carbon atom and only one of R 7 or R 8 is on the nitrogen atom and further provided that when two alkylene bridges are formed then X 5 and X 5a cannot be on the carbon atom and R 7 and R 8 cannot be on the nitrogen atom; [0056] or X 5 is taken together with X 5a and the carbon atom to which they are attached and form a partially saturated or fully saturated 3- to 7-membered ring, or a partially saturated or fully saturated 4- to 8-membered ring having 1 to 4 heteroatoms independently selected from the group consisting of oxygen, sulfur and nitrogen; [0057] or X 5 is taken together with X 5a and the carbon atom to which they are attached and form a bicyclic ring system consisting of a partially saturated or fully saturated 5- or 6-membered ring, optionally having 1 or 2 heteroatoms independently selected from the group consisting of nitrogen, sulfur and oxygen, fused to a partially saturated, fully saturated or fully unsaturated 5- or 6-membered ring, optionally having 1 to 4 heteroatoms independently selected from the group consisting of nitrogen, sulfur and oxygen; [0058] Z 1 is a bond, O or N—X 2, provided that when a and b are both 0 then Z 1 is not N—X 2 or O; or [0059] R 6 is —(CR a R b ) a -E-(CR a R b )b, where the —(CR a R b ) a — group is attached to the carbonyl carbon of the amide group of the compound of formula I and the —(CR a R b ) b group is attached to the terminal nitrogen atom of the compound of formula I; [0060] E is —O—, —S—, —CH═CH— or an aromatic moiety selected from [0061]  said aromatic moiety in the definition of E optionally substituted with up to three halo, hydroxy, —N(R c )(R c ), (C 1 -C 6 )alkyl or (C 1 -C 6 )alkoxy; [0062] R a and R b are, for each occurrence, independently hydrogen, (C 1 -C 6 )alkyl, trifluoromethyl, phenyl or monosubstituted (C 1 -C 6 )alkyl where the substituents are imidazolyl, naphthyl, phenyl, indolyl, p-hydroxyphenyl, —OR c , S(O) m R c , C(O)OR c , (C 3 -C 7 )cycloalkyl, —N(R c )(R c ), —C(O)N(R c )(R c ), or R a or R b may independently be joined to one or both of R 7 or E (where E is other than O, S or —CH═CH—) to form an alkylene bridge between the terminal nitrogen and the alkyl portion of the R a or R b and the R 7 or E group, wherein the bridge contains 1 to 8 carbon atoms; or R a and R b may be joined to one another to form a (C 3 -C 7 )cycloalkyl; [0063] R c , for each occurrence, is independently hydrogen or (C 1 -C 6 )alkyl; [0064] a and b are independently 0, 1, 2 or 3, with the proviso that if E is —O— or —S—, b is other than 0 or 1 and with the further proviso that if E is —CH═CH—, b is other than 0; [0065] R 7 and R 8 are each independently hydrogen or optionally substituted (C 1 -C 6 )alkyl; [0066] where the optionally substituted (C 1 -C 6 )alkyl in the definition of R 7 and R 8 is optionally independently substituted with A 1 , —C(O)O—(C 1 -C 6 )alkyl, —S(O) m (C 1 -C 6 )alkyl, 1 to 5 halo groups, 1 to 3 hydroxy groups, 1 to 3 —O—C(O)(C 1 -C 10 )alkyl groups or 1 to 3 (C 1 -C 6 )alkoxy groups; or [0067] R 7 and R 8 can be taken together to form —(CH 2 ) r -L-(CH 2 ) r —; [0068] where L is C(X 2 )(X 2 ), S(O) m or N(X 2 ); [0069] R 9 and R 10 are each independently selected from the group consisting of hydrogen, fluoro, hydroxy and (C 1 -C 5 )alkyl optionally independently substituted with 1-5 halo groups; [0070] R 11 is selected from the group consisting of (C 1 -C 5 )alkyl and phenyl optionally substituted with 1-3 substitutents each independently selected from the group consisting of (C 1 -C 5 )alkyl, halo and (C 1 -C 5 )alkoxy; [0071] R 12 is selected from the group consisting of (C 1 -C 5 )alkylsulfonyl, (C 1 -C 5 )alkanoyl and (C 1 -C 5 )alkyl where the alkyl portion is optionally independently substituted by 1-5 halo groups; [0072] A 1 for each occurrence is independently selected from the group consisting of (C 5 -C 7 )cycloalkenyl, phenyl, a partially saturated, fully saturated or fully unsaturated 4- to 8-membered ring optionally having 1 to 4 heteroatoms independently selected from the group consisting of oxygen, sulfur and nitrogen and a bicyclic ring system consisting of a partially saturated, fully unsaturated or fully saturated 5- or 6-membered ring, optionally having 1 to 4 heteroatoms independently selected from the group consisting of nitrogen, sulfur and oxygen, fused to a partially saturated, fully saturated or fully unsaturated 5- or 6-membered ring, optionally having 1 to 4 heteroatoms independently selected from the group consisting of nitrogen, sulfur and oxygen; [0073] A 1 for each occurrence is independently optionally substituted, on one or optionally both rings if A 1 is a bicyclic ring system, with up to three substituents, each substituent independently selected from the group consisting of F, Cl, Br, I, OCF 3 , OCF 2 H, CF 3 , CH 3 , OCH 3 , —OX 6 , —C(O)N(X 6 )(X 6 ), —C(O)OX 6 , oxo, (C 1 -C 6 )alkyl, nitro, cyano, benzyl, —S(O) m (C 1 -C 6 )alkyl, 1H-tetrazol-5-yl, phenyl, phenoxy, phenylalkyloxy, halophenyl, methylenedioxy, —N(X 6 )(X 6 ), —N(X 6 )C(O)(X 6 ), —S(O) 2 N (X 6 )(X 6 ), —N(X 6 )S(O) 2 -phenyl, —N(X 6 )S(O) 2 X 6 , —CONX 11 X 12 , —S(O) 2 NX 11 X 12 , —NX 6 S(O) 2 X 12 , —NX 6 CONX 11 X 12 , —NX 6 S(O) 2 NX 11 X 12 , —NX 6 C(O)X 12 , imidazolyl, thiazolyl and tetrazolyl, provided that if A 1 is optionally substituted with methylenedioxy then it can only be substituted with one methylenedioxy; [0074] where X 11 is hydrogen or optionally substituted (C 1 -C 6 )alkyl; [0075] the optionally substituted (C 1 -C 6 )alkyl defined for X 11 is optionally independently substituted with phenyl, phenoxy, (C 1 -C 6 )alkoxycarbonyl, —S(O) m (C 1 -C 6 )alkyl, 1 to 5 halo groups, 1 to 3 hydroxy groups, 1 to 3 (C 1 -C 1 0 )alkanoyloxy groups or 1 to 3 (C 1 -C 6 )alkoxy groups; [0076] X 12 is hydrogen, (C 1 -C 6 )alkyl, phenyl, thiazolyl, imidazolyl, furyl or thienyl, provided that when X 12 is not hydrogen, the X 12 group is optionally substituted with one to three substituents independently selected from the group consisting of Cl, F, CH 3 , OCH 3 , OCF 3 and CF 3 ; [0077] or X 11 and X 12 are taken together to form —(CH 2 ) r -L 1 -(CH 2 ) r —; [0078] L 1 is C(X 2 )(X 2 ), O, S(O) m or N(X 2 ); [0079] r for each occurrence is independently 1, 2 or 3; [0080] X 2 for each occurrence is independently hydrogen, optionally substituted (C 1 -C 6 )alkyl or optionally substituted (C 3 -C 7 )cycloalkyl, where the optionally substituted (C 1 -C 6 )alkyl and optionally substituted (C 3 -C 7 )cycloalkyl in the definition of X 2 are optionally independently substituted with —S(O) m (C 1 -C 6 )alkyl, —C(O)OX 3 , 1 to 5 halo groups or 1-3 OX 3 groups; [0081] X 3 for each occurrence is independently hydrogen or (C 1 -C 6 )alkyl; [0082] X 6 for each occurrence is independently hydrogen, optionally substituted (C 1 -C 6 )alkyl, (C 2 -C 6 )halogenated alkyl, optionally substituted (C 3 -C 7 )cycloalkyl, (C 3 -C 7 )halogenated cycloalkyl, where optionally substituted (C 1 -C 6 )alkyl and optionally substituted (C 3 -C 7 )cycloalkyl in the definition of X 6 is optionally independently mono- or di-substituted with (C 1 -C 4 )alkyl, hydroxy, (C 1 -C 4 )alkoxy, carboxyl, CONH 2 , —S(O) m (C 1 -C 6 )alkyl, carboxylate (C 1 -C 4 )alkyl ester or 1 H-tetrazol-5-yl; or when there are two X 6 groups on one atom and both X 6 are independently (C 1 -C 6 )alkyl, the two (C 1 -C 6 )alkyl groups may be optionally joined and, together with the atom to which the two X 6 groups are attached, form a 4- to 9-membered ring optionally having oxygen, sulfur or NX 7 as a ring member; [0083] X 7 is hydrogen or (C 1 -C 6 )alkyl optionally substituted with hydroxy; [0084] m for each occurrence is independently 0, 1 or 2; [0085] with the proviso that: [0086] X 6 and X 12 cannot be hydrogen when attached to C(O) or S(O) 2 in the form C(O)X 6 , C(O)X 12 , S(O) 2 X 6 or S(O) 2 X 12 ; and [0087] when R 6 is a bond then L is N(X 2 ) and each r in the definition —(CH 2 ) r -L-(CH 2 ) r — is independently 2 or 3; [0088] a prodrug thereof or a pharmaceutically acceptable salt of said compound or of said prodrug. [0089] In the combinations, pharmaceutical compositions, methods and kits of this invention, it is especially preferred that said GHS is a compound of the formula [0090] or a stereoisomeric mixture thereof, diastereomerically enriched, diastereomerically pure, enantiomerically enriched or enantiomerically pure isomer thereof, [0091] wherein: [0092] wherein [0093] f is 0; [0094] n is 0 and w is 2, or n is 1 and w is 1, or n is 2 and w is 0; [0095] Y is oxygen or sulfur; [0096] R 1 is hydrogen, —CN, —(CH 2 ) q N(X 6 )C(O)X 6 , (CH 2 ) q N(X 6 )C(O)(CH 2 ) t -A 1 , —(CH 2 ) q N(X 6 )SO 2 (CH 2 ) t -A 1 , (CH 2 ) q N(X 6 )S0 2 X 6 , —(CH 2 ) q N(X 6 )C(O)N(X 6 )(CH 2 ) t -A 1 , —(CH 2 ) q N(X 6 )C(O)N(X 6 )(X 6 ), (CH 2 ) q C(O)N(X 6 )(X 6 ), (CH 2 ) q C(O)N(X 6 )(CH 2 ) t -A 1 , (CH 2 ) q C(O)OX 6 —(CH 2 ) q C(O)O(CH 2 ) t -A 1 , (CH 2 ) q OX 6 , —(CH 2 ) q OC(O)X 6 , —(CH 2 ) q OC(O)(CH 2 ) t -A 1 , —(CH 2 ) q OC(O)N(X 6 )(CH 2 ) t -A 1 , —(CH 2 ) q OC(O)N(X 6 )(X 6 ), (CH 2 ) q C(O)X 6 , (CH 2 ) q C(O)(CH 2 ) t -A 1 , (CH 2 ) q N(X 6 )C(O)OX 6 , —(CH 2 ) q N(X 6 )SO 2 N(X 6 )(X 6 ), (CH 2 ) q S(O) m X 6 —(CH 2 ) q S(O) m (CH 2 ) t -A 1 , —(C 1 -C 10 )alkyl, —(CH 2 ) t -A, —(CH 2 ) q —(C 3 -C 7 )cycloalkyl, —(CH 2 ) q —Y—(C 1 -C 6 )alkyl, (CH 2 ) q -Y 1 l—(CH 2 ) t -A 1 or —(CH 2 ) q —Y 1 —(CH 2 ) t —(C 3 -C 7 )cycloalkyl; [0097] where the alkyl and cycloalkyl groups in the definition of R 1 are optionally substituted with (C 1 -C 4 )alkyl, hydroxyl, (C 1 -C 4 )alkoxy, carboxyl, —CONH 2 , —S(O) m (C 1 -C 6 )alkyl, —CO 2 (C 1 -C 4 )alkyl ester, 1H-tetrazol-5-yl or 1, 2 or 3 fluoro; [0098] Y 1 is O, S(O) m , —C(O)NX 6 —, —CH═CH—, —C≡C—, —N(X 6 )C(O)—, —C(O)NX 6 —, —C(O)O—, —OC(O)N(X 6 )— or —OC(O)—; [0099] q is 0, 1, 2, 3 or 4; [0100] t is 0, 1, 2 or 3; [0101] said (CH 2 ) q group and (CH 2 ) t group may each be optionally substituted with hydroxyl, (C 1 -C 4 )alkoxy, carboxyl, —CONH 2 , —S(O) m (C 1 -C 6 )alkyl, —CO 2 (C 1 -C 4 )alkyl ester, 1H-tetrazol-5-yl, 1, 2 or 3 fluoro, or 1 or 2 (C 1 -C 4 )alkyl; [0102] R 2 is hydrogen, (C 1 -C 8 )alkyl, —(C 0 -C 3 )alkyl-(C 3 -C 8 )cycloalkyl, —(C 1 -C 4 )alkyl-A 1 or A 1 ; [0103] where the alkyl groups and the cycloalkyl groups in the definition of R 2 are optionally substituted with hydroxyl, —C(O)OX 6 , —C(O)N(X 6 )(X 6 ), —N(X 6 )(X 6 ), —S(O) m (C 1 -C 6 )alkyl, —C(O)A, —C(O)(X 6 ), CF 3 , CN or 1, 2 or 3 halogen; [0104] R 3 is A 1 , (C 1 -C 10 )alkyl, —(C 1 -C 6 )alkyl-A, —(C 1 -C 6 )alkyl-(C 3 -C 7 )cycloalkyl, —(C 1 -C 5 )alkyl-X—(C 1 -C 5 )alkyl, —(C 1 -C 5 )alkyl-X—(C 0 -C 5 )alkyl-A 1 or —(C 1 -C 5 )alkyl-X—(C 1 -C 5 )alkyl-(C 3 -C 7 )cycloalkyl; [0105] where the alkyl groups in the definition of R 3 are optionally substituted with, —S(O) m (C 1 -C 6 )alkyl, —C(O)OX 3 , 1, 2, 3, 4 or 5 halogens, or 1, 2 or 3 OX 3 ; [0106] X 1 is O, S(O) m , —N(X 2 )C(O)—, —C(O)N(X 2 )—, —OC(O)—, —C(O)O—, —CX 2 ═CX 2 —, —N(X 2 )C(O)O—, —OC(O)N(X 2 )— or —C≡C—; [0107] R 4 is hydrogen, (C 1 -C 6 )alkyl or (C 3 -C 7 )cycloalkyl; [0108] X 4 is hydrogen or (C 1 -C 6 )alkyl or X 4 is taken together with R 4 and the nitrogen atom to which X 4 is attached and the carbon atom to which R 4 is attached and form a five to seven membered ring; [0109] R 6 is a bond or is [0110] where a and b are independently 0, 1, 2 or 3; [0111] X 5 and X 5a are each independently selected from the group consisting of hydrogen, trifluoromethyl, A 1 and optionally substituted (C 1 -C 6 )alkyl; [0112] the optionally substituted (C 1 -C 6 )alkyl in the definition of X 5 and X 5a is optionally substituted with a substituent selected from the group consisting of A 1 , OX 2 , —S(O) m (C 1 -C 6 )alkyl, —C(O)OX 2 , (C 3 -C 7 )cycloalkyl, —N(X 2 )(X 2 ) and —C(O)N(X 2 )(X 2 ); [0113] R 7 and R 8 are independently hydrogen or optionally substituted (C 1 -C 6 )alkyl; [0114] where the optionally substituted (C 1 -C 6 )alkyl in the definition of R 7 and R 8 is optionally independently substituted with A 1 , —C(O)O—(C 1 -C 6 )alkyl, —S(O) m (C 1 -C 6 )alkyl, 1 to 5 halogens, 1 to 3 hydroxy, 1 to 3 —O—C(O)(C 1 -C 10 )alkyl or 1 to 3 (C 1 -C 6 )alkoxy; or [0115] R 7 and R 8 can be taken together to form —(CH 2 ) r -L-(CH 2 ) r —; [0116] where L is C(X 2 )(X 2 ), S(O) m or N(X 2 ); [0117] A 1 in the definition of R 1 is a partially saturated, fully saturated or fully unsaturated 4- to 8-membered ring optionally having 1 to 4 heteroatoms independently selected from the group consisting of oxygen, sulfur and nitrogen, a bicyclic ring system consisting of a partially saturated, fully unsaturated or fully saturated 5- or 6-membered ring, having 1 to 4 heteroatoms independently selected from the group consisting of nitrogen, sulfur and oxygen, fused to a partially saturated, fully saturated or fully unsaturated 5- or 6-membered ring, optionally having I to 4 heteroatoms independently selected from the group consisting of nitrogen, sulfur and oxygen; [0118] A 1 in the definition of R 2 , R 3 , R 6 , R 7 and R 8 is independently (C 5 -C 7 )cycloalkenyl, phenyl or a partially saturated, fully saturated or fully unsaturated 4- to 8-membered ring optionally having 1 to 4 heteroatoms independently selected from the group consisting of oxygen, sulfur and nitrogen, a bicyclic ring system consisting of a partially saturated, fully unsaturated or fully saturated 5- or 6-membered ring, optionally having 1 to 4 heteroatoms independently selected from the group consisting of nitorgen, sulfur and oxygen, fused to a partially saturated, fully saturated or fully unsaturated 5- or 6-membered ring, optionally having 1 to 4 heteroatoms independently selected from the group consisting of nitrogen, sulfur and oxygen; [0119] A 1 for each occurrence is independently optionally substituted, in one or optionally both rings if A 1 is a bicyclic ring system, with up to three substituents, each substituent independently selected from the group consisting of F, Cl, Br, I, OCF 3 , OCF 2 H, CF 3 , CH 3 , OCH 3 , -OX 6 , —C(O)N(X 6 )(X 6 ), —C(O)OX 6 , oxo, (C 1 -C 6 )alkyl, nitro, cyano, benzyl, —S(O) m (C 1 -C 6 )alkyl, 1H-tetrazol-5-yl, phenyl, phenoxy, phenylalkyloxy, halophenyl, methylenedioxy, —N(X 6 )(X 6 ), —N (X 6 )C(O)(X 6 ), —SO 2 N(X 6 )(X 6 ), —N(X 6 )SO 2 -phenyl, —N(X 6 )SO 2 X 6 , —CONX IX 12, —SO 2 NX 1 IX 12 , —NX 6 S0 2 X 12 , —NX 6 CONX 11 X 12 , —NX 6 SO 2 NX 11 X 12 , —NX 6 C(O)X 12 , imidazolyl, thiazolyl or tetrazolyl, provided that if A 1 is optionally substituted with methylenedioxy then it can only be substituted with one methylenedioxy; [0120] where X 11 is hydrogen or optionally substituted (C 1 -C 6 )alkyl; [0121] the optionally substituted (C 1 -C 6 )alkyl defined for X 11 is optionally independently substituted with phenyl, phenoxy, (C 1 -C 6 )alkoxycarbonyl, —S(O) m (C 1 -C 6 )alkyl 1 to 5 halogens, 1 to 3 hydroxy, 1 to 3 (C 1 -C 10 )alkanoyloxy or 1 to 3 (C 1 -C 6 )alkoxy; [0122] X 12 is hydrogen, (C 1 -C 6 )alkyl, phenyl, thiazolyl, imidazolyl, furyl or thienyl, provided that when X 12 is not hydrogen, X 12 is optionally substituted with one to three substituents independently selected from the group consisting of Cl, F, CH 3 , OCH 3 , OCF 3 and CF 3 ; [0123] or X 11 and X 12 are taken together to form —(CH 2 ) r -L-(CH 2 ) r —; [0124] where L 1 is C(X 2 )(X 2 ), O, S(O) m or N(X 2 ); [0125] r for each occurrence is independently 1, 2 or 3; [0126] X 2 for each occurrence is independently hydrogen, optionally substituted (C 1 -C 6 )alkyl, or optionally substituted (C 3 -C 7 )cycloalkyl, where the optionally substituted (C 1 -C 6 )alkyl and optionally substituted (C 3 -C 7 )cycloalkyl in the definition of X 2 are optionally independently substituted with —S(O) m (C 1 -C 6 )alkyl, —C(O)OX 3 , 1 to 5 halogens or 1-3 OX 3 ; [0127] X 3 for each occurrence is independently hydrogen or (C 1 -C 6 )alkyl; [0128] X 6 is independently hydrogen, optionally substituted (C 1 -C 6 )alkyl, (C 2 -C 6 )halogenated alkyl, optionally substituted (C 3 -C 7 )cycloalkyl, (C 3 -C 7 )-halogenatedcycloalkyl, where optionally substituted (C 1 -C 6 )alkyl and optionally substituted (C 3 -C 7 )cycloalkyl in the definition of X 6 is optionally independently substituted by 1 or 2 (C 1 -C 4 )alkyl, hydroxyl, (C 1 -C 4 )alkoxy, carboxyl, CONH 2 , —S(O) m (C 1 -C 6 )alkyl, carboxylate (C 1 -C 4 )alkyl ester, or 1H-tetrazol-5-yl; or when there are two X 6 groups on one atom and both X 6 are independently (C 1 -C 6 )alkyl, the two (C 1 -C 6 )alkyl groups may be optionally joined and, together with the atom to which the two X 6 groups are attached, form a 4- to 9-membered ring optionally having oxygen, sulfur or NX 7 ; [0129] X 7 is hydrogen or (C 1 -C 6 )alkyl optionally substituted with hydroxyl; and [0130] m for each occurrence is independently 0, 1 or 2; [0131] with the proviso that: [0132] X 6 and X 12 cannot be hydrogen when it is attached to C(O) or SO 2 in the form C(O)X 6 , C(O)X 12 , SO 2 X 6 or SO 2 X 12 ; and [0133] when R 6 is a bond then L is N(X 2 ) and each r in the definition —(CH 2 ) r -L-(CH 2 ) r — is independently 2 or 3. [0134] In the combinations, pharmaceutical compositions, methods and kits of this invention, it is even more especially preferred that said GHS is 2-amino-N-(1 (R)-benzyloxymethyl-2-(1,3-dioxo-8a(S)-pyridin-2-ylmethyl-2-(2,2,2-trifluoro-ethyl)-hexahydro-imidazo[1,5-a]pyrazin-7-yl]-2-oxo-ethyl)-2-methyl-propionamide; 2-amino-N-[2-(3a-(R)-benzyl-2-methyl-3-oxo-2,3,3a,4,6,7-hexahydro-pyrazolo-[4,3-c]pyridin-5-yl)-1-(R)-benzyloxymethyl-2-oxo-ethyl]-isobutyramide; or 2-amino-N-(1-(R)-(2,4-difluoro-benzyloxymethyl)-2-oxo-2-(3-oxo-3a-(R)-pyridin-2-ylmethyl)-2-(2,2,2-trifluoroethyl)-2,3,3a,4,6,7-hexahydro-pyrazolo[4,3-c]pyridin-5-yl)-ethyl)-2-methylpropionamide, a prodrug thereof or a pharmaceutically acceptable salt thereof or of said prodrug. [0135] In the combinations, pharmaceutical compositions, methods and kits of this invention, it is still more especially preferred that the L-tartrate salt of 2-amino-N-(1 (R)-benzyloxymethyl-2-(1,3-dioxo-8a(S)-pyridin-2-ylmethyl-2-(2,2,2-trifluoro-ethyl)-hexahydro-imidazo[1,5-a]pyrazin-7-yl]-2-oxo-ethyl)-2-methyl-propionamide; the L-tartrate salt of 2-amino-N-(2-(3a(R)-benzyl-2-methyl-3-oxo-2,3, 3a, 4,6,7-hexahydro-pyrazolo-[4,3-c]pyridin-5-yl)-1 (R)-benzyloxymethyl-2-oxo-ethyl)-isobutyramide; or the L-tartrate salt of 2-amino-N-(1-(R)-(2,4-difluoro-benzyloxymethyl)-2-oxo-2-(3-oxo-3a-(R)-pyridin-2-yl)-2-(2,2,2-trifluoro-ethyl)-2,3,3a,4,6,7-hexahydro-pyrazolo-[4,3-c]pyridin-5-yl)-ethyl)-2-methyl-propionamide is used. [0136] In the combinations, pharmaceutical compositions, methods and kits of this invention, it is also preferred that said GHS is hexarelin, ipamorelin, MK-0677, NN703, L-162752, L-163022, GPA-748, KP102, GHRP-2 or LY444711. [0137] This invention is also directed to a method of improving the physical or psychological condition of a patient undergoing a medical procedure comprising administering to said patient: [0138] a) a pharmaceutical composition comprising a GHS, a prodrug thereof or a pharmaceutically acceptable salt of said GHS or of said prodrug, an antidepressant, a prodrug thereof or a pharmaceutically acceptable salt of said antidepressant or of said prodrug, and a pharmaceutically acceptable vehicle, carrier or diluent; or [0139] b) a GHS, prodrug thereof, pharmaceutically acceptable salt of said GHS or of said prodrug or a pharmaceutical composition thereof and an antidepressant, prodrug thereof, pharmaceutically acceptable salt of said antidepressant or said prodrug or a pharmaceutical composition thereof. This invention thus includes methods whereby a fixed combination is administered and methods whereby the individual components of the combination are administered separately. This invention is particularly directed to such methods wherein the cardiac function, metabolism, muscle tone or mental state of said patient is improved. [0140] It is preferred that said medical procedure is a surgical or dental procedure, though patients undergoing other medical procedures which adversely affect the mental state of said patient may also be treated by the methods of this invention. The combination may be administered before, during or after said surgical or dental procedure. [0141] This invention is also directed to a method for treating musculoskeletal frailty in a mammal comprising administering to said mammal: [0142] a) a pharmaceutical composition comprising a GHS, a prodrug thereof or a pharmaceutically acceptable salt of said GHS or of said prodrug, an antidepresant, a prodrug thereof or a pharmaceutically acceptable salt of said antidepressant or of said prodrug, and a pharmaceutically acceptable vehicle, carrier or diluent; or [0143] b) a GHS, prodrug thereof, pharmaceutically acceptable salt of said GHS or of said prodrug or a pharmaceutical composition thereof and an antidepressant, prodrug thereof, pharmaceutically acceptable salt of said antidepressant or said prodrug or a pharmaceutical composition thereof. This invention thus includes methods whereby a fixed combination is administered and methods whereby the individual components of the combination are administered separately. This invention is particularly directed to such methods wherein bone healing following facial reconstruction, maxillary reconstruction or mandibular reconstruction is treated, vertebral synostosis is induced or long bone extension is enhanced, the healing rate of a bone graft is enhanced or prosthetic ingrowth is enhanced. This invention is also particularly directed to such methods wherein muscle mass is increased. [0144] This invention is also directed to a kit comprising: [0145] a) a first unit dosage form comprising a GHS, a prodrug thereof or a pharmaceutically acceptable salt of said GHS or said prodrug and a pharmaceutically acceptable carrier, vehicle or diluent; [0146] b) a second unit dosage form comprising an antidepressant, a prodrug thereof or a pharmaceutically acceptable salt of said antidepressant or said prodrug and a pharmaceutically acceptable carrier, vehicle or diluent; and [0147] c) a container. [0148] This invention is also directed to a method of treating congestive heart failure in a mammal comprising administering to said mammal: [0149] a) a pharmaceutical composition comprising a GHS, a prodrug thereof or a pharmaceutically acceptable salt of said GHS or of said prodrug, an antidepressant, a prodrug thereof or a pharmaceutically acceptable salt of said antidepressant or of said prodrug, and a pharmaceutically acceptable vehicle, carrier or diluent; or [0150] b) a GHS, prodrug thereof, pharmaceutically acceptable salt of said GHS or of said prodrug or a pharmaceutical composition thereof and an antidepressant, prodrug thereof, pharmaceutically acceptable salt of said antidepressant or said prodrug or a pharmaceutical composition thereof. This invention thus includes methods whereby a fixed combination is administered and methods whereby the individual components of the combination are administered separately. [0151] This invention is also directed to a method of attenuating protein catabolic response after a major operation in a mammal comprising adminstering to said mammal: [0152] a) a pharmaceutical composition comprising a GHS, a prodrug thereof or a pharmaceutically acceptable salt of said GHS or of said prodrug, an antidepressant, a prodrug thereof or a pharmaceutically acceptable salt of said antidepressant or of said prodrug, and a pharmaceutically acceptable vehicle, carrier or diluent; or [0153] b) a GHS, prodrug thereof, pharmaceutically acceptable salt of said GHS or of said prodrug or a pharmaceutical composition thereof and an antidepressant, prodrug thereof, pharmaceutically acceptable salt of said antidepressant or said prodrug or a pharmaceutical composition thereof. This invention thus includes methods whereby a fixed combination is administered and methods whereby the individual components of the combination are administered separately. [0154] The phrase “condition which presents with low bone mass” refers to a condition where the level of bone mass is below the age specific normal as defined in standards by the World Health Organization “Assessment of Fracture Risk and its Application to Screening for Postmenopausal Osteoporosis (1994), Report of a World Health Organization Study Group. World Health Organization Technical Series 843′. Childhood idiopathic and primary osteoporosis are also included. Included in the treatment of osteoporosis is the prevention or attenuation of long term complications such as curvature of the spine, loss of height, prosthetic surgery, and prevention of prostate malfunctioning. Also included is increasing the bone fracture healing rate and enhancing the rate of successful bone grafts. Also included is periodontal disease and alveolar bone loss. [0155] The prospect of surgery, whether invasive or non-invasive, often leads to depressed mental states in patients. Such mental states can be detrimental to rapid recovery from the surgical procedure. Patients with depressed mental states or at risk of acquiring a depressed mental state can be treated with the combination of this invention. [0156] The phrase “musculoskeletal frailty” refers to a condition wherein a subject has low bone mass and/or low muscle mass, and includes such diseases, disorders and conditions as, but not limited to, conditions which present with low bone mass, osteoporosis, conditions which present with low muscle mass, osteotomy, childhood idiopathic bone loss, bone loss associated with periodontitis, bone healing following facial reconstruction, maxillary reconstruction, mandibular reconstruction and bone fracture. Further, musculoskeletal frailty encompasses such conditions as interfaces between newly attached prostheses and bone which require bone ingrowth. [0157] The term “pharmaceutically acceptable” means that a substance or mixture of substances must be compatible with the other ingredients of a formulation and not deleterious to a patient. [0158] The term “treating”, “treat” or “treatment” as used herein includes curative, preventative (e.g., prophylactic) and palliative treatment. [0159] The terms “patient” and “subject” are used interchangeably and refer to animals, particularly mammals such as dogs, cats, cattle, horses, sheep and humans. Particularly preferred patients and subjects are humans, including males and females. [0160] The parenthetical negative or positive sign used herein in the nomenclature denotes the direction plane polarized light is rotated by the particular stereoisomer. [0161] The subject invention also includes combinations, pharmaceutical compositions, methods and kits comprising isotopically-labeled compounds, which are identical to the compounds described hereinabove, but for the fact that one or more atoms are replaced by an atom having an atomic mass or mass number different from the atomic mass or mass number usually found in nature. Examples of isotopes that can be incorporated into compounds used in the invention include isotopes of hydrogen, carbon, nitrogen, oxygen, phosphorous, sulfur, fluorine and chlorine, such as 2 H, 3 H, 13 C, 14 C, 15 N, 18 O, 17 O, 31 P, 32 P, 35 S, 18 F and 36 Cl, respectively. Compounds used in the present invention, prodrugs thereof, and pharmaceutically acceptable salts of said compounds or of said prodrugs which contain the aforementioned isotopes and/or other isotopes of other atoms are within the scope of this invention. Certain isotopically-labeled compounds of the present invention, for example those into which racioactive isotopes such as 3 H and 14 C are incorporated, are useful in drug and/or substrate tissue distribution assays. Tritiated, i.e., 3 H, and carbon-14, i.e., 14 C, isotopes are particularly preferred for their ease of preparation and detectability. Further, substitution with heavier isotopes such as deuterium, i.e., 2 H, can afford certain therapeutic advantages resulting from greater metabolic stability, for example increased in vivo half-life or reduced dosage requirements and, hence, may be preferred in some circumstances. Isotopically labeled compounds used in this invention and prodrugs thereof can generally be prepared by carrying out the procedures disclosed in the Schemes and /or in the Examples and Preparations described in the patents and applications which are incorporated herein by reference, by substituting a readily available isotopically labeled reagent for a non-isotopically labeled reagent. [0162] The combinations, pharmaceutical compositions, kits and methods of this invention increase bone density and muscle mass while at the same time reducing fat mass and total serum cholesterol. Further, the combinations, pharmaceutical compositions, kits and methods of this invention result in improved cardiac output, improved wound healing, higher metabolism and improved mental state which provides for positive outcomes following medical procedures, including surgical and dental procedures. This invention also makes a significant contribution to the art by providing compositions and methods that increase and maintain bone mass resulting in prevention, retardation, and/or regression of osteoporosis and related bone disorders. [0163] Other features and advantages will be apparent from the description and claims which describe the invention. DETAILED DESCRIPTION OF THE INVENTION [0164] The first compound of this invention is a growth hormone secretagogue (GHS). Any GHS may be used in the combinations, pharmaceutical compositions, methods and kits of this invention. [0165] A representative first class of growth hormone secretagogues within those compounds of Formula I as described hereinabove is set forth in PCT Application Publication No. WO97/24369, which is incorporated herein by reference, as compounds having the structural formula: [0166] wherein the various substituents are as defined in WO97/24369. Said compounds are prepared as disclosed therein. [0167] 2-Amino—N-(2-(3a-(R)-benzyl-2-methyl-3-oxo-2,3,3a ,4,6,7-hexahydro-pyrazolo-[4,3-c]pyridin-5-yl)-1-(R)-benzyloxymethyl-2-oxo-ethyl)-isobutyramide, having the following structure: [0168] and 2-amino-N-(1-(R)-(2,4-difluoro-benzyloxymethyl)-2-oxo-2-(3-oxo-3a-(R)-pyridin-2-ylmethyl)-2-(2,2,2-trifluoro-ethyl)-2,3,3a,4,6,7-hexahydro-pyrazolo-[4,3-c]pyridin-5-yl)-ethyl)-2-methyl-propionamide, having the following structure: [0169] are both within the scope of the disclosure of International Pat. Application Publication No. WO97/24369. [0170] Those compounds of Formula I which are not within the disclosure of International Pat. Application Publication No. WO97/24369 may be prepared as disclosed in International Pat. Application Publication No. WO98/58947, which is incorporated herein by reference. [0171] 2-amino-N-(1 (R)-benzyloxymethyl-2-(1 ,3-dioxo-8a(S)-pyridin-2-ylmethyl-2-(2,2,2-trifluoro-ethyl)-hexahydro-imidazo[1,5-a]pyrazin-7-yl]-2-oxo-ethyl)-2-methyl-propionamide, having the following structure: [0172] is within the scope of the disclosure of International Pat. Application Publication No. WO98/58947. [0173] Other GHS compounds which may be used in the compositions, methods and kits of this invention include the following: [0174] (1) compounds of the formula [0175] wherein the various substituents are defined, and the compounds are prepared, as disclosed in U.S. Pat. No. 5,206,235, which is incorporated herein by reference; [0176] (2) compounds of the formula [0177] wherein the various substituents are defined, and the compounds are prepared, as disclosed in U.S. Pat. No. 5,283,241, which is incorporated herein by reference; [0178] (3) compounds of the formula [0179] wherein the various substituents are defined, and the compounds are prepared, as disclosed in International Pat. Application Publication No. WO97/41879, which is incorporated herein by reference; and [0180] (4) compounds of the formula [0181] wherein the various substituents are defined, and the compounds are prepared, as disclosed in U.S. Pat. No. 5,492,916, which is incorporated herein by reference. [0182] The most preferred compounds within (1) above have the following structures: [0183] The most preferred compound within (3) above has the following structure: [0184] The methanesulfonate salt of this compound is particularly preferred. [0185] Still other compounds which may be used within the compositions, methods and kits of this invention include: [0186] (5) GHRP-6, which is the prototype GH-releasing peptide H-His-D-Trp-Ala-Trp-D-Phe-Lys-NH 2 , (also called His 1 , Lys 6 )-GHRP), is sold commercially by Bachem, catalog number H-9990 and Peninsula Labs, catalog number 8071 and is disclosed in U.S. Pat. No. 4,411,890, which is incorporated herein by reference, and in Bowers et al., Endocrinology, 114:1537, 1984; [0187] (6) GHRP-1, also known as KP101, which is the second generation GH-releasing peptide Ala-His-D-βNaI-Ala-Trp-D-Phe-Lys-NH 2 and is disclosed in Akman, Endocrinology, 132:1286, 1993; [0188] (7) GHRP-2, also known as KP-102 (Kaken) and GPA-748 (Wyeth-Ayerst), which is the GH-releasing peptide D-Ala-D-βNaI-Ala-Trp-D-Phe-Lys-NH 2 and is disclosed in Bowers et al., Endocrinology, 114:1537, 1984 and in Bowers in: Molecular and Clinical Advances in Pituitary Disorders, pp. 153-157, 1993, edited by S. Melmed, Endocrine Research and Education, Inc., Los Angeles, Calif., USA; and [0189] (8) hexarelin, which is His-D-2-methyl-Trp-Ala-Trp-D-Phe-Lys-NH 2 , is sold commercially by Peninsula Labs, catalog number 8083, was synthesized by Europeptides, Argenteuil, France and is disclosed in Guillaume et al., Endocrinology, 135, 1073, 1994. [0190] Any antidepressant may be used in the combinations, pharmaceutical compositions, methods and kits of this invention. The term antidepressant means an agent used to treat affective or mood disorders and related conditions. Affective mood disorders are characterized by changes in mood as the primary clinical manifestation. Either extreme of mood may be associated with psychosis, manifested as disordered or delusional thinking and perceptions which are often incongruent with the predominant mood. Affective disorders include major depression and mania, including bipolar manic-depressive illness. Preferred classes of antidepressants include norepinephrine reuptake inhibitors (NERIs), including secondary and tertiary amine tricyclics; selective sertraline reuptake inhibitors; combined NERI/SSRIs; monoamine oxidase (MAO) inhibitors; and atypical antidepressants. [0191] Any norepinephrine reuptake inhibitor (NERI) may be used in the combinations, pharmaceutical compositions, methods and kits of this invention. The term norepinephrine reuptake inhibitor means agents which potentiate the actions of biogenic amines by blocking their major means of physiological inactivation, which involves transport or reuptake into nerve terminals, and specifically, agents which block the reuptake of norepinephrine into said nerve terminals. [0192] Preferred tertiary amine tricyclic norepinephrine reuptake inhibitors which may be used in accordance with this invention include, but are not limited to, amitriptyline, which may be prepared as described in U.S. Pat. No. 3,205,264; chlomipramine, which may be prepared as described in U.S. Pat. No. 3,467,650; doxepin, which may be prepared as described in U.S. Pat. No. 3,420,851; imipramine, which may be prepared as described in U.S. Pat. No. 2,554,736; and trimipramine, which may be prepared as described in Jacob and Messer, Compt. Rend. 252, 2117 (1961). [0193] Preferred secondary amine tricyclic norepinephrine reuptake inhibitors which may be used in accordance with this invention include, but are not limited to, amoxapine, which may be prepared as described in U.S. Pat. No. 3,663,696; desipramine, which may be prepared as described in U.S. Pat. No. 3,454,554; maprotiline, which may be prepared as described in U.S. Pat. No. 3,999,201; nortriptyline, which may be prepared as described in U.S. Pat. No. 3,442,949; and protriptyline, which may be prepared as described in U.S. Pat. No. 3,244,748. [0194] Any selective serotonin reuptake inhibitor (SSRI) may be used in the combinations, pharmaceutical compositions, methods and kits of this invention. The term selective serotonin reuptake inhibitor refers to a compound which inhibits the reuptake of serotonin by afferent neurons. Such inhibition is readily determined by those skilled in the art according to standard assays such as those disclosed in U.S. Pat. No. 4,536,518 and other U.S. patents recited in the next paragraph. [0195] Preferred selective serotonin reuptake inhibitors (SSRI) which may be used in accordance with this invention include, but are not limited to: citalopram, which may be prepared as described in U.S. Pat. No. 4,136,193; femoxetine, which may be prepared as described in U.S. Pat. No. 3,912,743; fluoxetine, which may be prepared as described in U.S. Pat. No. 4,314,081; fluvoxamine, which may be prepared as described in U.S. Pat. No. 4,085,225; indalpine, which may be prepared as described in U.S. Pat. No. 4,064,255; indeloxazine, which may be prepared as described in U.S. Pat. No. 4,109,088; milnacipran, which may be prepared as described in U.S. Pat. No. 4,478,836; paroxetine, which may be prepared as described in U.S. Pat. No. 3,912,743 or U.S. Pat. No. 4,007,196; sertraline and the hydrochloride salt of sertraline, which may be prepared as described in U.S. Pat. No. 4,536,518; sibutramine, which may be prepared as described in U.S. Pat. No. 4,929,629; and zimeldine, which may be prepared as described in U.S. Pat. No. 3,928,369. Fluoxetine is also known as Prozac®. Sertraline hydrochloride is also known as Zoloft®. Sibutramine is also known as Meridia®. [0196] Any combined NERI/SSRI may be used in the combinations, pharmaceutical compositions, methods and kits of this invention. The term combined NERI/SSRI refers to a compound which blocks the reuptake of both serotonin and norepinephrine by afferent neurons. A preferred combined NERI/SSRI which may be used in accordance with this invention is venlafaxine, which may be prepared as described in U.S. Pat. No. 4,535,186. [0197] Any monoamine oxidase (MAO) inhibitor may be used in the combinations, pharmaceutical compositions, methods and kits of this invention. The term monoamine oxidase inhibitor refers to a compound which inhibits monoamine oxidase, for example by blocking the metabolic deamination of a variety of monoamines by mitochondrial monoamine oxidase. Preferred monoamine oxidase inhibitors which may be used in accordance with this invention include, but are not limited to, phenelzine, which may be prepared as described in U.S. Pat. No. 3,000,903; tranylcypromine, which may be prepared as described in U.S. Pat. No. 2,997,422; and selegiline, which may be prepared as described in U.S. Pat. No. 4,564,706. [0198] Any atypical antidepressant may be used in the combinations, pharmaceutical compositions, methods and kits of this invention. The term atypical antidepressant refers to any antidepressant not within any of the aforesaid classes of antidepressants. Preferred atypical antidepressants which may be used in accordance with this invention include, but are not limited to, bupropion, which may be prepared as described in U.S. Pat. No. 3,885,046; nefazodone, which may be prepared as described in U.S. Pat. No. 4,338,317; and trazodone, which may be prepared as described in U.S. Pat. No. 3,381,009. [0199] The disclosures of each of the patents and published patent applications cited within this description are incorporated herein by reference. [0200] The expression “pharmaceutically acceptable salts” includes both pharmaceutically acceptable acid addition salts and pharmaceutically acceptable cationic salts, where appropriate. The expression “pharmaceutically-acceptable cationic salts” is intended to define but is not limited to such salts as the alkali metal salts, (e.g., sodium and potassium), alkaline earth metal salts (e.g., calcium and magnesium), aluminum salts, ammonium salts, and salts with organic amines such as benzathine (N,N′-dibenzylethylenediamine), choline, diethanolamine, ethylenediamine, meglumine (N-methylglucamine), benethamine (N-benzylphenethylamine), diethylamine, piperazine, tromethamine (2-amino-2-hydroxymethyl-1,3-propanediol) and procaine. The expression “pharmaceutically-acceptable acid addition salts” is intended to define but is not limited to such salts as the hydrochloride, hydrobromide, sulfate, hydrogen sulfate, phosphate, hydrogen phosphate, dihydrogenphosphate, acetate, succinate, d-tartrate, I-tartrate, citrate, methanesulfonate (mesylate) and p-toluenesulfonate (tosylate) salts. [0201] Pharmaceutically acceptable cationic salts of the compounds used in this invention may be readily prepared, where appropriate, by reacting the free acid form of said compound with an appropriate base, usually one equivalent, in a co-solvent. Typical bases are sodium hydroxide, sodium methoxide, sodium ethoxide, sodium hydride, potassium methoxide, magnesium hydroxide, calcium hydroxide, benzathine, choline, diethanolamine, piperazine and tromethamine. The salt is isolated by concentration to dryness or by addition of a non-solvent. In many cases, salts are preferably prepared by mixing a solution of the acid with a solution of a different salt of the cation (sodium or potassium ethylhexanoate, magnesium oleate), and employing a solvent (e.g., ethyl acetate) from which the desired cationic salt precipitates, or can be otherwise isolated by concentration and/or addition of a non-solvent. [0202] The acid addition salts of the compounds used in this invention may be readily prepared by reacting the free base form of said compound with the appropriate acid. When the salt is of a monobasic acid (e.g., the hydrochloride, the hydrobromide, the p-toluenesulfonate, the acetate), the hydrogen form of a dibasic acid (e.g., the hydrogen sulfate, the succinate) or the dihydrogen form of a tribasic acid (e.g., the dihydrogen phosphate, the citrate), at least one molar equivalent and usually a molar excess of the acid is employed. However when such salts as the sulfate, the hemisuccinate, the hydrogen phosphate or the phosphate are desired, the appropriate and exact chemical equivalents of acid will generally be used. The free base and the acid are usually combined in a co-solvent from which the desired salt precipitates, or can be otherwise isolated by concentration and/or addition of a non-solvent. [0203] In addition, the growth hormone secretagogues and antidepressants which may be used in accordance with this invention, prodrugs thereof and pharmaceutically acceptable salts thereof or of said prodrugs, may occur as hydrates or solvates. Said hydrates and solvates are also within the scope of the invention. [0204] The utility of the combinations, pharmaceutical compositions, kits and methods of the present invention as medical agents in the treatment of musculoskeletal frailty (e.g., conditions which present with low bone mass or low muscle mass including osteoporosis) in mammals (e.g. humans) is demonstrated by the activity of the compounds of this invention in conventional assays as set forth in U.S. Pat. No. 5,552,412 and International Pat. Application Publication No. WO97/24369. Such assays also provide a means whereby the activities of the compositions of this invention can be compared between themselves and with the activities of other known compounds and/or compositions. The results of these comparisons are useful for determining dosage levels in mammals, including humans, for the treatment of such diseases. [0205] Administration of the compounds used in this invention can be via any method which delivers the compounds or the combination of this invention systemically and/or locally. These methods include oral, parenteral, intraduodenal routes, etc. Generally, the compounds used in this invention are administered orally, but parenteral administration (e.g., intravenous, intramuscular, transcutaneous, subcutaneous or intramedullary) may be utilized, for example, where oral administration is inappropriate for the instant target or where the patient is unable to ingest the drug. The two different compounds used in this invention can be co-administered simultaneously or sequentially in any order, or a single pharmaceutical composition comprising a first compound as described above and a second compound as described above in a pharmaceutically acceptable carrier can be administered. [0206] In any event the amount and timing of compounds administered will, of course, be dependent on the subject being treated, on the severity of the affliction, on the manner of administration and on the judgment of the prescribing physician. Thus, because of patient to patient variability, the dosages given below are a guideline and the physician may titrate doses of the drug to achieve the activity (e.g., muscle mass improvement, mental state improvement and/or metabolism improvement) that the physician considers appropriate for the individual patient. In considering the degree of activity desired, the physician must balance a variety of factors such as muscle mass starting level, cardiac output, age of the patient, presence of preexisting disease, other ongoing or planned medical treatments or procedures, as well as the presence of other diseases. The following paragraphs provide preferred dosage ranges for the various components of this invention. [0207] This invention relates both to methods of treating the physical and mental condition of a patient and/or to improve the cardiac function, metabolism and muscle condition of a patient in which the GHS and antidepressant are administered together, as part of the same pharmaceutical composition, and to methods in which these two agents are administered separately, as part of an appropriate dosage regimen designed to obtain the benefits of the combination therapy. The appropriate dosage regimen, the amount of each dose administered and the intervals between doses of the active agents will depend upon the GHS and the antidepressant being used, the type of pharmaceutical formulations being used, the characteristics of the subject being treated and the severity of the complications. Generally, in carrying out the methods of this invention, an effective dosage for the GHS compounds of this invention is in the range of 0.0002 to 2 mg/kg/day, preferably 0.01 to 1 mg/kg/day in single or divided doses. It is preferred that the dosage amount of said GHS is about 1 mg to about 50 mg per day for an average subject, depending upon the GHS and the route of administration. The GHS compound and the antidepressant will be administered in single or divided doses. The preferred dosage ranges for the antidepressants used in this invention will vary depending upon the particular antidepressant used. The preferred dosage amounts of the antidepressants are well known to those skilled in the art or can be found in the Physicians Desk References (PDR®), 54 th Edition, 2000, Medical Economics Company, Inc., Montvale, N.J., 07645 or in Goodman and Gilman's The Pharmacological Basis of Therapeutics, Hardman, Limbird, Molinoff, Ruddon and Gilman, Eds., 9 th Edition, 1996, McGraw-Hill, New York, pp. 433-435. For example, SSRIs will generally be administered in amounts ranging from about 0.05 mg/kg/day to about 10 mg/kg/day in single or divided doses, preferably 5 mg to about 500 mg per day for an average subject, depending upon the SSRI and the route of administration. However, some variation in dosage will necessarily occur depending on the condition of the subject being treated. The prescribing physician will, in any event, determine the appropriate dose for the individual subject. [0208] Pharmaceutical compositions comprising a growth hormone secretagogue, a prodrug thereof or a pharmaceutically acceptable salt of said growth hormone secretagogue or said prodrug and an antidepressant, a prodrug thereof or a pharmaceutically acceptable salt of said antidepressant or said prodrug are hereinafter referred to, collectively, as “the active compositions of this invention.” [0209] Where the tartrate salt, hydrochloride salt or other pharmaceutically acceptable salt of any of the above compounds is used in this invention, the skilled person will be able to calculate effective dosage amounts by calculating the molecular weight of the salt form and performing simple stoichiometric ratios. [0210] The compounds, prodrugs and pharmaceutically acceptable salts used in the combinations of the present invention are generally administered in the form of a pharmaceutical composition comprising at least one of the compounds or pharmaceutically acceptable salts thereof of this invention together with a pharmaceutically acceptable vehicle or diluent. Thus, the compounds, prodrugs and pharmaceutically acceptable salts thereof of this invention can be administered separately or together in any conventional oral, parenteral or transdermal dosage form. When administered separately, the administration of the other compound or a pharmaceutically acceptable salt thereof of the invention follows. [0211] For oral administration a compound or pharmaceutical composition can take the form of solutions, suspensions, tablets, pills, capsules, powders, and the like. Tablets containing various excipients such as sodium citrate, calcium carbonate and calcium phosphate are employed along with various disintegrants such as starch and preferably potato or tapioca starch and certain complex silicates, together with binding agents such as polyvinylpyrrolidone, sucrose, gelatin and acacia. Additionally, lubricating agents such as magnesium stearate, sodium lauryl sulfate and talc are often useful for tableting purposes. Solid compositions of a similar type are also employed as fillers in soft and hard-filled gelatin capsules; preferred materials in this connection also include lactose or milk sugar as well as high molecular weight polyethylene glycols. When aqueous suspensions and/or elixirs are desired for oral administration, the compounds or pharmaceutically aceptable salts thereof of this invention can be combined with various sweetening agents, flavoring agents, coloring agents, emulsifying agents and/or suspending agents, as well as such diluents as water, ethanol, propylene glycol, glycerin and various like combinations thereof. [0212] For purposes of parenteral administration, solutions in sesame or peanut oil or in aqueous propylene glycol can be employed, as well as sterile aqueous solutions of the corresponding water-soluble salts. Such aqueous solutions may be suitably buffered, if necessary, and the liquid diluent first rendered isotonic with sufficient saline or glucose. These aqueous solutions are especially suitable for intravenous, intramuscular, subcutaneous and intraperitoneal injection purposes. In this connection, the sterile aqueous media employed are all readily obtainable by standard techniques well-known to those skilled in the art. [0213] For purposes of transdermal (e.g., topical) administration, dilute sterile, aqueous or partially aqueous solutions (usually in about 0.1% to 5% concentration), otherwise similar to the above parenteral solutions, are prepared. [0214] Methods of preparing various pharmaceutical compositions with a certain amount of each active ingredient are known, or will be apparent in light of this disclosure, to those skilled in this art. For examples, see Remington's Pharmaceutical Sciences, Mack Publishing Company, Easton, Pa., 19th Edition (1995). [0215] Pharmaceutical compositions according to the invention may contain 0.1%-95% of a combination of the compounds, prodrugs or pharmaceutically acceptable salts thereof used in this invention, preferably 1%-70%. In any event, the composition or formulation to be administered will contain a quantity of a combination of the compounds, prodrugs or pharmaceutically acceptable salts thereof used in the invention in an amount effective to treat the disease/condition of the subject being treated. [0216] Since the present invention relates to treatment with a combination of the two active ingredients which may be administered separately, the invention also relates to combining separate pharmaceutical compositions in kit form. The kit includes two separate pharmaceutical compositions: a GHS, a prodrug thereof or a pharmaceutically acceptable salt thereof or of said prodrug and an antidepressant, a prodrug thereof or a pharmaceutically acceptable salt thereof or of said prodrug. The kit includes a container for containing the separate compositions such as a divided bottle or a divided foil packet, however, the separate compositions may also be contained within a single, undivided container. Typically the kit includes directions for the administration of the separate components. The kit form is particularly advantageous when the separate components are preferably administered in different dosage forms (e.g., oral and parenteral), are administered at different dosage intervals, or when titration of the individual components of the combination is desired by the prescribing physician. [0217] An example of such a kit is a so-called blister pack. Blister packs are well known in the packaging industry and are being widely used for the packaging of pharmaceutical unit dosage forms (tablets, capsules, and the like). Blister packs generally consist of a sheet of relatively stiff material covered with a foil of a preferably transparent plastic material. During the packaging process recesses are formed in the plastic foil. The recesses have the size and shape of the tablets or capsules to be packed. Next, the tablets or capsules are placed in the recesses and the sheet of relatively stiff material is sealed against the plastic foil at the face of the foil which is opposite from the direction in which the recesses were formed. As a result, the tablets or capsules are sealed in the recesses between the plastic foil and the sheet. Preferably the strength of the sheet is such that the tablets or capsules can be removed from the blister pack by manually applying pressure on the recesses whereby an opening is formed in the sheet at the place of the recess. The tablet or capsule can then be removed via said opening. [0218] It is desirable to provide a memory aid on a card insert, e.g., in the form of numbers next to the tablets or capsules whereby the numbers correspond with the days of the regimen which the tablets or capsules so specified should be ingested. Another example of such a memory aid is a calendar printed on the card e.g., as follows “First Week, Monday, Tuesday, . . . etc . . . Second Week, Monday, Tuesday, . . . ” etc. Other variations of memory aids will be readily apparent. A “daily dose” can be a single tablet or capsule or several pills or capsules to be taken on a given day. Also a daily dose of antidepressant can consist of one tablet or capsule while a daily dose of a GHS can consist of several tablets or capsules and vice versa. The memory aid should reflect this. [0219] In another specific embodiment of the invention a dispenser designed to dispense the daily doses one at a time in the order of their intended use is provided. Preferably, the dispenser is equipped with a memory-aid, so as to further facilitate compliance with the regimen. An example of such a memory-aid is a mechanical counter which indicates the number of daily doses that has been dispensed. Another example of such a memory-aid is a battery-powered micro-chip memory coupled with a liquid crystal readout, or audible reminder signal which, for example, reads out the date that the last daily dose has been taken and/or reminds one when the next dose is to be taken. [0220] It should be understood that the invention is not limited to the particular embodiments described herein, but that various changes and modifications may be made without departing from the spirit and scope of this invention as defined by the following claims.

This invention is directed to combinations comprising a growth hormone secretagogue, a prodrug thereof or a pharmaceutically acceptable salt of said growth hormone secretagogue or said prodrug and an antidepressant, a prodrug thereof or a pharmaceutically acceptable salt of said antidepressant or said prodrug and to pharmaceutical compositions and kits comprising such combinations. Antidepressants within the scope of this invention include norepinephrine reuptake inhibitors (e.g., secondary and tertiary amine tricyclics), selective sertraline reuptake inhibitors, agents which are combined norepinephrine/sertraline reuptake inhibitors, monoamine oxidase inhibitors and atypical antidepressants. This invention is also directed to methods of improving the physical and/or psychological condition of a patient undergoing a medical procedure, to methods of treating musculoskeletal frailty, to methods of treating congestive heart failure and to methods of attenuating protein catabolic response after a major operation comprising administering such a combination. In particular, this invention relates to such compositions and kits that improve the cardiac function, metabolism, muscle tone and/or mental state of patients undergoing a medical procedure. The compositions and kits of this invention are also useful in treating central nervous system disorders of patients undergoing a medical procedure.

CROSS-REFERENCE TO RELATED APPLICATION [0001] The present non-provisional patent application claims the benefit of priority of foreign Patent Application No. GB1000997.5 which is entitled A FREE-STANDING EXERCISE APPARATUS and which was filed Jan. 22, 2010, which is incorporated in full by reference herein. FIELD OF THE INVENTION [0002] The present invention relates generally to a free-standing exercise apparatus, a method of assembly of said apparatus and to a method of exercise using said apparatus and finds particular, although not exclusive, utility in improving a user's fitness. BACKGROUND OF THE INVENTION [0003] Free standing exercise apparatus are useful for exercising in both domestic situations and gymnasia. Exercise apparatus which allows a user to pull themselves upwardly away from the floor are typically substantially attached in some way to the fabric of a building, or to the floor, or require to be braced against part of a building such as in a door way. However, free-standing apparatus does not require any such attachment or bracing which means it is more easily installed and allows it to be moved as required. [0004] Such apparatus may also be capable of disassembly for ease of transport and may therefore be portable. [0005] One such exercise apparatus is described in GB-A-2393919. However, the apparatus is relatively heavy and bulky and comprises separate members which have to be attached together using standard nuts and bolts. In other words, the apparatus has to be put together by selection of the appropriate adjacent members. Moreover, the apparatus provides limited positions for a user's hands to grip in use. It would be desirable therefore to provide an alternative apparatus which offers improved assembly/disassembly and the possibility of different hand gripping positions. BRIEF SUMMARY OF THE INVENTION [0006] In one aspect, the invention provides a free-standing exercise apparatus comprising a base, at least one leg extending, in use, upwardly from the base, and an upper gripping member attached to the at least one leg at an end substantially opposite to the base, wherein the upper gripping member comprises a substantially horizontal and rectilinear first portion, two second portions arranged substantially in the same plane as, but substantially non-perpendicular to, the first portion, and a third portion arranged substantially in the same plane as, and substantially perpendicular to, the first portion, wherein the two second portions are arranged either side of the third portion forming a triangular shape, with the first portion, in the said plane. [0007] In one embodiment, the apparatus may be assembled such that the upper gripping member is above a user's head when the user stands adjacent it such that the user may use the apparatus to pull themselves up. Alternatively, the apparatus may be assembled such that the upper gripping member is substantially at chest height when the user stand adjacent it. Alternatively, the apparatus may be at assembled such that the upper gripping member is at waist height so that a user may push themselves upwardly. Other intermediate positions are also possible for the height of the upper gripping member relative to the base. [0008] The arrangement of the first and second portions allows a user to grip one portion with each hand, in use, such that the user's hands are oriented at differing angles within the said plane. This may provide a more comfortable experience for the user and allows for different muscle groups to be worked compared to a situation where the user's hands are substantially in line with one another along a rectilinear bar. In this respect, the at least one second portion may be arranged such that it is not parallel to the first portion. [0009] The first, second and third portions may be tubular, although other shapes are contemplated. [0010] The base may include at least one telescopically extendable foot. This allows the area of the base to be adjusted as required. More than one foot may also be provided, such as two feet. The telescopic nature of the foot also allows for the apparatus to be packed into a relatively small volume when disassembled. The foot may be of square-section, although other shapes are contemplated. [0011] The second portion may be connected to the first and third portions. This connection may be at each end of the second portion. In this way a triangle of portions lying substantially in the same plane as each other may be provided. This allows more hand gripping positions and combinations thereof. [0012] There are three triangles provided with the arrangement of the first, second and third portions; one arranged on one side of the third portion and formed by the first, second and third portions, one arranged on the other side of the third portion and formed by the first, other second, and third portions, and one formed by the first and two second portions. This provides even more versatility and allows a user to grip the gripping member with each hand at a multitude of angles and also allows the user to position their body at differing angles relative to the apparatus. This allows for more muscle groups to be worked than has hithertofore been possible. [0013] The free-standing exercise apparatus may include more than one arrangement of second and third portions at differing locations along the length of the first portion. In this way, another one to three triangular shape portions may be provided at least at one other location along the length of the first portion. [0014] The gripping member may include a carrying handle. This permits the apparatus to be portable when disassembled. In one sense therefore the apparatus is portable. [0015] The first portion may include at least one fourth substantially rectilinear portion arranged at one end and extending out of the plane in which the first portion substantially lies. This portion may also be tubular. It may extend downwardly towards the base. Alternatively, it may extend upwardly. Two fourth portions may be provided one at each end of the first member. They may both extend downwardly or upwardly or in substantially opposite directions. [0016] The gripping member may be removably attachable to the apparatus and may be arranged to accept weights for the purpose of using it as a bar bell. This allows greater versatility for the user and obviates the need for a separate bar bell for the purpose of weight lifting. [0017] The free-standing exercise apparatus may include resiliently biased bolts (or “pull-pins”) for adjustably maintaining the position of at least some of the base, leg and upper gripping member in relation to one another. These resiliently biased bolts may include springs which bias the bolts to an extended or retracted position. Such bolts may have to be manually pulled, pushed or twisted to overcome the biasing force such that they can be moved to the retracted or extended position to allow movement between the various members comprising the apparatus. One or more such bolts may include means, such as cotter pins, for locking the bolts in the extended or retracted position such that free movement of two or more members is possible. These bolts allow for relatively quick assembly and disassembly and obviate the need for tools such as spanners etc. In at least this sense, the free-standing exercise apparatus may include quick-release bolts for allowing the apparatus to be assembled and disassembled relatively easily and substantially without the need for tools. [0018] In one embodiment, each of the adjacent members comprising the apparatus, apart from possibly the gripping member, remain linked to one another so that assembly is relatively easy in that the assembler does not have to select the correct members from a multitude of members. The link between members may be effected by hinges or pivots in the case of the feet and leg members. The link may be the telescopic nature of the feet members (front and rear members), and they may contain means for preventing the two portions from being completely separated. The leg members (upper and lower members) may also comprise such features to prevent their complete separation. In this way, the apparatus may be “un-folded”. [0019] In a second aspect, the invention provides a method of assembly of a free-standing exercise apparatus comprising the steps of providing a free-standing exercise apparatus according to the first aspect and as described and/or claimed herein, arranging the base on a surface, moving the at least one leg such that its length is substantially perpendicular to the base, and attaching the gripping member to the upper end of the leg. [0020] The locking of the various members relative to one another to prevent movement therebetween in use may be effected by means of resilient biased bolts although other means are contemplated. [0021] The at least one leg of the free-standing exercise device may be telescopic, and the method may further comprise the step of extending the length of the leg as required. [0022] The apparatus may include two legs and the length of each may be adjustable independently. This allows for the apparatus to be assembled on an uneven surface. [0023] The base of the free-standing exercise apparatus may include two feet each telescopically extendable, and the method may further comprise the step of extending the length of each foot as required. [0024] The free-standing exercise apparatus may include two legs and adjustable bracing therebetween, and the method may further comprise the step of bracing the two legs apart to substantially fix their positions relative to one another. [0025] The bracing may comprise two struts each pivotably connected at one end to each leg and pivotably coupled together at their other ends. A movable locking member may be provided to substantially fix the position of the two struts relative to one another. The pivotable connection allows the struts to move relative to the legs during disassembly thereby allowing the two legs to move close to one another thus effecting a small volume when “packed” and disassembled. [0026] In a third aspect, the invention provides a method of exercise comprising the steps of providing a free-standing exercise apparatus according to the first aspect and as described and/or claimed herein, wherein the at least one leg of the free-standing exercise apparatus is telescopic, attaching at least one weight to the gripping member, and moving the gripping member upwardly and downwardly relative to the base such that the at least one leg extends and contracts telescopically. [0027] In this way the gripping member is guided as it travels upwardly and downwardly. This provides a safer environment as the user does not need to be concerned if the gripping member is released as it will not hit the floor or the user. BRIEF DESCRIPTION OF THE DRAWINGS [0028] The above and other characteristics, features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention. This description is given for the sake of example only, without limiting the scope of the invention. The reference figures quoted below refer to the attached drawings. [0029] FIG. 1 is an elevational view of the apparatus in an assembled form with the legs extended; [0030] FIG. 2 is an elevational view of the apparatus in an assembled form with the legs retracted; and [0031] FIG. 3 is a perspective view of the apparatus in a disassembled and packed state. DETAILED DESCRIPTION OF THE INVENTION [0032] The present invention will be described with respect to particular embodiments and with reference to certain drawings but the invention is not limited thereto but only by the claims. The drawings described are only schematic and are non-limiting. In the drawings, the size of some of the elements may be exaggerated and not drawn to scale for illustrative purposes. The dimensions and the relative dimensions do not correspond to actual reductions to practice of the invention. [0033] Furthermore, the terms first, second, third and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequence, either temporally, spatially, in ranking or in any other manner. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein. [0034] Moreover, the terms top, bottom, over, under and the like in the description and the claims are used for descriptive purposes and not necessarily for describing relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other orientations than described or illustrated herein. [0035] It is to be noticed that the term “comprising”, used in the claims, should not be interpreted as being restricted to the means listed thereafter; it does not exclude other elements or steps. It is thus to be interpreted as specifying the presence of the stated features, integers, steps or components as referred to, but does not preclude the presence or addition of one or more other features, integers, steps or components, or groups thereof. Thus, the scope of the expression “a device comprising means A and B” should not be limited to devices consisting only of components A and B. It means that with respect to the present invention, the only relevant components of the device are A and B. [0036] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment, but may refer to different embodiments. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments. [0037] Similarly it should be appreciated that in the description of exemplary embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the detailed description are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment of this invention. [0038] Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those skilled in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination. [0039] In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practised without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description. [0040] The invention will now be described by a detailed description of several embodiments of the invention. It is clear that other embodiments of the invention can from the true spirit or technical teaching of the invention, the invention being limited only by the terms of the appended claims. [0041] In FIG. 1 , the assembled and erected apparatus 10 comprises a base 20 . This base 20 comprises two feet 30 , one at the lower end of each leg 40 . Each foot comprises a rectilinear length of box-section section. Each foot 30 comprises a rear 34 and a front 36 member. The front member 36 has a smaller cross-section than the rear member 34 such that it may be moved telescopically into and out of the larger rear member 34 . This allows the length of the feet 30 to be adjusted as required and allows the apparatus to be packed into a small volume as may be seen in FIG. 3 . The position of the two members 34 , 36 of each foot 30 relative to one another may be adjustably fixed by means of a pin (not shown), attached to the rear member 34 by means of a chain 93 , passing through a hole in each member 34 , 36 , the hole selected from a plurality of holes for the appropriate length as required. Other means of adjustably maintaining the relative positions of the two feet members 34 , 36 are contemplated such as the pull-pins discussed above. [0042] Each leg 40 comprises two members 44 , 46 of generally tubular shape. The lower leg 44 has a larger cross-section than the upper leg 46 such that the upper leg 46 may be moved telescopically into and out of the larger lower leg 44 . This allows the length of the legs 40 to be individually adjusted to cater for uneven ground and for adjustment of the height of the upper gripping member 50 relative to the base 20 . It also allows the apparatus to be packed into a small volume as may be seen in FIG. 3 . [0043] The upper 46 and lower 44 leg members are retained in position relative to one another by means of bolts 49 a provided at the upper end of the lower leg members 44 . Corresponding holes 49 b are provided in the upper leg members 46 at various positions along their lengths to allow positive locking of the bolts 49 a therein. Other means of adjustably maintaining the relative positions of the upper 46 and lower 44 leg members are contemplated such as the pull-pins discussed above. [0044] Each leg 40 may be releasably attached to each foot 30 . Alternatively, or additionally, each leg 40 may be pivotable connected to each foot 30 . [0045] Slots 91 , 92 are provided on each lower leg member 44 . These will be described in more detail in conjunction with the discussion regard FIG. 3 below. [0046] The upper gripping member 50 is provided at the upper end of the legs 40 . It comprises a first portion 52 which is substantially rectilinear and horizontally positioned. The first portion includes downwardly depending portions which fit inside the upper end of each upper leg member 46 . The position of these downwardly depending portions are indicated by reference numeral “ 54 ”. These portions 54 may be locked to the upper leg members 46 by use of bolts similar to the ones describe above and referenced “ 49 a ”. However, other means of releasably maintaining the upper gripping means 50 to the upper leg members 46 are contemplated such as the pull-pins discussed above. [0047] From the upper end of each downwardly depending portion 54 a portion 53 extends substantially horizontally. It is to these horizontal sections 53 that the first portion 52 is attached. The first portion 52 extends over the top of both legs 40 and projects beyond the area defined by the base 20 . [0048] Two second portions 55 are connected to the middle of the length of the first portion and each extends towards a leg 40 such that they extend in different directions to one another. Each second portion 55 extends to the same side of the first portion 52 . Each second portion 55 lies in the same plane as the first portion 52 , but not parallel to it. Each second portion 55 makes a “V” shape arrangement with the first portion 52 . [0049] A third portion 58 extends from the end of each horizontal portion 53 in the same direction thereas. Each third portion 58 connects the end of each second portion 55 , opposite from the end which is connected to the first portion 52 , to the first portion 52 , to form a triangular shape therebetween. Each third portion 58 extends beyond the end of each second portion 55 to provide another position for gripping by the user in use. [0050] An additional second portion 56 is also provided substantially above each leg 40 . These additional second portions 56 connect to each end of the first portion 52 at one end and to each of the third portions 58 at their other end in the vicinity where the second portions 55 connect to each third portions 58 . This arrangement provides a triangular shape therebetween. [0051] The additional second portions 56 also lie in the same plane as the first 52 and second 55 portions. [0052] A fourth portion 59 is also provided at each end of the first portion 52 . These fourth portions are not in the same plane as the first, second and third portions. Rather, they depend downwardly. [0053] The arrangement of various portions allows a user to grip the upper gripping member 50 in numerous ways. [0054] A handle 80 is included at one point along the length of the first portion 52 as will be described in more detail below. [0055] The various portions may be integral with one another in that they may be manufactured from one piece. Alternatively, one or more various portions may be attached or connected together, such as by welding. [0056] The apparatus 10 may comprise steel and/or aluminium, although other materials are contemplated. [0057] To provide greater stability to the apparatus 10 a brace 70 is provided between the legs 40 . This brace 70 comprises two struts 72 , 74 which are each connected at one end to each of the lower leg members 44 . The two struts 72 , 74 lie substantially horizontally, in this assembled state shown, and meet in the middle between the two legs 40 . The two struts are hinged or pivoted together. A locking means 76 in the form of a channel is located at this mid-point to prevent the two struts 72 , 74 from moving relative to one another. The locking means 76 may be moved to allow the struts 72 , 74 to pivot relative to one another during disassembly. [0058] FIG. 2 shows the apparatus 10 with the upper leg members 46 retracted fully inside the lower leg members 44 . A handle 80 is shown attached to the upper gripping member 50 for use as a carrying handle when the apparatus is disassembled and packed as shown in FIG. 3 . All other referenced elements are the same as described with reference to FIG. 1 . [0059] FIG. 3 demonstrates how the apparatus 10 may be packed into a relatively small volume for ease of storage and or portability. [0060] The upper gripping member 50 is attached to the lower leg members 44 , which have the upper leg members 46 substantially fully retracted inside. The lower leg members 44 are, in turn, attached to the rear feet members 34 , which have the forward members 36 fully retracted inside them. The legs 40 have been brought together and the feet 30 have been rotated relative to the legs (by means of pivoting means 90 ) such that the longitudinal axes of the feet 30 , legs 40 and first portion 52 of the upper gripping member 50 are substantially parallel and adjacent with one another. The legs 40 may be releasably fixed in this position, relative to the feet 30 , by use of a locking means, such as one or more pins 99 passing through appropriate holes in the pivoting means 90 . The upper gripping member 50 is attached to the lower leg members 44 by means of the slots 91 , 92 provided on the surface of the lower leg members 44 . The two third portions 58 each fit inside the slots 91 , 92 and are retained therein by means of a releasable pin 94 .

A free-standing exercise apparatus is provided which comprises a base, at least one leg extending, in use, upwardly from the base, and a substantially horizontal bar attached to the at least one leg at an end substantially opposite to the base, wherein the bar has a substantially rectilinear first portion and at least one second portion arranged substantially in the same plane as, but substantially non-perpendicularly to, the first portion.

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 10/547,986, filed Apr. 10, 2006, which is a national stage of PCT/IL2004/000232, filed Mar. 11, 2004, which claims priority to U.S. Ser. No. 60/454,505, filed Mar. 12, 2003. All of the above are herein incorporated by reference in their entirety. FIELD OF THE INVENTION [0002] This invention relates to the use of ADNF polypeptides in the treatment of anxiety and/or depression. The present invention also relates to drug discovery assays using the ADNF polypeptide mechanism of action and target interaction, as well as the manufacture of medicaments, methods of application and formulation therefor. Embodiments of the invention provide methods for preventing and/or treating anxiety and depression disorders in a subject by administering a NAP, an 8-amino-acid peptide derived from Activity Dependent Neurotrophic Factor (ADNF III), in an amount sufficient to improve postnatal performance. The ADNF polypeptides include ADNF I and ADNF III (also referred to as ADNP) polypeptides, analogs, subsequences, and D-amino acid versions (either wholly D-amino acid peptides or mixed D- and L-amino acid peptides), and combinations thereof which contain their respective active core sites and provide neuroprotective and anti-anxiety functions. BACKGROUND OF THE INVENTION [0003] NAP, an 8-amino-acid peptide (NAPVSIPQ=Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln), is derived from a novel protein, activity-dependent neuroprotective protein, ADNP (U.S. Pat. No. 6,613,740, Bassan et al., J. Neurochem. 72: 1283-1293 (1999)). The NAP sequence within the ADNP gene is identical in rodents and humans (U.S. Pat. No. 6,613,740, Zamostiano, et al., J. Biol. Chem. 276:708-714 (2001)). [0004] In cell cultures, NAP has been shown to have neuroprotective activity at femtomolar concentrations against a wide variety of toxins (Bassan et al., 1999; Offen et al., Brain Res. 854:257-262 (2000)). In animal models simulating parts of the Alzheimer's disease pathology, NAP was protective as well (Bassan et al., 1999; Gozes et al., J. Pharmacol. Exp. Ther. 293:1091-1098 (2000); see also U.S. Pat. No. 6,613,740). In normal aging rats, intranasal administration of NAP improved performance in the Morris water maze. (Gozes et al., J. Mol. Neurosci. 19:175-178 (2002). Furthermore, NAP reduced infarct volume and motor function deficits after ischemic injury, by decreasing apoptosis (Leker et al., Stroke 33:1085-1092 (2002)) and reducing damage caused by closed head injury in mice by decreasing inflammation (Beni Adani et al., J. Pharmacol. Exp. Ther. 296:57-63 (2001); Romano et al., J. Mol. Neurosci. 18:37-45 (2002); Zaltzman et al., NeuroReport 14:481-484 (2003)). In a model of fetal alcohol syndrome, fetal death after intraperitoneal injection of alcohol was inhibited by NAP treatment (Spong et al., J. Pharmacol. Exp. Ther. 297:774-779 (2001); see also WO 00/53217). Utilizing radiolabeled peptides these studies showed that NAP can cross the blood-brain barrier and can be detected in rodents' brains either after intranasal treatment (Gozes et al., 2000) or intravenous injection (Leker et al., 2002) or intraperitoneal administration (Spong et al., 2001). SUMMARY OF THE INVENTION [0005] This invention discloses the surprising finding that NAP, and consequently, NAP related peptides, e.g., ADNF polypeptides, can provide novel therapeutic treatments for serious diseases and disorders, particularly anxiety disorders and mood disorders such as depression. This invention further discloses for the first time the molecular target for NAP, tubulin, a novel target platform for drug discovery, neuroprotection, anxiety and depression. [0006] In one aspect, the present invention provides a method of treating or preventing anxiety or depression in a subject, the method comprising the step of administering a therapeutically effective amount of an ADNF polypeptide to a subject in need thereof. [0007] In one embodiment, the ADNF polypeptide is a member selected from the group consisting of: (a) an ADNF I polypeptide comprising an active core site having the following amino acid sequence: Ser-Ala-Leu-Leu-Arg-Ser-Ile-Pro-Ala (SEQ ID NO:1); (b) an ADNF III polypeptide comprising an active core site having the following amino acid sequence (NAP): Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln (SEQ ID NO:2); and (c) a mixture of the ADNF I polypeptide of part (a) and the ADNF III polypeptide of part (b). [0008] In one embodiment, the ADNF polypeptide is a member selected from the group consisting of a full length ADNF I polypeptide, a full length ADNF III polypeptide (ADNP), and a mixture of a full length ADNF I polypeptide and a full length ADNF III polypeptide. [0009] In one embodiment, the ADNF polypeptide is an ADNF I polypeptide. IN another embodiment, the active core site of the ADNF I polypeptide comprises at least one D-amino acid. In another embodiment, the active core site of the ADNF I polypeptide comprises all D-amino acids. In another embodiment, the ADNF I polypeptide is Ser-Ala-Leu-Leu-Arg-Ser-Ile-Pro-Ala (SEQ ID NO:1). In another embodiment, the ADNF I polypeptide comprises up to about 20 amino acids at least one of the N-terminus and the C-terminus of the active core site. In another embodiment, the ADNF I polypeptide is selected from the group consisting of: [0000] (SEQ ID NO: 3) Val-Leu-Gly-Gly-Gly-Ser-Ala-Leu-Leu-Arg-Ser-Ile- Pro-Ala; (SEQ ID NO: 4) Val-Glu-Glu-Gly-Ile-Val-Leu-Gly-Gly-Gly-Ser-Ala- Leu-Leu-Arg-Ser-Ile-Pro-Ala; (SEQ ID NO: 5) Leu-Gly-Gly-Gly-Ser-Ala-Leu-Leu-Arg-Ser-Ile-Pro- Ala; (SEQ ID NO: 6) Gly-Gly-Gly-Ser-Ala-Leu-Leu-Arg-Ser-Ile-Pro-Ala; (SEQ ID NO: 7) Gly-Gly-Ser-Ala-Leu-Leu-Arg-Ser-Ile-Pro-Ala; (SEQ ID NO: 8) Gly-Ser-Ala-Leu-Leu-Arg-Ser-Ile-Pro-Ala; and (SEQ ID NO: 1) Ser-Ala-Leu-Leu-Arg-Ser-Ile-Pro-Ala. [0010] In one embodiment, the ADNF polypeptide is an ADNF III polypeptide. In another embodiment, the ADNF polypeptide is a full length ADNF III polypeptide. In another embodiment, the ADNF III polypeptide is Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln (SEQ ID NO:2). In another embodiment, the active core site of the ADNF III polypeptide comprises at least one D-amino acid. In another embodiment, the active core site of the ADNF III polypeptide comprises all D-amino acids. In another embodiment, the ADNF III polypeptide comprises up to about 20 amino acids at least one of the N-terminus and the C-terminus of the active core site. In another embodiment, the ADNF III polypeptide is a member selected from the group consisting of: [0000] (SEQ ID NO: 9) Gly-Gly-Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln; (SEQ ID NO: 10) Leu-Gly-Gly-Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln-Gln- Ser; (SEQ ID NO: 11) Leu-Gly-Leu-Gly-Gly-Asn-Ala-Pro-Val-Ser-Ile-Pro- Gln-Gln-Ser; (SEQ ID NO: 12) Ser-Val-Arg-Leu-Gly-Leu-Gly-Gly-Asn-Ala-Pro-Val- Ser-Ile-Pro-Gln-Gln-Ser; and (SEQ ID NO: 2) Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln. [0011] In one embodiment, at least one of the ADNF polypeptides is encoded by a nucleic acid that is administered to the subject. [0012] In one embodiment, an ADNF I polypeptide and an ADNF III polypeptide are administered to the subject. [0013] In one embodiment, the ADNF I or ADNF III polypeptide contains a covalently bound lipophilic moiety to enhance penetration or activity. [0014] In one embodiment, the subject suffers from anxiety or depression. In another embodiment, the ADNF polypeptide is administered to prevent anxiety or depression. In another embodiment, the disease is selected from the group consisting of: panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, social phobia, social anxiety disorder, specific phobias, generalized anxiety disorder, Major depression, dysthymia, and bipolar disorder. [0015] In one embodiment, the ADNF polypeptide is administered intranasally. In another embodiment, the ADNF polypeptide is administered orally. In another embodiment, the ADNF polypeptide is administered intravenously or subcutaneously. [0016] In one aspect, the present invention provides use of an ADNF polypeptide in the manufacture of a medicament for the treatment of depression or anxiety. [0017] In one aspect, the present invention provides the use of the NAP-tubulin binding site(s) to identify anxiolytic drugs and drugs that alleviate depression and provide neuroprotection. BRIEF DESCRIPTION OF THE DRAWINGS [0018] FIG. 1 . NAP-treated mice are more relaxed than sham-treated mice. Elevated plus maze tests were performed on 13-month-old mice chronically treated (week days, daily for 5 months) with intranasal NAP (n=12) in comparison to controls (n=12). The maze (elevated above ground level) was in a “plus” form with 2 open arms and 2 closed arms. Each mouse was placed separately in the center of the maze, facing an open arm. Parameters measured (over a 5 min test period) included: A—percent time spent in the open arms; B—percent open arms entries; C—number of closed arms entries; D—total number of arms entries. (**p<0.01). [0019] FIG. 2 . Sixteen-month-old mice chronically treated (week days, daily for 8 months) with NAP are more relaxed than sham-treated mice. Experiments were performed as in FIG. 1A-D . NAP treated mice, n=11; control mice, n=10. (**p<0.01). [0020] FIG. 3 . NAP effects in the Morris water maze. Mice were subjected to two daily tests in the Morris water maze, and latency to reach the hidden platform over a 90 sec test period was recorded. A and B—5-months-old mice chronically treated (week days, daily for 7 months) with intranasal NAP applications in comparison to control mice (A—first daily trial and B—second daily trial). Results show the latency to find the hidden platform. NAP treated mice, n=11; control mice, n=10. DEFINITIONS [0021] The phrase “ADNF polypeptide” refers to one or more activity dependent neurotrophic factors (ADNF) that have an active core site comprising the amino acid sequence of SALLRSIPA (referred to as “SAL”) or NAPVSIPQ (referred to as “NAP”), or conservatively modified variants thereof that have neurotrophic/neuroprotective activity as measured with in vitro cortical neuron culture assays described by, e.g., Hill et al., Brain Res. 603:222-233 (1993); Brenneman & Gozes, J. Clin. Invest. 97:2299-2307 (1996), Forsythe & Westbrook, J. Physiol. Lond. 396:515 (1988). An ADNF polypeptide can be an ADNF I polypeptide, an ADNF III polypeptide, their alleles, polymorphic variants, analogs, interspecies homolog, any subsequences thereof (e.g., SALLRSIPA or NAPVSIPQ) or lipophilic variants that exhibit neuroprotective/neurotrophic action on, e.g., neurons originating in the central nervous system either in vitro or in vivo. An “ADNF polypeptide” can also refer to a mixture of an ADNF I polypeptide and an ADNF III polypeptide. [0022] The term “ADNF I” refers to an activity dependent neurotrophic factor polypeptide having a molecular weight of about 14,000 Daltons with a pI of 8.3±0.25. As described above, ADNF I polypeptides have an active site comprising an amino acid sequence of Ser-Ala-Leu-Leu-Arg-Ser-Ile-Pro-Ala (also referred to as “SALLRSIPA” or “SAL” or “ADNF-9”). See Brenneman & Gozes, J. Clin. Invest. 97:2299-2307 (1996), Glazner et al., Anat. Embryo . ((Berl). 200:65-71 (1999), Brenneman et al., J. Pharm. Exp. Ther., 285:619-27 (1998), Gozes & Brenneman, J. Mol. Neurosci. 7:235-244 (1996), and Gozes et al., Dev. Brain Res. 99:167-175 (1997), all of which are herein incorporated by reference. Unless indicated as otherwise, “SAL” refers to a peptide having an amino acid sequence of Ser-Ala-Leu-Leu-Arg-Ser-Ile-Pro-Ala, not a peptide having an amino acid sequence of Ser-Ala-Leu. A full length amino acid sequence of ADNF I can be found in WO 96/11948, herein incorporated by reference in its entirety. [0023] The phrase “ADNF III polypeptide” or “ADNF III” also called activity-dependent neuroprotective protein (ADNP) refers to one or more activity dependent neurotrophic factors (ADNF) that have an active core site comprising the amino acid sequence of NAPVSIPQ (referred to as “NAP”), or conservatively modified variants thereof that have neurotrophic/neuroprotective activity as measured with in vitro cortical neuron culture assays described by, e.g., Hill et al., Brain Res. 603, 222-233 (1993); Gozes et al., Proc. Natl. Acad. Sci. USA 93, 427-432 (1996). An ADNF polypeptide can be an ADNF III polypeptide, allelelic or polymorphic variant, analog, interspecies homolog, or any subsequences thereof (e.g., NAPVSIPQ) that exhibit neuroprotective/neurotrophic action on, e.g., neurons originating in the central nervous system either in vitro or in vivo. ADNF III polypeptides can range from about eight amino acids and can have, e.g., between 8-20, 8-50, 10-100 or about 1000 or more amino acids. [0024] Full length human ADNF III has a predicted molecular weight of 123,562.8 Da (>1000 amino acid residues) and a pI of about 6.97. As described above, ADNF III polypeptides have an active site comprising an amino acid sequence of Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln (also referred to as “NAPVSIPQ” or “NAP”). See Zamostiano et al., J. Biol. Chem. 276:708-714 (2001) and Bassan et al., J. Neurochem. 72:1283-1293 (1999), each of which is incorporated herein by reference. Unless indicated as otherwise, “NAP” refers to a peptide having an amino acid sequence of Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln, not a peptide having an amino acid sequence of Asn-Ala-Pro. Full-length amino acid and nucleic acid sequences of ADNF III can be found in WO 98/35042, WO 00/27875, U.S. Pat. Nos. 6,613,740 and 6,649,411. The Accession number for the human sequence is NP 852107, see also Zamostiano et al., supra. [0025] The term “subject” refers to any mammal, in particular human, at any stage of life. The term “contacting” is used herein interchangeably with the following: combined with, added to, mixed with, passed over, incubated with, flowed over, etc. Moreover, the ADNF III polypeptides or nucleic acids encoding them of the present invention can be “administered” by any conventional method such as, for example, parenteral, oral, topical, and inhalation routes. In some embodiments, parenteral and nasal inhalation routes are employed. [0026] A “mental disorder” or “mental illness” or “mental disease” or “psychiatric or neuropsychiatric disease or illness or disorder” refers to mood disorders (e.g., major depression, mania, and bipolar disorders), psychotic disorders (e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, brief psychotic disorder, and shared psychotic disorder), personality disorders, anxiety disorders (e.g., obsessive-compulsive disorder and attention deficit disorders) as well as other mental disorders such as substance-related disorders, childhood disorders, dementia, autistic disorder, adjustment disorder, delirium, multi-infarct dementia, and Tourette's disorder as described in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, (DSM IV). Typically, such disorders have a complex genetic and/or a biochemical component. [0027] A “mood disorder” refers to disruption of feeling tone or emotional state experienced by an individual for an extensive period of time. Mood disorders include major depression disorder (i.e., unipolar disorder), mania, dysphoria, bipolar disorder, dysthymia, cyclothymia and many others. See, e.g., Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition, (DSM IV). [0028] “Major depression disorder,” “major depressive disorder,” or “unipolar disorder” refers to a mood disorder involving any of the following symptoms: persistent sad, anxious, or “empty” mood; feelings of hopelessness or pessimism; feelings of guilt, worthlessness, or helplessness; loss of interest or pleasure in hobbies and activities that were once enjoyed, including sex; decreased energy, fatigue, being “slowed down”; difficulty concentrating, remembering, or making decisions; insomnia, early-morning awakening, or oversleeping; appetite and/or weight loss or overeating and weight gain; thoughts of death or suicide or suicide attempts; restlessness or irritability; or persistent physical symptoms that do not respond to treatment, such as headaches, digestive disorders, and chronic pain. Various subtypes of depression are described in, e.g., DSM IV. [0029] “Bipolar disorder” is a mood disorder characterized by alternating periods of extreme moods. A person with bipolar disorder experiences cycling of moods that usually swing from being overly elated or irritable (mania) to sad and hopeless (depression) and then back again, with periods of normal mood in between. Diagnosis of bipolar disorder is described in, e.g., DSM IV. Bipolar disorders include bipolar disorder I (mania with or without major depression) and bipolar disorder II (hypomania with major depression), see, e.g., DSM IV. [0030] “Anxiety,” “anxiety disorder,” and “anxiety-related disorder refer to psychiatric syndromes characterized by a subjective sense of unease, dread, or foreboding, e.g., panic disorder, generalized anxiety disorder, attention deficit disorder, attention deficit hyperactive disorder, obsessive-compulsive disorder, and stress disorders, e.g., acute and post-traumatic. Diagnostic criteria for these disorders are well known to those of skill in the art (see, e.g., Harrison's Principles of Internal Medicine , pp. 2486-2490 (Wilson et al., eds., 12th ed. 1991) and DSM IV). [0031] The terms “polypeptide,” “peptide” and “protein” are used interchangeably herein to refer to a polymer of amino acid residues. Generally, a peptide refers to a short polypeptide. The terms apply to amino acid polymers in which one or more amino acid residue is an analog or mimetic of a corresponding naturally occurring amino acid, as well as to naturally occurring amino acid polymers. [0032] The term “amino acid” refers to naturally occurring and synthetic amino acids, as well as amino acid analogs and amino acid mimetics that function in a manner similar to the naturally occurring amino acids. Naturally occurring amino acids are those encoded by the genetic code, as well as those amino acids that are later modified, e.g., hydroxyproline, .gamma.-carboxyglutamate, and O-phosphoserine. For the purposes of this application, amino acid analogs refers to compounds that have the same basic chemical structure as a naturally occurring amino acid, i.e., an a carbon that is bound to a hydrogen, a carboxyl group, an amino group, and an R group, e.g., homoserine, norleucine, methionine sulfoxide, methionine methyl sulfonium. Such analogs have modified R groups (e.g., norleucine) or modified peptide backbones, but retain the same basic chemical structure as a naturally occurring amino acid. For the purposes of this application, amino acid mimetics refers to chemical compounds that have a structure that is different from the general chemical structure of an amino acid, but that functions in a manner similar to a naturally occurring amino acid. [0033] Amino acids may include those having non-naturally occurring D-chirality, as disclosed in WO 01/12654, incorporated herein by reference, which may improve oral availability and other drug like characteristics of the compound. In such embodiments, one or more, and potentially all of the amino acids of NAP or the ADNF polypeptide will have D-chirality. The therapeutic use of peptides can be enhanced by using D-amino acids to provide longer half life and duration of action. However, many receptors exhibit a strong preference for L-amino acids, but examples of D-peptides have been reported that have equivalent activity to the naturally occurring L-peptides, for example, pore-forming antibiotic peptides, beta amyloid peptide (no change in toxicity), and endogenous ligands for the CXCR4 receptor. In this regard, NAP and ADNF polypeptides also retain activity in the D-amino acid form (Brenneman et al., J. Pharmacol. Exp. Ther . (2004), in press, see also Brenneman et al., The Journal of Pharmacology and Expermental Therpeutics Fasy Forward , Mar. 8, 2004; 10.1124/jpet103.063891). [0034] Amino acids may be referred to by either their commonly known three letter symbols or by the one-letter symbols recommended by the IUPAC-IUB Biochemical Nomenclature Commission. Nucleotides, likewise, may be referred to by their commonly accepted single-letter codes. The amino acids referred to herein are described by shorthand designations as follows: [0000] TABLE I Amino Acid Nomenclature Name 3-letter 1 letter Alanine Ala A Arginine Arg R Asparagine Asn N Aspartic Acid Asp D Cysteine Cys C Glutamic Acid Glu E Glutamine Gln Q Glycine Gly G Histidine His H Homoserine Hse — Isoleucine Ile I Leucine Leu L Lysine Lys K Methionine Met M Methionine sulfoxide Met (O) — Methionine methylsulfonium Met (S--Me) — Norleucine Nle — Phenylalanine Phe F Proline Pro P Serine Ser S Threonine Thr T Tryptophan Trp W Tyrosine Tyr Y Valine Val V [0035] “Conservatively modified variants” applies to both amino acid and nucleic acid sequences. With respect to particular nucleic acid sequences, conservatively modified variants refers to those nucleic acids which encode identical or essentially identical amino acid sequences, or where the nucleic acid does not encode an amino acid sequence, to essentially identical sequences. Specifically, degenerate codon substitutions may be achieved by generating sequences in which the third position of one or more selected (or all) codons is substituted with mixed-base and/or deoxyinosine residues (Batzer et al., Nucleic Acid Res. 19:5081 (1991); Ohtsuka et al., J. Biol. Chem. 260:2605-2608 (1985); Rossolini et al., Mol. Cell. Probes 8:91-98 (1994)). Because of the degeneracy of the genetic code, a large number of functionally identical nucleic acids encode any given protein. For instance, the codons GCA, GCC, GCG and GCU all encode the amino acid alanine. Thus, at every position where an alanine is specified by a codon, the codon can be altered to any of the corresponding codons described without altering the encoded polypeptide. Such nucleic acid variations are “silent variations,” which are one species of conservatively modified variations. Every nucleic acid sequence herein which encodes a polypeptide also describes every possible silent variation of the nucleic acid. One of skill will recognize that each codon in a nucleic acid (except AUG, which is ordinarily the only codon for methionine, and TGG, which is ordinarily the only codon for tryptophan) can be modified to yield a functionally identical molecule. Accordingly, each silent variation of a nucleic acid which encodes a polypeptide is implicit in each described sequence. [0036] As to amino acid sequences, one of skill will recognize that individual substitutions, deletions or additions to a nucleic acid, peptide, polypeptide, or protein sequence which alters, adds or deletes a single amino acid or a small percentage of amino acids in the encoded sequence is a “conservatively modified variant” where the alteration results in the substitution of an amino acid with a chemically similar amino acid. Conservative substitution tables providing functionally similar amino acids are well known in the art. Such conservatively modified variants are in addition to and do not exclude polymorphic variants, interspecies homologs, and alleles of the invention. [0037] The following groups each contain amino acids that are conservative substitutions for one another: [0038] 1) Alanine (A), Glycine (G); [0039] 2) Serine (S), Threonine (T); [0040] 3) Aspartic acid (D), Glutamic acid (E); [0041] 4) Asparagine (N), Glutamine (Q); [0042] 5) Cysteine (C), Methionine (M); [0043] 6) Arginine (R), Lysine (K), Histidine (H); [0044] 7) Isoleucine (1), Leucine (L), Valine (V); and [0045] 8) Phenylalanine (F), Tyrosine (Y), Tryptophan (W). (see, e.g., Creighton, Proteins (1984)). [0046] One of skill in the art will appreciate that many conservative variations of the nucleic acid and polypeptide sequences provided herein yield functionally identical products. For example, due to the degeneracy of the genetic code, “silent substitutions” (i.e., substitutions of a nucleic acid sequence that do not result in an alteration in an encoded polypeptide) are an implied feature of every nucleic acid sequence that encodes an amino acid. Similarly, “conservative amino acid substitutions,” in one or a few amino acids in an amino acid sequence are substituted with different amino acids with highly similar properties (see the definitions section, supra), are also readily identified as being highly similar to a disclosed amino acid sequence, or to a disclosed nucleic acid sequence that encodes an amino acid. Such conservatively substituted variations of each explicitly listed nucleic acid and amino acid sequences are a feature of the present invention. [0047] The terms “isolated,” “purified” or “biologically pure” refer to material that is substantially or essentially free from components that normally accompany it as found in its native state. [0048] “An amount sufficient” or “an effective amount” or a “therapeutically effective amount” is that amount of a given NAP or ADNF polypeptide that exhibits the anxiolytic or anti-depressant activity of interest or which provides either a subjective relief of a symptom(s) or an objectively identifiable improvement as noted by the clinician or other qualified observer. In therapeutic applications, the NAP or ADNF polypeptides of the invention are administered to a patient in an amount sufficient to reduce or eliminate symptoms of anxiety and/or depression. An amount adequate to accomplish this is defined as the “therapeutically effective dose.” The dosing range varies with the NAP or ADNF polypeptide used, the route of administration and the potency of the particular NAP or ADNF polypeptide, as further set out below, and in patents CA Patent 2202496, U.S. Pat. No. 6,174,862 and U.S. Pat. No. 6,613,740, herein incorporated by reference in their entirety. [0049] “Inhibitors,” “activators,” and “modulators” of expression or of activity are used to refer to inhibitory, activating, or modulating molecules, respectively, identified using in vitro and in vivo assays for expression or activity, e.g., ligands, agonists, antagonists, and their homologs and mimetics. The term “modulator” includes inhibitors and activators. Inhibitors are agents that, e.g., inhibit expression of a polypeptide or polynucleotide of the invention or bind to, partially or totally block stimulation or enzymatic activity, decrease, prevent, delay activation, inactivate, desensitize, or down regulate the activity of a polypeptide or polynucleotide of the invention, e.g., antagonists. Activators are agents that, e.g., induce or activate the expression of a polypeptide or polynucleotide of the invention or bind to, stimulate, increase, open, activate, facilitate, enhance activation or enzymatic activity, sensitize or up regulate the activity of a polypeptide or polynucleotide of the invention, e.g., agonists. Modulators include naturally occurring and synthetic ligands, antagonists, agonists, small chemical molecules and the like. Assays to identify inhibitors and activators include, e.g., applying putative modulator compounds to cells, in the presence or absence of a polypeptide or polynucleotide of the invention and then determining the functional effects on a polypeptide or polynucleotide of the invention activity. Samples or assays comprising a polypeptide or polynucleotide of the invention that are treated with a potential activator, inhibitor, or modulator are compared to control samples without the inhibitor, activator, or modulator to examine the extent of effect. Control samples (untreated with modulators) are assigned a relative activity value of 100% Inhibition is achieved when the activity value of a polypeptide or polynucleotide of the invention relative to the control is about 80%, optionally 50% or 25-1%. Activation is achieved when the activity value of a polypeptide or polynucleotide of the invention relative to the control is 110%, optionally 150%, optionally 200-500%, or 1000-3000% higher. [0050] The term “test compound” or “drug candidate” or “modulator” or grammatical equivalents as used herein describes any molecule, either naturally occurring or synthetic, e.g., protein, oligopeptide (e.g., from about 5 to about 25 amino acids in length, preferably from about 10 to 20 or 12 to 18 amino acids in length, preferably 12, 15, or 18 amino acids in length), small organic molecule, polysaccharide, lipid, fatty acid, polynucleotide, oligonucleotide, etc. The test compound can be in the form of a library of test compounds, such as a combinatorial or randomized library that provides a sufficient range of diversity. Test compounds are optionally linked to a fusion partner, e.g., targeting compounds, rescue compounds, dimerization compounds, stabilizing compounds, addressable compounds, and other functional moieties. Conventionally, new chemical entities with useful properties are generated by identifying a test compound (called a “lead compound”) with some desirable property or activity, e.g., inhibiting activity, creating variants of the lead compound, and evaluating the property and activity of those variant compounds. Often, high throughput screening (HTS) methods are employed for such an analysis. [0051] A “small organic molecule” refers to an organic molecule, either naturally occurring or synthetic, that has a molecular weight of more than about 50 Daltons and less than about 2500 Daltons, preferably less than about 2000 Daltons, preferably between about 100 to about 1000 Daltons, more preferably between about 200 to about 500 Daltons. DETAILED DESCRIPTION OF THE INVENTION [0052] This invention relates to the therapeutic use of NAP and ADNF polypeptides in the treatment of diseases and disorders including anxiety and depression, and disorders related thereto. The invention is based on the finding set out in Example 1 that treatment of mice with NAP peptide significantly reduces anxiety-like behavior in a widely used and accepted industry standard model of anxiety, the Elevated plus-maze (see Rodgers & Dalvi, Neurosci. Biobehav. Rev. 21(6) 801-810 (1997)). The invention further discloses that while providing anxiolytic effects, NAP does not inhibit cognitive functions. In another embodiment, this invention further discloses NAP mechanism of action and identifies tubulin as the molecular target for NAP's activity offering a novel target platform for anxiolytic drug discovery (see Example 2). The discovery of NAP's mechanism of action provides drug assays for compounds that also can be used to treat anxiety and depression. In such assays, compounds that modulate the interaction between NAP and tubulin are identified. [0053] ADNF Polypeptides [0054] In one embodiment, the ADNF polypeptides of the present invention comprise the following amino acid sequence: (R 1 ) x -Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln-(R 2 ) y (SEQ ID NO:13) and conservatively modified variations thereof. In this designation, R 1 denotes the orientation of the amino terminal (NH 2 or N-terminal) end and R 2 represents the orientation of the carboxyl terminal (COOH or C-terminal) end. [0055] In the above formula, R 1 is an amino acid sequence comprising from 1 to about 40 amino acids, wherein each amino acid is independently selected from the group consisting of naturally occurring amino acids and amino acid analogs. The term “independently selected” is used herein to indicate that the amino acids making up the amino acid sequence R 1 may be identical or different (e.g., all of the amino acids in the amino acid sequence may be threonine, etc.). Moreover, as previously explained, the amino acids making up the amino acid sequence R 1 may be either naturally occurring amino acids, or known analogues of natural amino acids that functions in a manner similar to the naturally occurring amino acids (i.e., amino acid mimetics and analogs). Suitable amino acids that can be used to form the amino acid sequence R 1 include, but are not limited to, those listed in Table I, infra. The indexes “x” and “y” are independently selected and can be equal to one or zero. [0056] As with R 1 , R 2 , in the above formula, is an amino acid sequence comprising from 1 to about 40 amino acids, wherein each amino acid is independently selected from the group consisting of naturally occurring amino acids and amino acid analogs. Moreover, as with R 1 , the amino acids making up the amino acid sequence R 2 may be identical or different, and may be either naturally occurring amino acids, or known analogues of natural amino acids that functions in a manner similar to the naturally occurring amino acids (i.e., amino acid mimetics and analogs). Suitable amino acids that can be used to form R 2 include, but are not limited to, those listed in Table I, infra. [0057] As used herein, “NAP” or “NAP peptide” refers to the formula above where x and y both equal 0. “NAP related peptide” refers to any of the other variants of NAP which are described the formula. [0058] R 1 and R 2 are independently selected. If R 1 R 2 are the same, they are identical in terms of both chain length and amino acid composition. For example, both R 1 and R 2 may be Val-Leu-Gly-Gly-Gly (SEQ ID NO:14). If R 1 and R 2 are different, they can differ from one another in terms of chain length and/or amino acid composition and/or order of amino acids in the amino acids sequences. For example, R 1 may be Val-Leu-Gly-Gly-Gly (SEQ ID NO:15), whereas R 2 may be Val-Leu-Gly-Gly (SEQ ID NO:16). Alternatively, R 1 may be Val-Leu-Gly-Gly-Gly (SEQ ID NO:17), whereas R 2 may be Val-Leu-Gly-Gly-Val (SEQ ID NO:18). Alternatives, R 1 may be Val-Leu-Gly-Gly-Gly (SEQ ID NO:19), whereas R 2 may be Gly-Val-Leu-Gly-Gly (SEQ ID NO:20). [0059] Within the scope of the above formula, certain NAP and NAP related polypeptides are preferred, namely those in which x and y are both zero (i.e. NAP). Equally preferred are NAP and NAP related polypeptides in which x is one; R 1 Gly-Gly; and y is zero (SEQ ID NO:21). Also equally preferred are NAP and NAP related polypeptides in which is one; R 1 is Leu-Gly-Gly; y is one; and R 2 is -Gln-Ser (SEQ ID NO:22). Also equally preferred are NAP and NAP related polypeptides in which x is one; R 1 is Leu-Gly-Leu-Gly-Gly- (SEQ ID NO:23); y is one; and R 2 is -Gln-Ser (SEQ ID NO:24). Also equally preferred are NAP and NAP related polypeptides in which x is one; R 1 is Ser-Val-Arg-Leu-Gly-Leu-Gly-Gly-(SEQ ID NO:25); y is one; and R 2 is -Gln-Ser (SEQ ID NO:26). Additional amino acids can be added to both the N-terminus and the C-terminus of the active peptide without loss of biological activity. [0060] In another aspect, the present invention provides pharmaceutical compositions comprising one of the previously described NAP and NAP related polypeptides in an amount sufficient to exhibit anxiolytic (e.g. anxiety reducing) or anti-depressant activity, in a pharmaceutically acceptable diluent, carrier or excipient. In one embodiment, the NAP or NAP related peptide has an amino acid sequence selected from the group consisting of SEQ ID NO:2, and 9-12, and conservatively modified variations thereof. [0061] In another embodiment, the ADNF polypeptide comprises the following amino acid sequence: (R 1 ) x -Ser-Ala-Leu-Leu-Arg-Ser-Ile-Pro-Ala-(R 2 ) y (SEQ ID NO:27) and conservatively modified variations thereof. In this designation, R 1 denotes the orientation of the amino terminal (NH 2 or N-terminal) end and R 2 represents the orientation of the carboxyl terminal (COOH or C-terminal) end. [0062] In the above formula, R 1 is an amino acid sequence comprising from 1 to about 40 amino acids, wherein each amino acid is independently selected from the group consisting of naturally occurring amino acids and amino acid analogs. The term “independently selected” is used herein to indicate that the amino acids making up the amino acid sequence R 1 may be identical or different (e.g., all of the amino acids in the amino acid sequence may be threonine, etc.). Moreover, as previously explained, the amino acids making up the amino acid sequence R 1 may be either naturally occurring amino acids, or known analogues of natural amino acids that functions in a manner similar to the naturally occurring amino acids (i.e., amino acid mimetics and analogs). Suitable amino acids that can be used to form the amino acid sequence R 1 include, but are not limited to, those listed in Table I, infra. The indexes “x” and “y” are independently selected and can be equal to one or zero. [0063] As with R′, R 2 , in the above formula, is an amino acid sequence comprising from 1 to about 40 amino acids, wherein each amino acid is independently selected from the group consisting of naturally occurring amino acids and amino acid analogs. Moreover, as with R 1 , the amino acids making up the amino acid sequence R 2 may be identical or different, and may be either naturally occurring amino acids, or known analogues of natural amino acids that functions in a manner similar to the naturally occurring amino acids (i.e., amino acid mimetics and analogs). Suitable amino acids that can be used to form R 2 include, but are not limited to, those listed in Table I, infra. [0064] As used herein, “SAL” or “SAL peptide” refers to the formula above where x and y both equal 0. “SAL related peptide” refers to any of the other variants of SAL which are described the formula. [0065] R 1 and R 2 are independently selected. If R 1 R 2 are the same, they are identical in terms of both chain length and amino acid composition. Additional amino acids can be added to both the N-terminus and the C-terminus of the active peptide without loss of biological activity. [0066] In another aspect, the present invention provides pharmaceutical compositions comprising one of the previously described SAL and SAL-related polypeptides in an amount sufficient to exhibit anxiolytic (e.g. anxiety reducing) or anti-depressant activity, in a pharmaceutically acceptable diluent, carrier or excipient. In one embodiment, the SAL or SAL related peptide has an amino acid sequence selected from the group consisting of SEQ ID NO:1 and 3-8, and conservatively modified variations thereof. [0067] Design and Synthesis of ADNF Polypeptides [0068] Polypeptides and peptides comprising the core NAPVSIPQ or SALLRSIPA active site can be easily made, e.g., by systematically adding one amino acid at a time and screening the resulting peptide for biological activity, as described herein. In addition, the contributions made by the side chains of various amino acid residues in such peptides can be probed via a systematic scan with a specified amino acid, e.g., Ala. [0069] One of skill will recognize many ways of generating alterations in a given nucleic acid sequence. Such well-known methods include site-directed mutagenesis, PCR amplification using degenerate oligonucleotides, exposure of cells containing the nucleic acid to mutagenic agents or radiation, chemical synthesis of a desired oligonucleotide (e.g., in conjunction with ligation and/or cloning to generate large nucleic acids) and other well-known techniques (see Giliman & Smith, Gene 8:81-97 (1979); Roberts et al., Nature 328:731-734 (1987)). [0070] Most commonly, polypeptide sequences are altered by changing the corresponding nucleic acid sequence and expressing the polypeptide. However, polypeptide sequences are also optionally generated synthetically using commercially available peptide synthesizers to produce any desired polypeptide (see Merrifield, Am. Chem. Soc. 85:2149-2154 (1963); Stewart & Young, Solid Phase Peptide Synthesis (2nd ed. 1984)). [0071] One of skill can select a desired nucleic acid or polypeptide of the invention based upon the sequences provided and upon knowledge in the art regarding proteins generally. Knowledge regarding the nature of proteins and nucleic acids allows one of skill to select appropriate sequences with activity similar or equivalent to the nucleic acids and polypeptides disclosed herein. The definitions section, supra, describes exemplar conservative amino acid substitutions. [0072] Modifications to the NAP and ADNF polypeptides are evaluated by routine screening techniques in suitable assays for the desired characteristic. For instance, changes in the immunological character of a polypeptide can be detected by an appropriate immunological assay. Modifications of other properties such as nucleic acid hybridization to a target nucleic acid, redox or thermal stability of a protein, hydrophobicity, susceptibility to proteolysis, or the tendency to aggregate are all assayed according to standard techniques. [0073] More particularly, it will be readily apparent to those of ordinary skill in the art that the small peptides of the present invention can readily be screened for anxiolytic and anti-depressant activity by employing suitable assays and animal models known to those skilled in the art. Among the animal models employed to evaluate the anxiolytic or anxiogenic effects of drugs, the elevated plus-maze is probably the most popular. (See Rodgers and Dalvi, supra). For factors controlling measures of anxiety and responses to novelty in the mouse, see File, Behav. Brain Res. 125:151-157 (2001). For a review of the validity and variability of the elevated plus-maze as an animal model of anxiety, see Hogg, Pharmacol. Biochem. Behav. 54:21-30 (1996); and Lister, Psychopharmacology (Berlin) 92: 180-185 (1987). The Elevated plus-maze model is described in some detail in Example 1. Still, those skilled in the art are aware of a wide range of alternative models which are also available to measure the anxiolytic effect of therapeutic agents. Such models may require measurement of physiological or endocrine functions (e.g., hyperthermic or corticosterone responses to stress) while others analyze behavior. Broadly speaking, suitable behavioral models for testing anxiolytic effects of a test compound involve exposure of animals to stimuli (exteroceptive or interoceptive) that appear capable of causing anxiety in humans. The animals are then treated with the test compound to determine if it generates an anxiolytic effect. The models may also be grouped into two general categories involving either conditioned (e.g. Geller-Seifter conflict, potentiated startle) or unconditioned (social interaction and light/dark exploration tests) responses. Those in the art are aware that any of these standard behavioral models may be used to test NAP or ADNF polypeptides to identify or confirm anxiolytic activity of test peptides. [0074] Using these assays and models, one of ordinary skill in the art can readily prepare a large number of NAP and ADNF polypeptides in accordance with the teachings of the present invention and, in turn, screen them using the foregoing animal models to find ADNF polypeptides, in addition to those set forth herein, which possess the desired activity. For instance, using the NAP peptide (i.e., Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln (SEQ ID NO:2)) or SAL peptide Ser-Ala-Leu-Leu-Arg-Ser-Ile-Pro-Ala (SEQ ID NO:1) as a starting point, one can systematically add, for example, Gly-, Gly-Gly-, Leu-Gly-Gly- to the N-terminus of the peptide and, in turn, screen each of these NAP or ADNF polypeptides in the foregoing assay to determine whether they possess anxiolytic or anti-depressant activity. In doing so, it will be found that additional amino acids can be added to both the N-terminus and the C-terminus of the active site, i.e., Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln (SEQ ID NO:2) or Ser-Ala-Leu-Leu-Arg-Ser-Ile-Pro-Ala (SEQ ID NO:1), without loss of biological activity. [0075] The peptides of the invention may be prepared via a wide variety of well-known techniques. Peptides of relatively short size are typically synthesized on a solid support or in solution in accordance with conventional techniques (see, e.g., Merrifield, Am. Chem. Soc. 85:2149-2154 (1963)). Various automatic synthesizers and sequencers are commercially available and can be used in accordance with known protocols (see, e.g., Stewart & Young, Solid Phase Peptide Synthesis (2nd ed. 1984)). Solid phase synthesis in which the C-terminal amino acid of the sequence is attached to an insoluble support followed by sequential addition of the remaining amino acids in the sequence is the preferred method for the chemical synthesis of the peptides of this invention. Techniques for solid phase synthesis are described by Barany & Merrifield, Solid - Phase Peptide Synthesis ; pp. 3-284 in The Peptides Analysis, Synthesis, Biology . Vol. 2: Special Methods in Peptide Synthesis , Part A.; Merrifield et al 1963; Stewart et al. 1984). NAP and related peptides are synthesized using standard Fmoc protocols (Wellings & Atherton, Methods Enzymol. 289:44-67 (1997)). [0076] In addition to the foregoing techniques, the peptides for use in the invention may be prepared by recombinant DNA methodology. Generally, this involves creating a nucleic acid sequence that encodes the protein, placing the nucleic acid in an expression cassette under the control of a particular promoter, and expressing the protein in a host cell. Recombinantly engineered cells known to those of skill in the art include, but are not limited to, bacteria, yeast, plant, filamentous fungi, insect (especially employing baculoviral vectors) and mammalian cells. [0077] The recombinant nucleic acids are operably linked to appropriate control sequences for expression in the selected host. For E. coli , example control sequences include the T7, trp, or lambda promoters, a ribosome binding site and, preferably, a transcription termination signal. For eukaryotic cells, the control sequences typically include a promoter and, preferably, an enhancer derived from immunoglobulin genes, SV40, cytomegalovirus, etc., and a polyadenylation sequence, and may include splice donor and acceptor sequences. [0078] The plasmids of the invention can be transferred into the chosen host cell by well-known methods. Such methods include, for example, the calcium chloride transformation method for E. coli and the calcium phosphate treatment or electroporation methods for mammalian cells. Cells transformed by the plasmids can be selected by resistance to antibiotics conferred by genes contained on the plasmids, such as the amp, gpt, neo, and hyg genes. [0079] Once expressed, the recombinant peptides can be purified according to standard procedures of the art, including ammonium sulfate precipitation, affinity columns, column chromatography, gel electrophoresis and the like (see, e.g., Scopes, Polypeptide Purification (1982); Deutscher, Methods in Enzymology Vol. 182: Guide to Polypeptide Purification (1990)). Once purified, partially or to homogeneity as desired, the NAP and ADNF polypeptides may then be used, e.g., to prevent neuronal cell death or as immunogens for antibody production. Optional additional steps include isolating the expressed protein to a higher degree, and, if required, cleaving or otherwise modifying the peptide, including optionally renaturing the protein. [0080] After chemical synthesis, biological expression or purification, the peptide(s) may possess a conformation substantially different than the native conformations of the constituent peptides. In this case, it is helpful to denature and reduce the peptide and then to cause the peptide to re-fold into the preferred conformation. Methods of reducing and denaturing peptides and inducing re-folding are well known to those of skill in the art (see Debinski et al., J. Biol. Chem. 268:14065-14070 (1993); Kreitman & Pastan, Bioconjug. Chem. 4:581-585 (1993); and Buchner et al., Anal. Biochem. 205:263-270 (1992)). Debinski et al., for example, describe the denaturation and reduction of inclusion body peptides in guanidine-DTE. The peptide is then refolded in a redox buffer containing oxidized glutathione and L-arginine. [0081] One of skill will recognize that modifications can be made to the peptides without diminishing their biological activity. Some modifications may be made to facilitate the cloning, expression, or incorporation of the targeting molecule into a fusion peptide. Such modifications are well known to those of skill in the art and include, for example, a methionine added at the amino terminus to provide an initiation site, or additional amino acids (e.g., poly His) placed on either terminus to create conveniently located restriction sites or termination codons or purification sequences. [0082] Use of NAP and ADNF Polypeptides for Treating Anxiety and/or Depression, Including Other Mood Disorders and Anxiety Disorders [0083] This invention discloses for the first time the surprising finding that NAP and ADNF polypeptides that were shown before to be neuroprotective and providing cognitive enhancement can be used in the treatment and/or prevention of a broad range of human clinical disorders such as anxiety and depression and a broad range of related disorders. As current medications used for treatment of anxiety disorders may adversely affect alertness, this surprising discovery offers an obvious advantage. Furthermore, anxiety is common in the elderly and can present as a primary anxiety disorder or as a symptom of another disorder. Generalized anxiety disorder (GAD), in particular, is a common syndrome in late life. Anxiety symptoms are also common features of late-life depression and dementia. [0084] Treatment of anxiety in elderly persons has typically involved the use of benzodiazepines, which are often effective but problematic because they are associated with increased risk of cognitive impairment, falls, and fractures (Lenze et al., CNS Spectr. 12 Suppl 3:6-13 (2003)). Benzodiazepines interact with the gamma-aminobutyric acid (GABA) receptor. Previously, gephyrin, a tubulin-binding protein, was found as the core of inhibitory postsynaptic scaffolds stabilizing glycine receptors (GlyRs) and/or GABA(A) receptors (Hanus et al., J Neurosci. 24(5):1119-28 (2004)). Here, a mechanism for NAP is disclosed and the molecular target—tubulin, the subunit protein of microtubules is identified as the NAP binding protein. The direct interaction of NAP with tubulin may circumvent the adverse side effects associated with benzodiazepines treatments and further offers a target platform for novel drug discovery. [0085] Anxiety is a cardinal symptom of many psychiatric disorders as well as a disease in itself. Symptoms of anxiety commonly are associated with depression and especially with dysthymic disorder (chronic depression of moderate severity), panic disorder, agoraphobia and other specific phobias, obsessive-compulsive disorder, eating disorders and many personality disorders. Anxiety in human includes those further divisions set out in the Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association, DSM-IV, 4th Ed. 1994). [0086] Anxiety disorders are serious medical illnesses that affect approximately 19 million American adults. (Narrow et al., NIMH epidemiology note: prevalence of anxiety disorders. One-year prevalence best estimates calculated from ECA and NCS data. Population estimates based on U.S. Census estimated residential population age 18 to 54 on Jul. 1, 1998. Unpublished). These disorders fill people's lives with overwhelming anxiety and fear. Anxiety disorders are acute attacks or are chronic, relentless, and can grow progressively worse if not treated. Examples include: panic disorder, obsessive-compulsive disorder, attention deficit disorder and attention deficit hyperactivity disorder, post-traumatic stress disorder, social phobia (or social anxiety disorder), specific phobias, and generalized anxiety disorder. [0087] Major depression is characterized by clinically significant depressions of mood and impairment of functioning as its primary clinical manifestations. Its clinical manifestations and current treatment overlap the anxiety disorders including panic-agorophobia syndrome, sever phobias, generalized anxiety disorder, social anxiety disorder, post-traumatic stress disorders and obsessive-compulsive disorder. Extremes of mood may be associated with psychosis, manifested as disordered or delusional thinking and perceptions, often congruent with the predominant mood. [0088] In any given 1-year period, 9.5 percent of the population, or about 18.8 million American adults, suffer from a depressive illness (Robins & Regier (Eds). Psychiatric Disorders in America, The Epidemiologic Catchment Area Study, 1990; New York: The Free Press). Depression often accompanies anxiety disorders (Regier et al., British Journal of Psychiatry Supplement 34: 24-8 (1998)) and, when it does, it needs to be treated as well. Symptoms of depression include feelings of sadness, hopelessness, changes in appetite or sleep, low energy, and difficulty concentrating. Most people with depression can be effectively treated with antidepressant medications, certain types of psychotherapy, or a combination of both. [0089] Depressive disorders is expressed in different forms: [0090] Major depression is manifested by a combination of symptoms (see symptom list) that interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. Such a disabling episode of depression may occur only once but more commonly occurs several times in a lifetime. [0091] A less severe type of depression, dysthymia, involves long-term, chronic symptoms that do not disable, but keep one from functioning well or from feeling good. Many people with dysthymia also experience major depressive episodes at some time in their lives. [0092] Another type of depression is bipolar disorder, also called manic-depressive illness. Not nearly as prevalent as other forms of depressive disorders, bipolar disorder is characterized by cycling mood changes: severe highs (mania) and lows (depression). Sometimes the mood switches are dramatic and rapid, but most often they are gradual. When in the depressed cycle, an individual can have any or all of the symptoms of a depressive disorder. When in the manic cycle, the individual may be overactive, overtalkative, and have a great deal of energy. Mania often affects thinking, judgment, and social behavior in ways that cause serious problems and embarrassment. For example, the individual in a manic phase may feel elated, full of grand schemes that might range from unwise business decisions to romantic sprees. Mania, left untreated, may worsen to a psychotic state. [0093] Gamma-Aminobutyric acid (GABA) is the major inhibitory neurotransmitter in the mammalian Central Nervous System (CNS). GABA participates in the regulation of neuronal excitability through interaction with specific membrane proteins (the GABAA receptors). The binding of GABA to these postsynaptic receptors, results in an opening of a chloride channel integrated in the receptor which allows the entry of Cl— and consequently leads to hyperpolarization of the recipient cell. The action of GABA is allosterically modulated by a wide variety of chemical entities which interact with distinct binding sites at the GABAA receptor complex. [0094] One of the most thoroughly investigated modulatory site is the benzodiazepine binding site. The benzodiazepines constitute a well-known class of therapeutics displaying hypnotic, anxiolytic and anticonvulsant effects. Their usefulness, however, is limited by a broad range of side effects comprising sedation, ataxia, amnesia, alcohol and barbiturate potentiation, tolerance development and abuse potential. Consequently, there has been an intensive search for modulatory agents with an improved profile, and a diversity of chemical entities distinct from the benzodiazepines, but with GABA modulatory effects have been identified. The existence of endogenous ligands for the GABAA receptor complex beside GABA has often been described, but their role in the regulation of GABA action is still a matter of controversy. [0095] The progress of molecular biology during the last decade has contributed enormously to the understanding of benzodiazepine receptor pharmacology. A total of 14 GABAA receptor subunits have been cloned from mammalian brain and have been expressed/co-expressed in stable cell lines. These transfected cells constitute an important tool in the characterization of subtype selective ligands. In spite of the rapidly expanding knowledge of the molecular and pharmacological mechanisms involved in GABA/benzodiazepine related CNS disorders, the identification of clinically selective acting drugs is still to come (Teuber et al., Curr Pharm Des 5(5):317-43 (1999)). [0096] Control of neurotransmitter receptor expression and delivery to the postsynaptic membrane is of great importance for neural signal transduction at synapses. The GABA type A (GABA(A)) receptor-associated protein GABARAP was reported to have an important role for movement and sorting of GABA(A) receptor molecules to the postsynaptic membrane. GABARAP not only binds to GABA(A) receptor gamma2-subunit but also to tubulin, gephyrin, and ULK1, suggesting regulation through the interaction with the microtubular network (Stangler et al., J Biol. Chem. 19:277 (2002), 16:13363-6. Epub 2002 Mar. 1) [0097] Anxiety is often defined as an organism's response to potential threat, as opposed to direct or immediate threat. Anxiety and depression also encompass disorders of mood such as affective disorders. The severity of these conditions covers an extraordinarily broad range from normal grief reactions and dysthymia to severe, incapacitating illnesses that may result in death. [0098] Thus, according to the instant invention, NAP and ADNF polypeptides may be used to treat anxiety and/or depression and diseases or disorders related thereto, as defined herein. [0099] Drug Discovery Using NAP-Tubulin Binding [0100] The identification of tubulin as the NAP-binding site allows the use of tubulin and tubulin—derived peptides as targets for further drug discovery, e.g., for the treatment of diseases related to ADNF polypeptides such as anxiety, depression, disease related to neuronal cell death and oxidative stress, neurodegenerative diseases such as Alzheimer's disease, AIDS-related dementia, Huntington's disease, and Parkinson's disease, HIV-related dementia complex, stroke, head trauma, cerebral palsy, conditions associated with fetal alcohol syndrome. Such therapeutics can also be used in methods of enhancing learning and memory both pre- and post-natally. Experiments can be carried out with the intact tubulin structure and NAP as a displacing agent, or by further identification of the precise tubulin-NAP interacting site (e.g., as described Katchalski-Katzir et al., Biophys Chem. 100(1-3):293-305 (2003); Chang et al., J Comput Chem. 24(16):1987-98 (2003)). [0101] Preliminary screens can be conducted by screening for agents capable of binding to a polypeptide of the invention, as at least some of the agents so identified are likely modulators of polypeptide activity. The binding assays usually involve contacting a polypeptide of the invention with one or more test agents and allowing sufficient time for the protein and test agents to form a binding complex. Any binding complexes formed can be detected using any of a number of established analytical techniques. Protein binding assays include, but are not limited to, methods that measure co-precipitation, co-migration on non-denaturing SDS-polyacrylamide gels, and co-migration on Western blots (see, e.g., Bennet and Yamamura, (1985) Neurotransmitter, Hormone or Drug Receptor Binding Methods , in Neurotransmitter Receptor Binding (Yamamura et al., eds.), pp. 61-89. The protein utilized in such assays can be naturally expressed, cloned or synthesized. [0102] Agents that are initially identified by any of the foregoing screening methods can be further tested to validate the apparent activity. Preferably such studies are conducted with suitable animal models. The basic format of such methods involves administering a lead compound identified during an initial screen to an animal that serves as a model for humans and then determining if expression or activity of a polynucleotide or polypeptide of the invention is in fact upregulated. The animal models utilized in validation studies generally are mammals of any kind Specific examples of suitable animals include, but are not limited to, primates, mice, and rats. In one embodiment, the Elevated plus maze and the Morris water maze tests are used, as described in Example 1. [0103] The agents tested as modulators of the polypeptides of the invention can be any small chemical compound, or a biological entity, such as a protein, sugar, nucleic acid, RNAi, or lipid. Typically, test compounds will be small chemical molecules and peptides. Essentially any chemical compound can be used as a potential modulator or ligand in the assays of the invention, although most often compounds that can be dissolved in aqueous or organic (especially DMSO-based) solutions are used. The assays are designed to screen large chemical libraries by automating the assay steps and providing compounds from any convenient source to assays, which are typically run in parallel (e.g., in microtiter formats on microtiter plates in robotic assays). It will be appreciated that there are many suppliers of chemical compounds, including Sigma (St. Louis, Mo.), Aldrich (St. Louis, Mo.), Sigma-Aldrich (St. Louis, Mo.), Fluka Chemika-Biochemica Analytika (Buchs, Switzerland) and the like. Modulators also include agents designed to reduce the level of mRNA of the invention (e.g. antisense molecules, ribozymes, DNAzymes and the like) or the level of translation from an mRNA. [0104] In one preferred embodiment, high throughput screening methods involve providing a combinatorial chemical or peptide library containing a large number of potential therapeutic compounds (potential modulator or ligand compounds). Such “combinatorial chemical libraries” or “ligand libraries” are then screened in one or more assays, as described herein, to identify those library members (particular chemical species or subclasses) that display a desired characteristic activity. The compounds thus identified can serve as conventional “lead compounds” or can themselves be used as potential or actual therapeutics. Libraries available for screening for small active molecules include the Available Chemical Directory (ACD, 278,000 compounds), ACD screening library (>1,000,000 compounds), CRC Combined Chemical Dictionary (˜350,000 compounds) Anisex (115,000 compounds) Maybridge (62,000 compounds) Derwent and NCI libraries. [0105] Pharmaceutical Administration [0106] The pharmaceutical compositions of the present invention are suitable for use in a variety of drug delivery systems. Peptides that have the ability to cross the blood brain barrier can be administered, e.g., systemically, nasally, etc., using methods known to those of skill in the art. Larger peptides that do not have the ability to cross the blood brain barrier can be administered to the mammalian brain via intracerebroventricular (ICV) injection or via a cannula using techniques well known to those of skill in the art (see, e.g., Motta & Martini, Proc. Soc. Exp. Biol. Med. 168:62-64 (1981); Peterson et al., Biochem. Pharamacol. 31:2807-2810 (1982); Rzepczynski et al., Metab. Brain Dis. 3:211-216 (1988); Leibowitz et al., Brain Res. Bull. 21:905-912 (1988); Sramka et al., Stereotact. Funct. Neurosurg. 58:79-83 (1992); Peng et al., Brain Res. 632:57-67 (1993); Chem et al., Exp. Neurol. 125:72-81 (1994); Nikkhah et al., Neuroscience 63:57-72 (1994); Anderson et al., J. Comp. Neurol. 357:296-317 (1995); and Brecknell & Fawcett, Exp. Neurol. 138:338-344 (1996)). [0107] Suitable formulations for use in the present invention are found in Remington's Pharmaceutical Sciences (17th ed. 1985)), which is incorporated herein by reference. In addition, for a brief review of methods for drug delivery, see Langer, Science 249:1527-1533 (1990), which is incorporated herein by reference. Suitable dose ranges are described in the examples provided herein, as well as in WO 9611948, herein incorporated by reference in its entirety. [0108] As such, the present invention provides for therapeutic compositions or medicaments comprising one or more of the NAP or ADNF polypeptides described hereinabove in combination with a pharmaceutically acceptable excipient, wherein the amount of the NAP or ADNF polypeptide is sufficient to provide a therapeutic effect. [0109] In a therapeutic application, the NAP and ADNF polypeptides of the present invention are embodied in pharmaceutical compositions intended for administration by any effective means, including parenteral, topical, oral, pulmonary (e.g. by inhalation) or local administration. Preferably, the pharmaceutical compositions are administered parenterally, e.g., intravenously, subcutaneously, intradermally, or intramuscularly, or intranasally. [0110] Thus, the invention provides compositions for parenteral administration that comprise a solution of NAP or ADNF polypeptide, as described above, dissolved or suspended in an acceptable carrier, preferably an aqueous carrier. A variety of aqueous carriers may be used including, for example, water, buffered water, 0.4% saline, 0.3% glycine, hyaluronic acid and the like. These compositions may be sterilized by conventional, well known sterilization techniques or, they may be sterile filtered. The resulting aqueous solutions may be packaged for use as is or lyophilized, the lyophilized preparation being combined with a sterile solution prior to administration. The compositions may contain pharmaceutically acceptable auxiliary substances as required to approximate physiological conditions including pH adjusting and buffering agents, tonicity adjusting agents, wetting agents and the like, such as, for example, sodium acetate, sodium lactate, sodium chloride potassium chloride, calcium chloride, sorbitan monolaurate, triethanolamine oleate, etc. [0111] For solid compositions, conventional nontoxic solid carriers may be used that include, for example, pharmaceutical grades of mannitol, lactose, starch, magnesium stearate, sodium saccharin, talcum, cellulose, glucose, sucrose, magnesium carbonate, and the like. For oral administration, a pharmaceutically acceptable nontoxic composition is formed by incorporating any of the normally employed excipients, such as those carriers previously listed, and generally 10-95% of active ingredient and more preferably at a concentration of 25%-75%. [0112] For aerosol administration, the NAP or ADNF polypeptides are preferably supplied in finely divided form along with a surfactant and propellant. The surfactant must, of course, be nontoxic, and preferably soluble in the propellant. Representative of such agents are the esters or partial esters of fatty acids containing from 6 to 22 carbon atoms, such as caproic, octanoic, lauric, palmitic, stearic, linoleic, linolenic, olesteric and oleic acids with an aliphatic polyhydric alcohol or its cyclic anhydride. Mixed esters, such as mixed or natural glycerides may be employed. A carrier can also be included, as desired, as with, e.g., lecithin for intranasal delivery. An example includes a solution in which each milliliter included 7.5 mg NaCl, 1.7 mg citric acid monohydrate, 3 mg disodium phosphate dihydrate and 0.2 mg benzalkonium chloride solution (50%) (Gozes et al., J Mol Neurosci. 19(1-2):167-70 (2002)). [0113] In therapeutic applications, the NAP or ADNF polypeptides of the invention are administered to a patient in an amount sufficient to reduce or eliminate symptoms of anxiety and/or depression. An amount adequate to accomplish this is defined as “therapeutically effective dose.” Amounts effective for this use will depend on, for example, the particular NAP or ADNF polypeptide employed, the type of disease or disorder to be prevented, the manner of administration, the weight and general state of health of the patient, and the judgment of the prescribing physician. [0114] For example, an amount of polypeptide falling within the range of a 100 ng to 10 mg dose given intranasally once a day (e.g., in the evening) would be a therapeutically effective amount. Alternatively, dosages may be outside of this range, or on a different schedule. For example, dosages may range from 0.0001 mg/kg to 10,000 mg/kg, and will preferably be about 0.001 mg/kg, 0.1 mg/kg, 1 mg/kg, 5 mg/kg, 50 mg/kg or 500 mg/kg per dose. Doses may be administered hourly, every 4, 6 or 12 hours, with meals, daily, every 2, 3, 4, 5, 6, or 7 days, weekly, every 2, 3, 4 weeks, monthly or every 2, 3 or 4 months, or any combination thereof. The duration of dosing may be single (acute) dosing, or over the course of days, weeks, months, or years, depending on the condition to be treated. Those skilled in the art can determine the suitable dosage, and may rely on preliminary data reported in Gozes et al., 2000, Gozes et al., 2002), Bassan et al. 1999; Zemlyak et al., Regul. Pept. 96:39-43 (2000); Brenneman et al., Biochem. Soc. Trans. 28: 452-455 (2000); Erratum Biochem Soc. Trans. 28:983; Wilkemeyer et al. Proc. Natl. Acad. Sci. USA 100:8543-8548 (2003)). Example 1 Intranasal Administration of NAP Decreases Anxiety-Like Behavior in Aging Mice in the Elevated Plus Maze [0115] The present study was designed to evaluate the long-term behavioral outcome of chronic intranasal exposure to NAP. [0116] Methods [0117] ND-Swiss male mice (8 months old; Harlan Sprague Dawley, Inc., Indianapolis, Ind.) were kept under a 12:12 hour light/dark regimen, with food and water available at all times. The mice were kept in the animal care facility of the Tel Aviv University in compliance with institutional and state guidelines. [0118] NAP was custom synthesized by Peninsula (Bachem, Torrance, Calif., USA) or Peptide Technologies (Bethesda, Md., USA). The peptide was dissolved in a solution DD, in which each milliliter included 7.5 mg NaCl, 1.7 mg citric acid monohydrate, 3 mg disodium phosphate dihydrate and 0.2 mg benzalkonium chloride solution (50%). The peptide was administered intranasally every day, 5 days a week, 0.5 μg in 10 μl for each mouse, half the portion in each nostril. The control group received 10 μl of the inert carrier per day. The mice were treated at least 1 h prior to the daily experiment (water maze). [0119] The elevated plus maze was built in a ‘plus’ form with two open arms (68×7.5×1 cm) and two closed arms (68×7.5×17.5 cm) opposing each other. The center of the four arms included a middle square (7.5×7.5 cm). The maze was elevated, at a height of 51 cm above ground level. Each mouse was placed separately in the center of the maze, facing an open arm. Each trial lasted 5 min. Parameters measured included: (1) Number of closed arms entries, an accepted index of motor function; (2) total number of open arms entries; (3) length of time spent in the open arms; (4) length of time spent in the closed arms. An entry was counted only after the mouse entered the arm with all four paws. The percentage of open arm entries out of total arms entries and the percentage of time spent in the open arms, accepted measures of anxiety levels, were further calculated. [0120] Mice were also subjected to two daily tests in a Morris water maze (diameter 90 cm; depth, 20 cm), as described in WO 01/092333, incorporated herein by reference. Latency to reach the hidden platform over a 90 second test period was recorded. The experiment was performed for 4-5 consecutive days. To measure motor functions, mice were placed on a platform for 30 seconds and then in the water facing the wall. The platform was then removed from the maze and the time spent by the mice in the pool's quarter where the platform used to be was recorded (for 90 seconds). Measurements were performed with the HVS video tracking system (HVS Image Ltd., Hampton, UK). The water maze was chosen as a test as current medication against anxiety often present a side effect of reduced cognitive functions. [0121] Statistical tests used one-way analysis of variance with pairwise multiple comparison procedure (Student-Newman-Kuels method). When only two groups were compared, the Student t-test was used. [0122] Results [0123] When tested in the elevated plus maze, at 13 months age, after 5 months of chronic treatment with NAP, the percentage of time spent in the open arms was significantly higher in the NAP-treated mice ( FIG. 1 a ). However, the mean percentage of open arm entries out of total arms entries, the number of closed arms entries and the total number of arms entries was similar in the control group and the NAP-treated group ( FIG. 1 b - 1 d ). [0124] When the same group of mice was re-tested 3 months later at the age of 16 months and after 8 months of chronic intranasal treatments, again measurements indicated a decreased level of anxiety. The decreased anxiety level in the NAP-treated older mice was even more prominent than in the younger animals. Similar to the results in 13-month old mice, the percentage of time spent in the open arms by the 16-month old animals was significantly higher in the NAP-treated group as compared to the control group ( FIG. 2 a ). However, in contrast to the younger mice that were treated with NAP for 5 months, in the older mice, treated for 8 months, the percentage of open arm entries out of total arms entries was significantly higher in the NAP treated mice ( FIG. 2 b ). Motor function indices including the number of closed arms entries and the total amount of arms entries were not significantly different between the two groups ( FIGS. 2 c and 2 d ). [0125] As anxiolytics tend to reduce learning and memory functions, long-term effects of NAP exposure were assessed in a spatial memory test using the Morris water maze paradigm. At the age of 15 months, and after 7 months of chronic intranasal NAP treatment an apparent improvement (measured over four testing days) was observed in the NAP-treated mice but not in the control mice, in the first daily trial, but not in the second daily trial ( FIG. 3 , A,B respectively). No significant differences were found when comparing the first to last daily trial in either group. Yet, a comparison of a block of the first daily trial in the first and the second testing days vs. a block of the first daily trials in the third and fourth testing days showed that only the NAP-treated mice were significantly faster in finding the platform in the last two days (second block) demonstrating learning (p<0.04). These experiments show a moderate improvement of spatial learning resulting from long-term exposure to intranasal NAP. No differences in motor behavior were apparent in eight month or 16-month-old mice measured as the time to reach the visible platform (24+7.6; NAP and 24+6.8; control, eight-month-old mice). Furthermore, only a small effect was seen at 15 months in the probe test, with the NAP-treated animals spending 25.8+3.4 sec/90 sec in the area of the pool where the platform used to be vs. 21.96+2.9 in the sham-treated mice. [0126] In the elevated plus model, anxiety-like behavior is measured by the percentage of time spent in the open arms and the percentage of open arms entries. Curiosity will lead mice to spend more time in the open arms which anxiety will probably make them stay in the closed, protected arms of the model. The number of closed arms entries is an accepted parameter of motor function. Intranasal NAP significantly increased the percentage of time spent in the open arms and longer exposure to NAP also increased open arm entries, thus demonstrating reduced anxiety-like behavior in NAP treated mice. Furthermore, in spatial learning and memory tests, an effect was observed after long-term NAP administration in aged mice, on the first daily test, indicative of reference memory. Example 2 NAP Stabilizes Microtubules by Direct Association with Tubulin [0127] The present study was conducted to identify primary targets for NAP for neuroprotection, and to identify NAP binding proteins. [0128] Methods: [0129] Cell cultures. Rat pheochromocytoma cells (PC12) were grown in Dulbecco's Modified Eagle's Medium (DMEM) supplemented with 8% fetal calf serum (FCS), 8% Horse donor serum, 2 mM glutamine, and 1% penicillin streptomycin solution for 48 h. NIH3T3 were grown in DMEM supplemented with 10% fetal calf serum (FCS), 2 mM L-Glutamine, 0.1 mg/ml streptomycin, 100 units/ml penicillin. For the experiments, cells were harvested, resuspended and seeded in 96 well dishes at a concentration of 2×10(4) cells/well. The cells were allowed to attach to the dish for 3 h and were then exposed to 300 uM H 2 O 2 for 24 h. When neuroprotective activity was tested, the peptides were added while seeding. Additional studies with nerve growth factor (NGF, 0.1 ug/ml)-treated PC12 cells plated on collagen (100 ug/ml) were conducted. In these experiments, nerve growth factor (NGF) was added at seeding. [0130] Rat cerebral cortical cells from newborn pups were prepared as before (Bassan et al., 1999). All procedures performed in these studies were conducted in accordance with the Tel Aviv University regulations and were approved by the Animal Care and Use Committee of Tel Aviv University. The use of animals was not excessive and no animal suffering occurred. In short, cerebral cortical tissue was incubated for 20 minutes at 37° C. in Hanks' balanced salt solution+15 mM HEPES, pH 7.3 containing trypsin B (Biological Industries, Beit Haemek, Israel). Dissociated cerebral cortical cells were added to the culture dish with 5% horse serum in DMEM. Cells were plated in a ratio of 1 cortex per two 75 cm 2 cell culture flasks (polystyrene, Corning, N.Y.). The medium was changed 1 day after plating. For astrocyte cultures, cells were split after 10 incubation days and plated in 24 well plates (each flask into 60 wells containing microscope cover glasses (12 mm diameter) and 250 μl medium). Cells were then incubated two additional weeks. For mixed neuroglial cultures, dissociated cerebral cortical cells were plated on a bed of astrocytes 2 weeks after the split and incubated in neuron-specific medium as before (Bassan et al., 1999; Brenneman, & Gozes, J. Clin. Invest. 97:2299-2307 (1996); based on Forsythe & Westbrook, J. Physiol. 396:515-533 (1988)). [0131] Metabolic activity measurements. Metabolic activity of viable cells in culture was measured by a calorimetric method using a tetrazolium compound [3-(4,5-dimethylthiazol-2-yl-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2H tetrazolium, MTS] and an electron-coupling reagent phenazine methasulfate (PMS). MTS is bio-reduced by the living cells to the Formazan form that is detected at 490 nm (Promega, Madison, Wis.). [0132] Affi-Gel 10 NAP affinity chromatography. A protein lysate was prepared from one-day-old rat brains in a buffer containing the following ingredients: 150 mM NaCl, 1 mM EDTA, 50 mM Tris-HCl, ph 4.5, 0.1% Triton X-100, 1% NP40 and a protease inhibitor cocktail (Roche Diagnostics, Mannheim, Germany). DNA was fragmented by sonication. Cell debris was discarded following 30 minutes centrifugation at 30,000×g. An affinity column containing NAP was prepared using elongated NAP (KKKGGNAPVSIPQC (SEQ ID NO:28) and Affi-Gel 10 in 0.2M NaHCO 3 /0.5 M NaCl, pH 7.5. Further column preparation was according to the manufacturer's instructions (Amersham Pharmacia Biotech, AB, Uppsala). The brain extract prepared as above was loaded (2 mg/ml) on the column at 20° C. and incubated for an hour; the column was then washed with PBS until all unbound protein eluted as confirmed by protein assay (Bradford, BioRad, Mannheim). NAP-binding proteins were eluted in 0.1 M glycine (pH 3.0); the eluted protein fractions were then adjusted to pH 7.5 with Tris-HCl buffer. Electrophoresis on a 12% polyacrylamide SDS-containing gel was performed as before (Zamostiano et al., 2001). [0133] Sulfolink coupling gel NAP affinity chromatography. The Second isolation efforts utilized a different affinity column, sulfolink coupling gel (Pierce, Rockford, Ill.). Binding of CKKGGNAPVSIPQ (SEQ ID NO:29) was performed according to the manufacturer's instruction. Brain extract was prepared as above and binding was performed at 4° C. for 20 h, washing was as above and bound proteins were eluted by incubation in the presence of excess soluble NAP (NAPVSIPQ) 2 mg/ml PBS (2 ml/2 ml column) at 4° C. for 20 hours. [0134] Sequence analysis. To further identify NAP binding protein(s) the polyacrylamide gel portion containing the affinity purified protein bands was subjected to in-gel proteolysis with trypsin and mass spectrometry analysis (Technion, Israel Institute of Technology, Smoler Protein Center, Department of Biology). [0135] Direct NAP binding to proteins assessed by dot blot analysis. Each protein (tubulin or muscle actin (Sigma, Rehovot, Israel), or non-muscle actin from human platelets (Cytoskeleton, Denver, Colo.) was applied on nitrocellulose membrane (Schleicher & Schuell, Dassel, Germany) at a concentration of 1-4 microgram/1 microliter/spot and dried (45 min 20° C.). The membrane was incubated in a blocking solution (10 mM Tris, 6 mM NaCl, 0.05% Tween-20 and 10% lowfat milk) for 16 h at 4° C. Detection was with biotin-labeled NAP (Gottlieb et al., Eur. J. Biochem. 125:631-638 (1982)) with excess amount of NAP (e.g., 5 microgram) added to tubulin (e.g., 1 microgram) or actin being attached to the membrane support). Avidin-horse radish peroxidase conjugate and ECL+(Western blotting detection system, Amersham Pharmacia Biotech, Buckinghamshire, UK) was used for further identification of interacting molecules. [0136] Confocal microscopy. Synthetic NAP or fluorescein-labeled NAP (FITC-NAP) was added to tissue culture cells (ascending concentrations) and incubated for 15 mins-24 hours. After incubation, cells were extensively washed and fixed in 4% paraformaldehyde. Following fixation, Triton X-100 (0.2% was added to allow antibody cellular penetration for mouse monoclonal tubulin antibodies (TUB 2.5; Gozes & Barnstable, Proc. Natl. Acad. Sci. USA 79:2579-2583 (1982)) and rhodamin-labeled secondary goat antimouse IgG (Jackson ImmunoResearch, West Grove, Pa.). For specific neuronal staining in primary neuronal cultures, mouse monoclonal tubulin antibodies TUB2.1 (Gozes & Barnstable, 1982) were used. Further neuronal identification was obtained by staining with antibodies against neuron specific enolase as before (Brenneman & Gozes, 1996). Fluorescent cells were analyzed with a Zeiss confocal laser scanning microscope. Zeiss LSM 410 inverted (Oberkochen, Germany) is equipped with a 25-milliwatt krypton-argon laser (488 and 568 nm maximum lines). A 40×/1.2 W Apochromat water-immersion lens (Axiovert 135M, Zeiss) was utilized for all imaging. [0137] Microtubule assembly. A microtubule assembly kit CytoDYNAMIX Screen 01(CDS01) was obtained from Cytoskeleton (Denver, Colo.). Bovine MAP-rich tubulin (HTS01) was resuspended in G-PEM buffer (80 mM PIPES pH 6.9, 1 mM MgCl, 1 mM EGTA and 1 mM GTP) and subjected to polymerization at 37° C. The reaction was performed in 96-well plate. Assembly was monitored with a spectrophotometer SPECTRAmax 190 (Molecular Devices, Sunnyvale, Calif.) employing continuous recording at 350 nm. [0138] Results [0139] In this example, affinity chromatography of brain extracts identified tubulin, the brain major protein and subunit protein of the microtubules as a NAP-binding ligand. Microtubules have been shown before to be associated with the mechanism of anxiety-associated neurotransmission ((Stangler et al., 2002). In addition, NAP binding to non-muscle actin was also detected, suggesting interaction with polymerizing proteins. Tubulin and non-muscle actin NAP binding was also confirmed by dot blot analysis. In a cell free system, NAP stimulated tubulin assembly into microtubules. When added to cerebral cortical astrocytes, mixed neuroglial cultures or pheochromocytoma cells (a neuronal-like model), NAP caused rapid microtubule re-organization into distinct microtubular structures. Furthermore, treatment of astrocytes with ZnCl 2 that induces the formation of tubulin Zinc sheets (Melki & Carlier, Biochemistry 32(13):3405-13 (1993)) induced cell death as suggested before (Juarranz et al., Photochem Photobiol. 73(3):283-9 (2001); Haase et al., Biol. Chem. 382(8):1227-34 (2001); Lobner et al., Cell Mol Biol (Noisy-le-grand) 46(4):797-806 (2000)). Co-treatment with NAP inhibited the Zn-associated death. These functional results support the role of NAP as a microtubule stabilizing agent by direct association with tubulin. As depression may be associated with cell death (Eilat et al., J Immunol. 163(1):533-4 (1999)) the neuroprotective properties of NAP, through interaction with key cytoskeletal elements is suggested to protect against anxiety. NAP structure is a random coil and it may require a conformational epitope on tubulin for it's catalytic-like activity enucleating tubulin polymerization. Regardless, the tubulin interaction site for NAP offers a target platform for drug discovery against anxiety-like conditions. [0140] NAP specificity: In order to test for NAP specificity and establish the identity of cell systems relevant for NAP activity tests, a number of cell lines were screened. The rat pheochromocytoma (PC12) cell line (a neuronal-like cell system) responded to NAP neuroprotection against the effects of oxidative stress (see also Steingart et al. J. Mol. Neurosci. 15:137-145 (2000)). Cells that did not respond to NAP included African green monkey kidney cell (COS-7), adenocarcinoma cells from human breast (MCF-7) and human colon (HT-29), human fibroblasts (BJ) as well as mouse fibroblasts (NIH3T3). No cell proliferation effect was seen on any of the above tested cell lines (Gozes et al., J Mol Neurosci. 20(3):315-22 (2003)). These results imply specificity for NAP's activity and suggest a NAP binding protein of neuronal lineage origin. [0141] Isolation of NAP binding proteins by affinity chromatography: Based on the previous results, brain homogenates were chosen as a putative enriched source for NAP interacting molecules. Extracts were subjected to affinity chromatography comprising NAP bound to either Affi-Gel 10 or sulfolink coupling gel, two different solid supports. Elution of the NAP interacting molecules was obtained by either reducing the pH or by competing the binding to the insoluble NAP with excess free soluble NAP. Electrophoresis on a 12% polyacrylamide SDS-containing gel revealed a purified protein band at about 50,000 Dalton and an additional protein at about 42,000 Dalton. [0142] Tubulin and actin are NAP binding proteins: When the gel portions containing the purified protein bands were submitted to in gel proteolysis with trypsin followed by mass spectrometry analysis, the ˜50,000 Dalton NAP-binding protein was identified as rat alpha tubulin (molecular mass 50,242); gi223556; the second band identified was beta actin, mass 41,737, gi450885. The identification of tubulin included the characterization of 6 different tryptic peptides. [0143] A dot blot assay on a cellulose nitrate filter was performed with spotted muscle and non-muscle actin and tubulin (1 microgram protein/microliter/spot). Results indicated binding to brain tubulin and to non-muscle actin, while no interaction with muscle actin was detected. [0144] NAP interaction with tubulin/microtubules: confocal microscopy. To further establish an association between tubulin and NAP in the living cell, confocal microscopy analysis of fluorescent NAP and immunodetection of tubulin was performed. As a first experiment, PC12 cells and NIH3T3 cells 2 h after exposure to NAP were analyzed. Tubulin is a heterodimer composed of two related but non-identical, ˜55-kDa subunits, α- and β-tubulin that exhibit microheterogeneity (Gozes & Littauer, Nature 276(5686):411-3 (1978); Gozes & Sweadner, Nature 294(5840):477-80 (1981)). To visualize the microtubule structure, monoclonal beta tubulin antibodies (TUB2.5; Gozes& Barnstable, Proc. Natl. Acad. Sci. USA 79:2579-2583 (1982)) were used. Results have shown that in PC12 cells, the microtubules seemed to assume a more definitive structure after NAP application. In contrast, in cells not responsive to NAP, such as NIH3T3 cells, no apparent change in the microtubule organization was observed. [0145] To study microtubule rearrangement in differentiated neuronal-like PC12, cells were exposed to nerve growth factor (NGF). Results indicated robust microtubule rearrangement (100% of the cells) in these differentiated PC12 cells as well. [0146] Two additional cell populations were tested: astrocytes as well as mixed astrocytes and neurons from newborn rat cerebral cortex. Either fluoresceine-labeled NAP (FITC-NAP) or native NAP was added to two-week-old astrocyte cultures and to one-week-old neuronal cultures originally plated on a bed of astrocytes. Astrocytes were used as a model, since previous results have indicated that while nanomolar concentrations of NAP protected neuronal-enriched cultures against beta amyloid toxicity (Zemlyak et al., 2000); a more potent protection at femtomolar concentrations of NAP was observed when neurons were plated on a bed of astrocytes (Bassan et al., 1999). In astrocytes, like in the PC12 cells, an effect of microtubule re-organization was observed. A time course experiment suggested that the microtubule re-organization effect was occurring 2 h after NAP application, with the microtubules undergoing an additional condensation 4 h after NAP application and returning to the original morphology 24 h after NAP application. Mitotic spindles were not apparent. Similar microtubule re-organizations were observed with NAP at concentrations ranging from 10 −15 M-10 −10 M with fluoresceine-labeled and with native NAP. Evaluation of the number of cells undergoing microtubule re-organization following NAP treatment showed maximal organization at 2-4 h with a decline at 24 h. [0147] A control peptide, C2 (VLGGGSALL) (SEQ ID NO:30) that does not protect neurons in vitro did not induce a microtubule-associated morphological change. [0148] Detection of fluoresceine labeled NAP inside cells: NAP can internalize cells and exhibit structural similarity to proteins/peptides used to permeate membranes: After a 2 h incubation period at 37° C., fluoresceine-labeled NAP was detected inside the cell. A critical question is whether NAP induces microtubule re-organization through interaction with a surface receptor, or is a pore-forming peptide that interacts with the lipid bilayer and is then internalized into cells. To evaluate potential surface labeling, initial incubation was carried out at 4° C. and in a parallel experiment at pH 3.0. When NAP (10 −15 M) was incubated with astrocytes at pH 3.0 for 15 minutes, microtubule reorganization was apparent and fluoresceine labeled NAP was visualized inside the cells. At 4° C., while microtubule reorganization did not take place, as microtubules undergo disassembly at 4° C., a dose-dependent intracellular accumulation of NAP was apparent. [0149] NAP structural analysis suggest similarities to peptides/proteins that transverse the cellular membrane, such as the VP22 translocation domain from HSV and signal peptides such as the Kaposi fibroblast growth factor (K-FGF) region. Bacterial toxins such as the C. perfringens iota toxin, diphtheria toxin, Pseudomonas exotoxin A, pertussis toxin, and B. anthracis toxin can deliver translocate peptide through the cell membrane. —Do we need references here? [0150] Changes in neuronal morphology toward a differentiated neuronal structures (neurotrophism): Previous results indicated that NAP protects neurons (e.g., Bassan et al., 1999). In the assay system of mixed cerebral cortical cells from newborn rat brains, the effect of NAP on the microtubule system was tested. Results, using confocal microscopy as above, identified fluorescent NAP in the neurons. These studies were extended to determine the degree of microtubule re-organization in the neurons using the tubulin monoclonal antibody TBU2.1 that shows preferential binding to neuronal tubulin (Gozes & Barnstable, 1982) as verified by staining with antibodies directed against neuron-specific enolase. Here, results showed extensive microtubule re-organization in the NAP-treated neurons. Further quantitations indicated that of 145 neurons counted in the control (untreated neurons) only 4 neurons exhibited a similar microtubule arrangement to that seen 2 h after 10 −15 M NAP treatment. After NAP treatment, out of 213 cells counted, 208 exhibited the NAP-related re-rearrangement, suggesting an effect on ˜97% of the treated neurons. Statistical analysis of the changes in neuronal morphology (number of processes per cell) indicated that in untreated neurons the number was 2.56+/−0.14/cell (mean+/−SEM, in 62 neurons). In NAP-treated neurons the number of processes was 6.47+/−0.3 (mean=+/−SEM, in 64 neurons, as also found in NAP 2 h-neurites). The difference was significant (P<0.001, Student's t-test). [0151] NAP promotes tubulin assembly: Using a high through-put analysis kit containing bovine tubulin (Cytoskeleton, Inc.), tubulin assembly was determined in the presence of increasing NAP concentrations. Measurements included absorbance determinations at 350 nm. While 10 −18 M NAP did not influence microtubule assembly in the test tube, 10 −15 M NAP stimulated microtubule assembly in a similar way to paclitaxel. Paclitaxel and taxol-like compounds have been suggested as possible neuroprotective agents, however, brain penetration issues and toxic side effects may exist (Rice et al., J Mol Neurosci. 20(3):339-43 (2003)). In contrast, NAP toxicology studies to-date indicate no adverse side effects (Gozes et al., 2000; Gozes et al., 2003). Further studies also indicate NAP brain penetration (Gozes et al., 2000) following intranasal administration using either radiolabeled NAP (Gozes et al., 2000) or mass spectrometry validated assays. NAP at 10 −10 M promoted tubulin assembly t the same degree as at a concentration of 10 −15 M. At higher concentrations of 10 −8 M NAP, no significant stimulation was observed over the 40 minutes assembly period at 37° C., paralleling the dose dependent survival-promoting response curve. Paclitaxel was used as a positive control and C2 a peptide that was utilized as a negative control in the cellular assay did not affect microtubule assembly as well. [0152] Tubulin as a discovery platform for neuroprotective and anxiolytic drug discovery: Results demonstrated that NAP cellular protection is specific and is paralleled by microtubule re-organization in glial cells and in differentiated neurons. A potential mechanism of action involves internalization into cells without a classical peptide receptor, followed by direct binding to tubulin and acceleration of microtubule formation. Because NAP activity is selective for cells of neuronal origin (PC12) not fibroblasts (NIH3T3) as well as to astrocytes, it suggests tubulin/microtubule microheterogeneity in these cells that is specific for NAP's activity (Gozes et al., 1978 and 1981). Microheterogeneity may result from expression of different tubulin isotypes in different cells, or it may result from post-translational modifications, or both. The NAP doses required for tubulin polymerization concurred with the doses required for cellular protection against oxidative stress. NAP and related peptide protection against anxiety, depression, and other anxiety disorders and mood disorders may be direct through interaction with the microtubular network or indirect through glial and neuroprotection. [0153] The examples set out above are intended to be exemplary of the effects of the invention, and are not intended to limit the embodiments or scope of the invention contemplated by the claims set out below. Other variants of the invention will be readily apparent to one of ordinary skill in the art and are encompassed by the appended claims. All publications, databases, Genbank sequences, GO terms, patents, and patent applications cited herein are hereby incorporated by reference. [0154] This application is related to PCT WO 1/92333;U.S. Ser. No. 07/871,973 filed Apr. 22, 1992, now U.S. Pat. No. 5,767,240; U.S. Ser. No. 08/342,297, filed Oct. 17, 1994 (published as WO96/11948), now U.S. Pat. No. 6,174,862; U.S. Ser. No. 60/037,404, filed Feb. 7, 1997 (published as WO98/35042); U.S. Ser. No. 09/187,330, filed Nov. 11, 1998 (published as WO00/27875); U.S. Ser. No. 09/267,511, filed Mar. 12, 1999 (published as WO00/53217); U.S. Pat. No. 6,613,740, U.S. Ser. No. 60/149,956, filed Aug. 18, 1999 (published as WO01/12654); U.S. Ser. No. 60/208,944, filed May 31, 2000; and U.S. Ser. No. 60/267,805, filed Feb. 8, 2001; herein each incorporated by reference in their entirety.

This invention relates to the use of ADNF polypeptides in the treatment of anxiety and/or depression. The present invention also relates to drug discovery assays using the ADNF polypeptide mechanism of action and target interaction, as well as the manufacture of medicaments, methods of application and formulation therefor. Embodiments of the invention provide methods for preventing and/or treating anxiety and depression disorders in a subject by administering a NAP, an 8-amino-acid peptide derived from Activity Dependent Neurotrophic Factor (ADNF III), in an amount sufficient to improve postnatal performance. The ADNF polypeptides include ADNF I and ADNF III (also referred to as ADNP) polypeptides, analogs, subsequences, and D-amino acid versions (either wholly D-amino acid peptides or mixed D- and L-amino acid peptides), and combinations thereof which contain their respective active core sites and provide neuroprotective and anti-anxiety functions.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] Not applicable. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH/DEVELOPMENT [0002] Not applicable. BACKGROUND OF THE INVENTION [0003] The present invention relates to heaters, such as positive temperature coefficient (PTC) heaters, used to vaporize air treatment chemicals from a substrate. More particularly it relates to spring assemblies which can adjust for thermal expansion of such heaters. [0004] Electrical heaters have been developed to heat a substrate (e.g. a mat) impregnated with an air treatment chemical, to thereby dispense the chemical. For example WO 2006/046209 (the disclosure of which is hereby incorporated by reference as if fully set forth herein) discloses one such PTC electrical heater. Also representative of the current state of the art are U.S. Pat. Nos. 4,404,463, 4,431,983, 4,728,779, 4,874,924, 5,256,857 and 5,471,034, and also WO 97/02054. [0005] However, devices of this type do have some drawbacks. For one thing, the outer housings of such PTC heaters tend to undergo thermal expansion during operation. As most of the electrical components are anchored to the housing, this can cause relative movement of the electrical parts with respect to each other, thereby disrupting electrical contact, or rendering heat transfer less efficient. [0006] To adjust for this to some extent there have been attempts to incorporate springs into the assembly. One approach is to make a portion of the electrical contact itself into an integral spring-like structure. However, this can increase production costs or complexity, or be difficult to reliably implement if one also wishes to use optimal electrical contact materials. [0007] There have also been attempts to instead use separate springs which bias an electrical contact against a heater, yet allow some relative movement. However, to date, these assemblies have had their own deficiencies (e.g. complexity; cost; inability to adjust for certain types of expansion). [0008] Apart from this, PTC heater elements are sometimes so fragile that their abutment with associated electrical contacts (particularly those that are stamped) can lead to breakage of the PTC element. A stamped contact can have a sharp edge which, over time, can lead to such cracking. While there have been attempts to avoid the use of stamped contacts with sharp ends (e.g. our company's U.S. Ser. No. 11/614,645 filed on Dec. 21, 2006), materials which are optimal for that purpose may not be optimal for certain spring related functions. [0009] Hence, a need still exists for improved electrical heaters useful for vaporizing air treatment chemicals. BRIEF SUMMARY OF THE INVENTION [0010] In one aspect the invention provides a heating device having a housing defining an internal cavity and having spaced supports extending there from into the cavity, a heating element positioned in the cavity, a first electrical contact abutting the heating element along a first side of the heating element, a second electrical contact abutting the heating element on a side thereof opposite the first side, and a spring suspended by the spaced supports and having a portion thereof biasing the second electrical contact towards the heater element. [0011] The spring has a convex surface pointed away from the second electrical contact and rising sufficiently there from so as to be pressed against the interior surface of the housing. As a result, the convex portion of the spring is compressed and remaining parts of the spring apply pressure against the second electrical contact, securing it against the heating element. The spring is sufficiently compressed that, even as the housing expands when heated, the spring remains in contact with the housing and continues to apply pressure against the second electrical contact. As a result, the second electrical contact remains properly engaged against the heating element, and the heating element, in turn, is also urged against the first electrical contact, ensuring uninterrupted electrical connections. [0012] In preferred forms the heating element is a pill-shaped positive temperature coefficient heating element, the spring has a convex surface pointed away from the second electrical contact and a concave surface pointed towards the second electrical contact, and the first electrical contact has a contact head that bulges towards the heating element. The first electrical contact may also serve a heat diffusion function. [0013] Our heaters are intended to be used with a substrate positioned against an outside surface of the housing, the substrate bearing a volatilizable air treatment chemical such as an insect control active ingredient, a scent, a deodorizer, or the like. Heating causes the chemical to volatize from the mat, thereby treating the room air. [0014] For example, in one preferred embodiment the heater could be used with a conventional mosquito control mat formed of compressed cellulosic fibers that have been impregnated with an insect control agent such as allethrin or metofluthrin. The art is well aware of a number of other substrates, and other air treatment chemicals, that can be used with these types of devices (e.g. repellents, fragrances, deodorizers). [0015] Our devices therefore accommodate thermal expansion, without imposing undesirable design constraints on the electrical contacts. Further, our devices can be inexpensively produced, which may be particularly important to their commercial potential in some third world markets. [0016] The foregoing and other advantages of the present invention will become apparent from the following description. In that description reference is made to the accompanying drawings which form a part thereof, and in which there is shown by way of non-limiting illustration a preferred embodiment of the invention. The claims which follow thereafter should be looked to in order to judge the full scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0017] FIG. 1 is a perspective view of an embodiment of the invention, shown with an impregnated mat about to be installed therein; [0018] FIG. 2 is an exploded perspective view of the FIG. 1 embodiment, albeit without the impregnated mat shown; [0019] FIG. 3 is an exploded perspective view of a PTC heater portion of the FIG. 1 device; [0020] FIG. 4 is another exploded perspective view of the PTC heater of FIG. 3 ; [0021] FIG. 5 is a perspective view of part of the PTC heater of FIG. 4 , but showing how alternate forms of the preferred spring could instead be used; [0022] FIG. 6 is a cross-sectional view taken along line 4 - 4 of FIG. 1 ; and [0023] FIG. 7 is a cross-sectional view taken along line 7 - 7 of FIG. 6 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0024] Referring first to FIGS. 1-2 and 6 - 7 , there is shown a vaporizer 10 which includes a cover 12 having a air grill 13 , a PTC heater 14 , an impregnated mat 16 , and a housing bottom 18 . As will be apparent from FIG. 3 , PTC heater 14 includes a first housing part 20 , a second housing part 22 , a first electrical contact 24 , a PTC pill form heating element 26 , a second electrical contact 28 , and most importantly spring 30 . The first housing part 20 supports the first electrical contact 24 , which abuts a second side 25 of the PTC heating element 26 . The second electrical contact 28 abuts a side 27 of the PTC heating element 26 opposite the side abutting the first electrical contact 24 . [0025] As shown in FIGS. 3 and 4 , the first housing part 20 and second housing part 22 form a clamshell type housing to define a cavity 33 there between. First housing part 20 has support pegs 32 integrally formed therewith and extending into the cavity 33 . These pass the first electrical contact 24 by virtue of cut outs 37 . The ends of the spring 30 can be pinned or otherwise fastened to the support pegs 32 spanning the distance between them. [0026] The second housing part 22 also has pegs 34 protruding inwards towards the first housing part 20 . These pegs 34 help fix the first electrical contact 24 in place when the housing is closed. [0027] The first electrical contact 24 preferably comprises a flat heat diffuser plate section 36 linked by a right angle bend to an elongated leg 38 . The leg 38 forms one terminal of a linkage to the power supply, and thus after assembly extends outside the housing. There are also apertures 40 for receiving additional pegs 32 from the first housing part 20 . [0028] The PTC heating element 26 includes a first side 27 and a second side 25 . While heating element 26 is shown in a “pill” form, other conventional PTC element shapes could also be used. Further, heating element 26 can have metallization on either or both sides (not shown). [0029] The second electrical contact 28 preferably comprises a U-shaped plate 50 including an elongated leg 52 extending away from the plate 50 at a right angle. Elongated leg 52 forms the second terminal of a linkage to the power supply and ultimately remains extending outside the housing. There is also a curved dome having a contact portion 56 . The dome can have a convex side 62 . [0030] A spring 30 is in the form of a stainless steel strip having apertures 68 , 70 in opposing ends 72 , 74 . The apertures 68 , 70 receive the tapered ends 39 of pegs 32 in wedging fashion, to thereby suspend the spring 30 over and against second electrical contact 28 . The middle suspended portion 76 of the spring 30 is convex in shape (i.e., bulges outwardly, away from the second electrical contact 28 ). [0031] While stainless steel is an optimal metal for the spring in this environment, it is not optimal for the second electrical contact 28 . For that we prefer a metal such as aluminum. [0032] Referring most specifically to FIG. 5 , alternate spring embodiments 30 A and 30 B of the spring 30 are shown. For spring 30 A two of the spring 30 elements are attached to each other face-to-face to create a convex bulge 86 and a concave bulge 88 . In spring 30 B the middle portion of a single spring 30 is split lengthwise, leaving three thinner strips 80 , 82 and 84 . Strips 80 and 82 are convex (curving away from the second electrical contact 28 ), while the middle strip 84 is concave in shape (curving toward the second electrical contact). [0033] The convex portion 76 of the spring 30 presses against the interior side of the second housing part 22 when the housing is assembled, somewhat compressing the convex portion of the spring. The convex portion 76 is sufficiently compressed that, when the housing expands in response to the heating of the heating element 26 , the convex portion rebounds to cause the spring 30 to remain in contact with the second housing part 22 and to continue to apply pressure against the second electrical contact 28 . The convex portions 80 and 82 of alternative embodiment spring 30 B and 86 of alternative embodiment spring 30 B function in that same way. Thus, regardless of the spring embodiment 30 , 30 A, 30 B used, the spring helps maintain a positive pressure contact between the second electrical contact 28 and the PTC heating element 26 , and thus indirectly between the first electrical contact 24 and the PTC heating element, even during thermal expansion of the housing. In fact, because the spring 30 receives heat directly from the heating element 26 by conduction through the second electrical contact 28 , the spring tends to expand to an extent proportionally greater than the expansion of the housing, which tends to urge the convex portion of the spring even more securely against the housing. The combination of convex and concave portions of alternative spring embodiments 30 A and 30 B allows those curved parts to be compressed so as to achieve the same overall displacement as is achieved by compression of the convex portion of spring 30 but with less distortion of each individual curved part. [0034] Note also that because the parts are held close together, heat can readily transfer from the pill form heating element 26 to the heat diffusing plate portion of the first electrical contact 24 . Thus, the process of transferring heat to an outer surface 92 of the PTC heater remains efficient even during thermal expansion. Note that the thermal expansion problem occurs even if preferred plastics are used for the outer housing. [0035] As seen in FIGS. 6 and 7 , the heater 14 is, after final assembly enclosed by protective cover 12 and housing bottom 18 of the vaporizer 10 . The mat 16 fits between that cover and outer surface 92 . [0036] While the present invention has been described with reference to a particular embodiment, various other embodiments are possible as well. For example, it is not essential that the heater be in pill form, or even be a PTC heater. [0037] Thus, the claims should be looked to in order to judge the full scope of the invention. INDUSTRIAL APPLICABILITY [0038] The present invention provides a heating device with an improved spring/electrical contact assembly to adjust for heat expansion.

An electrical heating device is disclosed that is suitable to vaporize air treatment chemicals from an impregnated substrate. The device is provided with a PCT heater held between electrical contacts and a spring that is compressed between the housing of the heating device and one of the electrical contacts to maintain pressure thereon in spite of thermal expansion of the housing, ensuring good electrical contact between the PCT heater and the electrical contacts.

BACKGROUND 1. Field of Invention This invention relates to a golf ball teeing device that easily permits a golfer, without bending over, to insert a golf tee into the ground with a golf ball situated on top of the tee in preparation for driving the ball. 2. Description of Prior Art Elderly golfers often find it difficult to bend over to place a golf tee in the ground and place a ball upon the tee. Additionally, golfers with back or knee problems have the same difficulty. Inventors have described several devices that allow the tee and ball to be positioned without bending over. Some of these devices can also be used to retrieve the tee out of the ground once the ball has been hit. These devices all involve a mechanism that clamps the ball and tee to the device which is mounted to the end of a handle or pole long enough to preclude the user from having to bend over. At the held end of the pole is a control which is in communication with the clamping mechanism. This control permits the golfer to unclamp the tee and ball from the device once the tee has been inserted into the ground. All of these devices are relatively elaborate and incorporate the use of several moving parts as exemplified by U.S. pat. Nos. 2,609,198 to Armstrong (1952), 4,526,369 to Phelps (1985), 4,616,826 to Trefts (1986), 4,714,250 to Henthorn (1987), 4,969,646 to Tobias (1988), 4,819,938 to Hill (1989), 4,949,961 to Milano (1990), 4,951,947 to Kopfle (1990), 5,080,357 to Wolf(1992), 5,171,010 to fanoue (1992), 5,205,598 to Miller (1993), 5,330,177 to Rogge (1994), 5,330,178 to Geishert (1994), 5,439,213 to Pimentel (1995), 5,499,813 to Black (1996), and 5,503,394 to Mauck and Shelton (1996). No inventor known to me has been able to eliminate the need for the golfer to manually unclamp the ball and tee from the device. Therefore, the prior devices all require a long handle with an unclamping control mounted to the end of the handle. Furthermore, they require some sort of mechanical linkage between the control and the clamping mechanism at the other end. This causes the following significant disadvantages common to all prior ball teeing devices: (a) The long handle and elaborate mechanisms incorporated in these devices weigh too much to be comfortably carried by a golfer as an accessory to golf clubs. (b) The elaborate nature of these devices make them too large to be carried in a golf bag in addition to golf clubs. (c) The number of parts required causes the material and labor costs associated with producing these devices to be inefficient with regard to bringing these devices to the buying public. (d) The large. elaborate nature of these devices causes them to be visually unappealing as a golf accessory prohibiting their commercial success in the marketplace. In addition to the above disadvantages, the use of such devices is cumbersome, time consuming, and inefficient. Using these devices to tee up a ball and to retrieve the tee without bending over requires four trips to the golf bag as the golfer alternates between the device and his club. Some inventors have attempted to minimize this by incorporating the use of a sharp member to anchor the device to the ground in an upright position while the golfer uses the club. This allows the device and club to be transported to and from the golf bag together instead of alternately as described in U.S. pat. Nos. 4,951,947 to Kopfle (1990), 5,439,213 to Pimentel (1995), 5,499,813 to Black (1996), and 5,503,394 to Mauck and Shelton (1996). However, this requires the golfer to operate the large heavy device one-handed while holding the golf club in the other hand to keep from bending over. Additionally, the sharp anchor can be a safety hazard to the golfer. With regard to other golf related inventions, inventors have described small light weight devices which can be temporarily attached to the end of a golf club to accomplish different tasks. For example U.S. pat. Nos. 2,801,875 to McEvoy (1957), 2,819,109 to Borah (1958), and 2,833,584 to McEvoy (1958) describe devices which are attached to the grip end of a golf club for use as golf ball retrievers. Similarly, U.S. pat. Nos. 3.870,300 to Amendola (1975), 5,012,872 to Cohn (1991), and 5,094,456 to Mitchell (1992) describe devices which are attached to the grip end of a golf club to serve as sand trap rakes. These devices utilize a golf club as the handle making the devices themselves small, lightweight, and portable. However, no other inventor has devised a tee and ball placing device which eliminates the need for an unclamping control incorporated into a long pole thereby allowing a golf club to be used as the handle. The teeing devices listed above all require the user to manually release the tee and ball by actuating some sort of control linkage incorporated into a long pole. OBJECTS AND ADVANTAGES Accordingly. several objects and advantages of my invention are: (a) to provide a golf ball teeing device which can operate without a manually controlled unclamping mechanism integral with the device; (b) to provide a golf ball teeing device which can utilize a golf club as a handle; (c) to provide a golf ball teeing device which contains relatively few parts making the device lightweight; (d) to provide a golf ball teeing device which is small, portable, and does not require a substantial amount of space in a golf bag; (e) to provide a golf ball teeing device which can be quickly and easily used without requiring the cumbersome juggling of a large device and a golf club; (f) to provide a golf ball teeing device which can also be used to retrieve the golf tee once the ball has been hit for both instances of the tee laying horizontally on the ground or remaining vertically inserted into the ground. Further objects and advantages will become apparent from a consideration of the ensuing description and drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an isometric illustration of the front of a specific illustrative embodiment. FIG. 2 is an isometric illustration of the rear of a specific illustrative embodiment. FIG. 3 is an isometric illustration of a specific illustrative embodiment from another angle. FIG. 4 is a partial sectional view taken along line 4--4 of FIG. 1 showing a golf club grip inserted into the preferred embodiment. FIG. 5A is a front view showing a specific illustrative embodiment prior to inserting the tee into the ground with the ball and tee being clamped together. FIG. 5B is a front view showing a specific illustrative embodiment as the tee is inserted into the ground. FIG. 5C is a front view showing a specific illustrative embodiment ready to release the tee and ball which are no longer clamped to the device. ______________________________________Reference Numerals In Drawings______________________________________10 teeing device 12 golf ball14 golf tee 16 head of golf tee18 shank of golf tee 20 golf club grip22 housing 24 upper housing26 lower housing 28 top wall30 rear wall 32 left vertical wall34 right vertical wall 36 left recess38 right recess 40 opening42 bottom wall 44 slot46 rounded end 48 delayed urging means50 interface member 52 annular wall54 taper 56 gripping fingers58 voids 60 rounded bottoms62 outward flares 64 chamfered edges66 supporting ribs 68 clip70 radius 72 inward bend74 outward bend______________________________________ DESCRIPTION OF THE PREFERRED EMBODIMENT THE entire device is referred to generally by the reference numeral 10. A golf ball is referred to generally by the reference numeral 12. A golf tee is referred to generally by the reference numeral 14, having a head 16, and a shank 18. A golf club grip is referred to generally by the reference numeral 20. The perferred embodiment of the present invention is illustrated in FIG. 1. The invention comprises a housing 22, which includes an upper portion 24, and a lower portion 26. The upper portion 24 includes a top wall 28, a rear wall 30, left vertical side wall 32, and a right vertical side wall 34. Side walls 32 and 34 incorporate a recessed portion 36 and 38 respectively to facilitate easy removal of the device 10 from the teed golf ball 12. The lower end of the rear wall 30 contains an opening 40 that extends between the two side walls 32 and 34. The opening 40 has a height that will permit passage of the golf tee shank 18 but will not allow passage of the golf tee head 16 and is used to facilitate the retrieval of the golf tee 14 lying horizontally on the ground. The lower portion 26 of the housing 22 includes a bottom wall 42 which contains a slot 44 that extends inward from the edge of the bottom wall 42. The slot 44 terminates with a rounded end 46. The entire wall of the slot 44 is angled such that the slot is larger on the top surface of the bottom wall 42 than the bottom surface of the bottom wall 42. The edges of the housing 22 are typically chamfered or rounded to avoid snagging or personal injury. Attached to the lower surface of the top wall 28 is a delayed urging means 48 which exhibits a delayed rebound after being compressed. Examples of such delayed urging means 48 are the ISODAMP® C-3000 series of energy absorbing foams manufactured by E-A-R Division, Cabot Corporation, Indianapolis, Ind. These foams rebound very slowly after being compressed. In the preferred embodiment, a cylindrical piece of E-A-R C-3002-50 low-recovery foam is used. However, means other than low-recovery foam could be used to provide a delayed urging function. The delayed urging means 48 is typically fastened to the top wall 28 by means of an adhesive. The placement of the delayed urging means 48 on the underside of the top wall 28 is such that it will be directly over the golf ball 12 when placed in the housing 22. Attached to the bottom of the delayed urging means 48 is a rigid ball interface member 50 used to provide a uniform surface to contact the golf ball 12. In the preferred embodiment, this member is a ring shaped object with an outer diameter equal to the delayed urging means 48 diameter and an inner diameter sufficiently large enough to provide engagement of the golf ball 12. However interface members of other shapes would equally suffice. The interface member 50 is typically attached to the delayed urging means 48 by means of an adhesive. FIG. 3 shows a better view of the interface member 50. The housing 22 height, interface member 50 size, slot 44 dimensions, and delayed urging means 48 size all affect the performance of the device 10. This combination of dimensions must be such that when the golf ball 12 is placed in the housing 22 below the interface member 50 and the golf tee 14 is slid into the slot underneath the ball 12, the delayed urging means 48 is slightly compressed exerting enough of a downward force to securely hold the ball 12 and tee 14 into the device 10. Additionally, these dimensions must be such that the delayed urging means 48 sufficiently further compresses due to the upward force on the tee 14 when the device 10 is used to insert the tee 14 into the ground. In the preferred embodiment, the interior height of housing 22 is 2.24 inches, slot 44 is 0.36 inches wide with angled walls at 21°, the interface member height is 0.12 inches with an inner diameter of 0.64 inches, and the delayed urging means 48 has a diameter of 0.75 inches and a height of 0.50 inches in its uncompressed state. These dimensions describe one possible embodiment of the invention. Other combinations of dimension values could also be used to achieve successful operation of the device 10. Extending from the upper side of the top wall 28 is the portion used to attach the device 10 to a golf club grip 20 as shown in FIG. 4. From the top wall 28, an annular wall 52 extends upward vertically and then flares outward becoming a taper 54. The annular wall 52 provides clearance for the end of the golf club grip 20 which is often convex in shape. The taper 54 ensures that the device 10 is aligned with the axis of the golf club by centering the end of the golf club grip 20. The diameters at the bottom and top of the taper 54 are sized to accommodate the full range of golf club grip 20 diameters available in the market place. Above the taper 54 the wall angles inward forming a plurality of individual gripping fingers 56 capable of flexing outward. In the preferred embodiment four gripping fingers 56 are used; however, any number greater or equal to two would work. FIG. 1 shows how the gripping fingers 56 are separated from each other by voids 58. The voids 58 incorporate rounded bottoms 60 to reduce stress concentrations in the flexing material. The gripping fingers 56 are of sufficient height to prevent the device 10 from becoming skewed with respect to the axis of the golf club. FIG. 4 shows how the gripping fingers 56 incorporate outward flares 62 at the top to provide easy insertion of the golf club grip 20. The very top of the gripping fingers 56 incorporate chamfered edges 64 to also aid in the insertion of the golf club grip 20. FIG. 1 shows a series of supporting ribs 66 used to provide strength to the annular wall 52 and to the taper 54 below the gripping fingers 56. These ribs 66 ensure that the stress created in the material during insertion of a golf club grip 20 will not cause a fracture in the material. FIG. 2 shows a clip 68 extending from the rear of the housing 22 just above the opening 40. The clip 68 is shaped with a large enough radius 70 to permit the device 10 to be clipped to the side of a typical golf bag. The clip 68 incorporates an inward bend 72 towards the housing 22 permitting the device 10 to be securely clipped to the pocket of a golfer's clothing. An outward bend 74 at the top of the clip 68 allows the device 10 to be easily clipped to a golf bag, pocket, or belt. In the preferred embodiment the entire device 10, except delayed urging means 48, is molded from an economical, flexible plastic material such as ABS. However, the device 10 can consist of any other material that exhibits the elasticity and impact resistance characteristics suitable for the application. From the description above, a number of advantages of the present invention become evident: (a) The device automatically unclamps the ball and tee once the tee is pushed into the ground since the delayed urging means becomes further compressed and will not immediately rebound. (b) The golfer can use a golf club as the device handle since no handle mounted unclamping control is needed. (c) The device makes it possible to tee up a golf ball from a standing position without the cumbersome use of relatively very large prior mechanisms. (d) The device allows a golfer to tee up golf balls without bending over by only carrying a small, lightweight device during a golf outing. (e) The device can be used to retrieve golf tees from the ground even if they are in a horizontal orientation. Operation-FIGS. 5A, 5B, 5C In use, the golfer removes the desired golf club from the golf bag and then unclips the device 10 from the golf bag, a pocket, a belt, or wherever the device 10 is stored. The device 10 is then attached to the golf club by pushing the gripping fingers 56 fully onto the end of the golf club grip 20 until the end of grip 20 comes in contact with the taper 54. A golf ball 12 is then placed in the housing 22 below the ball interface member 50. A golf tee 14 is then slid into slot 44 causing the ball 12 to push against the interface member 50 somewhat compressing the delayed urging means 48. The delayed urging means 48 exerts a downward force on the ball 12 clamping the ball 12 and tee 14 securely to the device 10 as shown in FIG. 5A The golf club is then held by the golfer at the club head end with the grip end towards the ground. The golf club is positioned in a vertical orientation with the shaft of the golf club perpendicular to the ground. The golfer holds the golf club at a height such that the tip of the golf tee 14 is a short distance above the ground as also shown in FIG. 5A. The golfer then moves the golf club straight down sinking the golf tee 14 into the ground. As the tee 14 enters the ground it exerts an upward force on the ball 12 causing the delayed urging means 48 to substantially compress. As this happens, the device 10 lowers with respect to the ball 12 and tee 14 such that the slot 44 is no longer in full contact with the underside of the tee head 16 as shown in FIG. 5B. Once the golf tee 14 has been sunk to the desired depth into the ground, the golfer releases the ball 12 and tee 14 from the device 10 by slightly moving the golf club straight up until the interface member 50 no longer is in contact with the ball as shown in FIG. 5C. The delayed urging means 48 remains compressed for a period of several seconds allowing the device 10 to be laterally removed from the teed ball 12 by moving the golf club in a motion parallel to the ground. After teeing up the ball 12, the golfer then pulls the device 10 off the end of the golf club and uses clip 68 to temporarily fasten the device 10 to a pocket or belt while the ball 12 is hit. The device 10 can then be reinstalled on the golf club grip 20 to be used to retrieve the golf tee 14 without bending over. For instances when the tee 14 remains in the ground while hitting the ball 12, the golfer uses the golf club as a long handle and maneuvers slot 44 of the device 10 under the head 16 of the tee 14. The tee 14 can then be pulled out of the ground and retrieved without bending. For instances when the tee 14 comes out of the ground while hitting the ball 12 and is lying horizontally on the ground, the golfer again uses the golf club as a long handle and retrieves the tee 14 using the device 10. This is accomplished by maneuvering the bottom wall 42 of housing 22 underneath the shank 18 of the tee such that the tip of the tee 14 protrudes through opening 40 of the housing 22. The opening 40 will not permit passage of the tee head 16 allowing the tee 14 to be scooped up without bending. Accordingly, this invention allows a golfer to easily tee up a golf ball without bending over. In addition, the invention permits a golfer to easily retrieve a golf tee without bending over whether or not the tee came out of the ground while hitting the ball. Furthermore, the teeing device has the additional advantages in that it permits a golf club to be utilized as the handle reducing the weight and size of the device; it is very simple to use with no cumbersome controls to release the tee and ball; it can easily and nonintrusively be clipped onto a golfer's apparel while hitting the ball; it can easily be attached to a golf bag; it can be made from far fewer parts than prior tee setting devices. Although the description above contains many specifics, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention. For example, a means other than low-recovery foam could be used to provide a delayed urging means. Furthermore, the dimensions given of the housing, interface member, low-recovery material, and slot could be different, the ball interface member could be eliminated; the gripping fingers could be of a different shape, the clip could be shaped differently, the supporting ribs could be eliminated, etc. Thus the scope of the invention should be determined by the appended claims and their legal equivalents, rather than by the examples given.

A small, lightweight golf ball teeing device is disclosed for allowing a golfer to tee up a golf ball without bending over using a golf club as a handle for the device. A housing positions the golf ball over the golf tee. A delayed urging means is used to clamp the ball and tee to the housing. While the tee is inserted into the ground, the delayed urging means compresses and rebounds slowly releasing the ball and tee from the device. Gripping fingers are positioned on top of the housing to provide a secure, aligned attachment to a golf club grip. An opening in the housing permits horizontal golf tees to be scooped up without bending. A clip is incorporated with the housing to provide attachment to golf bags, belts, etc.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application is a continuation of U.S. application Ser. No. 14/540,185, which was filed Nov. 13, 2014, now U.S. Pat. No. ______, which claims priority, under 35 U.S.C. §119(a), of European Application No. 13193375.6, which was filed Nov. 18, 2013, and each of which is hereby incorporated by reference herein. BACKGROUND [0002] The present disclosure relates to a person support apparatus, such as a bed and with a mechanism suitable for adjusting the height and orientation of a patient support frame forming part of that bed. It is more particularly suitable for a hospital or long-term care (LTC) bed. [0003] Person support apparatus, such as hospital and long-term care beds, typically include a patient support deck and a support surface, such as a mattress, supported by the deck. The patient support deck may be controllably articulated so as to take up different support configurations. [0004] The patient support deck is supported on a deck support or intermediate frame and the deck support frame is provided with a mechanism for adjusting the height of the deck and hence the height of the support surface above the floor on which the apparatus is located, and to control the orientation or inclination of the deck and hence the patient support surface relative to the floor. Adjustment of the height is helpful to allow care givers to access the patient, and to facilitate patient movement into and out of the bed. The inclination of the patient support surface is also desirable so as to make the patient more comfortable, or to, for example, take up the Trendelenburg position in which the body is laid flat on the back (supine position) with the feet higher than the head by 12-30 degrees, or the reverse Trendelenburg position, where the body is tilted in the opposite direction. [0005] The deck support frame is supported on leg assemblies which are pivotally connected at their upper end to the deck support frame and which have linear actuators for pivoting the leg assemblies relative to the deck support frame and hence adjusting the height of the deck support frame. Separate and separately controllable head end and foot end leg assemblies are provided so that the height of the foot and head ends may be separately adjusted. The leg assemblies can be pivoted together by their respective actuators and thereby raise or lower the deck support frame whilst keeping it substantially parallel to the floor. Alternatively, one of the foot or head end assemblies can be pivoted to lower just one of the foot or head ends and thereby move the deck support frame into the Trendelenburg or reverse Trendelenburg positions. [0006] Known arrangements for pivoting leg assemblies relative to a deck support frame to allow the raising and lowering of the deck support frame include a leg element pivotally connected at its upper end to a guide element which is coupled to and can slide along the outside of longitudinal elements arranged parallel to, or forming, the sides of the deck support frame. Those known arrangements comprise a U-shaped guide element arranged on its side (i.e. with its open side extending in a vertical direction) and arranged around the outside of longitudinal elements having a rectangular cross-section. Such arrangements suffer from a number of problems. These include: i) a risk of trapping fingers in the guide element which moves along the outside of the longitudinal elements: (ii) a need to overcome the frictional forces between the inner surface of the slideable guide element and the outer surface of the longitudinal element when pivoting the leg assembly and thereby sliding; and (iii) a propensity for dust and dirt to collect on the surface of the longitudinal element and hence interfere with the sliding operation. [0007] US 2009/0094747 and US 2010/0050343 disclose alternative arrangements in which channels which correspond to U-shapes on their sides (i.e. with an open vertical side) are arranged on the sides of the intermediate or deck support frame and have follower or guide elements extending into the interior of the channels through the vertical open side. The follower or guide elements engage and run along an interior surface of the respective channels. [0008] US 2006/0021143 discloses a further alternative arrangement in which guide tracks or channels are defined by slots extending through the vertical sides of longitudinal bed frame elements, and the upper end of the respective leg assemblies are provided with followers extending sideways out from the upper end of the leg assemblies to extend through or into the slots. The followers run along the guide tracks defined by the slots through the vertical sides of the bed frame elements. [0009] A need exists for further contributions in this area of technology. SUMMARY [0010] An apparatus, system and/or method according to the present disclosure includes one or more of the features recited below or in the appended claims, and which alone, or in any combination, may define patentable subject matter: [0011] The present disclosure, in a first aspect, provides a person support apparatus comprising: a person support frame for supporting a person support deck, the person support frame having two sides extending between a head end and a foot end; and a support assembly for supporting the person support frame and moving it relative to a floor surface, wherein the support assembly comprises at least one leg assembly pivotally coupled at a first upper end portion to the person support frame and coupled at its second lower end portion to floor engaging means, and an actuator element operable to move the leg assembly and thereby move the person support frame relative to the floor, wherein at least one of the sides of the person support frame comprises an inverted substantially U-shaped channel element having a substantially continuous upper surface, two substantially continuous side surfaces connected at their top edges to the upper surface, and a downward facing opening between the bottom edges of the two side surfaces, and the first upper end portion of the leg assembly includes a guide or follower element arranged to contact and run along an inner surface of the channel element. [0012] This arrangement results in a deck support frame which is robust and stable and can accommodate the changes in geometry necessary for movement or adjustment between the horizontal, Trendelenburg and reverse Trendelenburg positions. [0013] Some embodiments of the channel and roller mechanism change the height of a patient support deck by pivoting one or more leg assemblies relative to the under surface of the patient support frame. [0014] Features of some illustrative embodiments include the following: [0015] Some illustrative embodiments have a lower part count than known systems and are therefore likely to be both cheaper and more robust. More parts cost more to make and assemble and provide more elements capable of failure. [0016] The opening of the channel carrying the guide elements or rollers faces the floor. This means that dirt is less likely to enter it and interfere with the mechanism. Furthermore, any dirt that enters will not be visible in normal use. [0017] The leg assembly works vertically within the channel edges and a reduced force is therefore necessary to lift the patient support frame especially from the low position where the leg assemblies suspend a narrow angle relative to the underside of the patient support frame. The use of rollers in an optional embodiment rather than surfaces sliding relative to each other also reduces the frictional forces which must be overcome when moving the guide element. The use of a roller than a sliding element means that there is no need to overcome the friction between the sliding element and the frame element relative to which it slides thus reducing the force necessary to raise the deck support frame and makes the mechanism less likely to fail. [0018] The use of a mechanism which includes a guide element inside a channel element means that the outside surface of the longitudinal channel element can be used as a fixing area for accessories or other elements. [0019] Having the channel openly facing downwards and the guide element inside the channel make it harder for a patient or care-giver to trap their fingers or other body parts. [0020] Features described in relation to one aspect and/or embodiment of the present disclosure may equally be applied to other embodiments and/or aspects of the present disclosure. [0021] Additional features, which alone or in combination with any other feature(s), such as those listed above and/or those listed in the claims, may comprise patentable subject matter and will become apparent to those skilled in the art upon consideration of the following detailed description of various embodiments exemplifying the best mode of carrying out the embodiments as presently perceived. BRIEF DESCRIPTION OF THE DRAWINGS [0022] Illustrative embodiments will now be described in detail, by way of example only, with reference to the accompanying drawings, in which: [0023] FIGS. 1 a and 1 b are isometric and perspective views from, respectively, the foot and head ends of a patient support apparatus including a deck support frame according to one embodiment of the present disclosure; [0024] FIG. 2 is side view of the patient support apparatus of FIG. 1 with the patient support deck in a lowered position; [0025] FIG. 3 is a view similar to that of FIG. 2 but with the patient support deck in a lowered position; [0026] FIG. 4 is a detailed view of a section through the top of one of leg assemblies of the apparatus in FIG. 1 ; [0027] FIG. 5 is an end view of an alternative embodiment according to the present disclosure having a braking mechanism, in which the deck support frame is at its lowermost position and the brake engaged; [0028] FIG. 6 is a detailed view of portion VI of FIG. 5 ; [0029] FIG. 7 is a perspective view corresponding to the view of FIG. 6 ; [0030] FIGS. 8 a and 8 b are diagrams setting out roller dimensions (in mm) for an embodiment according to the present disclosure; [0031] FIG. 9 is a diagram setting out dimensions (in mm) for a channel element suitable for use with the roller of FIGS. 8 a and 8 b; and [0032] FIG. 10 is a diagram setting out dimensions (in mm) for a suitable brake lever and channel element. DETAILED DESCRIPTION [0033] Hospital beds typically include a deck supporting a mattress or other patient support element (not shown in the Figs.). The deck may be divided into articulated sections so as to create various seating and lying down configurations. Articulated beds with a controllable articulation system for the patient support surface are known and are not a novel and inventive part of embodiments of the subject disclosure so will not be described in detail. An example of such an articulated patient support surface is shown in EP 2 181 685 and WO 2004/021952 to which reference should now be made and whose contents are hereby expressly incorporated herein by reference. [0034] Referring to FIGS. 1 to 3 , a hospital bed support assembly according to one embodiment of the present disclosure includes a deck support frame 3 to which a headboard and a footboard may be mounted at, respectively, its head 4 and foot 5 ends. The head board is mountable on head board plates 33 and the foot board on foot board plates 34 . The deck support frame has two leg or support structures 6 pivotally mounted to its under surface. Each of the leg structures or assemblies 6 includes a pair of legs 7 each coupled to the deck support frame 3 by a moveable upper pivot or guide element 8 at their deck or upper end 9 . The moveable upper guide elements can move parallel to the longitudinal axis of the deck frame. For example, the moveable upper guide element 8 of the left-hand leg in FIGS. 2 and 3 can move in the directions shown by arrows D1 and D2. [0035] The lower portions of the legs 7 of each pair of legs are connected together by a lower bracing cross-element 10 at the bottom 12 of the legs. The lower cross-elements 10 are each in turn connected to a lower longitudinal or side element and able to rotate about their longitudinal axis. In the embodiment shown in FIGS. 1 to 3 , each end of the foot end leg assembly lower cross-element is pivotally connected to a lower portion of a respective length extension element and the upper portion of each length extension element is pivotally connected to the lower longitudinal side element. The foot and head ends of the lower side elements 35 each have a castor or castor device 14 so that the support assembly can move over a floor or surface on which it is placed. [0036] A pair of stabilizer elements 16 is connected to each pair of legs. A stabilizer element is connected to and links each leg to the underside of the deck support frame. The stabilizer elements 16 , which are each coupled to a leg 7 , are pivotally connected at their first upper ends 17 to the underside of the deck support frame 3 . The upper ends 17 of each stabilizer are connected to a fixed upper pivot 18 displaced from the leg upper moveable pivot 8 of the respective leg, and are pivotally connected at their second lower ends 19 to the respective pair of legs at a pair of respective lower stabilizer pivots 20 . [0037] A stabilizer cross-element 37 is pivotally connected between the pair of stabilizers 16 for each leg assembly. The respective stabilizer cross-element is connected to each respective stabilizer at a point 36 between its upper 17 and lower 19 ends. [0038] An actuator-stabilizer yoke 21 is connected to each stabilizer cross-element at a point substantially mid-way along the stabilizer cross-element so that it is in the middle of the bed. The actuator-stabilizer yoke 21 is pivotally coupled to an end of an actuator 22 (which may be a hydraulic actuator, or a linear actuator such as model No LA27 actuators supplied by Linak U.S. Inc. located at 2200 Stanley Gault Parkway, Louisville Ky. 40223) which controllably extends and retracts an actuator rod 23 connected to the actuator-stabilizer yoke 21 . Extension and retraction of the actuator rod 23 causes the respective stabilizer cross-element 37 and hence the pair of stabilizers 16 connected to that stabilizer cross-element 37 to move and thence the pair of legs 7 connected to that stabilizer 16 to rotate relative to the deck support frame 3 and thence raises or lowers the deck support frame 3 and the patient support surface arranged on that deck support frame. The actuators 22 may be controlled by either the patient or a care-giver. Control mechanisms for such actuators are well known and may be either a foot operated pedal, control panel on the side of the bed, remote control or other control mechanism. Suitable actuators are well known and are therefore not described in detail in this application. They may be hydraulic, electric or pneumatic. An example of hydraulic actuators controlling the height of a deck is described in EP 2 181 685 and WO 2004/021952. [0039] Referring to FIG. 1 , the deck support frame 3 is formed by three sides of a rectangle and comprises parallel side elements 24 connected at their head ends by a head frame element 25 . In the described embodiment there is no foot frame element closing the rectangle other than the foot board (not shown) when that is attached to the foot board plates 34 (not shown) but one could be provided if appropriate. One of the known patient support deck arrangements such as that described in EP 2 181 685 and WO 2004/021952 may be secured to the patient support frame. [0040] As shown in, for example, FIG. 4 , the side rail elements each comprise a hollow channel element open, along at least a portion of its length, on its lower side 27 . The channel element is a modified inverted U-shaped channel in which a portion of the bottom edges 28 are lipped such that the sides of the channel extend partially across the bottom of the inverted U-shaped channel. [0041] The upper end of each leg is connected to two rollers 29 . The rollers 29 are supported on axles 30 running through the leg 7 and can rotate relative to the leg 7 . The upper end 31 of each leg passes through the gap or space 32 in the bottom of the channel elements 24 defining the sides of the deck support frame. The rollers 29 each engage the inner surface of the channel element. [0042] Referring to FIGS. 2 and 3 , when the actuators 22 extend their respective rods 23 together to move the deck support frame 3 from a lowered position (see FIG. 3 ) to a raised position (see FIG. 2 ), the stabilizer element moves in direction E and pivots about its upper pivot. At the same time, the leg element pivots in direction F with its respective guide element moving in direction D1. As the guide element moves in direction D1 while the deck support surface is being raised, the respective set of rollers 29 roll relative to the respective channel element 24 . [0043] When the actuators 22 retract their respective rods 23 together to move the deck support surface from a raised position ( FIG. 2 ) to a lowered position ( FIG. 3 ), the stabilizer element moves in direction G and pivots about its upper pivot. At the same time, the leg element pivots in direction H with its respective guide element moving in direction D2. As the guide element moves in direction D2 while the deck support surface is being raised, the rollers roll relative to the channel element. [0044] Movement of the legs 7 and associated rollers 29 brought about by extension of the actuator rod to raise the deck support frame, pushes the rollers against the inner surface of the top of the respective channel element 24 so the roller rolls against that inner top surface of the channel. When the deck support frame is lowered by retraction of the actuator rod, the weight of the deck support frame and the patient support surface and patient supported thereon presses the inner top surface of the channel 24 against the respective rollers so that again the rollers roll along that top inner surface. [0045] The channel 24 is provided along a substantial part of its length with a lip portion 28 welded or otherwise attached to each of the bottom edges of the two sides of the channel element. This helps hold the rollers in place and, if the patient support deck is lifted manually or otherwise than using the actuators, pushes up against the bottom of the rollers such that they roll against the lipped bottom edges 28 . [0046] Moving the deck support frame into the Trendelenburg position or reverse Trendelenburg position is not illustrated in the Figs. However, it is achieved by having one of the leg assemblies in the raised position and the other in the lowered position and is otherwise the same as for lowering or raising the whole height of a substantially horizontal deck support frame. For the Trendelenburg position the foot end is raised to be about 15-30 degrees above the head end, whereas in the reverse Trendelenburg the head end is raised to be above the foot end. [0047] In a one embodiment of the patient support apparatus according to the present disclosure, at least one of the castors and/or castor devices at each of the foot and head ends of the apparatus are provided with a brake assembly with a brake lever as described in, for example, U.S. Pat. No. 7,703,157 and arranged to be contacted and pressed down by the lower surface of the channel element to lock or brake the respective castor or castor device when the respective portion of the deck support frame is lowered. [0048] Each of the castors includes a braking mechanism. FIGS. 5 to 7 show how a braking mechanism of the type used in castors of the type supplied by Tente as parts reference 5944 USC125 R36 may be incorporated in an embodiment according to the present disclosure. In such castors, the castor wheels 38 are braked when a pliable braking element 39 is squeezed down by a braking surface 40 so that the sides of the braking element contact and push against the sides of the castor wheels. An alternative braking element is shown in U.S. Pat. No. 7,703,157 in which braking is by means of a floor engaging element which is pushed into contact with the floor when the braking surface is ousted downwards. Any castor with an actuator mechanism operable by being pressed down or contacted may be used. [0049] The braking surface 40 at the foot ends of the bed is pushed downward by the action of a braking lever 41 which may be actuated by, for example, the foot of a care giver on, as is shown in FIGS. 5 to 7 , by contact with the underside of the channel element 24 as the bed is lowered to the lowermost position. The use of a guide element 8 which moves inside a channel 24 allows one to position the longitudinal channel 24 closer to the edges of the bed than is possible with the previous arrangements with a guide element on the outside of a channel. This means that the channel or longitudinal rod 24 can be positioned so it moves in a place sufficiently close to the wheels to itself directly engage the brake lever 41 . [0050] The brake surfaces (not shown) of the head end castors are connected to a respective foot end braking levers 41 by a rod element running inside each of the lower rail elements 35 . Movement of the braking lever 41 causes the rod to rotate and hence push the braking surfaces associated with the head end castors to move and hence brake or release the head end castors. [0051] Although certain illustrative embodiments have been described in detail above, variations and modifications exist within the scope and spirit of this disclosure as described and as defined in the following claims.

A patient support apparatus includes a frame having a first portion that is movable between a raised position and a lowered position to change an elevation at which a person is supported above a floor. Castors are coupled to the frame and are configured to rest upon the floor. An actuator is movable between a brake position in which at least one castor of the castors is braked and a release position in which the at least one castor is released. As the first portion of the frame is moved to the lowered position, the first portion automatically engages the actuator and moves the actuator to the brake position thereby to automatically brake the at least one castor.

This application is a continuation, of application Ser. No. 849,446, filed 4/8,86 now abandoned. The present invention relates to a skin reflectance measuring apparatus. BACKGROUND OF THE INVENTION The measurement of skin reflectance finds a particular application in pathology and in cosmetology. In particular, skin reflectance may be associated to other parameters such as the rate of secretion of sebum. The measurement of reflectance then becomes useful in the study of seborrhea. It may also present an advantage for studying other skin diseases such as lichen, SSM. . . . In cosmetology, the invention finds an application in measuring the effect of products known as "anti-reflectance" products for greasy skins, particularly for making efficiency-aimed tests. Another application of the present invention could be the grading of different types of skins. Various methods and devices already exist for measuring surface reflectance, for example in the industry of paints and varnishes, in order to determine the characteristics of reflection of coated surfaces. It has also been proposed to use reflectance measurement to determine a surface finish. All said known methods and processes which are used in industry are not applicable to the measurement of skin reflectance. A first problem to be solved with this particular application is the problem of influence of color. Indeed, with the known devices which can only measure the specular reflection, the results obtained for different surfaces are only comparable if the surfaces are all of the same color. To overcome the effect of color, it has been proposed to substitute to the specular reflection absolute measurement, a relative measurement between specular reflection and diffuse reflection. However, the known devices using such relative measurement remain inappropriate for measuring skin reflectance. Indeed, the apparatuses used in industry, generally comprise optical systems with focusing lenses which require an accurate positioning of the measuring apparatus with respect to the surface of which the reflectance is being measured. It is then necessary for said surface to be flat and for the measuring area to be, in general, of relatively large dimensions. Yet, in the case of the skin, the measuring area has to be relatively small in order to keep the characteristics of the skin uniform in that area and to make the measurement on as flat a surface as possible, without changing the characteristics to be measured by a flattening of the skin. It is also important to have a measuring apparatus which is easy to handle and requires no higher accurate positioning with respect to the skin. SUMMARY OF THE INVENTION It is therefore the object of the present invention to propose a reflectance measurement apparatus which is specifically adapted for measuring the reflectance of the skin. This object is reached with an apparatus which, according to the invention, comprises: a probe comprising a casing of which one face, which will be in contact with the skin, is provided with an aperture, a flexible connection in fiber optics, comprising at least three optical conductors which, at a first end, are secured in the casing of the probe such as to face the aperture thereof, the first and second conductors having their first end portions directed respectively in a first and a second directions which are symmetrical to each other with respect to an axis extending normally through the aperture, while the third conductor has its first end portion directed in another direction than said second direction, a measuring device comprising: light emitting means optically coupled to a second end of said first conductor; light receiving means optically coupled to a second end of said second conductor to produce a first signal representing the specular reflection, and to a second end of said third conductor to produce a second signal representing part of the non-specular or diffuse reflection; and processing means connected to said light emitting and receiving means, and provided with correcting means to compensate for variations in the emitted light and for the influence of ambient light, said correcting means producing a relative reflectance signal from the measured values of specular reflection and diffuse reflection, and a display device receiving the reflectance signal to indicate the amplitude of said signal. The structure of the measuring apparatus according to the invention, such as defined hereinabove, with a probe connected to a measuring device via a flexible connection in fiber optics, presents many advantages. The use of fiber optics having their end secured inside the casing of the probe in a relatively fixed configuration, permits the miniaturization of the probe. It becomes, as a result, possible to carry out measurements on reduced surfaces and, in particular, on surfaces less than 1 cm2, for example surfaces between 10 and 50 mm2. This also makes the apparatus readily usable since the probe is of reduced dimensions and is connected to the rest of the apparatus by way of a flexible connection. Such readiness of use is further increased due to the fact that, contrary to the systems using optical means with beam focusing lenses and requiring an extremely accurate positioning of the apparatus on a flat surface, the apparatus according to the invention can tolerate a few degrees of deviation of relative position between the probe and the skin surface. The correction of variations in the intensity of the emitted light and in the effect of the ambient light makes it possible to obtain a very accurate measurement without very strict operational conditions. The means for correcting variations in light intensity can be in the form of a circuit for regulating a source of light of the emitting means, using servo-control means. As a variant, means may be provided for measuring the intensity of the light produced by the emitting means in order to compensate for any variations occurring in that intensity, directly at the level of the signals produced by the reflected light receiving means. The compensation for the effect of ambient light is advantageously achieved by conducting measurements according to the "synchronous detection" principle, namely by carrying out cycles of measurements during which the specular reflection and the diffuse reflection are measured when the light-emitting means is operative and when the light-emitting means is inoperative. To control the course of said measurements and to process the results, the measuring device advantageously uses digital processing means such as a micro-computer. It will be further noted that the display of the reflectance not only enables the operator to view immediately the value that he is seeking, but also helps in correctly positioning the probe. The resulting reflectance is a relative value worked out from measurements of the specular reflection and of the diffuse reflection, for example the difference or the quotient between the measured values of specular and diffuse reflection. The difference is preferred to the quotient insofar as it introduces less scale distortion with respect to the judgement of the skin reflectance made by eye. A scale of reflectance may be defined from a measurement of a matt surface of reference (unit 1) and of a calibrated mirror (unit 10 n , n being an integer above 0). BRIEF DESCRIPTION OF THE DRAWINGS The invention will be more readily understood on reading the following description with reference to the accompanying drawings, in which: FIG. 1 is a general diagram of one embodiment of a reflectance measuring apparatus according to the invention. FIG. 2 is a more detailed cross-section of the probe of the apparatus shown in FIG. 1. FIG. 3 illustrates in more detail the structure of the emitter of the light emitting means of the apparatus shown in FIG. 1. FIG. 4 is a diagram of the circuits of emitting and receiving means and of the interface circuit of the apparatus shown in FIG. 1. FIG. 5 illustrates the variation in time of the output voltage of the receiving means during a measuring cycle. FIGS. 6 and 7 are flow charts of the operations carried out under the control of the digital processing means for, respectively measuring and calibrating. DESCRIPTION OF THE PREFERRED EMBODIMENT The apparatus illustrated very diagrammatically in FIG. 1. comprises a probe 10, a measuring device 30 and a flexible connection 20 in fiber optics connecting the measuring device to the probe 10. The probe 10 is designed to be placed in contact with the skin P in order to light up the part of the skin surface requiring to be examined. The connection 20 comprises three optical channels 21, 22, channel 21 conveys to the probe the light produced from a light-emitting device 31 in order to illuminate the skin surface to be examined. Channel 22 transmits to a receiving device 32 the light reflected specularly (normally) by the examined part of surface whereas channel 23 transmits to the receiving device part of the light reflected in non-specular or diffuse manner. In the illustrated example, the diffuse reflection is measured in the direction opposite to the direction of incidence of the light on the surface to be examined. Channels 21 and 23 can therefore be re-grouped, at least at their end portions connected to the probe, into a bi-directional optical cable. The emitting 31 and receiving 32 devices are connected to a control and processing device 33 via an interface circuit 34. Said device 31 comprises means of regulating the intensity of the emitted light and is operated by control signals issued by the processing device 33. The receiving device 32 comprises photo-electrical transducers working out electrical signals representing the normal reflection and the diffuse reflection. Said signals are transmitted to processing device 33 through the interface circuit 34, this transmission being achieved under the control of signals produced by the processing device. In conventional manner, said processing device 33 comprises memory circuits 35, an arithmetical and logical unit 36 and interface circuits 37 permitting the connection with a display device 38, such as a cathod ray tube, with a keyboard 39 and with a printer 40. The processing device may be constituted by any of the existing micro-computers, therefore it will not be described any further herein. Supply of the different circuits of the apparatus is ensured by supply circuits (not shown). FIG. 2 is a diagrammatical cross-section showing the probe 10 in more details. Said probe 10 comprises a casing 11 of which the front face 12 is provided in its center with an opening 13 such as of circular shape. The casing also presents two connecting parts 14, 15 in which are respectively secured the ends of channels 21 and 23 and the end of channel 22. Channels 21, 23 are re-grouped at their ends into a bidirectional optical cable 24 provided with an end socket 25 screwed into the connecting part 14, whereas optical cable 26 forming the channel 22 is provided with a ring 27 and is inserted in a tubular guide 17 housed in the connecting part 15. The axis of optical cable 24, namely the axis of connecting part 14, traverses the center of aperture 13 and is inclined with respect to the perpendicular N to the front face 12 of an angle i, said angle i corresponding to the angle selected for the incidence under which the part of skin surface to be examined is illuminated. In the illustrated example, the angle of incidence i is equal to about 45°, but another value could also be selected. The axis of optical cable 26, namely the axis of connecting part 15 is symmetrical to the axis of cable 24 with respect to the perpendicular N traversing the center of aperture 13 since channel 22 is designed to pick up the normally reflected light. Cables 24 and 26 are secured to the casing 11 in such a way that the ends of the fiber optics composing them are at predetermined distances d1 and d2 from the center of aperture 13. Adjustment of the position of the end of cable 24 is achieved by interposition of wedges 16 between the socket 25 and the connecting part 14 whereas the end of cable 26 is fixed in the required position in the guide 17 by a locking screw 18 traversing the connecting part 15 and resting against the ring 37. By way of example, distances d1 and d2 are about 20 mm. The use of a flexible connection composed of fiber optics of which the ends are secured to the probe, presents several advantages. For example, the probe may be small, its overall dimensions being determined by the connecting means of the optical cables. Moreover, the probe has no optical elements such as lenses which require high positioning accuracy. The measuring area, determined by the size of aperture 13 may then be small enough to allow significant measurements over a surface with as little rigidity and uniformity as the skin. For example, the surface of the measuring area may be between 10 and 50 mm2, such as about 25 mm2. The miniaturization of the probe and its flexible connection with the rest of the apparatus, also allow ready handling for taking measurements over different areas of the skin surface. FIG. 3 diagrammatically illustrates the structure of the emitter of the light emitting device 31. Said emitter comprises a casing 311 to which is connected the starting end of optical channel 21. Said casing 311 is provided with walls 312 used as support for the different elements housed in the casing. The light source is a lamp 314 with tungsten filament. The beam produced by the lamp is focussed by means of a lens 315 in order to obtain an adequate light intensity at the input 21a to optical channel 21. An infrared filter 316 may be interposed between the lamp 314 and the input to optical channel 21 in order to carry out measurements within the field of the infrared-free visible light. Two photodiodes 317, 318 are placed on both sides of the input to optical channel 21 so as to supply signals representing the light intensity at that input. Photodiodes 317 and 318 are connected to a circuit 319 for regulating the light intensity produced by lamp 314. Regulation circuit 319 (FIG. 4) comprises a source of voltage consisting of a transistor T1 of which the collector is at potential +V of a supply source and the emitter is connected to a terminal at the reference potential (earth) via the lamp 314. Photodiodes 317, 318 are connected to an amplifier circuit AMP which delivers a voltage V MES representing the real intensity of the light beam applied to the input of channel 21. Voltage V MES is compared to a reference voltage V REF , supplied by a voltage-adjustable generator SV; the comparison is carried out by means of a differential circuit CP which delivers a voltage V COM which is function of the difference between V REF and V MES . The voltage V COM is applied to the base of T1 and determines the voltage in the lamp 314 so as to return towards zero the difference between voltages V REF and V MES . The circuit 319 receives a start control signal SCA applied via a resistor R1 to the base of a transistor T2. The emitter thereof is connected to earth whereas its collector is connected, on the one hand, to the voltage source +V via a resistor R2 and, on the other hand, to the base of a transistor T3 via a resistor R3. Transistor T3 has its emitter-collector circuit connected between the base of T1 and the earth. When the start control signal is at a level between the triggering signal of transistor T2 (SCA=0, or low logic level), transistor 2 is in the OFF state, but transistor T3 is in the ON state, bringing the base of T1 to the earth potential; lamp 314 is switched off. When the ON control signal exceeds the triggering threshold of T2 (SCA=1, or high logic level), transistor T2 is turned to the ON state, this keeping T3 in the OFF state and lamp 314 is switched on, the intensity of the current through the lamp being determined by V COM . FIG. 4 also shows the circuit of receiving device 32. Two photodiodes 322, 323 receive light beams transmitted respectively by optical channels 22, 23. Diodes 322, 323 are silicon diodes connected in reverse. The cathodes of diodes 322, 323 are connected to the middle point of a voltage divider formed by two resistors R4, R5 connected in series between the earth and a terminal of potential V. Diodes 322, 323 thus produce a voltage substantially proportional to the intensity of the picked up light beams. The anodes of diodes 322, 323 are connected to two input contacts of an analog switch 324 of which the output contact is connected to the input of a logarithmic amplifier APL producing an analog signal S RFX representative of the specular reflection or of the diffuse reflection, depending on the position of switch 324. The use of a logarithmic amplifier procures greater dynamics. Moreover, the human eye constituting a logarithmic type receiver, the measuring apparatus makes it possible to come closer to the visual judgement which it is required to quantify. The receiving device receives a switch control signal SCM controlling the position of the switch. For example, when signal SCM has a high logic level (SCM=1), switch 324 connects photodiode 232 with amplifier APL to measure the specular reflection, whereas when signal SCM has a low logical level (SCM=0) switch 234 connects photodiode 233 to amplifier APL to measure the diffuse reflection. Interface circuit 34 comprises an analog-to-digital converter CAN which receives the signal S RFX to convert it in the form of a digit word N RFX of n bits. A connection circuit PIA ("parallel interface adapter") is interposed between the converter CAN and the micro-computer 33. Said circuit PIA also transmits signals SCA and SCM as well as the control signals of converter CAN. Circuit PIA is controlled in known manner by control signals produced by the micro-computer. The emitting and receiving devices are controlled to produce a reflectance measurement from the specular and diffuse reflection values; in the illustrated case, the worked out value represents the difference between the specular reflection intensity and the diffuse reflection intensity. Moreover, in order to take into account the influence of ambient light, the reflection is measured according to a principle of "synchronous detection" namely by alternately controlling the switching on and off of the light source. The light flux ΦS carried by channel 22 (specular reflection is composed of flux ΦSp effectively reflected by the skin, of flux ΦSa coming from the outside (ambient light) and from leaks from the detectors, and of flux ΦSs sent back by the casing of the probe. Likewise, the light flux ΦD carried by channel 23 (diffuse reflection) comprises components ΦDp, ΦDa and ΦDs. During a measuring cycle, the flux ΦDa, ΦSa are successively measured by actuating switch 324, the lamp being switched off, then after switching the lamp on, the flux ΦS and ΦD are measured successively by actuating the switch 324. The desired reflectance Re is equal to: Re=ΦSp-ΦDP=(ΦS-ΦSa-ΦSs)-(ΦD-ΦDa-ΦDs)/K, K being a corrective factor taking into account the geometry of the probe and of the optical channels 22, 23 since the reflectance is assessed by differences between intensities of the specular and diffuse reflections, and not by differences between flux. The quantities ΦSs, ΦDs and K are determined by calibration. By placing the probe before a light trap (instead of the skin) ΦSa+ΦSs and ΦDa+ΦDs are measured, when the lamp is switched on, and ΦSa and ΦDa are measured when the lamp is switched off, wherefrom ΦSs and ΦDs are deduced. The value of K is thereafter determined by placing the probe before a matt surface used as a reference of nil reflectance (Re=0) by measuring φD, ΦS, ΦDa and ΦSs, and by calculating: K=(ΦD-ΦDa-ΦDs)/(ΦS-ΦSa-ΦSs). A scale coefficient SC is also determined by placing the probe before a reflecting surface of reference such as a calibrated mirror at 80% reflection, the reflectance being then arbitrarily fixed to a predetermined value ReM (for Example 1000). After measuring φD, ΦS, and ΦSs, the coefficient SC is determined by dividing ReM by the quantity: (ΦS-ΦSa-ΦSs)-(ΦD-ΦDa-ΦDs)/K. The values of ΦSs, ΦDs, K and SC, determined by calibration, are stored in the memory circuits 34 of the micro-computer. FIG. 5 shows the variation in time of voltage S RFX in output of logarithmic amplifier APL. The times t.sub.ΦSa, t.sub.ΦDa, t.sub.ΦD, t.sub.ΦS correspond to the times of measurement of quantities ΦSa, ΦDa, ΦD and ΦS. The times t A and t E correspond to the switching on and switching off of the lamp, whereas times t S and t D correspond to the times of actuation of switch 234, respectively, towards photodiode 232 (specular reflection) and towards photodiode 233 (diffuse reflection). The successive measuring cycles are performed under the control of the micro-computer. The duration of one cycle may be less than 1 sec., for example around 0.7 sec., said duration being for example function of the times necessary for the stabilization of the lamp when this is switched on and off. The values of reflectance Re calculated during successive measurement cycles are displayed as successive positions of a cursor on the screen of tube 38. The operator can thus correct any incorrect positioning of the probe by observing the position variations in y-axis of the cursor when moving the probe slightly. Instantaneous display of the reflectance calculated value thus contributes to positioning the probe. The reflectance value finally retained may be a mean value worked out from the results of a predetermined number of measurement cycles. Said final value may be edited on the printer 40 and is displayed on the screen. The resulting reflectance value is recorded in a computer file which may contain other information concerning the patient whose skin is being examined, the date of examination and any special conditions of examination. The recorded information may be edited on paper via the printer, at the operator's request. The main programme including the operations of initialization of the system and the subroutines of recording on file and file readout are not specific phases of the proposed application; therefore they are not explained hereinafter in details. The measuring and calibrating operations use programmes such as per flow-charts illustrated in FIGS. 6 and 7. The measuring operation consists in the following phases: initialization of the graph, and tracing of the outline of the screen with a view to displaying the measurement results as a curve representing the variation of the reflectance (phase 400); positioning of the cursor in abscissa L=1 on the screen (phase 401); scanning of the keyboard (phase 402); if the operator, by actuating the keyboard, requests the exit of the subroutine (test 403), return to the main programme; if the operator, by actuating the keyboard, requests an integration on the reflectance values obtained during the successive cycles of measurement (test 404), a subroutine (420) is called during which a test is carried out on the positioning of an averaging indicator (E=-1!), so as, in the affirmative, to arrive at end of averaging, to return indicator E to zero, and to return to the programme, and, in the negative, to bring sum S and parameter N to zero, to position E to -1 and to return to the programme; measurement of the flux ΦDa, the signals SCA and SCM being in zero position, and readout of the corresponding digital value (phase 405); switching from channel 23 to channel 22 by placing SCM in position 1, measurement of flux ΦSa and readout of the corresponding digital value (phase 406); switching on of the lamp by bringing SCA to position 1, measurement of the flux ΦS and readout of the corresponding digital value (phase 407); switching from channel 22 to channel 23 by bringing SCM to position 0; measurement of ΦD and readout of the corresponding digital value (phase 408); calculation of Re from the readout values of ΦDa, ΦSa, ΦS and ΦD, and of the pre-recorded values of ΦSs, ΦDs, K and FE (phase 409) if an integration is called (test 410) calling of a summation subroutine 430 including updating of sum S (S=S+Re), incrementing of N (N=N+1), calculation of an "instant mean value" of reflectance M i (Re)=S/N, control of the display on the screen of the digital value of M i (Re) and return to the programme; editing of the digital values of Re or, optionally, of M i (Re)(phase 411); graphic display of the digital value of Re by control of the ordinate of the cursor on the screen (phase 412); incrementing of the abscissa of the cursor on the screen: L=L+1 (phase 413); if the value of L is equal to the maximum abscissa possible L MAX (test 414), clearing of the screen (phase 415) and return to initialization of the graph, if not, return to phase 402; The calibration operation consists in the following phases: recall of existing constant values (phase 5 1) passage to first constant value (phase 502); display on the screen of a message (phase 503) for placing the probe before the surface corresponding to the constant value to be determined (light trap, matt surface of reference, reference mirror); scanning of the keyboard (phase 504); if the operator, by actuating the keyboard, requests the exit of the subroutine (test 505), return to the main programme without changing the calibration; for every constant to be determined K1 to K4 (K1=ΦSs, K2=ΦDs, K3=K and K4=SC), performance of M successive cycles of measurement, for example 10 cycles, (phase 506) each one including: measurements of flux ΦDa, ΦSa, ΦS and ΦD (phases 405 to 408 of the aforesaid measuring programme): the calculation of quantities R1=ΦS-ΦSa, R2=ΦD-∠Da, R3=(R2-K2)/(R1-K1), R'4=(R1-K1)-(R2-K2)/K3 and R4=ReM/R'4; updating of sum Si by: Se=Si+Ri (i=1, 2, 3 or 4); and updating of sum ΣI by Σi=Σi+R.sup.2 (i=1, 2, 3 or 4); calculations of mean value and standard deviation for every constant (phase 507), namely mean value Xi=Si/M, standard deviation Vi=Σi/m-Xi 2 and reduced standard deviation Zi=⃡Vi/Xi: (i=1, 2, 3 or 4); display of calculated mean value X (phase 508); if the reduced standard deviation is greater than a predetermined threshold (test 509), it is displayed on the screen, if not, then direct passage to the next phase; consultation by the operator (phase 510) scanning of the keyboard (phase 511) if the operator, by actuating the keyboard, requests a new assessment of the same constant (test 512), return to phase 503; if the operator, by actuating the keyboard, requests that the new constant be kept (test 513), then Ki=Xi (phase 514) and passage to the next constant (phase 515); if the operator, by actuating the keyboard, refuses the value Xi (test 516), then the actual value of the constant is kept (phase 517) with passage to the next constant (phase 515); if the operator, by actuating the keyboard, requests the exit (test 518), then return to the main programme without modifying the calibration; when passing to the next constant (phase 515) and if the four constants have not yet been calculated (test 519), return to phase 503; if all the constants have been calculated, exit with modification of the calibration and return to the main programme. Tests have been conducted with a mesuring apparatus suc as described hereinabove by using a scale of reflectance Re ranging from 0 for the matt surface of reference to 1000 for the reflecting surface of reference (mirror with 80% reflection). The measurements taken on 34 people have given reflectance values within a range of 8 to 12.5 for the fore-arm and from 6 to 13.9 for the forehead. In the case of people (7 cases) whose skin appears to be greasy to the eye, the mean reflectance value measure on the forehead has been 11.7, to be compared with the general means value of 9.56 obtained from measurements taken in 32 random cases. Moreover, measurements taken on five subjects have shown a deviation of 5.4 between the mean reflectance values obtained before and after application of "Vaselin" on the fore-arm. These results show the effective correlation between the visual aspect of reflectance and the measurements taken, thereby justifying the use of the measuring apparatus according to the invention as an "objective"means of quantifying the reflectance of the skin.

A probe comprising a casing of which one face which will be in contact with the skin is providied with an aperture, is connected to a measuring device by means of a flexible connection in fiber optics comprising at least three optical conductors which, at a first end, are secured in the casing of the probe such as to face the aperture thereof, the first and second conductors having their first end portions directed respectively in a first and a second directions which are symmetrical to each other with respect to an axis extending normally through the aperture, while the third conductor has its first end portion directed in another direction than said second direction.

CROSS-REFERENCE TO RELATED APPLICATION The present application is a continuation of U.S. patent application Ser. No. 13/915,134, filed on Jun. 11, 2013, the entire content of which being incorporated by reference herein. BACKGROUND The present disclosure relates generally to displaying products on a shelf. More particularly, the present disclosure relates to storing and/or displaying products to provide for the space-efficient presentation of groups of products within a given or fixed display area, and/or allowing for convenient and orderly presentation, dispensing, stocking, and storage of products. Various types of product merchandisers are commonly used in retail environments to display different types of products. As opposed to simply positioning products on shelves, product displays are commonly used to position products on a shelf in manner which automatically advances (e.g., via gravity or a pusher) a trailing or distal product (i.e., a product that is behind a lead or proximal-most product) closer to a user once the lead product has been removed from the shelf. As can be appreciated, such product displays facilitate the arrangement and upkeep of products, as the trailing products don't have to be manually moved towards the front of the shelf, for instance. SUMMARY The present disclosure relates to a merchandising system for a displaying a plurality of products. The system comprises a base and a pusher member. The base includes a product-supporting surface and a track disposed beneath the product-supporting surface. The base defines a longitudinal axis. The pusher member is disposed in mechanical cooperation with the base and is configured to slide longitudinally with respect to the base. The pusher member includes a base-contacting surface and a plurality of legs downwardly depending from the base-contacting surface. Each of the plurality of legs is configured to mechanically engage the track. The track includes a discontinuity to enable the legs of the pusher member to selectively mechanically engage the track. In disclosed embodiments, the discontinuity in the track is between a proximal-most end of the track and a distal-most end of the track. Here, it is disclosed that the track extends proximally of the discontinuity and the track extends distally of the discontinuity. In disclosed embodiments, the track includes a plurality of spaced-apart tabs. In disclosed embodiments, the plurality of legs includes a first leg disposed on a first lateral side of the pusher member and a second leg disposed on a second lateral side of the pusher member. Here, it is disclosed that each of the first leg and the second leg includes a vertical portion disposed in contact with the base-contacting surface of the pusher member and a horizontal portion that extends from the vertical portion toward the second leg. The horizontal portion of the second leg extends from the vertical portion toward the first leg. Here, it is disclosed that each of the first leg and the second leg includes a substantially L-shaped cross-section In disclosed embodiments, at least one of the plurality of legs includes a substantially L-shaped cross-section. In disclosed embodiments, the base includes a lower surface and a gap. The gap is defined between the lower surface and the product-supporting surface. Here, it is disclosed that the track is disposed at least partially within the gap. It is further disclosed that the track is entirely disposed within the gap. Here, it is disclosed that the track includes a plurality of spaced-apart tabs. It is further disclosed that a plurality of the spaced-apart tabs define a first distance between adjacent tabs, the discontinuity includes a space between adjacent tabs defining a second distance, and the second distance is greater than the first distance. In disclosed embodiments, a distal section of the base is configured to be removed to effectively shorten the length of the merchandising system. Here, it is disclosed that the system further comprises a distal portion disposed distally of the distal section of the base. The distal portion is selectively removable from the distal section of the base, and the distal portion is re-installable with another section of the base after the distal section of the base has been removed. It is further disclosed that the distal portion includes a portion of the track. Here, it is disclosed that the pusher member is configured to slide along the entirety of the track both before the distal portion has been removed, and following removal of the distal section of the base and the re-installation of the distal portion. It is further disclosed that the distal portion includes a proximally-extending finger configured to mechanically engage a cut-out of the base. In disclosed embodiments, a plurality of distal sections of the base are configured to be individually removed to effectively shorten the length of the merchandising system. Here, the merchandising system further comprises a distal portion disposed distally of the distal section of the base. The distal portion is selectively removable from a distal-most section of the base, and the distal portion is re-installable with another section of the base after any number of the plurality of distal sections of the base have been removed. In disclosed embodiments, the system further comprises a proximal member disposed adjacent a proximal end of the base, and a biasing member mechanically coupled to both the pusher member and the proximal member. The biasing member is configured to proximally bias the pusher member. BRIEF DESCRIPTION OF DRAWINGS Embodiments of the present disclosure are described hereinbelow with reference to the drawings wherein: FIG. 1 is a perspective view of a merchandising system including one guide assembly for displaying items on a shelf according to embodiments of the present disclosure, and illustrated including one bottle thereon; FIG. 2A is a perspective view of the merchandising system of FIG. 1 including five guide assemblies with a plurality of bottles thereon; FIG. 2B is a perspective view of the merchandising system of FIGS. 1 and 2 including two guide assemblies with no bottles thereon; FIG. 3 is a perspective, assembly view of one guide assembly of the merchandising system; FIG. 4 is a perspective view, viewed from the rear, of one guide assembly of the merchandising system; FIG. 5 is a perspective view of one guide assembly of the merchandising system showing a pusher assembly separated from the remainder of the guide assembly; FIG. 6 is a perspective view of a portion of one guide assembly illustrating the pusher assembly in an intermediate position; FIG. 7 is a perspective view, viewed from the rear, of the portion of the guide assembly of FIG. 6 showing a biasing member separated from the remainder of the guide assembly; FIG. 8A is a perspective view, viewed from the bottom, of a portion of the guide assembly showing the biasing member separated from a proximal member; FIG. 8B is a perspective view, viewed from the bottom, of the portion of the guide assembly of FIG. 8A showing the biasing member engaged with the proximal member; FIG. 9 is a cross-sectional view of the pusher assembly engaged with a base of the guide assembly; FIGS. 10 and 11 are perspective views of the pusher assembly of the present disclosure; FIG. 12 is a front view of the pusher assembly of FIGS. 10 and 11 ; FIG. 13 is a side view of the pusher assembly of FIGS. 10-12 ; FIG. 14A is a perspective view of a portion of the guide assembly illustrating a distal portion separated from the remainder of the guide assembly; and FIG. 14B is a perspective view of the portion of the guide assembly shown in FIG. 14A illustrating the distal portion engaged with the remainder of the guide assembly. DESCRIPTION Embodiments of the presently disclosed merchandising system are described in detail with reference to the drawings wherein like numerals designate identical or corresponding elements in each of the several views. As is common in the art, the term “proximal” refers to that part or component closer to the user, e.g., customer, while the term “distal” refers to that part or component farther away from the user. Generally, with particular reference to FIGS. 1-3 , a merchandising system 10 is disclosed that includes a plurality of guide assemblies 100 . Each guide assembly 100 includes a base 200 , a pusher assembly 300 , a pair of lateral guides 400 , a distal section 450 , and a proximal member 500 . The base 200 , which is designed to be placed on a horizontal or included store shelf, is configured to support a plurality of products “P” thereon. The pusher assembly 300 is configured to urge product(s) “P” on the base 200 toward the proximal member 500 . The lateral guides 400 are disposed in mechanical cooperation with base 200 (e.g., are integrally formed therewith, connectable thereto, etc.) and help maintain the products “P” on the base 200 . A distal rail 452 of the distal section 450 and the proximal member 500 are also configured to help maintain the products “P” on the base 200 . One merchandising system 10 includes a plurality guide assemblies 100 . In the embodiment illustrated in FIG. 2A , merchandising system 10 includes five guide assemblies 100 , which, as shown, includes six lateral guides 400 . In disclosed embodiments, merchandising system 10 includes more or fewer than five guide assemblies 100 and that the number of lateral guides 400 equals one more than the number of guide assemblies 100 . As can be appreciated, several merchandising systems 10 are able to be positioned adjacent one another on a shelf. With reference to FIGS. 4-9 , the base 200 includes a product-supporting surface 210 , a lower surface 220 , a gap 230 , a plurality of longitudinally extending ribs 240 , and a track 250 . The product-supporting surface 210 is the portion of the base on which products “P” are positioned. The lower surface 220 is the underside of the base 200 . The gap 230 is the space between the product-supporting surface 210 and the lower surface 220 . The ribs 240 extend along at least a portion of the base 200 between a proximal end 202 of the base 200 and a distal end 204 of the base 200 (see FIG. 3 ), and are configured to provide stability to base 200 and to reduce friction when a product “P” slides along the product-supporting surface 210 , for example. The track 250 includes a plurality of spaced-apart tabs 252 that are positioned within the gap 230 . The track 250 is configured to guide legs 340 of the pusher assembly 300 (as discussed in further detail below). Referring now to FIGS. 3-13 , the pusher assembly 300 includes a pusher member 310 and a biasing member 360 (e.g., a coiled spring). Pusher member 310 includes a horizontal member 320 and a substantially vertical member 321 . In the illustrated embodiment, the vertical member 321 has an arcuate shape, which is configured to correspond to the contour of the product “P” (e.g., bottle) supported thereagainst. The horizontal member 320 includes an upper surface 322 (e.g., for supporting a product “P”), and a lower surface (or base-contacting surface) 324 that is configured to longitudinally slide along the product-supporting surface 210 of the base 200 . The horizontal member 320 also includes a proximal portion 326 , and a distal portion 328 . The proximal portion 326 is configured to support a distal-most product “P” thereon, and the distal portion 328 supports at least a portion of the biasing member 360 thereon ( FIG. 4 ). The horizontal member 320 also includes a track 330 ( FIGS. 5 and 11 ) within its lower surface 324 , and an opening 332 ( FIGS. 5, 7 and 11 ) extending between the upper surface 322 and the lower surface 324 . A portion of the biasing member 360 extends through the opening 332 and along the track 330 . The pusher member 310 also includes a plurality of legs 340 ( FIGS. 5, 8A, 8B, 9 and 11-13 ) that extend below the lower surface 324 of the horizontal member 320 . With particular reference to FIG. 11 , the pusher assembly 300 includes a first leg 340 a , a second leg 340 b , a third leg 340 c and a fourth leg 340 d . In the illustrated embodiments, each leg 340 includes a vertical portion 342 , and a horizontal portion 344 ( FIG. 12 ) extending inwardly from the vertical portion 342 , such that each leg 340 includes a substantially L-shaped cross-section. When the pusher assembly 300 is engaged with the base 200 , the legs 340 of the pusher assembly 300 extend below the product-supporting surface 210 of the base 200 and mechanically engage the tabs 252 of the track 250 , and are longitudinally slidable along the track 250 . More particularly, and with particular reference to FIG. 9 , when the pusher assembly 300 and the base 200 are mechanically engaged, the vertical portion 342 of each leg 340 abuts or is adjacent a lateral wall 254 of the tab 252 , and the horizontal portion 344 of each leg 340 abuts or is adjacent a lower wall 256 of the tab 252 . This engagement between the legs 340 of the pusher member 310 and the track 250 of the base 200 helps ensure the pusher member 310 remains on the base 200 during use of the merchandising system 10 . More particularly, when torque is applied to the merchandising system (e.g., during loading of the merchandising system 10 with products “P,” when a consumer's shopping cart bumps into the merchandising system 10 or the shelf that the merchandising system 10 is positioned on, etc.) the engagement between the pusher member 310 (e.g., the legs 340 ) and the base 200 (e.g., the track 250 ) helps prevent the pusher member 310 from toppling over. For instance, when a downward force is applied to right side of the pusher member 310 (e.g., during torquing of the merchandising system 10 ), the legs 340 a and 340 b on the left side of the pusher member 310 are forced upward. There engagement between the horizontal portions 344 of these legs 340 a and 340 b and the lower wall 256 ( FIG. 9 ) of a tab 252 of the track 250 helps prevent the pusher member 310 from becoming separated from the base 200 at that location. Additionally, the engagement between the legs 340 and the track 250 helps prevent the pusher member 310 from intentionally being separated from the base 200 (e.g., by vandals). With particular reference to FIG. 4 , to install the pusher member 310 onto the base 200 , a user positions each leg 340 adjacent a shortened tab 253 (i.e., a discontinuity in the track 250 ), and moves the pusher member 310 proximally or distally such that the horizontal portion 344 of each leg is under a tab 252 or a shortened tab 253 of the track 250 . It is envisioned that in lieu of, or in addition to shortened tabs 253 , track 250 includes a space between adjacent tabs 252 that is large enough to accommodate the legs 340 of the pusher member 310 . It is further envisioned that shortened tabs 253 (and/or the large space) are located at one or a plurality of locations between the proximal end 202 and the distal end 204 of the base 200 (e.g., not the proximal-most portion of the base 200 and not the distal-most portion of the base 200 ). With reference to FIG. 3 , the proximal member 500 of the merchandising system 10 is configured to attach to a proximal end of the base 200 via a snap-fit connection, for example. It is envisioned that at least a portion of the proximal member 500 is transparent or translucent to allow a consumer to view a portion of the proximal-most product “P 1 ” on the merchandising system 10 therethrough. Additionally, in the illustrated embodiment, the proximal member 500 has an arcuate shape, which is configured to correspond to the contour of the product “P” (e.g., bottle) supported thereagainst. It is also envisioned that the proximal member 500 includes a scooped portion 510 . The scooped portion 510 allows the proximal-most product “P 1 ” to be better viewed by a consumer, allows the proximal-most product “P 1 ” to be tipped down by a consumer to facilitate shopping of the products “P,” and/or facilitates the loading of the products “P” onto the merchandising system 10 , e.g., by a store employee. With particular reference to FIGS. 8A and 8B , a lower surface 522 of a base 520 of the proximal member 500 includes a pin 530 extending downwardly therefrom. The pin 530 is configured to mechanically engage a hole 362 disposed on a proximal portion 364 of the biasing member 360 (see also FIG. 3 ). Therefore, when the hole 362 is engaged with the pin 530 ( FIG. 7B ), the biasing member 360 , and thus the pusher assembly 300 , is mechanically coupled to the proximal member 500 . Additionally, the merchandising system 10 is configured to be used on shelves of various depths (i.e., the distance the shelf extends from the wall/support). Specifically, portions of the guide assemblies 100 are able to be broken-off or otherwise removed to effectively shorten the length of the guide assemblies 100 . More particularly, and with reference to FIGS. 3, 4, 14A and 14B , the base 200 includes breakaway features 260 , and the lateral guides 400 include breakaway features 410 , that each allow for selective removal of portions of the base 200 and the lateral guides 400 to shorten the length of the guide assemblies 100 . Referring now to FIGS. 14A and 14B , the distal section 450 includes the distal rail 452 , a distal base 460 , and distal lateral walls 470 . The distal base 460 includes a proximally-extending finger 462 that is configured to engage and interlock with a corresponding cut-out 262 disposed at a distal end of the base 200 . Accordingly, the distal section 450 is able to be removed ( FIG. 14A ), and re-installed ( FIG. 14B ) after one or more portions of the base 200 and lateral guides 400 have been removed. Further, the pusher assembly 300 of the merchandising system 10 is still able to properly function across the breakaway features 260 and 410 , the proximally-extending finger 462 and the cut-out 262 , after some or all of the portions of the base 200 and the lateral guides 400 have been removed, and after the distal section 450 has been removed and re-installed. The present disclosure also includes a method of displaying items using the merchandising system 10 described above, and a method of engaging the pusher assembly 300 with the base 200 , as discussed above. While several embodiments of the disclosure have been shown in the figures, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

A merchandising system for a displaying a plurality of products is disclosed. The system comprises a base and a pusher member. The base includes a product-supporting surface and a track disposed beneath the product-supporting surface. The base defines a longitudinal axis. The pusher member is disposed in mechanical cooperation with the base and is configured to slide longitudinally with respect to the base. The pusher member includes a base-contacting surface and a plurality of legs downwardly depending from the base-contacting surface. Each of the plurality of legs is configured to mechanically engage the track. The track includes a discontinuity to enable the legs of the pusher member to selectively mechanically engage the track.

BACKGROUND 1. Field of the Invention The present invention is directed to a child cup, commonly known as a “sippy cup,” comprising a cup coupled to a lid having an opening therethrough adapted to received a straw. More specifically, the invention is directed to a sippy cup having a sliding actuator positioning a straw coupled to a lid between an erect position accessible by a child and a closed position where the actuator covers over the straw making inaccessible an open end of the straw for drawing fluid from the sippy cup. 2. Background of the Invention Specialty child cups have been in the marketplace for a number of years. These child cups limit the availability of a fluid, typically a beverage, from entirely spilling from the cup once the cup has been overturned by the child. Prior art cups have included generally two pieces; a cup and a top lid having an opening therethrough. The opening through these prior art lids was designed to limit the cross sectional area through which the fluid may travel, thereby keeping the amount of unintended fluid exiting the cup to a minimum when the cup is overturned. These lids have generally included a molded nipple or other similarly shaped protrusion adapted to be received by the child's mouth to create a fluidic seal between the lid and child's mouth. An example might include U.S. Pat. No. 6,568,557. SUMMARY OF THE INVENTION The present invention is directed to a child cup, commonly known as a “sippy cup,” comprising a cup coupled to a lid having an opening therethrough adapted to received a straw. The straw provides a means for directing a fluid contained within the cup to a child's mouth by the child depressurizing a portion of the straw and drawing the fluid through the straw. More specifically, the present invention is directed to a sippy cup having a sliding actuator positioning a straw between an erect position accessible by a child and a closed position making inaccessible an open end of the straw for drawing fluid from the sippy cup. In an exemplary embodiment, the sippy straw cup includes a cup adapted to be coupled to a lid to create a fluidic seal therebetween. The cup includes an inner wall and an outer wall being separated by a space therebetween. The space may be occupied in part by a lenticular image providing a means of entertainment for the child. The lid includes a convex exterior and a concave interior, where the concave interior includes a conduit continuing through to the convex exterior/top. The convex exterior includes an arcuate, oblong channel receiving a sliding actuator therein. The sliding actuator is positionable between an open position where a straw riding within the conduit of the lid is in an erect position and a closed position where the straw is rendered inaccessible by the sliding actuator covering the straw and wedging the straw between the underside of the actuator and the recessed top surface of the lid. In the closed position, fluid within the cup is unable to be withdrawn through the straw. It is a first aspect of the present invention to provide a closure for a container adapted to house a beverage therein, the closure comprising: (a) a cap having a mating feature adapted to interface with a corresponding feature of a container to secure the cap thereto, the cap also including an orifice therethrough and a channel therewithin, the channel being adapted to receive a sliding member therein; and (b) a flexible conduit adapted to be in fluid communication with a beverage within the container, wherein the sliding member is operative to position the flexible conduit between an open position and a closed position, where the open position enables fluid communication between a drinking end and an interior of the container. In a more detailed embodiment of the first aspect, the flexible conduit biases the sliding member in the open position. In another more detailed embodiment, the sliding member includes a trench adapted to receive at least a portion of the flexible conduit when the flexible conduit is between the open position and the closed position. In yet another more detailed embodiment, the flexible conduit includes molded retention features thereon to inhibit the flexible conduit from being pulled through the orifice. In a further detailed embodiment, the trench runs parallel to the channel and parallel to a range of movement available to the sliding member. In still a further more detailed embodiment, the cap includes a trench adapted to receive at least a portion of the flexible conduit when in the closed position, wherein the trench includes a dam operative to discontinue fluid communication with the beverage in the closed position. In yet a further more detailed embodiment, the sliding member is substantially radially recessed within the channel. In another detailed embodiment, the sliding member includes at least one fin received within at least one guide groove formed within a side wall of the channel. In yet another more detailed embodiment, the flexible conduit is adapted to receive a rigid conduit for extending approximate a bottom of the container. In still a further more detailed embodiment, a bottom of the cap is substantially concave. In a more detailed embodiment of the first aspect, the cap is substantially dome shaped. In a further detailed embodiment, the container includes a lenticular image. In yet a further detailed embodiment, the container includes concentric gripping rings. In a more detailed embodiment, the sliding member slides radially. In another more detailed embodiment, the container includes a holographic image. In yet another detailed embodiment, the cap includes circumferentially arranged gripping aids. It is a second aspect of the present invention to provide a container comprising: (a) a cup adapted to hold a beverage therein, the cup having a lenticular image associated therewith; and (b) a cap having a mating feature adapted to interface with a corresponding feature of the cup to secure the cap thereto, the cap also including an orifice therethrough coupled to a flexible conduit adapted to be in fluid communication with the beverage within the cup, wherein at least one of a pivoting member and a sliding member coupled to the cap is operative to position the flexible conduit between an open position and a closed position, where the open position enables fluid communication between a drinking end of the flexible conduit and an interior of the cup. In a more detailed embodiment of the second aspect, the lenticular image is interposed between a clear outer cup and to an inner cup. In another more detailed embodiment, the clear outer cup and the inner cup are coupled together by spin molding. In yet another more detailed embodiment, the cap includes an arched channel therewithin, the arched channel being adapted to receive a sliding member therein, wherein the sliding member is operative to position the flexible conduit to protrude from an outer surface in the open position and recess the flexible conduit within the outer circumferential surface in the closed position. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side view of an exemplary embodiment of the present invention; FIG. 2 is a cross-sectional view the exemplary embodiment of the present invention taken along lines 1 — 1 of FIG. 1 ; FIG. 3 is a side view of an exemplary cup component in accordance with the exemplary embodiment of the present invention; FIG. 4 is a cross-sectional view the exemplary cup component in accordance with the exemplary embodiment of the present invention taken along lines 3 — 3 of FIG. 3 ; FIG. 5 is a side view of an exemplary lid component in accordance with the exemplary embodiment of the present invention; FIG. 6 is a cross-sectional view the exemplary lid component in accordance with the exemplary embodiment of the present invention taken along lines 5 — 5 of FIG. 5 ; FIG. 7 is a frontal view of an exemplary lid component in accordance with the exemplary embodiment of the present invention; FIG. 8 is a cross-sectional view the exemplary lid component in accordance with the exemplary embodiment of the present invention taken along lines 7 — 7 of FIG. 7 ; FIG. 9 is a side view of an exemplary sliding actuator component in accordance with the exemplary embodiment of the present invention; FIG. 10 is a rearward view of the exemplary sliding actuator component in accordance with the exemplary embodiment of the present invention; FIG. 11 is a bottom view of the exemplary sliding actuator component in accordance with the exemplary embodiment of the present invention; FIG. 12 is a cross-sectional view, from the side, of the exemplary lid and sliding actuator components in accordance with the exemplary embodiment of the present invention providing fluid communication between the fluid within the container and an external environment; and FIG. 13 is a cross-sectional view, from the side, of the exemplary lid and sliding actuator components in accordance with the exemplary embodiment of the present invention inhibiting fluid communication between the fluid within the container and an external environment. DETAILED DESCRIPTION The exemplary embodiments of the present invention are described and illustrated below as a fluid container, referred to below as a “sippy straw cup”, comprising a cup and corresponding lid having a sliding actuator to regulate fluid communication between an interior of the sippy straw cup and an external environment. The various orientational, positional, and reference terms used to describe the elements of the present invention are therefore used according to this frame of reference. However, for clarity and precision, only a single orientational or positional reference will be utilized; and, therefore it will be understood that the positional and orientational terms used to describe the elements of the exemplary embodiment of the present invention are only used to describe the elements in relation to one another. Referring to FIGS. 1 and 2 , an exemplary embodiment of a sippy straw cup 10 includes a cup 12 , a lid 14 , a sliding actuator 16 , and a straw 18 providing a selectively sealed fluid reservoir 20 available for holding a fluid therein, that may include, without limitation, a beverage. In an open position, as shown, the straw 18 is erect and provides fluid communication between the fluid reservoir 20 and an external environment 22 . The straw 18 may include two or more sections, with a first section 24 being resilient and a second section 26 coupled to the first section 24 that is less resilient and not readily amendable to spatial deformation. Referencing FIGS. 2–4 , the cup 12 includes a cavity 28 partially defined by an exterior wall 30 of an inner cup 32 and partially by an interior wall 34 of an outer cup 36 . The cavity 28 may be adapted to receive a graphical expression (not shown), in which case the outer cup may be transparent to facilitate visual appeal. The graphical expression may include a lenticular or holographic image on a medium positioned within the cavity 28 . Those of ordinary skill in the art are familiar with the methods of forming lenticular, holographic, or other images onto various mediums. The inner cup 32 includes an interior wall surface 38 defining the reservoir 20 and a spout 40 having spiral protrusions 42 on an exterior surface 44 adapted to be received within corresponding grooves 70 within the lid 14 for securing the lid 14 to the cup 12 . The spout 40 includes a ledge 46 transitioning into a circumferential wall 48 forming a recess 50 between the circumferential wall 48 and the exterior wall 30 of the inner cup 32 . The recess 50 is adapted to receive a top portion 52 of the outer cup 36 , where the outer cup 36 and the inner cup 32 may be coupled together by spin sealing. The outer cup 36 transitions from the top portion 52 into a sill 54 circumferentially thereabout that tapers inward to create a first indentation 56 . The first indentation 56 leads into a first mound 58 that gives rise to a second indentation 60 and thereafter a second mound 62 . Each indentation 56 , 60 and each mound 58 , 62 is circumferentially distributed about the outer cup 36 . The second mound 62 transitions into a smooth taper terminating at a bottom aspect 64 having a dome shaped underneath surface 66 . Referencing FIGS. 5–8 , the lid 14 is substantially domed shaped having a plurality of raised areas 68 circumferentially distributed thereabout to facilitate gripping as the corresponding grooves 70 within an outer wall 72 receive the spiral protrusions 42 of the inner cup 32 to couple the lid 14 to the cup 12 (See FIG. 12 ). A fluidic seal is created between an interior surface 74 of the outer wall 72 and the exterior surface 42 of the inner cup 32 , as well as between an interior surface 76 of an inner lip 78 (extending from the outer wall 72 ) and the interior surface 38 of the inner cup 32 . The outer wall 72 transitions upward from the inner lip 78 in an arcuate manner until terminating at a recess 80 . The recess 80 includes a side surface 82 being essentially square with an arcuate top surface 84 . The arcuate top surface 84 defines an orifice 86 therein and gives rise to a conduit 88 extending from the top arcuate surface 84 of the recess 80 to an underneath surface 90 of the lid 14 . The conduit 88 includes circumferential projection 92 separating a first cylindrical portion 94 and a second cylindrical portion 96 having a greater diameter than the first cylindrical portion 94 . A groove 97 , adapted to receive the straw 18 , is formed within the recess 80 and includes a finger 98 abutting the orifice 86 . The side surface 82 of the recess 80 includes a guide notch 100 cut therein following the generally arcuate shape of the recess that is adapted to receive guide pins 102 of the sliding actuator 16 (See FIGS. 9–11 ). Referring to FIGS. 9–12 , the sliding actuator 16 is adapted to be received within the recess 80 and includes a generally arcuate shape from the side, where an underneath surface 104 is adapted to ride along the top surface 84 of the recess 80 and a top surface 106 of the actuator 98 is adapted to be substantially flush with the outer wall 72 of the lid 14 upon being seated within the recess 80 . Two guide pins 102 protrude from each side 108 of the actuator 16 and are operative to guide the actuator 16 within the recess 80 from a closed position where the straw 18 is wedged between the underneath surface 104 and the top surface 84 and an open position where the straw 18 is erect. A contoured ridge 110 extends across the actuator 16 and includes two sliding guides 112 adapted to slide along the outer wall 72 . The contoured ridge 110 provides an actuation point for a user to push against or pull on the ridge 110 to effect motion of the actuator 16 with respect to the recess 80 . The underneath surface 104 includes a pair of rectangular projections 113 forming a mating channel 114 therebetween. The front 116 of the actuator 16 is partially open to guide the cylindrical nature of the straw 18 into the mating channel 114 when the actuator 16 is in the closed position. The straw 18 may include exterior features such as guide grooves or ridges (not shown) to further facilitate alignment within the groove 97 and the mating channel 114 . Referencing FIG. 12 , the open position of the sippy straw cup 10 is shown having the first section 24 of the straw 18 partially received within the conduit 88 and includes an exposed section 120 with a tip 122 at the end not received within the conduit 88 . An orifice 124 defined by a wall 126 of the straw 18 provides a generally constant internal diameter providing a circular cross-sectional area available for fluid flow therethrough. This generally constant internal diameter continues for the length of the first cylindrical portion 94 and part of the second cylindrical portion 96 . The radius of orifice 124 and the radius of the wall 126 aggregate to approximate the internal diameter of the conduit 88 . The straw 18 includes an indentation 128 that receives the circumferential projection 92 seating the straw 18 within the conduit 88 . The wall 126 increases in thickness to abut an interior wall 130 of the second cylindrical portion 96 , and when teamed with the indentation 128 and the circumferential projection 92 , inhibits vertical movement of the straw 18 within the conduit 88 . Just beyond the exit of the conduit 88 , a step change within the straw is present where the orifice 124 increases in cross-section to receive the second section 26 adapted be in direct contact with the beverage occupying the reservoir 20 of the sippy straw cup 10 . Referring to FIG. 13 , the closed position of the sippy straw cup 10 is shown having the straw 14 wedged between the underneath surface 104 of the actuator 16 and the top surface 84 of the recess 80 . In practice, as the actuator 16 is repositioned from the open position to the closed position, the front 116 of the actuator 16 contacts the external wall 126 of the exposed section 120 of the straw 18 and pushes the straw forward. The open section of the front 116 of the actuator 16 and the mating channel 114 receives the exposed section 120 of the straw 18 as the actuator 16 continues moving forward, thereby pushing the straw 18 over the finger 98 projecting outward from the conduit 88 and into the groove 97 formed within the recess 80 . As the straw 18 is received within the groove 97 and mating channel 114 , the finger 98 forces one side of the straw wall 126 against the other side of the straw wall 126 , discontinuing the orifice 124 within the straw 18 to inhibit fluid communication between the second section 26 and the tip 122 of the straw 18 . The forward movement of the actuator 16 pushes the straw 18 completely within the groove 97 and mating channel 114 while the rear section 118 of the actuator 16 covers the orifice 86 . When moving from the closed to the open position, the actuator 16 is moved backward, gradually uncovering the exposed section 120 of the straw 18 previously seated within the groove 97 and mating channel 114 such that the resiliency of first section 26 of the straw 18 gradually raises the straw 18 to an erect position abutting the front 116 of the actuator 16 . Following from the above description and invention summaries, it should be apparent to those of ordinary skill in the art that, while the methods and apparatuses herein described constitute exemplary embodiments of the present invention, the inventions contained herein are not limited to these precise embodiments and that changes may be made to them without departing from the scope of the invention as defined by the claims. Additionally, it is to be understood that the invention is defined by the claims and it is not intended that any limitations or elements describing the exemplary embodiments set forth herein are to be incorporated into the meanings of the claims unless such limitations or elements are explicitly recited in the claims. Likewise, it is to be understood that it is not necessary to meet any or all of the identified advantages or objects of the invention disclosed herein in order to fall within the scope of any claim, since the invention is defined by the claims and since inherent and/or unforeseen advantages of the present invention may exist even though they may not have been explicitly discussed herein.

A closure for a container adapted to house a beverage therein, the closure comprising: (a) a cap having a mating feature adapted to interface with a corresponding feature of a container to secure the cap thereto, the cap also including an orifice therethrough and a channel therewithin, the channel being adapted to receive a sliding member therein; and (b) a flexible conduit adapted to be in fluid communication with a beverage within the container, wherein the sliding member is operative to position the flexible conduit between an open position and a closed position, where the open position enables fluid communication between a drinking end and an interior of the container.

BACKGROUND OF THE INVENTION This invention relates to dental apparatus and more specifically to dental cleaning and massaging apparatus. Research has clearly shown that the brushing of teeth as commonly practiced does not provide adequate cleaning of the teeth and the area around the teeth to prevent caries and peridental disease. Toothpicks and dental floss have been used to augment brushing. However, even the use of toothpicks and/or dental floss in combination with brushing does not provide the cleaning necessary to adequately guard against caries and peridental disease. In recent years hydro-therapy devices that provide a higher degree of cleansing, particularly cleansing of the gingival crevices, have been devised and introduced on the market. This invention provides for the hydraulic cleaning of the teeth of a person and at the same time provides for the massaging of the gums. Research has also shown that gentle non-damaging massaging of the gums promotes dental health. SUMMARY OF THE INVENTION The apparatus of this invention provides a relatively simple and highly effective means for cleaning teeth and the gingival crevices and for massaging the gums. The apparatus comprises a mouthpiece having upper and lower channel members that fit over the upper and lower teeth, respectively, and fit snugly against the respective gums. The channel members are joined by a membrane structure and pneumatic means are provided to move the upper and lower channel members relative to the upper and lower gums, respectively, to thereby massage the gums. Hydraulic means to clean the teeth and gingival crevices and to lubricate the gums during massaging are also provided. BRIEF DESCRIPTION OF THE DRAWING A complete and full understanding of the invention can be obtained from the following detailed description when read in conjunction with the annexed drawing in which: FIG. 1 is a pictorial representation of the invention; FIG. 2 is a top view of the mouthpiece of the invention; FIG. 3 is a cross-sectional view of the mouthpiece along the line 3--3 of FIG. 2; FIG. 4 is a cross-sectional view of the mouthpiece taken along the line 4--4 of FIG. 2 with the air-socks of the pneumatic means inflated; and FIG. 5 is the cross-sectional view of FIG. 4 with the air-socks deflated. DESCRIPTION OF THE INVENTION Referring to the drawing, the invention comprises a mouthpiece 1 having an upper channel member 2 and a lower channel member 5 (FIGS. 3, 4 and 5). Upper channel member 2 is essentially identical to the upper mouthpiece worn by a boxer but modified according to this invention; and, similarly, lower channel member 5 is essentially identical to the lower mouthpiece worn by a boxer but modified according to this invention. This upper channel member 2 is designed to fit over the upper teeth of the user and to snugly fit against the upper gum and lower channel member 5 is designed to fit over the lower teeth of the user and to fit snugly against the lower gum. Upper channel member 2 and lower channel member 5 are made of a relatively soft but semi-rigid material. Holes 6 (see FIGS. 4, 5 and 6) are cut through both legs or sides of upper channel member 2 and lower channel member 5. The function of these holes will be described later herein. A first or outer membrane 7 extends from upper channel member 2 downward to lower channel member 5 as is more clearly shown in FIG. 3. As shown in FIG. 3, outer membrane 7 is integrally formed with the uppermost part of upper channel member 2 at one end and is integrally formed with the lowermost part of lower channel member 5. Instead of being integrally formed with upper and lower channel members 2 and 5, respectively, outer membrane 7 can be and from a production standpoint preferably is secured by any suitable means such as a non-toxic adhesive at one end to upper channel member 2 and at its other end to lower channel member 5. A second or inner membrane 8 extends from the uppermost part of upper channel member 2 downward to the lowermost part of lower channel member 5 (see FIG. 3). Again, the top part of second membrane 8 is shown in FIG. 3 as being integrally formed with upper channel member 2 at one end and with lower channel member 5 at its other end but can be and preferably is secured to the uppermost part of upper channel member 2 at one end and to the lowermost part of lower channel member 5 at its other end by any suitable means and is a non-toxic adhesive. Outer membrane 7 and inner membrane 8 are conveniently made of a relative soft material that is somewhat elastic. From the foregoing description of outer member 7 and inner membrane 8, it is apparent that the area between the uppermost part of upper channel member 2 and the lowermost part of the lower channel member 5 is enclosed by means of membranes 7 and 8. Although it is not clearly visible in FIGS. 1 and 2, membranes 7 and 8 are brought around the back of upper and lower channel members 2 and 5 such that the closed area formed by membranes 7 and 8 is a sealed area. A plurality of the bite blocks 10 are located in both upper and lower channel members 2 and 5. Three bite blocks 10 are shown in upper channel member 2. An identical number of bite blocks are located in lower channel member 5 directly below bite blocks 10. One of these bite blocks, the bite block 11, located in lower channel member 5 is shown in FIGS. 3, 4 and 5. Referring specifically to FIGS. 3, 4 and 5, a rod or post 12 has one end secured to or integrally fabricated with bite block 10. The other end of post or rod 12 is secured to or integrally fabricated with the block 13. A rod or post 14 has one end secured to or integrally fabricated with bite block 11 and its other end is integrally fabricated with or secured to block 13. A hole 15 is cut through block 13. All three bite block structures are identical. Thus, all three bite block structures comprise a bite block 10 in upper channel 2, a bite block 11 in lower channel 5, a post or rod 12, a block 13 having a hole 15 and a post or rod 14. While the number of bite block structures provided is not critical, it will be obvious later herein from the description of the operation that at least three bit block structures should be provided. A hose or tube 16 is positioned between the bottom of upper channel member 2 and the top of lower channel member 5. The hose or tube 16 is shaped to extend along the entire bottom and top surfaces of upper channel members 2 and 5, respectively, as is shown in FIG. 2. Hose or tube 16 is threaded through holes 15 of blocks 13 as shown in FIGS. 3, 4 and 5. A plurality of air-sacks 17 are integrally formed along tube or hose 16 as shown in FIG. 2. Conveniently, air-sacks 17 are areas formed along tube or hose 16 that are more elastic than the balance of hose 16 so that air-sacks 17 will expand when inflated by air while the balance of hose or tube 16 remains substantially unchanged when air-sacks 17 are inflated or deflated. While the number of air-sacks provided is not critical, four air-sacks located as shown in FIG. 2 is probably the minimum number required for satisfactory operation. More air-sacks 17 could be provided or for that matter the entire hose or tube 16 could be made of the same material as air-sacks 17 so that the entire tube or hose 16 would expand when inflated except, of course, in the area where hose or tube 16 passes through the holes 15 of blocks 13. Air-sacks 17 are secured to upper and lower channel members 2 and 5 by a suitable adhesive or the like. Referring specifically to FIGS. 1 and 2, a hose or tube 18B has one end secured to or is integrally fabricated with hose 16. The other end of hose 18B is secured to the coupler 18A. Coupler 18A is secured to and passes through membrane 7 such that one end, the end secured to hose 18B, is located in the enclosed area formed by membranes 7 and 8 and the other end extends slightly beyond the outer surface of membrane 7. A hose or tube 19B is secured along the outside of membrane 7 as shown more clearly in FIG. 1. Both ends of tube 19B are open. A coupler 19A, one end of which communicates with the inside of hose 19B, is secured to hose 19B at approximately the mid-point of hose 19B. The other end of coupler 19A extends slightly beyond the outside surface of hose 19B. A hose or tube 20B is located in the area formed by membranes 7 and 8. One end of hose 20B extends through membrane 8. This end of hose 20B conveniently and preferably is flush with the outside surface of membrane 8. The other end of hose 20B is secured to one end of the coupler 20A. Coupler 20A is secured to membrane 7 such that one end of coupler 20A, the end secured to hose 20B, is located in the area formed by membranes 7 and 8 and the other end extends slightly beyond the outside surface of membrane 7. A coupler 21A is secured to membrane 7 such that one end of coupler 21A extends into the enclosed area formed by membranes 7 and 8 and the other end extends slightly beyond the outer surface of membrane 7. Seals are provided around couplers 18A, 20A and 21A where they pass through membrane 7 so that a fluid tight seal is provided between membrane 7 and each of the couplers 18A, 20A and 21A. Similarly, a seal is provided between hose 19B and the area adjacent the end of coupler 19A that communicates with the inside of hose 19B so that a fluid tight seal is provided between hose 19B and this end of coupler 19A. One end of each of the hoses or tubes 18, 19, 20 and 21 is coupled to a control box 22. The other end of hoses 18, 19, 20 and 21 are coupled to couplers 18A, 19A, 20A and 21A, respectively. The end of each of the hoses 18, 19, 20 and 21 that is coupled to its mating coupler 18A, 19A, 20A and 21A, respectively, is preferably provided with a mating connector, not shown in the drawing, such that hoses 18, 19, 20 and 21 can be quickly coupled to and uncoupled from couplers 18A, 19A, 20A and 21A, respectively. Any type of suitable well known quick connect and disconnect coupling arrangement can be used to couple hoses 18, 19, 20 and 21 to their respective couplers. In addition to quick disconnect, the couplers permit one control unit 22 to be used interchangeably with a plurality of mouthpieces. Three ON-OFF switches, the switches 23, 24 and 25, are provided on control box 22. The outlet hoses 26 and 27 have one end coupled to control box 22. Control box 22 is provided with a remote control device 28 that is sized and shaped to be conveniently held in the hand of the user of the apparatus of this invention. Remote control device 28 is provided with the switches 29, 30 and 31. The apparatus of this invention operates as follows: The user inserts mouthpiece 1 into his or her mouth such that upper channel member 2 fits over the upper teeth and snugly against the upper gum and lower channel 5 fits over the lower teeth and snugly against the lower gum. Control box 22 is then activated to provide either air pulses and water or air pulses alone or water alone. The air pulses are provided to air-sacks 17 from control box 22 through hose 18, coupler 18A, hose 18B and hose 16. Control box 22 is provided with an air pump that operates cyclically to alternately provide pulses of air with periods of no air between the air pulses. When air pulses are provided, air-sacks 17 are inflated and during the period between air pulses air-sacks 17 are deflated. The elasticity of air-sacks 17 and the elasticity of membranes 7 and 8 forces the air out of air-sacks 17 through hose 16, hose 18B, coupler 18A and hose 18 during the period between air pulses. Instead of relying solely on the elasticity of air-sacks 17 to drive out the air, the pump of control box 22 could alternately pump air in and such air out; thereby ensuring positive inflation and deflation of air-sacks 17. In any event, control box 22 must operate such that air-sacks 17 are alternately inflated and deflated. Referring to FIGS. 4 and 5, FIG. 4 shows a single air-sack 17 in its inflated condition and FIG. 5 shows an air-sack 17 deflated. All of the air-sacks 17 are inflated or deflated at the same time. When the air-sacks 17 are inflated, upper channel member 2 rides up on the upper gum and lower channel member 5 rides down on the lower gum. When air-sacks 17 are deflated, the upper channel member 2 will ride down on the upper gum and lower channel member 5 will ride up on the lower gum. Thus, as air-sacks 17 are inflated and deflated, upper and lower channel members 2 and 5 provide a massaging action on the gums. The teeth are held in place by the bite blocks 10 and 11 so that the upper and lower channel members 2 and 5 will ride up and down on the gums with the teeth staying in place. The elasticity of the membranes and the air-sacks pulls upper and lower channel members toward each other when air-sacks 17 are deflated. At the same time that control box 22 is providing air to massage the gums, control box 22 also provides a source of water and/or cleaning fluid through hose 21 and coupler 21A into the area formed by membranes 7 and 8. This water and/or cleaning fluid flows through holes 6 in upper and lower channel members 2 and 5 to clean and flush out the teeth and gums. This fluid is preferably introduced into mouthpiece 1 as a gentle steady stream. In addition to providing a cleaning action, the fluid serves as a lubricant during the massaging action. Since some fluid will seep out between the gums and upper and lower channel members 2 and 5, suction hose 9 is provided on the outside of membrane 7. Suction hose 9 is coupled to control box 22 by means of coupler 19A and hose 19. Control box 22 sucks any fluid seepage out of the mouth of the user through hose 9, coupler 19A and hose 19. Similarly, hose 20B serves as a suction hose to suck out the fluid that seeps into the area of the mouth outside of inner membrane 8. This seepage is drawn out by control box 22 through hose 20B, coupler 20A and hose 20. A source of water is provided to control box 22 by means of the hose 26. This water can be mixed with a cleaning fluid that is stored inside of control box 22. If no cleaning fluid is to be used, no such fluid will be stored in control box 22. Similarly, if only cleaning fluid is used, the source of water is cut off. Also, a mixture of water and cleaning fluid can be stored in control box 22 and hose 26 eliminated, if control box 22 is provided with a sufficiently large storage compartment for the fluid. The fluid drawn out of the mouth around mouthpiece 1 through hoses 19 and 20 is drained out of control box 22 by means of hose 27. If a drain pan is provided in control box 22, hose 27 can be eliminated. While under most circumstances, the apparatus will be used with both cleaning fluid and with air to provide the massaging action, the apparatus can be operated such that either air only is provided or cleaning fluid only is provided, or both air and cleaning fluid are provided. Control box 22 is provided with three ON-OFF switches to provide the three modes of operation. For example, switch 23 would provide both air and water, switch 24 air only and switch 25 water only. While the apparatus can be operated from control box 22, a remote control device 28 is preferably provided. Remote control device 28 is of such size and shape that it is easily hand held and is provided with switches 29, 30 and 31 that correspond in operation to switches 23, 24 and 25, respectively. Alternately, remote control device 28 can be and preferably is provided with a single ON-OFF pushbuttom switch with the mode of operation set by switches 23, 24 and 25. This single switch or remote control device 28 would then operate to merely activate the control box 22. While the invention has been described with reference to a specific embodiment, it will be obvious to those skilled in the art that various changes and modifications can be made to this embodiment without departing from the spirit and scope of the invention as set forth in the claims. For example, bristles can be added to the upper and lower channels to assist the massaging action and a single coupling arrangement could be used to couple the control panel to the mouthpiece.

Apparatus for cleaning teeth and the gingival crevices and for massaging the gums is disclosed. The apparatus comprising a mouthpiece having an upper channel member adapted to fit over at least a part of the upper dentation and to snugly engage the upper gum and a lower channel member adapted to fit over at least a part of the lower dentation and to snugly engage the lower gum. The upper and lower channels are joined by a membrane means which form fluid chambers. Pneumatic means are provided to move the upper and lower channel members upward and downward over the respective gums to massage the gums. In addition water or any suitable cleaning fluid is introduced into and out of the apparatus to clean the teeth and gingival crevices and to provide lubrication for the massaging action of the pneumatic means.

[0001] This invention relates to devices for preparing corn-on-the-cob to be eaten. More specifically, the invention relates to devices for use in cleaning the silks of the corn away from the corn-on-the-cob, and to cutter devices for removing the corn kernels from the cob. [0002] Devices have been proposed and sold in the past for removing silks from the cob. Cutters also have been proposed for removing corn kernels from the cob. [0003] Some of the prior corn cutters suffer from the problem that an elongated handle gets in the way of the cutting operation and tends to make it difficult to use. [0004] It also has been proposed in the past to mount both a brush and a cutter on a single elongated handle, with the blade of the cutter being positioned so that the handle is perpendicular to the corn cob as the device is used to cut the corn off of the cob. This device, it is believed, also is relatively awkward to use, and has other shortcomings limiting its commercial acceptability. [0005] As a result, known prior devices for cutting corn from the cob, and for removing silks from the corn to be cooked, have generally been awkward to use, and otherwise less than fully satisfactory. [0006] Another problem with prior cutters is that the blades often do not cut the corn to a consistent depth; that is, sometimes, the blades dig into the cob too deeply or not deep enough. [0007] Therefore, it is the object of the present invention to provide a corn preparation device which eliminates or alleviates the foregoing problems. [0008] More specifically, it is an object to provide a device which can be held easily in the hand while cutting corn from the cob, or while removing silks from the corn cob, and with only minimal contact between the hands of the user and the corn. [0009] It also is an object of the present invention to provide a protective holder for the corn cutter to keep it from cutting inadvertently. [0010] It is a further object to provide such a device which is easily convertible from de-silking brush to a cutter so that both functions can be provided in a single compact device. [0011] In accordance with the present invention, the foregoing objectives are met by the provision of a single structure which is easy to grasp and can be used either as a corn cutter in cutting corn from the cob, or as a brush for removing silks from the cob. [0012] The foregoing is accomplished by the novel construction in which a base member is provided with first and second opposing faces of a relatively broad extent. Extending from a first one of the surfaces is a brush, and extending from the opposite one of the surfaces is a cutter. A cover is provided to cover either one of the two implements. The cover fits securely onto the body so as to form a palm-fitting pushing structure against which the user can push. The device can be converted from a cutter to a de-silking brush, or vice versa, simply by moving the cover from one surface to the other. [0013] The invention further provides a cutter blade which is sharpened on both sides of the edge. This tends to guide the blade in a straight path, not forcing it to dig too deeply or cut too shallowly in passing through the corn. [0014] Because the cover forms a palm-fitting structure for the device, it is believed to be easier to use and to push than certain other devices which have an elongated handle, and tends to hold the fingers of the user out of contact with the corn, thus minimizing such contact and minimizing covering the fingers with messy food juices, butter, and minimizing potential contamination. [0015] The foregoing and other objects and advantages of the invention will be set forth in or apparent from the following description and drawings. In the Drawings: [0016] FIG. 1 is an exploded perspective view of the scrubber-cutter device of the present invention; [0017] FIG. 2 is a bottom perspective view of the two units shown in FIG. 1 assembled together with parts of the structure cut away to better illustrate the device; [0018] FIG. 3 is a bottom perspective view of the base member of the present invention with the brush assembly removed and the bottom portion facing upwardly; [0019] FIG. 4 is an end elevation view, partially cut away, of the device shown in FIG. 2 with the cover reversed to the bottom side to cover the cutter and leave the brush exposed; [0020] FIG. 5 is a bottom plan view of a brush unit which fits into the base member shown in FIG. 3 , with the bristles on the other side of the structure shown in FIG. 5 and therefore not visible; [0021] FIG. 6 is a bottom plan view of the interior of the structure shown in FIG. 3 , with a bridge element positioned in the structure to help support the brush member; [0022] FIG. 7 is a side elevation view of the bridge member piece shown in FIG. 6 ; and [0023] FIG. 8 is a broken-away cross-sectional view through the cutting blade taken along line 8 - 8 of FIG. 2 . GENERAL DESCRIPTION [0024] Referring first to FIG. 1 of the drawings, a fresh corn cutter and de-silker 20 is shown in an exploded view. [0025] The device 20 includes a base member 22 with a brush 40 extending upwardly from the base on a first side 36 of the base, and (referring to FIG. 2 ) a corn cutter 48 with a blade 52 extending from the lower surface 38 of the base member. A cover 24 is provided. Cover 24 has side walls 28 and 30 , and a curved upper surface 26 which has a decorative finish simulating the look of an ear of corn. The cover 24 is shown lifted above the base 22 , as is customary in an exploded view. [0026] When it is desired to use the cutter 48 on the bottom surface 38 to cut corn off of the cob, the cover is placed over the brush by pressing the cover down over the edge 32 and against a ledge 34 extending circumferentially around the side of the base 22 . By this means, the cover is fastened securely to the base. The assembled unit is comparable in size and shape to a bar of soap, and can be fitted into the palm of the hand of the user to push the blade 52 longitudinally through the corn-on-the-cob to strip the fresh corn kernels from the cob. [0027] FIG. 4 of the drawings shows the cover 24 reversed and attached to the bottom edge of the base member 22 so that it covers the cutter 48 . This leaves the brush 40 exposed so that it can be used to de-silk the corn. [0028] Whether the device is used for de-silking the corn or cutting it, the cover forms a convenient, fairly tall grippable structure which fits neatly into the palm of an adult hand, much like a bar of soap. The cover provides an upwardly spaced gripping surface which raises the fingers of the hand above the surface of the corn so that the fingers are not so easily soiled and so that the corn tends to be more protected from possible contamination by contact with the fingers. When the device is stored, the cover can cover either the brush or the cutter. If it covers the cutting blade, this protects against accidental cutting of objects or fingers. DETAILED DESCRIPTION 1. Base Member [0029] The base member 22 is shown in FIGS. 1 , 2 and 3 . Referring particularly to FIG. 3 , the base member is a molded plastic part with a projecting ridge 34 around the periphery with slight extensions of the ridge at 35 . The projections 35 are used as grippers to hold the body member with one's fingers when the cover 24 is being removed or replaced on the body. The vertical walls are curved as at 62 and 64 in a shape approximating the curvature of a typical ear of corn. The base member is shaped to accommodate the ear of corn, both on the bottom surface 38 and the upper surface 36 . 2. Brush Structure [0030] The brush structure 40 is illustrated in FIGS. 1 , 4 and 5 . The brush structure is a single molded part comprising a molded bristle base 42 and molded brush bristles formed in the same molding operation. Low density polyethylene is the material of which the base and bristles are made so as to make them relatively soft and flexible. [0031] The underside of the brush unit is shown in FIG. 5 . Flexible vertical plastic walls 80 form an elongated rectangular shape to match that of the base member 22 and to fit into the cavity 60 shown in FIG. 3 with an interference fit. Tabs extend from the opposite short ends 44 of the bristle base to facilitate removing and replacing the bristle base in the base member 22 , thus providing means for separating the parts for washing. [0032] As it can be seen in FIG. 4 , the upper surface of the bristles and the upper edge of the bristle base 42 are given with a curvature approximating that of an ear of corn. [0033] Referring again to FIG. 5 , in the longitudinal center of the bristle base structure shown in FIG. 5 is a reinforcing rib 82 . A projection 84 is formed which, when the bristle base 42 is fitted into the base member 22 , extends downwardly by a predetermined distance to abut against a surface 90 (see FIG. 6 ) of a bridge member 86 which is fitted into the cavity 60 of the base member 22 shown in FIG. 3 . This provides vertical support for the flexible bristle base and bristles to prevent undue distortion under the scrubbing force or cutting force applied by the user. 3. Cover [0034] The cover 24 , which is shown in FIGS. 1 , 2 and 4 , has a thumb-shaped recess 43 ( FIG. 1 ), two pairs of slight projections 49 located above and below the projection or flange 34 , and two slight vertical projections on the internal surface of the side wall 28 of the cover to mate with the projections 49 to provide a secure but releasable friction fit between the cover and the base member. The thumb recess 43 increases the degree of effective projection outwardly of the areas 35 which facilitates gripping of the cover and the base to push them together or pull them apart. [0035] The cutter 48 and its blade 52 are best seen in FIGS. 2 , 4 and 8 . The cutter 48 comprises a blade which is generally U-shaped with a curvature in the direction shown in FIG. 3 so as to approximate the curvature of an ear of corn. [0036] Referring again to FIG. 3 , the base member 22 has a pair of through holes 72 and 74 , and a pair of upstanding projections, 76 and 78 near the holes. [0037] Referring to FIG. 2 , the cutter 48 includes the blade 52 with two legs 54 extending through the body 22 . FIG. 3 shows those legs 54 are attached to the projections 76 and 78 to anchor the legs of the cutter solidly. The legs are attached by adhesive and ultrasonic bonding. [0038] The bridge member 86 is shown in FIG. 7 and it forms two vertical receptacles 92 and 94 into which the projections 76 and 78 fit, with a pair of tabs 98 and 100 to fit into the holes 72 and 74 . The bridge has a curved undersurface as shown at 96 to match the curvature of the lower surface of the structure shown in FIG. 3 . That curvature includes a raised portion 66 flanked by recessed portions 68 and 70 . 4. Cutter [0039] Referring to FIG. 2 , the cutter 48 includes a blade 52 with serrated cutting teeth 50 . The cutter blade preferably is made of hard stainless steel of the type and quality used in food processor blades so that it maintains its sharpness for a long time. [0040] The undersurface 38 of the cutter/de-silker device has a longitudinal recess 46 which helps to allow the corn kernels to pass underneath the blade without being cut up any more than necessary. [0041] FIG. 8 is a broken-away, cross-sectional view of the blade 52 . The forward cutting edge is ground to be beveled on both sides of the cutting edge, as shown at 102 and 104 . This has the advantage that the edge shape does not force the blade downwardly towards the corn cob to cut more of the corn kernels than is desired, nor upwardly to cut too little. This is in contrast to those prior cutters whose blades have been ground only on one side. [0042] Some of the advantages of the invention have been described above. Others include the fact that the assembled device 20 is relatively broad compared with prior devices. This allows a somewhat greater width for the cutting blade of the cutter, therefore allowing more to be cut with each stroke than in some prior devices, and yet does not require the use of excessive force. Similarly, the greater width increases the width of the brush 40 compared with some prior devices, thereby increasing the coverage of the brush and, hence, the speed of the de-silking process. 5. Materials [0043] Some of the materials of which the device shown in the drawings is made have been mentioned above. The base 22 and the bridge 86 preferably are made of high impact polystyrene, and the cover 24 preferably is made of SAN. [0044] These materials can be replaced by other suitable materials, within the skill of those experienced in the art. [0045] The above description of the invention is intended to be illustrative and not limiting. Various changes or modifications in the embodiments described may occur to those skilled in the art. These can be made without departing from the spirit or scope of the invention.

A device is provided for cutting and/or de-silking corn on the cob. A single unit has a base and a removable cover. A brush for use in removing silks is mounted on one side of the base, and a cutter is mounted on the other side. When it is desired to use the tool on one side instead of the other, the cover is placed over the other tool. The cover then is used as an easy-to-grip palm-fitting structure to push the brush or the cutter along the ear of corn.

FIELD OF THE INVENTION This invention relates to plows for tilling the earth and more particularly to a moldboard type plow which is reversible for an improved result. BACKGROUND OF THE INVENTION Reversible moldboard and disc type plows have been used for some time. They require an implement support which is shiftable to change the angle at which the implement is pulled through the earth as it proceeds back and forth so that the angle for one direction is the same as that for the following opposite direction. A reversible plow throws the dirt in the same direction when travelling in opposite directions in a longitudinal path. The need for such a plow arises from the necessity to create equal furrows without leaving free spaces and to provide an even, levelled surface. HISTORY OF THE PRIOR ART In the past, reversible disks or an extra set of moldboards have been used so that right and left side plowing can be done, but at the cost of additional weight, equipment and power. Reversible plows with disks fixed to a tool bar or with only one set of moldboards have also been used as in the U.S. Pat. Nos. to Gomez 4,800,963, Fowler 2,764,075, and Johnson et al. 3,305,025. Other patents of related nature are Brown 1,149,720, Dukes 2,597,079, Barrett 2,672,801, Jennings 2,724,313, Heckathorn et al. 3,042,120, Jennings 3,101,789, Watvedt 4,646,849, Korf 4,869,327, British patent 1,497,259 of Jan. 5, 1978, and U.S.S.R. patents 640,688 of January 1979 and 812,199 of March 1981. The U.S. Pat. Nos. to Watvedt 4,603,745 and 4,825,955 disclose double plowshares mounted on a plow frame which is rotatable in a vertical plane about a shaft by the action of a pair of hydraulic cylinders and pistons. French patent 2,390,079 of January 1979, especially FIG. 1, and Johnson et al. 3,305,025, mentioned above, especially FIG. 3, disclose hitch bars that are pivotably mounted in order to move in a vertical plane between plow angular positions. The U.S. Pat. No. to Katayama et al. 4,553,605 discloses link arms that are movable up and down by lift rods operated by hydraulic cylinders for the purpose of tilting the implement. SUMMARY OF THE INVENTION It is an object of the invention to provide a moldboard type plow in which the moldboards may be shifted to plow from either side, the shifting being done by power means controlled as required by the tractor hydraulics and able to stand up to the demanding type of plowing done by moldboards. A further object is to provide a power operated means for tilting the frame carrying the moldboards in order to adjust the depth of cut of the bottom of the furrow. A further object is to provide a hydraulic hookup for the moldboard shifting cylinders and the frame tilting cylinder(s) in which the cylinders are operated sequentially, instead of simultaneously, thus reducing the hydraulic pressure required for the operation, and in which all cylinders are locked following actuation in order to hold the moldboards in the adjusted plowing position. The foregoing objects are accomplished by the use of a central moldboard carrying beam that is pivotally mounted in a frame having hitch connections, the beam being connected to trunnion mounted cylinder and piston assemblies that control the travel angle of the moldboards and the attitude or angle of the hitch connections being vertically shiftable by auxiliary cylinder and piston assemblies in order to adjust the tilt of the moldboards. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective from the right side of a preferred embodiment of the invention; FIG. 2 is a perspective to an enlarged scale from the left side of the same embodiment; FIG. 3 is a fragmentary perspective from the rear of the forward portion of the apparatus; FIG. 4 is a plan view indicating the pivotal movement of the beam which carries the moldboards; FIG. 5 is a section to an enlarged scale on the line 5--5 of FIG. 4; FIG. 6 is a section to an enlarged scale on the line 6--6 of FIG. 4; FIG. 7 is a section to an enlarged scale on the line 7--7 of FIG. 6; FIG. 8 is an enlarged perspective from the left side of a modification of the invention; FIG. 9 is a front elevation to an enlarged scale illustrating the hitch plate assembly; FIG. 10 is a section to an enlarged scale on the line 10--10 of FIG. 8; FIG. 11 is a section on the line 11--11 of FIG. 10; FIG. 12 is a perspective to an enlarged scale of a moldboard; FIG. 13 is a schematic of the hydraulic connections to the positioning and tilt cylinders; and FIG. 14 is a schematic of hydraulic connections to the positioning cylinders and tilt cylinder of the modification. DESCRIPTION OF THE PREFERRED EMBODIMENT With further reference to the drawings, there is illustrated a frame 10 having a front cross member 11, a rear cross member comprising upper and lower plates 12 and 13, right and left side members 14 and 15 extending perpendicularly rearwardly from the front cross member 11, and inclined side members 16 and 17 extending to the ends of the rear cross member 12 and 13. At the rear of the front cross member 11 an arcuate plate 20 bridges the sides 14 and 15 for purposes which will be described. Extending upwardly from the central and forward portion of the front cross member is an upper hitch plate 22, in two parallel sections, and having a hitch pin 23 extending therethrough for the purposes of attaching to the hitch point of the tractor's three point hitch. Spaced at either side of the upper hitch plate 22 are right and left lower hitch plates 25 and 26 each of which comprises a pair of spaced plate side members that are connected to the front cross member 11. Between the side members of each lower hitch plate is a cylinder and piston assembly including cylinders 27 and 28, pistons 29 and 30, which are connected to clevises 31 and 32 carrying hitch pins 33 and 34 projecting from the sides of the outer hitch plates where the hitch pin may be received by the lower connections of the three point hitch on the tractor. The cylinders 27 and 28 are mounted by pins 34 and 35 across the tops of the spaced hitch plates in order to permit any necessary swinging movement of the cylinder and piston assemblies. In order to reduce the wear on the hitch plates, a replaceable and reversible metal wear plate 36 is mounted at the rear of each of the clevises 31 and 32. This protects the slot in which the pin 33 reciprocates from excessive wear. The frame mounts a longitudinal beam which may be in two sections 40 and 41. The forward section 40 is received intermediate the upper and lower rear cross members 12 and 13 and connected thereto by a pivot 42 which permits the beam to swing laterally of the frame. The forward end of the frame has a ledge plate with upper and lower sections 45, 45 and wear strips 46, 47 which ride on the top and bottom of the arcuate plate 20 previously described, in order to support the forward end of the longitudinal beam. In order to control the position of the longitudinal beam within the frame 10 a pair of cylinders 50 and 51 are mounted, one on each side of the beam. Thus a right cylinder 50 is mounted with its cylinder intermediate the upper and lower portions of the rear cross member 12 and 13 by a pivot or trunnion mounting 52, its piston 53 extending to a pin 54 mounted between a pair of lugs 55 which are in spaced relation from the forward end of the beam. Similarly the cylinder 51 has a trunnion mounting 56 and a piston 57 which is connected to a pin 58 between lugs 59 on the opposite side of the beam. It will be apparent therefore that by the simultaneous operation of the piston assemblies that the forward portion of the longitudinal beam may be angularly shifted from side to side within the frame 10. The front and rear portions of the longitudinal beam 40-41 have a series of spaced brackets 60 which are connected to mounting plates 61 for holding a series of spaced moldboards 62. For purposes of convenience and flexibility, as previously indicated, the longitudinal beam may be divided into two portions 40 and 41. The rear portion 41 of the beam has supports 70 and 71 for a rear wheel beam 72 for carrying a gauge wheel 73. Suitable adjusting means 74 are carried in the support 71 in order that the height of the gauge wheel may be adjusted. With reference to FIG. 12, the moldboards 62 may be made of curved metal frame sections 90 having upper bracket means 91, central bracket means 92 and lower bracket means 93 with protective follower members 94 that aid in the control of the tractor. The frame sections 90 are faced with a wear sheet 95 secured by fasteners 96 and holder strip 97 for reducing the wear on the moldboards and the need for frequent replacement. The hydraulic control circuit for the positioning cylinders and tilt cylinders is illustrated in FIG. 13. In this figure lines 100-101 may connect to the hydraulic control lines of the tractor. These are connected to a double dual lock out box 102. In box 102 line 100 is connected to joints 104 and 105; line 101 is connected to joints 106 and 107. Joints 104 is connected to lines 110 and 111 to one side of tilt cylinders 27 and 28. Joint 105 is connected to lines 113 and 114 to one side of positioning cylinders 50 and 51. The return side of tilt cylinders 27 and 28 are connected by lines 115 and 116 to joint 106 and line 101 back to the tractor. Similarly, the return lines 118 and 119 from the positioning cylinders 50 and 51 are connected to the joint 107 and line 120 to the line 101 to the tractor. In the operation of the tractor hydraulics, the opening of the circuit will generally unlock the circuit with the less pressure, which is usually the positioning cylinder circuit, permitting movement of these cylinders until the plow beam goes the maximum extent and hits the stop, either on the right or the left side. At this point the pressure build up and causes the tilt cylinders to operate. After all of the hydraulic functions have been completed additional pressure will bleed over to the tractor relief. When the tractor lever is returned to neutral, the double dual lockout will lock all of the cylinders, preventing them from any movements during the plowing operation. It will be understood that at the end of each row, the tractor three-way hitch is generally operated to raise the frame and the beam with the moldboards attached clear of the field until the tractor has turned 180° and is in position to resume plowing in the opposite direction. Then the three-way hitch is lowered in order that plowing in the opposite direction may be done. During the time that the three way hitch is raised the hydraulic circuit may be operated in order to properly position the beam with the moldboards in the proper position for plowing (See FIG. 4) and also to properly position the frame in its appropriately tilted position. FIGS. 8-11 illustrate a modification of the invention. The modification is in the mounting by means of which the height of the left and right hitch pins are controlled. Instead of having a separate cylinder and piston assembly for each of the hitch pins, the modification includes a hitch plate pivot assembly, as particularly illustrated in FIGS. 8 and 9. The assembly includes a hitch plate 150 that is mounted on and depends downwardly from the front cross member 11, substantially centrally thereof. The hitch plate has a center pivot 152 which supports a hitch bar 153 that is pivotally mounted between left and right lower hitch plates 154 and 155. The hitch plates have openings 156 and 157, respectively, for receiving the ends of the hitch bar as it oscillates, the hitch bar carrying left and right lift pins 159 and 160. A pair of spaced lugs 162-163 are mounted over an opening 164 on the right side of the front cross member 11 and substantially over the right lower hitch plate 155. The lug 162 carries a pivot pin 166 which mounts a cylinder 167 which operates a piston 168 connected to a web 169 of a clevis 170 which engages the hitch bar 153 by means of a pin 171. Accordingly, by operation of the cylinder and piston assembly the hitch bar may be caused to pivot about the pivot support 152 in order to raise and lower the right and left lift pins 160 and 159. A replacement tee-shaped wear plate 173 is held by a clamp 174 connected to the hitch plate 155 and engaging the clevis 170. In order to control the operation of the positioning cylinders and the single tilt cylinder of the modification a hydraulic hookup as indicated on FIG. 14 is provided. The hookup includes the lines 100-101 to the tractor disconnects. The line 100 is connected to joint 180 and joint 181 which are connected to lines 182 and 183, respectively, to one side of the positioning cylinders and the tilt cylinder. The other line 101 is connected to line 184 and line 185 to the other side of the cylinders of the positioning cylinders and the tilt cylinder. Ordinarily, activating the tractor hydraulics will unlock the circuit with the lesser pressure, usually the position cylinder circuit, permitting movement of the cylinders until the plow beam hits the stop on either the right or the left side. This will then permit the tilt cylinder to function. After all of the hydraulic functions have been completed the additional pressure bleeds over to the tractor relief. When the tractor lever is returned to neutral the double dual lock-out, as previously described, will lock all the cylinders preventing any movement during plowing.

A reversible moldboard plow has a plow carrying beam swingably mounted at the rear crossbar of a frame which carries trunnion mounted cylinders connected to the beam for moving the beam, the front of the frame carrying hitch pins for connection to a tractor hitch, the hitch pins being vertically movable in alternate relation in order to tilt the frame and the beam with the moldboards supported thereon. The hitch pins may be moved by independent cylinders and pistons or, alternately, by the movement of a transverse hitch bar on which they are mounted.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The current application claims the benefit of and priority to Israel Patent Application No. 194519, filed Oct. 5, 2008, and incorporated herein by reference in its entirety. FIELD OF THE INVENTION [0002] The present invention relates to the field of pelvic floor reconstruction. In particular, the present invention relates to the field of pelvic floor reconstruction using implants. BACKGROUND OF THE INVENTION [0003] Pelvic organ prolapse (POP) is a common female problem that can have a profound impact on a woman's quality of life. [0004] The organs in the pelvic cavity, uterus, vagina, bladder and rectum, are held in place by a web of muscles and connective tissues that act much like a hammock. When these muscles and tissues become weakened or damaged, one or more of the pelvic organs shift out of normal position and literally “fall” into the vagina. [0005] Prolapse surgical reconstruction is performed through the vagina. During the procedure, the surgeon repositions the prolapsed organs, securing them to surrounding tissues and ligaments, and may use a synthetic non-absorbable polypropylene mesh implant. [0006] However, the prior art surgical procedures penetrate the patient from several directions. [0007] As well, they do not provide reliable anchoring of the mesh implant. [0008] It is an object of the present invention to provide a reliable anchoring of the mesh implant. [0009] Other objects and advantages of the invention will become apparent as the description proceeds. SUMMARY OF THE INVENTION [0010] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools methods, and so forth, which are meant to be merely illustrative, not limiting in scope. [0011] In one aspect, the present invention may be directed to a needle for surgical threading of a strap of an implant through a tissue, the needle comprising: a trap for trapping the strap to the needle, while the needle may be at the accessible side of the tissue; a tip for threading the trapped strap from the accessible side to the opposing side; and a mechanism for releasing the trap, the mechanism driven from the accessible side of the tissue, thereby allowing return of the tip to the accessible side of the tissue while abandoning the strap at the threaded point, thus performing threading from the accessible side of the tissue. The trap may comprise: a niche, for inserting an end of the strap of the implant; and a rod, for grasping the end of the strap. The niche may be located near the tip. [0018] The end of the strap may comprise a looped end for inserting the rod thereinto. [0019] According to another embodiment the rod is capable of applying physical force on the end of the strap towards the limiting wall thereof in the niche. [0020] The mechanism for releasing the trap may be manually driven. [0021] The mechanism for releasing the trap may comprise a cable, driven from the accessible side of the tissue, for removing the rod from the end of the strap. [0022] The needle may further comprise an arm for driving the mechanism, the arm located outside the surgical area. [0023] In another aspect, the present invention is directed to an anterior implant comprising: at least two first straps for threading thereof into the arcus tendineous fascia pelvic (ATFP) ligaments; at least two second straps for threading thereof into the sacrospinous (SS) ligaments; and a loop between the second straps for anchoring thereof to the cervix. [0027] The anterior implant may be used for reconstructing the organs selected from the group including: prolapse of the urinary bladder, the colon, the small intestine. [0028] The anterior implant may further comprise spaces for reducing weight of the implant. [0029] In another aspect, the present invention is directed to a posterior implant comprising: at least two straps for threading thereof into the sacrospinous (SS) ligaments; a first loop between the straps for anchoring thereof to the cervix; and a second loop at the side opposing the straps, the second loop for anchoring thereof to the perineal body. [0033] The posterior implant may be used for reconstructing the organs selected from the group including: the colon, the small intestine, the uterus. [0034] The posterior implant may further comprise spaces for reducing weight of the implant. [0035] In another aspect, the present invention is directed to a method for using a needle to thread a strap through a surface, the method comprising the steps of: trapping an end of the strap while the needle is at the accessible side of the surface tissue; threading the needle, together with the trapped strap, through the surface, from the accessible side of the surface; releasing the trap, such that the driving of release is from the accessible side; and returning the needle to the accessible side while abandoning the strap at the threaded point, thereby performing threading from the accessible side. [0041] The trapping of the end of the strap may comprise the steps of: inserting the end of the strap into a niche; and grasping the end of the strap. [0044] Grasping of the end of the strap may comprise the step of inserting a rod of the needle into a looped end of the strap. [0045] According to another embodiment grasping of the end of the strap may comprise the step of applying physical force on the end of the strap towards the limiting wall thereof in the niche. [0046] Releasing the trap may comprise the step of removing the rod from the end of the strap. [0047] In another aspect, the present invention is directed to a method for installing an anterior implant, the method comprising the steps of: threading at least two first straps of the implant into the arcus tendineous fascia pelvic (ATFP) ligaments; threading at least two second straps of the implant into the sacrospinous (SS) ligaments; and anchoring a loop between the second straps to the cervix. [0051] In another aspect, the present invention is directed to a method for installing a posterior implant, the method comprising the steps of: threading at least two straps of the implant into the sacrospinous (SS) ligaments; anchoring a first loop between the straps, to the cervix; and anchoring a second loop at the side opposing the straps, to the perineal body. [0055] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the figures and by study of the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS [0056] The objects and features of the present invention will become apparent from the following detailed description considered in conjunction with the accompanying drawings, in which: [0057] FIG. 1 illustrates an anterior implant according to one embodiment of the present invention. [0058] FIG. 2 illustrates an anterior view of the pelvic area before installing the anterior implant. [0059] FIG. 3 illustrates the view of FIG. 2 after installing the anterior implant. [0060] FIG. 4 illustrates a posterior implant according to one embodiment of the present invention. [0061] FIG. 5 illustrates the view of FIG. 2 after installing the posterior implant. [0062] FIG. 6 illustrates the head of a needle for threading the straps of the implants, according to one embodiment of the present invention. [0063] FIG. 7 illustrates the first step of threading the straps of the implants, using the needle of FIG. 6 . [0064] FIG. 8 illustrates the second step of threading the straps of the implants, using the needle of FIG. 6 . [0065] FIG. 9 illustrates the third step of threading the straps of the implants, using the needle of FIG. 6 . [0066] FIG. 10 illustrates the fourth step of threading the straps of the implants, using the needle of FIG. 6 . [0067] FIG. 11 illustrates the needle of FIG. 6 and its operation. [0068] FIG. 12 illustrates the operation of the needle of FIG. 6 from the aspect of the surgeon's access to the pelvic area. [0069] FIG. 13 illustrates the operation of the needle of FIG. 6 in the aspect of FIG. 12 , to another ligament. [0070] It is to be understood, however, that the drawings are designed solely for purposes of illustration and not as a definition of the limits of the invention, for which reference should be made to the appended claims. It should be further understood that the drawings are not necessarily drawn to scale and that, unless otherwise indicated, are merely intended to conceptually illustrate the structures and procedures described herein. Reference numerals may be repeated among the figures in order to indicate corresponding or analogous elements. DETAILED DESCRIPTION OF THE INVENTION [0071] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In some instances, well-known methods, procedures, components and circuits have not been described in detail, for the sake of brevity. [0072] FIG. 1 illustrates an anterior implant according to one embodiment of the present invention. [0073] Anterior implant 1 includes four straps 10 , each ending with a looped end 20 . Anterior implant 1 may also include a loop 8 between two interior straps 10 . [0074] Anterior implant 1 may include spaces 4 for reducing the weight thereof. [0075] FIG. 2 illustrates an anterior view of the pelvic area before installing the anterior implant. [0076] The anterior view of pelvic area 34 refers to the side allowing surgical access through the patient's vaginal opening. [0077] Denoted bones are the ischial spine 27 extending from the posterior border of the ischium 26 , and the sacrum 46 . [0078] Also shown are the perineal body 52 , and the cervix 50 extending from the uterus (womb) 48 . [0079] Pelvic area 34 includes two ligaments of arcus tendineous fascia pelvic (ATFP) 30 and two ligaments of sacrospinous (SS) 28 . [0080] FIG. 3 illustrates the view of FIG. 2 after installing the anterior implant. [0081] Anterior implant 1 is used for reconstructing the anterior pelvic floor, including prolapse of the urinary bladder and/or the colon and the small intestine. [0082] Two straps 10 of anterior implant 1 are threaded into two ATFP ligaments 30 , and the other two straps 10 are inserted into two SS ligaments 28 . [0083] Loop 8 may be sutured to cervix 50 for improving strength and security of the anchoring of anterior implant 1 . [0084] FIG. 4 illustrates a posterior implant according to one embodiment of the present invention. [0085] Posterior implant 2 includes two straps 10 , each ending with a looped end 20 . Posterior implant 2 may include a loop 36 between two interior straps 10 , and another loop 9 at the opposing side. [0086] Posterior implant 2 may include spaces 4 for reducing the weight thereof. [0087] FIG. 5 illustrates the view of FIG. 2 after installing the posterior implant. [0088] Posterior implant 2 is used for reconstructing the posterior pelvic floor, including prolapse of the colon, the small intestine and/or the uterus (womb). [0089] Two straps 10 of posterior implant 2 are inserted into two SS ligaments 28 . [0090] Loop 36 may be sutured to cervix 50 , and loop 9 may be sutured to perineal body 52 for improving the strength and security of the connection. [0091] FIG. 6 illustrates the head of a needle for threading the straps of the implants, according to one embodiment of the present invention. [0092] A needle 6 is used for threading each of straps 10 through ATFP ligaments 30 and SS ligaments 28 . [0093] The head of needle 6 includes a rod 18 , which may be manually slid back and forth in a track 16 within a body 14 , as in brake cables. [0094] The edge 42 of rod 18 may be inserted into a niche 40 . The tip 12 of needle 6 is located at the edge of body 14 . [0095] FIG. 7 illustrates the first step of threading the straps of the implants, using the needle of FIG. 6 . [0096] The surgeon inserts looped end 20 of strap 10 into niche 40 , and traps it by rod edge 42 of rod 18 into looped end 20 . [0097] In case that the surgeon has not succeeded in inserting rod 18 into looped end 20 , the surgeon may trap looped end 20 by applying physical force of rod edge 42 towards the limiting wall thereof in niche 40 . [0098] According to another embodiment the surgeon may trap strap 10 directly by applying physical force of rod edge 42 on the end of strap 10 towards the limiting wall thereof in niche 40 . [0099] FIG. 8 illustrates the second step of threading the straps of the implants, using the needle of FIG. 6 . [0100] The surgeon then pushes tip 12 together with body 14 into an ATFP ligament 30 or into an SS ligament 28 , threading looped end 20 and strap 10 through the ligament. [0101] FIG. 9 illustrates the third step of threading the straps of the implants, using the needle of FIG. 6 . [0102] The surgeon then slides rod edge 42 out of niche 40 , releasing looped end 20 from rod edge 42 . [0103] FIG. 10 illustrates the fourth step of threading the straps of the implants, using the needle of FIG. 6 . [0104] The surgeon then pulls body 14 together with tip 12 out of ATFP ligament 30 or SS ligament 28 . Since looped end 20 has been released at the third step, and since ligament 30 (or 28 ) shrinks tightly, as shown by the arrows, strap 10 remains threaded while tip 12 exits. [0105] FIG. 11 illustrates the needle of FIG. 6 and its operation. [0106] The surgeon holds handle 24 of needle 6 , and slides rod 18 by toggling a toggle arm 22 , which is connected to rod 18 . [0107] Needle 6 as a whole may be flexible like a brake cable, thin and long enough to occupy minimal surgery space. [0108] Since tip 12 is inserted into the pelvic area, and toggle arm 22 is far away tip 12 , toggle arm is located outside the body of the patient and may be located farther and outside the surgical area. [0109] It may be appreciated according to these steps that the surgeon can thread strap 10 from the side having surgical access, without requiring any additional perforations of the body from the opposing direction. [0110] FIG. 12 illustrates the operation of the needle of FIG. 6 in aspect of the surgeon's access to the pelvic area. [0111] The surgeon inserts finger 32 thereof into the vagina 44 between the patient's legs 38 and reaches pelvic area 34 (the lines of the parts inside are dashed). The surgeon then separates an SS ligament 28 from the other organs, locates tip 12 of needle 6 on a selected threading point on SS ligament 28 , and traps trapping looped end 20 to niche 40 of needle 6 . [0112] The surgeon then penetrates tip 12 through SS ligament 28 and pushes into the desired depth; then releases looped end 20 from needle 6 by toggling toggle arm 22 , using the other hand thereof. [0113] The surgeon can then pull tip 12 back, leaving looped end 20 and strap 10 at the side beyond, having tight shrinking of SS ligament 28 towards strap 10 at the threaded point. [0114] Tying of strap 10 is not required due to natural tying of SS ligament 28 to strap 10 . [0115] FIG. 13 illustrates the operation of the needle of FIG. 6 in aspect FIG. 12 , to another ligament. [0116] The surgeon inserts the finger 32 thereof into vagina 44 , then separates an ATFP ligament 30 , and locates tip 12 of needle 6 on the selected threading point, after trapping looped end 20 to niche 40 of needle 6 . [0117] The surgeon then penetrates tip 12 through ATFP ligament 30 and on to the desired depth; then releases looped end 20 from needle 6 by toggling toggle arm 22 , using the other hand thereof, then pulls tip 12 back leaving looped end 20 and strap 10 at the side beyond, having tight shrinking of ATFP ligament 30 towards strap 10 at the threaded point. [0118] In the figures and description herein, the following numerals and symbols have been mentioned: [0119] numeral 1 denotes an anterior implant; [0120] numeral 2 denotes a posterior implant; [0121] numeral 4 denotes a space for reducing the weight of an implant; [0122] numeral 6 denotes a needle according to one embodiment of the present invention; [0123] numeral 8 denotes a loop in the anterior implant for anchoring it to the cervix; [0124] numeral 9 denotes a loop in the posterior implant for anchoring it to the perineal body; [0125] numeral 10 denotes a strap extending from the implant; [0126] numeral 12 denotes a tip of the inventive needle; [0127] numeral 14 denotes the body of the inventive needle; [0128] numeral 16 denotes a track within the body of the needle; [0129] numeral 18 denotes a rod traveling within the body of the needle; [0130] numeral 20 denotes a looped end at the edge of the implant strap; [0131] numeral 22 denotes a toggle arm for trapping and releasing the looped end; [0132] numeral 24 denotes a handle of the needle; [0133] numeral 26 denotes the ischium (bone); [0134] numeral 27 denotes the ischial spine (bone); [0135] numeral 28 denotes a sacrospinous (SS) ligament; [0136] numeral 30 denotes an arcus tendineous fascia pelvic (ATFP) ligament; [0137] numeral 32 denotes a surgeon's finger; [0138] numeral 34 denotes the pelvic area; [0139] numeral 36 denotes a loop in the posterior implant for anchoring it to the cervix; [0140] numeral 38 denotes a patient's leg; [0141] numeral 40 denotes a niche in the needle for trapping the looped end of the strap; [0142] numeral 42 denotes the edge of the rod sliding in the track; [0143] numeral 44 denotes the vagina, into which the surgeon inserts the finger thereof; [0144] numeral 46 denotes the sacrum (bone); [0145] numeral 48 denotes the uterus (womb); [0146] numeral 50 denotes the cervix, extending from the uterus; and [0147] numeral 52 denotes the perineal body; [0148] While certain features of the invention have been illustrated and described herein, the invention can be embodied in other forms, ways, modifications, substitutions, canchores, equivalents, and so forth. The foregoing description of the embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of this disclosure. It is intended that the scope of the invention be limited not by this detailed description, but rather by the claims appended hereto.

In one aspect, the present invention may be directed to a needle for surgical threading of a strap of an implant through a tissue, the needle comprising: a trap for trapping the strap to the needle while the needle may be at the accessible side of the tissue; a tip for threading the trapped strap from the accessible side to the opposing side; and a mechanism for releasing the trap, the mechanism driven from the accessible side of the tissue, thereby allowing return of the tip to the accessible side of the tissue while abandoning the strap at the threaded point, thus performing the threading from the accessible side of the tissue.

FIELD OF THE INVENTION [0001] The invention relates to methods and apparatus for the provision of ventilatory assistance matched to a subject's respiratory need. The ventilatory assistance can be for a subject who is either spontaneously or non-spontaneously breathing, or moves between these breathing states. The invention is especially suitable for, but not limited to, spontaneously breathing human subjects requiring longterm ventilatory assistance, particularly during sleep. BACKGROUND OF THE INVENTION [0002] Subjects with severe lung disease, chest wall disease, neuromuscular disease, or diseases of respiratory control may require in-hospital mechanical ventilatory assistance, followed by longterm home mechanical ventilatory assistance, particularly during sleep. The ventilator delivers air or air enriched with oxygen to the subject, via an interface such as a nosemask, at a pressure that is higher during inspiration and lower during expiration. [0003] In the awake state, and while waiting to go to sleep, the subject's ventilatory pattern is variable in rate and depth. Most known ventilatory devices do not accurately match the amplitude and phase of mask pressure to the subject's spontaneous efforts, leading to discomfort or panic. Larger amounts of asynchrony also reduce the efficiency of the device. During sleep, there are changes in the neural control of breathing as well as the mechanics of the subject's airways, respiratory muscles and chest wall, leading to a need for substantially increased ventilatory support. Therefore, unless the device can automatically adjust the degree of support, the amplitude of delivered pressure will either be inadequate during sleep, or must be excessive in the awake state. This is particularly important in subjects with abnormalities of respiratory control, for example central hypoventilation syndromes, such as Obesity Hypoventilation Syndrome, where there is inadequate chemoreceptor drive, or Cheyne Stokes breathing such as in patients with severe cardiac failure or after a stroke, where there is excessive or unstable chemoreceptor drive. [0004] Furthermore, during sleep there are inevitably large leaks between mask and subject, or at the subject's mouth if this is left free. Such leaks worsen the error in matching the phase and magnitude of the machine's effort to the subject's needs, and, in the case of mouth leak, reduce the effectiveness of the ventilatory support. [0005] Ideally a ventilatory assistance device should simultaneously address the following goals: [0000] (i) While the subject is awake and making substantial ventilatory efforts, the delivered assistance should be closely matched in phase with the patient's efforts. [0000] (ii) The machine should automatically adjust the degree of assistance to maintain at least a specified minimum ventilation, without relying on the integrity of the subject's chemoreflexes. [0000] (iii) It should continue to work correctly in the presence of large leaks. [0006] Most simple home ventilators either deliver a fixed volume, or cycle between two fixed pressures. They do so either at a fixed rate, or are triggered by the patient's spontaneous efforts, or both. All such simple devices fail to meet goal (ii) of adjusting the degree of assistance to maintain at least a given ventilation. They also largely fail to meet goal (i) of closely matching the subjects respiratory phase: timed devices make no attempt to synchronize with the subject's efforts; triggered devices attempt to synchronize the start and end of the breath with the subject's efforts, but make no attempt to tailor the instantaneous pressure during a breath to the subject's efforts. Furthermore, the triggering tends to fail in the presence of leaks, thus failing goal (iii). [0007] The broad family of servo-ventilators known for at least 20 years measure ventilation and adjust the degree of assistance to maintain ventilation at or above a specified level, thus meeting goal (ii), but they still fail to meet goal (i) of closely matching the phase of the subject's spontaneous efforts, for the reasons given above. No attempt is made to meet goal (iii). [0008] Proportional assistist ventilation (PAV), as taught by Dr Magdy Younes, for example in Principles and Practice of Mechanical Ventilation , chapter 15, aims to tailor the pressure vs time profile within a breath to partially or completely unload the subject's resistive and elastic work, while minimizing the airway pressure required to achieve the desired ventilation. During the inspiratory half-cycle, the administered pressure takes the form: P ( t )= P 0 +R.f RESP ( t )+ E.V ( t ) where R is a percentage of the resistance of the airway, f RESP (t) is the instantaneous respiratory airflow at time t, E is a percentage of the elastance of lung and chest wall, and V(t) is the volume inspired since the start of inspiration to the present moment. During the expiratory half-cycle, V(t) is taken as zero, to produce passive expiration. [0009] An advantage of proportional assist ventilation during spontaneous breathing is that the degree of assistance is automatically adjusted to suit the subject's immediate needs and their pattern of breathing, and is therefore comfortable in the spontaneously breathing subject. However, there are at least two important disadvantages. Firstly, V(t) is calculated as the integral of flow with respect to time since the start of inspiration. A disadvantage of calculating V(t) in this way is that, in the presence of leaks, the integral of the flow through the leak will be included in V(t), resulting in an overestimation of V(t), in turn resulting in a runaway increase in the administered pressure. This can be distressing to the subject. Secondly, PAV relies on the subject's chemoreceptor reflexes to monitor the composition of the arterial blood, and thereby set the level of spontaneous effort. The PAV device then amplifies this spontaneous effort. In subjects with abnormal chemoreceptor reflexes, the spontaneous efforts may either cease entirely, or become unrelated to the composition of the arterial blood, and amplification of these efforts will yield inadequate ventilation. In patients with existing Cheyne Stokes breathing during sleep, PAV will by design amplify the subject's waxing and waning breathing efforts, and actually make matters worse by exaggerating the disturbance. Thus PAV substantially meets goal (i) of providing assistance in phase with the subject's spontaneous ventilation, but cannot meet goal (ii) of adjusting the depth of assistance if the subject has inadequate chemoreflexes, and does not satisfactorily meet goal (iii). [0010] Thus there are known devices that meet each of the above goals, but there is no device that meets all the goals simultaneously. Additionally, it is desirable to provide improvements over the prior art directed to any one of the stated goals. [0011] Therefore, the present invention seeks to achieve, at least partially, one or more of the following: [0000] (i) to match the phase and degree of assistance to the subject's spontaneous efforts when ventilation is well above a target ventilation, [0012] (ii) to automatically adjust the degree of assistance to maintain at least a specified minimum average ventilation without relying on the integrity of the subject's chemoreflexes and to damp out instabilities in the spontaneous ventilatory efforts, such as Cheyne Stokes breathing. [0000] (iii) to provide some immunity to the effects of sudden leaks. DISCLOSURE OF THE INVENTION [0013] In what follows, a fuzzy membership function is taken as returning a value between zero and unity, fuzzy intersection A AND B is the smaller of A and B , fuzzy union A OR B is the larger of A and B , and fuzzy negation NOT A is 1− A. [0014] The invention discloses the determination of the instantaneous phase in the respiratory cycle as a continuous variable. [0015] The invention further discloses a method for calculating the instantaneous phase in the respiratory cycle including at least the steps of determining that if the instantaneous airflow is small and increasing fast, then it is close to start of inspiration, if the instantaneous airflow is large and steady, then it is close to mid-inspiration, if the instantaneous airflow is small and decreasing fast, then it is close to mid-expiration, if the instantaneous airflow is zero and steady, then it is during an end-expiratory pause, and airflow conditions intermediate between the above are associated with correspondingly intermediate phases. [0016] The invention further discloses a method for determining the instantaneous phase in the respiratory cycle as a continuous variable from 0 to 1 revolution, the method comprising the steps of: selecting at least two identifiable features F N of a prototype flow-vs-time waveform f(t) similar to an expected respiratory flow-vs-time waveform, and for each said feature: determining by inspection the phase φ N in the respiratory cycle for said feature, assigning a weight W N to said phase, defining a “magnitude” fuzzy set M N whose membership function is a function of respiratory airflow, and a “rate of change” fuzzy set C N , whose membership function is a function of the time derivative of respiratory airflow, chosen such that the fuzzy intersection M N AND C N will be larger for points on the generalized prototype respiratory waveform whose phase is closer to the said feature F N than for points closer to all other selected features, setting the fuzzy inference rule R N for the selected feature F N to be: If flow is M N and rate of change of flow is C N then phase=φ N , with weight W N . measuring leak-corrected respiratory airflow, for each feature F N calculating fuzzy membership in fuzzy sets M N and C N , for each feature F N applying fuzzy inference rule R N to determine the fuzzy extent Y N =M N AND C N to which the phase is φ N , and applying a defuzzification procedure using Y N at phases φ N and weights W N to determine the instantaneous phase φ. [0025] Preferably, the identifiable features include zero crossings, peaks, inflection points or plateaus of the prototype flow-vs-time waveform. Furthermore, said weights can be unity, or chosen to reflect the anticipated reliability of deduction of the particular feature. [0026] The invention further discloses a method for calculating instantaneous phase in the respiratory cycle as a continuous variable, as described above, in which the step of calculating respiratory airflow includes a low pass filtering step to reduce non-respiratory noise, in which the time constant of the low pass filter is an increasing function of an estimate of the length of the respiratory cycle. [0027] The invention further discloses a method for measuring the instantaneous phase in the respiratory cycle as a continuous variable as described above, in which the defuzzification step includes a correction for any phase delay introduced in the step of low pass filtering respiratory airflow. [0028] The invention further discloses a method for measuring the average respiratory rate, comprising the steps of: [0029] measuring leak-corrected respiratory airflow, [0030] from the respiratory airflow, calculating the instantaneous phase φ in the respiratory cycle as a continuous variable from 0 to 1 revolution, calculating the instantaneous rate of change of phase dφ/dt, and [0031] calculating the average respiratory rate by low pass filtering said instantaneous rate of change of phase dφ/dt. [0032] Preferably, the instantaneous phase is calculated by the methods described above. [0033] The invention further discloses a method for providing ventilatory assistance in a spontaneously breathing subject, comprising the steps, performed at repeated sampling intervals, of: [0034] ascribing a desired waveform template function Π(φ), with domain 0 to 1 revolution and range 0 to 1, [0035] calculating the instantaneous phase φ in the respiratory cycle as a continuous variable from 0 to 1 revolution, [0036] selecting a desired pressure modulation amplitude A, [0037] calculating a desired instantaneous delivery pressure as an end expiratory pressure plus the desired pressure modulation amplitude A multiplied by the value of the waveform template function Π(φ) at the said calculated phase φ, and [0038] setting delivered pressure to subject to the desired delivery pressure. [0039] The invention further discloses a method for providing ventilatory assistance in a spontaneously breathing subject as described above, in which the step of selecting a desired pressure modulation amplitude is a fixed amplitude. [0040] The invention further discloses a method for providing ventilatory assistance in a spontaneously breathing subject as described above, in which the step of selecting a desired pressure modulation amplitude in which said amplitude is equal to an elastance multiplied by an estimate of the subject's tidal volume. [0041] The invention further discloses a method for providing ventilatory assistance in a spontaneously breathing subject as described above, in which the step of selecting a desired pressure modulation amplitude comprises the substeps of: specifying a typical respiratory rate giving a typical cycle time, specifying a preset pressure modulation amplitude to apply at said typical respiratory rate, calculating the observed respiratory rate giving an observed cycle time, and calculating the desired amplitude of pressure modulation as said preset pressure modulation amplitude multiplied by said observed cycle time divided by the said specified cycle time. [0046] The invention further discloses a method for providing ventilatory assistance in a spontaneously breathing subject, including at least the step of determining the extent that the subject is adequately ventilated, to said extent the phase in the respiratory cycle is determined from the subject's respiratory airflow, but to the extent that the subject's ventilation is inadequate, the phase in the respiratory cycle is assumed to increase at a pre-set rate, and setting mask pressure as a function of said phase. [0047] The invention further discloses a method for providing ventilatory assistance in a spontaneously breathing subject, comprising the steps of: measuring respiratory airflow, determining the extent to which the instantaneous phase in the respiratory cycle can be determined from said airflow, to said extent determining said phase from said airflow but to the extent that the phase in the respiratory cycle cannot be accurately determined, the phase is assumed to increase at a preset rate, and delivering pressure as a function of said phase. [0048] The invention further discloses a method for calculating the instantaneous inspired volume of a subject, operable substantially without run-away under conditions of suddenly changing leak, the method comprising the steps of: [0049] determining respiratory airflow approximately corrected for leak, [0050] calculating an index J varying from 0 to 1 equal to the fuzzy extent to which said corrected respiratory airflow is large positive for longer than expected, or large negative for longer than expected, [0051] identifying the start of inspiration, and [0052] calculating the instantaneous inspired volume as the integral of said corrected respiratory airflow multiplied by the fuzzy negation of said index J with respect to time, from start of inspiration. [0053] The invention further discloses a method “A” for providing ventilatory assistance in a spontaneously breathing subject, the method comprising the steps, performed at repeated sampling intervals, of: [0054] determining respiratory airflow approximately corrected for leak, [0055] calculating an index J varying from 0 to 1 equal to the fuzzy extent to which said respiratory airflow is large positive for longer than expected, or large negative for longer than expected, [0056] calculating a modified airflow equal to said respiratory airflow multiplied by the fuzzy negation of said index J, [0057] identifying the phase in the respiratory cycle, [0058] calculating the instantaneous inspired volume as the integral of said modified airflow with respect to time, with the integral held at zero during the expiratory portion of the respiratory cycle, [0059] calculating a desired instantaneous delivery pressure as a function at least of the said instantaneous inspired volume, and [0060] setting delivered pressure to subject to the desired delivery pressure. [0061] The invention further discloses a method “B” for providing ventilatory assistance in a spontaneously breathing subject, comprising the steps of: [0062] determining respiratory airflow approximately corrected for leak, [0063] calculating an index J varying from 0 to 1 equal to the fuzzy extent to which the respiratory airflow is large positive for longer than expected, or large negative for longer than expected, [0064] identifying the phase in the respiratory cycle, [0065] calculating a modified respiratory airflow equal to the respiratory airflow multiplied by the fuzzy negation of said index J, [0066] calculating the instantaneous inspired volume as the integral of the modified airflow with respect to time, with the integral held at zero during the expiratory portion of the respiratory cycle, [0067] calculating the desired instantaneous delivery pressure as an expiratory pressure plus a resistance multiplied by the instantaneous respiratory airflow plus a nonlinear resistance multiplied by the respiratory airflow multiplied by the absolute value of the respiratory airflow plus an elastance multiplied by the said adjusted instantaneous inspired volume, and [0068] setting delivered pressure to subject to the desired delivery pressure. [0069] The invention yet further discloses a method “C” for providing assisted ventilation to match the subject's need, comprising the steps of: [0070] describing a desired waveform template function Π(φ), with domain 0 to 1 revolution and range 0 to 1, [0071] determining respiratory airflow approximately corrected for leak, [0072] calculating an index J varying from 0 to 1 equal to the fuzzy extent to which the respiratory airflow is large positive for longer than expected, or large negative for longer than expected, [0073] calculating J PEAK equal to the recent peak of the index J, [0074] calculating the instantaneous phase in the respiratory cycle, [0075] calculating a desired amplitude of pressure modulation, chosen to servo-control the degree of ventilation to at least exceed a specified ventilation, [0076] calculating a desired delivery pressure as an end expiratory pressure plus the calculated pressure modulation amplitude A multiplied by the value of the waveform template function Π(φ) at the said calculated phase φ, and [0077] setting delivered pressure to subject to said desired instantaneous delivered pressure. [0078] The invention yet further discloses a method for providing assisted ventilation to match the subject's need, as described above, in which the step of calculating a desired amplitude of pressure modulation, chosen to servo-control the degree of ventilation to at least exceed a specified ventilation, comprises the steps of: [0079] calculating a target airflow equal to twice the target ventilation divided by the target respiratory rate, [0080] deriving an error term equal to the absolute value of the instantaneous low pass filtered respiratory airflow minus the target airflow, and [0081] calculating the amplitude of pressure modulation as the integral of the error term multiplied by a gain, with the integral clipped to lie between zero and a maximum. [0082] The invention yet further discloses a method for providing assisted ventilation to match the subject's need, as described above, in which the step of calculating a desired amplitude of pressure modulation, chosen to servo-control the degree of ventilation to at least exceed a specified ventilation, comprises the following steps: calculating a target airflow equal to twice the target ventilation divided by the target respiratory rate, deriving an error term equal to the absolute value of the instantaneous low pass filtered respiratory airflow minus the target airflow, calculating an uncorrected amplitude of pressure modulation as the integral of the error term multiplied by a gain, with the integral clipped to lie between zero and a maximum, calculating the recent average of said amplitude as the low pass filtered amplitude, with a time constant of several times the length of a respiratory cycle, and setting the actual amplitude of pressure modulation to equal the said low pass filtered amplitude multiplied by the recent peak jamming index J PEAK plus the uncorrected amplitude multiplied by the fuzzy negation of J PEAK . [0088] The invention yet further discloses a method for providing assisted ventilation to match the subject's need, and with particular application to subjects with varying respiratory mechanics, insufficient respiratory drive, abnormal chemoreceptor reflexes, hypoventilation syndromes, or Cheyne Stokes breathing, combined with the advantages of proportional assist ventilation adjusted for sudden changes in leak, comprising the steps, performed at repeated sampling intervals, of: calculating the instantaneous mask pressure as described for methods “A” or “B” above, calculating the instantaneous mask pressure as described for method “C” above, calculating a weighted average of the above two pressures, and setting the mask pressure to the said weighted average. [0093] The invention yet further discloses apparatus to give effect to each one of the methods defined, including one or more transducers to measure flow and/or pressure, processor means to perform calculations and procedures, flow generators for the supply of breathable gas at a pressure above atmospheric pressure and gas delivery means to deliver the breathable gas to a subject's airways. [0094] The apparatus can include ventilators, ventilatory assist devices, and CPAP devices including constant level, bi-level or autosetting level devices. [0095] It is to be understood that while the algorithms embodying the invention are explained in terms of fuzzy logic, approximations to these algorithms can be constructed without the use of the fuzzy logic formalism. BRIEF DESCRIPTION OF THE DRAWINGS [0096] A number of embodiments will now be described with reference to the accompanying drawings in which: [0097] FIGS. 1 a and 1 b show apparatus for first and second embodiments of the invention respectively; [0098] FIG. 2 is a pressure waveform function Π(Φ) used in the calculation of the desired instantaneous delivery pressure as a function of the instantaneous phase Φ in the respiratory cycle for a first embodiment of the invention; [0099] FIG. 3 shows fuzzy membership functions for calculating the degree of membership in each of five magnitude fuzzy sets (“large negative”, “small negative”, “zero”, “small positive”, and “large positive”) from the normalized respiratory airflow according to the first embodiment of the invention; and [0100] FIG. 4 shows fuzzy membership functions for calculating the degree of membership in each of five rate of change fuzzy sets (“rising fast”, “rising slowly”, “steady”, “falling slowly”, and “falling fast”) from the normalized rate of change of airflow according to the first embodiment of the invention; [0101] FIG. 5 is a pressure waveform function Π(Φ) used in the calculation of the desired instantaneous delivery pressure as a function of the instantaneous phase Φ in the respiratory cycle for a second embodiment of the invention; [0102] FIG. 6 shows calculation of a quantity “lead-in” as a function of time since the most recent mask off-on transition; [0103] FIG. 7 shows a fuzzy membership function for fuzzy set A I as a function of time since the most recent expiratory-to-inspiratory (negative-to-positive) zero crossing of the respiratory airflow signal, such that the membership function measures the extent to which the respiratory airflow has been positive for longer than expected; [0104] FIG. 8 shows a membership function for fuzzy set B I as a function of respiratory airflow, such that the membership function measures the extent to which respiratory airflow is large positive; [0105] FIG. 9 shows an electrical analog of the calculation of a recent peak jamming index J PEAK from the instantaneous jamming index J; [0106] FIG. 10 shows the calculation of the time constant τ used in low pass filtering steps in the calculation of the conductance of a leak, as a function of the recent peak jamming index J PEAK . [0107] FIG. 11 shows a prototypical respiratory flow-time curve, with time on the x-axis, marking nine features; [0108] FIG. 12 shows membership functions for fuzzy sets “large negative”, “small negative”, “zero”, “small positive”, and “large positive” as functions of normalized respiratory airflow according to a second embodiment of the invention; [0109] FIG. 13 shows membership functions for fuzzy sets “falling”, “steady”, and “rising” as functions of normalized rate of change of respiratory airflow df/dt according to a second embodiment of the invention; [0110] FIG. 14 shows the membership function for fuzzy set “hypopnea”; [0111] FIG. 15 shows the calculation of the time constant τ for calculation of normalized recent ventilation, as a function of “servo gain” being the gain used for servo-control of minute ventilation to at least exceed a specified target ventilation; [0112] FIG. 16 shows the membership function for fuzzy set “hyperpnea” as a function of normalized recent ventilation; [0113] FIG. 17 shows the membership function for fuzzy set “big leak” as a function of leak; [0114] FIG. 18 shows the membership functions for fuzzy sets “switch negative” and “switch positive” as a function of nomalized respiratory airflow; [0115] FIG. 19 shows the membership functions for fuzzy sets “insp_phase” and “exp_phase” as functions of the instantaneous phase in the respiratory cycle φ; [0116] FIG. 20 shows schematically how function W(y), used in defuzzification, calculates the area (shaded) of an isosceles triangle of unit base and height cut off below height y; [0117] FIGS. 21-26 show actual 60 second flow and pressure tracings from the second embodiment of the invention during operation; the vertical scale for flow (heavy trace) is ±1 L/sec, inspiration upwards and the vertical scale for the pressure (light trace) is 0-25 cmH 2 O; where: [0118] FIG. 21 shows that a short central apnea (b) is permitted when effort ceases at point (c) after a preceding deep breath (a); [0119] FIG. 22 shows that a central apnea is not permitted when effort ceases at arrow (a) without a preceeding deep breath; [0120] FIG. 23 is recorded with servo gain set high, and shows that a central apnea is no longer permitted when effort ceases at arrow (a) despite preceding deep breathing; [0121] FIG. 24 shows automatically increasing end-inspiratory pressure as the subject makes voluntarily deeper inspiratory efforts; [0122] FIG. 25 is recorded with a somewhat more square waveform selected, and shows automatically increasing pressure support when the subject voluntarily attempts to resist by stiffening the chest wall at point (a); [0123] FIG. 26 shows that with sudden onset of a sever 1.4 L/sec leak at (a), the flow signal returns to baseline (b) within the span of a single breath, and pressure continues to cycle correctly throughout; and [0124] FIG. 27 shows an actual 60 second tracing showing respiratory airflow (heavy trace, ±1 L/sec full scale) and instantaneous phase (light trace, 0-1 revolution full scale). DESCRIPTION OF PREFERRED EMBODIMENTS [0125] The two embodiments to be described are ventilators that operate in a manner that seeks to simultaneously achieve the three goals stated above. First Embodiment [0126] Apparatus to give effect to a first embodiment of the apparatus is shown in FIG. 1 a . A blower 10 supplies a breathable gas to mask 11 in communication with the subject's airway via a delivery tube 12 and exhausted via a exhaust diffuser 13 . Airflow to the mask 11 is measured using a pneumotachograph 14 and a differential pressure transducer 15 . The mask flow signal from the transducer 15 is then sampled by a microprocessor 16 . Mask pressure is measured at the port 17 using a pressure transducer 18 . The pressure signal from the transducer 18 is then sampled by the microprocessor 16 . The microprocessor 16 sends an instantaneous mask pressure request signal to the servo 19 , which compares said pressure request signal with actual pressure signal from the transducer 18 to the control fan motor 20 . The microprocessor settings can be adjusted via a serial port 21 . [0127] It is to be understood that the mask could equally be replaced with a tracheotomy tube, endotracheal tube, nasal pillows, or other means of making a sealed connection between the air delivery means and the subject's airway. [0128] The microprocessor 16 is programmed to perform the following steps, to be considered in conjunction with Tables 1 and 2. TABLE 1 Fuzzy Inference Rules for a first embodiment N Fuzzy Interference Rule Fuzzy Phase 1 if size is Zero and rate of Increasing then phase is Start Inspiration 2 if size is Small and rate of Increasing then phase is Early Inspiration Positive change is Slowly 3 if size is Large and race of Steady then phase is Peak Inspiration Positive change is 4 if size is Small and rate of Decreasing then phase is Late Inspiration Positive change is Slowly 5 if size is Zero and rate of Decreasing then phase is Start Expiration change is Fast 6 if size is Small and rate of Decreasing then phase is Early Expiration Negative change is Slowly 7 if size is Large and rate of Steady then phase is Peak Expiration Negative change is 8 if size is Small and rate of Increasing then phase is Late Expiration Negative change is Slowly 9 if size is Zero and rate of Steady then phase is Expiratory Pause change is 10 always phase is Unchanged [0129] TABLE 2 Association of phases with fuzzy rules for a first embodiment. N Phase Φ N 1 Start Inspiration 0.0 2 Early Inspiration values intermediate between 3 Peak Inspiration 0.0 and 0.5 4 Late Inspiration 5 Start Expiration 0.50 6 Early Expiration values intermediate between 7 Peak Expiration 0.5 and 1.0 8 Late Expiration 9 Expiratory Pause 10 Unchanged Φ 1. Set desired target values for the duration of inspiration TI TGT , duration of expiration TE TGT , and minute ventilation V TGT . Choose suitable constants P 0 and A STD where P 0 is the desired end expiratory pressure, and A STD is the desired increase in pressure above P 0 at end inspiration for a breath of duration TT TGT =TI TGT +TE TGT . 2. Choose a suitable pressure waveform function Π(Φ), such as that shown in FIG. 2 , such that the desired delivery pressure at phase Φ will be given by: P=P 0 +A Π(Φ)  where the amplitude A equals the difference between the end inspiratory pressure and end expiratory pressure. However, other waveforms may be suitable for subjects with particular needs. 3. Initialize the phase Φ in the respiratory cycle to zero, and initialize the current estimates of actual inspiratory and expiratory duration TI and TE to TI TGT and TE TGT respectively. 4. Initialize the rate of change of phase during inspiration ΔΦ I between sampling intervals of length T to: ΔΦ+=0.5 T/TI TGT 5. Initialize the rate of change of phase during expiration ΔΦ E to: Δ  E =0.5 T/TE TGT 6. Measure the instantaneous respiratory airflow f RESP . 7. Calculate the average total breath duration TT=TI+TE 8. Low pass filter the respiratory airflow with an adjustable time constant τf, where τf is a fixed small fraction of TT. 9. Calculate the instantaneous ventilation V, as half the absolute value of the respiratory airflow: V= 0.5 |f RESP | 10. From the target ventilation V TGT and the measured minute ventilation V, derive an error term V ERR , such that large values of V ERR indicate inadequate ventilation: V ERR =∫( V TGT −V ) dt 11. Take V BAR as the result of low pass filtering V with a time constant τV BAR which is long compared with TT. 12. Calculate a normalized airflow f NORM , where f NORM =f RESP /V BAR . 13. From f NORM , calculate the degree of membership in each of the fuzzy sets whose membership functions are shown in FIG. 3 . 14. Calculate a normalized rate of change df NORM /dΦ, equal to df NORM /dt divided by the current estimate of the average respiratory cycle time TT. 15. From the normalized rate of change, calculate the degree of membership in each of the fuzzy sets shown in FIG. 4 . 16. For each row N in Table 1, calculate the degree of membership g N in the fuzzy set shown in the column labelled Fuzzy Phase, by applying the fuzzy inference rules shown. 17. Associate with the result of each of the N rules a phase Φ N as shown in Table 2, noting that Φ 10 is the current phase Φ. 18. Increase each of the Φ N excepting Φ 10 by 0.89 τ/TT, to compensate for the previous low pass filtering step. 19. Calculate a new instantaneous phase Φ INST as the angle to the center of gravity of N unit masses at polar coordinates of radius g N and angle Φ N revolutions. [0150] 20. Calculate the smallest signed difference ΔΦ INST bewteen the phase estimated in the previous step and the current phase. ΔΦ INST = 1 − (ΔΦ INST − Φ) (Φ INST − Φ > 0.5) ΔΦ INST = Φ INST − Φ + 1 (Φ INST − Φ < − 0.5) ΔΦINST = Φ INST − Φ (otherwise) [0151] 21. Derive a revised estimate ΔΦ REV equal to a weighted mean of the value calculated in the previous step and the average value (ΔΦ I or ΔΦ E as appropriate). ΔΦ = (1 − W) ΔΦ I + WΔΦ INST (0 < Φ < 0.5) ΔΦ = (1 − W) ΔΦ I + WΔΦ INST (otherwise)  Smaller values of W will cause better tracking of phase if the subject is breathing regularly, and larger values will cause better tracking of phase if the subject is breathing irregularly. 22. Derive a blending fraction B, such that the blending fraction is unity if the subject's ventilation is well above V TGT , zero if the subject is breathing near or below V TGT , and increasing proportionally from zero to unity as the subject's ventilation increases through an intermediate range. [0154] 23. Calculate ΔΦ BLEND influenced chiefly by ΔΦ calculated in step 21 from the subject's respiratory activity if the subject's ventilation is well above V TGT ; influenced chiefly by the target respiratory duration if the subject is breathing near or below V TGT ; and proportionally between these two amounts if ventilation is in an intermediate range: ΔΦ BLEND = B ΔΦ + 0.5 (1 − B) T/TI TGT (0 < Φ < 0.5) ΔΦ BLEND = B ΔΦ + 0.5 (1 − B) T/TE TGT (otherwise) 24. Increment Φ by ΔΦ BLEND [0156] 25. Update the average rate of change of phase (ΔΦ I or ΔΦ E as appropriate). ΔΦ I = T/τ VBAR (ΔΦ BLEND − ΔΦ I ) (0 < Φ < 0.5) ΔΦ E = T/τ VBAR (ΔΦ BLEND − ΔΦ E ) (otherwise) 26. Recalculate the approximate duration of inspiration TI and expiration TE: TI= 0.5 T/ΔΦ I TE= 0.5 T/ΔΦ E [0158] 27. Calculate the desired mask pressure modulation amplitude A D : A D = A STD /2 (TT < TT STD /2) A D = 2 · A STD (TT > 2 · TT STD ) A D = A STD · TT/TT STD (otherwise) [0159] 28. From the error term V ERR , calculate an additional mask pressure modulation amplitude A E : A E = K · V ERR (for V ERR > 0) A E = 0 (otherwise)  where larger values of K will produce a faster but less stable control of the degree of assistance, and smaller values of K will produce slower but more stable control of the degree of assistance. 29. Set the mask pressure P MASK to: P MASK =P 0 +( A D +A E )Π(Φ) 30. Wait for a sampling interval T, short compared with the duration of a respiratory cycle, and then continue at the step of measuring respiratory airflow. Measurement of Respiratory Airflow [0163] As follows from above, it is necessary to respiratory airflow, which is a standard procedure to one skilled in the art. In the absence of leak, respiratory airflow can be measured directly with a pneumotachograph placed between the mask and the exhaust. In the presence of a possible leak, one method disclosed in European Publication No 0 651 971 incorporated herein by cross-reference is to calculate the mean flow through the leak, and thence calculate the amount of modulation of the pneumotachograph flow signal due to modulation of the flow through the leak induced by changing mask pressure, using the following steps: 1. Measure the airflow at the mask f MASK using a pneumotachograph 2. Measure the pressure at the mask P MASK 3. Calculate the mean leak as the low pass filtered airflow, with a time constant long compared with a breath. 4. Calculate the mean mask pressure as the low pass filtered mask pressure, with a time constant long compared with a breath. 5. Calculate the modulation of the flow through the leak as: δ(leak)=0.5 times the mean leak times the inducing pressure, where the inducing pressure is P MASK −mean mask pressure. Thence the instantaneous respiratory airflow can be calculated as: f RESP =f MASK −mean leak−δ(leak) A convenient extension as further disclosed in EP 0 651 971 (incorporated herein by cross-reference) is to measure airflow f TURBINE and pressure P TURBINE at the outlet of the turbine, and thence calculate P MASK and f MASK by allowing for the pressure drop down the air delivery hose, and the airflow lost via the exhaust: 1. ΔP HOS E=K 1 (F TURBINE )−K 2 (F TURBINE ) 2 2. PMASK =P TURBINE −ΔP HOSE 3. F EXHAUST =K3√P MASK 4. F MASK =F TURBINE −F EXHAUST Alternative Embodiment [0173] The following embodiment is particularly applicable to subjects with varying respiratory mechanics, insufficient respiratory drive, abnormal chemoreceptor reflexes, hypoventilation syndromes, or Cheyne Stokes breathing, or to subjects with abnormalities of the upper or lower airways, lungs, chest wall, or neuromuscular system. [0174] Many patients with severe lung disease cannot easily be treated using a smooth physiological pressure waveform, because the peak pressure required is unacceptably high, or unachievable with for example a nose-mask. Such patients may prefer a square pressure waveform, in which pressure rises explosively fast at the moment of commencement of inspiratory effort. This may be particularly important in patients with high intrinsic PEEP, in which it is not practicable to overcome the intrinsic PEEP by the use of high levels of extrinsic PEEP or CPAP, due to the risk of hyperinflation. In such subjects, any delay in triggering is perceived as very distressing, because of the enormous mis-match between expected and observed support. Smooth waveforms exaggerate the perceived delay, because of the time taken for the administered pressure to exceed the intrinsic PEEP. This embodiment permits the use of waveforms varying continuously from square (suitable for patients with for example severe lung or chest wall disease or high intrinsic PEEP) to very smooth, suitable for patients with normal lungs and chest wall, but abnormal respiratory control, or neuromuscular abnormalities. This waveform is combined either with or without elements of proportional assist ventilation (corrected for sudden changes in leak), with servo-control of the minute ventilation to equal or exceed a target ventilation. The latter servo-control has an adjustable gain, so that subjects with for example Cheyne Stokes breathing can be treated using a very high servo gain to over-ride their own waxing and waning patterns; subjects with various central hypoventilation syndromes can be treated with a low servo gain, so that short central apneas are permitted, for example to cough, clear the throat, talk, or roll over in bed, but only if they follow a previous period of high ventilation; and normal subjects are treated with an intermediate gain. [0000] Restating the Above in Other Words: [0000] The integral gain of the servo-control of the degree of assistance is adjustable from very fast (0.3 cmH 2 O/L/sec/sec) to very slow. Patients with Cheyne-Stokes breathing have a very high ventilatory control loop gain, but a long control loop delay, leading to hunting. By setting the loop gain even higher, the patient's controller is stabilized. This prevents the extreme breathlessness that normally occurs during each cycle of Cheyne-Stokes breathing, and this is very reassuring to the patient. It is impossible for them to have a central apnea. Conversely, subjects with obesity-hypoventilation syndrome have low or zero loop gain. They will not feel breathless during a central apnea. However, they have much mucus and need to cough, and are also often very fidgety, needing to roll about in bed. This requires that they have central apneas which the machine does not attempt to treat. By setting the loop gain very low, the patient is permitted to take a couple of deep breaths and then have a moderate-length central apnea while coughing, rolling over, etc, but prolonged sustained apneas or hypopneas are prevented. Sudden changes in leakage flow are detected and handled using a fuzzy logic algorithm. The principle of the algorithm is that the leak filter time constant is reduced dynamically to the fuzzy extent that the apparent respiratory airflow is a long way from zero for a long time compared with the patient's expected respiratory cycle length. Rather than simply triggering between two states (IPAP, EPAP), the device uses a fuzzy logic algorithm to estimate the position in the respiratory cycle as a continuous variable. The algorithm permits the smooth pressure waveform to adjust it's rise time automatically to the patient's instantaneous respiratory pattern. The fuzzy phase detection algorithm under normal conditions closely tracks the patient's breathing. To the extent that there is a high or suddenly changing leak, or the patient's ventilation is low, the rate of change of phase (respiratory rate) smoothly reverts to the specified target respiratory rate. Longer or deeper hypopneas are permitted to the extent that ventilation is on average adequate. To the extent that the servo gain is set high to prevent Cheyne Stokes breathing, shorter and shallower pauses are permitted. Airflow filtering uses an adaptive filter, which shortens it's time constant if the subject is breathing rapidly, to give very fast response times, and lenthens if the subject is breathing slowly, to help eliminate cardiogenic artifact. The fuzzy changing leak detection algorithm, the fuzzy phase detection algorithm with its differential handling of brief expiratory pauses, and handling of changing leak, together with the smooth waveform severally and cooperatively make the system relatively immune to the effects of sudden leaks. By suitably setting various parameters, the system can operate in CPAP, bilevel spontaneous, bilevel timed, proportional assist ventilation, volume cycled ventilation, and volume cycled servo-ventilation, and therefore all these modes are subsets of the present embodiment. However, the present embodiment permits states of operation that can not be achieved by any of the above states, and is therefore distinct from them. Notes Note 1: in this second embodiment, the names and symbols used for various quantities may be different to those used in the first embodiment. Note 2: The term “swing” is used to refer to the difference between desired instantaneous pressure at end inspiration and the desired instantaneous pressure at end expiration. Note 3: A fuzzy membership function is taken as returning a value between zero for complete nonmembership and unity for complete membership. Fuzzy intersection A AND B is the lesser of A and B, fuzzy union A OR B is the larger of A and B, and fuzzy negation NOT A is 1−A. Note 4: root(x) is the square root of x, abs(x) is the absolute value of x, sign(x) is −1 if x is negative, and +1 otherwise. An asterisk (*) is used to explicitly indicate multiplication where this might not be obvious from context. Apparatus [0182] The apparatus for the second embodiment is shown in FIG. 1 b . The blower 110 delivers air under pressure to the mask 111 via the air delivery hose 112 . Exhaled air is exhausted via the exhaust 113 in the mask 111 . The pneumotachograph 114 and a differential pressure transducer 115 measure the airflow in the nose 112 . The flow signal is delivered to the microprocessor 116 . Pressure at any convenient point 117 along the nose 112 is measured using a pressure transducer 118 . The output from the pressure transducer 118 is delivered to the microcontroller 116 and also to a motor servo 119 . The microprocessor 116 supplies the motor servo 119 with a pressure request signal, which is then compared with the signal from the pressure transducer 118 to control the blower motor 120 . User configurable parameters are loaded into the microprocessor 116 via a communications port 121 , and the computed mask pressure and flow can if desired be output via the communications port 121 . [0000] Initialization [0183] The following user adjustable parameters are specified and stored: max permissible maximum permissible mask pressure pressure max swing maximum permissible difference between end inspiratory pressure and end expiratory pressure. min swing minimum permissible difference between end inspiratory pressure and end expiratory pressure. epap end expiratory pressure min permissible minimum permissible mask pressure pressure target ventilation minute ventilation is sevo-controlled to equal or exceed this quantity target frequency Expected respiratory rate. If the patient is achieving no respiratory airflow, the pressure will cycle at this frequency. target duty cycle Expected ratio of inspiratory time to cycle time. If the patient is achieving no respiratory airflow, the pressure will follow this duty cycle. linear resistance resistive unloading = linear resistance * f + andquad resistance quad_resistance * f 2 sign(f), where f is the respiratory airflow. where sign(x) = −1 for x < 0, +1 otherwise elastance Unload at least this much elastance servo gain gain for servo-control of minute ventilation to at least exceed target ventilation. waveform time constant Elastic unloading waveform time constant as a fraction of inspiratory duration. (0.0 = square wave) hose resistance ΔP from pressure sensing port to inside mask = hose resistance times the square of the flow in the intervening tubing. diffuser conductance Flow through the mask exhaust port = diffuser conductance * root mask pressure At initialization, the following are calculated from the above user-specified settings: The expected duration of a respiratory cycle, of an inspiration, and of an expiration are set respectively to: STDT TOT =60/target respiratory rate STDT I =STDT TOT *target duty cycle STDT E =STDT TOT −STDT I The standard rates of change of phase (revolutions per sec) during inspiration and expiration are set respectively to: STDdφ I =0.5 /STDT I STDdφ E =0.5 /STDT E The instantaneous elastic support at any phase φ in the respiratory cycle is given by: PEL (φ)=swing*Π(φ) [0184] where swing is the pressure at end inspiration minus the pressure at end expiration, π(Φ) = e −2 τΦ during inspiration, e −4 t(Φ − 0.5) during expiration and τ is the user-selectable waveform time constant. If τ=0, then Π(φ) is a square wave. The maximum implemented value for τ=0.3, producing a waveform approximately as shown in FIG. 5 . The mean value of Π(φ) is calculated as follows: Π BAR = 0.5 ⁢ ∫ 0 .05` ⁢ Π ⁡ ( ϕ ) ⁢   ⁢ ⅆ ϕ Operations Performed Every 20 Milliseconds [0185] The following is an overview of routine processing done at 50 Hz: measure flow at flow sensor and pressure at pressure sensing port calculate mask pressure and flow from sensor pressure and flow calculate conductance of mask leak calculate instantaneous airflow through leak calculate respiratory airflow and low pass filtered respiratory airflow calculate mask on-off status and lead-in calculate instantaneous and recent peak jamming calculate time constant for leak conductance calculations calculate phase in respiratory cycle update mean rates of change of phase for inspiration and expiration, lengths of inspiratory and expiratory times, and respiratory rate add hose pressure loss to EPAP pressure add resistive unloading calculate instantaneous elastic assistance required to servo-control ventilation estimate instantaneous elastic recoil pressure using various assumptions weight and combine estimates add servo pressure to yield desired sensor pressure servo-control motor speed to achieve desired sensor pressure The details of each step will now be explained. Measurement of Flow and Pressure Flow is measured at the outlet of the blower using a pneumotachograph and differential pressure transducer. Pressure is measured at any convenient point between the blower outlet and the mask. A humidifier and/or anti-bacterial filter may be inserted between the pressure sensing port and the blower. Flow and pressure are digitized at 50 Hz using an A/D converter. Calculation of Mask Flow and Pressure The pressure loss from pressure measuring point to mask is calculated from the flow at the blower and the (quadratic) resistance from measuring point to mask. Hose pressure loss=sign(flow)*hose resistance*flow 2 where sign(x)=−1 for x<0, +1 otherwise. The mask pressure is then calculated by subtracting the hose pressure loss from the measured sensor pressure: Mask pressure=sensor pressure−hose pressure loss The flow through the mask exhaust diffuser is calculated from the known parabolic resistance of the diffuser holes, and the square root of the mask pressure: diffuser flow=exhaust resistance*sign(mask pressure)*root(abs(mask pressure)) Finally, the mask flow is calculated: mask flow=sensor flow−diffuser flow The foregoing describes calculation of mask pressure and flow in the various treatment modes. In diagnostic mode, the patient is wearing only nasal cannulae, not a mask. The cannula is plugged into the pressure sensing port. The nasal airflow is calculated from the pressure, after a linearization step, and the mask pressure is set to zero by definition. Conductance of Leak The conductance of the leak is calculated as follows: root mask pressure=sign(P MASK )√{square root over (abs(P MASK ))} LP mask airflow=low pass filtered mask airflow LP root mask pressure=low pass filtered root mask pressure conductance of leak=LP mask airflow/LP root mask pressure The time constant for the two low pass filtering steps is initialized to 10 seconds and adjusted dynamically thereafter (see below). Instantaneous Flow Through Leak The instantaneous flow through the leak is calculated from the instantaneous mask pressure and the conductance of the leak: instantaneous leak=conductance of leak*root mask pressure Respiratory Airflow The respiratory airflow is the difference between the flow at the mask and the instantaneous leak: respiratory airflow=maskflow−instantaneous leak Low Pass Filtered Respiratory Airflow Low pass filter the respiratory airflow to remove cardiogenic airflow and other noise. The time constant is dynamically adjusted to be 1/40 of the current estimated length of the respiratory cycle T TOT (initialized to STD_T TOT and updated below). This means that at high respiratory rates, there is only a short phase delay introduced by the filter, but at low respiratory rates, there is good rejection of cardiogenic airflow. Mask On/Off Status The mask is assumed to initially be off. An off-on transition is taken as occurring when the respiratory airflow first goes above 0.2 L/sec, and an on-off transition is taken as occurring if the mask pressure is less than 2 cmH 2 O for more than 1.5 seconds. Lead-In Lead-in is a quantity that runs from zero if the mask is off, or has just been donned, to 1.0 if the mask has been on for 20 seconds or more, as shown in FIG. 6 . Calculation of Instantaneous Jamming Index, J J is the fuzzy extent to which the impedance of the leak has suddenly changed. It is calculated as the fuzzy extent to which the absolute magnitude of the respiratory airflow is large for longer than expected. The fuzzy extent A I to which the airflow has been positive for longer than expected is calculated from the time t ZI since the last positive-going zero crossing of the calculated respiratory airflow signal, and the expected duration STD T I of a normal inspiration for the particular subject, using the fuzzy membership function shown in FIG. 7 . The fuzzy extent B I to which the airflow is large and positive is calculated from the instantaneous respiratory airflow using the fuzzy membership function shown in FIG. 8 . The fuzzy extent I I to which the leak has suddenly increased is calculated by calculating the fuzzy intersection (lesser) of A I and B I . Precisely symmetrical calculations are performed for expiration, deriving I E .as the fuzzy extent to which the leak has suddenly decreased. A E is calculated from T ZE and T E , B E is calculated from minus f RESP , and I E is the fuzzy intersection of A E and B E . The instantaneous jamming index J is calculated as the fuzzy union (larger) of indices I I and I E . Recent Peak Jamming If the instantaneous jamming index is larger than the current value of the recent peak jamming index, then the recent peak jamming index is set to equal the instantaneous jamming index. Otherwise, the recent peak jamming index is set to equal the instantaneous jamming index low pass filtered with a time constant of 10 seconds. An electrical analogy of the calculation is shown in FIG. 9 . Time Constant for Leak Conductance Calculations If the conductance of the leak suddenly changes, then the calculated conductance will initially be incorrect, and will gradually approach the correct value at a rate which will be slow if the time constant of the low pass filters is long, and fast if the time constant is short. Conversely, if the impedance of the leak is steady, the longer the time constant the more accurate the calculation of the instantaneous leak. Therefore, it is desirable to lengthen the time constant to the extent that the leak is steady, reduce the time constant to the extent that the leak has suddenly changed, and to use intermediately longer or shorter time constants if it is intermediately the case that the leak is steady. If there is a large and sudden increase in the conductance of the leak, then the calculated respiratory airflow will be incorrect. In particular, during apparent inspiration, the calculated respiratory airflow will be large positive for a time that is large compared with the expected duration of a normal inspiration. Conversely, if there is a sudden decrease in conductance of the leak, then during apparent expiration the calculated respiratory airflow will be large negative for a time that is large compared with the duration of normal expiration. Therefore, the time constant for the calculation of the conductance of the leak is adjusted depending on J PEAK , which is a measure of the fuzzy extent that the leak has recently suddenly changed, as shown in FIG. 10 . In operation, to the extent that there has recently been a sudden and large change in the leak, J PEAK will be large, and the time constant for the calculation of the conductance of the leak will be small, allowing rapid convergence on the new value of the leakage conductance. Conversely, if the leak is steady for a long time, J PEAK will be small, and the time constant for calculation of the leakage conductance will be large, enabling accurate calculation of the instantaneous respiratory airflow. In the spectrum of intermediate situations, where the calculated instantaneous respiratory airflow is larger and for longer periods, J PEAK will be progressively larger, and the time constant for the calculation of the leak will progressively reduce. For example, at a moment in time where it is uncertain whether the leak is in fact constant, and the subject has merely commenced a large sigh, or whether in fact there has been a sudden increase in the leak, the index will be of an intermediate value, and the time constant for calculation of the impedance of the leak will also be of an intermediate value. The advantage is that some corrective action will occur very early, but without momentary total loss of knowledge of the impedance of the leak. Instantaneous Phase in Respiratory Cycle The current phase φ runs from 0 for start of inspiration to 0.5 for start of expiration to 1.0 for end expiration=start of next inspiration. Nine separate features (peaks, zero crossings, plateaux, and some intermediate points) are identified on the waveform, as shown in FIG. 11 . Calculation of Normalized Respiratory Airflow The filtered respiratory airflow is normalized with respect to the user specified target ventilation as follows: standard airflow=target ventilation/7.5 L/min f′=filtered respiratory airflow/standard airflow Next, the fuzzy membership in fuzzy sets large negative, small negative, zero, small positive, and large positive, describing the instantaneous airflow is calculated using the membership functions shown in FIG. 12 . For example, if the normalized airflow is 0.25, then the airflow is large negative to extent 0.0, small negative to extent 0.0, zero to extent 0.5, small positive to extent 0.5, large positive to extent 0.00. Calculation of Normalized Rate of Change of Airflow The rate of change of filtered respiratory airflow is calculated and normalized to a target ventilation of 7.5 L/min at 15 breaths/min as follows: standard df/dt =standard airflow*target frequency/15 calculate d(filtered airflow)/dt low pass filter with a time constant of 8/50 seconds normalize by dividing by standard df/dt Now evaluate the membership of normalized df/dt in the fuzzy sets falling, steady, and rising, whose membership functions are shown in FIG. 13 . Calculation of Ventilation, Normalized Ventilation, and Hypopnea ventilation=abs(respiratory airflow), low pass filtered with a time constant of STDT TOT . normalized ventilation=ventilation/standard airflow Hypopnea is the fuzzy extent to which the normalized ventilation is zero. The membership function for hypopnea is shown in FIG. 14 . Calculation of Recent Ventilation, Normalized Recent Ventilation, and Hyperpnea Recent ventilation is also a low pass filtered abs(respiratory airflow), but filtered with an adjustable time constant, calculated from servo gain (specified by the user) as shown in FIG. 15 . For example, if the servo gain is set to the maximum value of 0.3, the time constant is zero, and recent ventilation equals instantaneous abs(respiratory airflow). Conversely, if servo gain is zero, the time constant is twice STD T TOT , the expected length of a typical breath. Target absolute airflow=2*target ventilation normalized recent ventilation=recent ventilation/target absolute airflow Hyperpnea is the fuzzy extent to which the recent ventilation is large. The membership function for hyperpnea is shown in FIG. 16 . Big Leak The fuzzy extent to which there is a big leak is calculated from the membership function shown in FIG. 17 . Additional Fuzzy Sets Concerned with Fuzzy “Triggering” Membership in fuzzy sets switch negative and switch positive are calculated from the normalized respiratory airflow using the membership functions shown in FIG. 18 , and membership in fuzzy sets insp_phase and exp_phase are calculated from the current phase f using the membership functions shown in FIG. 19 . Fuzzy Inference Rules for Phase Procedure W(y) calculates the area of an isosceles triangle of unit height and unit base, truncated at height y as shown in FIG. 20 . In the calculations that follow, recall that fuzzy intersection a AND b is the smaller of a and b, fuzzy union a OR b is the larger of a and b, and fuzzy negation NOT a is 1−a. The first fuzzy rule indicates that lacking any other information the phase is to increase at a standard rate. This rule is unconditionally true, and has a very heavy weighting, especially if there is a large leak, or there has recently been a sudden change in the leak, or there is a hypopnea. W STANDARD =8+16 *J PEAK +16*hyopopnea+16*big leak The next batch of fuzzy rules correspond to the detection of various features of a typical flow-vs-time curve. These rules all have unit weighting, and are conditional upon the fuzzy membership in the indicated sets: W EARLY INSP =W (rise and small positive) W PEAK INSP =W (large positive AND steady AND NOT recent peak jamming) W LATE INSP =W (fall AND small positive) W EARLY EXP =W (fall AND small negative) W PEAK EXP =W (large negative AND steady) W LATE EXP =W (rise AND small negative) The next rule indicates that there is a legitimate expiratory pause (as opposed to an apnea) if there has been a recent hyperpnea and the leak has not recently changed: W PAUSE =(hyperpnea AND NOT J PEAK )* W (steady AND zero) Recalling that the time constant for hyperpnea gets shorter as servo gain increases, the permitted length of expiratory pause gets shorter and shorter as the servo gain increases, and becomes zero at maximum servo gain. The rationale for this is that (i) high servo gain plus long pauses in breathing will result in “hunting” of the servo-controller, and (ii) in general high servo gain is used if the subject's chemoreceptor responses are very brisk, and suppression of long apneas or hypopneas will help prevent the subject's own internal servo-control from hunting, thereby helping prevent Cheyne-Stokes breathing. Finally, there are two phase-switching rules. During regular quiet breathing at roughly the expected rate, these rules should not strongly activate, but they are there to handle irregular breathing or breathing at unusual rates. They have very heavy weightings. W TRIG INSP =32 W (expiratory phase AND switch positive) W TRIG EXP =32 W (inspiratory phase AND switch negative) Defuzzification [0203] For each of the ten fuzzy rules above, we attach phase angles f N , as shown in Table ZZZ. Note that φ are in revolutions, not radians. We now place the ten masses W(N) calculated above at the appropriate phase angles φ N around the unit circle, and take the centroid. Rule N Φ N STANDARD 1 current Φ TRIG INSP 2 0.00 EARLY INSP 3 0.10 PEAK INSP 4 0.30 LATE INSP 5 0.50 TRIG EXP 6 0.5 + 0.05 k EARLY EXP 7 0.5 + 0.10 k PEAK EXP 8 0.5 + 0.20 k LATE EXP 9 0.5 + 0.4 k EXP PAUSE 10 0.5 + 0.5 k where k=STD T I /STD T E . Note that if the user has entered very short duty cycle, k will be small. For example a normal duty cycle is 40%, giving k= 40/60=0.67. Thus the expiratory peak will be associated with a phase angle of 0.5+0.2*0.67=0.63, corresponding 26% of the way into expiratory time, and the expiratory pause would start at 0.5+0.5*0.67=0.83, corresponding to 67% of the way into expiratory time. Conversely, if the duty cycle is set to 20% in a patient with severe obstructive lung disease, features 6 through 10 will be skewed or compressed into early expiration, generating an appropriately longer expiratory pause. The new estimate of the phase is the centroid, in polar coordinates, of the above ten rules: centroid = arc ⁢   ⁢ tan ⁡ ( ∑ W N ⁢ sin ⁢   ⁢ ϕ N ∑ W N ⁢ cos ⁢   ⁢ ϕ N ) The change in phase dφ from the current phase φ to the centroid is calculated in polar coordinates. Thus if the centroid is 0.01 and the current phase is 0.99, the change in phase is dφ=0.02. Conversely, if the centroid is 0.99 and the current phase is 0.01, then dφ=−0.02. The new phase is then set to the centroid: φ=centroid This concludes the calculation of the instantaneous phase in the respiratory cycle φ. Estimated Mean Duration of Inspiration, Expiration, Cycle Time, and Respiratory Rate If the current phase is inspiratory (φ<0.5) the estimated duration of inspiration T I is updated: LP ( dφ I )=low pass filtered dφ with a time constant of 4 *STDT TOT Clip LP(dφ I ) to the range (0.5/STDT I )/2 to 4(0.5/STDT I ) T I =0.5/clipped LP ( dφI ) Conversely, if the current phase is expiratory, (φ>=0.5) the estimated duration of expiration T E is updated: LP ( dφ E )=low pass filtered dφ with a time constant of 4 *STDT TOT Clip LP(dφE) to the range (0.5/STDT E )/2 to 4(0.5/STDT E ) T E =0.5/clipped LP ( dφ E ) The purpose of the clipping is firstly to prevent division by zero, and also so that the calculated T I and T E are never more than a factor of 4 shorter or a factor of 2 longer than expected. Finally, the observed mean duration of a breath T TOT and respiratory rate RR are: T TOT =T I +T E RR= 60 /T TOT Resistive Unloading The resistive unloading is the pressure drop across the patient's upper and lower airways, calculated from the respiratory airflow and resistance values stored in SRAM f=respiratory airflow truncated to +/−2 L/sec resistive unloading=airway resistance* f +upper airway resistance* f 2 *sign( f ) Instantaneous Elastic Assistance The purpose of the instantaneous elastic assistance is to provide a pressure which balances some or all of the elastic deflating pressure supplied by the springiness of the lungs and chest wall (instantaneous elastic pressure), plus an additional component required to servo-control the minute ventilation to at least exceed on average a pre-set target ventilation. In addition, a minimum swing, always present, is added to the total. The user-specified parameter elastance is preset to say 50-75% of the known or estimated elastance of the patient's lung and chest wall. The various components are calculated as follows: Instantaneous Assistance Based on Minimum Pressure Swing Set by Physician: instantaneous minimum assistance=minimum swing*Π(φ) Elastic Assistance Required to Servo-Control Ventilation to Equal or Exceed Target The quantity servo swing is the additional pressure modulation amplitude required to servo-control the minute ventilation to at least equal on average a pre-set target ventilation. Minute ventilation is defined as the total number of litres inspired or expired per minute. However, we can't wait for a whole minute, or even several seconds, to calculate it, because we wish to be able to prevent apneas or hypopneas lasting even a few seconds, and a PI controller based on an average ventilation over a few seconds would be either sluggish or unstable. The quantity actually servo-controlled is half the absolute value of the instantaneous respiratory airflow. A simple clipped integral controller with no damping works very satisfactorily. The controller gain and maximum output ramp up over the first few seconds after putting the mask on. If we have had a sudden increase in mouth leak, airflow will be nonzero for a long time. A side effect is that the ventilation will be falsely measured as well above target, and the amount of servo assistance will be falsely reduced to zero. To prevent this, to the extent that the fuzzy recent peak jamming index is large, we hold the degree of servo assistance at its recent average value, prior to the jamming. The algorithm for calculating servo swing is as follows: error=target ventilation−abs(respiratory airflow)/2 servo swing= S error*servo gain*sample interval clip servo swing to range 0 to 20 cmH 2 O*lead-in set recent servo swing=servo swing low pass filtered with a time constant of 25 sec. clip servo swing to be at most J PEAK *recent servo swing The instantaneous servo assistance is calculated by multiplying servo swing by the previously calculated pressure waveform template: instantaneous servo assistance=servo swing*Π(φ) Estimating Instantaneous Elastic Pressure The instantaneous pressure required to unload the elastic work of inspiring against the user-specified elastance is the specified elastance times the instantaneous inspired volume. Unfortunately, calculating instantaneous inspired volume simply by integrating respiratory airflow with respect to time does not work in practice for three reasons: firstly leaks cause explosive run-away of the integration. Secondly, the integrator is reset at the start of each inspiration, and this point is difficult to detect reliably. Thirdly, and crucially, if the patient is making no efforts, nothing will happen. Therefore, four separate estimates are made, and a weighted average taken. Estimate 1: Exact instantaneous elastic recoil calculated from instantaneous tidal volume, with a correction for sudden change in leak The first estimate is the instantaneous elastic recoil of a specified elastance at the estimated instantaneous inspired volume, calculated by multiplying the specified elastance by the integral of a weighted respiratory airflow with respect to time, reset to zero if the respiratory phase is expiratory. The respiratory airflow is weighted by the fuzzy negation of the recent peak jamming index J PEAK , to partly ameliorate an explosive run-away of the integral during brief periods of sudden increase in leak, before the leak detector has had time to adapt to the changing leak. In the case where the leak is very steady, J PEAK will be zero, the weighting will be unity, and the inspired volume will be calculated normally and correctly. In the case where the leak increases suddenly, J PEAK will rapidly increase, the weighting will decrease, and although typically the calculated inspired volume will be incorrect, the over-estimation of inspired volume will be ameliorated. Calculations are as follows: Instantaneous volume=integral of respiratory airflow*(1− J PEAK ) dt if phase is expiratory (0.5<φ<1.0 revolutions) reset integral to zero estimate 1=instantaneous volume*elastance Estimate 2: based on assumption that the tidal volume equals the target tidal volume The quantity standard swing is the additional pressure modulation amplitude that would unload the specified elastance for a breath of a preset target tidal volume. target tidal volume=target ventilation/target frequency standard swing=elastance*target tidal volume estimate 2=standard swing*Π(φ) Estimate 3: based on assumption that the tidal volume equals the target tidal volume divided by the observed mean respiratory rate RR calculated previously. Estimate 3=elastance*target ventilation/RR*Π(φ) Estimate 4: based on assumption that this breath is much like recent breaths The instantaneous assistance based on the assumption that the elastic work for this breath is similar to that for recent breaths is calculated as follows: LP elastic assistance=instantaneous elastic assistance low pass filtered with a time constant of 2 STDT TOT estimate 4= LP elastic assistance*Π(φ)/ P BAR [0204] The above algorithm works correctly even if Π(φ) is dynamically changed on-the-fly by the user, from square to a smooth or vice versa. For example, if an 8 cmH 2 O square wave (Π BAR =1) adequately assists the patient, then a sawtooth wave (Π BAR =0.5) will require 16 cmH 2 O swing to produce the same average assistance. [0000] Best Estimate of Instantaneous Elastic Recoil Pressure [0205] Next, calculate the pressure required to unload a best estimate of the actual elastic recoil pressure based on a weighted average of the above. If Π(φ) is set to the smoothest setting, the estimate is based equally on all the above estimates of instantaneous elastic recoil. If Π(φ) is a square wave, the estimate is based on all the above estimates except for estimate 1, because a square wave is maximal at φ=0, whereas estimate 1 is zero at φ=0. Intermediate waveforms are handled intermediately. Quantity smoothness runs from zero for a square wave to 1 for a waveform time constant of 0.3 or above. smoothness=waveform time constant/0.3 instantaneous recoil=(smoothness*estimate 1+estimate 2+estimate 3+estimate 4)/(smoothness+3) Now add the estimates based on minimum and servo swing, truncate so as not to exceed a maximum swing set by the user. Reduce (lead in gradually) if the mask has only just been put on. I=instantaneous minimum assistance+instantaneous servo assistance+instantaneous recoil Truncate I to be less than preset maximum permissible swing instantaneous elastic assistance= I *lead-in This completes the calculation of instantaneous elastic assistance. Desired Pressure at Sensor desired sensor pressure= epap +hose pressure loss+resistive unloading+instantaneous elastic assistance Servo Control of Motor Speed [0206] In the final step, the measured pressure at the sensor is servo-controlled to equal the desired sensor pressure, using for example a clipped pseudodifferential controller to adjust the motor current. Reference can be made to FIG. 1 in this regard. [0000] Device Performance [0207] FIGS. 21-27 each show an actual 60 second recording displaying an aspect of the second embodiment. All recordings are from a normal subject trained to perform the required manoeuvres. Calculated respiratory airflow, mask pressure, and respiratory phase are calculated using the algorithms disclosed above, output via a serial port, and plotted digitally. [0208] In FIGS. 21-26 respiratory airflow is shown as the darker tracing, the vertical scale for flow being ±L/sec, inspiration upwards. The vertical scale for the pressure (light trace) is 0.2 cmH 2 O. [0209] FIG. 21 is recorded with the servo gain set to 0.1 cmH 2 O/L/sec/sec, which is suitable for subjects with normal chemoflexes. The subject is breathing well above the minimum ventilation, and a particularly deep breath (sigh) is taken at point (a). As is usual, respiratory effort ceases following the sigh, at point (c). The device correctly permits a short central apnea (b), as indicated by the device remaining at the end expiratory pressure during the period marked (b). Conversely FIG. 22 shows that if there is no preceding deep breath, when efforts cease at (a), the pressure correctly continues to cycle, thus preventing any hypoxia. FIG. 23 is recorded with servo gain set high, as would be appropriate for a subject with abnormally high chemoreflexes such as is typically the case with Cheyne-Stokes breathing. Now when effort ceases at arrow (a), pressure continues to cycle and a central apnea is no longer permitted, despite preceding deep breathing. This is advantageous for preventing the next cycle of Cheyne-Stokes breathing. [0210] The above correct behaviour is also exhibited by a time mode device, but is very different to that of a spontaneous mode bilevel device, or equally of proportional assist ventilation, both of which would fail to cycle after all central apneas, regardless of appropriateness. [0211] FIG. 24 shows automatically increasing end-inspiratory pressure as the subject makes voluntarily deeper inspiratory efforts. The desirable behaviour is in common with PAV, but is different to that of a simple bilevel device, which would maintain a constant level of support despite an increased patient requirement, or to a volume cycled device, which would actually decrease support at a time of increasing need. [0212] FIG. 25 is recorded with a somewhat more square waveform selected. This figure shows automatically increasing pressure support when the subject voluntarily attempts to resist by stiffening the chest wall at point (a). This desirable behaviour is common with PAV and volume cycled devices, with the expectation that PAV cannot selectively deliver a squarer waveform. It is distinct from a simple bilevel device which would not augment the level of support with increasing need. [0213] FIG. 26 shows that with sudden onset of a severe 1.4 L/sec leak at (a), the flow signal returns to baseline (b) within the span of a single breath, and pressure continues to cycle correctly throughout. Although timed mode devices can also continue to cycle correctly in the face of sudden changing leak, the are unable to follow the subject's respiratory rate when required (as shown in FIG. 27 ). Other known bilevel devices and PAV mis-trigger for longer or shorter periods following onset of a sudden sever leak, and PAV can deliver greatly excessive pressures under these conditions. [0214] FIG. 27 shows an actual 60 second tracing showing respiratory airflow (heavy trace ±1 L/sec full scale) and respiratory phase as a continuous variable (light trace, 0 to 1 revolution), with high respiratory rate in the left half of the trace and low respiratory rate in the right half of the trace. This trace demonstrates that the invention can determine phase as a continuous variable. Advantageous Aspects of Embodiments of the Invention [0000] Use of Phase as a Continuous Variable. [0215] In the prior art, phase is taken as a categorical variable, with two values: inspiration and expiration. Errors in the detection of start of inspiration and start of expiration produce categorical errors in delivered pressure. Conversely, here, phase is treated as a continuous variable having values between zero and unity. Thus categorical errors in measurement of phase are avoided. [0000] Adjustable Filter Frequency and Allowance for Phase Delay [0216] By using a short time constant when the subject is breathing rapidly, and a long time constant when the subject is breathing slowly, the filter introduces a fixed phase delay which is always a small fraction of a respiratory cycle. Thus unnecessary phase delays can be avoided, but cardiogenic artifact can be rejected in subjects who are breathing slowly. Furthermore, because phase is treated as a continuous variable, it is possible to largely compensate for the delay in the low pass filter. [0000] Within-Breath Pressure Regulation as a Continuous Function of Respiratory Phase. [0217] With all prior art there is an intrusive discontinuous change in pressure, either at the start of inspiration or at the start of expiration. Here, the pressure change is continuous, and therefore more comfortable. [0218] With proportional assist ventilation, the instantaneous pressure is a function of instantaneous volume into the breath. This means that a sudden large leak can cause explosive pressure run-away. Here, where instantaneous pressure is a function of instantaneous phase rather than tidal volume, this is avoided. [0000] Between-Breath Pressure-Regulation as a Function of Average Inspiratory Duration. [0219] Average inspiratory duration is easier to calculate in the presence of leak than is tidal volume. By taking advantage of a correlation between average inspiratory duration and average tidal volume, it is possible to adjust the amplitude of modulation to suit the average tidal volume. [0000] Provision of a Pressure Component for Unloading Turbulent Upper Airway Resistance, and Avoiding Cardiogenic Pressure Instabilities. [0220] Although Younes describes the use of a component of pressure proportional to the square of respiratory airflow to unload the resistance of external apparatus, the resistance of the external apparatus in embodiments of the present invention is typically negligible. Conversely, embodiments of the present invention describes two uses for such a component proportional to the square of respiratory airflow that were not anticipated by Younes. Firstly, sleeping subjects, and subjects with a blocked nose, have a large resistance proportional to the square of airflow, and a pressure component proportional to the square of airflow can be used to unload the anatomical upper airway resistance. Secondly, small nonrespiratory airflow components due to heartbeat or other artifact, when squared, produces negligible pressure modulation, so that the use of such a component yields relative immunity to such nonrespiratory airflow. [0000] Smooth Transition Between Spontaneous and Controlled Breathing [0221] There is a smooth, seamless gradation from flexibly tracking the subject's respiratory pattern during spontaneous breathing well above the target ventilation, to fully controlling the duration, depth, and phase of breathing if the subject is making no efforts, via a transitional period in which the subject can make progressively smaller changes to the timing and depth of breathing. A smooth transition avoids categorization errors when ventilation is near but not at the desired threshold. The advantage is that the transition from spontaneous to controlled ventilation occurs unobtrusively to the subject. This can be especially important in a subject attempting to go to sleep. A similar smooth transition can occur in the reverse direction, as a subject awakens and resumes spontaneous respiratory efforts.

The apparatus provides for the determination of the instantaneous phase in the respiratory cycle, subject's average respiration rate and the provision of ventilatory assistance. A microprocessor ( 16 ) receives an airflow signal from a pressure transducer ( 18 ) coupled to a port ( 17 ) at a mask ( 11 ). The microprocessor ( 16 ) controls a servo ( 19 ), that in turn controls the fan motor ( 20 ) and thus the pressure of air delivered by the blower ( 10 ). The blower ( 10 ) is coupled to a subject's mask (ii) by a conduit ( 12 ). The invention seeks to address the following goals: while the subject is awake and making substantial efforts the delivered assistance should be closely matched in phase with the subject's efforts; the machine should automatically adjust the degree of assistance to maintain at least a specified minimum ventilation without relying on the integrity of the subject's chemoreflexes; and it should continue to work correctly in the pesence of large leaks.

BACKGROUND [0001] The invention relates to a discharge tool containing dispensing container for dental compound in the form of a compule, which is adapted for use together with a compule gun. The dispensing container comprises a housing, on the inside of which a slide surface is formed that is intended for engagement with a plunger. The housing encloses an interior and is provided with an outlet channel. The housing with outlet channel is designed as a one-piece injection-molded part. A portion of a needle is arranged in the outlet channel. A portion of a needle is arranged in the outlet channel. The invention also relates to a method for producing a dispensing container of this kind. [0002] Discharge tools and dispensing containers of this kind are used in order to discharge dental compounds in a specific and metered manner. Before use, the state of the dispensing container is generally one in which the interior is filled with the dental compound and the plunger is inserted into the interior in order to close off the interior and separate the dental compound from the environment. The dispensing container is then connected to a discharge tool, such that a ram of the discharge tool can apply pressure to the plunger. Under the pressure exerted by the plunger, the dental compound moves right through the needle and emerges at the front end of the needle. The dental compound can be discharged at locations that are otherwise accessible only with difficulty. [0003] In the production of the dispensing container, the needle is first manufactured as a separate part and is then connected to the housing of the dispensing container. When connecting the needle to the dispensing container, care must be taken that the connection is sufficiently firm to ensure that the connection does not come undone even when the dental compound in the container is subjected to pressure. Moreover, the connection must be tight, such that the dental compound can emerge only through the needle, not to the sides. [0004] This can be achieved if, for example, the housing is produced as an injection-molded part and the needle is injected into the housing directly during the injection molding. An intimate connection that meets the above requirements is then formed between the material of the housing and the outer wall of the needle. However, a disadvantage is that an injection mold is needed that is exactly adapted to the housing and to the needle. If a needle with a greater diameter is to be connected to the housing, a completely new injection mold is needed. SUMMARY [0005] A dispensing container in the form of a compule and discharge tool in the form of a compule gun for dental compound is produced in an adaptable and cost-effective manner. [0006] A gap is present between the circumference of the needle and the outlet channel, and an adhesive is introduced into said gap. [0007] Some terms will first be explained. The interior of the housing is intended to receive dental compound. The term housing does not mean that the interior is closed off all the way around. In addition to the outlet channel, a further opening is generally present which can be closed by a plunger and via which the dental compound can be subjected to pressure. The direction in which the needle protrudes from the outlet channel is designated as the front end, the opposite direction as the rear end. The term dental compound is not to be understood as a limitation in respect of the consistency of the material, For example, the dental compound can be liquid or pasty. [0008] In order to connect the needle to the housing, a portion of the needle is inserted into the outlet channel of the housing. The adhesive in the gap remaining between the needle and the outlet channel produces a firm connection between the needle and the housing. This type of production is cost-effective and, when a suitable adhesive is used, leads to a very stable connection between the needle and the housing. The stability of the connection is desired on account of the fact that, when the dispensing container is being used, various forces such as tensile forces, pressing forces, bending forces and torques may act on the connection. [0009] The gap can extend as an annular gap all the way around the needle portion. The diameter of the gap can be constant about the circumference. It is also possible for the width of the gap to vary about the circumference. For example, two portions of the gap can be separated from each other by a web that extends parallel to the needle. The web can bear on the outer surface of the needle, or a gap with a smaller diameter can be present between the web and the outer surface. [0010] The housing is preferably designed such that an unambiguous position for the needle is defined in the longitudinal direction. For this purpose, a limit stop can be provided in the outlet channel, on which limit stop the needle bears when it has reached the correct position in the outlet channel. The limit stop can protrude inward from the wall of the outlet channel, such that the end face of the needle bears on the limit stop. By inserting the needle into the outlet channel as far as the limit stop, it is easy to find the correct position for the needle. The limit stop can be dimensioned in such a way that it is suitable for needles of different diameter. [0011] If the gap extends about the entire circumference of the needle and along the entire length of the needle portion inserted into the outlet channel, the needle at first has play for movement in the lateral direction. It is only by the adhesive in the gap that the needle is fixed in its final position. It can be advantageous if the outlet channel is designed such that it provides a lateral guide for the needle, with the result that the orientation of the needle and its position in the lateral direction are unambiguously defined. For this purpose, a plurality of inwardly protruding webs can be present in the outlet channel, for example, and bear on the outer face of the needle. [0012] The outlet channel can also have, as a lateral guide, a first channel portion in which the inner surface of the channel is adapted to the outer surface of the needle. In the first channel portion, for example, a planar contact can exist between the needle and the channel and extend about the entire circumference of the needle. The gap is in this case present primarily in a second channel portion. [0013] The first channel portion is preferably arranged at the rear end of the outlet channel. The second channel portion adjoins the front of the first channel portion. The adhesive can then be introduced into the gap of the second channel portion from the front end of the outlet channel. [0014] For filling the gap with adhesive, it is advantageous if the outlet channel narrows from the front end in the direction of the rear end, i.e. with the diameter of the gap decreasing in this direction. It is possible that the narrowing extends along the entire length of the outlet channel. However, the narrowing often comprises only one portion of the outlet channel. This can be the second channel portion, for example. In order to promote uniform distribution of the adhesive in the gap, depressions can be formed in the narrowing channel portion. The gap has a slightly greater diameter in the area of the depressions, such that the adhesive can penetrate more easily in the direction of the rear end of the outlet channel. The adhesive is preferably heat-polymerizing or auto-polymerizing, such that hardening is possible without the influence of light. In order to optimize the adhesion, the surface of the needle and/or the outlet channel can be pretreated. Sand-blasting or an etching process with a roughening effect may be considered for metallic surfaces, for example. The pre-treatment of plastic surfaces can involve thermal treatment, corona discharge or another oxidative pre-treatment. [0015] It is possible that the narrowing extends substantially uniformly over the channel portion in question. Alternatively, the narrowing can be more pronounced at the front end of the outlet channel, such that the outlet channel has a widening mouth. The diameter of the gap is increased in the area of the widening mouth, such that the adhesive can be easily introduced. [0016] The gap surrounding the needle can extend along the entire length of the needle portion inserted into the outlet channel. This has the result that the needle is at first not guided in a defined manner in the outlet channel and instead can be moved in the lateral direction. Before the adhesive can be introduced into the gap, suitable means have to ensure that the needle is correctly centered in the outlet channel. The needle has a defined position in the outlet channel only after the gap has been filled with the adhesive and the adhesive has hardened. The adhesives that are presently available are suitable for filling a gap and at the same time producing a very stable connection. This way of producing a connection has the advantage that one uniformly dimensioned outlet channel can be provided with needles of different diameter. For example, a relatively short needle with a large diameter can be used for dental compounds of high viscosity. A longer needle with a small diameter can be used in order to ensure that the dental compound is subjected to certain shearing forces as it passes through the needle. The dispensing container can thus be adapted for different purposes, without anything having to be changed on the actual housing or the outlet channel. [0017] The housing with outlet channel is preferably a one-piece component, which can be inexpensively produced as an injection-molded part, for example. The housing is preferably dimensioned such that the quantity of the dental compound it receives is apportioned exactly for one use. Compared with dispensing containers that are able to receive several application units of the dental compound, the danger of infections is reduced, since no pathogens can be transferred from a first patient to a second patient. The ready-to-use dispensing container is filled with dental compound, and a plunger is inserted into the interior of the dispensing container so that the interior is closed. The dispensing container may be replaced for additional applications of dental compounds. [0018] The needle generally has an elongate cylindrical shape, of which the external diameter can be between 0.5 mm and 2 mm, for example. A channel through which the dental compound can pass extends within the needle. The needle can be made of metal. Since no great forces are applied to the needle when connecting the latter to the housing, the needle can be made of soft-annealed steel or a comparable material. This has the advantage that the needle is bendable, i.e. can be bent over, without breaking or without the channel in the interior being closed. During use, the user can shape the needle in the manner that appears suitable. The length of the needle can be between 13 mm and 23 mm, for example, such that the needle can be inserted deep into the root canal of a tooth. [0019] With fairly long needle lengths, for example of at least 15 mm, preferably of at least 20 mm, it is possible to heighten the shearing forces that act on the dental compound as it passes through the needle. In some dental compounds, shearing forces of this kind are desirable since the properties of the material are thereby influenced in a positive manner. [0020] The needle can be provided with an outlet opening at its front face, such that the dental compound can be forwardly discharged. In addition or alternatively, the needle can have one or more outlet openings pointing in the lateral direction. This permits better filling of the lateral branches of the root canal. [0021] A stable connection between the needle and the outlet channel is needed, since considerable forces may act on the needle in various situations. If a dental compound of high viscosity is forced through the needle, a strong force acts in the longitudinal direction of the needle. If the needle is bent in the lateral direction, strong bending forces are exerted. If the tip of the bent needle comes into abutment in the lateral direction during insertion into the tooth, a considerable torque can arise relative to the axis of the outlet channel. It has been shown that the adhesive connection provides sufficient stability in the face of all of these loads. [0022] The housing of the dispensing container can have a discharge tip inside which the outlet channel extends. The outer face of the discharge tip can be designed such that a cap can be fitted onto the discharge tip and seal off the front end of the dispensing container. For example, the discharge tip can be round in cross section and narrow slightly toward the front. The dispensing container can also comprise a cap adapted to the discharge tip. The cap is preferably dimensioned such that it entirely encloses the needle. When the cap is fitted in place, the inner end face of the cap can bear on the front end of the needle in order to close an outlet opening of the needle. For secure closure, a projection, which can be hemispherical or conical for example, can be formed on the inner end face of the cap. [0023] The inner wall of the cap can be bulged outward at the rear end. The cap can then be used to bend the needle when the bulge rests as an abutment on the bending point and a force acting in the lateral direction is applied to the front end of the cap. This ensures a uniform transfer of force to the needle and prevents damage to the needle. The risk of damage to the needle would be greater if, instead of the bulge, a sharp edge of the cap were to bear on the needle. [0024] The cap should be designed such that, on the one hand, it can be easily fitted onto the discharge tip and, on the other hand, forms a secure seal with the discharge tip. For this purpose, a peripheral web can be formed on the inner wall of the cap and, when the cap is fitted in place, this web bears on the discharge tip about the entire circumference. It is possible to provide a plurality of such webs, which are arranged in succession in the axial direction. [0025] To make the cap easier to handle, the outside of the cap can be provided with ribs, which preferably extend in the longitudinal direction. When the user wishes to fit the cap in place or remove it, the ribs provide a good purchase for his fingers. [0026] The cap can be provided with a limit stop that comes to rest on the dispensing container as soon as the needle has been bent to the correct angle. The angle in question, between the front portion of the needle and the longitudinal direction of the container, is chosen such that the front end of the needle can be easily inserted into the cavity of a molar. For example, the angle can be between 25° and 60°, preferably between 30° and 45°. Such a limit stop makes it easier for the user to bend the needle to the desired angle. [0027] An angle between the direction of the needle and the longitudinal axis of the dispensing container can also be obtained by virtue of the fact that the outlet channel encloses an angle with the longitudinal axis of the dispensing container. This angle is also preferably between 25° and 60°, preferably between 30° and 45°. In this case, the needle can extend rectilinearly in a continuation of the outlet channel but still be easily inserted into a cavity of a molar. [0028] The needle can also be made of a material that has an elastic flexibility. The needle can then deform, during insertion into the root canal, such that it is able to follow bends in the root canal. It is then easier to discharge the dental compound as far as the apex of the root canal. The material of the needle can be a titanium alloy, preferably a p-titanium alloy. There are known to be 13-titanium alloys with a very low modulus of elasticity. In an alternative embodiment, the needle can be made of polypropylene, which is preferably colored and light-tight. This material too has the desired flexibility. [0029] The invention further relates to a method for producing a dispensing container for dental compound. In the method, a needle and a housing are provided. On the inside of the housing, a slide surface is formed that is intended for engagement with a plunger. The housing encloses an interior and is provided with an outlet channel. A portion of the needle is inserted into the outlet channel, such that a gap remains between the circumference of the needle portion and the outlet channel. An adhesive is introduced into the gap. The method can be extended by further features, which are described with reference to the dispensing container. BRIEF DESCRIPTION OF THE DRAWINGS [0030] The invention is described below on the basis of advantageous illustrative embodiments and with reference to the attached drawings, in which: [0031] FIG. 1 shows a plan view of a dispensing container; [0032] FIG. 2 shows a cross-sectional view of the dispensing container from FIG. 1 ; [0033] FIG. 3 shows an enlarged view of the detail B of the housing from FIG. 2 ; [0034] FIG. 4 shows the view from FIG. 3 in other embodiments; [0035] FIG. 5 shows a dispensing container with a cap attached; [0036] FIG. 6 shows an enlarged view of the cap from FIG. 5 ; [0037] FIG. 7 shows the use of the cap for bending the needle; [0038] FIG. 8 shows a further embodiment of a dispensing container; and [0039] FIG. 9 shows a further embodiment of a dispensing container. DETAILED DESCRIPTION [0040] A dispensing container comprises a housing 14 , which encloses an interior 15 . The interior 15 has a cylinder shape and is open at the rear end. At the front end, the housing 14 has a discharge tip 17 with an outlet channel 18 in the interior thereof. A needle 19 extends in a continuation of the discharge tip 17 . [0041] In the state when ready for use, the interior 15 of the dispensing container is filled with a dental compound, and the open end of the interior 15 is closed off by a plunger 29 as shown in FIG. 2 . The plunger 29 is guided by the inner surface of the housing, which inner surface serves as a slide surface 32 . When pressure is applied to the dental compound via the plunger 29 , the dental compound moves through the needle 19 and emerges at the front end of the needle. Since the needle 19 is long and thin, the dental compound can be discharged with precision even at sites that are otherwise difficult to access. In order to apply pressure to the plunger 29 , a discharge tool (not shown) is provided that has a ram for pressing the plunger 29 forward. [0042] According to FIG. 3 , the outlet channel 18 of the housing 14 comprises a first channel portion 20 and a second channel portion 21 . In the first channel portion 20 , the inner surface of the outlet channel 18 is adapted to the outer surface of the needle 19 . The needle 19 can be inserted into the first channel portion 20 only when the needle 19 is centered and correctly aligned. At the rear end of the first channel portion 20 , a limit stop 23 is formed against which the needle 19 abuts when it has reached its end position. In the first channel portion 20 , a slight gap is at most present between the outer wall of the needle 19 and the inner wall of the outlet channel 18 , such that the needle 19 can be inserted without great resistance. [0043] In a second channel portion 21 , the diameter of the outlet channel 18 narrows in the direction of the rear end. At the rear end, the diameter coincides with the first channel portion 20 , such that there is a seamless transition between the channel portions 20 , 21 . The second channel portion 21 is adjoined by a widening mouth 22 , by means of which the channel diameter markedly increases toward the mouth. [0044] The needle 19 has a length of approximately 20 mm, and the outlet channel 18 has a length of approximately 6 mm. The needle 19 therefore protrudes forward by 14 mm from the discharge tip 17 . Depending on the embodiment, the diameter of the needle 19 can be between 0.5 mm and 1.8 mm. The needle 19 is made of a soft-annealed steel. The needle 19 can therefore be bent to the side without breaking or without the channel in the interior being closed. [0045] When the needle 19 is in its final position in the outlet channel, a gap 16 between the outer wall of the needle 19 and the outlet channel 18 remains in the area of the widening mouth 22 and of the second channel portion 21 . Using a suitable tool, an adhesive 24 is injected into the area of the widening mouth 22 , such that the adhesive penetrates rearward along the gap 16 . Adhesive 24 is introduced in such a quantity as to ensure that the gap 16 is filled completely with adhesive 24 . It is possible for some of the adhesive 24 also to penetrate into the first channel portion 20 . When the adhesive 24 has hardened and has formed a firm connection with the needle 19 and with the outlet channel 18 , the needle 19 is securely fixed in the outlet channel 18 . [0046] In FIG. 4 , view A on the left shows a discharge tip 17 in which the outlet channel 18 has a smaller diameter, and view B on the right shows a discharge tip 17 in which the outlet channel has a greater diameter. It is a considerable advantage that a single injection mold suffices to produce both of the embodiments according to FIG. 4A and FIG. 4B . For this purpose, another insert, which defines the dimension of the outlet channel 18 , simply has to be fitted into the injection mold. [0047] Alternatively, it is also possible to insert into the outlet channel 18 a needle 19 that has a smaller diameter than the outlet channel 18 along the entire length. The needle 19 is fixed only when the adhesive fills the gap and hardens. In this embodiment, the housing with the outlet channel 18 can be produced as a single injection-molded part and can be provided with needles 19 of different diameter depending on the intended use. [0048] A further difference from the embodiment according to FIG. 3 is that, in the second channel portion 21 , elongate depressions 25 are formed in the wall of the outlet channel 18 . As a result of the depressions 25 , the adhesive 24 has more space to force its way rearward in the gap 16 . [0049] FIG. 5 shows a dispensing container in which a cap 26 is fitted onto the discharge tip 17 . The cap 26 protects the dental compound from contact with the ambient air and protects the needle 19 from damage caused by impacts. To make fitting and removing the cap 26 easier, longitudinal ribs (not visible in the cross-sectional view in FIG. 6 ) are formed on the outer face of the cap 26 . The needle 19 is closed at its front end and instead has outlet openings 31 facing to the side. [0050] Peripheral webs 27 are formed on the inner wall of the cap 26 and are adapted to the circumference of the discharge tip 17 . The webs 27 bear on the discharge tip 17 , as a result of which the cap 26 is held in place and a seal is provided with respect to the environment. [0051] At its rear end, the cap 26 is provided with an outwardly facing bulge 28 . According to FIG. 7 , the bulge 28 can be used as an abutment for bending the needle 19 with the aid of the cap 26 . The cap 26 comprises a limit stop 30 at its rear end. The limit stop 30 abuts against the discharge tip 17 when the needle 19 is bent at the correct angle, about 30° in the example shown. [0052] In the embodiment in FIG. 8 , the discharge tip 17 extends at an angle of about 40° relative to the longitudinal axis of the housing 14 . In this configuration, it is not necessary to bend the needle 19 before it can be inserted into the cavity of a molar. The needle 19 is made of elastic polypropylene, such that the needle 19 , during insertion, can easily follow the course of the root canal. [0053] In the embodiment in FIG. 9 , the discharge tool 45 contains dispensing container 42 . Inside the dispensing container 42 there is a dental compound 41 and a plunger 29 . The discharge tool 45 comprises a ram 43 for pressing the plunger 29 forward. The ram is operated by pushing the handle, which is shown in the left side of the figure. The ram 43 pushes against the back surface of the plunger 29 , thereby pressing the dental compound 41 through outlet channel 18 . [0054] In the embodiment depicted in FIG. 9 , the dispensing container 42 is a disposable part. Once the dispensing container 42 is used, it may be separated from the discharge tool 45 . In order to use the discharge tool 45 once again, another dispensing container 42 with another amount of dental compound 41 is attached to the discharge tool 45 . The plunger 29 is pushed against the ram 43 of the new dispensing container 42 for dispensing the dental compound. In the depicted embodiment, the plunger 29 and dental compound 41 are incorporated into a single, replaceable dispensing container 42 . In alternate embodiments, the plunger 29 may be separate from the dispensing container 42 and may be replaced separately.

A dispensing system comprising a discharge tool in the form of a compule gun and a replaceable dispensing container in the form of a compule for dental compound. The dispensing container comprises a housing, on the inside of which a slide surface is formed that is intended for engagement with a plunger. The housing encloses an interior and is provided with an outlet channel. A portion of a needle is inserted into the outlet channel. A gap is present between the circumference of the needle and the outlet channel. An adhesive is introduced into the gap. A ram in the discharge tool engages the plunger. A method also produces a dispensing system of this kind.

CROSS REFERENCE This application is a Continuation of U.S. patent application Ser. No. 08/723,302, filed Sep. 30, 1996 now abandoned. BACKGROUND The present invention is directed to a grinder which can grind a large range of volumes of substance to be ground. More particularly, the present invention is directed to a grinder for use in grinding substances such as whole bean coffee. A variety of grinding devices or grinders have been provided by the prior art. In particular, the Assignee of the present invention notes three patents which show grinding devices: U.S. Pat. Nos. 5,042,731 issued Aug. 27, 1991 to Ford; 4,813,622 issued Mar. 21, 1989 to Nidiffer et al.; and 4,714,206 issued Dec. 22, 1987 to Nidiffer et al. All three of these patents show grinding devices which are designed to grind beverage brewing substances such as whole bean coffee for producing a brewed beverage therefrom. The Ford '731 patent and the Nidiffer et al. '622 patent show grinders which include a discharge chute or discharge chute assembly which prevents a separation of chaff from the ground coffee. Many types of coffee beans have a thin membrane which dries during the roasting process. Upon grinding of the coffee beans, the thin membrane is separated from the rest of the coffee bean creating a light bean debris which separates during grinding. The dried, ground membrane is commonly called chaff. Chaff does not detract from the flavor of coffee, however, due to its light weight, it is prone to being separated from the ground coffee discharged from the grinder to a container waiting therebelow. Free-floating chaff can create problems within the grinder and therefore it is desirable to retain the chaff within the bulk of the ground coffee. Further, it is desirable to retain chaff in the coffee in order to help reduce caking problems which typically occurs in ground coffee especially oiler, dark roasted coffee bean as such as ground coffee is discharged from the grinder. Both devices as shown in Ford '731 and Nidiffer '206 show such chaff retaining structures. One of the problems encountered with retaining chaff in the ground substance dispensed from the grinder is that the mechanisms to retain chaff often results in ground coffee or build-up within the grinder. One of the mechanisms for retaining chaff in the ground coffee is to provide a back pressure on the grinder to prevent the free-flow of ground coffee from the grinder which results in air separation of the chaff from the ground coffee. If the ground coffee were free to flow from the grinder, the chaff being a lighter substance, would tend to separate as the ground coffee is dispensed into the collection container. As such, structures are provided which prevent the "blowing" of ground coffee from the grinder. As the coffee is dispensed from the grinder, it tends to flow into the bag thereby preventing the separation of the chaff from the ground coffee. However, these back pressure creating structures tend to result in accumulation of chaff thereon or on the discharge assembly structure. As such, it is desirable to provide mechanisms to remove the ground coffee and chaff from these structures. As might be expected, when a finite volume of whole bean coffee is ground, it tends to be fluffed or expanded during the grinding process. As such, when the ground coffee is dispensed into a waiting container such as a bag, the finite volume which previously fit into the bag will likely overflow the bag as a result of the fluffing or lofting created during the grinding process. Part of the reasons for the lofting is the retention of the chaff within the ground coffee. However, it is desirable to retain the chaff in the ground coffee for the reasons noted hereinabove. Heretofore, prior art devices have not solved the problem of fluffing. As such, users of prior art devices have been required to manually shake or tap the ground contents into the container or bag in order to prevent overflowing. This problem is also seen in coffee stores which sell whole bean coffee for grinding on the premises. The salespeople must wait for coffee to be ground and tap or shake the bag in order to prevent overflowing. As might be expected, this waiting reduces the customer service rate and incrementally increases the labor time associated with the grinding of whole bean coffee. To further facilitate the automatic settling of coffee, it would be desirable to place a bag near or on the grinder and allow the operator to leave the bag during the grinding process. As such, a bag retaining device would be desirable for use with a grinding process which automatically settles the ground coffee. A bag retainer as shown in U.S. Pat. No. 2,290,747 issued Jul. 21, 1942 to Henry. The bag holder device as shown in Henry is complicated and as such it would be desirable to provide a simplified bag holding structure. Another problem encountered with coffee grinders is that it is desirable to prevent grinding prior to the proper placement of a bag near the dispensing chute. U.S. Pat. Nos. 5,220,998 issued Jun. 22, 1993 to Ford; 4,714,206 issued Dec. 22, 1987 to Nidiffer et al.; and 4,685,624 issued Aug. 11, 1987 to Nidiffer show switches which are generally activated by the placement of a bag beneath a dispensing or discharge chute assembly. While these devices assure that a bag must be somehow placed relative to the discharge chute assembly, they do not retain the bag in position against or for dispensing from the discharge chute assembly. Other problems which occur with prior art devices is that particles of metallic material may be accidentally deposited in the grinder hopper and subsequently ground into the ground coffee discharged therefrom. While coffee is placed into a filter, generally either paper or metal mesh, and thus kept separate from the actual beverage liquid produced during the brewing process, introduction of metal into the ground coffee may produce undesirable flavor. Additionally, it is always preferable to prevent undesirable substances from being mixed into foodstuffs. The prior art, heretofore known, has no means for extracting such metallic materials. As such, it would be desirable to extract such metallic materials from whole bean coffee prior to grinding. Finally, an additional problem which occurs with prior art grinders is that they generally handle only a small range of volumes. As such, such grinders may overheat and cease to operate if a substantial grinding burden is placed on them. As such, it would be desirable to provide a way of cooling the grinder to permit grinding of larger volumes and a greater range of volumes of whole bean coffee without overheating the grinding device. OBJECTS AND SUMMARY A general object of the present invention is to provide a grinder which can generally accommodate a large range of quantities of substances to be ground. Another object satisfied by the present invention is to provide a grinder which automatically settles the ground substance dispensed therefrom. A further object satisfied by the present invention is to provide a grinder which includes a switch assembly which prevents operation of the grinder unless a bag is placed in a preferred position. Yet a further object of the present invention is to provide a grinder which includes a bag retaining assembly to retain a bag relative to the grinder for capturing a ground substance dispensed therefrom. Further still, an object of the present invention is to provide a structure for releasing accumulating chaff from a discharge chute assembly. Yet another object of the present invention is to provide a grinder having a magnetic structure which captures magnetic material which may be inadvertently or accidentally placed in a grinder hopper thereof. Moreover, yet another object of the present invention is to provide a grinder which includes a thermostatic control and a fan for controllably venting heated air from a cabinet of the grinder to prevent overheating of a grinder motor retained therein. Briefly, and in accordance with the foregoing, the present invention envisions a grinder for grinding materials to produce a ground substance. The grinder includes a cabinet, a grinder motor retained in the cabinet, and a grinder mechanism coupled to the motor to grind the materials. A hopper is positioned in communication with the grinder mechanism to deliver materials for grinding. The container retainer is attached to the grinder for retaining a container in close proximity for capturing ground material dispensed thereby. An activation switch assembly is included with the grinder to selectively control the grinder and activate the grinder when a container is placed in a desired location. A substance settling assembly is included with the grinder for removing a container retained by the grinder to settle the substance as it is dispensed from the grinder to the container. A chaff retainer is provided for maintaining chaff included with the ground substance in mixture with the ground substance. A clean-out member is operatively attached to the grinder and selectively engageable with the chaff retainer for removing chaff from the grinder. A magnetic collection device is positioned in the hopper for capturing magnetic pieces which may be deposited in the hopper. An active ventilation system is also included with the grinder for actively and controllably removing heat from the grinder cabinet. BRIEF DESCRIPTION OF THE DRAWINGS The organization and manner of the structure and function of the invention, together with farther objects and advantages thereof, may be understood by reference to the following description taken in connection with the accompanying drawings, wherein like reference numerals identify like elements, and in which: FIG. 1 is a perspective view of a grinder of the present invention which includes a cabinet having a lid thereon for receiving and grinding whole bean coffee which is dispensed through a discharge chute assembly into a container (shown in phantom line as a coffee bag) which is positioned for agitation or shaking by a shaker assembly; FIG. 2 is a partial fragmentary, cross-sectional, side-elevational view of the grinder as shown in FIG. 1 further illustrating components of the discharge chute assembly, the shaker assembly, control switch mechanisms, the grinder, as well as a thermostatically operated active ventilation system; FIG. 3 is a partial fragmentary, cross-sectional, top plan view of a portion of the shaker assembly showing a cam attached to an eccentric portion of a motor shaft which operates an actuator rod to reciprocate the shaker arm; FIG. 4 is an enlarged, partial fragmentary, cross-sectional, side-elevational view of a switch assembly and a bag holder cam coupled therewith in which a switch of the assembly is in a motor deactivated position; FIG. 5 is a partial fragmentary, cross-sectional, side-elevational view similar to that as shown in FIG. 4 in which the switch has been moved to a motor activating position to activate the grinder motor; FIG. 6 is an enlarged, partial fragmentary, perspective view of a portion of the grinder assembly showing the bag retainer and switch assembly in which a bag holder control rod has been operated forwardly to move a bag retainer cam into a position which retains a bag against a channel chute of the discharge chute assembly and to move the switch to a motor activating position as shown in FIG. 5; FIG. 7 is an enlarged, partial fragmentary, perspective view similar to that as shown in FIG. 6 further including portions of the discharge chute assembly attached to a discharge hole of the grinder to show the assembly thereof and a dechaffer plate which is positioned and spring biased toward the discharge hole; FIG. 8 is an enlarged, partial fragmentary, cross-sectional, side-elevational view of the discharge chute assembly showing the operation of a clean-out rod to operate a pivot pin attached to the dechaffer plate; FIG. 9 is an enlarged, partial fragmentary, cross-sectional, side-elevational view similar to that as shown in FIG. 8 showing the operation and movement of a pivoting deflector upon rotating the clean-out rod in an opposite direction to the direction as shown in FIG. 8; and FIG. 10 is an electrical schematic of present invention. DESCRIPTION While the present invention may be susceptible to embodiment in different forms, there is shown in the drawings, and herein will be described in detail, an embodiment with the understanding that the present description is to be considered an exemplification of the principles of the invention and is not intended to limit the invention to that as illustrated and described herein. FIG. 1 shows a grinder 20 of the present invention including a cabinet 22 having an upper portion 24, a lower portion 26 and a lid 28 covering the upper portion. A discharge assembly 30 is positioned on a front side 32 of the cabinet 22 for dispensing a ground substance therethrough. A container or bag 34 (shown herein in phantom line in the interest of clarity) is positioned beneath the discharge assembly 30 and against a substance settling assembly 36 which is described in greater detail hereinbelow. The present invention includes the grinder 20 as well as various systems associated with and/or used with the grinder. While the grinder of the present invention is broadly used for grinding a material to produce a ground substance and the systems of the grinder may be used in a variety of different applications, the present description will generally refer to material as whole bean coffee or coffee beans and the ground substance as ground coffee. As the grinder may be used in other applications as will be evident upon review of this description, the description is not intended to limit the description of the present invention solely to a coffee grinder. With further reference to FIGS. 2-10, the present invention includes a container retaining assembly 38 (see FIGS. 2 and 4-7), a magnetic assembly 40 (see FIG. 2), an active ventilation system 42 (see FIGS. 2 and 10), an activation switch assembly 44 (see FIGS. 4-7 and 10), and a chaff retainer 46 operated by a clean-out member 48 (see FIGS. 2 and 7-9). Each of the foregoing portions of the present invention shall be described in greater detail hereinbelow. Also, FIGS. 1-3 provide an illustration of the substance settling assembly 36 of the present invention. As shown in FIG. 2, the substance settling assembly 36 includes a shaker arm 50 which has a shaker plate 52 on end thereof extending outside of the cabinet 22 and a mounting end 54 retained inside the cabinet 22. The substance settling assembly 36 also includes an agitating device 56 which is coupled to a drive shaft 58 driven by a motor 60. The motor 60 drives the drive shaft 58 to operate a grinder mechanism 62. The agitating device 56 utilizes the rotary motion of the motor shaft 58 to agitate, reciprocate or move the shaker arm 50. Movement of the shaker arm 50 moves or gently shakes the container 34 positioned near the discharge assembly 30 in order to settle ground coffee dispensed by the grinder. The agitating device 56 includes an eccentric cam assembly 64 retained on the drive shaft 58 and an actuator rod 66 positioned to abut both the eccentric cam assembly 64 and the shaker arm 50. The actuator rod 66 is retained in a bore 68 which permits axial movement of the actuator rod 66 in response to the eccentric movement of the cam assembly 64. The actuator rod 66 translates the eccentric movement of the cam assembly 64 to displace or move the shaker arm 50 positioned thereagainst. The mounting end 54 of the shaker arm 50 is attached to the grinder 20 by a spring 70. The spring 70 has a first end 72 and a second end 74. The first end 72 is mounted to the grinder 20 on a wall 76 of the grinder body. The second end 74 of the spring 70 is attached to the mounting end 54 of the shaker arm 50. As such, the spring 70 facilitates movement of the shaker arm 50 in response to the reciprocating action of the actuator rod 66. In use, the substance settling assembly 36 operates to automatically move or shake ground coffee dispensed through the discharge assembly 30 into the container 34. The shaking helps to settle the ground coffee which, as a result of grinding, has greater loft than the whole bean. For example, if the container 34 is filled with whole bean coffee and the whole bean coffee is then deposited into a hopper 78 of the grinder 20, the resultant ground coffee will have a greater volume than the whole bean coffee which originally filled the container. As a result, the settling assembly 36 helps to prevent overflowing the container 34. When operated, the drive shaft 58 rotates and thereby rotating the cam assembly 64 retained thereon. With further reference to FIG. 3, the cam assembly 64 is mounted on an eccentric portion 80 of the shaft 58. Because the eccentric portion 80 of the shaft 58 is offset from a central axis 82 of the shaft 58, the cam assembly 64 will oscillate relative to the axis 82. The oscillating motion of the cam assembly 64 will drive against the actuator rod 66 to drive the rod 66 outwardly through the bore 68 and against the abutting portion of the shaker arm 50. As can be seen from FIGS. 1 and 2, the arm 50 extends from the cabinet 22 a sufficient distance to abut a container 34 retained relative to the discharge assembly 30. The combination of the spring 70 to which the arm 50 is attached and the position of the arm 50 relative to the container creates a return force on the arm 50 as the container 34 fills with ground coffee. Therefore, the container 34 rests against the plate 52 of the arm 50 to produce a return force on the actuator rod 66 to promote the reciprocating action of the rod 66 and the subsequent reciprocal movement of the arm 50. With reference to FIG. 3, as the actuator rod 66 is driven towards the shaker arm 50 as a result of the movement of the cam 64, the arm 50 will create a return force driving the rod 66 towards the cam 64 in response to the continued eccentric rotation of the cam 64 relative to the axis 82 of the shaft 58. Ultimately, the operation of the substance settling assembly 36 while grinding coffee will result in simultaneously grinding coffee, dispensing coffee into the container 34, and settling the ground coffee in the container during the grinding process. At the end of the grinding process, the user of the grinder will not need to tap or manually settle the ground coffee. Also, the ground coffee will not overflow the container as a result of the lofting or fluffing of the ground coffee during the grinding process because the ground coffee will already be settled. Settling of the ground coffee will help to prevent waste, cleanup, and clogging or entrapment of ground coffee in components of the grinder. Having now described the substance settling assembly 36, attention is now turned to the container retainer or container retaining assembly 38 and the activation switch assembly 44. The container retaining assembly 38 and activation switch assembly 44 work in combination to retain a container 34 relative to the discharge assembly 30 and to prevent inadvertent operation of the grinder 20 in the absence of a container 34. The retaining assembly 38 and switch assembly 44 are shown in FIGS. 2 and 4-7. As shown in FIGS. 2, 4-6, the container retaining assembly 38 includes a cam body 84 which is pivotally retained on a portion of the grinder body 86 by attachment to a control rod 88 extending through the grinder body 86 and cam body 84. A set screw 90 extends through the cam body 84 to hold the cam body 84 to the control rod 88. As such, the cam body 84 may be moved from a release position (see FIG. 4) to a retaining position (see FIG. 5) whereby a portion of a container 34 is retained between the cam body 84 and a portion of the discharge assembly 30. The length of the cam body 84 from an axis of rotation 92 to a distal end 94 thereof is greater than a dimension from the axis of rotation 92 to the portion of the discharge assembly against which the container is held. The cam body 84 also includes at least one and, as illustrated, a pair of O-rings 96 which increase the frictional contact between the cam body 84 and the surface of the container 34 engaged by the cam body 84. The shape, mounting location and position of the cam body 84 prevents inadvertent disengagement of the container 34 from the discharge assembly 30 when the cam body 84 is in the retaining position (see FIG. 5). In fact, forces applied to the container to disengage the container from the discharge assembly will produce increased gripping forces by the cam body 84 on the container 34. The ability of the container retaining assembly 38 to increase the engaging force against a container 34 upon applying a disengaging force to the container 34 is useful in combination with the substance settling assembly 36 of the present invention. The substance settling assembly acts against a side of the container 34 and thus applies a degree of disengaging force to the container. Additionally, as the container 34 fills with ground coffee downward forces created by the weight of the coffee tend to work to disengage the container from the discharge assembly 30. As such, the container retaining assembly 38 holds a container 34 in proper position below the discharge assembly 30 during the grinding process. In the present invention, as illustrated, the switch assembly 44 operates in combination with the container retaining assembly 38. The switch assembly 44 includes a roller switch 100 generally of known construction. The roller switch 100 is attached to a switch bracket 102 and is positioned relative to an extending portion 104 of the control rod 88. The switch 100 is coupled to the motor 60 to enable or disable the motor as a result of the presence or absence of a container beneath the discharge assembly for receiving ground coffee therein. The switch disables the motor when the container retaining assembly is in the release position (see, FIG. 4) thereby preventing grinding of coffee and dispensing of ground coffee through the discharge assembly when a container is not present. As shown in FIG. 5, the switch 100 enables operation of the motor 60 when the container retaining assembly is in the retaining position. As such, the switch enables operation of the motor when a container is positioned relative to the discharge assembly. A switch arm 106 extends from the roller switch 100 towards the extending portion 104 of the control rod 88. The terminal end of the extending portion 104 includes an arcuate portion 108 and a generally planar portion 110. As shown in FIG. 4, the switch arm 106 advances forwardly against the planar portion 110 when the cam body 84 is raised into the release position. As the cam body 84 is rotated towards the discharge assembly 30 to engage a container therebetween, the switch arm 106 is displaced by the arcuate portion 108 thereby enabling the operation of the motor 60. The structure of the extending portion 104 is more clearly shown in FIGS. 6 and 7 and in which the cam body 84 is generally shown in the "retaining" position. In the preceding description, reference has been made to the discharge assembly 30. As shown in FIGS. 1, 2 and 7-9, the discharge assembly 30 includes a number of components. As shown in FIG. 1, the discharge assembly 30 includes a hood 112 extending from the cabinet 22. Underneath the hood 112 is a channel chute 114 which is positioned over a passage 116 extending from the grinder mechanism 62 to the discharge assembly 30. The channel chute 114 is positioned with a discharge hole 118 coincident with the passage 116 to allow coffee dispensed from the grinder mechanism 62 to flow into the channel chute 114 and into a container positioned below the discharge assembly 30. As shown in FIGS. 2 and 7, a deflector 120 is attached to the channel chute 114 to deflect ground coffee dispensed through the passage 116 downwardly into the channel chute 114. A pivoting cover 122 is attached to the channel chute proximate to the deflector 120. The pivoting cover 122 allows for some degree of movement to accommodate fluctuation in the flow through the discharge assembly 30. The chaff retaining plate or chaff retainer 46 is positioned over the discharge hole 118 to provide a degree of back pressure on the flow of ground coffee through the passage in order to retain chaff in the ground coffee. The retention of chaff in the ground coffee is generally known by the use of a chaff retaining plate. The chaff retaining plate 46 retained on the upper portion of the channel chute 114 by a pivot pin 124. A torsion spring 126 is retained on the pivot pin 124 and biases the chaff retaining plate 46 over the discharge hole 118 against the dispensing flow of ground coffee through the passage 116. A lever arm 127 extends from the pivot pin 124 and abuts a side of the chaff retaining plate 46 facing the discharge hole 118. In use, as whole bean coffee flows under the influence of gravity from the hopper 78 to the grinder mechanism 62, it is dispensed from the grinder mechanism 62 through the passage 116 and discharge hole 118. Ground coffee is initially deflected downwardly by the deflector 120 into and through the channel chute 114. During the grinding process, as ground coffee is dispensed through the discharge hole 118, the chaff retaining plate 46 acts against the flow of ground coffee to promote retention of the chaff within the ground coffee. The pivoting cover 122 freely pivots in response to fluctuations in the flow of ground coffee through the discharge assembly 30. At the end of the grinding cycle, the pivot pin 124 is manually rotated in order to release chaff which may have accumulated on the surface thereof. Rotation of the pivot pin upwardly (see arrow 129 in FIG. 8) engages the lever arm 127 against the plate 46 to overcome the biasing force of the spring 126 and move the plate 46 away from the hole 118. Chaff may also accumulate on the inside surfaces of the deflector 120, the channel chute 114 and the pivoting cover 122. As such, it would be desirable to quickly and easily remove the accumulated chaff from these surfaces. The present invention includes the clean-out rod or member 48 which is operated to remove the chaff from these surfaces. The clean-out member 48 includes a protruding portion 128 which extends to engage an arm 130 of the pivot pin 124 to move or tap the chaff retaining plate 46 (see FIG. 8). The clean-out member 48 can be rotated upwardly so that the protruding portion 128 taps against a shoulder 132 of the pivoting cover 122. As such, the clean-out member 48 can be moved upwardly and downwardly to quickly and efficiently knock off the chaff from the chaff retaining plate 46 and the pivoting cover 122, respectively. Additionally, action of the pivoting cover 122 against the channel chute may vibrate chaff from the internal surfaces of the channel chute 114 as well as the deflector 120. As briefly discussed hereinabove, the magnetic assembly 40 (as shown in FIG. 2) is positioned in the hopper 78 to prevent magnetic pieces, usually metallic pieces, from falling into the grinder mechanism 62. The magnetic assembly 40 is important to prevent magnetic pieces from entering the ground coffee and to prevent such pieces from becoming mixed in a beverage brewed therefrom. Additionally, it is important to keep magnetic pieces out of the grinder mechanism 62 to prevent damage to the grinding burrs. A top burr 134 is positioned over a bottom burr 136. The top and bottom burrs 134, 136 have faces with a plurality of grinding teeth or structures thereon. As at least one of the burrs is rotated, whole bean coffee is forced through the grinding burrs 134, 136 and dispensed through the passage 116. The magnetic assembly 40 includes a support 138 and a magnetic body 140 attached thereto. The support 138 is designed to position the magnetic body 140 in a throat area 142 of the hopper 78 communicating with the grinder mechanism 62. The supports 138 and magnetic body 140 are sized and dimensioned to allow beans to flow from the hopper 78 through the throat 142 and into the grinder mechanism 62. Additionally, the supports 138 abut an internal surface of the hopper 78 and allow the magnetic assembly 40 to be fastened in place. This allows the magnetic assembly 40 may be periodically removed to clean magnetic pieces therefrom. As shown in FIG. 2, the hopper 78 is positioned above the grinder mechanism 62 in a gravity feed relationship such that upon activation of the grinder mechanism 62, beans will flow through the throat 142 for grinding. As the beans pass in close proximity or in contact with the magnetic body 140, any magnetic pieces which may have been accidentally introduced into the coffee supply will be captured for later removal. A generally small clearance is provided between the hopper and/or throat and the magnetic body in order to facilitate a thorough removal of any metallic particle from the bean as a result of close or intimate contact with the magnetic body 140. A problem which commonly limits the grinding activity of prior art grinders is that operation of the grinder motor 60 and grinder mechanism 62 creates a considerable amount of waste heat. In prior art devices, the accumulation of heat, or more appropriately heated air, in the cabinet may produce a temporary or permanent failure of the grinder. In order to prevent accumulation of heated air, the present invention incorporates an active ventilation system 42. The active ventilation system 42 primarily include a thermostatic element or thermostat 144, a fan 146 and vents 148 formed in the cabinet 22. The active ventilation system 42 is operated when the thermostat 44 senses the temperature of the air within the cabinet 22 as being within a predetermined range. Air is moved through the cabinet by the fan 146 for removal therefrom. As shown in the illustrated embodiment in FIG. 2, the vents 148 are positioned in the upper area 24 of the grinder 20. The fan 146 is positioned in the lower portion 26 of the grinder 20. Preferably, the thermostatic element 144 is positioned near the grinder mechanism 62 in order to accurately sense the temperature range of the grinder mechanism 62. Also shown in FIG. 2, the fan 146 is positioned to draw air into the cabinet 22 and force air upwardly through the vents 148. This configuration facilitates and exploits the natural convection phenomenon of heated air rising. Even before the fan 146 is activated, the position of the vents 148 in the upper portion 24 of the body 30 facilitate natural removal of heated air from the cabinet. Turning now to FIG. 10, a circuit diagram is provided. The electrical control of the present invention consists of a master on/off switch 150 which enables or disables power to the motor 60. When the master switch 150 is in the on position and the switch assembly 44 is activated by positioning the cam body 84 in the retaining position, the motor 60 will start. If the cam body 84 is in the release position, the switch 100 will be open and thus prevent operation of the motor 60. Once the motor is started and it has achieved a running condition, an electric start switch in the motor 60 will open thus removing a start capacitor 152 from the circuit. A run capacitor 154 will be maintained in the circuit even after the start capacitor 152 has been removed from the circuit. The thermostatic element or motor temperature sensor 144 and fan 146 are also included in the circuit to remove heated air from the cabinet when the thermostat 144 senses excessive heat. While a preferred embodiment of the present invention is shown and described, it is envisioned that those skilled in the art may devise various modifications and equivalents without departing from the spirit and scope of the invention as defined by the appended claims. The invention is not intended to be limited by the foregoing disclosure.

A grinder for grinding materials to produce a ground substance. The grinder includes a cabinet, a grinder motor retained in the cabinet, and a grinder mechanism coupled to the motor to grind the materials. A hopper is positioned in communication with the grinder mechanism to deliver materials for grinding. The container retainer is attached to the grinder for retaining a container in close proximity for capturing ground material dispensed thereby. An activation switch assembly is included with the grinder to selectively control the grinder and activate the grinder when a container is placed in a desired location. A substance settling assembly is included with the grinder for removing a container retained by the grinder to settle the substance as it is dispensed from the grinder to the container. A chaff retainer is provided for maintaining chaff included with the ground substance in mixture with the ground substance. A clean-out member is operatively attached to the grinder and selectively engageable with the chaff retainer for removing chaff from the grinder. A magnetic collection device is positioned in the hopper for capturing magnetic pieces which may be deposited in the hopper. An active ventilation system is also included with the grinder for actively and controllably removing heat from the grinder cabinet.

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a Divisional Application claiming the benefit of and priority to U.S. patent application Ser. No. 12/629,185, filed Dec. 2, 2009, which is a Divisional Application claiming the benefit of and priority to U.S. patent application Ser. No. 10/516,434, filed on Nov. 30, 2004 (now U.S. Pat. No. 7,666,197), which is a U.S. National Stage Application filed under 35 U.S.C. §371(a) of International Application Serial No. PCT/US03/19516, filed on Jun. 19, 2003, which claims the benefit of and priority to U.S. Provisional Application Serial No. 60/390,106 filed on Jun. 19, 2002, now abandoned, the entire contents of each of which being incorporated herein by reference. BACKGROUND 1. Technical Field The present disclosure relates to apparatus and methods used for joining tissue portions and more particularly, to anastomotic devices and methods for positioning and joining two hollow body parts. 2. Background of Related Art Anastomosis is the bringing together and/or joining of two hollow or tubular structures. When it is desired to suture a body conduit, typically for attachment to another body conduit, sutures are placed around the circumference of the conduit in order to maintain the patency of its lumen or channel. It can be appreciated that the sutures made on top of the conduit (i.e., on the side facing the surgeon) are made relatively more easily than the sutures made underneath the conduit (i.e., on the side facing away from the surgeon). The complexity of joining two body vessels is made manifestly apparent in a surgical procedure referred to generally as a radical prostatectomy (i.e., a well established surgical procedure for patients with localized prostatic carcinoma). In general, radical prostatectomy procedures require the removal of cancerous tissue while preserving sexual function and continence in the patient. There are two primary types of radical prostatectomy approaches for the removal of prostate cancer, the retropubic approach and the perineal approach. In the retropubic approach, a long up-and-down incision is made in the midline of the abdomen from the navel to the pubic bone. After the lymph nodes have been removed for study by the pathologist and a determination has been made to proceed with the removal of the prostate gland, the space underneath the pubic bone is cleaned and dissected and the removal of the entire prostate gland is generally begun at the end that is farthest from the bladder, i.e., next to the external urethral sphincter. Next, the prostatic urethra is divided, the prostatic urethra and the prostate gland through which it goes are then pulled upwards toward the bladder while the dissection continues behind the prostate gland, separating it from the layer of tissue that is connected to the rectum on its other side. As the dissection continues between the prostate and the rectum, the seminal vesicles, which are behind the base of the bladder, will be removed along with the prostate gland. Once the seminal vesicles are free, the entire prostate gland and the seminal vesicles are removed. The bladder neck is then stitched closed to a small enough diameter so that it is about the same size as the stump of the urethra from which the prostate was detached. The bladder neck is then pulled down into the pelvis and positioned against the urethral stump and stitched thereto. This stitching is done typically around a Foley catheter which has been inserted through the penis all the way into the bladder. In the perineal approach, an inverted “U” shaped incision is made going right over the anus, with the center of the “U” about three centimeters above the margin of the anus. The prostate gland is then freed from its surrounding structures by gentle dissection, and the urethra at the end of the prostate farthest from the bladder is isolated and divided. The bladder neck is freed from the prostate, and, once the prostate gland has been removed and the bladder neck has been closed sufficiently so that the size of its opening approximates the size of the urethral opening, the urethra and the bladder neck are stitched together. Once again, a Foley catheter is left in place postoperatively for about two weeks. In each of the above described procedures, it is the attachment of the urethral stump to the bladder neck which is particularly difficult and complex. This difficulty is complicated by the tendency of the urethral stump to retract into adjacent tissue. As a result, considerable time and effort must be expended to re-expose the urethral stump and begin the re-anastomosis procedure. Further complicating this procedure is the fact that the urethral stump is hidden beneath the pubic bone thus requiring that the surgeon work at a difficult angle and in positions that are uncomfortable and limiting. Various devices have been proposed for facilitating this procedure. In U.S. Pat. No. 5,591,179, issued to Edelstein, there is disclosed a suturing device including a shaft with portions defining an interior channel extending between a proximal and a distal end of the shaft. This channel includes a generally axial lumen which extends to the proximal end of the shaft and a generally transverse lumen which extends from the axial lumen distally outwardly to an exit hole at the outer surface of the shaft. A needle and suture can be back loaded into the transverse lumen of the channel while a generally non-compressible member can be movably mounted in the axial lumen of the channel. At the proximal end of the shaft a handle is provided with means operative to push the member distally through the lumen to deploy or expel the needle. In U.S. Pat. No. 4,911,164, issued to Roth, there is disclosed a suture guide with a curved distal portion. The distal portion of the suture guide has a plurality of exterior axial grooves which can be used to align and guide a curved needle and attached suture. In order to drive the urethral stump to an accessible position, the device is provided with a plurality of outwardly extendable members which engage the lumen of the urethra. These members make it possible to push the urethral stump into approximation with the bladder neck. In U.S. Pat. No. 5,047,039, issued to Avant et al., there is disclosed a surgical device for the ligation of a dorsal vein and subsequent anastomosis. This device contains a pair of enclosed needles each having an attached suture which needles may be driven from the shaft of the device into adjacent tissue. In general, none of the devices disclosed in the prior art references above is simple to use or makes the anastomosis of the urethral stump to the bladder neck easier. As such, each surgical procedure using prior art devices continues to be time consuming and requires great skill in order to be performed. Accordingly, the need exists for anastomosis devices which overcome the drawbacks of the prior art devices and which are quick and simple to use. SUMMARY Apparatus and methods for performing a surgical anastomotic procedure are disclosed herein. According to one aspect of the present disclosure, an apparatus for approximating body vessels includes at least one fastener. Each fastener includes a first fastener portion having an anchoring leg portion, and a second fastener portion having an anchoring leg portion, wherein the first and second fastener portions are operatively associated with one another for selectively fixing the position of the first fastener portion and the second fastener portion with respect to one another. The apparatus further includes a first member configured and adapted to engage the first fastener portion, and a second member configured and adapted to engage the second fastener portion, the first member and the second member being movable with respect to one another to move the first fastener portion and second fastener portion with respect to one another. It is envisioned that each first fastener portion and second fastener portion has a locking leg portion and a first position in which the anchoring leg portion is adjacent the locking leg portion and a second position in which the anchoring leg portion is spaced a distance from the locking leg portion. Each of the anchoring leg portions of the first and second fastener portions can include a sharpened tip, wherein the sharpened tips are oriented substantially toward one another. Each anchoring leg portion can be integrally connected to the respective locking leg portion. In certain embodiments, the apparatus further includes an insertion sleeve. Accordingly, it is envisioned that each anchoring leg portion can be biased to a position spaced from the respective locking leg portion and collapsible to a position in close proximity to the respective locking leg portion. It is envisioned that each fastener can be made from stainless steel, titanium, polyglycolic acid and polylactic acid. In certain embodiments, the first fastener portion and the second fastener portion include inter-engaging fixing elements. The fixing elements can include a series of projections formed along a surface of the first fastener portion, and a locking passage formed along a surface of the second fastener portion, the locking passage being configured and dimensioned to receive an end of the first fastener portion therein. The locking passage can include at least one projection extending from an inner surface thereof which at least one projection is configured and dimensioned to engage the series of projections formed along the surface of the first fastener portion. Desirably, the fixing elements are saw toothed. Accordingly, the fixing elements permit movement of the first fastener portion relative to the second fastener portion in a first direction, while preventing movement in a second direction. It is envisioned that each of the first fastener portion and the second fastener portion can have a locking leg portion pivotably connected to the respective anchoring leg portion. Each anchoring leg portion can include a suture secured thereto. In certain embodiments, the apparatus can further include an insertion sleeve. It is envisioned that a plurality of fasteners can be radially disposed about the lumen of the insertion sleeve. It is envisioned that each first fastener portion can include a lip extending from the first fastener portion and the first member can include an anvil having a hook formed at a distal end thereof for engaging the lip of the first fastener portion. It is further envisioned that each second fastener portion can include a lip extending from the second fastener portion and the second member can include a pusher having a recess formed in a distal end thereof for engaging the lip of the second fastener portion. In certain embodiments, the apparatus can further include fixing elements on each of the first and second fastener portions. The fixing elements can include a series of projections formed along a surface of the first fastener portion, and a locking passage formed along a surface of the second fastener portion, the locking passage being configured and dimensioned to receive an end of the locking leg portion of the first fastener portion therein. The locking passage includes at least one projection extending from an inner surface thereof which at least one projection is configured and dimensioned to engage the series of projections formed along the surface of the first fastener portion. The locking passage can be defined by a pair of side walls extending from the locking leg portion of the second fastener portion and an end wall interconnecting and extending between the pair of side walls, the at least one projection of the locking passage being formed on an inner surface of the end wall. According to another aspect of the present disclosure, a method of approximating a first body vessel and a second body vessel is provided. The method includes the step of providing an apparatus for approximating the first body vessel and the second body vessel. The apparatus includes at least one fastener having a first fastener portion having an anchoring leg portion, and a second fastener portion having an anchoring leg portion, wherein the first and second fastener portions are operatively associated with one another for selectively fixing the position of the first fastener portion and the second fastener portion with respect to one another, a first member configured and adapted to engage the first fastener portion, and a second member configured and adapted to engage the second fastener portion, the first member and the second member being movable with respect to one another to move the first fastener portion and second fastener portion with respect to one another. The method further includes the steps of passing the apparatus through the first body vessel and through an opening in the second body vessel such that the anchoring leg portion of the first fastener portion is positioned within the second body vessel, withdrawing the at least one anvil to drive the anchoring leg portion of the first fastener portion into the wall of second body vessel, advancing the at least one pusher to drive the anchoring leg portion of the second fastener portion into the wall of the first body vessel, and approximating the at least one anvil and the at least one pusher to approximate the anchoring leg portions of the first and second fastener portions with one another and to approximate the first and second body vessels with one another, wherein the fixing elements engage one another and inhibit separation of the first and second body vessels from one another. It is envisioned that the anchoring leg portions can be biased to an expanded position and the fastener can be disposed within an insertion sleeve so as to maintain the fastener in a collapsed position. The method can further include the step of withdrawing the insertion sleeve so as to allow the anchoring leg portion to expand. These and other features of the apparatus disclosed herein, will become apparent through reference to the following description of embodiments, the accompanying drawings and the claims. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the detailed description of the embodiments given below, serve to explain the principles of the present disclosure. FIG. 1 is a top plan view of a fastener, in accordance with an embodiment of the present disclosure, shown in a separated condition; FIG. 2 is a side elevational view of the fastener of FIG. 1 ; FIG. 3 is a top plan view the fastener of FIGS. 1-2 , shown in a coupled condition; FIG. 4 is a side elevational view of the fastener of FIGS. 1-3 ; FIG. 5 is an enlarged cross-sectional view of the indicated area of FIG. 3 ; FIG. 6 is an enlarged end view of the fastener of FIGS. 1-5 ; FIG. 7 is a cross-sectional side elevational view illustrating the positioning of the insertion tool and fastener into a hollow body organ; FIG. 8 is a cross-sectional side elevational view illustrating the positioning of the insertion tool and the fastener as well as the expansion of the distal of the fastener in the hollow body organ in order to anchor the distal end of the fastener in the walls of the hollow body organ; FIG. 9 is a cross-sectional side elevational view illustrating the expansion of the proximal end of the fastener in order to anchor the proximal end of the fastener to the walls of the body lumen; FIG. 10 is a cross-sectional side elevational view illustrating the approximation of the hollow body organ to the body lumen; FIG. 11 is a cross-sectional side elevational view illustrating the retraction of the insertion tool; FIG. 12 is a cross-sectional side elevational view illustrating the final anastomosed hollow body organ and body lumen with the fastener anchored in position; FIG. 13A is a side elevational view of a proximal leg of a fastener in accordance with an alternative embodiment of the present disclosure; and FIG. 13B is a side elevational view of a distal leg of a fastener in accordance with the alternative embodiment of the present disclosure. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Preferred embodiments of the presently disclosed anastomosis apparatus will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. In the drawings and in the description which follows, the term “proximal”, as is traditional, will refer to the end of the surgical device or instrument of the present disclosure which is closest to the operator, while the term “distal” will refer to the end of the device or instrument which is furthest from the operator. An anastomosis apparatus 100 , in accordance with an embodiment of the present disclosure, is shown in FIGS. 1-12 . Although anastomosis apparatus 100 offers significant advantages to a radical prostatectomy procedure, it will be understood that the device is applicable for use in any anastomotic procedure where two body vessels are to be brought together and joined. As seen in FIGS. 1-6 , anastomosis apparatus 100 includes at least one fastener 102 and preferably a plurality of fasteners 102 radially disposed about a lumen 184 of an insertion sleeve 180 (see FIG. 7 ). Each fastener 102 includes a first fastener portion 104 and a second fastener portion 106 . First fastener portion 104 of fastener 102 includes a locking leg portion 108 and an anchoring leg portion 110 integrally formed with locking leg portion 108 . In particular, locking leg portion 108 includes a proximal end 112 and a distal end 114 from which anchoring leg portion 110 extends. Anchoring leg portion 110 includes a distal end 116 integrally coupled to distal end 114 of locking leg portion 108 and a sharpened proximal tip 118 . Desirably, sharpened proximal tip 118 of anchoring leg portion 110 is oriented towards proximal end 112 of locking leg portion 108 . Anchoring leg portion 110 has a first position “A” in which sharpened proximal tip 118 is spaced a distance from locking leg portion 108 and can be biased to a second position “C” (as seen in phantom in FIGS. 2 and 3 ) in which sharpened proximal tip 118 is in close proximity to locking leg portion 108 . Preferably, locking leg portion 108 of first fastener portion 104 includes fixing elements for engaging second fastener portion 106 . The fixing elements in certain embodiments comprise a series of projections 120 formed along a side thereof and extending from proximal end 112 toward distal end 114 . First fastener portion 104 of fastener 102 further preferably includes a lip 122 projecting distally from distal end 110 of locking leg portion 108 . Second fastener portion 106 of fasteners 102 includes a locking leg portion 124 and an anchoring leg portion 126 integrally formed with locking leg portion 124 . In particular, locking leg portion 124 includes a distal end 128 and a proximal end 130 from which anchoring leg portion 126 extends. Anchoring leg portion 126 includes a proximal end 132 integrally coupled to proximal end 130 of locking leg portion 124 and a sharpened distal tip 134 . Desirably, sharpened distal tip 134 of anchoring leg portion 126 is oriented towards distal end 128 of locking leg portion 124 . Anchoring leg portion 126 has a first position “A” in which sharpened distal tip 134 is spaced a distance from distal end 128 of locking leg portion 124 and can be biased to a second position “C” (as seen in phantom in FIGS. 2 and 4 ) in which sharpened distal tip 134 is in close proximity to locking leg portion 124 . Preferably, locking leg portion 124 of second fastener portion 106 includes a locking passage 136 formed along a side surface thereof. As seen in FIG. 6 , locking passage 136 is defined by an upper wall 138 extending from an upper surface of locking leg portion 124 , a lower wall 140 extending from a lower surface of locking leg portion 124 and an interconnecting side wall 142 extending between the terminal ends of upper wall 138 and lower wall 140 . Locking passage 136 includes at least one, and desirably a plurality of fixing elements for engaging the fixing elements of the first fastener portion 104 . The locking passage 136 shown has fixing elements in the form of a plurality of projections 144 formed along an inner surface of interconnecting side wall 142 and oriented toward locking leg portion 124 . Locking passage 136 is sized and dimensioned to slidably receive an end of first fastener portion 104 therethrough. In particular, when locking leg portion 108 of first fastener portion 104 is inserted into locking passage 136 of second fastener portion 106 , projections 120 of locking leg portion 108 engage projections 144 of locking passage 136 to thereby effectively lock first fastener portion 104 of fastener 102 in position with respect to second fastener portion 106 of fastener 102 . Similar to first fastener portion 104 of fastener 102 , second fastener portion 106 of fastener 102 includes a lip 148 projecting proximally from proximal end 130 of locking leg portion 124 . As seen in FIG. 5 , it is contemplated that projections 120 of locking leg portion 108 and projections 144 of side wall 142 of locking passage 136 are teeth-like (e.g., saw toothed) projections 146 a , 146 b , respectively, configured and adapted to permit locking leg portion 108 to be inserted into locking passage 136 and hindering withdrawal of locking leg portion 108 therefrom. In particular, projections 146 a , 146 b are configured and adapted to permit locking leg portion 108 to slide in direction “D” while locking passage 136 is permitted to slide in direction “E”. However, once projections 146 a and projections 146 b engage one another, projections 146 a , 146 b prevent locking leg portion 108 from sliding in a direction opposite to direction “D” and prevent locking passage 136 from sliding in the direction opposite from “E”. In other words, projections 146 a , 146 b are configured and adapted to allow uni-directional movement of locking leg portion 108 relative to locking passage 136 and in turn uni-directional movement of first fastener portion 104 relative to second fastener portion 106 . While projections 120 of locking leg portion 108 and locking passage 136 are shown and described as being formed along a side surface of first fastener portion 104 and second fastener portion 106 , respectively, it is envisioned and within the scope of the present disclosure that projections 120 can be provided along any surface of locking leg portion 108 of first fastener portion 104 and locking passage 136 can be provided along any surface of locking leg portion 124 of second fastener portion 106 . First fastener portion 104 and second fastener portion 106 of fastener 102 can be made from any surgical grade material, such as stainless steel or titanium. It is envisioned that first and second fastener portions 104 , 106 are preferably made from a medical grade bio-absorbable material, such as, for example, polyglycolic acid (PGA) and/or polylactic acid (PLA). Preferably, the material and dimensions of fasteners 102 are selected such that fasteners 102 will dissolve after a predetermined period of time while retaining their structural integrity for a period of time sufficient to assure proper healing of the anastomosis site. As seen in phantom in FIGS. 3 and 4 , anastomosis apparatus 100 includes an anvil 150 , a pusher 170 , and a shaft 190 for mounting the fasteners 102 in an insertion sleeve 180 (see FIG. 7 ). Anvil 150 includes an elongate body portion 152 and a hook 154 formed at a distal end 156 thereof. Hook 154 of anvil 150 is configured and adapted to engage lip 120 of first fastener portion 104 of fastener 102 . Pusher 170 includes an elongate body portion 172 and a recess 174 formed at a distal end 176 thereof. Recess 174 of pusher 170 is configured and adapted to engage lip 146 of second fastener portion 106 of fastener 102 . As seen in FIGS. 7-11 , insertion sleeve 180 includes a distal end 182 , a proximal end (not shown) and defines a lumen 184 extending therethrough which defines a central axis. Shaft 190 is configured and adapted to be slidably received in lumen 184 of insertion sleeve 180 . It is envisioned that shaft 190 include a plurality of radially oriented longitudinally extending grooves (not shown) formed therein. Accordingly, each groove of shaft 190 can be configured and adapted to receive a respective anvil 150 , pusher 170 and fastener 102 . Preferably, shaft 190 is sized such that when shaft 190 is inserted into sleeve 180 , anchoring leg portion 108 of first fastener portion 104 and anchoring leg portion 124 of second fastener portion 106 are in the second position “C” (see FIG. 7 ). Anvil 150 and pusher 170 are arranged with respect to one another so as to form a recess for receiving fastener 102 between hook 154 and lip 120 . Fastener 102 is disposed in the recess so that first fastener portion 104 and second fastener portion 106 are engaged with one another, leaving room for advancing the anchoring leg portions toward one another. Anvil 150 , pusher 170 and fastener 102 are disposed in insertion sleeve 180 , with shaft 190 disposed therebetween. (see FIG. 7 ). A preferred method of use and operation of anastomosis apparatus 100 in performing a radical prostatectomy anastomosis will now be described in greater detail with reference to FIGS. 1-12 and in particular with reference to FIGS. 7-12 . Anastomosis apparatus 100 can be used in either the retropubic or the perineal prostatectomy approaches. With the prostate removed, the bladder neck “N” of the bladder “B” is first reconstructed by everting the inner mucosal lining of bladder “B” and suturing it down to the outer wall of bladder “B”, using known surgical techniques. Likewise, urethral stump “S” of urethra “U” is reconstructed by everting the inner mucosal lining of urethral stump “S” and suturing it down to the outer wall of urethra “U”, using known surgical techniques. Preferably, with bladder neck “N” reconstructed, bladder neck “N” is sized to properly accommodate and retain distal end 180 of sleeve 180 within bladder “B” using a standard tennis racket type closure (i.e., the opening of the bladder neck constituting the head of the tennis racket and a radial incision extending from the bladder neck constituting the handle portion of the tennis racket). The size of the bladder neck will vary depending on the patient. Typically, the bladder neck “N” is sized to be approximately 7-8 mm in diameter. With bladder neck “N” reconstructed, apparatus 100 is passed trans-urethrally through urethra “U” until distal end 182 of insertion sleeve 180 extends out of urethral stump “S” and into bladder “B” through bladder neck “N”, as seen in FIG. 7 . With apparatus 100 so positioned, insertion sleeve 180 is withdrawn in a proximal direction to expose sharpened proximal tips 118 of first fastener portions 104 . With sharpened proximal tips 118 exposed from within insertion sleeve 180 , anchoring leg portions 110 of first fastener portions 104 are deployed to the first position “A”. (see FIG. 8 ). With anchoring leg portions 110 deployed, hooks 154 of anvils 150 are withdrawn in a proximal direction to engage lips 122 of first fastener portions 104 and to drive sharpened proximal tips 118 through the wall of bladder “B”, see FIG. 9 . As seen in FIG. 9 , insertion sleeve 180 is further withdrawn in a proximal direction until sharpened distal tips 134 and anchoring leg portion 126 of second fastener portion 106 are exposed. With anchoring leg portions 126 completely exposed from within insertion sleeve 180 , anchoring leg portions 126 of second fastener portions 106 are deployed to first position “A”. (see FIG. 9 ). With anchoring leg portions 126 deployed, pushers 170 are advanced in a distal direction to engage lips 148 and to drive sharpened distal tips 134 through the wall of urethral stump “S”. With sharpened proximal tips 118 of first fastener portions 104 penetrating the wall of bladder “B” and with sharpened distal tips 134 penetrating the wall of urethral stump “S”, hooks 154 of anvils 150 are approximated toward recesses 174 of pushers 170 to thereby approximate anchoring leg portions 110 of first fastener portion 104 and anchoring leg portions 126 of second fastener portion 106 towards one another. Concomitantly, as anchor leg portions 110 and 126 are approximated towards one another bladder neck “N” is approximated towards urethral stump “S”. (see FIG. 10 ). In accordance with the present disclosure, approximation of anchor legs 110 and 126 towards one another results in projections 120 and 144 incrementally engaging one another and maintaining the position of anchor leg 110 relative to anchor leg 126 . Accordingly, projections . 120 and 144 prevent bladder “B” from separating from urethra “U”. After bladder neck “N” has been approximated toward urethral stump “S”, pushers 170 and shaft 190 are withdrawn from insertion sleeve 180 and anvils 150 unhooked from lips 122 . (see FIG. 11 ). Thereafter, anvils 150 and insertion sleeve 180 are withdrawn from urethra “U”. An alternate embodiment of a fastener 200 , in accordance with the present disclosure, is shown in FIGS. 13A and 13B . Unlike fastener 102 from above, fastener 200 includes a first fastener portion 202 and a second fastener portion 204 . First fastener portion 202 includes a locking leg portion 206 and an anchoring leg portion 208 pivotally coupled to a proximal end of locking leg portion 206 . In the embodiment shown, anchoring leg portion 208 is pivotally coupled to locking leg portion 206 by a pivot pin 210 , but other means known in the art may also be used. Alternatively, locking leg portion 206 or anchoring leg portion 208 can be provided with an integrally formed pin that extends outwardly for receipt in an aperture formed in the other of locking leg portion 206 or anchoring leg portion 208 . First fastener portion 202 includes a suture 212 connected to anchoring leg portion 208 for pulling on anchoring leg portion 208 and lifting a distal end of anchoring leg portion 208 away from locking leg portion 206 (e.g., from first position “A” to second position “C”). It is contemplated that the proximal end of locking leg portion 206 includes a stop (not shown) for stopping the lifting of anchoring leg portion 208 beyond a predetermined amount. As seen in FIG. 13B , second fastener portion 204 includes a locking leg portion 214 and an anchoring leg portion 216 pivotally coupled to a distal end of locking leg portion 214 by a pivot pin 218 . Alternatively, locking leg portion 214 or anchoring leg portion 216 can be provided with an integrally formed pin and extending outwardly for receipt in an aperture formed in the other of locking leg portion 214 or anchoring leg portion 216 . Second fastener portion 204 further includes a suture 220 connected to anchoring leg portion 216 , extending around the distal end of locking leg portion 214 , for pulling on anchoring leg portion 216 and lifting a proximal end of anchoring leg portion 216 away from locking leg portion 214 (e.g., from first position “A” to second position “C”). It is contemplated that the distal end of locking leg portion 214 includes a stop (not shown) for stopping the lifting of anchoring leg portion 216 beyond a predetermined amount. While apparatus in accordance with the present disclosure have been described as being used in connection with a radical prostatectomy procedure, it is envisioned that apparatus having similar structures and modes of operation can be used in various other surgical procedures. It will be understood that various modifications may be made to the embodiments of the presently disclosed anastomosis device and method disclosed herein. For example, one or more fasteners may be arranged in the insertion sleeve. In further embodiments, the insertion sleeve is sized to accommodate the fastener without requiring the anchoring leg portions to collapse to position “C”. The fastener may comprise a single part with a corrugated, hinged or collapsible portion. The fasteners, in certain embodiments, comprise a fixing element comprising a separated part. Therefore, the above description should not be construed as limiting, but merely as an exemplification of a preferred embodiment. Those skilled in the art will envision other modifications within the scope of the present disclosure.

Apparatus and methods for performing a surgical anastomotic procedure are disclosed herein. Apparatus according to the present disclosure include at least one fastener including a first fastener portion having an anchoring leg portion, a second fastener portion including an anchoring leg portion, wherein the first and second fastener portions are operatively associated with one another to selectively fix the position of the first fastener portion relative to the second fastener portion.

BACKGROUND OF THE INVENTION This invention relates to surgical instruments and, more particularly, to a novel electro-surgical dissection and cauterization instrument for use primarily in laparoscopic/endoscopic procedures. Many surgical procedures of today involving the removal and/or cauterization of tissue (e.g. endometriosis, lysis of adhesions, cholecystectomy, appendectomy, etc.) are performed with an electro-surgical dissection and cauterization instrument either in open surgery where the surgeon has direct view and access to the operation site, or in combination with an endoscope. Referring to the endoscopic surgery and, in particular, laparoscopic surgery which refers specifically to the abdominal area, the surgeon first makes usually several small, spaced incisions through the abdominal wall of the anesthetized patient. A source of compressed CO 2 is then delivered through one of the incisions to inflate the abdomen which effectively raises the abdominal wall above the organs and intestines of the patient. A space is thereby created therebetween which facilitates manipulation of surgical instruments which have been inserted into the abdomen through one of the incisions. The surgeon views the internal operation site with a laparoscope which is a specialized type of scope inserted into the abdomen through an incision. The laparoscope is attached to a miniaturized, surgical camera assembly which operates by transmitting the image the camera is directed at inside the abdomen of the patient to the laparoscope eyepiece and/or a CRT screen in the operating room. A trochar is typically positioned within the incision to provide a smooth passageway for the instruments into and out of the abdomen. The electro-surgical instrument passes through the trochar to reach and perform surgery on the patient by the surgeon carefully manipulating the exposed end of the instrument. Electro-surgical instruments are used primarily to separate and remove diseased tissue from healthy tissue such as polyps from the colon, for example. They are also used as probes to move tissue about during exploratory surgery. Supplying the instrument with controlled, electrical energy is well known in the art. With the patient properly grounded, a high frequency electric current is discharged at the distal, electrode end of the tool which augments its cutting capability while simultaneously cauterizing bleeding tissue and blood vessels. The electro-surgical instrument includes a proximal end with a plug permitting connection of the tool to an electro-surgical unit which supplies electric energy to the distal, electrode end of the tool. A rigid, linear insulating sleeve surrounds the instrument which delivers electric energy from the proximal, plug end to the distal, electrode end which itself is formed of electrically conductive material such as stainless steel. The instrument's distal electrode may be found in a variety of configurations, each different configuration serving a different, specific function. For example, a working tip electrode in the shape of a snare or hook is used for grasping and pulling at tissue while a working tip electrode in the shape of a flattened spatula is used primarily to move tissue about and/or to cauterize bleeding tissue. Many other working tip electrode configurations appear on the market every day as the needs and likes of surgeons change. In most, if not all, of the dissecting tools available today, the working tip electrode of the instrument just described extends directly from the distal end of the insulating sleeve. As such, there is a minimum of distance between the sleeve and the working tip electrode which, in many instances of use, obstructs or impairs the surgeon's view of the operation site as viewed in either complete open surgery or with a laparoscope during the procedure just described. The problem exists due to the small size of the working tip electrode in relation to the relatively large diameter of the sleeve from which it extends. A second problem surgeons have reported when using present day electro-surgical instruments is that the portion of the working tip electrode directly adjacent the sleeve occasionally makes inadvertent contact with healthy tissue surrounding the surgical work site. This has resulted in unintentional cauterization of healthy tissue which poses serious consequences to both patient and surgeon alike. It is therefore a principle object of the present invention to provide an electro-surgical instrument including a rigid arm extending between the distal, working tip electrode and the insulating sleeve. The arm includes at least a portion thereof laterally offset from the longitudinal axis of the sleeve whereby obstruction of the surgeon's view of the working tip electrode and surgical work site by the sleeve is substantially reduced. It is a further object of the present invention to provide an electro-surgical instrument which provides an electrical insulating layer along the entire length of the tool up to the exposed working tip electrode such that inadvertent cauterization of tissue with portions of the tool other than the working tip electrode is eliminated. It is another object of the present invention to provide a single-use, disposable, electro-surgical and cauterizing instrument for endoscopic procedures which is designed for easy handling and use by the surgeon. Other objects will in part be obvious and in part appear hereinafter. SUMMARY OF THE INVENTION In accordance with the foregoing objects, the invention comprises an electro-surgical dissecting and cauterizing instrument for use primarily in standard endoscopic procedures which include the use of an endoscope to view the operation. The instrument has also proved very useful in open surgeries which do not include the use of an endoscope. An electric plug is included at the instrument's proximal end for connecting the tool to a conventional, electro-surgical unit which supplies high frequency electric energy to the working tip electrode of the tool at the control of the surgeon. The electric energy is delivered to the distal, working tip of the tool via a conductive rod surrounded by a linear, rigid sleeve formed of an insulating material, the sleeve extending from the plug end to the distal end of the tool which includes the working tip electrode. The distal end of the tool includes an electrically conductive, rigid arm extending from the sleeve portion of the tool. Although several embodiments of the tool will be described in detail below, in each embodiment of the tool the arm extends from the sleeve and includes portions laterally offset from the longitudinal axis of the sleeve. The working tip electrode is formed at the free end of the arm and is used to make direct contact with the patient at the internal operation site. A thin jacket of insulating material is disposed upon the arm from the point where it extends from the sleeve right up to, but not including, the working tip electrode. The working tip electrode comes in many different shapes depending on the needs of the surgeon in a particular surgical application. Electrode tips to be described in detail below include a hook and flattened spatula, for example. The fact that portions of the arm which extend between the sleeve and working tip are laterally offset from the main axis of the sleeve provides for maximum visualization of the working tip electrode and operation site by the surgeon. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side, elevational view of a first embodiment of the electro-surgical dissecting and cauterizing instrument shown operably connected to a conventional, electro-surgical unit in the intended manner; FIG. 2 is a perspective, fragmentary view of the distal working tip end of the electro-surgical instrument seen in FIG. 1; FIG. 3 is a side, elevational, enlarged view of the distal end of the electro-surgical instrument seen in FIG. 2; FIG. 4 is a top view of FIG. 3; FIG. 5 is a perspective, fragmentary view of a second embodiment of the distal end of the electro-surgical instrument; FIG. 6 is an enlarged, side, elevational view of FIG. 5; FIG. 7 is a bottom, fragmentary view of the working tip end of the arm as taken along the line 7--7 in FIG. 6; FIG. 8 is a perspective, fragmentary view of the distal end of a third embodiment of the electro-surgical instrument; FIG. 9 is an enlarged, side, elevational view of FIG. 8; and FIG. 10 is a bottom, fragmentary view of the working tip end of the arm as seen along the line 10--10 in FIG. 9. DETAILED DESCRIPTION Referring now to the drawings, there is seen in FIG. 1 a first embodiment of the electro-surgical dissecting and cauterizing instrument 10 including a distal, working end 12 and a proximal end 14 which includes an electric plug such that instrument 10 may be releasably and operably connected to a conventional, electro-surgical control unit 16. Control unit 16 is supplied high frequency, electrical energy via power supply 18 and further includes a switch means 20 which is used to control the flow of electrical energy from unit 16 to instrument 10. As such, a surgeon manually grasps unit 16 to work instrument 10 as described below. Although unit 16 is shown and described herein for the purpose of illustrating a typical electrical unit with which instrument 10 would be used, it is understood that plug 14 may be easily adapted to connect to a variety of electro-surgical units available today. Dissecting and cauterizing instrument 10 is used primarily in surgical procedures which may or may not include the use of an endoscope to view the operation site. For purposes of description, the surgical procedure using an endoscope will be discussed. Also, surgical procedures of the type discussed herein are termed laparoscopic because they target the abdominal area. The type of endoscope used in the abdomen is therefore termed a laparoscope. In particular, the surgeon inserts distal end 12 into the abdomen of the anesthetized patient through a trochar (not shown) positioned within an incision made in the abdominal wall. The operation site is viewed at the eyepiece of the laparoscope and/or on a CRT screen by passing the laparoscope (also not shown) through an adjacent incision in the abdomen which has been previously inflated with CO 2 as is customary surgical procedure in laparoscopic surgery of this type. The raising of the abdominal wall above the innards of the patient with the CO 2 creates a space therebetween which increases maneuverability of instrument 10 within the abdomen besides increasing the viewing area of the surgical site with the laparoscope. Examples of typical laparoscopic procedures in which dissecting and cauterizing instrument 10 would be used are lysis of adhesions, cholecystectomy and appendectomy. Dissecting and cauterizing instrument 10 includes a rigid insulating sleeve 22 which surrounds conducting rod 24 extending from plug 14 to distal end 12. Distal end 12 is seen to include a rigid arm 26 extending from substantially the center of the distal end 21 of sleeve 22. A working tip 28 electrode in the shape of a hook in the embodiment of tool 10 seen in FIGS. 1-4 integrally extends from arm 26. Arm 26 and working tip electrode 28 are formed of electrically conductive material such as stainless steel and are supplied electrical energy via a conductive rod 24 extending through sleeve 22. A thin layer or jacket of insulating material 30 in the form of a TEFLON heat-shrink tubing is disposed upon arm 26 from sleeve 22 to the base of working tip electrode 28. Prior art electro-surgical instruments of which the present inventors are aware do not include an arm such as 26 extending between the working tip electrode 28 and end of sleeve 22 but instead have their working tip electrodes extend directly from the sleeve. As such, the view of the operation site is obstructed because of the close proximity of the sleeve to the working tip electrode since the diameter of the sleeve is substantially larger than the size of the working tip electrodes. To overcome this problem, the present dissecting and cauterizing instrument 10 includes arm 26 to effectively space working tip electrode 28 from sleeve 22. Furthermore, arm 26 is seen to include portions laterally offset from the linear axis x--x extending through the center of sleeve 22 and arm 26. This feature also increases the visualization of the surgical work site by having the working tip electrode 28 extend from a portion of the arm 26 which lies along an axis y--y which is parallel to and spaced from linear axis x--x of sleeve 22. Referring to FIG. 3, arm 26 is seen to extend linearly from sleeve 22 for a first length having a distance d 1 and bend downwardly at an approximately 150 degree angle a 1 , with respect thereto for a second length having a distance d 2 . Arm 26 then bends upwardly at an approximately 150 degree angle a 2 to extend for a third length having a distance d 3 . As such, it may be seen that the first length of arm 26 labeled d 1 extends along linear axis x--x of sleeve 22 which is spaced from and extends parallel to third length d 3 . Working tip electrode 28 is seen to integrally extend from the distal end of third length d 3 and bend toward axis x--x to form a hook which is used primarily for pulling at tissue. The electricity which flows through arm 26 and electrode hook 28 at the control of the surgeon augments the cutting capability of hook 28 and cauterizes bleeding blood vessels. To prevent unintentional cauterization with portions of instrument 10 other than hook 28, an insulating jacket 30 is disposed upon the entire length of arm 26. Referring to FIGS. 5 and 6, a second embodiment of instrument 10 is seen. In this second embodiment, arm 26' linearly extends from sleeve 22' for a first length having a distance D 1 as with the embodiment of FIGS. 1-4, bending downwardly and then upwardly at approximately 135 degree angles A 1 and A 2 for second and third lengths having distances of D 2 and D 3 , respectively. As such, the third length of arm 26' spanning distance D 3 lies along an axis Y--Y which is parallel to and spaced downwardly from the linear axis X--X of sleeve 22' where the first length of arm 26' spanning distance D 1 lies. Arm 26' includes a third bend in an upwardly direction at an approximately 159 degree angle A 3 and extends linearly therefrom for a fourth length having a distance D 4 , crossing linear axis X--X such that the working tip electrode 32 lies on the side of axis X--X opposite to which axis Y--Y lies. It will be noticed in FIGS. 5-7 that working tip electrode 32 is in the shape of a flattened spatula which has a radial axis r--r which intersects linear axis Y--Y. Spatula 32 proves especially useful for cauterizing bleeding blood vessels rather than removing tissue from the patient's body. An insulating jacket 30' is disposed upon arm 26' from the distal end of sleeve 22' to the base of working tip electrode 32 to prevent any portion of arm 26' from unintentionally contacting and cauterizing healthy tissue surrounding the operation site. Referring now to FIGS. 8, 9 and 10 which show yet a third embodiment of the invention, arm 26" is entirely linear and extends from sleeve 22" along an axis z--z which makes an approximately 6 degree acute angle A 4 with linear axis Z--Z of sleeve 22". Working tip electrode 32', which is also in the shape of a substantially circular, planar spatula, extends upwardly from arm 26" toward axis Z--Z. Working tip electrode 32' has a radial axis R--R which intersects linear axis Z--Z at an obtuse angle A 5 . An insulating jacket 30" is disposed upon arm 26" from sleeve 22" to working tip electrode 32'. Based on the foregoing description of three embodiments of the invention, it may be realized that the length and configuration of the arms 26, 26' and 26" permit each of the respective working tip electrodes 30, 32 and 32' to be significantly spaced from and laterally offset from the longitudinal axis of the sleeve. This permits an enhanced viewing area of the surgical work site and working tip electrode for the surgeon. While the invention has been shown and described with particular reference to preferred embodiments thereof, it will be appreciated to those skilled in the art that variations in working tip electrode configuration and specific lengths and angles of the arm portion of the tool may be made to fit a particular surgical need without departing from the full scope of the invention as is set forth in the claims which follow.

An electro-surgical dissecting and cauterization tool comprises a linear, rigid insulating sleeve surrounding means providing an electric conducting path between a proximal, electric plug end and working tip electrode distal end. The plug attaches the tool to a conventional electro-surgical unit which supplies electrical energy to the working tip electrode end of the tool. A rigid arm extends between the sleeve and the working tip electrode and includes portions laterally offset from the main axis of the sleeve to increase visualization of the working tip electrode during surgery.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a magnetic resonance imaging apparatus of the type having a magnet with at least one patient receptacle and at least one support plate, as well as a predetermined number of transmit and/or receive coils, and which allows exposures with the subject in at least two predetermined exposure positions, with at least one exposure taking place using predetermined adjustment parameters. 2. Description of the Prior Art In known magnetic resonance imaging apparatuses, for different exposure positions the associated exposure parameters must in general be modified at least partially. The exposure parameters that may have to be modified include e.g. the position of the support plate and the connection or disconnection of transmit and/or receive coils. As a rule, a modification of the exposure parameters requires a readjustment of the magnetic resonance imaging apparatus. The adjustment essentially serves to optimize the RF chain (transmit and receive coils and associated amplifiers) and to optimize the homogeneity of the main magnetic field produced by the magnet (also called the basic magnetic field or B 0 field) in a volume under examination (imaging volume) located inside the patient receptacle. Due to the necessary homogeneity of the examination volume, this volume is also called the homogeneity volume. The exposure parameters are also patient-dependent, since the patient represents an attenuation or damping for the transmit and/or receive coils. A precise adjustment thus also serves for patient safety with respect to the RF exposure. In general, known magnetic resonance imaging apparatuses recognize automatically whether the. exposure parameters belonging. to particular exposure positions must be modified, and carry out a readjustment if warranted. This adjustment normally requires 10 to 90 seconds per exposure position. Given certain examination procedures, this time is not available. This includes e.g. the tracking of doses of contrast agent over a larger body region that exceeds the available homogeneity volume of the nuclear spin resonance apparatus. In such cases, the patient must be guided by displacement of the support plate in a manner corresponding to the flow of contrast agent. If a smaller viewing field is not acceptable, the readjustment that is thereby required per imaging measurement (exposure) requires a multiple dosage of contrast agent, which is not desirable for the patient. Alternatively to a smaller viewing field or to multiple injections of contrast agent, it is possible after the first adjustment to omit the further adjustments (readjustments) inherently required for high-contrast exposures. However, this leads to a considerable worsening of the image quality. SUMMARY OF THE INVENTION An object of the present invention is to provide magnetic resonance imaging apparatus of the type described above that provides high-contrast exposures in a short time, even given an examination of larger body segments. This object is achieved in accordance with the principles of the present invention in a magnetic resonance imaging apparatus having a magnet and at least one patient receptacle and at least one support plate, as well as a predetermined number of transmit and/or receive coils. At least in two predetermined exposure positions, an exposure respectively takes place using predetermined adjustment parameters. The required adjustment parameters are inventively determined in a preceding adjustment process, and the exposures are executed in a subsequent exposure process. For example, the exposure parameters can be modified by means of a spatial modification of position (longitudinal displacement, transverse displacement, rotation) of the support plate within the patient receptacle. Alternatively, or in addition, a modification of the adjustment parameters can take place by connection and/or disconnection of the transmit coils and/or the receive coils. In the inventive magnetic resonance imaging apparatus, the required adjustment parameters are not determined immediately before each individual exposure, as is conventional. Rather, the required adjustment parameters are determined in an adjustment process that precedes the exposure process. Only after the determination of the required adjustment parameters are the exposures carried out, in a separate imaging exposure process. The adjustment parameters are of course stored at least until the conclusion of the examination. The adjustment parameters thus can be used again, when identical or suitably similar exposure parameters (position of the support plate and configuration of the transmit and/or receive coils) are again reached in the context of the same examination. In examinations with the inventive apparatus, high-contrast exposures are thus obtained, since it is not necessary to omit an adjustment. Due to the fact that the adjustment is carried out in a separate adjustment process, and the adjustment parameters are stored until the conclusion of the examination, the transmit and receive coils, or their coil elements, can be switched quickly during the examination, so that, in addition, reduced examination times result. The inventive solution is suitable for a large number of different forms of magnetic resonance imaging apparatuses. Thus, for example, the magnet can be fashioned as a cylindrical magnet (solenoid) or as a horseshoe magnet (C-arm apparatus). Given cylindrically shaped magnets, the patient receptacle is fashioned as a patient tube. DESCRIPTION OF THE DRAWING FIG. 1 is a schematic block diagram of a magnetic resonance imaging apparatus constructed and operating in accordance with principles of the present invention. FIG. 2 schematically illustrates an embodiment of an apparatus in accordance with the invention, wherein the magnet which generates the basic magnetic field is a horseshoe magnet. FIG. 3 schematically illustrates an embodiment of an apparatus in accordance with the invention, wherein the magnet which generates the basic magnetic field is a cylindrical magnet. DESCRIPTION OF THE PREFERRED EMBODIMENTS The apparatus in FIG. 1 has a support plate 1 that is arranged in longitudinally placeable fashion inside an examination volume of a magnet. Within the scope of invention, the magnet can for example a cylindrical magnet 18 as shown in FIG. 3 (solenoid) or a horseshoe magnet (C-arm) 19 as shown in FIG. 2 . Given cylindrically shaped magnets, the patient receptacle is fashioned as a patient tube as own in FIG. 3 . The longitudinal displaceability of the support plate 1 is indicated with a double arrow 2 . Due to the longitudinal displaceability of the support plate 1 , larger body sections of a patient 3 lying on the support plate 1 can be examined. The nuclear spin resonance apparatus shown in the drawing additionally has a predetermined number of transmit coils 4 and a predetermined number of receive coils 5 . The transmit coils 4 can be connected, in a desired configuration, to a generator 7 by means of a transmit coil changeover switch 6 . The generator 7 supplies the transmit coils 4 with current via a-transmit amplifier 8 and via a matching element 9 . The receive coils 5 can be connected, in a desired configuration, to a receiver 11 by means of a receive coil changeover switch 10 . The signals of the connected receive coils 5 are given to the receiver 11 via. a matching element 12 and via a receive amplifier 13 . The configurations of the transmit coils 4 and the receive coils 5 , defined by the transmit coils changeover switch 6 and by the receive coils changeover switch 10 , are supplied to an adjustment unit 14 as inputs. As a further input, the position of the support plate 1 , which is determined by a position sensor 15 , is supplied to the adjustment unit 14 . The adjustment unit 14 processes the inputs that it has received from the transmit coils changeover switch 6 , from the receive coils changeover switch 10 , and from the position sensor 15 , and at its output supplies corresponding control signals to the generator 7 , to the transmit amplifier 8 , to the matching elements 9 and 12 , as well as to the receive amplifier 13 and to the receiver 11 . In addition, the adjustment unit 14 supplies a control signal to a shim coil system 16 . The inputs and the control signals (outputs) are stored, as adjustment parameters, in a memory 17 until the conclusion of the examination. With the embodiment shown in the drawing of the inventive apparatus, larger bodily segments of the patient 3 can be examined. Such examinations are, for example, the tracking of doses of contrast agent over a larger body region, as carried out for example in subtraction angiography or in physiologically controlled imaging. In the context of the preparation for measurement, which in the case of a peripheral angiography at the leg, includes slice positioning along the vascular tree, several measurements are already made without contrast agent. Due to the homogeneity volume of the magnet being too small, in these measurements the support plate 1 must be displaced, and so must be newly adjusted. The associated adjustment parameters for each position of the support plate 1 are stored in the memory 17 . As additional adjustment parameters, the connected configuration of the transmit coils 4 , as well as the connected configuration of the receive coils 5 , are stored in the memory 17 . In addition, the adjustment parameters include the corresponding control signals for the generator 7 , for the transmit amplifier 8 , for the matching elements 9 and 12 , as well as for the receive amplifier 13 , for the receiver 11 and for the shim coil system 16 . After the conclusion of the measurement preparation, which includes the determination of the adjustment parameters, the support plate 1 is guided back into the initial position, and the contrast agent is administered. In the imaging measurement that now takes place, each of the positions of the support plate 1 used in the measurement preparation is newly set in succession, and the transmit coils 4 and the receive coils 5 are connected as in the measurement preparation. Subsequently, an imaging measurement (exposure). is immediately carried out with the known adjustment parameters stored in the memory 17 , i.e. without a new adjustment. In the inventive apparatus, the required adjustment parameters are thus not determined immediately before each individual imaging measurement; rather, the required adjustment parameters are completely determined in a preceding adjustment process, in the context of the measurement preparation. According to the invention, the adjustment process thus precedes the exposure process. Only after the determination of the required adjustment parameters are the exposures (imaging measurement) carried out, in a separate exposure process. In examinations with the inventive apparatus, high-contrast exposures. are thereby obtained, since it is not necessary to omit an adjustment. In addition, due to the fact that the adjustment parameters are stored in a memory 17 until the conclusion of the examination, reduced examination times result. Due to the short examination times, in subtraction angiography the course of the contrast agent can thus be tracked without chronological gaps. Although modifications and changes may be suggested by those skilled in the art, it is the intention of the inventors to embody within the patent warranted hereon all changes and modifications as reasonably and properly come within the scope of their contribution to the art.

A magnetic resonance imaging apparatus has a magnet with at least one patient receptacle and at least one support plate, as well as a predetermined number of transmit and/or receive coils. In at least two predetermined exposure positions, at least one exposure respectively takes place using predetermined adjustment parameters. High-contrast exposures can be obtained in a short time, by the required adjustment parameters being determined in a preceding adjustment process, and the exposures are carried out in a subsequent exposure process.

BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to medical or surgical instruments and particularly to instruments for use in female sterilization or occlusion procedures. 2. Description of the Prior Art In the field of female sterilization, it is well known to provide permanent occlusion of the fallopian tube. More recently, the concept of using a fimbrial prosthesis for temporary or reversible female sterilization has been introduced. Capping the fimbria for sterilization involves the utilization of an inert device to protect the fimbria. U.S. Pat. No. 4,050,488 relates to use of fimbrial caps as a method of reversible sterilization. A paper entitled "The Fimbrial Prosthesis" was presented at a workshop held in San Francisco, Dec. 4-6, 1977, and gives further background and research in the area of reversible female sterilization. It is to this method of sterilization that the present invention instrument is directed. More specifically, the invention aims to provide an improved instrument for installing bands or hoods in occlusion procedures. SUMMARY OF THE INVENTION A forcep-like instrument is provided for mounting and ejecting either an elastic band or a hood for an occlusion procedure. One resilient leg of the device mounts a hollow open ended tube into which the fallopian tube or polypoid structure is drawn. The other somewhat shorter resilient leg is connected by a linkage to a collar which slides on the tube and ejects the band or hood for occluding the fallopian tube or polypoid structure. DESCRIPTION OF THE DRAWINGS FIG. 1 is a pictorial view of the instrument of the present invention being held by the operator and with a fimbrial hood about to be placed on the instrument prior to its application to the patient. FIG. 2 is a front elevation view of the instrument of the present invention. FIG. 3 is a side elevation view of the instrument of FIG. 2. FIG. 4 is an enlarged, fragmentary section view through the hood mounting and ejection mechanism with a fimbrial hood of a type employed with the present invention instrument in place. FIG. 5 is a view similar to FIG. 4 but with the fimbrial hood having been inverted and drawn into the hood mounting sleeve and with the fimbria of the fallopian tube of the patient being delivered into the fimbrial hood. FIG. 6 is a view similar to that of FIGS. 4 and 5 but with the ejection mechanism activated forcing the fimbrial hood from its mounting sleeve onto the fallopian tube of the patient. FIG. 7 is a section view through the fimbrial hood after it is put into place and the instrument withdrawn allowing the fimbrial hood to encompass the fimbria and allowing movement of the fimbria within the hood preparatory to anchoring the hood in place with permanent sutures. FIG. 8 is a pictorial view of an elastomeric, silastic band of the type employed with the instrument of the present invention when permanent occlusion of any tubular or polypoid structure is desired. DESCRIPTION OF THE PREFERRED EMBODIMENT Turning now to the drawings, instrument 10 of the present invention is composed of a forcep body 11 having a pair of resilient legs 12, 13 secured to and extending from body 11; an open ended tubular sleeve member 14 integrally secured to a leg extension 13a; a linkage spring 15 having a pair of legs 16, 17; linkage mount 18; and ejection collar 19. Sleeve member 14 is integrally secured to leg extension 13a which is set at a predetermined angle "X" (FIG. 5) appropriate to use of the instrument and is shown as approximately 120°. Leg 13 is slightly longer in length than leg 12 so that sleeve 14 resides outwardly from the free end of leg 12. A mount 18 is integrally secured to the outer free end of leg 12 and comprises a small sleeve having a bore 20 extending throughout its length. Linkage spring 15 is formed so that it passes through mount 18 by way of bore 20 and its legs 16, 17 extend outwardly and at their outer ends are bent inwardly to resiliently engage ejection collar 19 and provide a pivotal connection. Ejection collar 19 is designed to be slidably received by sleeve member 14. Collar 19 moves freely on sleeve member 14 between extension 13a which acts as a stop and the outer end of travel on sleeve member 14. A pair of holes 21, 22 are formed in the walls of collar 19 and receive the ends of legs 16, 17 so that collar 19 is retained on sleeve member 14. In a relaxed position, collar 19 rests against leg extension 13a and prevents any movement past this position. When leg 12 is forced toward leg 13 by the fingers of the operator, mount 18 abuts against leg 13 and spring legs 16, 17 force collar 19 forward on sleeve member 14 to the hood or band ejection position seen in FIG. 6. Turning now to a description of the operation of instrument 10, instrument 10 as shown in FIGS. 1-6 receives a vacuum line 23 which is slidably mounted on the rear end of sleeve member 14. With ejection collar 19 in a retracted position, see FIGS. 1-3, a fimbrial hood 25 is placed on the forward, free end of sleeve member 14, see FIG. 4. In order to do this, shoulder 26 must be stretched over the free end of sleeve member 14 as best seen in FIG. 4. Once in position, shoulder 26 abuts against collar 19. Next, through application of vacuum through vacuum line 23, hood 25 is inverted to the position of FIG. 5. Sometimes, in addition to vacuum, hood 25 must be urged inward by the operator nudging hood 25 with some instrument at hand. Once hood 25 is in position adjacent fimbria 28 as in FIG. 5, fimbria 28 of fallopian tube 29 is guided into hood 25, see FIG. 5. Once fimbria 28 is positioned within hood 25, leg 12 is depressed causing spring legs 16, 17 and correspondingly collar 19 to move forward until shoulder 26 of hood 25 is forced from sleeve member 14 and engages fallopian tube 29. At this point, instrument 10 is withdrawn allowing hood 25 to regain its form as illustrated in FIG. 7. Hood 25 is now anchored in place on tube 29 by placing a sufficient number of sutures 35 through shoulder 26 and into tube 29. Another application of instrument 10, although not illustrated, would be for situations where permanent occlusion is desired. Such permanent occlusion may be desired for permanent sterilization, permanent occlusion of blood vessels or permanent occlusion of polyps. In this application, an elastomeric, silastic band 30 as illustrated in FIG. 8 is employed and mounted on sleeve 14 and is ejected in the same manner as previously described with respect to hood 25. The fact that the central axis of the longer leg member 13 resides at an obtuse angle with respect to the central axis of the sleeve member provides a convenient working arrangement. Also, the natural resiliency of the leg members 12, 13 is used to always bring the collar 19 to its retracted position. Thus, the invention instrument may be used rapidly and efficiently in an occlusion procedure.

A forcep-like instrument is provided for mounting and ejecting either an elastic band or a hood for an occlusion procedure.

FIELD OF THE INVENTION [0001] The present invention refers to a ventilation system for hospital respiratory devices that are used to administer anesthesia in patients. [0002] More specifically, the invention refers to a ventilation system used in a respiratory circuit with re-inhalation by means of an upstream bellows that is activated by a microprocessed electronic ventilator and provided with a fresh gas control system. [0003] The present invention is appropriate for the use in respiratory devices to administer anesthesia in newly born, pediatric and adult patients. [0004] Additionally, the ventilation system of the present invention controls appropriately, efficiently and safely the excess of gas inside the respiratory circuit, thus eliminating the waste of fresh gas, promoting more efficient and safe breathing to patients, and not requiring harmful efforts for the respiratory cycle. BACKGROUND OF THE INVENTION [0005] The inhalatory administration of anesthesia is made by means of a breathing circuit that makes the partial re-inhalation of gases exhaled by patients. The purpose is to reduce the consumption of anesthesia, such as halogenated agents, because human organism absorbs only a small quantity of anesthesia at each respiratory cycle. Furthermore, said respiratory circuits have the purpose to reduce the environmental pollution caused by the exhaustion of said agents. [0006] Ventilation systems for anesthesia that uses respiratory circuits with re-inhalation, are different from those used, for example, in intensive care units, in which the gas controlled by the ventilation system is the same gas inhaled by the patient during the inhalation stage, and the gas is exhaled to the environment at the exhalation stage. In cases which re-inhalation occurs, it is necessary to separate the gas inhaled by the patient from the control gas in order to avoid eventual contamination of the re-inhaled air. [0007] Since the invention refers to a ventilation system for respiratory circuits with re-inhalation, the description below will focus more specifically on this kind of application. Therefore, as known by those skilled in the art, the gas contained in the respiratory circuit, which is inhaled by patients, is constituted by a portion of re-inhaled gas and by a portion of fresh gas continually introduced to the circuit. [0008] The respiratory circuit is initially full filled with fresh gas and at that time the re-inhalation process starts with the reposition of a fraction of the gas contained in the circuit by continuously-feeding fresh gas. The concentration of this gas is controlled by a set of flowmeters that uses oxygen and nitrous oxide. The flowmeters are associated with a calibrated vaporizer that adjusts the concentration of anesthesia agents, such as isoflurane, sevoflurane, enflurane or desflurane. [0009] Re-inhalation circuits used in the devices of the state of the art continuously feed fresh gas into the respiratory circuit. The fresh gas is collected in an expandable bag or bellows, depending on the selection of the type of ventilation system that may be manual, by means of the bag, or automatic, by means of a ventilator. Said selection is usually made by means of a manual/ventilator selecting valve. [0010] In summary, in the manual ventilation system, the anesthesia physician presses the bag and, due the presence of two unidirectional valves, the gas is directed to the patient through the inhaling branch of the circuit and passes through a carbon dioxide (CO 2 ) absorber. When the anesthesia physician stops pressing the bag, the gas exhaled by the patient returns to the bag through the exhaling branch. Therefore, the unidirectional valves guides the direction of the flow during patient's inhalation and exhalation, forcing the gas to pass through the carbon dioxide (CO 2 ) absorber before patient's re-inhalation. [0011] Usually, an adjustable pressure-limiting valve allows the release to the atmosphere of the excess of gas inside the circuit through an appropriate exhaustion system, since the circuit is continuously fed with fresh gas. [0012] In the automatic ventilation system, the bellows is filled in and the respiratory circuit is pumped by the control gas introduced by the ventilator into a rigid reservoir, in which said bellows is assembled. Therefore, during exhalation, the ventilator depressurizes the internal area of the rigid reservoir through an exhaling valve, thus allowing the gas exhaled by the patient to accumulate inside the bellows. Usually, said bellows is placed to act upwardly, i.e. the filling in of the bellows lifts up its free extremity in order to overcome its own weight. [0013] Since respiratory circuits with re-inhalation are continuously fed with fresh gas, the devices of the state of the art usually release the excess of gas in the respiratory circuit through a release valve, which is passive and placed in the bellows set. The purpose of this valve is to alleviate the excess of gas inside the respiratory circuit after the bellows is fully filled in, in order to avoid the excess of circuit pressurization above the previously set up pressure value. [0014] These release valves as known in the state of the art represents a dead weight, which is enough to generate a pressure, around 3 to 5 hPa that is higher than the weight of the bellows, which statically weights about 2 to 3 hPa. Therefore, in the inhaling stage, the release channel is closed, usually by the action of a diaphragm, in order to isolate said release valve and to allow the pressurization of the respiratory circuit. However, at the start of the exhaling stage, when the release channel is already open, there is a pressure peak due the exhaling pressure peak and inertia of the bellows, thus making the pressure inside the bellows higher than the pressure achieved under static conditions. This overpressure is enough to open the release valve. Consequently, there is gas leakage before the bellows is fully filled in. This is very undesirable because inhibits the use of low fresh gas flow and requires the reposition of flow above the clinically desired level. There are many advantages in the use of low fresh gas flow in respiratory circuits to administer anesthesia, especially regarding safety, saving of costs, environmental and clinical aspects, as those skilled in the art can appreciate it. [0015] Furthermore, the release systems of the state of the art present another inconvenience. There is dependence between the fresh gas flow and the residual pressure resulted in the respiratory circuit, i.e. the higher the fresh gas flow, the higher will be the residual pressure in the circuit. This makes the more difficult ventilator synchronism with the spontaneous breathing of the patient, consequently increasing the respiratory work and compromising hemodynamics, especially for cardiopathic patients. [0016] The patents U.S. Pat. No. 5,398,675 and U.S. Pat. No. 5,507,280 disclose a release system activated by a shaft in contact with a flexible bag. However, this system is not appropriate for newly born and pediatric applications, since it promotes undesirable positive pressure during system operation. This inconvenience is caused by the fact that there is no constant relationship between the volume of the flexible reservoir and the position of its flexible wall, as well as between the sensor's contact area and consequently the force exerted by the bag and the required force to activate the release system. [0017] The patent U.S. Pat. No. 5,678.540 discloses a system which purpose is to improve the pressure control inside the bellows and the reservoir, in order to allow the ventilation under controlled pressure. However, said system uses a conventional passive release valve of the state of the art, which is the same as those previously disclosed. [0018] Another inconvenience disclosed by the devices of the state of the art relates to the valve for the free flow of oxygen, which purpose is to quickly replace or renew the gas inside the respiratory circuit. Usually, when manually pressed, said values control a free flow of 30 to 40 l/min of oxygen without anesthetic agent. However, in automatically configured respiratory circuits, said free flow of oxygen may cause excessive increase of volume and pressure sent to the patient and may cause serious damage to the respiratory system or even to patient's hemodynamic. [0019] This kind of valve is observed in the patent U.S. Pat. No. 5,678,537, which discloses a system to avoid the increase of pressure in the respiratory circuit by means of an activated valve for the free flow of oxygen during the inhaling stage of the respiratory cycle. In this system, the respiratory cycle is interrupted whenever the valve for the free flow of oxygen is activated, opening the exhaling valve. However, despite eliminating the risk of pressure trauma caused by the overlaying of the respiratory cycle and the activation of the free flow of oxygen, this alternative interferes with the lung ventilation of the patient and may cause a reduction of oxygenation (hypoxia) and/or increase of CO 2 retention (hypercapnia), which may compromise the health of patients. [0020] Therefore, it is verified that the ventilation systems of the state of the art have serious inconveniences to patients, especially because they do not meet the technical and medical requirements for the administration of anesthesia through respiratory circuits with re-inhalation, since they can generate inefficient and dangerous gas flow to patient's respiratory system. SUMMARY OF THE INVENTION [0021] Therefore, it is an object of the present invention to provide a ventilation system for respiratory devices with re-inhalation, more specifically for the administration of anesthesia to newly born, pediatric and adult patients that overcomes all problems and inconveniences existing in the ventilation systems of respiratory devices of the state of the art. [0022] Another object of the present invention is to provide a ventilation system for respiratory circuits with re-inhalation that promotes an effective control of the excess of fresh gas, as well as the control of the internal pressure of the respiratory circuit. The present invention can also adequate the respiratory circuit to the spontaneous breathing of patients, not requiring efforts from the respiratory system, besides providing an appropriate and controlled respiratory cycle to patients. [0023] It is also a further object of the invention to provide a valve for the free flow of oxygen that actuates synchronously with the exhaling stage of respiratory cycles, in order to eliminate the risks of pressure trauma without intervening in the lung ventilation of patients. [0024] The system of the present invention may be preferably used in a respiratory device to administer anesthesia with re-inhalation provided with a carbon dioxide (CO 2 ) absorbing system, which in turn is the object of another patent application filed by the applicant under the serial number BR PI 0305789-5, filed on Nov. 17, 2003. BRIEF DESCRIPTION OF THE DRAWINGS [0025] These and other objects, enhancements and effects of the ventilation system object of this invention will be apparent for those skilled in the art from the detailed description below with relation to the attached figures that illustratively represent: [0026] FIG. 1 illustrates a schematic diagram of the respiratory cycle with re-inhalation of a device with a ventilation system according to the present invention; [0027] FIG. 2 illustrates a detailed sectional view of the bellows and reservoir set of the ventilation system according to the present invention; [0028] FIG. 3 shows an alternative embodiment of the bellows and reservoir set according to the present invention, for the application in newly born treatments; [0029] FIG. 4 shows a detailed sectional view of the manifold of the bellows and reservoir set according to the present the invention; [0030] FIG. 5 shows a detailed sectional view of an alternative embodiment of the manifold according to the present invention; and [0031] FIG. 6 shows a detailed sectional view of the valve for the free flow of oxygen according to the present invention. DETAILED DESCRIPTION OF THE INVENTION [0032] The FIG. 1 , as mentioned above, shows a schematic diagram of the respiratory cycle with re-inhalation of a respiratory device provided with the ventilation system of the present invention. As illustrated in FIG. 1 , the fresh gas coming from the anesthesia equipment ( 1 ), that adequately adjusts the composition of gases and the concentration of anesthetic agents, is introduced in the respiratory circuit through the fresh gas inlet ( 2 ). The gas is collected in a bag ( 3 ) or bellows ( 4 ), depending on the application requirements and according to the position of the selecting key ( 5 ), which determines the mode of operation of the device: manual or automatic through a lung ventilator ( 6 ). [0033] In case the selecting key ( 5 ) is in the manual position, the bag ( 3 ) is filled in with gas, so that the anesthesia physician or any other specialist may manually pump the gas to patient. When the bag is pressed, the gas passes through a carbon dioxide absorber ( 7 ), through the inhaling unidirectional valve ( 8 ), through the inhaling tube ( 9 ), and insufflates the lung of the patient. When the anesthesia physician releases the bag ( 3 ), the gas exhaled by the patient passes through the exhaling tube ( 10 ), through the unidirectional exhaling valve ( 11 ), and returns to the bag ( 3 ). The purpose of the unidirectional valves ( 8 ) ( 11 ) is to force the passage of the gas flow through the carbon dioxide absorber ( 7 ) before the re-inhalation by the patient. For this case, an adjustable pressure limit valve ( 12 ) releases to the environment the excess of gas within the respiratory circuit by means of an appropriate exhaustion system ( 13 ), since the fresh gas is continuously fed within the circuit. [0034] In case the selecting key ( 5 ) is in the ventilator/auto mode, the respiratory circuit works analogously to the manual mode. However, pumping is made by the bellows ( 4 ), which is filled in through the exhaling valve ( 21 ) by the route ( 14 ). Pumping is made through the lung ventilator ( 6 ) that pressurizes the internal side of the rigid reservoir ( 15 ), where said bellows ( 4 ) is assembled, through the inhaling route ( 16 ). In this case, the control of gas excess is made by a set of release valves, which comprises a release valve ( 17 ) activated by said bellows ( 4 ) and a release valve ( 18 ) activated by the lung ventilator ( 6 ) through the route ( 26 ). Said release valves ( 17 ), ( 18 ) are activated during the exhaling stage. This allows the excess of gas located inside the circuit to escape and to avoid circuit pressurization with values above the set up exhaling pressure value. [0035] The inhaling stage of the respiratory circuit starts with the ventilator ( 6 ) sending inhaling flow through the routes ( 16 ), ( 19 ), and ( 20 ) into the rigid reservoir ( 15 ). At the same time, the exhaling valve ( 21 ) and the release valve ( 18 ) are closed in order to pressurize the internal side of the rigid reservoir ( 15 ) and to compress the bellows ( 4 ). Through the ventilation system according to the present invention, all parameters controlled by the lung ventilator ( 6 ), such as flow, pressure and volume, are fully transmitted to the gas located inside the bellows ( 4 ) and consequently transmitted to the gas flow inhaled by the patient. For these reasons, the ventilation system of this invention can be used in various modes of ventilation, including but not limited to Volume Control Ventilation—VCV, Pressure Control Ventilation—PCV, Pressure Support—PSV, VAPS, APRV, PAV, etc. [0036] After the end of the inhaling stage, the exhaling stage starts. In this stage, the route ( 16 ) flow is closed, and the exhaling valve ( 21 ) and the release valve ( 18 ) are opened. The gas located inside the reservoir ( 15 ) is exhaled through the routes ( 20 ), ( 22 ), thus permitting the bellows ( 4 ) to expand up to the end of the exhaling stage of the patient. Said bellows ( 4 ) fully expands and activates the release valve ( 17 ), causing the exhaustion of the excess gas from the respiratory circuit through the routes ( 23 ), ( 24 ), ( 25 ) and through the release valve ( 18 ) activated by the ventilator ( 6 ). [0037] FIG. 2 illustrates the set constituted by the bellows ( 4 ) located upwardly within the reservoir ( 15 ) and by a manifold ( 27 ). Said bellows ( 4 ) is manufactured with flexible and sterilizable material, preferably silicone, which shape presents an accordion-like shape ( 28 ) to allow the expansion and contraction of the bellows ( 4 ) and thus offering low resistance and inertia. The base of said bellows ( 4 ) is provided with a ring-shaped opening ( 29 ) with circular cross section that is fitted in the base ( 30 ) of said rigid reservoir ( 15 ). The top of said bellows ( 4 ) is formed by a hard disk ( 31 ), preferably manufactured with aluminum with relatively small thickness, which is fitted under pressure through an external ring ( 32 ) in order to hermetically fix the accordion-like profile ( 28 ) to the hard disk ( 31 ), thus forming a flat and stable surface at the top of the bellows ( 4 ), as better observed in the detail of FIG. 2 . Furthermore, said external ring ( 32 ) has the purpose to avoid eventual mixing between the control gas and the gas inhaled by the patient. [0038] Therefore, the configuration of said bellows ( 4 ) permits the full transmission of all the pressure exerted over the external surface of the bellows to the gas of the respiratory circuit by the control gas inside the reservoir ( 15 ). Furthermore, it permits the inhaling effort exerted by the patient to be transmitted by the gas of the respiratory circuit to the control gas located inside the reservoir ( 15 ), thus not generating any resistance to the spontaneous breathing of the patient. [0039] Said reservoir ( 15 ) comprises a main body ( 33 ), a base ( 30 ) and a manifold ( 27 ). Said main body ( 33 ) is manufactured with a transparent material, preferably polycarbonate or acrylics. Said base ( 30 ) is provided with a first connection ( 35 ) to couple the re-inhalation tube (not shown) and a second connection ( 36 ) which is connected to the manifold ( 27 ) in the release valve ( 17 ) for the exit of excess gases. Said base ( 30 ) is fitted in the lower portion of the main body ( 33 ) by means of a pressure screw ( 37 ). The edge of the circular opening ( 29 ) of said bellows ( 4 ) is hermetically pressed between said base ( 30 ) and the main body ( 33 ) to avoid the mixing between the respiratory circuit gas and the control gas. [0040] The manifold ( 27 ) is assembled over the main body ( 33 ) by means of pins ( 38 ) located alongside the main body. The pins are fitted in indentations ( 39 ) located at the edge of said manifold ( 27 ), also provided with a sealing ring ( 40 ) to seal the main body ( 33 ) against the manifold ( 27 ). [0041] The volume capacity of the bellows ( 4 ) may vary according to the application. Bellows with varying capacity, for example from 250 to 1400 ml, are commonly used. For applications to newly born patients, the volume capacity should be small in order to minimize the total compressible volume of the respiratory circuit. FIG. 3 shows an alternative embodiment of the bellows ( 4 ) and reservoir ( 15 ) set, which presents a lower volume capacity than that shown in FIG. 2 , but keeping the same principle of operation. However, said set uses the same manifold ( 27 ) used for reservoirs with a higher volume capacity, since the diameter of the upper end of the reservoir (X) is equal to the diameter of the reservoir used in the embodiment shown in FIG. 2 . [0042] The ventilation system of the invention may be used in various applications. No matter which is the volumetric capacity of the gases in the respiratory circuit, it is just required the substitution of the bellows/reservoir set. [0043] FIG. 4 shows in detail said manifold ( 27 ), preferably of aluminum, comprising the exhaling valve ( 21 ) and the release valves ( 17 ), ( 18 ) responsible for the control of gas excess in the respiratory circuit. [0044] The exhaling valve of the control gas ( 21 ) comprises an air nozzle ( 41 ), which is opened and closed by means of the action of a flexible diaphragm ( 42 ), which in turn is activated by the pilot pressure through the gas inlet ( 43 ), with said pilot pressure being controlled by the lung ventilator ( 6 ) through a proportional solenoid valve and by an electronic control circuit provided with a pressure transducer, a microprocessor, and a PID control algorithm, such as those known by the man skilled in the art. [0045] In the inhaling stage, the lung ventilator ( 6 ) pressurizes the internal side of the reservoir ( 15 ) through the channel ( 44 ) in order to control the pilot pressure in the gas inlet ( 43 ), thus closing the air nozzle ( 41 ) and consequently closing the exhaustion channel ( 45 ). In the exhaling stage, the pilot pressure at the gas inlet ( 43 ) will be reduced, thus permitting said flexible diaphragm ( 42 ) to open the air nozzle ( 41 ) and permitting the control gas to be exhausted through the channel ( 44 ), through the air nozzle ( 41 ), and through the channel ( 45 ). In this stage, it is possible to control the pilot pressure with the purpose to keep a positive pressure over the bellows ( 4 ), which is called PEEP (Positive End Expiratory Pressure). [0046] The control of gas excess in the respiratory circuit is made by means of the release valves ( 17 ), ( 18 ). Each one of them is responsible for a control stage. More specifically, the first stage is performed by the valve ( 17 ), which is activated by the bellows ( 4 ) and comprises a cursor ( 46 ) which higher end is supported, under the action of a spring ( 47 ), over an air nozzle located within said manifold ( 27 ), and which lower end is supported over a flexible diaphragm ( 49 ). A second cursor ( 50 ) is assembled at the opposite side of the flexible diaphragm ( 49 ), which projects to the internal side of the reservoir ( 15 ) and has a disk ( 51 ) in its free end, which contacts the bellows ( 4 ). [0047] Therefore, when the bellows ( 4 ) is fully filled in, the hard disk ( 31 ), located at the top of the bellows ( 4 ), touches the disk ( 51 ) of the cursor ( 50 ) and consequently activates the cursor ( 46 ) that opens the air nozzle ( 48 ), thus permitting the passage of the flow of gas excess from the inlet channel ( 52 ) to the outlet channel ( 53 ) and conducing the gas to the release valve ( 18 ) responsible for the second control stage. Said inlet channel ( 52 ) is connected to the outlet connection for gas excess ( 36 ) located at the base ( 30 ) of the reservoir ( 15 ). Furthermore, said diaphragm ( 49 ) safely separates the control gas located inside the reservoir ( 15 ) from the gas coming from the inlet channel ( 52 ), which is the excess of gas exhaled by the patient coming from the respiratory circuit. Therefore, the mixing between gases is inhibited and consequently a safe and healthy respiratory circuit is obtained. [0048] The second stage is made by the release valve ( 18 ), similar to the exhaust valve of the control gas ( 21 ). The lung ventilator ( 6 ) also controls the release valve by the pilot pressure in the channel ( 54 ), which is equal to the pilot pressure of the channel ( 43 ). The release valve ( 18 ) is also provided with a flexible diaphragm ( 55 ) that closes and opens an air nozzle ( 56 ) according to the pilot pressure in the channel ( 54 ). [0049] During the inhaling stage, the lung ventilator ( 6 ), through the channel ( 44 ), sends control gas flow into the reservoir ( 15 ) simultaneously closing air nozzles ( 41 ) and ( 56 ) through the flexible diaphragms ( 42 ), ( 55 ) and consequently pressurizing the reservoir ( 15 ), compressing said bellows ( 4 ) and the gas contained inside it. The gas is pumped to the patient, passing through the carbon dioxide absorbing system, through the inhaling unidirectional valve and insufflating patient's lung. [0050] As previously explained, during the exhaling stage, the pilot pressure in the channel ( 43 ) is reduced, and consequently the pilot pressure of the channel ( 54 ) is also reduced. The pressure within diaphragms ( 42 , 55 ) remain reduced, thus allowing the opening of the air nozzles ( 41 , 56 ) and allowing the control gas exhalation through the channels ( 44 , 55 ) and the interconnection of the channels ( 53 , 57 ). However, the first stage to control the excess of gas remains closed due the force of the spring ( 47 ) that acts over the cursor ( 46 ) of the release valve ( 17 ). The air nozzle ( 48 ) remains closed and inhibits the exhaustion of the excess of gases through the channels ( 53 ), ( 57 ). Therefore, only when the bellows ( 4 ) is fully filled in, the hard disk ( 31 ) located on its top will activate the cursor ( 50 ), which will move the cursor ( 46 ) to open the air nozzle ( 48 ) to allow the passage of the excess of gas between the first stage and the second stage through the channels ( 53 , 57 ). [0051] The valve ( 18 ) of the second stage is controlled by the same pilot pressure of the exhaustion valve for the control gas ( 21 ). For this reason, the exhaustion pressure of the control gases and consequently the pressure inside the bellows is the same pressure kept by the ventilator inside the reservoir. This system allows the set up exhaling pressure value to be kept no matter which is the supplied fresh gas flow value, thus keeping the ventilation base line and allowing the spontaneous breathing of the patient with no additional effort to balance an eventual intrinsic PEEP. [0052] In an alternative embodiment of the manifold ( 27 ), as shown in FIG. 5 , the control of gas excess is made by one stage. The control is formed by the release valve ( 58 ), which comprises an air nozzle ( 59 ) supporting a flexible diaphragm ( 60 ) activated by the pilot pressure through the channel ( 61 ), no matter which is the pilot pressure supplied through the channel ( 43 ) of the control gas exhaustion valve ( 21 ). In this case, the pilot pressure in the channel ( 61 ) is controlled by means of a second proportional solenoid that keeps the channel ( 62 ) closed during the inhaling stage. During the exhaling stage and only after the patient fully exhales, the air nozzle ( 59 ) is opened to allow the flow of gas excess to pass through the exhaustion channel ( 63 ). [0053] The release valve ( 58 ) opens in a proportionally manner depending on the monitoring of the internal pressure increase of the respiratory circuit. The monitoring in turn is made by means of a pressure transducer, since it is required to keep the pressure in the circuit at the same value of the PEEP set up exhaling pressure value, in order to balance the pressure exerted by the weight of said bellows ( 4 ) itself. The full exhalation by the patient can be monitored, for example, by means of a specific device, such as a pneumotacograph located at the “Y” connection of the patient or even in the exhaling route. [0054] Therefore, the release system for the excess of gases in the respiratory circuit of the invention solves the problems described in the state of the art, thus eliminating the risk of gas escape during the start of exhalation, besides keeping minimum residual pressure, of about 1 hPa, even by using high flow of fresh gas. [0055] Additionally, the ventilation system of the present invention comprises a valve for the free flow of oxygen ( 64 ) provide with a solenoid valve ( 69 ) which is activated by the lung ventilator ( 6 ) synchronously with the inhaling stage of the respiratory cycle of the patient. The purpose of this valve ( 64 ) is quickly renewing the gases inside the respiratory circuit. [0056] The valve for the free flow of oxygen ( 64 ) is constituted by two stages, a pilot ( 65 ) and a main one ( 66 ). Oxygen is fed through the channel ( 67 ) to the main stage and through the channel ( 68 ) by the “usually open” route of the solenoid valve ( 69 ), which is itself connected to the pilot stage through the channel ( 90 ) which in turn is interconnected to the manual activating valve ( 71 ). [0057] The oxygen flow to the respiratory circuit is released through the channel ( 72 ) and occurs simultaneously when the solenoid ( 69 ) is turned off and the cursor ( 73 ) is manually activated by the key ( 74 ), therefore overcoming the spring ( 75 ) pressure and consequently allowing the oxygen flow between the channel ( 70 ) and the chamber ( 76 ). Hence, the activation of the pressure of the pilot stage over the diaphragm ( 77 ) causes the movement of the cursor ( 78 ), overcoming the force of the spring ( 79 ) and interconnecting the inlet ( 67 ) and outlet ( 72 ) channels of the main stage. [0058] The manual valve ( 71 ) is closed by the action of the spring ( 75 ) over the cursor ( 73 ) and by the depressurization of the chamber ( 76 ), which occurs through the restrictor ( 80 ) located in the channel ( 81 ), thus closing the main stage due to the action of the spring ( 79 ) under the cursor ( 78 ). The solenoid ( 69 ) is activated by the lung ventilator ( 6 ) synchronously with the inhaling stage of the respiratory cycle of the patient, i.e. during the inhaling stage. The feeding of oxygen through the channel ( 70 ) is interrupted and consequently the pilot pressure over the diaphragm ( 77 ) and the flow of oxygen through the outlet channel ( 72 ) is interrupted, even if the pilot stage had been manually activated. [0059] The valve for the free flow of oxygen of the present invention remains in operation even in the lack of power supply, thus allowing its operation for example by means of manual ventilation. This promotes a better safety during the administration of anesthesia, since it is possible to work even in case of lack of power supply or failure in the electronic system of the equipment. The synchronization of the free flow of oxygen during the exhaling stage avoids the risks of the equipments of the state of the art, allowing the operator to activate the flow at any moment of the ventilation, without the need to change the controlled standards, such as the respiratory frequency, and without need to interrupt the ventilation.

The present invention refers to a ventilation system used in hospital respiratory devices for the administration of anesthesia to newly born, pediatric and adult patients. More specifically, the present invention refers to a ventilation system that promotes a respiratory circuit with re-inhalation for the administration of anesthesia and that overcomes all inconveniences and deficiencies existing in respiratory devices of the state of the art. The ventilation system in respiratory devices comprises a bellows assembled within a reservoir, which is provided with a manifold with various gas exhaling valves, more specifically release valves to take out the excess of gases, and an exhaling valve for control gases. It is additionally constituted of a valve for the free flow of oxygen to quickly renew or replace the gases inside the respiratory circuit.

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 14/266,495 titled “Interactive Massaging Device”, filed on Apr. 30, 2014 which is a continuation of U.S. patent application Ser. No. 13/858,286 titled “Interactive Massaging Device,” filed Apr. 8, 2013 now U.S. Pat. No. 8,747,337 issued on Jun. 10, 2014, which is a continuation of U.S. patent application Ser. No. 13/606,966, filed Sep. 7, 2012, now abandoned, which is a continuation of U.S. patent application Ser. No. 12/723,426 titled “Interactive Massaging Device,” filed Mar. 12, 2010, now U.S. Pat. No. 8,308,667 issued on Nov. 13, 2012, all the contents of which are incorporated by reference herein in their entirety. BACKGROUND The present invention relates to massaging apparatus, and more particularly to sexual stimulation devices. Sexual stimulation devices of the prior art include dildos that have vibratory elements such as disclosed in U.S. Application Publication No 2002/1013415 and International Publication No. WO 2007/041853. It is also known to provide controls for various modes of operation. However, it is believed that none of this class of devices of the prior art has proven entirely satisfactory, for a variety of reasons. For example, manipulation of controls by the user to produce changes in operation tends to detract from desired effects to be obtained from the device. Thus there is a need for a massaging apparatus that provides improved stimulation without requiring a user to manipulate controls for producing changes in operation. SUMMARY The present invention meets this need by providing a vibratory massaging device that automatically changes in operation in response to proximity and/or contact between body parts to be massaged and particular locations on the device. In one aspect of the invention, the device includes a housing; a vibrator supported in the housing; a spaced plurality of proximity sensors supported in the housing; and a control circuit connected between the proximity sensors and the vibrator for driving the vibrator at plural predetermined levels in response to particular ones of the proximity sensors coming into close proximity with user's body parts being massaged by the device. The device can further include means for receiving a battery element within the device for powering the vibrator and the control circuit, and a removable cap for enclosing the battery element within the device. The device can further include the battery element, which can itself include a battery pack. The device can also include a control button supported by the cap for activation of the control circuit. The massaging device can be formed having a main outside surface defining a substantially cylindrical shape, being rounded at one end thereof, the proximity sensors being positioned proximate the outside surface and longitudinally disposed. The device can further include a sleeve covering the housing and defining the main outside surface. The means for receiving a battery element can include the removable cap forming a rounded end portion of the device opposite the one end, and the control button being coaxially located by the cap. The control circuit is preferably operative for powering the vibrator at a first, low intensity when a first one of the proximity sensors is activated, and at a second, medium intensity when a second one of the proximity sensors is activated for enhanced massaging effectiveness in response to operator manipulation. More preferably, the control circuit is further operative for powering the vibrator at a third, higher intensity when a third one of the sensors is activated. Preferably the main outside surface has a shape of an erect penis for forming vibratory dildo. Preferably the vibrator is a main vibrator, the elastic sleeve further including a laterally projecting arm portion, the dildo further having a secondary vibrator enclosed in the arm portion, the control circuit being further operative for powering the secondary vibrator. Preferably the dildo includes mode control means for operator control of plural modes of operation of the control circuit. The mode control means can include a mode actuator, the control circuit being responsive to successive operations of the mode actuator for activation in each corresponding mode. The modes can include a first mode of operation wherein both vibrators are inactive unless at least one of the proximity sensors is activated, and a second mode, at least one of the vibrators being activated otherwise; and a second mode wherein at least one of the vibrators is activated at a higher intensity than that in which it is activated in the first mode. There can be first and second ones of the proximity sensors, the first proximity sensor being located between the second proximity sensor and a head extremity of the sleeve, the second mode being activated in response to the second sensor. Preferably there can be a third one of the proximity sensors, the third proximity sensor being located beyond the second proximity sensor from the head extremity of the sleeve, a third mode being activated at an even higher intensity than that of the second mode in response to the third sensor. DRAWINGS These and other features, aspects, and advantages of the present invention will become better understood with reference to the following description, appended claims, and accompanying drawings, where: FIG. 1 is a lateral sectional view of a massaging device according to the present invention; FIG. 2 is a block diagram of a control circuit for the dildo of FIG. 1 ; FIG. 3 is a schematic diagram of the control circuit of FIG. 2 ; FIG. 4 is a lateral side sectional view showing an alternative configuration of the device of FIG. 1 in the form of a dildo; FIG. 5 is a front side view of the dildo of FIG. 4 ; FIG. 6 is a block diagram of a control circuit for the dildo of FIG. 4 ; FIG. 7 is a schematic diagram of the control circuit of FIG. 6 ; and FIG. 8 are graphic representations of the intensity levels generated by the different modes of operation of the massaging device of the present invention. DESCRIPTION The present invention is directed to a massaging device that is particularly effective in stimulating body parts such as female genitalia. With reference to FIGS. 1-3 of the drawings, a massaging device 10 includes a motorized vibrator 12 mounted in an elongate housing 13 , a screw-on cap 14 detachably connected to the housing and having a control button 15 projecting therefrom, a battery pack 16 inserted within the housing, a control module 18 and a sensor module 20 mounted in the housing and including a sensor circuit board 21 supporting a longitudinally distributed plurality of sensor elements 22 according to the present invention, the elements being individually designated 22 A, 22 B, and 22 C, the element 22 C being closest to the control button 15 , the element 22 A being closest to the opposite end of the device 10 . The housing 13 is also covered with a sleeve 24 , and the assembly is sealed with an elastic O-ring 25 interposed between the sleeve and the cap 14 . In the exemplary configuration shown in the drawings, the device 10 has a cylindrical shape with spherically rounded ends, the control button 15 projecting from one end of the device. The control button 15 operates a “push-on/push-off” power switch 26 that is mounted on a switch structure 19 within the cap 15 for activating the device 10 . Also included is appropriate wiring or other conductors (not shown) between the vibrator 12 , the battery pack 16 , the control module 18 , the sensor module 20 , and the control switch 26 . When activated, the device assumes an idle state unless and until a user's body part comes into close proximity with one of the sensor elements 22 . As more particularly described in connection with FIGS. 2 and 3 below, proximity with the sensor element 22 A only produces a first or low level of activation of the vibrator 12 ; proximity with the sensor element 22 B (but not 22 C) produces a second or medium level of activation; and proximity with the sensor element 22 C produces a third or high level of activation of the vibrator 12 . With further reference to FIGS. 4 and 5 , an alternative configuration of the massaging device, designated dildo 30 , includes counterparts of the motorized vibrator 12 , the housing, designated 13 ′, control button, designated power button 15 ′, the battery pack, designated 16 ′, the control module, designated 18 ′ and the control circuit board, designated 19 ′, the sensor module, designated 20 ′ and the sensor circuit board, designated 21 ′ with counterparts of the sensor elements, designated 22 ′ (individually 22 ′A, 22 ′B, and 22 ′C), and a momentary counterpart of the power switch, designated 26 ′. The battery pack 16 ′ is supported within a handle 32 and retained in place by a screw-in cap 34 . The power button 15 ′ projects through the handle 32 , the control module 18 ′ being located within the handle. An elastic counterpart of the sleeve, designated 36 has a main portion 37 covering the housing 13 ′ and having the form of an erect penis with a head portion 38 , and an arm portion 39 projecting to one side in a shape and dimension preferably facilitating contact with the clitoris of a user of the dildo, the arm portion enclosing a motorized secondary vibrator 40 that is locatingly supported within an arm cavity 42 of the arm portion 39 . Each of the sensor elements 22 ′ is biasingly pressed against the sleeve by a sensor spring 42 , the element 22 ′A being closest to the head portion 38 of the sleeve 36 , the element 22 C being farthest therefrom. As described above in connection with the massager 10 , appropriate wiring or other conductors (not shown) connect the battery pack 16 ′, the control module 18 ′, the sensor module 20 , and the vibrators 12 and 40 . The exemplary configuration of the dildo 30 of FIGS. 2 and 3 further includes a mode switch actuator 44 protruding the handle 32 for operation by a user and having a mode switch 46 that is mounted directly on the control circuit board 19 ′. A plurality of intensity indicators 48 also project through the handle, being supported by the control circuit board. The mode switch 46 sequentially selects a plurality of vibration modes, selectively modifying operation of the vibrators 12 and 40 in combination with response to the sensors 22 ′ as described above for the massaging device 10 . Suitable materials for the housings 13 and 13 ′, and the handle 32 include ABS. Suitable materials for the battery packs 16 and 16 ′ include polypropylene; and suitable materials for the sleeve 36 (and the control button 15 of FIG. 1 ) include elastic plastic materials such as TPE. A suitable battery complement is four type AAA alkaline batteries. With particular reference to FIGS. 6 and 7 , a control circuit 50 of the dildo 30 is formed by a combination of the control module 18 ′ and the sensor module 20 ′. As shown in FIG. 6 , the control circuit 50 includes a body touch detector 52 that operates in combination with a signal detector 54 that signals a microprocessor 56 , the microprocessor controlling a main driver 58 for powering the main vibrator 12 , and a secondary driver 59 for powering the secondary vibrator 40 . The touch detector 52 includes the sensor elements 22 ′A, 22 ′B, and 22 ′C, the elements 22 ′ each having a coupling capacitor 60 connected to a common pulse output 62 of the signal detector 54 , and a grounded blocking diode 63 connected for maintaining a positive potential at the sensor element 22 ′. That potential is fed through a signal filter that includes a charging resistor 64 , a filter capacitor 65 , and a discharge resistor 66 , the resulting filtered touch signal 67 being fed to a corresponding input of the detector 54 . The touch signals are individually designated 67 A, 67 B, and 67 C in FIG. 7 , corresponding respectively to the sensor elements 22 ′A, 22 ′B, and 22 ′C. The signal detector 54 monitors each of the touch signals 67 , periodically communicating status signals to the microprocessor 56 . When any of the sensor elements comes into close proximity to a user's body part, capacitive coupling alters (increases) loading of the associated coupling capacitor, correspondingly changing (decreasing) the resulting touch signal sufficiently to change the relevant status signal. In addition to the above-described communication with the signal detector 54 , the microprocessor is responsive to the power switch 26 ′ and the mode switch 46 for signaling the main and secondary drivers 58 and 59 as further described below, the microprocessor having separate outputs for driving each of the indicators 48 . In an exemplary configuration of the dildo 30 , the control circuit 50 , upon activation by the power switch 26 ′, is responsive to the mode switch 46 for controlling the secondary vibrator 40 as described herein, the main vibrator 12 being responsive to proximity of the sensor elements 22 ′ as described above regarding the sensor elements 22 of the massaging device 10 . In this configuration, successive activations of the mode switch 46 produces eight intensity modes of operation of the secondary vibrator 40 as set forth below in Table 1. It will be understood that other modes of operation of the secondary vibrator 40 are within the scope of the present invention. Corresponding variations in operation intensity levels of the main vibrator 12 are possible also, an exemplary schedule being indicated below in Table 2. In table 2, “Sensor A” excludes activation of the sensor elements 22 ′B and 22 ′C; “Sensor B” excludes activation of the sensor element 22 ′C. In both tables the activation levels are relative and arbitrary as is consistent with effective levels known to those skilled in the art. TABLE 1 Secondary Vibrator Modes Mode Level Shape 1 0 — 2 1 Flat 3 2 Flat 4 3 Flat 5 3/0 Sinusoid 6 3/0 Medium Square 7 3/0 Medium/Slow Square 8 2/0 Fast Square TABLE 2 Main Vibrator Modes Level Mode No Sensor Sensor A Sensor B Sensor C Shape 1 0 1 2 3 Flat 2 0 2 3 4 Flat 3 0 1 3 5 Flat 4 1 2 4 5 Flat 5 2/0 3/0 4/0 5/0 Sinusoid 6 0 1/0 3/0 5/0 Medium Sq. 7 0 1/0 3/0 5/0 Med./Slow Sq. 8 0 1/0 3/0 5/0 Fast Square The indicators 48 are driven by the control circuit 50 at low intensity in Modes 1 and 2, medium intensity in Mode 3, high intensity in Mode 3, variable intensity in Mode 4, and blinking in Modes 5-8 synchronously with activation of the secondary vibrator 40 . It will be understood that other and various indications in the different modes are possible. With reference to FIG. 8 , there are shown graphical illustrations of intensity represented by a waveform, wherein the shape of the waveform represents the level of intensity generated by the different modes of operation of the massaging device, such as those corresponding to the vibrator modes of Tables 1 and 2. A suitable device for the signal detector 54 is available as ACM3890 from Shizhenshi ACME Micro Electronics of Shenzhen, China. The device is operational with a crystal input at 16 MHz, generating the pulse output 62 at a rate of 500 Hz. A suitable device for the microprocessor 56 is available as ACM3831-3, also from ACME. A suitable 3.3 volt regulator 68 for providing VCC to the detector 54 is available as HT7133 from Holtek Semiconductor Inc. of Hsinshu, Taiwan. The regulator 68 is fed by a power driver 69 in response to activation of the microprocessor 56 by the power switch 26 ′ as described above. The control circuit 50 includes additional conventional circuitry for powering the signal detector 54 as well as the microprocessor 56 in a suitable manner known to those skilled in the art. Further regarding the massaging device 10 of FIG. 1 , and with particular reference to FIGS. 2 and 3 , a simplified counterpart of control circuit, designated 50 ′ is formed by a combination of the control module 18 and the sensor module 20 . As shown in FIG. 2 , the control circuit 50 ′ includes counterparts of the body touch detector 52 and the signal detector 54 for signaling a counterpart of the microprocessor, designated 56 ′, the microprocessor controlling a counterpart of the main driver 58 for powering the vibrator 12 . A suitable device for the microprocessor 56 ′ is available as ACM3831-2, also from ACME. The power switch 26 directly powers the control circuit 50 ; accordingly, the power driver 69 is implemented as a constant conduit to the regulator 68 when the power switch 26 is activated. The touch detector 52 includes the sensor elements 22 A, 22 B, and 22 C, the elements 22 each having the coupling capacitor 60 connected to the common pulse output 62 of the signal detector 54 , with counterparts of the blocking diode 63 , the signal filter including the charging resistor 64 , the filter capacitor 65 , and the discharge resistor 66 , for generating the touch signal 67 for feeding the detector 54 as described above in connection with FIG. 7 . The signal detector 54 monitors each of the touch signals 67 A, 67 B, and 67 C, periodically communicating status signals to the microprocessor 56 ′, also as described above. The control circuit 50 ′ also includes conventional circuitry for powering the signal detector 54 and the microprocessor 56 ′ in a suitable manner known to those skilled in the art. Although the present invention has been described in considerable detail with reference to certain preferred versions thereof, other versions are possible. For example, the power switch and the mode switch can be combined, the control circuit cycling through a substantially unpowered state and the various modes in response to successive operations of the mode switch. Therefore, the spirit and scope of the appended claims should not necessarily be limited to the description of the preferred versions contained herein.

A vibratory massaging device having a spaced plurality of proximity sensors distributed on a massaging surface of the device, and a control circuit operative for controlling vibratory intensities in response to activation of particular ones of the sensors being close to a user's body parts being massaged. The device can be configured as a dildo, including both main and secondary vibrators, the secondary vibrator being within an arm portion that is configured for clitoral stimulation. At least one of the vibrators is automatically driven at increased intensity as penetration increases.

CROSS-REFERENCES TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 09/881,283, filed Jun. 14, 2001, now U.S. Pat. No. 7,302,289, which is a continuation of U.S. application Ser. No. 09/233,409, filed Jan. 19, 1999, now U.S. Pat. No. 6,289,229, which claims the benefit of U.S. Provisional Application No. 60/071,906, filed Jan. 20, 1998. The entire disclosures of the above applications are incorporated herein by reference. BACKGROUND Polydeoxynucleotide and oligonucleotide sequencing with laboratory-based instruments has become inexpensive and reliable due to the variety and availability of complimentary fluorescent labeled target sequences. These fluorescent labeled probes may be specially tailored to hybridize with genomic DNA segments and form base pair matches that can accurately detect the presence of inherited genetic disorders or native-cell mutations. Under excitation light in the visible or UV range, the associated fluorescent marker attached to the probe emits a secondary emission that may be detected by a charge-coupled device (CCD) array, photodiode, or other spectrally sensitive light detector. However, current techniques require the use of specialized reagents and additional processing to separate the cell wall and other components before analysis. The analyte is removed and introduced into an assay chamber for analysis. The chambers are housed in portable or tabletop analytic instruments that typically contain an excitation source, detection sensors, spatial reading or imaging devices, and archiving capabilities. These systems are expensive and require that tissue samples be processed prior to use. The biggest drawback to these types of systems is their inherent inability to perform fast, localized reading of array probes in a convenient and repeatable manner in vivo. In vivo monitoring and detection of changes to the human body in response to therapy is needed to expedite trials and to monitor results from therapy, and would allow doctors to treat serious diseases such as cancer safely in a more effective and less costly manner. SUMMARY This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This summary is not intended to identify key features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. The present invention performs specific detection and analysis of biological analytes in vivo using a simplified, low-cost set of components. In one embodiment, the small size and simplified operation allow the entire device to be housed in a catheter. In one aspect, the device consists of a housing, a light excitation source, a detector, and at least one fluorescent-labeled probe material on a substrate that is exposed to the tissue of the body. The excitation source may be directed at the substrate carrying the probe, or may be a conductor of the excitation energy. Other embodiments include the use of a lumen to introduce a lysing agent or energy to the area of interest. The lysing agent or energy may be an ultrasonic transducer capable of rupturing cell membranes through the use of a brief burst of ultrasonic energy. In another aspect, a lysing system is used in which pressurization and evacuation of the sample via the lumen adjacent to the probe array creates a pressure capable of rupturing the cell membrane. Each of the probes may be read by application of electrical current to the excitation source and by detecting the presence or absence of signal via the probe sensor. The probe sensor may be a photodiode that is responsive to light emitted by the fluorescent probe material. Two probes may be mixed and read by two sensors if the spectrum is sufficiently separated. A ratio can then be obtained to facilitate analysis. In another embodiment, a normalizing patch may be adjacent to provide a reference signal, thereby simplifying the calibration of the instrument. DESCRIPTION OF THE DRAWINGS The foregoing aspects and many of the attendant advantages of this invention will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein: FIG. 1 is a planar view of a probe array containing a multiplicity of fluorescent probes on its surface. FIG. 1A is a cross-sectional view of the probe array of FIG. 1 . FIG. 1B is a cross-sectional view of a sheet of material carrying a probe array. FIG. 2 is a cross-sectional view of a readable polydeoxynucleotide array module and system. FIG. 2A is a block diagram of the readable polydeoxynucleotide array module and system. FIG. 3 is a cross-sectional view of an interventional device carrying the readable polydeoxynucleotide array module. FIG. 4 is a cross-sectional view of an interventional device fitted with a lysing core. FIG. 5 is a side view of a secondary insertable device having a tip and a multifilar shaft. FIG. 6 is a cross-sectional view of a hollow needle carrying the readable polydeoxynucleotide array module equipped insertable appliance. DETAILED DESCRIPTION Referring now to FIG. 1 , the planar view of a probe array 11 is shown as a grid-like array with a plurality of chambers 13 arranged to have separators 15 within a frame 17 . The frame 17 may be a small injection-molded component made of a plastic, such as polystyrene, or a molded material, such as glass. The separators 15 may be molded integrally to the frame 17 or may be separate elements placed within it. The overall dimensions of the frame 17 may be small. Typical dimensions are less than 1 mm by 1 mm. Referring now to FIG. 1A , which is a cross-sectional view of the probe array 11 , the aforementioned separators 15 are effective to separate a fluorescent probe material 21 that may have different characteristics from an adjacent fluorescent probe material 23 . Probe materials 21 and 23 are generally deposited in a thin layer on top of a substrate, in this case, the material of the frame 17 . Alternatively, the frame 17 may be made of a foraminous material or a partly foraminous substance such as sol gel (not shown). The probe materials may be incorporated into the substrate, which may be a flat surface that allows ink printing processes to be used to deposit the probe array materials at high speeds and at low cost. Probe materials generally are engineered molecular materials that are designed to have an affinity to one or more constituents that may be expected to be found in the tissue, fluid, or chemical mix to be analyzed. These probe materials may be made sensitive to specific genes or gene segments through complimentary genetic indicators that have been designed to fluoresce or change color, as observed by the naked eye or by spectrographic analysis methods, when they are linked to a molecule to which they have affinity. A large number of different types and combinations of optically readable probes are being manufactured today that have specific affinity to one or more genes, proteins, or other chemicals. In preferred embodiments, the present invention contemplates the use of two classes of probes: (i) protein sensitive probes, such as GFP (green fluorescent probe) from the jellyfish Aequorea Victoria ; and (ii) modified oligonucleotide probes that are fluorogenic, such as those manufactured by Synthegen LLC, Houston, Tex. 77042. Additional probes suited for use in the present invention are available from Midland Certified Reagent Company, Midland, Tex. 79701, and Transbio Corp., Baltimore, Md. 21220. Typically, these probes must be used in vitro due to either their lack of biocompatibility or because they must be used in conjunction with aggressive reagents that are toxic to cells. Various methods and configurations may be used to deposit or arrange probe locations and positions in an array or singly. For instance, a sheet of plastic material 33 , as shown in FIG. 1B , may have lines 35 made of probe-filled ink printed in any arrangement that may be produced with printing methods. More than one type of probe-filled ink may be used to produce various patterns and arrangements, including overlapping patterns (not shown). The ink pattern lines 35 may be protected with a topcoat 37 that may be made of a dissolvable gel such as ordinary gelatin, or another material such as soluble or even a waterproof polymer that only dissolves and provides access to the probe material in the probe-filled ink in lines 35 after the application of a solvent. The arrangement of the sensitive areas by this process allows the probe materials to be applied to a variety of surfaces and substrates, including medical devices, such as needles, trocars, forceps, catheters, guidewires, implants, and prostheses, in an inexpensive and reliable manner. The following discussion and description of the present invention is directed to a readable polydeoxynucleotide array module (RPAM). However, those skilled in the art will appreciate that the present invention and specific embodiments described below may be utilized with any number of probe arrays and the RPAM described here is provided as only one non-limiting example. Referring now to FIG. 2 , which is a cross-sectional view of a readable polydeoxynucleotide array module (RPAM) 41 , the probe array 11 may be positioned adjacent to a spectrometer module that is encapsulated in an at least partly transparent housing 45 . The probe array 11 may be cemented to the side, top, or other area within a spectrometer module 43 with an optical cement (not shown), or by a solvent bond line 47 that allows two plastics to be fused through partial melting. A spectrometer module suitable for use in this invention has been described in pending U.S. patent application Ser. No. 08/898,604, the entire disclosure of which is incorporated by reference herein. Specifically, the spectrometer module used in the present invention includes a light source and a light detector for placement inside a body such that optical conduits are not necessary to deliver light signals to and from the RPAM inside the body. The miniature spectrometer includes the light source and one or more light detectors. The light source illuminates a tissue region and the light detectors detect optical properties of the illuminated tissue by measuring modified light signals. The light detectors convert optical signals to electrical signals such that one or more electrical wires placed inside an interventional device can deliver the electrical signals from the RPAM to a signal display or a microprocessor. The light source and the light detectors are energized by an external power supply through electrical wires. In another embodiment, an optically transparent tip encapsulates a spectrometer. The tip is shaped to optimize tissue contact and optical transmission. The tip encapsulating the spectrometer is disposed at a distal end of an interventional device. The tip may be coated with a material to improve light transmission. The tip may include at least one fluid channel, which is in communication with a lumen inside the interventional device, to deliver a fluid to a tissue region. The spectrometer may also include a light source and the light detectors formed on a single substrate. The light source may be a light-emitting diode and the light detectors may be a photodiode comprising multiple channels, where both devices are formed on a silicon substrate. The light detector can include multiple channels to detect light emission at multiple wavelengths. Still referring to FIG. 2 , probe array 11 may be integrally molded onto the surface of the spectrometer module 43 , creating a somewhat simplified one-piece unit that may provide processing advantages in high-speed production environments where parts counts are intentionally kept low to minimize stock and therefore reduce cost of fabrication and assembly. Injection molding or casting of the components is effective to produce miniature components that correspond in size to conventional silicon-based integrated circuit scale. Therefore, it should be appreciated that the RPAM may be small, e.g., about the size of a miniature electronic component such as a surface mount device. Such devices include packaging, leads, and other components, and may be obtainable in size ranges of less than 1 mm in length. Such devices may typically be configured in the range from about 0.5 mm to about 3 mm to produce small, useful devices for in vivo use. The RPAM 41 may also have printable surfaces according to the construction of alternative probe array configurations as described in FIG. 1A and FIG. 1B , if desired. Referring once again to FIG. 2 , the internal components of the RPAM consist of a substrate material 49 such as silicon upon which a light-emitting diode light source 51 is mounted with power lead 53 attached to one of terminals 55 . Various colors and types of diode light sources may be used, including those now available that emit light in the infrared, the red, the yellow, the green, the blue, and the blue-violet regions. A working range of RPAM excitation wavelengths is from about 1100 nanometers to about 250 nanometers and may comprise monochromatic, bichromatic, or broadband emissions. The exit aperture 57 is positioned to illuminate a movable mirror 59 that is bonded to piezoelectric stack actuator 61 . Empowerment of the stack actuator 61 is effective to direct light emission from diode light source 51 to one or more chambers 13 . Light emission from the probe materials 21 is picked up by one or more light detectors 63 through filters 65 . Signals from the detectors 63 are brought out from the RPAM through other terminals 55 . Referring now to FIG. 2A , the operation of the RPAM is depicted in block diagram form as follows: Light is generated and directed from light source 51 and directed at one or more of chambers 13 by mirror 59 , which impinges upon at least one probe material 21 . Fluorescence or other secondary light generated by the action of the light energy upon the probe material causes a second emission that may be detected by one or more light detectors 63 after passing through a bandpass filter 65 . The signal may be amplified and/or conditioned by one or more amplifier stages 64 . Filters 65 allow the system to discriminate between various secondary light emission wavelengths, and signals from said light detectors 63 may be synchronized with the operation of light source 51 so that at any given time there is a known relationship between the particular probe that is illuminated and its response as detected by the light detectors. The timing and relationship of the light-generating, light-detecting event and the spatial position of the mirror 59 are controlled by CPU 71 and sent to the components via control lines 73 . The data obtained may be stored or presented in a display device or other therapeutic device that can be a graphical display, a television monitor, printout or drug delivery pump, interventional device, motor or actuator, etc. Accordingly, this apparatus may effectively scan or read a plurality of probe materials in a repeatable, fast, and controllable manner; and the information read may be stored, displayed, or used to initiate another action such as a therapeutic application of a drug, or control of a motor. The bandpass filter system of detecting one or more light wavelengths for this purpose is basic, and more complex schemes could be employed by those of ordinary skill in the art. Such schemes may include, without limitation, light wavelength detection systems comprising gratings, graduated filters, heterodyne detection, acousto-optic tunable filtering, and other light detectors that effectively provide an amplitude and frequency responsive signal. A diffraction grating (not shown), for instance, may be attached to movable mirror 59 to provide spatial and chromatic control simultaneously. FIG. 3 is the cross-sectional view of an interventional device incorporating the spectrometer and probe still referred to here as RPAM 41 ; there is a body-insertable appliance 81 such as a catheter that may have a distal end and a proximal end and may consist of a plastic, rubber, or metal material that is generally elongated in shape, has a small cross section allowing it to pass easily through the body, and has one or more lumens or conduits that may extend through the length of the device. Shown in FIG. 3 is a device having three lumens, although a greater or lesser number of lumens may be used, depending upon the application for which the device is intended. The main lumen 83 is relatively large and is used to deliver a drug, a reagent, or a device to or beyond the distal tip 89 . Suction lumen 85 is useful for drawing biological fluids, tissue, or other materials into proximity with the RPAM 41 , where the material can be analyzed. Signal wires 74 may extend to an external controller (not shown) or to a CPU, pump, motor, or other controller as shown in FIG. 2A , 75 . Returning once again to FIG. 3 , infusion lumen 87 may provide additional fluids, reagents, drugs, wires, or appliances that may be useful to the procedure. For example, the practitioner will appreciate that additional reagents can be introduced to facilitate analysis. Such additional reagents can include: denaturants, such as guanidinium thiosulfate; buffers, such as Tris-Cl; detergents, such as SDS; chelators, such as EDTA; enzymes, such as proteinases and/or DNAases; and other reagents known to those of ordinary skill in the art that may be appropriate to the particular analysis to be carried out using the apparatus of the present invention. Referring now to FIG. 4 , a cross-sectional view of an interventional device, such as a body-insertable appliance 81 fitted with a lysing core 101 , is shown. The lysing core 101 utilizes mechanical motion to disrupt cells in order to make the cell contents available for analysis by the RPAM (not shown). The use of a lysing device in conjunction with the RPAM system eliminates the need for potentially toxic reagents that are commonly used to open cells in vitro. The lysing head 105 consists here of a more or less hemispherical component that may be comprised of a metal or plastic, which is mounted at the distal end of a driveshaft 103 . Such driveshafts are well known for their ability to deliver torque and rotary motion from a proximal motor 107 or by hand control. As taught in this invention, motor 107 is one of a class of components shown in FIG. 2A as 75 which may be controlled by system CPU 71 , also shown in FIG. 2A . Numerous other lysing devices are known that may abrade, disrupt, dissolve, pressurize, vacuum, cavitate, or otherwise apply mechanical forces to a cell or cells that are effective to disrupt the cell and make its contents available for analysis. It should be pointed out that such damage to cells is usually minimized to avoid permanent damage to the organ, vessel, duct, or tissue being tested. The lysing head 105 need not be relatively large and may be made small enough so that it may easily pass through the device from the proximal end so that another device or implant may be inserted, if needed, through the same large lumen 83 . Such an implant may be a solid or porous, foraminous, or dissolvable seed, implant, stent, gel, or the like, which may carry therapeutic agents to a particular site in the body. This system provides the advantage that local conditions can be determined through use of the polydeoxynucleotide-readable array (afforded by the construction of the RPAM device as described herein); and, therefore, better and more precise application of appropriate medicaments, drugs, therapeutic genetically based substances, etc., is facilitated. Further advantages are provided in that the information is obtained at or near real time, and that information is obtainable from the exact location of a proposed therapeutic intervention. Such a device that may be used to place an implant is shown in FIG. 5 , which is a side view of a secondary insertable device 111 comprising a rotary, multifilar, flexible driveshaft 112 having a therapeutic tip 113 terminating in an anchoring device 115 shown as a screw form capable of being screwed into tissue until separable joint 117 breaks, after which the remaining part of insertable device 111 may be withdrawn. Driveshaft 112 may be hollow, to allow tether 119 to remain attached to therapeutic tip 113 . Tether material may be constructed of a wire to allow the sending and receiving of an electrical signal, or may simply be used as a retrieval device to retrieve any portion of the therapeutic tip that may remain after the need for it is over. Numerous carrying devices may be used to deliver the RPAM. FIG. 6 is a cross-sectional view of a hollow needle 121 carrying the RPAM insertable appliance 81 . The advantage of a needle is that it allows the introduction of the RPAM into portions of the body where there is no natural passageway. This method allows the user to position the distal tip of the lysing head 105 in various positions with respect to the sharp needle tip 106 . The needle may be of stainless steel and may be inserted into body tissue such as muscle, breast, prostate, or cardiac tissue. The needle may be left in place, and the RPAM withdrawn temporarily to allow another appliance (not shown) to be introduced. Other carrying devices may include guidewires, balloon catheters, ultrasound catheters with both imaging or non-imaging, and rotatable or array configurations, introducer sheaths, balloon angioplasty catheters for use in the blood vessels of the heart, the extremities, and the vascular system, atherectomy catheters, and many other types of interventional devices, as well as intraoperative devices. The device of the invention may be used anywhere there is the need for fast, precise localized detection and analysis of nucleotides, proteins, or the like, either for diagnostic purposes, or to guide therapy which itself may be made more localized, and therefore site-specific. Such uses are economical and have less impact on surrounding tissue that is free of disease. The invention allows use of any agent that may change color as a result of the application of a local chemical to be read and includes, without limitation, such agents as litmus, photodynamic therapeutic agents, such as photofrin, fluorescent agents or dyes, staining dyes, luciferin, etc. The present invention permits analysis in a real time fashion without the need to remove and transport tissue specimens for later analysis. While illustrative embodiments have been illustrated and described, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention.

A disposable high-density, optically readable polydeoxynucleotide array with integral fluorescence excitation and fluorescence emission channels is described. The compact array size allows integration into several types of interventional devices such as catheters, guidewires, needles, and trocars and may be used intraoperatively. Highly sensitive monitoring of the metabolic and disease pathways of cells in vivo under varying chemical, genetic, and environmental conditions is afforded.

TECHNICAL FIELD OF THE INVENTION [0001] The invention relates to a control coupling for a delimbing and cutting apparatus for feeding means and for changing their feeding speed. BACKGROUND OF THE INVENTION [0002] For the processing of tree trunks, a harvester head, i.e. an apparatus for the delimbing and cutting of tree trunks, is used for the purpose of gripping an upright growing tree, cutting the tree and felling it, after which the tree trunk is delimbed and cut into pieces of fixed length by means of a sawing device. One known harvester head is disclosed in WO publication 00/15025. The harvester head is normally connected to the end of the boom assembly of a forest working machine. The har-vester head is connected to the boom assembly in an articulated man-ner, and it comprises the necessary actuator means, normally hydraulic cylinders and hydraulic motors, by means of which the position of the head and its different functions can be controlled. The harvester head comprises delimbing means which can be articulated in relation to the frame structure and which comprise delimbing blades for delimbing branches while the trunk is supported and forced through the appara-tus. The means used as the feeding means comprise a feed roll or a feed track assembly which is pressed against the trunk and pulls it through the apparatus. The harvester head also comprises cutting means, for example a chain saw, for cutting the tree trunk. [0003] One known rubber feed pulley is disclosed in WO publication 95/01856, in which non-skid devices are connected by chains to the outer rim of the feed pulley. Another feed pulley is also presented in FI patent 102664. A shock absorbing feed pulley is presented in FI patent 97785, in which a rigid metal jacket with friction means is fitted on a gummy elastic rubber layer. One feeding device comprising a roll mat is disclosed in U.S. Pat. No. 3,669,161. The number of feed pulleys is normally two, but in WO 99/41972 and Fl patent 97340 there are four feed pulleys, wherein the feed pulley motors of the same side are cou-pled in series and the feed pulley motors of opposite sides are coupled in parallel. Two motors of opposite sides are coupled mechanically together to prevent the rotation of the feed pulleys at different speeds, particularly at high feeding speeds. [0004] The feed motors have normally a fixed rotational capacity, wherein the feeding speed is constant and only depends on the volume flow sup-plied to the motor. Also variable-speed motors are known, but they are larger in size and normally require a reduction gear, wherein their size increases further. To keep the speeds equal in the different feed pul-leys, valves or auxiliary feed pulleys and their mechanical couplings must be used, wherein the size and weight of the harvester head are increased and the placement of the components becomes more diffi-cult. In some radial piston motors, the volume flow can be divided, for example, to one half of the pistons only, wherein the speed is doubled (and the torque and the tractive force are halved). In this case, a com-mon disadvantage is poor efficiency, when the pistons are not all in operation. SUMMARY OF THE INVENTION [0005] It is an aim of the present invention to eliminate the above-presented drawbacks and to provide such a control circuit for the feeding means of the harvester head, which utilizes a motor of a given type and vari-ous couplings therein, to achieve multi-speed feeding in as simple a way as possible. [0006] By means of the coupling according to the invention, it is possible to expand the ranges of tractive force and feeding speed of the respective feeding motor with a fixed volume. The coupling and the motors according to the invention can also be installed afterwards in the har-vester end, wherein the alternatives for the feeding speed in known apparatuses are increased. The motor used has a structure with a light weight compared with corresponding motors with adjustable speed. [0007] A particular advantage is the coupling of the motors, whereby the speeds of two different feed pulleys can be locked together, wherein the aim is to prevent skid. The coupling can be used at high feeding speeds. The selection of the speeds is simple, because it can be implemented by on/off control. By suitable selection of the motor, speed steps are achieved which are smaller than in corresponding two-speed motors. With a suitable motor and different couplings, it is possible to achieve even a four-step feeding speed and an adjustment of even steps. [0008] The invention utilizes a multi-capacity motor which is known, for exam-ple, from U.S. Pat. No. 6,099,273. The motor is a radial piston motor com-prising an input and output connection as well as an extra connection which can be used as an input or output connection. The motor also comprises a selector, i.e. a stem in a drilling, by means of which some of the pistons direct the used volume flow to the normal output connec-tion and the other pistons feed it to the auxiliary output connection. In this way, the motor has at least two different capacities (dual-capacity motor), wherein it comprises, in a way, two half-motors. Alternatively, the extra connection can be an auxiliary inlet connection, through which the volume flow is supplied to one of the half-motors. Because of the common shaft, however, the rotation speeds of the half-motors are the same. Said selector can also be missing, in which case the motor always has three connections available, one being connected to all the pistons and the two others being connected to specific separate pis-tons only, wherein the speeds to be achieved will depend on the cou-plings with which the motor is controlled. [0009] U.S. Pat. No. 6,099,273 utilizes three said motors and the coupling there-between in the transmission of a vehicle. The most typical coupling of two separate motors is one in which two half-motors located in different motors are always coupled in series. Publication EP 1 026 025 A1 pre-sents examples of such series connections when they are applied in the wheels of a vehicle. U.S. Pat. No. 6,230,829 and EP publication 0 547 947 B1 also present a vehicle transmission utilizing said motor. [0010] The basic principle of the invention is the use of said motors as feed motors at the harvester head and the possibility to connect them either in parallel or in such a way that only two half-motors are in series. By means of the connections, two different feeding speeds are achieved. Furthermore, the invention utilizes the connection of all the half-motors in series, wherein at least three different speeds can be used. When the rotational capacities of the half-motors differ from each other, four different feeding speeds are achieved. Furthermore, when the ratio of the rotational capacities of the half-motors is approximately 1:2, it is possible to achieve three speeds with a substantially equal change and a very fast fourth speed. Moreover, said adjustment of even steps is achieved in the whole rotational capacity of the motor. BRIEF DESCRIPTION OF THE DRAWINGS [0011] The invention will be illustrated in the following description with refer-ence to the appended drawings, in which: [0012] FIGS. 1 to 4 show the principles of coupling half-motors when they are coupled in parallel, partly in series with each half-motor separately, and when they are coupled in series; [0013] FIGS. 5 to 7 show the more detailed structures of the control circuits to implement the couplings of FIGS. 1 to 4 , when two different feeding speeds can be further achieved with the motors, and [0014] FIGS. 8 and 9 show the more detailed structures of the control circuits to implement the couplings of FIGS. 1 to 4 , when four differ-ent feeding speeds can be further achieved with the motors. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0015] Table 1 shows three different motor models and example cases A, B and C of how the achievable rotational speed n of the feed roll varies according to the rotational capacity Vg of the two half-motors of the motor (Vg 1 and Vg 2 ) and when the feed volume flow remains the same. Furthermore, the feed force and speed of the feed roll depend on the pressure used and on the dimensions of the feed roll. The cou-pling 1 is a parallel coupling according to FIG. 1 , and the coupling 2 is a series coupling of two half-motors as shown in FIG. 2 . In the motor A, the ratio between the rotational capacities Vgl and Vg 2 is 1:2, wherein the coupling of FIG. 3 yields 67% and 83% of the rotational capacity Vg of the coupling of FIG. 1 and FIG. 2 , respectively, and the coupling of FIG. 4 yields the highest speed, wherein the rotational capacity Vg is 50% smaller than in the coupling 1 of FIG. 1 . To achieve four different speeds, it is required that the rotational capacities Vgl and Vg 2 in the same motor differ from each other, wherein their ratio differs from the value 1:1. With the ratio 1:2, equal changes are achieved in the rota-tional capacity Vg. Even if the ratio of the rotational capacities Vgl, Vg 2 were 1:2 or variable, half-motors refer to all the different alterna-tives in this description. TABLE 1 Motor A B C Size 943 cc 1048 cc 1404 cc Vg1 (cc/r) 314 419 561 Vg2 (cc/r) 629 629 843 Coupling 1: 100% 100% 100% Rotational speed n1 Coupling 2: 120% 125% 125% Rotational speed n2 Coupling 3: 150% 143% 143% Rotational speed n3 Coupling 4: 200% 200% 200% Rotational speed n4 [0016] FIG. 1 shows the coupling of the motors 1 and 2 in parallel, wherein the volume flow from the valve 6 is divided separately to the motors 1 and 2 (the connections A 2 , B 2 and R 1 are coupled together and to the channel 4 ) and wherein it also returns separately from the motors 1 and 2 (the connections Al, B 1 and R 2 are coupled together and to the channel 5 ). The half-motors 1 a , 1 b , 2 a , 2 b of the same motor 1 , 2 are indicated with motor symbols drawn next to each other. At the same time, the common shaft is illustrated, as well as the fact that the half-motors always have a common rotational speed. Alternatively, the half-motors are indicated with a symbol which comprises two motor sym-bols within each other. Each half-motor comprises two basic connections which are for the supply and for the return of the volume flow. In the connections of FIGS. 1 to 4 , either the first or the second basic connections of two half-motors are permanently joined to a con-nection R 1 or R 2 , wherein the connection is preferably within the motor. In practice, the motors 1 and 2 are completely equal models. [0017] Preferably, the motors 1 , 2 comprise three connections which are always in use. Each motor 1 , 2 comprises one return connection R 1 , R 2 and two working connections A 1 , A 2 and B 1 , B 2 . One should bear in mind that a pressurized volume flow can also be conducted to the return connection, and the volume flow of the half-motors can also be returned via the working connection. At the same time, the direction of rotation of the motors is reversed, which is the normal way of use when, for example during delimbing, the tree is reversed for some length, stopped, and the feeding is continued again. With the coupling alternatives of the two different motors 1 , 2 , it is possible to achieve the desired speed alternatives, even though the capacities Vgl, Vg 2 of each motor 1 , 2 were constant. The different coupling alternatives, which are illustrated in FIGS. 1 to 4 , are implemented with different valve means, which are shown in FIGS. 5 to 9 . In connection with FIGS. 2 to 4 , reference numerals are used, which correspond to FIG. 1 . [0018] In FIG. 1 , the common rotational speed n of the motors 1 , 2 can be rep-resented by the formula n 1 =Q/2·(Vg 1 +Vg 2 ), which is simultane-ously the rotational speed of the wheel guiding the feed pulley or feed roll, when no gears are used. Valve means 3 , for example a spool valve with 3 positions, are used to select the direction of rotation of the motors 1 , 2 , wherein the volume flow is fed either to the channel 4 (in which case the return flow comes from the channel 5 ) or to the channel 5 (in which case the return flow comes from the channel 4 ). In the mid-dle position of the valve 3 , the channels 4 , 5 are closed and the motors are stopped. The valve 3 may also have a position, in which the motors 1 , 2 are let on free circulation. The control circuit feeding the valve 3 is known as such, and it comprises at least a pressure connection P and a return connection T for the valve 3 . Furthermore, the valve 3 com-prises a pressure connection P and a return connection T. Preferably, the valve 3 is a pressure-controlled proportional directional valve as shown in FIG. 7 , comprising connections for the channels 4 , 5 , P and T. [0019] The tree trunk is placed between the feed pulleys, wherein the direction of rotation of each feed pulley and the motor must be such that they always transfer the tree trunk in the same direction. Consequently, the motor 1 revolves, for example, counter-clockwise, wherein the motor 2 always revolves clockwise, and vice versa. [0020] In FIG. 2 , the rotational speed n of the motors 1 , 2 can be represented by the formula n 2 =Q/(Vgl+2·Vg 2 ), (n 2 >n 1 ), wherein the connec-tions R 1 , B 2 are coupled together (and to the channel 4 ), and the con-nections B 1 , R 2 are coupled together (and to the channel 5 ), and the half-motors 1 a , 2 a (low capacities Vgl) are coupled in series (the con-nections A 1 , A 2 being coupled together). The aim of the coupling is to tie the rotational speeds of the motors 1 and 2 to be equal. The feed pulleys (not shown in the figures) are coupled in a way known as such on the shaft of the motors 1 , 2 , which is shown in FIG. 7 . [0021] In FIG. 3 , the rotational speed n of the motors 1 , 2 can be represented by the formula n 3 =Q/(2·Vg 1 +Vg 2 ), (n 3 >n 2 , when Vg 1 <Vg 2 , and n 3 =n 2 , when Vgl=Vg 2 ), wherein the connections R 1 , A 2 are cou-pled together (and to the channel 4 ), and the connections A 1 , R 2 are coupled together (and to the channel 5 ), and the half-motors 1 b , 2 b (high capacities Vg 2 ) are coupled in series (the connections B 1 , B 2 being coupled together). The coupling corresponds to the coupling of FIG. 2 , if Vg 1 =Vg 2 . The aim of the coupling is again to tie the rota-tional speeds of the motors 1 and 2 to be equal. [0022] In FIG. 4 , the rotational speed n of the motors 1 , 2 can be represented by the formula n 4 =Q/(Vg 1 +Vg 2 ), (n 4 >n 3 ), wherein both the half-motors 1 a , 2 a (low capacities Vg 1 ) and the half-motors 1 b , 2 b (high capacities Vg 2 ) are coupled in series. Only the connection R 1 is cou-pled to the channel 4 , and only the connection R 2 is coupled to the channel 5 . [0023] We shall now look at FIGS. 5 to 9 to discuss the different valve means by which the couplings of FIGS. 1 to 4 can be achieved. In the FIGS. 5 to 9 , the different valve means are shown in the way in which they are coupled to the connections R 1 , R 2 , A 1 , A 2 , B 1 , B 2 of FIGS. 1 to 4 or to the channels 4 , 5 . [0024] FIG. 5 shows a control circuit with 2 speeds (the connections of FIGS. 1 and 2 ), which is implemented by means of a 2-position 4-way spool valve 6 with pressure control and spring return, whose inlet side is coupled separately to the connections A 1 and B 2 (the connection B 2 communicating with the connections R 1 , 4 ), and whose outlet side is coupled separately to the connections A 2 and B 1 (the connection B 1 communicating with the connections R 2 , 5 ). The valve 6 is controlled via a pressure channel 7 which, in turn, is controlled by a 2-position 3-way spool valve 8 with electrical control and spring return. By the positions of the valves 6 , 8 shown in FIG. 5 , it is possible to achieve the speed n 1 . In connection with the valves, the inlet and outlet sides refer to the direction of the volume flow when the volume flow is supplied into the channel 4 , but when the direction of rotation is changed, the direction of the volume flow is changed as well. [0025] FIG. 6 shows a 2-speed (couplings according to FIGS. 1 and 2 ) con-trol circuit, which is implemented by means of cartridge valves with pressure control and spring return, namely 9 a (connection A 1 being coupled to the inlet side, which is so-called cartridge B-connection, and connection A 2 being coupled to the outlet side, which is so-called car-tridge A connection), 9 b (connection A 1 on the inlet side and connec-tion B 1 , R 2 and 5 on the outlet side) and 9 c (connection R 1 , 4 being coupled to the inlet side, which is an A-connection, and connection A 2 to the outlet side). A pilot valve is a 2-position 4-way spool valve 10 with electrical control and spring return, to whose outlet side valve 9 a is coupled separately and valves 9 b , 9 c are coupled together. By the positions of the valves 9 a , 9 b , 9 c and 10 shown in FIG. 6 , it is possible to achieve the speed n 1 . The valves of FIGS. 5 and 6 are placed in a separate frame which is connected for example to the motor, or they are integrated in a valve block which is placed in the harvester head and in which also the other valves controlling the harvester head are. [0026] FIG. 7 shows a 2-speed (connections of FIGS. 1 and 2 ) control circuit which is implemented by means of two 2-position 4-way spool valves with pressure control and spring return, namely 11 a (inlet side coupled to separate connections A 1 , B 1 and outlet side coupled independently to connection R 2 and simultaneously to channel 5 ) and 11 b (outlet side coupled to separate connections A 2 , B 2 and inlet side coupled inde-pendently to connection R 1 and simultaneously to channel 4 ). The valves 11 a , 11 b are controlled via a pressure channel 12 which, in turn, is controlled by a 2-position 3-way spool valve 13 with electrical control and spring return. The outlet side of the valve 11 a and the inlet side of the valve 11 b are connected by an independent channel 11 c. [0027] The valves 11 a , 11 b are integrated in the motor, wherein the valves are implemented as stems or selectors which are placed in a drilling which, in turn, is provided in the motor. Typically, the drilling comprises sepa-rate annular channels which are connected by channels provided in the stem in a desired way, when the stem is fitted in the drilling and it is moved into two different positions which correspond to the couplings of FIG. 7 . The annular channels, in turn, communicate, for example in the motor 1 , with the channels A 1 , B 1 and R 1 as well as with the dis-placement volumes of the pistons. The drilling of the motor is known as such, and it can be fitted with a stem which, in turn, is designed in such a way that the couplings according to FIG. 7 and the invention are possible. The final design and manufacture of the stem as such is easy for a man skilled in the art on the basis of this description, wherein a more detailed description of the stem will not be necessary. [0028] FIG. 8 shows a 4-speed (couplings of FIGS. 1 to 4 ) control circuit which is implemented by means of two 2-position 4-way spool valves with pressure control and spring return, namely 14 a (the inlet side cou-pled separately to the connections A 1 , R 1 and the outlet side sepa-rately to the connections A 2 , R 2 ) and 14 b (the inlet side coupled sepa-rately to the connections B 1 , R 1 and the outlet side separately to the connections B 2 , R 2 ). Each valve 14 a , 14 b is controlled via a pressure channel 16 a or 16 b , each closed by a 2-position 3-way spool valve 15 a or 15 b with electrical control and spring return. [0029] FIG. 9 shows a 4-speed (couplings of FIGS. 1 to 4 ) control circuit, which is implemented by means of cartridge valves with pressure con-trol and spring return, namely 17 a (connection A 1 on the inlet side and connection A 2 on the outlet side), 17 b (connection A 1 on the inlet side and connections R 2 , 5 on the outlet side) and 17 c (connection A 2 on the outlet side, connections R 1 , 4 on the inlet side), as well as cartridge valves 18 a (connection B 1 on the inlet side and connection B 2 on the outlet side), 18 b (connection B 1 on the inlet side and connections R 2 , 5 on the outlet side) and 18 c (connection B 2 on the outlet side and con-nections R 1 , 4 on the inlet side). The pilot valve for each series 17 a - 17 c and 18 a - 18 c is a 2-position 4-way spool valve 19 a , 19 b with electrical control and spring return, their couplings corresponding to the couplings of FIG. 6 . The cartridge valves are placed in a separate frame which is connected for example to the motor, or they are integrated in a valve block which is placed in the harvester head and which also accommodates the other valves controlling the harvester head. [0030] In FIGS. 5 to 9 , the connection R 1 is coupled to the channel 4 and the connection R 2 is coupled to the channel 5 , wherein the connections and valves coupled to the connections R 1 , R 2 simultaneously commu-nicate with the channels 4 , 5 and further with the valve 3 . [0031] The invention is not limited solely to the above-presented embodiments used as examples, but it can be modified within the scope of the appended claims.

A control coupling for a delimbing and cutting apparatus, provided for feeding means and for changing their feeding speed, and comprising at least two feed motors driven by a pressurized medium, each of the motors being intended to drive a feeding means which is intended to be placed against a tree trunk and to feed the tree trunk through said apparatus, a first channel, via which the pressurized medium can be supplied to the first feed motor and alternatively returned therefrom, and a second channel, via which the pressurized medium can be returned from the second feed motor and alternatively supplied to the same. Said feed motors are multi-capacity motors, wherein each motor has at least a first rotational capacity and at least a second rotational capacity as well as a first and a second basic connection for each capacity. The first basic connections of each motor are coupled together as a first connection , and the second basic connections of each motor constitute a second connection and a third connection, which are separate. The control coupling further comprises first valve means for coupling at least two different feeding speeds in operation, wherein the valve means are arranged to couple desired connections and channellings together.

FIELD [0001] This invention relates to medicine, cancer, chemotherapy, materials science and medical devices. In particular it relates to a method of treating solid tumors, especially hepatocellular carcinomas using an improved TACE procedure. BACKGROUND [0002] Cancer is currently the second greatest cause of death in the United States behind coronary heart disease. Even though there is trend toward lower death rates from cancer in the U.S., it has been estimated that the annual personal and financial cost of cancer will be $1.62 trillion dollars by 2017. Further, according to the World Health Organization cancer is set to become the leading cause of death world-wide by 2010. [0003] A particularly nefarious cancer is hepatocellular carcinoma (HCC). This is a primary liver cancer as opposed to a secondary or metastatic liver cancer that begins in another organ and migrates to the liver. HCC accounts for 80 to 90% of liver cancers and occurs in men more than women and is usually seen in patients between about 50 and 60 years old. It is more prevalent in Africa and Asia than the Americas and Europe. Its reputation is due not so much to any particular virulence compared to other solid tumor cancers but rather to the fact that it is rarely diagnosed at an early stage of development and when it is discovered, most chemotherapies and radiation treatment are usually ineffective. Surgery is the only recourse but even then it is very difficult to completely remove the entire tumor; the 5-year survival rate for patients with resectable HCCs is 60 %, which is low by current standards. For unresectable tumors the prognosis is extremely poor: the disease is usually deadly within 3-6 months of diagnosis. [0004] The currently preferred treatment for unresectable HCC, which is thought to extend the lifespan of a patient to 1-2 years, is transcatheter arterial chemoemolization (TACE). TACE is implemented in two ways. In the first, a drug is administered in a sterile drip into a selected artery servicing the tumor. After the drug has been administered over a period of time, usually about 30 minutes, microparticles such as gelfoam are infused into the artery to cut off the flow of blood to the tumor. In the second procedure, the chemotherapeutic agent itself is loaded onto microbeads which then are infused into the artery where they serve both to block blood flow and to deliver the drug. [0005] The problem is that by either of the above methods the drug concentration reaches a maximum in serum, i.e., blood in the vicinity of the tumor, within about 5 minutes of administration. It then drops to a baseline level within about 24 hours. Because of the variation in the drug concentration, TACE must presently be repeated every 4 to 12 weeks. [0006] What is needed is a method for applying TACE in a manner such that a single application of the procedure lasts for a prolonged period, preferably at least 6 months or more. The current invention provides such a method. SUMMARY [0007] Thus, in one aspect the current invention relates to a method, comprising; identifying a malignant solid tumor in a patient; providing a plurality of first biodegradable microparticles comprising a chemotherapeutic agent, wherein the first plurality of microparticles have a mean diameter of about 10 to 300 μm; delivering the first plurality of microparticles through an artery to a first location at or near the tumor; providing a second plurality of biodegradable microparticles, wherein the second plurality of microparticles have a mean diameter of about 900 to about 1200 μm; and delivering the second plurality of microparticles through the artery to a second location proximal to the location at which the first plurality of particles was delivered, wherein a therapeutically effective amount of the chemotherapeutic agent is released as the first plurality of microparticles degrades over a period of at least 6 months while the second plurality of microparticles substantially completely cuts off the flow of blood to the tumor upon initial delivery to its location and as it degrades over the same time-span as the first plurality of microparticles, blood flow is restored. [0008] In an aspect of this invention, the first and second plurality of microparticles independently comprise a polymer that undergoes about 50% to about 100% mass loss in vivo at about 6 months after delivery at or near the tumor. [0009] In an aspect of this invention, the first and second plurality of microparticles independent comprise a polymer that undergoes about 70% to about 80% mass loss in vivo at about 6 months after delivery of the microparticles at or near the tumor. [0010] In an aspect of this invention, the first plurality of microparticles comprise liposomes. [0011] In an aspect of this invention, the first plurality of microparticles comprise polymersomes. [0012] In an aspect of this invention, the first plurality of microparticles comprise solid polymeric particles. [0013] In an aspect of this invention, the first and second plurality of microparticles independently comprise a polymer selected from the group consisting of poly(D,L-lactide), poly(D,L-lactide-co-glycolide), poly(L-lactide-co-glycolide), poly(L-lactide-co-glycolide-co-ε-caprolactone) and poly(D,L-lactide-co-ethylene glycol), poly(L-lactide-co-ethylene glycol), poly(D, L-lactide-bl-glycolide), poly(L-lactide-bl-glycolide), poly(D,L-lactide-bl-ethylene glycol), poly(L-lactide-bl-glycolide), poly(D,L-lactide-bl-glycolide-bl-caprolactone), poly(L-lactide-bl-glycolide-bl-ethylene glycol, a poly(ester amide) and any combination thereof. [0014] In an aspect of this invention, the first plurality of microparticles comprises poly(L-lactide-co-glycolide). [0015] In an aspect of this invention, the molar ratio of L-lactide to glycolide is about 3:2 to about 9:1. [0016] In an aspect of this invention, the number average molecular weight of the poly(L-lactide-co-glycolide) is about 100 kDa to about 150 kDA. [0017] In an aspect of this invention, the first plurality of microparticles comprises a polymer comprising poly(ethylene glycol). [0018] In an aspect of this invention, the number average molecular weight of poly(ethylene glycol) in any of the poly(ethylene glycol)-containing polymers is about 500 kDa to about 10,000 kDa. [0019] In an aspect of this invention, the chemotherapeutic drug to polymer weight ratio is about 1:1 to about 1:5. [0020] In an aspect of this invention, two or more chemotherapeutic agents are loaded into or onto the same first microparticles. [0021] In an aspect of this invention, two or more chemotherapeutic agents are loaded into or onto different first microparticles, the different first microparticles being mixed together prior to delivery at or near the tumor. [0022] In an aspect of this invention, the malignant solid tumor is a hepatocellular carcinoma. [0023] In an aspect of this invention, the chemotherapeutic agent is doxorubicin. [0024] In an aspect of this invention, the chemotherapeutic agent further comprises an agent selected from the group consisting of cisplatin and mitomycin C. [0025] In an aspect of this invention, the second plurality of microparticles comprise solid polymeric particles. [0026] In an aspect of this invention, the first plurality of microparticles is delivered at or near the tumor prior to delivery of the second plurality of microparticles, or the second plurality of microparticles is delivered at or near the tumor after which the first plurality of microparticles is injected into the artery between the tumor and where the second plurality of microparticles have lodged in the artery. DETAILED DESCRIPTION [0027] It is understood that use of the singular throughout this application including the claims includes the plural and vice versa unless expressly stated otherwise. That is, “a” and “the” are to be construed as referring to one or more of whatever the word modifies. Non-limiting examples are: “a therapeutic agent,” which is understood to include one such agent, two such agents or, under the right circumstances, as determined by those skilled in the treatment of diseased tissues, even more such agents unless it is expressly stated or is unambiguously obvious from the context that such is not intended. Likewise, “a biodegradable polymer” refers to a single polymer or a mixture of two or more polymers unless, again, it is expressly stated or absolutely obvious from the context that such is not intended. [0028] As used herein, unless specified otherwise, any words of approximation such as without limitation, “about,” “essentially,” “substantially” and the like mean that the element so modified need not be exactly what is described but can vary from exact compliance with the written description by as much as ±15% without exceeding the scope of this invention. Thus, for example without limitation, to stop the flow of blood through an artery “substantially completely” means to cut off at least 85% of the flow of blood. [0029] The target tissue of this invention is a malignant solid tumor. A solid tumor refers to an abnormal mass of tissue that usually does not contain cysts or liquid areas. A tumor that is not cancerous is described as “benign” while a cancerous tumor, the targets of this invention, are termed “malignant.” Different types of solid tumors are named for the particular cells that form them, for example, sarcomas formed from connective tissue cells (bone cartilage, fat, etc.), carcinomas formed from epithelial tissue cells (breast, colon, pancreas, etc.) and lymphomas formed from lymphatic tissue cells (lymph nodes, spleen, thymus, etc.). Treatment of all types of solid tumors is within the scope of this invention. In particular the target tumor is an HCC. [0030] As used herein, “identifying” a malignant solid tumor simply refers to detecting its presence and its type by any means currently known in the art or as may become known in the future. [0031] As used herein, “chemotherapeutic agent” refers to any substance that, when administered in a therapeutically effective amount to a patient suffering from a solid tumor cancer, has a therapeutic beneficial effect on the health and well-being of the patient. A therapeutic beneficial effect on the health and well-being of a patient includes, but it not limited to: (1) curing the cancer; (2) slowing the progress of the cancer; (3) causing the tumor to retrogress; or (4) alleviating one or more symptoms of the cancer. As used herein, a chemotherapeutic agent also includes any substance that, when administered in a prophylactic amount to a patient afflicted with a solid tumor cancer or who has been rendered substantially free of cancer as the result of one or more therapeutic treatment regimes, has a beneficial effect on the health and well-being of the patient. A prophylactic beneficial effect on the health and well-being of a patient includes, but is not limited to: (1) maintaining the cancer at a retrogressed level once such level has been achieved by a therapeutically effective amount of a substance, which may be the same as or different from the substance used in a prophylactic effective amount; or, (2) preventing or delaying recurrence of the cancer after a course of treatment with a therapeutically effective amount of a substance, which may be the same as or different from the substance used in a prophylactic effective amount, has concluded. It is presently preferred that, when the solid tumor is an HCC, the chemotherapeutic agent comprises at least doxorubicin. Any other chemotherapeutic that has a beneficial effect on the HCC may be combined with the doxorubicin but at present cisplatin and mitomycin C are preferred co-therapeutic agents to be administered with doxorubicin. [0032] A “therapeutically effective amount” refers to that amount of a chemotherapeutic agent that will have a beneficial effect, which may be curative or palliative, on the health and well-being of the patient so afflicted. A therapeutically effective amount may be administered as a single bolus, as intermittent bolus charges, as short, medium or long term sustained release formulations or as any combination of these. As used herein, short-term sustained release refers to the administration of a therapeutically effective amount of a therapeutic agent over a period of about an hour to about 3 days. Medium-term sustained release refers to administration of a therapeutically effective amount of a therapeutic agent over a period of about 3 days to about 4 weeks and long-term refers to the delivery of a therapeutically effective amount over any period in excess of about 4 weeks. Presently, it is preferred that a therapeutically effective amount of the chemotherapeutic agent be delivered over a period of at least 6 months. [0033] As used herein, the use of “preferred,” “preferably,” or “more preferred,” and the like refer to modify an aspect of the invention refers to preferences as they existed at the time of filing of the patent application. [0034] Structural vehicles or “particles” that may be used with the method of this invention include, without limitation, liposomes, biodegradable polymersomes and biodegradable microparticles of a mean size such that at least 80% of them will not be able to pass through the vasculature servicing the target tumor, in particular an HCC. For the purposes of this invention, two different mean particle sizes are employed. One plurality of particles will have a mean size of about 10 nanometers (nm) to about 300 micrometers (μm), these being the drug-delivery particles. The other plurality of particles will have a mean size of about 900 μm to about 1200 μm and will be used to embolize an artery in the vicinity of a tumor being treated. The two pluralities of particles may comprise the same structural vehicle or they may be fabricated of different such vehicles. For example without limitation, the drug-carrying plurality of particles may be liposomes while the embolizing plurality of particles may be polymersomes or solid microparticles. [0035] As used herein, “embolization,” embolizing” and any other variations on the term refers to the procedure of introducing an artificial material at a site in a blood vessel such that the material lodges there and blocks the flow of blood. Materials that can be used to embolize a vessel include, without limitation, coils or hydrocoils, particles, foams and plugs but for the purpose of this invention, the structural vehicles mentioned above are preferred. [0036] As used herein, a “liposome” refers to a core-shell structure in which the shell comprises phospholipids or sphingolipids that surround a usually liquid, and in most cases aqueous, core. [0037] Phospholipids are molecules that have two primary regions, a hydrophilic head region comprised of a phosphate of an organic molecule and one or more hydrophobic fatty acid tails. In particular, naturally-occurring phospholipids have a hydrophilic region comprised of choline, glycerol and a phosphate and two hydrophobic regions comprised of fatty acid. When phospholipids are placed in an aqueous environment, the hydrophilic heads come together in a linear configuration with their hydrophobic tails aligned essentially parallel to one another. A second line of molecules then aligns tail-to-tail with the first line as the hydrophobic tails attempt to avoid the aqueous environment. To achieve maximum avoidance of contact with the aqueous environment, i.e., at the edges of the bilayers, while at the same time minimizing the surface area to volume ratio and thereby achieve a minimal energy conformation, the two lines of phospholipids, know as a phospholipid bilayer or a lamella, converge into a sphere and in doing so entrap some of the aqueous medium, and whatever may be dissolved or suspended in it, in the core of the sphere. Examples of phospholipids that may be used to create liposomes are, without limitation, 1,2-dimyristroyl-sn-glycero-3-phosphocholine, 1,2-dilauroyl-sn-glycero-3-phosphocholine, 1,2-distearoyl-sn-glycero-3-phosphocholine, 1,2-dimyristoyl-sn-glycero-3-phosphoethanolamine, 1,2-dipalmitoyl-sn-glycero-3-phosphoethanolamine, 1,2-dioleoyl-sn-glycero-3-phosphate monosodium salt, 1,2-dipalmitoyl-sn-glycero-3-[phosphor-rac-(1-glycerol)]sodium salt, 1,2-dimyristoyl-sn-glycero-3-[phospho-L-serine]sodium salt, 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine-N-glutaryl sodium salt and 1,1′,2,2′-tetramyristoyl cardiolipin ammonium salt. [0038] Liposomes may be unilamellar, composed of a single bilayer, or they may be multilamellar, composed of two or more concentric bilayers. Liposomes range from about 20-100 nm diameter for small unilamellar vesicles (SUVs), about 100-5000 nm for large multilamellar vesicles and ultimately to about 100 microns for giant multilamellar vesicles (GMVs). LMVs form spontaneously upon hydration with agitation of dry lipid films/cakes which are generally formed by dissolving a lipid in an organic solvent, coating a vessel wall with the solution and evaporating the solvent. Energy is then applied to convert the LMVs to SUVs, LUVs, etc. The energy can be in the form of, without limitation, sonication, high pressure, elevated temperatures and extrusion to provide smaller single and multi-lamellar vesicles. During this process some of the aqueous medium is entrapped in the vesicle. Generally, however, the fraction of total solute and therefore the amount of therapeutic agent entrapped tends to be rather low, typically in the range of a few percent. Recently, however, liposome preparation by emulsion templating (Pautot, et al., Langmuir, 2003, 19:2870) has been shown to result in the entrapment of virtually 100% of aqueous solute. Emulsion templating comprises, in brief, the preparation of a water-in-oil emulsion stabilized by a lipid, layering of the emulsion onto an aqueous phase, centrifugation of the water/oil droplets into the water phase and removal of the oil phase to give a dispersion of unilamellar liposomes. This method can be used to make asymmetric liposomes in which the inner and outer monolayers of the single bilayer contain different lipids. Any of the preceding techniques as well as any others known in the art or as may become known in the future may be used as compositions of therapeutic agents in or on a delivery interface of this invention. Liposomes comprising phospho- and/or sphingolipids may be used to deliver hydrophilic (water-soluble) or precipitated therapeutic compounds encapsulated within the inner liposomal volume and/or to deliver hydrophobic therapeutic agents dispersed within the hydrophobic core of the bilayer membrane. [0039] As used herein, a “microparticle” refers to a solid having as its smallest cross-sectional, i.e., through the solid as opposed to along its surface, dimension about one micron. Presently preferred are microparticles having a mean size of about 10 nm to about 300 μm if intended as the drug-carrying particles or about 900 to about 1200 μm if intended to be the embolizing particles. The solid can have any desired shape such as without limitation spherical, ellipsoid, rod-like, entirely random shaped, etc., although substantially spherical microparticles are well-known in the art, are readily prepared and are presently preferred. The microparticle may be constructed of one or more biocompatible substances and may be porous so as to permit elution of the therapeutic substance embedded in it or may be biodegradable such that as the particle degrades the therapeutic substance is released into the environment. [0040] Particle size distributions may be represented in a number of ways, one of the most common of which is “mean particle size.” A “mean” size may refer to a value based on particle length, width and/or diameter, on area or on volume. As used herein, “mean size” is determined by measuring the longest through-particle distance of each microparticle and then dividing by the total number of microparticles. Of course, this requires sophisticated equipment when dealing with the large numbers of microparticles contemplated by this invention but such equipment is well-known and readily available to those skilled in the art and such determination of mean size is commonplace in the art. To assure efficient capture of the microparticles of this invention, not only should the microparticles have the stated mean size, the distribution of particle size should be a narrow as possible, that is as close to monodisperse as can be achieved. No specific size dispersion is presently preferred because the narrower the better and, while several techniques are discussed below for achieving relatively narrow size distributions, as the state of the art advances, equipment and procedures for reaching even narrower size distributions will surely become available and all such equipment, procedures and size distributions will clearly be within the scope of this invention. [0041] A particular method of determining mean particle size is dynamic light scattering (“DLS”), which is also called photon correlation spectroscopy, and which determines the hydrodynamic or Stokes diameter based on diffusion measurements. The hydrodynamic diameter includes solvent associated with the particle. This mean hydrodynamic diameter obtained from DLS is close to the volume-average diameter. One method is outlined in the International Standards Organization (“ISO”) 13321. There are many other means of determining mean particle size known to those skilled in the art. Also known to those skilled artisans is the fact that the various means tend to give different results but the correlation of the results of one method to each other method is also well known. Thus, any method of particle size determination may be used but the result should be correlated with that obtained by DLS to assure a mean particle size that will be entrapped at the correct point in the circulatory system, i.e., the capillaries. [0042] With regard to mean size and size distribution, as noted above, it is presently preferred that at least 80% of the particles, be they liposomes, polymersomes or solid microparticles, administered into an artery serving a particular tissue are entrapped at the selected location in the vasculature servicing the target tumor. More preferably, at least 90% of the microparticles will be so entrapped and most preferably at present, at least 99% of the microparticles will be entrapped. [0043] The plurality of particles herein can comprise several different designs. In the simplest, the therapeutic agent is simply encapsulated in the carrier at a single concentration so that all particles are substantially the same with regard to drug load. In another design, the therapeutic agent can be encapsulated in the carrier, or if desired in several different carriers, at different concentrations in separate preparations and the particles formed in those separate preparations can be combined for administration to a patient. In yet another design, different therapeutic agents can be separately encapsulated in a carrier, or, again, in different carriers, at various concentrations, the particles being combined for administration or, if desired, administered sequentially. Two or more therapeutic agents can, of course, be encapsulated in the same particulate carrier such that the resulting particles each contain more than one therapeutic agent. Those skilled in the art will, based on the disclosure herein, be able to devise additional combinations of carrier and therapeutic agent(s); all such combinations are within the scope of this invention. [0044] The selection of the presently preferred range of particle sizes is based on the average diameter of various portions of the vasculature. A basic premise of this invention is that microparticles containing an appropriate therapeutic agent or combination of agents can be administered into an artery that directly services a tissue of interest. By “directly services” is meant that blood flowing through the artery proceeds in one direction only through the labyrinthine maze comprising artery→arterioles→metarterioles→capillaries→postcapillary venules→venules—vein. It is noted that the kidneys have a rather unique circulatory system: arteries afferent arterioles glomerular capillaries efferent arterioles but the methods of this invention are eminently suitable for use with the kidneys as well as other organs. Thus, particles injected into blood in the artery have nowhere to go but into the diseased tissue where, depending on their size, they lodge in whichever of the preceding substructures has a diameter that is smaller than the selected particle mean size. Arterioles are generally regarded as having inside diameters in the range of about 10 to 50 microns, metarterioles about 10 to 20 microns and capillaries approximately 4 to 15 (average about 8) microns in diameter. Thus, microparticles having a mean size of about 10 μm, the smallest size for drug-carrying particles of this invention, should be efficiently trapped at the capillary level. For example, it has been reported that in one experiment 97% of 15 micrometer radiolabeled microspheres injected in an artery servicing the eye were entrapped at the first pass. At the other end of the spectrum for drug-carrying particles, those with a mean size of about 300 μm, these will be entrapped in the main artery in the vicinity of where it necks down to arteriole size. [0045] Entrapping the drug-carrying particles at the capillary level is presently preferred in that it offers the broadest specific application of chemotherapeutic agent to the target tumor assuming the tumor has developed a mature capillary system. This is due to the physiology of the capillary system. That is, the capillary system comprises a vast network of minute (averaging approximately one millimeter in length and 8-10 microns in diameter) vessels that permeates virtually every tissue in the mammalian body. As testament to the ubiquity of capillaries, it has been estimated that their number is approximately 19,000,000,000 and that most living tissue cells lie within 1-3 cell lengths of a capillary. Thus, to achieve maximum dispersion of a therapeutic agent in a target tissue, it makes sense that the vehicle carrying the therapeutic agent be capable of maneuvering through the circulatory system to the capillary level. [0046] On the other hand, if the target tumor has not developed a sophisticated capillary system, it might be preferable to use larger size delivery vehicles/particles that will lodge in larger diameter vessels servicing the capillaries. Such determination is left to the attending physician and should be based on whatever diagnostic evidence is evinced during the course of treatment of the patient. [0047] Whatever the selected mean particle size of the drug delivery vehicles, the mean size of the embolizing particles must be larger so as to substantially or, if desired, completely cut off the flow of blood to the region where the drug-delivery vehicle has lodged. In this manner, drug can be released from the delivery vehicle and have time to enter into the surrounding tissue without the risk of being carried away by the blood. [0048] It may, on the other hand, be desirable to select the embolizing particle size based on the dimensions of the largest artery servicing the tumor that services only or predominantly the tumor. In this manner, stress can be placed on the entire tumor while at the same time embolization of healthy tissues is held to a minimum. [0049] In addition to solid microparticles and liposomes, a particle of this invention may be a polymersome, which is akin to a liposome wherein the shell is made up of synthetic amphiphilic polymers rather than phospholipids and sphigolipids. Examples of polymers that can be used to prepare polymersomes include, without limitation, poly(ethylene glycol)-b-poly(ε-caprolactone), poly(ethylene glycol)-b-polyesters, poly(ethylene glycol)-b-poly(L-aminoacids), poly(N-vinylpyrrolidone)-bl-poly(orthoesters), poly(N-vinylpyrrolidone)-b-polyanhydrides and poly(N-vinylpyrrolidone)-b-poly(alkyl acrylates). Depending on the length and chemical nature of the polymers in the diblock copolymer, polymersomes can be substantially more robust that liposomes. In addition, the ability to control completely the chemical nature of each block of the diblock copolymer permits tuning of the polymersome's composition to fit the desired application. For example, membrane thickness can be controlled by varying the degree of polymerization of the individual blocks. Adjusting the glass transition temperatures of the blocks will affect the fluidity and therefore the permeability of the membrane. Even the mechanism of release can be modified by altering the nature of the polymers. [0050] Polymersomes can be prepared in the same manner as liposomes. That is, a film of the diblock copolymer can be formed by dissolving the copolymer in an organic solvent, applying a film of the copolymer-containing solvent to a vessel surface, removing the solvent to leave a film of the copolymer and then hydrating the film. Polymersomes can also be prepared by dissolving the diblock copolymer in a solvent and then adding a poor solvent for one of the blocks, which will result in the spontaneous formation of polymersomes. [0051] As with liposomes, polymersomes can be used to encapsulate therapeutic agents by including the therapeutic agent in the water used to rehydrate the copolymer film. Polymersomes can also be force-loaded by osmotically driving the therapeutic agent into the core of the vesicle. Also as with liposomes, the loading efficiency is generally low. Recently, however, a technique has been reported that provides polymersomes of relative monodispersity and high loading efficiency; generation of polymersomes from double emulsions. Lorenceau, et al., Langmuir, 2005, 21:9183-86. The technique involves the use of microfluidic technology to generate double emulsions consisting of water droplets surrounded by a layer of organic solvent. These droplet-in-a-drop structures are then dispersed in a continuous water phase. The diblock copolymer is dissolved in the organic solvent and self-assembles into proto-polymersomes on the concentric interfaces of the double emulsion. The actual polymersomes are formed by completely evaporating the organic solvent from the shell. By this procedure the size of the polymersomes can be finely controlled and, in addition, the ability to maintain complete separation of the internal fluids from the external fluid throughout the process allows extremely efficient encapsulation. This technique along with any other technique know in the art or as may become known in the future can be used to prepare a composition of therapeutic agents for use in or on a delivery interface of this invention. [0052] As used herein, “delivering” microparticles “at or near” a tumor refers to deposition of the particles in an artery sufficiently close to the target tumor to assure to the extent possible that the first instance of encountering a vessel of sufficiently small internal diameter to prevent passage of the particles will be the capillary system of the tumor itself. Such delivery can be accomplished by a number of means including, without limitation, the use of catheters and direct injection. Both of these methods of delivering microparticles to a specific locale in a patient's body are well-known to those skilled in the art and require no further explication here. [0053] As use herein, “proximal to the location of the first plurality of microparticles” refers to a point in the target artery that is between where the first plurality of microparticles has lodges and the heart so as to substantially cut off the flow of blood past the region with the first plurality of microparticles has lodged. [0054] As mentioned previously, presently preferred delivery vehicles of this invention are microparticles, liposomes and polymersomes having a mean particle size such that the majority of the particles are entrapped in the vascular system at the chosen locale upon the first pass of the plurality of particles through the patient's circulatory system. [0055] As used herein, “first pass” refers to the first time a particle encounters a vessel of the correct inside diameter be it a capillary, an arteriole, etc. With regard, without limitation, to a capillary target, first pass refers to the first time the drug delivery vehicle encounters the capillary bed at the terminus of a selected artery serving a tumor. Microparticles that, for one reason or another, pass through the bed and find their way to venules and thence to veins will continue to circulate in the circulatory system until they once again encounter a capillary bed (although it may not be the capillary bed of the target tissue, which is why it is preferred that as high a percentage as possible are entrapped in the capillary bed of the target diseased tissue after having been administered into an artery serving that tissue). Again, for the purpose of this invention, it is preferred that at least 80% of the microparticles are entrapped at the first pass, more preferably 90% and presently most preferably, 99%. [0056] With regard to embolizing particles, they will clearly be trapped on the first pass since their size renders them incapable of passing through the capillary system to the veins. The critical aspect of these particles is that they interrupt blood flow upstream from where the drug-carrying particles are trapped. [0057] As mentioned above, in order to achieve the preceding degrees of entrapment it is necessary to produce microparticles having a size distribution a narrow as possible around the target mean size wherein the target mean size is determined by the vessel size in the tissue being treated. That is, again with reference to capillary bed entrapment, the mean particle size must be small enough to pass through an arteriole (afferent arteriole in the case of the kidneys) but large enough to be trapped by a capillary. While there may be other means to accomplish this and any such means is within the scope of this invention, presently preferred means include emulsification followed by supercritical fluid solvent extraction, ultrasonic atomization or droplet formation, electrohydrodynamic atomization and membrane emulsification. [0058] Emulsification followed by supercritical fluid solvent extraction to form microparticles having a very narrow size range is a well-known technique in the art and therefore need not be extensively discussed herein, In brief, the technique involves the formation of an emulsion by dissolving a polymer and a therapeutic agent in a solvent for both, adding the solution under high shear to water containing emulsifying agent, sonicating to achieve a narrow droplet size range, passing the droplets through a porous membrane of well-defined pore size and then extracting the solvent from the microparticles using a supercritical fluid to give a hardened particle. A supercritical fluid, that is a fluid above its critical temperature and pressure, is used because of the physical properties of such fluids, which are intermediate between those of a gas those of a liquid. For example, supercritical carbon dioxide has a viscosity in the range of about 0.02 to about 0.1 centipoise (cP) whereas liquids have viscosities 0.5-1.0 cP and gasses have viscosities around 0.01 cP. Further, the diffusivities of solutes in supercritical carbon dioxide are up to a factor of 10 higher than in liquid solvents. This and the tunability of the solvating properties of supercritical fluids, which are a complex (but relatively well-understood) function of pressure and temperature, permit extremely selective extraction of one material, the solvent herein for instance, from others it may be combined with. [0059] In any event, the hardened microparticles obtained after supercritical fluid solvent extraction may then be passed through yet another filter with well-defined pore size to still further control particle size distribution. [0060] Atomization of a solution using an ultrasonic transducer can produce relatively monodisperse droplets. When captured in a appropriate bath and hardened, this can result in a narrow distribution of microspheres. The ultrasonic energy may be applied using a “horn” with the solution either flowing through it or being applied to its surface. The ultrasonic horn oscillates at a fixed frequency supplied by an ultrasonic transducer. Ultrasonic spray nozzles of this sort are readily available from Sono-Tek Corp, Milton, N.Y. [0061] Another technique that produces relatively monodisperse particles involves the use of acoustic excitation of a liquid stream to break the stream up into monodisperse particles (Berkland, et al., J. Control. Rel., 2001, 73:59-74). The liquid stream is composed of a polymer and a therapeutic agent dissolved in one or more solvents. The droplets are carried by a carrier stream to a hardening bath where the solvent is removed. The frequencies needed to excite the liquid stream sufficiently to break it up into droplets are in the ultrasonic region of the spectrum. [0062] Electrohydrodynamic atomization (EDHA) is another, relatively new but nevertheless well-characterized technique in the art for producing narrow size distribution, i.e. essentially monodisperse, microparticles. Again, without going into unnecessary detail since those skilled in the art will be very familiar with the technique, electrohydrodynamic atomization involves pumping a solution through a nozzle wherein a high voltage potential has been established between the tip of the nozzle and a counter-electrode. The high potential causes a build-up of electric charge in droplets at the nozzle tip and when the coulombic forces exceed the surface tension of the droplets, they separate, essentially explode, into smaller droplets. If parameters are optimized to achieve a stable spray, monodispersed droplets are obtained. Removal of solvent from the droplets yields monodisperse solid microparticles. Parameters that may be varied to achieve a particular average size droplet/particle include, without limitation, the applied voltage, the flow rate, density, conductivity and surface tension. [0063] Normal emulsification techniques generally afford droplets of relative polydispersity, at least with regard to the narrow size distribution desired for use in the current invention. Thus, the requirement of one and perhaps two filtrations as set forth above with regard to emulsification/supercritical fluid solvent extraction. This is due primarily to the myriad parameters that come into play when preparing an emulsion such as, without limitation, the concentration of the agents, the nature of the drug/polymer/surfactant/solvent interaction, polymer molecular weight, sonication power, stir speed, fluid dynamics of the system and temperature. These shortcomings, at least with regard to the present invention, can be overcome by using the technique known as membrane emulsification. [0064] Membrane emulsification is another relatively new technique for producing essentially monodisperse microparticles. As with standard emulsification followed by multiple filtrations and electrohydrodynamic atomization, membrane emulsification, while a relatively recent development, is well-known to those skilled in the art and need not be detailed herein. In brief, membrane emulsification involves the injection of an intended discontinuous phase through a porous membrane in which pore size is very carefully controlled into the intended continuous phase, which is moving past the porous membrane on the side opposite that from which the discontinuous phase is being injected. Droplets are sheared off the membrane by the moving continuous phase. Control of droplet size is quite exquisite compared to normal emulsification techniques because size is determined predominantly by easily varied parameters including the speed of the continuous phase, viscosity of the continuous phase, interfacial tension between the phases, the chemistry of the system—surfactant type and physical properties of all the constituents—and, of course, pore size. Newer techniques for creating porous membranes with a very precise pore size such as laser drilling and lithographic procedures have made membrane emulsification even more attractive as a technique for control of particle size distribution. [0065] Any selected particle size can be prepared with relatively narrow mean size distribution using the above techniques, as well as others known in the art, by incorporating well-known mechanical and procedural changes in the methods described. [0066] Polymeric microparticies presently preferred drug delivery vehicles of this invention. The polymer(s) must be biocompatible and can be either biostable or biodegradable. As used herein, biodegradable includes all means by which a polymer can be disposed of in a patient's body, which includes bioabsorption, resorption, etc. Biostable simply means that the polymer does not biodegrade or bioabsorb under physiological conditions over a relatively long period of time that may reach years. [0067] As used herein, “biocompatible” refers to a polymer that both in its intact, that is, as synthesized, state and in its decomposed state, i.e., its degradation products, is not, or at least is minimally, toxic to living tissue; does not, or at least minimally and reparably, injure(s) living tissue; and/or does not, or at least minimally and/or controllably, cause(s) an immunological reaction in living tissue. [0068] As used herein, “biodegradable” refers to any natural means by which a polymer can be disposed of in a patient's body. This includes such phenomena as, without limitation, biological decomposition, bioerosion, absorption, resorption, etc. Biodegradation of a polymer in vivo results from the action of one or more endogenous biological agents and/or conditions such as, without limitation, enzymes, microbes, cellular components, physiological pH and temperature and the like. Bioabsorbable or bioresorbable on the other hand generally refers to the situation wherein the polymer itself or its degradation products are removed from the body by cellular activity such as, without limitation, phagocytosis. Bioerodible refers to both physical processes such as, without limitation, dissolution and chemical processes such as, without limitation, backbone cleavage by hydrolysis of the bonds linking constitutional units of a polymer together. As used herein, biodegradable includes bioerodible, bioresobable and bioabsorbable. [0069] The biodegradability of a polymer can be characterized by its “mass loss” in vivo over a period of time. By “mass loss” is meant loss in actual weight of a particle fabricated from the polymer a contrasted with “molecular weight loss,” which refers to the break-down of individual polymer chains to smaller fragments, a process that generally precedes mass loss when the smaller fragments break off of the polymeric particle. [0070] Physiological conditions merely refers to the physical, chemical and biochemical milieu that constitutes the mammalian body and includes, without limitation, pH, temperature, enzymes and the presence of destructive cells such as phagocytes. [0071] Among biocompatible, relatively biostable polymers useful as carriers for the preparation of microparticles of this invention are, without limitation, polyacrylates, polymethacryates, polyureas, polyurethanes, polyolefins, polyvinylhalides, polyvinylidenehalides, polyvinylethers, polyvinylaromatics, polyvinylesters, polyacrylonitriles, alkyd resins, polysiloxanes and epoxy resins. [0072] Biocompatible, biodegradable polymers that can be used for the carrier/particle-forming of this invention include, again without limitation, naturally-occurring polymers such as, without limitation, collagen, chitosan, alginate, fibrin, fibrinogen, cellulosics, starches, dextran, dextrin, hyaluronic acid, heparin, glycosaminoglycans, polysaccharides and elastin. [0073] Synthetic or semi-synthetic biocompatible, biodegradable polymers may also be used as carriers for the purpose of this invention. As used herein, a synthetic polymer refers to one that is created wholly in the laboratory while a semi-synthetic polymer refers to a naturally-occurring polymer than has been chemically modified in the laboratory. Examples of synthetic polymers include, without limitation, polyphosphazines, polyphosphoesters, polyphosphoester urethane, polyester urethanes, polyester urethane ureas, polyhydroxyacids, polyhydroxyalkanoates, polyanhydrides, polyesters, polyorthoesters, polyamino acids, polyoxymethylenes, poly(ester amides) and polyimides. [0074] Further non-limiting examples of biocompatible biodegradable polymers that may be suitable as carriers herein include, without limitation, polycaprolactone, poly(L-lactide), poly(D,L-lactide), poly(D,L-lactide-co-PEG) block copolymers, poly(D,L-lactide-co-trimethylene carbonate), polyglycolide, poly(lactide-co-glycolide), polydioxanone (PDS), polyorthoester, polyanhydride, poly(glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly(amino acids), polycyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), polycarbonates, polyurethanes, copoly(ether-esters) (e.g. PEO/PLA), polyalkylene oxalates, polyphosphazenes, PHA-PEG, and combinations thereof. The PHA may include poly(α-hydroxyacids), poly(β-hydroxyacid) such as poly(3-hydroxybutyrate) (PHB), poly(3-hydroxybutyrate-co-valerate) (PHBV), poly(3-hydroxyproprionate) (PHP), poly(3-hydroxyhexanoate) (PHH), or poly(4-hydroxyacid) such as poly poly(4-hydroxybutyrate), poly(4-hydroxyvalerate), poly(4-hydroxyhexanoate), poly(hydroxyvalerate), poly(tyrosine carbonates), poly(tyrosine arylates), poly(ester amide), polyhydroxyalkanoates (PHA), poly(3-hydroxyalkanoates) such as poly(3-hydroxypropanoate), poly(3-hydroxybutyrate), poly(3-hydroxyvalerate), poly(3-hydroxyhexanoate), poly(3-hydroxyheptanoate) and poly(3-hydroxyoctanoate), poly(4-hydroxyalkanaote) such as poly(4-hydroxybutyrate), poly(4-hydroxyvalerate), poly(4-hydroxyhexanote), poly(4-hydroxyheptanoate), poly(4-hydroxyoctanoate) and copolymers including any of the 3-hydroxyalkanoate or 4-hydroxyalkanoate monomers described herein or blends thereof, polyglycolide, poly(D,L-lactide-co-glycolide), poly(L-lactide-co-glycolide), polycaprolactone, poly(lactide-co-caprolactone), poly(glycolide-co-caprolactone), poly(dioxanone), poly(ortho esters), poly(anhydrides), poly(tyrosine carbonates) and derivatives thereof, poly(tyrosine ester) and derivatives thereof, poly(imino carbonates), poly(glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly(amino acids), polycyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), polyphosphazenes, silicones, polyesters, polyolefins, polyisobutylene and ethylene-alphaolefin copolymers, acrylic polymers and copolymers, vinyl halide polymers and copolymers, such as polyvinyl chloride, polyvinyl ethers, such as polyvinyl methyl ether, polyvinylidene halides, such as polyvinylidene chloride, polyacrylonitrile, polyvinyl ketones, polyvinyl aromatics, such as polystyrene, polyvinyl esters, such as polyvinyl acetate, copolymers of vinyl monomers with each other and olefins, such as ethylene-methyl methacrylate copolymers, acrylonitrile-styrene copolymers, ABS resins, and ethylene-vinyl acetate copolymers, polyamides, such as Nylon 66 and polycaprolactam, alkyd resins, polycarbonates, polyoxymethylenes, polyimides, polyethers, poly(glyceryl sebacate), poly(propylene fumarate), poly(n-butyl methacrylate), poly(sec-butyl methacrylate), poly(isobutyl methacrylate), poly(tert-butyl methacrylate), poly(n-propyl methacrylate), poly(isopropyl methacrylate), poly(ethyl methacrylate), poly(methyl methacrylate), epoxy resins, polyurethanes, rayon, rayon-triacetate, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ethers, carboxymethyl cellulose, polyethers such as poly(ethylene glycol) (PEG), copoly(ether-esters) (e.g. poly(ethylene oxide-co-lactic acid) (PEO/PLA)), polyalkylene oxides such as poly(ethylene oxide), poly(propylene oxide), poly(ether ester), polyalkylene oxalates, phosphoryl choline containing polymer, choline, poly(aspirin), polymers and co-polymers of hydroxyl bearing monomers such as 2-hydroxyethyl methacrylate (HEMA), hydroxypropyl methacrylate (HPMA), hydroxypropylmethacrylamide, PEG acrylate (PEGA), PEG methacrylate, methacrylate polymers containing 2-methacryloyloxyethyl-phosphorylcholine (MPC) and n-vinyl pyrrolidone (VP), carboxylic acid bearing monomers such as methacrylic acid (MA), acrylic acid (AA), alkoxymethacrylate, alkoxyacrylate, and 3-trimethylsilylpropyl methacrylate (TMSPMA), poly(styrene-isoprene-styrene)-PEG (SIS-PEG), polystyrene-PEG, polyisobutylene-PEG, polycaprolactone-PEG (PCL-PEG), PLA-PEG, poly(methyl methacrylate)-PEG (PMMA-PEG), polydimethylsiloxane-co-PEG (PDMS-PEG), poly(vinylidene fluoride)-PEG (PVDF-PEG), PLURONIC™ surfactants (polypropylene oxide-co-polyethylene glycol), poly(tetramethylene glycol), hydroxy functional poly(vinyl pyrrolidone), biomolecules such as collagen, chitosan, alginate, fibrin, fibrinogen, cellulose, starch, dextran, dextrin, hyaluronic acid, fragments and derivatives of hyaluronic acid, heparin, fragments and derivatives of heparin, glycosamino glycan (GAG), GAG derivatives, polysaccharide, elastin, elastin protein mimetics, or combinations thereof. [0075] Blends and copolymers of the above polymers may also be used and are within the scope of this invention. Based on the disclosures herein, those skilled in the art will recognize those implantable medical devices and those materials from which they may be fabricated that will be useful with the coatings of this invention. [0076] Any reference to the molecular weight of a polymer of this invention is reported as the number average molecule weight, the nature and determination of which is well-known in the art and need not be explicated further here. [0077] As used herein, The “weight ratio” of a chemotherapeutic drug to a polymer refers to quantity of the drug relative to the quantity of polymer that constitutes the microparticle carrying the drug in like units, e.g. without limitation, mg:mg so that, for instance, a drug to polymer weight ratio of 1:5 would mean that the amount of drug in or on a microparticle in which the polymer component weights 5 mg would be 1 mg. [0078] As noted previously, a chemotherapeutic agent may be administered to a patient using the method of this invention in a bolus or sustained release format. The manner of fabrication of the carrier microparticle including the material of which it is made will determine how the chemotherapeutic agent is released after the particles have been delivered at or near the target tumor. Such fabrication techniques are well-documented in the patent and technical literature and need not be replicated here. Suffice it to say that any fabrication materials and procedures resulting in a desired release format are all within the scope of this invention. [0079] As used herein, loading a chemotherapeutic drug “into or onto” a microparticle refers to (1) “into”—drug-carrying particles where the drug is encapsulated in the matrix of the particle, if it is solid, or at the core of the particle if it constitutes a core-shell structure—liposomes and polymersomes herein or (2) “onto”—drug-carrying particle where the drug is attached to the outer surface of the particle, which can be accomplished by any number of means well-known in the art. [0080] The method of this invention can be used to treat any solid tumor cancer to which blood is supplied by a dedicated, relatively reachable artery such as the renal, hepatic, pulmonary and cardiac arteries. In particular at present it can be used to treat HCC tumors. As such, the chemotherapeutic agent(s) which may be used in the instant method include virtually all known chemotherapeutics as well as those that become available in the future. [0081] As used herein, a “patient” refers to any species that might benefit from treatment using the method herein but at present is preferably a mammal and most preferably a human being.

This invention is directed to methods of treating solid tumor cancers, particularly refractory cancers by administration of two pluralities of microparticles, one comprising drug-carrying microparticles sized to lodge at the tumor preferably in the capillary bed of the tumor and the other comprising non-drug-carrying microparticles sized to lodge in the arterial system servicing the tumor so as to embolize the tumor.

CLAIM OF PRIORITY [0001] This application is a continuation application of U.S. patent application Ser. No. 09/549,350, filed Apr. 14, 2000, which is incorporated in its entirety by reference herein. FIELD OF THE INVENTION [0002] The present invention generally relates to improved medical devices and methods for the reduction of elevated pressure in organs of the human body. More particularly, the present invention relates to the treatment of glaucoma by trabecular bypass surgery, which is a means for using an implant or seton, such as a micro stent, shunt or the like, to bypass diseased trabecular meshwork at the level of trabecular meshwork and use/restore existing outflow pathways. BACKGROUND OF THE INVENTION [0003] About two percent of people in the United States have glaucoma. Glaucoma is a group of eye diseases that causes pathological changes in the optic disk and corresponding visual field loss resulting in blindness if untreated. Intraocular pressure elevation is the major etiologic factor in all glaucomas. [0004] In glaucomas associated with an elevation in eye pressure the source of resistance to outflow is in the trabecular meshwork. The tissue of the trabecular meshwork allows the “aqueous” to enter Schlemm's canal, which then empties into aqueous collector channels in the posterior wall of Schlemm's canal and then into aqueous veins. The aqueous or aqueous humor is a transparent liquid that fills the region between the cornea at the front of the eye and the lens. The aqueous humor is constantly secreted by the ciliary body around the lens, so there is a continuous flow of the aqueous humor from the ciliary body to the eye's front chamber. The eye's pressure is determined by a balance between the production of aqueous and its exit through the trabecular meshwork (major route) or via uveal scleral outflow (minor route). The trabecular meshwork is located between the outer rim of the iris and the internal periphery of the cornea. The portion of the trabecular meshwork adjacent to Schlemm's canal causes most of the resistance to aqueous outflow (juxtacanilicular meshwork). [0005] Glaucoma is grossly classified into two categories: closed-angle glaucoma and open-angle glaucoma. The closed-angle glaucoma is caused by closure of the anterior angle by contact between the iris and the inner surface of the trabecular meshwork. Closure of this anatomical angle prevents normal drainage of aqueous humor from the anterior chamber of the eye. Open-angle glaucoma is any glaucoma in which the angle of the anterior chamber remains open, but the exit of aqueous through the trabecular meshwork is diminished. The exact cause for diminished filtration is unknown for most cases of open-angle glaucoma. However, there are secondary open-angle glaucomas which may include edema or swelling of the trabecular spaces (from steroid use), abnormal pigment dispersion, or diseases such as hyperthyroidism that produce vascular congestion. [0006] All current therapies for glaucoma are directed at decreasing intraocular pressure. This is initially by medical therapy with drops or pills that reduce the production of aqueous humor or increase the outflow of aqueous. However, these various drug therapies for glaucoma are sometimes associated with significant side effects, such as headache, blurred vision, allergic reactions, death from cardiopulmonary complications and potential interactions with other drugs. When the drug therapy fails, surgical therapy is used. Surgical therapy for open-angle glaucoma consists of laser (trabeculoplasty), trabeculectomy and aqueous shunting implants after failure of trabeculectomy or if trabeculectomy is unlikely to succeed. Trabeculectomy is a major surgery which is most widely used and is augmented with topically applied anticancer drugs such as 5-flurouracil or mitomycin-c to decrease scarring and increase surgical success. [0007] Approximately 100,000 trabeculectomies are performed on Medicare age patients per year in the United States. This number would increase if the morbidity associated with trabeculectomy could be decreased. The current morbidity associated with trabeculectomy consists of failure (10-15%), infection (a life long risk about 2-5%), choroidal hemorrhage (1%, a severe internal hemorrhage from pressure too low resulting in visual loss), cataract formation, and hypotony maculopathy (potentially reversible visual loss from pressure too low). [0008] If it were possible to bypass the local resistance to outflow of aqueous at the point of the resistance and use existing outflow mechanisms, surgical morbidity would greatly decrease. The reason for this is that the episcleral aqueous veins have a backpressure that would prevent the eye pressure from going too low. This would virtually eliminate the risk of hypotony maculopathy and choroidal hemorrhage. Furthermore, visual recovery would be very rapid and risk of infection would be very small (a reduction from 2-5% to 0.05%). Because of these reasons surgeons have tried for decades to develop a workable surgery for the trabecular meshwork. [0009] The previous techniques, which have been tried, are goniotomy/trabeculotomy, and other mechanical disruption of the trabecular meshwork, such as trabeculopuncture, goniophotoablation, laser trabecular ablation and goniocurretage. They are briefly described below. [0010] Goniotomy/Trabeculotomy: Goniotomy and trabeculotomy are simple and directed techniques of microsurgical dissection with mechanical disruption of the trabecular meshwork. These initially had early favorable responses in the treatment of open-angle glaucoma. However, long-term review of surgical results showed only limited success in adults. In retrospect, these procedures probably failed secondary to repair mechanisms and a process of “filling in”. The filling in is the result of a healing process which has the detrimental effect of collapsing and closing in of the created opening throughout the trabecular meshwork. Once the created openings close, the pressure builds back up and the surgery fails. [0011] Trabeculopuncture: Q-switched Neodymiun (Nd):YAG lasers also have been investigated as an optically invasive technique for creating full-thickness holes in trabecular meshwork. However, the relatively small hole created by this trabeculopuncture technique exhibits a filling in effect and fails. [0012] Goniophotoablation/Laser Trabecular Ablation: Goniophotoablation is disclosed by Berlin in U.S. Pat. No. 4,846,172, and describes the use of an excimer laser to treat glaucoma by ablating the trabecular meshwork. This was not demonstrated by clinical trial to succeed. Hill et al. used an Erbium:YAG laser to create full thickness holes through trabecular meshwork (Hill et al., Lasers in Surgery and Medicine 11:341-346, 1991). This technique was investigated in a primate model and a limited human clinical trial at the University of California, Irvine. Although morbidity was zero in both trials, success rates did not warrant further human trials. Failure again was from filling in of created defects in trabecular meshwork by repair mechanisms. Neither of these is a valid surgical technique for the treatment of glaucoma. [0013] Goniocurretage: This is an ab-interno (from the inside) mechanical disruptive technique. This uses an instrument similar to a cyclodialysis spatula with a microcurrette at the tip. Initial results are similar to trabeculotomy that fails secondary to repair mechanisms and a process of filling in. [0014] Although trabeculectomy is the most commonly performed filtering surgery, Viscocanulostomy (VC) and non-penetrating trabeculectomy (NPT) are two new variations of filtering surgery. These are ab-externo (from the outside), major ocular procedures in which Schlemm's canal is surgically exposed by making a large and very deep scleral flap. In the VC procedure, Schlemm's canal is canulated and viscoelastic substance injected (which dilates Schlemm's canal and the aqueous collector channels). In the NPT procedure, the inner wall of Schlemm's canal is stripped off after surgically exposing the canal. [0015] Trabeculectomy, VC, and NPT are performed under a conjunctival and scleral flap, such that the aqueous humor is drained onto the surface of the eye or into the tissues located within the lateral wall of the eye. Normal physiological outflows are not used. These surgical operations are major procedures with significant ocular morbidity. When Trabeculectomy, VC, and NPT are thought to have a low chance for success, a number of implantable drainage devices have been used to ensure that the desired filtration and outflow of aqueous humor through the surgical opening will continue. The risk of placing a glaucoma drainage implant also includes hemorrhage, infection and postoperative double vision that is a complication unique to drainage implants. [0016] Examples of implantable shunts or devices for maintaining an opening for the release of aqueous humor from the anterior chamber of the eye to the sclera or space underneath conjunctiva have been disclosed in U.S. Pat. Nos. 6,007,511 (Prywes), 6,007,510 (Nigam), 5,893,837 (Eagles et al.), 5,882,327 (Jacob), 5,879,319 (Pynson et al.), 5,807,302 (Wandel), 5,752,928 (de Roulhac et al.), 5,743,868 (Brown et al.), 5,704,907 (Nordquist et al.), 5,626,559 (Solomon), 5,626,558 (Suson), 5,601,094 (Reiss), RE. 35,390 (Smith), 5,558,630 (Fisher), 5,558,629 (Baerveldt et al.), 5,520,631 (Nordquist et al.), 5,476,445 (Baerveldt et al.), 5,454,796 (Krupin), 5,433,701 (Rubinstein), 5,397,300 (Baerveldt et al.), 5,372,577 (Ungerleider), 5,370,607 (Memmen), 5,338,291 (Speckman et al.), 5,300,020 (L'Esperance, Jr.), 5,178,604 (Baerveldt et al.), 5,171,213 (Price, Jr.), 5,041,081 (Odrich), 4,968,296 (Ritch et al.), 4,936,825 (Ungerleider), 4,886,488 (White), 4,750,901 (Molteno), 4,634,418 (Binder), 4,604,087 (Joseph), 4,554,918 (White), 4,521,210 (Wong), 4,428,746 (Mendez), 4,402,681 (Haas et al.), 4,175,563 (Arenberg et al.), and 4,037,604 (Newkirk). [0017] All of the above embodiments and variations thereof have numerous disadvantages and moderate success rates. They involve substantial trauma to the eye and require great surgical skill by creating a hole over the full thickness of the sclera/cornea into the subconjunctival space. Furthermore, normal physiological outflow pathways are not used. The procedures are mostly performed in an operating room generating a facility fee, anesthesiologist's professional fee and have a prolonged recovery time for vision. The complications of filtration surgery have inspired ophthalmic surgeons to look at other approaches to lowering intraocular pressure. [0018] The trabecular meshwork and juxtacanilicular tissue together provide the majority of resistance to the outflow of aqueous and, as such, are logical targets for surgical removal in the treatment of open-angle glaucoma. In addition, minimal amounts of tissue are altered and existing physiologic outflow pathways are utilized. Trabecular bypass surgery has the potential for much lower risks of choroidal hemorrhage, infection and uses existing physiologic outflow mechanisms. This surgery could be performed under topical anesthesia in a physician's office with rapid visual recovery. [0019] Therefore, there is a great clinical need for the treatment of glaucoma by a method that would be faster, safer and less expensive than currently available modalities. Trabecular bypass surgery is an innovative surgery which uses a micro stent, shunt, or other implant to bypass diseased trabecular meshwork alone at the level of trabecular meshwork and use or restore existing outflow pathways. The object of the present invention is to provide a means and methods for treating elevated intraocular pressure in a manner which is simple, effective, disease site specific and can be performed on an outpatient basis. SUMMARY OF THE INVENTION [0020] In some preferred embodiments, the seton has an inlet portion configured to extend through a portion of the trabecular meshwork of an eye, and an outlet portion configured to extend into Schlemm's canal of the eye, wherein the inlet portion is disposed at an angle relative to the outlet portion. In some embodiments, the outlet portion has a lumen with an oval cross-section having a long axis. [0021] The outlet portion in certain embodiments has a longitudinal axis, such that the long axis of the oval cross-section and the longitudinal axis of the outlet portion define a plane, the inlet portion having a longitudinal axis which lies outside the plane at an angle θ (theta) thereto. [0022] In some preferred arrangements, the seton comprises an inlet portion, configured to extend through a portion of the trabecular meshwork; an outlet portion, configured to extend into Schlemm's canal; and at least one protrusion on the outlet portion, configured to exert traction against an inner surface of Schlemm's canal. This protrusion can comprise at least one barb or ridge. [0023] Some preferred embodiments comprise an inlet portion configured to extend through a portion of the trabecular meshwork, an outlet portion configured to extend into Schlemm's canal, and a one-way valve within the inlet and/or outlet portions. [0024] A method for delivering a seton within an eye is disclosed, comprising providing an elongate guide member, advancing a distal end of the guide member through at least a portion of the trabecular meshwork of the eye, advancing the seton along the guide member toward the distal end, and positioning the seton to conduct aqueous humor between the anterior chamber of the eye and Schlemm's canal. [0025] In certain embodiments, the advancing of the guide member comprises advancing it from the anterior chamber into the trabecular meshwork. In further embodiments, the positioning comprises positioning an end of the seton within Schlemm's canal adjacent to an aqueous collection channel. [0026] Certain preferred embodiments include an apparatus for delivering a seton to the anterior chamber of an eye comprising an elongate tube having a lumen, an outer surface, and a distal end; a removable, elongate guide member within the lumen, configured to permit the seton to be advanced and to be positioned in the trabecular meshwork of the eye. This apparatus can further comprise a cutting member positioned at the distal end of the tube. The cutting member can be selected from the group consisting of a knife, a laser probe, a pointed guide member, a sharpened distal end of said tube, and an ultrasonic cutter. The apparatus can also further comprise an opening in the outer surface of the tube, configured to allow fluid infusion into the eye. [0027] In further preferred embodiments, an apparatus for delivering a seton in an eye, comprises an elongate member adapted for insertion into an anterior chamber of the eye, the elongate member having a distal end portion configured to retain the seton therein, the distal end portion comprising a cutting member configured to form an opening in the trabecular meshwork of the eye for receipt of the seton, such that one end of the seton is in Schlemm's canal. The elongate member can further comprise a lumen which conducts fluid toward said distal end portion. [0028] The preferred embodiment provides further surgical treatment of glaucoma (trabecular bypass surgery) at the level of trabecular meshwork and restores existing physiological outflow pathways. An implant bypasses diseased trabecular meshwork at the level of trabecular meshwork and which restores existing physiological outflow pathways. The implant has an inlet end, an outlet end and a lumen therebetween. The inlet is positioned in the anterior chamber at the level of the internal trabecular meshwork and the outlet end is positioned at about the exterior surface of the diseased trabecular meshwork and/or into fluid collection channels of the existing outflow pathways. [0029] In accordance with a preferred method, trabecular bypass surgery creates an opening or a hole through the diseased trabecular meshwork through minor microsurgery. To prevent “filling in” of the hole, a biocompatible elongated implant is placed within the hole as a seton, which may include, for example, a solid rod or hollow tube. In one exemplary embodiment, the seton implant may be positioned across the diseased trabecular meshwork alone and it does not extend into the eye wall or sclera. In another embodiment, the inlet end of the implant is exposed to the anterior chamber of the eye while the outlet end is positioned at the exterior surface of the trabecular meshwork. In another exemplary embodiment, the outlet end is positioned at and over the exterior surface of the trabecular meshwork and into the fluid collection channels of the existing outflow pathways. In still another embodiment, the outlet end is positioned in the Schlemm's canal. In an alternative embodiment, the outlet end enters into fluid collection channels up to the level of the aqueous veins with the seton inserted in a retrograde or antegrade fashion. [0030] According to the preferred embodiment, the seton implant is made of biocompatible material, which is either hollow to allow the flow of aqueous humor or solid biocompatible material that imbibes aqueous. The material for the seton may be selected from the group consisting of porous material, semi-rigid material, soft material, hydrophilic material, hydrophobic material, hydrogel, elastic material, and the like. [0031] In further accordance with the preferred embodiment, the seton implant may be rigid or it may be made of relatively soft material and is somewhat curved at its distal section to fit into the existing physiological outflow pathways, such as Schlemm's canal. The distal section inside the outflow pathways may have an oval shape to stabilize the seton in place without undue suturing. Stabilization or retention of the seton may be further strengthened by a taper end and/or by at least one ridge or rib on the exterior surface of the distal section of the seton, or other surface alterations designed to retain the seton. [0032] In one embodiment, the seton may include a micropump, one way valve, or semi-permeable membrane if reflux of red blood cells or serum protein becomes a clinical problem. It may also be useful to use a biocompatible material that hydrates and expands after implantation so that the seton is locked into position around the trabecular meshwork opening or around the distal section of the seton. [0033] One of the advantages of trabecular bypass surgery, as disclosed herein, and the use of a seton implant to bypass diseased trabecular meshwork at the level of trabecular meshwork and thereby use existing outflow pathways is that the treatment of glaucoma is substantially simpler than in existing therapies. A further advantage of the invention is the utilization of simple microsurgery that may be performed on an outpatient basis with rapid visual recovery and greatly decreased morbidity. Finally, a distinctly different approach is used than is found in existing implants. Physiological outflow mechanisms are used or re-established by the implant of the present invention, in contradistinction with previously disclosed methodologies. BRIEF DESCRIPTION OF THE DRAWINGS [0034] Additional objects and features of the present invention will become more apparent and the invention itself will be best understood from the following Detailed Description of Exemplary Embodiments, when read with reference to the accompanying drawings. [0035] [0035]FIG. 1 is a sectional view of an eye for illustration purposes. [0036] [0036]FIG. 2 is a close-up sectional view, showing the anatomical diagram of trabecular meshwork and the anterior chamber of the eye. [0037] [0037]FIG. 3 is an embodiment of the seton implant constructed according to the principles of the invention. [0038] [0038]FIG. 4 is a top cross-sectional view of section 1 - 1 of FIG. 3. [0039] [0039]FIG. 5 is another embodiment of the seton implant constructed in accordance with the principles of the invention. [0040] [0040]FIG. 6 is a perspective view illustrating the seton implant of the present invention positioned within the tissue of an eye. [0041] [0041]FIG. 7 is an alternate exemplary method for placing a seton implant at the implant site. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0042] Referring to FIGS. 1 to 7 , what is shown is a method for the treatment of glaucoma by trabecular bypass surgery. In particular, a seton implant is used to bypass diseased trabecular meshwork at the level of trabecular meshwork to use or restore existing outflow pathways and methods thereof. [0043] For background illustration purposes, FIG. 1 shows a sectional view of an eye 10 , while FIG. 2 shows a close-up view, showing the relative anatomical locations of the trabecular meshwork, the anterior chamber, and Schlemm's canal. Thick collagenous tissue known as sclera 11 covers the entire eye 10 except that portion covered by the cornea 12 . The cornea 12 is a thin transparent tissue that focuses and transmits light into the eye and the pupil 14 which is the circular hole in the center of the iris 13 (colored portion of the eye). The cornea 12 merges into the sclera 11 at a juncture referred to as the limbus 15 . The ciliary body 16 begins internally in the eye and extends along the interior of the sclera 11 and becomes the choroid 17 . The choroid 17 is a vascular layer of the eye underlying retina 18 . The optic nerve 19 transmits visual information to the brain and is sequentially destroyed by glaucoma. [0044] The anterior chamber 20 of the eye 10 , which is bound anteriorly by the cornea 12 and posteriorly by the iris 13 and lens 26 , is filled with aqueous. Aqueous is produced primarily by the ciliary body 16 and reaches the anterior chamber angle 25 formed between the iris 13 and the cornea 12 through the pupil 14 . In a normal eye, the aqueous is removed through the trabecular meshwork 21 . Aqueous passes through trabecular meshwork 21 into Schlemm's canal 22 and through the aqueous veins 23 which merge with blood-carrying veins and into venous circulation. Intraocular pressure of the eye 10 is maintained by the intricate balance of secretion and outflow of the aqueous in the manner described above. Glaucoma is characterized by the excessive buildup of aqueous fluid in the anterior chamber 20 which produces an increase in intraocular pressure (fluids are relatively incompressible and pressure is directed equally to all areas of the eye). [0045] As shown in FIG. 2, the trabecular meshwork 21 constitutes a small portion of the sclera 11 . It is understandable that creating a hole or opening for implanting a device through the tissues of the conjunctiva 24 and sclera 11 is relatively a major surgery as compared to a surgery for implanting a device through the trabecular meshwork 21 only. A seton implant 31 of the present invention for either using or restoring existing outflow pathways positioned through the trabecular meshwork 21 is illustrated in FIG. 5. [0046] In a first embodiment, a method for increasing aqueous humor outflow in an eye of a patient to reduce the intraocular pressure therein. The method comprises bypassing diseased trabecular meshwork at the level of the trabecular meshwork and thereby restoring existing outflow pathways. Alternately, a method for increasing aqueous humor outflow in an eye of a patient to reduce an intraocular pressure therein is disclosed. The method comprises bypassing diseased trabecular meshwork at a level of said trabecular meshwork with a seton implant and using existing outflow pathways. The seton implant 31 may be an elongated seton or other appropriate shape, size or configuration. In one embodiment of an elongated seton implant, the seton has an inlet end, an outlet end and a lumen therebetween, wherein the inlet end is positioned at an anterior chamber of the eye and the outlet end is positioned at about an exterior surface of said diseased trabecular meshwork. Furthermore, the outlet end may be positioned into fluid collection channels of the existing outflow pathways. Optionally, the existing outflow pathways may comprise Schlemm's canal 22 . The outlet end may be further positioned into fluid collection channels up to the level of the aqueous veins with the seton inserted either in a retrograde or antegrade fashion with respect to the existing outflow pathways. [0047] In a further alternate embodiment, a method is disclosed for increasing aqueous humor outflow in an eye of a patient to reduce an intraocular pressure therein. The method comprises (a) creating an opening in trabecular meshwork, wherein the trabecular meshwork comprises an interior side and exterior side; (b) inserting a seton implant into the opening; and (c) transporting the aqueous humor by said seton implant to bypass the trabecular meshwork at the level of said trabecular meshwork from the interior side to the exterior side of the trabecular meshwork. [0048] [0048]FIG. 3 shows an embodiment of the seton implant 31 constructed according to the principles of the invention. The seton implant may comprise a biocompatible material, such as a medical grade silicone, for example, the material sold under the trademark Silastic™, which is available from Dow Corning Corporation of Midland, Mich., or polyurethane, which is sold under the trademark Pellethane™ which is also available from Dow Corning Corporation. In an alternate embodiment, other biocompatible materials (biomaterials) may be used, such as polyvinyl alcohol, polyvinyl pyrolidone, collagen, heparinized collagen, tetrafluoroethylene, fluorinated polymer, fluorinated elastomer, flexible fused silica, polyolefin, polyester, polysilison, mixture of biocompatible materials, and the like. In a further alternate embodiment, a composite biocompatible material by surface coating the above-mentioned biomaterial may be used, wherein the coating material may be selected from the group consisting of polytetrafluoroethlyene (PTFE), polyimide, hydrogel, heparin, therapeutic drugs, and the like. [0049] The main purpose of the seton implant is to assist in facilitating the outflow of aqueous in an outward direction 40 into the Schlemm's canal and subsequently into the aqueous collectors and the aqueous veins so that the intraocular pressure is balanced. In one embodiment, the seton implant 31 comprises an elongated tubular element having a distal section 32 and an inlet section 44 . A rigid or flexible distal section 32 is positioned inside one of the existing outflow pathways. The distal section may have either a tapered outlet end 33 or have at least one ridge 37 or other retention device protruding radially outwardly for stabilizing the seton implant inside said existing outflow pathways after implantation. For stabilization purposes, the outer surface of the distal section 32 may comprise a stubbed surface, a ribbed surface, a surface with pillars, a textured surface, or the like. The outer surface 36 , including the outer region 35 and inner region 34 at the outlet end 33 , of the seton implant is biocompatible and tissue compatible so that the interaction/irritation between the outer surface and the surrounding tissue is minimized. The seton implant may comprise at least one opening at a location proximal the distal section 32 , away from the outlet end 33 , to allow flow of aqueous in more than one direction. The at least one opening may be located on the distal section 32 at about opposite of the outlet end 33 . [0050] In another exemplary embodiment, the seton implant 31 may have a one-way flow controlling means 39 for allowing one-way aqueous flow 40 . The one-way flow controlling means 39 may be selected from the group consisting of a check valve, a slit valve, a micropump, a semi-permeable membrane, or the like. To enhance the outflow efficiency, at least one optional opening 41 in the proximal portion of the distal section 32 , at a location away from the outlet end 33 , and in an exemplary embodiment at the opposite end of the outlet end 33 , is provided. [0051] [0051]FIG. 4 shows a top cross-sectional view of FIG. 3. The shape of the opening of the outlet end 33 and the remaining body of the distal section 32 may be oval, round or some other shape adapted to conform to the shape of the existing outflow pathways. This configuration will match the contour of Schlemm's canal to stabilize the inlet section with respect to the iris and cornea by preventing rotation. [0052] As shown in FIG. 3, the seton implant of the present invention may have a length between about 0.5 mm to over a meter, depending on the body cavity the seton implant applies to. The outside diameter of the seton implant may range from about 30 μm to about 500 μm. The lumen diameter is preferably in the range between about 20 μm to about 150 μm. The seton implant may have a plurality of lumens to facilitate multiple flow transportation. The distal section may be curved at an angle between about 30 degrees to about 150 degrees, in an exemplary embodiment at around 70-110 degrees, with reference to the inlet section 44 . [0053] [0053]FIG. 5 shows another embodiment of the seton implant 45 constructed in accordance with the principles of the invention. In an exemplary embodiment, the seton implant 45 may comprise at least two sections: an inlet section 47 and an outlet section 46 . The outlet section has an outlet opening 48 that is at the outlet end of the seton implant 45 . The shape of the outlet opening 48 is preferably an oval shape to conform to the contour of the existing outflow pathways. A portion of the inlet section 47 adjacent the joint region to the outlet section 46 will be positioned essentially through the diseased trabecular meshwork while the remainder of the inlet section 47 and the outlet section 46 are outside the trabecular meshwork. As shown in FIG. 5, the long axis of the oval shape opening 48 lies in a first plane formed by an X-axis and a Y-axis. To better conform to the anatomical contour of the anterior chamber 20 , the trabecular meshwork 21 and the existing outflow pathways, the inlet section 47 may preferably lie at an elevated second plane, at an angle θ, from the first plane formed by an imaginary inlet section 47 A and the outlet section 46 . The angle θ may be between about 30 degrees and about 150 degrees. [0054] [0054]FIG. 6 shows a perspective view illustrating the seton implant 31 , 45 of the present invention positioned within the tissue of an eye 10 . A hole/opening is created through the diseased trabecular meshwork 21 . The distal section 32 of the seton implant 31 is inserted into the hole, wherein the inlet end 38 is exposed to the anterior chamber 20 while the outlet end 33 is positioned at about an exterior surface 43 of said diseased trabecular meshwork 21 . In a further embodiment, the outlet end 33 may further enter into fluid collection channels of the existing outflow pathways. [0055] In one embodiment, the means for forming a hole/opening in the trabecular mesh 21 may comprise an incision with a microknife, an incision by a pointed guidewire, a sharpened applicator, a screw shaped applicator, an irrigating applicator, or a barbed applicator. Alternatively, the trabecular meshwork may be dissected off with an instrument similar to a retinal pick or microcurrette. The opening may alternately be created by retrogade fiberoptic laser ablation. [0056] [0056]FIG. 7 shows an illustrative method for placing a seton implant at the implant site. An irrigating knife or applicator 51 comprises a syringe portion 54 and a cannula portion 55 . The distal section of the cannula portion 55 has at least one irrigating hole 53 and a distal space 56 for holding a seton implant 31 . The proximal end 57 of the lumen of the distal space 56 is sealed from the remaining lumen of the cannula portion 55 . [0057] For positioning the seton 31 in the hole or opening through the trabecular meshwork, the seton may be advanced over the guidewire or a fiberoptic (retrograde). In another embodiment, the seton is directly placed on the delivery applicator and advanced to the implant site, wherein the delivery applicator holds the seton securely during the delivery stage and releases it during the deployment stage. [0058] In an exemplary embodiment of the trabecular meshwork surgery, the patient is placed in the supine position, prepped, draped and anesthesia obtained. In one embodiment, a small (less than 1 mm) self sealing incision is made. Through the cornea opposite the seton placement site, an incision is made in trabecular meshwork with an irrigating knife. The seton 31 is then advanced through the cornea incision 52 across the anterior chamber 20 held in an irrigating applicator 51 under gonioscopic (lens) or endoscopic guidance. The applicator is withdrawn and the surgery concluded. The irrigating knife may be within a size range of 20 to 40 gauges, preferably about 30 gauge. [0059] From the foregoing description, it should now be appreciated that a novel approach for the surgical treatment of glaucoma has been disclosed for releasing excessive intraocular pressure. While the invention has been described with reference to a specific embodiment, the description is illustrative of the invention and is not to be construed as limiting the invention. Various modifications and applications may occur to those who are skilled in the art, without departing from the true spirit and scope of the invention, as described by the appended claims.

Surgical methods and related medical devices for treating glaucoma are disclosed. The method comprises trabecular bypass surgery, which involve bypassing diseased trabecular meshwork with the use of a seton implant. The seton implant is used to prevent a healing process known as filling in, which has a tendency to close surgically created openings in the trabecular meshwork. The surgical method and novel implant are addressed to the trabecular meshwork, which is a major site of resistance to outflow in glaucoma. In addition to bypassing the diseased trabecular meshwork at the level of the trabecular meshwork, existing outflow pathways are also used or restored. The seton implant is positioned through the trabecular meshwork so that an inlet end of the seton implant is exposed to the anterior chamber of the eye and an outlet end is positioned into fluid collection channels at about an exterior surface of the trabecular meshwork or up to the level of aqueous veins.

BACKGROUND OF THE INVENTION This invention relates in general to certain new and useful improvements in games, and, more particularly, to a competitive action board game in which there are goals at opposed player ends of the board and each player operates striker means at his end to engage a playing piece to defend his goal and propel the piece toward the opponent's goal. There are a large number of such competitive action board game devices commercially available. One of the major problems of many of these prior devices is that they fail to provide fast and uninterrupted play action. Where the striker means have restricted movement such as being attached to the board, the playing piece may become stalled in a location not readily accessible to the striker means. This tends to frustrate and annoy the players and detracts from the excitement and continuity of the game play. To alleviate this condition, the striker means may be totally separate from the game board and hand held so that all parts of the board are accessible to the striker means. Such separate striker means pose other problems in that the striker means are more readily lost or misplaced; further, the use of the separate striker means is much less controlled and can become wild and beyond the intended limits of the game play. It is, therefore, a primary object of the present invention to provide a competitive action game apparatus where a playing piece can be propelled back and forth between a pair of opposed ends of a game board by striker means which have only limited movement, the board being arranged to ensure that the play will not be stopped by the playing piece coming to rest out of the reach of the striker means. It is a further object to provide such a game apparatus where the board is inclined downwardly toward its opposed ends. It is a further object to provide such a game apparatus wherein the striker means are movably mounted on shiftable support members. It is a further object to provide such a game apparatus wherein the striker means on each support member comprise a pair of spaced apart rotatable flippers, and the support member is transversely shiftable. It is another object of the present invention to provide a game apparatus of the type stated in which the shiftable members and the striker means located thereon are arranged so that the playing piece can pass through various playing piece passages, and into a goal area, unless the support member is shifted and the striker means are located in the trajectory of the playing piece. It is another salient object of the present invention to provide a method of playing a game where a playing piece can be shifted across a game board toward either of a pair of opposed goal areas and where the game board has a surface which is inclined towards each of the goal areas, striker means at each goal area being limited in mobility and operable by a player to generally contemporaneously (i) move transversely and (ii) move to strike the playing piece. It is an additional object of the present invention to provide a game apparatus of the type stated which is relatively rigid and durable in its construction, and which can be manufactured at a relatively low unit cost. It is a further object of the present invention to provide a game apparatus of the type stated which is relatively simple in its construction, but which is nevertheless highly unique and designed to maintain the interest of the players. With the above and other objects in view, our invention resides in the novel features of form, construction, arrangement and combination of parts presently described and pointed out in the claims. BRIEF SUMMARY OF THE DISCLOSURE The disclosed apparatus relates in general to a game apparatus where a pair of opposed players attempt to propel a playing piece in the form of a spherical object or ball toward a goal area at each of the opposite ends of a game board. The illustrated apparatus comprises a game board having an upper playing surface with the pair of goal areas at each of the opposed ends. The playing surface is provided with a high section intermediate each of the goal areas and with inclined sections extending downwardly from the high section toward the goal areas. The playing surface may be curved from each of the opposed ends with the high section at the apex of the curve. Alternatively, the playing surface may include a pair of relatively flat, downwardly inclining sections which incline toward the goal areas and are connected at their upper ends by a curved section which defines a high point on the playing surface. In each case, the playing surface is generally solid and continuous and uninterrupted between each of the goal areas. The ball will always roll to a goal area. The game board also includes rebound surfaces which surround the playing surface except at the goal areas to retain and repel the ball on the playing surface. A shiftable support member is located in front of each of the goal areas. In the illustrated preferred form, the support members are shiftable transversely in a direction generally perpendicular to a line extending from goal to goal. Moreover, actuable striker elements, which may adopt the form of rotatable flippers, are disposed on each of the support members and are rotatable to engage the ball when actuated. Finally, a manually operable means is associated with each support member to actuate its flippers to cause them to rotate and thereby engage the ball. The illustrated game apparatus of the present invention can be further characterized in that the support members each carry a pair of manually actuable, spaced apart striker elements. Each of the striker elements can be shifted from an unactuated position to an actuated position where they are projected toward the opposed player end. In the illustrated game apparatus, the striker elements, which may be flippr flipper define a first passageway therebetween leading to the goal. Moreover, a second passageway to the goal is defined between one of the flipper elements and the portion of the rebound surface in proximity thereto, when the support member is shifted in a first transverse direction. A third passageway to the goal is defined between the other of the flipper elements and the opposed rebound surface when the support member is shifted in a second transverse direction. Each of these passageways are sized to permit passage of the playing piece through and into the goal area associated therewith. The present invention also provides a method of playing this game with the playing piece shifted across the game board toward one or another of the opposed goal areas. In this case, the method includes the introduction of the playing piece on the game board and permitting this playing piece to move toward one or another of the goal areas. The method further includes a shifting of the support members in a direction transverse to the longitudinal dimension of the game board and actuating a striker element on the shiftable support member to engage the playing piece and propel the same to the opposite goal area. BRIEF DESCRIPTION OF THE DRAWINGS Having thus described the invention in general terms, reference will now be made to the accompanying drawings in which: FIG. 1 is a top-plan view of a game apparatus constructed in accordance with and embodying the present invention; FIG. 2 is a vertical sectional view taken along line 2-2 of FIG. 1; FIG. 3 is a vertical sectional view, similar to FIG. 2, and showing a modified form of game board construction in accordance with the present invention; FIG. 4 is a top-plan view of a playing piece in the form of a ball, which may be used in the game apparatus of the present invention; FIG. 5 is a horizontal sectional view showing a portion of the manually operable actuating means to actuate the flippers used in the game apparatus of FIG. 1; FIG. 6 is a fragmentary top-plan view, partially shown in phantom lines, and showing the position of the flipper support member in a normal position; FIG. 7 is a fragmentary top-plan view, similar to FIG. 6, and showing the relative position of the flipper support member and the flippers thereon when the support member is shifted in one transverse direction; and FIG. 8 is a fragmentary top-plan view, similar to FIG. 7, and showing the position of the support member and the flippers thereon when the support member is shifted in the opposite transverse direction. DETAILED DESCRIPTION Referring now in more detail and by reference characters to the drawings which illustrate preferred embodiments of the present invention, A designates a game apparatus which includes a peripherally extending frame 10 having opposed end rails 12 and longitudinally extending goal rails 14. Each of the longitudinally extending rails 14 merge into diagonally located, outwardly struck arms 16, which, in turn, are connected by longitudinally extending legs or side rails 18, to thereby provide a pair of opposed transversely outset areas 20 within the frame 10. Each of the interior surfaces of the rails 12 and 14 and the arms 16 and legs 18 serve as rebound surfaces. Moreover, bumper pads 22 are located in the area of each of the diagonally located outwardly struck arms 16, and these rebound pads 22 extend into the interior of the frame 10 and provide rebound surfaces 24 generally facing toward one player end and the rebound surfaces 26 generally facing toward one player end and the rebound surfaces 26 generally facing toward the other player end. A playing board 28 extends between each of opposed player ends designated by reference numerals 30 and 32. The playing board 28 has a generally solid upper playing surface 34 defined by a transversely extending, centrally located high point or ridge 36, the playing surface 34 extending generally downwardly toward each of the player ends 30 and 32. The playing board 28 is generally carried between each of the player ends such that the surface is defined by a generally continuous arc. FIG. 3 illustrates a modified form of game playing board which may also be used in the present invention and which is designated by reference numeral 28'. In this case, the game playing board 28' is comprised of a pair of relatively flat inclined planar board sections 38 and 39 connected by an arcuate section 40. The game board 28' has a generally solid upper playing surface 34' defined by a transversely extending, centrally located high point or ridge 36' located at the apex of the arcuate section 40. In this case, it can be observed that the playing board 28' is essentially similar in operation to the playing board 28. However, it should be understood that the angle defined by the inclined board sections 38 and 39 should be sufficiently large so that the playing piece does not lift off of the game board at the high point due to the change of angle of the playing surface. The arcuate section 40 also serves to alleviate this condition. In each of these embodiments the playing piece, in the form of a ball, designated by reference numeral P, will always roll downwardly toward one player end 30 or the other player end 32, depending upon its location relative to the high point 36. In each of the aforementioned embodiments of the game apparatus, it is not necessary to employ the bumper pads 24. However, these bumper pads do serve to increase the number of possible rebound trajectories of the playing piece and therefore increase the player participation and the required skill of the players. Moreover, it is not necessary to employ the offset areas 20, such that the game board could be of generally rectangular shape. However, it has been found that the use of a rectangularly shaped game board without the employment of the offset areas 20 tends to increase the speed of operation of the game significantly and materially increase the difficulty of playing the game. Each of the player ends 30 and 32 are provided with transversely extending goal areas 42 located adjacent to each of the player ends 30 and 32. A pair of transversely extending rectangularly shaped recesses 44 are formed in the game board 28 and are located slightly inwardly of the respective goal areas 44 and which extend between the two longitudinal walls 14 for reasons which will presently more fully appear. In this case, each of the transversely extending recesses 44 are connected to the associated goal areas 42 through a horizontal shoulder surface 50 where the transverse ends of the playing board 28 merge into the recesses 44. However, each of the shoulder surfaces 50 are located in a plane somewhat below the upper surface of the playing surface. Moreover, each of the goal areas 42 are provided with goal pockets, or so-called "goal recesses," 52, which are defined by a transversely extending, vertically disposed goal wall 54 connected to the shoulder surface 50 and merging into a bottom wall 56. The functions of each of the goal pockets 52 and their positional relationship are defined in more detail hereinafter. Located within each of the recesses 44 are transversely shiftable player arms or support means 58, in the manner as illustrated in FIGS. 2 and 3. The player arms 58, which are also referred to as an "actuating arm" or "support member" extend transversely through apertures formed within the vertical walls 14, in the manner as illustrated in FIGS. 1 and 6 of the drawings. In this case, it can be observed that an individual player arm 58 is located at each player end 30 and 32. The player arms 58 have upper surfaces 60 which are substantially contiguous with the playing surface 34 of the game board 28 and above the shoulder surfaces 50. In this way, when the playing piece P is rolled across the game board 28, it will move across the upper surface 60 of each of the player arms 58 and across the relatively short shoulder surfaces 50 in the same manner as though the upper surfaces 60 constituted part of the playing surface 34. Moreover, each of the upper surfaces 60 on the player arms 58 connects to the shoulder surfaces 50 which terminate toward a player end at each of the goal pockets 52, such that the playing piece P which moves over the playing surface 34 and the upper surface 60 of the player arm 58 may be deposited in any one of the goal pockets 52 at either of the player ends. While the upper surfaces 60 and shoulder surfaces 50 are relatively flat, they are relatively thin in the transverse dimension so that they do not impair the movement of a playing piece P into the goal cups 52. However, it should be recognized that the upper surfaces 60 could be arcuately shaped with a radius conforming to the player surface 34 so as to be arcuately contiguous therewith. In addition, the recesses 44 could actually form part of the goal areas if desired, thereby eliminating the shoulder surfaces 50. In this case, a playing piece passing over the upper surfaces 60 of the arms 58 would be introduced directly into one of the goal cups 52. Each of the actuating arms 58 carry a pair of movable striker elements in the form of rotatable flippers 62 and 64 which are rotatably movable from a rearward, or unactuated, position, as illustrated by the phantom lines in FIG. 6, to a forward, or actuated, position, illustrated by the solid lines in FIG. 6. The exact angle of movement from the rearward to the forward position of each of the flippers 62 and 64 is dependent upon their overall length and the overall length of the player arms 58. However, typically, the flippers 62 and 64 will flip through about a 60° to about a 90° arc. Each of the flippers 62 and 64 may be actuated by manually operable push-button actuators 66 and 68, respectively, on each of the transverse ends of the player arms or support members 58. Thus, when the push-button actuator 66 or the actuator 68 is pushed inwardly with respect to the support rod 58, the associated flipper 62 or 64 will shift from the unactuated to the actuated position by means of an actuating mechanism hereinafter described in more detail. In accordance with the present construction, each of the flippers 62 and 64 are independently operable, although they could be constructed to be operable simultaneously, if desired, by pushing one of the push-button actuators 66 or 68. In accordance with the rules of play of the game apparatus, when the playing piece P is projected toward one player end, the player will shift the player rod 58 from side to side and will also actuate the push-button actuators 66 or 68 associated therewith. When pushing the push-button actuator 66, the flipper 62 will be propelled forwardly and when actuating the push-button actuator 68, the flipper 64 will be pushed forwardly to the actuated position. The player will attempt to align the particular flipper with respect to the playing piece P in order to propel this playing piece toward the opponent player's goal area. FIG. 4 illustrates one form of playing piece P in the form of a round ball which may be either a hollow ball or a solid ball, or any form of spherical object. In this respect, it should be observed that the particular playing piece could adopt the form associated with a particular playing sport. However, a round ball is preferred on a relatively solid playing surface due to the lower frictional effects and due to the fact that a round ball can roll across the playing surface as opposed to sliding across the playing surface. The actuating mechanism which permits actuation of the flippers 62 and 64 is more fully illustrated in FIG. 5 of the drawings. Only one such actuating mechanism is illustrated in connection with the flipper 62, although each of the other such actuating mechanism operate in like manner. The flipper 62 is located on the upper surface 60 of the support member 58, and is pivotally retained thereon by means of a pivot pin 70. The support member 58 is hollow providing a central interior chamber 72 and located within the chamber 72 is a link 74 which is also mounted on the pivot pin 70 and pivotal with the flipper 62. The link 74 is connected through a relatively rigid rod or guy wire 76 to a connecting rod 78 which is attached to the push-button actuator 66. In this case, it can be observed that the rod 78 extends into the central chamber 72 of the arm 58 and is biased outwardly by means of a compression spring 80 which bears against the inner surface of a limit plate 81 on the actuator 66 and also against a retaining plate 82 extending across the chamber 72 of the arm 58. It can be observed that when the push-button actuator 66 is in its outermost position, or unactuated position, the flipper 62 will assume its unactuated position, as illustrated in the dotted lines of FIG. 7 and the solid lines of FIG. 6. However, when the push-button actuator 66 is urged inwardly, the link 74 will shift in a clockwise direction and urge the pivot pin 70, and the flipper 62 carried therewith, to the actuated position as illustrated in the solid lines of FIG. 6 and the dotted lines of FIG. 7. In addition, it can also be observed that when manual pressure on the push-button actuator 66 is released, the compression spring 80 which has now been compressed will bias the pushbutton actuator 66 outwardly and will also return the link 74 to its position as illustrated in the solid lines of FIG. 5, and will also return the flipper 66 to its unactuated position, as also illustrated in the solid lines of FIG. 7. Referring now to FIGS. 6-8, it can be understood how the arm 58 and the flippers thereon are shiftable in relationship to the playing board 34. By further reference to FIG. 6, it can be observed that when the arm 58 is in its normal position, that is the position when each of the outwardly extending ends are approximately the same distance from the longitudinal walls 14, that a first playing piece passageway S 1 is created between each of the two flippers 62 and 64 on the arm 58. Moreover, it can be observed that the rebound pads 22 extend inwardly sufficiently to create a second playing piece passageway S 2 between the flipper 62 and the pad 22. Finally, a third playing piece passageway S 3 is created between the opposed flipper 64 and the upper pad 22. In this case, it can be observed that when the flipper arms are flipped from the unactuated position to the actuated position, or otherwise remain in the unactuated position, the passageway S 1 is sufficient to permit the playing piece P to pass therethrough into any one of the goal cups 52. In addition, the playing piece P can also pass through the passageways S 2 or S 3 . In order to more the support arms 58, the players will grasp or engage the two transverse outer ends of the arms, one end with each hand, and in this way the shiftable arms 58 are moved generally with both hands of the players. The transverse movement will normally occur in an attempt to align one of the flippers with the trajectory of an approaching playing piece. Each player will also generally contemporaneously actuate the actuator button 16 on one or both of the outer transverse ends of his support arm 58 to actuate the associated flipper. Referring to FIG. 7, it can be observed that when the arm 58 is shifted toward one position where the flippers 62 are located nearest one of the end walls 14, the passageway S 2 has been eliminated for passage of the playing piece P. However, the passageway S 3 is substantially wider and, in addition, the passage S 1 still exists. By examining FIG. 7, it can be observed that when the arm 58 is shifted in the opposite direction so that the flipper 64 is located nearest one of the longitudinal walls 14, the passage S 3 is eliminated. However, the passageway S 2 is substantially wide and, here again, the passageway S 1 exists. In order to play the game of the present invention, the playing piece is first deposited on the playing surface 34. One of the players at one of the playing ends 30 or 32 will attempt to shift the arm 58 in order to locate a flipper 62 or 64 in alignment with the playing piece P. When so aligned, the player will actuate the push-button actuator 66 or 68 in order to propel the playing piece P to the opposite player end. The player at the opposite player end will thereupon shift the arm 58 to the proper position so that one of the flippers 62 or 64 is located in alignment with the trajectory of the playing piece P. This latter player will also actuate one of the push-button actuators 66 or 68 in order to operate the associated flipper 62 or 64, and thereby propel the playing piece back to the first player's goal area. In accordance with the present invention, it can be observed that due to the inclined nature of the playing surface 34 toward each of the goal areas, that the playing piece will always move toward one or the other of the goal areas. Consequently, it is encumbent upon the player to shift the arm 58 and actuate the flipper 62 or 64 in order to repel the playing piece P, or otherwise the playing piece P would likely fall within one of the goal cups 52. It can be observed, in this respect, that the game of the present invention can be operated in a relatively quick manner and not only requires skill, but requires quick and keen action on the part of each of the players. Moreover, the players must carefully locate the particular arm 58 and properly actuate the flippers 62 or 64 in a time-related manner to the movement of the playing piece P in order to repel this playing piece so that it is moved in through one of the passageways S 1 or S 2 or S 3 into the goal cups 52. If one of the players propels the playing piece P in a trajectory which does not align with the opposing game area, it may carrom, i.e. abut against the opposite rebound surface 24 and be propelled back into the player's own goal area. Consequently, each player must operate the player arm 58 and the flippers 62 and 64 in such manner so that the playing piece P does not engage the bumper pads 22 for rebound toward its own goal area. In order to control the transverse shiftable movement of the player arms 58, enlarged abutment flanges 84 are located on the arms 58 outwardly of each of the longitudinal walls. If desired, these abutment flanges 84, which serve as stops shiftable on the arm 58 to serve as an adjustable control. In addition, it should be understood that the flippers 62 and 64 could be located with their pivot points close to the bumper pads 22 so as to eliminate a passageway therebetween. In this latter construction, the flipper arms 58 would probably have a longer length. Moreover, it should also be observed that the flippers 62 and 64 could be substituted by other forms of striker elements, as for example, longitudinally movable paddles or the like, and which striker elements would also be actuated by the actuators 66 or 68. In the case of the present invention, each of the goal cups 52 may be assigned a particular value, depending upon the degree of skill required to deposit the playing piece P into that particular goal cup. In the particular embodiment, as illustrated, the opposite end goal cups achieve the highest number of scored points when the playing piece is deposited in such goal cups. The next two outermost goal cups receive the next highest number of paints, and the center goal receives the lowest number of points. It can be observed that greater skill, and hence greater difficulty, is inherent in achieving a goal in the outermost goal cups, and the easiest score is obtained in shifting the playing piece into the center goal cup. Nevertheless, it should be understood that the game could be designed with respect to the relationship of the flippers on the support arms so that the goal cups could be assigned different score values. Thus, there has been illustrated and described a unique and novel playing game which fulfills all of the objects and advantages sought therefor. It should be understood that many changes and modifications and other uses and applications will become apparent to those skilled in the art after considering this specification and the accompanying drawings. Therefore, any and all such changes, modifications and other uses and applications which do not depart from the spirit and scope of the invention are deemed to be covered by the invention which is limited only by the following claims.

A competitive action game apparatus including a game board having a playing surface thereon. The playing surface has a high section intermediate each of a pair of opposed player ends and extends downwardly toward each of such player ends. A goal area is located at each of the opposed player ends. A rebound frame surrounds the playing surface except at the goal areas to retain a playing piece in the form of a ball on the surface. The playing surface is generally solid and continuous and uninterrupted between each of the goal areas. Manually shiftable support members are located in front of each of the goal areas and are capable of being shifted transversely in a direction substantially perpendicular to a line extending between the opposed playing ends. A pair of actuable striker elements, which may adopt the form of flippers, are disposed on each of the support members, and are manually actuated by means on the support members. Each player can shift his support member from side to side and can also actuate his flippers to strike the playing piece so as to protect his own goal while attempting to propel the ball into his opponent's goal. The double incline of the playing surface insures that the ball will not stall at an intermediate portion of the playing surface, but will always move down one or the other of the inclines toward a player area where it can be engaged by a striker element. This arrangement permits the use of striker elements which have limited movement such that portions of the playing surface are not within the reach of any of the striker elements.

This is a continuation of application Ser. No. 08/858,141, filed on Mar. 27, 1992 now abandoned. FIELD OF THE INVENTION The present invention relates to chest enclosures for use in producing assisted ventilation of the lungs of a patient when combined with an air oscillator. BACKGROUND TO THE INVENTION In medical practice it is frequently necessary to assist the breathing of a patient. Most frequently this is done by intubating the patient and applying periodic positive air pressure through the intubation into the patient's lungs. Intubation is associated with a number of clinical and practical disadvantages. The alternative to intubation is to use some form of external ventilator apparatus. External ventilator apparatus of the so-called "Cuirass Ventilator" type has a long history. Until recently, such devices have been of limited usefulness. In our British Patent Specification No. 2226959A, we have described chest enclosures for use in producing assisted ventilation which have proved successful in practice. However, we have found that there are a number of aspects in which still further improvement is possible. First, we have found that there is some tendency for the top surface of the chest enclosure or shell to move downwardly when suction is applied to the enclosure by the oscillator so as to produce a substantial sub-ambient pressure within the enclosure formed by the shell. The top surface of the shell is drawn downwardly against the patient's chest creating pressure on the chest partially blocking its expansion and this reduces the effectiveness of the ventilating action of the air oscillator to a degree. Secondly, one of the principal advantages of the chest enclosure described in the application referred to above is the speed with which it can be applied to a patient. The chest enclosure described had bands of closed-cell foam extending from its side edges which were to be wrapped around the patient in overlapping relationship and fastened by straps. We have found that it is possible to devise an edge seal for the shell which enables the shell to be applied over a patient and to form a seal sufficient for use whilst the patient is lying supine and still, even without the use of fastening straps, at least as a temporary measure. Furthermore, we have devised a form of seal for the shell still better adapted to resist the escape of super-ambient pressure from the shell during use. SUMMARY OF THE INVENTION According to a first aspect of the present invention there is provided a chest enclosure for use in producing assisted ventilation of the lungs of a patient comprising a chest covering shell of springy material for fitting over a patient's chest, said shell having side portions for extending over the sides of a patient's body, means for sealing the shell against a patient's body, an air passageway into said enclosure for connection in use to an air oscillator, said enclosure further comprising a support structure comprising a base member to be located beneath a recumbent patient's back, one or more support members rising from said base member, and means for engaging said shell with said support member or members, whereby to restrain bowing of the side portions of the shell in response to sub-ambient pressure within the shell. The said one or more support members for engagement with the shell may be integral with the said base member The base member may take the form of a plate which is sufficiently thin that a patient can lie over it without discomfort with portions of the patient overhanging the plate. Suitably the plate is between 3 and 10 mm thickness, e.g. about 5 mm in thickness. It is suitably formed from a rigid plastics material such as perspex. Preferably, there are at least a pair of support members rising from such a base member, one of said pair being disposed on each side of the patient in use so that the patient lies between the support members and the shell is engaged by both support members of the pair. Preferably, the shell is engaged by the support members at a location toward the top of the shell, e.g. at about the top of a or each side portion of the shell. Preferably, the height of the top of the shell when the shell is engaged with the support members is user selectable. The support members may each take the form of a support column having a series of locations along its length at which engagement means on said shell can be engaged with the column. Preferably, one support member of the or each pair of support members is removable from the base member to allow the base member to be slid underneath the patient with minimal lifting of the patient. The support member can then be replaced on the base member. The support member may be removably located on the base member for instance by a screw-in fitting. However, other forms of connection such as quick release couplings are envisaged. Preferably, the space between the or each pair of support members is upwardly open so that a patient fitted with a chest enclosure shell can be lowered between the two columns of the pair and the shell can then be engaged with the support members. The support members may take the form of a columns which are sufficiently flexible to be deflected apart and to spring inwards to grip a shell located between them. They may be provided with a series of tooth formations engagable by a dog or tongue provided on the adjacent portion of the shell. Alternatively, engagement means may be provided on the shell which is protrudable toward the support member to locate therewith. For instance, the support member may be a column and the shell may be provided with a collar which is sliding fit over the column and is provided with an inwardly directed latch member or with an inwardly directed screw to locate against the column. Instead of a plate the base member may be an evacuatable envelope having an opening for the evacuation of air therefrom and containing a multitude of small particles, such that the envelope is normally flexible and able to be conformed to a patient's body but upon evacuation of the air therefrom becomes stiff. Preferably, when such a base member is used the side portions can be turned upwards so that they overlap against side portions of the shell. The upturned portions can be attached to the shell so that on evacuation of the envelope to make it stiff the upturned portions become upwardly directed support means which serve to restrain movement of the shell side portions caused by pressure changes within the shell. In accordance with a second aspect of the invention there is provided a chest enclosure for use in producing assisted ventilation of the lungs of a patient comprising a chest covering shell of springy material for fitting over a patient's chest, said shell having side portions for extending over the sides of a patient's body, an air passageway into said enclosure for connection in use to an air oscillator, said shell having a front edge portion, opposed side edge portions and a rear edge portion, and means for sealing said edge portions against a patient's body, said sealing means including a sealing flap of resilient, flexible, air impermeable material running continuously around said front, side and rear edge portions. Said flap may for instance be of closed cell synthetic or natural foam rubber. Suitably, such a flap may be of 2 to 5 cm in width and from 3 to 10 mm, e.g. about 5 mm in thickness. It is preferably so arranged that in use it extends from the edge of the shell or from a further sealing member attached to edge of the shell, to contact the patient's body and in such a direction that its free edge is directed away from the interior of the enclosure. By such an arrangement, when there is sub-ambient pressure within the enclosure, external air pressure tends to force the sealing flap more closely against the patient's body to provide a still better seal. Those portions of the flap extending along the side edge portions of the shell preferably engage against the patient's back. By the adoption of such a sealing flap, it is possible to arrange that a springy enclosure shell can be fitted over a patient's chest by pulling the sides of the shell somewhat apart and may be allowed to relax to grip the patient such that the flap forms an adequate seal to allow immediate use of the enclosure for ventilation even without the fitting of straps around the patient. Of course, it may be desired to fit straps later to retain the shell on the patient, for instance if the patient is to be moved or is capable of spontaneous movement. Also, it may be necessary to use straps around the patient if the patient's body is not of a normal shape. In a third aspect, the invention provides a chest enclosure for use in producing assisted ventilation of the lungs of a patient comprising a chest covering shell of springy material for fitting over a patient's chest, said shell having side portions for extending over the sides of the patient's body, an air passageway into said enclosure for connection in use to an air oscillator, said shell having a front edge portion, opposed side edge portions and a rear edge portion, and means for sealing said edge portions against a patient's body, said sealing means including an inwardly directed sealing member of resilient, flexible, air impermeable material running over part or all of said front, rear and side edge portions and so directed as to overlie the surface of a patient's body in use in such a way that super-ambient pressure within said enclosure presses said sealing member more closely against said patient's body. Such a sealing member may take the form of a sealing flap extending inwardly from the edge of the shell or from a sealing member attached to the edge of the shell. Preferably, the flap runs continuously over the whole of the front, rear and side edge portions of the shell. Its dimensions and composition may be similar to those of the sealing flap described in connection with the second aspect of the invention. However, where the sealing member is a flap, it is angled inwardly so that its free edge is directed toward the interior of the shell to overlie the patient's body within the shell. In traditional cuirass ventilators, there has been no necessity for sealing the shell against super-ambient pressure within the shell. Such ventilators have been employed with air oscillators which produce periods of sub-ambient pressure within the shell followed by relaxation to atmospheric pressure rather than with oscillators which produce periods of super-ambient pressure alternating with sub-ambient pressure. According to a fourth aspect of the invention there is provided a chest enclosure for use in producing assisted ventilation of the lungs of a patient comprising a chest covering shell for fitting over a patient's chest, said shell having an air passageway to said enclosure for connection in use to an air oscillator, and backing means for location behind the patient in use, the said backing means comprising an evacuatable envelope having an opening for the evacuation of air therefrom and containing a multitude of small particles, such that the envelope is normally flexible and able to be conformed to a patient's body but upon evacuation of air therefrom becomes stiff. The backing means may function in conjunction with the cuirass shell to create a box-like enclosure enclosing the chest and associated back region of a patient in a substantially air-tight manner. Side regions of the shell are in such an arrangement connected in an adequately air-tight manner to the backing means. However, the backing means may instead act as the base member as described in connection with the first aspect of the invention. The backing means may include more than one such envelope. The envelopes may be provided separately or connected together. In use the weight of the patient causes the distortion of the backing means into a shape which exactly fits the patient. Removing the air from the backing causes the small particles to become locked to one another thereby causing the backing means to harden and become stiff. The degree of evacuation of the envelope can be controlled in order to adjust the firmness of the backing means. The source of the vacuum for evacuating the envelope may be a vacuum pump or a syringe. The opening in the envelope preferably includes a valve and the degree to which the backing means can be made more resistant to compression may be controlled by operating the valve. The valve may be a two-way vacuum valve. The said multitude of small particles may be sand or they may be small particles or beads made of plastics, glass or metal. Combinations of different kinds of small particles may be used. As mentioned above, the backing means and the shell may be linked together by fastening means. Preferably the fastening means are male and female refastenable sealing strips such as male and female hook and loop fabric strips, e.g. Velcro. The sealing strips may run longitudinally down each side of the cuirass shell and backing means. Male and female sealing strips may be provided between the cuirass shell and the straps. Alternatively, straps may be provided which are attached to the backing means and run over portions of the front and rear ends of the cuirass shell. Straps may be fixed to the cuirass shell and extend under portions of the backing means. The side portions of the backing means may be turned upwards or be capable of being turned upwards so that they can overlap with side portions of the cuirass shell. Preferably, such upturned side portions of the backing means overlap with portions of the outside of the cuirass shell. The backing means may be attached to the cuirass shell using fastening means such as clips, clamps or straps and buckles. Any one of the means of attachment described in connection with the first aspect of the invention can also be used to attach the backing means to the shell. The backing means may further include an upper layer of soft material. This soft layer is intended to make contact with the patient's back in use. The soft material layer is for the insulation and comfort of the patient and may be attached to the envelope by gluing, or if a plastics or rubber material, by welding. Alternatively, the soft material may be integrally formed with the envelope. The soft material may be a foamed material. The distance between the walls of the envelope in use is preferably from 1 to 1.5 cms. Preferably the backing means is substantially rectangular in shape and corresponds generally in size to the open underside of the cuirass shell. Preferably, the backing means is made from a flexible plastics material or rubber. The backing means may be provided in a size suitable for use with a correspondingly sized cuirass shell, e.g. sizes suitable for neonatal, paediatric or adult use. Preferably of course, chest enclosures according to the invention are provided which embody the features of any two or more of the four aspects identified above within a single chest enclosure. In particular, it is preferred that there be a pair of sealing flaps running around the whole of the front, rear and side edge portions of the shell, one being directed such that its free edge faces out from the enclosure in use and the other being directed so that its free edge faces in towards the interior of the enclosure, both overlying the patient's body and sealing there against. By this means, whether the pressure inside the enclosure is above or below ambient, an improved seal is achieved and there is a still further reduced need for the employment of sealing straps. This can enable a chest enclosure according to the most preferred embodiments of the invention to be applied to a patient's body and be in operation at least as fast as the most skilled operator can carry out an intubation. Preferably, the edge seal of a shell in an enclosure according to the second or the third aspect of the invention comprises a sealing bead of closed cell foam protruding inwardly from the inner face of the shell itself by from 1 to 4 cm, e.g. about 2 cm. From the internal face of the sealing bead there preferably protrudes the sealing flap according to the second aspect of the invention and/or the sealing member required by the third aspect of the invention. Where both are provided, they preferably extend from the sealing bead at an angle to one another which is from about 30° to about 90°. Preferably, the angle included between the two is smaller at the front and rear of the shell and larger at the side edge portions of the shell. At the front and at the rear it is for instance in the region of 30° to 50° and at the sides it is preferably in the region of 70° to 90°. The shell in each aspect of the invention is preferably constructed from a stiff but resilient plastics material such as perspex or polycarbonate, e.g. of about 0.5 to 4 mm thickness, larger thicknesses in this range being more appropriate for larger shells. Preferably it is transparent. It may be moulded into the required shape but a plane sheet of suitable material can simply be bent to form a U-shaped channel to constitute the shell. Any of the first, second or third aspects of the invention described above may be used in combination with the backing means of the fourth aspect of the invention. The invention will be further explained and illustrated by the following description of a preferred embodiment with reference to the accompanying drawings in which: BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view of a base member with support members for use in accordance with the first aspect of the invention; FIG. 2 is a front elevation of the base member illustrated in FIG. 1; FIG. 3 is a front elevation of the shell of a chest enclosure according to the first, second and third aspects of the invention with its sealing member omitted for clarity; FIG. 4 is a vertical cross-section through one of the mounting brackets of the shell of FIG. 3; FIG. 5 is a plan view of the mounting bracket of FIG. 4; FIG. 6 is a side elevation of the chest enclosure of FIG. 3 including the sealing member; FIG. 7 is an under plan view of the shell of FIG. 6; FIG. 8 is a section on the line VIII--VIII of FIG. 7; FIG. 9 is a section on the line IX--IX of FIG. 7; FIG. 10 is a section on the line X--X of FIG. 7; and FIG. 11 is a rear elevation of the shell and back support means of an embodiment according to the fourth aspect of the invention. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS In each of FIGS. 8 to 10, those portions of the enclosure which lie behind the plane of the section have been omitted for clarity. As shown in FIG. 1, a chest enclosure according to the first aspect of the invention includes a base member in the form of a base plate 10 which is generally rectangular in shape and approximately one third of the way along its length has a transverse row of eight threaded through holes 12 arranged in two groups of four, each group lying adjacent to and extending in from one long edge of the plate 10. A pair of support members in the form of columns 14 are screwed into respective ones of the holes 12 by means of threaded studs 16 (FIG. 2). Each column is circular in cross-section and comprises a first lower plain portion 18 carrying the stud 16 and an upper toothed portion 20 comprising about fifteen frustoconical regions 22 each having an upwardly facing sloping face 24 and a downwardly facing annular face 26 lying parallel to the base plate 10. The columns are preferably made of a tough fairly stiff but resilient plastics material. The shell 40 shown in FIG. 3 may be generally conventional except for the provision of a pair of outwardly facing mounting brackets 28 positioned one on each side of the shell toward the top of the shell. Alternatively, the shell can be provided with suitable sealing members such that it is in accordance with the second and third aspects of the invention. As shown in FIGS. 4 and 5, each mounting bracket defines a vertically extending U-shaped channel 30 having a wedge-shaped dog 32 extending out from the base of the channel and providing a horizontal upper semi-circular surface 34 and a downwardly facing sloping rectangular face 36. Below the level of the dog 32, the shape of channel 30 changes to being rectangular rather than U-shaped. The manner of use of the enclosure described is as follows. With a patient fitted with the shell and lying on a bed, one of the two columns 14 is unscrewed from the base plate 10 and the base plate is pushed underneath the patient so that the other column 14 lies by the patient's side. The first column 14 is then refitted to the base plate on the other side of the patient. The spacing of the columns 14 is selected such that they press against the mounting brackets 28 and the dog of each mounting bracket locates under one of the annular faces 26 of the frustoconical regions 22 on each column. When vacuum is applied to the air passageways of the shell, external air pressure will tend to push the top of the shell down on to the patient's chest with consequent bowing out of the side of the shell. This will be prevented by the engagement of the mounting brackets 28 with the columns 14. An alternative manner of use is to first fit the shell 10 pushing the mounting brackets down ratchet-wise between the columns 14 until the patient is lying on the base plate 10. The columns of the base plate are easily removed if it is necessary to move the patient. Alternatively, the mounting brackets can be released simply by pulling apart the tops of the columns 14. If desired, the mounting brackets and the formations on the columns 14 may be made such that it is necessary to press the mounting brackets down slightly before they can be released from the columns 14. For instance, an upstanding lug may be formed on the upper surface 34 of the dog 32 and a downwardly facing co-operating lug may be formed on each annular face 26 of the column 14. The shell illustrated in FIGS. 3 to 7 constitutes a chest enclosure according to the second, third and fourth aspects of the invention. Shell 40 is of springy plastics material having a front edge 42 a side edge 44 and rear edge 46. It comprises a pair of air passageways 48 for connection to a suitable air oscillator, one passageway being provided on each side of the mid line of the shell. With reference also to parts of FIGS. 8-10 there is a thick sealing bead 50 of closed cell resilient foam which extends around the internal face of the shell around the front, side and rear edges in a continuous strip. The sealing bead 50 is of generally rectangular cross-section having a rounded nose portion 52. In accordance with the second aspect of the invention, a sealing flap 54 of closed cell foam similar to that used for the sealing bead 50 extends from the sealing bead 50. Flap 54 is of 5 mm thick foam strip about 2 cm wide. More generally, such a flap is suitably from 3 to 10 mm in thickness, and from 1.5 to 4 cm in width, larger figures within these ranges being more appropriate for larger shells. It is attached by one edge face to the outer root portion of the face of the nose portion 52 of the bead 50, e.g. by adhesive, although of course it could be made integral with the bead 50. The flap 54 extends generally at an angle with respect to a perpendicular to the edge of the shell of from about 0° to 10° outwards in the vicinity of the side of the shell to about 0° to 20° inwards in the region of the front of the shell and about 0° to 10° outwards in the region of the rear of the shell. However, when the shell is placed over a patient, the free edge of the flap can be teased outwards to lie on the body of the patient outside of the shell or at least directed towards the outside of the shell so that atmospheric pressure tends to press the flap more tightly against the patient's body. In accordance with the third aspect of the invention, a second sealing flap 56 extends inwardly from the bead 50. This is attached to the bead 50 along the nose portion thereof spaced inwardly from the flap 54 by approximately 15 mm. Its dimensions are similar to those of the flap 54 but it is directed toward the interior of the shell so that in use it lies on the body of a patient within the shell and is pressed more tightly against the patient's body in response to super atmospheric pressure in the shell. It extends from the bead 50 at an angle to the adjacent part of the shell of about 5° to 20° in the region of the sides (FIG. 8) and front (FIG. 9) of the shell and about 20° to 60° in the region of the back (FIG. 10) of the shell. The angle included between the two sealing flaps is about 45° at the back of the shell about 70° to 90° along the sides of the shell and about 60° along the front of the shell. The entire sealing structure of bead 50 and flaps 54 and 56 can be made as an integrated whole or assembled from separate constituents. In use, the enclosure may be fitted to a patient by springing apart the sides of the shell and passing the sides of the enclosure over the patient's chest and releasing them so that the sealing flaps 54 and 56 seal on the patient's body. In the region of the sides of the shell, the flaps, particularly the flap 50, seals against the patient's back so that movement of the patient's ribs is not restricted. The shell may be fitted with mounting brackets so as to bring the enclosure within the first aspect of the invention. Such mounting brackets may be as illustrated or may for instance take the form of collars with an adjustment screw passing through the wall of each collar. Such collars can be fitted over support columns and held in position by tightening of the screws. The shell may be fitted with straps to enable it to be strapped on to a patient. It may be necessary to employ such straps if the patient has a chest region of abnormal shape or if the patient is to be moved wearing the enclosure but the seal provided by the sealing flaps 54 and 56 should under normal circumstances be sufficient to enable the enclosure to be used even before such straps are fitted. In accordance with the first and fourth aspects of the invention, a backing means in the form of a pad 58 is provided which is a generally rectangular shaped envelope comprising an upper layer 60 and a lower layer 62. The layer 60 and layer 62 are attached around their edges so as form the envelope with interior space 64. The space 64 contains sand. The pad 58 corresponds generally in shape to a rectangle of a size which is defined by the sides 44, the front 42 and rear 46 edges of the shell 40. Side portions 66 of the pad 58 are turned upwards so that portions of the upper layer 60 can be brought into contact with the outside lower edges of the shell 40. The side portions 66 of pad 58 are attached to the shell 40 by hook and loop fabric strips 68. The pad 58 has an access tube 70 which connects the space 64 with the surrounding atmosphere. The tube 70 includes a two-way valve 72. A layer of foam rubber 74 is attached to upper layer 62 of the pad 58 in order to insulate and provide the patient with a degree of comfort. In use the pad 58 is spread out flat on a surface. The patient is laid face up on the pad 58 and the shell 40 is placed over the patient's chest. The weight of the patient deforms the pad 58 so that it forms an impression of the contours of the patient's back. The shell 40 is then attached to the upturned portions 66 of the pad 58 by way of the strips 68. A vacuum pump (not shown) is connected to pipe 70 and switched on. Tap 72 is opened in order to allow air to be drawn out of the space 64. As the air is drawn out the pad 58 the particles are compressed together so that the pad "hardens" and fixes the impression of the patient's back therein. What results is a hard lower surface 62 and a softer upper surface 60. The shell 40 and the pad 58 both seal against the patient's body in a substantially air-tight manner so as to completely encase the patient's chest and associated back region. The stiffening of the pad 58 causes the upturned side portion connected to the shell 40 to act as support members against any movement of sides of the shell caused by pressure changes inside the shell. The hardened pad 58 therefore provides a relatively rigid support for the shell 40 and assists in the sealing of the shell 40 to the patient whilst maintaining a degree of comfort to the patient. The pad 58 is made from rubber or a flexible plastics material. The space 64 inside the pad 58 can be filled with sand or small particles or beads of plastics material, glass or metal. Many modifications and variations of the embodiments of the invention described above are possible within the scope of the invention.

A chest covering shell (4) of springy material for fitting over a patient's chest is coupled to an air oscillator. Changes in air pressure in the shell (40) cause ventilation of the patient. A back plate (10) can be used which has vertically extending supports (14) for engagement with the sides (28) of the shell (40) so as to support them and prevent their flexing during use. The edge of the shell (4) has a seal (50 which runs continuously around the periphery of the shell (40). The seal (50) can include an inwardly directed flap (56) in order to provide an effective seal when positive pressures are applied under the shell (40). A backing pad (58) comprising an evacuatable envelope containing solid particles can be used which is able to support the shell (40) and seal against the patient. The pad (58) can be deformed by the weight of the patient and can be evacuated via air outlet (70) to stiffen the envelope by compression of the particle.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to medical devices and, in particular, to an improved knee brace hinge. [0003] 2. Description of the Related Art [0004] Many types of braces have been made available for the support of body joints which have become weakened as a result of sports activity, accident, deterioration due to age, or disease. Braces for the knee are designed primarily to provide support while enabling the knee to function during normal activity. [0005] Knee braces are often utilized by people who have suffered a knee injury and require some means of protection against further aggravation of the knee during rehabilitation. A knee brace can limit the amount of damage to an injured knee by providing the patient with adequate knee stabilization and control. Stabilization and control is achieved in such a manner as to permit the patient relative freedom in the normal use of the knee joint while, at the same time, permitting control over the joint so as to optimize healing. [0006] In addition, knee braces are often employed by a person having previously suffered a knee injury who wishes to actively participate in strenuous and demanding physical activity. In such cases where the person seeks knee support in furtherance of activities involving heavy running or sprinting, it is extremely advantageous to design a knee brace which most accurately simulates the true motions of the anatomical knee joint. This will minimize the leg forces required to overcome mismatched motions and generally increase comfort levels. [0007] Knee braces generally serve two purposes. Firstly, the brace has to support the knee at all times, but especially during movement. Secondly, the brace should limit knee movements in flexion or extension within limits beyond which injury to the knee may occur. Further, movements are confined to the varus/valgus plane. [0008] Flexion is defined as flexing of the knee from the extended position to a position where the foot and ankle is bent towards the thigh. Extension is defined as being the opposite movement. An extended leg is normally straight with virtually no bending at the knee joint. [0009] Knee braces for providing support for the knee of a person are well known in the art. Such braces generally include a tibial shell which is constructed so as to be closely configured to the shape of the lower leg and a femoral shell which is constructed so as to be closely configured to the shape of the thigh area of the leg. The two shells are secured to their respective areas on the leg and are interconnected by some type of mechanism so as to pivot relative to each other as the knee is bent. The mechanism is usually a pair of hinge joints, one on each side of the knee brace, with the tibial shell usually being attached to the lower part of each one of the two knee joints and the femoral shell usually being attached to the upper part of each one of the two hinge joints. [0010] Often, a person will wear knee braces bilaterally. When wearing double upright rigid knee braces bilaterally, the medial hinges often interfere with one another. The hinges sometimes lock together, causing the knee brace wearer to fall or injure himself. This problem is evident during normal walking and running, but becomes pronounced in activities such as snow skiing or motocross. [0011] Therefore, there is a need for an improved knee brace which prevents interference and/or locking between the medial hinges. SUMMARY OF THE INVENTION [0012] The present invention provides an improved knee brace including an upper portion and a lower portion pivotally attached at a hinge, which permits rotation of the upper portion with respect to the lower portion. A plurality of adjustable straps secures the knee brace to the leg. A hinge deflector encases the hinge and prevents locking of opposite medial hinges during bilateral knee brace use. [0013] The hinge assembly includes a hinge cover, parallel plates and a plurality of fasteners for connecting the plates, cover, and hinge deflector to the knee brace. The hinge deflector comprises a shell having rounded surfaces, which encase the internal components of the medial hinge and also deflects the opposing medial hinge. BRIEF DESCRIPTION OF THE DRAWINGS [0014] [0014]FIG. 1 is a perspective view of a knee brace of the present invention. [0015] [0015]FIG. 2 is a perspective exploded view of a knee brace hinge of the knee brace of FIG. 1. [0016] [0016]FIG. 3 is a perspective exploded view of a knee brace hinge of the knee brace of FIG. 1. [0017] [0017]FIG. 4 is a perspective view of a knee brace hinge deflector of the knee brace of FIG. 1. [0018] [0018]FIG. 5 is a top view of the knee brace hinge deflector of FIG. 4. [0019] [0019]FIG. 6 is a side view of the knee brace hinge deflector of FIG. 4. [0020] [0020]FIG. 7 is an end view of the knee brace hinge deflector of FIG. 4. [0021] [0021]FIG. 8 is a cross-sectional view of the knee brace hinge deflector of FIG. 5 through line 8 - 8 . [0022] [0022]FIG. 9 is a bottom view of the knee brace hinge deflector of FIG. 4. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0023] Knee Brace [0024] [0024]FIG. 1 shows an orthopedic brace for supporting a joint having a plurality of complaint support components. The knee brace 100 of the present invention includes a hinged shell 105 and a plurality of adjustable support straps 110 engaging the brace at two points on opposite sides of the hinge to stabilize the weakened joint throughout its range of motion. The shell 105 has an upper portion 115 conformable to the thigh and a lower portion 120 conformable to the lower leg. Each of the shell portions 115 , 120 is preferably formed from a single continuous shaped piece of a stiff material such as certain plastics, fiberglass, composites, certain metals, and the like, as are known to those of skill in the art. [0025] The upper portion 115 includes a cuff 125 , having a lateral arm 130 and a medial arm 135 . The cuff 125 has a preformed arcuate shape sized to snugly conformingly engage the anterior portion of the thigh. [0026] The lower portion 120 includes a cuff 140 , having a lateral arm 145 and a medial arm 150 extending therefrom. The lower portion 120 has substantially the same structure as the upper portion, but is sized to conform to the lower leg of the user. The lower cuff 140 has substantially the same configuration as the upper cuff 125 , but the preformed arcuate shape thereof is sized somewhat smaller to snugly conformingly engage the calf of the lower leg. [0027] The upper and lower portions 115 , 120 are connected across rotatable hinges 155 , 160 . More specifically, lateral upper arm 130 is pivotally connected to lateral lower arm 145 and medial upper arm 135 is pivotally connected to medial lower arm 150 across lateral hinge 155 and medial hinge 160 , respectively. A resilient pad 180 may also be provided to cushion the knee joint from the rigid hinges 155 , 160 . (For simplicity, a pad is only shown on the hinge 155 .) [0028] Medial hinge 160 also preferably includes a hinge deflector 165 for preventing interference between medial hinges when a user is wearing a knee brace on each leg. The hinge deflector 165 acts as a shield to the internal components of the medial hinge 160 and deflects the opposite medial hinge, preventing the hinges from locking together. [0029] The support straps 110 are preferably adjustable in length, enabling the user to modify the support strap tension, and consequently the degree of support the brace provides to the joint. Support straps 110 are preferably formed from a wear-resistant supple material such as pliant leather, or natural or synthetic cloth, such as nylon and the like. The material should be compliant, but substantially unstretchable. [0030] Support straps 110 enable closure of brace 100 around the limb on which the brace is mounted. As seen in FIG. 1, each of the cuffs 125 , 140 is held in place by straps, and a strap connector. A separate strap is provided at the upper arms, surrounding the upper leg. A separate strap is provided at the lower arms, surrounding the lower leg. Each strap is integrally provided with a tab and cap fastener assembly 175 at the ends thereof to fix the strap and enable adjustment to the length of the straps 110 for close conformance of the shell 105 to the limb on which the brace is mounted. [0031] Hinge Assembly [0032] Referring to FIGS. 2 and 3, an exploded medial hinge assembly 160 and hinge deflector 165 are shown. Lateral hinge assembly 155 is also shown. It will be apparent to one of skill in the art that the hinge assembly 160 and an associated hinge deflector 165 can be incorporated into many other types of conventional hinged orthopedic braces without substantial modification. It is also appreciated that lateral hinge assembly 155 has the same features as medial hinge assembly 160 . Although hinge deflector 165 is intended for use with medial hinge assembly 160 , it is appreciated that hinge deflector 165 may also be used with lateral hinge assembly 155 . [0033] The hinge assembly 155 , 160 comprises a hinge cover 205 , parallel plates 210 , 215 , an upper rotary connector 220 and a lower rotary connector 225 . Washers 230 may also be provided between parallel plates 210 , 215 and connectors 220 , 225 . The cover 205 and plates 210 , 215 are formed from one or more high-strength, rigid materials, such as metals or plastics. Upper and lower rotary connectors 220 , 225 are respectively formed integrally with the upper and lower cuff arms 130 , 135 and 145 , 150 . The connectors 220 , 225 have semi-circular ends that are pivotally anchored by rivets 235 and are provided with interlocking teeth 240 . This construction of the hinge assembly 155 , 160 enables rotatable engagement of the upper and lower rotary connectors 220 , 225 and correspondingly enables rotation of the upper and lower portions 115 , 120 relative to each other. [0034] The hinge deflector 165 is secured to the parallel plates 210 , 215 , and connectors 220 , 225 by rivets 235 , or other suitable fasteners, passing through apertures 245 . Hinge cover 205 is secured to the parallel plates 210 , 215 and connectors 220 , 225 by screws 250 , or other suitable fasteners, passing through apertures 255 . [0035] A hinge extension stop 260 is preferably provided to interface with rotary connectors 220 , 225 at interlocking teeth 240 . Extension stop 260 limits the range of motion of the rotary connectors 220 , 225 and, consequently, brace 100 . [0036] Hinge Deflector [0037] The hinge deflector 165 shown in detail in FIGS. 4 - 9 comprises a thin walled shell 400 which is configured to encase the hinge assembly. The shell 400 has a generally elliptical shape as viewed in FIGS. 4 and 5. The shell has an outer or hinge side 415 which faces the hinge, encasing the hinge assembly, and facing away from the knee. The shell also has an inner side 420 which faces the knee, and thus may be referred to as the knee side. As seen in FIGS. 2 and 3, the shell is actually positioned between the knee and the brace hinge, although shell portions extend to the outer side of the hinge. [0038] The shell outer side 415 includes an outer perimeter surface 422 surrounding a central recess 425 having a generally elliptical shape also. The plate 215 and washer 230 of the hinge assembly fit within the recess 425 . [0039] The bottom wall of the recess includes a plurality of apertures 430 for attaching the hinge assembly to the knee brace. Two apertures 430 are shown, lying approximately on a longitudinal axis of the recess for attaching the hinge deflector to the knee brace with the fasteners or rivets 235 which pass through the components of the hinge assembly and the knee brace. Two apertures 435 are also shown, lying on an axis generally perpendicular to the longitudinal axis, for securing the stops 260 to the plates 210 and 215 with the screws or fasteners 250 . [0040] The outer side 415 includes a projection 405 which extends along a majority of the length of one side of the elliptically-shaped shell 400 . This can be referred to as the forward side or edge in that it is the side closest to the forward portion of a person's knee when the brace is in use. The projection includes a straight inner wall 405 a which protrudes from the recess 415 and the surrounding surface 422 , with a portion of that wall being flush with one side of the wall of the recess. The projection includes an outer surface 405 b which slopes toward a peripheral skirt 442 , and an outer edge 441 of the shell 400 , as seen in FIGS. 7 and 8. While the central portion of the projection curves basically toward the edge 441 , as seen in FIG. 7, the projection ends taper or curve to the surface 422 , as seen in FIGS. 4 and 6. [0041] The outer side 415 also includes a projection 440 extending from surface 422 on the edge of the shell opposite from the projection 405 . That edge of the shell can be referred to as the rear edge since it is closest to the back of the knee when the brace is in use. As seen, the projection 440 is only in the central portion of that edge in that space is needed for the rotational movement of the hinge. The projection 440 limits this movement. The projection 440 also has a straight inner wall 440 a and an outer curved surface 410 , for deflecting external objects. The curve surfaces 405 and 410 curve inward toward the knee brace and hinge assembly when assembled, for deflecting an interfering external object. The curved surfaces 405 and 410 have approximately the same slope; however, different slopes may be employed and the curved surface 405 preferably extends further than the curved surface 410 . The outer skirt 442 of the outer side 415 is also slightly tapered, so that there are no edges for interfering with the hinge. As seen, both projections extend above the surface 422 about the same amount to perform their deflector function. [0042] The shell inner side 420 preferably includes a plurality of ribs 445 for providing additional strength to the hinge deflector. [0043] In a preferred embodiment, hinge deflector 165 is a molded plastic material. However, any material having sufficient rigidity to withstand impact forces encountered during impact of hinge assemblies during physical activities are contemplated herein. [0044] Resilient pad similar to the pad 180 shown on hinge 155 in FIG. 15 is preferably releasably fastened to the shell inner side 420 by conventional releasable fastening means such as a hook and hoop fastener coupling, commonly referred to as VELCRO, wherein one element of the coupling is substantially permanently affixed to the inner side 420 and the other element of the coupling is substantially permanently affixed to resilient pad 180 . The resilient pad may be any knee brace pad, as known to those of skill in the art. [0045] Referring to FIGS. 2 and 3 as well as the description of the deflector shell, it may be seen that the deflector is positioned on the knee or inner side of the knee brace hinge. The plate 210 and washer 230 fit into the recess in the hinge side of the shell. The hinge side is next placed against the rotary hinge connectors 220 and 225 , with the connectors fitting between the projections 405 and 440 . A washer 230 and the plate 215 covered by the hinge cover 205 are next positioned adjacent the connectors and between the projections 405 and 440 . The upper edges of the projections are about flush with the outer surface of the hinge cover 205 so that interference of that cover with adjacent objects is deflected by the curved surfaces 405 b and 410 . Thus, it can be seen that an entire hinge assembly is substantially encased by the deflector shell. [0046] The hinge deflector prevents locking and/or interference of a medial hinge with a medial hinge of another knee brace or, alternatively, prevents locking with other external devices, such as components of a motocross bike. The hinge deflector 165 encases the hinge and deflects the external object with curved surfaces 405 , 410 . The curved surfaces 405 , 410 of the hinge deflector 165 prevent the locking because the external object slides along and off the curved surfaces 405 , 410 . The protruding curved surfaces 405 , 410 extend out and over knee brace and hinge assembly to deflect any surfaces or objects that may interfere with knee brace function. [0047] Although the present invention has been described in terms of certain preferred embodiments, other embodiments of the invention including variations in dimensions, configuration and materials will be apparent to those of skill in the art in view of the disclosure herein. In addition, all features discussed in connection with any one embodiment herein can be readily adapted for use in other embodiments herein. The use of different terms or reference numerals for similar features in different embodiments does not imply differences other than those which may be expressly set forth. Accordingly, the present invention is intended to be described solely by reference to the appended claims, and not limited to the preferred embodiments disclosed herein.

A knee brace hinge deflector is provided for preventing interference and/or locking of the medial hinges of bilateral knee braces. The hinge deflector includes a shell having rounded surfaces for encasing a first medial hinge assembly and deflecting a second medial hinge assembly of bilaterally worn knee braces.

FIELD OF INVENTION This invention relates to a novel herbal formulation advocated for the prevention and management of Coronary Heart Disease. BACKGROUND OF INVENTION In spite of tremendous advancement in the field of cardiovascular medicine and surgery the mobidity and mortality due to Coronary Heart Disease is still increasing in almost all the society. Worldwide attempt are being made to prevent coronary heart disease by modifying various risk factors. The alternate strategy that has gained wide spread application in the recent years is secondary prevention. Coronary Heart Disease (CHD) is the leading cause of morbidity and mortality in many developed countries and will be an increasing problem for developing countries. Recognition of the alarming risk of CHD among South Asian Nations has led to take initiatives focusing on understanding of pathophysiological mechanisms and emphasis has been given on establishment of new remedial measures for cardio protection. Several but not all, of the known risk factors for CHD have been associated with a level of oxidative stress including use of tobacco, hypertension, dyslipidemia, obesity and diabetes. A production of oxidative stress, LDL-oxidation has been hypothesized as primary underlying mechanism for the development of atherosclerosis and CHD. Abnormal blood lipid is the most important causative factor of Coronary Heart Disease. The association between serum cholesterol level and coronary heart disease is widely studied by several workers. Elevated serum Triglycerides and low HDL-c level is an independent risk factor of CHD. Various epidemiological studies have shown that increased levels of serum lipoprotein (a), homocysteine, fibrinogen, insulin resistance and thrombogenic factors are strongly associated with the increased CHD risk. These fast emerging risk factors have strong genetic predisposition and have their beginning in early childhood. It showed presence of elevated markers like CRP and Homocysteine in school going children. The level of homocysteine, a sulfydryl-containing amino acid and C-reactive protein (CRP), a protein found in the blood circulation, has shown to be predictive of future Coronary Heart Disease (CHD). There is also evidence that the elevated range of homocysteine and CRP concentration has association with atherosclerosis and thrombosis observed in many cases. The American Heart Association and the Centre for Disease Control and prevention, released a scientific statement regarding clinical assessment of inflammatory markers IL- 6 , TNF-α including CRP as a predictor for risk for cardiac event. It has been observed in several cases and also among the patient suffered from vascular disease that, genetic factor influence plasma homocysteine concentration. It is also reported that homocysteine rise with age in both men and women and its concentration are higher in men than women. This may be due to difference in muscle mass and renal function. Sex hormones may also influence homocysteine concentration in plasma. As pointed out earlier that elevated plasma homocysteine is a known factor for atherosclerotic vascular disease, it further increases the risk, associated with smoking and hypertension. Dietary regulation like folate, cobalamin and pyridoxal phosphate, modulate homocysteine metabolism. Homocysteine level rise with decreasing concentration of vitamin B 6 , vitamin B 12 and folate, further it increases due to their impaired metabolism by the kidneys and liver which enhances the risk of myocardial infarction and stroke. Certain drugs like combination of colestipol and niacin, methotrexate, phenytoin carbomazepine and nitrous oxide may increase homocysteine concentration in plasma. Further, it is pointed out that patients with inherited defects of methionine metabolism can develop severe hyperhomocysteinemia and can have premature atherothrombosis. Though a mild to moderate elevation of homocysteine are common in general population due to insufficient dietary intake of folic acid. Level of CRP is an acute phase marker and a predictor of the risk of atherosclerotic complication. High level of CRP is a significant marker of inflammation and it consistently predicts new coronary events in patients with unstable angina and acute myocardial infarction. It is reported that individuals with high-CRP levels has relative risks of future vascular events, three or four times higher than individuals with lower levels. Higher CRP may cause heart attack and is associated with lower survival rate of people. The other risk factors of CHD include lipoprotein remnants, lipoprotein (a), small LDL particles, HDL subspecies and various apolipoproteins including coronary calcium. It is widely accepted that evaluating CRP as a risk factor for CHD is of clinical significance in the prevention and management of CHD. High Body Mass Index (BMI) and insulin resistance are also contributing factors for CHD. Resistin has been considered as one of the most important inflammatory markers responsible for endothelial dysfunction, atherosclerosis and cardiovascular disorder. Plasma resistin level are highly correlated with level of diverse inflammatory markers, particularly circulating TNF-α, IL-6, hs-CRP and lipoproteins. The resistin is directly associated with the level of adiponectin which has shown association with diabetes and Metabolic syndrome. Recent studies have demonstrated the association of adiponectin with diabetes mellitus and its potential anti-diabetic, anti-atherogenic and anti-inflammatory activities. Psychological stress also plays an important role in precipitation of arterial hypertension, angina and myocardial infarction. Therefore stress management also contributes in the prevention of CHD. Keeping the above background in to consideration it was decided to propose a safer remedial measure for the improvement in atherosclerotic process, reduction in high level of homocysteine and the inflammatory marker C-reactive protein, IL-6, resistin and abnormal lipids responsible for an adverse cardiac event. Scientific evaluation of some of the Ayurvedic drugs have shown better efficacy over standard pharmacologic therapy as well as reduced side effects. The successful management of CHD is seldom possible with one drug alone. Generally it is observed that due to inadequate response of the drugs and troublesome side-effects the currently available drugs are not able to reduce the mortality and morbidity rate from CHD. It has long been recognized that the desirable action of the drugs conventionally used in CHD cases could be augmented and undesirable actions may be minimized by the use of two or more drugs in appropriate combination. In classical texts of Ayurveda many plant based drugs have been advocated for the prevention and management of cardiovascular disorders, without any adverse reaction. Ayurveda has given a comprehensive description about etiopathogenesis and management of coronary heart disease. Several single and combined formulations have been described in Ayurveda for the management of heart diseases. It includes all risk factors and their management. Taking the lead from ancient Indian literature it was thought to propose an Ayurveda formulation having multi-targeted action in CHD cases as well as CHD risk factors with the object to prevent the morbidity and mortality from CHD. OBJECT OF INVENTION The major object of present invention is to propose an Ayurveda plant based formulation beneficial in the prevention and management of risk factors causing Coronary Heart Disease in CHD cases as well as individuals at risk of development of CHD due to presence of CHD risk factors. Another object of present invention is to propose a plant based Ayurveda formulation effective in the prevention and management of dyslipidemia by modifying abnormal lipids among cases at risk of CHD as well as established cases of CHD. Another object of present invention is to propose a plant based formulation having triglyceride lowering property among CHD cases showing hypertriglyceridemia and also those individuals at risk of development of CHD due to elevated triglycerides. Further, object is to propose a plant based formulation having potentiality in the regulation of blood pressure among CHD cases as well as cases of essential hypertension as hypertension is one of the major risk factors of CHD. Still object is to propose a plant based Ayurveda formulation effective in the prevention and management of endothelial dysfunction by reducing atherosclerotic process among CHD cases as well as individuals at risk of development of CHD. Still, another object of present invention is to propose a novel plant based Ayurveda formulation effective in reducing vascular inflammation by reducing pro-inflammatory cytokines TNF-α, IL-6, and also hs CRP and resistin among cases at risk of CHD and also diagnosed CHD cases. Yet another object of present invention is to propose a plant based Ayurveda formulation having adiponectin enhancing and leptin lowering property. Further, object of present invention is to propose a plant based Ayurveda formulation beneficial in reducing elevated homocysteine level, among cases at risk of CHD and also cases suffering from CHD. Still, object is to propose a plant based Ayurveda formulation having anti-anxiety and anti-stress potential as anxiety and stress is one of the leading causes of CHD manifestation as well as precipitation of the disease condition. STATEMENT OF INVENTION According to this invention there is provided a novel plant based Ayurveda formulation beneficial in the prevention and management of coronary heart disease caused due to various CHD risk factors like atherosclerosis (dyslipidemia), obesity, impaired glucose tolerance (diabetes), Hyper-homocysteinemia, elevated inflammatory markers including resistin etc. Further, according to this invention there is provided a process for the preparation of novel plant based Ayurveda formulation as claimed in Claim-I comprising of preparing hydro-methanolic extract of Withania somnifera (Ashwagandha—root), Costus speciosus (Kebuk—rhizome), Terminalia arjuna (Arjuna—bark) and Hippophae rhamnoides (Amlavetas—fruits) by using water (aqueous) and methanol (30:70) at 60-80° C. and maintaining pH of solution between 7-10, separating chromatographically the active compound present in each plant candidate by using TLC, HPLC and HPTLC supporting the molecular characterization of plant extract by using IR and NMR. BRIEF DESCRIPTION OF THE FIGURES FIG. 1 is a flow diagram of the process. FIG. 2 is showing the effect of test formulation on Total Cholesterol among CHD cases. FIG. 3 is showing the effect of test formulation on LDL-c among CHD cases. FIG. 4 is showing the effect of test formulation on HDL-c content among CHD cases. FIG. 5 is showing the effect of test formulation on Triglycerides content among CHD cases. FIG. 6 is showing the effect of the decrease in Apolipo (B) following Ayurveda test formulation in CHD cases. FIG. 7 is showing the effect of the decrease in Lipoprotein (a) following Ayurveda test formulation among CHD cases. FIG. 8 is showing the effect of test formulation on Endothelin among CHD cases. FIG. 9 is showing the effect of the decrease in Interleukin-6 inflammatory marker among CHD cases following test drug treatment. FIG. 10 is showing the effect of the reduction in TNF-α inflammatory marker following test drug treatment among CHD cases. FIG. 11 is showing the effect of the decrease in plasma resistin level following Ayurvedic test formulation among CHD cases. FIG. 12 is showing the effect of the decrease in plasma Homocysteine level following Ayurvedic test formulation among CHD cases. FIG. 13 is showing the effect of test formulation on Brachial Artery thickening among CHD cases. DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a novel plant based Ayurveda formulation and the process thereof for the prevention and management of Coronary Heart Disease (CHD) particularly atherosclerosis. The preparation of present invention may be advantageous if used for the prevention and management of CHD risk factors like dyslipidemia, hypertension (atherosclerosis), obesity, hyper-homocysteinemia, diabetes mellitus etc. among the adult people. The beneficial effect of test formulation in diagnosed cases of CHD can be assessed on different fractions of lipids particularly oxidized LDL-c, HDL-c including triglycerides, inflammatory markers IL-6, TNF-α, resistin and CRP, adipokine, leptin and adiponectin, elevated homocysteine and also on some of the electrophysiological and psychological assessments. The hydro-methanolic extract of four Ayurveda plants i.e. Withania somnifera, Costus speciosus, Terminalia arjuna and Hippophae rhamnoides by using 30:70 ratio of water and methanol respectively is utilized for the development of present novel formulation by conducting various experimental and clinical studies. The water utilized for extraction was decontaminated for any type of bacterial or abnormal growth by using reverse osmosis plant. After extraction the presence of active molecules in various plant extracts were identified by HPLC, HPTLC and NMR procedures. The biological activity was studied on the basis of mode of action of single plant selected for preparation of combined formulation as well as combined formulation by assessing their role on various targets involved with CHD risk factors as well as already manifested CHD. The bio-molecular reaction following the interaction between the chemical and biological markers like abnormal lipids i.e. LDL-c, HDL-c, lipoprotein(a) and apolipo (B), Triglycerides, Homocysteine, Adiponectin, Leptin, inflammatory cytokines including resistin and also the neuropsychological assessments were evaluated. The pre-clinical toxicological studies of single as well as combined formulation were carried out to determine safety profile of present novel test formulation. The efficacy profile of test formulation were done in pre-clinical animal model of high cholesterol diet induced dyslipidemia, cafeteria diet induced obesity, altered inflammatory markers particularly CRP and resistin etc. The mode of action of single plant candidate and combined formulation was determined in animal studies. The beneficial role of present test formulation on abnormal lipids including lipoprotein (a) and apolipo (B), inflammatory biomarkers, adipocytes and plasma homocysteine concentrations were determined in various animal models before utilizing the drug for human use. Extraction Procedure: The dried root of Withania somnifera , rhizome of Costus speciosus , bark of Terminalia arjuna and fruits of Hippophae rhamnoides , were utilized for extraction. The hydro-methanolic extract of the plants were utilized for the identification of active compound present in the plants. After extraction, the extracted parts were taken for chromatographic HPLC, and HPTLC. After identification and separation of active compound, the molecular separation by using TLC, characterization was carried out by using IR and NMR. The extraction was done at the temperature of 60-80° C. The pH of the solution was maintained between 7-10. The steps carried out to isolate the active compound to assess the activity of test formulation are shown in FIG. 1 . According to this invention, there is provided an Ayurveda formulation for the prevention and management of Coronary Heart Disease by modifying the CHD risk factors. The present test formulation comprising of the following ingredients: Name of the Plants Parts used 1. Withania somnifera (Ashwagandha) root 2. Costus speciosus (Kebuk) rhizome 3. Terminalia arjuna (Arjuna) bark 4. Hippophae rhamnoides (amlavetas) fruits Preferably, the aforesaid plants are present in the formulation in the following doses— Name of the Plants Dose range 1. Withania somnifera 200-425 mg/day 2. Costus speciosus 150-350 mg/day 3. Terminalia arjuna 225-450 mg/day 4. Hippophae rhamnoides 200-325 mg/day The formulation also comprise known additive such as minerals, vitamins, salts filler (for capsulation or to prepare syrup) and binders, if required to present in trace amount. Thus any known additive or supplement is added to prepare the final formulation as required and present in trace amount. Reference is made here in capsule form (500 mg each). However, it would be apparent that the preparation may also be prepared in the form of syrup/tablet. Preferably but without implying any limitation the preparation comprises— Name of the plant Dose 1. Withania somnifera 250 mg/day 2. Costus speciosus 200 mg/day 3. Terminalia arjuna 275 mg/day 4. Hippophae rhamnoides 225 mg/day Hypothesis: The present plant based Ayurveda formulation is prepared out of four plant extract namely Withania somnifera, Costus speciosus, Terminalia arjuna and Hippophae rhamnoides . This formulation has been proven for its hypo-lipidemia, anti-atherosclerotic, anti-inflammatory, adiponectin enhancing homocysteine reducing and anti-anxiety activity among patients of CHD as well as individuals with positive evidence of CHD risk factors responsible for future development of CHD. Since coronary heart disease has a multi-factorial etiology it requires various drugs to manage the complex nature of disease. Therefore it was thought to validate a poly herbal formulation containing active compounds that acted on multi-targets involved in CHD. The association between cardiovascular disease, lipid metabolism, obesity and adipokine signaling is of complex nature. A number of reference are available showing role of adipose tissue of an endocrine organ and secretion of adipokines i.e. leptin, adiponectin, resistin, ghrelin, visfatin that act on non-adipose tissues such as heart, diverse cellular and whole body function. These effects are mediated an increase in adiponectin and reduction in resistin level as low adiponectin and high resistin is associated with an increase in the risk of mortality due to CHD, and increase in adiponectin has been suggested to produce its protective effect via activation of cyclo-oxygenase-2 (COX-2) in cardiac myocytes, as inhibition of these enzyme resulted in the cardioprotective effects. Adiponectin also exerts anti-ischemic effects by increasing endothelial nitric oxide. Further, reduction in leptin reduces blood pressure through interaction with nitric oxide pathway. It is hypothesized that present novel test formulation acts through stimulation of endothelial nitric oxide by AMP activated protein kinase (AMPK) dependent mechanism as these have a favourable impact on micro-vascular functions. The therapeutic intervention targets steps of atherosclerotic inflammation. Therapies include cytokine inhibitors, blockade of platelet derived growth factor (PDGF), cholesterol acetyl-transferase inhibition, anti-oxidant, anti-inflammatory agents and lipid lowering drugs. Cytokine inhibitors are anti-TNF-α antibodies. Inhibition of cytokine-stimulated PDGF, prevents accumulation of smooth muscle cells in atherosclerotic lesions and protection from plaque growth. The ingredients combined in the test formulation have shown great potential in inhibiting platelet aggregation. It is proposed on the basis of results that perhaps the test drug reduced the formation of thromboxane, inhibited the phospholipase activity and lipoxygenase products formed in platelet. Elevated levels of endothelin (ET) have been detected in patients with myocardial infarction. The test drug has shown blood pressure lowering effects due to decrease in peripheral vascular resistance. Test formulation modulates the production and function of both endothelium derived relaxation and constricting factors which causes protection against vasoconstriction. Thus, the test drug has vasodilatory activity as it inhibited endothelin to a great extent. Hypercholesterolemia promotes endothelial dysfunction in the absence of atherosclerotic lesions. Endothelial dysfunction results in a decrease in nitric oxide bioavailability. Endothelial dysfunction can also direct formation of atherosclerotic lesions. The effect of present test formulation has been attributed to its capacity to reduce lipid content in arterial wall. The possible mechanism of test drug is that it causes direct anti-atherogenic and anti-atherosclerotic effects at the level of arterial wall. It depressed the hepatic activity of lipogenic and cholestrogenic enzyme like malic enzyme, fatty acid synthase and 3-hydroxy-3 methyl-glutaryl-CoA reductase. Keeping the above facts in view and beneficial role of plants included in the present test formulation that acted on multiple targets involved in coronary heart disease and various CHD risk factors, determined in various pre-clinical models, it was thought to propose a safer remedial measure for the prevention and management of coronary risk factors involved with the onset of CHD so that morbidity and mortality due to CHD can be prevented/minimized. About the Plant: Withania somnifera : The plant belongs to family solanaceae, and is one of the ingredients of present test formulation. It has shown anti-stress, adoptogenic and hypotensive properties and is beneficial in the regulation of altered neurotransmitters through its active compound with anoloids, somniferine and withanine. One of the recent studies has indicated that Withania somnifera reconstruct the neuritic damage and also improves synaptic plasticity in the brain. Costus speciosus : It belongs to family costaceae (zingiberaceae). It is also known as Keu, kusth. It is a succulent perennial herb growing up to 2.7 m. high. It is found through out the county in moist tropical forest. The rhizome contains tigogenin and diosgenin (2.6% diosgenin), α-amyrin, stearate, β-amyrin and lupeol palmitates from leaves have been isolated. Diosgenin and the mixture of five saponins obtained from the rhizome showed estrogenic effects in rats. The saponin mixture showed anti-inflammatory and anti-arthritic effects. The mixture of four alkaloids isolated from rhizome exhibited cardiotonic, diuretic and CNS depresent activities. The Costus speciosus root extract possess anti-hyperlipidemic, anti-hyperglycemic and anti-oxidative effects. Terminalia arjuna : It belongs to Combretaceae family & commonly known as Arjuna. It is a deciduous tree found through out India, growing to height of 60-90 feet. The active constituents of Terminalia arjuna include tannins, triterpenoid saponins: Arjunic acid, Arjunolic acid, oleanolic acid, Arjungenin, Arjunin, Flavonoids: Arjunolone, Arjunone, Leuteolin, Steroids: B-Sitosterol and inorganic compounds. In Ayurveda Terminalia arujna has been prescribed as cardio protective drug indicating its anti-atherosclerotic property. Several experimental and clinical evidence have proven the anti-atherosclerotic property of Terminalia arjuna . It is beneficial in the treatment of coronary artery disease, hypercholesterolemia dyslipidaemia including hypertriglyceridemia and anti-coagulant activity. Hippophae rhamnoides : This is high altitude plant belongs to family Elaeagnaceae. Fruits and leaves have shown medicinal property. Hippophae rhamnoides is a rich source of flavonoids, vitamins, proteins, amino acids, folic acid, phytosterol, alpha-tocopherol and phenolic compounds. It has shown anti-oxidant, immuno-modulatory, anti-inflammatory and homocysteine lowering effects and uplifts the mental function. Example-I In experimental animal studies when the hydro-methanolic extract of Terminalia arjuna in the dose of 100 mg/kg/day and Costus speciosus in the dose of 75 mg/kg/day was administered to high cholesterol diet induced hypercholesterolemic rats for one month a significant reduction in total cholesterol, LDL-c with a moderate increase in HDL-c level was noticed which indicates anti-atherosclerotic and hypolipidemic potential of test drug. A decrease in TNF-α, IL-6 and CRP indicated the anti-inflammatory activity of the drug. Example-II When the hydro-methanolic extract of Withania somnifera in the dose of 80 mg/kg/day and Hippophae rhamnoides in the dose of 75 mg/kg/day and Terminalia arjuna in the dose of 75 mg/kg/day was mixed and given to obese rats a significant decrease in blood glucose level and triglycerides were measured following 30 days treatment. Example-III In clinical studies when the hydro-methanolic extract of Terminalia arjuna in the dose of 350 mg/day and Costus speciosus in the dose of 250 mg/day given to human subjects showing evidence of dyslipidemia, a decrease in total cholesterol, LDL-c and triglycerides were noticed. HDL-c level increased moderately in those cases indicating the hypo-lipidemic and cardio-protective activity of test drug. Example-IV When the hydro-methanolic extract of Costus speciosus in the dose of 275 mg/day and Terminalia arjuna in the dose of 350 mg/day was orally given to cases showing triglycerides 200 mg/dl and above, a marked decrease in the level was noticed, hs CRP level also decreased to a significant level in this group of study. Example-V When the hydro-methanolic extract of Withania somnifera in the dose of 325 mg/day, Hippophae rhamnoides in the dose of 300 mg/day and Costus speciosus in the dose of 250 mg/day mixed and given to cases showing high blood pressure a decreased in both systolic and diastolic blood pressure indicated the anti-hypertensive and anti-atherogenic effects of the drug. Further, the leptin level also decreased following treatment, which also supported the regulation of blood pressure. Example-VI When the hydro-methanolic extract of Hippophae rhamnoides in the dose of 250 mg/day, Costus speciosus in the dose of 325 mg/day and Terminalia arjuna in the dose of 225 mg/day mixed and given to CHD cases showing high level of inflammatory cytokines IL-6 and TNF-α a decrease in the level suggested the anti-inflammatory activity of the drug. Further, retard in hs CRP and resistin also confirmed the improved endothelial inflammation in those subjects. Example-VII When the hydro-methanolic extract of Costus speciosus in the dose of 325 mg/day and Withania somnifera in the dose of 350 mg/day mixed and given to CHD cases showing, low adiponectin and high leptin an increase in adiponectin and decrease in leptin level indicated the anti-atherogenic activity of test formulation. Body mass index also reduced following treatment with test formulation. Example-VIII When the hydro-methanolic extract of Hippophae rhamnoides in the dose of 325 mg/day and Withania somnifera in the dose of 325 mg/day was mixed and orally administered to cases suffering from CHD and showing elevated level of homocysteine, decrease in the homocysteine level indicated the anti-atherosclerotic effects resulting in reduced risk of onset of CHD as well as precipitation of CHD complications. Example-IX When the hydro-methanolic extract of Withania somnifera in the dose of 375 mg/day and Hippophae rhamnoides in the dose of 275 mg/day mixed and given to cases suffering from CHD and showing high anxiety level with high muscle action potential, the test drug exerted significant reduction in anxiety and stress with improvement in sleep pattern in those patients. Example-X A better and promising results were obtained when the hydro-methanolic extract of Withania somnifera in the dose of 250 mg/day, Costus speciosus in the dose of 200 mg/day, Terminalia arjuna in the dose of 275 mg/day and Hippophae rhamnoides in the dose of 225 mg/day mixed and given to diagnosed CHD patients or subjects showing presence of CHD risk factors, modification in abnormal lipids including Lipoprotein(a) and Apolipo (B), reduction in triglycerides, reduction in inflammatory cytokines and adipokines and reduced homocysteine with improvement in endothelial dysfunction were noticed. As synergistic effects this combination exerted anti-stress, anti-anxiety and anti-oxidant activity. A general feeling of well being was reported by most of the cases. The non-clinical and clinical safety profile assessment indicated that the drug is safe and can be given for longer time without any adverse reaction. Experimental Evidence Anti-Obesity Role of Test Formulation Animal—female Wistar rats—6 in each group Weight—95-125 gm. Group-I: Normal control Group-II: Treated with Cafeteria diet Group-III: Treated with cafeteria diet+test formulation Cafeteria Diet: 1st day—condensed milk 40 gm.+bread 40 gm. 2nd Day—Chocolate 15 gm+biscuits 30 gm+dried coconut 30 gm. 3rd day—Cheese 40 gm+boiled potato 50 gm (Repeated successively up to 30 days and given to 6 rats of Group-II & III) Parameters: Body wt., blood glucose, TC & TG, Adiponectin. Test formulation was suspended in distilled water and administered orally in a dose of 300 mg./kg P.O. twice in a day at a constant volume of 0.5 ml/100 gm. wt. for 30 days TABLE 1 Effect of test formulation on body wt. following cafeteria diet in experimental rats Body weight (gm) Comp. Initial vs Groups Initial After 15 days After 30 days after 30 days Normal control (N = 6) 104.93 ± 3.88  110.82 ± 6.03 117.36 ± 4.91 P < 0.001 Cafeteria diet only 99.22 ± 4.37 128.92 ± 6.11  158.90 ± 12.13 P < 0.001 (N = 6) Cafeteria diet + test 112.38 ± 10.45 126.74 ± 7.90 137.08 ± 9.31 P < 0.001 formulation (N = 6) TABLE 2 Effect of test formulation on total cholesterol and triglycerides following cafeteria diet in experimental animals Comp. TC (mg/dl) inital vs Comp. initial After after 30 Triglyceride (mg/dl) vs after 30 Groups Initial 30 days days Initial After 30 days days Normal Control 84.78 ± 4.69 88.36 ± 5.11 P > 0.05 81.89 ± 8.63 83.01 ± 9.34 P > 0.05 (N = 6) Cafeteria diet 87.11 ± 6.94 91.35 ± 9.12 P < 0.05 79.74 ± 5.80 98.34 ± 4.93 P < 0.05 only (N = 6) Cafeteria diet + 83.98 ± 7.13 79.45 ± 5.90 P < 0.05 81.04 ± 5.82 77.83 ± 6.71 P < 0.05 test formulation (N = 6) TABLE 3 Effect of test formulation on blood glucose level and adiponectin following cafeteria diet in experimental animals Blood glucose level (mg/dl) Comp. initial After 30 vs after 30 Adiponectin (μg/ml) Comp. initial vs Groups Initial days days Initial After 30 days After 30 days Normal control 58.90 ± 7.02 55.70 ± 6.88 P > 0.05 12.87 ± 1.91 13.16 ± 2.08  P > 0.05 (N = 6) Cafeteria diet 54.93 ± 6.12 71.11 ± 5.90 P < 0.001 — 7.82 ± 1.03 P < 0.001 only (N = 6) Cafeteria diet + 57.91 ± 5.16 63.90 ± 4.23 P < 0.01 — 9.37 ± 1.52 P < 0.01 test formulation (N = 6) Anti-Atherogenic Effect of Test Formulation Role of Test formulation on TC among high cholesterol diet treated rats Total cholesterol level (mg/dl) Groups Initial after 15 day after 1 month Normal control 64.32 ± 7.89 63.80 ± 6.52 64.70 ± 8.42 (N = 10)* High cholesterol diet — 895.42 ± 49.75 480.82 ± 40.72 (N = 10)** High cholesterol diet + — 738.44 ± 90.85 378.50 ± 38.20 Test formulation (N = 10)*** High cholesterol diet + — 691.52 ± 78.85 280.50 ± 16.80 statin (2.5 mg/kg/day) (N = 10)**** Comparison * vs** P > 0.05 P < 0.001 P < 0.001 ** vs*** P < 0.001 P < 0.001 *** vs **** P < 0.001 P < 0.001 Effect of Test formulation on HDL-c level among high cholesterol diet treated rats HDL-c level (mg/dl) after 1 Groups Initial after 15 day month Normal control 22.50 ± 4.33 23.32 ± 2.85 22.37 ± 3.85 (N = 10)* High cholesterol diet — 17.82 ± 5.32 13.85 ± 1.85 (N = 10)** High cholesterol diet + — 19.60 ± 3.85 21.20 ± 3.85 Test formulation (N = 10)*** High cholesterol diet + — 20.32 ± 4.85 21.85 ± 3.85 Statin (2.5 mg/kg/day) (N = 10)**** Comparison * vs** P > 0.05 P < 0.05 P < 0.001 ** vs*** P > 0.05 P < 0.001 *** vs **** P > 0.05 P < 0.05 Effect of Test formulation on LDL-c level among high cholesterol diet treated rats LDL-c level (mg/dl) Groups Initial after 15 day after 1 month Normal control 23.85 ± 4.78 22.75 ± 5.72 24.22 ± 6.85 (N = 10)* High cholesterol diet — 341.50 ± 62.32 314.40 ± 48.34 (N = 10)** High cholesterol diet + — 274.50 ± 41.93 142.55 ± 32.08 Test formulation (N = 10)*** High cholesterol diet + — 255.80 ± 37.38 108.85 ± 16.85 Statin (2.5 mg/kg/day) (N = 10)**** Comparison * vs** P > 0.05 P < 0.001 P < 0.001 ** vs*** P < 0.05 P < 0.001 *** vs **** P > 0.05 P < 0.05 Effect of Test formulation on Triglycerides level among high cholesterol diet treated rats Triglycerides level (mg/dl) Groups Initial after 15 day after 1 month Normal control 26.85 ± 8.70 30.32 ± 7.85 28.40 ± 5.52 (N = 10)* High cholesterol diet — 340.70 ± 64.80 298.50 ± 39.32 (N = 10)** High cholesterol diet + — 260.55 ± 69.85 174.93 ± 21.78 Test formulation (N = 10)*** High cholesterol diet + — 228.50 ± 31.80 112.85 ± 19.30 Statin (2.5 mg/kg/day) (N = 10)**** Comparison * vs** P > 0.05 P < 0.001 P < 0.001 ** vs*** P < 0.05 P < 0.01 *** vs **** P > 0.05 P < 0.05 Clinical Evidence TABLE 1 Effect of test formulation on Total Cholesterol among CHD cases Total cholesterol (mg/dL) After 3 After 6 Comp. Initial vs Treatment No. of Months Months After 6 months Groups Cases Initial therapy therapy therapy Treated 47 285.71 ± 53.80 200.90 ± 40.35 214.73 ± 39.65 T = 7.28 with Statin P < 0.001 Treated 52 296.93 ± 64.71 255.98 ± 51.69 231.82 ± 38.44 T = 6.24 with Test P < 0.001 Formulation Normal range: <200 mg/dl Results of the effect of test formulation on Total Cholesterol among CHD cases are shown in FIG. 2 . TABLE 2 Effect of test formulation on LDL-c among CHD cases LDL-c(mg/dL) After 3 After 6 Comp. Initial vs Treatment No. of Months Months After 6 months Groups Cases Initial therapy therapy therapy Treated 47 141.72 ± 11.30 128.76 ± 10.54 104.93 ± 9.45  T = 17.19 with Statin P < 0.001 Treated 52 146.94 ± 9.73  132.65 ± 8.88  123.88 ± 7.165 T = 13.80 with Test P < 0.001 Formulation Normal range: ≦100 mg/dl Results of the Effect of test formulation on LDL-c among CHD cases are shown in FIG. 3 . TABLE 3 Effect of test formulation on HDL-c content among CHD cases HDL-c (mg/dl) After 3 After 6 Comp. Initial vs Treatment No. of Months Months After 6 months Groups Cases Initial therapy therapy therapy Treated 47 37.81 ± 3.19 40.34 ± 3.87 44.73 ± 2.84 T = 11.34 with Statin P < 0.001 Treated 52 36.14 ± 2.75 38.44 ± 3.01 40.98 ± 3.13 T = 8.49 with Test P < 0.001 Formulation Normal range: ≧45 mg/dl Results of the effect of test formulation on HDL-c content among CHD cases are shown in FIG. 4 . TABLE 4 Effect of test formulation on Triglycerides content among CHD cases 7 Triglycerides (mg/dl) After 3 After 6 Comp. Initial vs Treatment No. of Months Months After 6 months Groups Cases Initial therapy therapy therapy Treated 47 564.84 ± 88.64  435.65 ± 87.35 375.91 ± 93.75 T = 10.04 with Statin P < 0.001 Treated 52 498.73 ± 102.64 409.65 ± 99.65 361.82 ± 75.44 T = 7.75 with Test P < 0.001 Formulation Normal range: ≦150 mg/dl Results of the Effect of test formulation on Triglycerides content among CHD cases are shown in FIG. 5 . TABLE 5 Decrease in Apolipo (B) following Ayurveda test formulation in CHD cases Apolipo (B) (mg/dl) After 3 After 6 Comp. Initial vs Treatment No. of Months Months After 6 months Groups Cases Initial therapy therapy therapy Treated 47 184.73 ± 42.33 162.98 ± 38.56 143.75 ± 35.28 T = 5.10 with Statin P < 0.001 Treated 52 198.75 ± 38.43 182.54 ± 34.36 158.85 ± 31.16 T = 5.81 with Test P < 0.001 Formulation Normal range: 55-159 mg/dl Results of the effect of Decrease in Apolipo (B) following Ayurveda test formulation in CHD cases are shown in FIG. 6 . TABLE 6 Decrease in Lipoprotein (a) following Ayurveda test formulation among CHD cases Lipoprotein (a) (mg/dl) After 3 After 6 Comp. Initial vs Treatment No. of Months Months After 6 months Groups Cases Initial therapy therapy therapy Treated 47 22.87 ± 5.46 19.65 ± 4.63 17.35 ± 3.75 T = 5.75 with Statin P < 0.001 Treated 52 27.03 ± 6.91 25.32 ± 5.55 23.82 ± 4.13 T = 2.89 with Test P < 0.01 Formulation Normal range: 15-30 mg/dl Results of the Decrease in Lipoprotein (a) following Ayurveda test formulation among CHD cases are shown in FIG. 7 . TABLE 7 Effect of test formulation on Endothelin among CHD cases Endothelin (pg/ml) After 3 After 6 Comp. Initial vs Treatment No. of Months Months After 6 months Groups Cases Initial therapy therapy therapy Treated 47 1223.75 ± 209.00 1125.54 ± 176.27 1012.98 ± 163.84 T = 5.44 with Statin P < 0.001 Treated 52  1498.35 ± 196.285 1208.48 ± 201.22 1182.77 ± 158.87 T = 9.01 with Test P < 0.001 Formulation Normal range: 0.32-1000 pg/ml Results of the effect of test formulation on Endothelin among CHD cases are shown in FIG. 8 . TABLE 8 Decrease in Interleukin-6 inflammatory marker among CHD cases following test drug treatment. Interleukin-6 (pg/ml) After 3 After 6 Comp. Initial vs Treatment No. of Months Months After 6 months Groups Cases Initial therapy therapy therapy Treated 47 2.32 ± 0.48 1.86 ± 0.62 1.09 ± 0.59 T = 11.18 with Statin P < 0.001 Treated 52 2.09 ± 0.51 1.82 ± 0.60 1.42 ± 0.48 T = 7.44 with Test P < 0.001 Formulation Normal range: <1 pg/ml Results of the Decrease in Interleukin-6 inflammatory marker among CHD cases following test drug treatment are shown in FIG. 9 . TABLE 9 Reduction in TNF-α inflammatory marker following test drug treatment among CHD cases TNF-α (pg/ml) After 3 After 6 Comp. Initial vs Treatment No. of Months Months After 6 months Groups Cases Initial therapy therapy therapy Treated 47 632.11 ± 68.91 585.32 ± 80.32 439.78 ± 76.02 T = 12.85 with Statin P < 0.001 Treated 52 673.12 ± 78.61 634.35 ± 69.05 568.75 ± 51.02 T = 8.03 with Test P < 0.001 Formulation Normal range: 25-800 pg/ml Results of the Reduction in TNF-α inflammatory marker following test drug treatment among CHD cases are shown in FIG. 10 . TABLE 10 Decrease in plasma resistin level following Ayurvedic test formulation among CHD cases. Resistin (ng/ml) After 3 After 6 Comp. Initial vs Treatment No. of Months Months After 6 months Groups Cases Initial therapy therapy therapy Treated 33 12.98 ± 3.22 10.45 ± 2.73 10.01 ± 2.85 T = 4.00 with Statin P < 0.001 Treated 41 14.10 ± 4.21 11.62 ± 2.95  9.22 ± 3.59 T = 5.65 with Test P < 0.001 Formulation Normal range: 3-8 ng/ml Results of the decrease in plasma resistin level following Ayurvedic test formulation among CHD cases are shown in FIG. 11 . TABLE 11 Decrease in plasma Homocysteine level following Ayurvedic test formulation among CHD cases. Homocysteine (mmol/l) After 3 After 6 Comp. Initial vs Treatment No. of Months Months After 6 months Groups Cases Initial therapy therapy therapy Treated 47 29.72 ± 6.22 26.32 ± 5.10 22.62 ± 5.12 T = 6.06 with Statin P < 0.001 Treated 52 30.71 ± 7.91 26.62 ± 5.32 18.02 ± 6.92 T = 8.75 with Test P < 0.001 Formulation Normal range: 5-15 μmol/L Results of the Decrease in plasma Homocysteine level following Ayurvedic test formulation among CHD cases are shown in FIG. 12 . TABLE 12 Effect of test formulation on Brachial Artery thickening among CHD cases Brachial artery thickening (mm) After 3 After 6 Comp. Initial vs Treatment No. of Months Months After 6 months Groups Cases Initial therapy therapy therapy Treated 47 3.42 ± 0.08 3.26 ± 0.09 3.12 ± 0.06 T = 30.00 with Statin P < 0.001 Treated 52 3.81 ± 0.10 3.68 ± 0.11 3.24 ± 0.11 T = 28.50 with Test P < 0.001 Formulation Results of the effect of test formulation on Brachial Artery thickening among CHD cases are shown in FIG. 13 .

According to this invention there a novel herbal formulation for the prevention and management of coronary heart disease and associated CHD risk factors, comprising, preparing a hydromethanolic extract of at least two plants selected from of Withania somnifera, Costus speciosus, Hippophae rhamnoides and Terminalia arjuna at 60-80° C., maintaining the pH of the solution between 7-10, separating the active compounds chromatographically, subjecting the active compounds to the step of molecular characterization.

The present invention relates generally to medical and surgical devices and methods, and in particular, relates to electrodes which are designed to be inserted through the circulatory system and into a patient's heart for purposes of permitting an artificial electronic stimuli to pace the patient's heart. The term "pacemaker" generally applies to a device from a family of electronic products which is electrically connected through an electrode for providing electronic pacing impulses to a patient's heart. One type of pacemaker, referred to as a permanent pacemaker, is packaged in a small, portable container and is usually implanted under the patient's skin in a major surgical technique. Pacemaker implants are carried out in an operating room or similar facility equipped with a fluoroscope, which permits the attending physician to precisely position the extremity of the permanent pacemaker electrode in a desired location in the heart. Another type of pacemaker provides temporary pacing stimuli to the patient, and employs an electrode which is designed to be inserted by a physician in a rapid manner while the patient is in an emergency room, intensive care unit, catheter laboratory or similar facility. Generally, a fluoroscopic unit of some type is used during insertion of a temporary pacing electrode, but occasionally in emergency situations, "blind insertion" has been attempted, but with limited success. It is well known that the heart may be effectively "paced" by an electronic stimulus located within the right atrium. However, it is very difficult to locate the extremity of an electrode in an appropriate location which is stable in the right atrium, even with the benefit of fluoroscopy. Without the benefit of fluoroscopy (as during the blind insertion of a temporary pacing electrode under the emergency circumstances described above), it has been heretofore unknown to insert a temporary pacing electrode in the right atrium. Because of the inability to effectively locate an electrode within the atrium in a stable manner, most pacing electrodes (both temporary and permanent) are inserted in the right ventricle, which offers stable positioning. In my U.S. Pat. No. 4,166,469, issued Sept. 4, 1979, I disclose apparatus and a related method for the rapid and atraumatic insertion of pacemaker electrodes through the subclavian vein. SUMMARY OF THE INVENTION The present invention contemplates a method and related apparatus for rapidly accurately inserting pacing electrodes, particularly temporary pacing electrodes, into the right atrium. The invention is also based, in part, on the recognition that the insertion through the right subclavian vein of a curved, or "J" electrode into the right atrium will always engage the right atrium in a stable manner when the electrode is oriented and manipulated in a predetermined direction and manner. More particularly, the electrode of the present invention contemplates a pacing electrode including a flexible conductor having an outer, electrically insulating sheath about the conductor, the conductor and the sheath forming a flexible curve at one end with the conductor having an exposed terminal along the flexible curved end, the terminal adapted for making electrical endocardial contact. Means are further provided along the sheath for indicating the orientation of the curve after the curved end has been inserted into the heart. In a preferred embodiment of the electrode in accordance with the present invention, the orientation indicating means is dimensioned along the sheath at a position outside the patient's body when the curved end has been inserted through the circulatory system and into the heart. Suitably, the orientation indicating means comprises a wing extending laterally from the sheath, the lateral direction of the wing indicating the orientation of the curved end. One side of the wing is provided with means for indicating which side of the wing should be facing away from the patient. The desired orientation will be obtained in accordance with the present invention when the wing lies flat against the patient's skin, with the "up" indicating means properly positioned. In accordance with another aspect of the present invention, the electrode includes means for indicating the distance along the sheath from the curved end, permitting the attending physician to first insert the straightened curved end through the circulatory system, manipulating the straightened electrode into the right atrial cavity and permitting the curved end to reform with its extremity pointed toward the right atrial appendage, and thereafter engaging the extremity of the curved end against the right atrial wall in a stable manner by withdrawing the electrode from the circulatory system a distance as determined by reference to the distance indicating means along the sheath. The distance indicating means may be a series of gradations along the outer periphery of the sheath. DESCRIPTION OF THE DRAWINGS FIG. 1(a) is a front view of the human anatomy, particularly illustrating the human heart with a portion cut away to show the inside of the right atrium and a portion of the right ventricle. FIG. 1(b) is a side view illustrating a portion of the human anatomy, and specifically illustrating the curvature of the subclavian vein as it enters and connects with the superior vena cava. FIG. 2(a) is a front view, partially cut away, illustrating an electrode in accordance with the present invention. FIG. 2(b) is a front sectional view of the electrode of FIG. 2(a), along the line 2(b)--2(b). FIG. 2(c) is an enlarged illustration of the end section of the view of FIG. 2(b). FIG. 3 is a front view of the human heart, the subclavian and cephalic veins and their connection to the superior vena cava, with portions of the superior vena cava and the heart cut away to illustrate the manner in which the electrode of the present invention is utilized. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT A preferred embodiment of the present invention will now be described with reference to the drawings. While one particular structural arrangement of the electrode in accordance with the present invention is shown in the drawing and described with reference thereto, it will be understood by those skilled in the art from the detailed description set forth below that various modifications may be made in the design of that electrode without departing from the spirit and scope of the present invention. With particular reference to FIGS. 1(a) and (b), there is illustrated a human body 10, the right subclavian vein 12, the cephalic vein 14 and the superior vena cava 16. The drawing of FIG. 1 is fanciful in nature, it being understood that the drawing is not to scale, but serves only to illustrate the functional relationships of the heart and associated circulatory system. Element 18 refers to the heart, which includes the right atrium 20, the right ventricle 24, and the inferior vena cava 22. The wall between the right atrium 20 and the right ventricle 24 is cut away in the area where the tricuspid valve would normally be located for purposes of permitting illustration of the right ventricle. As is known, blood from the arms, head, and body flow into the right atrium 20 via the superior vena cava 16 from, among others, the subclavian and cephalic veins 12 and 14. Blood from the trunk and legs enters the right atrium 20 via the inferior vena cava 22. As is also known, there is a portion of the right atrium known as the right atrial appendage, identified as element 26 in FIG. 1a. The right atrial appendage 26 is a small ear-like appendage forming a pocket located anteriorly and superiorly on the right atrial wall, the inner surface of which is particularly susceptible to pacing. Noting FIG. 1(b), it is seen that the curvature of the subclavian vein to the connection with the superior vana cava 16 is not flat, as it appears in FIG. 1(a), but rather is curved toward the rear of the patient's body, i.e. in the direction toward the spinal column, coming from the forward surface of the body 10. Reference is now made to FIGS. 2(a), (b) and (c), which disclose a temporary pacemaker electrode in accordance with the present invention. The electrode, referred to generally by the reference numeral 30, includes a flexible, electrically insulated sheath 32 with a pair of concentric conductors 34, 36 surrounding a central lumen 38 which may, though not necessarily, extend through the electrode 30 to the distal end 39. Each of the conductors 34, 36 are insulated by a layer of insulating material (not numbered--see FIG. 2(c)). Each of the conductors 34, 36 are exposed at the surface of the outer insulating sheath 32, in order to permit electrical contact in the heart when the electrode 30 is in place. By way of example, conductor 34 may have a surface terminal 42 and inner concentric conductor 36 may have a surface terminal 48 at the distal extremity 39. Typically, the outer conductor 34 will serve to shield the inner conductor 36, and the inner conductor will therefore be relied upon to provide pacing signals at the distal extremity 39 of the electrode 30. In accordance with a preferred embodiment of the present invention, the terminal 48 consists of a spherical conductor connected electrically with the inner conductor 36. Referring again to FIG. 2(a), the proximal extremity of the electrode 30 includes a hub 52 having an opening 54 which communicates with the central lumen 38. Each of the concentric conductors 34, 36 include external portions which likewise exit the electrode 30 at the proximal end 50, typically in the manner shown in FIG. 2(a). As is well known, the proximal extremities of each conductor 34, 36 may be connected to a temporary pacemaker (not shown). As is shown on the right-hand side of FIG. 2(a), the electrode 30 is provided with a somewhat gentle curve 44 between the terminal 42 and the distal extremity 39 which permits the conductor terminal 48 at the distal extremity 39 to be pointed in a direction approximately 180° + from the direction of the electrode 30, and in a plane substantially parallel with the plane of the electrode; that is to say, when the main body of the electrode 30 is lying on a flat surface, the curved portion 44 and the distal extremity 39 are likewise lying in the plane of the same flat surface. The insulative sheath 32, including the insulative materials between the conductive electrodes 34, 36 are of a material which has an elastic memory so that when the curved portion of the distal extremity 39 of the electrode 30 is straightened in the manner hereinafter described, the curved portion at the distal extremity 39 will thereafter resume its curved configuration. A number of conventional silastic and other non-toxic plastic materials are suitable for this purpose. Straightening of the curve 44 of the electrode 30 may be accomplished by simple manipulation with the hands, or with a stylet having an outer diameter sufficiently small to permit it to pass through the opening 54, down the central lumen 38 to straighten the curved end and hold the entire electrode, including the distal extremity straight. The stylet must be sufficiently flexible to permit the electrode to pass through the subclavian vein 12, the superior vena cava 16 and into the right atrium 20. In accordance with the present invention, the electrode 30 is provided with means for indicating the relative position of the curved distal extremity 39 with respect to the axial direction of the electrode 30 and the plane in which the electrode and the curved extremity lies. In the embodiment shown in FIG. 2(a), the indicating means in this regard comprises a pair of flat, relatively flexible plastic wings 59, 60 which extend laterally from the outer insulated sheath 32, joined by a sleeve 61. As is shown in FIG. 2(a), the indicating wings 59 and 60 extend generally perpendicular to the plane of the curve 44, the distal extremity 39 and the main body of the electrode 30. As shown in FIG. 2(a) and (b), the wings 59, 60 are curved slightly downward and include the notation "UP" on the upper side intended to be away from the patient's body, as described further below. The electrode 30 further includes means for indicating the distance along the insulating sheath 32 from the curve in the distal extremity 39. In the embodiment of FIG. 2(a), this distance indicating means comprises a series of gradations along the insulating sheath 32 forward of the indicating wings 59, 60 in the direction of the curve of the extremity 39. Typically, the gradations may include wide gradations 62 and thin gradations 64, each wide gradation indicating a 10 cm. segment and each thin gradation indicating a 5 cm. segment; thus, an individual marking of two wide gradations and one thin gradation would indicate a 25 cm. distance from the curved end. The manner in which the electrode of the present invention is employed for insertion through the right subclavian vein and into the right atrium without the use of fluoroscopy will now be described with reference to FIG. 3. Before beginning the technique of inserting the electrode 30 in the manner hereinafter described, the patient is properly prepared and normal sterilization techniques are observed. Initially, a puncture is made through the patient's skin in the area adjacent the clavicle so as to pass a small, thin-walled 18 gauge needle into the right subclavian vein 12, to thereafter permit the introduction of a removable introducer in the manner which is clearly described in my U.S. Pat. No. 4,166,469. Because the technique for inserting a removable introducer sleeve into the right subclavian vein is clearly described in the specification of that patent, it is incorporated here by reference. Once that sleeve is properly inserted, the curve 44 of the electrode 30 is straightened. The electrode 30 is then inserted down a removable introducer sleeve (not shown in FIG. 3, but see sleeve 56 in FIG. 11 of my aforementioned U.S. Pat. No. 4,166,469). Once the straightened distal extremity 39 of the electrode is inserted down the introducer sleeve into the subclavian vein 12, it is then manipulated through the superior vena cava 16 and into the right atrium 20. The removable introducer sleeve is then removed by peeling it away, allowing the wings 59, 60 to be positioned close to the entrance site into the subclavian vein 12. At this point in the technique, the electrode 30 has been inserted as desired so that the straightened distal extremity 39 is positioned in the right atrium 20. It will be understood that the insertion technique thus far described leaves the indicating wings 59 and 60 exteriorly of the patient's skin. As a next step, the attending physician ensures that the indicating wings 59 and 60 are lying substantially parallel to the plane of the patient's skin, and with the words "UP" facing the physician. If a stylet is being used, the stylet is removed. In either event, the curve 44 resumes its normal, curved configuration, as is shown by dotted lines on the right side of FIG. 3. If the physician has inserted the electrode a sufficient distance into the subclavian vein 12 (and down the superior vena cava 16 and into the right atrium 20), as is determined by reference to the indicating marks 62, 64 along the outer sheath 32, and if the indicating wings 59 and 60 are positioned in the manner described above, then the curved distal extremity 39 will assume a direction in which the terminal electrode 48 is pointed directly upward toward the right atrial appendage 26. This is because of the unique relationship of the curvature from the right subclavian vein 12, running down the superior vena cava 16 and into the right atrium 20, as is clearly shown in FIG. 1(b). As was noted previously, the subclavian vein 12 actually curves slightly backward toward the spinal column as it communicates with the superior vena cava 16, the superior vena cava communicating with the right atrium 20 at the rear of the heart 18. Thus, the indicating wings 59 and 60 and the curvature of the curve 44 are oriented such that when the indicating wings 59 and 60 are positioned substantially parallel to the patient's skin and with the "UP" side facing the physician, then the curve 44 at the distal extremity 39 is formed so that the conductive terminal 48 is pointed in the desired manner in the pocket under the right atrial appendage 26. Next, the attending physician then pulls the electrode 30 slightly outward away from the puncture wound in the skin and away from the subclavian vein 12, as is shown by the arrows 68 in FIG. 3. The electrode 30 may be withdrawn in this manner a distance of between 1 to 7 centimeters, as determined by reference to the gradations 62, 64 so as to ensure that the conductive terminal 48 engages the surface underneath the right atrial appendage 26. Because of the spherical configuration of the terminal 48, that terminal makes a broad electrical contact with the wall of the right atrium 20 in the pocket of the appendage 26, but without damage to the wall. The terminal 48 stays in the desired location because of the tension at the curve 44, despite continual movement of the atrial wall. It will be appreciated that the manipulative steps described above can take place without the benefit of fluoroscopy, thus permitting a temporary electrode to be placed easily and quickly into the right atrium 20 for purposes of obtaining the benefits of physiological atrial pacing under emergency or temporary conditions.

A pacing electrode for rapid endocardial insertion for pacing from the right atrium of a patient and for interconnection with a pacemaker includes a flexible conductor having an outer, electrically insulating sheath about the conductor with a flexible curve at one end of the conductor and an exposed terminal along the flexible curved end. The terminal is adapted for making electrical contact with an inner heart surface, preferably within the right atrium. The curved end of the electrode is straightened during insertion through the circulatory system, and thereafter permitted to resume its curved configuration after entering the heart. A wing extends laterally from the sheath at a position outside the patient's body after the curved end has been inserted into the heart. An established relationship between the lateral direction of the wing and the curved end allows the physician to control the orientation of the curved end after insertion to permit the positioning of the electrode in a stable manner within the right atrium, whereby physiological atrial pacing may be achieved.

RELATED APPLICATIONS [0001] The present application claims priority to U.S. Provisional Patent Application No. 61/864,958 filed Aug. 12, 2013, and entitled “WASHABLE ANALYTE METERS, SEALED CONNECTORS, AND METHODS OF MANUFACTURING AND USING SAME” (Attorney Docket No. BHC124017US) which is hereby incorporated herein by reference in its entirety for all purposes. FIELD [0002] The invention relates to analyte meters that may be used to detect an analyte concentration level in a bio-fluid sample, analyte sensor electrical connectors, and methods of using and manufacturing thereof. BACKGROUND [0003] The monitoring of analyte concentration levels in a bio-fluid may be an important part of health diagnostics. For example, an electrochemical analyte sensor may be employed with an analyte meter for monitoring a patient's blood glucose level as part of diabetes treatment and care. Other types of analytes may be measured as well. An electrochemical analyte sensor may be employed, for instance, for detecting an analyte concentration level in a bio-fluid sample, such as from a single sample of blood or other interstitial fluid. The bio-fluid may be obtained from the patient using a lancet (e.g., by a pinprick or needle). Typically, after a bio-fluid sample has been obtained, the sample may then be transferred to an analyte sensor (e.g., typically an analyte sensor strip) for measurement of the bio-fluid sample's analyte concentration level (e.g., a glucose analyte level). [0004] As part of the process, electrodes formed on the analyte sensor are placed in electrical contact with an electrical connector of the analyte meter. Typically, the analyte sensor (e.g., sensor strip) is inserted into a sensor port of the sensor connector. However, portions of the sensor connector housing may be partially open to the inside of the analyte meter and the electrical connection takes place within the interior of the analyte meter. Once the connection is established, the bio-fluid is applied to a receiving end of the sensor strip and the analyte measurement is carried out. During this process, bio-fluids such as blood may contaminate portions of the outside of the meter, such as near the port. Further, the port and the internal electrical connections may become contaminated. [0005] Accordingly, there is a need to provide an analyte meter configured for bio-fluid analyte testing that may overcome certain issues due to contamination. SUMMARY [0006] In a first aspect, an analyte meter is provided. The analyte meter includes an analyte sensor electrical connector having a sensor port configured to receive an analyte sensor in a port entryway, and at least one wash port coupled to the sensor port and separate from the port entryway, the at least one wash port configured to receive a cleaning fluid. [0007] In another aspect, another analyte meter is provided. The analyte meter includes a meter housing having a first part and a second part interfacing with each other to form an internal chamber, an electronic circuit within the internal chamber, and an analyte sensor electrical connector including a sealed electrical connection through the first part or the second part into the internal chamber, a sensor port configured to receive an analyte sensor in a port entryway, and at least one wash port coupled to the sensor port and separate from the port entryway, the at least one wash port configured to receive a cleaning fluid. [0008] In a method aspect, a method of cleaning an analyte meter is provided. The method includes providing an analyte meter having a sensor port configured to receive an analyte sensor, the sensor port having a port entryway and a wash port, and flowing a cleaning fluid through the wash port to clean the sensor port. [0009] In another method aspect, a method of manufacturing an analyte meter is provided. The method includes providing an analyte meter housing having an internal chamber, providing an analyte sensor electrical connector having at least two electrodes, providing an analyte meter battery connector, forming a sealed connection between the analyte sensor electrical connector and the internal chamber, and forming a sealed connection between the analyte meter battery connector and the internal chamber. [0010] In another aspect, another analyte meter is provided. The analyte meter includes a meter housing having a first part and a second part interfacing with and sealed to one another to form an internal chamber, an electronic circuit within the internal chamber, a sensor port configured to receive an analyte sensor in a port entryway, an analyte sensor electrical connector in the sensor port including a sealed electrical connection through the first part or the second part into the internal chamber, a screen display sealed to one of the first part and a second part, a keypad sealed to one of the first part and a second part, and a removable battery pack including a sealed electrical connection through the first part or the second part into the internal chamber. [0011] In another aspect, another analyte meter is provided. The analyte meter includes a display screen, a keypad, an analyte sensor port, and battery pack interfacing with an electronic circuit located in an internal chamber of a meter housing wherein the internal chamber is entirely sealed and liquid impermeable such that the analyte meter is washable and immersable. [0012] Still other aspects, features, and advantages of the invention may be readily apparent from the following detailed description wherein a number of example embodiments and implementations are described and illustrated, including the best mode contemplated for carrying out the invention. The invention may also be capable of other and different embodiments, and its several details may be modified in various respects, all without departing from the scope of the invention. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. The invention covers all modifications, equivalents, and alternatives falling within the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0013] The drawings, described below, are for illustrative purposes only and are not necessarily drawn to scale. The drawings are not intended to limit the scope of the invention in any way. [0014] FIG. 1A illustrates a top plan view of a washable analyte meter including a washable sensor connector according to embodiments. [0015] FIG. 1B illustrates a partial cross-sectioned side view of the analyte meter of FIG. 1A taken along section line “ 1 B- 1 B.” [0016] FIG. 1C illustrates a partial perspective view of the washable analyte meter including the washable sensor connector according to embodiments. [0017] FIG. 1D illustrates a front view of the washable sensor connector of FIG. 1C , shown in isolation. [0018] FIGS. 1E-1H illustrates various perspective views of certain components of the washable analyte meter including the washable sensor connector according to embodiments. [0019] FIG. 2 illustrates a flowchart of a method of using an analyte meter according to embodiments. [0020] FIG. 3 illustrates a flowchart of a method of manufacturing an analyte meter according to embodiments. [0021] FIGS. 4 and 5 illustrate perspective views of a washable analyte meter including a replaceable battery cartridge according to embodiments. [0022] FIGS. 6 and 7 illustrate perspective views of battery cartridge housings according to embodiments. [0023] FIGS. 8 and 9 illustrate cross-sectional and top plan views, respectively, of a replaceable battery cartridge according to embodiments. [0024] FIGS. 10 and 11 illustrate cross-sectional and top plan views, respectively, of another replaceable battery cartridge according to embodiments. [0025] FIG. 12 illustrates a perspective view of a battery cartridge connector and printed circuit board according to embodiments. [0026] FIG. 13 illustrates a perspective view of a battery cartridge housing according to embodiments. [0027] FIGS. 14 and 15 illustrate cross-sectional views of an assembly of a replaceable battery cartridge into the battery cartridge housing of FIG. 13 according to embodiments. [0028] FIGS. 16 and 17 illustrate cross-sectional views of an assembly of another replaceable battery cartridge into the battery cartridge housing of FIG. 13 according to embodiments. [0029] FIGS. 18-21 illustrate schematic circuit diagrams illustrating the electrical connections between a replaceable battery cartridge and an analyte meter according to embodiments. DESCRIPTION [0030] Reference will now be made in detail to the example embodiments of this disclosure, which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. [0031] Certain regulatory requirements regarding cleaning and disinfection efficacy in a clinical setting are becoming more stringent. Moreover, in cases of high levels of contamination, the analyte measurement itself taken by an analyte meter may be adversely affected because the electrical connection between the analyte (e.g., an analyte sensor strip) and one or more electrodes of the electrical connector may be contaminated or adversely affected in some way. [0032] In view of this concern, embodiments of the invention may provide an entirely hermetically sealed analyte meter that may be washable and, in some embodiments, may even be immersed in a liquid without damage. Accordingly, the sealed analyte meter may be washed in a washing fluid, such as a disinfecting liquid, or the like. In one or more embodiments, the one or more electrical connections of the analyte meter may be sealed. Some may be washable, such as, e.g., the analyte sensor port. Other electrical connections may be sealed and/or washable and/or removable such as a communication connector (e.g., a universal serial bus (USB) port) and/or a battery connection. In some embodiments, the analyte meter itself is entirely washable and all connections thereof may be sealed and washable, including the sensor port, enabling electrical connection with an analyte sensor. [0033] The analyte meter, in accordance with one or more embodiments, may be used to measure any number of analytes, such as glucose, fructose, lactate, keytone, microalbumin, bilirubin, total cholesterol, uric acid, lipids, triglyceride, high density lipoprotein (HDL), low density lipoprotein (LDL), hemoglobin Alc, and the like. These analytes may be detected in, for example, whole blood, blood serum, blood plasma, interstitial fluid, urine, etc. Other types of analytes may be measured provided a suitable reagent exists. [0034] These and other embodiments of washable analyte meters, washable analyte sensor electrical connectors, and methods of using and manufacturing and using the analyte meter are described below with reference to FIGS. 1A-21 . [0035] FIGS. 1A-1D illustrates various views of a first example of an analyte meter 100 that is washable according to one or more embodiments. The analyte meter 100 may include a meter housing 102 that may be made of two parts, such as first part 104 and second part 106 that engage each other to form an internal chamber 108 ( FIG. 1B ). The internal chamber 108 may be configured to contain various internal components of the analyte meter 100 , such as a printed circuit board 110 (shown dotted in FIG. 1A ), which may contain all or part of an internal electronic circuit. Internal chamber 108 may be entirely sealed and liquid impermeable such that the analyte meter 100 is washable and immersable. The first part 104 and second part 106 may be sealed to each other at their contact surfaces in order to form the internal chamber 108 as a sealed chamber that is sealed from the outside environment. Internal chamber 108 may be hermetically sealed. The first part 104 and second part 106 of the meter housing 102 may be formed of an insulating material such as plastic injection-molded pieces, for example. Sealing may be provided by ultrasonic welding of the first part 104 and second part 106 , or by providing a sealant (e.g., a curable sealant), o-ring, gasket, or the like between the first part 104 and the second part 106 . Other suitable sealing methods may be used. Connection of the first part 104 to the second part 106 may be made by screws, rivets, snap fit connectors molded on the first part 104 and second part 106 , or the like when using a sealant, o-ring, gasket, or the like. [0036] The printed circuit board 110 may reside within the confines of the internal chamber 108 . The printed circuit board 110 may include conventional electronic components such as a power supply, processor, memory, and the like that are conventional for carrying out analyte measurements and display thereof. The printed circuit board 110 may be retained in a defined position within the internal chamber 108 by projections and/or recesses formed in one or both of the first part 104 and second part 106 . Other suitable positioning features may be used. [0037] The meter housing 102 may have a first end 112 and a second end 113 opposite the first end 112 . The first end 112 may include an analyte sensor electrical connector 115 that is fully washable having a sensor port 116 configured to receive an analyte sensor 105 in a port entryway 119 thereof. The analyte sensor electrical connector 115 may also have a one or a plurality of wash ports 118 coupled to sensor port 116 that are separate from port entryway 119 . Wash ports 118 may be configured to receive a cleaning fluid there through. The analyte sensor electrical connector 115 may include a connector body 117 that may be received in a recessed pocket 114 of the first part 104 and/or the second part 106 . In some embodiments, the connector body 117 of the analyte sensor electrical connector 115 may include a first wall receiving two or more electrodes 121 , and a second wall opposite the first wall and including one or more wash ports 118 . Two or more electrical connectors 122 may be coupled to two or more electrodes 121 at the first wall. In some embodiments, the two or more electrical connectors 122 may be electrical connector pins. A sealing layer 123 may be provided in some embodiments between a surface of the analyte sensor electrical connector 115 and the first part 104 and/or second part 106 , such as in the recessed pocket 114 . [0038] In some embodiments, the wash ports 118 may cooperate with the port entryway 119 to form a fluid flow channel enabling flushing of the sensor port 116 . The wash ports 118 may be formed through a first wall of the analyte sensor electrical connector 115 . As shown best in FIG. 1C , the wash ports 118 may be configured as elongated slots. The wash ports 118 may be one or more in number. [0039] The analyte meter 100 may further include a display screen 120 that may be sealed to the first part 104 and/or second part 106 such that fluids are prevented from entering the internal chamber 108 from between the display screen 120 and the first part 104 and/or second part 106 . Similar sealing methods as described above may be used. For example, a sealing material layer 124 may be provided around the periphery of the display screen 120 . [0040] The analyte meter 100 may still further include a keypad 125 that may be sealed to the first part 104 and/or second part 106 such that fluids are prevented from entering the internal chamber 108 from between the keypad 125 and the first part 104 and/or second part 106 . The seal between the keypad 125 and the first part 104 and/or second part 106 may be provided by employing a thin layer 126 covering over the keys of the keypad 125 . The thin layer 126 may be sealed to the first part 104 and/or second part 106 and may be adhered thereto. The thin layer may be a plastic sheet in some embodiments and may include indicia printed or otherwise marked thereon. Other means for sealing the keypad 125 or individual keys may be used. [0041] In some embodiments, the analyte meter 100 may include a battery connector 127 that is sealed to the first part 104 and/or second part 106 such that fluids are prevented from entering the internal chamber 108 from between the battery connector 127 and the first part 104 and/or second part 106 . The battery connector 127 allows the use of a removable battery pack 128 , as will be described herein. [0042] The analyte meter 100 may also include a universal serial bus (USB) port sealed to the first part 104 and/or second part 106 on a side, for example, such that fluids are prevented from entering the internal chamber 108 from between the USB port and the first part 104 and/or second part 106 . Sealed connection for the universal serial bus (USB) port may be the same as for the battery connector 127 . A connection seal 127 S, such as an elastomer seal, may be provided on the connector or on the first part 104 and/or second part 106 to seal the connection interface. [0043] As further shown in FIGS. 1E-1H and as otherwise described herein, the analyte meter 100 may eliminate any opening allowing liquid ingress into to the internal chamber 108 , and may be configured to drain and dry the analyte sensor electrical connector 115 upon washing or cleaning thereof with a cleaning fluid or other liquid. In some embodiments, the analyte sensor electrical connector 115 may be seated within the recessed pocket 114 in the first part 104 of the analyte meter 100 . In some embodiments, the electrical connectors may project through one or more apertures in the first part 104 and may be configured to be connected to (e.g., plugged into or otherwise contact) conducting receptacle features on the printed circuit board 110 . Other suitable electrical connectors may be used such as bendable leaf spring contacts that contact conducting pads on the printed circuit board 110 . In some embodiments, the electrical connectors may be insert-molded in the analyte sensor electrical connector 115 forming a seal between plastic (e.g., the first part 104 ) and metal. In some embodiments, a sealing layer 123 such as a gasket-type sealing arrangement or other sealing arrangement (sealing compound) may be used between the analyte sensor electrical connector 115 and the surface(s) of the first part 104 and/or second part 106 . In some embodiments, the surfaces within the analyte sensor electrical connector 115 may be sloped and/or ventilated as needed to facilitate fluid egress after washing. [0044] FIG. 2 is a flowchart illustrating a method 200 of cleaning an analyte meter in accordance with one or more embodiments. At process block 202 , method 200 may include providing an analyte meter (e.g., analyte meter 100 ) having a sensor port (e.g., sensor port 116 ) configured to receive an analyte sensor (e.g., analyte sensor 105 ), the sensor port having a port entryway (e.g., port entryway 119 ) and a wash port (e.g., wash port 118 ). At process block 204 , method 200 may include flowing a cleaning fluid through the wash port to clean the sensor port. The method 200 of cleaning may be accomplished without adversely affecting the analyte meter. [0045] FIG. 3 is a flowchart illustrating a method 300 of manufacturing an analyte meter in accordance with one or more embodiments. At process block 302 , method 300 may include providing an meter housing (e.g., meter housing 102 ) having an internal chamber (e.g., internal chamber 108 ). At process block 304 , method 300 may include providing an analyte sensor electrical connector (e.g., analyte sensor electrical connector 115 ). The analyte sensor electrical connector may include at least two electrodes (e.g., electrodes 121 ). Analyte sensor electrical connector 115 may be attachable to the meter housing 102 . At process block 306 , method 300 may include providing an analyte meter battery connector (e.g., battery connector 127 ). At process block 308 , method 300 may include forming a sealed connection between the analyte sensor electrical connector and the internal chamber. And at process block 310 , method 300 may include forming a sealed connection between the analyte meter battery connector and the internal chamber. Any suitable means for accomplishing the sealed connection may be used. [0046] The above process blocks of method 300 may be executed or performed in an order or sequence not limited to the order and sequence shown and described. For example, in some embodiments, process block 304 may be performed after or in parallel with process block 306 . Similarly, process block 308 may be performed after or in parallel with process block 310 . [0047] FIGS. 4-6 illustrate an embodiment of a removable or replaceable battery cartridge 428 of an analyte meter 400 that includes a sealed battery connector 429 that may protect against liquid ingress into the internal chamber 108 . The sealed battery connector 429 may be provided via the use of a sealed or potted interface in accordance with one or more embodiments. In some embodiments, the replaceable battery cartridge 428 may be configured to attach to an meter housing 402 via slideable insertion. [0048] As shown in FIGS. 5 and 6 , some embodiments may include retention features, such as a pair of T-shaped retention rails 430 on opposite sides of a surface of an meter housing 402 ( FIG. 5 ) and a corresponding pair of retention slots 432 in the battery cartridge housing 428 H configured to receive the T-shaped rails. [0049] FIGS. 7-11 illustrate a battery cartridge housing 728 H ( FIG. 7 ) configured to receive battery cartridge inserts of different battery chemistries in accordance with one or more embodiments. FIGS. 8 and 9 illustrate a battery insert assembly 832 including coin cell batteries and FIGS. 10 and 11 illustrate a battery insert assembly 1032 including a prismatic battery cell, each configured to be inserted in battery cartridge housing 728 H. [0050] FIG. 12 illustrates a printed circuit board (PCB) 1200 that may be affixed to the inserts at locations 825 and 1025 (of FIGS. 8 and 10 , respectively) in accordance with one or more embodiments. In some embodiments, potting compound may be used to encapsulate the electronics creating a fluid-tight seal (e.g., a water-tight seal). A gasket or potting compound may additionally be used in some embodiments to seal the prismatic battery. Battery electrical connector 1227 extending from the printed circuit board (PCB) 1200 may couple to and provide a sealed connection (e.g., with connection seal 127 S) with the meter housing of the analyte meter, for example. Optionally, sealed electrical connectors may be the same as for the analyte sensor electrical connector 115 . Thus, power may be readily provided to the analyte meter and the internal chamber 108 may remain entirely hermetically sealed. [0051] As shown in FIGS. 13-17 , battery insert assemblies 832 , 1032 may be slid into the battery cartridge housing 728 H first at an angle such that the interface battery connector slides through an access hole 1335 (see FIG. 13 ) and then the battery insert assemblies 832 , 1032 may be snapped down into the battery cartridge housing 728 H. In addition, in some embodiments, the battery insert assembly 832 , 1032 may be secured in the battery cartridge housing 728 H with potting or an adhesive. In the case of the battery insert assembly 1032 this may also protect the prismatic battery and the battery compartment against liquid ingress. [0052] Embodiments of the battery cartridge housing 728 H may allow multiple battery chemistries to be used while maintaining an identical mechanical envelope for an analyte meter (or other suitable battery-powered device). In some embodiments, the electronics in the battery cartridge may be protected against liquid ingress such that the IP22 standard is met. The IP22 standard is part of the Ingress (or International) Protection Rating code published by the International Electrotechnical Commission (IEC). Embodiments of the replaceable battery cartridge may also allow an analyte meter (or other suitable battery-powered device) to meet the IP22 standard for liquid ingress. Embodiments of the replaceable battery cartridges may be user replaceable, thus reducing the cost of replacing a replaceable battery cartridge when the battery/batteries expire(s). In some embodiments, the coin cell batteries of the battery insert assembly 832 of the replaceable battery cartridge may be user replaceable. [0053] FIGS. 18-21 illustrate the electrical interface between a replaceable battery cartridge and an analyte meter (or other suitable battery-powered device). FIGS. 18 and 19 illustrate less complex circuit topologies of electrical interfaces wherein power management circuitry common to all battery chemistries may be contained in an analyte meter (or other suitable battery-powered device), while the power management circuitry unique to a battery chemistry may be contained in the battery cartridge. FIGS. 20 and 21 illustrate full cartridge electrical interface topologies wherein all power management circuitry may be contained in the battery cartridge. [0054] Accordingly, battery cartridges of different battery chemistries may be mechanically and electrically interchangeable, allowing an analyte meter (or other suitable battery-powered device) to be powered from different battery chemistries. [0055] The foregoing description discloses only example embodiments of analyte meters, sensor connectors, battery cartridges, and methods of manufacturing and using the analyte meters. Modifications of the above-disclosed analyte meters, sensor connectors, and methods, which fall within the scope of the invention, will be readily apparent to those of ordinary skill in the art. Accordingly, while the invention has been disclosed in connection with example embodiments thereof, it should be understood that other embodiments may fall within the scope of the invention, as defined by the following claims.

An analyte meter to detect an analyte concentration level in a bio-fluid sample may be cleaned and disinfected with a cleaning liquid without harming electrical and internal meter components. In some embodiments, the analyte meter is washable and immersable and may include a sealed sensor connector, sealed battery connector, and possibly a sealed USB connector that may be subjected to a cleaning liquid without the liquid entering an internal chamber of the analyte meter and contacting internal electronic components. In some embodiments, a sealed display screen and sealed keypad are provided such that liquids are prevented from entering the internal chamber. Manufacturing methods and systems utilizing the analyte sensors are provided, as are numerous other aspects.

FIELD OF THE INVENTION [0001] The present invention relates to exercise and/or recreational devices; and more particularly to an assembly for dressing a trampoline which provides decorative and safety features. BACKGROUND OF THE INVENTION [0002] Trampolines are well known devices used for both recreational use and for fitness reasons. Such devices are increasingly popular as they provide efficient exercise, increase cardiovascular fitness, provide for low impact exercising, and are believed to provide detoxification resulting from the stimulation of free flowing lymphatic drainage. Because using a trampoline does not necessarily require complex movement, individuals of all ages can obtain the many benefits of jumping up and down on the device. In addition, because the use of a trampoline is thought to be fun, use may have a positive impact on an individual's mental health. While these devices have many benefits, care must be undertaken when using to avoid injury. [0003] As trampolines became popular, finding their way into backyards and home basements, the number of injuries associated with trampoline use increased. Recent developments in the design of trampolines have helped lower the number of associated injuries. One such improvement is the use of trampoline mats which are designed to cover portions of the trampoline frame and springs. These pads are typically a gymnasium style floor mat adapted to fit the trampoline. In addition, many current trampolines include trampoline enclosures, typically some type of netting surrounding the trampoline perimeter and preventing the user from unwanted “jumping off” of the rebounding surface. [0004] The present invention improves upon traditional trampolines utilizing standard safety features by providing a decorative and safety assembly for dressing a trampoline which is easy to apply to and/or remove from the trampoline frame and can be used to enhance a user's experience. SUMMARY OF THE INVENTION [0005] A unique decorative and safety assembly for dressing a trampoline which can be easily secured to and removed from a trampoline is described. The trampoline assembly is designed to enhance the safety features associated with a trampoline, as well as enhance a user's experience. The trampoline assembly may include a first component coupleable to a horizontal frame of a trampoline, and a second component independently coupleable to the horizontal frame of a trampoline and covering the space between a rebounding surface and a surface supporting a trampoline. The first component comprises at least one portion sized and shaped to mirror the shape of the horizontal frame to cover one or more trampoline springs coupled to a rebounding surface, and at least one portion to cover at least a portion of the space between a rebounding surface and a surface supporting a trampoline. The first component, the second component, or combinations thereof may contain one or more features that can be used to enhance an individual's experience when using the device, and may include indicia such as colors, wordings, symbols, lighting, audio devices, or combinations thereof. [0006] Accordingly, it is an objective of the present invention to provide a safety assembly for dressing recreational or exercise equipment. [0007] It is a further objective of the present invention to provide a decorative assembly for dressing recreational or exercise equipment. [0008] It is yet another objective of the present invention to provide a decorative and safety assembly for dressing a trampoline which can be easily secured to and removed from the trampoline. [0009] It is a still further objective of the invention to provide a decorative and safety assembly for dressing a trampoline which includes a plurality of safety pads attached thereto to independent regions of the trampoline. [0010] It is a further objective of the present invention to provide a decorative and safety assembly for dressing a trampoline which includes a plurality of safety pads attached thereto to independent regions of the trampoline and contains visual enhancement features to enhance a user's experience. [0011] It is yet another objective of the present invention to provide a decorative and safety assembly for dressing a trampoline which includes a plurality of safety pads attached thereto to independent regions of the trampoline and contains visual enhancement features, audio enhancement features, or combinations thereof to enhance a user's experience. [0012] It is a still further objective of the invention to provide a decorative and safety assembly kit for dressing a trampoline. [0013] It is a further objective of the present invention to provide a decorative and safety assembly kit for dressing a trampoline which includes a plurality of safety pads attached thereto to independent regions of the trampoline. [0014] Other objectives and advantages of this invention will become apparent from the following description taken in conjunction with any accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. Any drawings contained herein constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof. BRIEF DESCRIPTION OF THE FIGURES [0015] FIG. 1 is a perspective view of a standard mini-trampoline; [0016] FIG. 2A is a schematic representation of a resilient member, showing attachment to mini-trampoline frame and rebounding surface; [0017] FIG. 2B illustrates an alternative embodiment for attaching the rebounding surface to the mini-trampoline frame; [0018] FIG. 3 is an exploded view of the trampoline dressing in accordance with the present invention with a standard mini-trampoline; [0019] FIG. 4 is a front perspective view of a standard mini-trampoline with an illustrative embodiment of a trampoline dressing; [0020] FIG. 5 is a back perspective view of the mini-trampoline with the trampoline dressing; [0021] FIG. 6 is a right side view of the mini-trampoline with the trampoline dressing; [0022] FIG. 7 is a left side view of the mini-trampoline with the trampoline dressing; [0023] FIG. 8 is a top view of the mini-trampoline with the trampoline dressing; [0024] FIG. 9 is a bottom side view of the mini-trampoline with the trampoline dressing; [0025] FIG. 10 is a partial view of an illustrative example of the pad assembly showing the various components; [0026] FIG. 11 is an additional partial view of the components of the assembly; [0027] FIG. 12 illustrates a partial view of the pad assembly secured to a portion of the horizontal frame of a trampoline; [0028] FIG. 13 is a cross-sectional view of an additional embodiment of the pad assembly; [0029] FIG. 14 is a front perspective view of an illustrative embodiment of the second component of the trampoline dressing assembly; [0030] FIG. 15 is a side perspective view of the second component of the trampoline dressing assembly; [0031] FIG. 16 is a back perspective view of the second component of the trampoline dressing assembly; [0032] FIG. 17 illustrates a standard mini-trampoline with an illustrative embodiment of a trampoline dressing depicting a race car; [0033] FIG. 18 illustrates a standard mini-trampoline with an illustrative embodiment of a trampoline dressing depicting a lady bug; [0034] FIG. 19 illustrates a standard mini-trampoline with an illustrative embodiment of a trampoline dressing depicting a turtle; [0035] FIG. 20 illustrates a standard mini-trampoline with an illustrative embodiment of a trampoline dressing with additional visual and audio features; [0036] FIG. 21 is a schematic drawing illustrating electronic connection to support visual and audio features; [0037] FIG. 22 illustrates a standard mini-trampoline with an illustrative embodiment of a sports-themed trampoline dressing with decorative rebounding surface; [0038] FIG. 23 illustrates an additional embodiment of the sports-themed trampoline dressing with decorative rebounding surface. DETAILED DESCRIPTION OF THE INVENTION [0039] While the present invention is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred, albeit not limiting, embodiment with the understanding that the present disclosure is to be considered an exemplification of the present invention and is not intended to limit the invention to the specific embodiments illustrated. [0040] The present invention is directed towards a decorative and safety assembly for dressing a trampoline, referred to generally as a trampoline dressing or assembly 10 . Referring to FIG. 1 , a standard mini-trampoline 12 is illustrated. The mini-trampoline 12 embodiment is used for illustrative purposes, and any trampoline known to one of skill in the art may be used with the trampoline dressing 10 . The trampoline 12 contains a horizontal frame 14 having a generally circular configuration. While such configuration may be preferred, the circular configuration is for illustrative purposes and not intended to be limiting as the horizontal frame 14 can assume, for example, a square shape, a hexagonal shape, or a rectangular shape. A plurality of vertical support frames or legs 16 provide elevated support for the horizontal frame 14 . The plurality of vertical support frames or legs 16 allow the horizontal frame 14 to be positioned above the floor or ground. Coupled to the horizontal frame 14 via a plurality of resilient members, illustrated herein as coil springs 18 , is a rebounding surface or trampoline mat 20 . The plurality of resilient members is designed to provide elasticity or bounce to the rebounding surface or trampoline mat 20 . One end of the coil spring 18 contains a hook-like structure 21 which connects to a metal ring 22 coupled to a band 23 secured to the rebounding surface or trampoline mat 20 and positioned at or near the inner edge margin 24 of the rebounding surface 20 , see FIGS. 1 and 2A . At the opposite end of the coil spring 18 is a second hook-like structure 25 which connects to an opening 26 positioned within the horizontal frame 14 . Such arrangement provides for a highly resilient surface when in use, i.e. a user jumps up and down on the rebounding surface 20 . Alternative mechanisms for and providing elasticity or bounce and for attaching the rebounding surface 20 to the horizontal frame 14 known in the art can be used as well. FIG. 2B illustrates a partial view of the trampoline 12 illustrating one such mechanism through the use of a foam strap for attaching the rebounding surface 20 to the horizontal frame 14 . As shown, the horizontal frame 14 contains a foam cover 29 . Alternatively, the rebounding surface 20 can attach to the horizontal frame 14 using a bungee cord. Attached to the trampoline 12 is a handrail 28 . The handrail 28 could be constructed as a single unit and coupled to, for example, the vertical support frames or legs 16 . Alternatively, the handrail 28 may be made of individual parts which can be fit and secured together, using, for example, male/female connecting means, to provide for ease of shipping and/or assembly. [0041] Referring to FIGS. 3-9 , an illustrative example of the trampoline dressing 10 secured to a trampoline 12 resting on a floor surface 31 is shown. The trampoline dressing 10 comprises a first component 30 constructed to couple or secure to at least one portion of the trampoline 12 and a second component 32 constructed to couple to or secure to at least one portion of the trampoline 12 . When both the first component 30 and the second component 32 are secured or coupled to the trampoline 12 , the trampoline 12 is preferably transformed to contain safety features as well as a theme-based motif. As shown in FIGS. 4-9 , the trampoline 12 is fitted with a trampoline assembly or dressing 10 so as to transform the trampoline 12 to appear as a bug when viewed in different views. In addition to animals, the theme-based motif may include but is not limited to machines such as cars, trucks, boats, or airplanes, sports related such as a general sport i.e. football, baseball, or basketball, or team specific such as a National Football League (NFL) team, or character related such as DISNEY characters, comic book characters, or superheroes such as SPIDERMAN. [0042] Referring back to FIG. 3 , the first component 30 is designed to cover multiple portions of the trampoline 12 to provide for the theme-based motif appearance. The upper portion of the first component 30 is designed to secure or couple to at least one portion of the horizontal frame 14 of the trampoline 12 in order to cover at least a portion of the horizontal frame 14 and the spring coils 18 . Accordingly, the first component 30 comprises a pad assembly 34 formed of cover material 36 and a cushioning material 38 , such as, for example, a foam strip, see FIG. 10 . As illustrated in FIG. 10 , the cover material 36 contains an upper portion 40 which when secured to the trampoline 12 is visualized by the user, forming the upper surface 41 of the trampoline dressing 10 , a lower portion 42 which contacts and covers the spring coils 18 and forms the lower surface 44 of the trampoline dressing 10 . The cushioning material 38 is inserted between the upper portion 40 and the lower portion 42 , see FIG. 11 . Alternatively, the cushioning material 38 may be secured directly to either the upper portion 40 or the lower portion 42 via stitching. [0043] Both the upper portion 40 and the lower portion 42 contain expandable edges 46 A and 46 B respectively. The expandable edges 46 A and 46 B are formed by using a stretchable and resilient material or band secured thereto, through for example being sewn within, to allow the edges to expand in size and be secured to a portion of the horizontal frame 14 . In use, the lower portion 42 can be secured to a portion of the horizontal frame 14 , see FIG. 12 , by stretching the expandable edge 46 B on and over the outer edge 48 of the horizontal frame 14 . As the band retracts back, it secures the lower portion 42 thereto. Once secured in position, the cushioning material 38 is inserted and rests on top of the lower portion 42 . The upper portion 40 is then folded over the cushioning material at a fold line 50 , and using expandable edge 46 A is secured to the outer edge 48 of the horizontal frame 14 . [0044] The fold line 50 is positioned at or extends past an outer edge 52 of the horizontal frame 14 and may include a stretchable and resilient band. The fold line 50 defines the inner edge 54 of the trampoline dressing 10 , and the upper portion 40 and the lower portion 42 when folded over define the outer edge 56 (see FIG. 3 ). In this construction, the first component 30 can be easily removed and secured to the trampoline. Such feature aids the user by providing ease of assembly, ease of removal, and ease of replacing the cushioning pad when need. Such construction further allows the first component 30 to be removed from the trampoline 12 and cleaned without the risk of damaging the cushioning material 38 . [0045] The pad assembly 34 may alternatively be constructed as an enclosed unit similar to a pillow, see FIG. 13 . The cushioning material 38 , therefore, is secured between the upper portion 40 and lower portion 42 through stitching lines 58 . Alternatively, the stitching may be replaced by other sealing mechanisms, such as but not limited to, a zipper, buttons, snaps, or hook and loops fastener such as VELCRO. [0046] Referring back to FIG. 3 , the first component 30 further includes a skirt 58 integrally formed or attached thereto to provide a side wall which covers at least a portion of the space 60 , preferably the entire space, between the rebounding surface 20 or the horizontal frame 14 and the floor surface 31 supporting a trampoline. The skirt 58 further provides for the transformation of the trampoline 12 to a theme-based appearance. The skirt 58 is positioned along the outer edge perimeter of the pad assembly 34 , but does not extend completely around the perimeter and is aligned in a generally perpendicular manner with respect to the pad assembly 34 . As such, a portion of the pad assembly 34 extends out past a skirt first end 62 and the opposing skirt second end 64 . [0047] Both the skirt first end 62 and the opposing skirt second end 64 are adapted to be securable to the second component 32 . Accordingly, each end 62 and 64 contains a first member of a first component to second component securing assembly 65 , illustrated herein as either the hook or loop portions of a hook and loop fastener such as VELCRO. Positioned at various locations along the body of the skirt are fastening members 66 illustrated herein as string ties. The fastening members 66 are designed to provide for securing the skirt 58 to a plurality of positions on the trampoline, such as the vertical support members 16 . While the illustrated embodiment is shown as string ties, other mechanisms may be used including buttons, snaps, VELCRO, or the other means known to one of skill in the art. Additionally, the trampoline dressing 10 may include a foam insert 59 , see FIG. 9 . [0048] Referring to FIGS. 14-16 , an illustrative example of the second component 32 is illustrated. The second component 32 includes a first surface 68 secured to a second surface 70 thereby forming an enclosed area. The enclosed area is filled with cushioning material to form a front pad. At each end 72 and 74 is an extension or flap 76 which contains a second member 78 of the first component to second component securing assembly, illustrated herein as either the hook or loop portions of a hook and loop fastener such as VELCRO. The second component 32 is designed to couple to the first component 30 within the area defined by the portion of the pad assembly perimeter which does not include the skirt 58 . The second component provides for an additional, independent padded area that protects the front portion of the trampoline 12 below the padded assembly 34 . Positioned on the back surface 70 is a recessed area 80 having a looped securing member 82 for receiving and securing thereto a vertical or leg support 16 . A plurality of fastening members 84 , illustrated herein as string ties, may be used as well for securing to other parts of the trampoline 12 or trampoline dressing 10 . [0049] A plurality of handrail guards 86 , such as foam bodies, are secured to one or more portions of a handrail 28 if a handrail is used, and prevents or minimizes injury if a user contacts the handrail 28 . [0050] As described previously, the trampoline dressing 10 is designed to provide both safety and decorative features. As such, the trampoline dressing 10 can be applied to any trampoline, thereby allowing the trampoline to assume a decorative or theme-based appearance. As illustrated in FIGS. 4-8 , the trampoline dressing 10 is designed to provide for the appearance of a bug. As such, one or more components of the trampoline dressing 10 may contain one or more colors, and indicia such as words, letterings, symbols. For example, the trampoline dressing 10 illustrated in FIGS. 4 and 5 have eyes 88 , a mouth 90 , and dots 92 . In addition, external features may be coupled to one or more portions of the trampoline dressing 10 , such as bug antenna 94 . Referring to FIGS. 17-19 , additional theme-based appearances are shown. FIG. 17 represents a race car having head lights 96 , attached wheels 98 , and a colored yellow racing strip 100 against a red back drop 102 . FIG. 18 represents a lady bug having a red body with spots 104 , eyes 106 , mouth 108 , and antenna 110 . FIG. 19 represents a turtle having eyes 112 , mouth 114 , and external features attached such as legs 116 . [0051] FIG. 20 illustrates additional features associated with the trampoline dressing 10 . In addition to all the featured as described previously, the trampoline dressing 10 is designed to provide visual and/or audio features. As such, the trampoline dressing 10 may include the necessary electronics to provide such features and may include a circuit board or microprocessor 118 electronically coupled, via wiring or wirelessly, to a light source 122 such as LED lights, white or colored, a speaker 124 for producing sound, and a sensor 126 , see FIG. 21 , which may induce the circuit board or microprocessor to produce sound or light based on a user jumping on the trampoline surface. A control unit 128 may be used to turn the lights or sound on and off, or to provide control of the volume of sound or type of lights produced, i.e. constant on or flashing. In the embodiment illustrated in FIG. 20 , the control unit 128 and wires 120 secure to portions of the handrail 28 . A pressure sensor 126 within the rebounding surface or trampoline mat 20 may be used to send a signal to the microprocessor (not shown) each time a person jumps on the mat 20 . LED lights 122 placed in the headlights 96 may be turned on and off as a result of the jumping. Speaker 124 may be imbedded within the trampoline dressing 10 , such as within the skirt, to provide a sound, such as a car roar, screech or honk. [0052] FIGS. 22 and 23 illustrate an embodiment of the trampoline dressing 10 having a sports-based theme. FIG. 22 is shown having a football based theme. The first component 30 contains features that indicate a football, including images that depict football white lacing 126 . In addition to or alternatively, the first component 30 may contain images that represent a specific professional or college football team, such as team colors, mascots, name/nick-names, or other symbols that represent the specific team. In addition to the features described throughout the specification, the trampoline dressing includes an additional feature in which the rebounding surface 20 forms part of the decorative image. As illustrated, the rebounding surface 20 includes printed images or overlays of a football field, illustrating the various components of a football field including hash marks 128 , yard lines 130 , and numerals 132 that indicate numerical values for the yard lines. [0053] FIG. 23 illustrates a trampoline dressing 10 depicting a basketball theme. The first component 30 may contain images that represent the sport in a general manner or represent specific professional or college basketball teams, such as team colors, mascots, name/nick-names, or other symbols that represent the specific team. As shown, first component 30 is designed to depict a basketball net 134 . The rebounding surface 20 includes printed images or overlays of a basketball 136 and components of the basketball court, including the free throw circles 138 , half-court line 140 , three point lines 142 , and free-throw lines 144 . [0054] All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. [0055] It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention, and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein. [0056] One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.

A decorative and safety assembly for dressing a trampoline which can be easily secured to and removed from a trampoline is described. The trampoline assembly is designed to enhance the safety features associated with a trampoline, as well as enhance a user's experience. The trampoline assembly may include a first component coupleable to a horizontal frame of a trampoline, and a second component independently coupleable to the horizontal frame of a trampoline and covering the space between a rebounding surface and a surface supporting a trampoline. The first component, the second component, or combinations thereof may contain one or more features that can be used to enhance an individual's experience when using the device and may include indicia, such as colors, wordings, symbols, lighting, audio devices, or combinations thereof.

TECHNICAL FIELD The invention relates to a dispenser or discharge device for media which may be gaseous, liquid, pasty and/or powdery. DESCRIPTION OF THE BACKGROUND ART Such dispensers are simultaneously held and actuated or applied single-handedly. Substantially all parts, more particularly, housing parts can be made of a plastics material or injection molded so that their wall thickness is not more than 5 mm or 2 mm. The medium can be finely dispersed in a fluid flow, conveyed in a gas or air and discharged in individual quantities precisely dispensed and sufficiently swirled for this purpose within the dispenser by multiple deflection. If the dispenser is intended to serve inhaling a pharmaceutical medium, the medium is expediently admixed in the conveying flow not before application, it previously being stored substantially more dense and compact. OBJECTS OF THE INVENTION An object of the invention is to provide a dispenser in which disadvantages of prior art embodiments are avoided. Another object is to ensure facilitated handling. Another object is to provide a most finely atomized discharge of medium. A further object is to precisely dose the amount of medium dispensed. Still another object is to permit administration of the medium deeply at the inner ends of the human respiratory ducts. SUMMARY OF THE INVENTION In the invention means are provided to very finely particulate the medium within the conveying paths of the dispenser, for example, by merely a single or multiple reciprocating motion of the medium so that already existing largish particles can be separated into smaller particles or droplets at at least two impact surface areas located opposite each other. In the case of a powder this may first gain access downwards into a dished impact or guiding surface area with or without an air flow, after which it is lifted by the air flow from this first surface area at high speed, swirled and catapulted against an opposite wall which results in any clumped powder particles being size-reduced. The proportion of respiratory particles, i.e. particles gaining access to the lungs of the patient is thus substantially enhanced as compared to such discharge devices which are merely intended for nasal application or for application of the medium in the region of the throat. The cited first or any other surface area may be provided as a buffer storage or initial hold for at least part of the single-shot dose of the medium. During opening and, where necessary also thereafter, at least part of this dose of the flowable medium then falls on the troughed upwardly flared initial hold and it is not until the then occuring conveying flow that this medium is lifted swirled from the initial hold, after which it is immediately catapulted against the wall located thereabove before being redeflected in the falling direction from the reservoir to the outlet or mouthpiece. Expediently by means of suitable sealing, the conveying flow flows through the reservoir space completely so that any remainders of the medium remaining therein are entrained up to the outlet. These remainders too, gain access from the reservoir with no contact directly to the initial hold which may feature inclined sliding surfaces so that the medium is able to gain access to the lowest point of the initial hold by its gravity effect even in the absence of a conveying flow. Between the reservoir outlet and the initial hold a parting member may be provided for fanning out the medium flow, for example, a spike or a tip which also serves to open the reservoir and protrudes into the reservoir space or the medium contained therein. The conveyance path between the reservoir and the outlet after which the medium emerges into the open in becoming totally detached from the discharge device, is configured to advantage as short as possible and as of the swirl zone as straight as possible or angled or curved at an obtuse angle once only to minimize flow losses. The path between the reservoir outlet and the swirl zone is shorter than the flow path between the middle of this swirl zone and the outlet, but maximally three-times as large. The middle of the swirl zone may coincide with the middle of the opposite impact surface area. The minimum passage cross-section of the conveyance paths which is to advantage smaller than the full-length constant passage cross-section of the reservoir space is located preferably at the transition point which is defined as the most constricted point of the two surface areas located opposite each other, it guiding the medium from the initial hold into the end passage leading to the outlet. This end passage may have a constant passage cross-section throughout. The outlet as well as the straight end passage forming this outlet by one end are located at an angle to the reservoir or main axis of the device so that the latter can be held more or less vertically in an oral application with the head slightly tilted backwards and the thumb of the person using the device is located between upper lip and mouthpiece or in contact with both. In the conveyance paths upstream and/or downstream of the reservoir space a valve may be provided which opens as a function of pressure so that it is not until a predetermined vacuum pressure is attained downstream of the valve that the conveying flow is abruptly set in motion through the opening of the valve, resulting in very high flow rates. The valve may be a sleeve valve. These and further features are evident from the description and the drawings, each of the individual features being achieved by themselves or severally in the form of subcombinations in one embodiment of the invention and in other fields. BRIEF DESCRIPTION OF THE DRAWINGS Example embodiments of the invention are explained in more detail in the following and illustrated in the drawings in which: FIG. 1 is an axial section through the discharge device in accordance with the invention, FIG. 2 is a partly sectioned view of the discharge device as shown in FIG. 1 as viewed from underneath and FIG. 3 is a scrap view of a further embodiment including a conveying flow pressurizer. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS The device 1 comprises a base body 2 of but five housing parts 3 to 7 of which in the readiness or operative condition merely three parts 3, 4, 6 firmly connected in common with a crib unit 8 form the completely outer surface area of the device 1. The part 5 is arranged totally countersunk firmly seated in the part 3 and directly located axially by the part 4. The unit 8 comprises at least four and not more than eight reservoir locations 9 for the medium arranged evenly distributed and directly juxtaposed in a circle about an axis 10. The axis 10 is located parallel to the main axis 11 in which the location 9 operative in each case is located to be discharged directly from this position for discharge through an outlet 12. The axis 13 of the latter is oriented at an obtuse angle of minimally 110° and maximally 160°, more particularly 135°, to the axis 10 or 11. As viewed parallel to the axis 10, 11 the outlet 12 is located totally within the outer circumference of the base body 2. Provided totally within the base body 2 is a fluid guide 14 or passageway connecting the latter at both ends, between which a reservoir outlet 15 is located for discharging the medium. The outlet 15 has a substantially smaller spacing away from the upstream end of the guide 14 than from its outlet end 12. The outlet 15 is formed by one end of an elongated, separate reservoir body 16 having an elongated reservoir space 17 which in the emptying position is coaxial to the axis 11. The dimensionally rigid body 16 is formed by a two-part capsule of rigid gelatine or the like, the two shell-shaped parts of which are axially combined in a tight fit and the ends of which face away from each other are hemispherical so that the medium contained in the space 17 is sealingly packaged prior to opening of the device 18, filling the space 17 totally or merely partly as a single-shot dose. The body 16 or the space 17 which permits opening only by destruction forms in operation a section of the guide 14 extending over its full length, the openings of which located at the two ends are substantially more constricted in a throttle like action than the full-length constant passage cross-section of the portion of the space 17 located between the ends. The exposed outer shell 19 formed merely by the parts 3, 4, 6, 8 of the device 1 can be clasped almost completely by a single hand. Within this shell 19 the guide 14 forms a zone 20 for swirling, size-reduction and atomized dispersion of the medium already entrained upstream by the air flow. In the middle between the ends of the guide 14 or device 1, in the operative position below the outlet 15 a dished or troughed initial hold 21 open only to the top is provided, the bottom 24 of which is spaced away from the outlet 15 by a spacing which is smaller than the length of the space 17. The concave curved bottom 24 adjoins a longer flank 22 and a shorter flank 23 which diverse upwards at an acute angle. The common axial plane of the surface areas 22 to 24 or bowl 21 located between the axes 10, 11 but nearer to the axis 10 is offset to one side of the axis 11 of the outlet 15 so that the outlet 15 is located vertically above the middle of the bottom 24 when the device 1 is slightly tilted rearwards in the operative position, the axis 13 thus being less inclined than in the vertical orientation of the axes 10, 11. The flank 22 sealingly adjoins the outlet 15 and the flank 23 extends only to a constricted transition point 25 between the bowl 21 and the part of the guide 14 located downstream thereof. The flank 23 extends to a rounded, lengthwise lip 26 which is located opposite a concave surface area 27 above the latter, this surface area 27 like the bowl 21 being curved about an axis located transversely at right angles to the axes 10, 11, but which has a radius of curvature larger than that of the bottom 24 by at least four or five times. The surface area 27 extends in and opposite to the direction of flow beyond the transition point 25 defining the lip 26, namely up to the outlet 15 and as a circumferential definition up to a straight passage section 28 adjoining upstream the transition point 25 and the lip 26. The end of the section 28 located downstream adjoins an end passage 29 in an obtuse angled curvature, the end of the end passage forming the outlet 12. The axis 30 of the section 28 is located parallel to the axis 10, 11 and on the side of the axis 10 facing away from the axis 11. The two passage sections 28, 29 are straight and have a constant flow cross-section throughout which is greater than that of the transition point 25. The section 29 is formed by a freely protruding, tubular port 31 of constant outer cross-sections which as the mouthpiece is to be introduced over the majority of its length into the mouth of the patient, whose lips sealing surround it. In this arrangement the section 29 may be slightly longer than the section 28 up to the lip 26. Bowl 21 and port 31 are located on the same side of the section 28. The bowl 21 including the surface areas 22 to 24, 26 and a first longitudinal section of the passage part 28 is defined exclusively by part 5 which is inserted totally countersunk as far as it will go in part 3 opposite the direction of flow and is axially located by the part 4 likewise inserted in this direction. This part 4 forms a longitudinal section of the passage part 28 adjoining the part 3 therewithin as well as the section 29, the port 21 and the outlet 12. The part 4 does not protrude beyond the outer circumference of part 3, it sealing contacting the lower annular face surface area of the latter by a ring shoulder. The surface area 27 extending over an angle of an arc of less than 90° and more than 45° is formed only by the part 3 as well as being smoothly continued at both ends so that it forms an intermediate section of a semi-circular or hemi-spherical or U-shaped impact surface area of the part 3, the part 5 sealingly contacting the continuations of the latter adjoining the surface area 27 by convex surface areas and subsequently thereto the part 4 by its circumferential surface area. The flank 22 extends up to these curved surface areas and the flank 27 is passed through in the region of the outlet 15 as well as subsequent to the flank 22 by a transition opening 46 for the medium and the air flow. The passage cross-section of this transition opening 46 located in the axis 11 corresponds to the largest passage cross-section of the space 17, but the clearance of the transition opening 46 is larger than the largest clearance of the space 17. The bowl 21 is located between the axes 11, 30 and the largest clearance of the bowl 21 level with edge 26 is larger than the associated depth of this bowl 21. The definitions of the passage sections 21, 25, 28 location parallel to the plane of the drawing may be more or less flat as well as parallel to each other so that as viewed axially the device is web-shaped in the associated region. Like the cited surface areas this region may be rotationally curved about the axis 11, however. Spaced away above the arrangements 12, 29, 31 part 4 of the body 2 forms a barrel-shaped handle 32 which adjoins the rear end of the outer circumference of the mouthpiece 31 in an inwardly directed acute angle at right angles transverse to the axis 11 and ascends to the region remote therefrom up to the outer circumference of the shell 19. The other handle 33 is formed by the rear end of the body 2, namely the outer side of the face end wall of the part 6 so that the two handles form a grip 32, 33 in which the thumb rests on the handle 32 and further fingers of the same hand clasp the handle 33 facing away from the latter, whilst the mouthpiece 31 is introduced between the lips of the patient and the finger supported by the convex handle 32 may be in contact with the upper lip of the patient as well as by its side facing away therefrom with the outer circumference of the mouthpiece 31. Throughout the complete operation and discharge of the device the handles 32, 33 are located rigidly positioned to each other. The unit 8 comprises a crib body 34 movable about the axis 10 which is defined axially between the parts 3, 6 and carries replacably on its side facing the part 6 a crib insert 35 having the cited number of reservoir bodies 16. The body 34 comprises for each location 9 a sleeve-shaped mount 36 freely protruding in the direction of flow, this mount surrounding the one lower end of the body 16 in a tight seal and forming by a constriction a stop for the lower curved end surface area of the body 16. A mount 37 correspondingly protruding only in the direction of flow, but substantially smaller also comprises the insert 35 for each location 9. The crib body 34 and crib insert 35 provide a dosage carrier, and the mounting structures 36, 37 provide receptacles for receiving doses of the medium encapsulated within reservoir spaces 17. The mount 37 which protrudes only beyond the lower face side of the otherwise circular or disk-shaped flat insert 35 engages by a conical outer circumference a conical inner surface area at the rear end of the mount 36 so that it adjoins the outer circumference of the narrower part of the body 16 in a radially constricted seal, whereby the flared cap part of the body may adjoin by its face surface area the upper face surface area of the insert disk 35. As a result of this, this rear end or the cap part protrudes opposite to the direction of flow non-contactingly into the internal space of the part 6 whilst the lower longitudinal section is located totally in the mounts 36, 37 and passes through the bodies 34, 35. The body 34 which like each of the parts 3 to 7, 35 is configured integrally comprises at its outermost circumference a shell 38 at the inner circumference of which spaced away between its ends a face end wall 39 adjoins, beyond the undersides of which the mounts 36 protrude and adjoin the insert 35 at their upper face surface area. The outer circumference of the shell 38 forms a handle 40 and is located in an angle of an arc of minimally 90° or 160° and maximally 220°, more particularly only 180° about the axis 10 freely accessible at the outer circumference of the bodies 3, 6 for actuation. In the operative position the constricted end of the mount 36 surrounding the outlet 15 is located directly adjacent the transition opening 46 in the surface area 27 or adjacent to the outer side of the curved wall 47 which forms the surface area 27. The body 34 located totally at this outer side is rotatably mounted directly on part 3 by two concentric bearings and is axially fixed in position in the opposite direction. The bearing parts configured integrally with the part 3 are formed by two nested bearing bodies such as sleeves freely protruding contrary to the direction of flow which slide on the underside of the wall 39 by their end surface areas. The outer sleeve of the bearing 41 slides by its outer circumference on the inner circumference of the shell 38 and by its inner circumference on the outer circumferences of the mounts 36. The inner sleeve of the bearing 42 slides by its outer circumference likewise on the outer circumferences of the mounts 36 which for this purpose form in common an inner circumference. Located between the two sleeves is the transition opening adjoining the outlet 15, the two sleeves translating integrally into the curved wall of the surface area 27. Since the sleeve of the bearing 41 is provided eccentrically to the axis 11 of the housing parts 3, 4 of the body 2 adjoining underneath, the sleeve protrudes beyond the parts 3, 4 at the side face away from the handle 32. For axial location a snap-action connector may be provided on one of the sleeves, more particularly between the outer circumference of the inner sleeve and the body 34 so that following completely removal of the part 6 the insert 35 including the emptied body 16 can be pulled out contrary to the direction of flow without releasing the body 34 from the bearings 41, 42. A further radial and axial bearing is provided on the upper side of the bodies 35, 39 for which the shell 43 of the part 6 slides on this side at the inner circumference of the shell 38 and on the upper face surface area of the body 35, as a result of which the body 36 is held in close contact with the upper side of the wall 39. The shell 43 also forms only over part of the circumference the outer shell of the part 6 since the shell is located eccentrically relatively to this outer shell. Outside of the bearing member 43 this outer shell engages the interior of the shell of part 3 firmly seated, the outer shell being locked in place by a springy snap-action connector preventing removal except when a suitably high removal force is applied for removal contrary to the direction of flow. After this removal the body 35 is located with the bodies 16 freely accessible for replacement. The device 18 comprises two opposing opening members 44, 45 in the axis 11 which may be formed by metal tips and serve to break open the end walls of the capsule 16 in the switching movement of the unit 8, as a result of which the capsule 16 is captured by the members 44, 45 in the last phase of translation into the operative position and is thus ruptured at the ends so that the tips protrude into the space 17, each being surrounded by a jagged opening. The member 44 passes through the associated transition opening 46 of the curved wall 47 after which it can be locked in place by the arms of a star-shaped mount. The outer circumference of this tip 44 forms a gliding surface area by which the medium and the air flow are flared into an envelope flow. The rear tip 45 is secured to the inner side of the face end wall of the part 3 so that the tips 44, 45 are oriented coaxially relative to each other. For making use of the device 1 the ring 38, which may be provided with a means for indicating its rotary position and which has spring action to lock into each opening position, is turned until the next capsule 16 is located in the axis 11 and is then opened at both ends. Due to this opening action part of the medium trickles via the tip 44 along the flank 22 or 23 onto the bottom 24 of the bowl 21, i.e. after having left the tip 44 via a free-fall distance. After this the patient sucks on the mouthpiece 31 so that air is drawn in from without through openings in the housing space accommodating the upper end of the capsule 16 and the tip 45, the air flowing through the upper opening of the capsule 16 into the space 17. The air flows through the space 17 entraining the remainder of the medium still left in this space 17, flows through the outlet 15 around the tip 44 directly into the opening 46 and from here against the flank 22 located nearer to the outlet 12 so that this conveying flow is diverted along the flank 22 and the bottom 24 back upwards as well as being directed directly against the surface area 27 on leaving the edge 26, the conveying flow thereby entraining the medium present in the bowl 21. In the region of the bowl 21 a rolling flow may briefly materialize, however, the conveying flow gains access whilst being accelerated due to the suction effect through the transition point 25 into the passage 28, 29 where mollification of the flow takes place which continues up to the outlet 12. On impinging against the surface area 27, opposite which the flank 23 is located on a direction of the radius the larger particles of the medium are reduced in size by the force of impact. For the next application the unit 8 is turned further to a location 9. The unit 8 is rotatable in one direction only, due to a free-wheel lock. Downstream of the outlet 15 or the transition point 25 a sieve 48 or a filter inserted e.g. between the parts 3, 4 is provided in the passage 28 so that any fragments of the fractured capsule 16 or excessively large medium particles cannot gain access to the throat of the patient. Furthermore, a valve 49 may be provided in the flow path, namely upstream or downstream of the space 17, this valve opening as a function of the pressure being lower downstream than upstream. The opening force of this valve may be constant or reducing, the more the opening is made, so that the valve abruptly opens fully following commencement of the opening movement to release the conveying flow pulsedly. The valve 49 returning to its closed position as a function of the pressure may be located near to the outlet 12 within the passage 29 so that the section of the guidance 14 located upstream is sealingly closed off to prevent the ingress of any contamination during the non-active periods. The part 7 is configured as a protective cap which is to be completely removed axially prior to use of the device and in its protective position sealingly accommodates the port 31 including the opening 12 as well as the complete part 4 and the lower section of the part 3. In FIG. 3 only the upper section of the device is shown as of part 6, on the underside of which an air pump 50 is arranged as a discharge actuator and pressure generator. Here, the upper face end wall of the part 6 does not form a handle, it instead comprising a shell 52 freely protruding upwards in which a dished piston 41 is inserted firmly in place by its shell as far as it will go against the face end wall of the part 6 so that its flared piston lip protrudes beyond the upper end of the shell 52. The piston lip slides on a cylinder 53 which closely surrounds the outer circumference of the shell 52 and which can be shifted downwards against the force of a spring 54 as far as it will go against the face end wall of the part 6 to supply air through an opening 55 in the crown of the piston as well as in the face end wall of the part 6 around the tip 45 of the capsule 16. The pump 50 is located in the axis 11 and the face end wall of the cylinder 53 forms the movable handle 33, on release of which the pump returns to its starting position in drawing in fresh air. Due to this action the path through the opening 55 may be closed off from suction by a valve, for example the valve 49. In this embodiment too, the air flow may be produced solely by suction action through the opening 12 and boosted at any time by actuating the pump 50. In FIG. 3 the insert 35 is shown in its change position by itself and without insert 34. All cited effects and properties, such as positions, sizes and the like may be provided precisely as described, merely roughly so or substantially so and may also greatly vary therefrom, depending on the particular application. The device may be configured true to scale as depicted in FIGS. 1 to 3. The defining surface areas of the portions coming into contact with the medium, more particularly the portions 12, 14, 18, 20 to 29, 44 to 46, 48 and 49 may be provided with an anti-stick or anti-static coating of metal and/or a plastics material such as tetrafluoroethylene to prevent the medium tacking due to electrostatic charging. The coating is but a few mm thick and may be applied by spraying, bonding, pressurization or the like to the surface areas of the cited portions.

A dispenser for discharging media has a duct (14) including a medium outlet (12), and a dosage carrier (34, 35) mounted on a base body (2) and including receptacles (36, 37) for receiving doses of the medium entirely enclosed in respective reservoir spaces (17), a medium holder (21) disposed beneath the reservoir spaces and adjacent the duct (14) for holding the medium when it is released from one of the reservoir spaces (17), and a device (44, 45) for opening one of the reservoir space (17) to allow the medium to be first deposited in the medium holder (21), and then picked up and conveyed out the medium outlet (12) by a transfer flow through the reservoir space (17).

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a Continuation Application of U.S. application Ser. No. 10/616,218 filed Jul. 8, 2003 now U.S. Pat. No. 7,455,673, the entire contents of which are incorporated by reference herein. FIELD OF THE INVENTION The present invention relates generally to apparatus for treating femoral fractures, and specifically to apparatus for coupling bone portions across a fracture. BACKGROUND OF THE INVENTION Intramedullary (IM) nails are implantable devices used to stabilize fractures and allow for bone healing. IM nails are inserted into the medullary canal of the long bones of the extremities, e.g., the femur or tibia. Currently-used IM nails have a head region that generally includes at least one hole, transverse to the longitudinal axis of the nail, for receiving anchoring means, such as a screw, to secure the nail within the medullary canal of the bone. Some such anchoring means include at least one sleeve, which passes through the transverse hole, and through which a screw assembly typically passes freely. A proximal end of the head region protrudes from the proximal end of the bone, to facilitate post-implantation access to the IM nail, if desired. The proximal end of the head region, which protrudes from the bone, is a continuous extension of the head region, not structurally or visually distinct from the more distal portion of the head region that includes the holes. U.S. Pat. No. 4,827,917 to Brumfield, which is incorporated herein by reference, describes an IM system including a screw and an intramedullary rod. The screw has a threaded portion and a smooth portion, and the rod has a head, stem and a longitudinal bore. There is at least one pair of coaxial holes through the stem, transverse to the longitudinal axis of the rod, for receiving first anchoring means, such as a nail, screw or bolt, to secure the rod within the marrow canal of the femur. There are at least a proximal pair of coaxial holes and a distal pair of coaxial holes in the head of the rod in an angled direction toward the femoral head relative to the longitudinal axis of the rod. The distal pair of head holes is adapted to slidingly receive the screw so as to permit the threaded portion of the screw, in use, to engage the femoral head and to allow sliding compression of a femoral neck or intertrochanteric fracture. U.S. Pat. No. 5,032,125 to Durham et al., which is incorporated herein by reference, describes an IM hip screw that includes an IM rod, a lag screw and a sleeve for slidably receiving the lag screw. The sleeve is received in a passage in the IM rod having an axis positioned at an angle relative to the longitudinal axis of the IM rod such that the axis of the sleeve is directed toward the head of the femur. The IM hip screw is described as permitting sliding compression of selected fractures, particularly intertrochanteric fractures and fractures of the femoral neck. U.S. Pat. No. 6,235,031 to Hodgeman et al., which is incorporated herein by reference, describes an IM system that includes an IM rod, a lag screw, and a lag screw collar. The rod has a proximal end with a transverse bore extending therethrough. The lag screw has a distal end with coarse bone engaging thread elements and a proximal end with screw threads. When in use, the lag screw is substantially axially aligned with the transverse bore of the rod. The lag screw collar has an outer diameter sized to rotatably fit within the transverse bore of the rod. The collar also has an inner diameter and internal screw threads adapted to cooperate with the screw threads of the proximal end of the lag screw. The lag screw collar may have an increased outer diameter at one end thereof which is at least slightly larger than a diameter of the transverse bore of the rod. U.S. Pat. No. 6,443,954 to Bramlet et al., which is incorporated herein by reference, describes an IM system that includes a lag screw assembly extending through a radial bore in an IM nail. The lag screw is inserted into one portion of a bone and deployed to fix the leading end. The IM nail is placed in the IM canal of a portion of the bone and the trailing end of the lag screw assembly is adjustably fixed in the radial bore to provide compression between the lag screw assembly and the IM nail. The IM nail has a cap screw in the proximal end holding the lag screw assembly and a tang in the distal end. The tang has legs extending through the nail to fix the distal end in the IM canal. U.S. Pat. No. 6,648,889 to Bramlet et al., which is incorporated herein by reference, describes an IM system that includes an IM nail for insertion in the femur. The nail has an axial bore and an intersecting transverse bore. A lag screw is inserted through the transverse bore and turned into the head of the femur. A slotted sleeve is inserted over the lag screw and through the transverse bore with the slots aligned with the axial bore. A sleeve lock is inserted into the axial bore, and has a locking tab which engages the slots in the sleeve preventing rotational movement between the sleeve and the nail and longitudinal movement of the sleeve relative to the nail. A compression screw is turned into the trailing end of the lag screw and engages the encircling sleeve to provide longitudinal translation between the lag screw and sleeve to apply compressive force across a fracture. U.S. Pat. No. 6,926,719 to Sohngen et al., which is incorporated herein by reference, describes an IM nail having a modular configuration, including a nail member having a chamber formed on the proximal end thereof. An insert having at least one opening therein for receiving a bone screw or fastener is disposed within the chamber and is secured therein by a locking ring. Various inserts are described for use to achieve selected bone screw or fastener configurations. European Patent Application Publication EP 0 521 600 to Lawes, which is incorporated herein by reference, describes an IM system that includes an IM rod having an angulated opening to receive a femoral neck screw having a threaded portion at its distal end, and locking means acting between the neck screw and the wall of the angulated opening to prevent relative rotation between the screw and the rod. PCT Publication WO 02/083015 to Ferrante et al., which is incorporated herein by reference, describes an orthopedic screw having a screw head, a screw body with a distal tip, a shank with an enlarged diameter at the trailing end and a thread extending radially outward from the shank, and an internal capture surface. The screw is used with an orthopedic implant system, which includes an orthopedic implant and a driver capable of engaging the internal capture of the screw. SUMMARY OF THE INVENTION In some embodiments of the present invention, an intramedullary (IM) system for implantation in a medullary canal of a femur of a subject, comprises an IM nail having a head and a stem. The head of the IM nail defines at least one hole, which is oriented in an angled direction toward the femoral head relative to the longitudinal axis of the IM nail. The head hole is adapted to receive a sleeve, which is adapted to slidably receive a screw, so as to permit a threaded portion of the screw to engage a femoral head of the subject and to allow sliding compression of a femoral neck or intertrochanteric fracture. The sleeve comprises a locking mechanism, which engages the head hole, preventing rotational and longitudinal movement between the sleeve and the head hole. The locking mechanism typically comprises a depressible male coupling element, such as a tab, configured so that when the sleeve is inserted into the head hole and properly aligned, the tab engages a female coupling element, such as a notch, located on the inner surface of the head hole, thereby locking the sleeve to the head hole. In some embodiments of the present invention, an IM system comprises an IM nail having a head and a stem. The head of the IM nail comprises a distal portion, which typically includes at least one head hole, and a proximal portion, having a diameter less than a diameter of the distal portion. For some applications, the diameter of the proximal portion is less than about 50% of the diameter of the distal portion. Such a narrower proximal portion typically allows greater regrowth and healing of the neck of the femur towards the area of the greater trochanter, than generally occurs upon implantation of conventional IM nail heads. At the same time, because a proximal end of the narrower proximal portion generally remains easily locatable on the external surface of the femur in the area of the tip of the greater trochanter or the piriformis, a surgeon typically can readily locate the IM nail if post-operative access to the implant becomes necessary. For some applications, the IM system further comprises the sleeve locking mechanism described hereinabove. In some embodiments of the present invention, an IM locating tool is provided for locating an IM nail, a proximal portion of which does not extend to the surface of the femur. Without the use of this IM locating tool, it is sometimes difficult for a surgeon to locate such an IM nail if post-operative access to the implant becomes necessary. To use the locating tool, the surgeon temporarily couples one or more connecting elements of the locating tool to respective head holes of the IM nail. As a result, a proximal end of the locating tool is positioned directly over the site on the surface of the femur at which the surgeon should drill. It is noted that use of the term “head” with respect to the IM nail is intended to distinguish at least a portion of the proximal end of the nail from the stem of the nail. In some embodiments, the head is separated by a neck region from the stem, while in other embodiments, the head and stem are generally continuous. There is therefore provided, in accordance with an embodiment of the present invention, apparatus for treating a fracture of a bone of a subject, including: an intramedullary (IM) nail, adapted to be inserted in a medullary canal of the bone of the subject, and including a proximal head that defines at least one hole therethrough; and a sleeve, including a locking mechanism, which locking mechanism is adapted to engage the hole when the sleeve is inserted in the hole, such engagement preventing rotational and longitudinal movement between the sleeve and the hole. In an embodiment, the apparatus includes a screw, and the sleeve is adapted to slidably receive the screw. In an embodiment, the proximal head is shaped so as to define a female coupling element located on a surface of the hole, and the locking mechanism includes a depressible male coupling element, configured to engage the female coupling element so as to prevent the rotational and longitudinal movement. For some applications, the female coupling element is shaped to define a notch. For some applications, the male coupling element includes a tab. For some applications, the depressible male coupling element is adapted to engage the female coupling element when the sleeve is inserted in the hole to a fixed depth and then rotated until the depressible male coupling element engages the female coupling element. There is also provided, in accordance with an embodiment of the present invention, apparatus for treating a fracture of a bone of a subject, including an intramedullary (IM) nail, adapted to be inserted in a medullary canal of the bone of the subject, the IM nail including a proximal head having a distal portion and a proximal portion, the distal portion having a distal diameter, and the proximal portion having a proximal diameter less than or equal to about 80% of the distal diameter. For some applications, the proximal diameter is less than or equal to about 50% of the distal diameter. For some applications, the proximal diameter is equal to between about 5 mm and about 10 mm and the distal diameter is equal to between about 11 mm and about 17 mm. For some applications, a length of the proximal portion is equal to between about 10% and about 50% of a length of the distal portion. In an embodiment, the distal portion defines at least one hole therethrough, and including a sleeve, which includes a locking mechanism, which locking mechanism is adapted to engage the hole when the sleeve is inserted in the hole, such engagement preventing rotational and longitudinal movement between the sleeve and the hole. There is further provided, in accordance with an embodiment of the present invention, apparatus for treating a fracture of a bone of a subject, including an intramedullary (IM) nail, adapted to be implanted in the bone, such that no portion of the IM nail extends to an external surface of the bone. In an embodiment, the IM nail includes a proximal head that defines one or more proximal head holes therethrough, and including a locating device, which includes: one or more connecting elements, fixed to a distal end of the locating device, the connecting elements adapted to be temporarily coupled to respective ones of the proximal head holes; and a location indicating element, fixed to a proximal end of the locating device, the location indicating element adapted to indicate, when the connecting elements are coupled to the holes, a location on the external surface of the bone substantially directly over a location of a proximal end of the proximal head. For some applications, the one or more connecting elements include exactly one connecting element. For some applications, each of the one or more connecting elements includes a locking mechanism, adapted to engage one of the proximal head holes when the connecting element is inserted in the proximal head hole, such engagement preventing rotational and longitudinal movement between the connecting element and the proximal head hole. In an embodiment, the apparatus includes one or more sleeves, adapted to be coupled to respective ones of the proximal head holes, and the one or more connecting elements are adapted to be coupled to the respective ones of the proximal head holes by being coupled to respective ones of the sleeves when the one or more sleeves are coupled to the respective ones of the proximal head holes. For some applications, each of the one or more sleeves includes a locking mechanism, adapted to engage one of the holes when the sleeve is inserted in the hole, such engagement preventing rotational and longitudinal movement between the sleeve and the hole. In an embodiment, the IM nail includes a proximal head having a proximal end, the proximal head defining at least one hole therethrough, and defining a longitudinal channel, open to the hole and to the proximal end, and the apparatus includes a bendable, resilient elongated element, which includes a sharp tip, the element adapted to be inserted (a) into the hole, (b) through at least a portion of the channel, (c) through the proximal end of the proximal portion, and (d) through the bone, so as to indicate a location on the external surface of the bone substantially directly over the proximal end of the proximal head. For some applications, the tip includes a screw thread. Alternatively, the tip includes a drill bit. There is yet further provided, in accordance with an embodiment of the present invention, apparatus for locating an intramedullary (IM) nail implanted in a bone of subject, the IM nail having a proximal head that defines one or more holes therethrough, the apparatus including: one or more connecting elements, adapted to be disposed at a distal end of the apparatus, the connecting elements adapted to be temporarily coupled to respective ones of the holes; and a location indicating element, fixed to a proximal end of the apparatus, the location indicating element adapted to indicate, when the connecting elements are coupled to the holes, a location on an external surface of the bone substantially directly over a location of a proximal end of the proximal head, when no portion of the IM nail extends to the external surface of the bone. For some applications, the one or more connecting elements include exactly one connecting element. In an embodiment, each of the one or more connecting elements includes a locking mechanism, adapted to engage one of the holes when the locking mechanism is inserted in the hole, such engagement preventing rotational and longitudinal movement between the connecting element and the hole. In an embodiment, the apparatus includes one or more sleeves, adapted to be coupled to respective ones of the holes, and the one or more connecting elements are adapted to be coupled to the respective ones of the holes by being coupled to respective ones of the sleeves when the one or more sleeves are coupled to the respective ones of the holes. For some applications, each of the one or more sleeves includes a locking mechanism, adapted to engage one of the holes when the sleeve is inserted in the hole, such engagement preventing rotational and longitudinal movement between the sleeve and the hole. There is still further provided, in accordance with an embodiment of the present invention, apparatus for treating a fracture of a bone of a subject, including an intramedullary (IM) nail, adapted to be inserted in a medullary canal of the bone of the subject, the IM nail including a proximal head having a distal portion and a proximal portion, the proximal portion visually discrete from the distal portion, the proximal portion adapted to aid in locating the IM nail, and the distal portion adapted to be coupled to at least one element. For some applications, the distal portion is adapted to be coupled to the at least one element, the at least one element being selected from the list consisting of: a nail, a screw, a pin, and a sleeve. In an embodiment, the distal portion defines at least one hole therethrough, and including a sleeve, which includes a locking mechanism, which locking mechanism is adapted to engage the hole when the sleeve is inserted in the hole, such engagement preventing rotational and longitudinal movement between the sleeve and the hole. There is additionally provided, in accordance with an embodiment of the present invention, a method for treating a fracture of a bone of a subject, including: inserting, in a medullary canal of the bone of the subject, an intramedullary (IM) nail having a proximal head that defines at least one hole therethrough; inserting a sleeve in the hole; and locking the sleeve to the hole by moving the sleeve within the hole, so as to prevent rotational and longitudinal movement between the sleeve and the hole. There yet additionally provided, in accordance with an embodiment of the present invention, a method for treating a fracture of a bone of a subject, including inserting, in a medullary canal of the bone of the subject, an intramedullary (IM) nail having a proximal head having a distal portion and a proximal portion, the distal portion having a distal diameter, and the proximal portion having a proximal diameter less than or equal to about 80% of the distal diameter. There is still additionally provided, in accordance with an embodiment of the present invention, a method for treating a fracture of a bone of a subject, including implanting an intramedullary (IM) nail in the bone, such that no portion of the IM nail extends to an external surface of the bone. There is also provided, in accordance with an embodiment of the present invention, a method for locating an intramedullary (IM) nail implanted in a bone of subject, the IM nail having a proximal head that defines one or more holes therethrough, the method including temporarily coupling one or more connecting elements to respective ones of the holes, in a manner that brings a location indicating element to a position from which the location indicating element indicates a location on an external surface of the bone substantially directly over a location of a proximal end of the proximal head, when no portion of the IM nail extends to the external surface of the bone. For some applications, the method includes coupling the connecting elements to the location indicating element. There is further provided, in accordance with an embodiment of the present invention, a method for locating an intramedullary (IM) nail implanted in a bone of a subject, the IM nail having a proximal head that has a proximal end, the proximal head defining at least one hole therethrough, the method including inserting a bendable, resilient elongated element, having a sharp tip, (a) into the hole, (b) through at least a portion of a longitudinal channel defined by the proximal head, the channel open to the hole and to the proximal end, (c) through the proximal end of the proximal portion, and (d) through the bone, so as to indicate a location on an external surface of the bone substantially directly over the proximal end of the proximal head, when no portion of the IM nail extends to the external surface of the bone. There is yet further provided, in accordance with an embodiment of the present invention, a method for treating a fracture of a bone of a subject, including: inserting, in a medullary canal of the bone of the subject, an intramedullary (IM) nail having a proximal head having a distal portion and a proximal portion, the proximal portion visually discrete from the distal portion; positioning the proximal portion to aid in locating the IM nail; and coupling at least one element to the distal portion. There is still further provided, in accordance with an embodiment of the present invention, apparatus for use with an intramedullary (IM) nail implanted in a bone of subject, the IM nail having a proximal portion and a distal portion that defines one or more holes therethrough, the apparatus including: a support, adapted to be coupled to the proximal portion; a pin, adapted to be inserted through, at any given time, one of the holes and into the bone in a vicinity of a fracture of the bone; and a multi-axial control element, adapted to be coupled to the support and to the pin, and to move the pin translationally and rotationally, so as to reduce and align the fracture, respectively. Typically, the multi-axial control element includes a biaxial control element, which is adapted to move the pin in a cephalad direction and rotationally, so as to reduce and align the fracture, respectively. In an embodiment, the biaxial control element includes a first member and a second member, both coupled to the support, the first and second members including a first set screw and a second set screw, respectively, the first and second set screws adapted to: move the pin in the cephalad direction when both of the first and second set screws are rotated substantially simultaneously, and move the pin rotationally when exactly one of the first and second set screws is rotated. For some applications, the biaxial control element includes a shaped element coupled to at least one of the set screws, such that rotation of the at least one of the set screws in a first direction induces movement of the pin in the cephalad direction, and such that rotation of the at least one of the set screws in a second direction, opposite to the first direction, induces movement of the pin in the caudal direction. The holes are typically elongated in parallel with a longitudinal axis of the IM nail. There is also provided, in accordance with an embodiment of the present invention, apparatus for treating a fracture of a bone of a subject, including: an intramedullary (IM) nail, adapted to be implanted in an intramedullary canal of the bone, the IM nail including a proximal portion and a distal portion that defines one or more holes therethrough; and an introducer, including: a support, adapted to be coupled to the proximal portion; a pin, adapted to be inserted through, at any given time, one of the holes and into the bone in a vicinity of the fracture; and a multi-axial control element, adapted to be coupled to the support and to the pin, and to move the pin translationally and rotationally, so as to reduce and align the fracture, respectively. There is additionally provided, in accordance with an embodiment of the present invention, apparatus for use with an intramedullary (IM) nail implanted in a bone of subject, the IM nail having a proximal portion and a distal portion that defines one or more holes therethrough, the apparatus including: a support, includes means for coupling the support to the proximal portion; a pin, adapted to be inserted through, at any given time, one of the holes and into the bone in a vicinity of a fracture of the bone; and means for moving the pin translationally and rotationally, so as to reduce and align the fracture, respectively. In an embodiment, the means for moving the pin include means for moving the pin in a cephalad direction and rotationally, so as to reduce and align the fracture, respectively. There is still additionally provided, in accordance with an embodiment of the present invention, a method for treating a fracture of a bone of a subject, the method including: inserting an intramedullary (IM) nail in an intramedullary canal of the bone, the IM nail having a proximal portion and a distal portion that defines one or more holes therethrough; inserting a pin through one of the holes and into the bone in a vicinity of the fracture; temporarily coupling, via at least one intermediary element, a portion of the pin external to a body of the subject to the proximal portion of the IM nail; and moving the pin translationally and rotationally, so as to reduce and align the fracture, respectively. BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which: FIG. 1 is a schematic illustration of an intramedullary (IM) system in place in a femur, in accordance with an embodiment of the present invention; FIG. 2A is a schematic illustration of a head of the IM nail of FIG. 1 , and FIG. 2B is a cross-sectional illustration of the head through the line 2 B- 2 B of FIG. 2A , in accordance with an embodiment of the present invention; FIG. 3 is a schematic illustration of a sleeve for use with the IM system of FIG. 1 , in accordance with an embodiment of the present invention; FIGS. 4A and 4B are cross-sectional illustrations of a head with one of the holes of FIG. 2A through the line 4 A- 4 A of FIG. 2A , in accordance with embodiments of the present invention; FIGS. 5A and 5B are schematic illustrations of a head of an IM nail, in accordance with embodiments of the present invention; FIG. 6 is a schematic illustration of an IM locating tool, in accordance with an embodiment of the present invention; FIG. 7 is a schematic illustration of another IM locating tool, in accordance with an embodiment of the present invention; FIG. 8 is a schematic illustration of an introducer applied to a femur, in accordance with an embodiment of the present invention; FIG. 8A is an enlarged view of the circled portion in FIG. 8 ; and FIGS. 9A and 9B are schematic illustrations of motion of a pin of the introducer of FIG. 8 , in accordance with an embodiment of the present invention. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS FIG. 1 is a schematic illustration of an intramedullary (IM) system 10 in place in a femur 20 , in accordance with an embodiment of the present invention. The IM system comprises an IM nail 30 , having a proximal head 32 and a stem 34 ; at least one screw 40 for securing the IM nail at the head within a femoral head 23 of femur 20 ; and at least one sleeve 50 . Alternatively, another anchoring element, such as a nail or bolt is used, instead of screw 40 . IM system 10 typically further comprises at least one distal anchoring element 60 , such as a screw, nail, or bolt, to secure IM nail 30 at stem 34 within a canal 22 of femur 20 . For some applications, head 32 and/or stem 34 define a longitudinal bore (not shown). FIG. 2A is a schematic illustration of head 32 of IM nail 30 , and FIG. 2B is a cross-sectional illustration of head 32 through the line 2 B- 2 B of FIG. 2A , in accordance with an embodiment of the present invention. Head 32 defines at least one hole 36 , typically two holes, as shown in the figures. Holes 36 are typically oriented in an angled direction toward a femoral head 23 ( FIG. 1 ) relative to a longitudinal axis of IM nail 30 . Reference is again made to FIG. 1 . In an embodiment of the present invention, head holes 36 are adapted to receive respective sleeves 50 , which in turn are adapted to slidably receive screws 40 , so as to permit a threaded portion of the screws to engage femoral head 23 and to allow sliding compression of a femoral neck 24 , an intertrochanteric fracture 25 , and/or a subtrochanteric fracture 26 . FIG. 3 is a schematic illustration of sleeve 50 , in accordance with an embodiment of the present invention. Sleeve 50 comprises a locking mechanism 51 , which engages head hole 36 , preventing rotational and longitudinal movement between sleeve 50 and head hole 36 . The locking mechanism typically comprises a male coupling element, such as a tab 52 fixed to the outer surface of a depressible tongue 54 , which is adapted to flex inwards toward the center of the sleeve when pressure is applied thereto. When the pressure is removed, tab 52 engages female coupling element, such as a notch 72 of hole 36 , as described hereinbelow with reference to FIG. 4A . It is noted that in embodiments of the present invention, prevention of rotational and longitudinal movement between sleeve 50 and head hole 36 is not obtained by simply pressure-fitting the sleeve in the hole, or by simply screwing the sleeve in the hole, either of which generally would result in gradual loosening of the sleeve over time. In addition, sleeve 50 typically is shaped to define at least one cutout 56 to receive a screwdriver used by the surgeon to align the tab with the notch, as described hereinbelow with reference to FIGS. 4A and 4B . FIGS. 4A and 4B are cross-sectional illustrations of one of holes 36 of head 32 through the line 4 A- 4 A of FIG. 2A , in accordance with an embodiment of the present invention. An inner grooved surface 70 of hole 36 is shaped to define a notch 72 , which tab 52 engages when sleeve 50 is inserted into hole 36 and properly aligned, thereby locking sleeve 50 to hole 36 . In the embodiment shown in FIG. 4A , the radius R 1 of grooved inner surface 70 adjacent to notch 72 is less than the maximum radius R 2 of inner surface 70 in a region further away from notch 72 . To insert sleeve 50 into hole 36 and engage locking mechanism 51 , the surgeon typically first rotationally orients the sleeve so that tab 52 is aligned with a region of hole 36 having maximum radius R 2 , for example at the upper portion of hole 36 . The surgeon then inserts the sleeve in the hole until tab 52 of sleeve 50 meets the upper portion of hole 36 , which blocks further insertion of the sleeve. The surgeon then rotates the sleeve so that tab 52 approaches notch 72 . As tab 52 approaches notch 72 , tab 52 (and tongue 54 ) is gradually depressed by inner surface 70 , until the tab reaches the notch and the tongue springs back into its original position, forcing the tab into the notch, and locking it therein. Such a locking mechanism is generally impervious to loosening under cyclical loading, even over the course of many years. By contrast, two pieces which are attached without a locking mechanism (e.g., by being screwed together or wedged together) are susceptible to gradual loosening over time. In the alternate embodiment shown in FIG. 4B , the radius R 3 of inner surface 70 adjacent to notch 72 is substantially equal to the maximum radius R 2 of inner surface 70 . Hole 36 in this alternate embodiment is typically flared, such that the tab is depressed during insertion of sleeve 50 into hole 36 . Insertion of sleeve 50 into hole 36 in this alternate embodiment does not necessarily include rotation of sleeve 50 (as is described with reference to FIG. 4A ). FIG. 5A is a schematic illustration of a head 132 of IM nail 30 , in accordance with an embodiment of the present invention. In this embodiment, head 132 of IM nail 30 comprises a distal portion 180 , which includes one or more head holes 136 , and a proximal portion 182 . Proximal portion 182 is adapted to aid in locating IM nail 30 , while distal portion 180 is adapted to be coupled to at least one element, such as a nail, screw, or a sleeve. Proximal portion 182 is visually and structurally distinct from distal portion 180 . Alternatively or additionally, proximal portion 182 has a diameter D 1 that is less than a diameter D 2 of distal portion 180 adjacent to proximal portion 182 . For some applications, diameter D 1 is between 50% and about 80% of diameter D 2 , or is less than about 50% of diameter D 2 . For some applications, diameter D 1 is between about 25% and about 50% of diameter D 2 . Typically, for IM nails intended for use in adults, diameter D 1 is between about 5 mm and about 10 mm, and diameter D 2 is between about 11 mm and about 17 mm. A length L 1 of proximal portion 182 is typically equal to between about 10% and about 50% of a length L 2 of head 132 . For example, length L 1 may be between about 10 mm and about 35 mm, and length L 2 may be between about 40 mm and about 60 mm, in IM nails intended for use in adults. Although head 132 is shown in the figures as narrowing suddenly, for some applications the diameter of the head decreases gradually from D 2 to D 1 . For some applications, such as for use in conjunction with the techniques described hereinbelow with reference to FIG. 6 or 7 , (a) proximal portion 182 is removable, in which case the surgeon typically removes the proximal portion after implanting IM nail 30 , or (b) head 132 does not comprise proximal portion 182 , so that head 132 does not extend to the surface of femur 20 . FIG. 5B is a schematic illustration of head 132 of IM nail 30 , in accordance with an embodiment of the present invention. In this embodiment, a longitudinal axis of proximal portion 182 is oriented at an angle β with respect to a longitudinal axis of distal portion 180 . Angle β is typically between about 4 and about 40 degrees, in this embodiment. Optionally, a proximal surface 190 of distal portion 180 is oriented at an angle α with respect to the longitudinal axis of distal portion 180 . Angle α is typically between about 4 and about 40. During an implantation procedure, IM nail 30 is typically inserted into femur 20 so that a proximal end 184 of proximal portion 182 is generally flush with or slightly protrudes from a surface region 27 of femur 20 in a vicinity of the greater trochanter or the piriformis ( FIG. 1 ). As a result, a surgeon generally can readily locate the IM nail if post-operative access to the implant becomes necessary. In addition, such a narrower proximal portion typically allows greater regrowth and healing of the neck of the femur towards the area of the greater trochanter, than generally occurs upon implantation of conventional IM nail heads. For some applications, IM nail 30 comprises both narrower proximal portion 182 and locking mechanism 51 , as described hereinabove. For other application, the IM nail comprises only one of these features, but is generally otherwise conventional. FIG. 6 is a schematic illustration of an IM locating tool 200 , in accordance with an embodiment of the present invention. In this embodiment, proximal portion 32 of IM nail 30 does not extend to surface region 27 of femur 20 . Without the use of IM locating tool 200 , it is sometimes difficult for the surgeon to locate proximal portion 32 of IM nail 30 if post-operative access to the implant becomes necessary. A distal end 220 of the locating tool comprises or is removably coupled to one or more connecting elements 240 , which typically comprise a locking mechanism similar to locking mechanism 51 , for locking to IM nail 30 , as described hereinabove with reference to FIG. 3 . Alternatively, connecting elements 240 comprise another locking mechanism, such as protrusions, clips, or pegs. To use the locating tool, the surgeon temporarily couples connecting elements 240 to respective head holes 36 of IM nail 30 . For some applications, the surgeon performs this coupling by removing any sleeves or screws present in holes 36 , and inserting a sleeve (not shown), which may be similar to sleeve 50 described hereinabove with reference to FIG. 3 , into each hole 36 . The surgeon then couples each connecting element 240 to one of the sleeves. Alternatively, connecting elements 240 are directly coupled to head holes 36 . In either case, after the connecting elements are in a fixed position with respect to IM nail 30 , tool 200 is typically placed or slid onto the connecting elements, so as to assume a known, rigid position with respect thereto. (In embodiments in which connecting elements 240 are an integral part of tool 200 , this step is not necessary.) The use of at least two connecting elements 240 provides for a known, fixed orientation of IM locating tool 200 with respect to IM nail 30 . For applications that use only a single connecting element 240 , means are provided for ensuring a fixed rotational angle between connecting element 240 and hole 36 , thereby providing a known, fixed orientation of IM locating tool 200 with respect to IM nail 30 . For example, such means may include a slot in hole 36 . Typically, coupling IM locating tool 200 to IM nail 30 automatically positions a proximal end 230 of the locating tool so as to indicate a site 228 of surface region 27 substantially directly over proximal portion 32 of the IM nail. The surgeon typically uses knowledge of the location of site 228 in order to determine an appropriate location at which to drill. For some applications, proximal end 230 comprises means for guiding a marking device 250 or drill, such as a hole through which the marking device or drill is inserted. FIG. 7 is a schematic illustration of an IM locating tool 300 , in accordance with an embodiment of the present invention. An IM nail 302 comprises a proximal portion 304 which does not extend to a surface region 306 of a femur 308 . The proximal portion defines one or more head holes 310 , and a longitudinal channel 312 open to at least one of the head holes and to a proximal end 314 of proximal portion 304 . Without the use of IM locating tool 300 , it is sometimes difficult for the surgeon to locate proximal portion 304 of IM nail 302 if post-operative access to the implant becomes necessary. IM locating tool 300 comprises an elongated element that is both bendable and resilient, i.e., is able to bend while maintaining longitudinal strength. A tip 316 of tool 300 is sufficiently sharp to pass through femur 308 . In order to locate a site 318 of surface region 306 substantially directly over proximal portion 304 of the IM nail, the surgeon inserts tool 300 , sharp end first, into one of head holes 310 . The surgeon guides the tool through channel 312 , so that the tool bends to conform with the channel. After pushing the tool so that tip 316 reaches the end of channel 312 at proximal end 314 , the surgeon continues to push with sufficient force so that tip 316 punches through femur 308 and emerges from surface region 306 at site 318 , thereby externally indicating the location of the site. Alternatively, tip 316 is threaded, and the surgeon rotates tool 300 so as to screw tip 316 through femur 308 . Further alternatively, tool 300 comprises a flexible drill bit, and the surgeon drills the tool through femur 308 . The surgeon typically uses knowledge of the location of site 318 attained through use of tool 300 in order to determine an appropriate location at which to drill during post-operative access to the IM nail. Reference is now made to FIGS. 8 and 8A , which are schematic illustrations of an introducer 400 applied to a femur 402 , in accordance with an embodiment of the present invention. Introducer 400 is adapted to actively reduce and align a fracture 404 of femur 402 , such as a subtrochanteric fracture, while generally minimizing the required size of an incision in the vicinity of the fracture. Introducer 400 comprises a support 406 , a coupling element 408 , and a multi-axial control element, such as a biaxial control element 410 . Coupling element 408 is adapted to couple introducer 400 to an IM nail 412 , which is inserted into a medullary canal 414 of femur 402 . For example, coupling element 408 may comprise a male element adapted to be inserted into a hole defined by a proximal end of a proximal head 416 of IM nail 412 . Other coupling mechanisms used by conventional introducers may also be used. One or more neck screws 420 secure the IM nail at the head within a femoral head 422 of femur 402 . Introducer 400 is typically shaped so as to define one or more holes (not shown) for guiding respective neck screws 420 during their insertion into femoral head 422 . Introducer 400 is shaped to facilitate use with a pin 424 . During a procedure (which is generally performed using real-time imaging, such as fluoroscopy), pin 424 is inserted through femur 402 and through an elliptical or otherwise elongated hole 426 , defined by a distal region 428 of IM nail 412 in a vicinity of fracture 404 , such that the fracture is between the pin and coupling element 408 . For some applications, pin 424 is threaded in a vicinity of a bone-penetrating tip 430 thereof and/or in a vicinity of one or both regions 432 thereof that pass through femur 402 . Pin 424 typically has a diameter of between about 3 and about 6 mm, typically between about 4 and about 5 mm. Reference is now made to FIGS. 9A and 9B , which are schematic illustrations of motion of pin 424 , in accordance with an embodiment of the present invention. Biaxial control element 410 is adapted to move pin 424 along two axes, as follows: translationally, for example, in a cephalad (anterior) direction toward support 406 (i.e., in the direction generally indicated by arrow 434 ). In this manner, bone-penetrating tip 430 and a physician-manipulated end 436 of pin 424 generally move equal distances ( FIG. 9A ). Such cephalad movement serves to reduce fracture 404 ; and rotationally, such that bone-penetrating tip 430 and physician-manipulated end 436 move in opposite directions, i.e., tip 430 moves closer to or further away from support 406 in one of the directions generally indicated by arrow 438 , while end 436 moves in the opposite direction ( FIG. 9B ). Such rotational movement serves to properly align fragments 440 and 442 of femur 402 with one another ( FIG. 8 ). Elongated hole 426 typically has a length of about 10 mm to about 12 mm. Pin 424 is typically inserted through elongated hole 426 near a distal end thereof, which allows substantial rotation and cephalad motion of the pin before the pin comes in contact with a proximal end of the hole, e.g., about 10 mm of motion. ( FIG. 8 shows the pin already at the proximal end of hole 426 .) Reference is again made to FIGS. 8 and 8A . After fracture 404 has been reduced and aligned, a screw (not shown) is typically screwed through a hole 444 , defined by distal region 428 of IM nail 412 , into fragment 440 , in order to fix IM nail 412 to fragment 440 . Hole 444 is typically circular and positioned distally to elongated hole 426 (as shown), or proximal thereto (configuration not shown). Pin 424 is then removed from elongated hole 426 . Optionally, a second screw (not shown) is screwed through elongated hole 426 into fragment 440 to further fix the IM nail to the fragment. In an embodiment of the present invention, distal region 428 of IM nail 412 defines a secondary elliptical or otherwise elongated hole 446 , in a distal vicinity of elongated hole 426 . In this embodiment, after removal of pin 424 from elongated hole 426 , the pin is inserted through secondary hole 446 . Biaxial control element 410 further moves pin 424 in the cephalad direction towards support 406 , in order to further reduce fracture 404 . Typically, about 10 mm of reduction is performed using elongated hole 426 , and up to about an additional 10 mm of reduction is performed using secondary elongated hole 446 , for a total reduction of up to about 20 mm. It has been the inventor's experience that fractures rarely require reduction of more than about 20 mm, after initial reduction with a fracture table. In an embodiment of the present invention, biaxial control element 410 comprises a first member such as a first leg 448 , and a second member such as a second leg 450 , the first and second members comprising set screws 452 and 468 , respectively. The first and second legs each define one or more elliptical or otherwise elongated holes 464 and 458 , respectively. When inserted into elongated hole 426 of IM nail 412 , pin 424 passes through one of holes 464 and one of holes 458 . The pin is initially positioned near respective distal ends of the holes. Tightening set screw 452 pushes the pin towards a proximal end of the one of the holes 464 , while tightening set screw 454 pushes the pin towards a proximal end of the one of the holes 458 . Therefore: tightening both set screws to the same extent and substantially simultaneously moves pin 424 in the cephalad direction towards support 406 ; tightening only set screw 452 rotates pin 424 clockwise, in order to align fragments 440 and 442 ; and tightening only set screw 468 rotates pin 424 counterclockwise, in order to align fragments 440 and 442 . Typically, a combination of such tightening motions is performed in order to reduce and align fracture 440 . It is noted that for some configurations (such as that shown in FIG. 8 ), tightening one of the set screws also induces some net cephalad motion of the center of pin 424 . For some applications, one or both of legs 448 or 450 are removably coupled to support 406 by coupling elements 460 or 462 , respectively (e.g., comprising screws or clips). For example, leg 450 may be removably coupled to support 406 , in which case leg 448 and support 406 are used to insert IM nail 412 into intramedullary canal 414 . The absence of leg 450 during this insertion generally makes introducer 400 easier to manipulate. After insertion of the IM nail, leg 450 is coupled to support 406 . In an embodiment, biaxial control element 410 comprises an optional shaped element, such as shaped element 454 , coupled within biaxial control element 410 so as to provide means for pulling pin 424 (or otherwise inducing motion of pin 424 ) in the caudal direction. Shaped element 454 is coupled via a joint 456 to the proximal tip of set screw 452 . (Alternatively or additionally, a shaped element is coupled to set screw 452 .) Pin 424 passes through a hole in shaped element 454 , such that joint 456 allows set screw 452 to rotate while shaped element 454 substantially does not rotate. In addition, joint 456 couples shaped element 454 and set screw 452 such that movement of either one along the proximal/distal axis induces movement of the other one in the same direction. In particular, distal (caudal) motion of set screw 452 causes corresponding caudal motion of pin 424 . (By contrast, in embodiments not having shaped element 454 or equivalents thereof, proximal motion of set screw 452 causes cephalad motion of pin 424 , while distal motion of set screw 452 does not induce any substantial motion of pin 424 .) It is noted that the configuration and shape of shaped element 454 shown in FIG. 8 is by way of illustration and not limitation. A person of ordinary skill in the art of mechanical design, having read the disclosure of the present patent application, would be able to develop other substantially equivalent means for providing cephalad and caudal motion of pin 424 . In an embodiment of the present invention, introducer 400 is used in conjunction with a surgical plate having one or more elliptical or otherwise elongated holes through which pin 424 is inserted (configuration not shown). The plate is secured to the outside of femur 402 in a position suitable for reducing fracture 404 and for aligning fragments 440 and 442 . For this embodiment, techniques described hereinabove with reference to FIGS. 8 , 9 A, and 9 B are adaptable for use with the surgical plate, in a manner which would be readily ascertainable by one skilled in the art to which this invention pertains. It will be appreciated that although some embodiments of the present invention have been shown and described herein for use in a femur, these embodiments may be adapted for use in other long bones of the extremities, such as the tibia and humerus, in a manner which would be readily ascertainable by one skilled in the art to which this invention pertains. It will also be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

Apparatus for treating a fracture of a bone of a subject including an intramedullary (IM) nail insertable into a medullary canal of the bone of the subject. The IM nail has a proximal head that defines at least one hole therethrough. A sleeve, which includes a locking mechanism, is engaged with the hole when the sleeve is inserted in the hole. This engagement prevents rotational movement between the sleeve and the nail and inward and outward longitudinal movement of the sleeve relative to the nail.

SUMMARY OF THE INVENTION An object of my invention is to provide a spray manifold for a commercial dishwasher that can be quickly mounted in the machine without the need to use any tools and novel means supports both ends of the hollow manifold, one end being connected to a hot water supply and the other end being supported by an adjustable self sealing cap. The spray manifold nozzles are automatically and correctly positioned to direct the hot water against the ware in the racks and this is accomplished when mounting the manifold in the dishwasher. The manifold has a smooth unobstructed interior that is coextensive with its length and this permits the manifold to be readily cleaned or examined when it is removed from the machine. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a side elevation of the spray manifold and shows how it is removably supported in a dishwasher, a portion of the dishwasher being shown in section. FIG. 2 is an enlarged transverse section through the rear portion of the spray manifold and is taken along the line 2--2 of FIG. 1. The novel means for supporting this rear manifold end is shown in elevation. FIG. 3 is a longitudinal vertical section taken along the line 3--3 of FIG. 2 and shows the apparatus for connecting the manifold rear end to a hot water supply pipe and illustrates how the manifold spray nozzles are held at a desired angle for spraying the ware in the racks. FIG. 4 is a horizontal longitudinal section taken along the line 4--4 of FIG. 3, and further illustrates how the spray manifold is held in the desired position so that the spray nozzles will direct hot water at the desired angle against the ware in the racks. FIG. 5 is an enlarged vertical section of the front manifold end shown in FIG. 1, and illustrates how the self sealing cap for this front end also supports the manifold. FIG. 6 is a front elevation of the closure cap and is taken along the line 6--6 of FIG. 5. DESCRIPTION OF THE PREFERRED EMBODIMENT In carrying out my invention I show in FIG. 1, a transverse section through a commercial dishwashing machine indicated generally at A. The machine has a dish-receiving compartment B, in which the ware may be washed, rinsed and sterilized. Since the novelty in the present invention lies in the particular shape of the spray manifold and the means for quickly mounting it in the compartment B, or removing it therefrom, I have not shown in detail how the ware is moved into and out from the compartment because this may be done by hand or by a mechanism. The rear wall 1 of the compartment B has a hot water inlet pipe C, and if the compartment is used for washing the ware, the hot water should be at a temperature of 140° F., and the detergent may be mixed with this hot water and then pumps, not shown, may be used for recirculating the wash water for a predetermined time period. On the other hand, if the compartment is used for rinsing and sterilizing the ware at a low temperature of 140° F., for the hot water, a sterilizing agent such as chlorine, is mixed with the hot water and the water is recirculated for a predetermined time period in the compartment. In my copending patent application on a Low Temperature Conveyor Rack-Type Dishwasher, Ser. No. 26,016, filed Apr. 2, 1979, I show the rinse compartment divided into two sections, the first section using hot rinse water at 140° F., for removing the detergent wash water from the ware and the second section using chlorine in the 140° F., rinse water for rinsing and sterilizing the ware. I will now describe in detail the particular structure of the hot water inlet pipe C and the novel means for removably supporting the inlet end of a spray manifold shown at D, in FIGS. 1, 2 and 3. The hot water inlet pipe C, is arranged in a vertical position and is in communication with a source of hot water, not shown. The top of the hot water inlet pipe C, is closed at 4, see FIG. 3, and the front portion of the pipe has a hot water outlet opening 5 therein. A U-shaped bracket E, see FIG. 2 and FIG. 4, has its web portion 6 extending across the front portion of the pipe C and it has an opening 7 that registers with the opening 5 in the inlet pipe. The bracket E, is secured to the wall 1 of the dishwasher A by bolts 8 or other suitable fastening means. A support F for the inlet end of the spray manifold D, is secured to the web portion 6 of the bracket E by bolts 9. Both FIGS. 3 and 4 show the spray manifold support F provided with a conical-shaped outlet 10 that is in alignment with the openings 5 and 7 of the hot water inlet pipe C, and the bracket E, respectively. The inlet end of the spray manifold D has an outwardly flared portion 11 that receives the conical-shaped outlet 10 of the manifold support F, and makes a water tight seal therewith. The spray manifold has a plurality of jet nozzles G, arranged in a straight row and spaced from one another as shown in FIG. 1. I provide novel cooperating means on the spray manifold support F, and the spray manifold D for arranging the row of jet nozzles G, in the proper angular position when the inlet end 11 of the spray manifold is coupled to the conical outlet 10 of the manifold support. The particular structure of the hot water pipe C, and the bracket E, may be altered without affecting one of the vital features in this invention. The point to keep in mind is that the support F for the inlet end of the spray manifold D, is anchored in a specific place in the compartment B of the dishwasher and the support F not only has a conical outlet 10 that is in communication with and receives hot water from the hot water inlet pipe C, but in addition, the support has an integral guide wing 12 shown in detail in FIGS. 3 and 4, that underlies a portion of the inlet end 11 of the spray manifold D. Also, the guide wing 12 has a central recess 13 with outwardly curved side edges 14 that will guide a pin 15, which depends from the manifold D, into the recess as clearly shown in FIG. 4. The center of the guide wing recess 13 lies in a vertical plane in which the longitudinal axis of the manifold D, also lies. The axes of the jet nozzles G, lie in the same vertical plane in which the pin 15 lies. The result is that the mere coupling of the flared inlet end 11 of the manifold D to the conical outlet 10 of the manifold support F will also properly align the row of jet nozzles G, at the correct angle because the coupling cannot be made until the pin 15 is received in the guide wing recess 13. I have illustrated the spray manifold D, in FIGS. 3 and 4, as directing the hot water spray downwardly from the jets G, because in this case the manifold is positioned above the dish ware, not shown, in the compartment B. It is also possible to place this spray manifold D below the dish ware in the compartment and when this is done, the manifold support F, is rotated about the axis of the conical outlet 10 through a full 180° arc so that the guide wing recess 13 will be positioned above the manifold and the manifold will have to be rotated 180° on its axis for causing the pin 15 and the jet nozzles G to project upwardly and cause the jets G to point upwardly for causing the hot water to contact the dish ware from the underside. In actual practice there will be at least one spray manifold D placed above and one manifold placed below the dish ware for directing the hot water downwardly and upwardly against the dishes and my invention is broadly drawn to include both arrangements of the manifold or either one. The apparatus for supporting and closing the front end of the spray manifold D, is shown in FIGS. 1 and 5. An arm H, is connected to the top 16 of the dish washer A by bolts 17 or other suitable fastening means. The arm has a downwardly inclined portion 18 and FIG. 5 shows this portion as having an integral boss 19 with a threaded bore 20 whose axis lies in a horizontal plane. A closure cap J, for the front end of the spray manifold D, has an axially aligned and integral threaded rod 21 that is received in the threaded bore 20 in the boss 19. The cap has a conical-shaped central portion 22 that protrudes from the interior of the cap and whose center is in alignment with the axis of the rod 21. This conical portion 22 is received in the outwardly flared front end 23 of the spray manifold D, and will make a liquid tight seal with the manifold as well as support it. The cap J may be connected to or disconnected from the front end of the spray manifold D, without the need of any tools. The cap has an integral and outwardly flared skirt or rim 24 and this rim has scallops 25 therein to permit the operator's fingers to grip the rim for rotating the cap in one direction for connecting the cap to the front end of the manifold for closing and supporting the manifold or for rotating the cap in the opposite direction for freeing the cap from the manifold. The axis of the threaded rod 21 of the closure cap J, is in horizontal alignment with the center of the conical outlet 10 of the manifold support F so that when the manifold D is supported at its outwardly flared forward end 23 by the closure cap J and is supported at its hot water inlet end by the conical outlet 10 of the manifold support F, the axis of the manifold will be in alignment with the axis of the threaded rod 21 and with the center of the conical outlet 10. In addition, the manifold D will have a water tight seal between the cap conical portion 22 on the cap and the outwardly flared forward end 23 of the manifold as well as have a water tight seal between the conical outlet 10 of the support for the inlet end of the manifold and the outwardly flared end 11 of the manifold. A rotation of the cap J, in one direction will accomplish this and will move the manifold against the conical outlet 10. Therefore a rotation of the cap in one direction will cause the manifold to be supported at both of its ends as well as water sealed at both of its ends. When the cap is rotated in the opposite direction, the spray manifold will be freed at both of its ends and may be removed for inspection and cleaning. The hollow cylindrical interior of the manifold is unobstructed throughout its entire length so that a cleaning brush or cloth can be used for cleaning purposes. This is one of the novel features of my present invention and the other feature is the automatic aligning of the spray jets G, so that they will be held at the proper angle for spraying the hot water either downwardly against the dish ware or upwardly against them or both. It should be noted from FIGS. 2 and 4 that the support F, for the inlet end 11 of the spray manifold D, has arcuate-shaped slots 26 for receiving the shanks of the bolts 9. The center for these arcuate slots coincides with the axis of the opening 7 in the bracket E. It is possible with this structure to loose the bolts 9 and rotate the support F, clockwise or counterclockwise through a desired angle so as to swing the guide wing 12 and its guide slot 13 to the right or to the left of a vertical plane that extends through the common axis of the openings 5, 7 and 10. Now when the manifold D, is connected to the member F, the manifold must be rotated on its longitudinal axis to swing the pin 15 into alignment with the guide slot 13 whereupon the manifold can be moved to cause the pin 15 to enter the guide slot. In this simple manner, the nozzles G on the manifold D will be inclined at the desired angle.

A removable and self sealing spray manifold that has an unobstructed cylindrical interior extending throughout its entire length. Novel self sealing and manifold supporting means is provided at each end of the manifold. The rear end supporting means for the manifold connects the manifold to a hot water inlet pipe and includes means for correctly positioning the spray nozzles for directing the hot water against the ware in the racks. The means for supporting the front manifold end includes a self-sealing cap that can be removably connected to the manifold without the need of using any tools.

Latin name of the genus and species: The mandarin cultivar of this invention is botanically identified as Citrus reticulata. Variety denomination: The variety denomination is ‘KinnowLS’. BACKGROUND OF THE INVENTION ‘KinnowLS’ is a mandarin selection developed at Riverside, Calif. and derived from an irradiated bud of the diploid mandarin cultivar ‘Kinnow’ (unpatented), a mid-to-late season maturing variety. ‘Kinnow’ is a hybrid of two Citrus cultivars, ‘King’ (unpatented, Citrus reticulata ‘Blanco’) and ‘Willowleaf’ (unpatented, Citrus reticulata ‘Blanco’), which was first developed by H. B. Frost in Riverside, Calif. After evaluation, the ‘Kinnow’ was released as a new variety for commercial cultivation in 1935. Irradiation of budwood from registered ‘Kinnow’ trees in Exeter, Calif., was accomplished in June of 1997 in Riverside, Calif. Specifically, irradiation of 150 buds of ‘Kinnow’ mandarin was accomplished using 40 Gray units of gamma irradiation from a Cobalt-60 irradiation source. Buds from this irradiation were propagated onto Carrizo rootstocks in a greenhouse in Exeter, Calif. where they were grown to field-plantable-sized trees. Out of these irradiations, a total of 73 trees were obtained. This low yield of trees is typical because the radiation kills many of the buds. These trees were then planted in May 1998 in Exeter, Calif. Fruit production and evaluation began in 2001. One selection from this irradiated population (propagated on Carrizo rootstock) distinguished itself from the others in having tree growth typical of ‘Kinnow’ mandarin, very low seed counts in comparison to the original ‘Kinnow’ cultivar, and excellent fruit quality and normal fruit production characteristic of the ‘Kinnow’ parent. After two seasons of fruiting, this selection was given the name ‘Kinnow IR5’ and selected for further trials. In January 2003, buds of this selection were taken and propagated onto Carrizo and C35 citrange rootstock for field trials. In June of 2004, 72 trees, produced in Exeter, Calif., were planted at six sites (twelve trees at each site): Arvin, Irvine, Lindcove, Thermal, Riverside, and Woodlake, Calif. All trials were propagated equally on Carrizo and C35 citrange rootstocks. All trials were in mixed-plantings with other cultivars, including seedy cultivars with high pollen viability. Fruit production of these propagated trees commenced in 2006 (a few trees at each site) and 2007 (all trees at all sites). In October 2008, budwood from the selected tree was sent to Exeter, Calif. for evaluation of disease status and, as needed, elimination of viruses and other pathogens. Six trees were then established as disease-free ‘mother’ trees in a greenhouse in Exeter, Calif. The properties of ‘KinnowLS’ were found to be true to type and transmissible by asexual reproduction in comparing these plantings with the original ‘KinnowLS’ selection. BRIEF SUMMARY OF THE INVENTION ‘KinnowLS’ is a mid-season maturing diploid mandarin that combines large-sized fruit of excellent quality and production with low seed content even in mixed plantings. It may be successful in the mid-to-late season marketing window that currently has few low-seeded, high quality cultivars. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows fruit of ‘KinnowLS’ taken at Riverside in February. FIG. 2 shows a side-by-side comparison of (left) ‘KinnowLS’ and (right) ‘Kinnow’. FIG. 3 shows the eleven-year old mother tree on Carrizo citrange rootstock. FIG. 4 shows a three-year old ‘KinnowLS’ tree in Exeter, Calif. FIG. 5 shows the bud union of ‘KinnowLS’ on ‘Carrizo’ citrange rootstock, eleven-years old. FIG. 6 shows fruit clusters on a three-year old ‘KinnowLS’ tree in Exeter, Calif. in the month of February. FIG. 7 shows leaves of ‘KinnowLS’. FIG. 8 shows open and closed flowers of ‘KinnowLS’. DETAILED DESCRIPTION OF THE INVENTION ‘KinnowLS’ is a mandarin selection developed at Riverside and Exeter, Calif. by mutation breeding of the mandarin cultivar ‘Kinnow’, for which harvest is typically begun from mid-January to mid-February, depending on location. Evaluation of ‘KinnowLS’ began on the original tree at Exeter, Calif. in 2001 and has continued annually until the present. ‘KinnowLS’ has been asexually reproduced by grafting (budding), using the standard T-bud method generally used to propagate Citrus in California. Asexual propagation of the selected tree was first accomplished in January 2003 at Exeter, Calif. to produce 72 trial trees on Carrizo and C35 rootstocks. ‘KinnowLS’ distinguishes itself by being low seeded (2-3 seeds/fruit) in all situations of cross-pollination, while ‘Kinnow’ has 15-30 seeds per fruit in cross-pollinated situations. At Riverside, Calif. ‘KinnowLS’ matures in winter (mid-January) and holds its fruit quality characteristics through April. Fruit size is large for mandarins, classed as Jumbo by State of California standards and size 21 for industry packing standards. Fruit are oblate in shape with an orange rind color and a very smooth rind texture. Flesh is deep orange in color and finely-textured. Fruit are easy to peel and juicy, with a rich, sweet and distinctive flavor when mature. Tree growth habit is vertical and vigorous, producing a large and rather dense upright crown with excellent production commencing in the third year after planting. ‘KinnowLS’ is well adapted to growing in all California climate zones normally associated with Citrus , including desert regions, because the fruit, which matures during January through April at most locations, does well in hot climates where it matures in December. Alternate bearing can be a problem in trees that are not culturally managed to reduce this tendency. ‘KinnowLS’ mandarin can be grown according to accepted cultural practices for larger, more vigorous mandarin varieties, including planting densities of 180-250 trees per acre, normal fertilization and pest control practices, and the use of standard rootstocks for mandarins. Other rootstocks adapted to more marginal growing conditions of salinity, high pH or very heavy soils, including the lemon types C. macrophylla , Volkameriana, and rough lemon, may be useful in those conditions but overall fruit quality would likely be affected negatively. Sour orange or mandarin type rootstocks such as Cleopatra might be more suitable in these marginal conditions since fruit quality would not be affected to the extent the lemon-type rootstocks impart. ‘KinnowLS’ is a very vigorously growing tree and therefore pruning will likely be necessary to control this vigor. Such pruning should include topping the trees to control vertical growth and selective interior pruning to enhance production and health of the tree. These pruning procedures can be applied after the second year of full fruit production and regularly thereafter. The Royal Horticulture Society (R.H.S.) color numbering system is used herein for the color description of the rind, seed, bark, leaf, flower, flesh color and other interest of the ‘KinnowLS’ mandarin cultivar. Comparison With Existing Mandarins A comparison of ‘KinnowLS’ with other low-seeded late-season mandarins is provided in Table 1 below. ‘KinnowLS’ is distinctive in having a very wide climatic growing area (including very hot desert areas), excellent production (though some tendency to alternate bear), and fruit quality characteristics (large size, shape, very smooth rind texture, and very rich, sweet flavor) that may be preferred in some markets. TABLE 1 Comparison of ‘KinnowLS’ with other late season, low-seeded mandarins. Data for Riverside, California. ‘TDE2’ ‘TDE3’ (U.S. Plant Pat. (U.S. Plant Trait ‘KinnowLS’ No. 15,461) Pat. No. 15,703) Maturity Mid-February February January-February Seeds per fruit 2.45 0.02 0.29 RHS rind color Orange 25A Orange-Red Orange-Red N30D N30C Rind texture very smooth slight pit papillate Fruit weight (g) 145 185 134 Fruit 0.81 0.78 0.85 height/width Alternate medium-high medium medium-high bearing ‘TDE4’ ‘Tango’ (U.S. Plant Pat. ‘Gold Nugget’ (U.S. Plant Trait No. 16,289) (unpatented) Pat. No. 17,863) Maturity February February-March February Seeds per fruit 0.32 <0.1 0.22 RHS rind color Orange-Red Orange 25A Orange N25A N30C Rind texture smooth bumpy smooth Fruit weight (g) 175 108 90 Fruit 0.78 0.88 0.81 height/width Alternate medium-high high medium bearing Trees, Foliage, and Flowers Tree size and growth characteristics of ‘KinnowLS’ have been consistent with those of ‘Kinnow’ throughout the evaluations. Growth of both the ‘Kinnow’ and ‘KinnowLS’ varieties have been quite vigorous throughout the evaluation period, producing large, vertically growing trees with dense crowns. The eleven-year-old ‘KinnowLS’ mother tree at Lindcove, Calif. on Carrizo citrange rootstock, shown in FIG. 3 , is 3.1 m high and 3.0 m wide with an upright, though beginning to spread, crown exhibiting a dense growth habit and yielding a canopy volume of 14.6 m 3 . In comparison, an eleven-year-old ‘Kinnow’ control tree has averaged 3.1 m tall and 2.9 m wide, yielding a canopy volume of 13.7 m 3 on Carrizo citrange rootstock. These trees are smaller than normal because they were in a very high density planting until surrounding trees were removed at 7 years-of-age. In the younger, multi-location trials with more typical tree spacing, five-year-old ‘KinnowLS’ trees on Carrizo rootstock have averaged 3.1 m in height and 2.9 m in diameter with canopy volumes of 13.7 m 3 . Trees on C35 rootstock averaged 3.2 m in height and 3.0 m in diameter with canopy volumes of 15.1 m 3 . Bud unions are slightly benched, as shown in FIG. 5 , resulting in a scion circumference for the eleven-year-old ‘KinnowLS’ mother tree on Carrizo rootstock of 44.5 cm with the rootstock circumference 56.5 cm measured 38 and 18 cm above the soil level, respectively. Scion circumference for five-year-old ‘KinnowLS’ trees on Carrizo rootstock averaged 40.0 cm with the rootstock circumference averaging 50.5 cm when measured about 25 and 15 cm above the soil level, respectively. Scion circumference for five-year-old ‘KinnowLS’ trees on C35 rootstock averaged 41.0 cm with the rootstock circumference averaging 51.5 cm when measured about 25 and 15 cm above the soil level, respectively. Leaves of ‘KinnowLS’, as shown in FIG. 7 , are moderately large for a mandarin (80.8 mm in length×25.5 mm in width), lanceolate in shape and concave in cross-section and are dark-green in color (adaxial — RHS Green 137A, abaxial — RHS Yellow-Green 146B). The leaves have an acute apex with occasional weak emargination and an acute base. Petioles are medium in length (10.1 mm) and normally lack wings. The selection further lacks thorns. As shown in FIG. 8 , flowers of ‘KinnowLS’ are hermaphroditic, borne in clusters, medium in length, with greenish-white (RHS Green White 157D, adaxial and abaxial) petals averaging 13.1 mm in length and 6.2 mm in width, and with about 18 anthers which are yellowish in color (Yellow 13B). The five sepals are rudimentary, yellow-green (RHS Yellow Green 1D) in color and partly fused into a calyx. The free portion of the sepals averages 1.53 mm in length and 1.97 mm in width. The fused portion is about 1.0 mm in length. Pollen is yellowish in color (RHS Yellow 12B). TABLE 2 Tree, leaf, flower and seed characteristics (for eleven-year-old tree) of ‘KinnowLS’ mandarin on Carrizo. 1. Tree height 3.1 m 2. Crown diameter 3.0 m 3. Crown shape/density Upright, spreading with age and dense 4. Scion circumference 44.5 cm 5. Height scion measured 38 cm above soil surface 6. Rootstock circumference 56.5 cm 7. Height Carrizo rootstock 18 cm measured above soil surface 8. Scion circumference z 40.0 cm 9. Rootstock circumference z 50.5 cm 10. Scion circumference y 41.0 cm 11. Rootstock circumference y 51.5 cm 12. Bud-union characteristics Slightly benched (scion diameter (on citrange rootstock) smaller than rootstock) 13. Rootstock-scion compatibility No evidence of incompatibility in trees Carrizo citrange at 11 years old (mother tree) or on C35 citrange at 7 years old (trial trees) 14. Tree vigor Vigorous 15. Bark color RHS Grey-Brown N199A 16. Leaf shape Lanceolate 17. Leaf cross-section Concave 18. Leaf blade length 80.8 mm 19. Leaf blade width 25.5 mm 20. Leaf apex Acute with weak emargination 21. Leaf base Acute 22. Leaf margins Very slightly crenate 23. Leaf abaxial color RHS Yellow-Green 146B 24. Leaf adaxial color RHS Green 137A 25. Petiole length 10.1 mm ± 0.7 26. Petiole width 1.5 mm 27. Petiole wings Absent 28. Petiole color RHS Green 137A 29. Thorniness Not present 30. Inflorescence type Clustered 31. Flowering habit Flowers once per year 32. Flower structure Complete 33. Bud length 12.2 mm (one day before opening) 34. Bud width 7.5 mm (one day before opening) 35. Bud shape oblong (one day before opening) 36. Petal number 5 37. Sepal number 5 38. Petal length 13.1 mm 39. Petal width 6.2 mm 40. Petal apex acute 41. Petal base truncate 42. Petal color (adaxial) RHS Green-White 157D 43. Petal color (abaxial) RHS Green-White 157D 44. Petal shape elliptic 45. Petal margin smooth 46. Sepal number 5 47. Sepal color RHS Yellow-Green 1D 48. Sepal shape partly fused, tips attenuate 49. Sepal length (free portion) 1.53 mm 50. Sepal width 1.97 mm 51. Number of anthers 18 (range 17-20) 52. Anther color RHS Yellow 13B 53. Pollen color RHS Yellow 12B 54. Pollen viability Moderately low (15-25%) z,y Bud union measurements are averages for 5-year-old trial trees on Carrizo z or C35 y measured about 10 cm above (for scion) and 10 cm below (for rootstock) budunion, generally about 15 and 25 cm above soil. Pollen viability for ‘KinnowLS’ is moderately low (15-25% germination) in comparison to ‘Kinnow’ (˜70% germination), and pollen production in comparison to normal ‘Kinnow’ is significantly reduced. These pollen characteristics suggest that ‘KinnowLS’ will not cause appreciable seediness in adjacent varieties. Crosses of ‘KinnowLS’ pollen onto Clemenules and W. Murcott gave low fruit set (6 and 9% respectively) and fruit set from these pollinations had few seeds (average 1.8 and 2.2 seeds/fruit respectively). Fruiting, Fruit and Production Characteristics As shown in FIG. 1 , fruit of ‘KinnowLS’ are oblate in shape with no neck. The fruit has a rounded basal end which is flattened at the stem attachment point with a truncate (slightly depressed) distal end. The fruit is large-sized for a mandarin (classed as Jumbo by State of California standards and size 21 for industry packing standards) averaging 2.7 in (68.0 mm) in diameter and 2.2 in (55.2 mm) in height. Fruit average 0.32 lb (145 g) in weight. It has a very smooth, orange color rind and slightly conspicuous, slightly depressed oil glands. The rind is slightly adherent at maturity and relatively thin, averaging 0.1 in (2.5 mm) in thickness. Fruit peel easily. The fruit interior has a moderately fine flesh texture with 10-11 segments and is quite juicy, averaging 49% juice. Fruit from trees on Carrizo and C35 citrange rootstocks average 12.2-13.9% soluble solids and 1.26-2.09% acid in mid-January at four trial locations in California increasing in soluble solids to 13.5-15.8% with acid decreasing to 0.97-1.98% in mid-February. By mid-March juice averaged 13.3-17.0% soluble solids and 0.80-1.87% acid. Fruit generally continue to increase in soluble solids and decrease in acidity well into April and May at all trial sites. See Tables 4a-4b below for mean and standard deviation of soluble solids, acid and solids/acid ratio for ‘KinnowLS’ on various rootstocks from 2007 to 2009. The earliest recommended harvest date occurs when fruit reach average soluble solids content of at least 12% and an average acid content of less than 1.2%. This may occur as early as late November in hot desert regions (Coachella Valley of Calif.), but can be as late as early April in cool locations (Irvine, Calif.) or years (2008-9). Based on evaluation of an average of 1500 fruit per location, fruit average 2.45 seeds per fruit in the presence of heavy cross-pollination at all locations from 2007 to 2009. Rarely, individual fruit may have 4-7 seeds. In the 2010-11 season one tree was identified with a branch on which most fruit had high seed content (more than 10 seeds/fruit). However, for 5200 fruit sampled from trail trees during 2009-10 and 2010-2011, the percentage of seedy fruit was about 0.06%. Seeds are polyembryonic. See Table 5 below for average number of seeds per fruit for ‘KinnowLS’ and ‘Kinnow’ (control trees) from 2007 to 2009. Seeds are polyembryonic, with a wrinkled surface and greyed yellow seed coat (RHS 161C). Seeds average about 140 mg in weight, with about 10% of seeds much smaller and apparently lacking developed embryos. TABLE 3 Fruit characteristics of ‘KinnowLS’ mandarin at maturity 1. Fruit shape Oblate 2. Fruit diameter 68.0 mm ± 2.8 3. Fruit height 55.2 mm ± 2.1 4. Aspect ratio (height/diameter) 0.81 5. Fruit: shape of basal end Rounded (flattened at stem) 6. Fruit: shape of distal end Truncate (slightly depressed) 7. Fruit: distal end areola Present but faint 8. Fruit: distal end areola diameter 18.8 mm 9. Fruit neck Not present 10. Style Not persistent 11. Rind texture Very smooth 12. Oil glands Slightly conspicuous, slightly depressed 13. Rind Color RHS Orange 25A 14. Rind thickness 2.5 mm 15. Albedo thickness 1.5 mm 16. Albedo color RHS Orange-White 159A 17. Rind adherence Medium-Low 18. Rind separation Slight 19. Flesh (pulp) color RHS Orange N25B 20. Flesh (pulp) texture Moderately fine 21. Number of segments 10-11 22. Axis: structure Semi-solid 23. Axis: size Medium 24. Navel presence Not present 25. # Seeds/fruit (mean) 2.45 (cross-pollinated conditions) 26. Seed embryony Polyembryonic 27. Seed coat color Greyed-Yellow 161C 28. Seed cotyledon color Greyed-Yellow 160C 29. Seed inner coat color Greyed-Brown 199D 30. Seed weight 140 mg 31. Seed length 12.2 mm 32. Seed width 6.0 mm 33. Seed thickness 4.2 mm 34. Fruit weight 145 g 35. % Juice 49.1% 36. % Soluble solids (at peak maturity) 14.7% 37. % Acid (at peak maturity) 1.18% 38. Season of maturity Late (January-May in Northern Hemisphere) 39. Fruit holding ability Excellent (6-8 weeks) on tree past maturity 40. Fruit quality after storage Very Good (5.6° C., 30 days) TABLE 4a Mean of soluble solids, acid and solids/acid ratio for ‘KinnowLS’ on Carrizo and C35 citrange rootstock at four trial sites for the 2007/8 crop year. Tree Age Soluble Soluble Dates In 2008 Solids % Solids % Site Sampled # Trees (yrs) Carrrizo C35 Riverside Jan. 15, 2008 6 4 13.2 13.1 Riverside Feb. 14, 2008 5 4 14.6 14.8 Riverside Mar. 12, 2008 3 4 16.5 16.6 Lindcove Jan. 14, 2008 6 4 13.0 12.8 Lindcove Feb. 12, 2008 6 4 14.5 14.3 Lindcove Mar. 13, 2008 3 4 16.4 16.9 Irvine Jan. 16, 2008 6 4 12.2 12.3 Irvine Feb. 15, 2008 6 4 13.9 13.5 Irvine Mar. 11, 2008 4 4 15.1 14.6 Arvin Jan. 15, 2008 6 4 13.6 13.1 Arvin Feb. 13, 2008 6 4 14.8 14.4 Arvin Mar. 14, 2008 4 4 15.7 15.6 S/A S/A Dates % Acid % Acid Ratio Ratio Site Sampled Carrizo C35 Carrizo C35 Riverside Jan. 15, 2008 1.60 1.66 8.3 7.9 Riverside Feb. 14, 2008 1.41 1.45 10.4 10.2 Riverside Mar. 12, 2008 1.19 1.25 13.7 13.3 Lindcove Jan. 14, 2008 1.29 1.36 10.1 9.4 Lindcove Feb. 12, 2008 1.20 1.26 12.1 11.3 Lindcove Mar. 13, 2008 0.91 0.90 18.0 18.8 Irvine Jan. 16, 2008 1.88 1.69 6.5 7.3 Irvine Feb. 15, 2008 1.50 1.56 9.3 8.7 Irvine Mar. 11, 2008 1.21 1.18 12.5 12.4 Arvin Jan. 15, 2008 1.20 1.23 11.3 10.7 Arvin Feb. 13, 2008 1.03 1.07 14.4 13.5 Arvin Mar. 14, 2008 0.88 0.90 17.8 17.3 TABLE 4b Mean of soluble solids, acid and solids/acid ratio for ‘KinnowLS’ on Carrizo and C35 citrange rootstock at four trial sites for the 2008/9 crop year. Tree Age Soluble Soluble Dates # In 2009 Solids % Solids % Site Sampled Trees (yrs) Carrrizo C35 Riverside Jan. 15, 2009 6 5 15.6 16.5 Riverside Feb. 4, 2009 5 5 15.8 15.8 Riverside Feb. 25, 2009 5 5 16.2 16.5 Riverside Mar. 16, 2009 3 5 16.9 17.0 Lindcove Jan. 13, 2009 6 5 13.4 13.9 Lindcove Feb. 2, 2009 6 5 13.4 14.5 Lindcove Mar. 14, 2009 3 5 14.0 14.4 Lindcove Apr. 1, 2009 3 5 15.6 15.5 Irvine Jan. 7, 2009 6 5 13.7 13.9 Irvine Jan. 26, 2009 6 5 13.5 14.3 Irvine Feb. 24, 2009 6 5 13.4 14.6 Irvine Mar. 16, 2009 4 5 13.4 14.7 Irvine Mar. 30, 2009 4 5 13.4 14.9 Arvin Jan. 14, 2009 6 5 13.3 12.3 Arvin Feb. 3, 2009 6 5 12.6 12.1 Arvin Mar. 14, 2009 4 5 13.3 13.4 Arvin Apr. 1, 2009 4 5 15.3 14.1 S/A S/A Dates % Acid % Acid Ratio Ratio Site Sampled Carrizo C35 Carrizo C35 Riverside Jan. 15, 2009 2.09 2.21 7.5 7.5 Riverside Feb. 4, 2009 1.78 1.98 8.9 8.0 Riverside Feb. 25, 2009 1.68 1.99 9.6 8.3 Riverside Mar. 16, 2009 1.50 1.87 11.3 9.1 Lindcove Jan. 13, 2009 1.26 1.47 10.6 9.5 Lindcove Feb. 2, 2009 1.18 1.17 11.4 12.4 Lindcove Mar. 14, 2009 0.80 0.97 17.5 14.8 Lindcove Apr. 1, 2009 0.70 0.89 22.3 17.4 Irvine Jan. 7, 2009 1.88 2.11 7.3 6.6 Irvine Jan. 26, 2009 1.79 2.62 7.5 5.5 Irvine Feb. 24, 2009 1.64 1.94 8.2 7.5 Irvine Mar. 16, 2009 1.37 1.77 9.8 8.3 Irvine Mar. 30, 2009 1.18 1.59 11.4 9.4 Arvin Jan. 14, 2009 1.17 1.16 11.4 10.6 Arvin Feb. 3, 2009 0.97 1.11 13.0 10.9 Arvin Mar. 14, 2009 0.80 0.87 16.6 15.4 Arvin Apr. 1, 2009 0.76 0.75 20.1 18.8 TABLE 5 Seed counts (average number of seeds per fruit) for ‘KinnowLS’ and ‘Kinnow’ (control trees) at four trial sites over two years, 2007/2008 and 2008/2009. Tree Age # In 2009 Site Selection Trees (yrs) Rootstock Riverside ‘KinnowLS’ 6 5 Carrizo Riverside ‘KinnowLS’ 5 5 C35 Riverside ‘Kinnow’ control 3 5 Carrizo/C35 Lindcove ‘KinnowLS’ 6 5 Carrizo Lindcove ‘KinnowLS’ 6 5 C35 Lindcove ‘Kinnow’ control 3 5 Carrizo/C35 Lindcove ‘KinnowLS’ 1 11 Carrizo (mother tree) Irvine ‘KinnowLS’ 6 5 Carrizo Irvine ‘KinnowLS’ 6 5 C35 Irvine ‘Kinnow’ control 4 5 Carrizo/C35 Arvin ‘KinnowLS’ 6 5 Carrizo Arvin ‘KinnowLS’ 6 5 C35 Arvin ‘Kinnow’ control 4 5 Carrizo/C35 2007/8 2008/9 Mean Seeds/Fruit Mean Seeds/Fruit Site Selection (range/tree) (range/tree) Riverside ‘KinnowLS’ 2.4 (1.6-3.0) 2.3 (2.1-3.0) Riverside ‘KinnowLS’ 2.2 (1.5-2.9) 2.4 (1.9-3.1) Riverside ‘Kinnow’ 18.9 (17.4-20.6) 20.8 (18.8-22.1) control Lindcove ‘KinnowLS’ 2.8 (2.3-3.1) 2.6 (2.2-2.9) Lindcove ‘KinnowLS’ 2.4 (1.7-2.9) 2.5 (2.0-3.0) Lindcove ‘Kinnow’ 26.2 (22.1-27.5) 22.3 (19.7-23.7) control Lindcove ‘KinnowLS’ 2.4 2.1 (mother tree) Irvine ‘KinnowLS’ 2.0 (1.7-2.8) 1.8 (0.8-2.3) Irvine ‘KinnowLS’ 1.9 (1.4-2.6) 2.4 (1.4-2.9) Irvine ‘Kinnow’ 20.6 (17.8-22.1) 18.6 (16.9-19.7) control Arvin ‘KinnowLS’ 1.6 (0.8-1.9) 1.8 (0.9-2.2) Arvin ‘KinnowLS’ 1.4 (1.0-2.0) 1.5 (0.7-2.1) Arvin ‘Kinnow’ 22.1 (18.6-24.5) 17.9 (17.3-18.4) control % Fruit with 0-3 seeds Site Selection (2008/9) Riverside ‘KinnowLS’ 87.3 Riverside ‘KinnowLS’ 88.8 Riverside ‘Kinnow’ control 0 Lindcove ‘KinnowLS’ 86.9 Lindcove ‘KinnowLS’ 90.7 Lindcove ‘Kinnow’ control 0 Lindcove ‘KinnowLS’ (mother tree) 89.1 Irvine ‘KinnowLS’ 86.5 Irvine ‘KinnowLS’ 91.4 Irvine ‘Kinnow’ control 0 Arvin ‘KinnowLS’ 91.2 Arvin ‘KinnowLS’ 87.1 Arvin ‘Kinnow’ control 0 Full fruit production of ‘KinnowLS’ normally begins in the third year after planting, however trees can be precocious and set some fruit in the second year after planting. FIGS. 4 and 6 illustrate fruit production on a three-year old tree. ‘KinnowLS’, is similar to ‘Kinnow’ in reaching high production levels relatively quickly. Mean yield of five year-old trees ranged from 152-211 lb (69-96 kg) on Carrizo rootstock and 165-196 lb (75-89 kg) on C35 rootstock at the four fruiting trial sites. The original ‘KinnowLS’ mother tree at Lindcove, Calif. produced 156 lb (71 kg) in the fifth year and in years 9, 10 and 11 yielded 191, 101, 240 lb of fruit respectively, which indicates that the variety has somewhat of a tendency to alternate bearing. In this respect, it is similar to ‘Kinnow’, which can exhibit severe alternate bearing if the crop is not managed to reduce overproduction in ‘on’ years. TABLE 6 Crop yields for ‘KinnowLS’ and ‘Kinnow’ (control trees) at three trial sites over two years, 2007/2008 and 2008/2009 Tree Age 2007/8 # in 2009 Mean Site Selection Trees (yrs) Rootstock Yield (kg) Riverside 'KinnowLS’ 6 5 Carrizo 40 Riverside 'KinnowLS’ 5 5 C35 32 Riverside 'Kinnow’ control 3 5 Carrizo/C35 36 Lindcove 'KinnowLS’ 6 5 Carrizo 59 Lindcove 'KinnowLS’ 6 5 C35 63 Lindcove 'Kinnow’ control 3 5 Carrizo/C35 52 Lindcove 'KinnowLS’ 1 11 Carrizo 46 (mother tree) Irvine 'KinnowLS’ 6 5 Carrizo 44 Irvine 'KinnowLS’ 6 5 C35 47 Irvine 'Kinnow’ control 4 5 Carrizo/C35 39 Arvin 'KinnowLS’ 6 5 Carrizo 70 Arvin 'KinnowLS’ 6 5 C35 73 Arvin 'Kinnow’ control 4 5 Carrizo/C35 64 2007/8 2008/9 2008/9 Yield Range Mean Yield Range Site Selection (kg) Yield (kg) (kg) Riverside 'KinnowLS’ 28-46 71 59-83 Riverside 'KinnowLS’ 20-36 75 48-89 Riverside 'Kinnow’ control 32-39 62 51-74 Lindcove 'KinnowLS’ 49-66 69 22-90 Lindcove 'KinnowLS’ 54-71 78 55-87 Lindcove 'Kinnow’ control 45-58 28 17-31 Lindcove 'KinnowLS’ 46 109 109 (mother tree) Irvine 'KinnowLS’ 35-50 72 33-91 Irvine 'KinnowLS’ 34-55 76 53-88 Irvine 'Kinnow’ control 30-44 58 31-80 Arvin 'KinnowLS’ 61-86 96  81-110 Arvin 'KinnowLS’ 60-89 89  78-112 Arvin 'Kinnow’ control 55-74 91  75-105 Fruit storage trials included storage of washed but not waxed fruit at 5.6° C. for up to 30 days with fruit samples taken every 15 days for analysis. Data indicates that the storage characteristics of ‘KinnowLS’ are very good with very little measureable loss of rind quality or color, no significant loss in juice quality or deterioration in taste, and no significant indication of fungal or other disease problems over the 30 day storage period. Overall ‘KinnowLS’ can be considered to be very good in storage ability for 4-6 weeks under controlled environment storage conditions. No susceptibilities to plant or fruit diseases, or to pests, beyond those normally associated with Citrus species, have been observed.

‘KinnowLS’ is a mid- to late-season maturing (depending on climate) diploid mandarin that combines large-sized fruit of excellent quality and production with low seed content even in mixed plantings. It may be successful in the mid-to-late season marketing window that currently has few low-seeded, high quality cultivars.

[0001] This application is based upon and claims priority from Provisional Application No. 61/555,990, filed Nov. 4, 2011, incorporated by reference herein. BACKGROUND OF THE INVENTION [0002] This invention is directed towards an apparatus and method for simultaneously setting the attack angle of a number of aerodynamic surfaces such as fins on a throwing toy. The ability to adjust the angle of attack of such fins greatly affects the performance of such throwing toy and also provides additional play value and marketability. [0003] It is known that the performance of a throwing toy is significantly affected by being spun along its travelling axis when it is thrown, much like a football that is thrown with a spiral. It is also known that most people find it difficult to throw a consistent spiral. It is also known that the direction of the rotation is different when thrown by left handed throwers verses right handed throwers, so that it would be desirable to provide a throwing toy that will spiral consistently when thrown with a direction and degree of rotation that can be adjusted as desired. [0004] One conventional game ball having a shape generally similar to an American football is known that has individually adjustable fins provided on the outside of the ball. However, the individually adjustable fins can be difficult to adjust together to have a common angle of attack with respect to a rotational axis of the game ball to have a consistent spiral. [0005] It would be desirable to provide a throwing toy that can be adjusted to have a consistent spiral about a rotational axis to suit the needs and handedness of the thrower. It would also be desirable to provide such a throwing toy with a timer for monitoring and displaying flight time of the throwing toy when it is thrown. The present invention addresses these and other needs. SUMMARY OF THE INVENTION [0006] Briefly, and in general terms, the present invention provides for a throwing toy having a leading end, a trailing end, and a longitudinal throwing axis extending along a length of the throwing toy from the leading end to the trailing end of the throwing toy. The throwing toy includes a main body having an elongated, ellipsoidal shape, a leading end and a trailing end, and a fin mounting portion integrally connected to the trailing end of the main body. In a presently preferred aspect, the fin mounting portion is a generally tubular tail portion. The fin mounting portion includes a plurality of fins mounted on the fin mounting portion of the throwing toy, each of the fins having a leading edge, a trailing edge, and a common aerodynamic angle of attack relative to the longitudinal axis. The fins are connected to the fin mounting portion and are configured for rotation of at least one of the leading edge and trailing edge relative to the other of the leading edge and trailing edge. [0007] In a presently preferred aspect, the fins are configured to be rotated simultaneously together to present a plurality of aerodynamic surfaces oriented with the same aerodynamic angle of attack, to cause the toy to rotate about the longitudinal throwing axis when the throwing toy is thrown. The fins can be rotated and set together at a desired aerodynamic angle of attack relative to the longitudinal throwing axis between maximum angles of attack on either side of the longitudinal throwing axis, such as to be rotated at an angle on either side of the longitudinal throwing axis, or to be oriented parallel to the throwing axis, and, for example. [0008] In one presently preferred embodiment, the leading edges of the fins are connected to a common rotatable member, such as a rotatable adjustment ring, for example, that is rotatably connected to the main body, and that in one preferred aspect can extend radially outwardly from the fin mounting portion. In a presently preferred aspect, each of the fins includes a flange or extension extending from the leading edge of the fin that protrudes through a corresponding one of a plurality of holes provided in the rotatable adjustment ring. When the adjustment ring is rotated about the longitudinal throwing axis of the throwing toy, the flanges or extensions protruding into the adjustment ring are caused to correspondingly be rotated and set the angle of all the fins to a new angle of attack, so that when one fin is adjusted all fins are adjusted simultaneously. In another presently preferred aspect, at least a portion of each fin rotates relative to a pivot point on the fin located rearwardly of the flange or extension. [0009] In another presently preferred aspect, an axial tubular bore is defined within the main body and fin mounting portion of the throwing toy, and extends along the longitudinal throwing axis through the throwing toy from the leading end of the main body of the throwing toy to the trailing end of the fin mounting portion of the throwing toy. [0010] In another presently preferred aspect, an internal electronic timer and timer display are disposed in the main body of the throwing toy for measuring, recording and/or displaying the time the throwing toy is in the air after it is thrown and before it is caught or flight is otherwise terminated, such as by hitting the ground. The electronic timer is started when the throwing toy leaves a thrower's hand, and is stopped by sensing the impact when the throwing toy is caught or hits the ground. In a presently preferred embodiment of the invention, the time of flight may be saved as a metric to be compared to other players or one's own performance. [0011] The mechanism for simultaneously setting the angle of the fins allows for a quicker operation of the adjustments for the toy, making play more enjoyable, provides improved accuracy in setting all fins to the same angle for optimum performance, and provides a valuable feature that can be demonstrated in the package, thus providing a strong marketing element. An electronic timer of the throwing toy of the invention for measuring the time the ball is in the air after it is thrown and before it is caught or flight is otherwise terminated also provides improved play value of the throwing toy by providing a metric of performance by a single player that is read out on the toy itself. [0012] The throwing toy of the invention also provides the additional benefits for individual play and improvement, in allowing one or more users to have a play pattern where a player can play individually or with a group of players in a meaningful manner, as they can attempt to improve on their measured performance, and in providing a way of positively measuring and demonstrating the remarkable performance of the throwing toy of the invention. [0013] Other features and advantages of the present invention will become more apparent from the following detailed description of the preferred embodiments in conjunction with the accompanying drawings, which illustrate, by way of example, the operation of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0014] FIG. 1 is a front perspective view of a throwing toy of the present invention. [0015] FIG. 2 is a side elevational view of the throwing toy of FIG. 1 . [0016] FIG. 3 is a side elevational view of the throwing toy similar to FIG. 2 , showing the throwing toy in a rotated position. [0017] FIG. 4 is a rear view of the throwing toy of FIG. 1 . [0018] FIG. 5 is an enlarged diagrammatic side elevational view of the throwing toy of FIG. 1 . [0019] FIG. 6 is an enlarged diagrammatic partial side sectional view of the throwing toy of FIG. 1 . [0020] FIG. 7 is a side elevational view of the throwing toy of FIG. 1 , illustrating a first aerodynamic angle of attack of the fins in a first rotational position of the rotatable adjustment ring. [0021] FIG. 8 is a side elevational view of the throwing toy similar to FIG. 7 , illustrating a second aerodynamic angle of attack of the fins in a second rotational position of the rotatable adjustment ring. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0022] With reference to the drawings, which are provided by way of example, for purposes of illustration, and not by way of limitation, the present invention provides for a throwing toy 10 having a leading end 12 , a trailing end 14 , and a longitudinal throwing axis 16 extending along a length of the throwing toy from the leading end to the trailing end of the throwing toy. The throwing toy includes a main body 18 having an elongated, ellipsoidal shape, a leading end 20 and a trailing end 22 , and a fin mounting portion 24 integrally connected to the trailing end of the main body. In a presently preferred aspect, the fin mounting portion is a generally tubular tail portion. The fin mounting portion includes a plurality of fins 26 mounted on the fin mounting portion of the throwing toy, each of the fins having a leading edge 28 , a trailing edge 30 , and a common aerodynamic angle of attack relative to the longitudinal axis. The fins are connected to the fin mounting portion and are configured for rotation of at least one of the leading edge and trailing edge relative to the other of the leading edge and trailing edge. The fins typically are formed of generally planar pieces of polymeric material or other similar suitable pliable material, and are typically adhered along at least a portion of an inner edge 31 of the fins to the outer surface of the generally tubular tail portion at the trailing end of the throwing toy, such as in slots or fin trays 32 , for example. [0023] In a presently preferred aspect, the fins are configured to be rotated simultaneously together to present a plurality of aerodynamic surfaces oriented with the same aerodynamic angle of attack, to cause the toy to rotate about the longitudinal throwing axis when the throwing toy is thrown. The fins can be rotated and set together at a desired angle of attack relative to the longitudinal throwing axis between maximum angles of attack on either side of the longitudinal throwing axis, such as to be in line with the throwing axis and to rotate at an angle on either side of this axis, for example. [0024] In one presently preferred embodiment, the leading edges of the fins are connected to a common rotatable member 33 , such as a rotatable adjustment ring, for example, that is rotatably connected to the main body, and which in one preferred aspect can extend radially outwardly from the fin mounting portion. The common rotatable member is typically rotatably connected to the main body by a ratchet mechanism, such as a plurality of detents, for example, allowing the common rotatable member to be rotated and set in a desired position relative to the main body and fin mounting portion. Alternatively, the common rotatable member can be similarly rotatably connected to the fin mounting portion to be rotated and set in a desired position relative to the main body and fin mounting portion. In a presently preferred aspect, each of the fins includes a flange or extension 34 , best seen in FIGS. 6 , 7 and 8 , extending from the leading edge of the fin that protrudes through a corresponding one of a plurality of holes 36 , shown in FIG. 6 , provided in the rotatable adjustment ring, so that each fin rotates about a medial pivot point 38 on the fin located rearwardly of the flange or extension. When the adjustment ring is rotated about the longitudinal throwing axis of the throwing toy, the flanges or extensions protruding into the adjustment ring are caused to correspondingly be rotated and set the angle of all the fins to a new angle of attack, so that when one fin is adjusted all fins are adjusted simultaneously. [0025] Alternatively, the fins can be mounted to the fin mounting portion of the throwing toy by pivot pins extending into the fin mounting portion at medial pivot points, and a mechanism can be provided that connects the pivot pins 39 of each fin with gears, a filament, or the like, so that when one pivot pin is rotated all pivot pins rotate, causing the fins to rotate together. In a presently preferred aspect, a simple locking mechanism such as a lockable tab or detent may additionally be provided on an adjustment ring to prevent movement from a setting until the thrower so desires. [0026] In another presently preferred aspect, an axial tubular bore 40 , shown in FIGS. 4 and 6 , is defined within the main body and fin mounting portion of the throwing toy, and extends along the longitudinal throwing axis through the throwing toy from the leading end of the main body of the throwing toy to the trailing end of the fin mounting portion of the throwing toy. [0027] In another presently preferred aspect, the throwing toy includes an internal electronic timer and timer display 42 disposed in the main body of the throwing toy for measuring, recording and/or displaying the time the throwing toy is in the air, the “hang time” after it is thrown and before it is caught or flight is otherwise terminated, such as by hitting the ground. The electronic timer is started when the throwing toy leaves a thrower's hand, and is stopped by sensing the impact when the throwing toy is caught or hits the ground. A device such as a weight on a spring can be used to sense the acceleration when thrown and the deceleration on being caught or hitting the ground. The number displayed can be a multiple of the seconds recorded to make the differential times more determinable and make the numerical impact more dramatic for an individual user who is using the timer and adjustable fins to improve his or her performance. [0028] There are numerous configurations of apparatus within the scope of the invention to adjust the angle of the fins simultaneously including, but not limited to connecting either end of the fins to a common structure or element so that when one fin is adjusted all fins are adjusted, and a mechanism that connects the pivot point of each fin with gears, filament, and the like, so that when one pivot is rotated all pivots rotate. [0029] The invention may be embodied in other forms without departure from the benefits and characteristics described. The embodiments described therefore are to be considered in all respects as illustrative and not restrictive. Although the present invention has been described in terms of certain preferred embodiments, other embodiments that are apparent to those of ordinary skill in the art are also within the scope of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.

Apparatus and method of adjusting the angle of attack to the longitudinal axis of a plurality of aerodynamic surfaces on a high performance throwing toy which affect the performance of such toy and to also provide a means of measuring such performance by recording the time the toy is airborne during flight.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to crutches and more specifically to leg support crutches designed to permit ambulatory movement by a patient recuperating from an injured foot or lower leg. 2. Description of Related Art A patient after injuring a foot or lower leg, commonly uses a pair of crutches to support himself or herself when recuperating. The crutches aid the patient when walking by supporting a portion of the patient's body weight. Each crutch conventionally includes a pair of legs attached to an upper cross bar or crutch head. The legs depend downwardly from the crutch head towards a lower end. The crutch also includes a hand grip attached to the legs and positioned between the crutch head and the lower end, about two-thirds up the length of the crutch from the lower end. The patient uses the crutch by placing the crutch head under his or her arm in the axilla (i.e., armpit) and grasping the hand grip. The patient generally supports his or her weight by the combination of grasping the hand grip and resting on the crutch head. Unfortunately, extended use of conventional crutches generally results in some discomfort to the axillae and lateral sides of the rib cage, and may result in nerve injury. To overcome the disadvantage of conventional crutches, there have been efforts to develop a single support crutch that more directly supports the user's leg without the need to grip the crutch with one's hands or bear upon the crutch at or about the axillae and rib cage. U.S. Pat. Nos. 5,575,299, 5,300,595 and 5,178,595 disclose examples of such prior single support crutches. In essence, each of these single support crutches removes stress from the user's axillae and rib cage and transfers that stress to the user's knee and thigh. None of the single support crutches to date, however, have been able (i) to satisfactorily minimize the stresses on a user's knee, (ii) to more evenly distribute the forces that bear upon the user's thigh during use, and (iii) to provide the stability required for full ambulatory movement of the user. SUMMARY OF THE INVENTION A need therefore exists for a method and a device for minimizing the stress upon the knee and thigh while permitting a patient as full ambulatory movement as possible during recuperation. One aspect of the present invention thus involves an improved leg support crutch that permits ambulatory movement of a user recuperating from a lower leg or foot injury. The leg support crutch supports the user's upper body and injured lower leg in a manner that transfers the user's body weight through the user's thigh and knee directly to the leg support crutch so as to bypass weight transfer through the user's injured lower leg or foot. The leg support crutch comprises a unitary leg cradle, a support strut connected to the leg cradle, an interengaging structure for releasably connecting the support strut to the leg cradle at a plurality of locations, and a plurality of fasteners to secure the user's leg within the leg cradle. The leg cradle desirably has a generally L-shaped configuration defined by a first portion contoured to loosely conform to the shape of a user's thigh and a second portion positioned generally normal to the first portion and integral therewith. The second portion is contoured to loosely conform to the shape of a user's lower leg. The junction of the first and second portion forms a curvilinear profile conforming loosely to the user's knee. The first and second portions include corresponding vertical and longitudinal axes that intersect at a generally right angle. The axis of each portion is defined centrally between the corresponding sides of the portion and is distanced from a front or lower wall of the corresponding first or section portion. For instance, the vertical axis of the first portion desirably is distanced from the front wall by a sufficient distance to generally align the vertical axis with the user's femur when in use. The first portion is sufficiently long so as to secure the first portion high-up on the user's thigh. This length of the first portion generally inhibits movement of the first portion relative to the user's thigh without unduly binding the thigh and overly constricting the arteries and veins in the leg (e.g., the popliteal artery). The cradle is further defined by integral gussets. The gussets join together and reinforce the first and second portions so as to transfer forces (e.g., weight) from the second portion to the first portion when the second portion is supporting the user's lower leg. Each gusset extends between the first and second portions and the gussets are positioned to straddle a portion of the user's lower leg and thigh when in use. The support strut detachably connects to the cradle proximal to the intersection of the first and second portions so as to be generally parallel with the longitudinal axis of the first portion when the support strut is attached to the cradle. The strut is adjustable in length to permit use of the prosthetic device by users of different leg lengths. The interconnecting structure detachably connects the support strut to the leg cradle at a plurality of locations. The position of the strut thus may be adjusted to position the strut to lie generally collinear with the user's femur to transfer of the user's body weight to the strut. The strut thereby simulates the balance and support normally provided by the user's lower leg and foot. There are a plurality of adjustable fasteners positioned on each of the first and second portions of the leg cradle to hold the user's thigh and lower leg tightly in the cradle. The fasteners are positioned to maximize the stability of the prosthetic device while in use and to minimize constriction of the user's leg. A first fastener of the plurality is positioned at an upper end of the first portion to maximize the force securing the first portion to the user's thigh (i.e., to maximize the moment arm created by the first portion with respect to an axis of rotation through the user's knee). This force resists the tendency of the strut, when in motion, to pull the first portion away from the user's thigh, thereby inhibiting the cradle from rotating about the user's knee. This arrangement also minimizes the reactive forces experienced by the user's thigh in resisting such rotation. A second fastener is also arranged on the first portion near a lower end of the first portion but sufficiently spaced therefrom to permit attachment of the cradle to the user's leg above the popliteal fossa. This arrangement minimizes constriction of the popliteal artery caused by this second fastener when in use. The plurality of fasteners further includes at least two fasteners--a third and a fourth fastener--positioned on the second portion. These fasteners permit attachment of the second portion to the lower leg of the user. The third fastener is desirably positioned proximal to the middle of the user's calf muscle when attached, and the fourth fastener is desirably positioned between the bottom of the user's calf and the user's ankle. Further aspects, features, and advantages of the present invention will become apparent from the detailed description of the preferred embodiment which follows. BRIEF DESCRIPTION OF THE DRAWINGS The above-noted and other features of the invention will now be described with reference to the drawings of a preferred embodiment which is intended to illustrate and not to limit the invention, and in which: FIG. 1 illustrates a side elevational view of the leg support crutch configured in accordance with a preferred embodiment of the present invention, as applied to a user's thigh and lower leg; FIG. 2 illustrates a perspective view of the leg support crutch of FIG. 1, from a rear-left side; FIG. 3 illustrates a perspective view of the leg support crutch of FIG. 1, from a front-right side; FIG. 4 illustrates a side elevational view of the leg support crutch of FIG. 1 with the user in a seated position and with a support strut disconnected; FIG. 5 illustrates an exploded perspective view of the leg support crutch of FIG. 1 from the rear-left side, showing the discrete components employed in the preferred embodiment; FIG. 6A illustrates an exploded perspective view of an embodiment of the interengaging structure that connects the strut to the underside of the leg cradle, with the strut arranged in a first position; and FIG. 6B illustrates an exploded perspective view of the strut, cradle and interengaging structure with the strut arranged in a second position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT With reference to FIGS. 1 through 3, a preferred embodiment of the leg support crutch 10 is shown as applied to a user (shown in phantom). The leg support crutch 10 is defined by a leg cradle 12, preferably molded in unitary construction, and a detachable support strut 14. An interengaging structure 16 connects the support strut 14 to the leg cradle 12 in a manner that permits quick detachment and adjustment relative to the cradle, as well as connects the support strut 14 to the cradle 12 in at least two different positions relative to a vertical axis a of the cradle 12, as described below. The leg cradle 12 supports the thigh, knee and lower leg of a user recuperating from a lower leg or foot injury in a manner that comfortably transfers the weight of the user through the cradle 12 to the support strut 14. This is done in a manner that also simulates the balance and support normally provided by the user's lower leg and foot, thus enhancing recuperation while the user remains ambulatory. The leg cradle 12 includes a desirably plurality of fasteners--four fasteners 20, 22, 24 and 26 in the illustrated embodiment--to securely attach the user's thigh and lower leg to the leg cradle while in use. Each fastener is strategically positioned along the cradle 12 to firmly hold the user's leg within the cradle 12 without unduly constricting user's leg. Leg Cradle As seen in FIGS. 1 through 3, the leg cradle 12 is principally defined by a first portion 30, which bears against the user's thigh, and a second portion 32, which carries the user's lower leg. The first and second portions 30, 32 are contoured to loosely conform to the shape of a user's thigh and lower leg, respectively. Thus, both the first and second portions 30, 32 generally have an arcuate channel that wraps about a anterior portion of the user's leg. The channel generally has a U-shaped cross-sectional shape formed between side walls and an interconnecting wall, i.e. a front wall on the first portion 30 and a bottom wall on the second portion 32. The first and second portions 30, 32 are formed in a generally L-shaped configuration. The intersection 34 of the first and second portions 30, 32 is curvilinear in profile to loosely conform to the user's knee. As shown more clearly in FIG. 2, the contour of the entire leg cradle 12 closely resembles the contour of the front and sides portions of a user's thigh, knee and lower leg, but not so closely, when in use, so as to uncomfortably constrict the user's leg. An unobstructed view of the leg cradle 12 is also shown in FIG. 5. As seen in FIG. 1, the first portion 30 is formed about a generally vertical axis "a" that intersects, in generally normal relationship, with a generally longitudinal axis "b." The second portion 32 is arranged to lie generally parallel to this longitudinal axis "b". In one embodiment, the angle between the longitudinal axes "a", "b" is acute by approximately 5° from normal so that, when the user is standing upright in the leg support crutch 10, the user's lower leg is supported by the second portion 32 in a slightly elevated manner, with the foot slightly higher than the knee. That is, the angle between the first and second portions is about 85°. This elevation of the lower leg enhances fluid draining away from the user's foot and ankle, as well as and blood circulation, during recuperation. It should be recognized that, depending upon the nature of the injury to the lower leg or foot, the incident angle between the first and second portions 30, 32 may depart from normal by varying degrees without losing the benefits of the present leg support crutch. The length of the first portion 30 desirably equals approximately two-thirds to three-quarters of the length of the user's thigh, such that the first portion 30 extends substantially up the user's thigh. This length serves the advantage of extending the moment arm created by the first portion 30, as discussed in detail below, which serves to minimize the forces experienced by the user's thigh during use. The extended length of the first portion 30 also serves the advantage of increasing the area across which forces are spread about the user's thigh, further minimizing the forces experienced by the thigh. The second portion 32 desirably has a length sufficient to support generally the entire length of the user's lower leg. In the illustrated embodiment, the second portion 32 extends to a point below the user's calf and just above the user's ankle to adequately support the user's foot. The outer end of the second portion 32 (i.e., the end near the user's ankle), however, does not extend so far as to cause discomfort to the user's dorsal foot and ankle. The length of the second portion is at least as long as the length of the first portion. With reference now to FIGS. 1 and 5, a pair of integral gussets 36 extend between the first portion 30 and the second portion 32. In the illustrated embodiment, the gussets 36 are integrally formed with the sides of the first and second portions 30, 32 and are arranged to straddle the side of the user's thigh and lower leg, when worn. The gussets 36 reinforce the leg cradle 12 and transfer the weight of the second portion's outer end (which supports the user's foot and lower leg) to the first portion 30 (thereby functioning as trusses). The gussets 36 also advantageously eliminate the direct transfer of rotational forces from the weight of the user's lower leg to the strut where shear forces would otherwise be generated on the strut. The leg cradle 12 preferably has curled edges 38 throughout, wherein the edges curl away from the user's body, as shown in FIGS. 1 through 3. This feature minimizes the risk of abrasive contact between the user and the edge of the cradle while in use. The edges also serve the added benefit of reinforcing the cradle 12 about the gussets 36 as they transfer weight from the second portion 32 to the first portion 30. Unlike other leg support crutches that consist of multiple bands mechanically interlinked to simulate a cradle, the preferred embodiment of the leg cradle 12 is made of unitary construction and conforms to the contour of the user's thigh and leg. This construction more evenly distributes the forces borne the user's thigh during use, as discussed further below. In the preferred embodiment, the leg cradle 12 is made of molded fiberglass that permits construction of a highly contoured cradle designed to comfortably support a user's thigh and lower leg by virtually encasing the front and side portions of the thigh and lower leg. This construction also permits highly customized leg support crutches. Other similarly sturdy and moldable materials of course can also be used, such as for example plastic (e.g., PVC or ABS) and the like. The cradle 12 also desirably includes an insert pad 40 to provide further comfort and secure fit. In the illustrated embodiment, the insert pad 40 is made of textured neoprene; however, other suitable material (e.g., nylon-wrapped foams) can also be used. As shown in FIG. 5, the insert pad 40, has a contour conforming generally to the inner surface of the cradle 12 that permits a slip fit of the insert pad 40 into the interior of the cradle 12. The edges of the insert pad 40 desirably extend beyond the curled edges 38 of the cradle 12 to further protect the user against potential abrasive contact with the rigid cradle during use. Support Strut FIGS. 1 and 5 also illustrate the support strut 14 which includes a rigid longitudinal portion. The rigid longitudinal portion in the illustrated embodiment comprises a telescoping support 44. The telescoping support 44 includes two concentric tubes 46, 48 in which an upper end of the smaller diameter tube 46 engages the interengaging structure 16 (which is described below). Quick-release engagement of the support strut 14 with the leg cradle is permitted by providing a quick-release fastener 50 positioned at the distal end of the smaller diameter tube 46. The quick-release fastener 50 mates with a corresponding feature in the interengaging structure 16. The smaller and larger diameter tubes 46, 48 are movable with respect to each other in a telescoping fashion to adjust the overall length of the telescoping support 44. A second quick-release fastener 52 is used to securely fasten these tubes together once the length of the support 44 has been adjusted to a desired length. In the illustrated embodiment, the quick-release fasteners each comprise a detent mechanism; however, other type of known quick-release fasteners can also be used. The quick-release fastener 52 at the lower end of the support 44 includes a pair of spring-biased detent balls positioned at opposite ends of the smaller diameter tube 46. The larger diameter tube 48 includes a plurality of holes 54 aligned in series to receive the second quick-release fastener 52. The second quick-release fastener 52 itself may be adjustably positioned within one of a series of holes 58 in the smaller diameter tube 46. The upper quick-release fastener 50 includes a similar structure and cooperates with a pair of holes formed in the corresponding structure of the interengaging structure, as described below. At a lower end of the support strut 14, the larger diameter tube 48 supports a non-skid cap 60 preferably made of rubber or other suitable material to minimize slippage of the support strut 14 with the ground during use. The non-skid cap 60 may be of various configurations and preferably comprises a generally form fitting sleeve closed at the distal end to increase the area of engagement between the support strut 14 and the ground. Other configurations are contemplated, including a form fitting sleeve that includes a plurality of projecting feet each of which engage the ground in a non-skid manner. Interconnecting Structure With reference to FIGS. 1 and 4, the leg cradle 12 detachably connects to the support strut 14 via an interconnecting structure 16 positioned near the intersection between the first and second portions 30, 32. The interconnecting structure 16 permits quick detachment of the support strut 14 from the leg cradle 12 and permits the user to adjust the support strut's position relative to the vertical axis "a" of the cradle 12. In the illustrated embodiment, best seen in FIGS. 1, 6A and 6B, the interconnecting structure comprises a plurality of studs 70 that depend from the leg cradle. These studs 70 generally extend parallel to the vertical axis "a." FIGS. 6A and 6B show the studs 70 projecting from the underside of the cradle 12. The studs 70 desirably form a geometric pattern that, in the illustrated embodiment, is a rectangle 72. A connecting plate 74 is mechanically secured to the studs 70. As seen in FIGS. 6A and 6B, the connecting plate 74 includes a plurality of holes 80 arranged in sets of geometric patterns that correspond with the geometric pattern 72 of studs 70. There are preferably at least two sets of hole patterns 84, 86 that ensure proper mating of the plate 74 to the studs 70 and define at least two positions of the support 44 relative to the front wall of the first portion 30. To attach the connecting plate 74 to the studs 70, and, thus, secure the socket sleeve 76 to the leg cradle 12, a plurality of wing nuts 90 may be used to securely tighten the connecting plate 74 against the cradle 12. By providing a plurality of hole patterns which mate with the plurality of studs 70, a user may adjust the support strut 14 with respect to the leg cradle 12 to more closely define a collinear relationship between the user's femur and the support strut 14, where desired. FIG. 1 shows the support strut 14 in collinear alignment with the longitudinal axis "a" of the first portion 30 and the user's femur. By doing so, the present leg support crutch 10 transfers the weight of the user's body through the femur to the support strut 14 and minimizes stress to the user's knee from the shear and torsional forces that may result from misalignment of the strut 14 and the femur. In effect, adjustability permits the user to place the strut in a location that most comfortably permits ambulatory movement. As seen in FIG. 1, the connecting plate 74 supports a socket sleeve 76 for detachable holding the support strut 14 to the leg cradle 12. The socket sleeve 76 includes a hole 78 therethrough that receives the detent balls of the quick-release fastener 50 to releasably lock the strut 14 to the socket sleeve 76. FIG. 1 also shows the support strut 14 securely fastened to the cradle 12. The connecting socket 76 slidably receives the upper end of the smaller diameter tube 46 which is locked in a seated position within the connecting socket 68 by the quick-release mechanical fastener 50. The quick-release feature is advantageous in that a user may quickly detach the support strut 14 from the leg cradle 12 when the user decides to sit down, as shown in FIG. 4. Fasteners FIGS. 1 through 3 best illustrate the plurality of fasteners 20, 22, 24, 26 used to secure the user's leg within the cradle. The fasteners 20, 22, 24, 26 are supported on the leg cradle 12 in a manner that permits effective securement to the user during use. In the illustrated embodiment, there are four fasteners that are include straps 100, 102 made of nylon, each threaded through a plurality of slots 104 provided in the leg cradle 12. The straps 100 of the upper two fasteners 20, 24 are preferably wider than the straps 102 of the lower two fasteners 24, 26. The difference in width reflects the difference in both the magnitude of the forces borne by the thigh as compared to the lower leg, as well as the size of the thigh as compared to the size of the lower leg. FIG. 5 illustrates the position of the slots 104 and the relative size of the preferred straps 100, 102 more clearly. The positions of the fasteners 20-26 in the present invention and the number thereof are important in achieving the improved level of comfort and effectiveness described herein. In the preferred embodiment, there are two fasteners 20, 22 associated with the first portion 30 of the cradle 12 and two fasteners 24, 26 associated with the second portion 32 of the cradle; however, more fasteners can be used. Providing multiple fasteners associated with each cradle portion more effectively distributes the load carried by the user's leg positioned within the cradle and eliminates potential rocking about a single fastener point of contact when only one fastener is used. The first fastener 20 is preferably placed at an upper end 106 of the first portion 30 of the cradle 12 away from the intersection between the first and second portions 30, 32. During use, while the user is in stride, the interaction between the strut 14 and the ground as the user walks have a tendency pull the first portion upper end away from the user's thigh, thereby causing the cradle to rotate about the user's knee. (This rotational axis is normal to the intersection of the longitudinal axes "a", "b"). Additional rotational forces are also experienced about generally the same axis due to the downward force of the user's leg weight caused by the lower leg being cantilevered beyond the second portion 32 of the cradle 12. While the rigid construction of the leg cradle 12 and the support strut 14 (as implemented by the interengaging structure 16) will effectively resist these rotational forces, the user's thigh must necessarily bear some of that resistance. The first portion 30 is, thus, a moment arm about the axis of rotation through the user's knee. The longer the moment arm, the less force will be transmitted at the first fastener 20 due in acting upon and reacting to the rotational forces. In other words, on the down stroke of the present leg support crutch, the ground (and the weight of the lower leg) will exert a rotational force that tends to push the first portion 30 of the cradle 12 against the user's thigh. The longer the first portion 30, the greater the area of engagement between the first portion 30 and the user's thigh, thus distributing those forces to a greater extend and minimizing the forces experienced by the thigh. On the upstroke, however, the user's forward momentum will translate into forces that tend to pull the first portion 30 away from the user's thigh. By placing the first fastener 20 as close to the distal end 106 of the first portion as feasible and, thus, maximizing the moment arm as measured by the location of the first fastener 20, the force transmitted to the thigh when the present leg support crutch is in use is minimized. Thus, the present invention minimizes the force exerted on or by the thigh by extending the moment arm of the first portion 30 as far as possible and selectively placing the first fastener 20 very close to the distal end of the first portion 30. The second fastener 22 is preferably placed proximal the intersection of the first and second portions 30, 32 but sufficiently spaced therefrom to avoid constriction of the popliteal fossa and popliteal artery contained therein. Prolonged constriction of the popliteal artery may result in irreparable damage and may diminish recuperation efforts, besides causing discomfort and pain. The present leg support crutch avoids such constriction by selectively placing the second fastener 22 above the intersection of the first and second portions 30, 32. The third and fourth fasteners 24, 26 are provided in the second portion 32 of the cradle 12 and are positioned such that the third fastener 24 is located about the longitudinal mid-point of the user's calf and the fourth fastener 26 is located at the narrowing portion of the user's calf and near the user's ankle, that is generally at the second portion's outer end. Although relatively minimal, some forces will be experienced by the lower leg on the upstroke of the user's gait. Thus, it is preferably that the third fastener 24 be positioned at the mid-point of the calf where the lower leg may sustain the most force. The fourth fastener 26 positioned at the bottom of the calf and close to the ankle serves to stabilize the lower leg and maintain the user's foot in a comfortably restrained position to enhance recuperation. With reference to FIG. 5, the first and second fasteners 20, 22 each preferably include two discrete strap segments, a first strap segment 108 and a second strap segment 110. At a first end of each first strap segment 108, a fastening mechanism 114 is provided for detachably affixing the strap segment 108 to a corresponding fastening mechanism 118 on the exterior of the leg cradle 12. Preferably the detachable fastening mechanism is a hook and loop fastener, such as Velcro®, with the hook portion (114) provided on the first strap segment 108 and the loop portion (118) provided on the exterior of the leg cradle 12. Similarly, at a first end of each second strap segment 110, a similar detachable fastening mechanism 116, such as a hook fastener, is also provided to mate with a corresponding loop fastener (not shown) provided on the exterior of the leg cradle 12 on the opposite side of the cradle 12 from the loop portion 118. The first and second strap segments 108, 110 may then be buckled together behind the user's thigh to adjust the straps as tightly as desired. It should be noted that any arrangement of one or multiple straps may be employed to effectively fasten the first portion 30 to the user's thigh. In the illustrated embodiment, the third and fourth fasteners include a single strap segment 112, each of which slidably moves within the slots 104 within the second portion 32 of the leg cradle. If desired, the third and fourth straps may also include hook fasteners to engage loop fasteners affixed to the underside of the lower portion to prevent undesired sliding of the straps 112. The straps may be buckled around the user's lower leg to comfortably restrain the lower leg within the leg cradle 12. Although this invention has been described in terms of a certain preferred embodiment, other embodiments apparent to those of ordinary skill in the art are also within the scope of this invention. Accordingly, the scope of the invention is intended to be defined only by the claims that follow.

A single leg support crutch provides improved stability and balance to a user, who suffers from foot, ankle or lower leg injury, in order to enhance ambulatory movement of the user during recuperation. The leg support crutch comprises a unitary leg cradle that conforms generally to a user's thigh, knee and lower leg, and a plurality of fasteners that comfortably secure the leg support crutch to the user's leg while in a bended position. A support strut is releasably attached to the cradle and is positioned to support the weight of the user when standing or walking. A releasable coupling attaches the strut to the cradle at one of a plurality of locations. The multiple locations of the strut on the cradle allow the position of the strut to be adjusted in order to properly align the axis of the strut with the location of the user's femur in the cradle. As a result, the weight of the user is transferred more efficiently to the strut to improve the user's comfort when standing or walking.

FIELD OF THE INVENTION [0001] The present invention generally relates to interactive gaming systems, and more specifically to on-line gaming systems wherein gaming clients are automatically configured and updated. BACKGROUND OF THE INVENTION [0002] A common trend is emerging in modern designs of basic operating systems for computer systems, wherein the need to store more and more complex configuration information is steadily increasing. Moreover, to support new hardware configurations, as well as new software applications, storage of hardware settings into non-volatile memory is required, which in many cases needs to be done individually for each product out of a plurality of products. The storage of this configuration setting in the non-volatile memory requires greater use of non-volatile memory, and is highly product and version specific. As new products are developed and new versions introduced, more information to distinguish one product from another is added to the configuration register, to adequately describe differences among various products, as well as to adjust to personal preferences of an individual user of a given product. Some of these requirements have been described for example in U.S. Pat. No. 5,999,989 to Patel, issued Dec. 7, 1999. [0003] In this context, new and exciting developments are currently taking place in computer gaming using gaming consoles (GC), and especially in interactive on-line computer gaming. During the last couple of years, on-line computer gaming has gained increasing popularity, and different Gaming Service Providers (GSP) have established themselves on the Internet network. On-line computer gaming is fast becoming a major money generating competitive virtual sport with tournament organizations and ranking services dedicated to providing the on-line community with the latest information and current rankings of global Internet gamers and game players. An interactive game server and on-line community forum is described for example in U.S. Pat. No. 6,339,761 to Sparks II, issued Mar. 5, 2002. [0004] Computer gaming is constantly growing. Today thousands of players are playing on-line all around the world. Many people stereotype these people as techno kids only, but this could not be more wrong. Both females and males of all ages can be found daily trying to out-think, out-maneuver, or just having a good time on-line. On the Eve of the Electronic Entertainment Expo (E3Expo), the world's largest trade event showcasing computer and video games and related products, a new survey by Peter D. Hart Research Associates, Inc., has found that three-in-five Americans age six or older, or about 145 million people, say they routinely play computer or video games, and that nearly half of these game players are female. It is predictable that interactive on-line computer gaming will blur the line between games and other entertainment or communication media, and that the avenues explored in the development of on-line gaming might well break new ground for interactive Internet applications in all areas of business relations and social life. [0005] Given the ongoing dynamic developments as well as future directions in the field of interactive on-line gaming, it would be highly advantageous to provide on-line gaming systems, wherein the configuration of a gaming console or any other gaming environment is automatically adjusted. This way, a system is able to easily react to flexible gaming scenarios, to be easily extendable to fulfill other functionalities besides gaming, to be easily adjustable according to certain user specific criteria. In view of the ever-changing world of on-line gaming covering all areas of human interest, some of which are of a restrictive nature for under-age audiences, it would also be highly desirable to achieve a good measure of parental control in interactive on-line computer gaming, yet not to exclude younger participants from possible future forms of social interaction. OBJECT OF THE INVENTION [0006] It is therefore an object of the present invention to provide a system and method for interactive on-line gaming that is automatically adjustable to changes in gaming environments and user preferences. SUMMARY OF THE INVENTION [0007] In accordance with an aspect of the instant invention, there is provided a gaming console for use as a gaming client and comprising at least a storage medium for having client data relating to a gaming client and for having data relating to a current game in execution stored therein, at least a processor in communication with the at least a storage medium for retrieving game instruction data therefrom and for executing the game instruction data to execute games on the gaming console and for retrieving client data therefrom for executing gaming client functions on the gaming console, and a transceiver for establishing a connection between the gaming console and a service provider, the connection for being controlled by the at least a processor in execution of the client data, wherein some of the client data is for execution of instructions for receiving further client data from the gaming service provider and for storing instruction data within the at least a storage medium and relating to the further client data, the stored instruction data for being executed by the processor to result in execution of gaming client functions, and, wherein the gaming console is absent an operating system supporting multiple simultaneous tasks for execution of multiple simultaneous games. [0008] In accordance with another aspect of the instant invention, there is provided a method for providing an interactive gaming system service, the method comprising the steps of providing a gaming console comprising a storage medium for storing a gaming client for establishing a connection between the gaming console and a gaming service provider and for controlling events taking place on the gaming console coupling the gaming console to the gaming service provider through a broadband access network, and setting a configuration of the gaming console according to at least one of messages sent to and received from the gaming service provider and messages stored within the gaming console in a personal profile. [0009] In accordance with yet another aspect of the instant invention, there is provided an interactive gaming system comprising a gaming console comprising at least a storage medium for having data relating to a configuration of the gaming console stored therein, the configuration including a current game in execution, and at least a processor in communication with the at least a storage medium for retrieving data therefrom and executing the data, the data relating to the configuration of the gaming console, a gaming service provider for providing instruction data to the gaming console, a connecting network for enabling a connection between the gaming console and the gaming service provider, wherein a gaming client is stored in the at least a storage medium of the gaming console, the gaming client for establishing a connection between the gaming console and a gaming service provider and for controlling events taking place on the gaming console; and wherein the configuration of the gaming console is established by the gaming client according to at least one of messages sent to and received from the gaming service provider and messages stored within a personal profile. BRIEF DESCRIPTION OF THE DRAWINGS [0010] An exemplary embodiment of the present invention will be described in conjunction with the following drawings, in which similar reference numbers designate similar items: [0011] [0011]FIG. 1 displays a schematic diagram of an on-line gaming architecture; [0012] [0012]FIG. 2 displays a schematic diagram of an on-line gaming software architecture; [0013] [0013]FIG. 3 a displays a message sequence chart of an auto-versioning process for an ultra-thin client; [0014] [0014]FIG. 3 b displays a message sequence chart of a support process for an ultra-thin client; and [0015] [0015]FIG. 3 c displays a message sequence chart of a selection process for an ultra-thin client. DETAILED DESCRIPTION OF THE INVENTION [0016] The present invention is now described with respect to a specific embodiment thereof, wherein a gaming link architecture G_linkA is used to provide an on-line gaming service, and wherein a certain gaming link protocol G_linkP is used to establish data communication within G_linkA. Of course, the invention described herein is not restricted to a particular example, which will be described in what follows, but equally applies to other architectures possibly used to establish and provide an on-line gaming scenario. [0017] Referring to FIG. 1, a schematic diagram of the gaming link architecture G_linkA for providing an on-line gaming environment is presented. The main components of G_linkA are a customer site containing customer located equipment CLE 110 , a provider site containing provider located equipment PLE 120 , and an access aggregation network AAN 130 connecting CLE 110 with PLE 120 . The customer located equipment CLE 110 includes a gaming console GC 111 and other hardware components necessary for playing a game, such as a monitor, joysticks, and the like, and a modem such as a broad band modem 112 for establishing the connection to the AAN 130 . On the PLE site 120 there is located a gaming service provider network GSP 121 , a management network 122 consisting of multi-service operator's operations support systems MSO-OSS 123 , a router 123 and a head-end 124 , establishing the connection to the ANN 130 , among other components. The access aggregation network ANN 130 generally is a wide area network WNA, and preferably a broadband access network BAN. However, local area networks LAN are also possible solutions for networks providing an on-line gaming service. [0018] Referring now to FIG. 2, a schematic diagram is shown, illustrating the basic elements of the software architecture used in providing an on-line gaming environment. On the CPE site, the main component is a gaming client G_Client 210 , whereas on the PLE site there is a gaming server G_Server 220 , an operations support services engine G_OSS 230 , a gaming portal G_Portal 240 , and support services G_support 250 . [0019] The purpose of the gaming client G_Client 210 is to provide the gaming console with services, such as establishing connectivity, registration, and instrumentation. G_Client 210 comprises a registration client, an authentication client, a console address management module, and a module for connectivity and service to a gaming service provider GSP 121 on the PLE site 120 . G_Client 210 supports established methods for data communication and transfer, such as Point-to-Point Protocol PPP, and other recognized data protocols. G_Client 210 checks for connection qualification, and administers bundled instrumentation. According to the embodiment of the present invention, and especially useful in connection with a broadband access network (BAN), a highly functional and adaptive client in form of an ultra-thin client UTC is chosen as the component G_Client 210 . UTC resides on the console in a small segment of random access memory (RAM), thus leveraging a high bandwidth connection to the gaming console, and using it to care and feed the highly functional and adaptive client. In this case, the component G_Client 210 is typically referred to as G_UTC. [0020] The UTC constitutes a continuously resident, tiny core framework, in which client functionality is partitioned into small code segments, loaded and launched as required at run time. The code segments or packages are small, in general 50 KB or less, and with a broadband bandwidth of about 2 Mbps take milliseconds to load. With UTC, there is no need to maintain state tables; UTC itself becomes a state onto itself, including possible launches from that state. UTC packages are thin, take little space away from the primary function of the GC, and do hardly interfere with the gaming software running on the GC. As a further advantage, the gaming client G_Client 210 becomes very scalable and flexible, and is growing outside the GC without impacting the footprint occupied within the GC. As another advantage, client upgrades and updates are done automatically and in-service, value-added services are simple to include, and individual client services are easier to design and to implement. Also, client code portability between different gaming platforms is highly simplified. This way, G_UTC is a prototypical example for a highly functional client. [0021] The purpose of the gaming server G_Server 220 is to provide the connectivity and registration services for gaming consoles (GC), and to manage the registered devices. Typically, G Server 220 deals with client registration, subscriber authentication, console address management, as well as Internet protocol (IP) connectivity management and proxy for gaming consoles (GC). G_Server 220 also manages the different GC and different subscribers being part of the on-line gaming architecture G_linkA. Further, G_Server 220 deals with connection qualification, instrumentation and debugging services for consoles, and with bundled instrumentation, and reports facilities for instrumentation, performance and management to G_Client 210 . Although designed as an on-line gaming environment, G_Server 220 enables one to extend the uses of a plurality of gaming consoles (GC) interconnected through a broadband access network beyond gaming and entertainment. [0022] The purpose of the operations support services engine G_OSS 230 is to provide an application program interface (API) to tie-in with the network service provider's software engines for subscriber authentication, network and policy management, notification, and billing functionalities. G_OSS 230 supports multi-protocol API, containing common utilities with plug-in adapters to facilitate connectivity to a majority of other operating support services (OSS), the plug-in adaptation cartridges supporting Hyper Text Transfer Protocol (http), Simple Network Management Protocol (SNMP), eXtensible Markup Language (XML), JAVA™, OSS/J, and the like. Further, G_OSS 230 handles the task of console-discovery-notification and registration, communicates console to subscriber associations, manages subscriber authentication, and administers connectivity management while addressing state functions such as in-service, suspend, or resume. Also, G_OSS 230 adds, modifies, or deletes a GC or a subscriber to the on-line gaming service, and takes care of billing and service notification, among other related functionalities. [0023] The purpose of the gaming portal G_Portal 240 is to provide a site for net-based gaming services. It also acts as a proxy site through which net-based game content providers offer content and services to the user of the gaming console GC. G_Portal 240 provides an entry point into the on-line gaming network for game specific servers, for connection servers enabling group gaming, head-to-head services and find-a-friend scheduling, for bulletin boards and chat rooms, as well as for gaming sites and news proxy. [0024] Optionally, G_Portal 240 offers possibilities such as pay-per-play services, advertising, download services, and others. G_Server 220 also locally offers the same services. [0025] The system of support services G_support 250 fulfills functions such as running a dynamic host configuration protocol (DHCP), Web servicing, platform and application management, subscriber management, license servicing, and the like. Within the system of support services, there is a dynamic host configuration protocol server G_DHCP 251 , a Web server G_Web 252 dealing with GSP content, GSP data, and GSP instrumentation, as well as a registration server G_Reg 253 . [0026] G_linkP is used to establish communication within the gaming architecture G_linkA, and is used in supporting the intermodule signaling and control communication and small batch data transfer. G_linkP further enables the use of ultra-thin clients (UTC) for gaming consoles (GC). In the present embodiment of the instant invention, the communication medium is an IP-based, packet protocol, running on IP directly, or on top of a Point-to-Point Protocol (PPP) including PPP use over Ethernet (PPPoE), utilizing XML for external interfaces, and supporting both connected clients via the Transmission Control Protocol (TCP) as well as connectionless clients via the User Datagram Protocol (UDP). Further, G_linkP attempts to keep small messages, typically smaller than the maximum transmission unit (MTU). [0027] All protocol messages have a common base structure, comprising header, payload, and tail. The header includes information regarding protocol version, message type, control flags, sequence counter, security field, identification of the originating module, identification of the destination module, gaming console class, gaming console vendor, gaming console model, payload size, payload type, and other relevant data characterizing the type and format of the message. The payload contains the main body of the message, comprising any or all of unstructured binary data, structured, formatted data, XML-text-based data, and other interpretable data. Optionally, depending on the message type, the tail comprises a sequence counter, a security field, and/or control flags. [0028] Typical message types of the gaming link protocol include a logon-message GlP_Hello, a response message GlP_Rsp, a request for download GlP_DReq, an acknowledgment message GlP_ACK, as well as a non-acknowledgement message GlP_NAK, an information package GlP_Info, a data package GlP_Data, and a control package GlP_Control. The main communication between the CLE site 110 and the PLE site 120 over the AAN 130 is handled by the client G_Client 210 and the server services G_Server 220 . [0029] A boot process of the gaming console GC generally starts an on-line gaming session. First loading the UTC base G_UTC from a compact disc (CD) or from read-only memory (ROM) into random access memory (RAM) initializes a sequence of start-up steps. In this first step, client identification (ID), information regarding the make and the model of the GC, as well as the Internet Protocol (IP) address all are retrieved from RAM. [0030] Referring now to FIG. 3 a, a message sequence chart (MSC) is shown for an auto-versioning process of the gaming console GC. It is assumed that the client has a valid and authenticated IP address and client ID. The client G_UTC transmits a logon message GlP_Hello to the GSP server G_Server, step 3101 . The logon message contains information regarding the client ID, the version number of G_linkP used, and the like. Next, G_Server is going to validate the client and the protocol used, step 3102 . G_Server looks up the client ID for validity, and decides whether the version of G_linkP is currently supported. In case of an outdated protocol version, a non-acknowledgment message is sent to the client, step 3103 , containing an address and port of updated client software. In a next step, the client requests a proper update, step 3104 , which is followed by the server determining the data for a correct update, step 3105 . The new updated version is determined taking into account new protocol versions, client console class and type, console make and model, and related information. The information is sent to the client G_UTC in form of an acknowledgment message, step 3106 . The client then requests a download for the updated version, step 3107 , transmitting the necessary information such as updated file name and client ID, to the server G_Server. The server G_Server transmits data containing the new UTC version of the client, step 3108 . The auto-versioning procedure is concluded with an upgrade, step 3109 . The new base client UTC is loaded, and an update flag for NVRAM is set. If the new client is successfully activated, and if the update flag is set, the new client is loaded into RAM. Optionally, after being loaded into RAM, the new client is preserved in NVRAM, if it was originally stored in NVRAM. Otherwise, if the update flag is not set, the old base client is reactivated, and the autoconfiguration procedure is repeated. [0031] Referring now to FIG. 3 b , a message sequence chart (MSC) is shown, how a UTC client is supported by the support services, and especially by G_Server. It is assumed that the client has a valid and authenticated IP address and client ID. It is further assumed that G_UTC is running. The client G_UTC transmits a logon message GlP_hello to the GSP server G_Server, step 3201 . The logon message contains information regarding the client ID, the version number of G_linkP used, and the like. Next, G_Web is going to validate the client and the protocol used, step 3202 . G_Web looks up the client ID for validity, and decides whether the version of G_linkP is currently supported. In case of authenticated information, an acknowledgment message is sent to the client, step 3103 . The client G_UTC then transmits information to the server G_Web, regarding an active element of the client, step 3204 . The active element refers for example to a particular gaming situation of an ongoing interactive computer game, or it possibly refers to information determining gaming characteristics of a certain user, such as information contained in a personal profile. The support server sets a state and a jump table, and updates a client record, step 3205 . This step is based on a current state and transition table of the client, and transition options with prompts and probabilities are determined. These options are sent back to the client as control data, step 3206 . G_UTC then presents a menu to the user, step 3207 . Possible options are different choices within a gaming scenario, different gaming services to be loaded and activated, different gaming qualities, and the like. After the selection is made, the client transmits the corresponding download request, step 3208 , and the server responds by transmitting the corresponding data to the client, step 3209 . Optionally, based on certain probabilities with respect to certain download requests, G_Server chooses to preload one or more selection modules, step 3210 , the modules resulting from a next probable transition taking place on the CLE site. This prefetching process represents a form of caching, which provides the end user with real-time responsiveness. [0032] Referring now to FIG. 3 c, a message sequence chart (MSC) is shown, for a method of UTC selection. The client G_UTC is running on the GC, and is offering a menu of selections to the subscriber, or to a user on the CLE site, step 3301 . Optionally, one or more than one probable selections are preloaded by G_UTC. The subscriber or user then makes a selection, which corresponds to a transition for G_UTC. G_UTC loads and runs the selected transition, step 3302 . Optionally, when the selection was preloaded, a process of loading the selection is not required. A new state is now loaded and activated. G_UTC stays active as supervisor, and for a return to a main menu, but spawns a selected transition module. The client G_UTC then transmits information to the server G_Server, regarding an active element of the client, step 3303 . The active element refers for example to a particular gaming situation of an ongoing interactive computer game, or it possibly refers to information determining gaming characteristics of a certain user, such as information contained in a personal profile. The support server sets a state and a jump table, and updates a client record, step 3304 . This step is based on a current state and transition table of the client, and transition options with prompts and probabilities are determined. These options are sent back to the client as control data, step 3305 . The client transmits a corresponding download request, step 3306 , and the server responds by transmitting the corresponding data to the client, step 3307 . Optionally, based on certain probabilities with respect to certain download requests, G_Server chooses to preload one or more selection modules, step 3308 , the modules resulting from a next probable transition taking place on the CLE site. [0033] The above-described procedures illustrate the basic modus operandi of the instant invention, and it is obvious to a person of skill in the art that the presented communication protocols are easily extended to incorporate and fulfill a variety of other functionalities. Besides the described autoconfiguration procedure, the UTC selection step possibly offers a selection of configuration options that are settable and adaptable by the subscriber or by the user. For example, certain gaming requests are excluded from the GC, or are only possible to be activated at a certain point in time, say in the evening after 10 p.m. Selected options are then stored in a personal profile. The selected options include options regarding gaming executed on the gaming console, options regarding parental control issues, and other options. The personal profile is either located on the provider site, associated with a client ID and IP address, and is accessed by the support services when a request from a certain client is registered, or the profile is stored in the NVRAM of the gaming console, and is loaded at boot time. Alternatively, a given personal profile is not associated with a specific IP address, but is associated with a net-mask or a subnet-mask. This way, for example, a complete home is declared as a violence free gaming zone. [0034] The personal profile is optionally used to protect the GSP from certain legal liabilities. For example, according to a given legislation, the provider of a game, and therefore by extension the GSP, has a liability and/or a responsibility to ensure age appropriate contents. By using the personal profile to determine an age profile of its audience, an appropriate UTC instance is loaded enforcing and allowing only approved age appropriate content. This way, the GSP exercises age control on the services and games provided. [0035] The same way as the personal profile is used to exercise age control, the personal profile is optionally used to exercise parental control. It is possible for parents to block the access to certain type of games, which for example engage their user in violent actions, confront their users with sexual content, and challenge their user with contents of profanity. This way, it is possible for parents to ensure that their educational measures are not undermined by gaming activities performed by their children in their recreational activities. This way, it is possible for younger audience to safely participate in new forms of social interactions related to online gaming activities. Of course, the concept of parental control as described above is easily extended to other forms of control for designated user groups of a given gaming console (GC). [0036] The autoconfiguration procedure also allows one to efficiently deal with security issues. G_UTC itself is the distributed key for security, and the possibility to constantly and automatically update G_UTC introduces enough flexibility into the gaming system, to provide a secure gaming environment. [0037] Although the instant invention has been described with respect to a specific embodiment thereof, various changes and modifications are optionally carried out by those skilled in the art without departing from the scope of the invention. Therefore, it is intended that the instant invention encompass such changes and modifications as fall within the scope of the appended claims.

An interactive gaming system comprising a gaming console and a gaming service provider is disclosed. The gaming console contains a storage medium, on which data relating to a configuration of the gaming console are stored. The gaming console further contains a processor in communication with the storage medium for retrieving data therefrom and executing the data, the data relating to the configuration of the gaming console. A gaming service provider provides instruction data to the gaming console, and a connecting network enables a connection between the gaming console and the gaming service provider. Further, a gaming client is stored on the gaming console. The gaming client establishes a connection between the gaming console and a gaming service provider and controls events taking place on the gaming console. The configuration of the gaming console is established by the gaming client according to messages sent to and received from the gaming service provider and to messages stored within a personal profile.

This application is a 371 of PCT/US95/10111, filed Aug. 7, 1995 which is a continuation of application Ser. No. 08/314,901, filed Sep. 29, 1994 now abandoned which is a continuation-in-part of application Ser. No. 08/297,416, filed Aug. 29, 1994 now abandoned. FIELD OF THE INVENTION This invention relates generally to the treatment of viral infections, and more specifically to the treatment of viral infections with phospholipids and phospholipid derivatives. BACKGROUND OF THE INVENTION A current treatment for combating human immunodeficiency virus type 1 (HIV-1) infections is the administration of the nucleoside analog 3'-azido-3'-deoxythymidine (AZT) to an afflicted subject. See, eg., U.S. Pat. No. 4,724,232 to Rideout et al. HIV-1 infection treatment methods have also included the administration of ether lipid compounds in an amount effective to inhibit replication of the virus in infected cells, see, e.g., Kucera et al., AIDS Research and Human Retroviruses 6:491 (1990), and ether lipids conjugated with AZT and other antiviral nucleoside analogs. See PCT Application No. US91/04289 (published Dec. 26, 1991). These compounds appear to act at the plasma membrane to block the endocytic process of HIV-1 into CD4 + cells and the process of virus assembly, cell fusion and pathogenesis. They also can inhibit the activity of protein kinase C. Given the seriousness of HIV-1 infection worldwide, there is an ongoing need for new methods of combating HIV-1 infections. Another virus of serious concern, hepatitis B virus (HBV), is one of a family of hepadnaviruses that cause acute and chronic liver disease, including liver cancer. HBV, which is found in the body fluids of infected persons, makes three antigenic proteins during multiplication in liver cells: hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg) and hepatitis B core antigen (HBcAg). These three virus antigenic proteins are important as markers for determining virus infection, as antibodies against the virus infection are made in response to these virus proteins in the blood. An HBV vaccine is available to prevent infection, and hyperimmune gamma globulin is available for temporary prophylaxis against developing HBV infection in persons at risk. Clearly specific antiviral agents are needed for treatment and control of HBV infections in humans. Based on the foregoing, it is an object of the present invention to provide a new treatment method for combating the effects of HIV-1. It is another object of the present invention to provide compounds and pharmaceutical compositions for carrying out HIV-1 treatment methods. It is also an object of the present invention to provide a new treatment method for combating the effects of HBV. It is a second object of the present invention to provide compounds and pharmaceutical compositions for carrying out HBV treatment methods. SUMMARY OF THE INVENTION These and other objects are satisfied by the present invention, which provides methods of combating viral infections. As a first aspect, the present invention provides a method of combating a viral infection in a subject in need of such treatment comprising administering to the subject an effective infection-combating amount of a compound of Formula I or a pharmaceutical salt thereof. ##STR1## In the compounds of Formula I, R 1 is a branched or unbranched, saturated or unsaturated C 6 to C 18 alkyl group optionally substituted from 1 to 5 times with --OH, --COOH, oxo, amine, or substituted or unsubstituted aromatic; X is selected from the group consisting of NHCO, CH 3 NCO, CONH, CONCH 3 , S, SO, SO 2 , O, NH, and NCH 3 ; R 2 is a branched or unbranched, saturated or unsaturated C 6 to C 14 alkyl group optionally substituted from 1 to 5 times with --OH, --COOH, oxo, amine, or substituted or unsubstituted aromatic; Y is selected from the group consisting of NHCO, CH 3 NCO, CONH, CONCH 3 , S, SO, SO 2 , O, NH, and NCH 3 ; R 6 is a branched or unbranched C 2 to C 6 alkyl group; and R 3 , R 4 , and R 5 are independently methyl or ethyl, or R 3 and R 4 together form an aliphatic or heterocyclic ring having five or six members and R 5 is methyl or ethyl. Preferred compounds include 1-dodecanamido-2-decyloxypropyl-3-phosphocholine, 1-dodecanamido-2-octyloxypropyl-3-phosphocholine, and 1-dodecanamido-2-dodecyloxypropyl-3-phosphocholine. The method is particularly preferred as a treatment to combat viral infections caused by HIV-1, HBV, and herpes simplex virus. The present invention also includes pharmaceutical compositions comprising a compound of Formula I and a suitable pharmaceutical carrier. As a second aspect, the present invention includes a method of combating viral infections in a subject in need of such treatment which comprises the administration to such a subject a compound of Formula II or a pharmaceutical salt thereof in an effective infection-combating amount. ##STR2## In Formula II, the ring structure is optionally substituted from 1 to 3 times with C 1 to C 3 alkyl; R 1 is an unbranched or branched, saturated or unsaturated C 6 to C 20 alkyl group; R 2 , R 3 , and R 4 are independently methyl or ethyl, or R 2 and R 3 together form an aliphatic or heterocyclic ring having five or six members and R 4 is methyl or ethyl; X is selected from the group consisting of NHCO, CH 3 NCO, CONH, CONCH 3 , S, SO, SO 2 , O, NH, and NCH 3 ; R 5 is a branched or unbranched C 2 to C 6 alkyl group; m is 1 to 3; and n is 0 to 2. Preferred compounds of Formula II are 3-hexadecanamido-cyclohexylphosphocholine and 3-hexadecylthio-cyclohexylphosphocholine. Adminstration of the compounds of Formula II is particularly useful in treating viral infections caused by HIV-1, HBV, and herpesviruses. The present invention also includes pharmaceutical compositions comprising a compound of Formula II and a suitable pharmaceutical carrier. A third aspect of the present invention is a method of treating viral infections comprising administering to a subject in need of such treatment an effective infection-inhibiting amount of a compound of Formula III. ##STR3## In compounds of Formula III, R 1 is a branched or unbranched, saturated or unsaturated C 6 to C 18 alkyl group optionally substituted from 1 to 5 times with --OH, --COOH, oxo, amine, or substituted or unsubstituted aromatic; X is selected from the group consisting of NHCO, CH 3 NCO, CONH, CONCH 3 , S, SO, SO 2 , O, NH, and NCH 3 ; R 2 is a branched or unbranched, saturated or unsaturated C 6 to C 14 alkyl group optionally substituted from 1 to 5 times with --OH, --COOH, oxo, amine, or substituted or unsubstituted aromatic; Y is selected from the group consisting of NHCO, CH 3 NCO, CONH, CONCH 3 , S, SO, SO 2 , O, NH, and NCH 3 ; and Z is a moiety of the Formula V, ##STR4## wherein: V is H or N 3 ; W is H or F; or V and W together are a covalent bond; and B is a purinyl moiety of Formula VI ##STR5## optionally substituted at position 2 with ═O --OH, --SH, --NH 2 , or halogen, at position 4 with NH 2 or ═O, at position 6 with Cl, --NH 2 , --OH, or C 1 -C 3 alkyl, and at position 8 with Br or I; or B is a pyrimidinyl moiety of Formula VII ##STR6## substitued at position 4 with ═O or NH 2 and optionally substituted at position 5 with halogen or C 1 -C 3 saturated or unsaturated alkyl optionally substituted 1 to 3 times with halogen. Pharmaceutical compositions comprising these compounds and a pharmaceutical carrier are also encompassed by the present invention. A fourth aspect of the present invention is a method of inhibiting viral infections comprising administering to a subject in need of such treatment an effective infection-inhibiting amount of a compound of Formula IV. ##STR7## In the compounds of Formula IV, the ring structure is optionally substituted from 1 to 3 times with C 1 to C 3 alkyl; R 1 is an unbranched or branched, saturated or unsaturated C 6 to C 20 alkyl group; X is selected from the group consisting of NHCO, CH 3 NCO, CONH, CONCH 3 , S, SO, SO 2 , O, NH, and NCH 3 ; m is 1 to 3; n is 0 to 2; and Z is a moiety of the Formula V, ##STR8## wherein: V is H or N 3 ; W is H or F; or V and W together are a covalent bond; and B is a purinyl moiety of Formula VI ##STR9## optionally substituted at position 2 with ═O --OH, --SH, --NH 2 , or halogen, at position 4 with NH 2 or ═O, at position 6 with Cl, --NH 2 , --OH, or C 1 -C 3 alkyl, and at position 8 with Br or I; or B is a pyrimidinyl moiety of Formula VII ##STR10## substitued at position 4 with ═O or NH 2 and optionally substituted at position 5 with halogen or C 1 -C 3 saturated or unsaturated alkyl optionally substituted 1 to 3 times with halogen. The present invention also includes pharmaceutical compositions comprising a compound of Formula IV and a suitable pharmaceutical carrier. DETAILED DESCRIPTION OF THE INVENTION As used herein, the term "alkyl" is intended to refer to an unbranched or branched alkyl group comprising carbon atoms, such as methyl, ethyl, propyl, isopropyl, n-butyl, tert-butyl, hexyl, and octyl. The term "pharmaceutical salt" refers to a salt that retains the desired biological activity of the parent compound and does not impart undesired toxicological effects thereto. Examples of such salts are (a) salts formed with cations such as sodium, potassium, NH 4 + , magnesium, calcium polyamines, such as spermine, and spermidine, etc.; (b) acid addition salts formed with inorganic acids, for example hydrochloric acid, hydrobromic acid, sulfuric acid, phosphoric acid, nitric acid and the like; (c) salts formed with organic acids such as, for example, acetic acid, oxalic acid, tartaric acid, succinic acid, maleic acid, fumaric acid, gluconic acid, citric acid, malic acid, ascorbic acid, benzoic acid, tannic acid, palmitic acid, alginic acid, polyglutamic acid, naphthalenesulfonic acid, methanesulfonic acid, p-toluenesulfonic acid, naphthalenedisulfonic acid, polygalacturonic acid, and the like; and (d) salts formed from elemental anions such as chlorine, bromine, and iodine. A first aspect of the present invention is a method of combating viral infection comprising administering a compound of Formula I, wherein R 1 , R 2 , R 3 , R 4 , R 5 , R 6 , X, and Y are defined as stated above, or a pharmaceutical salt thereof. The amphipathic compounds of Formula I, which are generally analogs of phosphatidylcholine, include a glycerol backbone (represented by the chain of three carbon atoms to which other functional groups are bonded), lipophilic moieties (represented by R 1 and R 2 ) bonded to positions 1 and 2 of the glycerol backbone through functional groups (represented by X and Y) that are generally resistant to phospholipase degradation, and polar phosphate and quaternary amine groups (linked to one another through a short alkyl group) bonded to position 3 of the glycerol backbone. Each of these components of the compounds of Formula I is described separately below. In Formula I, as described above, R 1 is a lipophilic moiety; the lipophilicity of R 1 allows the compounds of Formula I to bind with the cell membrane of a cell infected with a retrovirus to provide an anchor thereto. R 1 can be an unbranched or branched, saturated or unsaturated C 6 to C 18 alkyl group. Preferably, R 1 is an unbranched saturated or unsaturated C 8 to C 12 alkyl group, and more preferably, R 1 is an unbranched saturated C 10 or C 12 alkyl group. In compounds of Formula I, X is a functional group that links the lipophilic moiety R. and the glycerol backbone of the compound. X is selected from the group consisting of NHCO, CH 3 NCO, CONH, CONCH 3 , S, SO, SO 2 , O, NH, and NCH 3 ; these functional groups are resistant to the hydrolytic activity of cellular lipases, in particular phospholipase A, which is specific for ester linkages at position 1 (as are present in phosphatidyl choline). Preferably, X is S or NHCO, with NHCO being most preferred. In Formula I, R 2 is a lipophilic moiety which, as is true for R 1 , enables the compounds of Formula I to bind with the cell membrane of an infected cell. R 2 can be an unbranched or branched, saturated or unsaturated C 6 to C 14 alkyl group. Preferably, R 2 is an unbranched saturated or unsaturated C 8 to C 12 alkyl group, and more preferably, R 2 is an unbranched saturated C 8 or C 10 alkyl group. It is also preferred that R 1 and R 2 together contain between 18 and 22 carbon atoms. R 2 is bonded to position 2 of the glycerol backbone through a functional group Y, which is selected from the group consisting of NHCO, CH 3 NCO, CONH, CONCH 3 , S, SO, SO 2 , O, NH, and NCH 3 . Like X, Y should be a moiety that is resistant to the hydrolytic activity of cellular lipases, and in particular phospholipase B, as this enzyme is specific for ester linkages at position 2. Preferably, X is S or O, with O being more preferred. The polar hydrophilic end of the amphipathic compounds of Formula I, which can play a role in membrane interaction, comprises an amphoteric phosphoalkyl quaternary amine group in which the phosphate moiety carries the negative charge and the quaternary amine moiety carries the positive charge. In this group, R 6 , which is a branched or unbranched, saturated or unsatured C 2 to C 6 alkyl group, is preferably saturated C 2 . R 3 , R 4 , and R 5 are independently selected from the group consisting of methyl and ethyl, with methyl being preferred, and with R 3 , R 4 , and R 5 each being methyl being more preferred, or R 3 and R 4 together form an aliphatic or heterocyclic ring having five or six members and R 5 is methyl or ethyl. Exemplary compounds of Formula I include 1dodecanamido-2-decyloxypropyl-3-phosphocholine (CP-128), 1-dodecanamido-2-octyloxypropyl-3-phosphocholine (CP-130), 1-dodecanamido-2-dodecyloxypropyl-3-phosphocholine (CP-131), and 1-dodecyloxy-2-decyloxypropyl-3-phosphocholine (CP-129). These compounds of Formula I can be synthesized according to the procedures set forth in Examples 1 and 2 below. Other compounds of Formula I can be synthesized using the same method with the appropriate reagents substituted for those listed. Another aspect of the invention is a method of combating viral infection by administering compounds of Formula II, wherein R 1 , R 2 , R 3 , R 4 , R 5 , X, m, and n are defined as stated above, or a pharmaceutical salt thereof. Compounds of Formula II are amphipathic moieties having a lipophilic moiety (represented by R 1 ) linked to a five- or six-membered ring structure (which is optionally sustituted 1 to 3 times with C 1 to C 3 alkyl) and a hydrophilic moiety that includes phosphate and quaternary amine groups linked by a short alkyl group that is bonded to the ring structure through the phosphate group. The hydrophilic group is linked to the ring at position 1, and the lipophilic group is linked to the ring at positions 2, 3, or 4. Like the compounds of Formula I, the compounds of Formula II are analogs of phosphatidyl choline. However, the ring structure provides a more conformationally restricted framework for the compound than compounds lacking a ring structure; this restricted framework can provide the compound with more favorable interaction with the cellular membrane and thereby increase its efficacy. In the compounds of Formula II, R 1 can be an unbranched or branched, saturated or unsaturated C 6 to C 20 alkyl group. As with the compounds of Formulas II, R 1 is a lipophilic moiety which binds with the cell membrane of infected cells to provide an anchor thereto. Preferably, R 1 is unbranched saturated or unsaturated C 16 to C 18 alkyl. More preferably, R 1 is unbranched saturated or unsaturated C 16 to C 18 alkyl. In compounds of Formula II, X is a functional group that links the lipophilic moiety R 1 to position 1 of the ring structure. X should be a functional group, such as NHCO, CH 3 NCO, CONH, CONCH 3 , NH, NCH 3 , S, SO, SO 2 , or O, that is able to withstand the hydrolytic activity of cellular lipases. Preferably, Y is S or NHCO. As stated above, the polar hydrophilic end of the amphipathic compounds of Formula II comprises a phosphate group bonded to the ring structure, a short alkyl group R 5 linked at one end thereto, and a quaternary amine group linked to the opposite end of the short alkyl group. R 5 is a saturated or unsaturated, branched or unbranched C 2 to C 6 alkyl group, and is more preferably C 2 . R 2 , R 3 , and R 4 are independently selected from the group consisting of methyl and ethyl, with methyl being preferred, or R 2 and R 3 together form an aliphatic or heterocyclic five- or six-membered ring structure and R 4 is methyl or ethyl. It is more preferred that R 2 , R 3 , and R 4 are each methyl. In the compounds of Formula II, m can be 1, 2, or 3, and n can be 0, 1, or 2. Preferably the ring structure is a five- or six-membered ring; thus, preferably m is 2 or 3 when n is 0, m is 1 or 2 when n is 1, and m is 1 when n is 2. As noted above, the ring structure provides conformational rigidity to the compound. Exemplary compounds of Formula II include 3-hexadecylthio-cyclohexylphosphocholine (INK-1), 3-hexadecanamido-cyclohexylphosphocholine, 3-hexadecanamido-cyclopentylphosphocholine, and 3-hexadecylthio-cyclopentylphosphocholine. These compounds of Formula II can be synthesized by following the teachings of Example 3 below in combination with procedures known to those skilled in the art. An additional aspect of the present invention is a method of combating viral infection with compounds of Formulas III and IV. These compounds substitute a moiety Z for the alkyl-quaternary amine of the compounds of Formulas I and II, wherein Z is as defined above. Z is a moiety that has demonstrated anti-viral activity by itself; thus conjugation of Z to the remainder of the compounds of Formulas III and IV provides a compound that potentially includes multiple active sites for viral inhibition. In the compounds of Formula III R 1 , R 2 , X and Y are defined above. R 1 is a lipophilic moiety; the lipophilicity of R 1 allows the compounds of Formula I to bind with the cell membrane of a cell infected with a retrovirus to provide an anchor thereto. R 1 can be an unbranched or branched, saturated or unsaturated C 6 to C 18 alkyl group. Preferably, R 1 is an unbranched saturated or unsaturated C 8 to C 12 alkyl group, and more preferably, R 1 is an unbranched saturated C 10 or C 12 alkyl group. In compounds of Formula III, X is a functional group that links the lipophilic moiety R 1 and the glycerol backbone of the compound. X is selected from the group consisting of NHCO, CH 3 NCO, CONH, CONCH 3 , S, SO, SO 2 , O, NH, and NCH 3 ; these functional groups are resistant to the hydrolytic activity of cellular lipases, in particular phospholipase A, which is specific for ester linkages at position 1 (as are present in phosphatidyl choline). Preferably, X is S or NHCO, with NHCO being most preferred. In Formula III, R 2 is a lipophilic moiety which, as is true for R 1 , enables the compounds of Formula III to bind with the cell membrane of an infected cell. R 2 can be an unbranched or branched, saturated or unsaturated C 6 to C 14 alkyl group. Preferably, R 2 is an unbranched saturated or unsaturated C 8 to C 12 alkyl group, and more preferably, R 2 is an unbranched saturated C 8 or C 10 alkyl group. It is also preferred that R 1 and R 2 together contain between 18 and 22 carbon atoms. R 2 is bonded to position 2 of the glycerol backbone through a functional group Y, which is selected from the group consisting of NHCO, CH 3 NCO, CONH, CONCH 3 , S, SO, SO 2 , O, NH, and NCH 3 . Like X, Y should be a moiety that is resistant to the hydrolytic activity of cellular lipases, and in particular phospholipase B, as this enzyme is specific for ester linkages at position 2. Preferably, X is S or O, with O being more preferred. In the compounds of Formula III, Z is a moiety of Formula V. Moieties of Formula V are intended to be anti-viral agents, and thus potentially provide an additional active site for anti-viral activity that may act through a different mechanism. In the moieties of Formula V, V is H, or N 3 , or V and W together from a covalent bond with H and N 3 being preferred. W is H or F, with H being preferred. In the compounds of Formula IIII, B is a purinyl moiety of Formula VI or a pyrimidinyl moiety of Formula VII, each of which are substituted as described above. As used herein, a purinyl moiety comprises six- and five-membered aromatic rings having the molecular structure illustrated in Formula VI. Those skilled in this art will appreciate that the double bonds illustrated in Formula VI are present to represent that the purinyl moieties have aromatic character, and that these double bonds may shift their positions in certain compounds due to the presence of certain substituents to retain the aromatic character of the moiety; in particular, those moieties having ═O or NH 2 substituents at positions 2 and 4, such as adenine, guanine, xanthine, and hypoxanthine, are generally illustrated as having double bonds shifted from the positions shown in Formula VI. Similarly, as used herein a pyrimidinyl moiety comprises a six-membered aromatic ring having the molecular structure illustrated in Formula VII. Those skilled in this art will appreciate that the double bonds illustrated in Formula VII are included therein to represent that the moieties of Formula VII have aromatic character, and that these double bonds may shift for certain substituents, in particular for ═O and NH 2 at positions 2 and 4, in order for the moiety to retain its aromatic character. Preferably, B is selected from the group consisting of adenine, thymine, cytosine, guanine, hypoxanthine, uracil, 5-fluorouracil, 2-fluoro-adenine, 2-chloro-adenine, 2-bromo-adenine, and 2-amino-adenine. Preferably, Z is 3'-azido-3'-deoxythymidine, dideoxyinosine, dideoxycytidine, or 2', 3'-didehydro-3'-deoxythymidine. An exemplary preferred compound of Formula III is 3'-azido-3'-deoxy-5'-(3-dodecanamido-2-decyloxypropyl)-phosphothymidine. A further aspect of the present invention is a method of inhibiting viral infections comprising administering to a subject an effective infection-inhibiting amount of a compound of Formula IV, wherein R 1 , R 2 , X, m, n, and Z are as defined above. In the compounds of Formula IV, R 1 can be an unbranched or branched, saturated or unsaturated C 6 to C 20 alkyl group. As with the compounds of Formula II, R 1 is a lipophilic moiety which binds with the cell membrane of infected cells to provide an anchor thereto. Preferably, R 1 is unbranched saturated or unsaturated C 10 to C 18 alkyl. More preferably, R 1 is unbranched saturated or unsaturated C 16 to C 18 alkyl. In compounds of Formula IV, X is a functional group that links the lipophilic moiety R 1 to position 1 of the ring structure. X should be a functional group, such as NHCO, CH 3 NCO, CONH, CONCH 3 , NH, NCH 3 , S, SO, SO 2 , or O, that is able to withstand the hydrolytic activity of cellular lipases. Preferably, X is S or NHCO. As stated above, the polar hydrophilic end of the amphipathic compounds of Formula IV comprises a phosphate group bonded to the ring structure and a moiety Z as defined in Formula V. In the moieties of Formula V, V is H, or N 3 , or V and W together form a covalent bond, with H and N 3 being preferred. W is H or F, with H being preferred. In the compounds of Formula IV, B is a purinyl moiety of Formula VI or a pyrimidinyl moiety of Formula VII, each of which are substituted as described above. As used herein, a purinyl moiety comprises six- and five-membered aromatic rings having the molecular structure illustrated in Formula VI. Those skilled in this art will appreciate that the double bonds illustrated in Formula VI are present to represent that the purinyl moieties have aromatic character, and that these double bonds may shift their positions in certain compounds due to the presence of certain substituents to retain the aromatic character of the moiety; in particular, those moieties having ═O or NH 2 substituents at positions 2 and 4, such as adenine, guanine, xanthine, and hypoxanthine, are generally illustrated as having double bonds shifted from the positions shown in Formula VI. Similarly, as used herein a pyrimidinyl moiety comprises a six-membered aromatic ring having the molecular structure illustrated in Formula VII. Those skilled in this art will appreciate that the double bonds illustrated in Formula VII are included therein to represent that the moieties of Formula VII have aromatic character, and that these double bonds may shift for certain substituents, in particular for ═O and NH 2 at positions 2 and 4, in order for the moiety to retain its aromatic character. Preferably, B is selected from the group consisting of adenine, thymine, cytosine, guanine, hypoxanthine, uracil, 5-fluorouracil, 2-fluoro-adenine, 2-chloro-adenine, 2-bromo-adenine, and 2-amino-adenine. Preferably, Z is selected from the group consisting of 3'-azido-3'-deoxythymidine, dideoxyinosine, dideoxycytidine, and 2', 3'-didehydro-3'-deoxythymidine. In the compounds of Formula IV, m can be 1, 2, or 3, and n can be 0, 1, or 2. Preferably, the ring structure is a five- or six-membered ring; thus m is 2 or 3 when n is 0, m is 1 or 2 when n is 1, and m is 1 when n is 2. The ring structure provides conformational rigidity to the compound. An exemplary compound of Formula IV is 3'-azido-3'-deoxy-5'-(3-hexadecylthiocyclohexyl)-phosphothymidine. Experimentation has demonstrated the efficacy of the compounds of Formulas I, II, III and IV in combating viral infection. For example, compounds CP-128, CP-129, CP-130, CP-131, and INK-1 in nanomolar concentration substantially inhibit the HIV-1 activity in CEM-SS cells. Further, these compounds did so at noncytotoxic levels, thus indicating their promise as therapeutic agents for treatment of viral infections. The compounds of Formulas I, II, III and IV are believed to attach to the cell membrane and thus are particularly effective against infections caused by membrane-containing or envelope-containing viruses, as these viruses typically require access to the cell membrane to multiply and assemble through the manufacture of new viral particles. For example, the compounds of Formulas I, II, III and IV can inhibit the transport and/or incorporation of HIV-1 major glycoprotein gp12O in the cell membrane of an infected cell prior to viral assembly. Such inhibition can block the transmission of infectious HIV-1 into neighboring cells. In addition, compounds of Formulas I, II, III and IV can inhibit the production of the HBV core and "e" antigens, each of which contribute to the assembly of new virus particles and the spread of HBV infection. Other infections for which the compounds of Formulas I, II, III and IV should be efficious include those caused by other membrane-containing or envelope-containing herpesviruses, influenza, respiratory syncytial virus, mumps, measles, and parainfluenza viruses. Experimentation has also shown that the compounds of Formulae I, II, III, and IV have potent anti-tumor activity. In particular, some of these compounds have IC 50 values of approximately 1.2 μM against the KB-cell line. In the manufacture of a medicament according to the invention, hereinafter referred to as a "formulation," the compounds of Formulas I, II, III and IV are typically admixed with, among other things, an acceptable carrier. The carrier must, of course, be acceptable in the sense of being compatible with any other ingredients in the formulation and must not be deleterious to the patient. The carrier may be a solid or a liquid, or both, and is preferably formulated with the compound as a unit-dose formulation, for example, a tablet, which may contain from 0.5 percent to 95 percent by weight of the active compound. One or more active compounds may be incorporated in the formulations of the invention, which may be prepared by any of the well known techniques of pharmacy consisting essentially of admixing the components. The formulations of the invention include those suitable for oral, rectal, topical, intrathecal, buccal (e.g., sub-lingual), parenteral (e.g., subcutaneous, intramuscular, intradermal, or intravenous) and transdermal administration, although the most suitable route in any given case will depend on the nature and severity of the condition being treated and on the nature of the particular active compound which is being used. Formulations suitable for oral administration may be presented in discrete units, such as capsules, cachets, lozenges, or tablets, each containing a predetermined amount of the active compound; as a powder or granules; as a solution or a suspension in an aqueous or nonaqueous liquid; or as an oil-in-water or water-in-oil emulsion. Such formulations may be prepared by any suitable method of pharmacy which includes the step of bringing into association the active compound and a suitable carrier (which may contain one or more accessory ingredients as noted above). Suitable solid diluents or carriers for the solid oral pharmaceutical dosage unit forms are selected from the group consisting of lipids, carbohydrates, proteins and mineral solids, for example, starch, sucrose, lactose, kaolin, dicalcium phosphate, gelatin, acacia, corn syrup, corn starch, talc and the like. Capsules, both hard and soft, are filled with compositions of these active ingredients in combination with suitable diluents and excipients, for example, edible oils, talc, calcium carbonate and the like, and also calcium stearate. In general, the formulations of the invention are prepared by uniformly and intimately admixing the active compound with a liquid or finely divided solid carrier, or both, and then, if necessary, shaping the resulting mixture. For example, a tablet may be prepared by compressing or molding a powder or granules containing the active compound, optionally with one or more accessory ingredients. Compressed tablets may be prepared by compressing, in a suitable machine, the compound in a free-flowing form, such as a powder or granules optionally mixed with a binder, lubricant, inert diluent, and/or surface active/dispersing agent(s). Molded tablets may be made by molding, in a suitable machine, the powdered compound moistened with an inert liquid binder. Liquid preparations for oral administration are prepared in water or aqueous vehicles which advantageously contain suspending agents, for example, methylcellulose, acacia, polyvinylpyrrolidone, polyvinyl alcohol and the like. Formulations suitable for buccal (sub-lingual) administration include lozenges comprising the active compound in a flavored base, usually sucrose and acacia or tragacanth; and pastilles comprising the compound in an inert base such as gelatin, glycerin, sucrose, or acacia. Formulations of the present invention suitable for parenteral administration conveniently comprise sterile aqueous preparations of the active compound, which preparations are preferably isotonic with the blood of the intended recipient. These preparations are preferably administered intravenously, although administration may also be effected by means of subcutaneous, intramuscular, intrathecal, or intradermal injection. The formulation should be sufficiently fluid that for easy parental administration. Such preparations may conveniently be prepared by admixing the compound with water or a glycine buffer and rendering the resulting solution sterile and isotonic with the blood. Such preparations should be stable under the conditions of manufacture and storage, and ordinarily contain in addition to the basic solvent or suspending liquid, preservatives in the nature of bacteriostatic and fungistatic agents, for example, parabens, chlorobutanol, benzyl alcohol, phenol, thimerosal, and the like. In many cases, it is preferable to include osmotically active agents, for example, sugars or sodium chloride in isotonic concentrations. Injectable formulations according to the invention generally contain from 0.1 to 5 percent w/v of active compound and are administered at a rate of 0.1 ml/min/kg. Formulations suitable for rectal administration are preferably presented as unit dose suppositories. These may be prepared by admixing the active compound with one or more conventional solid carriers, for example, cocoa butter, and then shaping the resulting mixture. Formulations suitable for topical application to the skin preferably take the form of an ointment, cream, lotion, paste, gel, spray, aerosol, or oil. Carriers which may be used include vaseline, lanolin, polyethylene glycols, alcohols, and combinations of two or more thereof. The active compound is generally present at a concentration of from 0.1 to 15 percent w/w, for example, from 0.5 to 2 percent w/w. Formulations suitable for transdermal administration may be presented as discrete patches adapted to remain in intimate contact with the epidermis of the recipient for a prolonged period of time. Such patches suitably contain the active compound as an optionally buffered aqueous solution of, for example, 0.1 to 0.2M concentration with respect to the said active compound. Formulations suitable for transdermal administration may also be delivered by iontophoresis (see, for example, Pharmaceutical Research 3 (6), 318, (1986)) and typically take the form of an optionally buffered aqueous solution of the active compound. Suitable formulations comprise citrate or bis\tris buffer (pH 6) or ethanol/water and contain from 0.1 to 0.2M active ingredient. The compounds of Formulas I, II, III and IV are administered in an amount sufficient to combat viral infection. The dose can vary depending on the compound selected for administration, the subject, the route of administration, and other factors. Preferably, the compound is administered in an amount of at least 0.1 ng/kg, 1 ng/kg, 0.001 μg/kg or more, and is adminstered in an amount no greater than 0.1 g/kg, 0.01 g/kg, 1 mg/kg, or less. The invention is illustrated in greater detail in the following nonlimiting examples. In the Examples, "g" means grams, "mg" means milligrams, "μg" means micrograms, "μM" means micromolar, "mL" means milliliters, "° C." means degrees Celsius, "THF" means tetrahydrofuran, "DMF" means dimethylformamide, "mol" means moles, "mmol" means millimoles, and "psi" means pounds per square inch. EXAMPLE 1 Preparation of Amidoalkyl Derivatives The procedure set forth below was used to prepare the following compounds: (a) 1-dodecanamido-2decyloxypropyl-3-phosphocholine (CP-128) (b) 1-dodecanamido-2-octyloxypropyl-3-phosphocholine (CP-130) (c) 1-dodecanamido-2-dodecyloxypropyl-3-phosphocholine (CP-131) 3-Amino-1,2-propanediol was reacted with lauroyl chloride at room temperature in pyridine and dimethyl formamide. The resulting dodecanamido propanediol was recrystallized from chloroform, then reacted with triphenylmethyl chloride. The tritylated product was recrystallized from hexanes. The C-2 hydroxyl was alkylated by reaction with sodium hydride and the appropriate alkyl bromide in tetrahydrofuran for formation of the ether linkage at C-2 (1-bromodecane for CP-128; 1-bromooctane for CP-130; 1-bromododecane for CP-131). Column chromatography on silica gel with a discontinuous gradient of hexanes:ethyl acetate (95:5 to 80:20) produced the desired 1-dodecanamido-2-alkoxy-3-trityloxypropane. Detritylation with p-toluensulfonic acid in 5:1 methylene chloride:methanol gave product having a free primary hydroxyl after column chromatography (hexanes:ethyl acetate 95:5 to 0:100). Reaction with 2-bromoethyl phosphodichloridate in diethyl ether and pyridine produced the phosphate ester, which was purified on silica gel with chloroform:methanol (100:0 to 2:1). Displacement of the bromide with aqueous trimethylamine in chloroform:isopropanol:dimethyl formamide (3:5:5) gave the final phosphocholine product after column chromatography with chloroform:methanol:ammonium hydroxide (70:35:1 to 70:35:7). EXAMPLE 2 Preparation of 1-dodecyloxy-2-decyloxypropyl-3-phosphocholine (CP-129) Isopropylidene glycerol was alkylated using potassium hydroxide and 1-bromododecane in toluene. The resulting ketal was hydrolyzed with hydrochloric acid in methanol, and the diol formed thereby was recrystallized from methanol. The remaining reaction steps (tritylation, alkylation, detritylation, phosphorylation, amination) followed the procedures described above in Example 1 for the alkylamido derivatives. EXAMPLE 3 Preparation of cis- and trans-3-hexadecylthiocyclohexylphosphocholine (INK-1) 2-Cyclohexenone (0.14 mol, 13.4 mL) was dissolved in 10 mL of 10 percent sodium hydroxide and 50 mL of THF. An equimolar amount of hexadecyl mercaptan (0.14 mol, 42.9 mL) was added to the unsaturated ketone and the mixture refluxed to produce 3-hexadecylthiocyclohexanone (70 percent yield). This product (5.23 mmol, 1.851 g) was dissolved in methanol and reduced with sodium borohydride (5.23 mmol, 0.199 g) to give a racemic mixture of 3-hexadecylthiocyclohexanol (yield 62 percent; cis:trans ratio 4:1). The phosphorylating agent was prepared by refluxing phosphorus oxychloride (0.65 mol, 60.8 mL) and 2-bromoethanol (0.38 mol, 27.0 mL) in 25 mL of trichloroethylene to produce 2-bromoethyl dichlorophosphate (yield 53 percent). The 3-hexadecylthiocyclohexanol (0.56 mmol, 0.200 g) was dissolved in diethyl ether:THF (2:1) and refluxed with the 2-bromoethyl dichlorophosphate (222 mmol, 0.3 mL) to produce 3-hexadecylthiocyclohexyl phosphoethyl bromide (yield 54 percent). The latter (0.276 mmol, 0.150 g) was dissolved in isopropyl alcohol chloroform:DMF (5:3:5) and heated at 65° C. with trimethylamine (0.042 mol, 2 mL) to produce the desired product, 3-hexadecylthiocyclohexyl-phosphocholine (yield 38 percent). This procedure can also be used to prepare 3-alkylthio-cyclopentyl derivatives by substituting 2-cyclopentenone. EXAMPLE 4 Preparation of cis- and trans-3-hexadecanamido-cyclohexylphosphocholine 2-Cyclohexenone is reacted with benzylamine to give 3-benzylaminocyclohexanone. Hydrogenolysis of the benzylamino group then gives 3-aminocyclohexanone. Reaction with hexadecanoyl chloride affords 3-hexadecanamidocyclohexanone, which is then reduced with sodium borohydride to produce a cis/trans mixture of 3-hexadecanamidocyclohexanol. Separation by column chromatography then gives the pure isomers. Reaction with bromoethylphosphodichloridate, then with trimethylamine will produce 3-hexadecanamidocyclohexylphosphocholine. Synthesis of the 2- and 4-alkylamido derivatives can be carried out following essentially similar procedures with the substitution of appropriate starting materials. EXAMPLE 5 Preparation of 3'-azido-3'-deoxy-5'-(dodecanamido-2-decoxypropyl)-phosphothymidine 3-Dodecanamido-2-decoxy-propanol was synthesized via the scheme described in Morris-Natschke et al., C. I. Med. Chem. 29:2114 (1986). This alcohol was phosphorylated with diphenyl chlorophosphate in pyridine to give the corresponding phospate ester. The phenyl groups were then removed via hydrogenolysis with PtO 2 . The phosphatidic acid derivatives were then conjugated to the 5'-hydroxyl of AZT (DCC condensation). EXAMPLE 6 Preparation of 3'-azido-3 -deoxy-5'-(dodecyoxy-2-decyloxypropyl)-phosphothymidine A. 3-Dodecyloxy-1,2-propanediol Isopropylideneglycerol (solketal, 26.4 g, 0.20 mol) in 60 mL of tolune was added dropwise to a solution of powdered KOH (22.4 g., 0.04 mol) in 150 mL toluene. The resulting mixture was refluxed for 4 hours. 1-Bromododecane (50 g, 0.20 mol) in 40 mL of tolune was then added dropwise, and the solution was refluxed for 10 hours. After cooling, the reaction mixture was diluted with 200 mL of ice-water and extracted with diethyl ether (3×100 mL). The ether layers were dried over magnesium sulfate, and the solvent was removed in vacuo. The residue was dissolved in 60 mL of diethyl ether and 260 mL of MeOH. Concentrated HCl (60 mL) was added, and the solution was refluxed for 16 hours. After cooling, ice-water (150 mL) was added, and the layers were separated. The aqueous layer was extracted with diethyl ether (2×75 mL). The combined organic fractions were then dried over sodium sulfate, filtered, and concentrated in vacuo. The solid residue was recrystallized from MeOH to give 37 g (0.14 mol, 71%) of a white solid. B. 3-Dodecyloxy-1-triphenylmethoxy-2-propanol The diol synthesized in Section A was tritylated with trityl chloride (59 g, 0.21 mol) in pyridine (200 mL) at 70° C. for 5 hours and then at room temperature overnight. The pyridine was removed under vacuum, and the solid residue was partitioned between water and CHCl 3 . The CHCl 3 layer was washed with 5 percent HCl and water, then dried over magnesium sulfate. After removal of solvent, the product was recrystallized from hexanes:ethyl acetate (10:1) to give 19 g of pure product. C. 3-Dodecyloxy-2-decyloxy-1-triphenylmethoxypropane The trityl ether of Section B (13.5 g, 0.027 mol) was added dropwise to an ice-cooled suspension of sodium hydride (80%, 1.6 g, 0.054 mol) in 150 mL of tetrahydrofuran under nitrogen. After stirring for 2 hours at room temperature, heat was applied (55° C.). 1-Bromodecane (6 g, 0.027 mol) was added dropwise; heating was continued for 6 hours. After cooling for 3 hours, water was added slowly. Diethyl ether (2×100 mL) was added, and the solution washed with 15 percent sodium thiosulfite, water, and brine. After drying over sodium sulfate, the ether was removed, and the residue was chromatographed with a gradient of hexanes:ethyl acetate (100:0 to 20:1) to give 9 g (52%) of a clear liquid. D. 3-Dodecyloxy-2-decyloxy-1-propanol Detritylation of the product of Section C was accomplished using p-toluenesulfonic acid (0.9 g) in CHCl 3 :MeOH (72 mL:36 mL) (stirred at room temperature for 48 hours, added 10 percent sodium bicarbonate, extracted with CHCl 3 , dried over magnesium sulfate, and concentrated). The residue was purified by column chromatography using a gradient of hexanes:ethyl acetate (20:1 to 5:1) to give 3.5 g (63%) of pure 3-dodecyloxy-2-decyloxy-1-propanol. E. 3-Dodecyloxy-2-decyloxypropyl Diphenyl Phosphate Diphenylchlorophosphate (0.7 mL, 3.4 mmol) in 10 mL of diethyl ether was cooled to 4° C. under nitrogen. 3-Dodecyloxy-2-decyloxy-1-propanol (1.0 g, 2.6 mmol) in 15 mL of pyridine and 5 mL of diethyl ether was added. The solution was warmed to room temperature then heated to about 52° C. for 3 hours. It was then cooled to room temperature, diluted with 50 mL of diethyl ether, and washed with water (2×25 mL), 0.5 N HCl (25 mL), and then water (25 mL). The organic layer was dried over sodium sulfate, filtered, and concentrated in vacuo to an oil. Chromatography with a gradient of hexanes:ethyl acetate (10:1 to 1:1) produced 980 mg (1.5 mmol, 60%) of pure product. F. 3-Dodecyloxy-2-decyloxpropyl Phosphate PtO 2 (69 mg) was placed in a Parr hydrogenation bottle. The diphenyl phosphate of Section E (500 mg) in 100 mL of EtOH was then added. The reaction mixture was hydrogenated at 15 psi for 1.5 hours until hydrogen uptake ceased. The reaction mixture was then filtered through Celite, and the EtOH was removed in vacuo. The oil was dissolved in 25 mL of pyridine, concentrated in vacuo, and dried under high vacuum to give 350 mg of pure solid phosphatidic acid. G. 3'-Azido-3'-deoxy-5'-(3-dodecyloxy-2-decyoxypropyl)-phosphothymidine AZT (43 mg, 0.16 mmol) and the phosphatidic acid of Section F (105 mg, 0.22 mmol) were azeotropically dried with pyridine (3×3 mL) by in vacuo removal. Dicyclohexylcarbodiimide (220 mg, 1.07 mmol) was added, and the drying was repeated 4 times. A final 3 mL portion of pyridine was added, and the reaction mixture was stirred at room temperature in a desiccator for 4 days. Water (1 g) was added, and the mixture was stirred for 4 hours. The solvents were removed in vacuo, and the crude material was chromatographed on 2 g of silica gel using a gradient of CHCl 3 :MeOH (15:1 to 2:1). The product was dissolved in 11 mL of CHCl 3 :MeOH:H 2 O (4:6:1) and stirred with 1.5 g of Whatman preswollen microgranular cation (Na + ) exchange concentrated in vacuo to give 37 mg of product (22%). FAB ms showed a MH+Na! ion at 752.4350 (C 35 H 64 N 5 O 9 PNa, 1.4 ppm) and a M+2Na! + ion at 774.4179 (C 35 H 63 N 5 O 9 PNa 2 , 2.0 ppm). EXAMPLE 7 Procedure for Assessing Anti-HIV-1 Activity The inhibitory effects of synthetic phospholipid compounds on the replication of human immunodeficiency virus type 1 (HIV-1) virus in cells was examined by the plaque assay procedure of L. Kucera et al., Aids Research and Human Retroviruses 6, 491 (1990). In brief, CEM-SS cell monolayers were infected with HIV-1. Infected cells were overlaid with RPMI -1640 medium plus 10 percent fetal bovine serum (FBS) supplemented with different concentrations of inhibitor. Plaques were counted at five days after infection. In this assay HIV-1 syncytial plaques are seen as large, multicellular foci (10 to 25 nuclei/syncytium) that appear either brown and granular or clear. Since the number of HIV-1 syncytial plaques correlates with reverse transcriptase (RT) and p24 core antigen activity in the HIV-1 infected cell overlay fluids, the syncytial plaque assay can be used to quantify the amount of infectious virus. Reverse transcriptase activity was assayed according to a described procedure (B. J. Poeisz et al., Proc. Nat. Acad. Scie. (U.S.A.) 77, 7415 (1980)). The activity of p24 core antigen induced by HIV-1 infection of CEM-SS cells was measured spectrophotometrically using the commercial Coulter EIA. EXAMPLE 8 Results of Assessment of Anti-HIV-1 Activity The results (Table 1) showed that all of the lipid compounds tested have an IC 50 against HIV-1 syncytial plaque formation ranging from 0.11 to 0.64 μM. The compounds' IC 50 for cell cytotoxicity ranged from 11.85 to 75.7 μM. The highest differential selectivity (611.7), which is a ratio of the cytotoxicity to the anti-HIV-1 activity, was obtained with compound CP-130. TABLE 1______________________________________Evaluation of Ether Lipids for Cytotoxicityand Anti-Viral Activity in CEM-SS CellsIC.sub.50 (μM) DifferentialCompounds Cytotoxicity Anti-HIV-1 Activity Selectivity______________________________________CP-128 31.6 0.14 225.7CP-129 75.7 0.64 176.0CP-130 67.2 0.11 611.7CP-131 36.6 0.32 114.2JM-1 (cis) 11.85 0.42 28.2______________________________________ Cytotoxicity was measured by uptake of TdRH.sup.3 into total DNA in the presence of serial concentrations of compound. AntiHIV-1 activity was measured by standard plaque assay using CEMSS cell monolayers. Differential selectivity was determined by dividing the IC.sub.50 for cytotoxicity by the IC.sub.50 for antiHIV-1 activity. Cytotoxicity was measured by uptake of TdR-H 3 into total DNA in the presence of serial concentrations of compound. Anti-HIV-1 activity was measured by standard plaque assay using CEM-SS cell monolayers. Differential selectivity was determined by dividing the IC50 for cytotoxicity by the IC50 for anti-HIV-1 activity. EXAMPLE 9 Assessment of HBV Activity Inhibition Human hepatoblastomas (HepG2) cells were tranfected with plasmid DNA containing tandem copies of HBV genomes. These cells constituitively replicate HBV particles. HepG2 cells were treated with varying concentrations of CP-128 to determine the toxic cell concentration (TC 50 ) by neutral red dye uptake. Also, the inhibitory concentration (IC 50 ) of CP-128 for HBV replication was determined by ELISA. It was determined that CP-128 cytotoxicity (TC 50 ) was 61.7 μM and the anti-HIV-1 activity (IC 50 ) was 15.6 μM (Table 1). These data indicate that CP-128 has selective anti-HBV activity. Mechanism studies indicate that CP-128 can have an inhibitory effect on the cellular production of HBV-induced DNA, core antigen (HBcAg) and "e" antigen (HBeAg). As a result, it is postulated that CP-128 and other compounds of the present invention are likely inhibiting the assembly of HBV nucleocapids and the packaging of viral pregenomic DNA. The foregoing examples are illustrative of the present invention and are not to be construed as limiting thereof. The invention is defined by the following claims, with equivalents of the claims to be included therein.

A method of treating viral infections, and in particular HIV-1, hepatitis B virus and herpes viruses, is disclosed. The method comprising administering to a subject in need of such treatment an infection-combating amount of a phospholipid or phospholipid derivative.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/555,595 filed on Mar. 23, 2004, the contents of which are hereby incorporated by reference. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not applicable. REFERENCE TO A “SEQUENCE LISTING” [0003] Not applicable. FIELD OF INVENTION [0004] The present invention relates generally to breast enhancement aides and specifically to a breast enhancement method which is natural and non-invasive. BACKGROUND OF THE INVENTION [0005] Numerous instances exist where people desire enlargement of soft tissues in their bodies. One such instance is for the augmentation of physical attributes to improve cosmetics and self-esteem. These soft tissue enlargements are mainly directed at breast enlargements in females. [0006] Prosthetic implants have been developed for insertion below the skin. However, the severity of the potential complications including scarring, implant rupture, capsular contracture, necrosis and implant migration as well as the recent adverse publicity thereof have significantly reduced the desirability of these implants. Thus, there is a societal need for other means to obtain soft tissue enlargement. [0007] Moreover, the expense of surgery precludes many persons desiring to improve themselves from even considering it. [0008] The prior art also describes the use of a vacuum to produce soft tissue enlargement. However, the prior art does not disclose a vacuum technique which would generally provide controlled tissue enlargement. Furthermore, it is well established that the application of an excessive amount of vacuum can result in damage to the soft tissue. [0009] The above techniques have attempted to satisfy the demands of the public, but more often than not have left much to be desired or too much to be handled. [0010] In light of the foregoing, non-invasive breast augmentation methods have been proposed. Hydro therapy, the use of external creams or internal hormone preparations, the use of foam pads have proved to be damaging, ineffective, to cause side effects and look unnatural and feel foreign. [0011] Also, the use of herbal topical and oral compositions has been proposed but has proved to be unreliable since the human body will react differently from one person to another to a given composition, and some people prefer not to take any sort of supplementary pills. [0012] In view of the foregoing disadvantages inherent in the known types of methods and systems now present in the prior art, the breast enhancement method according to the present invention substantially departs from the conventional methods and systems. SUMMARY OF THE INVENTION [0013] It is an object of the present invention to provide an inexpensive, non-scarring, non-invasive method for breast augmentation which is all-natural and involves no drugs, topical or oral compositions, hormones or surgery and is self-administered. [0014] Another object is to provide a breast enhancement method that enhances breast size by mimicking natural hormones and natural development processes. [0015] Yet another object is to provide a breast enhancement method that improves an individual's quality of life and self-confidence. [0016] In accordance with the present invention, a manipulative method is provided for enhancing breasts of a human, comprising the steps of stimulating breast lobules with fingertips; kneading the breasts; touching and rubbing the breasts' nipples; and massaging the breasts to direct milk flow to the breasts' areola and nipple areas. [0017] In accordance with a further object of the present invention, a manipulative method is provided for enhancing breasts of a human, comprising the steps of stimulating breast lobules with fingertips in a repetitive 20-second manipulation of a breast area extending to about 50 contact points; kneading the breasts in a movement toward and away from the breasts' nipples for 5 to 10 minutes per breast; touching and rubbing said breasts' nipples; and massaging the breasts in large circles from the outer sections of the breasts towards the areola and nipple areas of said breasts to direct milk flow to said breasts' areola and nipple areas. [0018] While the practical advantages and features of the present invention and method have been briefly described above, a greater understanding of the novel and unique features of the invention may be obtained by referring to the detailed description which follows. DETAILED DESCRIPTION OF THE INVENTION [0019] As stated hereinabove, the present invention provides a safe and effective method for enhancing breasts. The method helps to firm up and support the breasts through the filling up of glands which end up taking up more space in the breasts hence resulting in stretching and enlarging said breasts. [0020] The method of the present invention is characterized by the following. [0021] One should find a room or a place where one will be able to relax and feel comfortable and uninterrupted. One can do the exercise in one 30 to 40 minute sitting for both breasts or two 15 to 20 minute sittings, one for each breast. One can do these exercises on oneself or can even have someone else help. [0022] To begin with, one should be in a comfortable and relaxed position lying down or sitting up. One can have some soft relaxing music playing to soothe mind and body. If one wishes to use some massage oil, it can be applied a little bit on the finger tips of your hand (optional—to prevent skin irritation but is not necessary). [0023] With three fingertips of the hand clumped together, one begins about two inches below the left collar bone and gently massages with the fingers in a tiny one inch circle for about 20 seconds. The massaging must be gentle. One must not dig into the breast and hurt oneself. [0024] One is just trying to gently stimulate the lobules. Take the time to feel the skin under the fingers and breast tissue and muscle below it. One wants to stimulate each individual lobule with the fingertips to make sure one massages each little section completely. After about 20 seconds one moves the fingers clockwise to the spot right next to where one just massaged and does the same thing for another 20 seconds. One continues doing this by going all the way around clockwise under the arm, at the bottom of the breast, to the middle of the chest and back to below the collarbone. One will continue going clockwise and working closer to the nipple in smaller and smaller circles. One should do this on about 50 contact points on the breast and for about 20 seconds each. [0025] It should take about 10 minutes. It is important to take the time to feel the texture of the breast. [0026] For the first few times until the lobules begin to grow, this exercise can also make one aware of any lumps or abnormalities. If so, one should stop immediately and have it checked by a doctor. [0027] Once one has completed this exercise, begin kneading the left breast with the right hand much like if one were kneading dough for making bread. Again paying special attention to try to contact all the lobules located in the breast tissue. One should knead and rub the breast going toward the nipple and away from the nipple. It should not hurt, if it does stop and try later. If it still hurts at a later time, stop doing it and contact a doctor. This should take between 5 and 10 minutes. [0028] While you are doing this, it is also important that one gently touches and rubs the nipple. The first few times it will probably be sensitive but it will become less sensitive as time passes. Again, it should not hurt. If it does, stop and try later. If it continues to hurt contact a doctor. After a few weeks, as one continues this process, one will notice that the nipples and areola will also get larger as the breasts get larger. [0029] Now do the same exercises with the right breast. As days pass, breasts and nipples will become less sensitive to the rubbing. One will notice the breasts beginning to feel slightly fuller. As one rubs the fingertips is small circles as in the first exercise and even when one kneads the breasts one will begin to feel the little lobules under the skin through the breast tissue. At this point, one knows that the breasts are beginning to change to be able to produce milk. [0030] In the second week, after each time one has finished kneading, touching and rubbing the breasts' nipples, one will begin to gently massage the breast in large circles from the outer sections of the breast, to the areola and nipple. Beginning about 2 inches from the collarbone and making large circular motions working down to the areola. Now move the hand to where the arm and chest meet and make circular motions down to the areola. Move the hand to where the chest meets the armpit and do circular motions to the areola. One should continue doing this around the whole breast from the outer part of the breast to the areola for about 2 to 5 minutes, to try to direct the milk flow to the areola and nipple area. Behind the areola are pockets where milk will run into. [0031] With the thumb and finger spread about 1½ to 2 inches apart, one will gently place the thumb and finger on the outside of the areola and press them on the breast towards the chest. You will slowly begin to squeeze the fingers towards the nipple to try to squeeze milk out of the nipple. Do not squeeze the nipple itself because it will hurt and not accomplish anything. [0032] Nothing will probably come out the first few times trying this procedure. By the end of the 2 nd or early in the 3 rd week one will notice a little bit of pasty discharge as one squeezes the areola out of the nipple. This is expected, because it is just clearing of the ducts. However, there should be no bleeding from the nipple. Since there are many ducts ending at the nipple one might see this discharge a couple of times. [0033] After the bit of discharge is finished one will begin to notice just a drop or two of clear liquid which is colostrum. In the next few days one will notice a little more of this clear liquid come out of the breast when squeezed. After a week or so the liquid begins to change into a hazy white colour. Later on as the milk production increases, the milk will become whiter. [0034] After the milk production is active, one has the choice to continue massaging and to extract the milk from each breast or just to continue stimulating the milk production every few days. One's body gets into a routine and will fill up with milk as per the routine that is chosen. [0035] Every person is different so monitoring one's own situation is key. The fact that one should remember is that if one stops extracting the milk on a routine basis, the breasts will slowly stop producing it. If one decides not to do it anymore one can stop altogether or stop for a while and then restart over again at a later time. You can choose to increase the breast size a few weeks before a special occasion and then stop. [0036] Some side effects may be associated to and result from the above described method but nothing out of the ordinary. They could include: tenderness or sensitivity in the breast and/or nipple due to the exercises/massages, tenderness or sensitivity in the breast and/or areola as the breast begins growing, muscle soreness due to some exercises, slight weight gain of approximately 5 to 10 pounds, and possibly slight leakage of milk from the breasts as the process advances. [0037] With respect to the above described method then, it is to be realized that the optimum results will be achieved by conforming as closely as possible to the program provided and that, in any event, results may vary from one participant to another. [0038] As a result of experiments utilizing the method of the present invention it has been recorded that if one were to stop the process, once restarting the process the results come faster. Chest measurements have also shown that the increase in size is consistent across the whole of the breast area. [0039] Further, it would appear that the method may work faster if a partner is present and performing the massaging steps probably due to the fact that said partner would have better access to all areas of the breast for performing the method. [0040] As for timeframes, it has been observed that a change in breast tissue texture would take place in the first week, followed by a slight size increase by the tenth day or so. A plateau is then reached between the second and third week, with continued increase after that. [0041] Finally, no permanent side effects have been observed during or after the trials. [0042] Other embodiments and uses of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. The specification and examples should be considered exemplary only and do not limit the intended scope of the invention.

A method for the enhancement of breasts is provided which is all natural and involves no drugs, topical or oral compositions, hormones or surgery and is self administered.

TECHNICAL FIELD OF THE INVENTION [0001] The invention belongs to the field of dentistry, specifically, the clinical treatment, both preventive and corrective, of dental cavities. STATE OF THE ART [0002] Dental enamel is the hardest, most mineralized human tissue; its mechanical, physical and chemical properties are dependent on and, in turn, encompass, from its mineral composition to its structural order ([1]). [0003] Dental enamel plays a very active role in the de-mineralisation and re-mineralisation ([4] and [5]); these dynamic properties are dependent on both the porosity and the electrochemical characteristics thereof ([6] and [7]). [0004] A calcium phosphate apatite, in the form of hydroxyapatite, is the basic component of dental enamel ([2]). Hydroxyapatite crystals are organised in densely condensed prismatic structures, perpendicularly arranged toward the outer surface. Its structural arrangement gives teeth considerable mechanical resistance ( FIGS. 1 and 2 ). [0005] The small quantities of organic matter of enamel (structural proteins, lipids and carbohydrates) located in interprismatic spaces, may play a significant role in the plasticity of such a rigid structure ([3]). [0006] However, enamel is also an organic tissue that is involved in both the transport of ions and solutions from saliva and in the de-mineralization and re-mineralisation process ([4] and [5]). [0007] Such dynamic properties are dependent on both the porosity and the electrochemical characteristics of enamel, that is, of its potential membrane and its fixed charge ([6] and [7]). [0008] The effect of laser irradiation on dental enamel, a field that started in the 1970's, has been the subject of several research projects in recent years ([2], [8], [9] and [10]). Some prior dental publications have applied several types of laser, primarily Carbon dioxide (C0 2 ), Neodymium Yag (Nd:YAG), Argon (Ar) or Erbium-Yag ((Er:YAG) lasers, which have been used under different conditions, depending on the desired results ([11] to [17]). [0009] In the case of the Nd:YAG laser, it has been normally applied to soft tissues (surgery) and hardly ever on hard tissues, since, when it has been used in this manner, it has been applied on an enamel that had to be previously coated and painted with colourings agents, in order to increase its absorption energy. These colourings agents cause a deeply unsightly effect due to the residues that remain trapped in the adamantine structure and, moreover, numerous cracks appear in the dental enamel, always after the latter is exposed to and irradiated by the laser ([18], [19] and [20]) ( FIGS. 2-10 ). [0010] These undesirable effects have limited scientific progress and research on lasers with might have the potential for dental usage on hard tissues, especially Nd:YAG lasers. To this, one must add the fact the use of the Nd:YAG laser in dentistry has been limited to the direct application thereof on the tissue to be treated, and it has not been previously used for the irradiation and microfusion of dental cementing and restorative materials. [0011] In this invention, by applying certain modifications and new parameters, it has not been necessary to previously coat or paint the tooth with absorbent colouring agents, and the formation of cracks in the dental enamel following treatment with the Nd:YAG laser has also been prevented. [0012] As regards corrective treatments of dental cavities, the restoration and cementing of human teeth is generally performed with materials (silver amalgams, compound resins, composites, glass ionomers) whose composition, hardness, abrasion resistance, aesthetics, etc., thereof are different from those of the tooth ([21]). [0013] As shown by numerous authors, all the materials that are currently used are somewhat toxic for the dental pulp and some of them are toxic for the human body ([22]); hence the controversy regarding the toxicity of the mercury vapours from silver amalgams and the oestrogenic character of resins, fissure, sealants and composites. [0014] Currently, amalgams and composites are applied to teeth by fixation in a mechanical-retentive and adhesive manner, respectively ([23] and [24]). [0015] Hydroxyapatite is a mineral that is present in nature and in the industry, whose chemical composition hereof is the same as that of dental enamel and very similar to that of dentin, elements that belong to the same family of apatites, for which reason their composition, hardness, abrasion resistance, aesthetics, etc., are practically identical to those of teeth ([24]). [0016] Moreover, mineral hydroxyapatite has no toxicity whatsoever, which prevents the clinical failures that take place with the current materials ([25]). [0017] For the reason described, mineral hydroxyapatite is considered to be the ideal new material for restoration and cementing, since it is the same mineral that forms teeth (both enamel and dentin), although it is true that these crystallise in the enamel in the form of prisms ([27]). [0018] The fixation thereof to the tooth may be performed by microfusion (laser irradiation), that is, by fusing it to the tooth to become a part thereof; this fixation is much superior to the mechanical-retentive and adhesive fixation of amalgams, glass ionomers and composites ([24] and ([26]). This process is the one applied in this invention. [0019] On the basis of the considerations explained above, a new process, preventive as well as corrective, has been developed for the treatment of cavities which is offered as an alternative to current techniques, since it overcomes the limitations posed by the latter. On the one hand, the invention consists of applying a new technology, the Nd:YAG laser, on the dental surface or enamel in order to prevent caries. On the other hand, the laser may also be applied on a biomaterial preferably composed hydroxyapatite, which is used as a new dental restorative and cement material, and is applied on the dental surface to be treated prior to applying the laser. In either case, the laser is irradiated under specific conditions and parameters that confer great advantages thereto as compared to other inventions. [0020] In this regard, it has been demonstrated that European Patent Application No. EP 0392951 A2 discloses a treatment for cavities similar to the one presented herein. However, both methods are significantly different, and this invention represents a clear advance with respect to the achievements of said European Application; moreover, evident technical differences between the processes and materials disclosed in both documents have been observed. The main differences between documents are summarised below: The process and the equipment disclosed in document EP 0392951 A2 have been specifically designed for a corrective treatment of dental cavities, unlike this invention, which additionally represents an advance in preventive treatment. The results described in document EP 0392951 A2 are not as conclusive as those obtained by means of this invention (occasionally, not even the desired results are obtained). The laser beam of the invention disclosed in EP 0392951 A2 does not have a variable focussing and defocusing system, that is, it is always focussed. The processed disclosed in document EP 0392951 A2 produces all the undesirable side effects caused by this type of dental treatment: It melts the hydroxyapatite and the dental enamel in the form of superimposed slices, Concave depressions form on the surfaces whereto it is applied, Large cracks form due the abrupt heating and cooling of the biomaterial and the tooth, It produces an unaesthetic appearance of the material treated since impurities and colouring agents are captured The process disclosed in document EP 0392951 A2 leads to a greater fragility of the tooth. The process of EP 0392951 A2 leads to an easy accumulation of bacterial plaque and filtration with penetration of lactic acid into the cracks produced; for this reason, dental cavities, of a larger size, reproduce and reappear. The process disclosed in document EP 0392951 A2 causes a great reflexion of the laser irradiation due to the lack of separation of the mineral surface to be treated, with the consequent need to increase the laser power and more significant side effects. The paste disclosed in document EP 0392951 A2 as a corrective treatment for dental cavities is composed of: 80% ceramics (a material that is very different in structure and composition from the material that forms teeth), and only 20% mineral hydroxyapatite, which should be the most important element in the composition of the paste, since teeth are completely made up of this mineral (from the apatite family). DESCRIPTION OF THE INVENTION [0033] This invention relates to a process for the treatment of dental cavities, characterised in that it comprises at least one step wherein the dental surface or enamel is irradiated with Neodymium Yag laser. Preferably, the dental surface or enamel is subject to an Nd:YAG laser irradiation with a degree of multi-focality and multiple focus which is variable and regulated at will from maximum focusing of the laser beam to complete defocusing. [0034] The variable focusing and defocusing is regulated at will and takes place on the optical fibre wherethrough the Nd:YAG laser is transmitted. The fact that different types of focus or focusing maybe applied at will on the laser beam is useful to eliminate and prevent many of the undesirable side effects that take place when there are abrupt thermal changes (heating and cooling) caused by irradiation on the dental enamel surface (and, as it will be seen further below in a preferred embodiment, also on a biomaterial that is applied to said surface). This undesirable side effects take place when the laser beam is focused, the most significant being the following: 1. Concave depressions in the form of super imposed slices of fussed and melted enamel on the treated surface, due to the abrupt heating. 2. Cracks of a very variable size on the same surface, due to the abrupt cooling. 3. Capture and incorporation of impurities and colouring agents in the enamel, which gives it an unaesthetic appearance. [0038] The possibility to regulate the focus or focusing of the laser beam at will allows for the treatment, whether preventive or corrective, of dental cavities and each of its applications to make all the undesirable side effects listed to disappear, leading to a microscopic, uniform, smooth, waterproof, very aesthetic microfusion, all of which increases the hardness and microhardness of the enamel (and, as it will be seen further below, also of the biomaterial that may be applied on the enamel). [0039] In a preferred embodiment, the dental surface or enamel is subjected to an Nd:YAG laser irradiation which density is between 3 and 30 J/mm 2 , both limits included, and, more preferably 4 J/mm 2 . In another preferred embodiment, the laser radiation frequency is between 1 and 10 kHz, both limits included, and, more preferably 1kHz. [0040] Also preferably, the dental surface or enamel is subjected to an Nd:YAG irradiation which pulse energy is between 1 y 10 mJ/pulse, both limits included, and, more preferably, 2 mJ/pulse. [0041] In another preferred embodiment, the laser irradiation spot size is between 1 and 6 mm, both limits included, and, more preferably, 3 mm or 5 mm. [0042] In another preferred embodiment, the process disclosed is characterised in that the dental surface or enamel is subjected to an Nd:YAG laser irradiation which exposure time is between 1 and 6 seconds, both limits included, and, more preferably, 2 seconds. [0043] Also preferably, the dental surface or enamel is subjected to an Nd:YAG laser irradiation which peak power is between 70 and 125 kW, both limits included, and, more preferably, 120 kW. [0044] In another preferred embodiment of the process, the dental surface or enamel is subjected to an Nd:YAG laser irradiation which pulse width is between 100 and 130 ns, both limits included, and, more preferably, 110 ns. [0045] Another preferred condition for the laser irradiation is that the mean energy is between 10 and 50 W, both limits included, and, more preferably, 13 W. [0046] Preferably, the dental surface or enamel is subjected to a Nd:YAG laser irradiation which total energy per application is between 15 and 220 J, both limits included, and, more preferably, 26 J. [0047] In a particular embodiment the process for the treatment of cavities is characterised in that the Nd:YAG laser is irradiated according to the following parameters: density: between 3 and 30 J/mm 2 both limits included, frequency: between 1 and 10 kHz, both limits included, pulse energy: between 1 and 10 mJ/pulse, both limits included, spot size: between 1 and 6 mm, both limits included, exposure time: between 1 and 6 s, both limits included, peak power: between 70 and 125 kW, both limits included, pulse width: between 100 and 130 ns, both limits included, average energy: between 10 and 50 W, both limits included, and total energy per application: between 15 and 220 J, both limits included. [0057] In another particular embodiment, the radiation parameters are specifically the following: density: 4 J/mm 2 , frequency: 1 kHz, pulse energy: 2 mJ/pulse, spot size: 3 mm, exposure time: 2 s, peak power: 120 kW, pulse width: 110 ns, average energy: 13 W, and total energy per application: 26 J. [0067] In another particular embodiment, the laser irradiation parameters are: density 4 J/mm 2 , frequency: 1 kHz, pulse energy: 2 mJ/pulse, spot size: 5 mm, exposure time: 2 s, peak power: 120 kW, pulse width: 110 ns, average energy: 13 W, and total energy per application: 26 J. [0077] Preferably in the process, prior to the laser irradiation, the dental surface or enamel to be treated is etched with an acid for a time between 0.5 and 2 minutes, primarily in order to reduce the light reflection thereof. Said acids is preferably orthophosphoric acid, and the etching time is 1 minute. [0078] The process disclosed so far is used for the total preventive treatment of dental cavities. If a step is added to the process wherein a biomaterial is applied on the dental surface or enamel or in dentin prior to the Nd:YAG laser irradiation, the process may also be applied as a corrective treatment for dental cavities. Said application of the biomaterial is preferably performed in layers, with a thickness of between 0.5 and 2 mm, both limits included, and, more preferably, with a thickness of 1 mm. [0079] If a biomaterial is applied on the dental surface or enamel to be treated, both (the biomaterial and dental surface) are subjected to an Nd:YAG laser irradiation with a degree of multi-focality and multiple focus, which is variable and regulated at will from maximum focusing of the laser beam to complete defocusing. In this way, the biomaterial is irradiated and focus to the dental enamel surface or the dentin, until complete fixation by microfusion is achieved. As mentioned above in regards to the preventive treatment for dental cavities, the variable focusing and defocusing is regulated at will and takes place on the optical fibre wherethrough the Nd:YAG laser is transmitted. The fact that different types of focus or focusing may be applied on the laser beam is useful to eliminate and prevent the same undesirable side effects that were listed upon describing the characteristics of the preventive treatment. [0080] In a preferred embodiment, the laser radiation parameters are: density 28 J/mm 2 , frequency: 5 kHz, pulse energy: 8 mJ/pulse, spot size: 3 mm, exposure time: 5 s, peak power: 72 kW, pulse width: 120 ns, average energy: 40 W, and total energy per application: 200 J. [0090] Preferably, prior to applying the biomaterial, the decayed tissue is eliminated; and, more preferably, the elimination is performed by means of diamond drills and tungsten carbide on a water-cooled turbine. [0091] Preferably, after eliminating the decayed tissue and prior to applying the biomaterial, the dental area to be treated is weakly etched with an acid, preferably orthophosphoric acid, for a time between 20 seconds and 1 minute, preferably 30 seconds for the dental enamel and 15 seconds for the dentin. [0092] In another preferred embodiment, the corrective treatment for dental cavities disclosed so far comprises the following steps: Eliminating the decayed tissue; Weakly etching the dental enamel surface or the dentin to be treated with orthophosphoric acid; Applying a biomaterial on said surface, and Irradiating with a Neodymium-YAG laser, with the following parameters: density: 28 J/mm2; frequency: 5 kHz; pulse energy: 8 mJ/pulse; spot size: 3 mm; exposure time: 5 s; peak power: 72 kW; pulse width: 120 ns; average energy: 40 w, and total energy per application: 200 J. [0106] This invention also relates to a dental cementing and restorative biomaterial to be used in the corrective treatment described above, characterised in that it is composed of at least mineral hydroxyapatite. [0107] Preferably, the content by weight of hydroxyapatite is at least 75%. [0108] In order to facilitate the application thereof the biomaterial preferably, consists of a paste that contains at least dense, powdered, micronised mineral hydroxyapatite, mixed with gelatine. [0109] In a particular embodiment, the hydroxyapatite maybe mixed with other substances that favour the application thereof and, moreover, leave no residues upon being irradiated with Nd:YAG laser. One example is the use of gelatines. EMBODIMENT EXAMPLES Example 1 Preventive Treatment for Dental Cavities [0110] Study of the Effects of the Neodymium Yag Laser Upon Being Applied on the Human Dental Surface or Enamel [0111] Nature and Processing of the Sample [0112] In order to perform the process of this invention, a sample was selected composed of 400 healthy human teeth, extracted for orthodontics reasons and carefully selected on the basis of the criterion that they did not present any lesion that might mask the morphological effects of the treatment. [0113] The teeth were fixed with 2.5% of glutraaldehyde in 0.1 M buffered sodium phosphate (ph 7.02) at a temperature of 4° C. for 12 hours. Subsequently, they were washed in the same buffered in 3 baths, 10 minutes each, and, later, with distilled water ([28]). [0114] Subsequently, they were washed with 12% Sodium Hypochlorite for 1 hour in order to remove the organic matter from the surface and, finally, all the teeth were weakly etched in a solution of 0.5 M orthophosphoric acid for 1 minute, and later rinsed with abundant distilled water ([28], [29], [30] and [31]) ( FIG. 11 ). [0115] The 400 teeth in the sample were coated with acid-resistant wax, leaving 2 uncoated square windows on the enamel of each tooth: one of the windows was used as a control and the other was irradiated with the Nd:YAG laser ( FIGS. 12 and 13 ). [0116] After this was done, each of the teeth was individually placed in 50 ml of a de-mineralising solution (pH=4.5) containing 5% of hydroxyethylcellulose, 0.1 M of lactic acid, 1.5 mM of calcium chloride and 1.5 mM of sodium phosphate, at 37° C. for 60 days, in order to form artificial cavity lesions. Nd:YAG Laser Irradiation Conditions: [0117] The corresponding window of each of the 400 teeth in the sample was subjected to irradiation with a DCR-2 Nd :YAG Laboratory Laser System from Quanta-Ray (United Kingdom). [0118] The following parameters were used for the laser irradiation: Density: 4 J/mm 2 . Frequency: 1 kHz. Pulse energy: 2 mJ/pulse. Spot size: 3 mm. Exposure time: 2 s. Pick power: 120 kW. Pulse width: 110 ns. Average energy: 13 w. Total energy per application: 26 J. [0128] Post-Treatment Measurements Observations With the Scanning Electron Microscope Analyser: [0129] From the total sample, 300 teeth were randomly processed in accordance with the conventional SEM examination method and coated or metallised with gold in the Bio-Rad metalliser, model SC 5.000 (Holland). [0130] This dental sample was examined with a Philips 515 SEM (Holland) at 20 kV, as well as with the Edax chemical elemental analyser from Philips (Holland) for the SEM. Hardness Measurements: [0131] The other sample, composed of a 100 teeth, which was not processed to be examined under the SEM, was used. Each of the teeth was embedded in epoxy resin such that a portion of a cross section of the lesion and the normal inner layer of the enamel were exposed. [0132] This surface was connected in a Buehler Motopol 8 polishing machine (Germany) using a metallographic paper grid. [0133] Subsequently, they were serially polished with 15 mμ, 6 mμ and 1 mμ with a Buehler diamond abrasive (Germany) and, subsequently, with Buelher Metadi diamond spray (Germany) on a Buehler polishing cloth (Germany). [0134] A diamond tip under a 10-g load was used in a Matsuzawa MTH-1 (Japan). The results for the KDN hardness were calculated using the equation: [0000] KHN=14230×F/L2 [0000] where L is the entry length of each depression in the diamond, in microns, and F is the applied force in grams. Results of the Treatment: [0135] The most significant structure or change following the laser treatment is the loss of the characteristics of the crystal surface structure (prisms), due to fusion of the enamel (FIGS. 14 , 15 and 16 ). These changes were not accompanied by the formation of cracks. [0136] The formation of artificial cavities as a lesion always appeared in the control enamel windows (not treated); the formation in appearance thereof was completely inhibited in the windows that were laser-irradiated. [0137] The microhardness profile of an enamel with laser and the profile of the enamel not treated with laser differ in the degree of hardness and the large increase in KHN, that is, a greater hardness, mat be clearly observed in the enamel of the windows treated with laser; likewise, a significant decrease KHN (lower hardness) is observed in the control enamel of the untreated windows. [0138] It seems to be acceptable that the hardness values measured are proportional to the enamel mineral content; and, from the profiles found, we may assume that the modifications in the enamel permeability may play a significant role in these processes, which have already been widely discussed in the literature by various authors ([32], [33], [34] and [35]). [0139] The effect presented is a combination of the change in permeability and the increase in the intrinsic resistance to the acid in the solution. Therefore, the decrease in the solubility of the enamel treated with the Nd:YAG laser under the conditions applied eliminates the pores or access spaces to deeper areas, thereby preventing ionic exchange between these areas and the de-mineralising solution (which produces the artificial cavity lesions). For all these reasons, it prevents and avoids the formation of cavity lesions. Example 2 Preventive Treatment for Dental Cavities [0140] Study of the Physical-Mechanical Effects of the Neodymium Yag Laser Upon Being Applied on the Human Dental Surface or Enamel. [0141] Nature and Processing of the Sample [0142] A total sample of 460 healthy teeth was used in this study, whereof 230 teeth were randomly selected for the measurements, and the other 230 were used as a control sample. As in the preceding example, they were carefully selected to ensure that there were no lesions that might mask the effects of the treatment. [0143] The teeth selected for the measurements were cleaned with 12% sodium hypoclhorite for 1 hour in order to eliminate the organic matter from the surface. Subsequently, they were rinsed with distilled water and their enamel crowns were cut and separated from the roots. [0144] From the 230 teeth, a random sample of 150 crowns was used for the microhardness measurements and the other sample, composed of 80 crowns, was used for the permselectivity and permeability studies. [0145] The teeth in the hardness measurement sample were polished perpendicularly to the direction of the prisms (parallel to the surface) with polishing paper in a Buehler Motopol (polishing machine (Germany), in order to obtain a small plateau and, subsequently, serially polish them with 15 mμ, 6 mμ and 1 mμ of Buehler abrasive diameter (Germany) and, later, with Buehler Metadi diamond spray (Germany) on a Buehler polishing cloth (Germany). [0146] The teeth in the permeability study sample were embedded in epoxy resins and subsequently polished. Later, an 800-mμ section was cut using a Buehler Isometo low-speed saw or cutter (Germany) and mounted on a concentration of cells. Laser Irradiation Conditions: [0147] The 230 teeth selected for the measurement sample were subjected to irradiation with a DCR-2 Nd:YAG Laboratory Laser System from Quanta-Ray (United Kingdom). [0148] The following parameters were used for the laser irradiation: Density: 4 J/mm 2 . Frequency: 1 kHz. Pulse energy: 2 mJ/pulse. Spot size: 5 mm. Exposure time: 2 s. Peak power: 120 kW. Pulse width: 110 ns. Average energy: 13 W. Total energy per application: 26 J. [0158] Post-Treatment Measurements: Microhardness Measurement: [0159] In order to measure the microhardness, a Knoop diamond under a 50-g load was used in a Matsuzawa MTH-I machine (Japan). [0160] The Knoop hardness values were calculated on the basis of the length of each depression in the diamond, using the equation: [0000] KHN−14,230×F/L 2 [0000] where F is the force applied in grams and L is the length of the depression produced by the diamond, measured in microns. [0161] 20 depressions were made on the plateau of each tooth at 150 mμ, separated by regular space intervals. [0162] The hardness measurements on the enamel treated with laser were performed by the same operator and close to the depressions made on the untreated enamel, in order to minimise the experimental error. Permselectivity Studies: [0163] In all the experiments, the electromagnetic field (e.m.f.) was measured in a concentration of cells of the type: [0000] Ref. electr. // Solution / Membrane- / Solution // Ref. 1 enamel 2 electr. Ag +/AgC // / / // Ag+/AgC. where the double vertical lines indicate the location of the Clk convergence points. The potential developed through the membranes was measured with a Hipotest high-impedance recording potentiometer, model PE-W (Belgium). [0164] All the solutions were prepared with analytical reagent-grade salts and distilled water. 25 of them were buffered with sodium phosphate at pH=7.02 and the influence of the buffer ions on the e.m.f. was discarded. [0165] The basis for the calculation is the theory of Teorell-Meyer-Sievers (TMS theory), which describes the transport of ions through a charged porous membrane the faces of which are in equilibrium with a solution of the same electrolyte. The total membrane potential E is calculated as follows: [0000] E = R · T F  [ U · ln  ( X 2 + 4  a 2 2 + U · X X 2 + 4  a 1 2 + U · X ) + ln  ( a 2 a 1 ) · ( X 2 + 4  a 1 2 + X X 2 + 4  a 2 2 + X ) ] [0000] where R is the gas constant, F is the Faraday constant, U=(D−1/D+1), a and X are the membrane charge, X and D are determined by applying an interactive minimum adjustment method. [0166] Results of the Treatment: [0167] The potentials of the membranes not treated with laser were positive and became more positive when the concentration of KCI increased. [0168] When the enamel membranes are treated with laser, the membrane potentials become more positive than those measured in the natural membranes of the control sample, indicating that the permselectivity of the enamel membranes is modified by the laser radiation. [0169] The microhardness values obtained in the control sample of a healthy enamel not treated with laser ranged between 340 and 388; these values agree with those previously published by other authors ([36] and [37]). [0170] In all the teeth in the sample we observe that the Knoop hardness increases when measured after the laser was applied. These increases were significant and always occurred when their values were connected and related to the initial hardness values of the corresponding enamel prior to being treated. [0171] We observe and show that the high initial hardness values correspond to a given increase in hardness; and a lower initial hardness corresponds to a big increase in hardness following the laser radiation. Example 3 Preventive Treatment for Dental Caries. [0172] Study of the Morphological Effects of the Neodymium Yag Laser Upon Being Applied on the Human Dental Surface or Enamel. [0173] Nature and Processing of the Sample: [0174] In order to perform this study, a sample of 350 human teeth extracted for orthodontic reasons was used. They were carefully selected, in order to ensure that there were no lesions that might mask the morphological effects for the treatment. [0175] From the total teeth selected, a random sample of 250 teeth were treated with laser on the labial or vestibular surface, and the other 100 teeth were used as a control sample. [0176] The 250 teeth in the sample to be treated with laser were fixed with 2.5% glutaraldehyde, in 0.1 M sodium phosphate buffer (pH=7.02), at a temperature of 4° C. for 12 hours. [0177] Subsequently, they were washed in the same buffer, with 10-minute baths each, and, later, with distilled water. Thereafter, the teeth were cleaned with 12% sodium hypochlorite for 1 hour, in order to eliminate the organic matter on the surface and, finally, they were etched with 0.5 M orthophosphoric acid for 1 minute and rinsed abundant distilled water. Laser Irradiation Conditions: [0178] The 250 teeth etched with acid were subjected to irradiation with a DCR-2 Nd:YAG Laboratory Laser System for Quanta-Ray (United Kingdom). [0179] The following parameters were used for the laser irradiation: Density: 4 J/mm 2 . Frequency: 1 kHz. Pulse energy: 2 mJ/pulse. Spot size: 5 mm. Exposure time: 2 s. Peak power: 120 kW. Pulse width: 110 ns. Average energy: 13 W. Total energy per application: 26 J. [0189] A Siemens LGK 7672 Helium-Neo laser (Meinchen, Germany) was used to visualise and locate the Nd:YAG laser beam in the treated area. [0190] Post-treatment Measurements [0000] Observations with the Scanning Electron Microscope: [0191] The teeth were processed in accordance with the conventional SEM method, and coated or coated with gold with a Bio-Rad sprayer, model SC 5000 (Netherlands). [0192] The entire sample of teeth was examined with a Philips 515 scanning electron microscope (Netherlands) at 5 kV. Roughness Measurements: [0193] The degree of roughness of the enamel surface was measured with a Mituyo Suftest 201 surface roughness meter (Japan). The measurements were performed on teeth treated with laser and control teeth, using a cut-off value (lambda c) of 0.25 mm and an evaluation length (5×lambda c) of 1.25 mm. [0194] Several roughness profile parameters were obtained. The most significant were Ra (lower arithmetic deviation of the roughness profiles) and Pc (peak count); defined as follows: [0000] R a = 1 lm  ∫ 0 lm   f  ( x )    x Ra is the lower arithmetic deviation of the absolute values of the profiles deviated from the central line with the evaluation of length lm. The roughness profiles are given as Y=f(x), with the “x” axis for the centre of the line, and the “y” axis in the direction of the magnification of the vertical line. Pc is the number of peak profiles (maximum) per unit of length. In order to determine the peak count, two parallel lines are drawn at a given level, below and above the central line over the longitudinal evaluation. A peak profile is defined as the proportion of the projecting profile that produces above the upper line, at the two adjacent points of intersection of the profile with the lower line. [0198] In this study, a level of 1.3 mμ was used to determine the peak count. [0199] Results of the Treatment: [0200] The surface of human dental enamel normally shows a somewhat smooth area, which may be observed under the SEM. [0201] In healthy human dental enamel not subjected to any treatment, the most significant structural reliefs are represented by the perikymata (21), which are regularly distributed as multiple small waves ( FIGS. 17 , 18 , 19 and 20 ). [0202] A typical roughness measurement of this surface is that obtained on the labial surface of a healthy human premolar tooth with the following parameters: Ra=1.6±0.1 mμ, and Pc=0 cm −1 ( FIG. 21 ). [0203] Under scanning electron microscopy, the characteristic morphology of the hydroxyapatite prisms and the interprismatic matter on an enamel surface etched with acid are clearly observed, and the polyedric structure of the prisms is also sharply seen. [0204] The roughness of the enamel etched with acid greatly increases. This increase is represented by a rise in the Ra and Pc parameters as compared to the values corresponding to healthy non-etched enamel. [0205] In all the samples etched with acid, it was observed that Ra ranged from 1.8 to 2.3 mμ, and Pc ranged from 35 to 50 cm −1 . [0206] The effects caused by application of the laser under certain parameters on the surface of an enamel previously etched with acid and observed under the SEM reveals the loss of the prisms' characteristic structure due to the surface fusion of the dental enamel ( FIG. 22 ). [0207] This structural change is directly related to the general decrease in the rough surface ( FIG. 23 ), taking into consideration the significant fact that the enamel etched with acid was evaluated by measuring its profile. [0208] The roughness parameter values obtained following the treatment with laser range between 1.2 and 1.6 mμ for Ra, and between 0 and 5 cm −1 for Pc. [0209] The comparative values of the roughness parameters obtained are: [0000] Control sample of teeth Treated sample of not etched and not etched teeth, not Treated sample of etched treated with laser treated with laser teeth, treated with laser (a) (b) (c) Ra: 1.6 ± 0.1 mμ 1.8 a 2.3 mμ 1.2 a 1.6 mμ Pc: 0 cm −1 35 a 50 cm −1 0 a 5 cm −1 [0210] The sample of teeth etched with acid and treated with laser exhibited a smoother surface, that is, with a lower roughness than the control sample. [0211] FIG. 24 shows the roughness profiles obtained on the vestibular face of the enamel surface of different tooth samples: a) Roughness profiles of the control dental sample, teeth not etched with acid and not treated with laser. b) Roughness profiles of the treated dental sample, teeth etched with acid and not treated with laser. c) Roughness profiles of the treated dental sample, teeth etched with acid and subsequently treat-ed with Nd:YAG laser. [0215] We observe the greatest increase in the roughness of the enamel following etching with acid (b) and a decreased in or loss of roughness following application of the laser (c), the latter being even lower than in the control sample (a). This indicates that the absorption of laser energy was sufficient to modify the structure of the enamel surface etched with acid, without the need to coat it with absorbent colouring substances. Example 4 Corrective Treatment for Dental Cavities [0216] Study of New Technology with Neodymium:YAG Laser and Mineral Hydroxyapatite as a New Cementing and Restorative Material for Human Teeth. [0217] Nature and Processing of the Sample: [0218] In order to perform the process of this invention, a sample composed of 350 human teeth was selected. The selection criterion was that they show dental cavities (250 teeth) or crown fractures (100 remaining ones). [0219] In order to eliminate the decayed tissue, the interior of each tooth with cavities was treated with Komet diamond drills and tungsten carbide (Germany); located on a water-cooled Kayo turbine (Germany). The entire inside of the cavities and the edges of the preparations were etched with 36% orthophosphoric acid, the enamel for 30 seconds and the dentin for 15 seconds; subsequently, they were washed with abundant water and dried. [0220] The cavities were made, prepared and treated by the same operator in order to minimise the potential experimental error. [0221] All the teeth in the sample were fixed with 2.5% glutaraldehyde in 0.1 M buffered sodium phosphate (pH=7.02), at 4° C., for 12 hours. Subsequently, they were washed with the same buffer in 3 baths, 10 minutes each, and, later, with distilled water. [0222] Post-Treatment Measurements: [0223] Hardness measurements were performed on cross sections of the biomaterial cements applied with the laser, in order to verify whether this hardness is similar to that of healthy dental enamel. [0224] The effects generated on the biomaterial by the Nd:YAG laser irradiation were studied in terms of the microhardness and permselectivity thereof, being evaluated by means of Knoop studies and by Teorell-Meyer-Sievers theory, respectively. [0225] The treated teeth were studied with the scanning electron miscroscope (SEM) on the entire outer surface of the inner junction area between the cement biomaterial and the tooth (enamel and dentin). [0226] Roughness measurements were also performed after applying the biomaterial with the laser, on the cementing and restorative surfaces, as well as on the adjacent enamel surface. [0227] The total sample was randomly distributed in the following manner: 80 teeth with cavities and 25 teeth with fractures were used for the hardness study and the observation in the SEM analyser; another 80 decayed teeth and 30 fractures teeth were used for the microhardness and permselectivity studies; and, as the final group, 90 teeth with cavities and 45 teeth with fractures were used for the roughness measurements and the observations with the SEM. [0228] The teeth in the sample for the hardness measurements were polished with a specific paper in a Buehler Motopol 8 polishing machine (Germany). [0229] Subsequently, they were serially polished with 15 mμ, 6 mμ and 1 mμ of Buehler abrasive diamond (Germany) and, later, with Buehler Metadi diamond spray (Germany) on a Buehler polishing cloth (Germany). [0230] The teeth in the sample for the permeability studies were embedded in an epoxy resin and polished; finally, an 800-mμ section was cut using a Buehler Isometo low-speed saw or cutter (Germany) and mounted on a concentration of cells. [0231] Composition and Application of the Biomaterial: Hydroxyapatite Paste [0232] The composition of the biomaterial paste applied on the teeth was the following: dense, powdered, micronized mineral hydroxyapatite, mixed with gelatine in order to form a very consistent, thick paste. The density of the paste was controlled by an Isaka RX-10 densiometer (Japan). [0233] This hydroxyapatite paste was used as a cementing and restorative material for teeth; it was applied with an Aesculap 1057 condenser-moulder instrument (Germany), by layers, each layer being approximately 1 mm thick. [0234] Nd:YAG Laser Irradiation [0235] During the application thereof, the hydroxyapatite was subjected to irradiation with a DCR-2 Nd:YAG Laboratory Laser System from Quanta-Ray (United Kingdom). [0236] Moreover, each layer of hydroxyapatite was fused to the preparation walls, dentin and/or dental enamel with the same laser. Nd:YAG Laser Irradiation Conditions [0237] The following Nd:YAG laser irradiation conditions were applied: Density: 28 J/mm 2 . Frequency: 5 kHz. Pulse energy: 8 mJ/pulse. Spot size: 3 mm. Exposure time: 5 s. Peak power: 72 kW. Pulse width: 120 ns. Average energy: 40 W. Total energy per application: 200 J. [0247] A Siemens LGK 7672 Helium-Neon laser (Meinchen, Germany) was used to visualise and locate the laser beam in the treated area. [0248] Post-Treatment Measurements Hardness Measurements: [0249] They were performed with a Matsuzawa MTH-1 hardness meter (Japan), using a diamond tip under a 10-g load. The KDN hardness numbers were calculated by developing the following equation: [0000] KHN=14,230×F/L2 [0000] where L is the length of each depression (entry) of the diamond in microns and F is applied force in grams. Microhardness Measurements: [0250] A Knoop diamond under a 50-g load in a Matsuzawa MTH-1 microhardness meter (Japan) was used. 20 depressions were made at 150μ, separated at regular space intervals (equidistant) on the hydroxyapatite plateau in each tooth. [0251] The microhardness measurements on the cementing and restorative material, in this case mineral hydroxyapatite, and on the adjacent dental enamel, were performed by the same operator in order to minimize the experimental error. Permselectivity Measurements: [0252] All the solutions for the permselectivity measurements were prepared using reagent-grade salts and distilled water. [0253] They were buffered with sodium phosphate at pH=7.02 and the influence of the buffer ions on the electromagnetic field (e.m.f.) was discarded. [0254] The bases for the calculation is the Teorell-Meyer-Sievers theory (TMS), which describes the transport of ions through a charged porous membrane the faces of which are in equilibrium with a solution of the same electrolyte. [0255] The total membrane potential, E, is calculated as: [0000] E = R · T F  [ U · ln  ( X 2 + 4  a 2 2 + U · X X 2 + 4  a 1 2 + U · X ) + ln  ( a 2 a 1 ) · ( X 2 + 4  a 1 2 + X X 2 + 4  a 2 2 + X ) ] [0000] where R is the gas constant, F is the Faraday constant, U=(D−1÷d+1), a and X are the membrane charge, X and D are determined by applying an interactive minimum adjustment method. Observations with the Scanning Electron Microscope: [0256] After being treated with the biomaterial and the Nd:YAG laser, the teeth in the sample were widely studied by the scanning electron microscope analyzer. [0257] The teeth in the sample were processed in accordance with the conventional method and coated with gold, using a Bio-Rad metalliser, model SC 5000 (Netherlands). [0258] Moreover, these teeth were subsequently examined with a Philips 515 SEM (Netherlands) at 20 kV. [0000] Roughness measurements: [0259] The degree of roughness of the surface of the cementing and restorative mineral hydroxyapatite was measured with a Mituyo Suftest 201 roughness and surface roughness meter (Japan). [0260] A cut-off value (lambda c) of 0.25 mm and an evaluation length (5×lambda c) of 1.25 mm were used. [0261] The Ra and Pc roughness parameters were used. The most significant were Ra (lower arithmetic deviation of the roughness profiles) and Pc (peak count); defined as follows: [0000] R a = 1 lm  ∫ 0 lm   f  ( x )    x Ra is the lower arithmetic of the absolute values of the profiles deviated from the central line with the evaluation of length lm. The roughness profiles are given as Y=f(x), with the “x” axis for the centre of the line, and the “y” axis in the direction of the magnification of the vertical line. Pc is the number of peak profiles (maxima) per unit of length. In order to determine the peak count, two parallel lines are drawn at a given level, below and above the central line over the longitudinal evaluation. A peak profile is defined as the proportion of the projecting profile that produces above the upper line, at the two points adjacent to the intersection between the profile and the lower line. [0265] In this work, we have used a level of 1.3 mμ to determine the peak count. In order to study the teeth, a Zeiss polarised-light optical microscope (Germany) was also used. [0266] Results of the Treatment [0267] Mineral hydroxyapatite, fused with a Nd:YAG laser and used as a cementing and restorative material, presented a completely amorphous structure, without a dense, compact crystallographic distribution ( FIGS. 25 and 26 ). [0268] The microfusion of mineral hydroxyapatite was not accompanied by the formation of cracks ( FIGS. 27 , 28 and 29 ). [0269] The hardness of mineral hydroxyapatite, measured in KDN in accordance with the KHN equation, is similar of that of healthy dental enamel. [0270] The permeability of mineral hydroxyapatite is null or practically non-existent. [0271] The Knoop microhardness values of mineral hydroxyapatite obtained range between 335 and 380, and are within the range of microhardness values for healthy enamel, that is, between 340 and 388, the values published by other authors ([37], [38], [39], [40] and [41]). [0272] The roughness measurement produced the parameters Ra=1.4 to 1.8 mμ and Pc=2 to 5 cm −1 , which, compared to those of healthy enamel, are equivalent and very similar. A typical roughness measurement for healthy enamel is that obtained on the labial surface of a healthy human premolar tooth, which has the parameters: Ra=1.6±0.1 mμ, and Pc=0 cm −1 . [0273] This indicates that the absorption of energy was sufficient to produce the microfusion of mineral hydroxyapatite without the need to use absorbent colouring substances ( FIGS. 30 and 31 ). [0274] No residues of the excipient (gelatine) of the hydroxyapatite paste were found following the microsufion, which shows that, although it is the necessary carrier to obtain a pasta consistency, when it is applied on the cavity, said excipient is volatilised by the laser radiation, and the fused mineral hydroxyapatite remains fully compact ( FIGS. 32 and 33 ). [0275] The junction of the dentin and dental enamel with the mineral hydroxyapatite takes place by the fusion of both parts ( FIGS. 34 , 35 , 36 and 37 ), which confers a very high resistance, much higher than that of mechanical-retentive (amalgams) and adhesive (glass ionomers and composites) retentions. [0276] The application of the laser radiation takes place with maximum energy, in a very short period of time; consequently, it does not cause thermal damage in soft tissues of in the dental pulp. DESCRIPTION OF THE FIGURES [0277] FIG. 1 . Scanning electron microscope (SEM) view: Normal appearance of human dental enamel. Structural distribution in the form of prisms perpendicular to the outer surface. [0278] FIG. 2 . SEM: Normal appearance of human dental enamel. The distribution of the hydroxyapatite prisms is perpendicular to the outer enamel surface, giving the tooth considerable mechanical resistance. [0279] FIG. 3 . Tooth (incisor) impregnated with colouring agent in order to increase the laser absorption energy. The colouring agent that was applied on this tooth was Indian ink. [0280] FIG. 4 . Tooth with absorbent colouring agent (Indian ink) prepared on epoxy resin. [0281] FIG. 5 . Unaesthetic appearance of the enamel after being laser irradiated. Residues of colouring agent trapped in the adamantine structure of the dental enamel. [0282] FIG. 6 . SEM: Superimposed impacts of enamel fused with laser in the form of slices. Appearance of the cracks produced. [0283] FIG. 7 . SEM: Appearance of the enamel crack following laser irradiation. [0284] FIG. 8 . SEM: Appearance of the fused, impacted enamel in slices and formation of cracks following laser irradiation. [0285] FIG. 9 . SEM: Appearance of the crack formed in the enamel following application of the laser. [0286] FIG. 10 . SEM: Appearance of the fused enamel and crack produced instantaneously with the application of the laser. [0287] FIG. 11 . SEM: Appearance of the normal enamel surface after preparing the dental sample. [0288] FIG. 12 . Tooth (canine) completely covered with acid-resistant wax and with two windows in the enamel, a control window and a window for the application of the Nd:YAG laser. [0289] FIG. 13 . Dental crown (molar) previously cut to separate it from the root and completely coated with acid-resistant wax and the two windows in the enamel, a control window and a window for the application of the Nd:YAG laser. [0290] FIG. 14 . SEM: The loss of the enamel surface structural characteristics on the upper area treated with laser (microfused enamel), and the structural preservation in the untreated lower area may be observed. No cracks formed following application of the laser. [0291] FIG. 15 . SEM: Appearance of the loss of the enamel surface structural characteristics in the upper area, treated with laser (microfused enamel), and structural preservation in the untreated lower area. No cracks formed following laser irradiation. [0292] FIG. 16 . SEM: Appearance of the enamel microfusion in the lower area, treated with laser. It was not accompanied by the formation of cracks. [0293] FIG. 17 . SEM: Normal structural distribution of dental enamel, represented by the perikymata, forming small waves. [0294] FIG. 18 . SEM: Normal structural distribution of dental enamel, represented by the perikymata, forming small waves. [0295] FIG. 19 . SEM: Normal structural distribution of dental enamel, represented by the perikymata, forming small waves. [0296] FIG. 20 . SEM: Normal structural distribution of dental enamel, represented by the perikymata, forming small waves. [0297] FIG. 21 . Tooth (molar) in epoxy resin for the roughness measurement. [0298] FIG. 22 . SEM: Surface microfusion of the enamel prisms produced by the laser and loss of roughness and surface roughness. [0299] FIG. 23 . SEM: Loss of the surface structure of the enamel prisms due to the microfusion thereof produced by the treatment with Nd:YAG laser. There is a loss of roughness and surface roughness. [0300] FIG. 24 . Graph of the roughness profiles of dental samples (a), (b) and (c). [0301] FIG. 25 . SEM: Amorphous, dense, compact structure of mineral hydroxyapatite fused by laser and used as a dental cementing and restorative material. [0302] FIG. 26 . SEM: The left-side area shows the mineral hydroxyapatite fused by the laser and its junction to the dental enamel of the untreated right-hand area, with the normal surface characteristics thereof. There is a total absence of cracks in the treated area. [0303] FIG. 27 . SEM: The lower area shows the mineral hydroxyapatite fused by the laser and its junction to the dental enamel in the untreated upper area, with the normal surface characteristics thereof. There is a total absence of cracks in the treated area. [0304] FIG. 28 . SEM: Mineral hydroxyapatite fused by the laser with its amorphous surface appearance. [0305] FIG. 29 . SEM: Absence of cracks in the upper area, treated with laser; we may observe the junction by fusion of mineral hydroxyapatite with the normal dental enamel of the lower area. [0306] FIG. 30 . Zeiss polarised-light optical microscope (Germany), for the study of teeth at lower magnifications. [0307] FIG. 31 . Optical microscope (O/M): We may observe the microfusion junction area (arrows) of fused mineral hydroxyapatite and the dental structure (dentin and enamel) in two cements (one of them identified with a blue gel). [0308] FIG. 32 . 0 /M: We may observe the microfusion junction areas (arrows) of fused mineral hydroxyapatite and the dental structure (dentin and enamel) in a cement. No gelatin residues from the paste are observed. [0309] FIG. 33 . O/M: We may observe the mircrofusion junction areas (arrows) of fused mineral hydroxyapatite and the dental structure (dentin and enamel) in a cement. No gelatine residues from the paste are observed. [0310] FIG. 34 . O/M: We may observe the microfusion junction areas (arrows) of fused mineral hydroxyapatite and the dental structure (dentin and enamel) in a cement. [0311] FIG. 35 . O/M: We may observe the microfusion junction areas (arrows) of fused mineral hydroxyapatite and the dental structure (dentin and enamel) in a cement. [0312] FIG. 36 . O/M: We may observe the microfusion junction areas (arrows) of fused mineral hydroxyapatite (H) and the dental structure (dentin and enamel) in a restoration. [0313] FIG. 37 . O/M: We may observe the microfusion junction areas (arrows) of fused mineral hydroxyapatite (H) and the dental structure (dentin and enamel) in a restoration. BIBLIOGRAPHY [0000] [1] Zhang X Z, Anderson P, Dowker S E, Elliott J C. Optical profilometric study of changes in surface roughness of enamel during in vitro demineralization. Caries Res. 2000 March-April; 34 (2) : 164-74. [2] Kawasaki K, Tanaka Y, Takagi O. Crystallographic analysis of demineralized human enamel treated by laser-irradiation or remineralization. Arch Oral Biol. 2000 September; 45(9) :797-804. [3] Margolis H C, Zhang Y P, Lee C Y, Kent R L Jr, Moreno E C. Kinetics of enamel demineralization in vitro. J Dent Res. 1999 July; 78 (7) :1326-35. [4] Brookes S J, Shore R C, Robinson C, Wood S R, Kirkham J. Copper ions inhibit the demineralisation of human enamel. Arch Oral Biol. 2003 January; 48 (1) : 25-30. [5] Kuhar M, Cevc P, Schara M, Funduk N. In vitro permeability and scanning electron microscopy study of acid-etched and ground enamel surfaces protected with dental adhesive coating. J Oral Rehabil. 1999 September; 26 (9) : 722-30. [6] Turssi C P, Schiavoni R J, Serra M C, Froner I C Permeability of enamel following light-activated power bleaching. Gen Dent. 2006 September-October; 54 (5) : 323-6. [7] Zanet C G, Arana-Chavez V E, Fava M. Scanning electron microscopy evaluation of the effect of etching agents on human enamel surface. J Clin Pediatr Dent. 2006 Spring; 30 (3) :247-50. [8] Pick R M. Lasers in dentistry: where we are today. Dent Today. 2000 September; 19 (9) : 50-3. [9] Cernavin I, Hogan S P. The effects of the Nd:YAG laser on amalgam dental restorative material. Aust Dent J. 1999 June; 44 (2) :98-102. [10] Neev J, Nelson J S, Critelli M, McCullough J L, Cheung E, Carrasco W A, et al. Ablation of human nail by pulsed lasers. Lasers Surg Med. 1997; 21 (2) : 186-92. [0324] [11] Yamada M K, Uo M, Ohkawa S, Akasaka T, Watari F. Three-dimensional topographic scanning electrón microscope and Raman spectroscopic analyses of the irradiation effect on teeth by Nd:YAG, Er:YAG, and CO (2) lasers. J Biomed Mater Res B Appl Biomater. 2004 Oct. 15; 71 (1): 7-15. [12] McCormack S M, Fried D, Featherstone J D, Glena R E, Seka W. Scanning electron microscope observations of CO2 laser effects on dental enamel. J Dent Res. 1995 October; 74 (10) : 1702-8. [13] Anic I, Segovic S, Katanec D, Prskalo K, Naj zar-Fleger D. Scanning electrón microscopic study of dentin lased with argon, CO2, and Nd:YAG láser. J Endod. 1998 February; 24 (2) : 77-81. [14] McDavid V G, Cobb C M, Rapley J W, Glaros A G, Spencer P. Láser irradiation of bone: III. Long-term healing following treatment by CO2 and Nd:YAG lasers. J Periodontol. 2001 February; 72 (2) :174-82. [ 15 ] Westerman G H, Hicks M J, Flaitz C M, Powell G L, Blankenau R J. Surface morphology of sound enamel after argon laser irradiation: an in vitro scanning electron microscopy study. J Clin Pediatr Dent. 1996 Fall; 21 (1): 55-9. [16] Hsu C Y, Jordán T H, Dederich D N, Wefel J S. Effects of low-energy C02 laser irradiation and the organic matrix on inhibition of enamel demineralization. J Dent Res. 2000 September; 79 (9): 1725-30. [17] Aminzadeh A, Shahabi S, Walsh L J. Raman spectroscopic studies of C02 laser-irradiated human dental enamel. Spectrochim Acta A Mol Biomol Spectrosc. 1999 June; 55A(6) :1303-8. [18] Bahar A, Tagomori S. The effect of normal pulsed Nd-YAG laser irradiation on pits and fissures in human teeth. Caries Res. 1994; 28 (6): 460-7. [19] Gelskey S C, White J M, Gelskey D E, Kremers W. Vapor emissions resulting from Nd:YAG laser interaction with tooth structure. Dent Mater. 1998 November; 14 (6): 453-7. [20] Myaki S I, Watanabe I S, Eduardo Cde P, Issao M. Nd:YAG laser effects on the occlusal surface of premolars. Am J Dent. 1998 June; 11 (3): 103-5. [21] Harris D M, White J M, Goodis H, Arcoria C J, Simon J, Carpenter W M, et al. Selective ablation of surface enamel caries with a pulsed Nd:YAG dental laser. Lasers Surg Med. 2002; 30 (5) :342-50. [22] Yamada Y, Hossain M, Kawanaka T, Kinoshita J, Matsumoto K. Removal effects of the Nd:YAG láser and Carisolv on carious dentin. J Clin Laser Med Surg. 2000 October; 18 (5) :241-5. [23] Depraet F J, De Bruyne M A, De Moor R J. The sealing ability of an epoxy resin root canal sealer after Nd:YAG laser irradiation of the root canal. Int Endod J. 2005 May; 38 (5):302-9. [24] Pick R M. Lasers in dentistry: where we are today. Dent Today. 2000 September; 19 (9): 50-3. No abstract available. [25] Ferro D, Barinov S M, Rau J V, Teghil R, Latini A. Calcium phosphate and fluorinated calcium phosphate coatings on titanium deposited by Nd:YAG laser at a high fluence. Biomaterials. 2005 March; 26 (7): 805-12. [26] Kobayashi C A, Fujishima A, Miyazaki T, Kimura Y, Matsumoto K, Osada T, et al. Effect of Nd:YAG laser irradiation on shear bond strength of glass-Ionomer luting cement to dentin surface. Int J Prosthodont. 2003 September-October; 16 (5) :493-8. [27] Pioch T, Moller D, Staehle H J, Hoppe W. Solubility of enamel and synthetic hydroxyl apatite on irradiation. Dtsch Zahnarztl Z. 1991 June; 46 (6): 413-5. German. [28] Quintana E, Márquez F, Roca I, Torres V, Salgado J. Some morphologic changes induced by Nd:YAG laser on the noncoated enamel surface: a scanning electron microscopy study. Lasers Surg Med. 1992; 12 (2): 131-6. [29] Swift E J Jr, Edwards G S, Perdigao J, Thompson J Y, Nunes M F, Ruddell D E, et al. Free-electron laser etching of dental enamel. J Dent. 2001 July; 29 (5): 347-53. [30] Sazak H, Turkmen C, Gunday M. Effects of Nd:YAG laser, air-abrasion and acid-etching on human enamel and dentin. Oper Dent. 2001 September-October; 26 (5): 476-81. [31] Zentner A, Duschner H. Structural changes of acid etched enamel examined under confocal laser scanning microscope. J Orofac Orthop. 1996 August; 57 (4): 202-9. English, German. [32] Korytnicki D, Mayer M P, Daronch M, Singer Jda M, Grande R H. Effects of Nd:YAG laser on enamel microhardness and dental plaque composition: an in situ study. Photomed Laser Surg. 2006 February; 24 (1): 59-63. [33] Kuramoto Júnior M, Matson E, Turbino M L, Marques R A. Microhardness of Nd:YAG laser irradiated enamel surfaces. Braz Dent J. 2001; 12 (1): 31-3. [34] Kielbassa A M, Wrbas K T, Schulte-Monting J, Hellwig E. Correlation of transversal microradiography and microhardness on in situ-induced demineralization in irradiated and nonirradiated human dental enamel. Aren Oral Biol. 1999 March; 44 (3): 243-51. [35] Salama S N, Kinawi N A. X-ray study and microhardness data of some dental enamel species. Biomaterials. 1989 April; 10 (3): 209-12. [36] Fosse G, Rosengren B, Skaale S, Leknes K, Wulff L. An in vivo method for microhardness measurements on human teeth. Scand J Dent Res. 1986 February 94 (1): 27-37. [37] Demetriades A, Koulourides T. Experimental studies of dental caries. Measurements of enamel microhardness. Stomatologia (Athenai). 1969 Mar.-Apr. 26 (2): 69-78. Greek, Modern. [38] Marquez F, Quintana E, Roca I, Salgado J. Physical-mechanical effects of Nd:YAG laser on the surface of sound dental enamel. Biomaterials. 1993; 14 (4): 313-6. [39] Danilina T F, Bagmutov V P, Slayskii lul. The microhardness of dental tissues as an index of their normal functional stability and in pathological states. Stomatologiia (Mosk). 1998; 77 (3): 9-11. Russian. [40] Klinger H G, Wiedemann W, Docos E. Mechanical properties and acid solubility of the dental surface. I. Microhardness. Dtsch Zahnarztl Z. 1980 August; 35 (8) : 823-7. German. [41] Florin R, Herrmann C, Bernhardt W. Measuring microhardness of laser exposed tooth surface. Stomatol DDR. 1990 February 40 (2): 49-51. German.

The object of this invention relates to a procedure for treatment, both preventive and corrective, of dental cavities. Said procedure consists fundamentally in irradiation of the dental surface to be treated with a Neodymium YAG laser in conformity with specific parameters and conditions, signifying an advance in respect of the state of the art in this field. In the case of the treatment of cavities for corrective purposes it is also necessary, among other stages, to apply a dental cementing and restorative biomaterial on the surface of the dental enamel or on the dentin in such a manner that irradiation by the laser produces microfusion between both thereof. The present invention also relates to the biomaterial used in the procedure described herein, preferentially based on hydroxyapatite, together with the use of the procedure and of the biomaterial in the treatment of dental cavities.

FIELD OF THE INVENTION [0001] This invention relates to a device implantable within the abdomen to treat urinary incontinence. BACKGROUND OF THE INVENTION [0002] In the United States, more than 13 million people suffer from the effects of urinary incontinence. Although significant numbers of men are afflicted, women suffer-from this disorder in disproportionate and overwhelming numbers. [0003] Some factors which lead to incontinence in women include the effects of childbirth, hysterectomies, urinary tract infections, relaxation of the pelvic muscles and the thinning of urethral tissue associated with hormone reduction during menopause. These factors contribute to a weakening of the urinary sphincter muscles (located beneath the bladder surrounding the urethra) which may lead to “stress incontinence”, “urge incontinence” or a mixture of both types of incontinence. Stress incontinence is associated with the involuntary leakage of urine due to increased pressure on the bladder occasioned by such mundane actions such as coughing, sneezing, laughing, bending or lifting heavy objects. Urge incontinence occurs when one has the need to urinate but is unable to prevent leakage until proper facilities are reached. [0004] FIG. 1 shows a sling 10 presently used for treating urinary incontinence. Sling 10 comprises an elongated flat strap or tape of material that is surgically implanted within the person's abdomen 12 between the vagina 14 and the urethra 16 . The sling 10 has a U-shaped portion 18 that cradles and supports the urethra. Extension portions 20 attached to the U-shaped portion extend through the abdomen away from the vagina and anchor the sling within the abdomen. The extension portions may be attached to the pubic bone 22 as shown or may merely be anchored within the tissue of the abdomen. The U-shaped portion 18 places the urethra under compression and constricts it so that it takes some muscular effort to exert pressure on the bladder and force urine from it through the constricted urethra. The tension in the sling determines the amount of muscular effort required to effect urination. [0005] There are several disadvantages to this device. It is not always possible to establish the proper sling tension. Too much tension means that it will be difficult, if not impossible, for the person to urinate using muscular contractions that compress the bladder. Too little tension means that the disorder remains uncorrected despite the person having undergone the procedure. It is, furthermore, difficult to adjust the tension once the sling is implanted. Adjustment is desirable because over time, the muscles and other tissue of the abdomen change in their compliance, strength and tone, and what may be sufficient tension at one point in time may be too much or too little later, leading to problems which must again be addressed by invasive surgery. Probably the worst problem associated with slings currently in use is known as “erosion”, whereby, in response to normal movement and pressure of the abdominal muscles, the edge of the sling, being relatively sharp, cuts through the abdominal tissue and enters the urethra. Erosion is indicated by burning pain during urination. [0006] There is clearly a need for an improved sling for the treatment of urinary incontinence that does not suffer the disadvantages of present treatment devices. SUMMARY OF THE INVENTION [0007] The invention concerns a urinary incontinence sling positionable in the abdomen between the urethra and the vagina to compress the urethra. In one embodiment, the sling comprises an elongated tube having opposite end portions and an intermediate portion positioned between the end portions. The intermediate portion is bendable to form a substantially U-shaped cradle positionable adjacent to the urethra. The end portions are positionable so as to extend through the abdomen in a direction away from the vagina. The end portions are in anchoring engagement with living tissue forming the abdomen. The intermediate portion compresses the urethra with a predetermined force. [0008] The tube has a cross sectional shape which may be circular, oval or elliptical for example. Preferably, the tube comprises a plurality of interlaced filamentary members. The filamentary members may be interlaced by knitting, weaving or braiding. The end portions are substantially inextensible, and the intermediate portion is lengthwise elastically extensible. [0009] In another embodiment, an elastically expandable and contractible body is positioned within the intermediate portion of the tube. The body has a predetermined internal pressure. The pressure substantially determines the compressive force exerted on the urethra by the tube. [0010] The tube may comprise a pouch positioned at the intermediate portion of the tube. The pouch is defined by closing the tube at two locations in spaced apart relation to one another. The pouch is used to contain the expandable and contractable body within the intermediate portion. [0011] In another embodiment, the urinary incontinence sling comprises elongated end portions oppositely disposed and an intermediate portion positioned between the end portions. The intermediate portion is bendable to form a substantially U-shaped cradle positionable adjacent to the urethra. The end portions are substantially inextensible and are positionable so as to extend through the abdomen in a direction away from the vagina. The end portions are in anchoring engagement with living tissue forming the abdomen. The intermediate portion compresses the urethra with a predetermined force. In this embodiment, the intermediate portion is preferably lengthwise elastically extensible. The end portions preferably comprise elongated straps and the intermediate portion comprises a tube. An elastically expandable and contractible body may be positioned within the tube that comprises the intermediate portion. The body has a predetermined internal pressure that substantially determines the compressive force exerted on the urethra by the intermediate portion. BRIEF DESCRIPTION OF THE DRAWINGS [0012] FIG. 1 is a partial perspective anatomical view of the female abdominal region illustrating use of a prior art incontinence sling; [0013] FIG. 2 is a perspective view of a sling according to the invention; [0014] FIG. 3 is a side view of an embodiment of a sling according to the invention; [0015] FIG. 4 is a partial sectional view of an abdomen in the medial plane; [0016] FIG. 5 is a partial perspective view on an enlarged scale taken from within circle 5 of FIG. 4 ; [0017] FIG. 6 is a perspective view of an embodiment of a sling according to the invention; [0018] FIG. 7 is a perspective view showing the sling of FIG. 6 implanted within an abdomen; [0019] FIG. 8 is a perspective view of an embodiment of a sling according to the invention; [0020] FIG. 9 is a side view of an embodiment of a sling according to the invention and a tool for implanting the sling within an abdomen; and [0021] FIGS. 10-12 illustrate steps in the use of the tool shown in FIG. 9 to implant the sling in an abdomen. DETAILED DESCRIPTION OF THE EMBODIMENTS [0022] FIG. 2 shows an incontinence sling 30 according to the invention. Sling 30 comprises an elongated flexible tube 32 having opposite end portions 34 and 36 . An intermediate portion 38 is positioned between end portions 34 and 36 . The intermediate portion 38 is bendable to form a substantially U-shaped cradle 40 positionable adjacent to the urethra 16 as shown in FIGS. 4 and 5 . End portions 34 and 36 are positionable so as to extend through the abdomen 12 away from the vagina 14 . The end portions 34 and 36 anchor the sling 30 in position within the abdomen as described in detail below. [0023] End portions 34 and 36 are substantially inextensible lengthwise, especially in comparison with center portion 38 , which is lengthwise elastically extensible. By varying the longitudinal stiffness as a function of position along the sling 30 it is possible to achieve better control over the transverse compressive force applied to the urethra and thereby avoid the aforementioned problems associated with too little or too much sling tension. Furthermore, because they are substantially inextensible, the end portions 34 and 36 , which anchor the sling 30 within the abdomen, are less susceptible to the effects of “sling recoil” as described in detail below. [0024] In a preferred embodiment, sling 30 is formed from warp knitted polypropylene monofilaments. [0025] Polypropylene is preferred because it is bio-compatible, provokes a healing response from living tissue and has a history of success as a material implantable within the human body. Other polymers such as nylon, polyester and polytetrafluoroethylene are also feasible as are bio-absorbable materials such as polyglycolic acid, polylactic acid, PEA, PEUR, PEG and PLLA. [0026] Warp knitting is preferred because it provides a filamentary mesh structure that yields a substantially lengthwise inextensible tube 32 , advantageous for reasons discussed in detail below. The axial stiffness that governs the lengthwise extensibility of the various portions may be controlled by increasing or decreasing the number of warp yarns in a portion, by introducing warp yarns having greater or lesser diameter, by making the warp yarns from materials having greater or lesser moduli of elasticity, or by a combination of any of these techniques. The substantially inextensible end portions 34 and 36 preferably have an extensibility between about 10% to about 20% per unit load, with about 15% extensibility per unit load being most preferred. [0027] Tube 32 may also be woven, the leno weave being preferred for woven embodiments because it too produces an axially inextensible structure. Braiding is also feasible, with the triaxial braid providing the desired control over lengthwise elongation of the tube. The tube may also be a substantially continuous membrane, preferably formed of expanded polytetrafluoroethylene. [0028] The tube 32 preferably has a round cross-section with a diameter of about 7 mm. Other cross-sectional shapes, such as oval, ellipsoidal or polygonal are of course feasible. The width of tube 32 is about 10 mm when flattened in contact with the abdominal tissue as shown in FIG. 5 . The tube 32 is about 12 inches long before implanting. [0029] Implanting of sling 30 is described with reference to FIGS. 3-5 . As shown in FIG. 3 , curved tunneling needles 42 are attached to end portions 34 and 36 of tube 32 . Tunneling needles 42 are used to penetrate the abdominal tissue and draw the sling 30 through the abdomen 12 on opposite sided of the urethra 16 as shown in FIG. 4 . As shown in detail in FIG. 5 , an incision 44 is made in the vagina 14 adjacent to the urethra 16 . Needles 42 are inserted through the incision 44 to pass on opposite sides of the urethra 16 . The needles 42 are forced through the abdomen tissue 46 and exit through the abdominal anterior surface where they are drawn out of-the patient, thereby drawing the sling 30 through the incision 44 , around the urethra 16 and through the abdominal tissue 46 . The appropriate tension is placed on the sling and the end portions 34 and 36 are trimmed so that they remain beneath the surface of the skin of the abdomen. [0030] Sling 30 is anchored in position by end portions 34 and 36 . Anchoring may be effected in various ways, for example, by the intergrowth of abdominal tissue 46 through the end portions 34 and 36 . For such anchoring, it advantageous to provide end portions 34 and 36 with appropriate material properties, surface texture and porosity that favors tissue ingrowth so that a strong anchoring of the sling is quickly achieved. Materials such as polypropylene are used in the end portions because polypropylene is known to provoke an aggressive healing response in living tissue. The surface texture of the end portions may be enhanced by the addition of a knap or by annealing the surface by the application of heat, or by using a particular stitch or multifilament yarn which gives a desired roughness. Furthermore, the porosity of the end portions 34 and 36 may be tailored to have interstitial spaces sized to promote tissue ingrowth. Porosity may be controlled by weave or stitch density as well as by varying the size of the filaments and their type, i.e., multifilaments, monofilaments and texturized filaments may be combined to yield a desired effect. The healing response may also be encouraged by the use of coatings on the end portions 34 and 36 such as thrombin and collagen. [0031] It is advantageous that cradle 40 have a smooth, soft surface that helps to mitigate erosion. To that end, the intermediate portion 38 may have different characteristics from the end portions 34 and 36 , for example, the density of the weave, knit or braid may be greater to better distribute the forces applied to the urethra 16 . Alternately, it may be advantageous to form intermediate portion 38 from a lower density material with a correspondingly softer surface. [0032] Two advantages of the sling 30 according to the invention may be explained with reference to FIGS. 1 and 5 . The first advantage is how the sling 30 mitigates or eliminates the detrimental effect of erosion. As explained above (see FIG. 1 ), erosion occurs as a result of normal body movement and describes a condition whereby the edge 48 of the U-shaped portion 18 of prior art incontinence sling 10 cuts through the abdominal tissue 46 and enters the urethra 16 . This happens largely because prior art slings are flat strips with two opposite edges that are relatively stiff and sharp as compared with the tissue in which they reside. If the strip forming the prior art sling is twisted when it is implanted, the risk of erosion is greatly increased. However, as shown in FIG. 5 , sling 30 according to the invention is a tube and not a flat strip, and therefore cannot present an edge to any portion of the tissue between the vagina 14 and the urethra 16 regardless of its orientation or if it is twisted. Tubular slings 30 according to the invention are far less likely to cause erosion than prior art flat strip slings because they have no sharp edge. [0033] The second advantage of the sling 30 is provided by the manner of interlacing the filamentary members comprising the tube 32 which emphasizes control over the axial stiffness of the tube. As explained above for the sling 30 according to the invention, the particular knit, weave or braid is chosen to produce a substantially lengthwise inextensible tube (i.e., little to no stretch under tensile load). The advantage of an inextensible tube is that, once set during implantation, the pressure exerted on the urethra 16 by the sling will not change significantly due to “recoil” of the sling. [0034] Recoil occurs most acutely with prior art slings 10 , shown in FIG. 1 , that have significant axial flexibility. As the sling 10 is drawn through the abdominal tissue during implantation, it encounters significant resistance in the form of surface drag. The drag applies a tensile load to the sling, notably the extension portions 20 , which, if flexible, will stretch lengthwise, placing the sling in a state of elastic tension within the abdominal tissue. Further tension (and stretching) may be applied to the extension portions 20 as the sling 10 is adjusted to apply pressure to the urethra 16 . Because the extension portions 20 have stretched, they are under tension and therefore they constantly try to shrink back to their nominal length and relieve the tension. This shrinkage occurs during the healing process before the extension portions are anchored and the result is an increase in the force applied to the urethra as the U-shaped portion 18 is drawn toward the extension portions 20 . The increased force on the urethra 16 caused by the recoil of the sling may mean that too much pressure is exerted by the sling 10 , making it difficult to impossible to urinate by exerting muscle pressure on the bladder. [0035] Sling 30 , being substantially lengthwise 20 inextensible, avoids the problems associated with sling recoil. As they are drawn through the abdominal tissue 46 , the end portions 34 and 36 of sling 30 do not stretch significantly and thus will not recoil and change the pressure on the urethra after implanting of the sling. Furthermore, because there is so little elastic tension within the end portions 34 and 36 as compared with the center portion 38 where the elasticity is concentrated, the pressure on the urethra may be established more precisely and reliably, as it is not necessary to account for the elasticity of the entire sling, only the more limited central portion 38 . Thus, by concentrating the elasticity of the sling in the center portion 38 (and not in the end portions 34 and 36 ) the problem of changing sling tension due to recoil is substantially reduced or eliminated. [0036] An alternate embodiment of a sling 50 allowing for adjustability of the pressure on the urethra is shown in FIG. 6 . Sling 50 is formed from a tube 52 having end portions 54 and 56 and an intermediate portion 58 as described above. A pouch 60 is positioned in the intermediate portion 58 . Pouch 60 may be formed in any number of ways and preferably by sealing the tube closed at two points 62 and 64 in spaced apart relation to one another. Sealing may be by heat fusion, sewing, interknitting, interweaving or interbraiding of the tube. Once the sling 50 is implanted, as shown in FIG. 7 , pouch 60 is filled with a compound such as silicone that is bio-compatible. The silicone body 66 is injected through a needle 68 in liquid form and then cures to form an elastic solid. While body 66 is curing a gas is injected into it to form a chamber 70 within the body 66 . After the body 66 is cured, the gas is replaced by a liquid. The body 66 with chamber 70 then forms an expandable and contractible body like a balloon within pouch 60 within which a fluid is maintained. If it becomes necessary to later change the pressure exerted by the sling 50 on the urethra 16 , this may be accomplished by inserting a needle into the chamber 70 and pumping in or removing fluid to increase or decrease the volume of the body 66 . [0037] FIG. 8 illustrates another embodiment of a sling 72 according to the invention. Sling 72 has a tubular intermediate portion 74 . From each end of intermediate portion 74 straps 76 and 78 extend. This sling embodiment is formed so as to be lengthwise inextensible so as to mitigate sling recoil. Straps 76 and 78 are relatively thin so as to better promote tissue ingrowth and anchoring during healing. The intermediate portion 74 has the tubular configuration so as to avoid erosion. [0038] FIG. 9 shows another embodiment of a sling 80 according to the invention. Sling 80 is similar to sling 30 but has openings 82 positioned between the end portions 84 and 86 and the intermediate portion 88 . The openings 82 allow tunneling needles 90 to be positioned within the end portions for implantation into the abdominal tissue. Tunneling needles 90 are attached to a tool 92 which facilitates manual manipulation of the needles and also allows for the deployment of mechanical anchors 94 as shown in FIGS. 10-12 . [0039] The needles 90 are inserted into the vaginal incision as described previously and through the abdominal tissue. The mechanical anchors 94 , in the form of a type of staple having deformable legs 96 , are attached to the end portions 84 and 86 but are deployable into engagement with the abdominal tissue by a mechanism (not shown) associated with the tools 92 . After the sling 80 is positioned as desired ( FIG. 10 ) the legs 96 of the anchors 94 are deployed ( FIG. 11 ) to engage the abdominal tissue and anchor the sling 80 in position. Tunneling needles 90 are then removed ( FIG. 12 ) and the sling 80 remains anchored in place by the engagement between legs 96 and the abdominal tissue. [0040] All of the sling embodiments according to the invention may have radiopaque markers installed to render the sling visible by fluoroscope techniques and thereby facilitate sling positioning within the abdomen. The markers may, for example, be positioned at point locations to indicate boundaries and orientation of the sling, and/or the markers may comprise filamentary members coated with radiopaque material and interlaced with the filamentary members comprising the sling to render the length of the sling visible during implanting. [0041] Slings according to the invention provide numerous advantages over prior art slings including the mitigation or elimination of erosion, the elimination or reduction of recoil effects on urethral pressure as well as providing a sling wherein the pressure on the urethra may be adjusted without the need for invasive surgery. Furthermore, the sling itself, being a tube, provides a guide for the disposition of anchoring systems or other accessories in that the tube interior defines a path through the abdominal tissue.

A sling for controlling urinary incontinence is disclosed. The sling is formed from a tube having substantially lengthwise inextensible end portions and an elastically lengthwise extensible intermediate portion between the end portions. The intermediate portion has a U-shape which cradles the urethra. The end portions extend through the abdominal tissue to anchor the intermediate portion in position. The sling places the urethra under a transverse compressive load to hold it closed and prevent inadvertent urination. The tube is formed from interlaced filamentary members. Interlacing may be by warp knitting, weaving using a leno weave or braiding using a tri-axial braid structure. The end portions have a rough texture to facilitate anchoring in the tissue of the abdominal wall. The intermediate portion is smooth and soft to prevent tissue erosion.

[0001] This application claims the benefit of U.S. Provisional Application No. 60/684,930, filed May 25, 2005. FIELD OF THE INVENTION [0002] The present invention relates to a guard for a header of a harvester, in particular a header having an adjustably mounted knife. BACKGROUND OF THE INVENTION [0003] In some headers of a combine or forage harvester, crop is cut near the ground by an oscillating cutter. Though the cutter may use a scissoring action, it is commonly referred to as a “knife” and this term will be used herein to include any form of cutter. A reel with tines rotates in front of the knife about a horizontal axis to gather the cut crop and to drive it onto an auger which advances the crop towards the vehicle centerline. From there, conveyors carry the crop into the processing machinery. In the case of a combine harvester, the processing machinery separates the grain from the stalks and the chaff. The grain is stored in a grain tank while the stalk and the chaff are discharged from the rear of the harvester. In a forage harvester, the processing machinery chops the entire crop into small pieces and discharges it from a spout into a second vehicle driven alongside the harvester. [0004] Commonly, the knife is mounted in a fixed position on the header and the various rotating and moving parts that drive the knife are covered by a guard. The guard is constructed as a door which can be hinged open to allow access to the parts which drive the knife. These parts include the so-called “wobble box,” which reciprocates a blade of the knife, and the pulley driving the wobble box. [0005] In some headers, the knife can be moved forwards and backwards from a central position by about 50 cms. In headers having an adjustably mounted knife, a problem is encountered because the movement of the knife can result in some rotating and moving parts becoming exposed, as they are no longer shielded by the guard. SUMMARY OF THE INVENTION [0006] With a view to mitigating the foregoing disadvantage, the present invention provides a header having a movably mounted knife and a guard for shielding moving and rotating components operating the knife, wherein the guard is formed of two interconnected parts of which the first is mounted on the header so as not to move with the knife and the second is coupled for movement with the knife, whereby the area shielded by the guard expands and contracts with movement of the knife. [0007] Preferably, the first part of the guard is hinged on the header (i.e. the header frame) and the second part is mounted for sliding movement relative to the first part. More specifically, a half-hinge, or any other suitable type of hinge, is affixed to the header frame, and another half-hinge is affixed to the first part of the guard. Both half-hinges are interconnected by any suitable means, such as a hinge pin. [0008] To enable the sliding movement between first and second parts of the guard, the first part of the guard may comprise upper and lower parallel supports for the second part and at least one of the supports is formed as a runner which receives rollers mounted on the second part. [0009] For example, the upper rail could comprise a bracket of L-shaped section on the first part engaged by a bracket of inverted L-shape section on the second part, the limbs of the two brackets interlocking with one another to prevent separation of the parts without supporting the weight of the second part on the first part. This makes for a less expensive construction that is easy to assemble and avoids problems if the two support brackets are not accurately aligned parallel to one another. The lower rail runner or track could be C-shaped to receive roller wheels. [0010] It is contemplated that the lower rail of the first part of the guard may contain a device to prevent the first part and the second part of the guards from separating. Preferably, the rail can include an upright rod at its rear end. Additionally, the roller wheels, which cooperate with the lower rail, can include a U-shaped safety lock, preferably made of spring steel, which is intended to receive the upright rod through interference fit. [0011] This safety lock will catch over the rod on the first part of the guard and release when sufficient force is applied. The aim of this lock is that, when the guard is opened, the operator can slide the first part fully backwards so the safety lock catches, and the guard will not slide forward or backward on its own. Pulling the second part of the guard forward with enough force will release the safety lock and allow the guard to be closed on the header again. [0012] In the preferred embodiment of the invention, the second part of the guard is also formed with a catch that is releasably engaged by a component that moves with the knife, so that the two parts of the guard automatically slide relative to one another with movement of the knife. Release of the catch permits the two parts of the guard to be pivoted together relative to the header. BRIEF DESCRIPTION OF THE FIGURES [0013] The invention will now be described further, by way of example, with reference to the accompanying drawings, in which: [0014] FIG. 1 is a perspective view of a conventional header having a header assembly including a header frame and guard; [0015] FIG. 2 is a left side view, relative to a forward direction of travel T of the harvester (this direction allocation hereinafter inherent in all figure descriptions), of the first and second part of the guard of the invention; [0016] FIG. 3 is a left side skeleton drawing of the guard in conjunction with the header frame of FIG. 2 ; [0017] FIG. 4 is a section view, taken along lines 4 - 4 in FIG. 3 , through the upper of two supports connecting the two parts of the guard of FIG. 3 to one another; [0018] FIG. 5 is a section view, taken along lines 5 - 5 in FIG. 3 , through the lower of the two supports connecting the two parts of the guard of FIG. 3 to one another; [0019] FIG. 6 is a left rear view of the lower support of FIG. 5 , showing the safety lock of the guard and header frame of FIG. 2 ; [0020] FIG. 7 is a left side view of the header frame of FIG. 2 , with the guard removed, illustrating the locking stirrup and locking pin aperture of the present invention; [0021] FIG. 8 is a front left view of the header frame of FIG. 7 , with the guard removed, illustrating the locking stirrup and locking pin aperture of the present invention; [0022] FIG. 9 is a front right inside view of the guard of FIG. 2 , illustrating the locking pin and dampers of the present invention; [0023] FIG. 10 is an additional front right inside view of the guard of FIG. 2 , illustrating the locking pin, dampers, and latch mechanism of the present invention; [0024] FIG. 11 is a front right inside view of the guard of FIG. 2 , illustrating the latch mechanism of the present invention; [0025] FIG. 12 is a top view of the guard of FIG. 2 in conjunction with the header frame at a beginning closing position “A”, illustrating the locking pin and dampers of the guard interacting with the locking stirrup and locking pin aperture of the header frame; [0026] FIG. 13 is a top view of the guard of FIG. 2 in conjunction with the header frame at an intermediate closing position “B”, illustrating the locking pin and dampers of the guard interacting with the locking stirrup and locking pin aperture of the header frame; [0027] FIG. 14 is a top transparent view of the guard of FIG. 2 in conjunction with the header frame at a final closed, locked position “C”, illustrating the locking pin and dampers of the guard with the locking stirrup and locking pin aperture of the header frame; and [0028] FIG. 15 is a top, outside transparent view of the locking stirrup of the header frame secured in place within the latch mechanism of the guard of FIG. 2 , further illustrating the interaction of the locking pin and dampers with the locking pin aperture of the header frame and a hex knob accessible from the outside of the guard to unlock the guard from the header frame. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0029] The header 10 shown in FIG. 1 has a crop cutter or knife 12 arranged close the ground. The knife comprises a stationary blade and a reciprocating blade which together act as shears which cut the crop near the ground. A reel 14 having tines 16 rotates about a horizontal axis next to the knife 12 to gather the cut crop and feed it into the processing machinery of the harvester (not shown). [0030] At one end only of the header, there is provided a wobble box 80 (shown in FIG. 8 ), which reciprocates the movable blade of the knife 12 . The wobble box 80 is driven by means of a drive belt 82 and a drive pulley 84 , which are shielded by means of a guard 18 . This serves to prevent crop from becoming entangled in the drive train of the wobble box 80 and also avoids the risk of injury to a person standing nearby. To allow access to the wobble box 80 and its drive train for servicing, the guard 18 is designed as a door which can be hinged open at its rear end and is kept closed by a catch at its front end. [0031] The header shown in FIG. 1 has a fixed knife. There are other headers, however, in which the knife 12 can be moved forwards and backwards to each side of a central position, through a distance of as much as, for example, 40 cms. In such a header 10 , the guard 18 , as shown in FIG. 1 , is not sufficiently large enough to shield the wobble box 80 and its drive train when the knife 12 is in its forward position. [0032] The preferred embodiment of the invention, which will now be described by reference to FIGS. 2-15 , mitigates the above problem by providing a guard 18 having a variable geometry, to be effective in all positions of the knife 12 . As illustrated in the left side view (relative to a forward direction of travel T of the harvester) of FIGS. 2-3 , the guard 18 is formed of a first part 20 , which is mounted on a stationary component of the header (i.e. header frame) by means of a hinge 24 . The guard 18 also comprises a second part 22 , which is slidably carried on the first part 20 by means of two supports 30 & 36 , which will be described below in greater detail. [0033] A catch 40 , which is shown in more detail in FIGS. 2 and 7 - 15 , releasably connects the front end of the second part 22 of the guard 18 for movement with the knife 12 . In this way, as the knife 12 moves forwards and backwards, it causes the second part 22 of the guard 18 to slide relative to the first part 20 so that the wobble box 80 and its drive train ( FIG. 8 ) always remain shielded. [0034] As can be seen from the section view of FIG. 5 , the lower support 30 for the second part 22 of the guard 18 preferably comprises rollers 32 secured to the second part 22 , which are held captive within, and slide along, a lower rail 34 , such as a runner or track, affixed to the first part 20 . Rollers and runners are of course commonly used in many applications, for example to mount drawers in furniture, and it is not therefore deemed necessary to describe them in detail. Their use provides a smooth and silent sliding action. Furthermore, because the rollers 32 are held captive in the runner 34 , they prevent relative movement between the two parts 20 , 22 in the vertical plane. [0035] If one of the two supports 30 is formed by rollers 32 guided in runners 34 , the second 36 need only be designed more simply, as shown in the section view of FIG. 4 , as two L-shaped brackets 38 & 39 having limbs which engage one behind the other. Such engagement prevents the two parts 20 , 22 from being separated from one another but does not serve to support the weight of the second part 22 . Aside from reducing cost, such a construction makes parallel alignment of the two supports 20 , 22 less critical. [0036] Turning now to FIG. 6 , it is preferred that the runner or track 34 of the first part 20 of the guard 18 contains a device 50 to prevent the first part 20 and the second part 22 of the guards 18 from separating at both ends. Preferably, this device 50 could be an upright rod 52 mounted at the front and rear ends of the lower runner or track 34 . In reference to the rear end of the lower runner or track 34 , the support of the rearmost roller wheels 32 can include a U-shaped safety lock 54 , preferably made of spring steel, which receives the rearmost upright rod 52 by an interference fit. [0037] This safety lock 54 will catch over the rod 52 on the first part 20 of the guard 18 and release when sufficient force is applied. The aim of this lock 50 is that, when the guard 18 is opened, the operator can slide the second part 22 fully backwards so the safety lock 54 catches, and the second part 22 of the guard 18 will not slide forward or backward on its own. Pulling the second part 22 of the guard 18 forward with enough force will release the safety lock 54 and allow the guard 18 to be closed on the header 10 again. [0038] Turning now to FIGS. 7-15 , the catch 40 is intended to serve two purposes. First, it couples the second part 22 of the guard 18 to the front section of the header frame 10 for movement with the knife 12 . Second, it supports the weight of the guard 18 because, when the guard 18 is extended to its maximum length, it can place undue stress on the hinge 24 . Thus the catch 40 prevents movement of the front end of the guard 18 in two mutually perpendicular planes. [0039] To ensure that the second part 22 of the guard 18 moves horizontally with the knife 12 , a U-shaped locking stirrup 42 is bolted to a plate 44 attached to the front section of the header frame 10 so that it moves with the knife 12 . The free ends of limbs of the locking stirrup 42 are preferably threaded and are secured to the plate 44 by means of nuts 45 . This method of fixing enables the amount that the stirrup 42 projects from the plate 44 to be adjusted. However, it should be realized that other suitable methods of affixing the locking stirrup 42 to the plate 44 are also contemplated. [0040] To support the weight of the free end of the guard 18 and prevent it from moving vertically, the header frame also includes a locking aperture 43 formed in the base plate 44 of the stirrup 42 . The locking aperture 43 includes a bushing, which is mounted thereto. The bushing preferably is made out of plastic material, such as polyamide. [0041] The interior of the second part 22 of the guard 18 includes a locking pin 46 having a preferably conical point, two dampers 47 , which may be formed of rubber or any other dampening material, and a latch mechanism 48 , which has an access knob 49 accessible to the exterior of the second part 22 of the guard 18 . The latch mechanism 48 may be constructed in a manner similar to latch mechanisms used on motor vehicles to hold down the hood or the lid of a trunk. [0042] In operation, such as when it is desired to close the guard 18 from an open position, the first part 20 of the guard 18 is hinged towards a closed position and when nearly closed the second part 22 is slid to the extent necessary to align the locking pin 46 with the bushing of the locking aperture 43 in the plate 44 . The locking pin 46 fits within the bushing and locking aperture 43 , such that the header frame bears the loads generated by sliding both parts 20 , 22 of the guard 18 relative to each other. The second part 22 of the guard 18 is then pushed shut so that the latching mechanism 48 engages with the locking stirrup 42 . [0043] In addition to the above, the two rubber dampers 47 , which are preferably mounted at an angle to each other (i.e. in a V-shape), touch a corresponding surface on the front section of the header frame 10 when the second part 22 of the guard 18 is closed. These dampers 47 are adjusted in such a way that they are slightly compressed when the guard 18 is closed. This arrangement provides additional vibration suppression (the reciprocating movement of the header knife 12 creates vibrations, which tend to propagate through the header 10 and can lead to premature failures and excessive noise generated by the plates of the guard 18 ). Once the catch 40 is engaged, the wobble box 80 and its drive train 82 , 84 will automatically remain adequately shielded in all positions of the knife 12 . [0044] When access to the wobble box 80 is required for servicing, the guard 18 can be opened in the same way as the guard 18 in FIG. 1 . In particular, the latch mechanism 48 must first be released. Release of the latch mechanism 48 can occur at a single access point, a luxury not afforded by the prior art. [0045] It is contemplated that the present invention may employ a variety of latch mechanisms 48 , such as those that may be released remotely either electrically or mechanically, for example using a Bowden cable. Additionally, and as shown in FIGS. 14 and 15 , the latch mechanism can be released mechanically through “an action”, that is, through the turning of a knob 49 from the exterior of the second part 22 of the guard 18 . Preferably, this knob 49 has a hexagonal or other distinctive shape, which requires a specific tool to actuate it, such that it cannot be opened by inadvertent by-passers. [0046] Thus, to open the guard 18 , the operator can simply turn the knob 49 on the lock to any pre-set, desired range, such as about 45 degrees, and pull the shield 18 toward him, thereby disengaging the locking stirrup 42 from the latching mechanism 48 . Alternatively, the latch mechanism 48 may simply be a spring latch designed to release the locking stirrup 42 when the guard 18 is released from its closed position. [0047] In reference to FIG. 3 , after the catch 40 is released through actuation of the latch mechanism 48 , the operator can then slide the second part 22 of the shield 18 backwards until the safety lock 50 at the back catches and then the two parts 20 , 22 of the guard 18 can be swung open about the hinge 24 .

In a header having a movably mounted knife and a guard for shielding the moving and rotating components operating the knife, the guard preferably comprising two interconnected parts of which the first part is mounted on the header so as not to move with the knife and the second part is coupled for movement with the knife. In this way, the area shielded by the guard automatically expands and contracts with movement of the knife.

RELATED APPLICATIONS [0001] This is a continuation-in-part of U.S. patent application Ser. No. 11/105,189, filed Apr. 11, 2005, which is a continuation of U.S. patent application Ser. No. 10/062,742, filed Jan. 29, 2002, now U.S. Pat. No. 6,878,122. COPYRIGHT NOTICE [0002] © 2006 Oregon Health & Science University. A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. 37 CFR § 1.71 (d). TECHNICAL FIELD [0003] The invention pertains to the use of therapy termed “AMES,” or Assisted Movement with Enhanced Sensation, of a type described in U.S. Pat. No. 6,878,122 in the rehabilitation of patients suffering from stroke, traumatic brain injury, and other neuromuscular disorders such as cerebral palsy and spinal cord injury and, in particular, to the use of AMES therapy on a sub-population of such patients who are unable to generate movement in one or both directions at a joint, such as the wrist or ankle. BACKGROUND INFORMATION [0004] In the United States, stroke-related illness is the leading cause of long-term disability. Each year approximately 750,000 individuals in this country suffer a stroke, and for those who survive, a majority will be afflicted with a motor disability. There are currently 4.5 million U.S. citizens permanently disabled by stroke, with annual health-care costs of approximately $50 billion. [0005] Neuromuscular symptoms of stroke include, but are not limited to, muscular paresis (i.e., reduced ability to activate muscles), plegia (i.e., complete paralysis of muscles), and dyssynergia (i.e., inability to activate certain muscles without inadvertent activation of inappropriate muscles in the same limb or other limbs). Often a stroke patient will be plegic at a joint for attempted movement in one direction and paretic in the other direction. [0006] The diagnosis of plegia in stroke victims does not necessarily mean that the individual is completely incapable of activating the appropriate muscles at a joint. Rather, in many cases, the absence of movement is a result of insufficient levels of muscle activation and joint torque to achieve overt movement. Moreover, movement at a joint may be prevented by inadvertent, concomitant activation of the muscles on the wrong side of the joint (i.e., dyssynergia), whereby inadvertent activation overpowers weak activation of muscles on the appropriate side of the joint. [0007] In certain embodiments of AMES therapy described in U.S. Pat. No. 6,878,122, which is assigned to the assignee of this patent application, patients with neuromuscular disorders receive feedback in the form of joint torque. The patients are fed back the amount of torque they are able to produce voluntarily while assisting joint motion produced by a motorized robotic device. If the patient is incapable of producing joint torque during AMES treatment, the patient receives no feedback, even if the patient's attempts to assist movement produce appropriate, but weak, activation of the appropriate muscles. Without useful feedback, these weak, but not completely paralyzed, patients are less likely to benefit from treatment. SUMMARY OF THE DISCLOSURE [0008] Preferred embodiments entail use of electromyographic (EMG) feedback of the electrical activity from muscles so that certain neuromuscular disorder-afflicted patients who are incapable of exerting overt torque at a joint can, during AMES treatment, receive feedback that is related to volitional muscle activation. These weak but not completely paralyzed patients can, therefore, benefit from AMES treatment. [0009] Such use of EMG feedback expands the patient population benefiting from AMES treatment to include individuals who are capable of activating muscles voluntarily at a joint, but to a degree that is too weak to produce overt joint torque and movement. [0010] Preferred embodiments of the invention use EMG feedback with AMES treatment to allow a patient who superficially appears to be totally paralyzed at a joint (i.e., in one or more directions) to recover to a point at which the patient can produce overt joint torque and movement. After the patient has regained some significant amount of voluntary movement, the patient may be shifted to treatment with joint torque feedback. [0011] In addition to stroke, cerebral palsy (CP), traumatic brain injury (TBI), and incomplete spinal cord injury (iSCI) are three of several neuromuscular disorders in which apparent plegia can be produced, but in which the patient is actually capable of weakly activating the muscles crossing a joint. These non-stroke patients with apparent, but not actual, plegia may respond to rehabilitation if EMG feedback is employed in conjunction with AMES treatment. [0012] Additional aspects and advantages will be apparent from the following detailed description of preferred embodiments, which proceeds with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0013] FIG. 1 is a pictorial view of a patient in position to be treated with AMES therapy while using visual feedback, auditory feedback, or both. [0014] FIGS. 2A, 2B , and 2 C are diagrammatic representations of, respectively, raw (i.e., unprocessed) EMG, rectified EMG, and rectified and low-pass filtered EMG waveform traces developed during voluntary movement of an appendicular joint of a patient. [0015] FIG. 3 is a diagrammatic representation of a simple visually presented embodiment of EMG feedback. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0016] AMES therapy is preferably practiced with use of a joint-ranging device that rotates the joint of a patient with concomitant vibration of lengthening muscles associated with the joint while the patient attempts to assist the joint rotation with voluntary contraction of corresponding muscles associated with the joint. A preferred joint-ranging device is an AMES rehabilitation device described in U.S. Pat. No. 6,878,122. [0017] FIG. 1 shows a patient 10 sitting in a chair 12 supporting a wrist joint-ranging device 14 affixed to the patient's right forearm. Wrist joint-ranging device 14 is powered to rotate the wrist joint alternately in flexion and to extension directions. Two vibrators 16 (only one shown in FIG. 1 ) apply during wrist joint rotation concomitant vibration (e.g., 40 Hz-80 Hz) of lengthening muscles associated with the wrist joint while patient 10 attempts to assist the wrist joint rotation with voluntary contraction of corresponding shortening muscles associated with the wrist joint. FIG. 1 also shows patient 10 with her right lower leg secured in a foot joint-ranging device 20 affixed to the patient's shoe and to the calf just below the knee. Foot joint-ranging device 20 is powered to rotate the ankle joint alternately in flexion and to extension directions. Two vibrators 26 apply during ankle joint rotation concomitant vibration of lengthening muscles associated with the ankle joint while patient 10 attempts to assist the ankle joint rotation with voluntary contraction of corresponding shortening muscles associated with the ankle joint. [0018] For operation of either wrist joint-ranging device 14 or foot joint-ranging device 20 , an EMG signal is typically acquired (i.e., recorded) from a patient's muscle or muscles to which pairs of electrodes 24 are attached. The EMG signal represents the differential voltage between electrodes 24 of an electrode pair, referenced to a neutral voltage obtained from an inactive location of the patient's body. Each electrode 24 may be composed of a rounded metal protuberance, typically 0.5 cm-0.7 cm in diameter and depressing the skin 1 mm-3 mm. Electrodes 24 may be embedded within an enclosure for the arm or leg, such as in an AMES rehabilitation device. Alternatively, EMG signals may be picked up by pairs of disposable electrodes 24 adhered to the patient's skin over the muscle or muscles of interest. Typically, pairs of EMG electrodes 24 are oriented parallel to the long dimension of a muscle and/or collinear to the orientation of muscle fibers within the muscle or muscles of interest. The EMG signals provide to patient 10 feedback information representing EMG activity of the lengthening and shortening muscles of interest. The feedback information identifies the degree to which patient 10 is able to assist joint rotation imparted by either wrist joint-ranging device 14 or foot joint-ranging device 20 . [0019] The EMG signal, typically 10 μV-2000 μV in amplitude, is delivered to an EMG instrument 28 for amplification prior to visualization or other usage. Amplification is typically carried out in two stages to minimize electrical noise, near the pick-up site (e.g., ×100) and near the usage site (e.g., ×20-×50), resulting in an amplified signal in the region of 1 V. At this stage of processing, the signal is termed “raw” EMG, is both positive- and negative-going, and has a spiky appearance (e.g., FIG. 2 , line A). [0020] To better utilize the raw EMG signal, further processing is usually carried out. Typically, the raw signal is rectified (i.e., the negative-going components are vertically flipped about 0 V to become positive-going) (e.g., FIG. 2 , line B), and the rectified signal is then low-pass filtered to smooth it (e.g., FIG. 2 , line C). This rectified, smoothed EMG signal can then be used to move a needle on a dial (not shown); to increment a number on a read-out (not shown); to move a graphic object 34 on a display screen 30 of a visual display monitor 32 (e.g., FIG. 3 ); or to modulate the intensity or frequency of a sound audible from a loudspeaker 36 in display monitor 32 (e.g., FIG. 1 ). Commercially available EMG instrumentation amplifier equipment suitable for practicing the above-described process is a Myosystem 2000 , manufactured by Noraxon USA, Inc., Scottsdale, Ariz. The electrodes are conventional ECG stick-on electrodes. [0021] In a first preferred embodiment, the rectified, low-pass filtered EMG signal is used to move graphics object 34 (e.g., FIG. 3 ) on display screen 30 of display monitor 32 . In the example shown in FIG. 3 , the height of a bar 34 represents the instantaneous amplitude of the processed EMG signal ( FIG. 2 , line C). [0022] In a second preferred embodiment, the rectified, low-pass filtered EMG signal is used to control the intensity, frequency, or both, of a tone or a recorded message played over loudspeaker 36 or headphones (not shown). [0023] In a third preferred embodiment, the rectified, low-pass filtered EMG signal is used to control both visual feedback and auditory feedback, which are simultaneously presented in a goal-directed virtual-reality (i.e., video) game displayed on display screen 30 . EXAMPLE 1 [0024] A 34 year-old female, 4 years post-stroke, with severe paresis and joint rigidity in her right wrist and fingers, was treated in accordance with the standard AMES therapy using joint torque feedback. Her wrist and fingers were paretic and spastic in the flexion direction and clinically plegic in the extensor direction. After 11 weeks of the standard AMES therapy, her flexion strength increased by 600%. In contrast, her extension strength changed from zero to negative values, that is, when she attempted to extend, she flexed. Closer examination with EMG recording revealed that her wrist and finger extensor muscles were active when she attempted to extend, but that inadvertent activation of the recently strengthened wrist and finger flexor muscles overpowered the extensor muscles. The patient was then provided EMG feedback for a total of 8 hours of therapy, after which she was better able to differentially activate the flexors and extensors of the wrist and fingers. She then returned to the standard AMES therapy using joint torque feedback. Three months later, her extensor torque had reversed from negative to positive and equaled the torque in her flexor muscles. EXAMPLE 2 [0025] A 44 year-old male, 3 years post-stroke, with severe paresis in his left wrist and fingers, was treated in accordance with the standard AMES therapy using joint torque feedback. His wrist and fingers were paretic in the flexion direction and clinically plegic in the extensor direction. Closer examination revealed a low level of EMG activity in the extensor muscles during attempted extension, but the activity was too weak to produce overt movement of the wrist and fingers. Prior to using the standard AMES device with joint torque feedback, the patient was provided EMG feedback for a total of 6 hours of therapy, after which he was able to generate extension torque and movement of the wrist and fingers. The feedback he received during AMES therapy was then changed from EMG to torque, and he began partial recovery of upper limb use. [0026] It will be obvious to those having skill in the art that many changes may be made to the details of the above-described embodiments without departing from the underlying principles of the invention. The scope of the present invention should, therefore, be determined only by the following claims.

A method of rehabilitating a patient suffering partial or total loss of motor control of an appendicular joint caused by injury or neurological disorder but exhibiting clinically plegic (i.e., paralyzed) muscles and retaining minimal ability to weakly contract the muscles develops overt movement at a joint and ultimately leads to improved functionality. The method entails use of feedback in which the patient views and/or hears a signal related to the intensity of electromyographic (EMG) activity the patient produces in the appropriate muscles while attempting to move the paretic or plegic joint. The method is intended as an alternative form of feedback for highly disabled patients while they receive therapy using an Assisted Movement with Enhanced Sensation (AMES) device providing joint torque feedback.

This Application is the U.S. National Phase Application of PCT International Application No PCT/GB03/004159 filed Sep. 22, 2003. The present invention relates to restraining apparatus, and especially but not exclusively to apparatus for securing children. DESCRIPTION OF THE RELATED ART It is often difficult to control a group of children and to keep them safe in the group, particularly when taking them for walks or excursions. BRIEF SUMMARY OF THE INVENTION According to the present invention there is provided restraining apparatus for coupling two or more users comprising at least one spine member with at least two lateral attachment members for coupling the users to the spine member, the spine member having two planes, and having more flexibility in one plane than in the other. The spine member can be an elongate rod or plate from which the lateral attachment members extend sideways. The rod or plate is typically inextensible along its long axis and is preferably rigid in its vertical plane but preferably has some lateral resilience, so that it can bend sideways in its horizontal plane with the movement of the users. Lateral resilience in the horizontal plane in use of the device is preferable to lateral resilience in the vertical planes because rigidity in the vertical plane with respect to the user has the benefit that parts of the spine member have a reduced tendency to sag and become trampled underfoot. Therefore, preferred embodiments of the device can bend laterally from side to side in the horizontal plane of the device, but not up and down in the vertical plane of the device. In some embodiments the spine member is axially compressible and/or extensible. Plastics material is suitable for the spine members. Optionally, at least a part of the spine member is made of corrugated plastic. Alternatively, the spine member is made of composite plastics material or rubber. The spine may have a stiffening member, such as a plastics, metal or composite plate covered with the plastics or rubber material, to enhance rigidity in one plane. The spine being flexible and/or compressible allows the users to approach each other and to turn corners. Preferably, the attachment members are securely attached, but in a releasable manner and are typically coupled to the spine member at nodes on the spine member. Preferably, each node has two attachment members. The attachment members are typically arms. The arms may be laterally flexible and/or axially extensible and/or compressible, to absorb sudden forces. In some embodiments they can be rigid or semi-rigid, or preferably non-flexible in some planes but flexible in others. Typically, the attachment members are pivotable with respect to the spine member. Optionally, each attachment member at each node is pivotable with respect to the other attachment member. In preferred embodiments, each node has a pair of attachment members extending laterally from opposite sides of the spine member. It is not necessary to have an attachment member extending from each side of each node; a single node can instead bear a single attachment member. Attachment members can all extend from the same side of the spine member, or from different sides. In one optional embodiment, members are staggered along the spine member. Pivotal attachment members allow users of different heights to share one node. Optionally, two or more spine members are connected together. This allows a long chain of spine members and nodes to be built up, which is useful to connect a large number of users. Preferably, the apparatus also includes harnesses to be worn by each user. Typically, each harness is adapted to releasably engage an attachment member, to attach the user to the spine member. Typically, the harness includes a belt. Optionally, the harness includes a shoulder strap, but simple waist belts would suffice. Preferably, each harness has at least one socket to engage a protrusion on an attachment member, but other attachment formations can be used instead. Optionally, the socket includes a first plate, biased apart from and pivotable relative to a second plate, and pivoting moves the ends of the plates at the socket mouth apart to enlarge the mouth to engage/release an attachment member. Typically, the plates are biased apart by a coil spring. Typically, both plates are pivotable with respect to the socket. Another alternative attachment system could involve moulded plastic ball-joints and sockets, clips, buckles, or other similar connectors that are commercially available. In another aspect the invention provides a method of securing or restraining a person, comprising harnessing the person to a spine member via an attachment member, the spine member having at least two planes, and having a different degree of flexibility in respective planes. Typically more than one person is harnessed to the spine member. In some embodiments the spine and/or the harness can be coloured brightly, and/or can incorporate luminous, reflective and/or light emitting devices such as LEDs and strobes to attract attention. BRIEF DESCRIPTION OF THE DRAWINGS An embodiment of the present invention will now be described by way of example only and with reference to the following drawings, in which:— FIG. 1 is a plan view of six children using a restraining apparatus; FIG. 2 is a plan view with the children with the apparatus in a compressed position; FIG. 3 is a plan view of the children in a curved configuration; FIG. 4 is a front view of a harness worn by each child; FIG. 5 is a front view of the apparatus worn by two children of different heights; FIG. 6 is a perspective view of one embodiment of the apparatus; FIG. 7 is a perspective view of an alternative embodiment of the apparatus; FIG. 8 is a perspective view of an alternative embodiment of the apparatus; FIG. 9 is a perspective view with interior detail of part of the apparatus, showing an arm located in a socket; FIG. 10 is a side view with interior detail of the arm and socket of FIG. 9 ; FIG. 11 is an exploded view of a node, spine members and attachment means; FIG. 12 is a perspective view of the apparatus of FIG. 11 with the node secured to the spine members; FIG. 13 is an exploded view of a node of the apparatus, spine members and an alternative attachment means; FIG. 14 is a perspective view of the apparatus of FIG. 13 with the node secured to the spine members; and FIGS. 15 a - 15 d show schematic views of different embodiments of the apparatus. DETAILED DESCRIPTION OF THE INVENTION FIG. 1 shows six children 12 secured together by restraining apparatus 10 . The apparatus 10 has two elongate spine members 14 , 16 . Each node 18 , 20 , 22 has two lateral arms 24 , 26 , 28 , 30 , and 32 , 34 . The spine members 14 , 16 are optionally axially compressible and/or extensible and/or laterally flexible in the horizontal plane of the apparatus in use, to allow the apparatus to bend. This allows the children 12 to approach each other ( FIG. 2 ) and turn corners ( FIG. 3 ). However, the spine members 14 , 16 are normally inextensible, or at least only very slightly axially resilient, so that the distance between the children cannot increase to any great extent. Also, the spine members are typically comparatively more rigid in the vertical plane than in the horizontal plane, so that the spine does not sag between nodes. Different sizes of apparatus 10 are envisaged, depending on the number of children to be secured. To make a larger version of apparatus 10 , additional spine members and nodes can simply be attached to the apparatus 10 . FIG. 4 shows a harness 36 that is used to attach the children 12 to the apparatus 10 . The harness 36 has a shoulder strap 38 and a belt 40 . The belt 40 is fastened by a simple buckle 42 . The belt 40 also has two sockets 44 for engagement with an arm of the apparatus 10 . Sockets 44 can optionally slide on rails 46 provided in the belt, so that the child can turn sideways with respect to the spine 14 , 16 . The sockets 44 can typically be switched between a first configuration where they are fixed immovably to the rails 46 , and a second configuration in which they can slide relative to the rails 46 . FIG. 5 shows two different-sized children 12 secured to node 22 by arms 32 , 34 . Each user 12 is wearing a harness 36 , and a socket 44 in each harness 36 is engaged with an arm 32 , 34 of the node 22 . The arms 32 , 34 are pivotable with respect to the node 22 , to allow the different-sized children 12 to be connected to the apparatus 10 without twisting the apparatus 10 . The arms 32 , 34 can also be axially and laterally resilient so as to resist the transfer of forces between the children connected to the node 22 . FIG. 6 shows an embodiment of apparatus 10 , having spine members 60 connected to each other by single pivot nodes 54 . The spine members typically comprise an elongate strip covered with a non-pvc rubber. The spine members 60 can typically comprise thin sheets of plastic, metal or composite material (such as GRP or carbon fibre), orientated so that in use the sheets lie in the vertical plane. This allows lateral but not vertical flexibility of the spine members. In this embodiment, each node 54 comprises a ring 56 and a rod 58 , which passes through the centre of the ring 56 in a direction parallel to the axis of the spine members 60 . Each pair of arms 62 , 64 is typically formed as a single piece, having a central bore arranged parallel to the axis of the spine members 60 and shaped to accommodate the rod 58 , which passes through the bore. Each pair of arms 62 , 64 is pivotal around the rod 58 and is thus pivotable with respect to the spine members 60 , but the arms 62 , 64 are not pivotable with respect to each other. The ends of arms 62 , 64 have elongate tabs 65 to engage in the sockets of the harness. Spine members 60 optionally have reflectors 68 , which help the children 12 to be seen in the dark. FIG. 7 shows an embodiment very similar to that of FIG. 6 , except that the rings 56 of each node 54 are closed or covered, typically by a rubber or plastics gaiter. This could help prevent fingers from becoming trapped in the nodes 54 . In this embodiment the arms 62 , 64 could be pivotable independently of one another. FIG. 8 shows an alternative embodiment of apparatus 110 , having a number of spine members 160 , each of which includes a portion of corrugated plastic tubing. The corrugated tubing allows the spine members 160 to bend laterally and to be compressed and stretched axially. The other major difference from the previous embodiment is that the arms 162 , 164 are pivotable relative to each other, as well as relative to nodes 154 . The arms 162 , 164 are also typically resilient and can be formed from a rubber material. These arms could of course be used with the earlier embodiments. FIGS. 9 and 10 show views of arm 62 engaged in socket 44 . Inside socket 44 is a grip device 90 , which includes two plates 92 , 94 , each having an aperture to receive opposite ends of elongate tab 65 on the end of the arm 62 . The plates 92 , 94 are pivotable about respective pivot points 96 , 98 and a coil spring 93 held in compression between the plates on one side of the pivot points 96 , 98 at the end furthest from the socket mouth urges the other ends of the plates together to capture the tab 65 in the apertures. Dual buttons 95 , 97 are connected to the plate ends above and below the spring 93 . The dual buttons enable release from the apparatus. Simpler connectors are possible, along the lines of buckles or clips conventionally used with backpacks and webbing straps, and any connector to secure the child to the arm can be used. FIGS. 11 to 14 show details of possible connections between nodes 54 and spine members 60 . FIG. 11 is an exploded view showing spine members 60 , the ends of which terminate in rods that can slide into vertical slots 72 in nodes 54 and are secured therein by bolts 74 or pins. Bolts 74 fit through a first aperture 76 in one side of ring 56 , a corresponding aperture 70 in the end of each spine member 60 and through a second aperture 76 in ring 56 . FIG. 12 is a non-exploded view of FIG. 11 . FIG. 13 shows an alternative connection between nodes 54 and spine members 60 . Ring 54 has two end lobes 80 , which each have a cylindrical lateral protrusion 82 in one side. The protrusions 82 are shaped to engage sockets 84 in the ends of spine members 60 . Securing caps 86 attach to the protrusions 82 once they are engaged in sockets 84 . The caps 86 are typically screwed to the protrusions by engaging interior screw threads of the cap 86 with exterior screw threads on the protrusion 82 , but other engagement means could also be used. FIG. 14 is a non-exploded view of FIG. 13 . To secure a child to the restraining apparatus 10 , the child 12 puts on a harness 36 and fastens the belt buckle 42 . One of the sockets 44 of the harness 36 is then connected to an arm 24 of the apparatus 10 . This is done by simultaneously pushing socket buttons 95 , 97 . This compresses the spring 93 and pivots the plates 92 , 94 so the ends of the plates 92 , 94 at the socket opening move away from each other. This widens the socket entrance enough to allow the elongate tab 65 to be inserted. Once the tab 65 is aligned with the apertures in the plates 92 , 94 , the buttons 95 , 97 are released, which moves the plate ends over the tab 65 , leaving the ends of the tab 65 projecting through the apertures in the plates 92 , 94 . Thus, the elongate tab 65 is trapped in the socket 44 and the child 12 is secured to apparatus 10 . The procedure is repeated to secure all the children required to respective arms of the apparatus 10 . To disengage a child 12 from the apparatus 10 , the socket buttons 95 , 97 , are simultaneously compressed and held down. This compresses spring 93 , and pivots the plates 92 , 94 to widen the socket opening as before. This releases the tab 65 from the apertures in the plates 92 , 94 and the arm 62 is then pulled out of the socket 44 . The buttons 95 , 97 are now released and the child takes off the harness 36 . This procedure is repeated to release all children 12 from the apparatus 10 . Modifications and improvements can be incorporated without departing from the scope of the invention. For example, the position of the tabs and sockets could be reversed, i.e. each arm could have a socket and the harness could have a tab to engage the socket. The arm and socket do not have to engage by apertures in plates engaging the arms; any way of attaching the arm to the socket would be adequate, e.g. the arm could screw into the socket. The socket could be replaced by a lock mechanism, requiring a special tool to release the arm, so that a child secured to the apparatus could not release itself. Two sets of apparatus could be used parallel to each other, with a central column of children attached to both apparatus. FIG. 15 shows a number of different schematic combinations of children 12 , spines 100 and arms 110 . Not all of the nodes need to be provided with arms at each side, nor do all the nodes or arms need to be occupied by children. Embodiments of the invention could be created using a single spine instead of separate spine members (thereby removing the need for nodes) where the arms extend out through apertures in the spine. The harnesses could be permanently attached to the apparatus (instead of releasably attached by the arm and socket connection).

Restraining apparatus for coupling together two or more users such as children while walking as a group. The apparatus comprises a spine member with lateral attachment arms for coupling the users to the spine member. The spine member is laterally flexible to allow the spine to bend from side to side when corners are being negotiated in use, but has sufficient stiffness in the vertical plane to resist sagging between the users.

RELATED APPLICATION This is a continuation of application Ser. No. 09/461,879, filed Dec. 15, 1999, which is a continuation-in-part of application Ser. No. 09/298,110 filed Apr. 22, 1999, now abandoned. SEQUENCE LISTING A printed Sequence Listing accompanies this application. In accordance with 37 CFR 1.821(a)(2)(e), it is requested that the previously submitted compliant sequence listing in computer readable format be transferred from application Ser. No. 09/461,879 to this application. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention is broadly concerned with attenuated avirulent atypical porcine reproductive and respiratory syndrome (PRRS) virus (PRRSV), and corresponding live virus vaccines for administration to swine in order to confer effective immunity in the swine against PRRSV. The invention also includes methods of immunizing swine against PRRSV, and a new, highly efficient method of passaging viruses to attenuation. 2. Description of the Prior Art PRRS emerged in the late 1980's as an important viral disease of swine. PRRSV causes severe reproductive failure in pregnant sows, manifested in the form of premature farrowings, increased numbers of stillborn, mummified and weak-born pigs, decreased farrowing rate, and delayed return to estrus. Additionally, the respiratory system of swine infected with PRRSV is adversely affected, which is evidenced by lesions that appear in the lungs of infected swine. To combat the problems associated with PRRSV infection, vaccines have been developed which conferred immunity to then extant PRRSV strains. Epidemics of an unusually severe form of PRRS, referred to hereafter as “atypical PRRS”, were first recognized in North America in the latter part of 1996. They differed from epidemics of “typical PRRS” in that: 1) clinical signs were more prolonged as well as more severe; 2) the incidence of abortion was greater, especially during early and middle gestation; 3) there was a higher incidence of gilt and sow mortality; 4) PRRSV was less often isolated from aborted fetuses, stillborn pigs, and liveborn pigs —perhaps because abortions were more often the result of acute maternal illness rather than transplacental infection; 5) lung lesions of young affected pigs were more extensive; and 6) commercially available vaccines provided little or no protection. Collectively these observation indicated the emergence of more virulent and antigenically distinct strains of PRRSV and the need for a new generation of PRRS vaccines. The most frequently used method for producing attenuated, live-virus vaccine is to serially passage the virus in a substrate (usually cell culture) other than the natural host (S) until it becomes sufficiently attenuated (i.e., reduced in virulence or diseases-producing ability) to be used as a vaccine. For the first passage, a cell culture is infected with the selected inoculum. After obtaining clear evidence of virus replication (e.g., virus-induced cytopathic effects [CPE] in the infected cells), an aliquot of the cell culture medium, or infected cells, or both, of the first passage are used to infect a second cell culture. The process is repeated until one or more critical mutations in the viral genome cause sufficient attenuation so that the virus can be safely used as a vaccine. The degree of attenuation is usually determined empirically by exposing the natural host (S) to progressively greater passage levels of the virus. The above procedure is fundamentally sound and has been successfully used for the development of numerous vaccines for human and veterinary use. However, it is relatively inefficient because the logarithmic phase of virus replication, during which mutations are most likely to occur, is often completed long before evidence of virus replication becomes visibly obvious. Therefore, there is a decided need in the art for a vaccine that confers effective immunity against PRRSV strains, including recently discovered atypical PRRSV strains. There is also a need in the art for a method of making such a vaccine. Finally, what is needed is a method of passaging a virus that attenuates the virus more efficiently than was heretofore thought possible with the resulting attenuated virus eliciting PRRSV specific antibodies in swine thereby conferring effective immunity against subsequent infection by PRRSV. SUMMARY OF THE INVENTION The present invention overcomes the problems outlined above, and provides attenuated, atypical PRRSV strains, and corresponding improved modified-live vaccines which confer effective immunity to newly discovered atypical PRRSV strains. “Effective immunity” refers to the ability of a vaccine to prevent swine PRRSV infections, including atypical PRRSV infections, which result in substantial clinical signs of the disease. That is to say, the immunized swine may or may not be serologically positive for PRRSV, but do not exhibit any substantial clinical symptoms. “Atypical PRRSV” refers to these new strains of PRRSV that are substantially more virulent than typical PRRSV strains. In preferred forms, the vaccine of the invention includes live virus which has been attenuated in virulence. The resulting attenuated virus has been shown to be avirulent and to confer effective immunity. A particularly virulent strain of atypical PRRS (denominated JA-142) which caused especially severe symptoms of PRRS and represents the dominant strain of atypical PRRSV, was chosen for subsequent attenuation through passaging. The resultant attenuated virus has been deposited in the American Type Culture Collection (ATCC), Rockville, Md. on Feb. 2, 1999, and was accorded ATCC Accession No. VR-2638. This attenuated virus is a preferred Master Seed Virus (MSV) which has been subsequently passaged and developed as an effective PRRSV vaccine. The name given the unattenuated virus, JA-142, arises from the restriction enzyme pattern. The 1 represents the inability of the enzyme MLU I to cleave the virus in open reading frame 5 (ORF 5). The 4 represents cleavage by Hinc II at base pair positions 118 and 249 of ORF 5 and short contiguous sequences. The 2 represents cleavage by Sac II at base pair position 54 of ORF 5 and short contiguous sequences. Passaging of the virus to attenuation was accomplished using a novel method which resulted in increased efficiency. Specifically, the virus was kept in the logarithmic phase of replication throughout multiple cell culture passages in order to materially shorten the time to attenuation. This is achieved by ensuring that in each cell culture there is a substantial excess of initially uninfected cells relative to the number of virus present. Thus, by transferring only small numbers of virus from passage-to-passage, logarithmic replication is assured. In practice, the process is normally initiated by inoculation of several separate cell cultures with progressively smaller viral aliquots (i.e., lesser numbers of virus in each culture.) For example, starting cultures could contain 200 μl, 20 μl and 2 μl viral aliquots. After an initial short incubation period (e.g., 24 hours), the same viral aliquots (in the example, 200 μl, 20 μl and 2 μl) from each cell culture are transferred to individual fresh (previously uninfected) cultures, while the starting cultures are monitored until cytopathic effect (CPE) is or is not observed. This process is continued in serial order for multiple passages, using the same viral aliquots in each case and preserving the cultures for CPE observation. If all of the serial culture passages exhibit CPE after a selected number of passages are complete, the larger viral aliquot series may be terminated (in the example 200 μl and 20 μl), whereupon another series of progressively smaller viral aliquots are employed (e.g., 2 μl, 0.2 μl and 0.02 μl) and the process is again repeated, again keeping the cell cultures after transfer for CPE observation. At some point in this successively smaller viral aliquot inoculation process, CPE will not be observed in a given cell culture. When this occurs, the next higher viral aliquot level showing CPE is substituted for the passage in which CPE was not observed, whereupon subsequent passages will be inoculated using previously employed viral aliquots. Inasmuch as a virus will tend to become more efficient at infecting cells and also replicate to a higher infectivity titer for cell cultures over time, (which is especially true with RNA viruses such as PRRSV), it will be seen that smaller and smaller viral aliquots are required to maintain infection during serial transfer. The use of the smallest aliquot that maintains infection helps to assure that viral replication remains in a logarithmic phase throughout the process. The DNA sequence of the attenuated passaged virus from the 201st passage was then determined using conventional methods. The sequence of this attenuated virus was designated as MSV JA-142 Passage No. 201, the sequence of which is given as SEQ ID No. 1. The sequence of the virulent virus, JA-142, is given as SEQ ID No. 2. As used herein, the following definitions will apply: “Sequence Identity” as it is known in the art refers to a relationship between two or more polypeptide sequences or two or more polynucleotide sequences, namely a reference sequence and a given sequence to be compared with the reference sequence. Sequence identity is determined by comparing the given sequence to the reference sequence after the sequences have been optimally aligned to produce the highest degree of sequence similarity, as determined by the match between strings of such sequences. Upon such alignment, sequence identity is ascertained on a position-by-position basis, e.g., the sequences are “identical” at a particular position if at that position, the nucleotides or amino acid residues are identical. The total number of such position identities is then divided by the total number of nucleotides or residues in the reference sequence to give % sequence identity. Sequence identity can be readily calculated by known methods, including but not limited to, those described in Computational Molecular Biology, Lesk, A. N., ed., Oxford University Press, New York (1988), Biocomputing: Informatics and Genome Projects, Smith, D. W., ed., Academic Press, New York (1993); ComputerAnalysis of Sequence Data, Part I, Griffin, A. M., and Griffin, H. G., eds., Humana Press, New Jersey (1994); Sequence Analysis in Molecular Biology, von Heinge, G., Academic Press (1987); Sequence Analysis Primer, Gribskov, M. and Devereux, J., eds., M. Stockton Press, New York (1991); and Carillo, H., and Lipman, D., SIAM J. Applied Math., 48: 1073 (1988), the teachings of which are incorporated herein by reference. Preferred methods to determine the sequence identity are designed to give the largest match between the sequences tested. Methods to determine sequence identity are codified in publicly available computer programs which determine sequence identity between given sequences. Examples of such programs include, but are not limited to, the GCG program package (Devereux, J., et al., Nucleic Acids Research, 12(1):387 (1984)), BLASTP, BLASTN and FASTA (Altschul, S. F. et al., J. Molec. Biol., 215:403-410 (1990). The BLASTX program is publicly available from NCBI and other sources (BLAST Manual, Altschul, S. et al., NCVI NLM NIH Bethesda, MD 20894, Altschul, S. F. et al., J. Molec. Biol., 215:403-410 (1990), the teachings of which are incorporated herein by reference). These programs optimally align sequences using default gap weights in order to produce the highest level of sequence identity between the given and reference sequences. As an illustration, by a polynucleotide having a nucleotide sequence having at least, for example, 95% “sequence identity” to a reference nucleotide sequence, it is intended that the nucleotide sequence of the given polynucleotide is identical to the reference sequence except that the given polynucleotide sequence may include up to 5 point mutations per each 100 nucleotides of the reference nucleotide sequence. In other words, in a polynucleotide having a nucleotide sequence having at least 95% identity relative to the reference nucleotide sequence, up to 5% of the nucleotides in the reference sequence may be deleted or substituted with another nucleotide, or a number of nucleotides up to 5% of the total nucleotides in the reference sequence may be inserted into the reference sequence. These mutations of the reference sequence may occur at the 5′ or 3′terminal positions of the reference nucleotide sequence or anywhere between those terminal positions, interspersed either individually among nucleotides in the reference sequence or in one or more contiguous groups within the reference sequence. Analogously, by a polypeptide having a given amino acid sequence having at least, for example, 95% sequence identity to a reference amino acid sequence, it is intended that the given amino acid sequence of the polypeptide is identical to the reference sequence except that the given polypeptide sequence may include up to 5 amino acid alterations per each 100 amino acids of the reference amino acid sequence. In other words, to obtain a given polypeptide sequence having at least 95% sequence identity with a reference amino acid sequence, up to 5% of the amino acid residues in the reference sequence may be deleted or substituted with another amino acid, or a number of amino acids up to 5% of the total number of amino acid residues in the reference sequence may be inserted into the reference sequence. These alterations of the reference sequence may occur at the amino or the carboxy terminal positions of the reference amino acid sequence or anywhere between those terminal positions, interspersed either individually among residues in the reference sequence or in the one or more contiguous groups within the reference sequence. Preferably, residue positions which are not identical differ by conservative amino acid substitutions. However, conservative substitutions are not included as a match when determining sequence identity. Similarly, “sequence homology”, as used herein, also refers to a method of determining the relatedness of two sequences. To determine sequence homology, two or more sequences are optimally aligned as described above, and gaps are introduced if necessary. However, in contrast to “sequence identity”, conservative amino acid substitutions are counted as a match when determining sequence homology. In other words, to obtain a polypeptide or polynucleotide having 95% sequence homology with a reference sequence, 95% of the amino acid residues or nucleotides in the reference sequence must match or comprise a conservative substitution with another amino acid or nucleotide, or a number of amino acids or nucleotides up to 5% of the total amino acid residues or nucleotides, not including conservative substitutions, in the reference sequence may be inserted into the reference sequence. A “conservative substitution” refers to the substitution of an amino acid residue or nucleotide with another amino acid residue or nucleotide having similar characteristics or properties including size, hydrophobicity, etc., such that the overall functionality does not change significantly. Isolated” means altered “by the hand of man” from its natural state., i.e., if it occurs in nature, it has been changed or removed from its original environment, or both. For example, a polynucleotide or polypeptide naturally present in a living organism is not “isolated,” but the same polynucleotide or polypeptide separated from the coexisting materials of its natural state is “isolated”, as the term is employed herein. Preferably, sequences sharing at least about 75%, more preferably at least about 85%, still more preferably at least about 90% and most preferably at least about 95% sequence homology with SEQ ID No. 1 are effective as conferring immunity upon animals vaccinated with attenuated viruses containing such homologous sequences. Alternatively, sequences sharing at least about 65%, more preferably at least about 75%, still more preferably at least about 85%, and most preferably at least about 95% sequence identity with SEQ ID No. 1 are also effective at conferring immunity upon animals vaccinated with attenuated viruses containing such identical sequences. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The following examples set forth preferred embodiments of the present invention. It is to be understood, however, that these examples are provided by way of illustration and nothing therein should be taken as a limitation upon the overall scope of the invention. EXAMPLE 1 Materials and Methods This example describes a passage method of attenuating viruses which maximizes attenuation efficiency by ensuring that the virus is preferably in a logarithmic phase of replication. Virus was passed (i.e. an aliquot of nutrient medium including the virus, unattached cells, and cell debris from a virus-infected cell culture was added to the nutrient medium of a noninfected culture) at daily intervals. Different amounts of virus were added at each interval by using multiple cultures. For example, at the beginning, 200 μl was transferred to one noninfected culture, 20 μl was added to a second noninfected culture, and 2 μl to a third noninfected culture. The goal was to have a sufficient amount of susceptible cells so that the replication cycles could continue until the next transfer. The procedure was deemed successful if the cells eventually showed CPE. However, because PRRSV-induced CPE do not appear until sometime after the logarithmic growth phase, passages were made before it was known whether or not they would be ultimately successful (“blind passages”). Passages that resulted in virus induced CPE were said to have resulted in a “take”. If a passage did not result in a take, the passage was restarted using the highest dilution from the last passage which did result in a take. As more and more passages were made, the virus became more adapted to replicate in the cell line and less able to produce disease symptoms in its original host. These changes occur through random mutations that occur during replication. Using this method, the following procedures were used to passage an exemplary virus in accordance with the present invention, MSV, JA-142. This strain was passaged in MARC-145 cell cultures at daily intervals. Twenty-four-well plates were used for the process to minimize the amount of cells and nutrient medium required, and to simplify the multiple-aliquot passage technique. Cells and nutrient medium were added to each well and the cells were allowed to form, or nearly form (greater than about 70%), a confluent monolayer. The nutrient medium comprised approximately 90% Earle's balanced salt solution minimal essential medium (MEM), 10% fetal calf serum and 0.05 mgm/ml of gentamicin sulfate. The volume of nutrient medium used was approximately 1 ml. Usually, three wells of a column were used for each amount of virus that was transferred. An aliquot of nutrient medium from the previous passage was transferred to the first well in the column at 48 or 72 hours, after the cell cultures had been prepared, nutrient medium from the first well was transferred to the second well of the same column at 72 or 96 hours and the third well of the same column at 96 or 120 hours. Plates were usually set up twice a week so sometimes the fourth well of the column was used and sometimes it was not used. Passaging conditions were maintained at 37° C. in a moist atmosphere containing 5% CO 2 . Different sized aliquots (having different amounts of virus) for each passage were tested to determine if the amount of virus was sufficient to induce CPE. For example, a separate series of aliquot transfers (passages) of 200 μl, 20 μl, and 2 μl, respectively, was used until the smaller aliquots consistently exhibited CPE with the goal being to transfer the smallest aliquot that produced CPE. When the smallest aliquot (e.g. 2 μl) of the group of aliquots being tested consistently resulted in CPE, smaller amounts were tested (e.g. 0.2 μl and 0.02 μl). When a certain dilution did not exhibit CPE, that series of cultures was restarted with the next lower amount which did result in CPE at that passage (i.e. if the 2 μl transfer was unsuccessful at producing CPE in the 25th passage but the 20 μl transfer in the 25th passage was successful, the 2 μl transfer was repeated using 20 μl with 2 μl transfers resuming for the 26th passage.) Using this method, the smallest amount of virus necessary to transfer to obtain CPE was determined. Virus was passed successfully at daily intervals using the following amounts of virus-infected nutrient medium (which reflect the highest dilution [i.e., smallest aliquot] which resulted in CPE keeping in mind that other dilutions would also work): Passage Number Amount Transferred  3-21  200 μl 22, 23   20 μl 24-41  200 μl 42-83 20/200 μl (alternating) 84-90   20 μl  91-112   2 μl 113  0.2 μl 114-116   2 μl 117  0.2 μl 118-120   2 μl 121  0.2 μl 122-124   2 μl 125-167  0.2 μl 168 0.02 μl 169-171  0.2 μl 172 0.02 μl 173-175  0.2 μl 176 0.02 μl 177-179  0.2 μl 180 0.02 μl 181-183  0.2 μl 184 0.02 μl 185-187  0.2 μl 188 0.02 μl 189-191  0.2 μl 192 0.02 μl 193-195  0.2 μl 196 0.02 μl 197  0.2 μl Results and Discussion The passaging of the virus using the above method resulted in an attenuated PRRSV, JA-142. As is apparent, the virus became more adapted to replicate in the cell culture and therefore required a smaller amount of virus-infected nutrient medium to be transferred as passaging continued. For transfers using a very small amount of virus-infected nutrient medium (e.g. 0.2 μl or 0.02 μl), a separate dilution was required. This dilution was accomplished by adding a small amount of virus-infected nutrient medium to a larger amount of nutrient medium. For example, to obtain a transfer of 0.2 μl, 2 μl of virus infected nutrient medium was added to 20 μl of nutrient medium and 2 μl of this dilution was added to the next culture in the series. Using this approach, the highest dilution which resulted in CPE was used and the time necessary for passaging the virus was minimized. Passaging at daily intervals ensured that the virus was always in a logarithmic phase of replication. Daily transferring also ensured that there was an adequate number of cells for virus replication. Because the mutations (which are probably cumulative) that are likely to result in attenuation only occur during replication, there is no advantage to having substantially all cells infected and replication either proceeding at a slower rate or stopping before the next transfer. Based on previous studies of PRRSV, it was known that the replication cycle is about 8 hours, therefore, transferring a minimal amount of virus from virus-infected nutrient medium to uninfected nutrient medium at daily intervals results in the virus always having plenty of cells within which to replicate. As can be readily appreciated, passaging using this method results in a savings of time that was heretofore thought impossible (i.e. each passage required less time). This is especially important when a high number of passages are required for adequate virus attenuation. If each passage, using old methods, was performed at a 3 day interval, a procedure requiring 200 passages would take 400 fewer days using the method of the present invention. EXAMPLE 2 Materials and Methods This example determined if passage 200 of PRRS Virus, JA-142, would revert in virulence when passed in the host animal six times. This study consisted of six groups. Five pigs from group 1 (principle group) were inoculated intra-nasally with PRRS MSV, JA-142 passage 200, while three pigs from group 1A, (control group) were inoculated intra-nasally with sterile diluent. The animals were provided commercial feed and water ad libitum throughout the study. Pigs of both treatment groups were monitored daily for clinical signs (appearance, respiratory, feces, etc.). After six days, the animals were weighed, bled and sacrificed. After scoring the lungs for lesions, lung lavages were collected from each animal. The lung lavages were frozen and thawed one time, and a pool was prepared using 2.0 ml of serum and 2.0 ml of lung lavage from each animal within a group to prepare Backpassage 1 and 1A, respectively. This pool was used to challenge (intra-nasally) the animals in group 2 and group 2A, respectively. This process was repeated for groups 3 and 3A through 6 and 6A. Animals in each group were housed in separate but identical conditions. Following inoculation, blood samples were collected and body temperatures were monitored. Rectal temperatures were measured for each animal periodically from −1 DPE (days post exposure) to 6 DPE and averaged together with other animal temperatures from the same group. The health status of each animal was monitored daily for the duration of the study. Results were compiled and scored on a daily observation form. The scoring parameters are as follows: 1. Appearance normal = 0; depressed = 1; excited = 2; comatose/death = 30. 2. Respiration normal = 0; sneeze = 1; cough = 1; rapid/short = 2; labored = 3. 3. Feces normal = 0; dry = 1; loose = 2; fluid = 3. 4. Eyes normal = 0; watery = 1; matted = 2; sunken = 3. 5. Nostrils normal = 0; watery discharge = 1; red/inflamed = 2; crusted ulcers = 3. 6. Mouth normal = 0; slobbers = 2; ulcer = 3. 7. Activity NA 8. Appetite normal = 0; decreased = 1; anorexic (none) = 3. 9. Other Animals were also weighed prior to inoculation and at necropsy. Average weight gains for each group were calculated for comparison. PRRS Enzyme Linked Immuno-Absorbent Assays (ELISA) and serum neutralization (SN) assays were performed following the exposures of the animals with test and control articles. Attempts to isolate PRRSV from serum samples were performed on MA-104 cells. Prior to and following vaccination, total white blood cell counts were determined using COULTER COUNTER MODEL Z 1, Coulter Corp., Miami, Fla. At necropsy, the lungs of each animal were scored. Lung scoring was done by separating the lung into 7 sections and determining the percentage of lung involvement (the percentage of the lung area affected as shown by lesions or redness for each section and multiplying by the approximate area of the whole lung) that percentage of total lung area that the section encompasses. Parameters for lung scoring are as follows: Left Apical Lobe % of involvement X 0.10 =        Left Cardiac Lobe % of involvement X 0.10 =        Left Diaphragmatic Lobe % of involvement X 0.25 =        Right Apical Lobe % of involvement X 0.10 =        Right Cardiac Lobe % of involvement X 0.10 =        Right Diaphragmatic Lobe % of involvement X 0.25 =        Intermediate Lobe of Right Lung % of involvement X 0.10 =        Total (Sum of all values in the far right column) =        Results and Discussion Each group of pigs was monitored for six days following vaccination. Clinical scores were low in all groups. Clinical score results are given in Table 1. TABLE 1 Daily Clinical Scores Treatment Pig # Day-1 Day 0 Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Average Group 1 JA-142 psg 200 545 0 0 2 0 0 0 0 0 0.25 551 0 0 0 0 0 0 0 0 0 561 0 0 0 0 0 0 0 0 0 565 0 0 0 0 0 0 0 0 0 806 0 0 0 0 0 0 0 0 0 Average 0 0 0.4 0 0 0 0 0 0.05 Saline 550 0 0 0 0 0 0 0 0 0 568 0 0 0 0 0 0 0 0 0 801 0 0 0 0 0 0 0 0 0 Average 0 0 0 0 0 0 0 0 0 Group 2 Backpassage 1 546 0 0 0 0 0 0 0 0 0 553 0 0 0 0 0 0 0 0 0 562 0 0 0 0 0 1 0 0 0.125 572 0 0 0 0 0 0 0 0 0 573 0 0 0 0 2 0 0 0 0.25 Average 0 0 0 0 0.4 0.2 0 0 0.075 Backpassage 1 556 0 0 0 0 0 0 0 0 0 566 0 0 0 0 0 0 0 0 0 802 0 0 0 0 0 0 0 0 0 Average 0 0 0 0 0 0 0 0 0 Group 3 Backpassage 2 548 0 0 0 0 0 0 0 0 0 567 0 0 0 0 0 0 0 0 0 569 0 0 0 0 1 1 0 0 0.25 574 0 0 0 0 0 0 0 0 0 804 0 0 0 0 0 0 0 0 0 Average 0 0 0 0 0.2 0.2 0 0 0.05 Backpassage 2A 547 0 0 0 0 0 0 0 0 0 5564 0 0 0 0 0 0 0 0 0 805 0 0 0 0 0 0 0 0 0 Average 0 0 0 0 0 0 0 0 0 Group 4 Backpassage 3 549 0 0 0 0 0 0 0 0 0 554 0 0 0 0 0 0 0 0 0 563 0 0 0 0 0 0 0 0 0 570 0 0 0 0 0 0 0 0 0 803 0 0 0 0 0 0 0 0 0 Average 0 0 0 0 0 0 0 0 0 Backpassage 3A 560 0 0 0 0 0 0 0 0 0 571 0 0 0 0 0 0 0 0 0 575 0 0 0 0 0 0 0 0 0 Average 0 0 0 0 0 0 0 0 0 Group 5 Backpassage 4 1 0 2 0 0 2 0 2 2 1 2 0 0 0 0 0 0 0 0 0 3 2 0 2 2 2 2 2 2 1.75 4 0 0 0 0 0 0 0 0 0 5 0 0 0 0 0 0 0 0 0 Average 0.4 0.4 0.4 0.4 0.8 0.4 0.8 0.8 0.55 Backpassage 4A 6 0 0 0 0 0 0 0 0 0 7 0 0 2 2 2 2 2 2 1.5 8 0 0 0 0 0 0 0 0 0 Average 0 0.08 0.48 0.48 0.56 0.48 0.56 0.56 0.4 Group 6 Backpassage 5 10 0 0 0 0 2 0 0 2 0.5 12 0 0 0 2 2 0 0 2 0.75 14 0 0 0 0 0 0 0 0 0 15 2 2 2 0 0 0 0 2 1 16 2 2 2 0 0 1 1 2 1.25 Average 0.8 0.8 0.8 0.4 0.8 0.2 0.2 1.6 0.7 Backpassage 5A 9 0 0 0 0 0 0 0 0 0 11 2 2 0 0 0 0 0 0 0.5 13 0 0 0 0 0 0 0 0 0 Average 0.666667 0.56 0.16 0.08 0.16 0.04 0.04 0.32 0.253333 There were no significant differences between groups for rectal temperatures or daily weight gains. All lung scores were negative. Serologically, ELISA S/P ratios and SN titers were negative throughout each group's trial period. Virus isolation was attempted on all serum samples and lung lavages. By day 6, 60-100% of the serum samples from the groups given JA-142, passage 200, and subsequent back passes were positive. The groups given saline were negative. In the first three passes, virus was recovered in the lung lavages from only 20-40% of the pigs, but by the last three passes, the virus was recovered from 50-80% of the pigs. Based on this data, JA-142 passage 200 did not revert to virulence when passed through pigs six times. EXAMPLE 3 Materials and Methods This example demonstrated that the level of attenuation of safety of MSV, JA-142, passage 200 did not change significantly during six backpassages in the host animal. Evaluation of level of attenuation or safety was performed using the pregnant sow model and monitoring the effect on reproductive performance. This model is the most sensitive test system and does not rely upon subjective factors for virulence testing. This example consisted of four groups (A, B, C & D) having seven sows per group. Group A was inoculated intra-nasally with PRRS MSV, JA-142 passage 200. Group B was inoculated intra-nasally with JA-142, passage 200, Backpassage 6. Group C was inoculated intra-nasally with sterile diluent, to act as normal controls. Group D was inoculated intra-nasally with PRRSV JA-142, passage 4. The test articles (challenge with JA-142, passage 4) were given at about 93 days gestation. Body temperatures of the sows were monitored for the first seven days following vaccination. Blood samples were collected from the sows once a week and at time of farrowing. Blood samples were collected and weights were recorded from piglets at birth, 7, and 14 days of age. The health status of each animal was monitored daily for the duration of the study up to and following farrowing for 14 days. The farrowing performance was evaluated by observing the health status of the piglets born. PRRS ELISA assays were performed following the exposures of the sows with the test article. PRRS ELISA assays were also performed on the piglet sera weekly following farrowing. Following exposure to the test article, attempts to isolate PRRSV from serum samples were performed on MA-104 cells. Rectal temperatures were measured periodically from 0 days post vaccination (DPV) to 7 DPV and the average temperature of each group was determined. Prior to and after inoculation, total white blood cell counts were determined as in Example 1. Clinical observations of the sows, as in Example 2, were made from −1 DPV through farrowing. Clinical observations of the piglets were made from farrowing until 14 days of age. Finally, at necropsy, the lungs of each piglet were scored for percent lung involvement. Results The ELISA results indicate that the animals used in this study were naive to PRRSV. Those animals that received virus inocula, groups A, B, and D, sero-converted at 14 days post treatment. Three sows of group B remained negative at 14 days post treatment. At the time of farrowing, the negative sows of group B tested positive for antibody to PRRSV. The pigs' ELISA results indicated that the majority of the piglets born to sows of group A and group B were sampled after they had nursed. Those pigs that were negative at zero days post farrowing (0 DPF) tested positive at 7 DPF. All pigs born to sows of group C tested sero-negative throughout the study. Only a few pigs were tested from group D, since the majority were either stillborn or mummies. Half of those pigs that were tested were sero-positive. This indicated that the sero-negative pigs were sampled prior to nursing or they were not capable of nursing. All piglets born to sows of group D died before 7 DPF. Isolations of PRRSV from the sows of groups A and B were sporadic. Although the results of the ELISA test indicated that these sows were successfully inoculated with the viral test articles, many remained negative for virus isolation from serum. The majority of pigs born to sows from groups A and B tested positive for virus isolation during the performance of the study. The litter born to one sow of group A never tested positive and the litter born to one sow of group B had only two of eight piglets test positive for virus isolation. No virus was recovered from the piglets born to sows from group C. Virus was recovered from the majority (71%) of piglets born from sows of group D. Post treatment rectal temperatures were unremarkable. The groups that were treated with either MSV, backpassage 6 or sterile diluent experienced no measurements exceeding 101.7° F. Group D, treated with JA-142, passage 4, had four (out of seven) sows that experienced temperatures that exceeded 102° F. with one sow reaching 103.4° F. for one of the days. The weight gain performance of the piglets born to sows of groups A (treated with MSV) and B (treated with MSV, backpassage 6) was greater than that of the pigs born to the control sows of group C. The average weight gain for the 14 day observation period was 7.9 lbs. For group A, it was 7.7 lbs; for group B and group C it was 6.9 lbs. The difference in the weight gain was not related to the size of the litter remaining at 14 days. The average litter sizes at 14 days post farrowing (DPF) were 9 for group A, 7 for group B, and 10 for group C. No pig born to the sows of group D survived beyond 3 DPF. The white blood cell (WBC) counts for the sows of groups A, B, and C remained relatively constant. The average percentages of the pre-challenge values were equal to or greater than 92% for the duration of the observation period. Three sows of group D experienced WBC counts that were lower than the expected normal range (7-20×10 6 /ml). The post inoculation clinical scores were unremarkable for the sows of groups A and B. Several sows of group C were observed to experience clinical signs over a period of several days. The majority of the clinical symptoms observed were in the category of decreased appetite, respiratory symptoms, and depression. One sow of group C died on trial day 31 of chronic bacterial pneumonia. Six of the seven sows of group D were observed to have clinical signs, primarily of varying degrees in severity, of lost appetite, ranging from decreased to anorexic. Results of the clinical scoring for the sows are given in Table 2. TABLE 2 Sow Clinical Scores Treatment Sow# −3 −2 −1 0 1 2 3 4 5 6 7 8 9 10 11 12 Group A  98 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 JA-142 MSV 133 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Passage 200 147 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 178 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 215 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 233 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 243 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Group A  98 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 JA-142 MSV 133 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Passage 200 147 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 178 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 215 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 233 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 243 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0 0.6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 Group A  98 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 JA-142 MSV 133 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Passage 200 147 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 178 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 215 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 233 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 243 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Treatment Sow# −3 −2 −1 0 1 2 3 4 5 6 7 8 9 10 11 12 Group B  49 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Backpassage6 100 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 135 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 149 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 209 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 212 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 226 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0 0 0 0 0 0 0 0 0 0 0 0 0.1 0.1 0.1 0.1 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Group B  49 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Backpassage6 100 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 135 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 149 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 0 209 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 212 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 226 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0 0 0 0 0 0 0 0.1 0.1 0 0 0 0 0 0 0 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 Group B 49 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Backpassage6 100 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 135 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 149 0 0 0 0 0 0 0 0 0 0 2 2 2 2 2 2 209 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 212 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 226 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0 0 0 0 0 0 0 0 0 0 0.3 0.3 0.3 0.3 0.3 0.3 Treatment Sow# −3 −2 −1 0 1 2 3 4 5 6 7 8 9 10 11 12 Group C  58 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Sterile 113 0 0 0 0 0 0 0 0 0 0 1 3 3 5 3 3 Diluent 117 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 144 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 156 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 166 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0 0 0 0 0 0 0 0 0 0 0.2 0.5 0.5 0.8 0.7 0.7 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Group C  58 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Sterile 113 3 3 3 3 3 3 4 4 4 4 6 6 2 4 2 2 Diluent 117 0 0 0 0 0 0 1 5 5 5 5 5 2 4 1 1 144 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 156 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 166 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0.8 0.5 0.5 0.5 0.5 0.5 0.8 1.5 1.5 1.5 1.8 1.8 0.7 1.3 0.5 0.5 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 Group C  58 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Sterile 113 2 2 30 Diluent 117 2 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 144 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 156 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 166 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0.7 0.7 6 0 0 0 0 0 0 0 0.2 0.2 0.2 0.2 0.2 0.2 Treatment Sow# −3 −2 −1 0 1 2 3 4 5 6 7 8 9 10 11 12 Group D  2 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 JA-142 106 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 Pass 4 159 0 0 0 0 0 0 0 0 0 3 1 1 1 1 1 1 190 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 206 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 232 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 234 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 Avg. 0 0 0 0 0 0 0 0 0 0.6 0.6 0.6 0.6 0.7 0.7 0.7 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Group D  2 1 1 3 3 1 0 0 0 0 0 0 0 0 0 0 0 JA-142 106 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Pass 4 159 1 1 1 1 3 4 2 3 3 3 2 0 0 2 0 0 190 1 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 206 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 232 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 234 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0.4 0.3 0.6 0.6 0.6 0.6 0.3 0.4 0.4 0.4 0.3 0 0 0.3 0 0 29 30 31 32 33 34 35 36 37 38 Group D  2 0 0 0 1 1 1 3 3 1 1 JA-142 106 0 0 0 0 0 0 0 0 0 0 Pass 4 159 0 0 0 0 0 0 0 0 0 0 190 0 0 0 0 0 0 0 0 0 0 206 0 0 0 0 0 0 0 0 0 0 232 0 0 0 0 0 0 0 0 0 0 234 0 0 0 0 0 0 0 0 0 0 Avg. 0 0 0 0.1 0.1 0.1 0.4 0.4 0.1 0.1 Clinical observations of the piglets fell into two major categories, death and reduced appetite. There were no significant differences between groups A, B and C in the area of average deaths per litter (DPL). Group A had an average of 1.3 DPL, group B had an average of 2.4 DPL, group C had an average of 2.0 DPL, and no pigs from group D survived beyond three days post farrowing. Clinical scores for the piglets are given in Table 3. TABLE 3 Treatment Sow# Pig# 1 2 3 4 5 6 7 8 9 10 11 12 13 14 GroupA 98 813 0 0 1 30 JA-142 814 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Pass 200 815 0 0 0 0 0 0 0 0 0 0 0 0 0 0 816 0 0 0 0 0 0 0 0 0 0 0 0 0 0 817 1 0 1 0 0 0 0 0 0 0 0 0 0 0 818 0 0 0 0 0 0 0 0 0 0 0 0 0 0 819 0 0 0 0 0 0 0 0 0 0 0 0 0 0 820 0 0 0 0 0 0 0 0 0 0 0 0 0 0 821 1 0 0 0 0 0 0 0 0 0 0 0 0 0 822 1 30 Avg. 0.3 3 0.2 3.3 0 0 0 0 0 0 0 0 0 0 133 720 30 721 0 1 0 0 0 0 0 0 0 0 0 0 0 0 722 0 0 0 1 0 0 0 0 0 0 0 0 0 0 723 0 0 0 0 0 0 0 0 0 0 0 0 0 0 724 0 1 0 0 0 1 0 0 0 0 0 0 0 0 725 0 0 0 0 0 0 0 0 0 0 0 0 0 0 798 0 0 0 0 0 0 0 0 0 0 0 0 0 0 799 30 800 0 0 0 0 0 0 0 0 0 0 0 0 0 0 807 0 0 0 0 0 0 0 0 0 0 0 1 0 0 809 0 0 0 0 0 0 0 0 0 0 0 0 0 0 810 0 0 0 0 0 0 0 0 0 0 0 0 0 0 812 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 4.6 0.2 0 0.1 0 0.1 0 0 0 0 0 0.1 0 0 147 823 0 0 0 0 0 0 0 0 0 0 0 0 0 0 824 0 0 0 0 0 0 0 3 1 1 1 1 1 1 825 0 0 0 0 0 0 0 0 0 0 0 0 0 0 845 0 0 0 0 0 0 0 0 0 0 0 0 0 0 846 0 0 0 0 0 0 0 0 0 0 0 0 0 0 847 0 0 0 0 0 0 0 0 0 0 0 0 0 0 848 0 0 0 0 0 0 1 0 0 0 0 0 0 0 849 0 0 0 0 0 0 0 0 0 0 0 0 0 2 850 30 976 0 0 0 0 0 0 0 0 0 0 0 0 0 0 977 0 0 0 0 1 1 3 30 978 30 Avg. 5 0 0 0 0.1 0.1 0.4 3.3 0.1 0.1 0.1 0.1 0.1 0.3 178 486 30 487 0 0 0 0 0 0 0 0 0 0 0 1 0 0 488 0 0 0 0 0 0 0 0 0 0 0 0 0 0 489 0 0 0 0 0 0 0 0 0 0 0 0 0 0 490 0 0 0 0 0 0 0 0 0 0 0 0 0 0 491 0 0 0 0 0 0 0 0 0 0 0 0 0 0 492 0 0 0 0 0 0 0 0 0 0 0 0 0 0 493 0 0 0 0 0 0 0 0 0 0 0 0 0 0 494 0 1 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 3.3 0.1 0 0 0 0 0 0 0 0 0 0.1 0 0 Group A 215 495 0 0 0 0 0 0 0 0 0 0 0 0 0 0 JA-142 496 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Pass 200 497 0 0 0 0 0 0 0 0 0 0 0 0 0 0 498 0 0 0 0 0 0 0 0 0 0 0 0 0 0 499 0 0 0 0 0 0 0 0 0 0 0 0 0 0 500 0 0 0 0 0 0 0 0 0 0 0 0 0 0 808 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 233 476 0 0 0 0 0 0 0 0 0 0 0 0 0 0 477 0 0 0 0 0 0 0 0 0 0 0 0 0 0 478 0 0 0 0 0 0 0 0 0 0 0 0 0 0 478 0 0 0 0 0 0 0 0 0 0 0 0 0 0 480 0 0 0 0 0 0 0 0 0 0 0 0 0 0 481 0 0 0 0 0 0 0 0 0 0 0 0 0 0 482 0 0 0 0 0 0 0 0 0 0 0 0 0 0 483 0 0 0 0 0 0 0 0 0 0 0 0 0 0 484 0 0 0 0 0 0 0 0 0 0 0 0 0 0 485 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 243 707 0 0 0 0 0 0 0 0 0 0 0 0 0 0 708 0 0 0 0 0 0 0 0 0 0 0 0 0 0 709 0 0 0 0 0 0 0 0 0 0 0 0 0 0 710 0 0 0 0 0 0 0 0 0 0 0 0 0 0 711 0 0 0 0 0 0 0 0 0 0 0 0 0 0 712 0 0 0 0 0 0 0 0 0 0 0 0 0 0 713 0 0 0 0 0 0 0 0 0 1 30 714 0 0 0 0 0 0 0 0 0 0 0 0 0 0 715 0 0 0 0 0 0 0 0 0 0 0 0 0 0 716 0 0 0 0 0 0 0 0 0 0 0 0 0 0 717 0 0 0 0 0 0 0 0 0 0 0 1 0 0 718 0 0 0 0 0 0 0 0 0 0 0 1 0 0 719 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0 0 0 0 0 0 0 0 0 0.1 2.3 0.2 0 0 Group B Backpassage 6  49 430 0 0 0 0 0 0 0 0 0 0 0 0 0 0 431 0 0 0 0 0 0 0 0 0 0 0 0 0 0 432 0 0 0 0 0 0 0 0 0 0 0 0 0 0 433 0 0 0 0 0 0 0 0 0 0 0 0 0 0 434 0 0 0 0 0 0 0 0 0 0 0 0 0 0 435 0 0 0 0 0 0 0 0 0 0 0 0 0 0 436 0 0 0 0 0 0 0 0 0 0 0 0 0 0 437 0 0 0 0 0 0 0 0 0 0 0 0 0 0 438 30 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 3.3 0 0 0 0 0 0 0 0 0 0 0 0 0 100 459 0 0 0 0 0 0 0 0 0 0 0 0 0 0 460 0 0 0 0 0 0 0 0 0 0 0 0 0 0 461 0 0 0 0 0 0 1 1 1 0 0 0 0 0 462 0 0 0 0 1 1 1 1 1 1 1 1 1 1 463 0 0 0 0 0 0 0 0 0 0 0 0 0 0 464 0 0 1 1 1 1 30 465 0 30 Avg. 0 4.3 0.2 0.2 0.3 0.3 5.3 0.4 0.4 0.2 0.2 0.2 0.2 0.2 135 439 0 0 0 0 0 0 0 30 440 0 0 0 0 0 0 0 0 0 0 0 0 0 0 441 0 0 0 0 0 0 0 0 0 0 0 0 0 0 442 0 0 0 1 1 1 1 1 1 1 3 3 3 30 443 0 0 0 0 0 0 0 0 0 0 0 0 0 0 444 0 0 0 0 0 0 1 1 0 0 0 0 0 0 445 0 0 0 0 0 0 0 0 0 0 0 0 0 0 446 0 0 0 0 0 0 0 0 0 0 0 0 0 0 447 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0 0 0 0.1 0.1 0.1 0.2 3.6 0.1 0.1 0.4 0.4 0.4 3.8 149 231 0 0 0 0 0 0 0 0 0 0 0 0 0 0 232 0 0 0 0 0 0 0 0 0 0 0 0 0 0 233 0 0 0 0 0 0 30 234 0 0 0 0 0 0 3 1 1 3 1 1 1 1 235 0 0 0 0 0 0 3 2 3 3 0 0 0 0 236 0 0 0 0 0 0 0 0 0 0 0 0 0 0 237 0 0 0 0 0 0 1 1 1 1 1 1 1 1 238 0 0 0 0 0 2 0 0 0 0 0 0 0 0 239 0 0 30 240 30 241 3 30 242 0 0 0 0 0 2 3 3 30 Avg. 2.8 2.7 3 0 0 0.4 4.4 0.9 4.4 1 0.3 0.3 0.3 0.3 Group B 209 448 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Backpassage 6 449 0 0 0 0 0 0 0 0 0 0 0 0 0 0 450 0 0 0 0 0 0 0 0 0 0 0 0 0 0 451 0 0 0 0 0 0 0 0 1 1 1 1 1 1 452 0 0 0 0 0 0 0 0 0 0 0 0 0 0 453 0 0 0 0 0 0 0 0 0 0 0 0 0 0 454 0 0 0 0 0 0 0 0 1 1 1 1 1 1 455 0 0 0 0 0 0 0 0 0 1 1 1 1 1 456 30 457 0 0 0 0 0 0 0 0 2 1 1 1 1 1 458 30 Avg. 5.5 0 0 0 0 0 0 0 0.4 0.4 0.4 0.4 0.4 0.4 212 243 0 0 0 0 0 0 0 0 0 0 0 0 0 0 244 0 0 0 0 0 0 0 0 0 0 0 0 0 0 245 0 0 0 0 3 1 30 246 0 0 0 0 0 0 0 0 0 0 0 0 0 0 247 0 0 0 0 0 2 2 0 0 0 0 0 0 0 248 0 0 0 0 2 0 0 0 0 0 0 0 0 0 249 0 0 0 0 0 0 2 2 0 0 2 0 0 0 250 0 0 0 3 30 426 0 0 0 0 0 0 0 0 0 0 0 0 0 0 427 0 0 0 1 3 1 1 30 428 0 0 0 1 3 3 30 429 0 0 0 0 2 3 3 3 3 3 3 1 30 Avg. 0 0 0 0.4 3.6 0.9 6.2 3.9 0.4 0.4 0.6 0.1 3.8 0 226 Not Preg. Group C Sterile  58  24 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Diluent  25 0 0 0 0 0 0 0 0 0 0 0 0 0 0  46 0 0 0 0 0 0 0 0 0 0 0 0 0 0  47 0 0 0 0 0 0 0 0 0 0 0 0 0 0  48 0 0 0 0 0 0 0 0 0 0 0 0 0 0  49 0 0 0 0 0 0 0 0 0 0 0 0 0 0  50 0 0 0 0 0 0 0 0 0 0 0 0 0 0  51 0 0 0 2 2 1 1 1 30 Avg. 0 0 0 0.3 0.3 0.1 0.1 0.1 3.8 0 0 0 0 0 113  17 30  18 30  19 30  20 30  21 0 30  22 30  23 30 Avg. 25.7 30 117  52 1 0 0 0 0 0 0 0 0 0 0 0 0 0  53 0 0 0 0 0 0 0 0 0 0 0 0 0 0  54 0 0 0 0 0 0 0 0 0 0 0 0 0 0  55 0 0 0 0 0 0 0 0 0 0 0 0 0 0  56 1 0 0 0 30  57 1 0 0 0 0 0 0 0 0 0 0 0 0 0  58 0 0 0 0 0 0 0 0 0 0 0 0 0 0  59 0 0 0 0 0 0 0 0 0 0 0 0 0 0  60 0 0 0 0 0 0 0 0 0 0 0 1 0 0  61 1 0 0 0 0 0 0 0 1 1 1 0 0 0  62 1 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0.5 0 0 0 2.7 0 0 0 0.1 0.1 0.1 0.1 0 0 144 146 0 0 0 0 0 0 0 0 0 0 0 0 0 0 147 0 0 0 0 0 0 0 0 0 0 0 0 0 0 148 0 0 0 0 0 0 0 0 0 0 0 0 0 0 149 0 0 0 0 0 0 0 0 0 0 0 0 0 0 150 0 0 0 0 0 0 0 0 1 0 1 1 1 0 221 0 0 0 0 0 2 2 0 0 0 0 0 0 0 222 0 0 0 0 0 2 2 1 1 1 1 1 0 1 223 0 0 0 0 0 0 0 0 0 0 0 0 0 0 224 0 0 0 0 0 0 0 0 0 0 0 0 0 0 225 0 0 0 0 0 0 0 0 0 0 0 0 0 0 970 0 0 0 0 0 0 0 0 0 0 0 0 0 0 971 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0 0 0 0 0 0.3 0.3 0.1 0.2 0.1 0.2 0.2 0.1 0.1 Group C 156  63 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Sterile  64 0 0 1 0 30 Diluent  65 0 0 0 0 0 0 0 1 1 1 1 1 0 0  66 0 0 0 0 1 0 0 0 0 0 0 0 0 0  67 0 0 0 0 1 0 1 1 30  68 0 0 0 0 0 0 0 0 0 0 0 0 0 0  69 0 0 0 0 0 0 0 1 0 0 0 0 0 0  70 0 0 0 0 0 0 0 0 0 0 0 0 0 0  71 0 0 0 0 0 2 2 0 0 0 0 0 1 0  72 0 0 0 0 0 0 0 0 0 0 0 0 0 0  73 0 0 0 0 0 0 0 0 0 0 0 0 0 0  74 0 0 0 0 1 0 0 0 0 0 0 0 0 0  75 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Avg. 0 0 0.1 0 2.5 0.2 0.3 0.3 2.6 0.1 0.1 0.1 0.1 0 166  76 0 0 0 0 0 0 0 0 0 0 0 0 0 0  77 0 0 0 0 0 0 0 0 0 0 0 0 0 0  78 0 0 0 0 0 0 0 0 0 0 0 0 0 0  79 0 0 0 0 0 0 0 0 0 0 0 0 0 0  80 0 0 0 0 0 0 0 0 0 0 0 0 0 0  81 1 0 0 0 0 0 0 0 0 0 0 0 0 0 141 0 0 0 0 0 0 0 0 0 0 0 0 0 0 142 0 0 0 0 0 0 0 0 0 0 0 0 0 0 143 0 0 0 0 0 0 0 0 0 0 0 0 0 0 144 0 0 0 0 0 0 0 0 0 0 0 0 0 0 145 1 30 Avg. 0.2 2.7 0 0 0 0 0 0 0 0 0 0 0 0 Group D JA-142  2 891 1 3 30 Passage 4 892 1 30 Avg. 1 16.5 30 106 Aborted NA 159 883 30 884 30 Avg. 30 190 Aborted NA 206 890 30 Avg. 30 232 888 30 889 30 Avg. 30 234 Aborted NA The farrowing performance results provided the most dramatic differences and similarities between the various treatment groups. Since the treatments would not have an effect on the size of the litters, the most appropriate way to compare the farrowing results would be by using percentage values. Group A had an average percentage of live/born of 85% (SD+/−9.6). Group B had an average percentage of live/born of 89% (SD+/−11.6). The control group (group C) had an average percentage of live/born of 83.4% (SD+/−7.9). The average percentages for stillborns for groups A, B and C were 8.8 (SD+/−9.66), 6.6 (SD+/−9.7), and 14 (SD +/−11.39), respectively. The average percentages of mummies born to sows of groups A, B, and C were 6.1 (SD+/−6.01), 3.9 (SD+/−4.45), and 2.6 (SD+/−4.01), respectively. The average percentages of live/born, stillborn and mummies born to the sows of group D were 8.7 (SD+/−8.92), 10.7 (SD+/−11.39), and 81.9 (SD+/−17.18), respectively. The results of this example demonstrated the stability of the MSV, JA-142, passage 200 after being passed in the host animal six times. There were no significant differences between the group of sows treated with the MSV (group A) and those sows that were exposed to the Backpassage 6 virus (group B) in the categories of farrowing performance, leukopenia, rectal temperatures, and the clinical observations of either the sows or the piglets. In addition, the results in these same categories for the groups A and B were comparable to those achieved by group C that had been treated with sterile diluent. Finally, the performance of the sows that had been exposed to the virulent parent virus of MSV, JA-142, passage 4, clearly illustrated the level of attenuation of the MSV and the lack of reversion to virulence by the Backpassage 6, JA-142 virus. EXAMPLE 4 Materials and Methods This example evaluated the safety and level of attenuation of administering a 10×concentration of MSV, JA-142, passage 201. The study was performed on the pregnant sow model and monitored the effect of this dosage on reproductive performance. The study consisted of three groups, A, C, and D. Group A was inoculated intra-nasally with PRRS MSV, JA-142, passage 200. Group C was inoculated intra-nasally with sterile diluent, to act as a normal control group. Group D was inoculated intra-nasally with l OX JA-142, passage 201. All inoculations were given at about 93 days gestation. Body temperatures of the sows were monitored for the first seven days following inoculation (vaccination). Blood samples were collected from the sows once a week and at time of farrowing. Prior to and following inoculation, total white blood cell counts were determined as in Example 2. The health status of each animal was monitored daily for the duration of the study up to and following farrowing for 14 days. Clinical observations of the sows were made from −1 DPV through farrowing. The farrowing performance was evaluated by observing the health status of the piglets born. PRRSV ELISA assays were preformed following the exposures of the sows with the test article. Attempts to isolate PRRSV from serum samples were performed on MA-104 cells following exposure to the test article. Clinical observations of the piglets were made from farrowing until 14 days of age. Blood samples were collected from the piglets at birth, 7 and 14 days of age. PRRSV ELISA assays were performed on the piglet sera weekly following farrowing. Piglets were also weighed at birth, day 7 post farrowing, and at necropsy. At necropsy, the lungs of each piglet were scored for percent lung involvement. Results and Discussion There were no significant differences between groups given a 10×dose of MSV, JA-142, passage 201, groups given a regular dose of MSV, JA-142, passage 200, and groups given sterile diluent. Therefore, based on the safety and attenuation of MSV, JA-142, passage 200 and the lack of any significant difference in the results comparing these groups, a 10×dose of MSV, JA-142, passage 201 was shown to be safe, attenuated and effective in inducing antibodies against PRRSV. EXAMPLE 5 Materials and Methods This example demonstrated that a minimal vaccine dose of PRRSV, JA-142, passage 205, representing MSV+5, is efficacious in an experimental respiratory challenge model in feeder pigs. Pigs were divided into three groups. Group 1 was inoculated intramuscularly with PRRS MSV, JA-142, passage 205 at a titer of 2.0 logs/dose. Group 2 was inoculated intramuscularly with sterile diluent. Group 3 acted as normal controls. Pigs from groups 1 and 2 were challenged with a PRRSV isolate with an RFLP pattern of 144 on day 28 post vaccination. Body temperatures of the pigs were monitored for the first seven days following vaccination and daily following challenge. Each animal was weighed at vaccination, challenge, weekly throughout the study, and necropsy. Blood samples were collected weekly following vaccination and every two days following challenge. The health status of each animal was monitored daily for the duration of the study. At necropsy, each animal was sacrificed and the lungs were scored for percent lung involvement as in Example 2. PRRSV ELISA assays were performed following the exposures of the pigs with the test articles and challenge. Following exposure to the test articles, attempts to isolate PRRSV from serum samples were performed on MA-104 cells. Virus isolation and ELISA results were analyzed using a Chi-square analysis which tests whether the percentage of positive animals is the same in each group. White blood cell counts were performed as in Example 2. Results and Discussion Pigs from group 1 (vaccinated pigs) fared better in all aspects of this example than did the pigs from group 2 (pigs given sterile diluent). Clinical scores, rectal temperatures, and percent lung involvement were all higher for the pigs given sterile diluent. Weight gain and white blood cell counts were lower for the pigs receiving the sterile diluent. There was also a significant reduction in viremia beginning on day 4 post-challenge in the group given vaccine. On days 10 and 11 post-challenge, the number of animals positive for viremia decreased further in the vaccinated group, but remained the same in the group receiving sterile diluent. An ELISA was used to monitor anti-PRRSV serological status prior to and following vaccination and challenge. All pigs were negative (S/P ratio <0.4) at the time of vaccination. All pigs including the vaccinates were negative at 7 DPV (Days Post Vaccination). Seven days later, 21 of 22 vaccinated pigs were tested as positive for antibody to PRRSV. Two pigs of group 1 remained negative during the pre-challenge period and serological converted at 8 days post challenge (8 DPC). All of the pigs in group 2 were negative at trial day 0 and remained negative throughout the pre-challenge period. On trial day 39 (8 DPC) 17 of the 22 non-vaccinated challenged pigs (Group 2) tested as sero positive. All of the pigs in group 3 (normal controls) remained sero-negative throughout the study. Virus isolations from sera were performed before and after vaccination. Of the 22 vaccinated pigs, 17 were positive by 2 DPV, 18 were positive by 4 DPV and 19 were positive by 7 DPV. Following vaccination, vaccine virus was not recovered at all from one pig and not until 0 DPC for another. These results correspond to the sero-negative status of these pigs during the post vaccination observation period. At the time of challenge, 55% of the vaccinated pigs were viremic positive. Following challenge, this percentage rose to 82% (at 2 DPC) and gradually decreased to 9% on 11 DPC. All pigs in group 2 were negative at 0 DPC and increased to 82% positive at 2 DPC and 91% at 4 DPC. On 6 and 10 DPC, group 2 was approximately 82% virus positive and 73% ofthis group was positive on 11 DPC. The normal controls, group 3, remained negative for the duration of the study. Rectal temperature monitoring showed an overall group increase experienced by group 2. One-half of the pigs in this group experienced a rise of 1° F. over the pre-challenge average for 2 or more days during the 11 day observation period. In comparison, only four of the 22 pigs in the vaccinated group experienced temperatures of 1° F. over their pre-challenge average. The average duration of those animals experiencing elevated temperatures for two or more days was 2.2 days for group 1 and 4 days for group 2. None of the pigs in group 3 experienced increases of 1° F. over their pre-challenge average for two days or longer. Weight gain was monitored over the 11 day observation period. Pigs in group 3 gained an average of 1.06 pounds/day, pigs in group 2 gained an average of 0.94 pounds/day and pigs in group 1 gained an average of 0.53 pounds/day. Therefore, non-vaccinated challenged pigs gained only about 57% as much weight as did vaccinated challenged pigs and only 50% as much weight as the control group. Leukopenia (white blood cell counts) were monitored during the post challenge observation period. Group 3 experienced a 5% reduction in the group average on trial day 33 (2 DPC) when compared to the pre-challenge average. For group 2, white blood cell counts dropped an average of 41% and did not return to pre-challenge levels until 11 DPC. The vaccinated group experienced a group average drop of 12% on trial day 34 (3 DPC). The counts returned to pre-challenge level on the next day and remained equal to the pre-challenge level for the duration of the observation period. Daily clinical observations were made from trial day 28 (−4 DPC) through trial day 42 (11 DPC). All pigs were free of any observable clinical signs during the pre-challenge period. Group 3 remained free of any clinical signs for the duration of the post challenge period. Five of the pigs in group 2 were observed to have post challenge clinical signs. These signs became evident at 6 DPC and were not considered to be severe. The vaccinated pigs had only 1 clinical sign observed during the 11 day post challenge observation period. At the termination of the study, lungs were evaluated for observable lung lesions. Group 3 had normal lungs and a group average score of 0.02. The individual pig scores for group 2 ranged from a low of 33 to a high of 98 for a group average of 78.33. The scores of the vaccinated group ranged from 30 to a high of 90 with a group average of 53.20. The data in this example demonstrated the efficacy of a modified live Atypical PRRS viral vaccine. The vaccine was administered at a minimal dose of 2.0 logs per dose containing the fifth passage beyond the MSV (JA-142, passage 205). Efficacy of the vaccine was demonstrated by significantly reducing the extent of lung lesions, the severity of post challenge leukopenia, and post challenge fever. Additionally, a normal growth rate was maintained in vaccinated/challenged pigs compared to that achieved by the normal control pigs and significantly better than that achieved by non-vaccinated/challenged pigs. EXAMPLE 6 Materials and Methods This example compared four groups, groups 1, 2, and 3 having twenty pigs each, and group 4 having 10 pigs. Group 1 was inoculated intramuscularly (IM) with PRRS MSV, JA-142, passage 205, at a titer of about 2,5 logs/dose. Group 2 was inoculated intra-nasally with PRRS MSV, JA-142, passage 205, at a titer of about 5.0 logs/dose. Group 3 was inoculated IM with sterile diluent. Group 4 acted as strict controls. Pigs were challenged with a PRRSV isolate from South Dakota State University (SDSU) with an RFLP pattern of 144 on day 28 post-vaccination. Body temperatures of the pigs were monitored daily following challenge. Each animal was weighed at vaccination, challenge, weekly for the duration of the study, and necropsy. Blood samples were collected weekly following vaccination and every two days following challenge. The health status of each animal was monitored daily for the duration of the study. At the termination of the study, animals were sacrificed and their lungs scored for percent lung involvement. PPRSV ELISA assays were performed following the exposures of the pigs with the test articles and challenge. Attempts to isolate PRRSV from serum samples were also performed on MA-104 cells following exposure to the test articles. WBC counts and clinical observations were determined post inoculation as in Example 2. Results and Discussion At zero days post vaccination (DPV), all pigs in this example were serologically negative to PRRSV as indicated by having a S/P ratio <0.4. At 14 DPV, 70% of the pigs in group 1 and 95% of the pigs in group 2 tested positive for the presence of anti-PRRSV antibody. Only one vaccinated pig of group 1, remained sero-negative throughout the pre-challenge period. This pig became sero-positive at seven days post challenge (DPC). All of the pigs in groups 3 and 4 remained negative throughout the pre-challenge period. At nine DPC, all of the pigs in group 3, the sterile diluent treated group, tested positive by ELISA for PRRSV antibody. The normal controls, group 4, remained negative for the duration of the study. The virus isolation results correlated well with serological results. Only one pig remained negative for virus isolation from serum and this corresponded to the sero-negative status during the post vaccination period. These results indicate a relationship between post vaccination viremia and serological conversion with vaccine dosage. Group 2 was 100% sero-positive at 14 DPV as compared to 70% for group 1. The high dose group (group 2) was 85% and 90% viremia positive at 14 and 21 DPV, respectively. In comparison, the low dose group (group 1) was 55% and 85% positive for the same test days. Following challenge, 89% of the animals in group 3 experienced temperatures that were one degree F or greater than the pre-challenge values for two or more days. In group 1, 75% of the animals experienced temperatures of one degree or greater for two or more days. While only 45% of the animals of group 2 experienced elevated temperatures. In comparison, 30% of the animals in the normal control group (group 4) experienced elevated temperatures for two or more days during the 11 day observation period. Treatment with either the high vaccine dose or the low vaccine dose appeared to have no detrimental effect on the growth performance during the post-vaccination period (−3 DPV to 28 DPV). The average daily weight gain for groups 1 and 2 was 0.77 lbs./day and 0.76 lbs./day, respectively. For comparison, groups 3 and 4 had average daily weight gains of 0.77 lbs. and 0.78 lbs., respectively. Following challenge, the vaccinated groups outperformed the sterile diluent group by 0.05 lbs./day (group 1) and 0.15 lbs./day (group 2). The normal controls outgained the vaccinates during the same time period by an average of 0.4 to 0.5 lbs./day. Eighty-four percent (16 of 19) of group 3, the sterile diluent treatment group, experienced a 25% or greater drop in their WBC count for one or more days after challenge. The normal controls had 3 of 10 (30%) that had experienced similar decreases. Following challenge, the vaccinated groups, the low dose (group1) and the high dose (group2) had 11 of 20 (55%) and 3 of 20 (15%) experiencing leukopenia of 25% for one or more days. The clinical observations made prior to the challenge indicated that the pigs were of good health status. Following challenge, the level of health status did not significantly change for those pigs that were challenged (groups 1, 2, & 3). Lethargy, respiratory signs, and lost appetite were the clinical signs observed and these were described as mild in severity. The clinical signs reported for one pig in group 2 could be attributed to the bacterial pneumonia (see discussion below on lung lesions) that it was experiencing. The normal control group (group 4) was free of any observable clinical signs during the 11 day observation period. At the termination of the study, pigs were sacrificed and the lungs were observed for PRRS-like lesions to score the extent of lung involvement. The percent of involvement was scored for each lobe then multiplied by the percent the lung represented for the total lung capacity. For example, 50% lung involvement for a diaphragmatic lobe was then multiplied by 25% to equal 12.5% of the total lung capacity. The maximum score that could be obtained was 100. The group average lung score for the normal controls (group 4) was zero. The group average score for the sterile diluent treatment group (group 3) was 70.08. The vaccinated treatment groups average scores were 48.83 for the low dose (group 1) and 17.76 for the high dose (group 2). One pig was observed to have a lung score of 62.5, the highest score within group 2. The lesions noted on this pig's lungs were described to be associated with bacterial pneumonia. From the results of this study, both dosage levels of the atypical PRRS MSV vaccine reduced the severity of the clinical signs associated with the respiratory disease caused by the PRRSV. A full field dose outperformed the minimal dose as indicated by the significant reduction in lung lesion scores. EXAMPLE 7 Materials and Methods This example determined the sequence of the attenuated MSV, JA-142 from the 201st passage as well as the sequence of passage 3 of the field isolate virus, JA-142. The attenuated virus isolate was obtained from the master seed stock representing the 201st passage in MA-104 simian cells of a PRRSV isolated from swine affected with PRRS. The virus was grown on 2621 cells, a monkey kidney cell line, also referred to as MA-104 and as USU-104 (Gravell et al., 181 Proc. Soc. Exp. Biol. Med. 112-119 (1986), Collins et al., Isolation of Swine Infertility and Respiratory Syndrome Virus (Isolate ATCC VR-2332) inNorth America and Experimental Reproduction of the Disease in Gnotobiotic Pigs, 4 J. Vet. Diagn. Invest. 117-126 (1992)) (the teachings of which are hereby incorporated by reference). Cells were cultured in 50 ml Dulbecco modified Eagle's MEM medium (Life Technologies, Inc., Gaithersburg, Md.), supplemented with 10% fetal calf serum and 50 μg/ml gentamicin (Sigma Chemical Co., St. Louis, Mo.) in a 5% humidified CO 2 atmosphere at 37° C. in 75 cm 2 plastic tissue culture flasks. Cells were maintained by passage at 5-7 day intervals. Cells were dislodged from the surface with trypsin-versene and split 1:4. To infect cells, media was decanted and 1 ml of cell supernatant containing virus at a titer of approximately 10 −5-10 6 tissue culture infective doses (TCID 50 ) was added for 30 min. Thirty ml fresh media containing 4% fetal calf serum was added. Cells were incubated as described above for 5 days, at which time cytopathic effect was evident in the culture. Culture medium containing virus was centrifuged at 2000 rpm in a Beckman TJ6 centrifuge to pellet cellular debris. Viral genomic RNA was purified by adding 1120 μl of prepared Buffer AVL (QIAamp Viral RNA Isolation Kit, Qiagen)(QIAGEN, Inc. Valencia, Calif.)/carrier RNA to a 280 μl sample of virus-containing culture medium. The mixture was vortexed and incubated at room temperature for 10 min. 1120 μl ethanol was added and the mixture was inverted several times. RNA was absorbed to the matrix of a QIAamp spin column by repeated centrifugation of 630 μl aliquots at 6,000×g for 1 min. The column was washed with 500 μl buffer AW and centrifuged to remove all traces of wash solution. RNA was eluted from the column with 60 μl of diethylpyrocarbonate-treated water at room temperature. Purified RNA was stored at −70° C. or used immediately for synthesis of cDNA. For cDNA synthesis, viral RNA was heated at 67° C. for 7 min, primed with random hexamers or PRRSV-specific primers, and reverse transcribed with Superscript II RNase H-reverse transcriptase (RT) (Life Technologies, Inc.). Reactions contained 5 mM MgCl 2 , 1×standard buffer II (Perkin Elmer Corp. Wellesley, Mass.), 1 mM each of dATP, dCTP, dGTP and dTTP, 1 unit/μl of RNase inhibitor, 2 units of RT, and 1 ×l of RNA in a 40 μl reaction. Reaction mixtures were incubated for 15 min at 42° C., for 5 min at 99° C. and for 5 min at 5° C. Polymerase chain reaction (PCR) was performed to obtained DNA fragments for sequencing as follows: 10 μl portions of cDNA reaction mixture were combined with the following reagents, resulting in a 25 μl reaction containing 2 mM MgCl 2 , 1×standard buffer II (Perkin Elmer), 0.2 mM each of dATP, dCTP, dGTP and dTTP, 0.3 μM of 5′- and 3′-PRRSV-specific primer, and 0.375 units AmpliTaq Taq polymerase (Perkin Elmer). Reactions were prepared by heating for 4 min at 93° C. in athermal cycler, then 35 cycles consisting of 50-59° C. for 30 sec, 72° C. for 30-60 sec, and 94° C. for 30 sec. Specific times and temperatures varied depending on the annealing temperatures of the primers in each reaction and the predicted length of the amplification product. A final incubation was performed for 10 min at 72° C. and reactions were placed at 4° C. PCR products were purified with a Microcon 100 kit (Amicon, Bedford, Mass.). Rapid amplification of cDNA ends (RACE) PCR was performed to obtain the extreme 5′-end sequence of the genomic RNA, based on the method of Frohman, Mass., On Beyond Classic RACE (Rapid Amplification of cDNA Ends), 4 PCR Methods and Applications S40-S58 (1994) (the teachings of which are hereby incorporated by reference). Viral RNA was isolated and converted to cDNA as described above, with random hexamers as primers. Reaction products were purified on a Microcon 100 column (Amicon). A poly(dA) tail was added to the 3′-end by incubating 10 μl of cDNA in a 20 μl volume containing 1×buffer 4 (New England Biolabs, Beverly, Mass.), 2.5 mM CoCl 2 , 0.5 mM dATP and 2 units terminal transferase (New England Biolabs), for 15 min at 37° C. The reaction was stopped by heating for 5 min at 65° C. and then was diluted to 200 μl with water. PCR was performed using the Expanda Long Template PCR System (Boehringer Mannheim, Mannheim, Germany) in a 50 μl reaction volume containing 10 μl of diluted, poly(dA)-tailed cDNA, 1×buffer 3, 0.35 mM each of dATP, dCTP, dGTP and dTTP, 0.625 mM MgCl 2 , 0.04 μM Q t primer (Frohman, 1994), 0.3 μM Q O primer (Frohman, 1994), 0.3 μM 5′-CGCCCTAATTGAATAGGTGAC-3′ and 0.75 μl of enzyme mix. Reactions were heated at 93° C. for 2 min in a thermal cycler and cycled 25 times with each cycle consisting of 93° C. for 10 sec, 63° C. for 30 sec. and 68° C. for 12 min. After 25 cycles, the reaction was incubated at 68° C. for 7 min and held at 4° C. An aliquot of the reaction was diluted 100-fold and 5 μl of diluted product was added to a second PCR reaction containing, in 50 μl, 1×buffer 1, 0.35 mM each of dATP, dCTP, dGTP and dTTP, 0.3 μM primer Qi (Frohman, 1994), 0.3 μM 5′-CCTTCGGCAGGCGGGGAGTAGTGTTTGAGGTGCTCAGC-3′, and 0.75 μl enzyme mix. Reactions were heated at 93° C. for 2 min in a thermal cycler and cycled 25 times with each cycle consisting of 93° C. for 10 sec, 63° C. for 30 sec, and 68° C. for 4 min. After 25 cycles, the reaction was incubated at 68° C. for 7 min and held at 4° C. Reaction products were electrophoresed on a 1% agarose gel and the band of approximately 1500 bp was purified using the QIAgen QXII gel purification kit. Eluted DNA was cloned into the pGEM-T vector (Promega, Madison, Wis.) using standard procedures. Individual clones were isolated and grown for isolation of plasmid DNA using QIAgen plasmid isolation kits. PCR products and plasmid DNA were combined with appropriate primers based on related PRRSV sequences in Genbank or derived from known sequences, and subjected to automated sequencing reactions with Taq DyeDeoxy terminator cycle sequencing kits (Applied Biosystems, Foster City, Calif.) and a PR 2400 Thermocycler (Perkin Elmer) at the University of Minnesota Advanced Genetic Analysis Center. Reactions were electrophoresed on an Applied Biosystems 3700 DNA sequencer. Sequence base calling and proofreading were performed primarily with the Phred program (University of Washington Genome Center) and fragment assembly was performed primarily with the Phrap program (University of Washington Genome Center). Additional computer software including the Lasergene Package (DNASTAR Inc., Madison, Wis.), Wisconsin package version 9.1 (Genetics Computer Group, Madison, Wis.), and EuGene (Molecular Biology Information Resource, Houston, Tex.) was used to analyze the sequence. The final viral genomic sequence was assembled from approximately 100 PCR reactions and 428 DNA sequencing reactions. Results The results of Example 7 are given as SEQ ID Nos. 1 and 2 wherein SEQ ID No. 1 represents the sequence of the 201st passage of the Master Seed Virus, JA 142 and SEQ ID No. 2 represents the sequence of the field-isolated virulent virus, JA 142 after three passages.                    #             SEQUENCE LISTING <160> NUMBER OF SEQ ID NOS: 2 <210> SEQ ID NO 1 <211> LENGTH: 15424 <212> TYPE: DNA <213> ORGANISM: Porcine reproductive and respiratory  #syndrome virus <400> SEQUENCE: 1 tcgcccgggc aggtgttggc tctatgcctt ggcatttgta ttgtcaggag ct #gcgaccat     60 tggcacagcc caaaactagc tgcacagaaa acgcccttct gtgacagccc tc #ttcagggg    120 agcttagggg tctgtcccta gcaccttgct tccggagttg cactgcttta cg #gtctctcc    180 aaccctttaa ccatgtctgg gatacttgat cggtgcacgt gcacccccaa tg #ccagggtg    240 tttatggcgg agggccaagt ctactgcaca cgatgtctca gtgcacggtc tc #tccttcct    300 ctgaatctcc aagttcctga gcttggagtg ctgggcctat tttacaggcc cg #aagagcca    360 ctccggtgga cgttgccacg tgcattcccc actgttgagt gctcccccgc cg #gggcctgc    420 tggctttctg cgatctttcc aattgcacga atgaccagtg gaaacctgaa ct #ttcaacaa    480 agaatggtgc gggtcgcagc tgagatttac agagccggcc agctcacccc tg #cagtcttg    540 aaggctctac aagtttatga acggggttgc cgctggtacc ctatagtcgg ac #ctgtccct    600 ggagtggccg attttgccaa ctccctacat gtgagtgata aacctttccc gg #gagcaact    660 catgtgctaa ccaacctgcc actcccagag aggcctaagc ctgaagactt tt #gcccttct    720 gagtgtgcta tggctgacgt ctatgatatt ggccatggcg ccgtcatgta tg #tggccaaa    780 gggaaagtct cctgggcccc tcgtggcggg gatgaggcga aatttgaacc tg #tccctagg    840 gagttgaagt tgatcgcgaa ccaactccac atctccttcc cgccccacca cg #cagtggac    900 atgtctaagt ttgtgttcat agcccctggg agtggtgtct ctatgcgggt cg #agtgccca    960 cacggctgtc tccccgctaa tactgtccct gaaggtaact gctggtggcg ct #tgtttgac   1020 tcgctcccac tggacgttca gaacaaagaa attcgccgtg ccaaccaatt cg #gctatcaa   1080 accaagcatg gtgtcgctgg caagtaccta caacggaggc tgcaagctaa tg #gtctccga   1140 gcagtgactg atacagatgg acccattgtc gtacagtatt tctctgttag gg #agagctgg   1200 atccgccact tcagactggc ggaagagcct agcctccctg ggtttgaaga cc #tcctcaga   1260 ataagggtag agcccaatac gtcgccattg agtgacaagg gtggaaaaat ct #tccggttt   1320 ggcagtcaca aatggtacgg tgctggaaag agagcaagga aagcacgctc tg #gtatgacc   1380 accacagtcg ctcaccgcgc cttgcccgct cgtgaaatcc agcaagccaa aa #agcacgag   1440 gatgccggcg ctgataaggc tgtgcatctc aggcactatt ctccgcctgc cg #acgggaac   1500 tgtggttggc actgcatttc cgccatcgcc aaccgaatgg tgaattccaa at #ttgaaact   1560 actcttcccg agagggtgag accttcagat gactgggcta ctgacgagga cc #ttgtgaac   1620 accatccaaa ttctcaagct ccctgcggcc ttggacagga acggtgcttg tg #ttggcgcc   1680 aaatacgtgc ttaagctgga aggcgagcat tggactgtct ctgtgaccct tg #ggatgtcc   1740 ccttctttgc tcccccttga atgtgttcag ggctgttgtg agcataagag cg #gacttggt   1800 cccccagatg cggtcgaagt tttcggattt gaccctgcct gccttgaccg ac #tggctgag   1860 gtaatgcact tgcctagcag tgtcatccca gctgctctgg ccgaaatgtc cg #gcgacccc   1920 aaccgtccgg cttccccggt cactactgtg tggactgttt cacaattctt tg #cccgccac   1980 agaggaggag agcaccctga tcaggtgcgc ttaggaaaaa tcatcagcct tt #gtcaagtt   2040 gttgaggaat gctgttgcca tcagaataaa accaaccggg ccaccccgga ag #aggttgcg   2100 gcaaggattg atcagtacct ccatggtgca acaagtcttg aagaatgctt ga #ttaggctt   2160 gagagggttt gcccgccgag cgctgcggac accttctttg attggaatgt tg #tgctccct   2220 ggggttgggg cttcaactca gacaaccaaa cagctccatg tcaaccagtg cc #gcgctctg   2280 gttcctgtcg tgactcaaga gcctttggac aaagacccag tccctctgac cg #ccttctcg   2340 ctgtccaatt gctactatcc tgcacaaggt gacgaggttc gtcaccgtga ga #ggctaaac   2400 tccgtactct ctaagctgga gggggttgtt cgtgaggaat atgggctcac gc #caactgga   2460 cctggcccgc gacccgcact accgaacggg ctcgtcgaac ttaaagacca ga #tggaggag   2520 gatctgctaa aactagtcaa cgcccaggca acttcagaaa tgatggcctg gg #cagccgag   2580 caggttgatc tgaaagcttg ggtcaaaaac tacccacggt ggacaccgtc ac #cccctcca   2640 ccaagagttc agcctcgaaa aacaaagcct gtcaagagct tgccagggaa ca #aacctgtc   2700 cccgctccac gcaggaaggt cagatctgat tgtggcagcc cgatttcgat gg #gcgacaat   2760 gttcctgacg gtcgggaaga tttgactgtt ggtggccccc ttgatctttc ga #caccatcc   2820 gagccgatga cacctctgag tgagcctgca cctatgcccg cgttgcaata ta #tttctagg   2880 ccagtgacac ctttgagtgt gctggcccca gtacctgcac cgcgtagaac tg #tgtcccga   2940 ccggtgacgc ccttgagtga gccaattttt gtgtctgcac cgcgacacaa at #ttcagcag   3000 gtggaagaag cgaatctggc ggcaacaatg ctgacgcacc aggacgaacc tc #tagatttg   3060 tctgcatcct cacagactga atatgaggct tctcccctaa caccactgca ga #acatgggt   3120 attctggagg tgggggggca agaagctgag gaagttctga gtgaaaactc gg #atacactg   3180 aatgacatca accctgcacc tgtgtcatca agcagctccc tgtcaagtgt ta #agatcaca   3240 cgcccaaaac actctgctca agccatcatt gactcgggcg ggccctgcag tg #ggcatctc   3300 cgaaagggaa aagaagcatg cctcagcatc atgcgtgagg cttgtgatgc gg #ctaagctt   3360 agtgaccctg ccacgcagga atggctttct cgcatgtggg atagggttga ta #tgctgact   3420 tggcgcaaca cgtctgctta ccaggcgttc cgcatcttag atggtaggtt tg #agtttctc   3480 ccaaagatga tactcgagac accgccgccc tacccgtgtg ggtttgtgat gc #tgcctcgc   3540 acgcctgcac cttccgtggg tgcagagagt gaccttacca ttggttcagt cg #ccactgaa   3600 gatgttccac gcatcctcgg gaaaatagaa aacgccggca agatgcccaa cc #aggggctc   3660 ttgacatcct tcggggaaga accggtgtgc gaccaacctg tcaaggactc ct #ggatgtcg   3720 tcgcgggggt ttgacgagag cacaacggct ccgtccgctg gtacaggtgg tg #ctgactta   3780 cccaccgatt tgccaccttc agatggtttg gatgcggacg agtgggggcc gt #tacggacg   3840 gtaagaaaga aagctgaaag gctcttcgac caattgagcc gtcaggtttt ta #acctcgtc   3900 tcccatctcc ctgttttctt ctcacacctc ttcaaatctg acagtggtta tt #ctccgggt   3960 gattggggtt ttgcagcttt tactttattt tgcctctttt tgtgttacag ct #acccattc   4020 tttggttttg ttcccctctt gggtgttttt tctgggtctt ctcggcgtgt gc #gcatgggg   4080 gtttttggct gttggttggc ttttgctgtt ggcctgttca agcctgtgtc cg #acccagtc   4140 ggcactgctt gtgagtttga ctcgccagag tgtaggaacg tccttcattc tt #ttgagctt   4200 ctcaaacctt gggaccctgt tcgcagcctt gttgtgggcc ccgtcggtct cg #gccttgcc   4260 attcttggca ggttactggg cggggcacgc tacatctggc attttttgct ta #ggcttggc   4320 attgttgcag attgtatctt ggctggagct tatgtgcttt ctcaaggtag gt #gtaaaaag   4380 tgctggggat cttgtgtaag aactgctcct aatgaaatcg ccttcaacgt gt #tccctttt   4440 acgcgtgcga ccaggtcgtc actcatcgac ctgtgcgatc ggttttgtgc gc #caaaaggc   4500 atggacccca ttttcctcgc tactgggtgg cgcgggtgct ggaacggccg aa #gtcccatt   4560 gagcaaccct ctgaaaaacc catcgcgttc gcccagttgg atgaaaagag ga #tcacggct   4620 agaactgtgg tcgctcagcc ttatgatcct aaccaagccg taaagtgctt gc #gggtgtta   4680 caggcgggtg gggcgatagt ggccgaggca gtcccaaaag tggtcaaggt tt #ccgctatt   4740 ccattccgag ctcccttttt tcccaccgga gtgaaggttg atcctgagtg ca #ggatcgtg   4800 gtcgaccccg acacttttac tacagctctc cggtctggtt actccaccac aa #acctcgtc   4860 cttggtgtag gggactttgc ccaactgaat ggattaaaaa tcaggcaaat tt #ccaagccc   4920 tcgggaggag gcccgcacct cattgctgcc ctgcatgttg cttgctcgat gg #cgttgcac   4980 atgcttgctg gagtttatgt aactgcagtg gggtcttgcg gtaccggcac ca #acgatccg   5040 tggtgcacta acccattcgc cgtccctggc tacggacctg gctccctctg ca #cgtccaga   5100 ttgtgcatct cccaacatgg ccttaccctg cccttgacag cacttgtggc ag #gattcggt   5160 cttcaggaaa ttgccctagt cgttttgatt ttcgtttcca tcggaggcat gg #ctcatagg   5220 ttgagttgta aggctgatat gctgtgcgtc ttacttgcaa tcgccagcta tg #tttgggta   5280 ccccttacct ggttgctctg tgtgtttcct tgctggttgc gctggttctc tt #tgcaccct   5340 ctcaccattc tatggttggt gtttttcttg atgtctgtaa atatgccttc gg #gaatctta   5400 accgtggtgt tattggttgc tctttggctt ctaggccgtt atactaatgt tg #ttggtctt   5460 gttaccccct atgatattca ccattacacc aatggccccc gcggtgttgc cg #ccttggct   5520 accgcaccag atgggactta cttggccgct gtccgccgcg ctgcgttgac tg #gccgcacc   5580 gtgctgttta ccccgtctca gcttgggtcc cttcttgagg gcgctttcag aa #ctcgaaag   5640 ccctcactga acaccgtcaa tgtggtcggg tcctccatgg gctctggcgg ag #tgttcact   5700 atcgatggga aaattaagtg cgtgactgcc gcacatgtcc ttacgggtaa tt #cagccagg   5760 gtttccgggg tcggctttaa tcaaatgctt gactttgatg taaaagggga ct #tcgccata   5820 gctgactgcc cgaattggca aggggctgct cctaagaccc aattctgcga gg #atggatgg   5880 actggccgcg cctattggct gacatcctct ggcgtcgaac ccggtgtcat tg #ggaatgga   5940 ttcgccttct gcttcaccgc gtgcggcgat tccgggtccc cagtgatcac cg #aagccggt   6000 gagcttgtcg gcgttcacac aggatcaaac aaacaaggag gaggcattgt ta #cgcgcccc   6060 tctggccagt tttgcaatgt ggcacccatc aagctgagcg aattaagtga gt #tctttgct   6120 ggacctaagg tcccgctcgg tgatgtgaag gttggcagcc acataattaa ag #acatatgc   6180 gaggtacctt cagatctttg cgccttgctt gctgccaaac ccgaactgga ag #gaggcctc   6240 tccaccgtcc aacttctgtg tgtgtttttc ctcctgtgga gaatgatggg ac #atgcctgg   6300 acgcccttgg ttgctgttgg gttttttatc ttgaatgagg ttctcccagc tg #tactggtc   6360 cggagtgttt tctcctttgg aatgtttgtg ctatcttggc tcacaccatg gt #ctgcgcaa   6420 gttctgatga tcaggcttct aacagcagct cttaacagga acagattgtc ac #tcgccttt   6480 tacagccttg gtgcagcgac cggttttgtc gcagatctgg cggcaactca ag #ggcacccg   6540 ttgcaggcag taatgaattt aagtacctat gccttcctgc ctcggataat gg #tcgtgacc   6600 tcaccagtcc cagtgattgc gtgtggtgtt gtgcacctcc ttgccataat tt #tgtacttg   6660 tttaagtacc gctgcctgca caatgtcctt gttggcgatg gtgcgttctc tg #cggctttc   6720 ttcttgcgat actttgccga ggggaaattg agggaagggg tgtcgcaatc ct #gcgggatg   6780 aatcatgagt cgctgactgg tgccctcgct atgagactta atgacgagga ct #tggatttt   6840 cttacgaaat ggactgattt taagtgtttt gtttctgcat ccaacatgag ga #atgcggcg   6900 ggccagttca tcgaggctgc ctatgctaaa gcacttagaa ttgaacttgc cc #agttggtg   6960 caggttgata aggttcgagg tactttggcc aaacttgaag cttttgctga ta #ccgtggca   7020 ccccaactct cgcccggtga cattgttgtt gctcttggcc atacgcctgt tg #gcggtatc   7080 ttcgacctaa aggttggtag caccaagcat accctccaag ccattgagac ca #gagttctt   7140 gccgggtcca aaatgaccgt ggcgcgtgtc gttgatccaa cccccacacc cc #cacccgca   7200 cccgtgccta tcccccttcc accgaaagtt ctggagaatg gtcccaacgc ct #ggggggat   7260 gaggatcgtt tgaataagaa gaagaggcgc aagatggaag ccgtcggcat ct #ttgttatg   7320 ggtggaaaga aatatcagaa attttgggac aagaactccg gtgatgtgtt tt #atgaggag   7380 gtccatgata acacagacgc gtgggagtgc ctcagagttg acaaccctgc cg #actttgac   7440 cctgagaagg gaactctgtg cgggcatact accattgaag ataagactta ca #gtgtctac   7500 gcctccccat ctggcaagaa attcctggtc cccgcctacc cagagagcaa aa #aaaaccaa   7560 tgggaagctg cgaagctttc cgtggaacag gcccttggca tgatgaatgt cg #acggtgaa   7620 ctgacagcca aagaagtgga gaaactgaaa agaataattg acaaactcca gg #gcctgact   7680 aaggagcagt gtttaaactg ctagccgcca gcggcttgac ccgctgtggt cg #cggcggct   7740 tggttattac tgagacagcg gtaaaaatag tcaaatttca caaccggacc tt #caccctag   7800 gacctgtgaa tttaaaagtg gccagtgagg ttgagctaaa agacgcggtc ga #gcataacc   7860 aacacccggt tgcaagaccg gttgatggtg gtgttgtgct cctgcgctcc gc #agttcctt   7920 cgcttataga cgtcttaatc tccggcgctg atgcatctcc caagttactc gc #ccgccacg   7980 ggccgggaaa cactgggatc gatggcacgc tttgggattt tgaggccgag gc #cactaaag   8040 aggaaattgc actcagtgcg caaataatac aggcttgtga cattaggcgc gg #cgacgcac   8100 ctgaaattgg tcttccttat aagctgtacc ctgtcagggg caaccctgag cg #ggtaaaag   8160 gagttttaca gaatacaagg tttggagata taccttataa aacccccagt ga #cactggaa   8220 gcccagtgca cgcggctgcc tgcctcacgc ccaatgccac tccggtgact ga #tgggcgct   8280 ccgtcttggc cacgactatg ccctccggtt ttgagttgta tgtaccgacc at #tccagcgt   8340 ctgtccttga ttatcttgat tctaggcctg actgccccaa acagttgaca ga #gcacggct   8400 gtgaggacgc cgcattaaga gacctctcca agtatgactt gtccacccaa gg #ctttgttt   8460 tacctggagt tcttcgcctt gtgcgtaagt acctgtttgc tcatgtgggt aa #gtgcccgc   8520 ccgttcatcg gccttccact taccctgcca agaattctat ggctggaata aa #tgggaaca   8580 ggtttccaac caaggacatc cagagcgtcc ctgaaatcga cgttctgtgc gc #acaggccg   8640 ttcgggaaaa ctggcaaact gttacccctt gtaccctcaa gaaacagtat tg #tgggaaga   8700 agaagactag gacaatactc ggcaccaata acttcattgc gctggctcac cg #ggcagcgt   8760 tgagtggtgt cacccagggc ttcatgaaaa aggcgtttaa ctcgcccatt gc #cctcggta   8820 aaaacaaatt taaagagctt cagactccgg tcttaggcag gtgccttgaa gc #tgatcttg   8880 catcctgcga tcgctccaca cctgcaattg tccgctggtt tgccgccaat ct #tctttatg   8940 aacttgcctg tgctgaagag caccagccgt cgtacgtgtt gaactgctgc ca #cgacctac   9000 tggtcacgca gtccggcgca gtaactaaga gaggtggcct gtcgtctggc ga #cccgatca   9060 cttctgtgtc caacaccatt tacagcttgg tgatatatgc acaacacatg gt #gctcagtt   9120 actttaaaag tggtcaccct catggccttc tgtttctaca agaccagctg aa #gtttgagg   9180 acatgctcaa ggttcaaccc ctgatcgtct attcggacga cctcgtactg ta #tgccgagt   9240 ctcccaccat gccaaactac cactggtggg ttgaacatct gaacctgatg ct #gggttttc   9300 agacggaccc aaagaagaca gccataacag actcgccatc atttctaggc tg #taggataa   9360 taaatggacg ccagctcgtc cctaaccgtg acaggattct cgcggccctc gc #ctaccata   9420 tgaaggcaag caatgtctct gaatactacg cctcggcggc tgcgatactc at #ggacagct   9480 gtgcttgttt agagtatgat cccgaatggt ttgaagagct tgtagttggg at #agcgcagt   9540 gtgcccgcaa ggacggctac agttttcccg gcccgccgtt cttcttgtcc at #gtgggaaa   9600 aactcagatc caatcatgag gggaagaagt ccagaatgtg cgggtactgc gg #ggccccgg   9660 ctccgtacgc cactgcctgt ggcctcgacg tctgtattta ccacacccac tt #ccaccagc   9720 attgtccagt catcatctgg tgtggccacc cggctggttc tggttcttgt ag #tgagtgca   9780 aaccccccct agggaaaggc acaagccctc tagatgaggt gttagaacaa gt #cccgtata   9840 agcctccacg gactgtaatc atgcatgtgg agcagggtct cacccctctt ga #cccaggca   9900 gataccagac tcgccgcgga ttagtctccg ttaggcgtgg cattagagga aa #tgaggttg   9960 atctaccaga cggtgattat gctagcaccg ccctactccc tacttgtaaa ga #gattaaca  10020 tggtcgctgt cgcctctaat gtgttgcgca gcaggttcat catcggcccg cc #tggtgctg  10080 ggaaaacata ctggctcctt caacaggtcc aggatggtga tgccatttac ac #gccaactc  10140 accagaccat gctcgatatg attagggctt tggggacgtg ccggttcaac gt #cccagcag  10200 gtacgacgct gcaattccct gccccctccc gtaccggccc ttgggttcgc at #cctagccg  10260 gcggttggtg tcctggcaag aattccttcc tggatgaagc agcgtattgt aa #tcaccttg  10320 atgtcttgag gcttcttagc aaaactaccc tcacctgtct gggagatttc aa #acaactcc  10380 acccagtggg ttttgattct cattgctatg tttttgacat catgcctcag ac #tcaactga  10440 agaccatctg gagatttgga cagaatatct gtgaggccat tcagccagat ta #cagggaca  10500 aacttgtatc catggtcaac acaacccgtg taacctacgt ggaaaaacct gt #caagtatg  10560 ggcaagtcct caccccttac cacagggacc gagaggacgg cgccatcaca at #tgactcca  10620 gtcaaggcgc cacatttgat gtggttacac tgcatttgcc cactaaagat tc #actcaaca  10680 ggcaaagagc ccttgttgct attaccaggg caagacatgc tgtctttgtg ta #tgacccac  10740 acaggcaact gcagagcatg tttgatcttc ctgcgaaagg cacacccgtc aa #cctcgctg  10800 tgcaccgtga cgagcagctg atcgtgctag atagaaataa caaagaatgc ac #ggttgctc  10860 aggctctagg caatggggat aaattcaggg ccacagacaa gcgcgttgta ga #ttctctcc  10920 gcgccatttg tgcagatctg gaagggtcga gctccccgct ccccaaggtc gc #acacaact  10980 tgggatttta tttctcgcct gatttgacac agtttgctaa actcccggta ga #acttgcac  11040 cccactggcc cgtggtgaca acccagaaca atgaaaagtg gccagaccgg tt #ggttgcta  11100 gccttcgccc cgtccataag tatagccgcg cgtgcatcgg tgccggctac at #ggtgggcc  11160 cctcagtgtt tctgggcacc cctggggttg tgtcatacta tctcacaaaa tt #tgtcaggg  11220 gcgaggctca aatgcttccg gagacagtct tcagcaccgg ccgaattgag gt #agattgcc  11280 gtgagtatct cgatgaccgg gagcgagaaa ttgctgagtc cctcccccat gc #tttcattg  11340 gcgacgtcaa aggcactacc gttggaggat gtcaccatgt cacctccaaa ta #ccttccgc  11400 gcttccttcc caaggaatca gtcgcggtag tcggggtttc aagccccggg aa #agccgcaa  11460 aagcagtttg cacattaaca gatgtgtatc tcccagatct cgaagcttac ct #ccacccag  11520 agacccagtc caagtgctgg aaaatgatgt tggacttcaa ggaagttcga ct #gatggtct  11580 ggaaggacaa gacggcctat tttcaacttg aaggccgcca tttcacctgg ta #ccagcttg  11640 caagctatgc ctcgtacatc cgagttcctg ttaactctac ggtgtatttg ga #cccctgca  11700 tgggccctgc cctttgcaac agaagagttg tcgggtccac tcattgggga gc #tgacctcg  11760 cagtcacccc ttatgattac ggtgccaaaa tcatcctgtc tagtgcatac ca #tggtgaaa  11820 tgccccctgg gtacaaaatc ctggcgtgcg cggagttctc gcttgacgat cc #agtgaggt  11880 acaaacacac ctgggggttt gaatcggata cagcgtatct gtacgagttc ac #cggaaacg  11940 gtgaggactg ggaggattac aatgatgcgt ttcgtgcgcg ccagaaaggg aa #aatttata  12000 aggccactgc caccagcatg aggtttcatt ttcccccggg ccctgtcatt ga #accaactt  12060 taggcctgaa ttgaaatgaa atggggtcca tgcaaagcct ctttgacaaa at #tggccaac  12120 ttttcgtgga tgctttcacg gaatttttgg tgtccattgt tgatatcatc at #atttttgg  12180 ccattttgtt tggctttacc atcgctggct ggctggtggt cttctgcatc cg #attggttt  12240 gctccgcggt actccgtgcg cgccctacca ttcaccctga gcaattacag aa #gatcctat  12300 gaggcctttc tttctcagtg ccaggtggat attcccacct ggggaactag ac #atcccctg  12360 gggatgcttt ggcaccataa ggtgtcaacc ctgattgatg aaatggtgtc gc #gtcggatg  12420 taccgcacca tggaaaaagc aggacaggct gcctggaaac aggtggtgag cg #aggccacg  12480 ctgtctcgca ttagtggttt ggatgtggtg gctcattttc agcatcttgc cg #ccattgaa  12540 gccgagacct gtaaatattt ggcctctcgg ctgcccatgc tacacaatct gc #gcatgaca  12600 gggtcaaatg taaccatagt gtataatagt actttgaatc aggtgtttgc ta #tttttcca  12660 acccctggat cccggccaaa gcttcatgat tttcagcaat ggctaatagc tg #tgcactcc  12720 tccatatttt cctccgttgc ggcttcttgt actctttttg ttgtgctgtg gt #tgcggatt  12780 ccaatgctac gtactgtttt tggtttccgc tggttagggg caatttttcc tt #cgaactca  12840 cggtgaatta cacggtgtgt ccgccttgcc tcacccggca agcagccgct ga #ggtctacg  12900 aaccaggcag gtctctttgg tgcaggatag ggcatgaccg atgtagtgag ga #agaccatg  12960 acgatctagg gttcatggtt ccgtctggcc tctccagcga aggccacttg ac #cagtgttt  13020 acgcctggtt ggcgttcctg tccttcagct acacggccca gttccatccc ga #gatatttg  13080 ggatagggaa tgtgagtcaa gtttatgttg acatcaagca ccaattcatc tg #cgccgttc  13140 acgacgggga gaacgccacc ttgcctcgtc atgacaatat ttcagccgta ta #tcagacct  13200 actaccaaca tcaagtcgac ggcggcaatt ggtttcacct agaatggctg cg #ccccttct  13260 tttcctcttg gttggtttta aatgtttctt ggtttctcag gcgttcgcct gc #aagccatg  13320 tttcagttca agtctttcgg acatcaaaac caacacaacc gcagcatcag gc #tttgttgt  13380 cctccaggac atcagctgcc ttaggcatgg cgactcgtcc tctcagacga tt #cgcaaaag  13440 ctctcagtgc cgcgcggcga tagggacgcc cgtgtacatc actgtcacag cc #aatgtcac  13500 agatgagaat tatttacatt cttctgatct ccttatgctt tcttcttgcc tt #ttctatgc  13560 ttctgagatg agtgaaaagg gattcaaggt gatgtttggc aatgtgtcag gc #atcgtggc  13620 tgtgtgtgtc aactttacca gctacgtcca acatgtcaag gagtttaccc aa #cgctcctt  13680 ggtggtcgat catgtgcggc tgctccattt catgacacct gagaccatga gg #tgggcaac  13740 cgttttagcc tgttttcttg ccatcttact ggcaatttga atgttcaagt at #gttgggga  13800 gatgcttgac cgcgggctgt tgctcgcgat tgctttcttt gtggtgtatc gt #gccatttt  13860 gttttgctgc gctcgtcaac gccaacagca acagcagctc tcatcttcag tt #aatttaca  13920 acttgacgct atgtgagctg aatggcacag attggctgaa agacaaattt ga #ttgggcat  13980 tggagacttt tgtcatcttt cccgtgttga ctcacattgt ctcatatagt gc #actcacca  14040 ctagccattt ccttgacaca gtcggtctgg ttactgtgtc tactgccggg tt #ctaccacg  14100 ggcggtatgt tctgagtagc atctacgcgg tctgcgctct ggccgcattg ac #ttgcttcg  14160 tcattaggct tgcgaagaac tgcatgtcct ggcgctactc ttgtaccaga ta #tactaact  14220 tccttctgga cactaagggc agactctatc gctggcggtc gcccgttatc at #agagaaag  14280 ggggtaaggt tgaggtcgaa ggtcacctga tcgacctcaa aagagttgtg ct #tgatggtt  14340 ccgtggcaac ccctttaacc agagtttcag cggaacaatg gggtcgtctt ta #gacgactt  14400 ttgctatgat agcacggctc cacaaaaggt gcttttggcg ttttccatta cc #tacacgcc  14460 agtgatgata tatgctctaa aggtaagtcg cggccgactt ttagggcttc tg #cacctttt  14520 gatctttctg aattgtactt ttaccttcgg gtacatgaca tgcgtgcact tt #aatagcac  14580 aaataaggtc gcgctcacta tgggagcagt agttgcactt ctttgggggg tg #tactcagc  14640 catagaaacc tggaagttca tcacctccag atgtcgtttg tgcttgctag gc #cgcaagta  14700 cattctggcc cccgcccacc acgtcgaaag tgccgcgggc tttcatccga tc #gcggcaaa  14760 tgataaccac gcatttgtcg tccggcgtcc cggctccact acggttaacg gc #acattggt  14820 gcccgggttg aaaagcctcg tgttgggtgg cagaaaagct gttaaacagg ga #gtggtaaa  14880 ccttgtcaaa tatgccaaat aacaacggca agcagcaaaa gaaaaagagg gg #gaatggcc  14940 agccagtcaa tcagctgtgc cagatgctgg gtaagatcat cgcccagcaa aa #ccagtcca  15000 gaggcaaggg accggggaag aaaattaaga ataaaaaccc ggagaagccc ca #ttttcctc  15060 tagcgactga agatgacgtc aggcatcact tcacccctag tgagcggcaa tt #gtgtctgt  15120 cgtcgatcca gactgccttt aaccagggcg ctggaacctg taccctatca ga #ttcaggta  15180 ggataagtta cactgtggag tttagtttgc cgacgcatca tactgtgcgc ct #gatccgcg  15240 tcacagcgcc atcatcagcg taatgggctg gcattcctta agcacctcag tg #ttagaatt  15300 ggaagaatgt gtggtgaatg gcactgattg gcactgtgcc tctaagtcac ct #attcaatt  15360 agggcgaccg tgtgggggtt aagtttaatt ggcgagaacc atgcggccga aa #ttaaaaaa  15420 aaaa                  #                   #                   #          15424 <210> SEQ ID NO 2 <211> LENGTH: 15424 <212> TYPE: DNA <213> ORGANISM: Porcine reproductive and respiratory  #syndrome virus <400> SEQUENCE: 2 tcgcccgggc aggtgttggc tctatgcctt ggcatttgta ttgtcaggag ct #gcgaccat     60 tggtacagcc caaaactagc tgcacagaaa acgcccttct gtgacagccc tc #ttcagggg    120 agcttagggg tctgtcccta gcaccttgct tccggagttg cactgcttta cg #gtctctcc    180 aaccctttaa ccatgtctgg gatacttgat cggtgcacgt gcacccccaa tg #ccagggtg    240 tttatggcgg agggccaagt ctactgcaca cgatgtctca gtgcacggtc tc #tccttcct    300 ctgaatctcc aagttcctga gcttggagtg ctgggcctat tttacaggcc cg #aagagcca    360 ctccggtgga cgttgccacg tgcattcccc actgttgagt gctcccccgc cg #gggcctgc    420 tggctttctg cgatctttcc aattgcacga atgaccagtg gaaacctgaa ct #ttcaacaa    480 agaatggtgc gggtcgcagc tgagatttac agagccggcc agctcacccc tg #cagtcttg    540 aaggctctac aagtttatga acggggttgc cgctggtacc ctatagtcgg ac #ctgtccct    600 ggagtggccg tttttgccaa ctccctacat gtgagtgata aacctttccc gg #gagcaact    660 catgtgctaa ccaacctgcc actcccgcag aggcctaagc ctgaagactt tt #gccctttt    720 gagtgtgcta tggctgacgt ctatgatatt ggtcatggcg ccgtcatgta tg #tggccaaa    780 gggaaagtct cctgggcccc tcgtggcggg gatgaggcga aatttgaaac tg #tccctagg    840 gagttgaagt tgatcgcgaa ccaactccac atctccttcc cgccccacca cg #cagtggac    900 atgtctaagt ttgtgttcat agcccctggg agtggtgtct ctatgcgggt cg #agtgccca    960 cacggctgtc tccccgctaa tactgtccct gaaggtaact gctggtggcg ct #tgtttgac   1020 tcgctcccac tggacgttca gaacaaagaa attcgccgtg ccaaccaatt cg #gctatcaa   1080 accaagcatg gtgtcgctgg caagtaccta caacggaggc tgcaagctaa tg #gtctccga   1140 gcagtgactg atacagatgg acccattgtc gtacagtatt tctctgttag gg #agagctgg   1200 atccgccact tcagactggc ggaagagcct agcctccctg ggtttgaaga cc #tcctcaga   1260 ataagggtag agcccaatac gtcgccattg agtgacaagg gtggaaaaat ct #tccggttt   1320 ggcagtcaca aatggtacgg tgctggaaag agagcaagga aagcacgctc tg #gtatgacc   1380 accacagtcg ctcaccgcgc cttgcccgct cgtgaaatcc agcaagccaa aa #agcacgag   1440 gatgccggcg ctgataaggc tgtgcatctc aggcactatt ctccgcctgc cg #acgggaac   1500 tgtggttggc actgcatttc cgccatcgcc aaccgaatgg tgaattccaa at #ttgaaact   1560 actcttcccg agagggtgag accttcagat gactgggcta ctgacgagga cc #ttgtgaac   1620 accatccaaa ttctcaagct ccctgcggcc ttggacagga acggtgcttg tg #ttggcgcc   1680 aaatacgtgc ttaagctgga aggcgagcat tggactgtct ctgtgaccct tg #ggatgtcc   1740 ccttctttgc tcccccttga atgtgttcag ggctgttgtg agcataagag cg #gacttggt   1800 cccccagatg cggtcgaagt tttcggattt gaccctgcct gccttgaccg ac #tggctgag   1860 gtaatgcact tgcctagcag tgtcatccca gctgctctgg ccgaaatgtc cg #gcgacccc   1920 aactgtccgg cttccccggt cactactgtg tggactgttt cacaattctt tg #cccgccac   1980 agaggaggag agcaccctga tcaggtgcgc ttaggaaaaa tcatcagcct tt #gtcaagtt   2040 gttgaggaat gctgttgcca tcagaataaa accaaccggg ccaccccgga ag #aggttgcg   2100 gcaaggattg atcagtacct ccatggtgca acaagtcttg aagaatgctt ga #ttaggctt   2160 gagagggttt gcccgccgag cgctgcggac accttctttg attggaatgt tg #tgctccct   2220 ggggttgggg cttcaactca gacaaccaaa cagctccatg tcaaccagtg cc #gcgctctg   2280 gttcctgtcg tgactcaaga gcctttggac aaagactcag tccctctgac cg #ccttctcg   2340 ctgtccaatt gctactatcc tgcacaaggt gacgaggttc gtcaccgtga ga #ggctaaac   2400 tccgtactct ctaagctgga gggggttgtt cgtgaggaat atgggctcac gc #caactgaa   2460 cctggcccgc gacccgcact accgaacggg ctcgtcgaac ttaaagacca ga #tggaggag   2520 gatctgctga aactagtcaa cgcccaggca acttcagaaa tgatggcctg gg #cagccgag   2580 caggttgatc tgaaagcttg ggtcaaaaac tacccacggt ggacaccgcc ac #cccctcca   2640 ccaagagttc agcctcgaaa aacaaagtct gtcaagagct tgccagggaa ca #aacctgtc   2700 cccgctccac gcaggaaggt cagatctgat tgtggcagcc cgattttgat gg #gcgacaat   2760 gttcctgacg gtcgggaaga tttgactgtt ggtggccccc ttgatctttc ga #caccatcc   2820 gagccgatga cacctctgag tgagcctgca cttatgcccg cgttgcaata ta #tttctagg   2880 ccagtgacat ctttgagtgt gctggcccca gttcctgcac cgcgtagaac tg #tgtcccga   2940 ccggtgacgc ccttgagtga gccaattttt gtgtctgcac cgcgacacaa at #ttcagcag   3000 gtggaagaag cgaatctggc ggcaacaacg ctgacgcacc aggacgaacc tc #tagatttg   3060 tctgcatcct cacagactga atatgaggct tctcccctaa caccactgca ga #acatgggt   3120 attctggagg tgggggggca agaagctgag gaagttctga gtgaaatctc gg #atacactg   3180 aatgacatca accctgcacc tgtgtcatca agcagctccc tgtcaagtgt ta #agatcaca   3240 cgcccaaaac actctgctca agccatcatt gactcgggcg ggccctgcag tg #ggcatctc   3300 cgaagggaaa aagaagcatg cctcagcatc atgcgtgagg cttgtgatgc gg #ctaagctt   3360 agtgaccctg ccacgcagga atggctttct cgcatgtggg atagggttga ca #tgctgact   3420 tggcgcaaca cgtctgctta ccaggcgttc cgcatcttag atggtaggtt tg #agtttctc   3480 ccaaagatga tactcgagac accgccgccc tacccgtgtg ggtttgtgat gc #tgcctcac   3540 acgcctgcac cttccgtggg tgcagagagt gaccttacca ttggttcagt cg #ccactgaa   3600 gatgttccac gcatcctcgg gaaaatagaa aacgccggcg agatgcccaa cc #aggggctc   3660 ttgacatcct tcggggaaga accggtgtgc gaccaacctg tcaaggactc ct #ggatgtcg   3720 tcgcgggggt ttgacgagag cacaacggct ccgtccgctg gtacaggtgg tg #ctgactta   3780 cccaccgatt tgccaccttc agatggtttg gatgcggacg agtgggggcc gt #tacggacg   3840 gtaagaaaga aagctgaaag gctcttcgac caattgagcc gtcaggtttt ta #acctcgtc   3900 tcccatctcc ctgttttctt ctcacacctc ttcaaatctg acagtggtta tt #ctccgggt   3960 gattggggtt ttgcagcttt tactttattt tgcctctttt tgtgttacag ct #acccattc   4020 tttggttttg ttcccctctt gggtgttttt tctgggtctt ctcggcgtgt gc #gcatgggg   4080 gtttttggct gttggttggc ttttgctgtt ggcctgttca agcctgtgtc cg #acccagtc   4140 ggcactgctt gtgagtttga ctcgccagag tgtaggaacg tccttcattc tt #ttgagctt   4200 ctcaaacctt gggaccctgt tcgcagcctt gttgtgggcc ccgtcggtct cg #gccttgcc   4260 attcttggca ggttactggg cggggcacgc tacatctggc attttttgct ta #ggcttggc   4320 attgttgcag attgtatctt ggctggagct tatgtgcttt ctcaaggtag gt #gtaaaaag   4380 tgctggggat cttgtgtaag aactgctcct aatgaaatcg ccttcaacgt gt #tccctttt   4440 acgcgtgcga ccaggtcgtc actcatcgac ctgtgcgatc ggttttgtgc gc #caaaaggc   4500 atggacccca ttttcctcgc tactgggtgg cgcgggtgct ggaccggccg aa #gtcccatt   4560 gagcaaccct ctgaaaaacc catcgcgttc gcccagttgg atgaaaagag ga #ttacggct   4620 agaactgtgg gcgctcagcc ttatgatcct aaccaagccg taaagtgctt gc #gggtgtta   4680 caggcgggtg gggcgatagt ggccgaggca gtcccaaaag tggtcaaggt tt #ccgctatt   4740 ccattccgag ctcccttttt tcccaccgga gtgaaggttg atcctgagtg ca #ggatcgtg   4800 gtcgaccccg acacttttac tacagctctc cggtctggtt actccaccac aa #acctcgtc   4860 cttggtgtgg gggactttgc ccaactgaat ggattaaaaa tcaggcaaat tt #ccaagccc   4920 tcgggaggag gcccgcacct cattgctgcc ctgcatgttg cttgctcgat gg #cgttgcac   4980 atgcttgctg gagtttatgt aactgcagtg gggtcttgcg gtaccggcac ca #acgatccg   5040 tggtgcacta acccattcgc cgtccctggc tacggacctg gctccctctg ca #cgtccaga   5100 ttgtgcatct cccaacatgg ccttaccctg cccttgacag cacttgtggc ag #gattcggt   5160 cttcaggaaa ttgccctagt cgttttgatt ttcgtttcca tcggaggcat gg #ctcatagg   5220 ttgagttgta aggctgatat gctgtgcgtc ttacttgcaa tcgccagcta tg #tttgggta   5280 ccccttacct ggttgctctg tgtgtttcct tgctggttgc gctggttctc tt #tgcaccct   5340 ctcaccattc tatggttggt gtttttcttg atgtctgtaa atatgccttc gg #gaatctta   5400 accgtggtgt tattggttgc tctttggctt ctaggccgtt atactaatgt tg #ttggtctt   5460 gttaccccct atgatattca tcattacacc aatggccccc gcggtgttgc cg #ccttggct   5520 accgcaccag atgggactta cttggccgct gtccgccgcg ctgcgttgac tg #gccgcacc   5580 gtgctgttta ccccgtctca gcttgggtcc cttcttgagg gcgctttcag aa #ctcgaaag   5640 ccctcactga acaccgtcaa tgtggtcggg tcctccatgg gctctggcgg ag #tgttcact   5700 atcgatggga aaattaagtg cgtgactgcc gcacatgtcc ttacgggtaa tt #cagccagg   5760 gtttccgggg tcggcttcaa tcaaatgctt gactttgatg taaaagggga ct #tcgccata   5820 gctgattgcc cgaattggca aggggctgct cctaagaccc aattctgcga gg #atggatgg   5880 actggccgcg cctattggct gacatcctct ggcgtcgaac ccggtgtcat tg #ggaatgga   5940 ttcgccttct gcttcaccgc gtgcggcgat tccgggtccc cagtgatcac cg #aagccggt   6000 gagcttgtcg gcgttcacac aggatcaaac aaacaaggag gaggcattgt ta #cgcgcccc   6060 tctggccagt tttgcaatgt ggcacccatc aagctgagcg aattaagtga gt #tctttgct   6120 ggacctaagg tcccgctcgg tgatgtgaag gttggcagcc acataattaa ag #acatatgc   6180 gaggtacctt cagatctttg cgccttgctt gctgccaaac ccgaactgga ag #gaggcctc   6240 tccaccgtcc aacttctgtg tgtgtttttc ctcctgtgga gaatgatggg ac #atgcctgg   6300 acgcccttgg ttgctgttgg gttttttatc ttgaatgagg ttctcccagc tg #tactggtc   6360 cggagtgttt tctcctttgg aatgtttgtg ctatcttggc tcacaccatg gt #ctgcgcaa   6420 gttctgatga tcaggcttct aacagcagct cttaacagga acagattgtc ac #tcgccttt   6480 tacagccttg gtgcagcgac cggttttgtc gcagatctgg cggcaactca ag #ggcacccg   6540 ttgcaggcag taatgaattt aagtacctat gccttcctgc ctcggataat gg #tcgtgacc   6600 tcaccagtcc cagtgattgc gtgtggtgtt gtgcacctcc ttgccataat tt #tgtacttg   6660 tttaagtacc gctgcctgca caatgtcctt gttggcgatg gtgcgttctc tg #cggctttc   6720 ttcttgcgat actttgccga ggggaaattg agggaagggg tgtcgcaatc ct #gcgggatg   6780 aatcatgagt cgctgactgg tgccctcgct atgagactta atgacgagga ct #tggatttt   6840 cttacgaaat ggactgattt taagtgtttt gtttctgcat ccaacatgag ga #atgcggcg   6900 ggccagttca tcgaggctgc ctatgctaaa gcacttagaa ttgaacttgc cc #agttggtg   6960 caggttgata aggttcgagg tactttggcc aaacttgaag cttttgctga ta #ccgtggca   7020 ccccaactct cgcccggtga cattgttgtt gctcttggcc atacgcctgt tg #gcggtatc   7080 ttcgacctaa aggttggtag caccaagcat accctccaag ccattgagac ca #gagttctt   7140 gccgggtcca aaatgaccgt ggcgcgtgtc gttgatccaa cccccacacc cc #cacccgca   7200 cccgtgccta tcccccttcc accgaaagtt ctggagaatg gtcccaacgc ct #ggggggat   7260 gaggatcgtt tgaataagaa gaagaggcgc aggatggaag ccgtcggcat ct #ttgttatg   7320 ggtggaaaga aatatcagaa attttgggac aagaactccg gtgatgtgtt tt #atgaggag   7380 gtccatgata acacagacgc gtgggagtgc ctcagagttg acaaccctgc cg #actttgac   7440 cctgagaagg gaactctgtg cgggcatact accattgaag ataagactta ca #gtgtctac   7500 gcctccccat ctggcaagaa attcctggtc cccgtctacc cagagagcaa aa #aaaaccaa   7560 tgggaagctg cgaagctttc cgtggaacag gcccttggca tgatgaatgt cg #acggtgaa   7620 ctgacagcca aagaagtgga gaaactgaaa agaataattg acaaactcca gg #gcctgact   7680 aaggagcagt gtttaaactg ctagccgcca gcggcttgac ccgctgtggt cg #cggcggct   7740 tggttgttac tgagacagcg gtaaaaatag tcaaatttca caaccggacc tt #caccctag   7800 gacctgtgaa tttaaaagtg gccagtgagg ttgagctaaa agacgcggtc ga #gcataacc   7860 aacacccggt tgcaagaccg gttgatggtg gtgttgtgct cctgcgctcc gc #agttcctt   7920 cgcttataga cgtcttaatc tccggcgctg atgcatctcc caagttactc gc #ccgccacg   7980 ggccgggaaa cactgggatc gatggcacgc tttgggattt tgaggccgag gc #cactaaag   8040 aggaaattgc actcagtgcg caaataatac aggcttgtga cattaggcgc gg #cgacgcac   8100 ctgaaattgg tcttccttat aagctgtacc ctgtcagggg caaccctgag cg #ggtaaaag   8160 gagttttaca gaatacaagg tttggagaca taccttataa aacccccagt ga #cactggaa   8220 gcccagtgca cgcggctgcc tgcctcacgc ccaatgccac tccggtgact ga #tgggcgct   8280 ccgtcttggc cacgactatg ccctccggtt ttgagttgta tgtaccgacc at #tccagcgt   8340 ctgtccttga ttatcttgat tctaggcctg actgccccaa acagttgaca ga #gcacggct   8400 gtgaggacgc cgcattaaga gacctctcca agtatgactt gtccacccaa gg #ctttgttt   8460 tacctggagt tcttcgcctt gtgcgtaagt acctgtttgc tcatgtgggt aa #gtgcccgc   8520 ccgttcatcg gccttccact taccctgcca agaattctat ggctggaata aa #tgggaaca   8580 ggtttccaac caaggacatc cagagcgtcc ctgaaatcga cgttctgtgc gc #acaggccg   8640 tgcgggaaaa ctggcaaact gttacccctt gtaccctcaa gaaacagtat tg #tgggaaga   8700 agaagactag gacaatactc ggcaccaata acttcattgc gctggcccac cg #ggcagcgt   8760 tgagtggtgt cacccagggc ttcatgaaaa aggcgtttaa ctcgcccatt gc #cctcggta   8820 aaaacaaatt taaagagctt cagactccgg tcttaggcag gtgccttgaa gc #tgatcttg   8880 catcctgcga tcgctccaca cctgcaattg tccgctggtt tgccgccaat ct #tctttatg   8940 aacttgcctg tgctgaagag cacctgccgt cgtacgtgtt gaactgctgc ca #cgacctac   9000 tggtcacgca gtccggcgca gtaactaaga gaggtggcct gtcgtctggc ga #cccgatca   9060 cttctgtgtc caacaccatt tacagcttgg tgatatatgc acaacacatg gt #gctcagtt   9120 actttaaaag tggtcaccct catggccttc tgtttctaca agaccagctg aa #gtttgagg   9180 acatgctcaa ggttcaaccc ctgatcgtct attcggacga cctcgtactg ta #tgccgagt   9240 ctcccaccat gccaaactac cactggtggg ttgaacatct gaacctgatg ct #gggttttc   9300 agacggaccc aaagaagaca gccataacag actcgccatc atttctaggc tg #taggataa   9360 taaatggacg ccagctcgtc cctaaccgtg acaggattct cgcggccctc gc #ctaccata   9420 tgaaggcaag caatgtctct gaatactacg cctcggcggc tgcgatactc at #ggacagct   9480 gtgcttgttt agagtatgat cccgaatggt ttgaagagct tgtagttggg at #agcgcagt   9540 gtgcccgcaa ggacggctac agttttcccg gcccgccgtt cttcttgtcc at #gtgggaaa   9600 aactcagatc caatcatgag gggaagaagt ccagaatgtg cgggtactgc gg #ggccccgg   9660 ctccgtacgc cactgcctgt ggcctcgacg tctgtattta ccacacccac tt #ccaccagc   9720 attgtccagt catcatctgg tgtggccacc cggctggttc tggttcttgt ag #tgagtgca   9780 aaccccccct agggaaaggc acaagccctc tagatgaggt gttagaacaa gt #cccgtata   9840 agcctccacg gactgtaatc atgcatgtgg agcagggtct cacccctctt ga #cccaggca   9900 gataccagac tcgccgcgga ttagtctccg ttaggcgtgg cattagagga aa #tgaggttg   9960 atctaccaga cggtgattat gctagcaccg ccctactccc tacttgtaaa ga #gattaaca  10020 tggtcgctgt cgcctctaat gtgttgcgca gcaggttcat catcggcccg cc #tggtgctg  10080 ggaaaacata ctggctcctt caacaggtcc aggatggtga tgtcatttac ac #gccaactc  10140 accagaccat gctcgatatg attagggctt tggggacgtg ccggttcaac gt #cccagcag  10200 gtacgacgct gcaattccct gccccctccc gtaccggccc ttgggttcgc at #cctagccg  10260 gcggttggtg tcctggcaag aattccttcc tggatgaagc agcgtattgt aa #tcaccttg  10320 atgtcttgag gcttcttagc aaaactaccc tcacctgtct gggagatttc aa #acaactcc  10380 acccagtggg ttttgattct cattgctatg tttttgacat catgcctcag ac #tcaactga  10440 agaccatctg gagatttgga cagaatatct gtgatgccat tcagccagat ta #cagggaca  10500 aacttgtatc catggtcaac acaacccgtg taacctacgt ggaaaaacct gt #caagtatg  10560 ggcaagtcct caccccttac cacagggacc gagaggacgg cgccatcaca at #tgactcca  10620 gtcaaggcgc cacatttgat gtggttacac tgcatttgcc cactaaagat tc #actcaaca  10680 ggcaaagagc ccttgttgct attaccaggg caagacatgc tatctttgtg ta #tgacccac  10740 acaggcaact gcagagcatg tttgatcttc ctgcgaaagg cacacccgtc aa #cctcgctg  10800 tgcaccgtga cgagcagctg atcgtgctag atagaaataa caaagaatgc ac #ggttgctc  10860 aggctctagg caatggggat aaattcaggg ccacagacaa gcgcgttgta ga #ttctctcc  10920 gcgccatttg tgcagatctg gaagggtcga gctccccgct ccccaaggtc gc #acacaact  10980 tgggatttta tttctcgcct gatttgacac agtttgctaa actcccggta ga #acttgcac  11040 cccactggcc cgtggtgaca acccagaaca atgaaaagtg gccagaccgg tt #ggttgcta  11100 gccttcgccc cgtccataag tatagccgcg cgtgcatcgg tgccggctac at #ggtgggcc  11160 cctcagtgtt tctgggcacc cctggggttg tgtcatacta tctcacaaaa tt #tgtcaggg  11220 gcgaggctca aatgcttccg gagacagtct tcagcaccgg ccgaattgag gt #agattgcc  11280 gtgagtatct tgatgaccgg gagcgagaaa ttgctgagtc cctcccccat gc #tttcattg  11340 gcgacgtcaa aggcactacc gttggaggat gtcaccatgt cacctccaaa ta #ccttccgc  11400 gcttccttcc caaggaatca gtcgcggtag tcggggtttc aagccccggg aa #agccgcaa  11460 aagcagtttg cacattaaca gatgtgtatc tcccagatct cgaagcttac ct #ccacccag  11520 agacccagtc caagtgctgg aaaatgatgt tggacttcaa ggaagttcga ct #gatggtct  11580 ggaaggacaa gacggcctat tttcaacttg aaggccgcca tttcacctgg ta #ccagcttg  11640 caagctatgc ctcgtacatc cgagttcctg ttaactctac ggtgtatttg ga #cccctgca  11700 tgggccctgc cctttgcaac agaagagttg tcgggtccac tcattgggga gc #tgacctcg  11760 cagtcacccc ttatgattac ggtgccaaaa tcatcctgtc tagtgcatac ca #tggtgaaa  11820 tgccccctgg gtacaaaatc ctggcgtgcg cggagttctc gcttgacgat cc #agtgaggt  11880 acaaacacac ctgggggttt gaatcggata cagcgtatct gtacgagttc ac #cggaaacg  11940 gtgaggactg ggaggattac aatgatgcgt ttcgtgcgcg ccagaaaggg aa #aatttata  12000 aggccactgc caccagcatg aggtttcatt ttcccccggg ccctgtcatt ga #accaactt  12060 taggcctgaa ttgaaatgaa atggggtcca tgcaaagcct ctttgacaaa at #tggccaac  12120 tttttgtgga tgctttcacg gaatttttgg tgtccattgt tgatatcatc at #atttttgg  12180 ccattttgtt tggctttacc atcgctggct ggctggtggt cttctgcatc cg #attggttt  12240 gctccgcggt actccgtgcg cgccctacca ttcaccctga gcaattacag aa #gatcctat  12300 gaggcctttc tttctcagtg ccaggtggat attcccacct ggggaactag ac #atcccctg  12360 gggatgtttt ggcaccataa ggtgtcaacc ctgattgatg aaatggtgtc gc #gtcggatg  12420 taccgcacca tggaaaaagc aggacaggct gcctggaaac aggtggtgag cg #aggccacg  12480 ctgtctcgca ttagtggttt ggatgtggtg gctcattttc agcatcttgc cg #ccattgaa  12540 gccgagacct gtaaatattt ggcctctcgg ctgcccatgc tacacaatct gc #gcatgaca  12600 gggtcaaatg taaccatagt gtataatagt actttgaatc aggtgtttgc ta #tttttcca  12660 acccctggat cccggccaaa gcttcatgat tttcagcaat ggctaatagc tg #tgcactcc  12720 tccatatttt cctccgttgc ggcttcttgt actctttttg ttgtgctgtg gt #tgcggatt  12780 ccaatactac gtactgtttt tggtttccgc tggttagggg caatttttcc tt #cgaactca  12840 cggtgaatta cacggtgtgt ccgccttgcc tcacccggca agcagccgct ga #ggtctacg  12900 aaccaggcag gtctctttgg tgcaggatag ggcatgaccg atgtagtgag ga #cgaccatg  12960 acgatctagg gttcatggtt ccgcctggcc tctccagcga aggccacttg ac #cagtgttt  13020 acgcctggtt ggcgttcctg tccttcagct acacggccca gttccatccc ga #gatatttg  13080 ggatagggaa tgtgagtcaa gtttatgttg acatcaagca ccaattcatc tg #cgccgttc  13140 acgacgggga gaacgccacc ttgcctcgtc atgacaatat ttcagccgta tt #tcagacct  13200 actaccaaca tcaagtcgac ggcggcaatt ggtttcacct agaatggctg cg #ccccttct  13260 tttcctcttg gttggtttta aatgtttctt ggtttctcag gcgttcgcct gc #aagccatg  13320 tttcagttca agtctttcgg acatcaaaac caacactacc gcagcatcag gc #tttgttgt  13380 cctccaggac atcagctgcc ttaggcatgg cgactcgtcc tctcagacga tt #cgcaaaag  13440 ctctcagtgc cgcgcggcga tagggacgcc cgtgtacatc actgtcacag cc #aatgtcac  13500 agatgagaat tatttacatt cttctgatct ccttatgctt tcttcttgcc tt #ttctatgc  13560 ttctgagatg agtgaaaagg gattcaaggt gatatttggc aatgtgtcag gc #atcgtggc  13620 tgtgtgtgtc aactttacca gctacgtcca acatgtcaag gagtttaccc aa #cgctcctt  13680 ggtggtcgat catgtgcggc tgctccattt catgacacct gagaccatga gg #tgggcaac  13740 cgttttagcc tgtttttttg ccatcttact ggcaatttga atgttcaagt at #gttgggga  13800 gatgcttgac cgcgggctgt tgctcgcgat tgctttcttt gtggtgtatc gt #gccatttt  13860 gttttgctgc gctcgtcaac gccaacagca acagcagctc tcatcttcag tt #gatttaca  13920 acttgacgct atgtgagctg aatggcacag attggctgaa agacaaattt ga #ttgggcag  13980 tggagacttt tgtcatcttt cccgtgttga ctcacattgt ctcatatggt gc #actcacca  14040 ctagccattt ccttgacaca gtcggtctgg ttactgtgtc taccgccggg tt #ctaccacg  14100 ggcggtatgt tctgagtagc atctacgcgg tctgcgctct ggccgcattg at #ttgcttcg  14160 tcattaggct tgcgaagaac tgcatgtcct ggcgctactc ttgtaccaga ta #tactaact  14220 tccttctgga cactaagggc agactctatc gctggcggtc gcccgttatc at #agagaaag  14280 ggggtaaggt tgaggtcgaa ggtcacctga tcgacctcaa aagagttgtg ct #tgatggtt  14340 ccgtggcaac ccctttaacc agagtttcag cggaacaatg gggtcgtctt ta #gacgactt  14400 ttgctatgat agcacggctc cacaaaaggt gcttttggcg ttttccatta cc #tacacgcc  14460 agtgatgata tatgctctaa aggtaagtcg cggccgactt ttagggcttc tg #cacctttt  14520 gatctttctg aattgtactt ttaccttcgg gtacatgaca ttcgtgcact tt #aatagcac  14580 aaataaggtc gcgctcacta tgggagcagt agttgcactt ctttgggggg tg #tactcagc  14640 catagaaacc tggaagttca tcacctccag atgccgtttg tgcttgctag gc #cgcaagta  14700 cattctggcc cccgcccacc acgtcgaaag tgccgcgggc tttcatccga tc #gcggcaaa  14760 tgataaccac gcatttgtcg tccggcgtcc cggctccact acggttaacg gc #acattggt  14820 gcccgggttg aaaagcctcg tgttgggtgg cagaaaagct gttaaacagg ga #gtggtaaa  14880 ccttgtcaaa tatgccaaat aacaacggca agcagcaaaa gaaaaagagg gg #gaatggcc  14940 agccagtcaa tcagctgtgc cagatgctgg gtaagatcat cgcccagcaa aa #ccagtcca  15000 gaggcaaggg accggggaag aaaattaaga ataaaaaccc ggagaagccc ca #ttttcctc  15060 tagcgactga agatgacgtc aggcatcact tcacccctag tgagcggcaa tt #gtgtctgt  15120 cgtcgatcca gactgccttt aaccagggcg ctggaacctg taccctatca ga #ttcaggta  15180 ggataagtta cactgtggag tttagtttgc cgacgcatca tactgtgcgc ct #gatccgcg  15240 tcacagcgcc atcatcagcg taatgggctg gcattcctta agcacctcag tg #ttagaatt  15300 ggaagaatgt gtggtgaatg gcactgattg gcactgtgcc tctaagtcac ct #attcaatt  15360 agggcgaccg tgtgggggtt aagtttaatt ggcgagaacc atgcggccga aa #ttaaaaaa  15420 aaaa                  #                   #                   #          15424

Substantially avirulent forms of atypical porcine reproductive and respiratory syndrome (PRRS) virus and corresponding vaccines are provided which result from cell culture passaging of virulent forms of PRRS. The resultant avirulent atypical PRRS virus is useful as a vaccine in that PRRS specific antibody response is elicited by inoculation of host animals, thereby conferring effective immunity against both previously known strains of PRRS virus and newly isolated atypical PRRS virus strains. The preferred passaging technique ensures that the virus remains in a logarithmic growth phase substantially throughout the process, which minimizes the time required to achieve attenuation.

[0001] This application claims benefit of U.S. Provisional Patent Application No. 60/133,179 filed May 7, 1999, which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION [0002] The present invention is directed to an drug-delivery tool and method of delivering selected therapeutic and/or diagnostic agents to target sites in selected body tissues. More particularly, the invention provides for the creation of temporary cavities in desired layers of a selected tissue, for example, myocardial tissue of the heart, and for the delivery of one or more selected agents therein. BACKGROUND OF THE INVENTION [0003] Intra-muscular needle injection of therapeutic compounds is well known in the medical arts, as is intra-coronary injection where pre-existing intra-coronary arteries provide perfusate conduits. In heart disease, the existing coronary artery in-flows to capillary beds is often compromised. Newly developed gene and protein therapeutic agents hold promise in their ability to act on the surviving smaller capillary beds to grow and expand them. As has been witnessed, the intra-myocardial cellular lattice limits angiogenic response to about 5-10 mm and similar limits occur with direct needle injections in stunned or ischemic heart tissue. The physician must work within an environment of compromised capillary bed vascularity. Physicians are further limited to some degree by drug viscosity—where the drug viscosity is too low, rapid wash-out can occur; and where too high, capillary occlusion can occur—as well as by high infusate pressure induced cellular damages. These problems are not typical of common healthy muscle tissue injections in the arm or leg. The prior art teaches the creation of permanent channels with the use of lasers, radio frequency heating and mechanical cutting means. Such channels often compromise the capillaries that are sought to be accessed with a drug, wash out readily, and resolve ultimately as fibrous connective scar tissue. Needle and membrane tools may improve access to capillaries but offer no stretching forces and don't offer unobstructed capillary access. SUMMARY OF THE INVENTION [0004] One embodiment of the invention provides a drug-delivery tool for delivering a drug to an internal member of a tissue, such as a heart-wall. The tool comprises an accessing device having distal and proximal ends, an inner lumen extending therebetween, a drug-delivery reservoir adapted to hold such drug, and a user-control structure at the accessing device's proximal end. The tool further includes a tissue-penetrating implement carried at the accessing device's distal end for axial movement into and out of the lumen. The implement has first and second expandable members which are disposed in a substantially co-extension condition, when the implement is disposed in a retracted condition within the lumen. Alternatively, the implement may assume an expanded, spaced-apart condition when the implement is advanced to an extended condition out of the lumen. At least one of the members has a tip for penetrating such tissue. A first operative connection exists between the control structure and the implement that is operable, upon user activation of the control structure, to advance the implement from its retracted to its extended condition. When the accessing device's distal end is placed against a surface region of the tissue, the implement is advanced into the tissue, causing the two expandable members to expand to form a cavity within the tissue. A second operative connection exists between the control structure and the reservoir that is operable, upon user activation of the control structure, to deliver drug from the reservoir into such cavity. Placement of the accessing device's distal end against a surface region of such tissue, and activation of the control structure results in the delivery of drug into a cavity within the tissue. [0005] In another embodiment, the implement includes at least two expandable elements which move away from one another as the implement is being advanced, from its retracted to its extended condition, into such tissue, to form a cavity in the tissue. [0006] In yet another embodiment, the second expandable member of the tissue-penetrating implement defines a lumen having a plurality of openings that permit direct communication of an drug passed into a cavity formed by the tool with at least about 90% of the surface area of the tissue directly bordering the drug receiving space. [0007] In a particularly preferred embodiment, the accessing device is a flexible catheter accessing device; and further comprises a pull-wire assembly extending longitudinally through the catheter accessing device, the pull-wire assembly being operable to deflect the distal end of the accessing device substantially within a plane; and one or more force contact transducers mounted at the distal end of the accessing device within the deflection plane. This embodiment may further comprise one or more additional force contact transducers mounted at the distal end of the accessing device outside of the deflection plane. [0008] In another embodiment, the first expandable member further comprises construction from a shape memory material capable of a first remembered curved shape, and a second, stress induced linear shape causing the first expandable member to cut in an arc shape as it is advanced through a tissue upon extension from the confines of the accessing device lumen. [0009] In still another embodiment, the second expandable member comprises a ribbed balloon, wherein each rib defines a lumen in fluid communication with the drug-delivery reservoir, and each rib further defines a plurality of exit ports from the rib lumen that the drug may perfuse through into the formed cavity. [0010] In another embodiment, the first expandable member is formed in a cork-screw shape tubular member defining a lumen within exiting at an end distal to the accessing device and in communication with the drug-delivery reservoir, the first expandable member is rotatable along its axis to permit it to screw into a tissue upon axial rotation, and upon stopping axial rotation, withdraw into the lumen of the accessing device thereby pulling the tissue up into the lumen of the accessing device until such tissue is sealably urged against the accessing implement's lumen edge causing a seal to form between the accessing implement's lumen edge and the tissue, and further causing a cavity to form between the distal region of the first expandable member and the tissue adjacent to that region. [0011] In one embodiment, some of the expandable members of the tissue-penetrating implement define lumens with a plurality of openings in fluid communication with the drug-delivery reservoir such that a drug may be introduced into a formed cavity with at least about 90%, and preferably greater than about 95%, of the surface area of the tissue directly bordering the cavity. [0012] The accessing device can be, for example, a flexible catheter accessing device or the accessing device of an endoscope-type tool. In an embodiment of the former (i.e., a catheter-type tool), the tool further includes (i) a pull-wire assembly extending longitudinally through the catheter accessing device, with the pull-wire assembly being operable to deflect a distal-end region of the accessing device substantially within a plane; and (ii) one or more (for example, two) ultrasound or force contact transducers mounted on opposing sides of the orifice at the distal end of the accessing device within the deflection plane. Optionally, one or more (for example, two) additional transducers can be mounted at the distal end of the accessing device outside of the deflection plane. [0013] One aspect of the present invention provides an drug-delivery tool for delivering a selected diagnostic or therapeutic agent to a target site within a selected body tissue, such as myocardial tissue of the heart. Generally, the drug-delivery tool includes an accessing device having proximal and distal ends, with a lumen extending between such ends and terminating at an orifice at the distal end. A tissue-penetrating implement is movable between a retracted condition, within a distal region of the lumen, and an extended condition, extending out of the orifice. The tissue-penetrating implement includes a tip configured to penetrate a selected body tissue when (i) the distal end of the accessing device is placed thereagainst and (ii) the implement is advanced from its retracted condition to its extended condition. In addition, the tissue-penetrating implement includes a first expandable member, disposed proximal of the tip, for following the tip to a target site as the tip penetrates the selected tissue. A second expandable member, also proximal to the tip of the implement, is adapted to expand radially as the implement is advanced to its extended condition, with a force sufficient to form a cavity at the target site by pressing the tissue adjacent the penetration site away from the longitudinal axis of the implement. An agent-delivery passage or conduit extends longitudinally through at least a member of the accessing device, with a distal end of the passage defining an exit port facing the expandable member of the tissue-penetrating implement. By this construction, an agent, passed or drawn through the passage and out of the exit port, is directed into a central region of the expandable member, and any cavity formed thereby. [0014] In one embodiment, the tissue-penetrating implement of the drug-delivery tool includes (i) a cutting or slicing tip at its distal-end region, and (ii) one or more resiliently flexible expandable members extending proximally therefrom, with the expandable members being adapted to expand radially outward in their normal state. The expandable members can be, for example, wires or filaments made of Nintinol, or the like. Movement of the tissue-penetrating implement can be effected using an actuation line attached at one end to a proximal end of the implement and attached at its other end to a manually operable deflection mechanism at a proximal end of the drug-delivery tool. By this construction, sliding movement of the line within the accessing device is transmitted to the implement—causing the implement to move. [0015] The agent-delivery passage of the drug-delivery tool can be formed, for example, by an elongate conduit having an internal lumen that extends between the proximal end of the accessing device and a distal-end region of the accessing device. In one embodiment, such a conduit is adapted for sliding movement within the accessing device, coupled with movement of the tissue-penetrating implement. [0016] One embodiment of the drug-delivery tool, particularly useful for delivering a selected agent having a net negative charge (for example, DNA), further comprises first and second electrodes adapted to be placed in electrical communication with a power supply. The first electrode, in this embodiment, is disposed at a distal region of the tissue-penetrating implement and the second electrode is disposed proximally of the implement. Generation of a positive charge at the first terminal is effective to draw at least a portion of the negatively charge species from a supply or holding reservoir, through the agent-delivery passage, and into the expandable member of the tissue-penetrating implement. [0017] Another embodiment of the drug-delivery tool is particularly well suited for placing a solid or semi-solid agent in a cavity formed by the cavity forming implement and then permitting the agent to move outwardly as portions of it dissolve or otherwise slough off. In one particular construction, the expandable member of the tissue-penetrating implement includes a plurality of resiliently flexible expandable members (for example, wires or filaments of Nintinol, or the like) disposed at spaced positions about the longitudinal axis of the implement so as to define a cage or skeleton capable of holding the agent as it is placed in a cavity formed by the implement. The cage is provided with open regions between its expandable members sufficient to provide direct exposure of the agent to at least about 95% of the tissue bordering the cavity. [0018] Another general embodiment of the drug-delivery tool of the invention includes (i) an accessing device having proximal and distal ends, with a lumen extending therebetween and terminating at an orifice at the distal end; (ii) a tissue-penetrating implement movable between a retracted condition, within a distal region of the lumen, and an extended condition, extending out of the orifice; with the implement including (a) a tip configured to penetrate a selected body tissue when the distal end of the accessing device is placed thereagainst and the implement is moved from its retracted condition to its extended condition, and (b) a cage member disposed proximal of the tip for following the tip to a target site within such tissue, and adapted to assist in the formation and maintenance of a cavity at the target site by pressing the tissue at the target site away from the longitudinal axis of the implement as it is inserted therein and having sufficient rigidity to resist inwardly directed forces of the tissue tending to collapse the cavity; and (iii) an agent-delivery passage extending longitudinally through at least a member of the accessing device, with a distal end of the passage defining an exit port facing the cage member for directing a selected agent, passed through the passage, into a central region of the cage member and any such cavity formed thereby. [0019] The cage member can comprise, for example, a plurality of expandable elements disposed about the central, longitudinal axis of the implement, with open regions between adjacent expandable members. Preferably, at least about 95% of the cage member is open. The cage member can be expandable (tending to flex outwardly), or generally non-expandable. [0020] In another of its aspects, the present invention provides a method for delivering a selected diagnostic or therapeutic agent to a target site within a selected body tissue. [0021] According to one general embodiment, the method includes the steps of: [0022] (i) forming a cut or slice extending from a wall of the selected tissue to the target site; [0023] (ii) moving or pressing the tissue bordering the cut or slice radially outward, thereby forming a cavity within the tissue at the target site; [0024] (iii) delivering a selected agent into the cavity, with the cavity being maintained; and [0025] (iv) permitting the cavity to collapse once a selected amount of the agent has been delivered therein. [0026] In one embodiment, at least about 90 % (and preferably greater than 95%) of the surface area of the tissue bordering the cavity is directly exposed to the cavity, so that the agent delivered into the cavity can pass directly into the exposed tissue. [0027] Step (i) of the method (i.e., cutting/slicing) is preferably effected using a cutting or slicing implement, such as a blade edge or tip, that is configured to avoid the removal of tissue along the region of the cut or slice beyond the inherent cellular injury due to the cutting or slicing. [0028] According to one embodiment, the cut or slice formed in step (i) is made along a substantially linear axis, with the axis being oriented generally normal to the wall of the selected tissue. Ultrasound can be used to achieve such orientation. [0029] The agent can be delivered using, for example, an elongate agent-delivery conduit defining a passage or lumen terminating at a distal orifice through which the agent can exit. Preferably, during delivery of the agent using such a tool, the orifice does not make substantial contact with the selected tissue, thereby maximizing the tissue surface area available for contact with the agent. [0030] In one embodiment, the selected tissue is heart tissue (for example, myocardial tissue), and the cut or slice is formed from an endocardial wall, a septal wall, or an epicardial wall. [0031] In another embodiment, the selected tissue is stunned, ischemic and/or hibernating organ tissue that has at least partially lost its normal capillary ability at vasomotion. The greater surface area and capillary access provided by practicing the present invention permits the agent to be moved through micro-capillaries even where assistance by natural vasomotion is greatly diminished or unavailable. [0032] A wide variety of agents can be delivered using the present invention. The selected agent can be, for example, an angiogenic agent (for example, a protein and/or nucleic acid). In one embodiment, the agent is a nucleic acid, for example, naked DNA, intended for delivery to heart tissue. [0033] A further aspect of the present invention provides a method where the normal pressure drug tissue treatment area of 5-10 mm obtained with direct needle injection or TMR can be improved upon by creating a temporary cavity having significantly greater direct capillary access due to surface area, lack of non-perfusing delivery implement to cell contact patches and implement stretching force. [0034] These and other features and advantages of the present invention will become clear from the following description. BRIEF DESCRIPTION OF THE DRAWINGS [0035] The structure and manner of operation of the invention, together with the further objects and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings, in which: [0036] [0036]FIG. 1 is an elevational view of a steerable catheter assembly, with its distal end region enlarged and in section showing a tissue-penetrating implement therein, as taught by an embodiment of the present invention; [0037] [0037]FIG. 2 is a side sectional view showing two angle-mounted ultrasound transducers on the distal end of a steerable catheter accessing device, in accordance with an embodiment of the present invention; [0038] [0038]FIG. 3 is a cross sectional view of the catheter assembly shown in FIG. 1, taken laterally across a mid-member of the catheter accessing device; [0039] [0039]FIG. 4 is a side sectional view of the catheter-assembly distal-end region of FIG. 1, taken longitudinally therealong, with the tissue-penetrating implement inserted into a selected tissue to form a cavity therein for receiving a selected agent; [0040] [0040]FIG. 5A illustrates a section of normal myocardial tissue; [0041] [0041]FIG. 5B illustrates a section of myocardial tissue with a temporary cavity formed therein; [0042] [0042]FIG. 6 is a side elevational view, with members shown in cross section, of an endoscope-type agent delivery tool having a tissue-penetrating implement like that of the catheter assembly of FIG. 1; [0043] FIGS. 7 (A)- 7 (C) illustrate an accessing device, shown in section, with a movable implement for forming a cavity in a selected tissue and delivering a selected agent therein, in accordance with the teachings of one embodiment of the present invention; and, [0044] FIGS. 8 (A)- 8 (C) illustrate an accessing device, shown in section, with a movable implement for forming a cavity in a selected tissue and placing a selected agent therein, in accordance with an embodiment of the present invention. [0045] FIGS. 9 ( a - d ) depict an embodiment having a force contact transducer. [0046] FIGS. 10 ( a - b ) depict a corkscrew shaped expandable member embodiment. [0047] FIGS. 11 ( a - c ) depict a balloon expandable member embodiment. [0048] FIGS. 12 ( a - c ) depict an arc cutting embodiment. DETAILED DESCRIPTION OF THE INVENTION [0049] The following discussion of the preferred embodiments of the present invention is merely exemplary in nature. Accordingly, this discussion is in no way intended to limit the scope of the invention. [0050] An exemplary drug-delivery tool which embodies various features of the invention is shown in FIGS. 1 through 4. As will become apparent, the illustrated drug-delivery tool is particularly well suited for percutaneous introduction into a subject for intravascular delivery of a selected agent into temporary cavities formed in a desired layer of a selected tissue. With initial reference to FIG. 1, a catheter assembly (which may be disposable, in whole or in part), indicated generally by the reference numeral 12 , includes a control structure (hand unit) 14 attached to a steerable catheter accessing device 16 having a controllably deflectable distal-end member. Steering of the catheter assembly can be accomplished in a variety of ways. For example, the catheter assembly can include steering components like those disclosed in U.S. Pat. No. 5,876,373, entitled “Steerable Catheter,” to Giba et al.; and/or in co-pending U.S. Provisional patent application Ser. No. 09/080,175 filed May 16, 1998, entitled, “Drug Delivery Module,” to Glines et al.; and/or in published European Patent Application No. EP 0 908 194 A2, each of which is expressly incorporated herein by reference. Briefly, in the illustrated embodiment, a pull wire 18 , having an enlarged head member 18 a at its distal end, extends from the tip of catheter accessing device 16 , through a wire-guide channel 19 extending through catheter accessing device 16 , to control structure (hand unit) 14 , whereat the wire's proximal end is coupled to a deflection or steering actuator assembly. Rotation of a deflection knob 20 , which is threadedly mounted along a forward end of the hand unit, causes the pull wire to be pulled backward, or the catheter accessing device to be pushed forward, relative to one another, thereby inducing deflection of the distal end of the steerable catheter accessing device. Rather than running the pull wire through a channel extending through the catheter accessing device, another embodiment provides the pull wire extending longitudinally along the interior wall of the catheter accessing device (FIG. 3). Other steering mechanisms and arrangements, suitable for use herein, will be apparent to those skilled in the art. In yet another preferred embodiment, the catheter is further guided by a coaxial second catheter as described in co-pending application U.S. Ser. No. 09/052,971 and PCT publication WO 9949773A2 titled “Delivery catheter system for heart chamber” by Payne, filed Mar. 31, 1998, both herein incorporated in their entireties by reference. [0051] Catheter accessing device 16 is dimensioned to be placed in the vasculature of a subject and steered therethrough until the tip is disposed adjacent a selected region of tissue, for example, a surface or wall within a heart chamber (such as against the endocardial wall within the heart's left ventricle). [0052] Visualization enhancement aids, including but not limited to radiopaque markers, tantalum and/or platinum bands, foils, and/or strips can be placed on the various components of drug-delivery tool-catheter assembly 12 , including on the deflectable end member of catheter accessing device 16 . In one embodiment, for example, a radio-opaque marker (not shown) made of platinum or other suitable radio-opaque material is disposed adjacent the tip for visualization via fluoroscopy or other methods. In addition, or as an alternative, one or more ultra-sonic transducers can be mounted on the catheter accessing device at or near its tip to assist in determining its location and/or placement (for example, degree of perpendicularity) with respect to a selected tissue in a subject, as well as to sense wall contact with, and/or wall thickness of, the tissue. Ultra-sonic transducer assemblies, and methods of using the same, are disclosed, for example, in published Canadian Patent Application No. 2,236,958, entitled, “Ultrasound Tool for Axial Ranging,” to Zanelli et al., and in co-pending U.S. patent application Ser. No. 08/852,977, filed May 7, 1997, entitled, “Ultrasound Tool for Axial Ranging,” to Zanelli et al., each of which is expressly incorporated herein by reference. In one embodiment of the present invention, depicted in FIG. 2, two transducers, denoted as 26 and 28 , are angle mounted at the tip of catheter accessing device 16 in the axis of pull-wire deflection. This construction permits an operator to determine, by comparing signal strength, whether the catheter tip region is perpendicular to a selected tissue surface or wall. Additionally, this two-transducer arrangement provides an operator with information useful for determining an appropriate adjustment direction for improving perpendicularity, as compared to single-transducer arrangements that, while capable of indicating perpendicularity by signal strength amplitude, are generally incapable of indicating a suitable direction in which to move the tip to improve perpendicularity. In a related embodiment, third and fourth transducers (not shown) are added, off of the deflection axis, to aid an operator with rotational movement and rotational perpendicularity in the non-deflecting plane of the subject tissue surface. Each of the above ultrasound transducers may preferably be substituted with force contact transducers described in co-pending U.S. patent application Ser. No. 60/191,610 by C. Tom titled “Apparatus and method for affecting a body tissue at its surface”, filed Mar. 23, 2000, [Attorney docket 5756-0011] herein incorporated by reference. An additional benefit of using a force contact transducer is that the contact force and incident angle are know to the user enabling the user to achieve a seal between the distal end of the accessing device and a tissue such that a seal is formed between the two preventing administered drug from seeping out of a formed cavity. [0053] In some preferred embodiments, one or more elongate lumens may extend between the proximal and distal ends of the catheter accessing device, with (i) at least one lumen being dimensioned to accommodate a cavity forming implement for axial movement along a region of the assembly's distal end, and (ii) at least one lumen being configured to permit passage of one or more selected therapeutic and/or diagnostic agents from an agent-supply region (for example, a reservoir in the hand unit) to, and out of, a terminal orifice at the assembly's distal end. The just-described items (i) and (ii) can be achieved using a single lumen, or multiple lumens. In one embodiment, for example, catheter accessing device 16 , as depicted in FIG. 1, is preferably formed with an outer diameter of between about 2.25 to 2.75 mm (preferably 7 French), and an inner diameter, defining a primary lumen 22 , of about 1 mm. At its distal end, lumen 22 terminates at an orifice 24 . A tissue-penetrating implement 48 (described below) is adapted for movement within a distal-end region of lumen 22 . A selected agent can be passed through the main lumen directly, i.e., in contact with the main lumen's interior walls, and/or indirectly, for example, using one or more additional lumens (for example, sub-lumens) extending coextensively and/or coaxially with the main lumen. An embodiment of the latter construction is also illustrated, in part, in FIGS. 3 and 4. For example, FIGS. 1, 3, and 4 each depict different aspects of an elongate, flexible agent-delivery conduit 30 is disposed substantially coaxially within catheter accessing device 16 , extending from control structure (hand unit) 14 to a distal region of lumen 22 . Conduit 30 can be formed, for example, of a substantially inert polymeric material that resists collapse during bending or twisting, such as braided polyimide, braided PEBAX, or the like. Conduit 30 defines a hollow, axial lumen or passage 32 , having a diameter within a range of from about 0.25 mm to about 1 mm (for example, about 0.5 mm), or from about 0.010″ to about 0.040″ (for example, about 0.020″), that communicates at its proximal end with an agent-supply reservoir disposed in control structure (hand unit) 14 , and terminates at its distal end at an exit or infusion port 34 , through which a selected therapeutic and/or diagnostic agent can pass. As described below, conduit 30 is adapted for reciprocal sliding movement within catheter accessing device 16 and, thus, is provided with an outer diameter less than the inner diameter of catheter accessing device 16 , for example, about 1 mm or less in certain constructions. [0054] At this point, certain details of the hand unit relating to agent storage and dispensing will be described, bearing in mind that additional details are set forth in co-pending U.S. Provisional Patent Application Ser. No. 09/080,175 filed May 16, 1998, entitled, “Drug Delivery Module,” to Glines et al., incorporated herein by reference. In one preferred embodiment depicted in FIG. 1, control structure (hand unit) 14 is provided with a fixed drug-delivery reservoir for holding a supply of a selected agent to be dispensed. In this embodiment, a supply vessel, such as syringe 36 , can communicate with the drug-delivery reservoir via a connector provided in the unit's outer housing 38 . The connector is preferably a substantially sterile connector, such as a standard Luer-type fitting or other known standard or proprietary connector. In another embodiment, the supply reservoir comprises a syringe, pre-loaded with a selected agent, that can be removably fit into a holding area inside the housing. In both such embodiments, a dosage volume adjustment thumbscrew 40 can be mounted in the housing 38 so as to be externally accessible for accurate, local and rapid dosage volume adjustment. Also, a dosage volume scale or indicator, as at 42 , can be provided in the housing 38 . Upon depressing a trigger mechanism 44 along one side of control structure (hand unit) 14 , manually or otherwise, the agent stored in the drug-delivery reservoir moves into conduit 30 . It should also be noted that trigger mechanism 44 is coupled to the proximal end of conduit 30 such that, upon being depressed, the conduit is pushed forward (advanced) within catheter accessing device 16 from a normal, retracted condition, depicted in FIG. 1, to a dispensing condition, shown in FIG. 4, whereat conduit orifice 34 can be positioned closely adjacent a selected tissue, such as 46 , against which catheter-accessing device orifice 24 has been placed. Upon releasing the trigger mechanism, conduit 30 shifts back to its normal condition. The distance traversed by conduit 30 , in each direction, is from about 2 to about 10 mm, and preferably about 5 mm. [0055] A tissue-penetrating implement, indicated generally as 48 , is also longitudinally movable within catheter accessing device 16 , between a retracted condition, within a distal region of lumen 22 (FIG. 1), and an extended (advanced) condition, passed through and extending out of orifice 24 (FIG. 4), over a stroke of about 4-6 mm, and preferably about 5 mm. Movement of implement 48 is effected by way of an elongate actuation line 50 , depicted in cross-section in FIG. 3, operatively coupled at one end to trigger mechanism 44 (FIG. 1) and extending axially through conduit 30 from control structure (hand unit) 14 to a proximal end of implement 48 . Preferred materials for forming the actuation line are laterally flexible, permitting movement through tortuous pathways, and sufficiently incompressible along the longitudinal direction to provide for the efficient transmission of motion from the proximal end to the distal end. Suitable materials include, for example, stainless steel or a braided composite. In operation, upon the depressing trigger mechanism, implement 48 is shifted from its normal, retracted condition to its extended condition, and upon release of the trigger mechanism, implement 48 returns to its retracted condition. [0056] For reasons that will become apparent below, it should be noted that the above-described advancement of both conduit 30 and cutting implement 48 takes place substantially simultaneously (i.e., these motions are coupled) with a single depression of trigger mechanism 44 . In addition, optionally, with the same trigger depression, an agent held in a reservoir in the hand unit is dispensed from conduit 30 . Preferably, such dispensing is effected immediately after (not before) the conduit and cutting implement have reached their respective extended conditions. For example, the initial depression can actuate axial movement of the conduit and cutting implement, and the latter member of the depression can effect dispensing. Similarly, both conduit 30 and cutting implement 48 are retracted together with release of the trigger mechanism, and the dispensing of the selected agent is stopped. [0057] With further regard to the tissue-penetrating implement 48 , its distal end includes a cutting or slicing tip, denoted as 52 . In the illustrated arrangement, tip 52 takes the form of a narrow, three-sided pyramid-like structure that tapers to a sharp point. Alternatively, tip 52 could taper to a two-sided knife edge or blade, or any other suitable cutting or slicing structure. Preferred cutting or slicing structures are configured to substantially avoid the removal of tissue beyond the cellular injury inherent in cutting. [0058] Implement 48 further includes an expandable member, proximal of tip 52 , comprised of one or more resiliently flexible expandable elements or expandable members, three of which are visible (out of a total of four) at 54 in the embodiment of FIGS. 1 and 4. The expandable members are arranged at spaced positions about the implement's longitudinal axis, and configured to flex outwardly, away from such axis, to collectively form a three dimensional support skeleton or cage. The expandable members can be, for example, narrow, elongate wires, filaments or ribbons, formed of a substantially inert, resiliently flexible material, such as a metal or metal alloy (for example, stainless steel, nickel-titanium, or similar material) or from an injection molded plastic. The distal end of each expander is turned inward and attached to the proximal side of tip 52 . When the expandable member is disposed at its retracted condition (FIG. 1), the expandable members are compressed toward the implement's longitudinal axis; and when advanced to its extended condition (FIG. 4), the expandable members are allowed to flex outward, so that, overall, the expandable member achieves a maximum diameter of about 1-3 mm, and preferably from about 1.75 mm to about 2 mm. [0059] According to one preferred construction of the expandable member, between about 3-10 nickel-titanium (for example, as available commercially under the name “Nintinol”) filaments, each between about 4-5 mm in length and from about 0.003″ to about 0.005″ in diameter are employed as expandable members. The particular number, dimensions, and material composition of the expandable members are not critical, provided only that the expandable members are capable of forming a cavity when inserted into a selected tissue (i.e., they have sufficient strength and spring capabilities), and, when in the expanded condition, a drug or other agent delivered into the region within the expandable members can move outwardly into the tissue about the cavity, with very little interference presented by the expandable members themselves, as shown in FIG. 4 with agent 58 in cavity 60 . Regarding the latter, the expandable members preferably occupy no more than about 10%, and more preferably less than about 3%, of the region defining the boundary between the cavity and the target tissue thereabout. In this way, the vast majority of the tissue boarding a cavity can be directly exposed to an agent delivered into the cavity. [0060] An exemplary method of using the above catheter assembly will now be described, wherein the catheter assembly is used for intra-myocardial delivery of a selected therapeutic and/or diagnostic agent. Initially, catheter accessing device 16 is percutaneously introduced via femoral or radial artery access. This can be accomplished, for example, by way of the Seldinger technique ( Acta Radiologica, 38, [1953], 368-376; incorporated herein by reference), a variation thereof, or other conventional technique. Optionally, a conventional guiding or shielding catheter (not shown) can be employed to assist in tracking the catheter tool through the patient's vasculature and into targeted regions of the heart. Once arterial access is established, the catheter accessing device 16 is slid across the aortic valve and into the left ventricle chamber. The distal end of the catheter accessing device 16 is maneuvered so as to be substantially perpendicular to the endocardial wall 46 (FIG. 4), using fluoroscopic visualization and/or ultrasound guidance, and pressed thereagainst. Trigger mechanism 44 is next depressed, causing cutting tip 52 to advance into the myocardial tissue, in the direction of arrow 64 , to a pre-set or adjustable depth. Expandable members 54 follow cutting tip 52 into the myocardium and expand radially (for example, in the direction of arrows 66 ), creating a cavity about the axis of penetration (i.e., the axis of cutting or slicing). Once the cavity has been created, the expandable members serve to maintain the cavity by resisting heart contractile forces. The same trigger depression serves to deliver a selected agent through conduit 30 into the cavity 60 . After allowing the agent to enter into the surrounding tissue for appropriate period of time, for example, typically less than about 2 minutes, the tissue-penetrating implement is withdrawn, at which point the cavity can close. [0061] Healthy myocardial tissue is illustrated in FIG. 5A. As shown, healthy tissue contains capillaries 70 , interstitial tissue 72 , and heart muscle cells 74 (See, for example, “Gray's Anatomy” (1959) at page 597). FIG. 5B shows how a temporary cavity 60 can be created to directly access, for example, along the direction of arrows 68 , more capillaries 70 , more heart muscle cells 74 , and tissue surface area 76 . It should be appreciated that the creation of temporary cavities, as taught therein, provides direct access to a greater number of capillaries than has been possible by the prior techniques. As a result, the performance of the infusate tool is greatly enhanced. [0062] It is believed that abrasion to the wall of the cavities may aid in absorption of the agent. Accordingly, it may be desirable to configure the cutting tip and/or cavity expandable members of the invention so as to allow selective abrasion. This can also be accomplished, for example, by RF, thermal, acidic and/or ultrasonic means acting on the cutting tip and/or cavity expandable members. [0063] It is noted that the above-described method is exemplary in nature. Those skilled in the art will appreciate that the present invention provides for the delivery of selected agents to a wide variety of body organs and regions. [0064] Another embodiment of the drug-delivery tool of the present invention is shown in FIG. 6, wherein the tool is embodied in an endoscope-type tool, shown generally at 80 . As described next, the drug-delivery tool of this embodiment is configured for intraoperative use, to be introduced thoracoscopically or through a thoracotomy, to form temporary cavities in a selected tissue. The tool includes a proximal handpiece 82 (similar to the previously-described control structure (hand unit) 14 ) adapted to accommodate an drug-delivery reservoir syringe 84 , and a depressible trigger mechanism 86 . This particular surgical tool incorporates a reusable 5 mm thoracoscopic camera 88 axially mounted to provide an operator with a field of view 90 through lens 92 . This allows the operator to work through a common Trocar access port 94 placed, for example, through a patient's chest wall 96 . In an exemplary use, upon traversing the epicardial surface 98 of the heart, a tissue-penetrating implement 48 , substantially as described above, can create a temporary cavity for receiving a selected agent. As with the catheter assembly, the tool is adapted to permit a user to both extend the tissue-penetrating implement and dispense a drug or other agent, with a single depression of the trigger mechanism 86 . Additional details of the handpiece are presented in co-pending U.S. Provisional Patent Application Ser. No. 09/080,175 filed May 16, 1998, entitled, “Drug Delivery Module,” to Glines et al., incorporated herein by reference. One skilled in the art would recognize that the above mentioned endoscopic embodiment may further be adapted for use without an endoscopic port, for example, such as in open surgery. Such an embodiment may be guided with or without visualization aids such as an optical endoscope or other optical enhancement device. [0065] It should be noted that, especially when used in open surgery, the tissue-penetrating implement need not retract. Thus, movement of the implement between its retracted and advanced conditions, in such cases, need only involve movement of the implement move from its retracted to its advanced condition. [0066] In another embodiment of the present invention, a selected therapeutic and/or diagnostic agent comprising a charged species (for example, DNA) is held within the distal-end region of an accessing device and delivered into a cavity formed by in a selected tissue via an electrical field. An exemplary cavity-forming and delivery implement, which can be incorporated in a catheter-type tool or an endoscope-type, such as previously described, is shown in FIGS. 7 A- 7 C. Here, the implement includes drug-delivery reservoir or storage vessel 114 which opens into the region between a plurality of expandable members 116 via short passage 118 through a neck member 120 . First and second lead wires, denoted as 122 and 124 respectively, extend through a flexible actuation accessing device 126 and terminate at respective terminals, or electrodes, fixed in the implement. The first terminal, indicated as 123 , being placed at a rearward (proximal) region of the vessel 114 , and the second terminal, denoted as 125 , being placed at a forward (distal) region of the implement's cutting/slicing tip 128 . In an exemplary operation, whereby DNA, indicated as 130 , is delivered into myocardial tissue 132 of a subject, the catheter accessing device 134 is introduced into a subject body and placed against an endocardial or epicardial wall 136 of the heart's left ventricle (FIG. 7A). During such introduction and placement, the vessel terminal 123 is made positive (+) and the tip terminal 125 is made negative (−), thereby establishing an electrical field that maintains the negatively charged DNA in the vessel 114 . It should be noted that the lead wires 122 , 124 and regions about the terminals 123 , 125 are shielded, using conventional materials, to limit the field's reach into the surrounding heart tissue. Such shielding about the forward (distal) region of the implement is indicated by back-hatching in the drawings. After placement of the catheter, actuation accessing device 126 is advanced, via a remote shifting mechanism (such as previously described), to push the slicing tip 128 through the wall 136 and into a region of myocardium 132 , with the expandable members 116 following the tip therein. Once a cavity has been formed in the myocardium, the polarity is reversed, so that the tip terminal 128 is positive (+) and the vessel terminal 123 is negative (−) (FIG. 7B), thereby establishing an electrical field effective to draw the negatively charged DNA 130 toward the tip 128 . After a short time, with at least a substantial member of the DNA drawn out of the vessel 114 , the electrical field is discontinued (FIG. 7C), so that the DNA can move outwardly into the surrounding tissue and capillaries of the myocardium. [0067] In another embodiment, a selected therapeutic and/or diagnostic agent is held within the distal-end region of an accessing device and placed in a cavity formed in a selected tissue. An exemplary cavity-forming and placement implement, which can be incorporated in a catheter-type tool or an endoscope-type, such as previously described, is shown in FIGS. 8 A- 8 C. Here, the implement includes a plurality of expandable members 142 attached at their rearward (proximal) ends to a flexible actuation accessing device 144 , and at their forward (distal) ends to a cutting/slicing tip 146 . The expandable members 142 are arranged to serve as a cage or skeleton for containing a selected agent 148 , in solid or semi-solid form, as the catheter accessing device 150 is placed against a selected organ wall, as at 152 (FIG. 8A). Actuation accessing device 144 is then advanced, via a remote shifting mechanism, to push the slicing tip 146 of the implement through the wall 152 and into a selected layer of tissue 154 , with the expandable members 142 following the tip 146 therein (FIG. 8B). Once a cavity has been formed in this manner, the agent 148 is allowed to move outward into the surrounding tissue and capillaries (FIGS. 8 B- 8 C). The agent can be configured to for controlled release after placement, for example, via swelling and sloughing over a period of several minutes. In one embodiment, wherein the agent is DNA, controlled-release preparations are formulated through the use of polymers to complex or absorb the selected gene sequence (with or without an associated carrier, for example, liposomes, etc.). The agents can be formulated according to known methods to prepare pharmaceutically useful compositions, whereby these materials, or their functional derivatives, are combined in admixture with a pharmaceutically acceptable carrier vehicle. Suitable vehicles and their formulation, are described, for example, in Nicolau, C. et al. ( Crit. Rev. Ther. Drug Carrier Syst 6:239-271 (1989)), which is incorporated herein by reference. In order to form a pharmaceutically acceptable composition suitable for effective administration, such compositions will contain an effective amount of the desired gene sequence together with a suitable amount of carrier vehicle. [0068] [0068]FIG. 9 a depicts a preferred embodiment of the invention where accessing device 900 further comprises force contact transducer 902 mounted on distal end 904 of accessing device 900 . As accessing device 900 is urged toward tissue 906 , as shown in FIG. 9 b, force contact transducer 902 contacts tissue 906 causing detectable contact pressure to develop between force contact transducer 902 and tissue 906 . Such detectable pressure, detected by force contact transducer 902 is communicated back to the end user who then can further manipulate accessing device 900 to achieve perpendicularity between the thrust axis of accessing device 900 and tissue 906 . Upon achieving perpendicularity and contact force, tissue-penetrating implement 908 , with cutting tip 908 a, may be advanced to an extended condition, from a retracted position, thus causing the formation of cavity 910 in tissue 906 . Because accessing device 900 is urged against tissue 906 in a perpendicular manner, distal end 904 of accessing device 900 develops a seal for sealing in later delivered drug into cavity 910 . FIG. 9 c depicts accessing device 900 without force contact transducer 902 . FIG. 9 c suggests how a non-perpendicular orientation of accessing device 900 with respect to tissue 906 could result in seepage of delivered drug 912 from cavity 910 . FIG. 9 d further depicts accessing device 900 without force contact transducer 902 urged against tissue 900 . Tissue 900 is further depicted in two states, diastolic state tissue 906 a and systolic state tissue 906 b correlating to the movement of myocardial tissue in a beating heart. As shown in FIG. 9 d, diastolic position tissue 906 a provides a seal between tissue 906 and accessing device 900 . However, upon systolic movement, tissue 906 moves away from accessing device 900 unless sufficient contact force exists between accessing device 900 and tissue 906 . Force contact transducer 902 provides information to the user to enable the user to apply sufficient and perpendicular force to the accessing device to create a seal between accessing device 900 and tissue 906 during the movements of beating heart between tissue 900 a and 900 b states. Moreover, FIG. 9 d depicts how delivered drug 912 may be further ejected or pumped out of cavity 910 by the contractile actions between heart tissue 900 a and 900 b states. [0069] [0069]FIG. 10 depicts another embodiment of the invention utilizing corkscrew shaped tissue-penetrating implement 1000 . Accessing device 1002 houses tissue-penetrating implement 1000 that may be rotated within accessing device in either a retracted condition or an extended condition. FIG. 10 a depicts tissue-penetrating implement 1000 secured into tissue 1004 by screwing. As tissue-penetrating implement 1000 is withdrawn back towards a retracted condition, tissue 1004 is likewise pulled into lumen 1006 of accessing device 1002 thus creating seal 1006 between accessing device 1002 and tissue 1004 . Such pulling further creates cavity 1008 at distal end 1010 of tissue-penetrating implement 1000 . Cavity 1008 may then be filled with delivered-drug, not shown, delivered through lumen orifice 1012 to treat the walls of cavity 1008 with such drug. [0070] [0070]FIG. 11 depicts another embodiment of the invention where the expandable members comprise a balloon structure with drug-delivery lumen orifices distributed along the surface of the expandable members. FIGS. 11 a and 11 b depicts a tissue-penetrating implement 1101 comprising four radially distributed expandable members 1100 defining lumens 1102 with exit ports 1104 outwardly situated on balloon 1106 . Penetrating tip 1108 is situated on the end of the balloon distal from accessing device 1110 , not shown. As balloon 1106 is inflated, expandable members 1100 are urged outward against the tissue of a cavity, not shown. FIG. 11 c further shows yet another embodiment using a balloon as an expandable member and drug-delivery channel. Accessing tool 1110 is urged against tissue 1112 , whereby tissue-penetrating implement 1101 comprises a balloon expandable member 1106 with distally situated exit ports 1104 and penetrating or cutting tip 1108 . [0071] [0071]FIG. 12 depicts a preferred embodiment of the invention where tissue penetrating implement 1200 comprises at least one first expandable member 1202 made from a shape memory material composition having a first remembered arc shape and a second, stress induced, straight shape. First expandable member 1202 assumes a stress induced straight shape when housed within lumen 1204 of accessing tool 1206 , but returns to its remembered shape upon extension beyond lumen 1204 . As first expandable member 1202 extends from lumen 1202 , it cuts an arc shaped path through tissue 1210 as first expandable member 1202 regains its remembered shape. Tissue-penetrating implement 1200 has cutting tip 1208 situated distal to accessing tool 1206 for cutting tissue 1210 as tissue-penetrating implement 1200 is advanced into tissue 1210 when advanced from a retracted condition to an extended condition out of lumen 1204 . Second expandable member 1211 extends from lumen 1204 coaxial to first expandable member 1202 . Adjacent tissue-penetration implement's distal end, first and second expandable members are positioned together either fixedly or slidably. When fixedly positioned, both expandable members 1202 and 1211 extend together, but expand longitudinally from one another to form cavity 1212 . When first and second expandable members 1202 and 1211 are slidably positioned, the user may either extend one expandable member, preferably the first expandable member 1202 having cutting tip 1208 , and then extend second expandable member 1211 to follow along cut path 1216 created by previously extended first expandable member 1202 , expanding longitudinally away from first expandable member 1202 to create cavity 1212 where a drug may be infused from a drug-delivery reservoir, not shown, in fluid communication through a conduit with the distal region of accessing device 1222 . FIG. 12 b depicts a variation where second expandable member further comprises construction from shape memory tube 1218 , such as nitinol or NiTi tubing, defining a longitudinal lumen in fluid communication with a drug-delivery reservoir, not shown, and terminating with exit ports 1220 adjacent to the distal end of second expandable member. During or after the formation of cavity 1212 , drug may be delivered from the drug-delivery reservoir, not shown, to the cavity 1212 through the lumen and exit ports 1220 of second expandable member 1211 . FIG. 12 c depicts a variation where first and second expandable members 1202 and 1211 are spaced-apart from one another by, for example, having two lumens, not shown, defined within accessing device 1222 . Force contact transducer 1224 is located on the distal end of accessing device 1222 to assist a user in achieving the sufficient and perpendicular contact force with respect to tissue 1210 to create a seal between tissue 1210 and the distal end of accessing device 1222 . One skilled in the art would readily recognize the benefits of the above mentioned embodiment. In particular, the presence of second expandable member 1211 made from a shape memory material that assumes a stress induced straight shape when housed within lumen 1204 of accessing tool 1206 , but returns to its remembered shape upon extension beyond lumen 1204 , when configured as shown in FIG. 12, provides the ability to shepherd first expandable member 1202 further in its arc shape cutting path by applying lateral force to cutting tip 1208 as it cuts through tissue 1210 . This further prevents cutting tip from accidentally cutting too deep through a wall like tissue and thus perforating the wall and turning a cavity into a passage. [0072] Additional pharmaceutical methods may be employed to control the duration of action. Controlled delivery may be exercised by selecting appropriate macromolecules (for example polyesters, polyamino acids, polyvinyl, pyrrolidone, ethylenevinylacetate, methylcellulose, carboxymethylcellulose, or protamine, sulfate) and the concentration of macromolecules as well as the methods of incorporation in order to control release. Another method to control the duration of action by controlled release preparations is to incorporate the agent into particles of a polymeric material such as polyesters, polyamino acids, hydrogels, poly(lactic acid) or ethylene vinyl acetate copolymers. Alternatively, instead of incorporating these agents into polymeric particles, it is possible to entrap these materials in microcapsules prepared, for example, by coacervation techniques or by interfacial polymerization, for example, hydroxymethylcellulose or gelatin microcapsules and poly(methylmethacylate) microcapsules, respectively, or in colloidal drug delivery systems, for example, liposomes, albumin microspheres, microemulsions, nanoparticles, and nanocapsules or in macroemulsions. [0073] The drug-delivery tool and method of the present invention may employ a wide variety of agents, for example, ranging from active compounds to markers to gene therapy compounds. Exemplary agents, contemplated for use herein, are set forth in U.S. Pat. Nos. 5,840,059; 5,861,397; 5,846,946; 5,703,055; 5,693,622; 5,589,466; and 5,580,859, each expressly incorporated herein by reference. In one embodiment, for example, the invention is employed to deliver one or more genes (for example, as so-called “naked DNA”) into cavities formed in the myocardium of a subject. [0074] In appropriate situations, the agent can be delivered in a form that keeps the agent associated with the target tissue for a useful period of time, such as with a viscosity-enhancer to produce a thixotropic gel. In certain embodiments, the therapeutic or diagnostic agent is mixed with a viscous biocompatible polyol to maintain prolonged, high concentration of the agent in the channels and affect the kinetics of the agent-target region interaction. [0075] Alternatively, a catheter could be employed to deliver an agent incorporated in a biocompatible polymer matrix. Suitable polymeric materials are known in the art, for example, as set forth in U.S. Pat. No. 5,840,059, incorporated herein by reference. For example, non-biodegradable polymers can be employed as hollow reservoirs or other structures. Additionally, conventional pharmacologically inert fillers may be employed to tailor the time release characteristics of the agent. Certain embodiments contemplate the use of biodegradable polymers, such as collagen, polylactic-polyglycolic acid, and polyanhydride. For example, the agent can be dispersed in a polymer which is configured to degrade over a useful period of time, releasing the agent. In one embodiment, the agent is released by swelling and sloughing of the biodegradable polymer. Various means for employing polymer compounds to secure a therapeutic agent are disclosed, for example, in Levy et al., WO 94/21237 and in U.S. application Ser. No. 08/033,307, filed Mar. 15, 1993, which is hereby incorporated by reference. In still other embodiments, a biocompatible material is delivered to seal and retain the agent within the cavity. For example, a delivery lumen could be employed to deliver a sealing agent after delivery of the agent. [0076] Those skilled in the art can now appreciate from the foregoing description that the broad teachings of the present invention can be implemented in a variety of forms. Therefore, while this invention has been described in connection with particular embodiments and examples thereof, the true scope of the invention should not be so limited. Various changes and modification may be made without departing from the scope of the invention, as defined by the appended claims. For example, the expandable members of the tissue-penetrating implement can be configured not to expand, but rather to maintain a substantially constant configuration as it is moved between its retracted and advanced conditions. By this construction, the cage or skeleton structure defined by the expandable members can serve, when inserted into a tissue, to help form a temporary cavity, and maintain the cavity as one or more selected agents are delivered and/or drawn therein. Thus, while an expandable member (as described above) is advantageous for many purposes, a non-expandable cage or skeleton in place of the previously described expandable member can provide useful advantages, as well.

The present invention provides an drug-delivery tool and method for delivering a selected diagnostic or therapeutic agent to a target site within a selected body tissue, such as the myocardium of the heart. In one embodiment, the drug-delivery tool is configured to be introduced percutaneously for intravascular delivery into temporary cavities formed in the myocardium from the epicardial surface. In another embodiment, the drug-delivery tool is configured for intraoperative use, to be introduced thoracoscopically or through a thoracotomy, to form temporary cavities in the myocardium from the epicardial surface. The drug-delivery tool generally comprises an accessing device having a tissue-penetrating implement in its distal-end region, and means for delivering a selected agent in a cavity formed by the implement. In an exemplary use, wherein a patient's heart is treated with an agent for transferring genetic information to the heart tissue, the distal end of the accessing device is conditioned adjacent a selected region of the heart wall, and the tissue-penetrating implement is advanced to form a temporary channel in the myocardium. The gene-therapy agent is introduced into the cavity by the delivery means and retained therein by means overcoming the intra-myocardial pressures. In one embodiment, the treated tissue is stunned, ischemic or hibernating organ tissue that has at least partially lost its normal capillary ability at natural vasomotion.

CROSS-REFERENCE TO RELATED APPLICATION(S) [0001] This application claims priority to U.S. Provisional Application Ser. No. 60/933,321, filed on Jun. 5, 2007, the entire content of which is incorporated herein by reference. FIELD OF THE INVENTION [0002] The invention is directed to the use of semiconductor-based core-shell nanoparticles for blocking selected wavelengths of electromagnetic radiation. BACKGROUND OF THE INVENTION [0003] Sunscreens have long been used to block the UV rays that cause skin damage. The shorter UVB wavelengths are the principle cause of sunburn, though UVA wavelengths can penetrate and harm deeper layers of the skin. Because both UVA and UVB wavelengths cause skin damage, an effective sunscreen should block both. Traditionally, chemical sunscreens and physical sunblocks are effective against either UVA or UVB, so a combination of different ingredients is required for protection against the full UV spectrum. [0004] Chemical sunscreens and physical sunblocks each have disadvantages. Chemical sunscreens are generally large organic molecules that absorb certain wavelengths of UV. Although they can be formulated to cover specific bands of the UV spectrum, they can trigger skin sensitivity or allergic reactions, or affect hormonal activity. Some chemical sunscreens are affected by exposure to the sun and degrade after some time, so there is a need to add chemical stabilizers to the sunscreen formulation. In the United States, chemical sunscreens are regarded as drugs, so development of new sunscreens is limited by the drug regulation process. [0005] Physical sunblocks are typically micronized particles of zinc oxide or titanium dioxide about 500 to 2000 nm in size. Titanium dioxide protects only against radiation wavelengths shorter than 360 nm, while zinc oxide protects against radiation wavelengths shorter than 380 nm. Since the UVA band ranges from 315-400 nm, and some suggest total protection up to 420 nm, the current physical sunblocks are insufficient to fully protect from the total harmful spectrum of sunlight. Although these particles are thought to be less irritating than chemical sunscreens, they are more difficult to spread evenly on the skin and tend to leave the skin chalky and white, both cosmetically unacceptable consequences. Newer formulations use nanoparticles, solving the cosmetic issues but raising possible health concerns. Particles under 40 nm are suspected to be able to penetrate the skin, where they can potentially cause subcutaneous damage. Both zinc oxide and titanium dioxide are photoactive, meaning they catalyze chemical reactions when exposed to light. Because the high surface area of such nanoparticles provides many catalytic sites, there is the possibility that the nanoparticles themselves can cause skin damage, including damage to cellular DNA. Furthermore, there is evidence that titanium dioxide nanoparticles are taken up by the roots of trees and interrupt plant growth. Because sunscreen use is widespread and ever increasing, environmental considerations are important in sunscreen development. SUMMARY OF THE INVENTION [0006] In one embodiment of the present invention, a semiconductor nanoparticle core that prevents transmission of light below a specified wavelength is encapsulated by a biologically inert shell. The core-shell nanoparticle is small enough to be spread easily on the skin without creating a chalky white film, yet large enough to prevent diffusion through the outer skin layer or penetration into cells. In another embodiment of the invention, a single shell encapsulates several semiconductor nanoparticle cores of the same size. [0007] In another embodiment of the invention, the above-described particles may be suspended in a cream or lotion and applied to skin for protection against UV wavelengths from sunlight. [0008] Still another embodiment of the invention includes the method for producing the above-described particles. [0009] Thus, the invention includes a plurality of particles for blocking electromagnetic radiation, each particle having at least one semiconductor core encased within a shell, the semiconductor cores being of substantially uniform diameter, such diameter selected according to the quantum size effect such that radiation incident on the particles is absorbed below a preselected radiation wavelength. In one embodiment, the diameter of the semiconductor cores does not vary between semiconductor cores by more than a preselected percentage. In another embodiment, the diameter may fall within the range of approximately one to approximately five nanometers, possibly approximately four or approximately three nanometers. In further embodiments, each particle may include a single semiconductor core surrounded by a single shell, or a plurality of semiconductor cores surrounded by a single shell. The core may also be include silicon and the shell may include a compound containing silicon. [0010] The invention may also include a method of forming particles having at least one semiconductor core encased within a shell, the method comprising; forming the at least one semiconductor core in a first reaction zone; and forming a shell encapsulating the at least one semiconductor core in a second reaction zone. In one embodiment, the semiconductor cores can be processed by agglomerating a plurality of semiconductor cores together prior to formation of the encapsulating shell. BRIEF DESCRIPTION OF THE DRAWINGS [0011] The above and other features and advantages of the present invention will be better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings in which: [0012] FIG. 1 is a schematic of a core-shell particle, where the core has a diameter d and the shell creates a particle with diameter D; [0013] FIG. 2 is a schematic of a multicore-shell particle, where each core particle has a diameter d and the shell encapsulates more than one core to create a particle with diameter D; [0014] FIG. 3 is an absorbance spectrum of an ideal sunscreen containing particles of uniform size showing a sharp absorption edge at 400 nm; [0015] FIG. 4 is an absorbance spectrum of a sunscreen containing nanoparticles of varying size showing a gradual decline in absorbance at increasing radiation wavelengths; [0016] FIG. 5 is a plot showing absorbance spectra of Si/SiO x core-shell nanoparticles grown from silane/Ar in an inductively-coupled plasma and deposited for 30, 60, and 120 minutes on a quartz substrate, where the cores are of approximately the same size and the spectra show fairly sharp declines in absorbance around 400 nm; [0017] FIG. 6 is a schematic of a two-zone reactor for producing core-shell nanoparticles; [0018] FIG. 7 is a schematic of a four-zone reactor for producing multicore-shell nanoparticles. DETAILED DESCRIPTION OF THE INVENTION [0019] The present invention is directed to the use of core-shell nanoparticles having semiconductor cores of substantially uniform diameter to block selected wavelengths of electromagnetic radiation. The size of the semiconductor cores determines which radiation wavelengths are blocked, while the shell thickness and composition establish the size and surface characteristics of the overall particle. The independent nature of the semiconductor core and the shell allows a particle to be designed to meet specific needs. [0020] In one embodiment, a core-shell particle 10 includes a semiconductor core 12 encapsulated by a shell 14 , as shown in FIG. 1 . In another embodiment, a multicore-shell particle 20 includes a plurality of semiconductor core particles 22 encapsulated by a shell 24 , as shown in FIG. 2 . The semiconductor core particles 12 and 22 each have a diameter substantially equal to d, and are composed of silicon, germanium or any other material or combination of materials suitable for blocking transmission of electromagnetic radiation. Suitable materials for the semiconductor core 12 or 22 include materials that exhibit the quantum size effect, can be made into core particles of the appropriate size, and block the transmission of radiation of the desired wavelengths. One method of blocking transmission of electromagnetic radiation is by absorption. A suitable material for the semiconductor core 12 or 22 may be tuned to efficiently absorb light below a specified radiation wavelength by adjusting core size or by doping, which is the addition of other materials. The shells 14 and 24 each have an outer diameter D, and are composed of silicon dioxide, silicon nitride, aluminum oxide, titanium oxide or any other suitable material or combination of materials. Suitable materials for the shell 14 or 24 include materials that allow at least partial transmission of radiation wavelengths that are absorbed by the cores 12 or 22 ; are inert to air, skin and oils; prevent or reduce oxygen diffusion into the semiconductor core; or impart other desirable characteristics in the core-shell particle 10 or 20 . In the multicore-shell particle 20 , each semiconductor core 22 has a protective layer 26 to prevent the semiconductor cores 22 from fusing together to create larger particles. This change in particle size would affect the absorbance spectrum of the particle. The protective layer 26 may be the same material as the exterior shell 24 or other suitable material. Suitable materials for the protective layer 26 include materials that prevent the bare surfaces of the semiconductor cores 22 from fusing and allow for agglomeration of the semiconductor cores into clusters. [0021] The absorption edge for a single particle is the wavelength of electromagnetic radiation at which absorption by the particle sharply increases. Typically a material absorbs all wavelengths of radiation shorter than the critical wavelength defined by the absorption edge. An ideal sunscreen would be one that blocks all harmful UV wavelengths but does not block any visible light. If the sunscreen blocks visible light, the color of the skin can change according to the wavelengths of visible light affected by the sunscreen. Therefore, the absorbance spectrum 30 of an ideal sunscreen would resemble a step function, as represented in FIG. 3 . The absorbance spectrum 30 shows complete absorbance of radiation wavelengths corresponding to UVB and UVA regions 32 . Absorbance edge 34 shows a sharp decline in absorbance around 400 nm, the upper bound of the UVA region. The absorbance spectrum 30 shows no absorbance in the visible light region 36 . [0022] As set forth below, at small particle sizes, the absorption edge is a function of semiconductor core particle size due to the quantum size effect. If the bulk of the core particles was of substantially uniform size, small amounts of differently-sized particles would not significantly change the absorbance spectrum. However, a sunscreen containing a large distribution of semiconductor core particle sizes has a corresponding distribution of individual absorption edges. This results in an overall spectrum 40 with a gradual decrease in absorbance 42 as radiation wavelength increases, as shown in FIG. 4 . In order to get full protection from UV wavelengths 44 in a sunscreen containing a large distribution of semiconductor core particle sizes, the sunscreen would have to be designed to block out some visible light 46 . Such a sunscreen would be cosmetically unacceptable because it would change the color of the skin. For example, if the sunblock absorbed violet and blue light, the skin would appear have a yellowish tint because the absorbed light wavelengths would not be available for reflection by the skin. If the sunblock absorbed all visible light, the skin would appear black. To address this issue, one embodiment of the present invention is a sunscreen comprised of semiconductor core particles of substantially uniform size. When in a dispersed phase, these similarly-sized particles can be referred to as “monodisperse.” This monodisperse product retains the desired sharp absorption edge of a single semiconductor core particle, so only harmful UV rays are blocked and skin color remains unaffected. FIG. 5 shows the absorbance spectra of Si/SiO x core-shell nanoparticles grown from a silane/Ar reaction in an inductively-coupled plasma. The shell oxide was formed by spontaneous oxidation in ambient conditions. Spectra 50 , 52 and 54 show absorbance of radiation by particles deposited on a quartz substrate for 120, 60 and 30 minutes, respectively. The spectra 50 and 52 show fairly sharp declines in absorbance 56 and 58 , respectively, around 400 nm. The spectra 50 , 52 and 54 all show very little absorption in the visible light region 59 . [0023] By selecting a semiconductor core material that both exhibits a quantum size effect and can be made into nanoparticles of uniform size, the core-shell product may have a tunable absorbance spectrum with a sharp cutoff. This is a desirable property for a sunscreen because it completely blocks harmful UV rays without affecting skin color. One advantage of this method over current sunscreen formulations is that in one embodiment only one active ingredient is required to block the entire spectrum of harmful rays. [0024] In an embodiment of the invention, the semiconductor core 12 or 22 of the particle 10 or 20 is made of silicon. Silicon is the second most abundant element in the Earth's crust. Due to the widespread use of silicon in the electronics industry, the requisite precursors and techniques for making nanoparticles are readily available. Silicon is a semiconductor, and like all semiconductors, there is a quantum size effect at small particle sizes wherein a deviation from bulk properties occurs. The energy band gap increases as particle size decreases, and there is a corresponding decrease in the radiation wavelengths absorbed. This means that the absorbance spectrum for a silicon nanoparticle may be tuned by adjusting the size of the particle itself. The size of the particle can be changed in several ways. One method is to increase residence time in the reactor to allow the particle to grow larger. Another is to oxidize the surface of the particle to reduce the effective size of the core material. Still another method of changing particle size is to allow small particles with bare surfaces to cluster together and fuse into a larger particle. A further benefit of using silicon is that any particles released into the environment naturally degrade into silicon dioxide, or sand. The timescale for degradation depends on the thickness and composition of the shell, but oxygen diffusion through any shell will eventually occur. [0025] In one embodiment using silicon, the size of the semiconductor core 12 or 22 required to put the absorption edge 34 around the UV-visible light spectrum is a dimension chosen from the approximate range 1-5 nm. The preferred semiconductor core size range is between 2-4 mm or more specifically, 2.5-3.5 nm. The semiconductor core diameter may be chosen from a range, but all of the semiconductor cores must be substantially uniform in diameter. Substantially uniform means that the majority of particles will deviate from the mean diameter by no more than a specified percentage. That percentage ranges from 5-25%. Particles of this small length scale may be able to penetrate the skin to cause subcutaneous damage. Although silicon itself is inert, the effects of any particles of such small scale are not yet well understood. Further, silicon is readily oxidized to silicon dioxide in the presence of oxygen at ambient conditions, so it is impossible to expose skin to bare silicon. The formation of an oxide layer also decreases the effective size of the semiconductor core, thus affecting the absorption edge. To protect the integrity of the semiconductor core 12 or 22 and to increase the size of the overall core-shell particle 10 or 20 to prevent subcutaneous penetration, a shell 14 or 24 is grown to encapsulate the semiconductor core 12 or 22 . [0026] In one embodiment, the shell 14 or 24 can be a silicon oxide. Silicon oxides are biologically inert and do not trigger skin sensitivity or allergies. Also known as silica, it is the principal component of glass and sand, and is even used in food applications as a flow agent for powders. Silicon oxides form easily on silicon surfaces. The prevalence of silicon oxide use in the electronics industry has led to the vast availability of both raw materials and techniques for its precise manufacture. In one embodiment, the silicon dioxide shell 14 , 24 or 26 may be grown as large as desired and may be designed to become more or less hydrophilic. It is naturally hydrophilic, which makes it more difficult to penetrate the skin. The surface of the shell 14 or 24 may also be altered by chemical or physical means to provide other desired characteristics. It is therefore possible to make a core-shell particle 10 or 20 with a semiconductor core 12 or 22 of particular size for selective radiation absorption, yet independently change other characteristics of the core-shell particle 10 or 20 by tuning the size and composition of the shell 14 or 24 . [0027] The shell 14 or 24 can be of any thickness. In one embodiment, the minimum thickness of a silicon dioxide shell 14 or 24 on a silicon core 12 or 22 is about 5 nm. This is the size at which oxygen diffusion through the silicon dioxide shell 14 or 24 is slow enough that the silicon core 12 or 22 is effectively protected from further oxidation and will therefore remain constant in size over the lifetime of the product. In another embodiment, the shell 14 or 24 is sized such that the core-shell particle 10 or 20 is too large for subcutaneous absorption. The preferred size of core-shell particle 10 or 20 would be between about 40 nm, the size at which particles can no longer be subcutaneously absorbed, and 100 nm, the size at which the particle begins to scatter visible light and create a white or chalky film on the skin. In one embodiment, the core-shell particle 10 or multicore-shell particle 20 may be of a size and surface characteristic such that the core-shell particles 10 or multicore-shell particles 20 spontaneously aggregate in suspension to create core-shell or multicore-shell particle bunches that are large enough to prevent subcutaneous penetration. In such cases, the individual core-shell particles 10 or multicore-shell particles 20 may be as small as 10 nanometers. [0028] In one embodiment, the multicore-shell particle 20 may be composed of several semiconductor cores 22 encased within a single shell 24 . This increases the absorption capacity of each multicore-shell particle 20 since there are more radiation-absorbing semiconductor cores 22 per unit volume. However, the effective size of each semiconductor core 22 may remain the same, so the sharp absorption edge 34 is unaffected. One method of making the multicore-shell particles 20 is to make the semiconductor cores 22 , grow a protective layer 26 on each, aggregate the semiconductor cores 22 into small clusters, then finally grow another shell 24 to encapsulate the entire cluster. A protective layer 26 is grown on each semiconductor core 22 to prevent them from fusing to form larger particles, which would affect the absorption characteristics. The size of the overall multicore-shell particle 20 , established by the size of the cluster and the thickness of the final shell 24 , determines whether it can be subcutaneously absorbed or form a chalky residue on the skin. The number of semiconductor cores 22 in the multicore-shell particle 20 is limited by the number of semiconductors 22 that can physically fit within the specified size of the multicore-shell particle 20 . There may be as few as two semiconductor cores 22 within the shell 24 to create a multicore-shell particle 20 . The final shell 24 may be adjusted to impart different surface characteristics in the overall multicore-shell particle 20 . [0029] One embodiment of the invention is a process for creating silicon core particles 12 or 22 with a narrow size distribution. One method for producing silicon core particles 12 or 22 of substantially uniform size is in a plasma reactor using silane gas (SiH 4 ) in an aerosol reaction. In one embodiment of this invention, the reactor consists of a quartz tube 1″ in diameter and 6″ in length, wrapped with an inductive coil and mechanically pumped down to a pressure of 100 mTorr. The coil is used to deliver 100 W of power through a matched network to an inductively coupled plasma formed inside the tube. 20 ppm of silane in argon serves as the precursor to particle formation and is passed through the tube. Alternate reaction parameters include increasing the quartz tube up to 4″ in diameter, increasing the operating pressure up to 10 Torr, increasing power inputs ranging up to 2000 W, and increasing precursor concentration up to 4% silane in argon. [0030] There are several ways to grow an encapsulating layer 14 , 24 or 26 , such as an oxide layer on a semiconductor material. The choice of method may affect the properties of the oxide. One method for silicon is natural oxidation. Silicon is highly reactive with oxygen at ambient conditions, and an oxide layer up to about 5 nm thick will spontaneously form on a silicon surface. The rate of oxidation increases exponentially with temperature according to kinetic rate laws and. increasing oxygen concentration also increases the oxidation rate. Oxygen diffuses through each subsequently formed silicon dioxide layer to react with the silicon beneath. However, this native oxide layer 14 or 26 is formed out of the silicon base itself, and therefore reduces the size of the silicon core 12 or 22 . One could design this into the process by starting with a semiconductor core 12 or 22 slightly larger than the size required for the desired absorption edge, such that subsequent conversion of semiconductor into an oxide would reduce the semiconductor core 12 or 22 to the intended size. But a remaining disadvantage of this process is that the native oxide layer 14 or 26 cannot be greater than about 5 nm thick. Diffusion of oxygen through an oxide layer of that thickness is slow enough that it would be impractical to grow a thicker layer by this method. [0031] In order to grow a silicon oxide layer thicker than 5 nm, one must employ a different technique. Shell 14 , 24 or 26 overgrowth may be accomplished in a reactor using either tetraethyl orthosilicate (TEOS, Si(OCH 2 CH 3 ) 4 ) or a mixture of silane and oxygen (SiH 4 +O 2 ). The reactor for either technique may be a quartz tube in a furnace or a plasma gas reactor. Jet injection/turbulent mixing of the precursor, either TEOS or oxygen, will lead to more uniform oxide growth. Silicon oxidation may also be carried out with molecular oxygen (O 2 ). The shell 14 , 24 or 26 produced by this method may be up to 20 nm thick. [0032] Agglomeration of particles will occur spontaneously because of the small scale. To control to size of the clusters formed, it is crucial to control the residence time in the agglomeration zone of the reactor. Residence time will depend upon particle concentration, particle size, particle size distribution, gas pressure and gas temperature. Temperature and particle concentration may also be used to control the size of the clusters formed. Increasing temperature, particle concentration and particle size distribution leads to faster agglomeration while decreasing gas pressure increases agglomeration for the particle size of interest. As particles emerging from a plasma are usually charged, a corona discharge or charge neutralization source may be necessary in this zone to enable particle agglomeration. [0033] In one embodiment of the invention as shown in FIG. 6 , a reactor used to produce core-shell particles 10 includes a) a short reaction zone for forming monodisperse semiconductor cores 12 and b) a shell 14 overgrowth zone to accomplish the desired final size. The zones may be either separate regions of a single reactor or separated into distinct reactors. Those with ordinary skill in the field will understand that permutations of this scheme are possible and that some characterization, adjustments and calibration are required to get the desired result. [0034] In one embodiment of the invention as shown in FIG. 7 , a reactor used to produce multicore-shell particles 20 includes a) a short reaction zone for forming monodisperse semiconductor cores 22 , b) a zone for growing a protective layer 26 around each semiconductor core, c) an adjustable afterglow zone to permit controlled agglomeration of particles into clusters and d) a shell 24 overgrowth zone to accomplish the desired final size. The zones may be either separate regions of a single reactor or separated into distinct reactors. Those with ordinary skill in the field will understand that permutations of this scheme are possible and that some characterization, adjustments and calibration are required to get the desired result.

A plurality of particles for blocking electromagnetic radiation wherein each particle includes at least one semiconductor core encased within a shell, the semiconductor cores being of substantially uniform diameter, which diameter is selected according to the quantum size effect such that radiation incident on the particles is absorbed below a preselected radiation wavelength. In particular embodiments, the diameter may not vary between cores by more than a preselected percentage, and the diameter may fall within the range of approximately one to approximately five nanometers. Each particle may have a single semiconductor core surrounded by a single shell or a plurality of semiconductor particles surrounded by a single shell. In other embodiments, the particles may be created by forming at least one semiconductor core in a first reaction zone and forming a shell encapsulating the at least one semiconductor core in a second reaction zone. A plurality of semiconductor cores may optionally be agglomerated together before the shell is formed.

PRIORITY CLAIM [0001] The present application claims priority to U.S. Provisional Application Ser. No. 60/800,951 filed May 17, 2006 and entitled, “RECOMBINED WHOLE GRAIN WHEAT HAVING VISUALLY INDISTINGUISHABLE PARTICULATE MATTER AND RELATED BAKED PRODUCTS”, which is herein incorporated by reference to the extent not inconsistent with the present disclosure. FIELD OF THE INVENTION [0002] The invention relates generally to baking products with whole grains. The invention relates more particularly to whole grain products made with recombined whole grain flour. BACKGROUND OF THE INVENTION [0003] For centuries, grains have been grown and harvested as one of the most basic food staples. Grains including corn, wheat, durum, rye, oats and others are traditionally ground into flour for use as the main building block for making a variety of baked goods, including breads, pastas, tortillas and dessert items. [0004] Regardless of the grain type, the individual grain kernels comprise a fibrous exterior shell referred to as bran, an interior starch portion called the endosperm, and a nutrient-rich core called the germ. During milling of the grain kernels, processes can be used to separate and remove the bran and germ from the endosperm resulting in a refined grain that is almost pure starch. While refined grains have advantages such as appearance and consistency, health studies have suggested that diets high in starches, like those from refined grains, play a role in certain unhealthy conditions, such as, obesity, heart disease and diabetes among others. Conversely, many of these same studies have indicated that the use of whole grains or grains that contain the entire kernel, including the bran, endosperm and germ, promote certain health advantages. [0005] One reason suggested for the health advantages associated with whole grains is that the bran and germ are both nutrient-rich portions of the grain kernel and include concentrated portions of essential vitamins and nutrients. Further, the fibrous make-up of bran provides an excellent source of dietary fiber. Studies have shown that diets rich in whole grains can reduce the risk of heart disease, diabetes and certain cancers. Furthermore, other studies have suggested that individuals who consume whole grains tend to eat less, and as a consequence, may weigh less or lose weight. [0006] While the use of whole grains in baking provides numerous health benefits, the use of whole grains can lead to a significant difference in appearance compared to traditional white breads made with refined wheat. In particular, the use of whole grains in baking products can result in visual particulate matter that is visible and distinguishable in the final baked product due to color and size differences between the bran, endosperm and germ. To the consumer, the presence of visual particulate matter and color differences may be less preferred than, for example, refined, white-style bread, which tends to have very uniform color and generally no visible particulates. [0007] Due to the specific health benefits associated with bran consumption, it may be desired to provide a bran fortified whole grain for use in preparing whole grain products. However, bran generally makes up the majority of the visual particulate matter in whole grains, such that, a bran fortified whole grain can have significantly larger amounts of visible particulate matter making the bran fortified whole grain visually less preferred than a non-fortified whole grain. SUMMARY OF THE INVENTION [0008] The invention addresses the aforementioned needs of providing a whole grain product comprising recombined whole grain constituents that are recombined so as to provide minimal visual impact to the whole grain product. By selectively controlling the particle size of the milled bran and germ constituents used in the recombined whole grain, the visual impact associated with bran and germ particulates can be substantially eliminated from the recombined whole grain. In particular, presently contemplated embodiments can comprise a whole grain product, such as, whole grain breads, dough products, mixes and biscuits made with recombined whole grain flour. Representative embodiments of recombined whole grain products contemplated by the present disclosure are advantageous in that they incorporate the health advantages associated with whole grains while eliminating the characteristic, visual color differences noticeable within the crumb due to particulates, such as, bran and germ particulates found in traditional whole grain products. [0009] Within the scope of the disclosure, recombining whole grain constituents that have been milled to desired particle sizes, have been found to produce a whole grain flour wherein particulate matter, such as, for example, bran particulates and germ particulates, have little to no visual impact on the overall appearance of the recombined whole grain flour. When milled bran and germ particulate matter is present in a size range of about 0.006 inches to about 0.017 inches, the milled bran and germ particulate matter has been found to have minimum particulate visibility against the majority endosperm background of a baked good. In an alternative embodiment, the bran and/or germ particulate matter can be present in a size range from about 0.007 inches to about 0.015 inches. Particulate matter can comprise bran particulate matter and/or germ particulate matter. [0010] In one aspect, the disclosure is directed to representative embodiments of whole grain baked products made with recombined whole grain flour. Presently contemplated whole grain flour based baked products can comprise bread, biscuits, bagels, bread sticks, buns, cakes, rolls, English muffins, pizza crust, tortillas, pancakes, waffles, battered and breaded products, such as, for example, corn dogs and breaded vegetables, cookies, soft and hard pretzels, crackers and the like. The recombined whole grain based baked products can comprise products in a variety of states, such as, for example, raw, partially or par-baked, pre-baked, fresh baked and shelf-stable baked products. In some representative embodiments, these recombined whole grain products can subsequently be refrigerated and/or frozen for use and/or storage. [0011] In another aspect, the disclosure relates to embodiments of a non-fully baked, recombined whole grain dough, e.g., a raw or par-baked recombined whole grain dough, made with recombined whole grain flour. The recombined whole grain dough can be freshly prepared for immediate use or can comprise a frozen or refrigerated recombined whole grain dough for use at a time subsequent to dough preparation. Representative recombined whole grain dough products can comprise pizza crust dough, bread dough, cake dough, roll dough, biscuit dough and bread stick dough. [0012] In another aspect, the disclosure relates to embodiments of a recombined whole grain baking mix made with recombined whole grain flour for preparing whole grain baked products having little to no visible particulate matter. The recombined whole grain baking mix can comprise a substantially anhydrous complete mix requiring only the addition of at least one liquid or wet ingredient, such as, for example, water, oil and/or eggs, or a concentrated mix or premix comprising one or more functional ingredients blended into an amount of recombined whole grain flour requiring the addition of bulk ingredients, such as, for example, a bulk portion of recombined whole grain flour at a time of preparation. Concentrated mixes or premixes can be formulated to include any number of functional ingredients based upon a desired level of completeness by a user of such concentrated mix or premix, which is frequently a commercial bakery or food service group. Representative recombined whole grain mixes, in either a complete or concentrated mix/premix can comprise mixes for bread dough, pizza crust, cakes, brownies, cookies, pancake batter, muffins as well as variety baking mixes, such as, for example, Bisquick® mix. [0013] In another aspect, the disclosure relates to partially baked or “par-baked” whole grain products made with recombined whole grain flour. Generally, the par-baked whole grain product requires an additional thermal processing step, such as, for example, heating, baking, frying, microwaving and the like, to achieve a fully baked format. [0014] In another aspect, representative methods for preparing a recombined whole grain baked product can comprise milling bran and germ particulate matter to desired particle sizes so as to reduce and/or substantially eliminate the visual impact of the particulate matter within the recombined whole grain baked product. The recombined whole grain baked products achieve commonly accepted standards for whole grain baked products including Baked Specific Volume, slice height, symmetry and cell structure. [0015] In another aspect, a representative embodiment of a whole grain baked product can comprise an amount of recombined whole grain flour so as to achieve recommended whole grain levels as suggested and promulgated by the Whole Grains Council of Boston, Mass. For instance, whole grain baked products of the present disclosure can comprise levels of recombined whole grain flour in an amount satisfying the “Good Source” standard of at least 8 grams of whole grains per serving. Alternatively, the whole grain baked products can comprise levels of recombined whole grain flour in an amount satisfying the “Excellent Source” standard of at least 16 grams of whole grains per serving. Finally, the whole grain baked products can comprise recombined whole grain flour satisfying the “100% Whole Grain” standard wherein all of the grains are whole grains. In some embodiments, recombined whole grain flour can comprise 100% of the total whole grains within the whole grain baked product. [0016] In another aspect, whole grain constituents can be recombined so as to form fortified versions of recombined whole grain flour. For example, a bran fortified whole grain flour can be prepared through the addition of milled bran in amounts exceeding the level of bran typically found in whole grain flour. In addition to adding milled bran, milled germ can be added either individually or in combination with the milled bran to form a germ or bran/germ fortified whole grain flour. [0017] As used throughout the present disclosure, “recombined whole grain product” refers to whole grain products, such as, but not limited to, biscuits, bagels, bread sticks, buns, cakes, rolls, English muffins, pizza crust, tortillas, pancakes, waffles, batter-based products, breaded products, cookies, soft pretzels, hard pretzels and crackers, that are formulated using a fortified or non-fortified recombined whole grain flour. [0018] As used throughout the present disclosure, the term “fortified” is intended to refer to the addition of one or more components that are generally already present within whole grain flour beyond the levels generally attributed to milling of a whole grain. One representative example can include a bran fortified recombined whole grain flour where the amounts of bran added during a recombination step can exceed the levels of bran that would be present from simply milling the whole grain. In addition, recombined whole grain flour according to the present disclosure can be fortified with increased amount of germ, either individually or in combination with bran. [0019] As used throughout the present disclosure, the term “recombined” is intended to describe the reintegration of individual grain components such as, for example, endosperm, bran and germ, into an integral, whole grain flour. The individual grain components can be previously separated for any of a variety of reasons including for individual milling of bran and/or germ to desired particle sizes. BRIEF DESCRIPTION OF THE DRAWINGS [0020] The disclosure may be more completely understood in consideration of the following detailed description of various representative embodiments of the invention in connection with the accompanying drawings, in which: [0021] FIG. 1 is a representative depiction of a section view of a grain kernel. [0022] FIG. 2 is a schematic illustration of a representative milling process for milling a refined, wheat flour. [0023] FIG. 3 is a schematic illustration of a representative milling process for milling a whole grain wheat flour. [0024] FIG. 4 is a schematic illustration of a representative milling process for milling a whole grain wheat flour having particulate matter that is visually indistinguishable to an unassisted eye. [0025] While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the appended claims. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0026] In representative embodiments of the invention as disclosed herein, whole grain baked products and related whole grain products are comprised of recombined whole grain flour. Representative embodiments of recombined whole grain flour comprise individually milled and recombined portions of endosperm, bran and germ, wherein the bran portion and/or germ portions are milled to have particle sizes within a desired particle size range wherein the desired particle size range has been found to minimize the visual and color impact of the bran and/or germ within the recombined whole grain flour. In some embodiments, the bran and/or germ portions can be milled to have particle sizes from about 0.006 inches to about 0.017 inches. In another representative embodiment, the bran and/or germ portions can be milled to have particle sizes from about 0.007 inches to about 0.015 inches. An embodiment of the whole grain baked products and related products can be formulated such that the recombined whole grain flour comprises from about 0.1% to about 100% of the farinaceous content. In another alternative embodiment, the whole grain baked products and related products can be formulated such that recombined whole grain baked products can comprise a good source of whole grain providing at least 8 grams of whole grain per serving. In another alternative embodiment, the whole grain baked products and related products can be formulated, such that, the recombined whole grain baked products comprise an excellent source of whole grain providing at least 16 grams of whole grain per serving. [0027] As illustrated in FIG. 1 , a grain kernel 100 comprises a hard outer shell called bran 102 , a nutrient-rich core called germ 104 and an interior starch portion called endosperm 106 . Grain kernel 100 is representative of differing grain varieties, such as, for example, wheat kernels (including spring and winter wheat, as well as, varieties including red, white, spelt, emmer, faro, einkorn, Kamutg, and durum), amaranth, barley, buckwheat, corn (including whole cornmeal and popcorn), millet, oats, quinoa, rice (including brown and colored rice), rye, sorghum, teff, triticale and wild rice. When grain kernel 100 comprises a wheat kernel, bran 102 generally comprises about 14.5% by weight of the kernel, germ 104 generally comprises about 2.5% by weight of the kernel and endosperm 106 generally comprises the balance or about 83% by weight of the kernel. As will be understood by one of skill in the art, the amounts of bran 102 , germ 104 and endosperm 106 will vary according to the grain type. [0028] In a conventional milling operation 108 as schematically illustrated in FIG. 2 , grain kernel 100 can be milled to form refined flour 110 . In its most basic form, milling operation 108 can comprise a grain cleaning step 112 , a grain conditioning step 114 , a grain grinding step 116 , a grain sifting step 118 and a grain purifying step 120 . When making refined flour 110 , grain purifying step 120 is followed by a bleaching step 122 and an enrichment step 124 . [0029] Within grain cleaning step 112 , a variety of processes can be utilized to separate the grain from foreign materials. Representative cleaning techniques can comprise the use of magnetic separators, vibratory screens, air aspirators, de-stoning machines, disc separators, scourers, used individually or in suitable combinations. [0030] Within grain conditioning step 114 , a variety of processes can be utilized to prepare the grain for grinding. Representative conditioning processes can include a tempering process and an impact scouring step, applied individually or in combination. [0031] Within grain grinding step 116 , grain kernel 100 is gradually reduced to a smaller, desired flour size by passing size graded kernels and middlings through rollers adjusted to break the grain kernel 100 into the bran 102 , germ 104 and endosperm 106 . Representative roller adjustments can include roller positioning, roller speed and selection of the rolling surface. [0032] Within grain sifting step 118 , the ground bran 102 , germ 104 and endosperm 106 can be shaken and separated within a series of box-like sifters having screens with openings that get sequentially smaller and smaller. Generally, large particles are shaken and removed from a top sifter while the finest particles or flour sift to the bottom. [0033] Within grain purifying step 120 , the ground bran 102 is lifted and separated from germ 104 and endosperm 106 by a controlled air stream. The remaining germ 104 and endosperm 106 can then be passed through a series of break rolls wherein germ 104 is flattened for easier separation and the endosperm 106 is ground into flour. [0034] Within bleaching step 122 , the flour consisting essentially of ground endosperm 106 is exposed to a bleaching-maturing agent, such as, for example, chlorine gas or benzoyl peroxide, to both whiten the flour and mature or oxidize the flour to improve the baking characteristics of the flour. [0035] Within enrichment step 124 , a measured quantity of enrichment components, such as, for example, thiamin, niacin, riboflavin, iron, folic acid, leavening agent, salt and calcium, are added to the whitened/matured flour. [0036] In a whole grain milling operation 126 as schematically illustrated in FIG. 3 , grain kernel 100 can be milled to form whole grain flour 128 . Whole grain milling operation 126 similarly comprises grain cleaning step 112 , grain conditioning step 114 , grain grinding step 116 , grain sifting step 118 and grain purifying step 120 . Following grain purifying step 120 , a reconstituting step 130 blends back the separated portions of the grain kernel 100 , for example, the milled bran, germ and endosperm to form whole grain flour 128 . Through the use of reconstituting step 130 , whole grain flour 128 can be stabilized. In addition, whole grain milling operation 126 can comprise one or more heat treating steps so as to further stabilize the bran and/or germ. [0037] When milled with whole grain milling operation 126 , whole gain flour 128 includes visual particulate matter that is viewable and distinguishable by an unassisted eye in baked products made with the whole grain flour 128 due to color differences between the bran 102 , germ 104 and endosperm 106 . To the consumer, the presence of visual particulate matter within a final baked product can be less preferred than the generally visually homogenous appearance of baked products made with refined flour 110 . [0038] As illustrated in FIG. 4 , a milling recombination process 132 of the invention for milling grain kernel 100 to form a substantially visually homogenous whole grain flour 134 resembles whole grain milling operation 126 with the further inclusion of a particulate grinding step 136 . Within particulate grinding step 136 , bran 102 and germ 104 which, generally comprise the visually distinguishable particulate matter in whole grain flour 128 , are ground to a desired particle size that has been surprisingly found to provide a visually indistinguishable homogenous appearance when viewed with the unassisted eyed to baked products made with whole grain flour 134 . More specifically, bran 102 and germ 104 are milled in the particulate grinding step 136 so as to have a selected particle size in a range from about 0.006 inches to about 0.017 inches, which has been surprisingly found to limit the unassisted eye to distinguish bran 102 and germ 104 from the background of the majority milled endosperm 106 . More preferably, bran 102 and germ 104 can be milled to have particle sizes ranging from about 0.007 inches to about 0.015 inches. [0039] Referring to Table 1 below, milling recombination process 132 was simulated on a conventional red wheat grain to confirm particle size ranges for bran 102 that provided a grain flour and resulting baked product in which the bran 102 is visually indistinguishable from the majority endosperm 106 background. As illustrated in Table 1, milling recombination process 132 was simulated using 6 different particle ranges for bran 102 , with the resulting flour and baked products being compared against one another in addition to being compared with conventional milled non-whole red wheat brans. [0000] TABLE 1 Comparison of baked products produced from recombined flour having bran particles milled to a specified size range. Size Bran Particulate “L” “A” “B” Size Range measure- measure- measure- Bran Style (inches) ment ment ment Coarse Bran Variable with >45% 70.07 4.02 14.89 by weight larger than 0.041 Medium Bran Variable with >6% 63.65 4.23 15.69 by weight larger than 0.041 Red Bran 0.033-0.059 65.92 5.51 16.30 Red Bran 0.017-0.033 63.86 5.90 16.05 Red Bran 0.009-0.017 62.63 5.75 16.53 Red Bran 0.007-0.009 64.99 4.50 17.71 Red Bran 0.006-0.007 63.20 5.22 17.47 Red Bran <0.006 66.98 4.35 17.73 [0040] Each sample was individually evaluated with respect to the color or “lightness” of the bread produced with the different bran particle sizes. For many consumers, particularly children, lightness is generally associated with taste and a light or white-like appearance for the internal crumb is generally preferred. The internal crumb color of breads can be objectively measured using standard techniques known to one in the art such as, for example, using a Minolta Chroma Meter available from the Minolta Corporation of Ramsey, N.J., to measure the reflective color of a surface. Using the Minolta Chroma Meter, the appearance of the different bread products were measured using the L*a*b color scale, wherein “L*” corresponds to a lightness measurement based on a black to white scale, “a*” corresponds to measurements on a red to green scale and “b*” corresponds to measurements on a blue to yellow scale. Generally, it has been found that bread products having increased “L*” measurements, reduced “a*” measurements and increased “b*” measurements are most preferred as consumers tend to associate such readings with conventional white breads. In addition to measuring crumb color, each of the breads products was visually compared using an unassisted eye to compare the various bran particle size ranges with respect to visibility of the bran particles against the crumb (milled endosperm and germ) background. [0041] In comparing bran visibility against the crumb background, it was determined that the bread products prepared from recombined flour having bran particles milled to a range of 0.006 inches to 0.017 inches had the least amount of visible contrast between the bran particles and the crumb without adversely affecting background color. [0042] In some embodiments, milling recombination process 132 can further comprise a bran fortification step 138 and/or a germ fortification step 140 as illustrated in FIG. 4 for forming a bran fortified whole grain flour 142 , a germ fortified whole grain flour 144 or a bran and germ fortified whole grain flour 146 . In milling recombination process 132 , bran 102 and/or germ 104 that has been milled to the desired advantageous particle size range can be added to the endosperm 106 in amounts exceeding the typical amounts of bran 102 and/or germ 104 found in the grain kernel 100 , such as, for example, adding bran 102 such that the amount of bran 102 in whole grain flour 134 exceeds 14.5% by weight of a whole wheat flour made according to the milling recombination process 132 . Accordingly, germ 104 can be added in amounts such that germ 104 exceeds 2.5% by weight of a whole wheat flour made according to the milling recombination process 132 . [0043] Whole grain flour 134 can be used within a variety of baked products and related products. For example, whole grain flour 134 can be used in the preparation of whole grain baked products, such as, for example, breads and whole grain biscuits having cross-sectional slices displaying a consistent, homogeneous color and visual appearance. In another example, whole grain flour 134 can be used in baking kits, such as, anhydrous mixes requiring the addition of wet ingredients, such as, for example, water, oil, eggs the like, or in bulk concentrate mixes or premixes requiring additional bulk ingredients prior to baking. Whole grain flour 134 can be used in preparing baking dough, such as, frozen dough, refrigerated dough and fresh dough. Whole grain flour 134 can also be used in the preparation of partially-baked or “par-baked” products that require baking to completion prior to consumption. In addition, whole grain flour 134 can be used in the preparation of “stiff” dough for use in crackers and pretzels. While the use of whole grain flour 134 is specifically described, it will be understood that bran fortified whole grain flour 142 , germ fortified whole grain flour 144 and bran and germ fortified whole grain flour 146 can be utilized instead of or in conjunction with whole grain flour 134 . [0044] As described throughout the specification, the attainment of certain dough characteristics are more important in some doughs than in others, and depend largely on the intended end use of the dough product. It will be understood that the term dough as used through the present specification applies equally to refrigerated, raw dough products that are formed as either a developed dough or an undeveloped dough. Developed dough is that in which a protein or gluten network has been more or less fully formed or created. Representative examples of developed doughs can include dough for breads, bagels, croissants or rolls. Undeveloped dough is that in which, the gluten network is not fully developed. One representative example of an undeveloped dough is biscuit dough and batters. [0045] Dough formulations, and the ingredients they contain, can differ depending on the finished product that is obtained from the dough. However, most doughs generally have a number of ingredients in common and examples of some such common ingredients are described and illustrated in more detail below. [0046] The dough formulation and products as described herein, generally contain an amount of whole grain flour 134 constituent that contributes to the structure of the dough. The whole grain flour 134 provides the dietary benefits associated with consumption of whole grains. As described herein, whole grain baked products, mixes and dough, as contemplated by the present disclosure comprise at least about 15% whole grain flour 134 within the flour constituent. In some contemplated embodiments, whole grain baked products, mixes and dough can comprise at least about 30% whole grain flour 134 within the flour constituent. In some embodiments, whole grain baked products can comprise substantially all, or greater than about 90%, whole grain flour 134 within the flour constituent. In some embodiments, whole grain flour 134 can be utilized in conjunction with other suitable whole grain flour, such as, for example, durum whole grain flour, or alternatively, with refined flour 110 . [0047] Whole grain dough compositions comprised of whole grain flour 134 , as described herein, can be caused to expand (leaven) by any leavening mechanism, such as, by one or more of the effects of: entrapped gas, such as, entrapped carbon dioxide, entrapped air, or both; a laminated dough structure; by action of chemical leavening agents; or by action of a biological agent, such as, a yeast. Thus, a leavening agent may be an entrapped gas, such as, layers or cells (bubbles) that contain carbon dioxide, water vapor, or air, etc., any type of yeast (e.g., cake yeast, cream yeast, dry yeast, etc.); or a chemical leavening system, e.g., containing a basic chemical leavening agent and an acidic chemical leavening agent that react to form a leavening gas, such as, carbon dioxide. [0048] Examples of acidic chemical leavening agents are generally known in the dough and baking arts, with examples including sodium aluminum phosphate (SALP), sodium acid pyrophosphate (SAPP), monosodium phosphate, monocalcium phosphate monohydrate (MCP), anhydrous monocalcium phosphate (AMCP), dicalcium phosphate dihydrate (DCPD), glucono-delta-lactone (GDL), as well as, a variety of others. Optionally, an acidic chemical leavening agent for use according to the invention, can be encapsulated. [0049] Examples of basic chemical leavening agents include many that are generally known in the dough and baking arts, such as, soda, i.e., sodium bicarbonate (NaHCO 3 ), potassium bicarbonate (KHCO 3 ), ammonium bicarbonate (NH 4 HCO 3 ), etc. A basic chemical leavening agent may also be encapsulated, if desired. [0050] The evolution of carbon dioxide essentially follows the stoichiometry of typical acid-base reactions. The amount of leavening base present determines the amount of carbon dioxide evolved, whereas the type of leavening acid affects the speed at which the carbon dioxide is liberated. The amount of leavening base used in combination with the leavening acid can be balanced, such that a minimum of unchanged reactants remain in the finished product. An excess amount of leavening base can impart a bitter flavor to the final product, while excess leavening acid can make the baked product tart. [0051] Yeast is also utilized for leavening baked goods, and is often preferred because of the desirable flavor it imparts to the dough. Baker's yeast is generally supplied in three forms: yeast cream, a thick suspension with about 17% solids; a moist press cake with about 30% solids; and an active dry yeast, with about 93 to 98% solids. Generally, active dry yeasts of acceptable quality have been available for some time, and recently instant active dry yeast has also been available for commercial use. [0052] The quantity of yeast added to dough is directly related to the time required for fermentation, and the form of the yeast utilized. Generally, most bread doughs are made with from about 2 to 3% fresh compressed yeast, based on the amount of flour. [0053] Whole grain dough comprising whole grain flour 134 as described herein can also contain additional functional ingredients. Some such additional ingredients can be used to modify the texture of the whole grain dough. Texture modifying agents can improve many properties of the dough, such as, viscoelastic properties, plasticity, or dough development. Examples of texture modifying agents include fats, emulsifiers, enzymes, hydrocolloids, and the like. [0054] Shortening helps to improve the volume, grain and texture of the final product. Shortening also has a tenderizing effect and improves overall palatability and flavor of a baked good. Either natural shortenings, animal or vegetable, or synthetic shortenings can be used. Generally, shortening is comprised of triglycerides, fats and fatty oils made predominantly of triesters of glycerol with fatty acids. Fats and fatty oils useful in producing shortening include cotton seed oil, ground nut oil, soybean oil, sunflower oil, rapeseed oil, sesame oil, olive oil, corn oil, safflower oil, palm oil, palm kernel oil, coconut oil, or combinations thereof. [0055] Emulsifiers include nonionic, anionic, and/or cationic surfactants that can be used to influence the texture and homogeneity of a dough mixture, increase dough stability, improve eating quality, and prolong palatability. Emulsifiers include compounds, such as, lecithin, mono- and diglycerides of fatty acids, propylene glycol mono- and diesters of fatty acids, glyceryl-lacto esters of fatty acids, and ethoxylated mono- and diglycerides. [0056] Hydrocolloids are added to dough formulations to increase moisture content, and to improve viscoelastic properties of the dough and the crumb texture of the final product. Hydrocolloids function both by stabilizing small air cells within the batter and by binding to moisture within the dough. Hydrocolloids include compounds, such as, xanthan gum, guar gum, and locust bean gum. [0057] Dough-developing agents can also be added to the system to increase dough viscosity, texture and plasticity. Any number of agents known to those of skill in the art may be used including azodicarbonamide, diacetyl tartaric acid ester of mono- and diglycerides (DATEM) and potassium sorbate. [0058] Another example of a dough-developing additive is PROTASE™. PROTASE™ is a proprietary product containing enzymes and other dough conditioners. PROTASE™ is generally used to reduce mixing time and improve machinability. A double strength version, PROTASE 2X™, is commercially obtained from J. R. Short Milling Co. (Chicago, Ill.). [0059] Dough conditioners are also examples of dough additives. One example of a dough conditioner is NUBAKE™, commercially available from RIBUS (St. Louis, Mo.). Another example of a dough conditioner is L-cysteine, commercially available from B.F. Goodrich (Cincinnati, Ohio). [0060] Dough can also frequently contain nutritional supplements, such as, vitamins, minerals and proteins, for example. Examples of specific nutritional supplements include thiamin, riboflavin, niacin, iron, calcium, or mixtures thereof. [0061] Dough can also include flavorings, such as, sweeteners, spices, and specific flavorings, such as, bread or butter flavoring. Sweeteners include regular and high fructose corn syrup, sucrose (cane or beet sugar), and dextrose, as well a bake stable non-nutritive sweeteners such as sucralose, for example. In addition to flavoring the baked good, sweeteners, such as, sugar can increase the moisture retention of a baked good, thereby increasing its tenderness. [0062] Dough can also include preservatives and mold inhibitors, such as, sodium salts of propionic or sorbic encapsulated acids, sodium diacetate, vinegar, monocalcium phosphate, lactic acid and mixtures thereof. [0063] Preparation of whole grain products can be accomplished using traditional mixing methods to form a whole grain dough from whole grain flour 134 . Generally, the whole grain flour 134 can be combined with various wet ingredients, such as, for example, water, oil, eggs and milk, using traditional mixers and mixing methods. For example, whole grain flour 134 can be combined with suitable wet ingredients using any standard mixing technology, such as, for example, a standard horizontal bar mixer or a paddle mixer available from the Hobart Corporation of Troy, Ohio. [0064] Whole grain bread dough, as used herein, can comprise a variety of formulations wherein the flour portion of the bread dough can solely comprise a single variety of whole grain flour 134 or can comprise various combinations of whole grain flour 134 , such as, for example, whole grain wheat flour and whole grain durum flour. [0065] Alternatively, refined flour 110 can also be combined with whole grain flour 134 . In some embodiments, a whole grain bread dough can be classified as a “Good Source,” wherein the whole grain bread dough is formulated so as to provide 8 grams of whole grain per serving (generally considered 2 slices or 50 grams of bread). In some embodiments, a whole grain bread dough can be classified as an “Excellent Source,” wherein the whole grain bread dough is formulated so as to provide 16 grams of whole grain per serving. In some embodiments, a whole grain bread dough can be classified as a “100% Whole Grain,” wherein the whole grain bread dough is formulated such that the flour portion of the bread dough solely comprises whole grain flour 134 . [0066] As the percentage of whole grain flour 134 increases in a bread dough, vital wheat gluten can be added in an effective amount so as to improve the bake qualities of a whole grain bread including increasing the Baked Specific Volume (BSV) of the whole grain bread. BSV is a term of art in the industry that defines the inverse of density or fluffiness of a baked good, and is simply the volume of the baked product divided by its weight. For bread products, BSV is frequently used as an objective measurement for non-sliced or artisan breads. Generally, a baked good is considered to have an acceptable BSV when the baked good doubles in size during baking from a raw dough to a baked dough product. More specifically, a traditionally accepted BSV for traditional white bread generally exceeds about 3.0 cc/g. As such, effective amounts of vital wheat gluten for use with whole grain bread dough will achieve baked whole grain breads having a BSV exceeding about 3.0 cc/g. Adding vital wheat gluten to a mixture comprising whole grain flour 134 compensates for whole grain baking characteristics, which can inhibit achieving desired baked good characteristics. In addition to formulating whole grain bread dough with an effective amount of vital wheat gluten, effective amounts of vital wheat gluten can be added to baking mixes, either complete mixes or concentrated mixes or premixes, such that a user experiences the same baking performance as traditional mixes or mixtures based upon refined flour 110 . [0067] In addition to use in the preparation of whole grain breads, whole grain flour 134 can be similarly employed for use in whole grain baking mixes for preparing whole grain baked products. These whole grain mixes can comprise a complete anhydrous mix requiring the addition of a liquid, such as, for example, water, oil, eggs and/or milk, or a concentrate mix requiring additional bulk ingredients, as well as, liquid ingredients, at a time of preparation. A complete mix is generally considered a mix in which all of the dry ingredients necessary for preparing a dough are present in the mix, including the flour portion. A concentrate mix or premix is generally considered a mix including one or more key functional ingredients but still requiring addition of one or more bulk ingredients. At time of use, bulk ingredients, such as, for example, a bulk whole grain flour portion and/or vital wheat gluten can be added to the concentrate mix or premix. Depending upon the application and the end user, representative whole grain baking mixes, including whole grain flour 134 can be provided at varying levels of completeness between the concentrate mix and the complete mix. [0068] Key functional ingredients can comprise one or more of dough conditioners, hydrocolloids, protein sources, oxidizers, mold inhibitors, salt, and nutrients blended with flour, used to provide specific attributes to a finished baked product. Representative dough conditioners can comprise DATEM, enzymes, sodium stearoyl lactylate and monoglycerides. Representative hydrocolloids can comprise guar gum. Representative protein sources can comprise vital wheat gluten. Representative oxidizers can comprise ascorbic acid and azodicarbonamide. Representative mold inhibitors can comprise calcium propionate. Representative whole grain baking premixes can comprise effective amounts of functional ingredients, such as, for example, vital wheat gluten, dough conditioners, emulsifiers, preservatives, salt, nutrients and the like, blended with whole grain flour other whole grain ingredients. [0069] Whole grain bread dough mixes, either complete mixes or concentrated mixes or premixes, can include functional ingredients such that whole grain breads made from the mix and whole grain flour 134 achieve a BSV of at least about 2.5 cc/g and/or a slice height of at least about 4.0 inches. Alternatively, other whole grain products based on whole grain flour 134 and milled whole grain mixes, either complete mixes or concentrated mixes or premixes, can be specifically tailored to provide desirable characteristics to other baked products such as, for example, cookie spread for whole grain cookie mixes, slice height and cell structure for whole grain cake mixes, spread and height for whole grain pancakes. Further characteristics that can be tailored can include, for example, appropriate bake performance for other whole grain flour 134 based mixes including pizza crust mixes, brownie mixes, muffin mixes and variety baking mixes such as, for example, Bisquick® mix. Exemplary Evaluations [0070] Six different breads were formulated and prepared for visual comparison by experienced observers. Three of the breads were formulated using whole grain flour 134 while the remaining three breads were used as test controls and did not undergo milling recombination process 132 . The bread types used for testing were as listed in Table 2. [0000] TABLE 2 Sample Bread Description Bread Number Bread Description Visual Description 1 Bread formulated with Pale color with small red recombined red whole wheat particulates visible milled according to milling recombination process 132. 2 Bread formulated with Tan color with small recombined white whole wheat particulates visible milled according to milling recombination process 132. 3 Bread formulated with Yellow color with small recombined durum whole grain particulates visible milled according to milling recombination process 132. 4 White bread formulated with White bleached and refined flour milled according to conventional milling operation 108. 5 Bread formulated with finely Yellow color with no ground durum whole grain visually identifiable including finely ground bran particulates and germ particulates. 6 White wheat ultra fine bread Tan color with no visually formulated with finely ground identifiable particulates whole wheat including finely ground bran and germ particulates. [0071] Experienced observers viewed and rated the sample breads based on appearance characteristics including: Overall Appearance, Color and Amount of Visible Particulate Flecks. In addition, consumers were asked to consider how each bread sample fit the concept of a visually appealing whole grain bread, whether they were likely to purchase the sample breads and whether or not they felt their children would eat the sample breads. Results of the experienced observer consumer rankings are summarized in Table 3. [0000] TABLE 3 Visual Ratings Bread Bread Bread Bread Bread Bread Characteristic 1 2 3 4 5 6 Like Overall Appearance 7.0 6.3 6.3 6.1 5.9 5.3 0(least)-9 (most) Like Color 6.8 6.2 6.2 6.1 5.8 5.2 0(least)-9 (most) Color Rating 4.4 4.0 4.0 1.8 2.9 3.6 0(light)-7 (dark) Liked amount of grain 6.5 5.8 5.6 5.1 5.3 4.8 flecks 0 (disliked)-9 (liked) Amount of grain flecks 5.2 3.2 3.1 1.6 2.2 2.5 0 (none)-7 (many) Concept Fit 3.7 3.5 3.4 3.3 3.4 3.2 0 (poor)-5 (good) Purchase Intent After 3.5 3.3 3.3 3.1 3.1 3.0 Visual 0 (no intent)-5 (intend to purchase) Children Would Eat 4.7 4.8 4.8 5.0 4.7 4.6 0 (would not eat)-5 (would eat) [0072] Experienced observer responses indicated that the reviewers did perceive visual distinctions among the bread samples. The recombined red whole wheat bread (Sample 1) having red wheat milled using milling recombination process 132 was liked best for overall appearance, color and amount of grain fleck liking. For concept fit and purchase intent after visual, the recombined red whole wheat bread received higher ratings than the recombined white whole wheat bread (Sample 2) and the recombined durum whole wheat bread (Sample 3) and had significantly higher ratings than the remaining bread samples. The white wheat ultra fine bread was liked consistently less than the other whole grain breads. As indicated in the consumer testing, milling recombination process 132 can be used successfully to recombine whole wheat flour having bran and germ milled within a desirable particle size range so as to prepare visually acceptable whole grain baked products. Milling bran and germ to a desirable particle size range was more visually acceptable than flour having the bran and germ milled to ultra fine particle sizes. [0073] Although various embodiments of the present invention have been disclosed here for purposes of illustration, it should be understood that a variety of changes, modifications and substitutions may be incorporated without departing from either the spirit or scope of the present invention.

A recombined whole grain flour for use in preparing whole grain products such that whole grain particulates provide minimal visual impact to the whole grain product. By selectively controlling the particle size of the milled bran and germ constituents used in the recombined whole grain flour, the visual and color impact associated with bran and germ particulates can be substantially eliminated from the whole grain product. In particular, whole grain products such as whole grain breads, dough products, mixes and biscuits can be made with recombined whole grain flour. Whole grain products made with recombined whole grain flour are advantageous in that they incorporate the health advantages associated with whole grains while eliminating the characteristic, visual color differences noticeable within a whole grain crumb due to visually identifiable bran and germ particulates found in traditional whole grain products.

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application No. 61/830,676 filed Jun. 4, 2013. U.S. Provisional Application No. 61/830,676 is hereby incorporated by reference. STATEMENT REGARDING FEDERALLY-SPONSORED RESEARCH AND DEVELOPMENT [0002] (Not Applicable) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT [0003] (Not Applicable) REFERENCE TO AN APPENDIX [0004] (Not Applicable) BACKGROUND OF THE INVENTION [0005] The invention relates to garden tools and more specifically to garden tools that extract a weed, including the root, from the soil and eject the weed from the tool. [0006] Conventional garden tools extract weeds from lawns using serrated tines, spikes and levers that securely fasten to a handle. In most of these devices the weed and roots are removed by a lower portion that is spaced a significant distance from the operator's hands. The weed must typically be removed from the lower portion manually using a plunging mechanism or lever action. The force required to eject the weed from the base is excessive and often difficult to generate, particularly for those with limited dexterity or strength in their hands. There is a need to improve on the efficiency of the release mechanism of these devices. BRIEF SUMMARY OF THE INVENTION [0007] The device and alternatives described herein provide an efficient means of removing weeds with roots from soil. The device has a mechanism that releases the weed from the tool with minimal effort. The present invention has all of the advantages of existing weed removing tools without the disadvantages. [0008] The preferred device contemplates an improved weed extraction device having an elongated frame with a central bore through which a rod extends. A foot pedal is rigidly mounted to the frame and a handle extends from the frame for gripping by an operator. [0009] Multiple pins are drivingly linked to the rod and extend away from the frame for inserting into soil surrounding a weed. The improvement comprises a spring that is drivingly linked to the rod and frame for compressing the spring when the rod is moved in a first direction relative to the frame. A lock limits movement of the rod relative to the frame in a second, opposite direction. A trigger is mounted adjacent the handle and is configured to unlock the lock upon movement of the trigger. Unlocking of the trigger allows the rod to move relative to the frame in the second direction under expansion of the compressed spring at speed sufficient to eject the weed from the device and project the weed a predetermined distance from the device. This avoids the need to stoop over to remove the weed from the device, and allows the user to project the weed a distance into a receptacle, waste pile or other location. [0010] In a preferred embodiment of the invention, the weed extraction device lock further comprises a tab formed on the trigger, and a bias mounted to the trigger to bias the tab toward the rod. Multiple indentations are formed on the rod, and the tab can insert into an indentation for locking the rod against movement in the second direction. The trigger in a preferred embodiment is mounted beneath the handle when the device is in an operable orientation, such as when the device is substantially perpendicular to the surface in which the weed is growing. The trigger pivots about a pivot point on an opposite side of the frame from the handle, and the indentations on the rod are formed on a side of the rod facing away from the handle. The preferred foot pedal mounts rigidly to an end of the frame, directly below the handle, and has a pair of spaced sidewalls forming a gap therebetween. An anti-rotation guide extends toward the frame from attachment to a lower disk. The lower disk is mounted to the rod and the guide extends into the gap between the sidewalls of the pedal. [0011] The invention also contemplates a method of using a weed extraction device having an elongated frame with a central bore through which a rod extends. A foot pedal is rigidly mounted to the frame and a handle extends from the frame so an operator can grasp the handle. Multiple pins are drivingly linked to the rod and extend away from the frame for inserting into soil surrounding a weed. The method comprises depressing the frame at the foot pedal downwardly toward the soil surrounding the weed. The step of depressing the frame thereby moves the rod in a first direction relative to the frame, which compresses a spring that is drivingly linked to the rod and the frame. The pins are thereby inserted into the soil around the weed and grasp the weed and at least some soil. Furthermore, a lock that limits movement of the rod relative to the frame in a second, opposite direction is locked. The method further comprises lifting the device by at least the handle, thereby removing at least the device and the weed from the soil. And, while grasping the device handle, the method includes the step of raising from the ground a lower end of the device that includes at least the pins. The method includes positioning the lower end of the device substantially between the user and a receptacle and grasping a trigger mounted adjacent the handle to unlock the lock. By grasping the trigger, the operator thereby causes the rod to move relative to the frame in the second direction under expansion of the compressed spring. This movement occurs at speed sufficient to eject the weed from the device and project the weed a predetermined distance from the device, for example into a trash container, compost heap or other receptacle. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0012] FIG. 1 is a view in perspective illustrating the preferred embodiment of the present invention. [0013] FIG. 2 is a side view illustrating the preferred embodiment of the present invention with the handle and mechanism enlarged. [0014] FIG. 3 is a top view in perspective illustrating the preferred embodiment of the present invention with the handle and mechanism enlarged. [0015] FIG. 4 is a side view illustrating the preferred embodiment of the present invention with the base portion enlarged. [0016] FIG. 5 is a view in perspective illustrating the preferred embodiment of the present invention with the base portion enlarged. [0017] FIG. 6 is schematic side view in section illustrating the preferred embodiment with the mechanism in a first position for when the base portion engages the soil. [0018] FIG. 7 is a schematic side view in section illustrating the preferred embodiment with the mechanism in a second position for when the mechanism has compressed the spring and grasped a weed. [0019] In describing the preferred embodiment of the invention which is illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, it is not intended that the invention be limited to the specific term so selected and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar purpose. For example, the word connected or terms similar thereto are often used. They are not limited to direct connection, but include connection through other elements where such connection is recognized as being equivalent by those skilled in the art. DETAILED DESCRIPTION OF THE INVENTION [0020] The above claimed priority application is hereby incorporated in this application by reference. [0021] The device 8 shown in FIG. 1 is a manually-operated weed removal tool. A frame 10 has a central bore 11 formed through the center thereof, thereby defining the frame as a tubular body. The frame 10 is preferably circular in cross section, but can be rectangular, triangular, U-shaped or irregularly shaped. Unless described otherwise the frame 10 and all other components are made of steel. Of course, aluminum, plastic, fiber-reinforced polymer composite and other suitable materials can be substituted for steel, as will become apparent from the description herein to a person having ordinary skill. [0022] A central rod 12 extends slidably through the bore 11 and exits at the top through a narrow opening near a handle 18 as shown in FIGS. 2 and 3 . The rod 12 exits at the bottom of the frame 10 through a narrow opening at the base portion 14 as shown in FIG. 4 , and attaches to the disk 20 as described in more detail below. The terms “top”, “bottom”, “upper”, “lower” and similar terms are used in relation to the orientation of the device 8 as shown in FIG. 1 . Of course, the device 8 can be used in different orientations than that shown in FIG. 1 , and the person of ordinary skill will understand that the terms used herein transfer to the components in those different orientations. [0023] As shown in FIGS. 2 and 3 , a cap 13 fastens, such as by screwing onto a threaded tip (not visible) of the rod 12 . The cap 13 permits a user to readily push and pull on the top end of the rod 12 as needed. Multiple substantially V-shaped indentations 30 are formed in one side of the rod 12 near the top end. Each of the indentations 30 can receive a distal end of a tab 32 . The tab 32 is formed at the interior edge of a trigger 34 that is preferably spring-loaded toward the rod 12 by a bias, such as the coil spring 36 . The coil spring 36 may be replaced, as will be understood by the person having ordinary skill, by a leaf spring, an elastomeric spring, a pneumatic spring, a magnetic spring or any other equivalent structure that tends to force the tab 32 toward the rod 12 . The trigger 34 is mounted to the frame 10 , such as through a bracket 38 welded to the opposite side of the frame 10 as the handle 18 , to rotate relatively freely about the pivot 35 , which is preferably a hinge. This configuration permits a person grasping the handle 18 to pivot the trigger 34 with one or more fingers toward or away from the rod 12 . [0024] The tab 32 can insert into the deepest or lowest region of one of the indentations 30 when the tab and the cooperating indentation 30 are aligned, or the tab 32 can rest against the surface of the rod 12 between the lowest regions of adjacent indentations 30 . Regardless of whether the tab 32 and the lowest regions of an indentation are aligned, because of the angle of the tab 32 and the surfaces of the rod's indentations 30 , the tab 32 preferably presents little to no resistance to upward movement of the rod 12 relative to the frame 10 (which can likewise be referred to as “downward movement of the frame 10 relative to the rod 12 ”). This is because the preferred embodiment forms a ratchet mechanism in which the indentations 30 are asymmetrical and define spaces between gear teeth and the tab 32 serves as a pawl. Thus, relative movement in one direction is not resisted significantly by the ratchet mechanism. [0025] With regard to downward (opposite) movement of the rod 12 relative to the frame 10 , when there is not alignment of the tab 32 with the lowest region of an indentation, the tab 32 is biased by the spring 36 against the surface of the rod 12 adjacent the lowest region of one of the indentations 30 , and merely rests against the smooth surface. Under these conditions, the tab 32 does not resist downward movement of the rod 12 . Downward movement of the rod 12 is permitted until the tab 32 is seated in the lowest region of an indentation 30 . During normal use, upon insertion of the tab 32 into the lowest region of one of the indentations 30 , the rod 12 is prevented from moving downward relative to the frame 10 until the tab 32 is removed from the indentation or the rod 12 is moved upwardly relative to the frame 10 . Thus, when the tab 32 is in the lowest region of an indentation, the rod 12 cannot move downwardly relative to the frame 10 , and when the tab 32 is not in the lowest region of an indentation, the rod 12 is able to move downwardly relative to the frame 10 until the lowest region is reached. [0026] The coil spring 36 biases the tab 32 toward the rod 12 , but the bias can be overcome by an average human grasping the trigger 34 . The tab 32 may thus be pivoted away from the rod 12 by a finger-graspable portion of the trigger 34 that mounts below the handle 18 as shown in FIGS. 2 and 3 . The finger-graspable portion of the trigger 34 is preferably grasped by an operator whose hand is around the handle 18 , and whose finger or fingers extend beneath the trigger 34 . The trigger 34 therefore can be displaced upwardly toward the handle 18 in the manner of a trigger of a typical firearm. When this occurs with sufficient force, the tab 32 withdraws from any indentation 30 in which the tab 32 is positioned, and the rod 12 is able to move downwardly relative to the frame 10 . [0027] As shown in FIGS. 4-5 , an upper end of the foot pedal 16 mounts rigidly to the lower end of the frame 10 , such as by welding. The foot pedal 16 permits a user to press downwardly with substantial force on the device 8 with a foot on the top of the foot pedal 16 . This downward force is typically applied when the base portion 14 rests on the soil around a weed. [0028] As shown in FIGS. 1 and 4 , a lower disk 20 that can be about two inches in diameter is rigidly mounted to the lower end of the rod 12 , such as by welding. This disk 20 increases the effective surface area of the end of the rod 12 so that upon a user pressing the base portion 14 against the ground, such as when the frame 10 is perpendicular to the surface of the ground, the disk 20 and attached rod 12 do not substantially penetrate the soil, and thus stay at the same point on the ground while the frame 10 and its associated components are driven downwardly relative to the substantially stationary rod 12 . [0029] As shown in FIGS. 4-7 , a coil spring 42 within the bore 11 of the frame 10 surrounds the lower end of the rod 12 . The spring 42 can be a 12-15 pound, one-half inch outer diameter coil spring that is approximately four inches long when relaxed. Of course, other spring sizes, types and weights can be used under different circumstances. [0030] One end of the coil spring 42 seats against a pin 44 closer to the upper end of the rod 12 , and the opposite end of the spring 42 seats against a ferrule 40 (see FIGS. 6-7 ) near the lower end of the rod 12 . The pin 44 is rigidly mounted to the frame 10 , and the rod 12 can bypass the pin 44 . The rod 12 slidably extends through an opening between the two ends of the pin 44 . The spring 42 cannot bypass the pin 44 but is compressed against the pin 44 . [0031] The ferrule 40 is rigidly mounted to the rod 12 , and seats against the flange 70 when the coil spring 42 is expanded (see FIG. 6 ). As the rod 12 moves upwardly relative to the frame 10 , the ferrule 40 moves upwardly away from the flange 70 with the rod 12 (see FIG. 7 ) and causes compression of the spring 42 between the ferrule 40 and the pin 44 . The ferrule 40 provides an opposing surface against which the spring's 42 lower end abuts and a mechanical stop to prevent the rod 12 from traveling in the downward direction out of the frame 10 when the trigger releases the rod 12 . [0032] The preferred spring 42 provides a resistive force against movement of the rod 12 upwardly relative to the frame 10 . Upon relative upward movement of the rod 12 by overcoming the spring force (typically caused by placing the operator's foot on the pedal 16 ), the spring 42 compresses to store potential energy. Upward movement of the rod 12 corresponds to compression of the spring 42 against the lower face of the pin 44 , and downward movement of the rod 12 relative to the frame 10 corresponds to expansion of the spring 42 . Because the pin 44 is rigidly affixed to the wall of the frame 10 , the pin 44 provides a rigid base for the force of the spring 42 to push against to move the rod 12 downwardly relative to the frame 10 after the rod 12 is released when the spring 42 is compressed. [0033] As shown in FIG. 4 , a preferably L-shaped bracket 48 is rigidly attached to one side of the lower disk 20 . The upper leg of the bracket 48 extends upwardly through a guide slot 51 (see FIG. 5 ), preferably formed at one end of the upper disk 50 , and into a void formed between the sidewalls of the support 46 for the foot pedal 16 . The bracket 48 is rigidly mounted to the lower disk 20 and is guided by the sidewalls of the support 46 and the slot 51 in the upper disk 50 , which upper disk 50 is rigidly mounted to the frame 10 . Because the bracket 48 is so retained, the rod 12 cannot rotate substantially, such as when the rod 12 is moving up or down relative to the frame 10 . [0034] The flange 70 ( FIG. 4 ) is substantially the same diameter as the upper disk 50 and is rigidly mounted, such as by welding, to the lower end of the foot pedal 16 . The flange 70 has a central opening through which the lower end of the rod 12 extends freely. The upper disk 50 is fastened to the flange 70 by screws 71 and 72 . Multiple downwardly extending spikes 60 are spaced evenly around the rod 12 and are mounted with their heads pivotably mounted in spaces between the upper disk 50 and the flange 70 . The shafts of the spikes 60 extend downwardly through spaced openings in the upper disk 50 , and the pointed tips of the spikes 60 are at the opposite ends from the enlarged heads, extending through holes in the lower disk 20 . [0035] The rod 12 is free to travel through a central opening in the upper disk 50 , and extends down to attachment to the lower disk 20 , which has similarly spaced openings as the upper disk 50 that allow the spikes 60 to pass freely through the disk 20 . The openings of the lower disk 20 are spaced slightly closer to the axis of the rod 12 than the openings of the upper disk 50 . Thus, when the lower disk 20 moves upwardly with the rod 12 relative to the frame 10 , the spikes 60 are guided by the sidewalls of the openings in the lower disk 20 to pivot inwardly until, when the disk 20 is as high as it can raise and the spring 42 is fully compressed, the tips of the spikes 60 are close to, or touching, one another. This movement inward is illustrated in FIG. 7 , and causes the soil and the roots of a weed positioned between the spikes 60 to be grasped by the spikes 60 . [0036] The upper disk 50 and lower disk 20 are mounted directly below the flange 70 , shown in FIGS. 4 and 5 . Serrated tines (not shown) may be rigidly mounted around the flange 70 at evenly spaced intervals. The tines can attach to the flange 70 by screws, welds or any fastener. The tines increase the area to include the broad leaves that extend from the center of the plant as will be described below. [0037] In use, the operator locates a weed in the soil, sand or other particulate found in a conventional yard and disposes the pointed tips of the spikes 60 against or close to the ground with the tips of the spikes 60 disposed around, and encircling, the main root of the weed. The frame 10 is oriented approximately vertically by disposing the handle 18 at about waist height, where the operator firmly grasps the handle 18 . The operator places his or her foot on the top surface of the foot pedal 16 , and begins to rest his or her body weight down on the foot pedal 16 . This initial downward force displaces the entire device downwardly until the contacting surface (the lower disk 20 ) compresses any grass plants surrounding the weed. Upon continued downward force, the disk 20 seats against the upper surface of the ground, or more typically the compressed grass plants surrounding the weed, and with further force the frame 10 begins to move downwardly relative to the rod 12 and disk 20 . [0038] In order for the frame 10 to move downwardly relative to the rod 12 and disk 20 , the downward force must exceed the force necessary to compress the spring 42 . Once this occurs, the tips of the spikes 60 begin to extend downwardly through the disk 20 . The spikes 60 enter the soil and are driven further downwardly (along with insertion of the tines, if any). At this time, the disk 20 stays in the same position relative to the top of the ground. Further pressure results in further compression of the spring 42 and further insertion of the spikes 60 and tines, if any. [0039] As the spikes 60 move downwardly and the disk 20 remains stationary, the spikes 60 pivot inwardly as shown in the illustrations of FIG. 6 to FIG. 7 . Simultaneous with the rod 12 being held stationary relative to the ground while the frame 10 moves downwardly, the spring 42 compresses as described above. While the frame 10 moves downwardly relative to the rod 12 , the tab 32 slides without significant resistance over the indentations 30 on the side of the rod 12 facing away from the handle 18 . [0040] Once the spikes 60 have reached their full insertion into the soil and the spring 42 is fully compressed, the weed's root and some surrounding soil have been grasped by the spikes 60 as a soil “plug”. At this point the tab 32 seats in the lowest region of an indentation 30 , or is between lowest regions of adjacent indentations. If the operator rotates the handle 18 approximately 90 degrees to permit any tines to form a cylindrical cut in the soil, this rotating action will free a larger “plug” consisting of soil and weed that might contain more roots and more leaves. [0041] The operator then extracts the plug from the ground by lifting the device 8 vertically upwardly. When lifting the device 8 , the operator's downward force is removed, which may cause the rod 12 to begin to move in the opposite direction as the compressed spring 42 begins to expand. The movement of the rod 12 relative to the upwardly moving frame 10 is arrested by the tab 32 being biased into the lowest region of the closest one of the indentations 30 in the rod 12 by the bias of the spring 36 . Thus, the ratchet mechanism allows some, but then prevents further, relative movement of the rod 12 and frame 10 . In this “locked” condition, the operator continues lifting the device 8 upwardly to completely remove the plug of soil containing the weed and no relative movement of the rod 12 occurs. [0042] Whenever he or she chooses, but preferably when the device 8 is raised to between the weed and the operator, the operator squeezes the trigger 34 to release the plug and weed. Squeezing the trigger 34 lifts the tab 32 from the lowest region of the respective indentation 30 , thereby freeing the rod 12 to move under the influence of the compressed spring 42 relative to the frame 10 . Because the spring 42 is significantly compressed and has a high spring constant, the rod 12 moves rapidly relative to the frame 10 during spring expansion, thereby rapidly displacing the lower disk 20 away from the upper disk 50 . This high speed movement causes the weed and soil plug to be ejected from the device 8 with sufficient force to allow the operator to expel the weed into a container, such as a trash can, brush container or compost container. This permits the operator to avoid bending over to obtain the plug and weed from the tip of the tool, or completely rotating the tool so the distal end is close to the user for removal. The device 8 instead serves as a “gun” that “shoots” the weed and plug out of the tool into a container or area that can be a few feet, and up to many feet, away. [0043] The present invention has improved on the prior art's attempt to eject the weed. The present invention provides a significant enough force to propel the weed rather than merely release it. The weed is ejected with enough force to reach a container six to eight feet away, thereby eliminating the need to stoop or bend over to collect the weed, which the prior art requires. Furthermore, the mechanical “catch” formed where the tab 32 positively engages the rod 12 by inserting into the indentation is not subject to failure when the components thereof are wet, dirty or otherwise not encountering ideal conditions. [0044] This detailed description in connection with the drawings is intended principally as a description of the presently preferred embodiments of the invention, and is not intended to represent the only form in which the present invention may be constructed or utilized. The description sets forth the designs, functions, means, and methods of implementing the invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and features may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention and that various modifications may be adopted without departing from the invention or scope of the following claims.

A weed removal device having a handle and a frame through which a rod extends. The rod has a mechanical lock near one end that connects the rod mechanically to the frame, and a base portion near the opposite end. The base portion includes pins that extend into soil around the weed to grasp the weed, and a foot pedal on which the user rests his weight to drive portions of the device into the soil. A spring is compressed when the pins are driven into the soil and grasp the weed, and upon removal of the weed and a plug of soil the mechanical lock can release the spring to expand and thereby eject the weed and soil with force sufficient to propel the weed many feed into a receptacle.

BACKGROUND OF THE INVENTION [0001] The present invention relates to oximeters, and in particular to methods for reducing cross-talk between red and IR signals in pulse oximeters. [0002] Pulse oximetry is typically used to measure various blood chemistry characteristics including, but not limited to, the blood-oxygen saturation of hemoglobin in arterial blood, the volume of individual blood pulsations supplying the tissue, and the rate of blood pulsations corresponding to each heartbeat of a patient. Measurement of these characteristics has been accomplished by use of a non-invasive sensor which scatters light through a portion of the patient's tissue where blood perfuses the tissue, and photoelectrically senses the absorption of light at various wavelengths in such tissue. The amount of light absorbed is then used to calculate the amount of blood constituent being measured. [0003] The light scattered through the tissue is selected to be of one or more wavelengths that are absorbed by the blood in an amount representative of the amount of the blood constituent present in the blood. The amount of transmitted light scattered through the tissue will vary in accordance with the changing amount of blood constituent in the tissue and the related light absorption. For measuring blood oxygen level, such sensors have typically been provided with a light source that is adapted to generate light of at least two different wavelengths, and with photodetectors sensitive to both of those wavelengths, in accordance with known techniques for measuring blood oxygen saturation. [0004] Known non-invasive sensors include devices that are secured to a portion of the body, such as a finger, an ear or the scalp. In animals and humans, the tissue of these body portions is perfused with blood and the tissue surface is readily accessible to the sensor. [0005] A typical pulse oximeter will alternately illuminate the patient with red and infrared light to obtain two different detector signals. One of the issues with each signal, for the red and infrared (IR), is cross-talk. For example, the red signal, after filtering, will still be tailing off when the IR LED is turned on, and vice-versa. Typically pulse oximeter circuits include such filters to filter out noise before demodulating, such as the 50 or 60 Hz ambient light from fluorescent or other lights, or electrical interference. Such filtering can result in crosstalk when the filtering spreads out the red and IR pulses so they overlap. [0006] One approach for dealing with cross-talk in the form of phase distortion, as opposed to the amplitude distortion the present invention addresses, is shown in U.S. Pat. No. 5,995,858. This patent shows an approach where the same signal drives the red and IR at opposite phases, giving a phase offset problem. This patent deals with a phase error in the response of the band pass filter of a reference signal causing cross-talk of red into IR and vice versa. In order to minimize or compensate for this phase error, the oximeter is operated with only the IR LED active, and then only with the red LED active. From this, a correction constant is determined that is used in the equation for determining oxygen saturation. BRIEF SUMMARY OF THE INVENTION [0007] The present invention provides a method and apparatus for reducing cross-talk in an oximeter. The oximeter includes a band pass filter. The amount of cross-talk through the band pass filter is estimated. Based on this estimate, the corner frequencies of the band pass filter are adjusted to minimize the cross-talk. [0008] In one embodiment, the band pass filter is a hardware filter, and the corner frequencies are adjusted in the design and selection of the appropriate resistors and capacitors. In another embodiment, the band pass filter is in hardware, and the frequencies can be adjusted during operation or calibration. [0009] In another embodiment, the present invention also includes a calibration mode which is performed when a sensor is attached to the oximeter. In the calibration mode, the signals are measured with first only the red LED on and then with only the IR LED on. Any signal measured in the off channel is assumed to be a result of cross-talk from the other channel. The effect is linear, enabling it to be compensated for in software. The magnitude of the cross-talk is determined as a percentage, and subsequently the percentage is multiplied by the actual signal and subtracted from the other LED signal as cross-talk compensation. [0010] For a further understanding of the nature and advantages of the invention, reference should be made to the following description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0011] FIG. 1 is a block diagram of an oximeter incorporating the present invention. [0012] FIG. 2 is a block diagram of a portion of the circuit of FIG. 1 illustrating the placement of a filter according to the present invention. [0013] FIG. 3 is a circuit diagram of a band pass filter according to an embodiment of the invention. [0014] FIG. 4 is a timing diagram illustrating the low and high pass filtering effects on the red and IR signals according to an embodiment of the invention. [0015] FIG. 5 is a circuit diagram illustrating an embodiment of a LED drive circuit including the circuit connections for the calibration mode according to an embodiment of the invention. DETAILED DESCRIPTION OF THE INVENTION [0000] Overall System [0016] FIG. 1 illustrates an embodiment of an oximetry system incorporating the present invention. A sensor 10 includes red and infrared LEDs and a photodetector. These are connected by a cable 12 to a board 14 . LED drive current is provided by an LED drive interface 16 . The received photocurrent from the sensor is provided to an I-V interface 18 . The IR and red voltages are then provided to a sigma-delta interface 20 incorporating the present invention. The output of sigma-delta interface 20 is provided to a microcontroller 22 . Microcontroller 22 includes flash memory for a program, and SRAM memory for data. The processor also includes a microprocessor chip 24 connected to a flash memory 26 . Finally, a clock 28 is used and an interface 30 to a digital calibration in the sensor 10 is provided. A separate host 32 receives the processed information, as well as receiving an analog signal on a line 34 for providing an analog display. [0000] Bandpass Filter [0017] FIG. 2 is a block diagram illustrating the location of the filter according to an embodiment of the invention. Shown is a sensor 10 that is driven by an LED drive circuit 16 . The LED drive circuit 16 alternately drives an IR LED 40 and a red LED 42 . A photodetector 44 provides a signal to a current-to-voltage (I-V converter 46 ). The voltage signal is provided to high pass and anti-aliasing filter 48 . This block includes the band pass filter according to an embodiment of the invention. The output signal is then provided to a sigma-delta modulator 50 . The output of sigma-delta modulator 50 is provided to a demodulator 52 , which is then provided to filtering and decimating blocks 54 and 56 . [0018] FIG. 3 illustrates a band pass filter 60 according to an embodiment of the invention. The filter includes an amplifier 62 and a resistor and capacitor circuit comprising capacitors C 2 , C 110 , C 111 , and C 40 and resistors R 7 , R 111 , R 112 , R 110 , and R 109 . An input to this circuit is provided from I-V converter 46 along a line 64 to a first switch 66 for an offset correction not relevant to the present invention. The signal is then provided to a second switch 68 , which is used for a calibration mode according to the present invention. A cross-talk control signal 70 couples the switch to an LED current sense line 72 for calibration mode. [0000] Design of Bandpass Filter [0019] In the design and manufacture of the band pass filter of FIG. 3 , the corner frequencies are adjusted by varying the capacitor and resistor values to offset and minimize the cross-talk effect. The corner frequencies are the high pass and low pass ends of the band pass filter, which is in place to filter out ambient interferences. [0020] There is a major trade off involved in the design of the band pass filter. It is desirable to have the filter corners as close to the modulation frequency as possible. Raising the frequency of the high pass corner makes the filter better able to reject any AC portion of ambient light. Typically in the US, fluorescent lights have strong AC component at 120 Hz and the harmonics of 120 Hz. It is desirable to filter this out of the signal. Lowering the cut off frequency of the low pass filter limits the high frequency noise from the I-V converter, and provides some anti-aliasing to keep ambient noise out of the system. [0021] However, any filtering spreads out the signal in the time domain, for example some of the IR pulse will leak into the dark pulse following it. This has two drawbacks. The first is cross-talk where the IR signal “leaks” into the red signal, and vice versa. The second is an offset resulting from a transient that occurs due to capacitances in the patient cable between the LED wires and the detector wires. When this transient is filtered, part of it leaks into the sampled part of the signal causing an offset. Both of these effects get worse as the corners of the filters are pulled closer to the modulation frequency. [0022] Tuning the band pass filter to optimize for cross-talk is done when it is designed by adjusting the high pass filter corner and the low pass corner to force the cross-talk to be zero. The size of the Red pulse is measured by comparing the sample P 5 (see FIG. 4 ) to the samples taken in the dark states P 4 and P 6 . Red = P ⁢   ⁢ 5 - P ⁢   ⁢ 4 + P ⁢   ⁢ 6 2 [0023] Since the signal from the IR pulse is still decaying in the Dark2 time period, the P 4 sample will be higher due to the low pass response and the lower due to the high pass response. The effect of the IR pulse on P 4 will affect the size of the measured red signal. This is a cause of cross-talk where the IR signal leaks into the Red signal and vice versa. [0024] This effect is minimized if the filter is a band pass, with both high pass and low pass effects. The effect of the high pass filtering compensates for the effect of the low pass filtering. [0025] Thus, the corners are adjusted so that the high pass and low pass signals shown in FIG. 5 are adjusted so that the effect of the high pass filtering compensates for the effect of the low pass filtering to minimize cross-talk. The low pass filter causes a positive cross-talk, and the high pass filter causes an offsetting negative cross-talk. [0026] In one embodiment, the band pass filter consists of an RC high pass followed by a Salen-Key low pass configured as a second order Butterworth filter. The impedance of the RC high pass section will have an effect on the transfer function of the Salen-Key circuit, however this effect is negligible if capacitance C 2 is much larger than C 110 and C 111 . The high pass filter cut off frequency is 32 Hz., and the low pass filter cut off frequency is 12.7 kHz. [0000] Calibration [0027] In addition to designing the hardware of the band pass filter to reduce cross-talk, a calibration mode allows a further correction for cross-talk using a cross-talk calibration test. A subtle cross-talk effect arises from the filtering in the circuit causing light and dark pulses to spread out into each other in the time domain. Fortunately the effects from the band pass filter are linear and measurable, and so can be compensated for in software. Since this is the result of the filtering, the magnitude of the effect is known ahead of time. A constant is used to subtract the effects of the IR signal from the Red signal and vice versa: Red′−Red−IR*Kcross IR′=IR−Red*Kcross [0028] FIG. 5 is a circuit diagram of an embodiment of LED drive circuit 16 of FIG. 2 . Included in the circuit are a connection to the red LED on a line 80 , and a connection to the IR LED on a line 82 . These are provided through MOSFET transistors 84 and 86 to a 1 ohm resistor 88 . In the calibration mode, the LED current sense signal on line 72 is taken from the current through this 1 ohm resistor with line 72 of FIG. 5 connected to line 72 of FIG. 3 as an input through switch 68 to the band pass filter. [0029] In addition to designing the hardware of the band pass filter to reduce cross-talk, the connection of line 72 in FIG. 5 during a calibration mode allows a further correction for cross-talk using a cross-talk calibration test. [0030] While doing the cross-talk test, most of the analog circuits on the board are used and so this is a good test to check the integrity of the analog hardware. This test connects the 1 Ω current sense resistor 88 to the input to the band pass filter. This way a fixed LED current can inject a signal into the signal acquisition circuits. This allows the operation of the LED drive 16 , the band pass filter 60 and the sigma-delta modulator 50 to be verified. In addition, measuring the LED current using the 1 Ω resistor allows the LED's current sense circuit to be calibrated more accurately than the 10% tolerance capacitors in the circuit would ordinarily allow. [0031] Thus, during the calibration mode, current is shunted into the current sense input from the LED drive current. The only analog circuitry not being used is the photodetector and the I-V converter. In a preferred embodiment, whenever a sensor is connected, this is detected and the software automatically does the cross-talk calibration test. [0032] A 50% drive signal is applied to the LEDs during the calibration circuit to give a sufficiently large signal without going to full range and risking too high of a signal being provided. Alternately, other percentages of the drive current could be used. [0033] The following steps are performed: 1) Set IR LED to 50%, Red LED to 0; then measure the 0 red signal; 2) Set Red LED to 50%, IR LED to 0; then measure the) IR signal. [0036] Subsequently, during actual operation, the red cross-talk effect is determined by multiplying the percentage cross-talk times the red signal, and then it is subtracted from the IR signal. The corresponding action is done for the red signal. [0037] As will be understood by those of skill in the art, the present invention could be embodied in other specific forms without departing from the essential characteristic thereof. For example, the drive current could be obtained in a different manner and a different design could be used for the band pass filter. Alternately, the band pass filter could be used alone, without the software calibration added. Accordingly, the foregoing description is intended to be illustrative, but not limiting, on the scope of the invention which is set forth in the following claims.

A method and apparatus for reducing cross-talk in an oximeter. The oximeter includes a band pass filter. The amount of cross-talk through the band pass filter is estimated. Based on this estimate, the corner frequencies of the band pass filter are adjusted when it is designed to minimize the cross-talk. In one embodiment, a calibration mode is performed when a sensor is attached to the oximeter. In the calibration mode, the signals are measured with first only the red LED on and then with only the IR LED on. Any signal measured in the off channel is assumed to be a result of cross-talk from the other channel. The magnitude of the cross-talk is determined as a percentage, and subsequently the percentage is multiplied by the actual signal and subtracted from the other LED signal as cross-talk compensation.

BACKGROUND OF THE INVENTION As large expanses of semi-arid grasslands west of the Mississippi River were converted into crop producing areas in the 20th Century, native perennial plants, such as grasses, shrubs and flowers, were removed. A large portion of these grasslands have for many years been planted to crop plants, in particular various varieties of winter wheat. As historical fluctuations in the value of farm commodities have made the economies of growing dry land grain crops, as opposed to grazing cattle, somewhat uncertain, many farmers have chosen to take such land out of production and return it to grasslands. The problem encountered in this conversion is that not only the desirable grasses and shrubs naturally reseed these formerly tilled areas. Typically, a large number of undesirable plants exemplified by Russian and Canadian Thistle and Morning Glory, invade the disturbed area and effectively compete with the more desirable native or introduced rangeland plants, such as Crested Wheat Grass, Blue Bunch Grass, Side Oats Grama, Silver Sage Brush, Winterfat, Penstemons, Yarrows, etc. Various attempts have been made to reseed such areas in the more desirable native grasses and shrubs, but because the areas involved (in many cases thousands of acres) are so great, a ready supply of an adequate seed source has been difficult if not impossible to assure. Methods of harvesting such native seed sources have been relatively inefficient, resulting in extremely high prices for such seeds, thereby making reseeding of such areas financially impracticable. For instance, the prices currently being charged for various common rangeland seeds are: Crested Wheat Grass, $3.50/pound; Great Basin Wild Rye, $7.00/pound; Western Wheat Grass, $5.50/pound. Depending upon the variety, it can take anywhere from 22 to 50 pounds per acre of grass seeds and from 30 to 40 pounds per acre of shrub seeds to adequately replant tilled areas. Such costs are prohibitive over large areas. Given the agricultural surpluses occurring in the production of corn, wheat and barley in the United States and Canada in the decade of the 1980's, the U.S. Government has instituted a Conservation Reserve Program whereby farmers are paid to remove certain cropland from production and return it to its native state. These are lands which are highly erodable and which were placed in production when profit margins were high enough to make such marginally productive land profitable. The incentives for so doing are sufficient to induce relatively large numbers of farmers to enter the program (approximately 10 million acres in 1986 were accepted). Therefore, it is an object of the present invention to provide an apparatus which efficiently harvests native seeds from grasses, shrubs and flowers so that they may be used to reseed formerly tilled areas. Such apparatus is more effective than prior seed harvesting apparatus, and therefore can provide such native seeds at a lower cost, thereby increasing the incentive to replant to native vegetation. Seed harvesting devices for attachment to tractors and/or combines are well known in the art. For example, U.S. Pat. No. 4,373,322, Beisel, discloses a seed harvester which combines a rotating brush member with an elongate hollow housing, wherein when the device is moved through a seed-bearing grass crop, the brush "flails" the seeds from the plant and propels them rearwardly into the housing. Air movement into the device is such that a portion of the debris removed by the brush exits the device through a forward-facing exit. Seeds removed from the plants are deposited in a rearward portion of the housing by centrifugal force. Likewise, U.S. Pat. No. 2,693,072, Belzer et al., discloses a grass seed harvester which is preferably pulled behind a tractor through a grass crop. The device comprises a seed-harvesting brush carried within a housing and an impeller mounted within a duct interconnecting the housing and a seed collector. The impeller and its housing are located at the rearward end of a suction-chamber through which the seeds pass when traveling from the brush to the seed collector. A similar device is disclosed in U.S. Pat. No. 1,297,349, Herr, in which a rotating brush directs seeds into a fan housing. Suction into a drum where the seeds and hulls are separated. The mixed product is then discharged onto a vibrating screen, with the seeds dropping through the screen and the hulls being discharged over the screen. U.S. Pat. No. 2,345,969, Halley, et al., discloses a seed harvester in which a rotating brush strips seeds from plants and deposits them on an elevator canvas. Deflectors are provided, which apparently remove seeds entrained in the bristles of the brush. Lastly, U.S. Pat. No. 1,587,349, Otis, et al., discloses a seed harvester in which a clam shell-type hood is provided with a rotating brush therein. The hood is constructed such that seed bearing plants are forced within the hood where upon the brush removes the seeds therefrom and deposits them in receptacles within the hood. Brush fires or range fires in the Western U. S. often burn large expanses of native vegetation. As is the case with former crop land, natural reseeding of burned-over areas many times results in a predominance of unwanted or undesirable plant species. In order to assure such burned over areas are returned to the most desirable condition (i.e., for cattle and wild life grazing), it is advantageous that such areas be mechanically reseeded if sufficient economical supplies of such seeds were available. Lastly, there is a need for an effective seed harvesting device for harvesting seeds from certain commercial seed crops. For instance, while there are devices currently marketed which will harvest seeds from alfalfa plants, the nature of the seed habit, i.e., a plurality of seeds is arranged in a helically shaped "curl", requires that a multi-step procedure be utilized in order to acquire seeds suitable for planting. Additionally, certain commercially valuable seed sources, such as wild rice, wheat, barley and other grains, flowers and selected seed or vegetable crops could advantageously be harvested by use of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1, is a side elevational view of a seed harvesting device of the present invention; FIG. 2, is a longitudinal sectional view taken substantially upon the plane indicated by the section line 2--2 of FIG. 1; FIG. 3, is a partial sectional view to show the manner in which the seeds harvested by the present invention are processed; and FIG. 4, is a sectional view taken substantially along the plane indicated by the section line 4--4 of FIG. 2. SUMMARY OF THE INVENTION The present invention comprises a non-destructive seed harvesting apparatus, and a method of using the apparatus, for use in harvesting seeds from either native or agricultural plants. The apparatus comprises a header attachment which is adapted to be removably affixed to a propulsion device, such as a self-propelled windrower or hay swather. An adjustable rotatable flexible brush is disposed within the housing such that plant parts bearing seeds are frictionally engaged between the brush and a lower wall portion of the housing. At least one auger is disposed in an auger trough rearwardly of the brush and directs the seeds harvested thereby to one end of the housing. The seeds are removed from the auger trough by a vacuum created by blower or impeller means located outside the housing. A screen member is disposed between the auger trough and the blower so that seeds are sucked through the screen, but plant debris is retained thereon. After being sucked through the screen member, the seeds impact the impeller, which is advantageously provided in the form of fan blades. In this manner, seed agglomerations or seed pods are broken so that individual seeds may be deposited in a seed storage means. A cyclone cleaner can be provided to remove debris, seed pods, etc., which otherwise would be collected with the seeds. In a preferred embodiment, the brush is provided with flexible bristles so that minimal damage is done to the vegetative plant parts. Also, the brush is adapted to be adjusted either horizontally or vertically with respect to the housing, and is preferably provided in the form of a rope, having bristles woven therein, wrapped in spiral configuration about a shaft. DETAILED DESCRIPTION OF THE INVENTION The present invention is especially adapted to be affixed to the front end of a windrower or hay swather . In the conversion of a typical combine or hay swather, the cutter bar assemblies are removed and the present invention is installed with either a 2-point or 4-point attachment. While it would appear to be somewhat less desirable, the apparatus of the present invention could likewise be mounted on hydraulically-actuated front end loader arms, commonly found on farm tractors. While it would not be the preferred mode of operation, it is equally clear that the apparatus of the present invention could likewise be mounted on any other propulsion device, such as a pickup truck, boat, continuous-track vehicle, etc. The present invention can be generically described as a "seed-harvesting header" and is denoted generally in FIG. 1, by the numeral 10. The header is comprised of a housing member 20, a brush 30, auger 40 and conduit means 50. Generally speaking, as the present invention is moved through a seed source in the direction of arrow 60, the brush 30 is rotated in the direction of arrow 62. Seed-bearing plants are stripped of their seeds by brush 30, the seeds being propelled to auger 40 and thence through the conduit means 50 to a seed storage area (not shown), which may take the form of a bag, hopper, etc. The operation of the present invention is to be distinguished from conventional combine harvesting of, for instance, wheat, wherein the entire above-ground portion of the plant is severed by a cutter bar and the rotating paddles direct the plant to a deseeding cylinder. After harvesting the seeds from, for instance a grass, the present invention leaves the bulk of the plant standing, affording vegetation for subsequent grazing by wild or domesticated animals, cover for birds, windbreaks for snow (thereby increasing available water for subsequent years growth) and decreased wind erosion. More specifically, the housing comprises a pair of end walls 22 and 24, a top wall 26, a back wall 28 and a bottom 32. It is contemplated that the housing will be constructed of a medium gauge steel which can be welded, although any suitable material will suffice, such as sheet metal, fiberglass, wood, etc. The brush 30 is carried on a pair of side brackets 34 which project forwardly from the end walls 22, 24. A pair of skids 35, can be provided at the lowermost portion of each end wall so that as uneven terrain is encountered by the invention, damage to the unit is minimized. The brush 30 is preferably adjustably mounted to the brackets 34 so that it may be adjusted either horizontally or vertically as viewed in FIG. 1. The brush 30 comprises a plurality of flexible bristle members 36 mounted to an outer shaft 38. Adjustability may be provided by any means available to those skilled in the art. For instance, a plurality of shims 42 provides adjustability vertically, by either adding or removing shims to raise or lower the brush. The shims are provided with a plurality of apertures which permit the journal to be moved horizontally, thereby adjusting the brush horizontally. Alternatively, brush 30 may be carried on an adjustable carriage 80 as shown in FIG. 1. The carriage 80 may be adjustably affixed to bracket 82 which is secured to member wall 22 by bolts 84. In this manner, the brush may be moved vertically by adjusting bolts 84 and bracket 34 upwardly or downwardly, and may be adjusted horizontally by sliding carriage 80 horizontally to a new location on bracket 34 prior to securement. An auger 40 is provided in a rearward and lowermost portion of housing 20. The auger 40 directs seeds collected throughout the width of housing 20 to one end of the housing for removal to the seed storage area. The seeds exit housing 20 through an opening covered by screen 48 in back wall 28. As shown in FIG. 3, a blower or impeller assembly 52 is positioned in conduit 50 to create a vacuum sufficient to pull seeds from the auger 40 through the screen 48 and thence through the pipe 54 to the seed storage area. A cyclone-type separating cleaner 90 can be provided in conduit 50 to remove debris that passes through screen 48. It has been found that a preferred method of making the brush 30 is to utilize a "rope" having bristles of appropriate length woven therein, with the "rope" thereafter being wound in a helical fashion (represented by the broken lines 56 of FIG. 2) about shaft 38. In such manner, relatively uniform point density can be obtained throughout the surface of the brush and replacement of the brush is a relatively simple matter. By winding the "flights" of the rope 56 about the shaft 38 in a tighter fashion, the point density of the brush can be increased; similarly, by winding the rope in more spaced-apart flights, the point density of the brush can be decreased. Such feature can be of great significance since the point density will, to some degree, determine the "stiffness" or "flexibility" of the brush. For example, when harvesting a grass species which requires very little force to separate the seed from the stem, a more flexible (lesser point density) brush may be utilized, whereas when removing seeds from a woody shrub, a more dense, stiff brush may be needed to penetrate th exterior of the plant and remove a high percentage of the seeds. While a point density of from about 6 points/square inch to about 20 points/square inch is acceptable (depending upon the length and diameter of the individual bristles) it has been found that a point density of from about 10 points/square inch to about 12 points/square inch is acceptable for harvesting most native grasses, shrubs, flowers and other crop plants. Within housing 20 is an arcuate lower wall portion 58 as shown in FIG. 4. Primary seed removal is accomplished on this arcuate lower wall as the plant is biased between the bristles 36 and wall 58. As the brush 30 is adjusted by moving it either to a lower or more rearward position, greater frictional engagement between the bristles 36 and wall 58 occurs. As the brush 30 is adjusted either upwardly or forwardly, the frictional engagement therebetween can be either reduced or totally eliminated. This feature permits the operator to select the desired amount of force necessary to remove the particular seeds being harvested without causing undue damage either to the seeds or the remaining vegetative material, or to the brush 30. As seeds are removed from the plants, they are propelled rearwardly and fall into an auger trough 64. The auger 40 can be constructed in any conventional manner. For instance, it can be a conventional screw-type auger, or applicant has found that an auger constructed similar to that of the brush 30 can be advantageously employed. In tee latter instance, a rope of bristles 66 can be relatively loosely wound about an auger shaft 68 to provide conventional canted auger flights. Depending upon the volume of seeds to be harvested, the housing can be provided with a plurality of augers arranged either one above the other or side-by-side. Such arrangement might be necessary when harvesting a large quantity of seeds in a short period of time. As shown in dashed lines in FIG. 4, a portion of the top wall 26 can be hinged to provide a maintenance or observation port. Applicant has found that it is advantageous to extend the home end of the auger slightly outside housing 20, as shown in FIG. 2. During seed removal, there will inevitably be plant debris (leaves, seed pods, stems, etc.) entrained with the seeds, which is advantageously removed prior to final collection of seeds. Applicant has found that when the seeds are removed through the screen 48 a substantial portion of the plant debris will be retained upon the screen. By positioning the auger 40 such that it sweeps across the screen 48, the screen is continually cleaned and the debris is carried outside housing 20 by auger 40 and deposited in the field. Preferably, the screen is easily removable for cleaning (if it becomes clogged with debris) or for changing for a screen having a different aperture size if different size seeds are harvested. Many seeds (especially grass seeds) naturally occur in agglomerations of two or more, being fused together either external of or within a seed pod or head. Additionally, many seeds naturally occur singly within seed pods. Such seeds are not suitable for planting, since individual seeds must be provided to a seed drill. Conventionally, seeds are harvested in whatever form they occur and thereafter the seed merchant attempts to break apart the agglomerations or pods to provide individual seeds. An important feature of the present invention is that the device combines these heretofore separate steps and provides a method of separating agglomerated seeds and breaking seed pods. The blower/impeller 52 is provided in the form of a conventional fan having a plurality of blades which substantially span the inside diameter of conduit 50. When operated at high speed in order to create the vacuum necessary to draw seeds through screen 48, virtually all of the seeds passing through screen 48 will contact one or more of the rotating fan blades 70. It is important to note that the seeds being sucked from the auger trough through screen 48 are travelling directly into the fan blades: e.g., they travel in a direction parallel to the axis of shaft 72 about which blades 70 rotate. Such arrangement insures that the seeds will contact the fan blades and separate agglomerations or break open seed pods. This material then preferentially enters a cyclone-type separating cleaner, where seed hulls, seed pods, small debris, etc., are separated, leaving a relatively pure seed stream. While the moveable parts disclosed herein can be actuated by any conventional power source, applicant has found that hydraulic motors are the preferred power source. For instance, a hydraulic motor 74 can be mounted on shaft 76 within shaft 30 to drive the brush 30. Similarly, hydraulic motors can be used to drive auger 40 and blower 52. EXAMPLE Five prototype headers substantially as described above were manufactured and affixed to Heston model 6555 swather tractor. The headers had approximate dimensions of heighth 431/2"×depth 481/2"×width 14'5", with the seed harvesting brush being constructed of a bristle rope wound about a 10" shaft such that the point density was about 10 points/inch square. The auger was likewise constructed of bristle rope wound about a 2" shaft. The diameter of the seed harvesting brush was 36", while the diameter of the auger brush was 12". The combines were run through a very thinly vegetated stand of Crested Wheat Grass, representing a minimally adequate seed stock source. The headers were maintained approximately 14" above the ground surface. The following variables were maintained as closely as possible over the test run: 1. ground speed: 6 mph 2. seed harvesting brush rotation speed: 210 rpm 3. auger rotation speed: 160 rpm 4. blower/impeller speed: 3000 rpm The following results were obtained: 1. number of acres covered: 80/day/machine 2. time per acre per machine: 9 minutes 3. pounds of seed recovered per acre: 12.5 pounds 4. percentage of seeds recovered as doubles: 20%-25% (est.) 5. amount of plant debris in harvested seeds: 20% (est.) Observations 1. minimal damage to grasses, leaving forage for grazing animals; 2. minimal damage to shrubs when harvesting grass; 3. virtually all seed harvested from plants; 4. cyclone cleaner not utilized on these machines-- plant debris expected to be substantially lower with its use. The foregoing description should be considered illustrative of the principles of this invention. It should be readily apparent that those skilled in the art can make modifications or changes to various aspects of the invention without departing from the spirit thereof. It is not necessarily desired to limit the invention to the precise configuration shown and described herein but rather the limits of this invention are to be construed solely in light of the appended claims.

An elongate housing is provided for removable attachment to either a self-propelled windrower or conventional farm tractor. A flexible-bristle brush is adjustably secured to the housing such that when the housing is moved through a field of seed-bearing plants, the rotating brush interacts with the housing to strip seeds from the plants. The seeds are deposited in an auger trough and moved by the auger to one end of the housing. An impeller or blower located outside the housing creates a vacuum such that the seeds are drawn through a screened opening in the housing and conveyed to a seed storage area. In order to break apart agglomerations of seeds or seed bearing pods, the blower/impeller is preferably provided in the form of a fan having blades which rotate about a shaft aligned such that the harvested seeds strike the fan blades, thereby breaking apart the seed agglomerates and seed pods. The flexible bristle brush is adjustable so that varying forces may be applied to varying plants having greater or lesser force required to remove seeds therefrom.

FIELD OF THE INVENTION This invention relates to seed dispensing tools, specifically to such tools using vacuum suction for seed pickup. BACKGROUND AND PRIOR ART In the operation of seeding, seeds are transferred from a hopper and deposited uniformly in the soil. In one type of seeding machines the seeds are pulled by gravity through a flow control mechanism attached to the bottom of the hopper. This mechanism consists of a set of two plates: one plate, having a plurality of holes sized slightly larger than the seed, is made to rotate at a rate proportional to the seed discharge rate. Seeds fall into these holes and are trapped in place by a stationary plate placed below the rotating plate and having a single discharge opening. As the first plate rotates it carries the trapped seeds toward the opening in the stationary plate. The seeds then gravitates towards the soil. These types of machines are only suitable for large and uniform size seeds. An adaptation of this type of machine for use in small scale gardening is described by Beckworth in U.S. Pat. No. 4,315,580. For the purpose of sowing small or nonuniform size seeds, the power of air flow or of vacuum suction is employed. Dobson et al in U.S. Pat. No. 4,239,126 describe such a machine: the round portion of a rotating drum fits closely against the opening of a seed hopper thus making contact with the seeds. The portion of the circumference of the drum which contacts the seeds has a plurality of holes having a size smaller than the seed. Vacuum suction is applied to the drum via the center of its pivot. The suction force draws seeds towards the holes in the drum. Consequently, the holes are plugged up with seeds. If the size of the holes and the power of the vacuum is chosen properly, only one seed is picked up by each hole. As the drum rotates the picked seed is carried up, then out of the hopper and then down. A wheel which is mounted on a separate and internal pivot, is engaged to the inner surface of the drum and covers momentarily the hole that moves to the point of contact between the drum and the wheel. The suction force is thus interrupted and the seed which is held against that hole is released and falls onto the soil. A hobbyist gardener who needs to seed a small scale back-yard garden with small seeds such as carrot or lettuce seeds can appreciate the difficulty of attempting the task of distributing the seeds manually into prepared furrows. He can of course resort to pelletized seed or seed tape which are available commercially for limited seed varieties and at a substantially greater cost. The objective of the invention is to provide the small scale gardener the means for planting small seeds with ease. The invention uses the principle of vacuum seed pickup as described above but eliminates the need for a continuous vacuum source. The power is provided by the operator who guides a wheel along a prepared furrow and the wheel rotation in turn drives the rest of the mechanism. In addition, since small seed is often indistinguishable once deposited on the soil, it is a second objective of the invention to provide the operator with an electronic monitor that gives him the assurance that seeding is indeed taking place. BRIEF DESCRIPTION OF THE DRAWINGS The following drawings illustrate the preferred embodiment or parts thereof: FIG. 1--General view of the seeder. FIG. 2--Front view with the seed container removed. FIG. 3--Isometric view of the seed container. FIG. 4--Details the construction of the suction bellow. FIGS. 5A, 5B, 5C,--Depicts the operation of the suction bellow. FIG. 6--The schematic of the seed detector. FIG. 7--Illustrates the addition of a second bellow. FIG. 8--Illustrates the addition of a second pickup aperture. FIG. 9--Illustrates the configuration with a stationary bellow. DESCRIPTION OF THE PREFERRED EMBODIMENT With reference to FIGS. 1 and 2, the operator holding on to handle 11 guides the seeder along a prepared furrow and consequently wheel 12 rotates in the direction of the arrow. Wheel 12 and wheel 13 are mounted on chassis 14 and are coupled via belt 15 and pulleys 16 and 17. The belt and the pulleys are cogged to eliminate slippage. Belt 15 is twisted like the figure eight, thus transferring to wheel 13 rotation in the direction of the arrow next to it in FIG. 1. Seed-container 18 is detailed in FIG. 3. It is constructed of two transparent plastic walls 19, a sloping bottom 20 and a swivel cover 21. Wheel 13 fits closely in the slot formed by the two walls and the bottom, thus enclosing seeds 22. A gap larger than a single seed remains between wheel 13 and the edge of cover 21. Funnel 23 which extends through a hole in cover 21 facilitates loading the container with seeds. With reference to FIGS. 4 and 5, the suction bellow 24, constructed of an elastic element 25 and two rigid disks 26 which are held together by compression rings 27, is mounted on wheel 13 inside a diamond shaped opening. One rigid disk 26 is attached to wheel 13 by means of screws through holes in bracket 28 and the other disk is made to oscillate back and forth as wheel 13 rotates, by means of a mechanism comprised of connecting rod 29 pivots 30 and 31 and arm 32. Arm 32 is attached to mounting bracket 33 which is riveted to chassis 14 as shown in FIG. 2. Arm 32 extends away from wheel 13, thus providing enough clearance for bellow 24 as it passes under the arm as shown in FIG. 5A. A radial hole 34 in wheel 13 is aligned with a hole 35 in disk 26 and an O-ring 36 provides a tight seal. Again with reference to FIG. 5A, bellow 24 is shown in its most compressed position. As wheel 13 rotates, the bellow expands and as hole 34 enters the seed container 18 the rate of suction is sufficient for a single seed to be picked up. The picked up seed is carried upwards as shown in FIG. 5B. The seed is held in place until the suction stops, i.e. until the bellow is fully expanded as shown in FIG. 5C. As wheel 13 continues, the bellow contracts and instead of suction it provides an explusive flow of air which pushes the seed away. The seed is then already located inside the bent portion of duct 39 which guides the seed toward the ground as shown in FIG. 1. The passage of the seed is detected by electronic module 61 which produces an audible beep. Duct 39 is made of a square tube and is attached to bracket 33. The upper portion of the duct is bent and it has a slot in which wheel 13 fits, leaving enough clearance for the passage of the seed. To adapt the tool for different seeds, a replaceable constrictor 37 is inserted at the opening of hole 34 as shown in FIG. 4. The constrictor has a smaller orifice than the diameter of hole 34 and a flared opening to provide a better grip on the seed. In addition, a replaceable plug 38, having an orifice through which air leakage is allowed is provided as shown in FIG. 4. By selecting the correct orifice, the counteracting force exerted by the bellow on the drive mechanism is reduced to the minimum and the incidents of multiple seed pickup due to excessive suction force are also reduced. With reference to FIG. 6. the operation of the electronic monitor will now be explained. As switch 41 is turned on current from battery 40 flows through resistor 42 and causes light-emitting-diode 43 to emit light which enters via a through-hole in duct 39 and falls on light detector 44 which is a cadmium-sulfide photo resistor. The current through detector 44 is set by resistor 45 and by the intensity of light from the emitting diode. As a seed falls down duct 39 it partially interrupts the light path between the emitter and the detector, causing a small change in the voltage across the detector. This voltage change is amplified by the amplifier circuit composed of capacitor 46 resistors 47, 48, 50 and transistor 49. The amplified voltage swing at the collector of transistor 49 is enough to trigger the monostable flip-flop circuit composed of AND-gates 51, 53, capacitor 52 and resistor 54. The monostable flip-flop produces an approximately 0.1 second enable signal to the free-running flip-flop composed of AND-gates 55, 56, resistors 57, 58 and capacitor 59. The free-running flip-flop feeds the piezoelectric loudspeaker 60 with a tone signal of approximately 2000 Hz. Thus, every time a seed is deposited, an audible beep of 0.1 second duration is produced, giving the operator the confidence that seeding is taking place. SUMMARY AND RAMIFICATIONS For the new invention to operate smoothly it is required that the ground engaging wheel 12 roll easily over a worked garden soil. Therefore, the diameter of this wheel cannot be arbitrarily small. A diameter of approximately 6 inches is the optimum size for wheel 12. This means that the wheel traverses approximately 18 inches for each complete rotation. Since the distance between seeds as required for most seeding operation is much shorter, i.e. 2 to 6 inches, and since the new seeder as described previously deposits a single seed for every turn of wheel 13, it follows that the coupling ratio between wheel 12 and wheel 13 must be as high as 9:1. If we assume for this discussion that the coupling ratio is 9:1 and that a reasonable slowest walking speed for the operator is 1.5 feet/second, it follows that wheel 13 will rotate approximately 9 revolutions per seconds. At that speed no seed pickup is possible because of the inertia of the seed. Experiments showed that for efficient operation, the rotation speed of wheel 13 with a diameter of approximately 4 inches is limited to 3 revolutions per second. In order to increase the density of deposited seeds, it is possible that the operator will run over the same furrow more than once; each time with a slight off-set to the starting point. Alternatively the seeder can be modified as follows: 1. With reference to FIG. 7, two or more suction elements 24 can be mounted on the same wheel 13, coupled by a separate connecting rod 29 to a single pivotal point. Each suction element is thus made to contract and expand once every rotation, proportionally increasing the number of seeds deposited per rotation. 2. With reference to FIG. 8, the suction bellow has two suction ports 37 in close proximity thus picking up and depositing seed in pairs for each rotation of wheel 13. This method does not offer uniform distribution, but this is not a limitation since most crops are planted at a high density in order to allow thinning after the seedlings emerge. Statistically, thinning after planting in pairs also results in adequate uniformity in plant distribution. If modifications (1) and (2) above are combined, it gives the operator the flexibility to select a seeding density by enabling only part of the suction ports and plugging the rest and without changing the coupling ratio between wheels 12 and 13. Although in the preferred embodiment the suction element 24 is mounted on wheel 13, an embodiment in which the suction element is mounted on chassis 14 is within the scope of the new invention. Such an embodiment is depicted in FIG. 9. A tube 62 connects the suction element to the radial hole 34 in wheel 13 by means of a rotary seal bushing 63. The oscillatory motion to the suction element is conveyed by means of connecting rod 64 mounted on an off-center pivot 65. Also, within the scope of this invention are all the embodiments which employ suction elements that are based on a piston inside a cylinder instead of an elastic bellow, and all the embodiments which employ mechanical gear coupling instead of a cogged belt and pulleys.

A tool for depositing seed uniformly along a prepared furrow. The tool uses the rolling motion of a ground engaging wheel to drive a seed pickup and delivery mechanism. A pickup wheel which is coupled to the ground engaging wheel contacts the seeds via a slot in the seed container. A suction force created by an oscillating bellow is channeled to a pickup aperture in the circumference of the pickup wheel. Picked seed is carried by the pickup wheel to a guiding duct to be released and delivered to the soil. The tool also includes an electronic monitor that produces a short audible beep for every deposited seed.

REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of application Ser. No. 08/868,499 filed Jun. 4, 1997, now U.S. Pat. No. 5,879,323 issued Mar. 9, 1999, which is a divisional of allowed U.S. patent application Ser. No. 08/646,853 filed May 8, 1996 now U.S. Pat. No. 5,767,648. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates generally to the transdermal electrokinetic mass transfer of medication into a diseased tissue, and, more specifically, to a portable apparatus for the iontophoretic delivery of medication across the skin and incorporation of the medication into diseased tissues and blood vessels adjacent to the delivery site. The apparatus provides a new method for treating and managing diseases presenting cutaneous lesions. 2. Prior Art Iontophoresis has been employed for several centuries as a means for applying medication locally through a patient's skin and for delivering medicaments to the eyes and ears. The application of an electric field to the skin is known to greatly enhance the skin's permeability to various ionic agents. The use of iontophoretic transdermal delivery techniques has obviated the need for hypodermic injection for many medicaments, thereby eliminating the concomitant problems of trauma, pain and risk of infection to the patient. Iontophoresis involves the application of an electromotive force to drive or repel oppositely charged ions through the dermal layers into a target tissue. Particularly suitable target tissue include tissues adjacent to the delivery site for localized treatment or tissues remote therefrom in which case the medicament enters into the circulatory system and is transported to a tissue by the blood. Positively charged ions are driven into the skin at an anode while negatively charged ions are driven into the skin at a cathode. Studies have shown increased skin penetration of drugs at anodic or cathodic electrodes regardless of the predominant molecular ionic charge on the drug. This effect is medicated by polarization and osmotic effects. Regardless of the charge of the medicament to be administered, a iontophoretic delivery device employs two electrodes (an anode and a cathode) in conjunction with the patient's skin to form a closed circuit between one of the electrodes (referred to herein alternatively as a "working" or "application" or "applicator" electrode) which is positioned at the delivered site of drug delivery and a passive or "grounding" electrode affixed to a second site on the skin to enhance the rate of penetration of the medicament into the skin adjacent to the applicator electrode. Recent interest in the use of iontophoresis for delivering drugs through a patient's skin to a desired treatment site has stimulated a redesign of many of such drugs with concomitant increased efficacy of the drugs when delivered transdermally. As iontophoretic delivery of medicaments become more widely used, the opportunity for a consumer/patient to iontophoretically administer a transdermal dosage of medicaments simply and safely at non-medical or non-professional facilities would be desirable and practical. Similarly, when a consumer/patient travels, it would be desirable to have a personal, easily transportable apparatus available which is operable for the iontophoretic transdermal delivery of a medication packaged in a single dosage applicator. The present invention provides a portable iontophoretic medicament delivery apparatus and a unit-dosage medicament-containing applicator electrode which is disposable and adapted for use with the apparatus for self-administering medicament. SUMMARY OF THE INVENTION The present invention discloses a portable iontophoretic transdermal or transmucoscal medicament delivery apparatus and a unit dosage medicament applicator electrode adapted for use with the apparatus for the self-administration of a unit dose of a medicament into the skin. The apparatus is particularly suited for the localized treatment of herpes infections. Recurrent herpetic infections (fever blisters or herpes labialis) are very common and usually involve the mucocutaneous juncture. The established treatment for recurrent herpetic lesions (oral or genital) has been primarily supportive; including local topical application of anesthesia. Severe cases have been treated with systemic Acyclovir® (Zovirax Burroughs-Wellcome). Some cases the condition is managed with prophylactic long-term dosing administration with a suitable antiviral agent at great expense. Systemic treatment of acute herpetic flare-ups may reduce the normal 10-12 day course of cutaneous symptoms into a 6-8 day episode. Topical treatment of lesions with Acyclovir® has not been as effective as in vitro studies would suggest. A compound which is not presently available to clinicians but has demonstrated significant anti herpetic activity is 5-iodo-2 deoxyuridine (IUDR). Both of those agents have shown limited clinical efficacy when applied topically to the herpetic lesion. It is the present inventor's contention that the limited efficacy of topical administration previously observed is, at least in part, due to the poor skin penetration of these medicaments when applied topically. The present invention provides improved transdermal delivery of these medicaments and demonstrates improved clinical results in the case of Herpes. Oral Herpes (most commonly Herpes simplex I infection) as well as genital Herpes (usually Herpes Simplex II infection) afflict many people, cause discomfort, shame, and may contribute to more severe and costly illnesses such as cervical cancer, prostate cancer, and perinatal blindness from herpetic conjunctivitis. The present invention discloses a portable, user-friendly transdermal delivery device and a method for using the device with Acyclovir® (or similar antiviral agent) to greatly benefit these afflicted patients. The present inventor has constructed embodiments of this device and conducted human clinical trials which clearly demonstrate improved therapeutic efficacy using iontophoretically administered antiviral agents when compared to unassisted topical application of the agent. It is an object of the present invention to provide an iontophoretic medicament delivery apparatus which is portable and operable for self-administration of medicament into the skin of a person. It is another object of the present invention to provide an improved iontophoretic transdermal drug delivery apparatus having a medicament-containing application electrode which disperses a single dosage and is disposable and non-reusable. It is a feature of the present invention that the iontophoretic medicament delivery apparatus is easily maneuverable and operable when hand-held. It is another feature of the present invention that the iontophoretic medicament delivery apparatus is battery powered and conveniently transported by a person. It is a further feature of the present invention that the iontophoretic medicament delivery apparatus employs a tactile electrode which is in electrical contact with the skin of a user's hand when the apparatus is held in the user's hand, obviating the need for a separate grounding electrode connector or wire. It is still another feature of the present invention that the iontophoretic medicament delivery apparatus is adapted to be operable with a disposable medicament containing applicator electrode which applicator electrode includes an absorbent, inert, non-corrosive portion containing a therapeutic agent. It is yet another feature of the present invention to provide an embodiment of an iontophoretic transdermal delivery device wherein the disposable iontophoretic medicament-containing applicator electrode is adapted for releasable attachment to use with a hand-held base assembly housing a grounding electrode. It is yet another feature of the present invention that the disposable iontophoretic medicament applicator electrode include indicator means operable for enabling a user to determine when the medicament within the removable applicator electrode has been released in delivery and/or depleted. It is yet another feature of the present invention that the circuitry employed in the disposable iontophoretic medicament applicator include current limiting means operable for limiting the electrical current flowing between the surface of the applicator and the skin to less than about one milliampere per square centimeters of application electrode skin-contacting, surface. It is another advantage of the present invention that the iontophoretic medicament delivery apparatus employs a disposable application electrode which conducts the electrical current to the tissue through the solution in which the medicament is dissolved. It is still another advantage of the present invention that the improved disposable iontophoretic medicament applicator is inexpensive, safe to use, substantially unitary in construction and greatly increases the therapeutic efficacy of a medicament administered thereby. The apparatus in accordance with the present invention provides a means for topically administering medicament directly and with, high efficiency into a diseased tissue thereby providing a novel method for treating clinical conditions presenting mucocutaneous symptoms and particularly mucocutaneous Herpes Simplex viral eruptions and sequelle associated therewith. In one embodiment the electrode comprises a unitary flexible strip (such as SILASTIC®- by Dow Corning) having perforations dimensioned to accommodate a medicament placed therein. The perforations or "cells" can be made to store and dispense gels, ointments, fluids and other medicament vehicles without requiring the reformulation of the either the medicament or the vehicle. The above objects, features and advantages of the invention are realized by the improved monopolar iontophoretic, medicament applicator which is easily transportable. The applicator employs a detachable medicament containing application electrode. The objects, features and advantages of the invention will become apparent upon consideration of the following detailed disclosure of the invention, especially when it is taken in conjunction with the accompanying drawings wherein: BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevational plan view of the iontophoretic medicament delivery apparatus showing the circumferential tactile ground electrode on the outer surface of the base housing and a disposable iontophoretic application electrode; FIG. 2 is a side elevational view of the disposable non-reusable iontophoretic application electrode with a portion broken away to view the medicament dose packet; FIG. 3 is a top view of a medicament dispensing electrode adapted for use with an iontophoresis handpiece. FIG. 4 is a side elevational exploded view of the medicament dispensing electrode of FIG. 3. FIG. 5 is a perspective view illustrating the medicament dispensing electrode of FIGS. 3 and 4 attached to an iontophoresis handpiece in preparation for use. FIG. 6 is a perspective view illustrating a patient preparing to self-administer medicament to lesions adjacent to the mouth employing the iontophoretic electrode/handpiece delivery system in accordance with the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 shows, in side elevation, a preferred embodiment of the hand-held iontophoretic transdermal medicament delivery apparatus of the present invention. The apparatus, indicated generally by the numeral 10, has an elongate base assembly 11 the major portion of which is preferably formed of plastic and shaped to conform to and comfortably fit within a users hand. An applicator electrode module 12, containing a unit dose of medicament 23, is releasably attached to a applicator electrode receptacle 14 on the distal end of the base assembly 11. The application electrode 12 is preferably a "clip-on" type of electrode similar in configuration to an electrocardiogram electrode. In the drawing presented in FIGS. 1 and 2, electrically conductive elements such as wires and busses are presented as heavy lines. A wire 16 provides electrical connection between the applicator electrode receptacle 14 and wire 1 within the neck 15 of the base assembly 11. Connecting wire 18, in turn, provides electrical connection between the wire 16 and the current driver unit 19 housed within the base assembly 11. A conductive tactile electrode 20 forms a portion of the exterior skin-contacting surface of the base assembly 11 preferably circumferentially enclosing a portion of the base housing or it may be interrupted or discontinuous on the outer surface. The tactile electrode 20 is in electrical communication with the cathode 24C of battery 24 by means of a buss 17 and conductive urging spring 25 which secures the battery in position within the base assembly 11. For the self-administration of medicament a user must have. skin contact with the tactile electrode 20 for the unit to operate. Current driver 19 underlies the cathodic (ground) tactile electrode 20 and is electrically connected via wire 21 to a voltage multiplier 22. The voltage multiplier 22 receives low voltage power from the anode 24a of the battery power source 24 and increases the available voltage for presentation to the application electrode 12. The battery 24 is preferably a size AA or AAA. Battery 24 is held in place by an electrically conductive biasing spring 25 and ensures that electrical power is available at the application electrode 12 when the user grasps and holds the base housing 11 of the apparatus 10 thereby touching the cathodic tactile electrode 20. The application electrode 12 and the tactile electrode 20 thus form a closed circuit in series with the user's skin. When current flows across the user's skin to the application electrode in response to an applied voltage the current promotes and hastens the penetration of the medicament 23 contained in a reservoir 26 within the working electrode 12 into the skin. The polarity of the working electrode 12 is preferably unidirectional to promote the above described penetration without requiring a separate grounding electrode. The working application electrode 12 will be described in greater detail below. The base assembly 11 of apparatus 10 serves as a housing to the aforesaid components as a handle. The portion of the base assembly 11 exclusive of the tactile electrode, is preferably made of a plastic such as polyethylene, acrylonitrile, butadiene, styrene or similar durable plastic. The battery portion 24 is connected to a voltage multiplier 22 which steps up the voltage supplied by the battery 24 and applies the stepped up voltage to the current driver 19. Current driver 19 presents a defined current and voltage output at the application electrode 12 the value of the current, which may be empirically determined being sufficient to drive the medicament through the porous, open-celled material 27 (FIG. 2) within the application electrode interposed between the skin contacting surface 13 and reservoir 26 containing the unit dose medicament and penetrate the patient's skin. The circuitry limits the maximum current available to the application electrode to preferably to less than about one milliampere per two square centimeters of the skin-contacting surface area 13 of the application electrode 12. However, depending upon working electrode's 12 skin-contacting surface 13 configuration, the current level can vary from about 0.1 to about 1.2 milliamps. Currents ranging between 0.1 ma to 5 ma have been used clinically by the present inventor, but the higher currents caused the user minor discomfort and, with chronic use over time, may produce untoward effects. FIG. 2 shows a preferred embodiment of the iontophoretic medicament-containing application electrode 12. The application electrode 12 is preferably disposable and non-reusable and is suitable, for example, for transdermally delivering antiviral agents such as Acyclovir® for the treatment of cold sores or genital herpes. The size of the skin-contacting surface 13 of application electrode 12 may vary to accommodate specific clinical applications. The application electrode 12 is detachably housed within a recess within the receptacle 14 which recess presents an electrically conductive interior surface to complete the electrical flow path from the connecting wires 18 and 16 to a conductive element 29 within the application electrode. The electrical current from the current driver 19 is conducted through conductive inner surface of the application electrode receptacle 14 to the electrically conductive element 29 within the applicator electrode which element 29 is in electrical contact with the inner surface of the receptacle in contact therewith to drive the medicament 23 or treatment agent through the open-celled sponge-like matrix material 27 and through the user's skin (not shown). The medicament or treatment agent 23 is contained within a rupturable polymer reservoir 26 until dispensed during treatment. A slight exertion of pressure or squeezing of the reservoir 26 against reservoir puncture means 28 releases the medicament or treatment agent into an open-celled sponge-like material 27 within the application electrode for iontophoretic delivery into the patient's skin. Medicament 23 release can occur at the time of application or upon peruse compression of the electrode 12. Application electrode 12 can be advantageously designed to include a stripping portion adapted so that upon removal of the application electrode 12 from the electrode receptacle 14 a protruding stripping portion (not shown) scrapingly strips the conductive coating from the conductive support arm 29 to prevent reuse of the disposable electrode 12. Application electrode 12 is intentionally packaged with a single dose packet or reservoir 26 of treatment agent or medicament 23. In addition to the medicament, the reservoir 26 can include a coloring agent, such as iodine, which turns dark blue upon contact with starch in the open-celled material to visibly indicate that the unit dose encapsulation has been used. Other suitable coloring agents can include pH indicators, wet saturation indicators or oxidizable pigments. The open-celled sponge-like material 27 surrounding reservoir 26 should be inert to the medicament or treatment agent being employed, as well as being non-corrosive and stable when in contact with the treatment agent. Suitable materials include plastic pads, such as polyethylene, paper or cotton, porous ceramics, open-celled porous polytetrafluoroethylene, polyurethane and other inert plastics, and open-celled silicone rubber, such as may be employed with vertically aligned medicament-containing tubes. A typical medicament that can be contained within the rupturable polymer reservoir 26 is xylocaine or similar topical anesthetic. The disposable electrode 12 possesses the advantages of preventing leaching or migration of the medicament from within the rupturable polymer reservoir, no attendant loss of efficacy, a long shelf life and little or no electrode corrosion. A suitable electrical control circuit for use in the iontophoretic medicament delivery apparatus 12 is shown in U.S. patent application, Ser. No. 07/579,799, filed Sep. 10, 1990, now U.S. Pat. No. 5,160,316 and hereby specifically incorporated by reference herein in pertinent part. FIG. 3 shows a particularly preferred embodiment of a disposable, one-time use electrode 30 for use with the iontophoresis handpiece 10 of the present invention. FIG. 3 is a top view of the disposable electrode 30 with the upper release film 41 (FIG. 4) removed. A non-conductive substrate 31 is formed into a flat strip having a central portion A and two end portions B. The end portions B each have a cut-out therein containing an electrically conductive gel 32. The gel 32 may be imbedded within a mesh or it may be constrained within the cut out by means of a porous, non-wicking and non-electrically conducing containment layer 34 and 35 much as tea is contained within a porous tea bag. The central portion A of the strip 31 has a medicament-containing reservoir 33 therewithin. The medicament-containing reservoir 33 may comprise a suitable medicament embedded within the mesh of a pharmacologically inert material. The medicament-containing reservoir 33 is positioned between die cuts 36 in the non-conductive substrate 31 which die cuts provide means for facilitating the predictable bending the electrode strip 30 to matingly conform to the shape of the exterior surface of an iontophoresis handpiece 10 (FIG. 1). Magnets 43 and 43' (shown in phantom in FIG. 3) disposed laterally to the central portion A provide means for magnetically activating a handpiece when the electrode is in position. An exploded side view of the electrode 30 is shown in FIG. 4. The conductive gel 32 filling the cut-outs may be contained within a mesh or may be contained within the cut-out by means of porous, non-wicking layers 34 and 35. Similarly, the medicament-containing cut-out 33 may comprise the medicament embedded within a mesh, a gel, or similar substrate which releases the medicament in response to an electrical communication therewith. The upper containment layer 34 and the lower containment layer 35 serve to restrain the conductive gel within the medicament reservoir 33 to their respective cut-outs. An upper release film 41 is used to protect the adhesive surface (not shown) on the uppermost surface of the containment layer 34. A lower release film 42 serves a similar function to protect the adhesive surface of the lower medicament containment layer 35. The cut-outs 36 are shown to penetrate the strip of non-conductive material 31 adjacent to the medicament-containing reservoir 33. It is particularly desirable to provide one or more activating magnetic bodies 43 and 43' within the strip 31 in order to properly position the electrode strip 30 and activate the handpiece 10. Since it is anticipated that the handpiece/electrode assembly of the present invention will most likely be used in the bathroom, it is particularly desirable to hermetically seal the handpiece's internal operational mechanisms. The on/off switch within the handpiece can be in the form of a magnetically responsive switch which is turned "on" and "off" in response to the position of the electrode. Turning now to FIG. 5, we see a disposable electrode 30 in the process of being applied to the terminal end of an iontophoresis handpiece 10. The electrode 30 is applied to the active terminal 16 of the handpiece in such a manner that the medicament-containing reservoir 33 overlies and is in electrical contact with the active terminal 16 of the handpiece 10. The conductive gel layers 32 are positioned on the handpiece to overly the ground electrode on the handpiece 10. The ground electrode is indicated at 20 in FIG. 5. An alternate but equally effective embodiment of FIG. 4 electrode can be manufactured from a mold injected soft, inert material, non-conductive and non-porous (such as SILASTIC®- by Dow Corning) in the shape embodied in FIG. 3. The unit will contain vertically aligned open cells for containing and acting as reservoir for therapeutic medicaments as well as a conductive gel (if necessary). Such an embodiment is less costly to produce and avoids the process of assembling numerous layers. The iontophoresis handpiece and electrode assembly in accordance with the preferred embodiment shown in FIGS. 3 and 4 is shown being used by a patient 60 in FIG. 6. The patient 60 grasps the handpiece by means of placing a finger 61 on at least one of the conductive gel ground electrodes thereby grounding the patient's body. The active electrode driver 19 of the handpiece is in electrical communication with the medicament-containing reservoir 33. The medicament-containing reservoir 33, thus positioned and grasped by the patient, is advanced to come in contact with a lesion 63 on the patient's skin. Upon contact, electrical current flows between the active electrode 19 in the handpiece to the ground electrode(s) 32 via passage through the medicament-containing reservoir 33 comprising the active electrode. The polarity of the current may be reversed to accommodate the charge on the medicament. The flow of an electrical current facilitates entry of the medicament within the reservoir 33 into the skin overlying the lesion 63 thereby locally delivering the medicament to the exact area to be treated. EXPERIMENTAL CLINICAL TRIALS The inventor has conducted a clinical study using a prototype iontophoretic device in accordance with the present invention for the treatment of cold sores. The clinical response was promising. A second independent, qualified investigator, a board-certified Urologist, conducted a study using the present apparatus and method for treating male genital herpes lesions with encouraging results. Table 1 summarizes data (discussed below) supporting the claim to unexpected clinical benefits treating disease with this novel method. The method and medicament application device when used together for treating these common, embarrassing, and previously not easily-treatable ailments provide surprising advantages. The embodiment of the device shown in FIG. 1 and described hereinabove is a improvement over the prototype used in the clinical study, which was a larger unit, not user friendly, which required physically connecting wires to the patient's body which created anxiety, and could not be used without attending personnel. Notwithstanding design, the apparatus used in the clinical study summarized in Table 1 employed electronics similar to the apparatus described herein and was used to optimize the clinical performance of the embodiment 12 of the device described herein. TABLE 1______________________________________STAGE I TREATMENT RESULTSRESPONSE IUDR ACYCLOVIR ® TOTALS______________________________________No response 1 1 2Some response 1 3 4Major response 26 42 68______________________________________ The study included a control situation wherein seven patients were found who had simultaneous concurrent herpes lesions at separate locations on their bodies. In each case one lesion was treated with iontophoretic application of antiviral agent (Acyclovir® or IUDR) and the other lesion was treated in the standard method employed in the prior art comprising repeated topical application of the same antiviral agent. The iontophoretically enhanced treated lesion received a single 10-15 minute treatment. All iontophoretically treated lesions demonstrated resolution in 24 hours and none of the unassisted topically treated lesions demonstrated a similar response. The results for the control group are summarized in Table 2. TABLE 2______________________________________CONTROL GROUP RESULTS No response Some resp. Major resp.______________________________________IUDRTreated lesion 0 0 7Control lesion 5 2 0ACYCLOVIR ®Treated lesion 0 0 1Control lesion 1 0 0______________________________________ The clinical studies included patient volunteers with full informed consent who suffered from recurrent cold sores. The study demonstrated greatest treatment efficacy if the herpes lesion received iontophoretic treatment within 36 hours of lesion onset. The treatment incorporated an electrode saturated with Acyclovir® ointment (ZOVIRAX®) or IUDR (STOXIL®) Ophthalmic drops as supplied by the manufacturer. Thus mounted Anodic electrode of the prototype system was used for a 10-15 minute application directly to the lesion with the average current setting of 0.2 ma-0.6 ma which was well tolerated by all patients. The lesion was evaluated in 24 hours. In 92% of the iontophoretically treated cases (>70 lesions treated) a major response was noted. A major response was categorized by resolution of pain in <6 hours and lesion crusted and healing within 24 hours. The normal course of cold sores involves an average period of 10-12 days before resolution and healing occurs. The present apparatus and clinical method for treatment of mucocutaneous Herpes Simplex (type I and Type II) eruptions presented herein have been described and performed with excellent results. This novel user friendly apparatus in combination with the disclosed clinical treatment method presents a very effective new treatment for Herpes Simplex eruptions. While the invention has been described above with references to specific embodiments thereof, it is apparent that many changes, modifications and variations in the materials, arrangements of parts and steps can be made without departing from the inventive concept disclosed herein. For example an impregnated conductive gel can also be used to as medicament containing medium to increase the physical stability and the tissue adhering characteristics of the electrode. Accordingly, the spirit and broad scope of the appended claims is intended to embrace all such changes, modifications and variations that may occur to one of skill in the art upon a reading of the disclosure. All patent applications, patents and other publication cited herein are incorporated by reference in their entirety.

A portable iontophoresis apparatus for facilitating delivery of medication across the cutaneous membrane into adjacent underlying tissues and blood vessels. The apparatus employs a modular, detachable non-reusable medicament-containing applicator electrode which is adapted to attach to a base assembly. The apparatus is designed to be hand-held and includes a circumferential tactile electrode band on the base assembly which provides electrical connection between the skin of the user's hand and one pole of a bipolar power source housed within the base assembly. The opposing pole of the power source is connected to the applicator electrode. The user's body completes the electrical circuit between the applicator and tactile electrodes. A method for using the device for the treatment of Herpes simplex infection and related viral infections which produce similar cutaneous lesions is presented. The apparatus, when used in accordance with the method described herein, demonstrated >90% treatment efficacy in clinical trials.

This application claims the benefit of U.S. Provisional Application No. 60/139,834, filed Jun. 21, 1999. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to the field concerning the game of golf, and more particularly to a novel automatic placement device for use in practicing the game of golf by automatically storing and placing a golf ball on a tee preparatory for driving. 2. Brief Description of the Prior Art In the past, a variety of practice aids and devices have been employed for improving a golfer's skill in the game of playing golf. Once such accessory for improving a golfer's driving skills is to employ a device for automatically placing a golf ball on the top of a tee preparatory for swinging the club and driving the ball in a desired direction. Several devices have been developed for receiving a quantity of balls in a hopper and then selecting a ball from the supply which is then placed on a golf tee. Difficulties and problems have been encountered with such conventional devices since they are not fully automatic and require that the player or golfer remove the selected ball from,the apparatus and place the ball on the tee himself. In other instances, the player must relocate the selected ball to a device which then places the ball on the tee. In these prior situations, the golfer must step away from his driving stance and bend or lean into the hopper for ball selection or for machine operation. Particularly in instances of full use, few machines include counters or other means for determining the number of balls used so that proper charge or ball replacement can be determined. In other prior situations, the ball dispensing devices are usually constructed of materials which easily fatigue or readily damage when placed out-of-doors and in an inclement environment. In many situations, the prior devices are not readily maintainable and require skilled adjustment as well as technical knowledge for maintenance and usage. Therefore, a long-standing need has existed to provide a novel device for placing a golf ball on a tee which is automatic and which may be activated by the golfer without stepping away from his normal swinging stance. The novel device provides a means for automatically selecting and placing the selected ball onto a tee without the golfer having to bend or twist away from his golf swing position. SUMMARY OF THE INVENTION Accordingly, the above problems and difficulties are avoided by the present invention which provides a novel automatic means for placing a golf ball on a golf tee which includes a storage tube for holding a quantity of golf balls having an open end for receiving the golf balls for storage and having an opposite end for selecting and dispensing a ball into a rotating cylinder so that when the cylinder rotates, the selected ball is transferred to a dispensing shoot for delivery over the tee resulting in the placement of the ball on top of the tee. The device further includes a series of links attaching the cylinder to a rotatable pedal whereby depression of the pedal causes the linkage to rotate the cylinder for conducting the selected ball from the storage tube to the dispensing shoot. Counter means are provided which automatically count the dispensing of balls onto the tee operable in response to pivotal movement of the dispensing shoot which rotates in response to depression of the pedal. A feature of the invention resides in the fact that the pedal may be depressed by engagement of the golfer's golf club with the pedal and with mild depression, actuation ensues. Therefore, it is among the primary objects of the present invention to provide a novel automatic ball-setting or placement device whereby a supply of golf balls is introduced to a selection cylinder for transport to a dispensing shoot wherein the ball is placed automatically on top of a tee. Another object of the present invention is to provide a novel golf ball dispensing device having a storage tube feeding a selected ball to an intermediate collection cylinder wherein the cylinder is actuated by a foot pedal for discharging the ball into a dispensing shoot. Another object resides in providing a counter for counting the number of balls which are dispensed automatically from the dispensing device. Yet another object of the invention is to provide a novel automatic golf ball dispensing device which may remain out-of-doors in an inclement climate without damage or requiring constant maintenance. Still a further object resides in providing a golf ball dispensing device wherein the golfer may use the head of his golf club for actuating dispensing mechanism and linkages so that a selected golf ball from a storage or hopper is automatically placed on top of a tee preparatory for striking with the golf club. BRIEF DESCRIPTION OF THE DRAWINGS The features of the present invention which are believed to be novel are set forth with particularity in the appended claims. The present invention, both as to its organization and manner of operation, together with further objects and advantages thereof, may best be understood with reference to the following description, taken in connection with the accompanying drawings in which: FIG. 1 is a front perspective view of the novel automatic golf ball placement device incorporating the present invention; FIG. 2 is a cross-sectional view of the placement device shown in FIG. 1; FIG. 3 is a view similar to the view of FIG. 2 illustrating the dispensing shoot activated to place the ball on the top of a tee; FIG. 4 is a view similar to the view of FIG. 3 illustrating return of the dispensing shoot after the ball has been placed on the tee; FIG. 5 is a view similar to the view of FIG. 4 illustrating the dispensing shoot in its non-operative position and receiving a second ball for placement purposes; FIGS. 6 and 7 illustrate front and side elevational views of the golf ball placement device preparatory for operation. FIGS. 8-11 illustrate another embodiment of the invention which reduces parts and complexity; and FIG. 12 is an enlarged fragmentary view, in section, of a portion of the pad on which the tee rests. DESCRIPTION OF THE PREFERRED EMBODIMENTS A current practice when a golfer wishes to refine his golf stroke, most often used at commercial driving ranges, is for the golfer to purchase a bucket of balls and then methodically place a golf ball onto a tee and take a practice stroke. Repeating this process over and over in rapid succession is not only tedious and disruptive of the learning process, but constantly stooping over can place a strain on a golfer's back, potentially causing injury. Once a golfer is tired or sore, it is unlikely that he will continue to take practice shots and, as a result, his golf game may suffer. There is a need for providing equipment by which a golfer automatically tees up his golf ball so that the golfer may rapidly tee up successive balls without having to greatly alter his stance or hand position on the grip of the club. Given the importance of a good golf swing and a strong drive to success in the sport of golf, numerous attempts have been made over the years to perfect a teeing device which mechanically places a ball onto a golf tee for a golfer to strike. Generally speaking, these devices have either been for installation below ground or utilize an above ground approach. However, devices utilizing either of these approaches have additional inherent drawbacks which have prevented their acceptance in the golf industry. Teeing devices which are installed below ground are often mechanically and electronically complex and require excavation prior to their installation. U.S. Pat. No. 5,352,964, for example, teaches an underground system where a photoelectric sensor detects movement of the tee (i.e. once the golfer swings and displaces the ball), whereupon the tee is retracted below ground by an electric motor driving a pinion gear and a replacement ball is gravity fed onto the tee at its lowermost retracted position. The height to which the tee will rise is adjusted by use of a height adjustment micro switch. U.S. Pat. No. 5,356,148 teaches an underground trough which receives golf balls from a hopper and a pneumatic device which raises the tee to a position higher than ground level. In all of these teeing devices, ball handling requires complex equipment which is costly and requires high maintenance. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIG. 1, the novel golf ball placement device of the present invention is indicated in the general direction of arrow 10 which includes an elongated storage and feed tube 11 which is fixedly carried on a base 12 by means of a bracket 13 . End 14 of feed tube 11 is open so that a plurality of golf balls may be introduced to the tube 11 for storage purposes and for eventually feeding the lowermost ball in a series to a rotatable cylinder 16 via an open end 15 in tube 11 . The intermediate collection cylinder 16 includes an opening 17 so that a ball captured within the cylinder can be transferred through an opening 18 located in the side of a dispensing tube 20 . The dispensing tube is pivotally mounted on a bracket 21 by means of a pivot 22 and a bracket 23 . The pivot rod 22 passes through a sleeve which is attached to a support plate 24 to which the end of tube 20 is fixedly attached. Therefore, it can be seen that the tube 20 can be rotated on its pivot 22 between the brackets 21 and 23 . In order to actuate the pivotal movement of tube 20 , the device is provided with an actuator plate 25 against which a player's golf club head may be placed in order to actuate the device. Therefore, the golfer may remain in a fixed stance of his selection without having to bend, lean or otherwise lose his stance in order to operate the device. It is of importance to note that the intermediate collection cylinder 16 has a counter weight attached thereto so that after the device has been actuated so that the cylinder is rotated, and the ball placed on a tee 27 , the device is automatically reset by causing the dispensing tube 20 to revert to its vertical and standby position, as illustrated. Also, the cylinder 16 will rotate to its standby position in order to receive another ball from the feed tube 11 . The ball is indicated by numeral 28 which has been placed on the tee 27 and the dispensing tube has been automatically returned to its at rest or start position. A feature resides in placing the tee 27 so as to serve as a hub for receiving a mat 30 in which a center hole is placed over the tee 27 . The mat augments the device by simulating turf and prevents the golfer's club head from striking or damaging the base for support on which the device is mounted. A linkage 31 extends from a crank arm 32 attached at one end to the cylinder 16 and to the actuator plate 25 via the pivot 22 and the feed tube 20 . Therefore, any actuation of the plate 25 will cause the cylinder 16 to rotate via the linkage 31 and bell crank 32 . Since the device is intended to be used for commercial applications, it is important to count balls as they are dispensed from the dispensing tube and for this reason, an automatic ball counter 33 is provided on the base 12 which is operated by the pivotal movement of the dispensing tube 20 . Therefore, as the tube 20 dispenses a ball onto the tee 27 , a count will be taken. Referring now in detail to FIG. 2, it can be seen that the cylinder 16 serves as a stop for the sequence of balls numbered 2 - 7 which are in the feed tube 11 . However, when the cylinder 16 is rotated so that the opening 17 is beneath the feed tube 11 at opening 15 , the lowermost ball which in this case is numbered 2 , will drop into the cylinder preparatory for introduction to the dispensing tube 20 . However, it is to be understood that the previous placement of a ball on the tee 27 caused the ball numbered 1 to drop into the bottom of the dispensing tube 20 where it rests on a platform or pin 34 . Therefore, any one of the series of balls which rests on the pin or platform 34 is the next ball to be dispensed when the actuating plate 25 has been depressed. In the position shown in FIG. 2 which is preparatory for dispensing ball 1 onto the tee, the counter weight has previously caused the cylinder 16 to revolve to where the outside surface of the cylinder serves as a stop for the supply of balls in the feed tube 11 . When the actuating plate 25 has been depressed, as shown in FIG. 3 by arrow 35 , the dispensing tube 20 pivots so that its dispensing end 36 conducts the ball 1 to the top of the tee 27 . At this point, actuation of plate 25 ceases and the counter weight 26 will cause the cylinder 27 to revert back to its originating position. However, ball number 2 from the feed tube 11 will now be on the inside of the cylinder 16 . In FIG. 4, a transition illustration shows that the tube 20 is now returning to its start position wherein ball number 2 has now left the interior of the cylinder 16 via the opening 17 and the ball number 2 enters opening 18 so as to enter the passageway of dispensing tube 20 . As further illustrated in FIG. 4, ball number 3 is now the lower ball in the series of stored balls within the feed tube 11 and is bearing against the outside surface of cylinder 16 preparatory for another actuation of the plate 25 . Referring now to FIG. 5, it can be seen that the dispensing tube 20 has returned to its original position for starting the next ball dispensing procedure. The FIG. 5 position is identical to that shown in FIG. 1 with the exception that ball number 2 , as shown in FIG. 4, is now in its preparatory position for the next sequence as it rests against the stop or platform 34 and as shown in FIG. 5, the ball has been renumbered to that of number 1 . Depression of plate 25 causes the next sequence to occur, as previously described, and the ball number 1 will be placed onto the tee 27 . Of course, a count will be made at every ball placement for commercial purposes. Referring now to FIGS. 6 and 7, views are shown of the inventive device in its stationary and ready position for dispensing of golf balls. It is to be understood that the opening 14 to the feed tube 11 may be attached to any convenient reservoir or supply of golf balls such as those which may be kept at a control station, club house or pro shop. It is also to be understood that the mechanism including linkages, bell cranks and even the counter 33 are of mechanical operation and that no electricity is required. The construction of the device is robust and will withstand damage or fatigue when placed in outdoor locations. Again, it is to be understood that all that is necessary to operate the dispensing tube 20 so that a ball is placed on the top of tee 27 , is that the golfer need only place or push the end of his golf club against the actuating plate 25 . As force is placed downward on the plate, pivoting occurs so that the dispensing tube will assume the position shown in FIG. 3 and the ball previously stored against the platform or pin 34 will roll by gravity feed through the tube for placement on the tee 27 . The force necessary to cause pivoting and downward movement of plate 25 is sufficient to overcome the force of the counter weight 26 . However, when that force is removed from the plate, the counter weight 26 will cause the cylinder 16 to rotate to its start position, as shown in FIGS. 1 and 2. Referring to FIG. 8, another embodiment of the present invention is illustrated in the general direction of arrow 40 which includes an elongated housing 41 , arranged in a vertical orientation and which is resting on a simulated golf green pad 42 . The pad includes an opening 43 through which a conventional golf tee 44 is disposed. The housing 41 includes a pivoting, dispensing member 45 which rotates on the housing 41 by means of pivot connection 46 . It is to be noted that the opposite end of the dispensing member 45 includes an opening 47 through which the first golf ball is dispensed on to the tee 44 . The housing 41 is located from the hole 43 in such a manner that the hole 47 is indexed with the tee 44 or when the dispensing member 45 is pivoted as illustrated with respect to the first embodiment, a pedal or actuation member 48 is attached to the dispensing member 45 and may be actuated either by the foot of the user or the end of a golf club as previously described. A storage tube 50 is included in the housing 41 and outwardly projects from the top thereof with an opening for receiving a quantity of golf balls such as golf ball 51 . Referring now in detail to FIG. 9, it can be seen that the golf balls in storage tube 50 are fed into a cup 52 when in a rotatable receiver 53 . The lower most ball in the stack of golf balls in the storage tube 50 is automatically disposed in the cup 52 when the dispensing member 45 is in its fully pivoted or rotated position in order to place ball 54 onto the top of tee 44 . The receiver 53 is rotated about axle 55 when the receiver further includes a counter-weight identified by numeral 56 . Therefore, when the device is in a position preparatory for use, a lower most ball in the sack will be disposed in the cup 52 and when the dispensing member 45 is actuated by depression of the lever or pedal 48 , the dispensing member will move into the position shown in FIG. 9 and the ball which was previously in the member will be dispensed through the opening 47 . Simultaneously, the next ball in the series in the storage tube So will be transferred to the cup 52 . It can be seen that a link or lever arm 57 has its opposite ends connected to the rotatable receiver 53 and to the dispensing member 45 . Once the ball has been dispensed, the counter-weight 56 will cause opposite rotation of the receiver 53 to the position shown in FIG. 10 . Also, the dispensing member 45 will have pivoted in a clock-wise direction to it's storage position in the housing 41 . In both FIGS. 9 and 10, it can be seen that a stop-pin 58 prevents the ball in the dispensing member from falling further into the tube once it has been received into the member to an opening 60 . Thus, both embodiments of the invention include storage of multiple golf balls with the bottom-most ball being received into cup in the receiver for eventual transfer to the opening in the dispensing member for placement onto a tee via an end opening on the member. In FIG. 12, the green pad 42 is illustrated as having an opening 61 which insertably receives a pin or plug 62 , so that the pad is properly centered and the tee properly placed on the plug 62 in alignment with opening 47 when the dispensing member 45 is fully deployed into position as shown in FIG. 9 . The tee 44 may be held in position on the plug by any suitable means. While particular embodiments of the present invention have been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from this invention in its broader aspects and, therefore, the aim in the appended claims is to cover all such changes and modifications as fall within the true spirit and scope of this invention.

An automatic golf ball placement device having a storage tube for holding a quantity of golf balls preparatory for placement onto a tee. One end of the tube receives the balls for storage while the opposite includes an opening for dispensing the first ball into a rotatable receiver for transfer to a dispensing shoot for delivery to the tee. The receiver is weighted so that upon placement of a ball on the tee, the receiver revolves back to the storage tube for accepting the next ball for dispensing onto the tee. A pedal attached to the receiver is actuated by a player's foot or engagement with a golf club to urge rotation of the receiver to dispense the first ball.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This Divisional U.S. Patent Application, filed under 37 C.F.R. § 1.53(b) and 35 U.S.C. § 121, claims the benefit of priority under 35 U.S.C. § 120 of U.S. patent application Ser. No. 10/877,659 (filed on 24 Jun. 2004), which claims the benefit under 35 U.S.C. § 119(e)(1) of U.S. Provisional Patent Application No. 60/482,097, filed under 35 U.S.C. § 111(b) on 24 Jun. 2003, each of which are hereby incorporated by reference in their entireties. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not applicable. THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT [0003] Not applicable. INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON COMPACT DISC [0004] Not applicable. BACKGROUND OF THE INVENTION [0005] 1. Field of the Invention [0006] The present invention relates to a novel method of creating an immunogen and using it to produce antibodies against nonenveloped and enveloped viruses, bacterial pathogens, fungal pathogens, other microbial pathogens, and proteins. The invention relates generally to agents and methods for preventing a viral outbreak and, more specifically, to compositions containing a β-cyclodextrin (β-CD) and methods of using such compositions to decrease the probability and/or reduce the severity of a viral outbreak. The present invention also relates to a pharmaceutical composition, which includes β-CD, which is in a sufficient amount to block viral passage through lipid rafts in the membrane of nerve cells. The present invention further relates to a composition, comprising a solid substrate that contains an effective amount of β-CD useful for reducing viral release. [0007] 2. Description of Related Art [0008] The plasma membrane of immune and non-immune cells is composed of detergent insoluble domains called lipid rafts, which are membrane compartments enriched in cholesterol and sphingolipids. In some tissues these specialized domains are referred to as caveolae. The initiation and propagation of intracellular signaling events occurs in these specialized membrane regions. Lipid rafts also contain many lipid-modified signaling proteins, and restrict their diffusion. Some examples of proteins associated with lipid rafts are tyrosine kinases of the Src family, glycophosphatidylinositol (GPI)-linked proteins, as well as adaptor proteins. [0009] The confinement of signaling molecules to membrane subdomains suggests that lipid rafts are platforms for the formation of multicomponent transduction complexes. When immune receptors bind to their ligands, they become associated with lipid rafts. Additional components of the receptor signaling pathways are subsequently recruited to the rafts and form macromolecular signaling complexes. The initial translocation of immune receptors into lipid rafts is an important step in regulating cell activation. [0010] Numerous experiments have provided substantial evidence that the integrity of lipid rafts is crucial for the initiation and maintenance of intracellular signals. Depletion of cholesterol, a component of lipid rafts, has been shown to inhibit HIV infection and illustrates the importance of lipid rafts in viral infection. Virus fusion and entry involves sequential interactions between viral proteins and proteins of the cell surface. These fusion and entry interactions proceed via three-dimensional rearrangements of viral and cell-surface proteins, thus giving rise to novel, but transient antigenic features. The present invention exploits those unique antigenic features to create novel anti-viral antibodies. [0011] Virus entry into host cells involves the specific interaction of virus with receptor molecules contained within. Virus assembly and increases in viral concentration also occur in lipid rafts. Thus, the interaction between virus particles and lipid rafts presents an environment in which novel viral epitopes may be exposed. The interaction of proteins and lipid rafts generates novel configurations of the proteins that may be exploited to produce novel antibodies against the protein. [0012] The significance of detergent-insoluble, glycolipid-enriched membrane domains (“lipid rafts”) has been demonstrated, particularly in regard to activation and signaling in T lymphocytes. Lipid rafts can be viewed as floating rafts comprised of sphingolipids and cholesterol that sequester glycosylphosphatidylinositol (GPI)-linked proteins such as Thy-1 and CD59. CD45, a 200 kDa transmembrane phosphatase protein, is excluded from these domains. Human immunodeficiency virus type 1 (HIV-1) particles produced by infected T cell lines acquire the GPI-linked proteins Thy-1 and CD59, as well as the ganglioside GM1, which is known to partition preferentially into lipid rafts. In contrast, despite its high expression on the cell surface, CD45 is poorly incorporated into virus particles. Confocal fluorescence microscopy revealed that HIV-1 proteins colocalized with Thy-1, CD59, GM1, and a lipid raft-specific fluorescent lipid, DiIC16 (see below), in uropods of infected Jurkat cells. CD45 did not colocalize with HIV-1 proteins and was excluded from uropods. Dot immunoassay of Triton X-100-extracted membrane fractions revealed that HIV-1 p17 matrix protein and gp41 were present in the detergent-resistant fractions and that ( 3 H)-myristic acid-labeled HIV Gag protein showed a nine-to-one enrichment in lipid rafts. As disclosed herein, the budding of HIV virions through lipid rafts is associated with the presence of host cell cholesterol, sphingolipids, and GPI-linked proteins within these domains in the viral envelope, indicating preferential sorting of HIV Gag to lipid rafts (see Example 1). [0013] Glycolipid-enriched membrane (GEM) domains are organized areas on the cell surface enriched in cholesterol, sphingolipids, and GPI-linked proteins. These domains have been described as “rafts” that serve as moving platforms on the cell surface (Shaw and Dustin, Immunity. 6:361-369, 1997). The domains, now referred to as “lipid rafts,” exist in a more ordered state, conferring resistance to Triton X-100 detergent treatment at 4° C. (Schroeder et al., J. Biol. Chem. 273: 1150-1157, 1998). Many proteins are associated with lipid rafts, including GPI-linked proteins, Src family kinases, protein kinase C, actin and actin-binding proteins, heterotrimeric and small G proteins, and caveolin (see, for example, Arni et al., Biochem. Biophys. Res. Commun. 225:8001-807, 1996; Cinek and Horejsi, J. Immunol. 149:2262-2270, 1992; Robbins et al., Mol. Cell. Biol. 15:3507-3515, 1995; and Sargiacomo et al., J. Cell. Biol. 122:789-807, 1993). Saturated acyl chains of the GPI anchor have been shown to be a determinant for the association of GPI-linked proteins with lipid rafts (Rodgers et al., Mol. Cell. Biol. 14:5384-5391, 1994; Schroeder et al., Proc. Natl. Acad. Sci., USA. 91: 12130-12134, 1994). Lipid rafts exclude certain transmembrane molecules, specifically the membrane phosphatase CD45 (Arne et al., supra, 1996; Rodgers and Rose, J. Cell. Biol. 135: 1515-1523, 1996). Exclusion of CD45 results in the accumulation of phosphorylated signaling molecules in lipid rafts, and T cell activation requires clustering of signaling molecules in these membrane domains (Lanzavecchia et al., Cell. 96: 1-4, 1999). [0014] The role of lipid rafts in viral infection can further be extended to viruses other than HIV. For example, selective budding occurs for a virus of the influenza family, fowl plague virus, from ordered lipid domains (Scheiffele et al., J. Biol. Chem. 274:2038-2044, 1999, which is incorporated herein by reference). The requirement for cholesterol and sphingolipids in target membranes for Semliki Forest virus fusion also has been established (Nieva et al., EMBO J. 13:2797-2804, 1994; Phalen and Kielian, J. Cell Biol. 112:615-623, 1991, each of which is incorporated herein by reference). The interactions of lipid rafts with accessory HIV-1 molecules such as Vif and Nef can have important roles in virus budding, since interactions of myristylated HIV and simian immunodeficiency virus Nef with Lck, which is present in lipid rafts, and its incorporation into virions have been established (see, for example, Collette et al., J. Biol. Chem. 271:6333-6341, 1996; Flaherty et al., AIDS Res. Hum. Retrovir. 14:163-170, 1998). [0015] Example 1 describes the interaction of HIV virus with lipid raft resident molecules such as GM1. The results disclosed in Example 1 indicate that HIV-1 buds through lipid rafts. During the course of infection, the cell becomes activated and polarization occurs, capping normally dispersed lipid rafts along with GPI-linked proteins and associated intracellular signaling molecules, and membrane areas containing CD45 can be cleared out of the cap site. The newly translated viral Gag precursor protein associated with lipid rafts then can be directed to the capped pole, where assembly and budding occurs. Palmitylated gp41 (gp160) is also directed into lipid rafts, and the interaction of its cytoplasmic tail with Gag protein in lipid rafts can prevent its internalization, allowing for the incorporation of gp160 into virions only at the site of budding (see Egan et al., J. Virol. 70:6547-6556, 1996; Yu et al., J. Virol. 66:4966-4971, 1992). Individual targeting of Gag and Env to the same site at the membrane can be an important means for delivering these proteins to the site of budding, since Gag and Env are processed and transported in different pathways within the cell. The host membrane then can become the new viral coat, resulting in the incorporation of cholesterol, sphingolipids, Thy-1, and CD59 and in the exclusion of CD45. HIV-1 also acquires functional adhesion molecules from host cells (Orentas and Hildreth, supra, 1993). These host-acquired proteins can significantly affect the biology of HIV-1 (see, for example, Fortin et al., J. Virol. 71:3588-3596, 1997). BRIEF SUMMARY OF THE INVENTION [0016] The present invention relates to a novel method of designing an immunogen and producing antibodies to nonenveloped and enveloped viruses, and proteins. Specifically, it uses the co-culture of purified lipid rafts and viral particles as an immunogen. [0017] The present invention also relates to a novel therapeutic method of preventing viral outbreaks (budding), using β-cyclodextrins. [0018] This invention provides a novel application for β-cyclodextrin, a cholesterol depletor, as an inhibitor of viral outbreak. Topical applications of β-cyclodextrin are recommended to inhibit or reduce the severity of viral outbreaks such as oral or genital herpes. This invention also provides a novel technique for the creation of immunogens. Viral entry and outbreak also occurs at specialized lipid raft domains and disruption of rafts with cholesterol depletors blocks viral entry and outbreak (budding). Lipid microdomains (lipid rafts) are mobile regions of the plasma membrane and exist in all mammalian cell membranes. They are produced by the preferential packing of cholesterol and sphingolipids into the plasma membrane and are identified by their low solubility in detergents and enrichment with gangliosides such as GM1. The size and composition of rafts can be dynamically altered during transmembrane signaling. Depletion of membrane cholesterol disrupts lipid rafts and inhibits viral entry and outbreak. Virus entry into cells involves virus/lipid raft interaction wherein the virus unfolds to enter the cell via the lipid raft. I provide a technique for the creation of an immunogen with novel viral epitopes based on the virus/lipid raft interaction and viral unfolding. Viral unfolding only occurs in lipid rafts. This fact can be exploited to create novel immunogens based on viral interaction with lipid rafts. The virus/lipid raft co-culture technique will create novel immunogens which will be used to create novel neutralizing monoclonal and polyclonal antibodies to fight viral disease such as HIV infection. [0019] Viral entry into cells involves unfolding of the virus and penetration into the cell at specific lipid raft sites. Antibodies created against the lipid raft/virus co-culture exploit viral unfolding to reveal novel epitopes in the virus that may be exploited as immunogens to create novel neutralizing antibodies. Purified preparations of lipid rafts are easily prepared from primary lymphoctes or transformed lymphocytes such as the Jurkat cell line. Purified isolates of HIV obtained from infected cell supernatants can be co-cultured with purified fractions of lipid rafts. These co-cultures can be used intact as immunogens or partially proteolysed to create viral/raft fragments. Additionally, the viral/raft co-cultures can remain co-cultured intact or fixed while co-cultured in mild fixative such as paraformaldehyde or glutaraldehyde. The steps involve mixing purified raft fractions with isolated virus. This admixture of raft/virus serves as the novel immunogen. Antibodies created against the lipid raft/virus co-culture will recognize antigenic determinants of the virus unique to the lipid raft/virus interaction. The method employs lipid raft/virus or lipid raft/protein suspensions as immunogens to develop polyclonal or monoclonal antibodies. Alternatively, lipid raft fractions may be made from infected cells such as lymphocytes or an immune cell line such as Jurkat. Lipid rafts produced in this fashion would already contain interactive virus and would be ready for use as a raft/virus immunogen. A lipid raft/virus or lipid raft/protein co-cultured immunogen that will generate an antibody response able to neutralize a broad spectrum of primary viral isolates and generate immune responses is created in this fashion. Antibodies to novel epitopes in virus and proteins are also created in this fashion. [0020] The use of lipid raft terminology in this disclosure also includes use of caveolae (i.e., cocultures of caveolae/virus or co-cultures of caveolae/protein) as immunogens. This method can also be applied to the co-culture of lipid rafts and any pathogen. As such, the pathogen can be an enveloped virus, including but not limited to an immunodeficiency virus such as human immunodeficiency virus, a T lymphocytic virus such as human T lymphocytic virus (HTLV), a herpes virus such as herpes simplex virus (HSV), a measles virus, or an influenza virus. The pathogen also can be a microbial pathogen, for example a bacterium, a yeast such as Candida, a mycoplasma, a protozoan such as Trichomonas, or a Chlamydia. [0021] Lipid raft preparations are easily obtained from a variety of cell sources. Immune cells susceptible to viral infection represent good source for raft preparation. Whole immune cells exposed to virus could also be used as a source of lipid raft/virus immunogen. Co-culture combinations of lipid rafts, viral proteins and various peptides (e.g., the HIV envelope glycoprotein gp120) would also be used as immunogens. Thus, this method is also applicable to generating antibodies to novel conformations of viral, microbial, fungal, and animal proteins when co-cultured and interacting with lipid rafts. [0022] Many proteins translocate into lipid rafts following stimulation. This translocation involves modifications such as palmitylation and/or myristylation. Antibodies raised against such lipid raft/protein immunogens may recognize novel epitopes in the translocated protein. Natural lipid raft/virus co-cultures will serve as immunogens, but lipid raft/virus co-cultures or whole cell/virus co-cultures fixed with low concentrations of fixative such as formalin, glutaraldehyde, or methanol may also be used. Lipid raft preparations can also be modified to include or exclude selected proteins in order to vary the immunogenic effect of the raft/virus, raft/protein co-culture. In a preferred embodiment, immunizations are performed in mice engineered to be transgenic for human antigens, thus reducing the possibility that the antibodies generated would recognize human proteins. [0023] This novel method of immunogen production may prove useful in the generation of anti-viral vaccines. In the case of human immunodeficiency virus type 1 (HIV-1), success has been gauged by the ability of candidate immunogens to generate measurable immune responses in human volunteers and animal models. The two crucial responses have been the generation of virus-specific CD8 + cytotoxic T lymphocytes (CTLs), which attack and destroy infected cells, and production of neutralizing antibodies, which bind to the virus and prevent infection of new cells. For HIV-1, an effective anti-viral vaccine has remained elusive. [0024] A number of studies published in recent years have shown that neutralizing monoclonal antibodies of the IgG class alone can be effective in blocking the infection of non-human primates by mucosal challenge with SHIV. Such studies provided a rationale for testing groups of monoclonal antibodies with synergistic neutralizing antibodies in vitro as immediate postexposure prophylaxis, modeling for perinatal exposure in infants. Cocktails of human IgG1b12, 2G12, 2F5, and 4E10 neutralizing monoclonal antibodies prevented disease in newborn macaques and prevented the establishment of SHIV89.6P infection in half of the animals when given within an hour of exposure (Ferrantelli et al., AIDS; 17: 301-309, 2003). Studies in recently infected HIV patients indicated that neutralizing antibodies are indeed involved in controlling viral replication during the first months after infection, and that the pressure they exert on the virus is significant (Richman et al., Proc Natl Acad Sci, USA; 100:4144-4149, 2003). [0025] Budding of nascent virus also occurs from lipid rafts. Thus, in addition to preventing new infection, the present invention is applicable to preventing the spread of infection or re-infection. Clinical application of antibodies created by this method may also prevent outbreaks of virus in infected individuals (e.g., herpes outbreaks). Beta-cyclodextrins deplete cholesterol and disrupt lipid rafts. A novel use of β-cyclodextrins is extended to applications (e.g., topical cream) to prevent recurrent herpes zoster, herpes oral or genital outbreaks. Topical use of β-cyclodextrins may also reduce the severity of outbreaks as well as shorten their duration. Many pathogens exploit lipid rafts for cell infection as well as cell outbreak. This use of β-cyclodextrins and the disruption of raft structure as a portal for entry or exit are applicable to any pathogen outbreak, which involves lipid rafts. As such, pathogen release from infected cells or neurons may be prevented by the disruption of raft structure by β-cyclodextrins. [0026] The present invention relates to methods of reducing the risk of virus budding or diminishing the severity of outbreak of viral infections. It also may be used to diminish pain and associated symptoms of post-outbreak neuralgia. In one embodiment, a method of the invention is performed by contacting area of viral release (e.g., dermatomes in shingles) with a β-cyclodextrin (β-CD). The afflicted dermatomes may be identified by a tingling sensation (a prodrome), which signals the onset of viral release. Examples of said releasable viruses include but are not limited to: an enveloped virus, for example, an immunodeficiency virus such as human immunodeficiency virus (HIV); a T lymphotrophic virus such as human T lymphotrophic virus (HTLV); a herpes virus such as a herpes simplex virus (HSV); a measles virus; a chicken pox virus or an influenza virus. The β-CD can be any β-CD derivative, for example, 2-hydroxypropyl-β-cyclodextrin. In the case of herpes zoster or any outbreak resulting in an outbreak-induced neuralgia, the pain and associated symptoms may be amenable to topical treatment of β-CD. [0027] The present invention also relates to a pharmaceutical composition, which includes β-CD, which is in a sufficient amount to block viral release through lipid rafts in the membrane of a nerve cell. [0028] The present invention further relates to a composition, comprising a solid substrate that contains an effective amount of β-CD useful for reducing the risk of viral release and the severity of viral outbreak. The pharmaceutical composition can be formulated in a solution, a gel, a foam, an ointment, a cream, a paste, a spray, or the like. BRIEF DESCRIPTION OF THE DRAWINGS [0029] FIG. 1 shows a cyclodextrin molecule. Linking D-glucose units together with α-1,4 linkages means that the growth of the polysaccharide follows a helical path. Occasionally, this coiling brings the D-glucose at the end of the growing polymer chain close enough to the one at the beginning that a glycosidic bond can form between them, thereby creating a cyclic polysaccharide. These structures are known as cyclodextrins. FIG. 1 presents the structure of one such compound which contains a ring comprised of eight D-glucose units. This compound is known as γ-cyclodextrin. Cyclodextrins are natural products formed by the action of enzymes called cycloglucosyltransferases, CGTases, on starch. These enzymes are found in a microorganism called Bacillus macerans. Cyclodextrins participate in host-guest interactions, serving as hosts for a variety of small molecules. The number of monomer units in the macrocyclic ring determines the size of the cavity the host makes available to the guest. The ability of cyclodextrins to “encapsulate” small molecules has led to their use as cholesterol depletors and disruptors of lipid rafts in cells and neurons. FIG. 1 depicts the cavity from above. [0030] FIG. 2 presents a perspective drawing of the 3-dimensional structure of γ-cyclodextrin. The conformation of the glucose units in the cyclodextrin places the hydrophilic hydroxyl groups at the top and bottom of the three dimensional ring and the hydrophobic glycosidic groups on the interior. Note that the polar OH groups project to the exterior of the structure while the hydrogens attached to the glucose units point into the cavity. Thus the interior is comparatively non-polar. These structural features make the polymer water soluble while still able to transport non-polar materials such as cholesterol. When cyclodextrin is applied to cells or neurons cholesterol is depleted from cellular membranes and resides within the interior non-polar cavity. The depletion of cholesterol from cell membranes disrupts lipid rafts and inhibits cell signaling through raft domains. DETAILED DESCRIPTION OF THE INVENTION [0031] To isolate detergent resistant membranes (DRMs) from a cell type including but not limited to primary or transformed lymphocytes. Cells are washed in Buffer A (100 mM NaCl, 10 mM KCl, 10 mM EGTA, 10 mM imidazole, pH 6.8), then in TKM buffer (50 mM Tris-HC1, pH 7.4, 25 mM KCl, 5 mM MgCl, and 1 mM EGTA). To reduce proteolysis, the following protease inhibitors are included in Buffer A: 2 mg/ml of leupeptin (Calbiochem Novabiochem Corp., La Jolla, Calif.); 5 mM Pefa-Bloc (Roche Molecular Biochemicals, Indianapolis, Ind.); 1% aproptinin (Sigma); 1% pepstatin A (Roche Molecular Biochemicals); and 100 nM benzamidine (Sigma). DRMs were prepared using a discontinuous sucrose density gradient. DRMs are located at the interface between 5 and 36% sucrose. [0032] Alternatively, isolation of low-density, Triton X-100-insoluble membrane complexes is easily performed. Briefly, cells were homogenized in 2-morpholinoethanesulfonic acid (MES)-buffered saline containing 1% Triton X-100 (unless otherwise indicated), and sucrose was added to a final concentration of 40%. A 5 to 30% discontinuous sucrose gradient was layered on top of this detergent extract followed by ultracentrifugation [54,000 rpm in a rotor (Beckman Coulter, Fullerton, Calif.)] for 18 to 24 hours at 4° C. in a TL-100 ultracentrifuge (Beckman Coulter). Successive gradient fractions were collected from the top and subjected to SDS-PAGE and Western blot analysis. [0033] HIV-1 RF viral supernatant from an infected Jurkat cell line can be collected and clarified through a 0.45 μm filter. Virus supernatant (10 ml) can be co-cultured with purified lipid raft fractions as described above. These lipid raft/virus co-cultures serve as immunogens for the creation of novel antibodies. Following hybridoma fusion to create monoclonal expressing immortalized B-cells, antibodies produced in this fashion can be mass screened to determine their effectiveness as neutralizing antibodies. The capacity of purified IgG as well as whole serum, to neutralize HIV can be tested in an assay with phytohemagglutinin-stimulated peripheral blood mononuclear cells. Briefly, antibodies or sera were incubated for 1 h at 37° C. with diluted tissue culture supernatant of virus-infected peripheral blood mononuclear cells (40 to 100 50% tissue culture infective doses, 100 μl). Peripheral blood mononuclear cells (10 5 in 50 μl) were added to the virus-antibody reaction mixture, and the mixture was incubated overnight. All dilutions were performed with RPMI 1640 medium (GIBCO, Life Technologies Ltd., Paisley, Scotland) supplemented with 10% fetal calf serum, 3 mM glutamine, 20 IU of interleukin-2, and antibiotics. Medium changes were performed on days 1 and 4. Seven days after infection, supernatants were collected and analyzed for HIV antigen by a capture ELISA. The neutralization titer was defined as the reciprocal of the last dilution step that showed an 80% or greater reduction in the OD at 490 nm of the culture supernatant compared to that of HIV antibody-negative serum. [0034] Beta-cyclodextrins β-CDs) are widely used as solubilizing agents, stabilizers, and inert excipients in pharmaceutical compositions (see U.S. Pat. Nos. 6,194,430; 6,194,395; and 6,191,137, each of which is incorporated herein by reference). Beta-CDs are cyclic compounds containing seven units of α-(1,4) linked D-glucopyranose units, and act as complexing agents that can form inclusion complexes and have concomitant solubilizing properties (see U.S. Pat. No. 6,194,395; see also, Szejtli, J. Cyclodextrin Technol. 1988). [0035] The compositions and methods of the invention are exemplified using 2-hydroxypropyl-β-CD (2-OH-β-CD). However, any β-CD derivative can be used in a composition or method of the invention, provided the β-CD derivative disrupts lipid rafts in the membranes of nerve cells. Beta-CDs act, in part, by removing cholesterol from cell membranes, and different β-CDs are variably effective in such removal. For example, methyl-β-CD removes cholesterol from cell membranes very efficiently and quickly and, as a result, can be toxic to cells, which require cholesterol for membrane integrity and viability. In comparison, a β-CD derivative such as 2-OH-β-CD can effectively remove cholesterol from cells without producing undue toxicity. Thus, it will be recognized that a β-CD useful in a composition or method of the invention is one that removes cholesterol in an amount that disrupts lipid rafts, without substantially reducing cell viability (see, for example, Rothblat and Phillips, J. Biol. Chem. 257:4775-4782 (1982), which is incorporated herein by reference). [0036] Beta-CDs useful in the present invention include, but are not limited to, β-CD derivatives wherein one or more of the hydroxy groups is substituted by an alkyl, hydroxyalkyl, carboxyalkyl, alkylcarbonyl, carboxyalkoxyalkyl, alkylcarbonyloxyalkyl, alkoxycarbonylalkyl or hydroxy-(mono or polyalkoxy)alkyl group or the like; and wherein each alkyl or alkylene moiety contains up to about six carbons. Substituted β-CDs that can be used in the present invention include, for example, polyethers (see, for example, U.S. Pat. No. 3,459,731, which is incorporated herein by reference); ethers, wherein the hydrogen of one or more β-CD hydroxyl groups is replaced by C 1 to C6 alkyl, hydroxy-C 1-C6-alkyl, carboxy-C 1-C6 alkyl, C 1-C6 alkyloxycarbonyl-C1-C6 alkyl groups, or mixed ethers thereof. In such substituted β-CDs, the hydrogen of one or more β-CD hydroxy group can be replaced by C1-C3 alkyl, hydroxy-C2-C4 alkyl, or carboxy-C1-C2 alkyl, for example, by methyl, ethyl, hydroxyethyl, hydroxypropyl, hydroxybutyl, carboxymethyl or carboxyethyl. It should be recognized that the term “C1-C6 alkyl” includes straight and branched saturated hydrocarbon radicals, having from 1 to 6 carbon atoms. Examples of β-CD ethers include dimethyl-β-CD. Examples of β-CD polyethers include hydroxypropyl-p-β-CD and hydroxyethyl-β-CD (see, for example, Nogradi, “Drugs of the Future” 9(8):577-578, 1984; Chemical and Pharmaceutical Bulletin. 28:1552-1558 (1980); Yakugyo Jiho No. 6452 (Mar. 28, 1983); Angew. Chem. Int. Ed. Engl. 19:344-362 (1980); U.S. Pat. No. 3,459,731; EP-A-0,149,197; EP-A-0,197,571; U.S. Pat. No. 4,535,152; WO-90112035; GB-2,189,245; Szejtli, “Cyclodextrin Technology” (Kluwer Academic Publ. 1988); Bender et al., “Cyclodextrin Chemistry” (Springer-Verlag, Berlin 1978); French, Adv. Carb. Chem. 12:189-260; Croft and Bartsch, Tetrahedron 39:1417-1474, 1983; Irie et al., Pharm. Res. 5:713-716, 1988; Pitha et al., Internat'l. J. Pharm. 29:73, 1986; U.S. Pat. No. 5,134,127 A; U.S. Pat. Nos. 4,659,696 and 4,383,992, each of which is incorporated herein by reference; see, also, U.S. Pat. No. 6,194,395). [0037] A method of the invention is performed, for example, by contacting an area of skin susceptible to viral release with a β-CD. As used herein, the term “contacting,” when used in reference to a β-CD and the pathogen or cells susceptible to a sexually transmitted pathogen, means that the β-CD is applied to the susceptible area such that it prevents viral budding through lipid rafts at nerve terminals. [0038] As described above, budding of HIV-1 particles occurs at lipid rafts, which are characterized by a distinct lipid composition that includes high concentrations of cholesterol, sphingolipids, and glycolipids. Since cholesterol plays a key role in the entry of some other viruses, the role in HIV-1 entry of cholesterol and lipid rafts in the plasma membrane of susceptible cells was investigated. Example 2 demonstrates that intact lipid rafts are necessary for viral infection. A β-CD derivative, 2-hydroxypropyl-β-cyclodextrin (2-OH-β-CD), was used to deplete cellular cholesterol and disperse lipid rafts. As disclosed herein, removal of cellular cholesterol rendered primary cells and cell lines highly resistant to HIV-1-mediated syncytium formation and to infection by both CXCR4- and CCR5-specific strains of HIV-1 virus. 2-OH-β-CD treatment of the virus or cells partially reduced HIV-1 binding, while rendering chemokine receptors highly sensitive to antibody-mediated internalization, but had no effect on CD4 expression. These effects were readily reversed by incubating cholesterol-depleted cells with low concentrations of cholesterol-loaded 2-OH-β-CD to restore cholesterol levels. Cholesterol depletion also made cells resistant to SDF-1-induced binding to ICAM-1 through LFA-1. This may have contributed to the reduction in HIV-1 binding to cells after treatment with the β-CD, since LFA-1 contributes significantly to cell binding by HIV-1 which, like SDF-1α, can trigger CXCR4 function through gp120. These results indicate that cholesterol is involved in the HIV-1 co-receptor function of chemokine receptors and is required for infection of cells by HIV-1 (Example 2). [0039] As discussed above, cholesterol, sphingolipids, and GPI-anchored proteins are enriched in lipid rafts (see Simons and Ikonen, Nature. 387:569-572, 1997). The high concentration of cholesterol and sphingolipids in lipid rafts results in a tightly packed, ordered lipid domain that is resistant to non-ionic detergents at low temperature. The structural protein caveolin causes formation of flask-shaped invaginations (caveolae) in the cell membrane with a lipid composition very similar to that of lipid rafts (Schnitzer et al., Science 269: 1435-1439, 1995). Signaling molecules, including Lck, LAT, NOS, and G protein α subunit, are localized to rafts on the intracellular side of the membrane, and are targeted by lipid modifications such as palmitylation, myristylation, or both. In comparison, many other transmembrane proteins do not show a preference for lipid rafts; for example, CD45 and E cadherin are excluded from these areas. Certain lipid modified transmembrane proteins such as the HA molecule of influenza virus localize to lipid rafts. [0040] As disclosed herein, HIV-1 buds selectively from lipid rafts of infected T cells (Example 1). In addition, Semliki Forest Virus (SFV), measles viruses, influenza viruses, and polioviruses all assemble by raft association and, in the case of influenza virus, bud from lipid rafts (see, for example, Marquardt et al., J. Cell Biol. 123:57-65, 1993; Manie et al., J. Virol. 74:305-311, 2000; Zhang et al., J. Virol. 74:4634-4644, 2000, each of which is incorporated herein by reference). The involvement of lipid rafts in HIV-1 biology beyond its role in virus budding has been further examined. As further disclosed herein, partial depletion of cholesterol from cell membranes using a β-CD inhibited HIV-1-induced syncytium formation in cell lines and primary T cells (Example 2). β-CD treatment of cells also increased CR internalization induced by monoclonal antibody (MAb) binding. Primary cells and cell lines were rendered resistant to infection CXCR4-specific and CCR5-specific HIV-1 strains by treatment with 2-OH-β-CD (Example 2). The effects observed were not due to loss of cell viability after treatment with the β-CD, and demonstrate that intact lipid rafts and cholesterol are required for HIV-1 infection and syncytium formation. [0041] The present invention also provides compositions useful for reducing the risk of transmission of sexually transmitted disease. A composition of the invention contains a β-CD, which can be in a form suitable for topical administration to a subject, particularly intravaginal or intrarectal use, including a suppository or a bioadhesive polymer, which can provide timed release of the β-CD (see, for example, U.S. Pat. Nos. 5,958,461 and 5,667,492, each of which is incorporated herein by reference); or can be formulated in combination with a solid substrate to produce a condom, diaphragm, sponge, tampon, a glove or the like (see, for example, U.S. Pat. Nos. 6,182,661 and 6,175,962, each of which is incorporated herein by reference), which can be composed, for example, of an organic polymer such as polyvinyl chloride, latex, polyurethane, polyacrylate, polyester, polyethylene terephthalate, polymethacrylate, silicone rubber, a silicon elastomer, polystyrene, polycarbonate, a polysulfone, or the like (see, for example, U.S. Pat. No. 6,183,764, which is incorporated herein by reference). [0042] For topical administration, the β-CD can be formulated in any pharmaceutically acceptable carrier, provided that the carrier does not affect the activity of the β-CD in an undesirable manner. Thus, the composition can be, for example, in the form of a cream, a foam, a jelly, a lotion, an ointment, a solution, a spray, or a gel (see U.S. Pat. No. 5,958,461, which is incorporated herein by reference). In addition, the composition can contain one or more additional agents, for example, an antimicrobial agent such as an antibiotic or an antimicrobial dye such as methylene blue or gentian violet (U.S. Pat. No. 6,183,764); an antiviral agent such as a nucleoside analog (e.g., azacytidine), a zinc salt (see U.S. Pat. No. 5,980,477, which is incorporated herein by reference), or a cellulose phthalate such as cellulose acetate phthalate or a hydroxypropyl methylcellulose phthalate (see U.S. Pat. No. 5,985,313, which is incorporated herein by reference); a contraceptive (see U.S. Pat. No. 5,778,886, which is incorporated herein by reference); a lubricant, or any agent generally useful to a sexually active individual, provided the additional agent, either alone or in combination, does not affect the activity of the β-CD or, if it affects the activity of the β-CD, does so in a predictable way such that an amount of β-CD that is effective for reducing viral outbreak can be determined. [0043] A pharmaceutically acceptable carrier useful in a composition of the invention can be aqueous or non-aqueous, for example alcoholic or oleaginous, or a mixture thereof, and can contain a surfactant, emollient, lubricant, stabilizer, dye, perfume, preservative, acid or base for adjustment of pH, a solvent, emulsifier, gelling agent, moisturizer, stabilizer, wetting agent, time release agent, humectant, or other component commonly included in a particular form of pharmaceutical composition. Pharmaceutically acceptable carriers are well known in the art and include, for example, aqueous solutions such as water or physiologically buffered saline or other solvents or vehicles such as glycols, glycerol, oils such as olive oil or injectable organic esters. A pharmaceutically acceptable carrier can contain physiologically acceptable compounds that act, for example, to stabilize or to increase the absorption of the β-CD, for example, carbohydrates, such as glucose, sucrose or dextrans, antioxidants, such as ascorbic acid or glutathione, chelating agents, low molecular weight proteins or other stabilizers or excipients. [0044] The pharmaceutical composition also can comprise an admixture with an organic or inorganic carrier or excipient suitable for intravaginal or intrarectal administration, and can be compounded, for example, with the usual non-toxic, pharmaceutically acceptable carriers for tablets, pellets, capsules, suppositories, solutions, emulsions, suspensions, or other form suitable for use. The carriers, in addition to those disclosed above, can include glucose, lactose, mannose, gum acacia, gelatin, mannitol, starch paste, magnesium trisilicate, talc, corn starch, keratin, colloidal silica, potato starch, urea, medium chain length triglycerides, dextrans, and other carriers suitable for use in manufacturing preparations, in solid, semisolid, or liquid form. In addition auxiliary, stabilizing, thickening or coloring agents and perfumes can be used, for example a stabilizing dry agent such as triulose (see, for example, U.S. Pat. No. 5,314,695). [0045] The β-CD also can be incorporated within an encapsulating material such as into an oil-in-water emulsion, a microemulsion, micelle, mixed micelle, liposome, microsphere or other polymer matrix (see, for example, Gregoriadis, Liposome Technology, Vol. 1 (CRC Press, Boca Raton, Fla. 1984); Fraley, et al., Trends Biochem. Sci., 6:77 (1981), each of which is incorporated herein by reference). Liposomes, for example, which consist of phospholipids or other lipids, are nontoxic, physiologically acceptable and metabolizable carriers that are relatively simple to make and administer. “Stealth” liposomes (see U.S. Pat. Nos. 5,882,679; 5,395,619; and 5,225,212, each of which is incorporated herein by reference) are an example of such encapsulating materials particularly useful for preparing a pharmaceutical composition of the invention, and other “masked” liposomes similarly can be used, such liposomes extending the time that the β-CD remains at the site of administration. [0046] The amount a β-CD in a composition can be varied, depending on the type of composition, such that the amount present is sufficient to reduce viral outbreak or reduce severity of outbreak. An example of such an amount is about 1 to 100 mM, generally about 5 to 30 mM, when administered in an ointment, gel, foam, spray or the like, or about 0.1 to 2 grams, generally about 0.25 to 0.75 grams, when administered as a suppository or in combination with a solid substrate. An effective amount of a β-CD also can be measured in a weight:weight (w:w) or weight:volume (w:v) amount, for example, about 0.1% to 3% w:w with respect to a solid substrate or about 0.1% to 3% w:v with respect to a pharmaceutically acceptable carrier. In addition, an amount of a β-CD sufficient to reduce viral outbreak or decrease outbreak severity can be determined using routine clinical methods, including Phase I, II and III clinical trials. [0047] Currently, several HIV-1 vaccine approaches are being developed, each with its own relative strengths and weaknesses. These approaches include the development of live attenuated vaccines, inactivated viruses with adjuvant peptides and subunit vaccines, live vector-based vaccines, and DNA vaccines. Envelope glycoproteins were considered as the prime antigen in the vaccine regimen due to their surface-exposure, until it became evident that they are not ideal immunogens. This is an expected consequence of the immunological selective forces that drive the evolution of these viruses: it appears that the same features of envelope glycoproteins that dictate poor immunogenicity in natural infections have hampered vaccine development. However, modification of the vaccine recipe through the use of raft/virus co-cultures to expose novel viral epitopes may overcome these problems. [0048] Accordingly, there is a need in the art for new effective methods of identifying candidate sequences for vaccine development to prevent and treat HIV infection. The present invention fulfills this and other needs. [0049] “Antibody” refers to a polypeptide substantially encoded by an immunoglobulin gene or immunoglobulin genes, or fragments thereof, that specifically bind and recognize an analyte (antigen). The recognized immunoglobulin genes include the kappa, lambda, alpha, gamma, delta, epsilon and mu constant region genes, as well as the myriad immunoglobulin variable region genes. Light chains are classified as either kappa or lambda. Heavy chains are classified as gamma, mu, alpha, delta, or epsilon, which in turn define the immunoglobulin classes, IgG, IgM, IgA, IgD and IgE, respectively. [0050] An exemplary immunoglobulin (antibody) structural unit comprises a tetramer. Each tetramer is composed of two identical pairs of polypeptide chains, each pair having one “light” (about 25 kDa) and one “heavy” chain (about 50-70 kDa). The N-terminus of each chain has a variable region of about 100 to 110 or more amino acids primarily responsible for antigen recognition. The terms variable light chain (VL) and variable heavy chain (VH) refer to these light and heavy chains, respectively. [0051] Antibodies exist, for example, as intact immunoglobulins or as a number of well characterized antigen-binding fragments produced by digestion with various peptidases. For example, pepsin digests an antibody below the disulfide linkages in the hinge region to produce an F(ab′) 2 fragment, a dimer of Lab which itself is a light chain joined to VH-CH1 by a disulfide bond. The F(ab′) 2 fragment can be reduced under mild conditions to break the disulfide linkage in the hinge region, thereby converting the F(ab′) 2 dimer into an Fab′ monomer. The Fab′ monomer is essentially an Fab with part of the hinge region (see, Fundamental Immunology, Third Edition, W. E. Paul (ed.), Raven Press, N.Y. (1993)). While various antibody fragments are defined in terms of the digestion of an intact antibody, one of skill will appreciate that such fragments can be synthesized de novo either chemically or by utilizing recombinant DNA methodology. Thus, the term antibody, as used herein, also includes antibody fragments, such as a single chain antibody, an antigen binding F(ab′) 2 fragment, an antigen binding Fab′ fragment, an antigen binding Fab fragment, an antigen binding Fv fragment, a single heavy chain or a chimeric antibody. Such antibodies can be produced by the modification of whole antibodies or synthesized de novo using recombinant DNA methodologies. [0052] Thus, an immunogenic composition to this subtype B ancestor protein will elicit broad neutralizing antibody against HIV-1 isolates of the same subtype. An immunogenic composition to this subtype B ancestor protein will also elicit a broad cellular response mediated by antigen-specific T-cells. [0053] Monoclonal antibodies (MAbs) have been available for over 25 years and have revolutionized biomedical research, especially in the areas of disease diagnosis and the treatment of infection and diseases. [0054] The conventional method for the production of monoclonal antibodies involves hybridomas (Kohler & Milstein, Nature 256:495-7, 1975). In this method, splenic or lymphocyte cells from a mammal which has been injected with antigen are fused with a tumor cell line, thus producing hybrid cells. These hybrid cells, or “hybridomas”, are both immortal and capable of producing the genetically coded antibody of a B cell. To select a hybridoma producing a single antibody, the hybridomas made by cell fusion are segregated by selection, dilution, and regrowth until a single genetically pure antibody-expressing cell line is selected. Because hybridomas produce homogeneous antibodies against a desired antigen, they are called “monoclonal” antibodies. Hybridoma technology has primarily been focused on the fusion of murine lines, but also human-human hybridomas, human-murine hybridomas, rabbit-rabbit hybridomas and other xenogenic hybrid combinations have been made. EXAMPLES Example 1 [0055] HIV-1 Selectively Buds from Lipid Rafts [0056] This example demonstrates that HIV-1 budding occurs through lipid rafts, thereby accounting for the cholesterol-rich, sphingolipid-rich virus membrane, which bears GPI-linked proteins such as Thy-1 and CD59, but lacks CD45. [0057] The relative incorporation of GM1, a ganglioside marker specific for lipid rafts, also was examined. Using a soluble CTB binding assay, as much as 75% of HIV-1 was precipitated using goat anti-CTB and SaC after treating the virus with GM1-specific CTB. The CTB binding to virus was specific and dose dependent, and no virus was precipitated in the absence of CTB as measured by p24 ELISA. These results demonstrate that the majority of HIV-1 particles incorporate the lipid raft-specific marker GM1. [0058] Thy-1, CD59, and GM1 colocalized with HIV-1 proteins on infected cell uropods, which excluded CD45. To determine the distribution of HIV-1 proteins relative to GPI-linked proteins that serve as lipid raft markers, infected cells were subjected to immunofluorescence staining followed by confocal microscopy. Expression of HIV-1 proteins was localized to uropods projecting from one end of the cell. This capping pattern was seen on most cells in the infected cell culture. Uropods protruding from HIV-1-infected cells have been described for adherent T cells. Thy-1 and CD59 both colocalized with cell surface HIV-1 proteins, as shown by a superimposed green (Thy-1 or CD59) and red (HIV-1 proteins) fluorescence (see Nguyen and Hildreth, supra, 2000; FIG. 4 ). Cells that were prefixed with 2% paraformaldehyde before staining showed a similar appearance, indicating that the colocalization was not due to antibody crosslinking of viral and GPI-linked proteins. Since the cells were not permeabilized before staining, the HIV proteins seen in these studies are likely gp41 and gp120. This was confirmed in studies with anti-gp41 MAb T32 in the colocalization studies. Uninfected cells showed no capping of Thy-1 or CD59. CD45 did not localize to areas of HIV-1 protein expression and was excluded from uropods. The distribution of CD45 was unaffected by HIV-1 infection, and the molecule remained evenly dispersed in patches all over the cell surface. These results confirm those obtained using the virus phenotyping studies. The ability of GM1 to colocalize on the cell surface with HIV-1 proteins was examined to confirm the finding that GM1 was present on virions. GM1 staining was relatively faint with rabbit anti-GM1 antibody, but confocal microscopy showed colocalization of this molecule with HIV-1 labeled cells. [0059] HIV-1 proteins were detected in isolated lipid raft fractions. Lipid rafts were purified by cell lysis and equilibrium centrifugation in order to confirm the presence of HIV-1 proteins in these membrane structures. The fractions were assayed for the presence of viral and host proteins by immunoblot analysis. The separation of detergent-resistant lipid rafts was confirmed by the abundance of Thy-1 and CD59 in fractions 3 through 5, while CD45 was present only in the bottom fractions 9 and 10 (see Nguyen and Hildreth, supra, 2000; FIG. 6 ). Immunoblot detection of membrane fractions revealed that the HIV MA protein, p17, and gp41 were both present in the detergent-insoluble lipid rafts of infected cells. Example 2 [0060] Host Membrane Cholesterol is Required for HIV-1 Infection [0061] By removing cholesterol, 2-OH-β-CD is believed to partially perturb organized lipid rafts, resulting in dispersal of their components (Ilangumaran and Hoessli, Biochem. J. 335:433-440, 1998). The capture of HIV-1 by MAbs against CD59 and gp41 decreased substantially after treating cells with 2-OH-β-CD, as measured by the percentage of total p24. CD45 capture remained unaffected. The effects on virus precipitation through gp41 indicate that intact lipid rafts are required for efficient gp41 incorporation into virions, since the overall cellular release of p24 actually increased after 2-OH-β-CD treatment. [0062] Results. 2-OH-β-CD treatment blocked syncytium formation of primary cells and cell lines. The role of lipid rafts in the HIV-1 fusion process was examined by treating CD4+ HIV-susceptible target cells with 2-OH-β-CD to deplete membrane cholesterol and disperse lipid rafts. Treatment of cells with 10 to 20 mM 2-OH-β-CD for 1 hour at 37° C., followed by washing to remove free 2-OH-β-CD, depleted greater than 70% of total cellular cholesterol without any loss in cell viability as measured by Trypan Blue exclusion. Furthermore, treated cells continued to grow normally after 2-OH-β-CD treatment when placed back into culture in cholesterol-containing medium. The non-toxicity of β-CD treatment was further demonstrated by finding 2-OH-β-CD treated Jurkat cells still showed Ca 2+ flux responses to anti-CD3 MAb.

Disclosed is a novel application for β-cyclodextrin (β-CD, a cholesterol depletor), and a novel technique for the creation of immunogens. Topical application of β-CD inhibits or reduces the severity of viral outbreaks such as oral or genital herpes by disrupting lipid rafts, through which viral entry and outbreak occur. Viral entry involves virus/lipid raft interaction, wherein the virus unfolds—only in lipid rafts—to enter the cell via the lipid raft. The invention provides a technique for creating immunogens with novel viral epitopes based on the virus/lipid raft interaction and viral unfolding. This fact can be exploited to create novel immunogens based on viral interaction with lipid rafts. The virus/lipid raft co-culture technique creates novel immunogens which will be used to create novel neutralizing monoclonal and polyclonal antibodies to fight viral disease such as HIV infection.

BACKGROUND OF THE INVENTION The well known toilet tissue dispenser is a U-shaped bracket having a wall attaching portion and a pair of projecting arms. A roller with spring biased ends snap into depressions in the arms. A holder of this type accepts rolls of tissue which generally have a cardboard cylindrical tube through which the roller is inserted such that the spring biased end project beyond the roll to snap into the depressions in the holder arms. Another commonly used tissue dispenser is also a U-shaped bracket with a wall attaching portion and projecting arms. Instead of a roller, the arms are spring biased and hinged where they attach to the wall portion. Each arm has an inwardly facing projection which fits into the cylindrical tube of a roll of tissue. To install a roll of tissue, the arms are biased outwardly and the projections are snapped into the cylindrical tube. The inventor is aware of U.S. Pat. No. 2,500,514, entitled, Paper Roll Holder. A roller with spring biased ends supports a roll of tissue on the holder in one embodiment. In the other embodiment, spring biased plunger rods hold a tube between the arms. A roll of tissue is slipped on the tube and then the plunger rolls fit in the tube. Each of the described tissue dispensers has been serviceable over the years, however, the problem of replacing a roll of tissue in the holder has led to the present invention. The prior art holders require at least two steps to install a roll of tissue, and in most cases, it seems next to impossible. Therefore, the object of this invention is to provide a one step process for loading a roll of tissue on the holder. SUMMARY OF THE INVENTION The present invention relates to a tissue dispenser for bathroom tissue or paper towles, and in particular, to a tissue holder with limited moving parts for loading a roll of tissue. In the general mode of the invention, the tissue dispenser has a pair of projecting arms which extend from a wall and are spaced at a distance from one another to accept a roll of tissue. Each arm has an inwardly facing coil spring or a similar resilient member which fits in the cardboard tube of a roll of tissue. When a roll of tissue is inserted in the holder, the coil springs flex to allow the tube to align between the springs with a spring fitting into each end of the tube. In one embodiment, the projecting arms are integral with a wall bracket to form a U-shaped holder. While in the other embodiment, the arms have their own wall mounting elements which allows the arms to be spaced at any comfortable distance. The main object of this invention is to provide a tissue dispenser for rolls of tissue which has an easy to use method for installing rolls of tissue. An object is to provide a tissue dispenser that does not allow the roll of tissue to freely spin thereby wasting tissue. Because of the simple and straightforward design of the tissue dispenser, it is another object to provide a tissue dispenser that is inexpensive to manufacture. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of one embodiment of the tissue dispenser of this invention. FIG. 2 is a top plan view of the tissue dispenser shown in FIG. 1. FIG. 3 is a fragmentary side view of the tissue dispenser in FIG. 1. FIG. 4 is a front plan view of another embodiment of a tissue dispenser of this invention. FIG. 5 is a side plan view of the device taken along the line 5--5 of FIG. 4. DESCRIPTION OF THE INVENTION Referring to the drawings, there is shown in FIGS. 1 to 3 a preferred embodiment of the invention. The tissue dispenser 10 is a U-shaped structure with a wall mounting bracket 12 and a pair arms 14 and 16 at right angles to the bracket. Each arm has a coil spring 18 and 20, respectively, molded in the arm to project inwardly, as shown in FIGS. 1, 2 and 3. The bracket 12 has a pair of screw holes 22 for attaching the tissue dispenser 10 to a wall. In FIGS. 1 and 2, a roll of tissue R is shown supported by the coil springs 18 and 20. To install the roll R, the cardboard cylindrical tube, T, in the center of the roll is fitted on the springs 18 and 20. By pressing the roll R between the arms 14 and 16, the coil springs 18 and 20 flex until the tube is in place. At which point, the coil springs 18 and 20 snap into the tube, and are smaller in diameter than recesses 22' and 24. By squeezing the tube to change its cross-sectional shape from round to oblong, the tissue can be payed from the roll R at a controlled rate. That is, the roll R will not freely rotate on the coil springs 18 and 20. In fact, without squeezing the tube the roll R will not rotate as freely as it would on a roller found in most tissue holders. This is because as the roll turns the weight is not evenly supported around the coil springs, causing a drag on the roll's rotation. Manufacturing the tissue dispenser 10 may use a molding technique where the entire holder is integrally formed, or an assembly procedure where each arm is welded or attached in some manner to the bracket 12. In either manufacturing method, the coil springs can be molded directly with the arms, or each arm can be bored and the coil springs bonded in the bores. Since plastics and metals are simple to mold it is preferred to use a molding technique. However, it is possible to make wooden dispensers in one piece or assembled pieces. There are obviously a wide range of materials and manufacturing methods which can be used. Turning to FIGS. 4 and 5, the tissue dispenser 100 in this embodiment is made with two separate arms 102 and 104. Each arm has its own wall bracket portion 106 and 108 integrally formed with the arm. There are screw mounting holes 110 in the brackets for attaching the dispenser to a wall. The coil springs 112 and 114 are fixed to the arms 102 and 104 so that when the tissue dispenser 100 is mounted on a wall, they face each other. FIG. 4 shows one of the arms, 102, with a large knob end 116 and coil spring 112 fixed in the knob, recesses 118, 120 larger than springs. With the separate arms and wall brackets of this embodiment, the tissue dispenser 100 can be adjusted to accommodate any size roll. For example, the same pair of arms 102 and 104 can be used as a holder for toilet tissue or paper towels even though the towels are much wider. Installing a roll of tissue on dispenser 100 is exactly the same as described in the first embodiment. While two embodiments of the invention have been disclosed, it is understood that one skilled in the art could make changes in the invention without changing the inventive concept. Therefore, one should study the drawings and the specification together with the claims to fully understand the invention. There is one simple illustration where changing the coil springs for resilient elements of rubber or similar materials would not change the invention.

A roll tissue dispenser having resilient members for supporting a roll of tissue by its center tube thus making a simple, easy loading and unloading device of this type.

RELATED APPLICATIONS [0001] This application claims priority to provisional application No. 61/121,072 filed on Dec. 9, 2008, which is hereby incorporated by reference in its entirety. TECHNICAL FIELD [0002] The present disclosure provides welted footwear and a method of manufacturing the same. BACKGROUND [0003] Footwear having welted constructions are well known. For example, see U.S. Pat. No. 1,656,564 titled Welting and Method of Making the Same, U.S. Pat. No. 2,754,600 titled Shoe Welting, and U.S. Pat. No. 6,802,138 titled Cushioning System for Footwear and Related Method of Manufacture. Though traditional welted type constructions are known and have been improved upon, further improvements in welted footwear are desirable. SUMMARY [0004] The present disclosure provides an improved welted footwear and related method of manufacture. The welted footwear and related method of manufacturing is directed to a foot support platform that provides a number of advantageous features. Toe cap features are also provided. BRIEF DESCRIPTION OF THE DRAWINGS [0005] FIG. 1 is a perspective view of an article of footwear according to an embodiment of the present disclosure; [0006] FIG. 2 is an exploded perspective view of the footwear of FIG. 1 ; [0007] FIG. 3 is a sectional view of the footwear taken along line 3 - 3 of FIG. 1 ; [0008] FIG. 4 is a sectional view of the footwear taken along line 4 - 4 of FIG. 1 ; [0009] FIG. 5 is a bottom perspective view of a foot support platform of the footwear of FIG. 1 ; [0010] FIG. 6 is a top view of the foot support platform of the footwear of FIG. 1 ; [0011] FIG. 7 is a bottom view of the foot support platform of the footwear of FIG. 1 ; [0012] FIG. 8 is a sectional view of the foot support platform taken along line 8 - 8 of FIG. 6 ; [0013] FIG. 9 is a sectional view of the foot support platform taken along line 9 - 9 of FIG. 6 ; [0014] FIG. 10 is an enlarged view of a portion of FIG. 9 ; [0015] FIG. 11 is a top perspective view of an alternative embodiment of the foot support platform; [0016] FIG. 12 is a top view of the foot support platform of FIG. 11 ; [0017] FIG. 13 is a longitudinal sectional view of the foot support platform of FIG. 12 at line 13 - 13 ; [0018] FIG. 14 is a sectional view of a footwear including a toe cap; [0019] FIGS. 15A-B are schematic representations of the interface between a toe cap retaining structure and a toe cap flange; and [0020] FIG. 16 is a perspective view of a toe cap. DETAILED DESCRIPTION [0021] An embodiment of an article of footwear in accordance with the principles of the present disclosure is described herein with reference to the figures. In the depicted embodiment the footwear is a boot 10 having a welted construction. It should be appreciated that the article of footwear according to the principles of the present disclosure is applicable to many different types of welted footwear (e.g., dress shoes, athletic shoes, winter boots, sandals, hiking boots, etc.). [0022] Referring to FIG. 1 , the boot 10 includes an upper portion 12 connected to an outsole 14 via a welt 16 . The upper portion 12 of an article of footwear is configured to hold the outsole 14 to a foot. In the depicted embodiment the upper portion 12 is also configured to protect a foot and an ankle of the person wearing the boot. In the depicted embodiment the upper portion 12 is constructed of leather. Many other materials can also be used in the construction of the upper portion 12 (e.g., canvas, nylon, etc.). [0023] The outsole 14 is configured to engage the ground surface. In particular, the outsole 14 in the depicted embodiment includes a bottom surface 54 that is configured to contact the ground surface. In the depicted embodiment the bottom surface 54 includes a tread surface that provides grip. In the depicted embodiment the outsole includes a shock absorbing material (e.g., soft rubber, foam, gel, etc.) that is molded to the bottom surface 54 . In alternative embodiments, the shock absorbing material may be the same material that contacts the ground surface. Also, it should be appreciated that the outsole can also include stiff material such as wood, plastic, metal or a combination of materials to provide auxiliary support in the midfoot portion of the footwear. The construction of the outsole 14 is described in greater detail below. [0024] Referring to FIGS. 2-10 , an exploded assembly view the boot 10 is shown. The boot 10 includes a foot support platform 18 that is connected to the welt 16 and the outsole 14 . In some embodiments the foot support platform 18 supports a removable foot bed cushion 20 , which contacts the user's foot. In other embodiments the user's foot directly contacts the foot support platform 18 or non-removable (e.g., stitched and/or cemented) foot bed cushion materials are provided over the foot support platform 18 . In the depicted embodiment the foot support platform 18 includes a first surface 22 (an upper surface) and a second surface 24 (a lower surface). The foot support platform 18 includes a downwardly extending rib 26 which extends from the second surface adjacent a periphery edge 28 of the foot support platform 18 . In the depicted embodiment the rib 26 includes an outer side wall 32 that is radiused to the periphery edge 28 and an inner side wall 34 that is generally vertical. The shape of the outer side wall 32 minimizes or eliminates the gaps between the upper portion 12 and the rib 26 where they are stitched together. [0025] In the depicted embodiment the foot support platform 18 is molded and the rib 26 is integrally molded to the foot support platform 18 . In the depicted embodiment a pliable material 30 (e.g., fabric) is molded to the second surface 24 and to a portion of the rib 26 . The pliable material 30 can be any material that can make the rib 26 more tear resistance when molded thereto (e.g., a pliable material made by weaving, felting, knitting). It should be appreciated that the pliable material can be a fabric made of natural fibers, synthetic fibers, or a combination of natural and synthetic fibers. [0026] In the depicted embodiment, the pliable material 30 is molded through a portion of the rib 26 such that a portion of the lower portion of the rib 26 is on one side of the pliable material 30 , and another portion of the rib 26 is on the other side of the fabric material. In the depicted embodiment the pliable material 30 is present on both the inner side wall 34 and the outer side wall 32 of the rib 26 . The pliable material provides the rib 26 improved tear resistance. In the depicted embodiment, the pliable material 30 is placed in a mold and polymeric molten material is molded to the pliable material 30 . In the area of the rib 26 the molten material is molded through the pliable material 30 , which results in portions of the rib 26 being on either side of the pliable material 30 . It should be appreciated that in alternative embodiments, the fabric 30 is molded over the rib 26 such that the fabric covers the rib 26 rather than extending through the rib 26 as depicted. [0027] In the depicted embodiment the welt 16 is stitched to a lower periphery edge of the upper portion 12 and to the rib 26 . In the depicted embodiment the stitches 36 that connect the welt to the upper portion and rib extend through the pliable material on both an inner side wall 34 and an outer side wall 32 portion of the rib 26 . In the depicted embodiment, the stitches 36 extend through two layers of the pliable material 30 when the stitch extends through the zone 53 of the rib 26 , which is shown between the dashed lines in FIG. 10 . This configuration prevents separation due to the rib 26 tearing away from the foot support platform 18 due to stress applied to the rib 26 via the stitches. It should be appreciated that in some embodiments the stitches do not extend through both layers of the pliable material. In some embodiments the stitches extend through only one layer of pliable material and in other embodiments the stitches extend through no layers of pliable material. [0028] In the depicted embodiment the welt 16 is molded to the outsole 14 . The connection between the welt 16 and the outsole 14 does not include stitches. However, it should be appreciated that in alternative embodiments the welt 16 can be connected to the outsole with stitches (e.g., the welt can be stitched to a midsole structure that is cemented to the outsole). In addition, in the depicted embodiment the welt 16 includes a flexible construction with a generally T-shaped cross-sectional profile. However, it should be appreciated that the welt can have many alternative configurations. For example, the welt 16 could be constructed of leather and have a generally L-shaped cross-sectional profile, the welt could include a nylon construction with a generally triangular cross-sectional profile, etc. [0029] In the depicted embodiment the foot support platform 18 includes a hindfoot zone 40 , a forefoot zone 42 , and a midfoot zone 44 . The forefoot zone 42 includes a metatarsal support area 46 and a toe support area 48 . The hindfoot zone 40 supports a person's heel, the midfoot zone 44 support a person's midfoot, the forefoot zone 42 support a person's forefoot, the metatarsal support area 46 of the forefoot zone 42 supports a person's metatarsals, and the toe support area 48 of the forefoot zone 42 supports a person's toes. [0030] In the depicted embodiment the foot support platform 18 is substantially stiffer in the midfoot zone 44 than the hindfoot zone 40 . A relatively stiff material (e.g., glass reinforced nylon) is molded into the midfoot zone 44 of the support platform 18 to provide additional support in the midfoot zone 44 . This added stiffness provides many advantages, including minimizing fatigue when the person wearing the boot 10 is standing on a ladder rung. The added stiffness in the midfoot zone 44 can avoid the need to provide a separate shank member in the outsole 14 . [0031] In the depicted embodiment the hindfoot zone 40 includes a resilient pliable construction that allows a person's heel to press into the shock absorption materials in a heel area 56 of the outsole 14 . In the depicted embodiment, the hindfoot zone 40 is pliable and conforms to the shape of the person's heel in use, thereby avoiding pressure points and hot spots in the heel area. [0032] In the depicted embodiment the toe support area 48 of the foot support platform 18 is substantially stiffer than the metatarsal support area 46 . Conversely, the metatarsal support area 46 is more flexible than the midfoot zone 44 of the support platform 18 . [0033] The relative flexibility in the metatarsal support area 46 enables the person to easily flex the shoe when walking, while the stiffness in the toe support area 48 provides a platform for support for a protective toe covering ( FIGS. 14 and 16 ). The flexibility also allows shock to be transferred to and be absorbed by the shock absorption materials in the forefoot area 58 of the outsole 14 . In the depicted embodiment, the metatarsal support area 46 is pliable and conforms to the shape of the person's foot, thereby avoiding pressure points and hot spots in the metatarsal area. In the depicted embodiment the rib 26 is notched in the metatarsal support area to provide added flexibility. [0034] The relative stiffness in the toe support area 48 provides axial support for a protective toe coverings (e.g., steel covering) common in work boots. When the protective toe covering is pressed downward, the force is transferred onto the stiffer toe support area 48 , which distributes the force down to a relatively large area of the outsole 14 . The above-described configuration prevents the toe covering from substantially sinking down into the outsole 14 when impacted, and thereby helps to maintain a relatively constant vertical space in the toe box of the boot 10 when in use. [0035] In the depicted embodiment, the material used to mold the relatively flexible hindfoot zone 40 and the metatarsal support area 46 is thermoplastic polyurethane (TPU), the relatively stiffer material 50 used to mold a portion of the midfoot zone 44 and toe support area 48 is glass reinforced nylon ( FIGS. 9 and 10 ). The construction of the midfoot zone 44 is at least ten percent stiffer than the construction of the hindfoot zone 40 . The toe support area 48 is at least ten percent stiffer than the construction of the metatarsal support area 46 . The toe support area 48 is at least ten percent stiffer than the construction of the hindfoot zone 40 , and the midfoot zone 44 is at least ten percent stiffer than the metatarsal support area 46 . In the depicted embodiment midfoot zone 44 is sufficiently stiff to prevent the midfoot from significant bending when a person stands on a ladder rung, the hindfoot zone 40 is sufficiently soft to conform to a person's heel, the metatarsal support area 46 is sufficiently flexible to allow the metatarsal area of the shoe to bend in use, and the toe support area 48 is sufficiently stiff to distribute the force applied from the toe covering to a larger area of the outsole 14 . In the depicted embodiment the midfoot zone 44 includes an integrally molded dog bone shaped shank member that provides stiffness. In the depicted embodiment the transition between the zones (e.g., line 84 ) is wavy rather than straight and does not have abrupt corners. This construction avoids stress concentration at the transitions as a result of the bending of the platform and results in overlap between the zones in the longitudinal direction. It should be appreciated that many alternative constructions are possible, including transition with sharp corners, straight line transition, or overlaps in the vertical direction. [0036] In the depicted embodiment the outsole 14 is a multi material type body that is directly connected to the upper 12 . The outsole 14 includes a shock absorption portion 52 that is molded into the portion that is configured to engage the ground surface 54 , otherwise referred to herein as the tread. In the depicted embodiment, the shock absorption portion 52 of the outsole 14 is molded to the pliable material 30 on the second surface of the foot support platform 18 . In the depicted embodiment the shock absorption portion 52 is delivered into the cavity defined by the tread portion 54 and the bottom surface 24 of the foot platform 18 . This step adheres the outsole 14 to the support platform 18 , and thereby also connects the outsole 14 to the upper. In the depicted embodiment softer materials are molded into the heel areas 56 and the forefoot areas 58 of the shock absorption portion 52 of the outsole 14 . In the depicted embodiment gel-like materials are molded in these areas. In some embodiments the softer materials are preformed and provided as inserts into the heel areas 56 and forefoot areas 58 . [0037] In an alternative embodiment, the tread portion of the outsole may be constructed of the same material that is used to construct the shock absorption portion. In such embodiments, the outsole 14 may still be directly connected to the upper via molding. In such an embodiment, molten outsole material would be provided in a cavity defined by a mold portion and the bottom surface 24 of the foot support platform 18 . [0038] It should be appreciated that the foot support platform 18 can also be used in construction where the outsole is indirectly attached to the upper. In such embodiments the outsole can be preformed. In such embodiments one surface of a midsole can be cemented to the bottom surface 24 of the foot support platform 18 , and another surface of the midsole can be cemented to the outsole. In such an embodiment the welt can also be stitched to the foot support platform 18 , the midsole, and the outsole. [0039] Referring to FIGS. 11-14 an alternative embodiment of the foot support platform is shown. In the depicted embodiment the foot support platform 60 is similar to the support platform 18 as it also includes a hindfoot zone 62 , a forefoot zone 64 , and a midfoot zone 66 . Moreover, the forefoot zone 64 includes a metatarsal support area 68 that is less stiff than a toe support area 70 . [0040] The support platform 60 further includes a toe cap retaining structure 72 . In the depicted embodiment the toe cap retaining structure 72 includes a ramp 74 having a curved forward raised edge 76 . In the depicted embodiment forward raised edge 76 is configured to engage a portion of a toe cap (e.g., a flange on the toe cap). In the depicted embodiment the raised edge 76 has a height H of about 1.0 mm. It should be appreciated that the height can vary from application to application (e.g., in another embodiment H could be between 0.5 mm and 5.0 mm). The raised edge defines the front arc shape of the ramp 74 . The toe cap retaining structure 72 is configured to engage the toe cap wherein the toe cap has a different profile than the arc shape raised edge. For example, if the toe cap has a curvature that is greater than the radius of curvature of the ramp, the toe cap will engage the raised edge along the center line. See, for example, FIG. 15A . However, if the toe cap has a curvature that is less than the radius of curvature of the front of the toe cap, the toe cap will engage the raised edge on either side of the center line. See, for example, FIG. 15B . The configuration enables a certain size toe cap to fit with a variety of side support platforms. [0041] In the depicted embodiment the ramp has a sloped profile that transitions the plane of the toe support area upward towards the upper surface of the flange 78 of the toe cap 80 . See FIG. 14 . In the depicted embodiment the ramp slopes upward from the upper surface of the platform in 180 degrees (both in the forward direction and towards each side). See FIG. 11 (see arc 73 identifying the location where the ramp begins to slope upward). In the depicted embodiment a securing layer 82 is cemented over the ramp 74 and the flange 78 of the toe cap to secure the toe cap 80 down on the platform 60 . The securing layer can be, for example, a fibrous board material (e.g., Texon). It should be appreciated that the toe cap retaining structure 72 can have many different configurations. For example, alternatively, the toe cap retaining structure can be a raised rib with a squared off edge rather than a ramp shaped wedge, or the toe cap retaining structure can also be raised spaced apart posts. In addition, the toe cap retaining structure could also be a recess in the foot support platform. In the depicted embodiment the toe cap retaining structure 72 is molded integrally as part of the support platform 60 . It should be appreciated that the toe cap retaining structure can be attached in many other ways (e.g., cemented, riveted, stitched, etc.). [0042] The above specification, examples and data provide a complete description of the manufacture and use of the composition of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended.

The present disclosure provides an improved welted footwear and related method of manufacture. The welted footwear and related method of manufacturing is directed to a molded foot support platform that provides a number of advantageous features.

BACKGROUND OF THE INVENTION The present invention relates to livestock watering devices and in particular to those devices which are equipped with heating devices. Previous generations of livestock waterers consisted of open tubs in barnyards or pens. There livestock could access the water as needed. Improvements were then made to the cattle waterers which allowed the tubs to be filled automatically. Although the automatic fillers solved a number of problems with the waterers, problems relating to freezing persisted. Specifically, in sub-freezing climates, the water in the waterer is susceptible to freezing. In order to abate this problem, farmers began to use heaters to warm the water to above freezing. Although heaters aided in keeping most of the water in a liquid state, freezing still occurred at the air-water interface. Additionally, the costs of heating the waterers became more expensive. Improvements to better insulate the waterers led to insulation material utilized in the outer shell of the waterer and inventions directed at insulating the upper surface of the water itself. U.S. Pat. No. 4,646,687 discloses a waterer with a circular cover or lid which floats upon the water's surface. The lid could be manipulated by the animal in such a way to allow access to the water beneath. Other patents sized the lid to avoid its freezing to the surrounding opening. U.S. Pat. No. 4,883,022 implemented guide rails anchoring the cover to the waterer while still allowing the animals access to the water below. The guide rails assisted in preventing the animals from being able to physically remove the lids from the waterer. With conventional lids, movement of the lids by animals seeking to drink creates turbulence and splashing of water from the waterer. This wastes water and also creates a muddy ground surface around the waterer or leads to ice build up on the outside of the waterer. The shape of previous lids made them prone to generating wave action within the waterer. Wave action causes water to be lost which in turn add extra costs in the replacing of the water as well as heating of the replacement water. One other shortcoming is the placement of the heater within the waterer. Traditionally, the heater is placed in a protected central location away from the basins accessible by the animals so that the animals will not damage the heating element. The heat created by the heating element must travel from the central location of the waterers to the basins and may be sufficiently dissipated before water in the basins is sufficiently warmed to prevent freezing in frigid weather conditions. BRIEF SUMMARY OF THE INVENTION An improved livestock waterer includes a base which provides one or more basins for containing water which may be accessed by an animal seeking water. The basins are separated by an enclosure which is an integral part of the base. The enclosure may house heater and water supply elements and may also include a central water container from which water may circulate to the basins through ports connecting the basins to the central water container. Each of the basins is provided with a polymeric or other non-metal floating lid. Each lid is constructed as a hollow enclosure in which air is trapped. The upper surface of each lid is in the form of a dome or convex curve so that water will not remain standing on the upper surface. The underside of each lid includes a number of baffles which reduce wave action on the surface of the water below the lid as the lid is depressed or displaced by an animal seeking water below the lid. By reducing turbulence below the lid, less chance exists that water will splash from the basin during drinking activity, or when an animal experiments with the lid out of curiosity. Heating elements may be placed within the water basins. Each heating element is supported on a post which is formed integrally with the base such that the post will stand upright upon the bottom of a water basin. A primary object of the invention is to provide an improved livestock waterer which reduces the incidence of splashing from the waterer when an animal displaces the lid floating on the water made available to the animal. Another object of the invention is to provide an animal waterer which is less susceptible to ice accumulation on the floating lids overlying the water within the waterer. A further object of the invention is to provide an improved mounting structure for a heater element stationed within the water in the waterer. Yet another object of the invention is to provide an animal waterer which always maintains water covering the heating elements. These and other objects of the invention will be apparent from the detailed description which follows. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) FIG. 1 is a perspective view of an embodiment of the waterer having elongate water basins separated by a central enclosure. FIG. 2 is a top view perspective of the lid of the embodiment of FIG. 1 . FIG. 3 is a bottom view perspective of the lid of the embodiment of FIG. 1 . FIG. 4 is a three-dimensional front perspective of a second embodiment of the invention. FIG. 5 is a cross-sectional view taken along line 5 - 5 of FIG. 4 , shown with water in the waterer. FIG. 6 is a bottom view perspective of the lid for each of the basins of the livestock waterer of FIG. 4 . DETAILED DESCRIPTION OF THE INVENTION Referring now to the drawings, one embodiment of the livestock waterer 4 can be seen in perspective in FIG. 1 positioned to demonstrate the three dimensional shape of the structure. Mounting points 6 can be used to secure the invention to a surface such as a concrete platform with the use of a selected type of mounting hardware. Mounting recesses 8 allow easier access to the mounting points 6 and ease in the facility of accessing the chosen mounting hardware. Livestock waterer 4 includes a housing 12 which comprises two basins 10 separated by an elevated enclosure 7 . The housing 12 further comprises front and rear longitudinal sidewalls 5 , 13 and opposing end walls 9 , 11 . Sidewalls 5 , 13 , end walls 9 , 11 and elevated enclosure 7 are formed integrally of polymeric material. Lids 14 substantially cover the opening of basins 10 . Lids 14 are buoyant, preferably hollow and are made from a polymeric material. Lids 14 preferably float on the surface of water contained within each basin 10 . Pass through openings 16 in the lids 14 allow guides 18 to pass through the lids 14 . Guides 18 each consist of elongate vertically disposed rods which extend into basin 10 and are fixed at the bottom of basin 10 . Guides 18 are also retained in an upstanding orientation by their attachment to guide mounts 20 atop opposing end walls 9 , 11 or by attachment to the sidewalls 15 of elevated enclosure 7 . Guides 18 are spaced apart from basin sides a small distance. Preferably one guide 18 is located along each opposite side of the basins 10 . A top access panel 22 on the top of the elevated enclosure 7 is removable to access equipment such as a float valve (not shown) within elevated enclosure 7 . Recess 25 facilitates removal of the top access panel 22 . Side access panel 26 is selectively removable from the livestock waterer 4 and provides access to the interior of the elevated enclosure 7 . Plugs 28 are received in openings 30 in end walls 9 , 11 to seal openings 30 which are in communication with the basins 10 . The plugs 28 are selectively removable and once removed, allow water to drain from the basins 10 . Details of the structure of each lid 14 may be seen in FIGS. 2 and 3 . Each lid 14 includes an upper surface 50 and an underside 70 . Upper surface 50 of each lid 14 is preferably convex in shape and upper surface 50 may be formed as a segment of a cylinder or may otherwise be domed in shape. Peripheral regions 57 of upper surface 50 may be planar though they are not required to be so. Peripheral regions 57 of upper surface 50 are preferably kept minimal in area to provide little planar surface on which water may collect. Lid 14 is preferably hollow with upper surface 50 sealed at side edges 80 , 82 , 84 and 86 to underside 70 so that air is trapped within lid 14 and it is buoyant. As seen specifically in FIG. 3 , the underside 70 of lid 14 is substantially planar. A baffle system 61 depends from the underside 70 . Baffle system 61 comprises transverse walls 60 , 68 and longitudinal walls 62 , 66 , each of which are generally perpendicular to the underside 70 of lid 14 . Bottom edges 74 of baffle system 61 may be parallel to underside 70 and may extend approximately one to five (preferably two to three) inches from underside 70 of lid 14 . The baffle system 61 may be integral with the other structures of lid 14 . Longitudinal walls 62 , 66 of baffle system 61 extend substantially the length of underside 70 but are interrupted by gaps 71 therein. In the preferred embodiment transverse walls 60 , 68 interconnect longitudinal walls 62 , 66 at a substantial perpendicular near distal ends 64 , 69 of longitudinal walls 62 , 66 . Distal ends 64 , 69 of longitudinal walls 62 , 66 extend past their intersections with transverse walls 60 , 68 a short distance which, in the case of a lid 14 which is of a total length of approximately thirty-six inches, may be one to two inches. Distal ends 64 , 69 may be inclined from bottom edge 74 at twenty to seventy degrees and preferably from thirty to sixty degrees. Proximal edges 72 , 73 of longitudinal walls 62 , 66 extend approximately ten to twelve inches past transverse walls 60 , 68 in the case of a lid 14 of length in the range of thirty-six inches. Longitudinal walls 62 , 66 are longitudinally aligned with proximal ends 72 , 73 thereof spaced apart from one another to form gaps 71 . Proximal ends 72 , 73 may be inclined at ten to eighty degrees from perpendicular to underside 70 preferably at 30 to 60 degrees. Gaps 71 between proximal ends 72 , 73 of longitudinal walls 62 , 66 are critical in providing turbulence damping so that air is not trapped between longitudinal walls 62 , 66 and transverse walls 60 , 68 below lid 14 . The gaps 71 separate baffle system 61 into first set of baffles 63 and a second set of baffles 67 . The second set of baffles 67 mirrors the first set of baffles 63 in the preferred embodiment. The baffle system 61 interrupts and abates the wave motion of the water caused when an animal manipulates lid 14 to access the water. The baffle system 61 may be formed on underside 70 as an integral part of lid 14 and each wall 60 , 62 , 66 and 68 may be hollow. A second embodiment of the invention is seen in FIG. 4 and FIG. 5 . Livestock waterer 104 shares many of the structures and characteristics of the embodiment detailed in FIGS. 1-3 . Mounting recesses 108 allow access to mounting points 106 which can be fitted with hardware to anchor the livestock waterer 104 to a ground surface. Livestock waterer 104 contains basins 110 set in housing 112 . The housing 112 further comprises front and rear longitudinal sidewalls 105 , 113 and opposing end walls 109 , 111 . Recess 125 allows a top access panel 122 to be removed easier. The top access panel 122 and side access panel 126 are selectively removable and allow access to the interior of the elevated enclosure 107 . A lid 114 substantially covers each of basins 110 . Openings 116 in lids 114 allow guides 118 to pass through lids 114 . Guide mounts 120 extend from the sidewalls 105 , 113 and secure the guides 118 . Guides 118 are further secured by being anchored to bottom 141 of basins 110 . Now referring to FIG. 5 , a cross-sectional view shows more detail of the second embodiment livestock waterer 104 . Cavity 140 within the livestock waterer 104 extends to the bottom 141 of basin shelf 142 . Housing 112 comprises end walls 109 , 111 which cooperate with basin shelf 142 and longitudinal sidewalls 105 (seen in FIG. 4 ), 113 to define cavity 140 . Sidewalls 115 of elevated enclosure 107 , end walls 109 , 111 , longitudinal sidewalls 105 , 113 and basin shelf 142 cooperate to define basins 110 which are elevated above a ground surface. Longitudinal sidewalls 105 , 113 , sidewalls 115 of elevated enclosure 107 and end walls 109 , 111 can be seen to be an integral one-piece polymeric structure formed by molding. A water supply pipe (not shown) may traverse cavity 140 and pass through basin shelf 142 to enter central fill tub 146 . Float compartment 144 adjoins central fill tub 146 and provides a location far a float valve (not shown) from which central fill tub 146 is filled. The water enters the basins 110 via ports 148 which connect basins 110 with central fill tub 146 . Lids 114 are buoyant and are supported on water surface 132 within basins 110 . Therefore, lids 114 rise with the addition of water to the basins 110 . Lids 114 slide vertically on guides 118 as water is added to or removed from the basins 110 and as animals seeking water depress lids 114 to gain access to water below lids 114 . Once basins 110 are filled to a desired level with water, a float valve (not shown) located in elevated enclosure 107 closes to prevent further inflow of water from a water source. An animal gains access to the water by pushing lid 114 downward. As the animal exerts downward force, the lid 114 partially submerges and water rolls over upper surface 150 . Once the animal ceases to exert downward force on lid 114 , water rolls off convex lid 114 and the lid 114 returns to its floating position on top of water contained in basin 110 . Again referring to FIG. 5 , basin floor 154 contains elements aiding in the heating of the water contained in basins 110 . Post 152 extends from basin floor 154 and may be integrally formed with basin floor 154 . In the preferred embodiment, post 152 is cylindrical. The shape and size of post 152 is selected such that heater 156 may attach to the periphery of post 152 . The heater is positioned in the middle of basin floor 154 in such a way so it cannot be accessed by an animal drinking from the livestock waterer 104 . As water is removed from the livestock waterer by the animals or through evaporation, the lids 114 descend toward the basin floor 154 . The baffle system 161 of lids 114 of livestock waterer 104 depend from underside 170 of lids 114 to a distance of at least the height of post 152 . This minimal length assures water will always sufficiently cover the heater 156 and minimize overheating of heater 156 . Again referring to FIG. 4 and FIG. 5 , the basin floor 154 may be sloped to provide enhanced emptying and cleaning of the livestock waterer 104 . Once plugs 128 are removed from openings 130 , water drains from basins 110 . The top access panel 122 and side access panel 126 allow a person to more easily access a heating element or water supply within the housing 112 . FIG. 6 discloses a lid 114 for the embodiment of the livestock waterer 104 of FIG. 4 . Lid 114 comprises an upper convex surface 150 and an underside 170 which is substantially planar. Baffle systems 161 depend from underside 170 and each comprises a transverse wall 163 joined perpendicularly to longitudinal walls 162 and 166 which are spaced apart. Each of longitudinal walls 162 and 166 inclines from its attachment to transverse wall 163 to the underside 170 , leaving a small gap between baffle systems 161 approximately midway along underside 170 . Walls 162 , 163 , 166 each preferably depends at a substantial perpendicular from underside 170 . In the foregoing description, the container has been described in connection with preferred embodiments, but it should be understood that the description does not intend to limit the container to the embodiments described. Rather, this description is intended to include such alternatives, modifications and equivalents as may be included in the sphere and scope of this invention, as more particularly set forth in the claims.

A livestock waterer for use in frigid climates includes a lid which floats on the surface of the water in each basin of the waterer. The lid is hollow with a convex upper surface and with baffle walls depending from the underside of the lid. The baffle walls interrupt wave action on the surface of the water created by depression of the lid into the water when an animal presses down on the lid to gain access to the water. The floor of each basin is provided with an integrally formed mounting post to support a heater within the basin. The baffles walls prevent exhaustion of water within the basin thereby preserving submersion of the heater at all times.

BACKGROUND [0001] Field [0002] The disclosed embodiments relate generally to herbal smoking blends and methods for preparing and using herbal smoking blends, and more particularly to herbal smoking blends having terpenoids added thereto. [0003] Description of the Related Art [0004] The smoking of various herbs can provide physiological and/or psychological effects, some of which can provide therapeutic benefits. For example, cannabis, also known as marijuana, is an herb that can be smoked for recreational purposes or therapeutic purposes, such as to treat nausea, pain, muscle spasticity, and loss of appetite, among other conditions. It has been observed that different herbs, including different species, different strains, or different varieties of an herb can have different therapeutic effects. Consequently, different species, strains, or varieties of herbs have been cultivated to achieve desired effects. Such cultivation, however, can be time-consuming, can limit the availability herbs with a desired effect, and may be cost-prohibitive for rare or difficult to cultivate plants. [0005] Accordingly, there is a continuing need for methods of providing smoking herbs with desired effects. SUMMARY [0006] In one aspect, a method of preparing an herbal smoking blend comprises providing a smoking herb preparation. The method additionally comprises providing a terpenoid solution comprising a terpenoid. The terpenoid solution is added to the smoking herb preparation. [0007] In another aspect, a smoking herb preparation system comprises a smoking herb. The system additionally comprises a terpenoid solution comprising at least one terpenoid. The system further comprises an applicator for administering a dose of the terpenoid solution to the smoking herb. [0008] In another aspect, an herbal smoking blend comprises a smoking herb and a terpenoid at a terpenoid concentration, where the terpenoid is not naturally occurring in the smoking herb at the terpenoid concentration. In some embodiments, examples of a terpenoid include a terpenoid is selected from the group consisting of d-limonene, α-pinene, β-myrcene, linalool, pulegone, 1,8-cineole (eucalyptol), α-terpineol, terpineol-4-ol, p-cymene, borneol, Δ-3-carene, β-caryophyllene, caryophyllene oxide, nerolidol, phytol, Eugenol, Sabinene, Linalyl Acetate, Camphor, Chamazulene, beta-Farnesene, alpha-Humulene, Benzyl Benzoate, Benzyl Acetate, Geraniol, Geranyl Acetate, gamma-Terpinene, beta-Pinene, and combinations thereof, wherein the terpenoid is not naturally occurring in the smoking herb at the terpenoid concentration in the smoking herb blend. In some embodiments, the terpenoid is not naturally produced by smoking herb plant. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 is a flow chart illustrating a method of preparing an herbal smoking blend, according to some embodiments. [0010] FIG. 2 is a schematic illustration of a smoking herb preparation system comprising a smoking herb, according to some embodiments. [0011] FIG. 3 is a schematic illustration of a smoking herb preparation system comprising a smoking herb, according to some other embodiments. [0012] FIG. 4 is a schematic illustration of a smoking herb preparation system comprising a smoking herb, according to yet other embodiments. DETAILED DESCRIPTION [0013] Since the discovery of therapeutic effects of inhaled smoke of cannabis, the chemical origins of the therapeutic effects have been an intense area of research. The primary focus of the research into the chemical origins of the therapeutic effects of cannabis has been centered around a class of active compounds called cannabis phytocannabinoids. Phytocannabinoids, also referred to as cannabinoids, refer to a group of C 21 terpenophenolic compounds that are uniquely produced in cannabis. The most widely known phytocannabinoid is tetrahydrocannabidol (THC), which is known to be responsible for producing psychoactivity commonly associated with cannabis. Since the isolation of THC, other phytocannabinoids have been isolated and some have been associated with therapeutic effects. While over 100 phytocannabinoids are known to exist, a group of well-documented phytocannabinoids include tetrahydrocannabidol (THC), cannabidiol (CBD), cannabichromene (CBC), cannabigerol (CBG), tetrahdrocannabivarin (THCV), cannabidivarin (CBDV) and cannabinol (CBN). Some of the therapeutic effects of phytocannabinoids include, without being bound to any theory, euphoric effects (associated, for example, with THC and THCV), analgesic effects (associated, for example, with THC, CBD and THCV), sedative effects (associated, for example, with CBD), antipsychotic effects (associated, for example, with CBD), anti-inflammatory effects (associated, for example, with THC, CBD, CBC, CBG and CBN), anti-convulsant effects (associated, for example, with CBD and CBN), anti-biotic effects (associated, for example, with CBC, CBN and CBG), and anti-fungal effects (associated, for example, with CBC and CBG), to name a few. Under certain circumstances, there may be synergistic enhancement of certain therapeutic effects in naturally occurring cannabis when certain amounts and/or ratios of phytocannabinoids are present in combination. For example, an overall enhancement in therapeutic effects of cannabis may be achieved when a certain balance is struck between THC and CBD. For example, sedative effects of CBD may serve to oppose certain undesirable effects of THC, such as anxiety, thereby enhancing the overall therapeutic effects. [0014] Other isolated compounds of cannabis may have certain therapeutic effects when inhaled as part of cannabis smoke, including terpenoids, flavonoids, and phytosterol. Terpenoids are derived from repeating units of isoprene (C 5 H 8 ), such as monoterpenoids (with C 10 skeletons), sesquiterpenoids (C 15 ), diterpenoids (C 20 ), and triterpenoids (C 30 ). The final structure of terpenoids can range from simple linear chains to complex molecules and may simply be a hydrocarbon, or may include alcohol, ether, aldehyde, ketone, or ester functional groups attached to a carbon skeleton. As used herein, the term terpenoids include terpenes. Over 200 naturally occurring terpenoids have been identified and isolated from cannabis. Such terpenoids include d-limonene, α-pinene, β-myrcene, linalool, pulegone, 1,8-cineole (eucalyptol), α-terpineol, terpineol-4-ol, p-cymene, borneol, Δ-3-carene, β-caryophyllene, caryophyllene oxide, nerolidol, and phytol. Some of the therapeutic effects of terpenoids include, without being bound to any theory, analgesic effects (associated, for example, with β-myrcene), sedative effects (associated, for example, with linalool, pulegone and α-terpineol), antidepressant effects (associated, for example, with linalool and d-limonene), anti-inflammatory effects (associated, for example, with β-myrcene, β-caryophyllene, 1,8-cineole, α-pinene and Δ-3-carene), anti-mutagenic effects (associated, for example, with β-myrcene and d-limonene), anti-biotic effects (associated, for example, with β-myrcene, 1,8-cineole, p-cymene, terpineol-4-ol, borneol and α-pinene), and Acetylcholinesterase (AChE) inhibitor effects (associated, for example, with pulegone, p-cymene, terpineol-4-ol and α-terpineol), to name a few. It will be appreciated that, under certain circumstances, there may be synergistic enhancement of certain therapeutic effects in naturally occurring cannabis when certain amounts and/or ratios of terpenoids are present in combination. [0015] In addition, under certain circumstances, when phytocannabinoids and terpenoids are simultaneously present in cannabis, there may also be cross-compound synergistic effects. That is, the therapeutic effects obtained from cannabis having certain combinations of some phytocannabinoids and some terpenoids is greater than the sum of therapeutic effects obtained from the phytocannabinoids or the terpenoids taken alone. For example, without being bound to any theory, analgesic effects of THC may be synergistically boosted by various terpenoids, anticonvulsant effects of CBD and THCV may be synergistically boosted by linalool, anti-inflammatory/antifungal effects of CBC and CBG may be synergistically boosted by caryophyllene oxide, anti-inflammatory/analgesic effects of CBC may be synergistically boosted by various terpenoids, sedative effects of CBN may be synergistically boosted by β-myrcene and nerolidol, to name just few examples of synergistic effects when phytocannabinoids and terpenoids are inhaled together as part of cannabis smoke. [0016] Naturally occurring therapeutic compounds in cannabis, including phytocannabinoids and terpenoids, are synthesized in secretory cells inside glandular trichomes of cannabis. In addition, different strains of cannabis produce and can be bred to produce varying amounts of certain compounds. For example, common “street” cannabis may have been bred such that relatively high amounts of THC are present to maximize the “high” of the person using the cannabis for recreational purposes. The same strain of “street” cannabis, however, may not have been bred to maximize, and therefore contain less than desired amounts of terpenoids or phytocannabinoids other than THC. As a result, while the effect of such cannabis strain as a euphoriant may be relatively high, their therapeutic effects may be relatively low. Therefore, to improve the therapeutic effects and to target certain therapeutic effects from cannabis, attempts to cultivate different strains of cannabis having particular combinations and amounts of specific phytocannabinoids and terpenoids have been made. However, such effort has been time consuming and not necessarily aimed at mass cultivation to serve the general public. [0017] While some terpenoids naturally occur in cannabis, terpenoids also naturally occur in plants other than cannabis. As with cannabis, terpenoids in some plants give rise to the distinctive odor of the plants. For example, d-limonene occurs naturally in citrus plants, and is the predominant compound that gives rise to the familiar scent of citrus. Similarly, α-pinene occurs naturally in coniferous plants and is the predominant compound that gives rise to the familiar scent of pine. Thus, some terpenoids, such as d-limonene and α-pinene, occur relatively abundantly. [0018] It has been found that the therapeutic effects of smoking herbs may be tailored by varying the terpenoid composition of the smoking herbs. In some embodiments the smoking herb may be cannabis and the therapeutic effects may include synergistic effects between the phytocannabinoids that are naturally present in a particular strain of cannabis and terpenoids that may be isolated from plants other than the particular strain of cannabis or other than cannabis in general. The terpenoids may be added to a preparation made from the particular strain of cannabis and may provide a terpenoid concentration that is just as high, if not higher, than terpenoid levels that are naturally occurring in, for example, other cannabis strains. Thus, in some embodiments, the terpenoid added to the smoking herb preparation may be at a higher concentration than that naturally found in the smoking herb or the terpenoid may not be naturally produced by the smoking herb plant at all. [0019] It will be appreciated that adding desired types and amounts of terpenoids from plants other than the particular strain cannabis can offer several advantages. For example, terpenoids from other plants can be economically favorable compared to, for example, breeding particular strains of cannabis having similar types and amounts of terpenoids. In addition, the desired types and amounts can be targeted more specifically to enhance or magnify known therapeutic effects, or even create new therapeutic effects that may not be possible using natural or engineered strains of cannabis alone. [0020] Reference will now be made to the drawings, in which like numerals refer to like parts throughout. [0021] FIG. 1 is a flow chart illustrating a method 10 of preparing an herbal smoking blend, according to some embodiments. The method of preparing an herbal smoking blend comprises providing 20 a smoking herb preparation. The method additionally includes providing 30 a terpenoid solution comprising a terpenoid. The method further includes adding 40 the terpenoid solution to the smoking herb preparation. [0022] In some embodiments, providing 20 the smoking herb preparation includes providing a smoking herb including smoking cannabis, including any species, subspecies, strain or variety of cannabis. The herb preparation can include any part of the plant of the cannabis, including the leaf, the root, the stem, the flower, or any other part of the plant that occurs naturally. In some embodiments, the smoking herb includes cannabis plants cultivated for fiber and seed production, sometimes described as low-intoxicant, non-drug, or fiber types. In some other embodiments, the smoking herb includes cannabis plants cultivated for drug production, sometimes described as high-intoxicant or drug types. In some other embodiments, the smoking herb includes cannabis plants that are escaped, hybridized, or wild forms of either of the above types. [0023] In some embodiments, a preparation includes smoking herb that has been sufficiently dried so that it can be combusted under ordinary ambient conditions, such that the resulting smoke can be inhaled. In some embodiments, a preparation includes a smoking herb and a rolling paper that can be used to roll the smoking herb into a thin cylinder using a rolling paper, similar to a cigarette. [0024] In other embodiments, providing 20 the smoking herb preparation can include providing a smoking herb other than cannabis. Examples of other smoking herbs include amaranthus dubius, arctostaphylos uva - ursi, argemone mexicana, arnica, artemisia vulgaris, calea zacatechichi, canavalia maritima, cecropia mexicana, cestrum nocturnum, cynoglossum virginianum, cytisus scoparius, entada rheedii, eschscholzia californica, fittonia albivenis, hippobroma longiflora, humulus japonica, humulus lupulus, lactuca virosa, laggera alata, leonotis leonurus, leonurus cardiaca, leonurus sibiricus, lobelia cardinalis, lobelia inflata, lobelia siphilitica, nepeta cataria, nicotiana (i.e., tobacco), nymphaea alba, opium poppy, passiflora incarnate, pedicularis densiflora, pedicularis groenlandica, salvia divinorum, salvia dorrii, salvia, scutellaria galericulata, scutellaria lateriflora, scutellaria nana, scutellaria, sida acuta, sida rhombifolia, silene capensis, syzygium aromaticum, tagetes lucida, tarchonanthus camphoratus, turnera diffusa, verbascum, and zornia latifolia, to name a few. [0025] In some embodiments, providing 20 the smoking herb preparation comprises providing a smoking herb comprising at least one phytocannabinoid, such as a phytocannabinoid selected from the group consisting of delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), cannabichromene (CBC), cannabigerol (CBG), tetrahydrocannabivarin (THCV), cannabidivarin (SBDV) and cannabinol (CBN). [0026] In some embodiments, providing 20 the smoking herb preparation comprises providing a smoking herb other than cannabis. In some embodiments, for example where a synergistic effect between a phytocannabinoid and terpenoids is desired, the smoking herb other than cannabis may comprise at least one added phytocannabinoid, such as a phytocannabinoid selected from the group consisting of delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), cannabichromene (CBC), cannabigerol (CBG), tetrahdrocannabivarin (THCV), cannabidivarin (SBDV) and cannabinol (CBN). [0027] Still referring to FIG. 1 the illustrated method of method 10 of preparing an herbal smoking blend additionally includes providing 30 a terpenoid solution comprising a terpenoid. As used herein, a terpenoid solution refers to a mixture comprising a terpenoid and a solvent, where at least a portion of the terpenoid is incorporated in the mixture to form the terpenoid solution. The terpenoid can be miscible, immiscible, or partially miscible in the solvent. In embodiments where the terpenoid is at least partially immiscible, the resulting mixture is sometimes referred to as an emulsion. [0028] In some embodiments, providing 30 the terpenoid solution includes providing a solution including a terpenoid selected from the group consisting of d-limonene, α-pinene, β-myrcene, linalool, pulegone, 1,8-cineole (eucalyptol), α-terpineol, terpineol-4-ol, p-cymene, borneol, Δ-3-carene, β-caryophyllene, caryophyllene oxide, nerolidol, phytol, Eugenol, Sabinene, Linalyl Acetate, Camphor, Chamazulene, beta-Farnesene, alpha-Humulene, Benzyl Benzoate, Benzyl Acetate, Geraniol, Geranyl Acetate, gamma-Terpinene, beta-Pinene, and combinations thereof. [0029] In some embodiments, providing 30 the terpenoid solution comprises providing a terpenoid and a solvent, and mixing the terpenoid and the solvent. The solvent can include any liquid, e.g., a volatile liquid, which can incorporate a desired amount of the terpenoid in the terpenoid solution. As used herein, a liquid that incorporates the terpenoid includes a liquid that can hold the terpenoid in either dissolved form or undissolved form (e.g., suspended in the form of an emulsion). In some embodiments, a terpenoid solution having a terpenoid incorporated therein can be a solution having at least 0.1% terpenoid by volume at room temperature and atmospheric pressure. [0030] In some embodiments, the solvent comprises an alcohol, e.g., ethanol, and water. In some embodiments, the terpenoid solution comprises about 1% to about 5% by volume of the terpenoid, about 40% to about 90% by volume of ethanol and about 10% to about 55% by volume of water. In some embodiments, the terpenoid solution comprises about 2% to about 4% by volume of the terpenoid, about 66% to about 80% by volume of ethanol and about 20% to about 30% by volume of water. Advantageously, such a solution can allow the terpenoid to be evenly distributed or suspended in the solvent, thereby facilitating the formation of a homogenous solution that allows a desire quantity of terpenoid to be added to a smoking herb preparation. [0031] Still referring to FIG. 1 , in some embodiments, the terpenoid in the terpenoid solution can be in a substantially purified form including a targeted terpenoid selected from the group consisting of d-limonene, α-pinene, β-myrcene, linalool, pulegone, 1,8-cineole (eucalyptol), α-terpineol, terpineol-4-ol, p-cymene, borneol, Δ-3-carene, β-caryophyllene, caryophyllene oxide, nerolidol, phytol, and combinations thereof. As used herein, a substantially purified terpenoid refers to the terpenoid being free of impurities other than the targeted terpenoids, with a volume percent of the impurities not exceeding about 5%, about 1%, or about 0.1%. For example, if a substantially pure terpenoid includes a first terpenoid (e.g., d-limonene) and a second terpenoid (e.g. α-pinene) as targeted terpenoids, any other substance including other terpenoids (e.g., β-myrcene, linalool, etc.) would be considered impurities. [0032] As described above, terpenoids can naturally originate from cannabis or other plants. In some embodiments, the terpenoid in the terpenoid solution does not naturally occur in the herb or herbs forming the smoking herb preparation. In some embodiments where the smoking herb preparation includes cannabis, providing 30 the terpenoid solution includes providing a solution including a terpenoid that is derived from a plant other than cannabis in general. In some other embodiments where the smoking herb preparation includes cannabis, providing 30 the terpenoid solution includes providing a solution including a terpenoid that is derived from a plant other than the cannabis strain from which the smoking herb has been prepared. [0033] In some embodiments, the terpenoid in the terpenoid solution can be provided in the form of an essential oil. An essential oil, sometimes referred to as a volatile oil, an ethereal oil, or an athereola, refers to a concentrated liquid extracted from a plant that can contain, among other compounds, terpenoids. Compounds such as terpenoids included in essential oil often carry a distinctive scent, or essence (hence the name). [0034] In some embodiments, the essential oils can be prepared using one of several methods including, without limitation, distillation, expression and solvent extraction, among others. In distillation, raw plant material, which can include the flowers, leaves, wood, bark, roots, seeds, and/or peel, is put into a distillation apparatus over water. The water is then heated above the boiling point to generate steam therefrom, which passes through the plant material. As the stem passes through the plant material, the volatile compounds are vaporized. The vapors may flow through a coil, where they condense back to liquid, which is then collected in a receiving vessel. In expression, the raw plant material is expressed mechanically or cold-pressed. Expression can be a suitable method where the raw material is available in relatively large quantities at relatively lower cost, such as orange peels for producing citrus-fruit oils. In solvent extraction, a solvent such as hexane or supercritical carbon dioxide is used to extract the oils. Solvent extraction can be a suitable method where the raw material is available in relatively small quantities at relatively higher cost, such as flowers. Solvent extraction can also be a suitable method where the chemical components are too delicate and easily denatured by the high heat used in steam distillation. [0035] A non-exhaustive list of plant species from which essential oils can be extracted to provide a terpenoid in the method 10 of FIG. 1 include: Abies Alba, Abies Balsamea, Abies Sibirica, Achillea Millefolium, Achillea Millefolium Ligustica, Acorus Calamus, Agathophyllum Anisata, Agathophyllum Aromatica, Agathosma Betulina, Agathosma Crenulata, Allium Cepa, Allium Sativum, Aloysia Triphylla, Alpinia Galanga (L.) Sw., Alutinosum Druce, Ammi Visnaga, Amyris Balsamifera, Anethum Graveolens, Angelica Archangelica, Angelica Glauca, Aniba Rosaeodora Var. Amazonica, Anthemis Nobilis, Anthopogon Rhododendron D. Don, Apium Graveolens, Aquilaria Malaccensis, Artemisia Absinthium, Artemisia Afra, Artemisia Annua, Artemisia Dracunculus, Artemisia Pallens, Artemisia Vulgaris, Backhousia Citriodora, Boswellia Carteri, Boswellia Carterii, Boswellia Neglecta, Boswellia Serrata, Bulnesia Sarmienti, Callitris Intratropica, Cananga Odorata, Cananga Odorata Genuina, Cananga Odorata Macrophylla, Canarium Luzonicum, Carum Carvi, Cedrelopsis Grevei, Cedrus Atlantica, Cedrus Deodara, Chamaecyparis Callitropsis Nootkatensis, Chamaecyparis Lawsoniana, Chamaecyparis Obtusa Endl., Chamaemelum Nobile ( Anthemis Nobilis ), Cinnamomum Camphora, Cinnamomum Camphora L, Cinnamomum Cassia, Cinnamomum Glaucescens, Cinnamomum Polyandrum, Cinnamomum Zeylanicum, Cinnamosma Fragrans, Cistus Ladaniferus, Citrus Aurantifolia, Citrus Aurantium, Citrus Aurantium Var. Amara, Citrus Bergamia, Citrus Bergamia Risso, Citrus Clementine, Citrus Hystrix, Citrus Junos, Citrus Junos Siebold, Citrus Limonum, Citrus Paradisi, Citrus Reticulata, Citrus Sinensis, Citrus Tangerina, Coleonema Album, Commiphora Holtziana, Commiphora Myrrha, Copaifera Officinalis, Coriandrum Sativum, Cotinus Coggygria, Croton Eluteria, Cryptocarya Massoia, Cuminum Cyminum, Cupressus Rotundus, Cupressus Sempervirens, Curcuma Longa, Cymbopogon Citratus, Cymbopogon Flexuosus, Cymbopogon Flexuosus Stapf, Cymbopogon Martini Var. Martinii (Var. Motia ), Cymbopogon Nardus, Cymbopogon Winterianus Jewitt, Cymbopogon Winterianus Jowitt, Cympobogan Martini Type Sofia, Cyperus Scariosus, Daucus Carota, Elettaria Cardamomum Maton, Eremophila Mitchellii, Eriocephalus Africanus, Eriocephalus Punctulatus, Eucalyptus Citriodora, Eucalyptus Citriodora Hook., Eucalyptus Dives, Eucalyptus Globulus, Eucalyptus Polybractea, Eucalyptus Radiata, Eucalyptus Smithii, Eugenia Caryophyllata, Ferula Galbaniflua, Foeniculum Vulgare Mill Var Dulce, Foeniculum Vulgare Mill., Fokienia Hodginsil, Gaultheria Procumbens, Geranium Macrorrhizum, Helichrysum Gymnocephalum, Helichrysum Italicum, Helichrysum Stoechas, Hippophae Rhamnoides, Humulus Lupulus, Hydicum Spicatum, Hypericum Perforatum L, Hyssopus Officinalis, Illicium Verum, Juniperus Communis, Juniperus Communis L., Juniperus Oxycedrus, Juniperus Virginiana, Kaempferia Galanga L, Kunzea Ericoides, Lantana Camera, Laurus Nobilis, Lavandula Hybrida, Lavandula Latifolia, Lavandula Officinalis, Leptospermum Petersonii, Leptospermum Scoparium, Levisticum Officinalis, Lippia Citriodora, Lippia Javanica, Litsea Cubeba, Marjorana Hortensis, Matricaria Chamomilla, Matricaria Recutita, Matricaria Recutita, Melaleuca Alternifolia, Melaleuca Minor, Melaleuca Quinquenervia, Melaleuca Viridiflora, Melissa Officinalis, Mentha Arvensis, Mentha Citrata, Mentha Piperita, Mentha Pulegium, Mentha Spicata, Michelia Alba, Mix Of 4 Species, Monarda Fistulosa L., Murraya Koenigii, Myristica Fragrans, Myrocarpus Fastigiatus, Myroxylon Pereirae, Myrtus Communis, Myrtus Communis, Nardostachys Grandiflora, Nardostachys Jatamansi, Nepeta Cataria, Ocimum Basilicum, Ocimum Basilicum L., Ocimum Basillicum, Ocimum Sanctum, Ocotea Cymbarum, Oleum Abies Sibirica, Oleum Chamomille, Oleum Pinus Nigra, Oreganum Vulgare, Origanum Compactum Benth., Origanum Minutiflorum, Origanum Syriacum, Origanum Vulgare, Ormenis Mixta, Pandanus Odoratissimus, Pelargonium Graveolens, Pelargonium×Asperum, Perilla Frutescens Crispa, Petroselinum Crispum, Petroselinum Sativum, Picea Mariana, Pimenta Dioica ( Pimenta Officinalis ), Pimenta Officinalis, Pimenta Racemosa, Pimpinella Anisum, Pimpinella Anisum L., Pinus Pinaster, Pinus Pumilio, Pinus Sylvestris, Piper Cubeba, Piper Nigrum, Pistacia Lentiscus, Pogostemon Cablin, Prunus Amygdalus, Pseudotsuga Menziesii (Mirb.) Franco, Psiadia Altissima, Rhus Tarantana, Rosmarinus Officinalis, Ruta Graveolens, Salvia Lavandulifolia, Salvia Officinalis, Salvia Sclarea, Salvia Stenophylla, Santalum Album, Santalum Spicatum, Santolina Chamaecyparissus, Satureja Hortensis, Satureja Montana, Schinus Molle, Tagetes Bipinata L, Tagetes Minuta, Tanacetum Annuum Linnaeus, Tarchonanthus Camphoratus, Thuja Occidentalis, Thuja Orientalis, Thuja Plicata, Thujopsis Dolabrata, Thymbra Spicata, Thymus Capitatus, Thymus Mastichina, Thymus Satureioides, Thymus Serpillum, Thymus Vulgare, Thymus Vulgaris, Thymus Zygis, Trachyspermum Ammi, Tsuga Canadensi, Valeriana Officinalis, Vetivera Zizanioides, Vitex Agnus - Castus L, Vitis Vinifera, Xanthoxylum Armatum, Zanthoxylum Armatum Dc. (Rutaceae), Zingiber Cassumunar, Zingiber Officinale, and Zinziber Officinale, among others. [0036] In some embodiments, examples of the the essential oil mixture includes mixtures that comprise at least one essential oil extracted from the group of plants consisting of Salvia Sclarea, Pimenta Racemosa, Pistacia Lentiscus, Citrus Limonum or a combination thereof. In some embodiments, the essential oil mixture consists essentially of Salvia Sclarea and Pimenta Racemosa. In some of other embodiments, the essential oil mixture consists essentially of Salvia Sclarea and Pistacia Lentiscus. In yet other embodiments, the essential oil mixture consists essentially of Pistacia Lentiscus and Citrus Limonum. [0037] In some other embodiments, the essential oil mixture comprises first and second essential oils extracted from the group of plants consisting of Salvia Sclarea, Pimenta Racemosa, Pistacia Lentiscus, or Citrus Limonum, wherein a volume ratio between first and second essential oils is between about 0.01:1 and about 1:1. In some other embodiments, the volume ratio is between about 0.10:1 and about 1:1, or between about 0.50:1 and about 1:1, for instance about 1:1. [0038] Still referring to FIG. 1 , the illustrated method 10 of preparing an herbal smoking blend further includes adding 40 the terpenoid solution to the smoking herb preparation. The terpenoid solution can be added using a suitable method for incorporating at least a portion of the terpenoid in the terpenoid solution into the smoking herb preparation. [0039] In some embodiments, adding 40 the terpenoid solution comprises dropping the terpenoid solution on the smoking herb. As used herein, adding the terpenoid solution by dropping refers to delivering a volume of liquid using, for example, a dropper, to deliver the liquid. In some embodiments, the dropper may deliver the liquid in an amount of between about 5-100 drops per mL, depending on, among other things, the viscosity of the terpenoid solution and the type of dropper used. [0040] In other embodiments, adding 40 the terpenoid solution comprises spraying a mist (or droplets) of the terpenoid solution on the smoking herb. As used herein, adding the terpenoid solution by spraying refers to delivering fine drops of the terpenoid solution dispersed in a gas by using, for example, a spray nozzle or atomizer, to deliver the terpenoid solution. The spray characteristics, including the spray pattern, the spray capacity, and the spray drop size depend on, among other things, the viscosity of the terpenoid solution and the type of spray nozzle used. In yet other embodiments, adding the terpenoid solution comprises spraying using an aerosol spray which includes the terpenoid solution. [0041] In some embodiments, adding 40 the terpenoid solution comprises dipping, or at least partially immersing the smoking herb into the terpenoid solution. By way of an example, the smoking herb can be placed in a dip net or a similar device and lowered into a container containing the terpenoid solution. In some embodiments, a soaking time can be tailored to control the amount of terpenoid solution that is absorbed, impregnated, or incorporated into the smoking herb. In some embodiments, the soaking time is between about 1 second and about 1 day, or between about 10 seconds and about 1 hour, or between about 1 minute and about 10 minutes. The smoking herb can be subsequently dried in air, or by heating the smoking herb, for example at a temperature below a temperature at which the smoking herb ignites. [0042] In some other embodiments, the smoking herb preparation comprises a smoking herb and a rolling paper. In these embodiments, adding 40 the terpenoid solution comprises adding the terpenoid solution to the rolling paper, which can subsequently be used to roll the smoking herb. The terpenoid can be added to the rolling paper using a suitable method to impregnate the rolling paper with the terpenoid solution. For example, the rolling paper can be dipped in a bath of terpenoid solution. Other methods include dropping or spraying the terpenoid solution on the rolling paper. For example, in some embodiments, the terpenoid can be added to a pre-rolled cigarette containing smoking herbs. [0043] It will also be appreciated that the terpenoid solution can be added to the smoking herb by more than one method, for example, by two or more of the methods disclosed herein. For example, the terpenoid solution can be added to the smoking herb by dipping and drying the smoking herb preparation, and subsequently by providing drops of the terpenoid solution to the smoking herb or rolling paper for the smoking herb. In some embodiments, this can increase the concentrations of terpenoids (e.g., volatile terpenoids) in the preparation. In some other embodiments, different terpenoids solutions are added to the smoking herb preparation at different times. For example, a solution with relatively less volatile terpenoids may be added to the smoking herb concentration initially (e.g., hours before consumption, or from a manufacturer or supplier) and a solution with relatively more volatile terpenoids may be added to the smoking herb preparation immediately (e.g., minutes) before smoking. [0044] In some embodiments where the smoking herb preparation includes cannabis, the amount of terpenoid added to the smoking herb preparation exceeds the amount of cannabis terpenoid that was present in the smoking herb prior to adding the terpenoid solution to the smoking herb preparation. In some embodiments, the amount of terpenoid added to the smoking herb preparation exceeds the amount of cannabis terpenoid that was present in the smoking herb prior to adding the terpenoid solution to the smoking herb preparation, such that the overall amount of terpenoid increases by more than about 50%, by about 100%, or by about 1000%. [0045] In some embodiments, the amount of added terpenoid exceeds about 0.001% by weight of the smoking blend, about 0.01% by weight of the smoking blend, or about 0.05% by weight. [0046] In some embodiments, the method 10 of preparing an herbal smoking blend further comprises subjecting the smoking herb preparation to a drying process after adding the terpenoid solution. [0047] FIG. 2 is a schematic illustration of a smoking herb preparation system comprising according to some embodiments. The smoking herb preparation system comprises a smoking herb 80 and a terpenoid solution application kit 70 . [0048] In some embodiments, the terpenoid solution application kit 70 comprises a terpenoid solution 62 , a terpenoid solution container 74 for holding the terpenoid solution, and a terpenoid solution applicator 72 for administering a dose of the terpenoid solution to the smoking herb. [0049] Still referring to FIG. 2 , in some embodiments, the terpenoid solution 62 can be prepared by using a terpenoid solution preparation system 50 . The terpenoid preparation system includes a terpenoid measurement device 52 , a terpenoid mixture 54 comprising at least one terpenoid, a solvent measurement device 56 , a solvent 58 , and a terpenoid solution mixing container 60 . The terpenoid measurement device 52 can be any suitable container for measuring and mixing terpenoids to form the terpenoid mixture 54 , such as a beaker, a graduated cylinder, a measuring cup, and the like. In some embodiments, the terpenoid mixture 54 includes one or more terpenoids, such as terpenoids selected from the group consisting of d-limonene, α-pinene, β-myrcene, linalool, pulegone, 1,8-cineole (eucalyptol), α-terpineol, terpineol-4-ol, p-cymene, borneol, Δ-3-carene, β-caryophyllene, caryophyllene oxide, nerolidol, phytol, and combinations thereof. In some other embodiments, the terpenoid mixture 54 includes an essential oil mixture extracted from the group of plants consisting of Salvia Sclarea, Pimenta Racemosa, Pistacia Lentiscus, Citrus Limonum, and combinations thereof. The solvent measurement device 56 can be any suitable container for measuring and mixing different solvent components to form the solvent 58 , such as a beaker, a graduated cylinder, a measuring cup, and the like. The solvent 58 can include any liquid, e.g., a volatile liquid, which can incorporate a desired amount of the terpenoid in the terpenoid solution. In some embodiments, the solvent components include ethanol and water, in proportions described above. [0050] In some embodiments, the terpenoid solution 62 is formed by mixing the terpenoid mixture 54 and the solvent 58 in the terpenoid solution mixing container 60 . The terpenoid solution 62 includes the terpenoid mixture 54 incorporated into the solvent 58 . In some embodiments, at least a portion of the terpenoid mixture 54 is miscible in the solvent 58 and can be dissolved in the solvent 58 to form the terpenoid solution 62 . In other embodiments, at least a portion of the terpenoid mixture 54 is immiscible in the solvent 58 and can be suspended in the solvent 58 to form the terpenoid solution 62 . The terpenoid solution 62 can then be transferred into the terpenoid solution container 74 of the terpenoid solution application kit 70 . [0051] Still referring to FIG. 2 , the terpenoid solution application kit 70 comprises any suitable terpenoid solution applicator 72 for administering a dose of the terpenoid solution 62 to the smoking herb 80 . In some embodiments, the applicator comprises a dropper having a bulb member and a pipette member. The dropper can have any suitable design for forming suitable drops as discussed above for application on the smoking herb 80 . For example, the dropper member may have a bulb made of elastic material configured to fill the pipette member with the terpenoid solution 62 thorough a vacuum suction effect. In some embodiments, the dropper may have a threaded closure to enable long term storage of the terpenoid solution. In some embodiments, the pipette member can be graduated to guide a user to administer a predetermined dose of the terpenoid solution on the smoking herb 80 . In some other embodiments, the applicator 72 may deliver a stream of the terpenoid solution to the smoking herb 80 , rather than delivering drops. In some other embodiments, the dropper may be integrated into the container 74 itself, which may provide drops directly from an opening in the container 74 . For example, the container 74 may be dropper bottle and the dropper section may be the drop generating opening of the bottle. [0052] FIG. 3 is a schematic illustration of a smoking herb preparation system comprising a smoking herb according to some embodiments. The smoking herb preparation system comprises a smoking herb 80 and a terpenoid solution application kit 90 . The smoking herb preparation system of FIG. 3 is similar to the smoking herb preparation system of FIG. 2 except for the terpenoid solution application kit 90 . The terpenoid solution application kit 90 comprises a terpenoid solution 62 , a terpenoid solution container 94 for holding the terpenoid solution, and a terpenoid solution applicator 92 for administering a dose of the terpenoid solution to the smoking herb. The terpenoid solution container 94 can be, for example, a plastic spray bottle made of plastic, or other terpenoid solution reservoir in fluid communication with a nozzle for dispensing the terpenoid solution, such as an atomizer that dispenses the terpenoid solution as mist or spray. The terpenoid solution 62 can be mixed in the terpenoid solution container 94 and dispensed, for example through the terpenoid solution applicator 92 , which can be a trigger sprayer, mounted on the terpenoid solution container. In some embodiments, the trigger sprayer may have a threaded closure to enable long term storage of the terpenoid solution. In some embodiments, the trigger sprayer can be configured to administer a predetermined dose of the terpenoid solution on the smoking herb 80 . The trigger sprayer 92 can also be configured to determine other spray characteristics such as droplet volume, spray angle, etc. [0053] FIG. 4 is a schematic illustration of a smoking herb preparation system comprising a smoking herb according to some embodiments. The smoking herb preparation system comprises a smoking herb 80 and a terpenoid solution application kit 90 . While the smoking herb preparation system of FIG. 4 includes terpenoid solution application kit 90 is similar to FIG. 3 , a terpenoid solution application kit similar to the terpenoid solution application kit 70 of FIG. 4 , or any other similar application kits can be used. In addition, the smoking herb preparation system of FIG. 4 further includes a rolling sheet 100 . Unlike FIG. 2 or FIG. 3 , instead of incorporating the terpenoid solution directly into the smoking herb 80 , the smoking herb preparation system of FIG. 4 is configured such that the terpenoid solution can be incorporated into the rolling sheet 100 instead of, or in addition to, incorporating the terpenoid solution into the smoking herb 80 using the suitable terpenoid application kit 90 . In these embodiments, the resulting terpenoid rolling sheet 104 can be subsequently dried and used to roll the smoking herb 80 into a thin cylinder 110 having the smoking herb 80 rolled therein, in a similar manner to a rolled cigarette. In some embodiments, the rolling sheet 100 can be a paper made from wood pulp. In other embodiments, the rolling sheet 100 can be made from rice or other plant matter such as hemp. In some other embodiments, the rolling sheet can be a pre-formed wrapper (e.g., a cylindrical wrapper) for holding the smoking herb 80 . [0054] Although this invention has been described in terms of certain embodiments, other embodiments that are apparent to those of ordinary skill in the art, including embodiments that do not provide all of the features and advantages set forth herein, are also within the scope of this invention. Moreover, the various embodiments described above can be combined to provide further embodiments. In addition, certain features shown in the context of one embodiment can be incorporated into other embodiments as well. Accordingly, the scope of the present invention is defined only by reference to the appended claims.

The disclosed embodiments relate generally to herbal smoking blends and methods for preparing and using herbal smoking blends, and relate more particularly to herbal smoking blends having terpenoids added thereto. In one aspect, a method of preparing an herbal smoking blend comprises providing a smoking herb preparation. The method additionally comprises providing a terpenoid solution comprising a terpenoid. The terpenoid solution may be added to the smoking herb preparation to, for example, provide a smoking herb preparation that achieves a desired effect on a consumer of the preparation.

BACKGROUND OF THE INVENTION The present invention relates to a wheelchair. DESCRIPTION OF THE RELATED ART With conventional wheelchairs, there is a need of manually braking a wheelchair when a user goes away from the wheelchair. Therefore, in the case where a user goes away from a wheelchair failing to apply braking, there is a possibility that the wheelchair begins to move the moment the user puts a hand or hands on the wheelchair trying to move the user's body weight to the wheelchair again. Conventionally, the following wheelchair is known as solving such problem. The wheelchair comprises a metallic sheet stopper, which is cut to afford meshing with a spoke of a rear wheel. A detector is mounted below a central portion of a seat to actuate the stopper. When a user rises from the wheelchair, the seat having sunk due to weight ascends and the detector detects such ascent. Based on the detecting action, the cut in the stopper meshes with the spoke of the rear wheel and the rear wheel is made stationary to apply braking. Also, when the user sits and the user's body weight is applied on the seat to lower the seat, a signal from the detector causes the stopper to separate from the spoke of the rear wheel to release braking. With the wheelchair with an automatic brake according to the prior art, however, when a user rises from the wheelchair and the stopper is not positioned in opposition to a spoke, rear wheels will rotate until a next spoke comes to a position of the stopper. That is, “idle time” is generated in the meantime and the wheelchair freely runs to become unstable. Also, since the stopper meshes with a spoke of the rear wheels to apply braking, large forces concentrate on a spoke made of a thin metallic bar. Therefore, there is involved a problem that spokes are liable to break in repeated use. Also, steps are mounted on all wheelchairs and get in the way forwardly of a course to obstruct beginning of walking when a user gets off a wheelchair to begin walking, so that it is necessary to remove steps to positions not to obstruct a user's course before the user begins walking. With conventional wheelchairs, a user must bend forward exceedingly to spring up the steps with hands, or with feet. In addition, although not related to the gist of the invention, for example, JP-A-5-103815 and JP-A-7-232646 are enumerated to disclose a brake device for wheelchairs. SUMMARY OF THE INVENTION It is an object of the invention to provide a wheelchair with an automatic brake, in which braking is applied the moment a user rises, and which is excellent in safety. To achieve the above object, the present invention provides a wheelchair. The wheelchair includes a seat, a pair of rear wheels fixed to axle shafts arranged below the seat and arranged outside both sides of the seat, a grasping portion arranged rearwardly of the seat to be grasped and operated by a helper, at least one front wheel arranged forwardly of the axle shafts. Actuation plates provided in juxtaposition with the seat to descend when a user sits on the seat to lower the seat with the weight and to ascend when the user rises from the seat to permit the seat to return with removal of the weight. Brake means mounted on the axle shafts to brake the axle shafts and energized constantly in a non-braking direction. Levers coupled directly or indirectly to the brake means to move according to descending motions of the actuation plates to act on the brake means to put the brake means in a non-braking state and to move according to ascending motions of the actuation plates to act on the brake means to put the brake means in a braking state. The user sits on the seat, the user's body weight causes the seat to descend and the actuation plates to move downward and positional movements of the actuation plates cause the levers to move to release braking on the axle shafts by the brake means, and when the user having sat on the seat rises, the actuation plates having been pushed down by the user's body weight move upward and positional movements of the actuation plates cause the levers to move to permit the brake means to brake the axle shafts. A further aspect of the present invention is a wheelchair including a seat, a pair of rear wheels fixed to axle shafts arranged below the seat and arranged outside both sides of the seat, a grasping portion arranged rearwardly of the seat to be grasped and operated by a helper, at least one front wheel arranged forwardly of the axle shafts, legs extended forward and downward from the seat, steps mounted on the legs. Actuation plates provided in juxtaposition with the seat to descend when a user sits on the seat to lower the seat with the weight and to ascend when the user rises from the seat to permit the seat to return with removal of the weight. Brake means mounted on the axle shafts to brake the axle shafts and energized constantly in a non-braking direction. Levers coupled directly or indirectly to the brake means to move according to descending motions of the actuation plates to act on the brake means to put the brake means in a non-braking state and to move according to ascending motions of the actuation plates to act on the brake means to put the brake means in a braking state. The legs being turnably supported horizontally in base positions and biased in one directions of turning by second bias means. Position holding means for holding the legs in positions. The steps are used, against the bias of the second bias means and released from a holding state as the actuation plates move upward, and wherein when the user sits on the seat, the user's body weight causes the seat to descend and the actuation plates to move downward and positional movements of the actuation plates cause the levers to move to release braking on the axle shafts by the brake means, and when the user having sat on the seat rises, the actuation plates having been pushed down by the user's body weight move upward and positional movements of the actuation plates cause the levers to move to permit the brake means to brake the axle shafts and the holding state by the position holding means is released to cause the bias of the second bias means to evacuate the legs. A further aspect of the present invention is a wheelchair including a seat, a pair of rear wheels fixed to axle shafts arranged below the seat and arranged outside both sides of the seat, a grasping portion arranged rearwardly of the seat to be grasped and operated by a helper, at least one front wheel arranged forwardly of the axle shafts, legs extended forward and downward from the seat, steps mounted on the legs. Actuation plates provided in juxtaposition with the seat to descend when a user sits on the seat to lower the seat with the weight and to ascend when the user rises from the seat to permit the seat to return with removal of the weight. Brake means mounted on the axle shafts to brake the axle shafts and energized constantly in a non-braking direction. Levers coupled directly or indirectly to the brake means to move according to descending motions of the actuation plates to act on the brake means to put the brake means in a non-braking state and to move according to ascending motions of the actuation plates to act on the brake means to put the brake means in a braking state, the steps being turnably supported in base positions and biased in one directions of turning by third bias means. Position holding means for holding the steps in positions. The steps are used, against the bias of the third bias means and released from a holding state as the actuation plates move upward, and wherein when the user sits on the seat, the user's body weight causes the seat to descend and the actuation plates to move downward against the first bias means and positional movements of the actuation plates cause the levers to move to release braking on the axle shafts by the brake means, and when the user having sat on the seat rises, the actuation plates having been pushed down by the user's body weight move upward by the first bias means and positional movements of the actuation plates cause the levers to move to permit the brake means to brake the axle shafts and the holding state by the position holding means is released to cause the bias of the third bias means to evacuate the steps. Other aspects and advantages of the present invention will become apparent from the following description, taken in conjunction with the accompanying drawings, illustrating by way of example the principles of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side view showing an embodiment of a wheelchair with an automatic brake according to the invention when a left side of a wheelchair body in a state, in which a user sits on a seat, is viewed from inside; FIG. 2 is a perspective view showing an essential part of FIG. 1 as viewed from obliquely downward and inside of a rear side; FIG. 3 is a side view showing an embodiment of a wheelchair with an automatic brake according to the invention when a left side of a wheelchair body in a state, in which a user goes away from a seat, is viewed from inside; FIG. 4 is a perspective view showing an essential part of FIG. 3 as viewed from obliquely downward and inside of a rear side; FIG. 5 is a perspective view showing an essential part of FIG. 3 as viewed from forwardly downward and inside; FIGS. 6A and 6B show a control device of an automatic step opening mechanism housed in a horizontal strut of a step holding leg, or in a lower portion of the step holding leg, FIG. 6A being a cross sectional view showing a state, in which a stopper projects, and FIG. 6B being a cross sectional view showing a state, in which the stopper withdraws; FIG. 7 is a side view showing a further embodiment of a wheelchair with an automatic brake according to the invention when a left side of a wheelchair body in a state, in which a user sits on a seat, is viewed from inside; FIG. 8 is a side view showing a still further embodiment of a wheelchair with an automatic brake according to the invention when a left side of a wheelchair body in a state, in which a user goes away from a seat, is viewed from inside; FIGS. 9A and 9B show a still further embodiment of a wheelchair with an automatic brake according to the invention, FIG. 9A being a perspective view showing a left side of an essential part of a wheelchair body in a state, in which a user sits on a seat, as viewed from obliquely rearward and inside, and FIG. 9B being a schematic side view showing only related portions for the purpose of explaining the function of the embodiment; and FIGS. 10A and 10B show a state, in which a user goes away from a seat, FIG. 10A being a perspective view similar to FIG. 9A , and FIG. 10B being a schematic side view similar to FIG. 9 B. DESCRIPTION OF THE PREFERRED EMBODIMENTS First Embodiment A first embodiment of the invention will be described with reference to FIGS. 1 to 10 . The embodiment comprises the following four mechanisms. The first one is a brake mechanism used in the case where a user rises from a wheelchair and in the case where a user rides on the wheelchair, the second one is a brake actuating mechanism for a helper, the third one is a brake release mechanism during conveying an empty wheelchair, and the fourth one is an automatic opening mechanism for steps. First, an explanation will be given to a constitution of the brake mechanism. As shown in FIG. 1 , a frame of the wheelchair comprises main rear columns 1 A composed of a pair of left and right pipes extending vertically, a pair of left and right, main lower columns 1 B extending forward from lower ends of the main rear columns 1 A, a pair of left and right, first main front columns 1 C extending upward from forward ends of the main lower columns 1 B, a pair of left and right, main upper and horizontal columns 1 D fixed to intermediate portions of the main rear columns 1 A and extending forward therefrom, a pair of left and right, second main front columns 1 E extending downward from forward ends of the main upper and horizontal columns 1 D, a pair of left and right, first mount pipes 1 F, both ends of which are interposed between the main rear columns 1 A and the second main front columns 1 E and fixed to upper ends of front and rear, cross braces 40 , and a pair of left and right, second mount pipes 1 G, which are arranged below and in parallel to the first mount pipes 1 F, and one ends of which are fixed to the main rear columns 1 A and the other ends of which are fixed to the first and second main front columns 1 C, 1 E. The front and rear, cross braces 40 are fixed at upper ends thereof to front or rear portions of the first mount pipes 1 F and at lower ends thereof to front or rear portions of the main lower columns 1 B on an opposite side, and intersect each other at central portions thereof to be turnably fixed to each other at the intersections, thus enabling folding of the wheelchair. Upper ends of the main rear columns 1 A make rearwardly bent handles 2 held by a helper. A pair of left and right, rear wheels 3 are rotatably mounted to the main rear columns 1 A, and a pair of left and right, front wheels 4 are rotatably mounted to lower portions of the first main front columns 1 C. Mounted to the pair of left and right, first mount pipes 1 F is a seat 5 having elasticity and capable of moving downward with an underside thereof bending. In addition, depiction of spokes of the rear wheels 3 and the front wheels 4 is omitted in FIGS. 1 and 3 . As shown in FIGS. 1 and 2 , mounted on left and right axle shafts 10 of the rear wheels 3 are axle-shaft clamping type brake means 11 . Fixed to brake actuating portions of the brake means 11 are ends of brake levers 12 . Used as the brake means 11 are, for example, “SERVO BRAKES”, “BAND BRAKES” (both being JIS. NO. 6415) manufactured by Karasawa Seisakusho Kabushiki-kaisha, which are used for axle shaft brakes for bicycles, and so on. Fixed to the pair of left and right, second mount pipes 1 G are upper ends of first mount plates 13 each extending below the brake levers 12 and toward the main rear columns 1 A. Lower end of the first mount plates 13 , respectively, are fixed to the pair of left and right, main lower columns 1 B. Fixed to upper portions of the pair of left and right, first mount plates 13 , respectively, are second mount plates 14 , to which one ends of actuation plates 16 are mounted through hinges 15 to be able to swing vertically. Here, the actuation plates 16 are arranged in a manner to contact with an underside of a portion amounting to about ¼ of a rear portion of the seat 5 . Upper ends of dampers 20 composed of a gas damper, an air damper, an oil damper, or the like to serve as first bias means are pivotally mounted to the actuation plates 16 , and lower ends of the dampers 20 are pivotally mounted to support plates 21 fixed to lower portions of the first mount plates 13 . Extension forces of the dampers 20 push up the actuation plates 16 to bring the same into contact with the underside of the seat 5 . Lower ends of lengths of wire 22 for actuation of braking are fixed to the brake levers 12 , and upper ends of the lengths of wire 22 are mounted to the actuation plates 16 through small windows 13 a provided on the first mount plates 13 . As shown in FIGS. 1 and 2 , the lengths of wire 22 loosen in a state, in which the dampers 20 are not extended and the actuation plates 16 swing downward, that is, a user of the wheelchair sits on the seat 5 , and the brake levers 12 swing downward owing to restoring forces of bias means housed in the brake means 11 , so that braking of the axle shafts 10 is released. As shown in FIGS. 3 and 4 , in a state, in which the dampers 20 are extended and the actuation plates 16 swing upward, that is, a user of the wheelchair rises from the wheelchair, the lengths of wire 22 are pulled upward and the brake levers 12 are pulled upward, so that the axle shafts 10 are braked against restoring forces of bias means housed in the brake means 11 . Subsequently, an explanation will be given to an action of the brake mechanism. FIGS. 1 and 2 show a state, in which a user of the wheelchair sits on the seat 5 and body weight is applied on a corresponding portion of the seat 5 to the actuation plates 16 , so that the seat 5 is pushed down at the corresponding portion to push down the actuation plates 16 against extension forces of the dampers 20 . Also, the actuation plates 16 are pushed down whereby the lengths of wire 22 with upper ends thereof fixed to the actuation plates 16 loosen and the upward pulling forces of the lengths of wire 22 acting on the brake levers 12 disappear, so that biasing forces of bias means housed in the brake means 11 are restored to swing the brake levers 12 downward and braking of the axle shafts 10 is released (put in a non-braked state). In contrast, when a user rises from a state, in which the user sits on the seat 5 , that is, a state shown in FIGS. 1 and 2 , weight produced by body weight applied on the seat 5 disappears, so that pressure on the dampers 20 is released and so the dampers 20 are extended to push up the actuation plates 16 as shown in FIGS. 3 and 4 . When the lengths of wire 22 with upper ends thereof fixed to the actuation plates 16 are thereby pulled upward, the brake levers 12 , to which lower ends of lengths of wire 22 are joined, are pulled up whereby restoring forces of the bias means housed in the brake means 11 to release braking are applied on the brake levers 12 and so the axle shafts 10 are braked (put in a braked state). In this manner, since braking is applied the moment a user rises, and there is no play, the wheelchair remains stable and safe. Also, since the axle-shaft clamping type brake means 11 , of which durability and safety are warranted on the basis of results of use in many years, are adopted to clamp and brake the axle shafts 10 , they are excellent in durability and safety. Incidentally, there is in many cases the possibility that when a user by one self rides on a wheelchair, the user first puts a hand or hands on the seat 5 trying to support a body, and so risk of fall is highly possible since the user's posture is not stable in the case where forces produced when the user puts a hand or hands on the seat 5 release braking to permit the wheelchair to move. Accordingly, in order to avoid such risk, the actuation plates 16 in the first embodiment are arranged in a manner to contact with an underside of a portion amounting to about ¼ of a rear portion of the seat 5 . More specifically, body weight of the user is applied on that portion amounting to about ¼ of the rear portion of the seat 5 , which is disposed at the back of the seat to be adequately distant from that portion, on which the user possibly puts a hand or hands, and braking is released after the user's posture becomes adequately stable, which warrants safety. In addition, while the first embodiment uses the dampers 20 as tension applying means for pushing up the actuation plates 16 , springs or the like may be used to bias the actuation plates 16 . Also, while the actuation plates 16 are pivotally on the first mount plates 13 , they may be provided on the first mount plates 13 to be vertically movable. Subsequently, an explanation will be given to the brake actuating mechanism. As shown in FIGS. 1 and 3 , handle levers 30 , respectively, are mounted on the pair of left and right handles 2 . Lengths of brake wire 31 are coupled at upper ends thereof to the handle levers 30 , and at lower ends thereof to the brake levers 12 as shown in FIGS. 1 to 5 . Hereupon, in the case where there is a need of braking when a user rides on the wheelchair and a helper pushes the wheelchair, the lengths of brake wire 31 are pulled upward upon grasping of the handle levers 30 and so the brake levers 12 coupled to the lengths of brake wire 31 are pulled up to apply braking. In addition, although not shown, it goes without saying that when there is a need of braking by a user who sits on the wheelchair, a conventional manual brake mounted on the wheelchair is used as it is. Subsequently, an explanation will be given to a constitution of the brake release mechanism when an empty wheelchair is to be conveyed. As described, when a user goes away from the wheelchair to make the same empty, braking is automatically applied to come to a state shown in FIG. 4 . Accordingly, there is a need of releasing braking when an empty wheelchair is to be conveyed. As shown in FIG. 5 , both ends of a release lever 41 are pivotally mounted to a portion substantially intermediate between an intersection 40 a of the rear cross braces 40 among the two pairs of front and rear cross braces 40 , which connect between the first mount pipes 1 F and the main lower columns 1 B on a side opposed to the first mount pipes 1 F, and upper ends of the cross braces 40 and to the main rear column 1 A disposed on the same side as that of the portion. An upper end of a length of release wire 42 is fixed to the release lever 41 and a lower end of the length of release wire 42 is fixed to the brake lever 12 from below through wire through of the support plate 21 and holes 13 b formed on bent portion the first mount plate 13 . A location 12 a , in which the length of release wire 42 is fixed to the brake lever 12 , is positioned much distant from a pivot of the brake lever 12 relative to a location 12 b , in which the lengths of brake actuating wire 22 are fixed to the brake lever 12 , such that a larger force than brake actuating forces with the wheelchair being empty acts on the brake lever 12 in a release direction as shown in FIG. 5 . Subsequently, an explanation will be given to an action of the brake release mechanism when an empty wheelchair is to be conveyed. Generally, wheelchairs can be folded by causing a pair of left and right, rear wheels 3 and a pair of left and right, front wheels 4 to approach in an overlapping manner. More specifically, by lifting a longitudinal center line of the seat 5 in a manner to make the center line upwardly convex when an empty wheelchair is to be conveyed, it is possible to cause the pair of left and right, first mount pipes 1 F, to which both left and right, outer edges of the seat 5 are fixed, to approach each other. Hereupon, when the pair of left and right, first mount pipes 1 F are caused to approach each other in a manner described above, the pair of left and right, second mount pipes 1 G, the pair of left and right, main lower columns 1 B, the pair of left and right, rear wheels 3 , and the pair of left and right, front wheels 4 are caused interlocking therewith to approach each other, and further the front cross braces 40 and the rear cross braces 40 are caused interlocking therewith to approach each other. Therefore, a fixed end of the release lever 41 on a side of the cross brace 40 , the release lever being arranged between the cross brace 40 and the main rear column 1 A, is lifted upward about an axis of turning on a fixed end of the release lever on a side of the main rear column 1 A. Then, the length of release wire 42 is simultaneously pulled upward, and a force, which the length of release wire 42 applies on the brake lever 12 from below, exceeds the brake actuating forces in association with points of action on the brake lever 12 and directions of forces, so that braking is released to enable conveying an empty wheelchair. Finally, an explanation will be given to a constitution of the first embodiment of the automatic opening mechanism for legs, which hold steps, with reference to FIGS. 1 , 3 , and 6 . Struts 51 fixed to upper portions of legs 50 are pivotally fitted and inserted into upper ends of the first main front columns 1 C. Torsion springs 52 mounted on the first main front columns 1 C bias the struts 51 to open the same outside as viewed from a front of the wheelchair. The struts 51 may be reversely biased so that the left and right legs 50 are closed inside to be folded to overlap each other. Formed on lower ends of the legs 50 are supports 50 A to extend substantially horizontally and forward. Provided on intermediate portions of the legs 50 are horizontal struts 50 B to extend toward the first main front columns 1 C. Ends of the horizontal struts 50 B are pivotally mounted on the first main front columns 1 C. Strut supports 60 are fixed below the horizontal struts 50 B. The strut supports 60 house therein structures as shown in FIG. 6 . The strut supports 60 comprise top-opened casings 61 , in which top-opened spring supports 62 are fixed. Bushes 63 are fixed in upper areas of the spring supports 62 . Stoppers 64 arranged through the spring supports 62 are slidably inserted into the bushes 63 . Springs 65 are arranged between the spring supports 62 and flanges 64 a of the stoppers 64 to bias the stoppers 64 so that tip ends of the stoppers 64 project from the bushes 63 . Fixed to inner ends of the stoppers 64 are wire fixing members 66 . Fixed to the wire fixing members 66 are lower ends of lengths of wire 68 for opening of steps. The lengths of wire 68 are surrounded by wire guides 67 . Upper ends of the lengths of wire 68 are fixed through the damper support plates 21 to the actuation plates 16 . Recesses 50 a are provided in those positions on undersides of the horizontal struts 50 B, which correspond to the stoppers 64 . Subsequently, an explanation will be given to an action of the automatic opening mechanism for legs. As described with respect to an action of the automatic brake mechanism, the brake levers 12 swing downward to release braking in a state, in which a user sits on the seat 5 of the wheelchair as shown in FIGS. 1 and 2 . At the same time when the lengths of wire 22 for actuation of braking, connected to the brake levers 12 loosen, the lengths of wire 68 for opening of steps also loosen, so that the springs 65 in the casings 61 for the stopper bias and project the stoppers 64 , as shown in FIG. 6A , to engage the same with the recesses 50 a in the horizontal struts 50 B so that the legs 50 are not opened by the bias of the torsion springs 52 when the legs 50 are set in positions for use. In contrast, when a user rises from a state of sitting on the seat 5 as shown in FIGS. 1 and 2 , extension forces of the dampers 20 pull the lengths of wire 22 upward and the brake levers 12 coupled to the lengths of wire 22 are pulled up to apply braking, as described with respect to the action of the brake mechanism. Since the lengths of wire 68 coupled at upper ends thereof to the actuation plates 16 are also pulled in the same as the lengths of wire 22 , the stoppers 64 of the strut supports 60 withdraw, as shown in FIG. 6B , to be released from engagement with the recesses 50 a in the horizontal struts 50 B. Thereby, control on the bias of the torsion springs 52 is released, so that the bias of the torsion springs 52 opens steps 53 left and right together with the pair of left and right legs 50 and so no obstacle is constituted when a user of the wheelchair begins walking. Setting of the legs 50 to positions for use is effected such that when the legs 50 are manually turned to positions for use after a user goes away from the wheelchair, the stoppers 64 are projected to engage with the recesses 50 a to thereby fix the legs in a forwardly directed, neutral state, which corresponds to positions for use when a user rides on the wheelchair. Conventionally, the steps 53 must be removed to positions constituting no hindrance to walking with hands or feet before a user rises and begins walking. In the first embodiment, accidents are prevented, in which a paralytic user or a user who cannot bend forward to reach hands to the steps 53 stumbles and falls, since the steps 53 are moved to positions constituting no hindrance to beginning of walking before a user rises and begins walking. Second Embodiment FIGS. 7 and 8 show a second embodiment of the automatic opening mechanism for steps. In addition, in the second embodiment, members being the same as, or corresponding to those in FIGS. 1 to 6 are denoted by the same reference numerals, and an explanation therefor is omitted. In the present embodiment, legs 50 are fixed to first main front columns 1 C. Tip ends of lower portions of the legs 50 constitute supports 50 A, and steps 53 are rotatably born by the supports 50 A. The steps 53 turn to assume two positions including a horizontal position and a vertical position. Springs 70 are mounted on the supports 50 A to bias the steps 53 to vertical position at all times. Also, formed in base positions of the supports 50 A are stoppers 64 having the same function as that of the stoppers 64 in the control device for the leg opening mechanism in the first embodiment. Provided on the steps 53 are recesses 53 a , with which the stoppers 64 engage. Like the first embodiment, lengths of wire 68 for opening of steps are fixed at lower ends thereof to wire fixing members 66 in the casings 61 for the stoppers and at upper ends thereof through support plates 21 to actuation plates 16 . Accordingly, with the embodiment, the stoppers 64 at lower portions of the step holding legs project to engage with the recesses 53 a in the same manner as the case in FIG. 1 , in a state, in which a user sits on a seat 5 of the wheelchair as shown in FIG. 7 . Therefore, the steps 53 are held in positions (horizontal) for use notwithstanding the bias of springs 70 . Also, when a user rises from a state shown in FIG. 7 , the stoppers 64 withdraw and separate from the recesses 53 a on the steps 53 , and so the steps 53 are put in a vertical position from a horizontal position as shown in FIG. 8 by the bias of the springs 70 not to constitute an obstacle when a user of the wheelchair begins walking. Such arrangement produces the same effect as that in the first embodiment. Third Embodiment FIGS. 9 and 10 show a third embodiment of the automatic opening mechanism for steps. Fixed to a first mount plate 13 is a crank support arm 80 extending toward an actuation plate 16 , and swingably born by the crank support arm 80 is a bent portion of a L-shaped crank 81 having a short arm 81 a and a long arm 81 b . An end of the short arm 81 a of the crank 81 is pivotally coupled to the actuation plate 16 , and an upper end of a length of wire 82 for opening of a step is fixed to an end of the long arm 81 b of the crank 81 . The length of wire 82 for opening of a step extends through a second mount pipe 1 G and passes guide rollers 83 , 84 , 85 , which are rotatably provided on the second mount pipe 1 G and a leg 50 , and a lower end of the length of wire is fixed to a step actuation arm 54 , which is united with the step 53 , from below. Subsequently, an explanation will be given to an action. When a user sits on a wheelchair, the user's body weight lowers a seat 5 as shown in FIG. 9 , and the actuation plate 16 is correspondingly pushed down. Thereby, the crank 81 is caused to swing about a support shaft of the crank support arm 80 in a clockwise direction as viewed in FIG. 9A , so that the end of the short arm 81 a lowers and the end of the long arm 81 b rises. When the end of the long arm 81 b rises, the length of wire 82 for opening of a step, an upper end of which is coupled to the end of the long arm, is pulled up to go round the step actuation arm 54 from beneath, thus acting as a force to pull down the step actuation arm. Thereby, the step 53 having been put in a vertical position is turned inside 90 degrees to come to a horizontal position to be set in a position for use. Meanwhile, when a user of the wheelchair rises, the seat 5 ascends and the actuation plate 16 is pushed upward by the force of a damper 20 as shown in FIG. 10 , the crank 81 is caused to swing about the support shaft of the crank support arm 80 in a counterclockwise direction, so that the end of the short arm 81 a rises and the end of the long arm 81 b lowers. Thereby, since the length of wire 82 for opening of a step loosens to release a pulling force acting on the step actuation arm 54 , the restoring force of the springs 70 housed in the step 53 shifts the step 53 from the horizontal position to the vertical position, so that the step is positioned not to prevent a user of the wheelchair from rising and then beginning walking. In this manner, according to the third embodiment, when a user sits on a wheelchair, the step 53 automatically comes to a horizontal position to be set in a position for use, and when a user rises, the step automatically comes to a vertical position to be set in a position not to obstruct walking, so that a more excellent effect than that in the first embodiment is produced. An explanation will be given below to other modifications. In the above embodiments, the brake levers 12 are connected directly to the brake means 11 but may be connected to the brake means through a length of wire. The first bias means adopts the dampers 20 but may adopt other means. The second bias means adopts the coil springs 52 and the third bias means adopts the coil springs 70 but may adopt other bias means than coil springs. The actuation plates 16 are not necessarily disposed on the back side of the seat 5 . The present examples and embodiments are to be considered as illustrative and not restrictive, and the invention is not to be limited to the details given herein, but may be modified within the scope and equivalence of the appended claims.

A wheelchair has actuation plates provided in juxtaposition with the seat to descend when a user sits on the seat to lower the seat with the user's weight and to ascend when the user rises from the seat to permit the seat to return with removal of the weight. A brake is mounted on the axle shafts to brake the axle shafts and energized constantly in a non-braking direction. Levers are coupled directly or indirectly to the brake to move according to descending motions of the actuation plates to put the brake in a non-braking state and to move according to ascending motions of the actuation plates to put the brake in a braking state. Biasing devices for evacuating legs that extend from the seat and/or steps that are mounted onto the legs.

FIELD OF THE INVENTION [0001] This invention relates generally to systems for cooling a person for therapeutic purposes. More particularly, this invention relates to an enclosure or tent and support system for a patient who is to be cooled to a temperature below normal body temperature. BACKGROUND [0002] International patent applications published under WO 97/42919 and WO 00/27323, which are incorporated herein by reference for all purposes, describe systems for rapidly cooling a patient to a temperature a few degrees below normal blood temperature, e.g. in the range of about 32 to 34 degrees Celsius. This clinical procedure has been used with some success in reducing brain damage to cardiac or stroke patients as a result of reduced flow of oxygenated blood. SUMMARY OF THE INVENTION [0003] The present invention provides an improved patient cooling system, which, according to a first feature of the invention, comprises an enclosure or tent having an inlet connected to an air cooling system, and an outlet which is connected to re-circulate exhaust air back to the inlet of the cooling system in order to minimize energy losses. Preferably, the enclosure is arranged so that it can be used on a variety of patient support devices such as mattresses, including support devices mounted in an ambulance fitted with a suitable source of cold air. [0004] Preferably, the enclosure is connected to a cooling system that includes an inlet for ambient air, a main blower that supplies air to the enclosure via the cooling section of a refrigeration system, and a re-circulation duct that connects an outlet from the air tent to the inlet side of the main blower. [0005] Preferably the air inlet, main blower, and cooling section are all embodied in a single housing that is connected to the air tent through a dedicated hose set. Preferably the hose set is coaxial, and includes an inner tube for the inlet air to the enclosure surrounded by an outer tube for the return air. In this way, the outer air jacket advantageously isolates and insulates the colder inner tube from the ambient temperature. [0006] Preferably, a valve is included in the return path to enable the proportion of re-circulated air to be varied, in accordance with operational requirements. [0007] Preferably, the air tent is also provided with a separate outlet to the atmosphere, including a vane type valve to control the exhaust flow, which allows independent control of the pressure inside the enclosure. In this way it is possible to maintain the pressure within the preset limits even if the enclosure is subject to variable leakage. [0008] Preferably, the patient is supported on a mattress system comprising a plurality of inflatable compartments, which can also be supplied with cooled air. Preferably, the compartments comprise elongate members that extend transversely across the width of the mattress, and can be alternately inflated to avoid any particular regions of the patient's body from being subjected to high pressure continuously. [0009] According to a further feature of the invention, there is provided a patient support mattress comprising a plurality of transversely extending inflatable compartments, which are so arranged that each compartment can be alternately pressurized, either with relatively low pressure cold air, which assists in cooling the patient but provides relatively little support, or with higher pressure air which acts to support the patient, but provides relatively less cooling effect. [0010] Preferably the mattress is connected into the re-circulating air supply system of the cooling enclosure, and may be provided with an additional blower to boost the pressure, for its high pressure supply. [0011] According to a still further feature of the invention there is provided an air tent or enclosure for enclosing a patient in a controlled environment, comprising a plurality of panels of flexible material, and having an opening with releasable fastener means to enable a patient to be enclosed, at least one panel including an aperture or apertures to allow the passage of a duct or pipe to communicate with the interior of the enclosure, the aperture comprising a radially collapsible sleeved opening having a split along the side of the sleeve which communicates with a further split in the panel for introduction of the conduit, the sleeve being flexible and being adapted to be tightened around the conduit. [0012] Preferably the outer edge of the sleeve is provided with a ring of hook or loop covered attachment material, which is adapted to cooperate with inter-engageable loop or hook material on the panel around the base of the sleeve, whereby the sleeve can be secured tightly around the conduit after it has been placed in position, by twisting the sleeve around the conduit and pressing the ring of material against the co-operating material on the panel. [0013] Preferably the outer edge of the sleeve is also reinforced with a “split ring” of a resilient material such as aluminum. The split ring maintains the sleeve in a generally circular configuration as it is closed around the conduit and maintains the edge of the sleeve in continuous contact with the surface of the conduit. [0014] These and other aspects and features of the present invention will be readily apparent to those skilled in the art from the following detailed description taken in conjunction with the annexed sheets of drawings, which illustrate the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0015] [0015]FIG. 1 is a schematic diagram of a patient cooling system according to the invention. [0016] [0016]FIG. 2 is a schematic diagram of a patient support mattress having an air flow control system. [0017] [0017]FIG. 3 a is a side elevation of a first type of patient enclosure. [0018] [0018]FIG. 3 b is a plan view of the patient enclosure of FIG. 3 a. [0019] [0019]FIG. 3 c is an end elevation of the enclosure of FIG. 3 a. [0020] [0020]FIG. 4 a is a side elevation of a second type of patient enclosure. [0021] [0021]FIG. 4 b is a plan view of the enclosure of FIG. 4 a. [0022] [0022]FIG. 4 c is an end elevation of the enclosure of FIG. 4 a. [0023] [0023]FIG. 5 a is an enlarged view of the end panel of FIG. 4 c. [0024] [0024]FIG. 5 b is a plan view of the end panel of FIG. 5 a. [0025] [0025]FIG. 5 c is a detailed view of a cross-section through part of the structure of FIG. 5 a. DETAILED DESCRIPTION [0026] Based on the description and illustrations provided herein, the many benefits provided by the invented structure and methods of utilization are apparent. These described benefits, as well as those that are inherent to those skilled in the art, fall within the scope of the invention of the present patent application as limited only by the claims appended hereto. [0027] Referring to the drawings, FIG. 1 illustrates the general layout of a patient cooling system in accordance with the invention, comprising an air tent 2 forming an enclosure with an air inlet duct 4 and an outlet duct 6 . The tent is preferably constructed from panels of fabric material, as described in more detail below. [0028] The tent is supplied with cool air through an air inlet duct 8 , with an intake filter 10 and an intake valve 12 comprising a movable vane that communicates with a main blower 14 . This pressurizes the air, and it then passed through a heat exchanger 16 , which comprises the evaporator section of a refrigeration circuit. The refrigeration circuit further comprises a compressor 18 and a condenser 24 , which is provided in a conventional fashion with a condenser fan having an intake filter 20 , a wick 26 for absorbing condensate drain from the evaporator section, and an outlet air filter 28 . [0029] Having passed through the heat exchanger 16 and thus being cooled, the air passes into the patient enclosure via the inlet 4 , circulates past the patient, and leaves the enclosure via the outlet 6 . The outlet is connected by means of a re-circulation filter 30 to a re-circulation flow sensor 32 and a re-circulation valve 34 comprising a vane that can be moved in order to control the proportion of re-circulated air. [0030] The enclosure 2 is also provided with a vane type exhaust valve 36 that enables the pressure inside the enclosure to be independently controlled. In this way, the proportion of re-circulated air and the internal temperature of the enclosure can be controlled without unduly increasing or decreasing the total pressure inside the enclosure. [0031] The apparatus also includes a patient-supporting mattress, indicated generally at 42 in FIG. 1, which comprises a plurality of inflatable compartments or cells to which air is supplied through an arrangement of valves 44 which are connected to the cooling circuit by a conduit 46 containing a further blower 48 . As illustrated, the conduit 46 is also incorporated in the coaxial hose set, forming a central core 50 , so that the air passing through the conduit is insulated from the ambient temperature by the outer coaxial passageways 38 and 40 . [0032] [0032]FIG. 2 illustrates in more detail bow air is supplied to the mattress, so that alternate cells are pressurized with high and low pressure air in successive cycles. As shown, there are two interleaved sets of cells or compartments A and B, both of which are connected continuously to a source of cold air at low pressure by means of non-return valves 54 and 56 respectively. In the general arrangement of FIG. 1, these will normally be connected via line 52 to the conduit 4 which supplies the air tent, and will therefore provide little supporting effect for the patient (being at low pressure) but will have fairly substantial cooling capacity. [0033] The high pressure air supply 46 driven by the blower 48 (as described above with reference to FIG. 1) is connected to each set of cells A or B, by a respective servo valve 44 , and these are activated alternately so that during a first cycle, all cells A are inflated to a high pressure so as to support the patient while cells B are connected to the re-circulation line 6 . A controlled amount of leakage is of course permitted through the fabric of each cell, as indicated by arrow C, since the high pressure air cannot escape via the non-return valves 54 , 56 . Since the air supply 46 has been subjected to greater pressurization, it is, of course, at a somewhat higher temperature than the low pressure supply, and thus, primarily performs a supporting function rather than a cooling function for the patient's body. [0034] At the same time, however, the cells B are receiving the supply of colder air 52 at relatively low pressure, so these cells primarily provide a cooling function rather than a supporting function. [0035] At the next cycle, the high pressure air supply is shut off from the cells A, by operating their respective servo valve 44 and instead, they are connected to the re-circulation line so that they now act primarily to provide cooling, as passageways for the cold air supply 52 . At the same time, the cells B are connected to the high pressure supply, so as take over the patient supporting function, in the same way, as described above for the cells A in the previous cycle. [0036] In this way, each region of the patient's body is alternately supported by the high pressure, or subjected to cooling, rather than being continuously subjected to high pressure. [0037] [0037]FIG. 3 illustrates the patient enclosure system in more detail, and as shown, this comprises a generally semi-cylindrical fabric structure, having a base portion (not visible in the Figure) that is supported on a mattress cover 62 enclosing a mattress structure of the kind described above with reference to FIG. 2. [0038] As can be seen from the plan view of FIG. 3 b, the upper or covering portion of the enclosure comprises a pair of elongate flaps 64 whose adjoining edges can be connected with a “Velcro” seal (i.e., separable complementary hook and loop fasteners) or similar seal 66 , each flap being formed with a flexible, transparent inspection panel 68 . A “head end” panel 70 (FIG. 3 c ) is formed with an aperture 72 for the neck of the patient, to allow the patient's head to protrude from the enclosure, and this aperture 72 is connected to the circular edge of the panel 70 , by means of a slit 74 to facilitate the process of positioning the patient's neck. The slit is also provided with Velcro along its adjacent edges, for subsequent closure. [0039] The enclosure is also provided with a series of specially adapted apertures 76 , for the entry of various conduits and connectors, as will be described in more detail below while the foot end (FIG. 3 d ) is provided with a pair of ports 78 for air input ducts, as well as an aperture 80 for connection to re-circulation and pressure relief valves. [0040] [0040]FIG. 4 illustrates a “full enclosure” version of the system of FIG. 3, in which, as depicted in FIGS. 4 a and 4 b, the enclosure is longer so as to enclose the patient's head. This version includes additional transparent panels 68 in the head region to allow the patient external vision. In this case, of course, the end panel 70 does not include a neck aperture. [0041] [0041]FIGS. 5 a and 5 b illustrate the arrangement by which pipes and conduits are passed through the walls of the tent, with minimum air leakage. Each conduit aperture 76 is provided with a radially collapsible tubular sleeve 78 made of flexible material such as fabric. The tubular sleeve 78 is stitched into the head end wall 70 in the arrangement shown and projects from the wall. The outer edge of the tubular sleeve 78 is reinforced with a split aluminum anchor ring 82 (FIG. 5 c ) having a covering of Velcro material stitched around it. Thus the Velcro-covered ring 82 forms a rim at the outer end of the tube to maintain the sleeve in a generally circular configuration as it is closed around the conduit. This rim, as well as the sleeve 78 itself, are formed with corresponding slits 84 which enable the sleeve to be closed around a conduit, as explained in more detail below. [0042] Four Velcro “loop” pads 86 stitched to the wall of the enclosure surround the sleeve 78 . The wall itself includes a slit 88 that extends from the split 84 of the sleeve to the outer edge 90 of the wall. In this way, a pipe or conduit (which may for example already be connected to the patient) can be passed into the enclosure, so as to exit through the sleeve 78 , without disconnecting either end. [0043] After the conduit has been properly positioned, the reinforced end 82 of the sleeve is twisted around and squeezed into engagement with the conduit, and pressed against the Velcro pads 86 . The rim is then attached to the pads, locating the conduit tightly in position. It will be appreciated that this closure system works equally well for a wide range of conduit sizes. In addition, if any particular aperture is not needed, the sleeve can be twisted up more tightly to close the aperture completely (as indicated schematically in FIGS. 3 and 4). [0044] It will be appreciated that the slit 88 is also provided with suitable Velcro or similar closure means along its adjacent edges, so that the entire closure can be made substantially leak proof, thus reducing significantly the overall re-circulation losses in the system. [0045] Although the foregoing specific details describe various embodiments of the invention, persons reasonably skilled in the art will recognize that various changes may be made in the details of the method and apparatus of this invention without departing from the spirit and scope of the invention as defined in the appended claims. Therefore, it should be understood that, unless otherwise specified, this invention is not to be limited to the specific details shown and described herein.

A patient cooling system comprises a patient enclosure or tent having a coaxial hose connection to a re-circulating air-cooling system. The hose comprises an inner tube to introduce air into the enclosure and an outer tube for the return air. The patient cooling system further comprises a patient-supporting mattress comprising a plurality of inflatable compartments extending transversely across the width of the mattress, which can also be supplied with cooled air. The compartments can be alternately pressurized for pressure relief therapy. Moreover, the compartments can be pressurized either with relatively low pressure cold air from the air cooling system, or with higher pressure air which acts to support the patient, but provides relatively less cooling effect. Radially collapsible, sleeved openings in the tent panel enable connection of conduits or patient care lines to the patient.

RELATED APPLICATIONS The present invention was first described in Disclosure Document No. 595,156 filed on Feb. 16, 2006. FIELD OF THE INVENTION This invention relates to tree stands and, more particularly, to a combined tree supporting and watering stand for maintaining a tree at a vertical position while supplying a predetermined quantity of water to the tree. BACKGROUND OF THE INVENTION The holiday season is a time of great fun and happiness for everyone. A great deal of the holiday cheer comes from the yearly traditions that are passed from generation to generation. Perhaps the most well known of all traditions is that of the Christmas tree. The act of putting it up and decorating it in one's home is a process that can be enjoyed by all members of the family. However, the physical size of most Christmas trees causes a number of aggravations. First, it is difficult to get the tree to be straight and plumb in the stand. Second, the tree stand takes an inordinate amount of space that takes away from space for presents and/or other holiday decorations. Third, it is difficult to clean or vacuum around. Finally, one must kneel down or bend over to water the tree, which is difficult to do on a daily basis. Accordingly, there is a need for a means by which Christmas trees can be supported in a manner that reduces or eliminates the aggravations as described above. The development of the present invention fulfills this need. Several attempts have been made in the past to develop a combined tree supporting and watering stand for maintaining a tree at a vertical position while supplying a predetermined quantity of water to the tree. U.S. Pat. No. 5,575,110 in the name of Couture discloses a self-watering tree stand having an external reservoir for holding a supply of water and a tube leading from the reservoir to a compartment in the tree stand. The compartment has a float valve for controlling the amount of water which is allowed to flow from the reservoir to the tree stand, and also, has a screen, the upper portion is made from a solid material and the lower portion is made from a screen type mesh which prevents debris and tree pitch from entering the compartment and interfering with the float valve. Unfortunately, this prior art example does not allow for supporting a tree from the middle section, thereby freeing up a quantity of space below the tree. U.S. Pat. No. 5,522,179 in the name of Hollis discloses an automatic water level control system, for use in conjunction with a Christmas tree stand of the type having a watering basin with an outer rim and a tree clamping mechanism for holding the Christmas tree in an upright manner with the base portion of the tree disposed within the watering basin. The water level control system includes a water supply container, a flexible conduit, an attachment mechanism, and a valve mechanism. The water supply container serves as a holding tank for water which is supplied to the watering basin of the Christmas tree stand via the flexible conduit. The water level in the watering basin is regulated by the valve mechanism attached to the Christmas tree stand. The attachment mechanism has a main body and is attachable to the outer rim of the watering basin in a manner to functionally secure the main body to the Christmas tree stand. The valve mechanism includes a watering port, a valve, and a float member. The watering port is in fluid communication with the second end of the flexible conduit member such that water flowing from the water supply container through the flexible conduit ultimately exits the watering port into the watering basin. Unfortunately, this prior art example does not provide a means of suspending a water supply container in conjunction with the tree stand. U.S. Pat. No. 5,791,083 in the name of Giangrossi describes a device for monitoring and maintaining the water level in the reservoir of a Christmas tree stand having a filler portion communicating with a flexible filler conduit. A water level indicator, includes an indicator float which is slidably engaged within the indicator float housing and which travels freely along a substantially vertical axis within the indicator float housing, a flexible indicator stem is attached to the indicator float and extends up through a flexible conduit for indicating, by means of the relative extension of the flexible indicator stem, the water level in the tree stand reservoir. The indicator float housing is formed having a number of holes through its outer wall for the free passage of water in and out of the indicator float housing from the reservoir for buoyantly raising or lowering the indicator float, consistent with the level of water in the reservoir. Unfortunately, this prior art example requires a separate tree stand be used in conjunction with the device, as opposed to incorporating the watering means with the tree stand. U.S. Pat. No. 5,446,993 in the name of Cullen discloses a watering system which permits the convenient watering of potted plants and trees, in particular, evergreen trees, i.e. Christmas trees, in tree stands. The watering system is a tubular device having one end enlarged to form a funnel-like receptacle to receive the water or other liquid which is delivered via the tubular device to the pot or stand through an exit port at the opposite end. The base of the watering system is upheld upright by a band hooked about a projection on the watering system which supports the system against the base of a plant or tree. Between the two ends of the watering system, there is a bend which causes the funnel-like receptacle to extend beyond or into the foliage providing easy access for watering. Decorating elements may be added to camouflage or add ornamentation as desired. The watering system may be divided into several segments for convenience of storage and/or manufacturer. Unfortunately, this system does not incorporate a tree stand with the watering means, and also does not provide a water supply container. None of the prior art particularly describes a combined tree supporting and watering stand for maintaining a tree at a vertical position while supplying a predetermined quantity of water to the tree. Accordingly, there is a need for a system which provides such features while overcoming the above-noted shortcomings. SUMMARY OF THE INVENTION In view of the foregoing disadvantages inherent in the prior art, it has been observed that there is need for a combined tree supporting and watering stand for maintaining a tree at a vertical position while supplying a predetermined quantity of water to the tree. The system includes a base removably positioned on a ground surface, a vertical member directly coupled to the base, without the use of intervening elements, and extending upwards therefrom, and a support member directly connected to the vertical member, without the use of intervening elements, and extending perpendicularly away therefrom. The support member is telescopically slidable along an extension member of the vertical member, which is important such that the support member is biased along a lateral direction. Of course, such members can be produced in a variety of sizes, as is obvious to a person of ordinary skill in the art. The assembly further includes a power strip removably attached to the vertical member, which is essential for providing an electric power source to a plurality of decorative lights positioned on the tree. The system further includes a mechanism for automatically watering a stalk of the tree during an extended period of time. Such an automatic watering mechanism is directly anchored to the support member, without the use of intervening elements. Such an automatic watering mechanism includes a water reservoir attached to the support member and suspended at an elevated height above the ground surface. A water receptacle is removably attached to the stalk of the tree and is in fluid communication with the reservoir. Of course, such a reservoir and receptacle can be produced in a variety of shapes and sizes, as is obvious to a person of ordinary skill in the art. A flexible tube has opposed ends directly mated to the reservoir and the receptacle, without the use of intervening elements, which is critical such that the tube selectively delivers water from the reservoir to the receptacle, which is advantageously located downstream of the reservoir. Of course, such a tube can be formed from a variety of suitable materials, as is obvious to a person of ordinary skill in the art. The reservoir includes an unobstructive lid removably and snuggly fitted directly against an upper surface of the reservoir, without the use of intervening elements, which is essential for allowing necessary pressure equalization. The water receptacle is located subjacent to the water reservoir, which is critical for providing positive water pressure to the reservoir and thereby advantageously preventing the water from flowing upstream from the receptacle towards the reservoir. The automatic watering system further includes a float valve operably attached to a distal end of the tube. Such a float valve has a float operably coupled thereto, which is crucial such that the float rises when a water level increases within the receptacle, and falls when the water level decreases within the receptacle. Such a float cooperates with the float valve in such a manner that the float valve advantageously opens and closes when the water level falls below and rises above a predetermined threshold respectively. Of course, such a float valve can be produced in a variety of shapes and sizes, as is obvious to a person of ordinary skill in the art. The system further includes an extended arm that has opposed ends directly coupled to the float valve and the float respectively, without the use of intervening elements. Such an extended arm withholds a weight of the float and thereby advantageously absorbs a force due to buoyancy from the float for causing the extended arm to pitch. Upward movement of the float causes the extended arm to pitch upwardly, which is vital to close the float valve and to stop water, while downward movement of the float causes the extended arm to pitch downwardly, which is important to open the float valve and thereby permit water to flow into the receptacle. The system further includes a mechanism for supporting the tree at an elevated vertical position above the ground surface. Such a tree supporting mechanism is advantageously anchored to the support member. The tree supporting mechanism includes a clamping mechanism monolithically formed with the support member. Such a clamping mechanism is adjustably and perpendicularly mounted to the vertical member via an extension member of the vertical member. Such a clamping mechanism is “U”-shaped and has a plurality of threaded bores formed therein. A plurality of fasteners is threadably affixed with the bores respectively. Of course, such fasteners can be produced in a variety of shapes and sizes, as is obvious to a person of ordinary skill in the art. The clamp mechanism further includes a plurality of arcuate members adjustably coupled to the fasteners and directly abutted against the stalk of the tree, without the use of intervening elements. Each of such arcuate members includes a shaft rotatably connected directly to a corresponding one of the shafts, without the use of intervening elements. The fasteners define a plurality of sleeves, which is crucial for allowing the shafts to advantageously rotate about a lateral axis while the arcuate members remain disposed at a predetermined vertical height from the ground surface respectively. The combination of a watering apparatus and a support mechanism in one system provides the unexpected benefit of allowing a user to both water and support a tree using only one associated group of elements within the one system, thereby overcoming prior art shortcomings. BRIEF DESCRIPTION OF THE DRAWINGS The advantages and features of the present invention will become better understood with reference to the following more detailed description and claims taken in conjunction with the accompanying drawings, in which like elements are identified with like symbols, and in which: FIG. 1 is a side view of a self-watering vertically adjustable tree stand 10 securing a Christmas tree 100 , according to the preferred embodiment of the present invention; FIG. 2 is a perspective view of a base member 20 with a vertical member 30 embedded thereon having a ground fault circuit interrupter (GFCI) power strip 40 removably attached thereon, according to the preferred embodiment of the present invention; FIG. 3 is a top view of the base member 20 with the vertical member 30 removably attached thereon having the ground fault circuit interrupter (GFCI) power strip 40 removably attached thereon, according to the preferred embodiment of the present invention; FIG. 4 is a perspective view of the base member 20 and the vertical member 30 with an adjustable clamping mechanism 96 and a pictorial representation of the placement of a water receptacle 120 , according to the preferred embodiment of the present invention; FIG. 5 is a perspective view of the self-watering vertically adjustable tree stand 10 , according to the preferred embodiment of the present invention; FIG. 6 is a side view of the self-watering vertically adjustable tree stand 10 with a transparent view of the water reservoir 130 , channeling tube 136 , and water receptacle 120 , according to the preferred embodiment of the present invention; FIG. 7 a is a transparent side view of the water receptacle 120 and a float valve 150 having a float 125 with no water 140 residing in said water receptacle 120 , according to the preferred embodiment of the present invention; FIG. 7 b is a transparent side view of the water receptacle 120 and a float valve 150 having a float 125 with water 140 residing in said water receptacle 120 , according to the preferred embodiment of the present invention; FIG. 8 is a top close-up view of the clamping mechanism 96 securing cross-section of a tree stalk 105 thereof, according to the preferred embodiment of the present invention; and, FIG. 9 is a side view of a rubber-coated member 115 and the insertion thereinto a winged screw 110 , according to the preferred embodiment of the present invention. DESCRIPTIVE KEY 10 self-watering vertically adjustable tree stand 20 base 25 rubber feet 30 vertical member 40 ground fault circuit interrupter power strip 45 female adapter 46 cord 47 plug 48 plug prongs 55 extension member 56 pin aperture 57 receiving aperture 90 projection pin 95 support member 96 clamping mechanism 98 washer 99 shaft 100 Christmas tree 103 bore 105 tree stalk 110 winged screw 115 rubber-coated member 120 water receptacle 125 float 126 screw 130 water reservoir 135 lid 136 tube 137 protrusion 138 chain 140 water 145 extended arm 150 float valve DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The best mode for carrying out the invention is presented in terms of its preferred embodiment, herein depicted within FIGS. 1 through 9 . However, the invention is not limited to the described embodiment and a person skilled in the art will appreciate that many other embodiments of the invention are possible without deviating from the basic concept of the invention, and that any such work around will also fall under scope of this invention. It is envisioned that other styles and configurations of the present invention can be easily incorporated into the teachings of the present invention, and only one particular configuration shall be shown and described for purposes of clarity and disclosure and not by way of limitation of scope. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced items. The present invention describes an apparatus and method that incorporates a self-watering, vertically adjustable tree stand. The self-watering vertically adjustable tree stand (herein described as the “apparatus”) 10 comprises a base 20 , a vertical member 30 , a water receptacle 120 , a clamping mechanism 96 , a water reservoir 130 , a ground fault circuit interrupter (GFCI) power strip 40 , and a means for attachment of said components. Referring now to FIGS. 1 through 3 , pictorial representations of the apparatus 10 and a portion of the components according to the preferred embodiment of the present invention, is disclosed. A base member 20 of circular design is envisioned to support the apparatus 10 before, during, and after securing a Christmas tree 100 . The base 20 comprises a circular framework having an overall diameter sizable to accommodate the weight of the apparatus 10 and the tree 100 . The base 20 comprises a rectangular cross-section in a coplanar format with a reasonably dense thickness for optimum stability and strength capabilities. The bottom of the base 20 is envisioned to comprise a plurality of removably attachable rubber feet 25 for the minimization of damage done to rugs, hardwood floors, ceramic floors, or other floors. The feet 25 are envisioned to be fabricated of a hard rubber and may be attached thereto the bottom surface of the base 20 to protect the floor from scraping, scratching, rubbing, and the like against the desired floor surface while preventing sliding of the apparatus 10 . The base member 20 comprises a vertical member 30 removably attached thereto, envisioned to comprise a circular cross-sectional tubing, projecting vertically upwards at a designated distance. The vertical member 30 can be welded, bolted, or otherwise permanently fixed transversally thereto the axial plane of the base 20 ; however, it is preferred if the vertical member 30 to be temporally affixed thereto the base 20 . The vertical member 30 comprises an upper end and a lower end thereof such that the lower end is detachably affixed thereto the base 20 thereof. The lower end is centrally positioned thereon the base 20 having the diameter preferably the same as the base 20 thickness for optimal stabilization. The upper end comprises an extension member 55 having a support aperture 57 receiving and accepting a support member 95 having a clamping mechanism 96 described in more detail subsequently. A ground fault circuit interrupter (GFCI) power strip 40 is removably attached thereto the upper portion of the vertical member 30 to provide an electric power source to electrically power decorative lights and/or other ornamentation. The GFCI power strip 40 has a rectangular face comprising two (2) to four (4) openings or female adapters 45 embedded on the face in electrical communication with a power supply. The female adapter 45 is adapted to except and retain prongs 48 of an electric plug 47 , from decorative lights for example, and maintain electrical continuity. The GFCI power strip 40 comprises a cord 46 with a plug 47 electrically connected at the distal end thereof. The GFCI power strip 40 operates from an AC or DC input voltage power source preferably having remote reset capability to provide protection for the power supply and against user injury. The cord 46 extends downwardly and may be affixed to the vertical member 30 via ties, binding, string, or other suitable means such to prevent entanglement of the cord 46 . Referring now to FIGS. 4 through 6 , pictorial representations of the apparatus 10 and a portion of the components according to the preferred embodiment of the present invention, is disclosed. A water receptacle 120 is removably attached thereto a stalk 105 of a desired Christmas tree 100 . The water receptacle 120 , envisioned to be fabricated brass coupling, which is dense, corrosion resistant, inexpensive, and readily available, has a diameter considerably larger than that of a conventional tree 100 such to encircle the stalk 105 of said tree 100 while leaving sufficient space to contain water 140 and to allow a user put in additives such as vitamins, preservatives, and the like. The water receptacle 120 comprises a screw 126 or nail welded thereon the base surface of the receptacle 120 . The receptacle 120 is designed as a one-piece component being leak-proof while keeping the minimum system water level 140 above the tree stalk 105 cut, insuring the tree stalk 105 is always in the water 140 . The water level 140 will typically be approximately one (1) to three (3) inches from the base of the stalk 105 such that it will remain immersed for adequate consumption for a live tree 100 . The removability features of the water receptacle 120 permit the occasional discarding of water 140 which may become dirty and somewhat stagnant. The reservoir 130 is envisioned to be designed in a cylindrical format capable of holding a sufficient amount of water 140 to supply the water receptacle 120 with the necessary water 140 . The reservoir 130 is designed to be leak-proof while being unobstructive having a lid 135 to fit snuggly thereon the upper surface without having a seal, allowing the necessary pressure equalization to occur. The lid 135 protects from outside substances (i.e. pine needles) undesirably from traveling within the reservoir 130 while preventing spillage of water 140 residing therewithin. The lid 135 could be screwed threaded or could be simply a friction fit on the reservoir 130 . The reservoir 130 will have a height sufficient to contain a water level 140 high enough to permit the flow of water 140 to the receptacle 120 . The size of the reservoir 130 will vary depending on the size of the tree 100 to be withheld. The reservoir 130 is capable of containing a sufficient amount of water 140 while still delivering a certain amount of water 140 to the receptacle 120 until the receptacle 120 is containing a sufficient amount of water 140 . The reservoir 130 is at a higher elevation therefrom the receptacle 120 thereby providing positive water 140 pressure thereto said reservoir 130 without the opportunity of the “old” water 140 in the receptacle 120 to flow backwardly and upwardly towards the reservoir 130 thereby providing clean water 140 therewithin. The receptacle 120 and/ reservoir 130 may be of plastic or glass such to contain transparent or translucent qualities so the amount of water 140 left residing therewithin may be easily discernible. The base of the reservoir 130 comprises a fluid dispersing aperture (not pictured) to which the water 140 exits therethrough to a tube 136 . A flexible tube 136 of certain diameter, preferably, but not essentially, one-fourth (¼) of an inch, delivers the water 140 from the reservoir 130 to the receptacle 120 . The tube 136 comprises a fluid dispersing end which is in fluid communication with the receptacle 120 and a fluid receiving end which is in fluid communication with the fluid dispersing aperture of the reservoir 130 . Both ends of the tubing 136 , the fluid receiving end and the fluid dispersing end is connected and sealed to the fluid receiving aperture of the receptacle 120 and the fluid dispersing aperture of the reservoir 130 . The tube 136 allows a continuously inter-connection of the reservoir 130 and receptacle 120 water-sealed thereby preventing leakage. The tube 136 may be transparent or translucent such to permit a user to observe that the reservoir 130 and the receptacle 120 are continuously inter-connected. The tube 136 is long enough to span across the reservoir 130 thereto the receptacle 120 with ample excess remaining should additional tubing 136 be needed. The reservoir 130 is secured thereon a support member 95 via a strapping mechanism preferably a chain 138 having links, as depicted in the figures. The strapping mechanism may be any other device suitable to secure and withstand the weight of the reservoir 130 and the water 140 residing therewithin. Protruding members 137 allow the points of connection of the chain 138 . The chain 138 is attached on two (2) sides of the outer diameter of the reservoir 130 preferably 180° apart thereof. The upward tension on the chain 138 , exerted by the weight of the reservoir 130 and water 140 stabilizes the chain 138 tightly against the support member 95 which allows the chain 138 to support the weight of the reservoir 130 and water 140 . The reservoir 130 may comprise a handle (not pictured) thereupon the surface so it can be easily moved and/or refilled. Referring now to FIGS. 7 a and 7 b , transparent side views of the water receptacle 120 and a float valve 150 having a float 125 according to the preferred embodiment of the present invention, is disclosed. The receptacle 120 comprises a float valve 150 utilized as a mechanical electrical which operates having a float 125 to raise when the water level 140 goes up, as depicted in FIG. 7 b , and drop when the water level 140 goes down, as depicted in FIG. 7 a , with respect to a specified level. The float valve 150 is a mechanical feedback mechanism in fluid communication with the fluid receiving aperture of the tube 136 to regulate the water level 140 therewithin the receptacle 120 via a float 125 to drive an inlet valve such that a higher water level 140 will force the valve 150 closed whilst a lower water level 140 will force the valve 150 open. Thus, the float valve 150 will allow a predetermined level of water 140 to enter the receptacle 120 , thereby shutting off the water supply 140 , the water reservoir 130 . The float 125 , fabricated of a buoyant material, is free to move up and down according to the level of water 140 and is mounted thereupon an extended shaft arm 145 at the distant end. The extended arm 145 withholds the weight of the float 125 thereby absorbing the force due to buoyancy from the float 125 and causing the extended arm 145 to pitch. Upward movement of the float 125 causes the extended arm 145 to pitch upwardly to close the float valve 150 and to stop the flow of water 140 , while downward movement of the float 125 causes the extended arm 145 to pitch downwardly to open the float valve 150 and to permit the flow of water 140 therein. It will be appreciated to those skilled in the art that other float valve 150 designs may also be used in accordance with the invention to permit the automatic control of water flow 140 without intervening with the scope of the invention. Referring now to FIG. 8 , a top close-up view of the clamping mechanism 96 securing a tree stalk 105 thereof according to the preferred embodiment of the present invention, is disclosed. A support member 95 is adjustably and perpendicularly mounted to the vertical member 30 via an extension member 55 permanently and perpendicularly integrated thereon the uppermost portion of said vertical member 30 . The vertical member 30 may bend perpendicularly such to provide the extension member 55 or the extension member 55 may be later installed thereupon the vertical member 30 at the uppermost edge. The support member 95 is provided to provide support for the Christmas tree 100 and help maintain the upright position of the tree 100 . The extension member 55 is envisioned to have an opened end 57 such to slidably receive the support member 95 . The extension member 55 and the support member 95 are envisioned to comprise a circular cross-section, preferably tubular having the extension member 55 with a larger diameter than the support member 95 such that the inner diameter of said extension member 55 is similar or slightly larger than the outer diameter of said support member 95 . The support member 95 has a first and second end comprising a circular cross-section, preferably tubular shaped to correspondingly be inserted therewithin the extension member 55 such that the inside walls of the extension member 55 uniformly abuts against the outside walls of the support member 95 . The support member 95 is sized to slidably move in a lateral direction within the extension member 55 . The extension 55 and support 95 members each have a contact surface having a plurality of apertures 56 equally spaced therethrough said surface. The apertures 56 are drilled therethrough the extension member 55 for selectively receiving a projection pin 90 to secure the relative position of the support member 95 . The apertures 56 are selectively alignable with the projection pen, and then fastenable with said projection pin 90 . Referring now to FIG. 9 , a side view of the rubber-coated member 115 and the insertion thereinto a winged screw 110 according to the preferred embodiment of the present invention, is disclosed. The support member 95 comprises a clamping mechanism 96 for the proper secure the placement of the stalk 105 of a tree 100 in an upright position perpendicularly with respect to the ground or other horizontal surface. The clamping mechanism 96 is envisioned to be “U” shaped with a plurality of bores 103 with threads incorporated therewithin each to operably engage and receive a threaded screw 110 . The two (2) threaded winged screws 110 are utilized to secure the stalk 105 of the tree 100 within said clamping mechanism 96 . The threaded screws 110 comprise a rubber-coated member 115 incorporated at the distal end shaped much like a “U”. The rubber-coated member 115 is slightly contoured and rounded to abut thereagainst the stalk 105 of the tree 100 . The rubber-coated member 115 is envisioned to comprise a shaft 99 to be operably received therewithin a bore or the like (not pictured) centered in the winged screws 110 with a washer 98 abutting thereagainst the rubber member 115 . The winged screw 110 acts like a sleeve or the like to allow rotatable motion of the rubber-coated member 115 and/or shaft 99 about the lateral axis I-I, without the longitudinal movement of said rubber-coated member 115 and shaft 99 , as depicted in FIG. 9 . The rubber-coated members 115 are designed specifically to completely or partially encircle the stalk 105 of the tree 100 above the central point of the base 20 thereby securing the tree 100 with a center of gravity on or in close proximity to the center of the base 20 thereby providing optimum stability. The rubber-coated members 115 have an adjustable opening for receiving and securing the stalk 105 of the tree 100 . Said opening may be expanded by the utilization of the two (2) winged screws 110 mirrored equidistantly therefrom the axis of the support member 95 . The winged screws 110 bring the rubber-coated members 115 closer together for trees 100 whose stalks 105 comprise a relatively small diameter. On the contrary, the opposite applies for those stalks 105 which comprise a relatively large diameter, to which case, the screws 110 may bring the rubber-coated members 115 outwardly further apart thereby providing a wide range of opening space for larger and/or unsymmetrical stalks 105 . The threaded screws 110 are inserted therewithin the clamping mechanism 96 comprising two (2) apertures defining bores for rotatably accepting said screws 110 so that the rubber coated member 115 may be abutting thereagainst the stalk 105 of the tree 100 in order for securely holding said tree 100 . The rubber-coated members 115 are envisioned to conform thereto the outer periphery of the stalk 105 of the tree 100 without puncturing said stalk 105 . The rubber material provides a frictional force against the stalk 105 for optimum holding stability capabilities. Further, the rubber-coated member 115 is envisioned to be rotatable and/or pivotable along the lateral axis, I, of the threaded screws 110 , as depicted in FIG. 9 , to provide adjustments as needed. The rotatable and/or pivotable rubber-coated member 115 allows said member 115 to adjust accordingly thereby providing a wide range of securing features for trees 100 comprising symmetrical or unsymmetrical stalks 105 . Alternate fastening mechanisms may be used. An alternate embodiment of the present invention 10 may disclose alternate fixing means for the support member 95 to be adjustably slidably received therewithin the extension member 55 . The extension 55 and support 95 members may each have a contact surface having a plurality of matching and transverse apertures 56 equally spaced therethrough two (2) surfaces spaced 180 therefrom each other such to receive a through pin 90 . The transverse apertures of the support member 95 correspondingly match with the matching apertures 56 of the extension member 55 which may be selectively aligned and secured with the through pin to fix the relative position of the support member 95 . The through pin will be inserted therethrough the matching aperture 56 on the upper surface of the extension member 55 , therethrough the transverse aperture on the upper surface of the support member 95 , therethrough the transverse aperture on the lower surface of the support member 95 , and therethrough the matching aperture on the lower surface of the extension member 55 . Yet further, the present invention 10 may disclose a supporting member 95 that comprises a pivot point with a position pin inserted through one of the pivot position holes. Thus the support arm 95 may pivot sideways, downwardly, and/or upwardly. Another alternate embodiment of the present invention 10 may disclose an adjustable vertical member 30 of telescoping construction so that the apparatus 10 may be adjusted in height. The vertical member 30 may be designed in sections such that each section is slightly smaller than the next such that the sections may be slid within one another so that the overall height of the apparatus 10 may be varied. Alternately, the vertical member 30 may contain apertures 56 for receiving a projection pin 90 or a through pin similar to the method used for the adjustable attachment of the extension member 55 and support member assembly 95 aforementioned. Yet another alternate embodiment of the present invention 10 may disclose a decorative design with the colors symbolizing the time of the season with or without decorative motifs thereupon. Still yet another alternate embodiment of the present invention 10 may disclose a support arm or the like integrally connected thereto the water receptacle 120 for further stabilization of the tree 100 . Said support arm may comprise adjustment means such that it may adjustably and slidably move upwardly and downwardly along the vertical member 30 and releasably secured in a desired position thereon said vertical member 30 utilizing a clamping mechanism or the like. Yet still another alternate embodiment of the present invention 10 may utilize a float switch having a float 125 connected to an extended shaft of a determined weight. Once the water level 140 reaches a certain height, the float 125 and the extended shaft closes a circuit which either closes a valve. This may be done with a ball valve with an electromechanical actuator to effect a positive shut-off when the water 140 reaches a certain height; however, other valves or a solenoid may be utilized. The float switch would sense the level of water 140 within the receptacle 120 to activate a valve producing discrete outputs as the water 140 reaches many different levels within the receptacle 120 and actuates a micro-switch designed to be actuated by the physical motion of a mechanical device. The preferred embodiment of the present invention can be utilized by the common user in a simple and effortless manner with little or no training. After initial purchase or acquisition of the self-watering, vertically adjustable tree stand 10 , it would be configured as indicated in FIGS. 1 through 9 . The method of utilizing the device may be achieved by performing the following steps: securing the rubber feet 25 thereon the underside surface of the circular base 20 via screws, bolts, nuts, or other fastening means; securing the vertical member 30 perpendicularly thereon the base 20 with an extension member 55 protruding in a parallel arrangement therewith the floor; filling the water reservoir 130 therewith water 140 with or without additives therein; closing the lid 135 thereon the water reservoir 130 ; slidably attaching the support member 95 therein the extension member 55 until a designated position is achieved and locked via a projection pin 90 therethrough an aperture 56 ; attaching the reservoir 130 thereto the support member 95 via a chain 138 or other attachment means; fluidly attaching the float valve 150 and float 125 thereto the fluid receiving end of the receptacle 120 ; rotatably screwing the water receptacle 120 thereon the stalk 105 via a welded screw 126 positioned at the base of said receptacle 120 ; inserting the tree stalk 105 therein the clamping mechanism 96 ; securing said tree stalk 105 via rotatably screwing the screws 110 until the contoured rubber-coated members 115 are abutted thereagainst said tree stalk 105 ; fluidly attaching the tube 136 thereto the water reservoir 130 and/or water receptacle 120 , if needed; and, utilizing the GFCI power strip 40 to power the holiday decor. The apparatus 10 is envisioned to come in a variety of sizes and utilized to securely hold a Christmas tree 100 at various specified distances from the floor later to be determined to allow a storage area for gifts and/or decorations under the tree 100 . The components of the apparatus 10 provide minimum storage space with the support member 95 , vertical member 30 , water receptacle 120 , and the water reservoir 130 being unattachably secured. The apparatus 10 or portions of the apparatus 10 may be decorative to resemble the holidays. The apparatus 10 may further disclose the securement and watering of other trees 100 not prone to the holidays. The apparatus 10 may be used to water other plants and/or animals. Because the water receptacle 120 and water reservoir 130 are envisioned to fabricated of plastic, they can be colorful and decorative being transparent, translucent, or opaque. The water receptacle 120 receives water 140 therefrom a water reservoir 130 . The water level 140 can likewise be checked either by lifting the lid 135 of the reservoir 130 , if not of transparent or translucent qualities, observing the water flow 140 therethrough the tube 136 , and/or observing the water receptacle 120 , if needed. The water level 140 is specifically maintained via a horizontal float valve 150 . The reservoir 130 is located at an easily accessible point away from the tree 100 . The vertical member 30 is positioned at a reasonable distance away from the tree 100 such to prevent obstruction to the tree 100 and/or the decorations laid upon the tree 100 . The water 140 flows from the reservoir 130 into the receptacle 120 via a tube 136 . As the water level 140 in the receptacle 120 rises, the buoyancy causes the float 125 to rise. The buoyancy exerted by the float 125 is reflected upon the extended arm 145 to which closes and seals the float valve 150 . As the water level 140 lowers in the receptacle 120 due to evaporation and absorption, the float 125 lowers accordingly eventually resulting in a buoyancy force no longer acting upon the float 125 and the extended arm 145 respectfully. The valve 150 is then opened to allow water 140 to flow from the reservoir 130 to the receptacle 120 . This cycle is repeated continuously and automatically until the apparatus 10 is not longer of use for the holidays. As a result of evaporation and the absorption of water by the tree 100 , the water level 140 in the water receptacle 120 lowers. Float 125 lowers accordingly. With the force due to buoyancy of float 125 no longer acting upon the extended arm 145 , the float valve 150 opens. Water 140 again flows from the water reservoir 130 , through the tube 130 , and into the water receptacle 120 , and the cycle is repeated. The foregoing descriptions of specific embodiments of the present invention have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention and method of use to the precise forms disclosed. Obviously many modifications and variations are possible in light of the above teaching. The embodiment was chosen and described in order to best explain the principles of the invention and its practical application, and to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. It is understood that various omissions or substitutions of equivalents are contemplated as circumstance may suggest or render expedient, but is intended to cover the application or implementation without departing from the spirit or scope of the claims of the present invention.

The invention as presently conceived discloses a unique system and method that incorporates a self-watering tree stand that is an improvement on a conventional floor-standing holiday tree stand and watering system. The design of this novel tree stand is that it supports the tree from the tree's midsection that allows gravity to self-level the tree held within the stand. The stand comprises a large circular base for stability as well as adjustable height watering cup that can be brought up to the bottom of the tree and is fed from a water reservoir located on the vertical section of the stand at the outside perimeter of the tree. Also integral to the system and apparatus is a power receptacle fed from a power cord located near the top of the stand in order to power decorative lights or other electric tree decorations.

This application relates to a process for the preparation of a creamed honey product and to the product thereby obtained. BACKGROUND OF THE INVENTION As far as is known, there has always been a problem among honey producers in achieving a creamed honey product having desirable properties and having good stability relative to those properties over a reasonable shelf life. Furthermore, the desire for particular properties has tended to change over time. Honey producers have generally produced both liquid and creamed honeys. It has almost invariably been the case that the creamed honeys have rapidly crystallized into a relatively hard mass. Furthermore, the size of the crystals or of the crystal groupings has often been such as to result in a relatively coarse product. Clearly a desirable property for a creamed honey is smoothness. For a number of years liquid honey has been available in so-called squeeze bottle containers. Such containers are utilized with a variety of closure means, but, once the closure means has been placed in the open position, all such containers are inverted and a desired amount of product is ejected by squeezing the nonrigid container. There has been an ongoing desire to produce a creamed honey product which will retain properties permitting it to be utilized in a similar squeeze bottle container. Such a product must retain smoothness and viscosity properties over a reasonable shelf life. To date no such creamed honey product has been made available. The present invention is directed toward such a creamed honey product. PRIOR ART Various honey products have been proposed in the past and have been made the subject of patents. Two of those which relate to creamed honey are U.S. Pat. No. 1,987,893, issued to Cornell University on Jan. 15, 1935; and Canadian Patent No. 376,338, issued to MacFeeters on Sept. 6, 1938. Neither of these patents includes the process steps of the present application nor will they result in the creamed honey product of the present invention. SUMMARY OF THE INVENTION A process has now been developed which approaches the crystallization of liquid honey in two ways to produce a creamed honey product. First, the liquid honey is seeded with finely ground seed honey granules to provide evenly distributed crystallization cites throughout the mass of liquid honey to encourage the liquid honey to crystallize into smaller finer crystals at these cites rather than into the large coarse crystals that would otherwise result. Second, the honey is treated at various stages in the crystallization process to break up larger crystals and crystal groups. The resulting product is of a consistency which is suitable for use with a squeezable container and is sufficiently stable to maintain its consistency over an acceptable shelf life at room temperature. Thus, the invention provides a process for the preparation of a honey product, the process comprising adding a predetermined quantity of seed honey to a mass of liquid honey; treating the mass of honey a first time to physically break up crystals and crystal groups; holding the crystallized honey a first time for a predetermined period to allow crystallization to occur; treating the crystallized honey at least one additional time to physically break up crystals and crystal groups; and holding the honey a second time for a predetermined period. In the preferred case the crystallized honey is treated a total of three times to break up crystals and crystal groups. In the preferred case the treatment of the crystallized honey comprises pumping the honey through a positive displacement pump. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Liquid honey if permitted to crystallize naturally will normally form large coarse crystals and will invariably result in a relatively solid product of a consistency, for example, which may or may not be spreadable, but which is in the nature of a rather solid product. It has long been known that honey can be induced to crystallize in smaller crystals and crystal groups by seeding liquid honey with ground crystalline honey. The seed honey provides crystallization cites which initially lead to formation of smaller crystals. The resulting creamed honey product has a much more desirable texture and consistency. Unfortunately, the creamed honey product produced from seed honey was invariably unstable and would rather quickly revert to the harder and more granular creamed honey product. Liquid honey is of a consistency that makes use by the average consumer somewhat difficult. This is particularly so in attempting to transfer the liquid honey from a retail container to a food product in association with which honey would normally be eaten as, for example, bread. This transfer is, in short, often quite messy, particularly when attempted by younger children. To alleviate this problem to some extent liquid honey is currently often sold in squeezable bottles or containers having an appropriate closure device with an orifice of, say, 0.25 inch, and from which a liquid honey can be ejected by inverting and squeezing the container. The product can thus be transferred directly to the food product in association with which it will be eaten. While the problems associated with hardened creamed honey differ from those associated with liquid honey, there has nonetheless been a strong desire to have available creamed honey which can be marketed in a similar squeezable container. To date the problems discussed above have always prevented the use of squeezable containers for creamed honey because the required texture and consistency for both attractiveness of product and usability of squeezable containers could not be maintained. A "squeezable" creamed honey can be produced according to the following process. While not part of the invention as such, liquid honey would normally be treated in the same way as is conventional among most, if not all, commercial honey producers. That is to say, the raw liquid honey is first pasteurized and then filtered to remove impurities. The preferred pasteurization temperature is between 150° to 160° F. and may be carried out in a normal high temperature short time pasteurizer which is exemplified by typical dairy type plate heat exchangers. Filtration is preferably carried out utilizing a 100 mesh stainless steel filter coated with a diatomaceous earth (Kenite 3000™ or equivalent filter media). The liquid honey is preferably cooled immediately after the pasteurization and filtration steps. The temperature to which the honey is chilled is chosen to be below the temperature at which the seed honey to be added subsequently would melt and above the temperature at which hard granulation would occur. The most preferred temperature is 78° to 80° F. This temperature is preferably maintained until the final process step to be discussed below. The cooling step may be carried out with the same type of plate heat exchanger as that used for the pasteurization step. Finely ground seed honey is next added to the liquid honey. It is desirable that the seed honey be thoroughly mixed with the liquid honey but also that the mixing be sufficiently gentle to minimize air entrainment. In that regard a ribbon type mixer operated at a speed of 33 to 44 rpm, and preferably 44 rpm, has been found suitable. Seed honey is preferably added to comprise 25% of the total resulting honey volume. In that regard use of an insufficient amount of seed honey results in the formation of larger crystals resulting in a very coarse hard granulation. As indicated, the preferred amount of seed honey is 25% by volume of the total honey. Adding additional seed honey will produce the required product but simply increases production cost and reduces net yield. The seed honey is hard granulated honey which has been ground. It is preferably very finely ground to have a particle size which will freely pass through an 80 mesh screen. The mixture is then pumped through a positive displacement pump into a storage tank where it is held to allow substantially complete crystallization of the liquid to occur. The temperature requirement is as discussed above and is preferably maintained at 78° to 80° F. in the storage tank. The mixture is held in the tank until crystallization has advanced to the required extent. This period will normally be at least 96 hours. The crystallized honey is then transferred to a second storage tank. Again a positive displacement pump is preferably used to effect this transfer. The temperature is preferably maintained with the constraints discussed above and most preferably in the 78° to 80° F. range. The effect of the positive displacement pumps utilized in the transfer steps is to physically break down the honey crystals and crystal groups in such a way that they will not continue to grow or reform into groups. Any other means apart from a positive displacement pump may be utilized provided the desired breakup of crystals and crystal groups is achieved. The crystallized honey is preferably pumped a third time through the positive displacement pump or whatever other apparatus has been used to effect the crystal breakup. The honey is at this point preferably pumped directly to a filling line and into retail containers. While a great advantage of the product of the present invention is its use in squeezable bottles, it is of course possible to utilize any other conventional container. The temperature is preferably maintained in the 78° to 80° F. range through this third transfer and container filling step. The packaged product is then preferably placed in a cool storage area and held for a period of time sufficient to permit the crystallized honey to stabilize. This holding period is preferably carried out at a temperature of about 54° F. for a period of preferably at least 96 hours. The 54° F. holding temperature in the final step is in a range which is optimum for crystallization. Accordingly, in the event that the process steps have not been correctly carried out, so that crystal breakup has been insufficient to result in a stable product, it is highly likely that this storage step will provide evidence of that fact through the appearance of hard or granular crystallization. In the normal course, however, the product will after the stabilization period have an acceptable shelf life at room temperature. For example, the consistency and smoothness will be maintained for up to a year. At 54° F. or cooler, the product will have an essentially unlimited shelf life. Refrigeration is not, however, required. Thus it is apparent that there has been provided in accordance with the invention a process for the preparation of a creamed honey product that fully satisfies the objects, aims and advantages set forth above. While the invention has been described in conjunction with a specific embodiment thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art in light of the foregoing description. Accordingly, it is intended to embrace all such alternatives, modifications and variations as fall within the spirit and broad scope of the invention.

There is provided a new and useful honey product and a process for the preparation thereof, the process comprising adding a predetermined quantity of seed honey to a mass of honey, treating the mass of honey a first time to physically break up crystal groups, holding the mass of honey a first time for a predetermined period to allow crystallization, treating the crystallized honey at least one additional time to physically break up crystal groups, and holding the honey a second time for a predetermined period.

This application is a continuation-in-part of application Ser. No. 227,014, filed Apr. 13, 1994, now U.S. Pat. No. 5,571,149, which is a continuation-in-part of applications Ser. No. 082,131, filed Jun. 23rd, 1993 now abandoned, a continuation-in-part of application Ser. No. 877,873, filed May 4, 1992, now abandoned, which is a continuation of application Ser. No. 703,610, filed May 21, 1991, now U.S. Pat. No. 5,109,847, the disclosures of which are all incorporated herein by reference. BACKGROUND OF THE INVENTION 1. The Field of the Invention and Related Applications The invention of our prior application, now U.S. Pat. No. 5,109,847, generally relates to an apparatus that modulates the neurological responses associated with certain biological dysfunctions, neural pain, and pain caused by blood flow deficiency. More specifically, it is an apparatus and system for the treatment of selected pain and/or neural dysfunction-induced maladies. The invention of our prior application Ser. No. 127,163, now U.S. Pat. No. 5,421,817, relates to an apparatus for the topical iontophoretic administration of medication for the treatment of various conditions, and an apparatus for modulating neural responses using an additional modulation frequency. The present application relates to further improvements thereof; more specifically, to body and/or cranial stimulation using a triple-modulated TENS (transcutaneous electrical nerve stimulation), the TENS operating in the gigahertz frequency range (millimeter wavelength) and the modulating frequencies including those of the prior application, and preferably also including a sensory stimulation in combination therewith. 2. The State of the Art The sensation of pain is associated with numerous physiological and psychological ailments and is a universal experience of all complex living organisms. Pain, as the mental manifestation of a neurological response, is an important biological attribute and is critical to living and enabling a person (or other likewise sentient animal) to understand dangers in the environment and to adapt thereto. Concomitant with this important role, the alleviation of pain has been a fundamental goal of medicine and philosophy for as long as the medical profession has existed. Indeed, the ability to control the neurological pathways through which pain is conveyed has made complex procedures far simpler to implement and much less traumatic to the patient. There is a class of neurological response which is associated with pain that does not correspond to or act as a warning for a particular physical damage or biological dysfunction. In fact, many biologically important transitions are characterized by significant pain, such as the withdrawal period of an addict, during which time the addict's system is depleted of a specific endogenous narcotic. Other mental conditions which are neurologically response-dependent conditions include depression, hypertension, causalgia pain, insomnia and jet lag. Analogous to pain being an indication that the local environment is being dangerous, occurrences such as jet lag and drug withdrawal are both essentially a severe change in a person's environment. The importance of the ability to control neurological response and associated perceptions of pain and distress has led to the development of many pain control methodologies. The most common of which employs bio-active chemical agents that act to block neural transmission pathways within the body. These are designed to operate locally for spot treatment or broadly for generalized control or inhibition of pain response throughout the body. Chemical interference with pain signals has broad based appeal, but in many instances is unacceptable. For example, some chemicals have toxic side affects or cause allergic reactions to certain patients, and toxic side effects are not uncommon when two or more drugs are used in combination (whether or not for treating the same condition). For more chronic ailments, such as chronic migraine headache syndrome, repeated absorption of chemical narcotics may reduce the associated pain, but at unacceptably high costs associated with interference with routine activities, addiction, and/or toxicity of the narcotic. In view of the problems associated with chemical pain control, efforts have abounded to discover treatment approaches which would not involve pharmacological (chemical) interference with neural transmitters in the body. One approach that has recently sparked tremendous interest is the use of low power electrical stimulator devices capable of passing currents across key neural transmitter junctions in the body and thus effecting a blockage of neurological pathways which are inducing messages of pain to the brain. A practical implementation of this approach is disclosed in U.S. Pat. No. 3,902,502 to Liss et al.; the teachings of which are herein incorporated by reference. The system disclosed in the '502 patent presented a pulsed direct current waveform having a high frequency carrier modulated by a single low frequency modulation. It was discovered that this waveform was particularly successful at controlling symptoms of certain neurological disorders. Although effective for its applied treatment, many electrical stimulatory devices are limited to certain applications and lack the requisite flexibility for broad-based appeal. In addition, a drawback to the use of electrical stimulation to control pain is the concern by patients and others about the impact of power dissipation on the patient. Although low current, the power dissipation of many of the electrical stimulation devices is still quite significant. Efforts to reduce the applied power have resulted in stimulation devices with little or no physiological impact. There has been, therefore, a search for new electrical stimulation devices characterized by exceptional pain management capabilities while reducing the overall patient exposure to electrical energy. It is also clear that pain can be caused by organic physiologic conditions, trauma, infections, and the like. While systemic analgesic agents have been used with some success, it is often desirable to attempt administration directly to the area of the patient where the medication is required. This concept also has application to the administration of a wide variety of pharmacological agents. For example, Joseph Kleinkort delivered a presentation almost a decade ago at the USAFE Medical Convention in Garmisch, Germany, in which he described iontophoretic administration of hydrocortisone; the technique was referred to as transionic injection. Using two moistened electrodes and a particular type of micronized hydrocortisone dispersed in a petrolatum ointment base, it was found that transionic injection was as effective as percutaneous injection. The apparatus used by Kleinkort provided an electrical waveform to the electrodes which consisted of a carrier frequency of 12-20 KHz and a modulation frequency of 8-20 Hz. More recently, Sibalis in U.S. Pat. No. 5,135,478, the disclosure of which is incorporated herein by reference, described an electrical transdermal drug applicator which provides a particular waveform to counteract the apparent decrease in the amount of the pharmaceutical delivered as the duty cycle of the apparatus increases (i.e., the time during which current is "on" relative to the time current is "off"). Sibalis provides a waveform to the electrodes which comprises a negative conditioning pulse and a sequence of different waveforms which dilate blood vessels, impede coagulation and vasoconstriction, and thereby allow for better transdermal delivery of the drug. The complex waveform generally uses an AC carrier frequency of 1.5-3.5 MHz, a pulse width of 1.25-11.25 ms, and is modulated by both an AC modulated square wave at 250 Hz and a second AC modulator at 570-870 Hz. In what might appear to be in contrast to such rigor, there has been an increased awareness (in the Western world) of various non-western medical techniques, include acupuncture, Chakra, Shiatsu, and the use of "trigger points" in the body through which mediation of body "imbalances" or ailments is effected. Nevertheless, stimulation of the body through such techniques typically takes the form of mechanical energy (e.g., massage, manipulation, or pins inserted into the skin) or thermal energy (e.g., pins with a heat source (often comprised of incense or a botanical composition that will smoke) or hot, wet heat). There is presently still a need for improved apparatus and techniques for alleviating pain and discomfort. Further, there is a need for an integration of various techniques for treating pain and other discomfort, and especially where the techniques are from medical philosophies that are diverse if not also contradictory (e.g., western and eastern medicine). SUMMARY AND OBJECTS OF THE PRESENT INVENTION This invention may be summarized, at least in part with reference to its objects. It is, therefore, an object of the present invention to provide an apparatus for the selective generation of low current nerve stimulation waveforms configured to control pain and/or reduce the symptoms of certain neurological dysfunctions. It is another object of the present invention to provide an apparatus for generating a complex waveform that when applied to a patient involves very low power dissipation. It is a further object of the present invention to provide a pain control system that includes a means for creating a complex waveform and a data processing means for managing and recording the implementation of that waveform. It is yet another object of the present invention to provide a method for low power, electrically induced analgesic treatment by the placement of at least two electrodes on selected neurologically important sites and the controlled introduction of a complex waveform for a predetermined time forming a treatment regimen. It is still another object of the present invention to provide a method for treating the neurological dysfunctions associated with such ailments as diabetic neuropathy, depression, migraine headaches, PMS, and drug withdrawal. The above and other objects of the present invention are realized in a specific illustrative electrical stimulator device. This device includes a small DC power source and a means for converting the current output of the power source into a complex waveform as an output across two or more electrodes attached to the patient's body. The complex waveform includes a carrier frequency with at least two low frequency modulations, the result of which is used to modulate a TENS application in the gigahertz regime. This complex waveform may be further modulated in a synchronous or asynchronous mode using a conventional monopolar or preferably bipolar spike waveform. Typical frequencies for the bipolar spike waveform are 2 n where 0<n<8, or a randomly varying selection thereof, or a frequency between 1 and 256 Hz, or a continuously varying frequency in the range between 1 and 128 Hz or 60 to 120 Hz. The carrier frequency will preferably range between 1 KHz and 300 GHz. The first modulation to this carrier wave will have a frequency between 0.01 and 199 kilohertz (i.e., between 10 Hz and 199 KHz). The second modulation to the carrier will have a frequency range between 0.1 and 300 kilohertz (i.e., between 100 Hz and 300 KHz). An optional third modulation to the carrier will have a frequency in the range between about 0.1 and 1,000 Hz. Each modulation to the carrier is preferably a pulse train in the form of a square waveform. This resulting complex waveform of three components is then used to modulate (i.e., triple modulate) a millimeter wave signal in the GHz range. The placement of the electrodes will depend on the ailment of the subject of treatment and the chosen philosophy or discipline of the care provider (e.g., Eastern, Western, Chakra, acupuncture, homeopathic, etc.). The frequency of treatment will depend on the severity of the pain or dysfunction. In accordance with the varying aspects of the present invention, the stimulator device may include a digital data processor and stored programming for enhanced implementation of the prescribed treatment or lumped constant components. In this manner, the program controlling the output of the stimulator will prevent use beyond a number of times and beyond the time set for each use. The limits of number of uses and of length of time for each use will be set by the prescribing physician. This promotes and enhances the use of expressly developed treatment regimens by a prescribing physician. The patient's progress can be compared to patient compliance in the context of continuing the prescription or altering same on behalf of the patient. One object of our invention is to minimize the amount of electrical energy which must be applied to the patient to enable a suitable dosage of the drug to be administered. Yet another object of the invention is to avoid harsh sensation response to the electrical energy, thereby improving patient comfort and compliance with the procedure. On the other hand, many patients find it desirable to experience some level of sensory input (e.g., to know the apparatus is working), and so this invention in another embodiment provides the patient with a mild sensory stimulus indicative of the functioning of the apparatus. The foregoing features of the present invention may be more fully understood in view of the illustrative description presented below and the claims. BRIEF DESCRIPTION OF THE FIGURES FIGS. 1A-1G are representations of sample carrier, modulation, stimulatory TENS, and composite waveforms utilized in one embodiment of the present invention; FIGS. 2A-2G are representations of sample carrier, modulation, stimulator TENS, and composite waveforms utilized in another embodiment of the present invention. FIG. 3 is a block diagram of the inventive apparatus for generating the waveform depicted in FIG. 1. FIG. 4 is a logic flow chart of the data processing program controlling the operation of the apparatus of FIG. 2. FIGS. 5A and 5B are, respectively, anterior and posterior views of human dermatomes overlaid on a figure from A. Versalius' De Humani Corporis Fabrica (1555). FIGS. 6A-6D show examples of the placement of electrodes on a patient for administering the therapeutic waveforms of the present invention to such patient. FIGS. 7A-7C depict oscilloscope tracings showing the resistive load (7A) of a human body subject to the present system as well as the capacitive load (7B-7C). DESCRIPTION OF PREFERRED EMBODIMENTS Discussing the present invention first in overview, it is a fundamental desideratum to provide a portable non-invasive analgesia inducing apparatus that exhibits a selectively developed complex waveform of electrical output. This output is applied between at least two contact probes for generating intracorporal current. The placement of the probes will depend on the treatment regimen. For example, migraine headache syndrome may involve the placement of the contacting probes on each side of the patient's cranium, one at the primary site of pain and the second at the contralateral trapezius insertion. Other locations may include intraoral, e.g., for local analgesia to control the pain associated with a dental restoration procedure. Although the theory describing the underlying pain control phenomenon is not well known or, for that matter, even established, and while not desirous of being constrained to a particular theory, it is generally believed that the introduction of an intracorporal current acts upon the electrically conducted neural transmitters of the patient. It has been discovered that the particular complex waveform of the present invention when applied to a patient creates distinct changes in the blood plasma and cerebral spinal fluid concentration of such compounds as melatonin, serotonin, beta endorphin, norepinephrine and cholinesterase which are highly correlated with the pain/pleasure centers of the central nervous system. In operation, the present invention involves two functional attributes. The first involves the generation of the complex waveform of a select signature. The second attribute is directed to the implementation of the treatment in a delineated treatment regimen. With the above overview in mind, attention is first directed to FIGS. 1A-1F which presents the various components of the complex waveform of the present invention. More particularly, and starting with FIG. 1A, a graphical representation is provided of the carrier frequency for one specific time segment. In this representation, the carrier frequency equals 15 kilohertz. The amplitude is 40.0 volts peak max (DC) with a duty cycle of 50%. The waveform contains 25 bursts of 15 pulses for each burst. The period for each burst is 2 milliseconds and the period for each pulse is 66.7 microseconds. For each, the burst and the pulse, the duty cycle is 50% on time. Continuing, FIG. 1B presents the first modulation to the carrier frequency. In this example, the first modulation has a frequency of 15 Hertz and a duty cycle of 75%. The second modulation is depicted in FIG. 1C. The second modulation has a frequency of 500 Hertz and a 50% duty cycle. Continuing through FIG. 1D, the complex waveform combining the components depicted in FIGS. 1A through 1C are presented. The complex waveforms of the present invention may be generated with sinusoidal, sawtooth, hyperbolic or other wave shapes; for simplicity and clarity, the waveforms presented in FIGS. 1A through 1D and further discussed below have been exemplified by simple square waves. A cycle for the waveform will consist of 50 milliseconds "on" time, in which the pulses for that frequency combination are generated, and an "off" time of 16.7 milliseconds. Finally, in FIG. 1D, a complex waveform according to the present invention is provided, in which the polarity of the output is switched from positive to negative on a periodic basis, e.g., 67 ms, resulting in a bipolar waveform. For purposes of rough approximation, the energy dissipation in using the present invention is represented by the area under the pulses depicted in FIG. 1D. It can, therefore, be recognized that by adding the second modulation, having a 50% duty cycle, results in a 50% decrease in power dissipation. In another particular embodiment, wherein a monopolar waveform is used, the monopolar stimulation contains a 15 KHz square wave carrier which is rectified and which varies in current (via intensity adjustment) from zero to a maximum of about 4 ma. The first modulating signal of 15 Hz provides an "on" time of 50 ms and an "off" time of 16.7 ms. The second modulating signal of 500 Hz changes the "on" time series of the 15 KHz carrier pulses (750 pulses in 50 ms) into 25 minibursts of 15 pulses each of the 15 KHz carrier signal (375 pulses in the same 50 ms). In yet another embodiment wherein a bipolar stimulation is used, the bipolar waveform can be composed of the same just-aforementioned frequency specification, with each basic 15 Hz signal alternated positively and then negatively. In this manner, the first 66.7 ms period (50 ms of "on" time and 16.7 ms of "off" time) is a given voltage and the next 66.7 ms period is a voltage of the same absolute value but of the opposite sign. In summary, the carrier frequency will preferably range between 1 KHz and 300 GHz. The first modulation to this carrier wave will have a frequency between 0.01 and 199 kilohertz (i.e., between 10 Hz and 199 KHz). The second modulation to the carrier will have a frequency range between 0.1 and 300 kilohertz (i.e., between 100 Hz and 300 KHz). Preferred combinations for these three frequencies, and as also shown in the figures, include: 15 Hz, 500 Hz, and 15 KHz (FIGS. 1A-G); and 10 Hz, 100 Hz, and 3.3 KHz (FIGS. 2A-G); all values are preferably ±2%. As noted in the above U.S. Pat. No. 5,109,847, an optional third modulation of the carrier wave having a frequency range of 0.1 Hz to 1,000 Hz, more preferably 1-50 Hz, and most preferably 5-25 Hz can be utilized. In accordance with the present invention, the combined waveform, such as shown in FIG. 1D, is used to modulate a TENS signal, shown in FIG. 1E, or a stimulatory signal, administered to the patient. TENS devices are commonly known and used (e.g., as described by Katims, in U.S. Pat. No. 4,305,402, Rossen, in U.S. Pat. No. 4,989,605, the disclosures of which are incorporated herein by reference, and others), and by this invention the application of a TENS signal having conventional frequencies and durations is administered to a patient and modulated by means of the aforedescribed combined waveform. Two types of TENS devices are recognized by the American National Standard for Transcutaneous Electrical Nerve Stimulators #NS4 (a standard developed by the Assn. for the Advancement of Medical Instrumentation and approved by ANSI). One standard type of TENS device creates an accommodative or habituating condition that can be controlled by the patient; this type is believed to provide a counter-stimulation signal that is able to overload the body's one pain-communicating signal. Another type of conventional TENS device involves microcurrent stimulation ("MENS"). Particularly preferred TENS frequencies are 2 n where 0<n<8 (i.e., 1, 2, 4, 8, 16, 32, 64, and 128 Hz) and the frequency remains constant, or the frequency changes randomnly among those between one and 256 Hz in either a continuous or discontinuous manner (preferably continuous), or is some constant frequenct between one and 256 Hz or one randomnly and continuously or discontinuously varying therebetween (or between 60 and 120 Hz). Further, this TENS signal may be administered totally asychronously with any of the other signals (i.e., totally unmodulated), or may be synchronous with one or more of the other simple or complex waveforms and thus be modulated along therewith. In yet another embodiment of the present invention, gigaHertz (GHz) frequencies can be administered to the patient (these signals have wavelengths on the order of millimeters, near the boarder in the electromagnetic spectrum where "light" waves meet "radio" waves). In particular, the GHz signal is preferably provided as a bipolar signal. It is also preferred that the GHz signal be provided in the gap (silence) in the combined waveform when the first modulation is off the duty cycle, as shown in FIG. 1G; it can also be seen that the GHz signal likewise occurs when the duty cycle of the combined waveform-modulated TENS signal is off. For the UHF signal (ultrahigh frequency, i.e., the GHz signal), frequencies of 1 KHz to 300 GHz, preferably 100 MHz to 200 GHz, more preferably 20-100 GHz, and most preferably 50-75 GHz are used. As just described, and as shown in the Figures, the combined waveform, the TENS signal, and the GHz signal can be considered to be synchronized, the TENS signal being modulated by the combined waveform and the GHz signal occurring opposite thereto. In other embodiments, the TENS signal and/or the GHz signal can be administered asynchronously to the combined waveform and/or to each other; that is, the combined, TENS, and GHz signal can be in any combination of synchronicity or asynchronicity with each other. Although the square waveforms in FIGS. 1A-1F may not be of uniform height, it is preferred that the total current delivered in any combination of signals administered to the patient be in the range of about one to about 50 ma. The modulated waveform, with the optional bipolar spike waveform synchronous or asychronous therewith, can be administered to the patient using any of a number of the modulated subcombinations of signals as described herein. For example, using the waveforms depicted in FIG. 1, the patient can receive simultaneously the typical combined waveform of FIG. 1D and the TENS and/or bipolar stimulation signal (FIGS. 1E and 1F), and during the "off" portion of the duty cycle of these `combined` waveforms there is adminstered the millimeter wave GHz frequency signal (FIG. 1G). On the other hand, all of the signals can be modulated together, or any combination can be used. In fact, based on the empirical nature of medical treatment, whether in Eastern or Western medicine, it would likely be beneficial to the care provider to try different combinations (i.e., mutual modulations) of these signals to determine with which particular combination the patient finds the most relief. Turning now to FIG. 3, the functional elements of the inventive device are presented. The power source to the present system will either be a battery having nominal 9 volt terminal voltage or some rectified and properly transformed line (AC) power source. The battery provides the basic DC power source for generating the complex waveform. This is channeled and controlled by the voltage multiplier, 20. The output of the voltage multiplier 20 which is between 27 v to 40 v, is fed to signal generating circuit 60 which is the oscillating circuit that converts the constant DC output into the complex waveform having the desired characteristics. The specific constant current and current limited waveform generated by signal generating circuit 60 is pre-set by entering the various frequency settings for the two modulations, and the carrier. This may be entered manually through adjusting the settings on control panel 90. Alternatively, these settings may be stored in digital memory 40 as previously set values. The actual output of this system is regulated by monitor 70 which then provides the system output on a display, via control panel 90, or a memory value for subsequent retrieval from memory 40. The signal generating circuit 60 receives the voltage of 27 v to 40 v from the voltage multiplier. Within the signal generating circuit 60, the voltage branches off into a carrier frequency and two modulation frequencies. An example of the branching of the waveform is depicted in FIGS. 1A-1C. In FIG. 3, the system supports two separate probes for placement on the patient. Probe 63 represents the positive terminal as generated by signal generating 60. The second probe 65, is grounded within the circuit. For operation applying a bipolar waveform, the probes are connected to terminals 65 and 68, respectively. Terminal 68 is the output from reversing circuit 50, which may be present and which acts to flip the signal generating circuit pursuant to pre-set timing constraints. The following ancillary systems are also present in this circuit. The low battery and system on indicator 10 which monitors the battery output via voltage multiplier 20 generates an alarm signal when battery output voltage drops below the pre-set limit, say 7.0 volts. It also shuts the system down if the battery voltage falls below the preset limit of approximately 6.0 volts. The analog/digital converter 92 converts the signal from the signal generating circuit 60 so that the patient can read it. The analog/digital converter 92 reads the level of output and converts it to the appropriate signal for the four gate integrated circuit which uses that signal to turn on the appropriate sequence of four LEDs 110. Finally the impedance detector 160 is used to determine if the system is being used on a person (as opposed to someone just running the system without attaching it to a person). While conventional impedence detection/determining apparatus uses an alternating 1000 cycle signal, it is preferred in the present invention to use the preferred 15 KHz cycle as a reference for matching impedience. Impedence is then measured by determining the voltage across the 15 KHz leads on the patient's body. In other preferred embodiments, it is desirable for any device incorporating the present invention to have an indication verifying, if not also displaying, the impedance of the subject. In yet another preferred embodiment, it is desirable for such a device to have a detector to confirm the presence of millimeter wave energy; such a detector is constructed using a field detecting diode like analogous devices used for detecting laser energy (e.g., as in hand-held scanners). FIG. 4 depicts an exemplary flow chart of the timer unit 90 which the apparatus will use to monitor usage by the patient. A computer program embodying the protocol shown in the flow chart operating in combination with the present invention will prevent the patient from misusing the apparatus, and will allow the physician to set an individual treatment program and to monitor the patient's compliance to the set program. The timer unit 90 will allow the therapist to set the number of days the system is to be used, the number of times per day the system will be used, and the time duration for each use. In various embodiments, conventional timing circuits, preferably with associated audible alarms, can be set to provide 1, 2, 3, 10, 20, 30, 40, or 60 minutes of administration the waveform, or any particular duration as is desirable for affecting the patient. The program will start 800 with an Origination Decision module 810. The Origination Decision Module 810 will give the therapist three choices for use. If the Individualized Program 820 pathway is chosen, the timer unit will load the Individualized Program 820. Then the Individualized Program will begin with a display showing the Current Setting 900, for each of the parameters (i.e. the number of days of use, the number of times per day of use and the length of time for each use). Next the program will ask the therapist whether he wants to Keep the Current Settings 900, or Input New Settings 830. If the therapist wishes to use the same settings as are already registered in the program, the Individualized Program 820, will Store 860 the values and will End 840. However, if the therapist wishes to change the settings, the program will proceed to the Change Input Values 850 module in which the computer will ask the therapist for the new values for the settings. Then the computer will Store 860 the new values and will End 840. Another selection which a therapist may make at the Origination Decision Module 810 is to read the stored information from the patient's system. If the therapist decides to access the Read Stored Results 865 module,the Setting and Use information will be displayed 870, and the therapist will decide whether to store the patient information in the Patient Storage Module 880, or else it will Dump the information 890 and it will End 840. A final selection which the therapist may access through the Origination Decision Module 910, is actually to use the system. If this choice is the inputted selection, the Run Timed Program 910 will be initialized. The Run Timed Program 890 will read the stored 860 values. Then the program will Check 920 the Stored 860 values against the Current Running Settings 900 which is the values of the Run Timed Program 890 for this usage of the system. If the Current Running Settings 900 for the number of days of use is greater than the Stored 860 values, the program will End 840 without the system being turned on. Next, the Run Timed Program 890 will check the value of the Stored 890 values for the number of uses for a given day and if the Current Running Settings 900 is greater than the Stored 890 values for number of uses for a day, the system will End 840 for that day and the system will not be able to be used until the next day. Finally, as the system is being used, a Running Time Clock will be compared to the Run Timed Program, 890, and when the Current Running Settings in 900 is greater than the Stored 890 values for the length of time for that session, the system will End 840 for that session and the system will not be able to be used until the next session period. In operation, it is preferred to use a conventional monopolar or bipolar waveform; generally, the monopolar should be attempted first and, if the patient does not find relief, a bipolar waveform is then attempted. The modulated combined waveform (combined waveform modulation of a gigaTENS signal, optionally including a synchronous or asynchronous conventional spike waveform) is transmitted to the patient preferably using physiologically related reactive sites on the body. These sites can be derived from the meridians of acupuncture, from Chakra trigger points, from Shiatsu trigger points, or from dermatomes (neurogenic), myotomes (myogenic), or sclerotomes (osteogenic); examples of dermatomes on the male human body are shown in FIGS. 5A and 5B. In general, these "physiologically related reactive sites" effectively join what may appear as anatomically distant sites on the body but which, by Western, Eastern, or other acknowledged standards, are actually related to the same physiological condition. See. e.g., J. J. Keegan et al., "The Segmental Distribution of the Cutaneous Nerves in the Limbs of Man," Anat. Rec., 102:409 (1948); J. H. Martin, "Somatic Sensory System II: Anatomical Substrates for Somatic Sensation," in Principles of Neural Science, Ed. by E. R. Kandel et al. (North Holland, N.Y.: Elsevier, 1981); and Janet G. Travel et al., Myofascial Pain and Dysfunction: The Trigger Point Manual (Baltimore, Md.: Williams & Wilkins) (defining a "trigger point" as a focus of hyperirritability in a tissue that, when compressed, is locally tender and, if sufficiently hypersensitive, give rise to referred pain and tenderness, and sometimes to referred autonomic phenomena and distortion of proprioception). In general, the combined modulated waveform is preferably administered to the patient using electrodes. The positive electrode is typically placed on the spinous process and the negative electrode is placed distally of the positive electrode with respect to the location of the discomfort perceived by the patient. (It is not uncommon that alleviating one symptom will expose a prior existing condition which may, in fact, have been the cause of the perceived pain or other problem.) More particularly, the negative electrode(s) are preferably placed in the dermatome (or myotome or sclerotome, or along the acupuncture meridian, etc.) corresponding to the location of discomfort as well as distally from such location. Alternatively, for example, it may be desirable to place the negative electrode (or another negative electrode) at the point of insertion of the muscle apparently associated with the myotome of the location of the discomfort. (As is typical in the medical arts, treatment is performed on a empirical basis due to the unpredictability of many treatments.) As an example, if treatment of a patient using conventional TENS therapy is ineffective, the present invention can be used, with the electrodes placed as describe, and the intensity is increased until the patient feels any of the typical stimulation sensations (itching, pins and needles, warmth, or an insect-biting sensation). The intensity is then decreased and maintained just at subthreshold of this sensation (with further adjustments in intensity depending upon the patient's sensations). The treatment time is preferably for about 10 to about 60 minutes, and the skin condition is typically observed every 10 to 20 minutes to check for irritation. In another mode, where the equipment is so designed, the patient is immersed in a bath (preferably at least warm), the positive electrode is placed on the spinous process at the back of the neck above the water line, and the negative electrode is placed in the water for whole body stimulation (only low, microcurrents should be used). This invention can be used in the treatment and/or prophylaxis of such conditions as migraine headaches, tension headaches, sinus headaches, tic doloreux, TMJ (tribomandibular joint) syndrome, post-herpetic facial neuralgia, stress, spasticity, depression, drug dependence or withdrawal, anxiety, insomnia, general or localized muscle pain (e.g., neck, shoulder (e.g., bursitis), elbow (e.g., tennis elbow), back (e.g., sciatica), wrist (e.g., carpal tunnel syndrome and other repetitive motion disorders)), post-operative pain, arthritis, phantom limb pain, finger pain, shingles, decubitus ulcers, gastroenterological pain, and other maladies. FIGS. 6A-6D depict schematic representations of electrode placements for treating various maladies, specifically (in respect of the figures) bursitis, postoperative pain, GI pain, and TMJ pain. In general, blood flow is increased towards the negative electrode. The embodiment of the above description has been based on discrete components to enhance the understanding of the functional characteristics of the system. Numerous modifications and adaptations thereof will be readily apparent to those skilled in the art without departing from the spirit and scope of the present invention.

This invention provides a system and apparatus for treating neurally responsive conditions by use of a novel combined waveform in combination with, and preferably modulated onto, a gigaTENS waveform administered to a patient. This modulated combined waveform can also be administered synchronously or asynchronously with a conventional mono- or bipolar spiked waveform, useful for TENS applications and/or for stimulatory input to the patient.

[0001] This application claims the benefit under 35 U.S.C. 119(e) of the filing date of Provisional U.S. Application Ser. No. 61/542,688, entitled Suture Anchor, filed on Oct. 3, 2011, which application is herein expressly incorporated by reference, in its entirety. BACKGROUND OF THE INVENTION [0002] There are many suture anchor designs on the market today which are intended to secure suture, wherein the suture is passed through soft tissue to bone. Preferred methods often use anchors that do not require placing knots in the suture to secure the tissue to the anchor. This shift has allowed for a simpler, less time consuming procedure. Also, the knots have been shown to be a common source of anchor failure. [0003] However, the knotless anchors have many challenges. Many anchors can change the tension in the suture during deployment, which requires the surgeon to estimate how much tension will be added during the final installation step. This can result in under- or over-tensioning of the tissue against the bone. Anchors that allow the suture to be tensioned after the anchor is implanted can be complicated, with many components which lead to expensive and unreliable anchors. These types of anchors can have user-assisted tensioning devices that can lead to over-tensioned suture that have the ability to pull the anchor out of the bone. [0004] Other anchors that allow the suture to be tensioned prior to implanting the anchor can leave the sutures with uneven tension. Also, many of the anchors are unable to utilize more than two suture ends and have undesirable metal components. [0005] There have been many different anchors used t secure suture to bone. As described above, the knotless anchor designs are preferred due to knot failures. [0006] The PUSHLOCK™ anchor, marketed by Arthrex, is a two-part anchor. The tip of the anchor has an eyelet through which the suture legs are loaded. This tip is placed at the bottom of a hole drilled into the bone. At this point, the surgeon may adjust the tension on the suture, thereby pulling the tissue closer to the surface of the bone. Since the suture is tensioned all at once, without any engagement with the hole when the rear portion of the anchor is driven into the hole, the tension may not be correct. Once the rear portion of the anchor is in the hole, the suture tension cannot be adjusted. [0007] Smith and Nephew market the KINSA™ suture anchor. This anchor is a knotless design made of PEEK (polyether ether ketone) which is tapped into a pre-drilled hole in the bone. The anchor is preloaded with suture tied in a one-way sliding knot within the anchor body, which allows the surgeon to adjust the tension after the anchor has been deployed. This cannot utilize suture that is already passed through tissue and only can provide a simple stitch in the tissue. [0008] The POPLOK™ by Conmed Linvatec is another knotless anchor. It is a two piece polymer anchor that has the ability of accepting and tensioning the suture individually prior to locking the suture to the anchor. However, the anchor has multiple pieces that can fail. [0009] The VERSALOK™ by Mitek is also a knotless anchor. It is a two piece polymer and metal design that has the ability of accepting and tensioning the suture individually prior to locking the suture to the anchor. It does have multiple parts forming the anchor and the inner member is metallic. [0010] The CUFFLINK™ Knotless and CUFFLINK SP™ Knotless suture (self punching with metal tip) anchors, also marketed by Mitek, are fabricated of PEEK, using a one-piece polymer design without the employment of any metal. The design allows the anchor to accept more than two suture ends, and each of these ends can be tensioned or have tension released individually by hand, prior to final anchor deployment, providing the surgeon the ability to achieve the desired tension on each suture. The anchor may also accept tissue (such as a tendon, ligament, zenograft, allograft, or collagen scaffold) with or without suture, enabling a direct tissue to bone repair. The metal tip version allows the anchor to be malleted directly into the bone without the need for a pilot hole. Finally, the design incorporates a metal deployment device to provide strength to the anchor during deployment, thereby reducing breaking of the anchor. SUMMARY OF THE INVENTION [0011] The present invention provides a suture or tissue anchor which is intended to secure suture or tissue to bone. There are many soft tissue to bone repair procedures, such as rotator cuff, SLAP (Superior Labral tear from Anterior to Posterior), and Bankart lesion repairs, or reconstruction of labral tissue to the glenoid rim, in which a surgeon needs to secure tissue in close contact with bone. Often the bone surface is roughened, and when tissue is pulled into intimate contact, the body's healing response will fuse the tissue and bone together. This suture is then passed through the soft tissue at the desired location, and the suture is secured to the anchor by tying a knot. Other methods include passing suture through the tissue first and then fastening the anchor and suture to the bone without knots. [0012] More particularly, there is provided in one aspect of the present invention an anchoring system for securing tissue to bone, which comprises an implant having a body which includes a suture eyelet extending transversely therethrough, a suture recess extending along a portion of a length of the body, having a predetermined depth below an outer surface of the body; and a suture pinch ramp disposed at a proximal end of the suture recess. The suture pinch ramp has a depth approximately equal to the predetermined depth at a distal end thereof and sloping outwardly in a proximal direction so that a depth of a proximal end of the suture pinch ramp approaches zero. [0013] Preferably, the implant further comprises external surface features for securing the implant within surrounding bone. These external surface features comprise bone barbs. Suture barbs are disposed on the outer surface of the body at a proximal end thereof, for clamping suture or tissue between the outer surface of the body and adjacent bone. Bone displacement tabs are disposed on a distal portion of the implant body, for displacing bone distal to suture for allowing optimal suture sliding during initial deployment of the anchor. [0014] An inner cavity is provided in the anchor body, having an opening at a proximal end of the anchor body for receiving an insertion device. The anchoring body further comprises a suture cleat adjacent to the suture pinch ramp. [0015] The anchoring system further comprises an insertion member which is engageable with the anchor body to deploy the anchor in bone. The insertion member comprises a proximal handle portion and an insertion tube connected to a distal end of the handle portion. A suture pulley rod is extendable from and retractable into a distal end of the insertion tube. A pair of cleat retainers are provided on a distal end of the pulley rod, wherein a gap is disposed between the pair of cleat retainers. A rotatable knob is disposed on the handle portion for retracting and extending the pulley rod relative to the insertion tube. A knob release slide disposed on the handle. [0016] In another aspect of the invention, there is disclosed a method for securing soft tissue to bone, which comprises steps of driving an implantable anchor having a body distally into a desired bone site, using an insertion device, to a predetermined initial deployment depth, and applying pressure to suture or tissue disposed between the anchor body and adjacent bone, using a recess disposed on an outer surface of the body and a pinch ramp also disposed on the outer surface of the body, proximal to the suture recess. Additional steps include tensioning free ends of the suture or tissue disposed between the anchor body and adjacent bone to a desired level, withdrawing a pulley rod proximally into an insertion tube comprising a portion of the insertion device, and driving the implantable anchor a further distance distally into the bone site to finally deploy the anchor. The suture or tissue is pinched between barbs on an outer surface of the implant body and adjacent bone and also between cleats on both sides of the anchor body to lock the suture or tissue in place. Further inventive method steps include withdrawing the pulley rod from the anchor body and releasing the insertion device therefrom; and trimming the free suture ends to complete the procedure. [0017] In still another aspect of the invention, there is provided an anchoring system for securing tissue to bone, which comprises an insertion member which is engageable with an anchor body to deploy the anchor body in bone. The insertion member comprises a proximal handle portion, an insertion tube connected to a distal end of the handle portion, and a suture pulley rod extendable from and retractable into a distal end of the insertion tube. A pair of cleat retainers are disposed on a distal end of the pulley rod, wherein a gap is disposed between the pair of cleat retainers. A rotatable knob is provided on the handle portion for retracting and extending the pulley rod relative to the insertion tube, and a knob release slide is disposed on the handle. [0018] The invention, together with additional features and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying illustrative drawing. BRIEF DESCRIPTION OF THE DRAWINGS [0019] FIGS. 1-4 are isometric views of an implantable anchor constructed in accordance with the principles of the present invention, illustrating the anchor from four different perspectives; [0020] FIG. 5 is an elevational view of the anchor of FIGS. 1-4 ; [0021] FIG. 6 is an elevational view similar to FIG. 5 , from an opposed orientation; [0022] FIG. 7 is an isometric view of the insertion system of the present invention; [0023] FIG. 8 is an isometric view similar to FIG. 7 illustrating the assembled insertion system and anchor of the present invention in position to be deployed; [0024] FIG. 9 is an isometric view similar to FIG. 8 , wherein the assembly is being inserted into a desired bone location; [0025] FIGS. 10-13 are isometric views illustrating the insertion system of the present invention, including the handle portion; [0026] FIG. 14 is an elevational view illustrating a first step of a method of using the present invention; [0027] FIG. 15 is an isometric view showing the same step as that shown in FIG. 14 ; [0028] FIG. 16 is an elevational view similar to FIG. 14 with the suture removed for clarity; [0029] FIG. 17 is an isometric view similar to FIG. 15 with the suture removed for clarity; [0030] FIG. 18 is an elevational view showing a second step of the described inventive method; [0031] FIG. 19 is an isometric view of the step illustrated in FIG. 18 ; [0032] FIG. 20 is an elevational view similar to FIG. 18 , with the suture removed for clarity; [0033] FIG. 21 is an isometric view similar to FIG. 19 , with the suture removed for clarity; [0034] FIG. 22 is an elevational view showing a third step of the described inventive method; [0035] FIG. 23 is an isometric view of the step illustrated in FIG. 22 ; [0036] FIG. 24 is an elevational view similar to FIG. 22 , with the suture removed for clarity; [0037] FIG. 25 is an isometric view similar to FIG. 23 , with the suture removed for clarity; [0038] FIG. 26 is an elevational view of the anchor of the present invention showing a step which is performed prior to final deployment of the anchor; [0039] FIG. 27 is an elevational view similar to FIG. 26 , showing the illustrated step from a different orientation; [0040] FIG. 28 is an elevational view illustrating the first step of the inventive method which is also shown in FIGS. 14-17 , with the suture removed for clarity; [0041] FIG. 29 is an elevational view similar to FIG. 28 , illustrating the second step of the inventive method which is also shown in FIGS. 18-21 , with the suture removed for clarity; [0042] FIG. 30 is an elevational view similar to FIGS. 28 and 29 , illustrating the third step of the inventive method which is also shown in FIGS. 22-25 , with the suture removed for clarity; [0043] FIG. 31 is an elevational view similar to FIG. 30 , showing the proximal withdrawal of the suture pulley rod in accordance with the method of the present invention; and [0044] FIG. 32 is an elevational view similar to FIGS. 28-31 , showing the final completed deployment of the inventive anchor. DESCRIPTION OF THE PREFERRED EMBODIMENT [0045] The inventive system and methods disclosed herein comprise a simple-to-insert suture anchor which allows adjustment of suture or tissue tension prior to deployment, does not change the tension on the suture or tissue (and as a result, the captured tissue) when it is deployed, does not require a knot to secure the suture or tissue, and accepts multiple suture ends. [0046] Referring now more particularly to the drawings, there is shown in FIGS. 1-6 a suture anchor 10 constructed in accordance with the principles of the present invention. The anchor 10 comprises a body 12 having a plurality of proximal suture barbs 14 , as well as bone barbs 16 . A portion of the outer surface of the body 12 comprises a suture recess 18 . An inner cavity 20 ( FIG. 3 ) is provided for accommodating a suture pulley rod, to be described below. The distal end of the anchor body 12 includes bone displacement tabs 22 . [0047] Within the suture recess 18 are disposed a suture pinch ramp 24 , a suture cleat 26 , and a suture eyelet 28 , which extends transversely through a width of the body 12 so that it is open to opposing sides of the body. [0048] Now with reference to FIGS. 7-13 , the insertion system 30 for the anchor 10 will be described. The insertion system or inserter 30 comprises a suture pulley rod 32 ( FIG. 7 ), suture cleat retainers 34 on the distal end of the pulley rod 32 (also FIG. 7 ), and an insertion tube 36 . In some embodiments, an optional metal distal tip 38 ( FIG. 9 ) may be employed. [0049] A handle portion 40 of the insertion system 30 is illustrated in FIGS. 10-13 . The handle portion 40 comprises a knob release slide 42 and a proximal knob 44 . [0050] The anchor 10 has a number of features that are important to its innovative function. For example, the suture barbs 14 pinch the suture against the surrounding bone when the implant is deployed. The remaining barbs are the bone barbs 16 , distal to the suture barbs 14 , function to engage the bone during the initial and final deployment. The suture recess 18 , because of its recessed profile relative to remaining portions of the outer surface of the body 12 , allows the suture to slide between the anchor body and adjacent bone during the initial deployment. The inner cavity 20 for the suture pulley rod 32 , allows for the metal suture pulley rod 32 to support the anchor during initial deployment. The bone displacement tabs 22 displace the bone distal to the suture to allow for optimal suture sliding during initial deployment. [0051] The suture pinch ramp 24 helps to maintain tension during individual tensioning of the suture. It is configured to slope outwardly in a proximal direction, so that its distal end is at a depth approximating the depth of the suture recess 18 and its proximal end is at the outer surface of the implant body 12 , i.e. a depth of approximately zero. The suture cleat 26 pinches the suture to increase the suture pullout strength of the construct. The suture eyelet 28 allows for one or more suture ends to be placed in the implant. Each suture end is individually tensionable, as well be described below. Though the tip 46 of the anchor 10 is illustrated as being closed, as shown in FIG. 9 , the optional metal tip 38 may be added to the anchor 10 to allow for the anchor to be inserted directly into bone without the requirement of a pilot hole. [0052] The insertion system 30 , as well, has several important features which contribute to the innovative function of Applicant's inventive system. In particular, the suture pulley rod 32 , in the initial deployment stage, allows the suture to move freely in the suture eyelet 28 , by preventing the suture from entering the suture cleat 26 . The pulley rod 32 also increases the strength of the anchor 10 by extending to the distal tip 46 of the anchor body 12 during initial deployment. The insertion tube 36 , as well as the pulley rod 32 , transmits the insertion force from a mallet to the anchor during initial deployment. Rotation of the proximal knob 44 actuates a mechanism that retracts the pulley rod 32 between initial and final deployment stages. The knob release slide 42 releases the knob 44 to allow for removal of the inserter 30 after final deployment. The suture cleat retainers 34 maintain a set gap in the suture cleat 26 during final deployment. [0053] The remaining FIGS. 14-32 will now be referenced in connection with a description of methods of using the inventive system to deploy an anchor 10 in bone 48 . [0054] To deploy the anchor 10 in a suitable bone site, suture 50 is first passed through soft tissue (not shown) requiring repair. Viewing, for example, FIG. 19 , the suture loops 51 in the suture 50 would normally be occupied by the soft tissue to be approximated against the bone 48 , but that tissue is not shown, for clarity. Alternatively, soft tissue itself may be anchored directly in place within the desired bone site 48 , rather than using suture 50 , in which case the tissue is manipulated in the same way as the suture to be described in this explanation. For this reason, though the term “suture” is used throughout this specification, for convenience, the term should be considered sufficiently broad to include other media having similar functional characteristics, including soft tissue itself. A pilot hole 52 ( FIGS. 9 and 28 ) is drilled or punched into the attachment site (bone 48 ), through the cortical bone layer 54 and into the cancellous bone layer 56 . In some circumstances, the optional metal distal tip 38 may be employed ( FIG. 9 ), in which case the step of drilling a pilot hole is unnecessary. The suture is then fed through the suture eyelet 28 , as shown in FIGS. 14 and 15 , directly or with a snare. One or more suture ends 58 , 60 ( FIG. 15 ) may be placed through the eyelet 28 . [0055] With the anchor 10 and attached inserter 30 positioned at the desired bone site, as shown in FIGS. 14 and 15 , initial deployment of the anchor 10 can occur. It should be noted that FIGS. 16 and 17 , and FIG. 28 , illustrate the same step as FIGS. 14 and 15 , with the suture 50 removed for clarity. To initiate this initial deployment, a mallet is driven against the proximal end of the handle portion 40 to drive the anchor 10 distally to its initial deployment position, as shown in FIGS. 18 and 19 , and also in FIGS. 20 and 21 , and 29 , with the suture again removed for clarity. At this juncture, the suture recess 18 is acting to apply pressure to the sutures or tissue 50 disposed between the outer surface of the anchor body 12 and the adjacent bone surface, as well as against the suture pinch ramp 24 . This pressure maintains the tension on the suture 50 . [0056] The free suture ends 58 , 60 may be individually tensioned around the suture pulley rod 32 to approximate the tissue within the suture loops 51 up against the anchor and repair site and its surrounding bone 48 . If the suture is over-tensioned, a probe may be used to loosen the tissue side of the suture. [0057] Once the desired tension is achieved, the suture pulley rod 32 is pulled proximally into the insertion tube 36 , by rotating the threaded proximal knob 44 on the handle portion 40 until further rotation is prevented. When the tube 36 is retracted by the rotation of knob 44 , the gap of the suture cleat 26 is exposed. At this point, the suture cleat retainers 34 are in position on either side of the suture cleat 26 . This retracted pulley rod position is illustrated in FIGS. 26 and 27 , which is the position required prior to the final insertion step. As noted above, the suture cleat 26 is exposed and held open by the suture cleat retainers 34 , which thus allow the suture to pull into proper position during final insertion. [0058] At this juncture, the final deployment steps are initiated, as shown in FIGS. 22 and 23 , and also in FIGS. 24 and 25 , and 30 , wherein the suture 50 has been removed for clarity. With the gap of the suture cleat 26 maintained by the suture cleat retainers 34 , the inserter handle 40 is again malleted, directing insertion force into the insertion tube 36 until the anchor 10 rests below the surface of the bone, as shown in FIG. 30 . Because the suture 50 has maintained an equal distance from the surface of the bone, post-tensioning and post-final deployment, the tension in the suture 50 is maintained. If additional tension is required, the anchor can be malleted deeper into the bone, pulling the suture ends with it, thereby increasing tension. [0059] The suture 50 is now pinched between the suture barbs 14 and the bone on the tissue side of the anchor, as shown in FIG. 23 . It is also pinched between the suture cleats 26 on both sides of the anchor body 12 . Finally, the free suture ends 58 , 60 are pinched between the suture barbs 14 and the bone opposite to the tissued side of the anchor. [0060] The suture pulley rod 32 may now be pulled out of the anchor body 12 , as shown in FIG. 31 , releasing the inserter 30 by actuating the knob release slide 42 to allow the threaded knob 44 to be free to rotate. The knob 44 is then rotated until the inserter is released from the implant. At this juncture, the free suture ends can be cut, as shown in FIG. 32 , which completes the repair. [0061] Accordingly, although an exemplary embodiment of the invention has been shown and described, it is to be understood that all the terms used herein are descriptive rather than limiting, and that many changes, modifications, and substitutions may be made by one having ordinary skill in the art without departing from the spirit and scope of the invention, which is to be limited only in accordance with the following claims.

An anchoring system for securing tissue to bone includes an implant having a body through which a suture eyelet extends transversely, a suture recess extending along a portion of a length of the body, having a predetermined depth below an outer surface of the body, and a suture pinch ramp disposed at a proximal end of the suture recess. The suture pinch ramp has a depth approximately equal to the predetermined depth at a distal end thereof and sloping outwardly in a proximal direction so that a depth of a proximal end of the suture pinch ramp approaches zero. An insertion member includes an insertion tube and a handle which is engageable with the anchor body to deploy the anchor in a selected bone site.

RELATED APPLICATIONS [0001] This patent application is related to the following co-pending and commonly assigned applications: U.S. patent application Ser. No. ______, entitled “Tachyarrhythmia Therapy Selection Based On Patient Response Information,” filed on Nov. 23, 2004 (Attorney Docket No. GUID.198PA); and U.S. patent application Ser. No. ______, entitled “Template Generation Based On Patient Response Information”, filed on Nov. 23, 2004 (Attorney Docket No. GUID.203PA), both of which are hereby incorporated by reference. TECHNICAL FIELD [0002] This patent document pertains generally to administration of antitachyarrhythmia therapy, and more particularly, but not by way of limitation, to arrhythmia memory for tachyarrhythmia discrimination. BACKGROUND [0003] Arrhythmia is an abnormal rhythm of the heart. A tachyarrhythmia is an abnormally fast heart rhythm. A tachyarrhythmia originating in the ventricular region of the heart is called a ventricular tachyarrhythmia (VT). Ventricular tachyarrhythmia can produce symptoms of fainting, dizziness, weakness, blind spots, and potentially, unconsciousness and cardiac arrest. A tachyarrhythmia that does not originate from the ventricular region of the heart is called a supraventricular tachyarrhythmia (SVT). An SVT episode typically originates from an impulse arising in the atrium, the atrioventricular node (AV node), or the bundle of His. SVT episodes tend to be much less lethal than VT episodes. [0004] Treatment for cardiac tachyarrhythmia can be administered by a medical device, such as a pacemaker or a defibrillator, which can be implanted in the human body. These devices can be configured to sense an intrinsic electrical heart signal and analyze the signal to determine whether a tachyarrhythmia is occurring. Such devices can also be configured to deliver antitachyarrhythmia therapy, such as electric stimulation. Improved cardiac rhythm management methods and systems are needed. BRIEF DESCRIPTION OF THE DRAWINGS [0005] In the drawings, which are not necessarily drawn to scale, like numerals describe substantially similar components throughout the several views. Like numerals having different letter suffixes represent different instances of substantially similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document. [0006] FIG. 1 is a schematic illustration of medical device and a heart. [0007] FIG. 2A is a flow chart that illustrates a process in which a degree of similarity is determined between a SVT template and a heart signal. [0008] FIG. 2B is a flow chart that illustrates a process in which a degree of similarity is determined between a SVT template and a heart signal. [0009] FIG. 2C is a flow chart that illustrates a process in which a template is generated for an arrhythmia morphology that does not require antitachyarrhythmia therapy. [0010] FIG. 3 is a flow chart that illustrates a method in which a degree of similarity is determined between a monitored heart signal and a SVT template selected from a group of candidate SVT templates. [0011] FIG. 4 is a flow chart that illustrates a method in which a heart signal is compared to a normal sinus rhythm and a SVT template. [0012] FIG. 5 is a flow chart that illustrates methods by which a SVT template is discarded from a storage medium and a new SVT template is added. [0013] FIG. 6 is a flow chart that illustrates an embodiment of a process in which a heart signal from a tachyarrhythmia episode is compared to a normal sinus rhythm (NSR) template and then compared to a supraventricular tachyarrhythmia (SVT) template. [0014] FIG. 7 is a block diagram of an implantable device. [0015] FIG. 8 shows an example of a normal sinus rhythm morphology. [0016] FIG. 9 shows an example of a SVT morphology. DETAILED DESCRIPTION [0017] The following detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments, which are also referred to herein as “examples,” are described in enough detail to enable those skilled in the art to practice the invention. The embodiments may be combined, other embodiments may be utilized, or structural, logical and electrical changes may be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents. [0018] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one. In this document, the term “or” is used to refer to a nonexclusive or, unless otherwise indicated. Furthermore, all publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls. [0019] In varying examples, a morphological template can be generated from a tachyarrhythmia episode and used to identify a later episode. For example, a tachyarrhythmia episode can be detected by an implantable medical device and analyzed to determine whether the episode is a type that necessitates antitachyarrhythmia therapy. In one example, a morphological graph of a tachyarrhythmia episode is presented to a human analyst, such as a physician, and an assessment of the tachyarrhythmia episode is received from the human analyst. The assessment can, for example, include an input that indicates whether the human analyst deems the tachyarrhythmia episode is a VT episode or a SVT episode. In another example, the tachyarrhythmia episode can be analyzed by a computer to determine whether it is a VT or SVT episode. The computer can be in an implanted medical device, or external to the patient. A morphological template can be generated from the tachyarrhythmia episode and later used to identify a similar episode as it is occurring. For example, if a tachyarrhythmia episode correlates with an SVT template, an SVT can be declared, i.e. the episode can be identified as an SVT and treated accordingly. Templates can be selected or discarded based a variety of factors including conditions in the patient or characteristics of arrhythmias. [0020] In an example, a template is a sampled data representation of a heart depolarization. In another example, a template is a set of selected features from a sampled data representation of a heart depolarization. In another example a template is generated from multiple SVT beats, for example by taking an average of several beats. [0021] FIG. 1 shows a schematic illustration of an exemplary medical device 10 and a heart 20 . A processing circuit 30 communicates with a sensing circuit 40 and an antitachyarrhythmia therapy circuit 50 . The sensing circuit 40 detects an intrinsic electrical signal from a heart. The antitachyarrhythmia therapy circuit 50 delivers defibrillation or other antitachyarrhythmia therapy to the heart 20 . The processing circuit 30 analyzes input from the sensing circuit 40 and directs the antitachyarrhythmia therapy circuit 50 to administer antitachyarrhythmia therapy as necessary. The processing circuit 30 also sends information to a memory circuit 60 . [0022] The memory circuit 60 includes a storage medium, such as solid state RAM. In an exemplary configuration, the processing circuit 30 sends data received from the sensing circuit 40 during a tachyarrhythmia episode to the memory circuit 60 and the memory circuit 60 stores the data for later reference. The processing circuit 30 also communicates with a wireless communication system 70 . The wireless communication system 70 sends data to or receives data from an external system 80 , which typically includes a display system on which a user can view a graphical representation of the data. The medical device 10 can be configured as an implantable device, but is not necessarily implantable. While one processing circuit is shown, examples of the medical device including multiple processors are also possible. In varying examples, the processor is in a device implanted in the patient, or in a device such that is external to the patient, such as a programmer or a remote computer system. [0023] FIG. 2A is a flow chart that illustrates a process in which a SVT episode is identified and declared. At 210 , an implantable medical device senses an intrinsic heart signal. At 220 , the medical device stores a portion of the intrinsic electrical heart signal that was sensed during a tachyarrhythmia episode. At 230 , a user indicates whether the portion of the intrinsic electrical heart signal is considered to be indicative of a SVT. In an alternative embodiment, a processor analyzes the portion of the signal to determine whether it is indicative of a SVT. If the portion of the intrinsic electrical heart signal is determined to be indicative of a SVT, a SVT template is generated at 240 . In an example, a processor in the implanted medical device generates the template. In another example, the template is generated on an external computer system and downloaded to the implanted medical device. Various techniques can be used to generate the template. In an example, the template consists of one heart beat from the SVT episode. Alternatively, the template includes more than one heart beat. In an example, the template consists of the actual data from the intrinsic electrical heart signal as the template. Alternatively, a processor converts the intrinsic electrical heart signal data into a file that requires less storage space than the original data. [0024] Returning to FIG. 2A , at 250 , a processor determines at least one degree of similarity between a second portion of the heart signal from a later tachyarrhythmia episode and at least one SVT template. The degree of similarity is a quantity that is computed through an algorithm that uses the sensed intrinsic electrical heart signal (or a derivative thereof) as an input. In varying examples, determining the degree of similarity includes computing a feature correlation coefficient, a wavelet coefficient, or areas or integrals of a heart signal waveform or an approximation thereof. In varying examples, determining the degree of similarity involves computation of data in the time domain, wavelet domain, frequency domain, or other domains. [0025] At 260 , the device declares the second portion of the heart signal to represent a SVT episode if the degree of similarity exceeds a threshold valued. In one example, a processor in the medical device declares a SVT episode if a feature correlation coefficient for a heart beat exceeds a threshold. In another example, a processor declares a SVT if multiple feature correlation coefficients for respective multiple beats exceed a threshold value. In one scenario, a SVT is declared if a specified fraction of heart beats in a sequence of beats (e.g. 3 out of 10 beats) exhibit a feature correlation coefficient that exceeds a threshold. In another example, a SVT is declared if an average feature correlation coefficient for a number of beats exceeds a threshold (e.g. the average for 10 beats≧0.94). [0026] In an example, the processor determines a degree of similarity between the second portion and multiple SVT templates. In one example, the processor begins determining degrees of similarity for the second portion for a sequence of templates and stops determining the degree of similarity if the degree of similarity for one of the templates exceeds a threshold. In other words, the processor compares the heart signal to a sequence of templates until a template match is found or all the templates are used. In another example, the portion of the heart signal is compared to all of the templates regardless of whether a match is found, and an SVT is declared if the degree of similarity for any one of the templates exceeds a threshold. [0027] In addition to supraventricular tachyarrhythmia (SVT) episodes, a heart can exhibit other types of tachyarrhythmia that do not warrant antitachyarrhythmia therapy, including some instances ventricular tachyarrhythmia (VT). Such other non-lethal VT episodes can also be identified and used to generate templates. [0028] FIG. 2B is another flow chart that illustrates a process in which a degree of similarity is determined between a SVT template and a heart signal. At 212 , an implantable medical device senses an intrinsic heart signal. At 222 , the medical device stores a tachyarrhythmia portion of the intrinsic electrical heart signal that was sensed during a tachyarrhythmia episode. At 232 , a processor determines at least one degree of similarity between the tachyarrhythmia portion of the heart signal and at least one SVT template. At 242 , the processor determines whether the at least one degree of similarity exceeds at least one threshold value. In an example, the processor determines degrees of similarity for multiple beats and determines whether the degree of similarity exceeds a threshold for at least a predetermined fraction of the beats (e.g. 3 out of 8 beats). If the at least one degree of similarity exceeds at least one threshold value, the portion of the heart signal is declared to represent a SVT episode and antitachyarrhythmia therapy is suppressed, at 252 . If the at least one degree of similarity does not exceed at least one threshold value (e.g. fewer than 3 out of 10 beats exhibit a degree of similarity in excess of a threshold), the portion of the heart signal is declared to represent a VT episode and antitachyarrhythmia therapy is delivered, at 262 . The portion of the heart signal is stored and later presented to a user. If, at 272 , an input from the user indicates that the portion is indicative of SVT, an SVT template is generated at 282 . If another tachyarrhythmia event occurs, the process returns to box 232 and determines at least one degree of similarity between the tachyarrhythmia portion of the heart signal from the next tachyarrhythmia event and at least one SVT template, which can be the template generated at 282 . If the user input does not indicate that the portion is indicative of SVT, a template is not generated, at 292 . [0029] FIG. 2C is a flow chart that illustrates a process in which a template is generated for an arrhythmia morphology that does not require antitachyarrhythmia therapy. At 205 , an implantable medical device senses an intrinsic heart signal. At 215 , the medical device stores one or more portions of the intrinsic electrical heart signal that were sensed during a tachyarrhythmia episode. At 225 , a graphical representation of one or more stored portions of the intrinsic electrical heart signal is presented to a user. At 235 , the user provides input that identifies at least one tachyarrhythmic portion of the intrinsic electrical heart signal that did not require antitachyarrhythmia therapy. The portion of the intrinsic electrical heart signal that did not require antitachyarrhythmia therapy can be, but is not necessarily, indicative of SVT. At 245 , input is received from a user designating at least one portion of the intrinsic electrical heart signal that should be used to generate a template. At 255 , a template is generated from a portion of the heart signal designated by the user. In an embodiment, an external computer system receives the input from the user to generate the template, which is downloaded to the implantable medical device. In another example, the user communicates directly with the implantable medical device, which generates the template. In an example, the user designates multiple portions of the heart signal, and multiple templates are generated. [0030] Referring again to FIG. 2C , At 265 , a processor in the medical device determines one or more degrees of similarity between a second portion of the intrinsic electrical heart signal from a later tachyarrhythmia episode and the template. At 275 , the processor determines whether the one or more degrees of similarity exceed a threshold value. If the one or more degrees of similarity exceed a threshold value, the processor suppresses an antitachyarrhythmia therapy at 285 . [0031] In an alternative embodiment, in lieu of presenting a graphical representation to a user and receiving an input, a portion of the heart signal is analyzed automatically by a processor to determine whether antitachyarrhythmia therapy is appropriate. [0032] FIG. 3 is a flow chart that illustrates a method in which a degree of similarity is determined between a monitored heart signal and a SVT template selected from a group of candidate SVT templates. At 305 , a medical device monitors a heart signal. At 310 , portions of the heart signal that are indicative of SVT are identified. In varying examples, the portions that are indicative of SVT can be identified by a physician, for example, or identified by an automated computerized analysis. At 315 , portions of the heart signal that are indicative of SVT are stored as candidate SVT templates. The candidate template can be stored with a corresponding heart rate at which the template was observed. One or more selection protocols can be used to select a SVT template from a group of candidate SVT templates when analyzing a later tachyarrhythmia episode. For example, at 320 , a SVT template is selected from a group of candidate templates based upon the heart rate associated with the candidate templates. The processor selects a template having a heart rate that is closest to the heart rate of the later tachyarrhythmia episode. Alternatively, at 325 , a candidate SVT template is selected based other information about the patient. In an example, the drug treatment regimen of a patient is considered in the selection of a SVT template. The morphology of SVT episodes in a patient can vary depending upon the drug treatment regimen of the patient. In one example, the medical device stores information about drug treatment regimens associated with the tachyarrhythmia episodes used to generate the candidate templates. The current drug regimen is also stored in the device. The processor selects a SVT template based upon a similarity between the drug treatment associated with the selected template and the current drug treatment. In another example, the medical device detects one or more of neural activity, patient activity, sleep state, hemodynamic status, transthoracic impedance, or cardiac impedance. In further examples, the device detects REM (random eye movement) status, sympathetic/parasympathetic tone, intercardiac blood pressure including right ventricular pressure, left atrial pressure, or pulmonary artery pressure, oxygen saturation, heart size and contractability, blood flow, or edema. In varying examples, the medical device considers one or more of these parameters in selecting an SVT template. In another example, the processor identifies one or more characteristics of the patient, and selects a SVT template using statistics from other patients having similar characteristics. In varying examples, the characteristics include (but are not limited to) as height, weight, age, disease history, medication, and patient status (such as neural activity, blood pressure, etc.) In another alternative, at 330 , a candidate SVT template is selected based upon multiple factors. In an example, both the heart rate and the drug treatment regimen are taken into consideration. [0033] At 335 , the processor determines a degree of similarity between the heart signal from the later tachyarrhythmia episode and the selected SVT template. The processor compares the degree of similarity to at least one threshold, at 340 . If the degree of similarity falls below a threshold, a SVT episode is not declared. In an example, if a SVT episode is not declared, the medical device declares a VT episode at 341 and delivers a ventricular antitachyarrhythmia therapy at 342 . Alternatively, other determinations can be made before the medical device administers ventricular antitachyarrhythmia therapy. [0034] If the degree of similarity does exceed a threshold, the medical device declares the heart signal from the later tachyarrhythmia episode to represent a SVT episode at 345 . The medical device then suppresses ventricular antitachyarrhythmia therapy at 350 . [0035] FIG. 4 is a flow chart that illustrates a method in which a heart signal from a tachyarrhythmia episode is compared to a normal sinus rhythm and to a SVT template. At 405 , a medical device senses an intrinsic electrical heart signal. The medical device monitors the heart rate at 410 . At 415 , the medical device compares the heart rate to a threshold. If the heart rate does not exceed the threshold, the medical device continues sensing the heart signal but does not perform a tachyarrhythmia discrimination algorithm. If the heart rate does exceed a threshold, the medical device declares a tachyarrhythmia episode at 420 . At 425 , the medical device compares the tachyarrhythmia portion of the heart signal to the normal sinus rhythm (NSR) template for the patient. In an example, the medical device computes a feature correlation coefficient between the tachyarrhythmia portion of the heart signal and the NSR template. If the tachyarrhythmia portion of the heart signal sufficiently correlates with the NSR template (e.g. the feature correlation coefficient exceeds a threshold), the medical device declares the tachyarrhythmia portion of the heart signal to represent a SVT episode at 430 and suppresses a ventricular antitachyarrhythmia therapy during the episode, at 435 . [0036] If the tachyarrhythmia portion of the heart signal is not similar to the NSR template, at 440 the medical device determines a degree of similarity between a portion of the heart signal and a SVT template. At 445 , the medical device determines whether the degree of similarity exceeds a threshold. If the degree of similarity exceeds a threshold, the medical device declares the portion of the heart signal to represent a SVT episode at 450 . In an example, declaring the portion of the heart signal to represent a SVT episode merely means making a determination to executing a response that is consistent with a SVT, such as suppressing a ventricular antitachyarrhythmia episode at 455 . [0037] If, at 445 , the degree of similarity does not exceed a threshold, the medical device stores the tachyarrhythmia portion of the heart signal at 460 . The stored portion is displayed to a user at 465 and an input is received from the user at 470 . At 475 , if the user indicates that the heart signal is indicative of SVT, a template is generated from the tachyarrhythmia portion of the heart signal, at 480 . [0038] FIG. 5 is a flow chart that illustrates examples of methods by which a SVT template is added and an old SVT template is discarded. A medical device monitors a heart signal at 510 . Portions of the heart signal that are indicative of SVT are identified at 520 through computer analysis or input from a user. The medical device stores the portions of the heart signal that are indicative of SVT as SVT candidate templates at 530 . At 540 , the medical device discards the oldest SVT template. Alternatively, the medical device tracks the frequency of similarity of a portion of the heart signal from a tachyarrhythmia episode to one of a plurality of SVT templates at 550 and discards the SVT template exhibiting the least frequent similarity with the heart signal and saves a new template at 560 . In another alternative example, the medical device discards a SVT template with a heart rate similar to heart rates of other SVT templates at 570 . In the example at 580 , the medical device discards a SVT template that is associated with a discontinued drug therapy regimen. In the example at 590 , the medical device discards a SVT template that is most correlated to other SVT templates. In varying examples, a decision of which template to discard is made by a computer system, the medical device, or a user who inputs a direction to discard a template. [0039] FIG. 6 is a flow chart that illustrates an example of a process in which a heart signal from a tachyarrhythmia episode is compared against a normal sinus rhythm (NSR) template 630 and then a supraventricular tachyarrhythmia (SVT) template 660 . At 610 , a tachyarrhythmia episode is detected. A NSR correlation module 620 computes a NSR feature correlation coefficient (FCC) for 10 heart beats. If the NSR feature correlation coefficient is equal to or greater than 0.94 for 3 out of 10 beats, the correlation module 620 declares a SVT and a SVT protocol 640 is followed. If the fewer than 3 out of 10 beats have a NSR feature correlation coefficient greater than or equal to 0.94, a SVT correlation module 650 computes a SVT feature correlation coefficient for the 10 heart beats. If the SVT feature correlation coefficient is equal to or greater than 0.95 for 3 out of 10 beats, the SVT correlation module 650 declares a SVT. If fewer than 3 out of 10 beats have a SVT feature correlation coefficient equal or greater than 0.95, the episode is treated as a ventricular tachyarrhythmia (VT) and a VT protocol is followed. For example, VT protocol 670 can include administration of antitachyarrhythmia therapy. [0040] FIG. 7 is a block diagram of an exemplary implantable device 700 incorporating a processor 710 and that runs software modules to analyze a signal from a heart 720 through a lead 770 . A sensor 720 detects an intrinsic electrical heart signal. The processor 710 receives the signal from the sensor 720 and interprets the signal to determine whether an antitachyarrhythmia therapy should be delivered. A similarity module 740 determines a degree of similarity between portion of the heart signal from a tachyarrhythmia episode and a SVT template representative of a previous SVT episode. A suppress therapy module 750 suppresses a ventricular antitachyarrhythmia therapy if the degree of similarity exceeds a threshold value. SVT templates are stored in a memory circuit 760 . A lead 770 delivers ventricular antitachyarrhythmia therapy as directed by the processor. [0041] While the present examples have generally been described in terms of an implanted or implantable device, the presently described examples can also be implemented in non-implantable devices and systems. [0042] FIG. 8 shows an example of a normal sinus rhythm morphology. FIG. 9 shows an example of a SVT morphology. In an example, a template includes a morphology for a single beat, as shown in FIG. 8 . In another example, a template includes multiple beats, as shown if FIG. 9 . In another example, a template for an atrial tachyarrhythmia can be created. The atrial tachyarrhythmia template can be used to declare a future episode of atrial tachyarrhythmia and suppress antitachyarrhythmia therapy as appropriate. [0043] Varying algorithms can be used to generate a template and determine the degree of similarity between a heart signal and a template. In one example, a set of pre-determined rules are used to locate a number of points on a waveform, and those points are used as the template for comparison against a heart signal. In an example, eight pre-determined points can be located. In one example, the maxima, minima, and inflection points are located. The located points are stored as the template. Features are extracted from a portion of the heart signal by aligning the portion of the heart signal with the template. In an example, a peak on the template is aligned with a peak on the portion of the heart signal from one beat of a tachyarrhythmia episode. The amplitude of the points on the portion of the heart signal is measured at times corresponding to the points in the template. To determine the degree of similarity, a feature correlation coefficient (FCC) is computed using the amplitudes measured from the signal and the amplitude in the template. Computation of the feature correlation coefficient is further described in U.S. Pat. No. 6,708,058, which is incorporated herein by reference in its entirety. [0044] In an example, a cardiac rate channel signal and a shock channel signal are sensed. The rate channel signal is measured from a sensing tip to a distal coil on a lead. The shock channel is measured from a distal coil to a proximal coil of the RV lead. A fiducial point is determined from the cardiac rate channel signals. A shock channel signal is aligned using the fiducial point. A template is generated using the aligned shock channel signal. Use of signals from rate and shock channels is further described in U.S. Pat. No. 6,708,058, which is incorporated by reference in its entirety. In other examples, a signal is sensed and then aligned using the same channel from which it was sensed. [0045] In another example, a processor computes a wavelet transform or Fourier transform of the signal from which a template is to be generated. A predetermined number of largest wavelet coefficients are saved as a template. Features are extracted from a heart signal by aligning the peak of the signal with the peak of the template and computing the wavelet transform of the aligned tachy beat waveform. A predetermined number of largest wavelet coefficients are saved. The sum of the absolute value of the differences between the saved wavelet coefficients and the wavelet coefficients in the template is determined and divided by the sum of absolute value of the wavelet coefficients in the template. The resulting value is subtracted from 1 and multiplied by 100 to provide a “percent match score”, which is compared to a threshold. In an example, the threshold is 70%, and beats having a percent match score greater than or equal to 70% are considered SVT in origin. In an example, if 3 out of 8 beats are SVT, an SVT episode is declared. Wavelet-based algorithms are further discussed in U.S. Pat. Nos. 6,393,316 and 5,782,888, which are incorporated herein by reference in their entirety. [0046] In another example, a heart signal waveform is approximated as three consecutive triangles. The areas of each of the triangles is calculated and saved in a template. To extract features from a portion of a heart signal, peaks in the heart signal are aligned with the template, and the heart signal is approximated as three triangles. The area of each of the three triangles is calculated. To determine the degree of similarity to the template, a “similarity score” is determined based on the sum of the differences in the areas of the signal triangles and the template triangle. The similarity score is inversely proportional to this sum. If the similarity score is greater than a threshold, the beat is considered SVT in origin. If a predetermined number of beats exceed a threshold, an SVT episode is declared. [0047] The preceding descriptions of techniques for determining a degree of similarity are considered exemplary. Other techniques, or variations of the described techniques, can be employed with the methods described in this application. [0048] It is to be understood that the above description is intended to be illustrative, and not restrictive. For example, the above-described embodiments (and/or aspects thereof) may be used in combination with each other. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects. [0049] The Abstract of the Disclosure is provided to comply with 37 C.F.R. § 1.72(b), requiring an abstract that will allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, it can be seen that various features are grouped together in a single embodiment for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment.

This document discusses, among other things, a method of identifying a non-fatal tachyarrhythmia episode by determining a degree of similarity between the episode and a template generated from a previous tachyarrhythmia episode.

FIELD OF THE INVENTION The field of the present invention relates generally to amusement devices and systems, and more specifically to such devices and systems that are responsive to a missile such as a ball striking a target for causing a seat or platform to swivel downward, dropping therefrom an object or person sitting upon the seat prior to the missile striking the target. BACKGROUND OF THE INVENTION In Gaus, U.S. Pat. No. 1,991,610, a complicated mechanical apparatus is disclosed for dropping a person from a seat into a pool of water upon the striking of a ball or like missile on a target. The mechanism includes a plurality of bevel gears, level arms, rods, and so forth, for concurrent with the seat moving downward to drop the person, causing an animated object to move toward the person as he drops into the water. In Abraham et al, U.S. Pat. No. 3,262,704, when a target is struck by a missile, a rod having one end connected to the target is moved in a manner for unlatching a mechanism holding, at a height, an animated object, for permitting the object to fall downward via a guided slotway. SUMMARY OF THE INVENTION The present invention includes a target mounted upon one end of an elongated and pivotally mounted target arm, whereupon the striking of a missile against the target, the target moves in a direction causing the other end of the target arm to engage and rotate a latching bar means in a direction for releasing latching cam means, in turn causing a seat associated therewith to swivel downward for dropping a person or other object into a water tank, whereafter means are provided for automatically resetting the present apparatus by merely rotating the seat back to its original, upright and latched position. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be hereinafter more specifically described with reference to some exemplary embodiments as shown in the drawing wherein like items are indicated by the same reference designation: FIG. 1 is a front perspective view, from the right, of a preferred embodiment of the invention; FIG. 2 is a front perspective view, from the right, showing more details than FIG. 1 of certain components; FIG. 3 is a detail perspective view, from the rear, showing the target tripping mechanism and seat asssembly; FIG. 4 is a detail perspective view, of a portion of the right side of the tripping mechanism; FIG. 5 is a rear detail view of the invention; FIG. 6 is a partial detail view, of the left side, of the invention; FIG. 7 is a partial detail view, of the right side, of the invention; FIG. 8 is a partial detail view, of the front, of the invention; FIG. 9 is an exploded front perspective detail view from the right of the water tank of the invention; FIG. 10 is an exploded front perspective detail view from the left of a portion of the seat assembly of the invention; FIG. 11 is a perspective view of the construction of a latching tooth of the invention; and FIG. 12 is a perspective view of the drain assembly for the water tank of the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention was actually reduced to practice by the present invention as shown in the FIGS. 1 through 12, and with reference to Table 1 showing the material and dimensions used for substantially each item. Although specific materials, dimensions, and hardware are indicated in Table 1, such indications are for purposes of example only and not meant to be limiting, in that different dimensions, hardware, and materials may be substituted therefore without deviating from the spirit and scope of the invention. With reference to FIGS. 1 through 7, and Table 1, the various items of the invention are either welded or bolted together, or otherwise secured. A canopy 45 is provided for shielding a person sitting on seat 8 from the sun, and for cosmetic purposes. Typically, the frame is fabricated from steel tubing and angle iron, for example. TABLE 1__________________________________________________________________________REF. REF.NO. DESCRIPTION NO. DESCRIPTION__________________________________________________________________________ 1 1 ea. @ 1/8" × 48" × 48 " * ALUMINUM 27 1 ea. @ 11/2" × 11/2" × 16 ga. × 5'0" STEEL TUBE 2 1 ea. @ 3/16" × 47 3/4" × 48" * 28 1 ea. @ 1" dia. × 55" × 171/2" STEEL ALUMINUM LATCH BAR 3 4 ea. @ 11/2 dia. × 4'3" * 29 1 ea. @ 1" × 1" × 14 ga. × 18" STEEL ALUMINUM TUBE ANGLE 4 3 ea. @ 21/2" × 21/2" × 3/16" 30 2 ea. STEEL LATCHING TEETH ALUMINUM ANGLE 5 4 ea. @ 1" dia. × 2" LONG × 1/4" 31 2 ea. @ 3/8 " × 21/4" CAM BOLT, NUT EYEBOLT & LOCK WASHER 6 4 ea. SPRINGS 32 4 ea. @ 1/4" × 11/4" STAINLESS HEX BOLT, NUT, & LOCK WASHER 7 2 ea. @ 1/4" × 1" × 1" HARDENED 33 12 ea. @ 11/4" × 11/2" HEX BOLT, NUT, STEEL D NOTCH STOPS OR STEPS & LOCK WASHER 8 1 ea. @ 1/4" × 16" × 44" * 34 24 ea. @ 1/4" × 11/4" STAINLESS STEEL ALUMINUM SEAT HEX BOLT NUT, & LOCK WASHER 9 5 ea. @ 1" BALLBEARING PILLOW 35 8 ea. @ 3/8" × 21/2" CAM BOLT, NUT, BLOCK & WASHER10 1 ea. @ 1" dia. × 48" * 36 68 ea. @ 1/4" × 11/4" STAINLESS STEEL HEX ALUMINUM BAR BOLT, NUT, & LOCK WASHER11 2 ea. @ 1" × 51/2" * ALUMINUM 37 6 ea. @ 3/8" × 21/2" CAM BOLT, NUT, LATCH SPINDLE & WASHER12 1 ea. @ 48" × 48" × 236. ACRYLIC 38 2 ea. @ 3/8" × 2 3/4" CAM BOLT, NUT, PLASTIC (CLEAR) & WASHER13 1 ea. @ 471/2" × 48" × 1/2" ACRYLIC 39 1 ea. @ 3/32" × 2" × 47" * ALUMINUM PLASTIC (CLEAR)14 1 ea. @ 1/4" × 11/2" × 2" × 4'5" 39' 2 ea. @ 3/32" × 2" × 451/2" * ALUMINUM STEEL ANGLE15 4 ea. @ 1" × 1" × 16 ga. × 9'0" 40 8 ea. @ 1/4" × 2" × 4" * ALUMINUM ANGLE STEEL TUBE16 2 ea. @ 1" × 2" × 1" × 16" × 1/4 41 1 ea. @ 1/4" × 3" × 7" × 3" STEEL STEEL CHANNEL BRACKET17 4 ea. @ 3" × 31/2" × 1/4" STEEL 42 1 ea. @ 3/4" × 3/4" × 5'0" × 16 ga. WINDOW BRAZE TARGET ARM18 4 ea. @ 1" × 1" × 1/8"× 4'0" 43 1 ea. @ 10" dia. × 16 ga TARGET STEEL ANGLE WINDOW FRAME19 8 ea. @ 1" × 1" × 1/8" × 4" 44 DRAIN BUSHING (1" TANK ADAPTER) STEEL ANGLE FRAME BRACKET20 4 ea. @ 1" × 1" × 16 ga. × 4'2" 45 1 ea. @ 7'6" × 4'6" CANOPY STEEL TUBE21 3 ea. @ 1" × 1" × 16 ga. × 4'0" 46 4 ea. @ 1/2" × 3/16" COUNTERSUNK BOLT STEEL TUBE22 8 ea. @ 1" × 2" 1/8" × 4" STEEL 47 1 ea. @ 1" × 2" × 1" × 4 3/4" × 1/4" ANGLE FRAME BRACKET STEEL CHANNEL23 1 ea. @ 1" × 1" × 16 ga. × 4'1/2" 48 1 ea. @ 1" × 41/2" VERTICAL SHAFT STEEL TUBE24 2 ea. @ 11/2" × 11/2" × 16 ga. × 9'2" 49 1 ea. ALUMINUM LADDER STEEL TUBE 50 2 ea. RUBBER BUMPER25 1 ea. @ 11/2" × 11/2" × 16 ga. × 4'3" 101 1 ea. 1" × 3" PIPE NIPPLE STEEL TUBE26 2 ea. @ 11/2" × 11/2" × 16 ga. × 47 103" 1 ea. 1" GATE VALUE STEEL TUBE * 606-T6 TEMPERED ALUMINUM__________________________________________________________________________ As shown in FIG. 8, the front of the target apparatus of the invention further includes a clear or transparent shield 12 of acrylic plastic, for example, for protecting a person sitting on seat 8 from being struck by an errant ball or like missile thrown at target 43. One example of a method of mounting the shield 12 is via use of the hardware indicated, including window frame 18 and window brazes 17. Also, the front panel 13 of the water tank (see FIG. 9) is fabricated from a clear or transparent material such as acrylic plastic, for example. The transparent shield 12 and panel 13 permit observers to see a person sitting on the seat 8, and falling into a tank of water subsequent to a missile striking target 43, as will be described. The sides 2' and back 2, and the bottom 1, of the water tank are fabricated from aluminum sheets, and assembled together, as shown in FIG. 9, using aluminum tubing 3, angle 4, struts 39, 39', and angles 40. Appropriate sealing material is used around the seams of the water tank to make it leak proof. A tank adapter 44 is mounted through the back panel of the tank near the bottom panel 1, as shown. FIG. 12 shows a pictorial of the drainage system 44, 101, 103, that protrudes from the outside surface of the back panel 2. Rubber stops 50 are included on the upper inside surface of the back panel 2 for dampening the fall of the seat 8. In FIG. 10, the seat assembly includes a seat 8 welded to a bar 10 (also see FIGS. 2 and 3). The latch spindles 11 are welded to the spindle bar 10 proximate its ends, respectively, as shown. Ballbearing pillow blocks 9 are used to rotationally secure the ends of the spindle bar 10 to the inside surface of the frame 24. With reference to FIGS. 3 and 11, latch teeth 30 are fabricated from steel members 30', 30", 30"' via welds W as shown. An eyebolt 5 is welded to one of members 30"' as shown, with the ends of members 30"' being welded to latch bar 28, and positioned as shown. With reference to FIGS. 1, 2, and 3, a target 43 is rigidly mounted upon an extreme end of a target arm 42. A vertical shaft 48 is rigidly attached to the underside of target arm 42 near the latter's other end, with the end of the shaft 48 being rotationally mounted via a bushing 9 to a protruding end of a cross member 27, as shown. The horizontally aligned portion of latch bar 28 is mounted via bushings or ballbearing pillow blocks 9, and channels 16 to vertical members 24. One end of latch bar 28 is bent at about ninety degrees and oriented as shown for engaging an end portion of target arm 42. A U-shaped bracket 41 is mounted to cross member 27 as shown, for providing a stop means for limiting the movement of target arm 42 and latch arm 28 which are moveable between the upright arms of bracket 41. Springs 6 are mounted between one arm of bracket 41 and eyelets 5 on either side of vertical shaft or pivot arm 48, as shown, for urging target arm 42 against the end of the bent portion or vertically oriented portion of latch arm 28. Other springs 6 are mounted between eyelets 5 attached to latch spindles 11 and their associated latching teeth 30, respectively, for urging the latching teeth 30 against their associated latch spindles 11. Such spring biasing ensures that the latching teeth 30 firmly engage the notch stops 7 (see FIG. 10) of latch spindles 11, respectively, for ensuring that the seat 8 is firmly latched into its upright position in the ready or cocked state of the present target apparatus invention. Also, the combination of the spring biasing of the target arm 42, and latch spindles 11 with associated latch teeth 30, provides for automatic resetting of the apparatus by merely raising the seat 8 to its latched position, as will be described below. In operation, water is placed in the water tank, and the seat 8 is latched into its upright position as shown in FIGS. 1 through 3. A person climbs a ladder 49 (partially shown in FIG. 1) and sits on seat 8 above the water tank. When a ball or like missile strikes target 43, the associated end of target arm 42 moves back, causing its other end to move foward and rotate latch arm 28 in a direction for lifting the latching teeth 30 away from the notch stops or surfaces 7 of the spindle latches 11, respectively, permitting the seat 8 to swivel downward, dropping the person seated thereupon into the water. The spindle latches 11 will also rotate in the same direction as the seat. When seat 8 so swivels downward or drops it will strike the rubber stops or bumpers 50 mounted on the back of the tank, as previously mentioned. The present target apparatus is thereafter reset by raising up the seat 8 until the latching spindles 11 rotate back to a position permitting the latching teeth 30 to drop down against the notch stops 7, respectively, thereby completing the latching or cocking operation. As the latching teeth 30 so drop into their respective latching positions with their associated latch spindles 11, latch arm 28 is automatically rotated and moves the target arm 42 back into its cocked position. Although particular embodiments of the present invention have been shown and described, other embodiments may occur to those of ordinary skill in the art which fall within the true spirit and scope of the appended claims.

A missile responsive amusement apparatus comprising a target mounted upon one end of an elongated target arm, the latter being pivotally mounted to a box-like frame, whereupon when a missile strikes the target, the target arm pivots in a direction causing its other end to engage and rotate a latch bar for lifting latching teeth out of notches located in a pair of spindle cams, thereby releasing a spindle bar to which a seat is attached for rotation in a direction causing the seat to swivel downward for dropping a person sitting thereupon into a tank of water below the seat. Thereafter, via spring biasing of the spindle cams and target arm, the apparatus can be reset by rotating the seat upward until it latches in its upright position via the latching teeth engaging the notches of the spindle cams attached to the spindle bar, while concurrently causing the latching bar to rotate for pivoting the target arm back to its "cocked" or "ready" position.