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CROSS REFERENCE TO RELATED APPLICATION This application is a continuation-in-part of U.S. Ser. No. 12/713,380 filed Feb. 26, 2010 which is a continuation of U.S. Ser. No. 61/254,784 filed Oct. 26, 2009. BACKGROUND OF THE INVENTION This invention is directed toward a method of producing cellulose encased preformed, peeled and pack sausages, and more particularly a method of producing food safe and/or peeled and pack encased sausages. Presently, during production, preformed sausages are provided with a cellulose, collagen, alginate (or a combination) casing that is (at least partially) removed before the sausages are packed. The casing provides, during production, a temporary peelable cover that controls the shape of the dough. In addition, preformed sausages may be provided during the production process with a cellulose-casing that is (at least partly) removed before the sausages are packed. The casing to be removed enables the production of sausages with controlled shape from dough that is not to be shaped as desired without the temporary peelable cover. After production of the covered sausage the sausages are initially heated such that the sausages are fully cooked. The sausages are then actively cooled down to temperatures below 4° C. for thermo shocking the sausage such that the casing loosens. Shocking occurs by exposing the encased sausages to an environment having a different temperature such as for example using cold water or cold air. Steam may also be used to shock the sausage. Once shocked the encased sausages may be introduced to a peeler where the casing is removed from the sausages. The peeled sausages may afterwards be auto loaded using a loader into a packaging machine and packed to enable transport, storage and/or preservation of the sausage. The package may vary, and well known types of packages are foil, jars, tins, packs and so on. The preformed peeled and packed sausages are exposed to the environment after heating (to effect the sausage hardening) and peeling but before packaging. Such sausages are potentially exposed to pathogen contaminants such as Listeria or Salmonella. When consumed, pathogen infected food products can cause serious illness or even death. Present production methods attempt to minimize this risk by post packaging treatments such as high pressure pasteurization, post heat pasteurization and irradiation. While these treatments produce a food-safe product, they also degrade the quality of the product, are complex to use and/or are costly. Therefore, a need exists in the art for a method that produces safe preformed peeled and packed sausages, while maintaining a high quality product reducing production costs, and being easy to perform. An objective of the present invention is to provide an efficient method of producing safe preformed peeled and packed sausages that maintains high product quality. Another objective of the present invention is to provide an effective method of producing preformed peeled and packed sausages that reduces production costs and energy consumption. A still further objective of this invention is to provide a method of producing preformed peeled and packed sausages where the method is easy to perform. In an additional embodiment a method for producing preformed peeled packed sausages, comprising the steps of subsequently: A) heating an encased sausage; B) peeling a casing from the sausage at a sausage surface temperature of at least 20° C.; and C) packing the peeled sausage. The heating of the encased sausage during step A) results in the at least partial hardening of the sausage dough (e.g. meat, fish and/or organic dough) due to e.g. the at least partial coagulation of proteins enhancing the rigidity of the sausage to withstand any further production process steps. The sausage is peeled when the sausage minimum surface temperature during peeling is at or above 20° C., even to or at least 30° C., at least 40° C. or at least 50° C. Alternatively, other minimum surface temperatures for the sausages during peeling may be applied; e.g. minimum of 25° C., 35° C., 45° C. or 55° C. The advantage of keeping the sausage temperature at a higher level during the “hot peeling” is that less energy is required for cooling down the sausage between the heating during step A) and the peeling during step B). The less cooling also requires less cooling time (thus limiting the total production process time of preformed peeled packed sausages) and less cooling (equipment) capacity. Shortening processing time and limiting the (cooling) capacity of the equipment required both contribute in enhancing the efficiency of the production of preformed peeled packed sausages. The process is faster, simpler, easier to perform, energy saving and less costly particularly as compared to irradiation and high pressure processing. The method also increases capacity, improves yield, eliminates the need for anti-microbial additives, improves shelf life, eliminates microbial contamination and is compliant with HACCP standards. These and other objectives will be apparent to one skilled in the art based upon the following disclosure. SUMMARY OF THE INVENTION A method of producing preformed peeled, encased and pack sausages including partially cooking an encased sausage, hot peeling the encased sausage, and finishing the cooking of the sausage inside the final packaging. The critical control points such as the high temperature for lethality and the low chill temperature are monitored and controlled by a controller. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a flow diagram of a method of producing cellulose encased sausages. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Generally, the method involves the development of a cooking process where the casing of the sausage is hot peeled in an undercooked state and then fully cooking and chilling the product within the packaging. Initially, through a conventional process, a casing is filled, linked, hung, and transported to an oven. Next, the encased sausages are heated (or partially cooked) to preferably an internal temperature of between 125° F. to 145° F. so that enough of the sausage proteins are coagulated to make the sausages sufficiently rigid to withstand the remaining production process. The cooking time for this step is based upon the oven temperature and the diameter and composition of the sausage. Preferably, in one example, the sausages are exposed to a natural smoke or liquid smoke shower and then exposed to a first cooking zone having a 140° F. dry bulb and a 100° F. wet bulb for a desired period of time. Optionally, the sausages are then exposed to a second natural smoke or liquid smoke shower before entering a second cooking zone. The second cooking zone preferably has a 158° F. dry bulb and a 130° F. wet bulb. Once the sausages reach a desired internal temperature, the encased sausage is shocked so that the casing is loosened from the sausages. Shocking occurs by exposing the encased sausages to an environment having a different temperature such as for example using hot water, cold water, or steam. Once shocked, the encased sausages are introduced to a peeler where the casing is removed from the undercooked sausages. This is different from the conventional process where an encased sausage is fully cooked prior to peeling. The process of undercooking, shocking and peeling is defined as hot peeling. Preferably, hot peeling occurs when the encased sausages are peeled at a temperature where the sausages are in an undercooked state, but not chilled (approximately between 100° F. and 140° F.). Once peeled the sausages are auto loaded using a loader into a packaging machine and vacuum packed. After the sausages have been vacuum packed, the packages are cooked to lethality preferably in hot water. The cooking can be continuous or intermittent. Intermittent cooking is particularly beneficial for double stacked products to avoid over cooking of the outside of the product. Once the packaged sausages are cooked, the products are chilled, preferably in cold water to 40° F. or less. Throughout the production process the cooking and chilling temperatures are electronically monitored by a controller. This monitoring insures that critical control points (i.e., high temperature lethality and low chill temperature) are always met. Also, this monitoring allows feedback for automatic adjustments to the system can be made. This method provides several benefits. First, the process eliminates microbial contamination. Second, the quality of the product is not compromised as, for example, it is not recooked through post pasteurization as the cooking of the sausages are completed in the packaging. Third, the process is much more simple, easy to perform, and less costly particularly as compared to irradiation and high pressure processing. The method also increases capacity, improves yield, eliminates the need for anti-microbial additives, improved shelf life, improved compliance with HACCP standards, and uses less energy. The encased sausage is advantageously heated during step A) to such an extent that it is not fully coagulated (also referred to as “partially cooked”), or in other words to such an extent that only a part of the sausage proteins are set but the sausage surface is stable enough to enable the peeling of the sausage. To make sure that the sausage surface is adequately stable the sausages are heated to a surface temperature of at least 50° C. As there are no restrictions towards a minimum temperature to which the internal temperature of the sausages have to be raised it has advantages, both in relation to food-safety and stability, to raise the internal temperature of the sausages to a temperature of between 50° C. to 65° C. The heating time for this step is based upon the oven temperature and the diameter and composition of the sausage. The thermal processing (at least partial cooking, hardening) enables the subsequent removal (peeling) of the external casing. The casing peeled from the sausage may comprise a cellulose, an alginate and/or a collagen. As such casings are easy to apply, e.g. using coextrusion technique. As cellulose, alginate and collagen are all temperature sensitive ingredients there is a preference for the skilled person to cool the casing down to a low temperature (e.g. below 4° C.) before peeling the casing from the sausage, as both the effects of thermo shocking and hardening will facilitate easy peeling. However the method provides the inventive understanding that also peeling at higher sausage surface temperatures (at or above 20° C.) provides unexpected advantages for cellulose, alginate and collagen peelable casings. After packing the peeled sausage according step C) the peeled packed sausage may be heated in the packaging to a surface temperature of at least 72° C. Heating the peeled packed sausage to a surface temperature of at least 72° C. ensures that any pathogen contaminants are eliminated. When the peeled sausage according step is heated in the packaging to even a core temperature of at least 72° C. the cooking process is finished after packing (“cook in pack”) which may be applied when the sausage is hot peeled in an undercooked state, being the not fully coagulation of the sausage during processing step A), thus to be fully cooked within the packaging. The heating can be continuous or intermittent, intermittent heating is particularly beneficial for double stacked products to avoid over heating of the outside of the sausages. Subsequently the packed sausages may also be chilled within the packaging to limit degrading of the sausage quality, e.g. in cold water to 5° C. or less. An additional process step may be the smoking of the peeled sausages before they are packed. The smoking can be realized with natural smoke and/or liquid smoke. In one example, the sausages are exposed to a natural smoke or liquid smoke shower and then exposed to a first cooking zone having a 60° C. dry bulb and a 38° C. wet bulb for a desired period of time. Optionally the sausages are then exposed to a second natural smoke or liquid smoke shower before entering a second cooking zone. The second cooking zone preferably has a 70° C. dry bulb and a 55° C. wet bulb. An alternative additional processing step is to actively cool the encased sausages between steps A) and B). As elucidated before the peeling during step B) according to the present invention takes place at an enhanced temperature, however such enhanced temperature (of at least 20° C.) still enables, though not requires, the preceding cooling of the encased sausages, for instance to loosen the casing form the sausage (thermo shock). Further advantages can be realized when the temperature of the sausage is monitored throughout the process with at least one controller, while the process steering may subsequently automatically be arranged based on the measured values(s). Especially the critical control points such as the high temperature for lethality and a lower chill temperature are monitored and controlled (automatically adjusted) by a controller.

The invention relates to a method for producing preformed peeled packed sausages, comprising the steps of subsequently: A) heating an encased sausage; B) peeling a casing from the sausage at higher surface temperatures; and C) packing the peeled sausage. The invention also relates to a production device for producing preformed peeled packed sausages with such a method.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a divisional application of U.S. patent application Ser. No. 12/861,729, filed on Aug. 23, 2010, entitled Biocompatible Bonding Method and electronics Package Suitable for Implantation now U.S. Pat. No. 8,121,697, which is a division of U.S. patent application Ser. No. 11/455,028, filed on Jun. 15, 2006, entitled “Biocompatible Bonding Method and Electronics Package Suitable for Implantation”, now U.S. Pat. No. 7,813,796, which is a divisional of U.S. patent application Ser. No. 10/174,349, filed on Jun. 17, 2002, entitled “Biocompatible Bonding Method and Electronics Package Suitable for Implantation”, now U.S. Pat. No. 7,211,103, the disclosure of which is incorporated herein by reference, and which claims benefit of U.S. Patent application Ser. No. 60/372,062, filed on Apr. 11, 2002, entitled “Platinum Deposition for Electrodes,” the disclosure of which is incorporated herein by reference. FEDERALLY SPONSORED RESEARCH This invention was made with government support under grant No. R24EY12893-01, awarded by the National Institutes of Health. The government has certain rights in the invention. FIELD OF THE INVENTION This invention relates to an electrode array or flexible circuit, electronics package and a method of bonding a flexible circuit or electrode array to an integrated circuit or electronics package in the manufacture of a visual prosthetic. BACKGROUND OF THE INVENTION Arrays of electrodes for neural stimulation are commonly used for a variety of purposes. Some examples include U.S. Pat. No. 3,699,970 to Brindley, which describes an array of cortical electrodes for visual stimulation. Each electrode is attached to a separate inductive coil for signal and power. U.S. Pat. No. 4,573,481 to Bullara describes a helical electrode to be wrapped around an individual nerve fiber. U.S. Pat. No. 4,837,049 to Byers describes spike electrodes for neural stimulation. Each spike electrode pierces neural tissue for better electrical contact. U.S. Pat. No. 5,215,088 to Norman describes an array of spike electrodes for cortical stimulation. U.S. Pat. No. 5,109,844 to de Juan describes a flat electrode array placed against the retina for visual stimulation. U.S. Pat. No. 5,935,155 to Humayun describes a retinal prosthesis for use with a flat retinal array. Packaging of a biomedical device intended for implantation in the eye, and more specifically for physical contact with the retina, presents a unique interconnection challenge. The consistency of the retina is comparable to that of wet tissue paper and the biological media inside the eye is a corrosive saline liquid environment. Thus, the device to be placed against the retina, in addition to being comprised of biocompatible, electrochemically stable materials, must appropriately conform to the curvature of the eye, being sufficiently flexible and gentle in contact with the retina to avoid tissue damage, as discussed in Andreas Schneider, Thomas Stieglitz, Werner Haberer, Hansjörg Beutel, and J.-Uwe Meyer, “Flexible Interconnects for Biomedical Microsystems Assembly, IMAPS Conference, Jan. 31, 2001. It is also desirable that this device, an electrode array, provides a maximum density of stimulation electrodes. A commonly accepted design for an electrode array is a very thin, flexible conductor cable. It is possible to fabricate a suitable electrode array using discrete wires, but with this approach, a high number of stimulation electrodes cannot be achieved without sacrificing cable flexibility (to a maximum of about 16 electrodes). A lithographically fabricated thin film flex circuit electrode array overcomes such limitations. A thin film flex circuit electrode array can be made as thin as 10 um (0.0004 inches) while accommodating about 60 electrodes in a single circuit routing layer. The flex circuit electrode array is essentially a passive conductor ribbon that is an array of electrode pads, on one end, that contact the retina and on the other end an array of bond pads that must individually mate electrically and mechanically to the electrical contacts of a hermetically sealed electronics package. These contacts may emerge on the outside of the hermetic package as an array of protruding pins or as vias flush to a package surface. A suitable interconnection method must not only serve as the interface between the two components, but must also provide electrical insulation between neighboring pathways and mechanical fastening between the two components. Many methods exist in the electronics industry for attaching an integrated circuit to a flexible circuit. Commonly used methods include wire-bonding, anisotropic-conductive films, and “flip-chip” bumping. However, none of these methods results in a biocompatible connection. Common materials used in these connections are tin-lead solder, indium and gold. Each of these materials has limitations on its use as an implant. Lead is a known neurotoxin. Indium corrodes when placed in a saline environment. Gold, although relatively inert and biocompatible, migrates in a saline solution, when electric current is passed through it, resulting in unreliable connections. In many implantable devices, the package contacts are feedthrough pins to which discrete wires are welded and subsequently encapsulated with polymer materials. Such is the case in heart pacemaker and cochlear implant devices. Flexible circuits are not commonly used, if at all, as external components of proven implant designs. The inventor is unaware of prior art describing the welding of contacts to flex circuits. Attachment by gold ball bumping has been demonstrated by the Fraunhofer group (see Hansjoerg Beutel, Thomas Stieglitz, Joerg Uwe Meyer, “Versatile ‘Microflex’-Based Interconnection Technique,” Proc. SPIE Conf on Smart Electronics and MEMS, San Diego, Cal., March 1998, vol 3328, pp 174-82) to rivet a flex circuit onto an integrated circuit. A robust bond can be achieved in this way. However, encapsulation proves difficult to effectively implement with this method. Because the gap between the chip and the flex circuit is not uniform, under fill with epoxy is not practical. Thus, electrical insulation cannot be achieved with conventional under fill technology. Further, as briefly discussed earlier, gold, while biocompatible, is not completely stable under the conditions present in an implant device since it “dissolves” by electromigration when implanted in living tissue and subject to an electric current (see M. Pourbaix, Atlas of Electrochemical Equilibria in Aqueous Solutions, National Association of Corrosion Engineers, Houston, 1974, pp 399-405). Widespread use of flexible circuits can be found in high volume consumer electronics and automotive applications, such as stereos. These applications are not constrained by a biological environment. Component assembly onto flex circuits is commonly achieved by solder attachment. These flex circuits are also much more robust and bulkier than a typical implantable device. The standard flex circuit on the market is no less than 0.002 inches in total thickness. The trace metalization is etched copper foil, rather than thin film metal. Chip-scale package (CSP) assembly onto these flex circuits is done in ball-grid array (BGA) format, which uses solder balls attached to input-output contacts on the package base as the interconnect structures. The CSP is aligned to a corresponding metal pad array on the flex circuit and subjected to a solder reflow to create the interconnection. A metallurgical interconnect is achieved by solder wetting. The CSP assembly is then underfilled with an epoxy material to insulate the solder bumps and to provide a pre-load force from the shrinkage of the epoxy. Direct chip attach methods are referred to as chip-on-flex (COF) and chip-on-board (COB). There have been some assemblies that utilize gold wirebonding to interconnect bare, integrated circuits to flexible circuits. The flipchip process is becoming a reliable interconnect method. Flipchip technology originates from IBM's Controlled Collapse Chip Connection (C4) process, which evolved to solder reflow technique. Flipchip enables minimization of the package footprint, saving valuable space on the circuit, since it does not require a fan out of wirebonds. While there are a variety of flipchip configurations available, solder ball attach is the most common method of forming an interconnect. A less developed approach to flipchip bonding is the use of conductive adhesive, such as epoxy or polyimide, bumps to replace solder balls. These bumps are typically silver-filled epoxy or polyimide, although electrically conductive particulate of select biocompatible metal, such as platinum, iridium, titanium, platinum alloys, iridium alloys, or titanium alloys in dust, flake, or powder form, may alternatively be used. This method does not achieve a metallurgical bond, but relies on adhesion. Polymer bump flip chip also requires underfill encapsulation. Conceivably, polymer bump attachment could be used on a chip scale package as well. COB flipchip attach can also be achieved by using gold stud bumps, as an alternative to solder balls. The gold bumps of the chip are bonded to gold contacts on the hard substrate by heat and pressure. A recent development in chip-to-package attachment was introduced by Intel Corporation as Bumpless Build Up Layer (BBUL) technology. In this approach, the package is grown (built up) around the die rather than assembling the die into a pre-made package. BBUL presents numerous advantages in reliability and performance over flipchip. Known technologies for achieving a bond between a flexible circuit and a electronics package suffer from biocompatibility issues. Novel applications of a biomedical implant that utilize a flexible circuit attached to a rigid electronics package require excellent biocompatibility coupled with long term mechanical attachment stability, to assure long lived reliable electrical interconnection. Known deposition techniques for a bond, such as an electrically conductive metal bond or “rivet” are limited to thin layers. Plating is one such known method that does not result in an acceptable bond. It is not known how to plate shiny platinum in layers greater than approximately 1 to 5 microns because the dense platinum layer peels off, probably due to internal stresses. Black platinum lacks the strength to be a good mechanical attachment, and also lack good electrical conductivity. Known techniques for bonding an electronic package to a flex circuit do not result in a hermetic package that is suitable for implantation in living tissue. Therefore, it is desired to have a method of attaching a substrate to a flexible circuit that ensures that the bonded electronic package and flex circuit will function for long-term implant applications in living tissue. SUMMARY OF THE INVENTION An implantable electronic device comprising a hermetic electronics control unit, that is typically mounted on a substrate, that is bonded to a flexible circuit by an electroplated platinum or gold rivet-shaped connection. The resulting electronics assembly is biocompatible and long-lived when implanted in living tissue, such as in an eye or ear. The novel features of the invention are set forth with particularity in the appended claims. The invention will be best understood from the following description when read in conjunction with the accompanying drawings. OBJECTS OF THE INVENTION It is an object of the invention to provide a hermetic, biocompatible electronics package that is attached to a flexible circuit. It is an object of the invention to attach a hermetically sealed electronics package to a flexible circuit for implantation in living tissue. It is an object of the invention to attach a hermetically sealed electronics package to a flexible circuit for implantation in living tissue to transmit electrical signals to living tissue, such as the retina. It is an object of the invention to provide a hermetic, biocompatible electronics package that is attached directly to a substrate. It is an object of the invention to provide a method of bonding a flexible circuit to a substrate with an electroplated rivet-shaped connection. It is an object of the invention to provide a method of plating platinum as a rivet-shaped connection. Other objects, advantages and novel features of the present invention will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawing. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a perspective cutaway view of an eye containing a flexible circuit electrode array. FIG. 2 is a side view of an electronics package. FIG. 3 illustrates a cutaway side view of an electronics package. FIG. 4 is a top view of a flex circuit without the electronics package. FIG. 5 presents a side view of a flex circuit with the electronics package. FIGS. 6A-6E are a side view of a flex circuit that is bonded with adhesive to a hybrid substrate. FIGS. 7A-7E are a series of illustrations of a flexible circuit being bonded using conductive metal pads to a hybrid substrate. FIGS. 8A-8F are a series of illustrations of weld staple bonding of a flexible circuit to a hybrid substrate. FIGS. 9A-9D are a sequence of steps illustrating tail-latch interconnect bonding of a flexible circuit to a hybrid substrate. FIGS. 10A-10L depict a sequence of steps illustrating formation of an integrated interconnect by vapor deposition. FIG. 11 is a side view of a flexible circuit bonded to a rigid array. FIG. 12 is a side view of an electronics control unit bonded to an array. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The following description is the best mode presently contemplated for carrying out the invention. This description is not to be taken in a limiting sense, but is made merely for describing the general principles of the invention. The scope of the invention should be determined with reference to the claims. The present invention provides a flexible circuit electronics package and a method of bonding a flexible circuit to a hermetic integrated circuit which is useful for a number of applications, including implantation in living tissue as a neural interface, such as a retinal electrode array or an electrical sensor. The tissue paper thin flexible circuit 18 , FIG. 1 , transmits electrical signals to the eye 2 by means of electrodes, that are located in a stimulating electrode array 10 , that are in contact with the retina 14 . It is obvious that in addition to a stimulating electrode array or sensing electrode, the electrodes may be contacts connecting to remote electrodes. FIG. 1 illustrates the electronics control unit 20 in a perspective cutaway view of an eye 2 containing a flexible circuit electrode array 18 . The electronics control unit 20 is hermetically sealed. The electronics control unit 20 may be a hermetic ceramic case with electronics inside, or it may be a hermetically sealed integrated circuit, or any other environmentally sealed electronics package. The stimulating electrode array 10 is implanted on the retina 14 . Flexible circuit ribbon 24 connects the stimulating electrode array 10 to the electronics control unit 20 . The flexible circuit ribbon 24 preferably passes through the sclera 16 of the eye 2 at incision 12 . Another embodiment of the invention is the flexible circuit ribbon 24 replaced by alternative means of electrical interconnection, such as fine wires or thin cable. The lens 4 of the eye 2 is located opposite the retina 14 . A coil 28 , which detects electronic signals such as of images or to charge the electronics control unit 20 power supply, located outside the eye 2 , near the lens 4 , is connected to the electronics control unit 20 by wire 30 . FIG. 2 illustrates a side view of the hermetic electronics control unit 20 and the input/output contacts 22 that are located on the bottom of the unit 20 . The input/output contacts 22 are bonded in the completed assembly to the flexible circuit 18 . Thick film pad 23 is formed by known thick film technology, such as silk screening or plating. FIG. 3 illustrates a cutaway side view of the hermetic electronics control unit 20 . The pad 23 facilitates attachment of wire 30 , and is preferably comprised of a biocompatible material such as platinum, iridium, or alloys thereof, and is preferably comprised of platinum paste. Wire 30 is preferably bonded to pad 23 by welding. The microelectronics assembly 48 is mounted on the hybrid substrate 44 . Vias 46 pass through the substrate 44 to input/output contacts 22 . Electrical signals arrive by wire 30 and exit the electronics control unit 20 by input/output contacts 22 . A top view of the flexible circuit 18 is illustrated in FIG. 4 . Electrical signals from the electronics control unit 20 (see FIG. 3 ) pass into bond pads 32 , which are mounted in bond pad end 33 . Flexible electrically insulating substrate 38 , is preferably comprised of polyimide. The signals pass from the bond pads 32 along traces 34 , which pass along flexible circuit ribbon 24 to the stimulating electrode array 10 . The array 10 contains the electrodes 36 , which are implanted to make electrical contact with the retina 14 of the eye 2 , illustrated in FIG. 1 . An alternative bed of nails embodiment for the electrodes 36 is disclosed by Byers, et al. in U.S. Pat. No. 4,837,049. In FIG. 5 , the hermetic electronics control unit 20 is illustrated mounted to flexible circuit 18 . In order to assure electrical continuity between the electronics control unit 20 and the flexible circuit 18 , the electrical control unit 20 must be intimately bonded to the flexible circuit 18 on the bond pad end 33 . A cutaway of the electronics control unit 20 ( FIG. 5 ) illustrates a bonded connection 42 . The flexible electrically insulating substrate 38 is very thin and flexible and is able to conform to the curvature of the retina 14 ( FIG. 1 ), when implanted thereon. Methods of bonding the flexible insulating substrate 18 to the hermetic electronics control unit 20 are discussed next. Platinum Conductor in Polymer Adhesive A preferred embodiment of the invention, illustrated in FIG. 6 , shows the method of bonding the hybrid substrate 244 to the flexible circuit 218 using electrically conductive adhesive 281 , such as a polymer, which may include polystyrene, epoxy, or polyimide, which contains electrically conductive particulate of select biocompatible metal, such as platinum, iridium, titanium, platinum alloys, iridium alloys, or titanium alloys in dust, flake, or powder form. In FIG. 6 , step a, the hybrid substrate 244 , which may alternatively be an integrated circuit or electronic array, and the input/output contacts 222 are prepared for bonding by placing conductive adhesive 281 on the input/output contacts 222 . The rigid integrated circuit 244 is preferably comprised of a ceramic, such as alumina or silicon. In step b, the flexible circuit 218 is preferably prepared for bonding to the hybrid substrate 244 by placing conductive adhesive 281 on bond pads 232 . Alternatively, the adhesive 281 may be coated with an electrically conductive biocompatible metal. The flexible circuit 218 contains the flexible electrically insulating substrate 238 , which is preferably comprised of polyimide. The bond pads 232 are preferably comprised of an electrically conductive material that is biocompatible when implanted in living tissue, and are preferably platinum or a platinum alloy, such as platinum-iridium. FIG. 6 , step c illustrates the cross-sectional view A-A of step b. The conductive adhesive 281 is shown in contact with and resting on the bond pads 232 . Step d shows the hybrid substrate 244 in position to be bonded to the flexible circuit 218 . The conductive adhesive 281 provides an electrical path between the input/output contacts 222 and the bond pads 232 . Step c illustrates the completed bonded assembly wherein the flexible circuit 218 is bonded to the hybrid substrate 144 , thereby providing a path for electrical signals to pass to the living tissue from the electronics control unit (not illustrated). The assembly has been electrically isolated and hermetically sealed with adhesive underfill 280 , which is preferably epoxy. Studbump Bonding FIG. 7 illustrates the steps of an alternative embodiment to bond the hybrid substrate 244 to flexible circuit 218 by studbumping the hybrid substrate 244 and flexible electrically insulating substrate 238 prior to bonding the two components together by a combination of heat and/or pressure, such as ultrasonic energy. In step a, the hybrid substrate 244 is prepared for bonding by forming a studbump 260 on the input/output contacts 222 . The studbump is formed by known methods and is preferably comprised of an electrically conductive material that is biocompatible when implanted in living tissue if exposed to a saline environment. It is preferably comprised of metal, preferably biocompatible metal, or gold or of gold alloys. If gold is selected, then it must be protected with a water resistant adhesive or underfill 280 . Alternatively, the studbump 260 may be comprised of an insulating material, such as an adhesive or a polymer, which is coated with an electrically conductive coating of a material that is biocompatible and stable when implanted in living tissue, while an electric current is passed through the studbump 260 . One such material coating may preferably be platinum or alloys of platinum, such as platinum-iridium, where the coating may be deposited by vapor deposition, such as by ion-beam assisted deposition, or electrochemical means. FIG. 7 , step b presents the flexible circuit 218 , which comprises the flexible electrically insulating substrate 238 and bond pads 232 . The flexible circuit 218 is prepared for bonding by the plating bond pads 232 with an electrically conductive material that is biocompatible when implanted in living tissue, such as with a coating of platinum or a platinum alloy. Studbumps 260 are then formed on the plated pad 270 by known methods. Step c illustrates cross-section A-A of step b, wherein the flexible circuit 218 is ready to be mated with the hybrid substrate 244 . FIG. 7 , step d illustrates the assembly of hybrid substrate 244 flipped and ready to be bonded to flexible circuit 218 . Prior to bonding, the studbumps 260 on either side may be flattened by known techniques such as coining. Pressure is applied to urge the mated studbumps 260 together as heat is applied to cause the studbumps to bond by a diffusion or a melting process. The bond may preferably be achieved by thermosonic or thermocompression bonding, yielding a strong, electrically conductive bonded connection 242 , as illustrated in step e. An example of a thermosonic bonding method is ultrasound. The bonded assembly is completed by placing an adhesive underfill 280 between the flexible circuit 218 and the hybrid substrate 244 , also increasing the strength of the bonded assembly and electrically isolating each bonded connection. The adhesive underfill 280 is preferably epoxy. Weld Staple Interconnect FIG. 8 illustrates the steps of a further alternative embodiment to bond the hybrid substrate 44 to flexible circuit 18 by weld staple bonding the substrate 244 and flexible electrically insulating substrate 38 together. In step a, a top view of the flexible circuit 18 is shown. Flexible circuit 18 is comprised of flexible electrically insulating substrate 38 , which is preferably polyimide, and bond pads 32 having a through hole 58 therethrough each bond pad 32 and through the top and bottom surfaces of flexible circuit 18 . The bond pads 32 are comprised of an electrically conductive and biocompatible material which is stable when implanted in living tissue, and which is preferably platinum or a platinum alloy, such as platinum-iridium. FIG. 8 , step b presents section A-A, which is shown in the illustration of step a. The through holes 58 pass completely through each bond pad 58 , preferably in the center of the bond pad 58 . They are preferably formed by plasma etching. The bond pads 58 are not covered on the top surface of flexible circuit 18 by flexible electrically insulating substrate 38 , thereby creating bond pad voids 56 . FIG. 8 , step c shows the side view of hybrid substrate 44 with input/output contacts 22 on one surface thereof. The hybrid substrate 44 is positioned, in step d, to be bonded to the flexible circuit 18 by placing the parts together such that the input/output contacts 22 are aligned with the bond pads 32 . Then wire 52 , which is preferably a wire, but may equally well be a ribbon or sheet of weldable material, that is also preferably electrically conductive and biocompatible when implanted in living tissue, is attached to input/output contact 22 and bond pad 32 to bond each aligned pair together. The wire 52 is preferably comprised of platinum, or alloys of platinum, such as platinum-iridium. The bond is preferably formed by welding using the parallel gap welder 50 , which moves up and down to force the wire 52 into the through hole 58 and into contact with input/output contact 22 . This process is repeated for each aligned set of input/output contacts 22 and bond pads 32 , as shown in step e. The weld staple interconnect bonding process is completed, as shown in step f, by cutting the wire 54 , leaving each aligned set of input/output contacts 22 and bond pads 32 electrically connected and mechanically bonded together by staple 54 . Tail-Latch Interconnect FIG. 9 illustrates yet another embodiment for attaching the hybrid substrate 244 to a flexible circuit 218 by using a tail-ball 282 component, as shown in step a. The hybrid substrate 244 is preferably comprised of a ceramic material, such as alumina or silicon. In one embodiment, a wire, preferably made of platinum or another electrically conductive, biocompatible material, is fabricated to have a ball on one end, like the preferred tail-ball 282 illustrated in step a. The tail-ball 282 has tail 284 attached thereto, as shown in the side view of step a. The tail-ball 282 is aligned with input/output contact 222 on hybrid substrate 244 , in preparation to being bonded to flexible circuit 218 , illustrated in step b. The top view of step b illustrates flexible electrically insulating substrate 238 , which is preferably comprised of polyimide, having the through hole 237 passing completely thorough the thickness and aligned with the tail 284 . The bond pads 232 are exposed on both the top and bottom surfaces of the flexible circuit 218 , by voids 234 , enabling electrical contact to be made with input/output contacts 222 of the hybrid substrate 244 . The voids are preferably formed by plasma etching. The side view of FIG. 9 , step c, which illustrates section A-A of step b, shows the hybrid substrate 244 in position to be bonded to and aligned with flexible circuit 218 . The tails 284 are each placed in through hole 237 . Pressure is applied and the tail-balls 282 are placed in intimate contact with bond pads 232 and input/output contacts 222 . Step c illustrates that each of the tails 284 is bent to make contact with the bond pads 232 . The bonding process is completed by bonding, preferably by welding, each of the tails 284 , bond pads 232 , tail-balls 282 , and input/output contacts 222 together, thus forming a mechanical and electrical bond. Locking wire 262 is an optional addition to assure that physical contact is achieved in the bonded component. The process is completed by underfilling the gap with an electrically insulating and biocompatible material (not illustrated), such as epoxy. Integrated Interconnect by Vapor Deposition FIG. 10 illustrates a further alternative embodiment to creating a flexible circuit that is electrically and adhesively bonded to a hermetic rigid electronics package. In this approach, the flexible circuit is fabricated directly on the rigid substrate. Step a shows the hybrid substrate 44 , which is preferably a ceramic, such as alumina or silicon, having a total thickness of about 0.012 inches, with patterned vias 46 therethrough. The vias 46 are preferably comprised of frit containing platinum. In step b, the routing 35 is patterned on one side of the hybrid substrate 44 by known techniques, such as photolithography or masked deposition. It is equally possible to form routing 35 on both sides of the substrate 44 . The hybrid substrate 44 has an inside surface 45 and an outside surface 49 . The routing 35 will carry electrical signals from the integrated circuit, that is to be added, to the vias 46 , and ultimately will stimulate the retina (not illustrated). The routing 35 is patterned by know processes, such as by masking during deposition or by post-deposition photolithography. The routing 35 is comprised of a biocompatible, electrically conductive, patternable material, such at platinum. Step c illustrates formation of the release coat 47 on the outside surface 49 of the hybrid substrate 44 . The release coat 47 is deposited by known techniques, such as physical vapor deposition. The release coat 47 is removable by know processes such as etching. It is preferably comprised of an etchable material, such as aluminum. Step d illustrates the formation of the traces 34 on the outside surface 49 of the hybrid substrate 44 . The traces 34 are deposited by a known process, such as physical vapor deposition or ion-beam assisted deposition. They may be patterned by a known process, such as by masking during deposition or by post-deposition photolithography. The traces 34 are comprised of an electrically conductive, biocompatible material, such as platinum, platinum alloys, such as platinum-iridium, or titanium-platinum. The traces 34 conduct electrical signals along the flexible circuit 18 and to the stimulating electrode array 10 , which were previously discussed and are illustrated in FIG. 4 . Step e illustrates formation of the flexible electrically insulating substrate 38 by known techniques, preferably liquid precursor spinning. The flexible electrically insulating substrate 38 is preferably comprised of polyimide. The flexible electrically insulating substrate electrically insulates the traces 34 . It is also biocompatible when implanted in living tissue. The coating is about 5 um thick. The liquid precursor is spun coated over the traces 34 and the entire outside surface 49 of the hybrid substrate 44 , thereby forming the flexible electrically insulating substrate 38 . The spun coating is cured by known techniques. Step f illustrates the formation of voids in the flexible electrically insulating substrate 38 thereby revealing the traces 34 . The flexible electrically insulating substrate is preferably patterned by known techniques, such as photolithography with etching. Step g illustrates the rivets 51 having been formed over and in intimate contact with traces 34 . The rivets 51 are formed by known processes, and are preferably formed by electrochemical deposition of a biocompatible, electrically conductive material, such as platinum or platinum alloys, such as platinum-iridium. Step h illustrates formation of the metal layer 53 over the rivets 51 in a controlled pattern, preferably by photolithographic methods, on the outside surface 49 . The rivets 51 and the metal layer 53 are in intimate electrical contact. The metal layer 53 may be deposited by known techniques, such as physical vapor deposition, over the entire surface followed by photolithographic patterning, or it may be deposited by masked deposition. The metal layer 53 is formed of an electrically conductive, biocompatible material, which in a preferred embodiment is platinum. The patterned metal layer 53 forms traces 34 and electrodes 36 , which conduct electrical signals from the electronics control unit 20 and the electrodes 36 (see FIGS. 4 and 5 ). Step i illustrates the flexible electrically insulating substrate 38 applied over the outside surface 49 of the rigid substrate 44 , as in step e. The flexible electrically insulating substrate 38 covers the rivets 51 and the metal layer 53 . Step j illustrates the hybrid substrate 44 having been cut by known means, preferably by a laser or, in an alternative embodiment, by a diamond wheel, thereby creating cut 55 . The portion of hybrid substrate 44 that will be removed is called the carrier 60 . The flexible electrically insulating substrate 38 is patterned by known methods, such as photolithographic patterning, or it may be deposited by masked deposition, to yield voids that define the electrodes 36 . The electrodes 36 transmit electrical signals directly to the retina of the implanted eye (see FIG. 4 ) Step k illustrates flexible circuit 18 attached to the hybrid substrate 44 . The carrier 60 is removed by utilizing release coat 47 . In a preferred embodiment, release coat 47 is etched by known means to release carrier 60 , leaving behind flexible circuit 18 . Step l illustrates the implantable electronic device of a flexible circuit 18 and an intimately bonded hermetic electronics control unit 20 . The electronics control unit 20 , which contains the microelectronics assembly 48 , is hermetically sealed with header 62 bonded to rigid circuit substrate 44 . The header 62 is comprised of a material that is biocompatible when implanted in living tissue and that is capable of being hermetically sealed to protect the integrated circuit electronics from the environment. FIG. 11 illustrates an electronics control unit 320 attached to flexible electrically insulating substrate 338 , which is preferably comprised of polyimide, by bonded connections 342 . The electronics control unit 320 is preferably a hermetically sealed integrated circuit, although in an alternative embodiment it may be a hermetically sealed hybrid assembly. Bonded connections 342 are preferably conductive adhesive, although they may alternatively be solder bumps. The bond area is underfilled with an adhesive 380 . Rigid stimulating electrode array 310 is attached to the flexible electrically insulating substrate 338 by bonded connections 342 . FIG. 12 illustrates an electronics control unit 320 attached to rigid stimulating electrode array 310 by bonded connections 342 . The bond area is then underfilled with an adhesive 380 , preferably epoxy. Bonded connections 342 are preferably conductive adhesive, although they may alternatively be solder bumps. Accordingly, what has been shown is an improved flexible circuit with an electronics control unit attached thereto, which is suitable for implantation in living tissue and to transmit electrical impulses to the living tissue. Obviously, many modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that, within the scope of the appended claims, the invention may be practiced other than as specifically described.

The invention is directed to a method of bonding a hermetically sealed electronics package to an electrode or a flexible circuit and the resulting electronics package that is suitable for implantation in living tissue, for a retinal or cortical electrode array to enable restoration of sight to certain non-sighted individuals. The hermetically sealed electronics package is directly bonded to the flex circuit or electrode by electroplating a biocompatible material, such as platinum or gold, effectively forming a plated rivet-shaped connection, which bonds the flex circuit to the electronics package. The resulting electronic device is biocompatible and is suitable for long-term implantation in living tissue.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates generally to non-working copies of brace systems for adjusting human teeth, and, in particular, visually simulated tooth brace visual indicia. [0003] 2. Description of the Prior Art [0004] In the field of dentistry and orthodontics, braces are used to assist in adjusting the angle and displacement of human teeth. As the technology of manufacturing and applying braces to human teeth develops, the market and class of patients increase accordingly. Both children and adults utilize braces to straighten their teeth for aesthetic reasons. [0005] Children, once despising braces for the appearance when applied, have come to enjoy the myriad of shapes and colors that are now available due to these technological and manufacturing improvements. Originally, in order to reduce the metallic appearance of the braces in the mouth, clear braces, or partially clear braces, were developed. In a further improvement, the use of a phosphorescent or fluorescent pigment applied to the braces was conceived to increase the aesthetic quality of the appearance of a person's braces. See U.S. Pat. No. 5,592,895 to Farrokh et al. This same colorizing technique applied directly to a human tooth has also been developed, as seen in U.S. Pat. No. 6,036,494 to Cohen. In a further cosmetic advance, temporary tattoos have been developed by KidGenics for use on teeth. See www.ToothTat2.com. Indeed, many children now look to the opportunity to wear braces as a right of passage to adulthood. It is therefore an object of the present invention to provide temporary visually simulated braces for children who seek the aesthetic appeal of those who wear braces for teeth adjustment purposes. SUMMARY OF THE INVENTION [0006] The present invention is a plurality of connected visually simulated indicia for braces on human teeth. The present invention includes an FDA approved substance that temporarily attaches to the user's teeth by the use of a dissolvable FDA approved adhesive. In use, the attaching carrier is attached to the teeth such that the visual indicia are visible to others when the user opens his or her mouth. [0007] The present invention is shaped to simulate functional braces and can be worn for up to four hours or even up to twelve hours. The present invention adaptably molds to the teeth of the user either prior to use or during attachment. The present invention serves no functional purpose for adjusting human teeth. [0008] The present invention, both as to its construction and its method of operation, together with the additional objects and advantages thereof, will best be understood from the following description of exemplary embodiments when read in connection with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 is a front view of visually simulated tooth brace indicia attached to teeth; [0010] FIG. 2 is a front view of visually simulated tooth brace indicia with a connecting band attached; [0011] FIG. 3 is a front view of a clear plastic tooth mold with inset tooth brace indicia; and [0012] FIG. 4 is a front view of s U-shaped self-molding material with laminated tooth brace indicia. DETAILED DESCRIPTION OF THE INVENTION [0013] FIG. 1 shows a plurality of individual nonfunctional tooth brace indicia 5 applied to a consumer's teeth. A consumer can choose to cover simply the four central incisors 15 or can additionally cover the lateral incisor teeth 20 . [0014] FIG. 2 shows a plurality of individual nonfunctional tooth brace indicia 5 with a connected band 25 linking the individual tooth brace indicia. The connecting band can connect the top and bottom sets of either two or four tooth brace indicia. [0015] FIG. 3 shows a clear plastic tooth mold 30 with a plurality of tooth brace indicia inset. The clear plastic mold can be form fitted to a consumer's teeth much like that of an athletic mouth guard and slips over the teeth in a removable fashion. [0016] FIG. 4 shows a U-shaped clear self-molding material with a plurality of tooth brace indicia laminated with the self-molding material. [0017] A first embodiment of the present invention is generally shown in FIG. 1 . It is envisioned that the consumer, upon selecting the number of tooth brace indicia 5 desired, will attach the individual nonfunctional tooth brace indicia 5 on each desired tooth ( 15 , 20 ) using FDA approved adhesive. The visual tooth brace indicia 5 can be letters of the alphabet, numbers, and other symbols or any combination thereof. The FDA approved adhesive, such as Dermabond skin glue, can be made as a contact adhesive or as a wettable adhesive so that the consumer either applies the indicia 5 directly or wets them prior to application. The user can remove the indicia 5 by using excess amounts of water and swirling it in their mouth while applying tongue pressure. If the indicia 5 are the sugar-free candied version, the consumer can simply wait until the indicia 5 dissolve to remove them. [0018] In a second embodiment of the present invention, as show in FIG. 2 , the same individual nonfunctional tooth brace indicia 5 are used but are attached to one another by a connecting band 25 . The connecting band 25 can simulate wire as in functioning tooth adjusting braces. The consumer, upon selecting the number of tooth brace indicia 5 desired, will attach the braces by applying to the teeth ( 15 , 20 ) in a formable manner. The consistency of the brace material is such that as the consumer applies the braces to the teeth ( 15 , 20 ), the braces will flex in a manner so that the attachment to all the desired teeth ( 15 , 20 ) can be made. The braces can be attached in the same manner using the same FDA approved adhesive as in the first embodiment. The user can remove the braces by using excess amounts of water and swirling it in their mouth while applying tongue pressure. If the braces are the sugar-free candied version, the consumer can simply wait until the braces dissolve to remove them. [0019] A third embodiment according to the present invention is shown in FIG. 3 . A formable plastic mouthpiece 30 can be used to mold the desired tooth shape and form a cap to cover the teeth in much the same fashion as an athletic mouthguard. The individual nonfunctional tooth brace indicia 5 are embedded into the plastic between the teeth and the lips of the consumer so that the indicia 5 are visible as the consumer reveals their teeth. The mouthpiece 30 containing the tooth brace indicia 5 can either be removable or can be glued using the FDA approved glue as in embodiments one and two. [0020] A fourth embodiment according to the present invention is shown in FIG. 4 . Braces are laminated in a U-shaped clear self-molding material such as silicone. In this manner the U-shaped self-molding material can be custom fit to the user's teeth and attached with an FDA approved glue as in embodiments one, two, and three. The self-molding material can be white to match the teeth or any other color or any combination of colors. [0021] It is clear that the present invention in all of its embodiments can be uniformly or diversely colored, including but not limited to silver, black, yellow, or red. The individual tooth brace indicia 5 can be colored differently than the connecting band allowing for a myriad color combination of choices, allowing the consumer to express him or herself as seen fit. [0022] Additionally, it is also clear that the present invention in embodiments one and two can be adapted to cover any number of top or bottom teeth. For example, a user could choose to cover six top or bottom teeth in a symmetrical fashion. [0023] This invention has been described with reference to the preferred embodiments, obvious modifications and alterations will occur to others upon reading and understanding the proceeding detailed description. It is intended that the invention be construed as including all such modifications and alterations.

Visually simulated tooth braces include individual visual tooth brace indicia to simulate real functional braces commonly worn by children and adults alike to adjust human teeth. The visually simulated tooth braces allow for children to temporarily wear braces as many of their classmates, friends, and siblings do.

FIELD [0001] The present invention generally relates to medical systems and apparatus and uses thereof for treating obesity and/or obesity-related diseases, and specifically relates to injection ports penetrable by a needle to add or remove saline and/or other appropriate fill materials to a gastric banding system. BACKGROUND [0002] Adjustable gastric banding apparatus have provided an effective and substantially less invasive alternative to gastric bypass surgery and other conventional surgical weight loss procedures. Unlike gastric bypass procedures, gastric band apparatus implantations are reversible and require no permanent modification to the gastrointestinal tract. Moreover, it has been recognized that sustained weight loss can be achieved through a laparoscopically-placed gastric band, for example, the LAP-BAND® (Allergan, Inc., Irvine, Calif.) gastric band or the LAP-BAND APO (Allergan, Inc., Irvine, Calif.) gastric band. Generally, gastric bands are placed about the cardia, or upper portion, of a patient's stomach forming a stoma that restricts food's passage into a lower portion of the stomach. When the stoma is of an appropriate size that is restricted by a gastric band, food held in the upper portion of the stomach may provide a feeling of satiety or fullness that discourages overeating. An example of a gastric banding system is disclosed in Roslin, et al., U.S. Patent Pub. No. 2006/0235448, the entire disclosure of which is incorporated herein by this specific reference. [0003] Over time, a stoma created by a gastric band may need adjustment in order to maintain an appropriate size, which is neither too restrictive nor too passive. Accordingly, prior art gastric band systems provide a subcutaneous fluid injection port connected to an expandable or inflatable portion of the gastric band. By adding fluid to or removing fluid from the inflatable portion by means of a hypodermic needle inserted into the access port, the effective size of the gastric band can be adjusted to provide a tighter or looser constriction. [0004] However, medical professionals frequently encounter difficulty with the process of targeting the injection port, including problems with locating the access port, determining the appropriate angle at which the needle should penetrate the access port, and determining whether the needle has sufficiently penetrated the access port. [0005] Some attempts have been made to overcome these difficulties. For example, with reference to FIG. 1A , the heliogast® EV3 implantantable port (“EV3 port”) may allow needle penetration at a portion A of the EV3 port. However, the surface area of portion A constitutes only a fraction of the surface area of the entire outer surface of the EV3 port. In addition, the EV3 port still requires very precise needle insertion angles and locations such that they are in a discrete septum, as shown in FIG. 1B , and cannot facilitate a directionless or virtually directionless needle injection port, as shown in FIG. 1C . Indeed, FIG. 1C appears to illustrate that the EV3 port requires that needle insertions be orthogonal to the surface. SUMMARY [0006] This Summary is included to introduce, in an abbreviated form, various topics to be elaborated upon below in the Detailed Description. [0007] In certain embodiments, it may be desirable to develop an injection port that is virtually or entirely orientation-independent such that the entire composite outer shell acts as a viable access point. By allowing needle penetration at various angles over a greater surface area of the injection port, such embodiments improve the process of targeting the injection port, among other benefits. [0008] Generally described herein are certain embodiments directed to an orientation-independent injection port fluidly coupled to a gastric banding system, the injection port for simplifying the port-targeting process when a medical professional attempts to penetrate the injection port with a needle during a gastric band-adjusting procedure. [0009] In one embodiment, the present invention is an injection port for the treatment of obesity or obesity-related diseases, the injection port implantable in a patient's body and fluidly coupled to tubing connected to an inflatable portion of a gastric band, the injection port comprising (1) an inner core made of a material to prevent a needle from penetrating the inner core, (2) an outer shell surrounding the inner core, and having a lower durometer than the inner core, the outer shell configured to allow penetration by the needle from any location on a surface of the outer shell and at any angle, and (3) a fluid conduit positioned between the inner core and the outer shell, the fluid conduit accessible by the needle to inject or remove fluid from the injection port of the gastric band. [0010] In one embodiment, the injection port may be orientation independent with the entire outer shell or core acting as the needle access point. Alternatively, and/or in addition, the inner core of the injection port may be hard or firm (e.g., impenetrable by the needle), thereby allowing medical professionals to easily locate the injection port (e.g., when performing palpation). Furthermore, the hard inner core may prevent the needle from penetrating too deeply and exiting the injection port (e.g., preventing needle over-throws). [0011] In one embodiment, a fluid conduit entirely or substantially encompasses the inner core. For example, the fluid conduit might not encompass the flange portion. [0012] In one embodiment, the outer shell is concentric with the inner core. [0013] In one embodiment, the outer surface of the inner core does not contact the inner surface of the outer shell. [0014] In one embodiment, the outer shell may be a self-sealing membrane configured to be penetrable by a needle. [0015] In one embodiment, the injection port may include internal features that allow fluid to flow when the outer shell or core of the injection port is under compression and/or when a vacuum is applied. [0016] In one embodiment, the injection port may require less needle targeting when trying to penetrate the outer shell or core for saline removal/injection. [0017] In one embodiment, the injection port may prevent pressure spikes (intentional or unintentional) from occurring due to volume occupation of the inner core. [0018] In one embodiment, the injection port may be implanted without stitching during the implantation process. BRIEF DESCRIPTION OF THE DRAWINGS [0019] The features, obstacles, and advantages of the present invention will become more apparent from the detailed description set forth below when taken in conjunction with the drawings, wherein: [0020] FIG. 1A illustrates a prior art injection port; [0021] FIG. 1B illustrates the access locations of the injection port of FIG. 1A ; [0022] FIG. 1C illustrates the allowable and non-allowable access angles of the injection port of FIG. 1A ; [0023] FIG. 2 illustrates a perspective view of a gastric banding system according to an embodiment of the present invention; [0024] FIG. 3A illustrates a perspective view of a directionless needle injection port according to an embodiment of the present invention; [0025] FIG. 3B illustrates a cross-sectional view of a directionless needle injection port according to an embodiment of the present invention; [0026] FIG. 3C illustrates a close-up view of an inner core of a directionless needle injection port according to an embodiment of the present invention; [0027] FIG. 4A illustrates a top view of an inner core of a directionless needle injection port according to an embodiment of the present invention; [0028] FIG. 4B illustrates a perspective view of an inner core of a directionless needle injection port according to an embodiment of the present invention; [0029] FIG. 5 illustrates a perspective view of an inner core of a directionless needle injection port according to an embodiment of the present invention; and [0030] FIG. 6 illustrates a perspective view of a directionless needle injection port according to an embodiment of the present invention. DETAILED DESCRIPTION [0031] Apparatus, systems and/or methods that implement the embodiments of the various features of the present invention will now be described with reference to the drawings. The drawings and the associated descriptions are provided to illustrate some embodiments of the present invention and not to limit the scope of the present invention. Throughout the drawings, reference numbers are re-used to indicate correspondence between referenced elements. [0032] The present invention generally provides a directionless needle injection port having a hard inner core and a soft outer shell. The soft outer shell may be made from a needle penetrable and self-sealing material and may make available the entirety of its outer surface for needle penetration, replacing the need to target a restricted septum area of prior art ports, and thereby making the injection port easier to access when a medical professional needs to inject or remove fluids via the injection port. [0033] While discussed herein as related to a gastric banding system, one skilled in the art will understand that the present invention is versatile and may be implemented with respect to any medical system, gastric-band related or not, which may be enhanced with a directionless needle injection port. For example, cancer patients who require an access port for frequent access to their veins may benefit from the implementation of an embodiment of a directionless injection port as described herein. [0034] Turning to FIG. 2 , an implanted gastric banding system 200 is illustrated as implanted within a patient's body 230 , and more specifically, forming a stoma around an upper region of a stomach 225 of the patient's body 230 . The gastric banding system 200 may include a gastric band 205 having an inflatable portion 210 . The gastric band 205 may be fluidly coupled with an injection port 215 via a tubing 220 . A fluid injection device 245 may include a syringe 240 and a needle 235 which may penetrate the patient's body 230 at a location proximal to the injection port 215 to add or remove fluid. The fluid added or removed may either inflate (if fluid is added) or deflate (if fluid is removed) the inflatable portion 210 of the gastric band 205 , thereby increasing (if fluid is added) the degree of constriction that the gastric band 205 imparts on the upper region of the stomach 225 or decreasing (if fluid is removed) the degree of constriction that the gastric band 205 imparts on the upper region of the stomach 225 . In this manner, adjustments to the gastric banding system 200 may be performed via the injection port 215 . [0035] FIG. 3A is an injection port 300 attached to a tubing 305 . In one embodiment, the injection port 300 may be the injection port 215 of FIG. 2 , and the tubing 305 may be the tubing 220 of FIG. 2 . The rest of the gastric banding system has been omitted for clarity. The injection port 300 may include an outer shell 310 and an inner core 315 . A fluid conduit 320 may be formed between an inner surface 311 of the outer shell 310 and an outer surface 316 of the inner core 315 . In one embodiment, the fluid conduit 320 may be the entire spatial gap between the inner surface 311 of the outer shell 310 and the outer surface 316 of the inner core 315 . The inner core 315 may further include channels 325 for fluid flow. The channels 325 may be grooves or indentations formed on the outer surface 316 of the inner core 315 to improve fluid flow. In addition, the injection port 300 may include an attachment flange 330 to prevent the fluid from leaking out of the fluid conduit 320 and to hold the tubing 305 in place at the location where the tubing 305 is coupled to the injection port 300 . [0036] As shown, the fluid conduit 320 wraps around virtually the entire outer surface 316 of the inner core 315 , thereby allowing a medical professional access to the fluid conduit 320 by inserting a needle (e.g., the needle 335 ) virtually anywhere and at any angle on the outer shell 310 . In this manner, the medical professional may be able to add or remove fluid via the injection port 300 without regard to the orientation or direction that the injection port 300 is facing. Accordingly, the injection port 300 may be deemed orientation-less and/or direction-less. In one embodiment, the outer surface 316 of the inner core 315 does not contact the inner surface 311 of the outer shell 310 thereby forming the fluid conduit 320 . [0037] The outer shell 310 may be constructed out of a soft plastic, polymer or other material penetrable by a needle since the outer shell 310 is designed to be punctured by a needle (e.g., the needle 235 ) to allow for the addition or removal of fluid. In addition, the soft plastic, polymer or other material used to construct the outer shell 310 may have self-sealing characteristics as it may be desirable to allow the outer shell 310 to withstand repeated, periodic insertion and withdrawal of needles. The outer shell 310 may be shaped as an ellipsoid or an “olive”, but other geometric configurations may be possible such as a sphere, etc. [0038] In one embodiment, the outer shell 310 may be a membrane having a characteristic of being penetrable by a needle to allow for fluid addition or removal to the injection port 300 while acting as a barrier to prevent the leakage of the fluid from within the injection port 300 (i.e., the fluid conduit 320 ). [0039] In one embodiment, the outer shell 310 may have a composite build and may incorporate a micro-mesh to allow for leak-free needle insertions and removals. The entire outer surface of the outer shell 310 may also be loosely covered in a polypropylene bio-integrating mesh to allow for stitch-free implantation, thereby reducing procedural complexity and duration. [0040] In addition to and/or alternatively, other materials of low durometer may be used. The outer shell 310 may also be designed such that a medical professional, in performing palpation with his or her fingers, may be able to locate the injection port 300 by feeling the inner core 315 (which is hard) through the outer shell 310 (which is soft). [0041] Once the needle (e.g., the needle 335 ) is inserted through the outer shell 310 , the inner core 315 may prevent the needle (e.g., the needle 335 ) from unintentionally overshooting (and/or unintentionally exiting) the fluid conduit 320 , as the inner core 315 is constructed out of a relatively high durometer plastic core, titanium, stainless steel, composite ceramics, and/or other suitable material, configured to withstand and/or prevent needle penetration. In one embodiment, the durometer of the inner core 315 is greater than the durometer of the outer shell 310 . [0042] FIG. 3B is a cross-sectional view of the injection port 300 illustrating the operation of the injection port 300 . Also shown is a fluid injection device 345 which may include a syringe 340 and a needle 335 . The needle 335 may penetrate the outer shell 310 before being stopped by the inner core 315 . The stoppage of the needle 335 by the inner core 315 serves to ensure that the needle 335 is correctly inserted because if the needle 335 has reached the outside surface 316 of the inner core 315 , the needle 335 is necessarily at a location configured to access the fluid conduit 320 . Accordingly, the medical professional need not guess whether the needle 335 is correctly inserted. Once positioned, the needle 335 may be utilized to access the fluid conduit 320 to add or remove fluid from the injection port 300 . As shown, the fluid conduit 320 may be in fluid communication with the tubing 305 via a fluid conduit-tubing connection path 350 at an opening 355 . In this manner, fluid communication between the injection port 300 and the rest of the gastric banding system (not shown) is achieved via the tubing 305 . [0043] The fluid within the fluid conduit 320 is prevented from leaking out of the gastric banding system (e.g., the gastric banding system 200 ) by the attachment flange 330 . The attachment flange 330 may be constructed out of a fluid-impenetrable material and may include a cylindrical portion which attaches to the outside of the tubing 305 and a flange portion which attaches to the inside surface 311 of the outer shell 310 . In this manner, fluid within the fluid conduit 320 is prevented from exiting or leaking out of the injection port at a location designated by arrows 360 . The attachment flange 330 may further provide strain relief for the injection port 300 . The tubing 305 is connected to and inserted into the inner core 315 . The tubing 305 and/or the attachment flange 330 are used to hold the inner core 315 in place within the outer shell 310 . [0044] FIG. 3C illustrates the inner core 315 with the outer shell (e.g., the outer shell 310 ) omitted for clarity. As shown, the inner core 315 may be shaped as an ellipsoid or an “olive”, but other geometric configurations may be possible such as a sphere, etc. The inner core 315 may include channels 325 spaced apart extending from one end of the inner core 315 to another, and culminating at the opening 355 , which may be an interface to a lumen (e.g., the fluid conduit-tubing connection path 350 ) for fluid flow between the injection port 300 and the rest of the gastric banding system (not shown). As shown, all the channels 325 may be spaced apart from one another but may converge at the ends and come into contact with one another at single end points such as at the opening 325 . The channels 325 allow the fluid to converge at the opening 325 to better and more easily flow into and out of the path 350 . [0045] In one embodiment, the geometry of the channels 325 may be configured to optimize the overall volume of the fluid conduit 320 . For example, deeper and/or wider channels 325 may increase the overall volume capabilities of the fluid conduit 320 , whereas shallower and/or narrower channels 325 may decrease the overall volume capabilities of the fluid conduit 320 . Similarly, the lumen (e.g., the fluid conduit-tubing connection path 350 ) may be configured and sized to support a larger volume of fluid or a smaller volume of fluid. [0046] In one embodiment, additional lumens may be included to provide additional conduits between the access or injection port 300 and the inflatable portion (e.g., the inflatable portion 210 ) of the gastric band (e.g., the gastric band 205 ). [0047] In one embodiment, the inner core 315 may be further modified to include any of a number of features. For example, pressure relief holes (not shown) may be beneficial in a situation where one side of the outer shell (e.g., the outer shell 310 ) is under compression, thereby allowing fluid to still flow to the opening 340 . Alternatively, non-smooth geometry may provide better tactile feedback to the medical professional when the needle (e.g., the needle 335 ) penetrates the outer shell (e.g., the outer shell 310 ). [0048] In one embodiment, the inner core 315 may have multiple functionalities. For example, the inner core 315 may prevent needle overthrows by offering a hard surface impenetrable by the needle 335 . Also, the inner core 315 may enhance patient safety and discomfort by limiting unintentional pressure spikes. By preventing the injection port from collapsing, unintentional constriction by the inflatable portion (e.g., the inflatable portion 210 ) of the gastric band (e.g., the gastric band 205 ) may be stopped. Furthermore, the mass and/or hardness of the inner core 315 may enable medical professionals to more easily locate the injection port 300 under the patient's skin. [0049] In one embodiment, a fluid conduit (e.g., the fluid conduit 320 ) may entirely or substantially encompasses the inner core 315 . For example, the fluid conduit 320 might not encompass the attachment flange 360 . [0050] In one embodiment, the outer shell 310 is positioned concentric with the inner core 315 . [0051] FIGS. 4A and 4B illustrate a top view and a side perspective view, respectively, of one embodiment of an inner core 415 . Here, the other portions of the gastric banding system including the tubing have been omitted for clarity. In addition, certain parts of an injection port 400 such as the outer shell and/or the attachment flange have also been omitted for clarity. In this embodiment, the inner core 415 may be flattened, thereby providing the benefit of flip-resistance immediately after the implantation procedure. As shown, the inner core 415 may have a smooth surface. [0052] FIG. 5 illustrates another embodiment of an inner core 515 . Again, for clarity, the other portions of the gastric banding system, and certain parts of an injection port 500 have been omitted for clarity. However, as shown, the inner core 515 may include alternative fluid channels created by protrusions 525 (e.g., formed in the shape of circles or ovals) which allow fluid flow and pressurization of the fluid layer during a needle penetration procedure while the outer shell (not shown) is compressed over the inner core 515 . Arrow 520 illustrates an example of one such fluid channel that the fluid may take along the exterior of the inner core 515 . In addition, the protrusions 525 may prevent an outer shell (not shown) from collapsing against the inner core 515 during vacuum. The size and spacing of the protrusions 525 may be designed to allow for more efficient fluid flow. For example, in one embodiment, the protrusions 525 may be unevenly spaced apart and have varying heights and diameters. In another embodiment, the protrusions 525 may have uniform spacing, heights and diameters. [0053] FIG. 6 illustrates an embodiment of an injection port 600 . In one embodiment, an injection port 600 may be the injection port 215 of FIG. 2 and a tubing 605 may be the tubing 220 of FIG. 2 . The rest of the gastric banding system has been omitted for clarity. As shown, the injection port 600 may include an outer shell 610 surrounding virtually the entirety of an inner core 615 . A fluid conduit 620 may be formed between an inner surface of the outer shell 610 and an outer surface of the inner core 615 . The inner core 615 may further include ridges 645 having ridge interruptions 650 . [0054] As shown, the ridges 645 may be oriented longitudinally about the exterior of the inner core 615 , and may form channels 625 between adjacent ridges 645 for fluid flow. The ridges 645 may be multi-functional. For example, in addition to forming the channels 625 for fluid flow (e.g., which may occur when the fluid volume is under vacuum, such as when the medical professional is removing fluid from the injection port 600 ), the ridges 645 may further provide exaggerated needle-stopping structures to prevent needle over-throws when the medical professional is attempting to insert a needle (e.g., the needle 235 ) into the fluid conduit 620 . In one embodiment, the ridges 645 and the rest of the inner core 615 may be constructed out of a relatively high durometer plastic core configured to withstand and/or prevent a needle (e.g., the needle 235 ) from puncturing through. The one or more ridge interruptions 650 on each ridge 645 may provide for fluid flow circumferentially to ensure volume and/or pressure stability when portions of the injection port 600 are collapsed (e.g., when the patient is in a sitting position, a portion of the injection port 600 may be compressed on one side). [0055] The channels 625 may include one or more fluid holes 655 between the ridges 645 which allow for fluid communication between the injection port 600 and the gastric band (not shown) via the tubing 605 even when the injection port 600 is under compression or a vacuum. In addition, the channels 625 may allow for easier fluid travel to and from an opening 640 (which is configured to fluidly couple the injection port 600 to the rest of the gastric banding system). [0056] In addition, the injection port 600 may include an attachment flange 630 to prevent fluid from leaking out of the fluid conduit 620 and to hold the tubing 605 in place at the location where the tubing 605 is coupled to the injection port 600 . [0057] Similar to the injection port 300 of FIG. 3 , the fluid conduit 620 may wrap around virtually the entire surface of the inner core 615 including the ridges 645 , thereby allowing a medical professional to access the fluid conduit 620 by inserting a needle (e.g., the needle 235 ) virtually anywhere and at any angle on the outer shell 610 . In this manner, the medical professional may be able to add or remove fluid via the injection port 600 without regard to the orientation or direction that the injection port 600 is facing. Accordingly, the injection port 600 may be deemed orientation-less and/or direction-less. [0058] In addition, as the outer shell 610 is designed to be punctured by a needle (e.g., needle 235 ), the outer shell 610 may be constructed out of a soft plastic and may, in one embodiment, have a composite build and incorporate a micro-mesh to allow for leak-free needle insertions and removals. The entire outer surface of the outer shell 610 may also be loosely covered in a polypropylene bio-integrating mesh to allow for stitch-free implantation, thereby reducing procedural complexity and duration. [0059] In addition and/or alternatively, other materials of low durometer may be used. The outer shell 610 may also be designed such that a medical professional in performing palpation with his or her fingers may be able to locate the injection port 600 by feeling the ridges 645 of the inner core 615 through the outer shell 610 . [0060] Unless otherwise indicated, all numbers expressing quantities of ingredients, volumes of fluids, and so forth as used in the specification and claims are to be understood as being modified in all instances 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 present invention. 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 invention 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. [0061] The terms “a,” “an,” “the” and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention. [0062] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims. [0063] Certain embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context. [0064] Furthermore, certain references have been made to patents and printed publications throughout this specification. Each of the above-cited references and printed publications are individually incorporated herein by reference in their entirety. [0065] Specific embodiments disclosed herein may be further limited in the claims using consisting of or and consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term “consisting of” excludes any element, step, or ingredient not specified in the claims. The transition term “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s). Embodiments of the invention so claimed are inherently or expressly described and enabled herein. [0066] In closing, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described.

Generally described herein are certain embodiments directed to an orientation-independent injection port fluidly coupled to a gastric banding system. The injection port may be configured to simplify the port-targeting process when a medical professional attempts to penetrate the injection port with a needle during a gastric band-adjusting procedure. For example, the injection port may be orientation-independent with the entire outer shell acting as the needle access point. Alternatively, and/or in addition, the inner core of the injection port may be hard or firm, thereby allowing for easier locating (e.g., when the medical professional performs palpation). Furthermore, the hard inner core may prevent needle over-throws, and help stabilize pressure.

[0001] This application is a continuation of U.S. Ser. No. 10/886,847, filed July 8, 2004, which is a continuation-in-part of U.S. Ser. No. 10/189,992, filed Jul. 5, 2002, which is a continuation-in-part of U.S. Ser. No. 10/090,675, filed Mar. 5, 2002, which are both incorporated by reference herein in their entireties. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention relates broadly to ophthalmic implants. More particularly, this invention relates to intraocular lenses which are focusable and allow for accommodation for near vision. [0004] 2. State of the Art [0005] Referring to FIG. 1 , the human eye 10 generally comprises a cornea 12 , an iris 14 , a ciliary body (muscle) 16 , a capsular bag 18 having an anterior wall 20 and a posterior wall 22 , and a natural crystalline lens 24 contained with the walls of the capsular bag. The capsular bag 18 is connected to the ciliary body 16 by means of a plurality of zonules 26 which are strands or fibers. The ciliary body 16 surrounds the capsular bag 18 and lens 24 , defining an open space, the diameter of which depends upon the state (relaxed or contracted) of the ciliary body 16 . [0006] When the ciliary body 16 relaxes, the diameter of the opening increases, and the zonules 26 are pulled taut and exert a tensile force on the anterior and posterior walls 20 , 22 of the capsular bag 18 , tending to flatten it. As a consequence, the lens 24 is also flattened, thereby undergoing a decrease in focusing power. This is the condition for normal distance viewing. Thus, the emmetropic human eye is naturally focused on distant objects. [0007] Through a process termed accommodation, the human eye can increase its focusing power and bring into focus objects at near. Accommodation is enabled by a change in shape of the lens 24 . More particularly, when the ciliary body 16 contracts, the diameter of the opening is decreased thereby causing a compensatory relaxation of the zonules 26 . This in turn removes or decreases the tension on the capsular bag 18 , and allows the lens 24 to assume a more rounded or spherical shape. This rounded shape increases the focal power of the lens such that the lens focuses on objects at near. [0008] As such, the process of accommodation is made more efficient by the interplay between stresses in the ciliary body and the lens. When the ciliary body relaxes and reduces its internal stress, there is a compensatory transfer of this stress into the body of the lens, which is then stretched away from its globular relaxed state into a more stressed elongated conformation for distance viewing. The opposite happens as accommodation occurs for near vision, where the stress is transferred from the elongated lens into the contracted ciliary body. [0009] In this sense, referring to FIG. 2 , there is conservation of potential energy (as measured by the stress or level of excitation) between the ciliary body and the crystalline lens from the point of complete ciliary body relaxation for distance vision through a continuum of states leading to full accommodation of the lens. [0010] As humans age, there is a general loss of ability to accommodate, termed “presbyopia”, which eventually leaves the eye unable to focus on near objects. In addition, when cataract surgery is performed and the natural crystalline lens is replaced by an artificial intraocular lens, there is generally a complete loss of the ability to accommodate. This occurs because the active muscular process of accommodation involving the ciliary body is not translated into a change in focusing power of the implanted artificial intraocular lens. [0011] There have been numerous attempts to achieve at least some useful degree of accommodation with an implanted intraocular lens which, for various reasons, fall short of being satisfactory. In U.S. Pat. No. 4,666,446 to Koziol et al., there is shown an intraocular lens having a complex shape for achieving a bi-focal result. The lens is held in place within the eye by haptics which are attached to the ciliary body. However, the implant requires the patient to wear spectacles for proper functioning. Another device shown in U.S. Pat. No. 4,944,082 to Richards et al., also utilizes a lens having regions of different focus, or a pair of compound lenses, which are held in place by haptics attached to the ciliary body. In this arrangement, contraction and relaxation of the ciliary muscle causes the haptics to move the lens or lenses, thereby altering the effective focal length. There are numerous other patented arrangements which utilize haptics connected to the ciliary body, or are otherwise coupled thereto, such as are shown in U.S. Pat. No. 4,932,966 to Christie et al., U.S. Pat. No. 4,888,012 to Home et al. and U.S. Pat. No. 4,892,543 to Turley, and rely upon the ciliary muscle to achieve the desired alteration in lens focus. [0012] In any arrangement that is connected to the ciliary body, by haptic connection or otherwise, extensive erosion, scarring, and distortion of the ciliary body usually results. Such scarring and distortion leads to a disruption of the local architecture of the ciliary body and thus causes failure of the small forces to be transmitted to the intraocular lens. Thus, for a successful long-term implant, connection and fixation to the ciliary body is to be avoided if at all possible. [0013] In U.S. Pat. No. 4,842,601 to Smith, there is shown an accommodating intraocular lens that is implanted into and floats within the capsular bag. The lens comprises front and rear flexible walls joined at their edges, which bear against the anterior and posterior inner surfaces of the capsular bag. Thus, when the zonules exert a tensional pull on the circumference of the capsular bag, the bag, and hence the intraocular lens, is flattened, thereby changing the effective power of refraction of the lens. The implantation procedure requires that the capsular bag be intact and undamaged and that the lens itself be dimensioned to remain in place within the bag without attachment thereto. Additionally, the lens must be assembled within the capsular bag and biasing means for imparting an initial shape to the lens must be activated within the capsular bag. Such an implantation is technically quite difficult and risks damaging the capsular bag, inasmuch as most of the operations involved take place with tools which invade the bag. In addition, the Smith arrangement relies upon pressure from the anterior and posterior walls of the capsular bag to deform the lens, which requires that the lens be extremely resilient and deformable. However, the more resilient and soft the lens elements, the more difficult assembly within the capsular bag becomes. Furthermore, fibrosis and stiffening of the capsular remnants following cataract surgery may make this approach problematic. [0014] U.S. Pat. No. 6,197,059 to Cumming and U.S. Pat. No. 6,231,603 to Lang each disclose an intraocular lens design where the configuration of a hinged lens support ostensibly allows the intraocular lens to change axial position in response to accommodation and thus change effective optical power. U.S. Pat. No. 6,299,641 to Woods describes another intraocular lens that also increases effective focusing power as a result of a change in axial position during accommodation. In each of these intraocular lenses, a shift in axial position and an increase in distance from the retina results in a relative increase in focusing power. All lenses that depend upon a shift in the axial position of the lens to achieve some degree of accommodation are limited by the amount of excursion possible during accommodation. [0015] U.S. Pat. No. 5,607,472 to Thompson describes a dual-lens design. Prior to implantation, the lens is stressed into a non-accommodative state with a gel forced into a circumferential expansion channel about the lens. At implantation, the surgeon must create a substantially perfectly round capsullorrhexis, and insert the lens therethrough. A ledge adjacent to the anterior flexible lens is then bonded 360° around (at the opening of the capsulorrhexis) by the surgeon to the anterior capsule to secure the lens in place. This approach has numerous drawbacks, a few of which follow. First, several aspects of the procedure are substantially difficult and not within the technical skill level of many eye surgeons. For example, creation of the desired round capsullorrhexis within the stated tolerance required is particularly difficult. Second, the bonding “ledge” may disrupt the optical image produced by the adjacent optic. Third, intraocular bonding requires a high degree of skill, and may fail if the capsullorrhexis is not 360° round. Fourth, the proposed method invites cautionary speculation as to the result should the glue fail to hold the lens in position in entirety or over a sectional region. Fifth, it is well known that after lens implantation surgery the capsular bag, upon healing, shrinks. Such shrinking can distort a lens glued to the bag in a pre-shrunk state, especially since the lens is permanently affixed to a structure which is not yet in equilibrium. Sixth, Thompson fails to provide a teaching as to how or when to release the gel from the expansion channel; i.e., remove the stress from the lens. If the gel is not removed, the lens will not accommodate. If the gel is removed during the procedure, the lens is only in a flattened non-accommodating shape during adhesion to the capsule, but not post-operatively, and it is believed that the lens therefore will fail to interact with the ciliary body as required to provide the desired accommodation as the capsular bag may change shape in the post-operative period. If the gel is otherwise removed thereafter, Thompson ostensibly requires an additional surgical procedure therefor. In view of these problems, it is doubtful that the lens system disclosed by Thompson can be successfully employed. [0016] Thus, the prior art discloses numerous concepts for accommodating intraocular lenses. However, none are capable of providing an accommodating implant which does not, in one way or another, risk damage to the ciliary body or the capsular bag, present technical barriers, or present potential serious consequences upon failure of the device. SUMMARY OF THE INVENTION [0017] It is therefore an object of the invention to provide an intraocular lens that functions similarly to the natural crystalline lens. [0018] It is another object of the invention to provide an intraocular lens that changes shape and increases power during accommodation. [0019] It is also an object of the invention to provide an intraocular lens that produces a sufficient increase in focusing power such that it is clinically useful. [0020] It is an additional object of the invention to provide an intraocular lens that permits uncomplicated implantation of the lens in a manner compatible with modern-day cataract surgery techniques. [0021] In accord with these objects, which will be discussed in detail below, an intraocular lens (IOL) system that permits accommodation and a method of implanting such an intraocular lens system are provided. Generally, the invention includes an intraocular lens that is maintained in a stressed non-accommodating configuration during implantation into the capsular bag of the eye and maintained in the stressed configuration during a post-operative healing period during which the capsular bag heals about the lens. After the post-operative healing period, the intraocular lens is preferably atraumatically released from the stressed state and permitted to move between accommodative and non-accommodative configurations in accord with stresses placed thereon by the ciliary body and other physiological forces. [0022] According to one embodiment of the invention, the intraocular lens system includes a flexible optic having a skirt (periphery or haptic), and a restraining element about the skirt and adapted to temporarily maintain the flexible optic in a stressed, non-accommodating configuration during a post-operative period. The retraining element may comprise a dissolvable bioabsorbable material such that the element automatically releases the optic after a post-operative period, or may be released under the control of a eye surgeon, preferably via a non-surgically invasive means such as via a laser or a chemical agent added to the eye. [0023] According to another embodiment of the invention, the intraocular lens system includes an optic, a pair of haptics located on sides of the optic, and hinge portions at each of the optic haptic junctions. The hinge portions have stressed and non-stressed state configurations. In accord with the invention, one or more restraining elements are provided to maintain the stressed state configuration of the hinge portion during implantation and during a post-operative period. [0024] Generally, the method includes (a) inducing cycloplegia; (b) providing an intraocular lens having an optic portion and haptics and having an as manufactured bias induced between the optic portion and haptics, the intraocular lens being held in a non-accommodating stressed state by a restraining means such that the intraocular lens has a lower optical power relative to an accommodating non-stressed state of the lens; (c) inserting the stressed state intraocular lens into a capsular bag of the eye; (d) maintaining cycloplegia until the capsular bag physiologically affixes to the intraocular lens; and (e) non-surgically invasively releasing the restraining means to permit the intraocular lens to move from the stressed state into the non-stressed state in which the intraocular lens has an increased optical power, and wherein the optical power of the intraocular lens is reversibly adjustable in response to stresses induced by the eye such that the lens can accommodate. [0025] More particularly, according to a preferred method of implantation, the ciliary body muscle is pharmacologically induced into a relaxed stated (cycloplegia), a capsulorrhexis is performed on the lens capsule, and the natural lens is removed from the capsule. The prosthetic lens is then placed within the lens capsule. According to a preferred aspect of the invention, the ciliary body is maintained in the relaxed state for the duration of the time required for the capsule to naturally heal and shrink about the lens; i.e., possibly for several weeks. After healing has occurred, the restraining element automatically or under surgeon control releases the lens from the stressed state. The ciliary body and lens may then interact in a manner substantially similar to the physiological interaction between the ciliary body and a healthy natural crystalline lens. [0026] Alternatively, a fully relaxed lens (i.e., without restraining element) can be coupled to a fully stressed and contracted ciliary body. [0027] The intraocular lens system of the invention is compatible with modern cataract surgery techniques and allows for large increases in optical power of the implanted lens. Unlike other proposed accommodating intraocular lens systems, the lens described herein is capable of higher levels of accommodation and better mimics the function of the lens of the human eye. Further, unlike other lens systems previously described, the lens take into account certain reciprocal aspects of the relationship between the natural crystalline lens and the ciliary body. Moreover, the implantation is relatively easy and rapid. [0028] Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures. BRIEF DESCRIPTION OF THE DRAWINGS [0029] FIG. 1 is a diagrammatic view of a cross-section of a normal eye; [0030] FIG. 2 is a graph of the stresses on the ciliary body-crystalline lens system of the eye in a continuum of states between distance vision and full accommodation; [0031] FIG. 3 is a schematic front view of an intraocular lens according to the invention configured into a stressed state with a restraining element; [0032] FIG. 4 is a schematic transverse section view of the intraocular lens of FIG. 3 in a stressed state; [0033] FIG. 5 is a schematic transverse section view of the intraocular lens of FIG. 3 in a non-stressed accommodating state; [0034] FIGS. 6 and 7 are other schematic transverse section views of intraocular lenses according to the invention; [0035] FIG. 8 is a schematic front view of an intraocular lens according to the invention with the restraining element removed, and thus, configured in a non-stressed accommodating state; [0036] FIG. 9 is a transparent front view of an intraocular lens according to the invention shown with a second embodiment of a restraining element; [0037] FIG. 10 is a schematic transverse view of the intraocular lens of FIG. 9 ; [0038] FIG. 11 is a transparent front view of an intraocular lens according to the invention shown with a third embodiment of a restraining element; [0039] FIG. 12 is a schematic transverse view of the intraocular lens of FIG. 11 ; [0040] FIG. 13 is a transparent front view of an intraocular lens according to the invention shown with a fourth embodiment of a restraining element; [0041] FIG. 14 is a schematic transverse view of the intraocular lens of FIG. 13 ; [0042] FIG. 15 is a schematic front view of an intraocular lens according to the invention having a particular skirt configuration which include haptics and another alternate embodiment restraining element; [0043] FIG. 16 is a schematic front view of another intraocular lens according to the invention having a particular skirt configuration which include haptics and yet another alternate embodiment restraining element; [0044] FIG. 17 is a schematic side view of the intraocular lens of FIG. 16 ; [0045] FIG. 18 is an intraocular lens according to the invention having a particular skirt configuration which include haptics and yet a further alternate embodiment restraining element; [0046] FIG. 19 is a block diagram of a first embodiment of a method of implanting an intraocular lens according to the invention; [0047] FIG. 20 is a block diagram of a second embodiment of a method of implanting an intraocular lens according to the invention; [0048] FIG. 21 is a block diagram of a third embodiment of a method of implanting an intraocular lens according to the invention; [0049] FIG. 22 is a schematic front view of a second embodiment of an intraocular lens according to the invention, shown in a stressed configuration; [0050] FIG. 23 is a schematic side view of the intraocular lens of FIG. 22 , shown in a stressed configuration; [0051] FIG. 24 is a schematic side view of the intraocular lens of FIG. 22 , shown in a non-stressed configuration; [0052] FIG. 25 is a schematic side view of the intraocular lens according to the second embodiment of the invention held in a stressed configuration with a bridge-type restraining element; [0053] FIG. 26 is a schematic side view of the intraocular lens of FIG. 25 shown in a non-stressed configuration; [0054] FIG. 27 is a schematic front view of an intraocular lens according to the invention having four haptics; [0055] FIG. 28 is a diagrammatic view of a cross-section of an eye having an intraocular lens according to the second embodiment of the invention implanted therein, the lens being in a stressed configuration; and [0056] FIG. 29 is a diagrammatic view of a cross-section of an eye having an intraocular lens according to the second embodiment of the invention implanted therein, the lens being in a non-stressed configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0057] Turning now to FIG. 3 , a first preferred embodiment of an intraocular lens 100 according to the invention is shown. The lens includes a pliable optic portion 102 having an elastic memory, and is peripherally surrounded by a skirt portion 104 . A restraining element 106 is provided on the skirt portion 104 and operates to hold the skirt portion and optic portion 102 in a stressed (i.e., stretched) configuration. Comparing FIG. 3 , showing the optic portion in a stressed configuration, with FIG. 8 , showing the optic portion in a non-stressed configuration, it is seen that the optic portion has a smaller diameter in the non-stressed configuration. [0058] More particularly, the optic portion 102 is typically approximately 5 to 6 mm in diameter and made from a silicone polymer or other suitable flexible polymer. The optic portion defines an anterior surface 110 and a posterior surface 112 . The optic portion may have a biconvex shape in which each of the anterior surface 110 and posterior surface 112 have similar rounded shapes. FIG. 4 illustrates such a lens in a stressed non-accommodating configuration, while FIG. 5 illustrates such a lens in the non-stressed accommodating configuration. Alternatively, referring to FIG. 6 , the anterior surface 110 a may be provided with a substantially greater curvature than the posterior surface 112 a . In addition, referring to FIG. 7 , the anterior and posterior surfaces 110 , 112 of the optic portion can be evenly pliable throughout, or, referring back to FIG. 6 , greater flexibility and pliability can be fashioned into the central portion 114 of the anterior 110 surface of the lens to enhance the accommodating effect. This may be done by using materials of differing modulus of elasticity or by altering the thickness of the central portion and/or anterior surface 110 of the optic portion 102 . [0059] Referring back to FIG. 3 , the skirt portion 104 has substantially less pliability than the optic portion 102 . The periphery 116 of the skirt portion 104 is preferably provided with a plurality of circumferentially displaced fenestration holes 118 . The fenestration holes 118 operate to promote firm attachment of the capsular bag to the lens skirt 104 during the healing period. That is, during the healing process, the capsular bag shrinks by a substantial amount and portions of the anterior and posterior capsular bag enter into the fenestration holes 118 and join together to lock the lens 100 within the capsule without necessitating any bonding agent, sutures, or the like. Alternatively, the peripheral portion 104 could be fashioned with a textured surface, ridges or any surface modification that promotes strong adhesion of the capsule to the lens skirt 104 . [0060] Referring to FIGS. 3 and 4 , according to a preferred, though not essential, aspect of the invention, a preferably thin and pliable collar 120 is positioned around the anterior surface of lens near the junction 122 ( FIG. 8 ) of the optic portion 102 and the skirt portion 104 to keep the more central portions of the anterior capsular remnant from adhering to the optic portion. The collar is preferably made from silicone or another smooth polymer. [0061] As discussed above, the skirt portion 104 is maintained in a stressed configuration by the restraining element until the restraining element is removed. According to a preferred embodiment of the restraining element, the restraining element is a band provided on the outside of the skirt portion. The band 106 is preferably comprised of a dissolvable, preferably bioasborbable material that is adapted to preferably naturally dissolve in the fluid of the eye within a predetermined period of time after implantation. Alternatively, the dissolvable material may be selected so that it dissolves only upon the addition of a dissolving-promoting agent into the eye. Preferred dissolvable materials for the restraining band 106 include collagen, natural gut materials, glycan, polyglactin, poliglecaprone, polydioxanone, or other carbohydrate-based or protein-based absorbable material. [0062] Referring now to FIGS. 9 and 10 , according to a second embodiment of the restraining element 106 a , the restraining element comprises a circumferential channel 130 a in the skirt 104 that is filled with a fluid or gel 132 a . Preferably an isotonic solution such as a balanced salt solution is used. Alternatively, other suitable fluids, solution, or gels, including viscoelastics can be used. The channel 130 a has an outlet 134 a that is blocked by a dissolvable, preferably bioabsorbable seal 136 a . The filled channel 130 a operates to stress the optic portion 102 into a non-accommodating configuration until the seal 136 a is dissolved and the outlet 134 a is thereby opened. Then, the material 132 a within the channel 130 a is forced out of the channel by the natural elasticity of the lens and permits the lens to move in accord with the excitation state of the ciliary body; i.e., between non-accommodative and accommodative states. Alternatively, the seal material 136 a may not be naturally dissolvable within the environment of the eye, but rather is dissolvable within the presence of a chemical agent, such as an enzyme, which can be added to the eye. In such case, the eye surgeon can non-surgically control the release of the seal. [0063] Turning now to FIGS. 11 and 12 , according to a third embodiment of the restraining element, the restraining element 106 b comprises a circumferential channel 130 b in the skirt portion 104 that is filled with a balanced salt solution or other suitable material 132 b that maintains the optic portion into a non-accommodating stressed configuration. The channel 130 b has an outlet tube 134 b that is biased outward from the optic portion 108 but which is preferably anchored with an anchor 135 b toward the optic portion 102 but which preferably does not overlie a central area of the optic portion which would interrupt the vision of the patient when the lens is implanted. The outlet tube 134 b is provided with a seal 136 b made from a material, e.g., hard silicone, polymethylmethacrylate (PMMA) or plastic, that is ablatable or otherwise able to be unsealed by laser light from a YAG laser or other laser suitable for eye surgery. Likewise, the anchor 135 b is also made from such a material. When the lens is implanted, as discussed in detail below, the anchor 135 b and the outlet tube 134 b , by being directed toward the optic portion 102 , is visible to the eye surgeon through a dilated iris and is positioned to receive laser light. In this embodiment, the seal 136 b can be removed and the outlet tube 134 b opened under the full control of the eye surgeon (at his or her discretion upon post-operative evaluation of the lens recipient) by use of a laser to remove the pressure in the channel 130 b to equilibrate with the anterior chamber pressure of the eye. Moreover, removal of the anchor 135 b enables the outlet tube to move away from the optic portion in accord with its bias and toward the periphery to minimize any potential interference with the patient's vision. [0064] According to a fourth embodiment of the restraining element, any mechanical means for maintaining the lens in a stressed configuration can be used. For example, referring to FIGS. 13 and 14 , a relatively stiff restraining element 132 c having a circular form can be inserted or otherwise provided within a circumferential channel 130 c. The restraining element is made from a material designed to be ablated or broken upon receiving laser energy, e.g., hard silicone, polymethylmethacrylate (PMMA) or plastic. Alternatively, the end of the element 132 c can be provided with a length of flexible material 134 c , e.g., suture, which can be extended to outside the eye. When it is desired to remove the restraining element, the surgeon grasps the suture with a forceps and pulls the suture. This either removes the restraining element from the lens or breaks the restraining element. In either case, the stress is released from the optic. As yet another less preferred alternative, stiff restraining element is removable or broken only upon an invasive (requiring an incision) surgical procedure. [0065] Other embodiments for the restraining elements and removal thereof are possible. For example, and not by way of limitation, the seal for an inflated channel can be attached to a suture or other length of flexible material which extends outside the eye. The suture can be pulled by the surgeon to remove the seal. In yet another example, shallow shells, adapted to be dissolvable naturally or in conjunction with an additive agent, may be provided to the front and back of the optic portion to force the optic portion to adopt a flatter (i.e., stressed) configuration. By way of another example, dissolvable or laser-removable arced struts may be provided across the lens which force the optic portion into a stressed state. [0066] Moreover, embodiments of the restraining element which maintain the stressed state of the optic via external flattening of the optic or by arced struts are suitable for use with a non-circumferential skirt portion; i.e., where the skirt portion is defined by a plurality of haptics extending outward from the optic portion. For example, FIGS. 15-18 , illustrate the “skirt portion” defined by a plurality of haptics, rather than a complete ring about the optic. FIG. 15 discloses a skirt portion 104 a defined by three haptics 140 a , each of which preferably includes fenestration holes 118 a . Dissolvable or laser-ablatable arced struts 142 a are situated to maintain a radial stress on the optic portion 102 a ; i.e., the struts 142 a function together as a restraining member. FIGS. 16 and 17 discloses a skirt defined by four haptics 140 b , each of which preferably includes fenestration holes 118 b . Shells 144 b are coupled to the haptics anterior and posterior of the optic to flatten the optic. FIG. 18 discloses a skirt defined by two haptics 140 c , each of which preferably includes fenestration holes 118 c . Multiple struts 142 c are coupled to each haptic 140 c. [0067] In addition, it is recognized that the optic portion may be provided in an optically transparent bag, and the bag may be pulled or otherwise forced taught to stress the optic. The bag may be pulled taught by using one of the restraining element described above, e.g., retaining rings, channels, shells, or struts, or any other suitable means, provided either directly to the bag or provided to an element coupled about a periphery of the bag. [0068] Moreover, it is recognized that the lens of the invention may comprise two optic elements: one stationary and the other adapted to change shape and thereby alter the optic power of the dual optic system. In such an embodiment, the optic element adapted to change shape would be provided in a stressed-configuration, according to any embodiment described above. [0069] In each embodiment of the restraining element, the restraining element is preferably configured on or in the lens during manufacture, such that the lens is manufactured, shipped, and ready for implant in a fully stressed configuration. [0070] The lens is implanted according to a first method of implantation, as follows. Referring to FIG. 19 , the patient is prepared for cataract surgery in the usual way, including full cycloplegia (paralysis of the ciliary body) at 200 . Cycloplegia is preferably pharmacologically induced, e.g., through the use of short-acting anticholinergics such as tropicamide or longer-lasting anticholinergics such as atropine. [0071] An anterior capsullorrhexis is then performed at 202 and the lens material removed. A stressed lens according to the invention is selected that preferably has an optic portion that in a stressed-state has a lens power selected to leave the patient approximately emmetropic after surgery. The lens is inserted into the empty capsular bag at 204 . [0072] Cycloplegia is maintained for several weeks (preferably two to four weeks) or long enough to allow the capsular bag to heal and “shrink-wrap” around the stressed and elongated lens at 206 . This can be accomplished post-operatively through the use of one percent atropine drops twice daily. As the lens shrinks, the anterior and posterior capsular bag walls enter into the fenestration holes and join together to lock the lens in position. [0073] If the lens includes a restraining element having a dissolvable component, eventually the dissolvable material is lost from the lens, and the lens is unrestrained. If the lens includes a restraining element having a laser-removable component, a surgeon may at a desired time remove the component to place the lens in a unrestrained configuration. If the lens includes a retraining element which must be surgical removed or altered, the surgeon may at a desired time perform a second eye procedure to remove the component and place the lens in an unrestrained configuration. [0074] Regardless of the method used, when the lens is unrestrained (i.e., released from the stressed state) at 208 and the post-operative cycloplegic medicines are stopped at 210 the lens is initially still maintained in a stressed state ( FIG. 4 ) due to the inherent zonular stress of the non-accommodating eye. When the patient begins accommodating, the zonular stress is reduced and the implanted lens is permitted to reach a more relaxed globular conformation, as shown in FIGS. 5 and 8 . This change in shape provides the optic with more focusing power and thus accommodation for the patient is enabled. As with the natural crystalline lens, the relaxation of the implanted lens to a more globular shape is coupled with a development of strain or stress in the ciliary body during accommodation. Further, when the patient relaxes accommodation, the stress in the ciliary body is reduced, and there is a compensatory gain in stress as the lens is stretched into its non-accommodative shape (See again FIG. 2 ). [0075] Referring to FIG. 20 , according to another embodiment of the method of the invention, a lens of similar design as described above is used, except that there is no restraining element on the lens. Temporary cycloplegia is induced, and a capsulorrhexis is performed 300 . The lens is implanted while the ciliary body is in a fully relaxed state at 302 . The patient is then fully accommodated (i.e., the ciliary body is placed in a contracted state) at 304 , preferably through pharmacological agents such as pilocarpine. [0076] Once the capsular bag is fully annealed (affixed) to the lens periphery at 306 , the pharmacological agent promoting accommodation is stopped at 308 . Then, as the ciliary body relaxes, the lens is stretched into an elongated shape having less focusing power. Conversely, as accommodation recurs, the lens returns to it resting shape having greater focusing power. [0077] Referring to FIG. 21 , in yet another embodiment of the method of the invention, the patient is cyclopleged during cataract surgery at 400 , a capsulorrhexis is performed at 402 , and a flexible lens in an unstressed state is implanted in the capsular bag at 404 . After a few weeks of complete cycloplegia and during which capsular fixation of the lens periphery is accomplished at 406 , light (e.g., ultraviolet or infrared), a chemical agent, or another suitable means is used to shrink or otherwise alter the optic or the adjacent skirt of the lens while the patient is still fully cyclopleged at 408 . In this manner, the optic is again placed into a stressed configuration while the ciliary body is fully relaxed. As with previous embodiments, when cycloplegia is stopped and accommodation occurs at 410 , the lens is able to return to a more relaxed globular configuration. [0078] The intraocular lens systems described with respect to FIGS. 1 through 18 operate to provide accommodation through a change in shape in the optic resulting from an equilibrium of the anatomical forces and the forces in the lens. As now described, it is also possible to provide accommodation through axial movement of a lens within the eye, all while maintaining equilibrium between the anatomical forces and the structural stress designed into the lens. [0079] Turning now to FIG. 22 through 24 , an embodiment of another intraocular lens system according to the invention is shown. The lens 500 includes a central optic 502 , two peripheral haptics 504 , and a junction 506 between the optic 502 and the haptics 504 . The junction 506 preferably has an elastic memory such that, in a relaxed configuration of the lens 500 , free ends 505 of the haptics 504 are oriented at a posterior angle a relative to the optic 502 ( FIG. 24 ); i.e., there is a bias induced between the optic and haptics along an anterior-posterior axis A. A preferred range for angle a includes 1 to 60 degrees, with a more preferred angle a being 25 to 35 degrees. The junction 506 can be a skirt portion attached about the periphery of the optic, or can be integrated into the periphery of the optic, particularly where the optic and junction are unitarily formed as one piece from a flexible polymeric material. In addition, the junction 506 can vary in size allowing elastic bias over part or all of the haptic. For instance, the unstressed conformation of the haptic can describe an arc over all or part of its length. A restraining element 508 is preferably provided either at the junction 506 to restrain flexing at the junction ( FIG. 22 ) or extends as a bridge from the optic 502 to the haptics 504 ( FIG. 25 ) to maintain the lens 500 in a stressed preferably substantially planar configuration during implantation and for a post-operative period. Alternatively, the stressed configuration can be any configuration of the lens in which the optic is oriented in a more posterior orientation relative to the haptic than in the non-stressed configuration. When the restraining element 508 is removed, the haptics 504 are biased toward an angled configuration relative to the optic 502 , with the optic moved anteriorly relative to the haptics ( FIG. 26 ). [0080] More particularly, the optic 502 can be a flexible construction, as in the previous embodiments, or may be substantially rigid. The optic is preferably fixed in power, but may contain zones of different optic power. As such, the optic is either constructed of a suitable flexible polymer such as a silicone polymer, or a suitable stiff plastic such as polymethylmethacrylate (PMMA). The optic preferably has a diameter of approximately 4 mm to 7 mm, and most preferably approximately 5 mm. [0081] The haptics 504 can be substantially planar, curved or loop-like in structure; i.e., they may generally conform to any well-known haptic structure. Moreover, as shown in FIG. 27 , there may be more than two haptics, e.g., four haptics 504 a . Furthermore, as described with respect to the previous embodiments, the haptics 504 may be provided with any number of surface modifications, including knobs, protuberances, textures, fenestration holes, ridge, etc., that promote strong adhesion with the shrink-wrapped capsular remnant. For example, referring back to FIGS. 25 and 26 , a peripheral ridge 510 may be provided to the haptics 504 . The ridge 510 promotes adhesion as well as forces the lens into a more posterior portion of the capsular bag upon implantation, which may be desirable. In addition, the haptics may contain portions of varying flexibility, such as a more flexible peripheral extent to promote flexion of the peripheral haptic against the capsular rim. [0082] The restraining elements 508 , as described with respect to the earlier embodiments, are preferably bio-resorbable, chemically resorbable, laser-removable, or surgically removable. Any restraining element that is removable in the one of the above listed manners or in any other relatively atraumatic manner and which provides the necessary function of maintaining the lens in a relatively planar stressed configuration during implantation and during a post-operative period can be similarly used. [0083] The lens 500 is implanted as described above. That is, cycloplegia is induced, an anterior capsullorrhexis is performed and the lens material removed. Referring to FIG. 28 , the lens, in a stressed, substantially planar configuration is inserted into the empty capsular bag. Cycloplegia is maintained long enough to allow the capsular bag to heal, “shrink-wrap”, and fibrose around the stressed lens. After the bag has healed, cycloplegia is terminated and the restraining element (not shown in FIG. 28 ) is removed. [0084] Referring to FIG. 29 , with the lens unrestrained, the optic 502 of the lens 500 is able to move anteriorly forward during accommodation and increase the focusing power of the eye. The optic 502 moves forward for at least two reasons. First, with accommodation, the stress in the ciliary body 16 is increased causing constriction of the ciliary body, and resultant reduced tension on the zonules 26 . This allows bending of the haptic-optic junction 506 back to its relaxed non-planar configuration. Second, during accommodation there is anterior movement of the ciliary body 16 . [0085] Then, when the patient relaxes accommodation, the stress in the ciliary body 16 is reduced and the ciliary body dilates and moves posteriorly. There is a compensatory gain in stress across the optic-haptic junction 506 as the junction is bent against its memory into a more planar configuration and the optic 502 moves posteriorly (See again FIG. 28 ). [0086] In addition, as discussed above with respect to the first embodiment, a photoreactive intraocular lens may be implanted in an unstressed state. After capsular fixation of the lens, light (e.g., ultraviolet or infrared), a chemical agent, or another suitable means is used to alter the optic into a stressed configuration while the ciliary body is fully relaxed. Then, when cycloplegia is stopped and accommodation occurs, the lens is able to return to non-stressed configuration in which the lens is located anteriorly relative to the haptic portion. [0087] Moreover, as also discussed above with respect to the first embodiment, the lens can be implanted in the eye in a non-stressed configuration, and the ciliary can be pharmacologically induced to contract during the healing period. After healing, pharmacological inducement of ciliary contraction is stopped, and the lens operates in the same manner as described above. [0088] There have been described and illustrated herein several embodiments of an intraocular lens and methods of implanting the same into an eye. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while two particular states of intraocular lenses (fully stressed and fully accommodating) have been disclosed, it will be appreciated that there is a continuum of states of stress that can be fashioned in the inserted lens that would be appropriate for any given state of the ciliary body. In addition, while particular types of materials have been disclosed for the lens, the dissolving material, and a viscoelastic material (where used), it will be understood that other suitable materials can be used. Also, while exemplar pharmacological agents are disclosed for maintaining a state of the ciliary body, it is understood that other agents can be used. Furthermore, while the skirt has been shown comprised of two to four haptics, it is recognized that a single haptic or five or more haptics may be utilized. Moreover, while the restraining struts and shells have been described with respect to skirts comprising haptics, it will be appreciated that the restraining struts and shells can be used with a circular skirt, as described with respect to the preferred embodiments. In addition, while in the second embodiment the optic-haptic junction is stated to preferably have a memory, it is appreciated that other means may be employed to cause the haptics to assume a non-stressed angle configuration relative to optic. For example, an elastic membrane or struts may connect the free ends of the haptics to urge the free ends toward each other and consequently the optic forward. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.

An intraocular lens (IOL) system includes an optic, a pair of haptics located on sides of the optic, and hinge portions at each of the optic haptic junctions. The hinge portions have stressed and non-stressed configurations. One or more restraining elements are provided to maintain the stressed state configuration of the hinge portion during implantation and during a post-operative period during which the capsular bag of the eye heals about the lens. The restraining elements are thereafter removable, preferably via a non-surgically invasive manner, e.g., via dissolution or laser light. Removal of the restraining elements allows anteriorization of the optic as the lens assumes a non-stressed configuration during accommodation. The ciliary body and lens may then interact in a manner substantially similar to the physiological interaction between the ciliary body and a healthy natural crystalline lens.

BACKGROUND OF THE INVENTION The mechanism of bone loss is not completely understood, but bone loss disorders arise from an imbalance in the formation of new healthy bone and the resorption of old bone, skewed toward a net loss of bone tissue. This bone loss involves a decrease in both mineral content and protein matrix components of the bone. Ultimately, such bone loss leads to an increased fracture rate of, predominantly, femoral bones and bones in the forearm and vertebrae. These fractures, in turn, lead to an increase in general morbidity, a marked loss of stature and mobility, and, in many cases, an increase in mortality resulting from complications. Bone loss occurs in a wide range of subjects, including post-menopausal women, patients who have undergone hysterectomy, patients who are undergoing or have undergone long-term administration of corticosteroids, patients suffering from Cushing's syndrome, and patients having gonadal dysgenesis. The need for bone repair or replacement also arises locally in the case of bone fracture, non-union, defect, prosthesis implantation, and the like. Further, such need also arises in cases of systemic bone diseases, as in osteoporosis, osteoarthritis, Paget's disease, osteomalacia, osteohalisteresis, multiple myeloma and other forms of cancer and the like. SUMMARY OF THE INVENTION This invention provides methods for inhibiting bone loss, comprising administering to an animal an amount that inhibits bone loss of a compound of formula (I): ##STR3## wherein: R 1 and R 2 are, independently, --H, --OH, halo, --OC 1 -C 17 alkyl, --OC 3 -C 6 cycloalkyl, --O(CO)C 1 -C 17 alkyl, --O(CO) aryl, --O(CO)O aryl, or --OSO 2 -(n-butyl or n-pentyl); R 3 is ##STR4## R 4 is --H, methyl, ethyl, propyl, ethenyl or ethynyl; or a pharmaceutically acceptable salt or solvate thereof. DETAILED DESCRIPTION OF THE INVENTION The general chemical terms used in the description of a compound of formula I have their usual meanings. For example, the term "alkyl" by itself or as part of another substituent means a straight or branched chain alkyl radical having the stated number of carbon atoms, such as methyl, ethyl, propyl and isopropyl, and higher homologs and isomers where indicated. The term "cycloalkyl" means a cyclic alkyl radical having the stated number of carbon atoms. Examples of cycloalkyl groups are cyclopropyl, cyclopentyl and cyclohexyl. The term "aryl" includes groups such as phenyl, naphthyl, thienyl or furyl, each of which may be unsubstituted or monosubstituted with a group selected from hydroxyl, halo, C 1 -C 3 alkyl, or C 1 -C 3 alkoxy. The term "halo" means chloro, fluoro, bromo or iodo. Specific examples of the compounds of formula I include the following: Compound 1 2-[4-[2-(1-piperidino)ethoxy]phenyl]-3-(4-hydroxyphenyl)-7-hydroxy-2H-l-benzopyran Compound 2 2-[4-[2-(1-piperidino)ethoxy]phenyl]-3-(4-hydroxyphenyl)-2H-1-benzopyran Compound 3 2-[4-[2-(1-piperidino)ethoxy]phenyl]-3-phenyl-7-methoxy-2H-1-benzopyran Compound 4 2-[4-[2-(1-pyrrolidino)ethoxy]phenyl]-3-(4-hydroxyphenyl)-7-hydroxy-2H-1-benzopyran Compound 5 2-[4-[2-(1-piperidino)ethoxy]phenyl]-3-(4hydroxypheny)-4-methyl-7-hydroxy-2H-1-benzopyran The current invention concerns the discovery that the compounds of formula I are useful for inhibiting bone loss. The methods of treatment provided by this invention can be practiced by administering to an animal an amount that inhibits bone loss of a compound of formula I, or a pharmaceutically acceptable salt or solvate thereof. The methods include both medical therapeutic and/or prophylactic treatment, as appropriate. Generally, the formula I compound is formulated with common excipients, diluents or carriers, and put into capsules or compressed into tablets, or formulated as elixirs or solutions for convenient oral administration, or administered by the intramuscular or intravenous routes. The compounds may also be administered transdermally. The methods of this invention also include the administration of a compound of formula I together with estrogen, either independently or in combination. The term estrogen as used herein refers to any compound which approximates the spectrum of activities of the naturally acting molecule which is commonly believed to be 17β-estradiol. Examples of such compounds include estriol, estrone, ethynyl estradiol, Premarin (a commercial preparation of conjugated estrogens isolated from natural sources--Ayerst), and the like. All of the compounds used in the methods of the current invention can be made according to established or analogous procedures, such as those detailed in European Patent Application No. 0 470 310 A1 and PCT Application WO 93/10741. Modifications to these methods may be necessary to accommodate reactive functionalities of particular substituents. Such modifications would be either apparent to, or readily ascertained by, those skilled in the art. Thus, the compounds of formula I in which R 4 is H can be manufactured, for example, by reacting a compound of formula II: ##STR5## in which R 5 and R 6 are R 1 and R 2 , respectively, or a protected hydroxyl group, with 4-hydroxybenzaldehyde to produce a compound of formula III: ##STR6## 2) forming a compound of formula IV: ##STR7## 3) reacting this compound with a compound of formula V: ##STR8## which X is a halide, to form a compound of formula VI: ##STR9## and, if necessary, 4) deprotecting and acylating or alkylating R 5 and R 6 Alternatively, the compounds of formula I in which R 4 is not H can be manufactured, for example, by reacting a compound of formula II in which R 5 and R 6 are R 1 and R 2 , respectively, or a protected hydroxyl group, with 4-hydroxybenzaldehyde to produce a compound of formula VIII: ##STR10## 2) reacting this compound with a compound of formula V in which X is a halide to form a compound of formula X: ##STR11## 3) reacting this compound with a Grignard reagent of formula R 4 MgX in which X is a halide to form a compound of formula XI: ##STR12## 4) dehydrating compound XI to form a compound of formula XII: ##STR13## and, if necessary, 5) deprotecting and acylating or alkylating R 5 and R 6 . When producing the formula I compounds wherein R 1 is H, preferably in the above processes R 5 is H and R 6 is a protected hydroxy group. When the processes are used to produce a formula I compound in which R 1 and R 2 are each alkoxy or carboxy, then R 5 and R 6 may be R 1 and R 2 , respectively, or may each be in the form of a protected hydroxy group. If R 1 or R 2 is a hydroxy group, then R 5 or R 6 , respectively, in the above process is preferably in the form of a protected hydroxy Group. If R 5 or R 6 is a protected group, then preferably the protecting group is 3,4-dihydropyran. The 3,4-hydropyran may be reacted with a compound of formula IX: ##STR14## where one of R 7 and R 8 is a hydroxy group and the other is hydrogen or a hydroxy group or an alkoxy or carboxy group, to form a tetrahydropyranyl ether. Preferably the reaction is carried out in the presence of a sulphonic acid, such as para-toluene sulphonic acid or the like in an ether solvent, such as dioxan or the like. The reaction may be effected for a period of up to 4 hours; and the crude reaction product, after stipulated processing, may be purified, e.g., by crystallization from a petroleum solvent such as hexane or by rapid chromatography over silica gel. The reaction of the compound of formula II with the 4-hydroxybenzaldehyde may be effected in the presence of a cyclic or open chain secondary and/or tertiary amino base such as piperidine or triethyl amine, and an aromatic hydrocarbon solvent such as benzene or the like. The solvent may be added at periodic intervals to replenish its loss during the reaction. This reaction may be effected for a period of about 30 hours. Thereafter, the reaction mixture may be cooled and washed with water, the organic layer separated, dried over Na 2 SO 4 and concentrated. The solidified material may be filtered off, washed with a halogenated solvent such as chloroform, methylene dichloride or the like to give a compound of formula III. Generally, compound III will be produced as a mixture with a compound of formula VIII: ##STR15## For example, the product mixture may contain a ratio of compound VIII to compound III of 1.0:1.5. The filtrate containing compounds III and VIII may be concentrated, chromatographed and eluted with an eluate of increasing polarity, such as ethyl acetate in hexane or the like, thereby separating out the compound of formula III. The compound of the formula III may be converted to a compound of formula IV by reduction, for example by treating with a hydride such as sodium borohydride or the like in an alcoholic solvent such as ethyl alcohol or the like. Cyclodehydration may also be carried out; typically, work-up of the product, e.g., thermal work-up, may cause cyclodehydration. The hydride may be added in different proportions, at intervals of 10 to 15 minutes, at room temperature under stirring. The reaction may be continued a period of up to 12 to 15 hours. The reaction product, after concentration, pH adjustment and extraction with a polar solvent such as ethyl acetate, is purified by chromatography, e.g., flash chromatography over silica gel to yield a compound of formula IV. The compound of formula IV can be treated with an appropriate heterocyclic alkyl halide, e.g., a piperidino- or pyrrolidinoalkyl halide, preferably in the presence of a basic catalyst such as potassium carbonate and a suitable ketonic solvent such as acetone or the like. This reaction may be followed by purification by chromatography, e.g., on alumina using hexane or a mixture thereof with a polar solvent to yield a compound of formula VI. If R 5 and R 6 are not protected hydroxy groups, then the compound produced is a compound of formula I. If R 5 or R 6 is a protected hydroxy group, then the protecting group(s) may be removed by known methods, e.g., by use of an acid such as hydrochloric acid in an alcoholic solvent such as ethanol. The deprotected hydroxy group(s) may, if desired, be alkylated or acylated by known methods to give other compounds of formula I. Alternatively, the compound of formula III can be converted to the compound of formula VIII by heating with sodium acetate in methanol. The compound of formula VIII can be treated with an appropriate heterocyclic alkyl halide, e.g., a piperidino- or pyrrolidinoalkyl halide preferably in the presence of a basic catalyst such as potassium carbonate and a suitable ketonic solvent such as acetone or the like. This reaction may be followed by purification by chromatography, e.g., on silica gel using a mixture of hexane and a polar solvent containing a small amount of triethylamine or ammonium hydroxide, to yield a compound of formula X. The compound of formula X can be treated with an appropriate Grignard reagent, e.g., methylmagnesium bromide or ethylmagnesium bromide, in diethyl ether or a tetrahydrofuran at 0° C. This reaction may be followed by purification by chromatography, e.g., on silica gel using a polar solvent such as ethyl acetate or acetone or a mixture thereof, to yield a compound of formula XI. The compound of formula XI can be dehydrated by treating with acetic acid and water at 100° C. for 10 min. This reaction may be followed by purification by chromatography, e.g., on silica gel using a polar solvent such as ethyl acetate or acetone or a mixture thereof, to give a compound of formula XII. when R 5 and R 6 are not protected hydroxy groups, then the compound produced is a compound of formula I. If R 5 and R 6 are hydroxy group(s) protected as the tetrahydropyranyl ether(s) they are also deprotected in this reaction to yield a compound of formula I in which R 1 and R 2 are hydroxy. The deprotected hydroxy group(s) may, if desired, by alkylated or acylated by known methods to give other compound of formula I. The unprotected starting compound of formula II)': ##STR16## where R 1 and R 2 are as defined supra can be prepared by methods known in the art. For example, when R 1 is H and R 2 is OH, it can be prepared by condensation of phenol with 4-methoxy-phenylacetyl chloride (in turn prepared from 4-methoxy-phenylacetic acid) to afford an ester which on typical Fries rearrangement in the presence of anhydrous aluminum chloride yields a mixture which can be resolved chromatographically to afford the desired starting material that can be characterized by its physical and spectral data. When R 1 is, e.g., methoxy and R 2 is as defined supra, the starting compound II' may be prepared by Friedel-Crafts acylation of a corresponding phenol, such as 3-methoxyphenol or the like, with a suitable substituted or unsubstituted phenylacetyl chloride, using a catalyst, such as anhydrous aluminum chloride. The resultant product may be purified by steam distillation and/or column chromatography. In turn, when R 1 and R 2 are both OH, the starting compound can be prepared by Friedel-Crafts acylation of resorcinol with 4-methoxyphenyl acetyl chloride. This reaction affords a mixture of trihydroxydeoxybenzoin and methoxy dihydroxydeoxybenzoin. The latter compound may be converted into the desired trihydroxy compound by heating it with anhydrous pyridine hydrochloride. The formula I compounds can form pharmaceutically acceptable acid and base addition salts with a variety of organic and inorganic acids and bases and include the physiologically acceptable salts which are often used in pharmaceutical chemistry. Such salts are also part of this invention. Typical inorganic acids used to form such salts include hydrochloric, hydrobromic, hydroiodic, nitric, sulfuric, phosphoric, hypophosphoric and the like. Salts derived from organic acids, such as aliphatic mono and dicarboxylic acids, phenyl substituted alkanoic acids, hydroxyalkanoic and hydroxyalkandioic acids, aromatic acids, aliphatic and aromatic sulfonic may also be used. Such pharmaceutically acceptable salts thus include acetate, phenylacetate, trifluoroacetate, acrylate, ascorbate, benzoate, chlorobenzoate, dinitrobenzoate, hydroxybenzoate, methoxybenzoate, methylbenzoate, o-acetoxybenzoate, naphthalene-2-benzoate, bromide, isobutyrate, phenylbutyrate, β-hydroxybutyrate, butyne-1,4-dioate, hexyne-1,4-dioate, caprate, caprylate, chloride, cinnamate, citrate, formate, fumarate, glycollate, heptanoate, hippurate, lactate, malate, maleate, hydroxymaleate, malonate, mandelate, mesylate, nicotinate, isonicotinate, nitrate, oxalate, phthalate, terephthalate, phosphate, monohydrogenphosphate, dihydrogenphosphate, metaphosphate, pyrophosphate, propiolate, propionate, phenylpropionate, salicylate, sebacate, succinate, suberate, sulfate, bisulfate, pyrosulfate, sulfite, bisulfite, sulfonate, benzene-sulfonate, p-bromophenylsulfonate, chlorobenzenesulfonate, ethanesulfonate, 2-hydroxyethanesulfonate, methane-sulfonate, naphthalene-1-sulfonate, naphthalene-2-sulfonate, p-toluenesulfonate, xylenesulfonate, tartrate, and the like. In addition, some of the formula I compounds may form solvates with water or organic solvents such as ethanol. These solvates are also contemplated for use in the methods of this invention. The pharmaceutically acceptable acid addition salts are typically formed by reacting a compound of formula I with an equimolar or excess amount of acid. The reactants are generally combined in a mutual solvent such as diethyl ether or benzene. The salt normally precipitates out of solution within about one hour to 10 days and can be isolated by filtration or the solvent can be stripped off by conventional means. Bases commonly used for formation of salts include ammonium hydroxide and alkali and alkaline earth metal hydroxides, carbonates and bicarbonates, as well as aliphatic and aromatic amines, aliphatic diamines and hydroxy alkylamines. Bases especially useful in the preparation of addition salts include ammonium hydroxide, potassium carbonate, sodium bicarbonate, calcium hydroxide, methylamine, diethylamine, ethylene diamine, cyclohexylamine and ethanolamine. The pharmaceutically acceptable salts generally have enhanced solubility characteristics compared to the compound from which they are derived, and thus are often more amenable to formulation as liquids or emulsions. Pharmaceutical formulations can be prepared by procedures known in the art. For example, the formula I compounds, either alone or in combination with estrogen, can be formulated with common excipients, diluents, or carriers, and formed into tablets, capsules, suspensions, powders, and the like. Examples of excipients, diluents, and carriers that are suitable for such formulations include the following: fillers and extenders such as starch, sugars, mannitol, and silicic derivatives; binding agents such as carboxymethyl cellulose and other cellulose derivatives, alginates, gelatin, and polyvinylpyrrolidone; moisturizing agents such as glycerol; disintegrating agents such as agaragar, calcium carbonate, and sodium bicarbonate; agents for retarding dissolution such as paraffin; resorption accelerators such as quaternary ammonium compounds; surface active agents such as cetyl alcohol, glycerol monostearate; adsorptive carriers such as kaolin and bentonite; and lubricants such as talc, calcium and magnesium stearate, and solid polyethyl glycols. The formula I compounds, either alone or in combination with estrogen, can also be formulated as elixirs or solutions for convenient oral administration or as solutions appropriate for parenteral administration, for instance by intramuscular, subcutaneous or intravenous routes. Additionally, the compounds, either alone or in combination with estrogen, can be formulated as sustained release dosage forms and the like. The formulations can be so constituted that they release the active ingredient only or preferably in a particular part of the intestinal tract, possibly .over a period of time. The coatings, envelopes, and protective matrices may be made, for example, from polymeric substances or waxes. The particular dosage of a compound of formula I required to inhibit bone loss according to this invention will depend upon the severity of the condition, the route of administration, and related factors. In humans, generally accepted and effective daily doses will be from about 0.1 to about 1000 mg, and more typically from about 50 to about 600 mg. Such dosages will be administered to the patient from once to about three times each day, or more often as needed to inhibit bone loss effectively. If estrogen is also administered, generally accepted and effective daily doses of estrogen will be from about 0.01 to about 4.0 mg, and more typically from about 0.1 to about 2.0 mg. These doses are also administered to the patient from once to about three times a day, or more often as needed. A preferred formula I compound of this invention is the compound wherein R 1 is H or OH; R 2 is OH; R 3 is ##STR17## R 4 is H or methyl. It is usually preferable to administer the formula I compound in the form of an acid addition salt, as is customary in the administration of pharmaceuticals bearing a basic group, such as the piperidino ring. It is also advantageous to administer the compound orally. A particularly important group of patients are aging humans (e.g., post-menopausal females). For the purposes of this invention, the following are typical oral dosage forms. In these examples, "Active ingredient" means a compound of formula 1. Capsules Formulation 1: Hard gelatin capsules are prepared using the following: ______________________________________Ingredient Quantity (mg/capsule)______________________________________Active ingredient 0.1-1000Starch, NF 0-650Starch flowable powder 0-650Silicone fluid 350 centistokes 0-15______________________________________ The ingredients are blended, passed through a No. 45 mesh U.S. sieve, and filled into hard gelatin capsules. Tablets The components in Formulation I can be blended and compressed to form tablets. Alternatively, tablets each containing 0.1-1000 mg of active ingredient are made up as follows: Formulation 2: ______________________________________Ingredient Quantity (mg/tablet)______________________________________Active ingredient 0.1-1000Starch 45Cellulose, microcrystalline 35Polyvinylpyrrolidone 4(as 10% solution in water)Sodium carboxymethyl cellulose 4.5Magnesium stearate 0.5Talc 1______________________________________ The active ingredient, starch, and cellulose are passed through a No. 45 mesh U.S. sieve and mixed thoroughly. The solution of polyvinylpyrrolidone is mixed with the resultant powders which are then passed through a No. 14 mesh U.S. sieve. The granules so produced are dried at 50°-60° C. and passed through a No. 18 mesh U.S. sieve. The sodium carboxymethyl starch, magnesium stearate, and talc, previously passed through a No. 60 U.S. sieve, are then added to the granules which, after mixing, are compressed on a tablet machine to yield tablets. Suspensions Suspensions each containing 0.1-1000 mg of medicament per 5 mL dose are made as follows: Formulation 3: ______________________________________Ingredient Quantity (amount/5 mL)______________________________________Active ingredient 0.1-1000 mgSodium carboxymethyl cellulose 50 mgSyrup 1.25 mgBenzoic acid solution 0.10 mLFlavor q.v.Color q.v.Purified water qs to 5 mL______________________________________ The medicament is passed through a No. 45 mesh U.S. sieve and mixed with the sodium carboxymethyl cellulose and syrup to form a smooth paste. The benzoic acid solution, flavor, and color are diluted with some of the water and added, with stirring. Sufficient water is then added to produce the required volume. The following nonlimiting test examples illustrate the methods of this invention. Test Procedures Six month old, female Sprague Dawley rats (weight range of 275 to 350 g; Harlan Sprague Dawley, Indianapolis, Ind.) are used in these studies. Ovariectomies (or a sham surgical procedure for controls) are performed by the vendor. The animals are shipped the day following surgery and housed in hanging wire cages. Room temperature is maintained at 22.2°±1.7° C. with a minimum relative humidity of 40%. The photoperiod in the room is 12 hr light and 12 hr dark, with light onset at 0600 hr. The animals ad lib access to food (Teklad diet, TD 89222, 0.5% calcium, 0.4% phosphorus; Madison, Wis.) and water. The animals are allowed one day to acclimate to these conditions prior to experimental manipulation. The test compound is suspended in 20% β-cyclodextrin (CDX). 20% CDX is used as the control vehicle. 17α-Ethynyl-estradiol (obtained from Sigma Chemical Co., St. Louis, Mo.) also dissolved in 20% CDX, is used as an internal standard for these studies. On the third day post-ovariectomy dosing with test compounds is initiated. Oral gavages of 20% CDX, Compound 1(0.1 to 10 mg/kg) or 17α-ethynyl-estradiol (100 μg/kg) are delivered daily for 35 consecutive days. On the evening following the final dose, the animals are fasted. The animals are anesthetized with a mixture of Ketaset® and Rompun® (67 and 6.7 mg/kg, respectively) the next morning, and a 3-mL sample of blood is obtained by cardiac puncture. The animals are then asphyxiated with carbon dioxide, and body weight and uterine weight are recorded. The left femur is removed from each animal, cleaned and frozen for subsequent x-ray evaluation. The distal end of the femur is X-rayed using a Norland NXR-1200 X-ray machine with a voltage of 47 kV and contrast at 4.5. Digitized X-ray images are transferred directly to a Macintosh computer station, and image analysis of the X-ray scan is conducted using the Ultimage® software program. Quantitation is achieved by measuring the total number of pixels in a standard region of interest proximal to the growth plate, over a gray scale range of zero to 60. Experimental groups consist of 6 to 8 rats. Data for control and treated rats are compared by one way analysis of variance (ANOVA). The compounds of formula I exhibit a positive impact on inhibition of bone loss under this assay.

A method of inhibiting bone loss comprising administering to an animal an effective amount of a compound having the formula ##STR1## wherein: R 1 and R 2 are, independently, --H, --OH, halo, --OC 1 -C 17 alkyl, --OC 3 -C 6 cycloalkyl, --O(CO)C 1 -C 17 alkyl, --O(CO) aryl, --O(CO)O aryl, or --OSO 2 -(n-butyl or n-pentyl); R 3 is ##STR2## R 4 is --H, methyl, ethyl, propyl, ethenyl or ethynyl; or a pharmaceutically acceptable salt or solvate thereof.

BACKGROUND OF THE INVENTION [0001] A. Field [0002] The present invention refers to a steam automatic dispensing device for preparing hot and/or frothed drinks. [0003] B. Related Technology [0004] Preferably, but not exclusively, the invention is employed as an accessory separated or integrated of the espresso coffee machine for bar, for producing frothed hot milk to be used for instance for preparing cappuccinos. [0005] It is known that, for producing milk froth with espresso coffee machines, the operator uses a container within which he pours a certain amount of milk, inside which he introduced steam through a jet simultaneously shaking the container, so to generate a certain turbulence inside the milk and to add in the environment air needed for producing froth. [0006] The qualities and the quantity of the produced froth depend on the way the milk is shaken and on the amount of steam introduced, and they are therefore linked to the sensibility and experience of each operator. It follows that such features, and then the ones of the cappuccino within which the frothed milk is used, vary from operator to operator and they can be completely unsatisfactory to the client even deemed to be excellent by the operator. [0007] A solution to the problem of how making the quality of the obtained product independent from the operator is the subject of the international patent application WO 01/97668, in the name of the applicant. Such patent application discloses a device essentially consisting of a container within which milk to be heated and to be frothed can be poured, inside which are provided a first duct for introducing steam in milk and a second duct, joined to said first duct, for introducing in milk the air needed for producing froth. The duct for steam dispensing is provided with a radial opening for the exit of steam and the duct for air ends within an axial opening placed in front of said radial opening of the steam duct. This way, the steam dispensing from said radial opening produces a depression that in its turn causes the air suction through the corresponding duct, the steam effusion velocity generates a turbulence at the bottom of milk causing that it is heated and mixed with air and a milk-air-steam mixture is therefore produced directly inside milk, with consequent froth formation. [0008] However effective, the device above illustrated proves to be not much versatile, because it always provides the production of a milk-air-steam mixture and it makes impossible, for instance, the production of hot milk without froth. [0009] Other devices using steam for heating drinks or food are respectively described in the documents U.S. Pat. No. 6,099,878 and FR 2 824 249. [0010] U.S. Pat. No. 6,099,878 discloses a fully automatic, milk inclusive espresso coffee machine which includes coffee bean grinding and brewing apparatus and a milk aeration system which pumps a selection of milk from an internal refrigerator through a choice of aeration processes to a steaming apparatus for heating and further conditioning the milk for joining the brewed coffee liquor. With each beverage production cycle all milk is hygienically either served or returned to its refrigerated reservoir. A process is disclosed which includes pumping milk, all in a refrigerated environment, selectively along a plurality of milk lines one of which may inject air for foaming the milk to a steam delivery line for heating and steaming it and delivering it to a beverage cup. After the desired amount of milk has been delivered, the steam flow continues momentarily to cleanse the line of residual milk. FR 2 824 249 discloses a device for heating food comprising a temperature measurement rod including an agitator section with steam outlets and temperature sensor. A handle is used for stirring. The steam generator feeds the outlets through a flexible tube connected to the rod. An electrical controller is wired to the sensor and steam generator and/or a display unit. BRIEF SUMMARY OF THE INVENTION [0011] It is the main object of the present invention to realise a device for heating and/or preparing froth of a liquid that allows to automatically obtain different kinds of drinks, such as for instance, hot milk, hot and frothed milk, infusions, etc. [0012] Another object of the present invention is to realise a device for heating and/or preparing froth of a liquid having limited size, that can be easily used in association with a professional coffee machine. [0013] A further object of the present invention is to realise a device for heating and/or preparing froth of a liquid that allows to control the temperature of the liquid to be heated. [0014] These and other objects are achieved with the automatic device for heating and/or preparing froth of a liquid as claimed in the accompanying claims. [0015] By following the teachings of WO 01/97668, the device according to the invention comprises a first duct to introduce steam and a second duct through which it is possible to introduce air inside a liquid to be heated in order to obtain the formation of froth. [0016] Advantageously, according to the present invention, each of said ducts is connected to an electrovalve: the user can select the kind of wanted drink and, on the basis of said selection, a microprocessor controls the opening and the closing of said electrovalves, so to permit or prevent according to a preset cycle the introduction of air and steam in the drink. [0017] Said microprocessor can be equipped with a storage within which a plurality of operating cycles are stored, corresponding to a plurality of drinks that can be prepared with said device. Each of said operating cycles provides a sequence of steps of preset duration of opening and closing of each valve. [0018] Advantageously, the device according to the invention can further comprise a sensor for measuring the temperature, so to control the temperature of the liquid to be heated and/or frothed and, in case, to correct the parameters of the above-mentioned operating cycles in order to obtain a drink at the desired temperature. DESCRIPTION OF THE DRAWINGS [0019] A preferred embodiment of the invention will be now described in detail with particular reference to the attached drawings, supplied as non limiting example, in which: [0020] FIG. 1 is a schematic side view of the ducts dispensing steam and air of the device according to the invention; [0021] FIG. 2 a is a scheme of a first embodiment of the device according to the invention; [0022] FIG. 2 b is a scheme of a second embodiment of the device according to the invention; [0023] FIG. 3 is a block diagram of the electronic control unit of the device according to the invention; [0024] FIG. 4 is a graph showing the opening and closing steps of the valves in an example of preparing cycle of a drink. DETAILED DESCRIPTION [0025] With reference to FIG. 1 , an embodiment of the device according to the invention is shown that comprises a first duct 13 for steam and a second duct 15 for air. In the example shown said ducts are immersed into the liquid, for instance milk, contained inside a container 11 . [0026] The steam duct 13 has the lower end 13 a closed and it is provided, near said end, with a radial hole 17 . The air duct 15 , having a diameter smaller than one of the steam duct, has the end portion 19 tapered and it ends with an axial opening 21 , placed in front of said radial hole 17 of said steam duct 13 . [0027] A temperature electronic sensor 23 , fit for measuring the temperature of the liquid to be heated, is further fastened to one of said ducts 13 , 15 . Said sensor 23 is electronically connected to an electronic control unit through a couple of conductors passing inside a protective sheath 25 . [0028] In FIG. 2 a a first embodiment of the hydraulic circuit of the device according to the invention is shown. [0029] The air duct 15 is provided with a first three-way electrovalve 16 , whose remaining two ways are connected one to the outside environment through a suction pipe 33 that has the end 35 open and the other to a second three-way electrovalve 14 through an intermediate pipe 31 . [0030] The remaining two ways of said second electrovalve 14 are in their turn connected one to said steam duct 13 and the other to a steam source 27 through a dispensing pipe 29 . [0031] In such way, according to the opening or closing condition of said electrovalves 14 , 16 one and/or the other of said ducts 13 , 15 can be put in communication with said steam source 27 or with the outside environment. [0032] In particular, thanks to the intermediate pipe 31 that connects the two electrovalves 14 , 16 , it is possible to introduce steam into the liquid to be heated through both said ducts 13 , 15 , or, alternatively, to simultaneously introduce into said liquid steam through duct 13 and air through duct 15 . [0033] Advantageously, thanks to the above-mentioned expedient it is possible to obtain drinks that require different preparation modes. [0034] For instance, in case said second electrovalve 14 is positioned so to put in communication the steam dispensing pipe 29 both with the intermediate pipe 31 and with the steam duct 13 and said first electrovalve 16 is positioned so to put in communication the intermediate pipe 31 with the air duct 15 and to close said suction pipe 33 , the steam generated from said steam source 27 will reach both the ducts 13 , 15 and the liquid will be heated, substantially without froth formation. [0035] In case, on the contrary, said first electrovalve 16 is positioned so to close the intermediate pipe 31 and to put in communication the suction pipe 33 with the air duct 15 , the steam generated from said steam source 27 will only reach the steam duct 13 , while the air duct 15 will be reached by the air sucked from the outside environment and it will be therefore obtained the froth formation during the liquid heating. [0036] It is evident that, with the device according to the invention, it is possible to set numerous operating cycles based on the sequence of a plurality of steps, each characterised by a set duration and by a different condition of opening/closing of said electrovalves 14 , 16 , correspondingly obtaining numerous preparation modes of different drinks. [0037] It is to be noted that, in a preferred embodiment, said steam source 27 consists of a steam jet of an espresso coffee machine for bar and, to this purpose, said pipe 29 can be equipped with means to be tight fastened to said steam jet. [0038] Alternatively, the device according to the invention can be provided with an autonomous steam generator and it can therefore be used independently from other apparatuses for bar. [0039] With reference to FIG. 2 b a second embodiment of the device according to the invention is shown. In said second embodiment the first three-way electrovalve 16 , instead of being connected through the intermediate pipe 31 to the second three-way electrovalve 14 , is directly connected through a pipe 37 to the pipe 29 carrying steam from the source 27 to the second electrovalve 14 (alternatively, pipe 37 could be connected to duct 13 immediately downstream the second electrovalve 14 as shown in FIG. 2 b with the dotted line). In such way, the second three-way electrovalve 14 can be advantageously equipped with a pipe 39 open to the outside at 43 in order to allow the downwards easy flow by gravity of the liquid in case present in the duct 13 that, otherwise, should tend to clog, when said second valve 14 is positioned so to allow the passage from pipe 41 to duct 13 . [0040] It is to be noted that in the shown examples two three-way electrovalves have been employed for reasons of simplicity and economy, but it will be also possible to provide arrangements that employ a combination of other kinds of electrovalves and connections. [0041] FIG. 3 is a block diagram that illustrates in a simplified way the electronic control unit 51 of the device according to the invention. [0042] Said control unit 51 comprises a selector 53 onto which the user can select the kind of wanted drink. The selection carried out onto the selector 53 controls a microprocessor 55 , provided with a storage 57 , within which the data relevant to the operating cycle corresponding to each possible user's selection are stored. [0043] On the basis of the instructions stored inside the storage 57 said microprocessor 55 performs a cycle based on a sequence of opening and closing steps of each electrovalve 14 , 16 . [0044] Said microprocessor 55 is further connected to the temperature sensor 23 , if this is present. On the basis of the temperature-indicative signal sent by said sensor 23 , the microprocessor 55 can modify the duration of the different steps of the opening and closing cycle of the electrovalves stored inside the storage 57 in order to obtain a drink with the optimum temperature and froth amount. [0045] As an example, in FIG. 4 is reproduced a graph that illustrates the operating cycle of the device according to the invention in case of preparing a cappuccino. [0046] In said graph, on the axis of abscissae the time for preparing the drink is quoted and on the axis of ordinates the milk temperature is quoted. [0047] During a first step 1 , shown with a dotted line in the graph, said first electrovalve 16 and said second electrovalve 14 are maintained in such a position to simultaneously send steam to both the ducts 13 and 15 and to prevent air entering through the suction pipe 35 . [0048] When milk reaches a preset temperature T 1 , for instance about 35° C. (or after a fixed time when the temperature control is not present), in a second step 11 , shown with a continuous line in the graph, the first electrovalve 16 is positioned so to allow the air entering through the duct 15 and to prevent steam passing from the intermediate pipe 31 . [0049] Said first electrovalve is maintained open up to a preset temperature T 2 (or for a fixed time when the temperature control is not present), for instance of 5° C. under the final wanted temperature T 3 (in the example 65° C.). [0050] Once reached said temperature T 2 , in a third step III, shown with a dot-point line in the graph, said first electrovalve 16 is again positioned so to allow the steam entering also through duct 15 and to prevent air suction through the suction pipe 35 . [0051] This arrangement is maintained until the preset temperature T 3 is reached, having reached which the second valve 14 is closed so to prevent steam introduction into both the ducts and to allow the removal of the drink. [0052] Though in the preferred embodiment the ducts of the device according to the invention are directly connected to the steam jet of a professional espresso coffee machine, by following the teachings of WO 01/97668 it will be possible to provide a device comprising a container for the liquid to be heated, wherein said ducts are fastened to said container.

A steam automatic dispensing device for preparing hot and/or frothed drinks, includes a first duct ( 13 ) for introducing steam inside a drink; a second duct ( 15 ) for introducing air inside the drink; an electronic control unit ( 51 ) for controlling the introduction of steam and/or air through said first and second duct, the control unit being programmable to carry out a predetermined control cycle depending on the desired drink to be obtained and on the drink temperature.

[0001] This application claims priority from and incorporates by reference U.S. provisional patent application Ser. No. 60/475,187 filed Jun. 2, 2003. FIELD OF THE INVENTION [0002] A two-sided “emotional” interactive hand puppet for use with teaching. BACKGROUND [0003] Teaching, especially teaching children is often assisted and enhanced for the use of a play toy. Most children are interested in and entertained by puppets. Applicant has found that the use of puppets, including the unique puppets set forth herein is a valuable and effective teaching device, which also has applications in child therapy. OBJECTS OF THE INVENTION [0004] To provide a unique puppet and sets of puppets that display, on opposite sides thereof, two faces of a single character, which two faces reflect contrasting motions. [0005] Another object of the present invention is to provide for a novel, interactive two sided puppet and method of use of the interactive puppet as part of the teaching lesson. [0006] Another object of the present invention is to provide for a novel two sided puppet and method for teaching the same, the method of teaching including providing a story line to go with each of the two sides and the contrasting emotions thereof which story line turns in a bad or sad situation (sad face) into a good situation (happy face). SUMMARY OF THE INVENTION [0007] A teaching and/or therapy device adapted for fitting the hand of a teacher or therapist, the device comprising a puppet having a first side with a first face depicting a first emotion, and a second side, generally opposite the first side, depicting the same face generally except with an expression reflecting a second, contrasting emotion. [0008] Applicant's novel puppet may be used with a story line, the story line reflecting a bad/sad situation, which story line is provided to the children while generally simultaneously displaying a first (sad/bad) side of the puppet and a second story line while generally simultaneously displaying explaining a second/happy emotion on the face of the puppet. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1A and 1B are two sides of a first embodiment ( 10 A) of a hand puppet which embodiment discloses a female figure including face. The expression on the face in FIG. 1A contrasts with the reverse or opposite side of the hand puppet as illustrated in 1 B. [0010] FIG. 2A and 2B illustrate a second alternate preferred embodiment ( 10 B) of Applicant's novel puppets. In this embodiment the two opposite sides appear generally the same except for the expression of the face, which carries contrasting emotions. In this embodiment a highly stylized costume, here displaying an oriental origin is provided. [0011] FIG. 3A and 3B are provided to illustrate the third embodiment of Applicant's two sided puppets. Here embodiment ( 10 C) illustrating a “humanized” animal with the two sides being substantially similar except for the contrasting expressions on the face. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0012] FIG. 1A and 1B , 2 A and 2 B and 3 A and 3 B illustrate three of Applicant's novel puppets ( 10 A, 10 B and 10 C), each adapted to fit the hand of the teacher, instructor or therapist. Each puppet depicts, on two sides, a first side ( 12 A) and a second side ( 12 B) thereof, the same character with the same features, except that the first side reflects a first emotion, for example a sad face, and the second side depicts the same face reflecting a face depicting a second emotion, such as a glad/happy emotion depicted by a smile. [0013] The characters which may be depicted include original and non-original cartoon characters, and stylized depictions of “humanized” animals such as illustrated in FIGS. 3A and 3B . [0014] The figures may be multi-cultural as represented for example by the facial features and generally dress illustrated in FIGS. 2A and 2B , depicting an oriental character. The human characters may also be multi-racial or depict known fairy tale and folk tale characters. [0015] The two sided puppets may be constructed from washable felt and may be used to act out stories while teachers, parents, or friends read a book or script. Children can be encouraged to use the puppets to interact with a teacher, parent, or friend. [0016] The two sided puppets may also include a collection of silly animals with a happy side and a sad side. The idea of positive behavior or negative behavior may be reinforced through using the contrasting two sides ( 12 A and 12 B) of the puppets. Being able to flip the hand held puppet quickly from one side to the other encourages a child to develop a dialogue with a friend or a puppet or to help explain good and bad behavior. Moreover, the puppets, with one on each hand, can be used simultaneously reflecting contrasting emotions. [0017] The two sided puppets may also be used to help young people deal with troubles and difficulties encountered in family, school or society in general, and may be used by a therapist to help develop dialogue with a child patient. One puppet may be used on one hand by the therapist or two puppets on two hands to assist in drawing out a child or explaining proper or improper behavior to a child. [0018] A series of drama puppets may be provided with characters drawn from operas or plays. Typically, in operas or plays characters have a positive side and a negative side. The puppets may be configured with facial expressions but reflect these two different sides and may be used in conjunction with telling the story of the play. Indeed, the puppets may carry indicia thereon, such as the name of the character (see “Olga” FIGS. 1A and 1B ) from the play such that there is an immediate positive and direct association between the name of the puppet and the character of the play. [0019] A first example of using Applicant's novel two sided puppets, in conjunction with a story line involving a young clumsy bear (see puppet 10 C). The bear was having a difficult time doing anything right (see FIG. 3A side 12 A). One day someone teaches him how to do things right and he is happy ( FIG. 3B side 12 B of the bear displayed to the children). The sad side of the character is typically displayed when he couldn't do anything right and when he learned how, the happy side may be displayed. [0020] Aesop's Fables are well known with story lines that conclude with a “moral” or lesson learned. Characters including those depicted in Aesop's Fables maybe provided with contrasting emotions depicted and used to tell the Fable and explain the lesson to be derived from the story line. [0021] A lesson planned designed around Applicant's novel two sided puppets are set forth below. [heading-0022] Hibernation Lesson Plan [none] Lesson 1: Olga the Ballerina Grade Level: Kindergarten Approximate Time: 5 minutes Objectives: Knowledge—students will identify letters “B” in the word Ballerina and “O” in the name “Olga”. Application—students will interact with the puppet during the lesson. Comprehension—students will explain what they learned about the Ballerina after the puppet presentation. Synthesis—students will illustrate their knowledge of dance and effort by drawing in their journals. Materials: 1. Puppets and Script 2. Student Journals 3. Lesson Plan 4. Pencils 5. Crayons Procedures: 1. Call the students to their story telling area. 2. Tell the students that they will learn about “Olga the Ballerina”. Ask them what letter “Olga” and “Ballerina” start with the alphabet, introduce the puppet. Olga the Ballerina's Script: “I am so clumsy when I dance . . . Boo” “My teacher says she will teach me . . . Rah!” “Today I was too scared to dance . . . Boo” “Then I danced anyway and did very well! . . . Rah!” [0045] As be seen, Applicant's novel puppets ( 10 A, 10 B and 10 C) maybe provided with a script personalized to the character and describing a sad/bad and happy/glad situation by utilizing the contrasting expressions on the face of the two sides of the puppets. Applicant further provides a kit with puppets and a script. As seen from the accompanying illustrations, puppets ( 10 A, 10 B and 10 C) have a first side ( 12 A), and a second side ( 12 B). The two sides are substantially similar in appearance except in the expression of the face ( 14 ). The face ( 14 ) will typically include a mouth ( 15 ). While the face of the two sides is generally the same, typically mouth and other anatomical parts of the face will express contrasting expressions. That is, it is immediately clear that the same face is on both sides of the same character ( 10 A, 10 B or 10 C) but the expression on the face thereof, including a mouth portion ( 15 ) is contrasting—for example a smile and a frown. [0046] Other scripts illustrating contrasting emotions, the naming of the character and a word to reflect the facial expression and situation (“Boo/Rah” as set forth below) are: [0047] BooRah Puppet Script: Mel the Monkey's Script: “EEEk, Eek, I have nothing to eat . . . Boo” “My Mommy is going to give me a banana! . . . Rah!” “OOOO! I have a banana but can't open it . . . Boo” “My mommy showed me how, now I can eat it . . . Rah!” [0053] Sue Shee's Script: “I have no fish . . . Boo” “Daddy is going fishing . . . Rah!” “Daddy didn't catch a big fish . . . Boo” “But he did catch a little fish just for me . . . Rah!” [0058] Lab Pups' Script: “Whimper, Whimper, I lost my ball . . . Boo” “Woof, woof, I got a new one . . . Rah” [0061] Sides 12 A and 12 B typically, then, include a face portion and a body portion ( 16 ) which may include clothing or highly stylized costumes (see FIG. 2A and 2B ). Opening ( 18 ) is typically provided at the base or primitive portion ( 19 ) of the puppet for insertion for the hand therein. Indicia ( 20 ) may be provided and may personalize the puppet with a name (“Olga”) and/or an activity (the “Ballerina”) and/or indicia reflecting an emotion as in “Boo” and “Rah” as set forth in FIGS. 3A and 3B . [0062] Although the invention has been described with reference to specific embodiments, this description is not meant to be construed in a limited sense. Various modifications of the disclosed embodiments, as well as alternative embodiments of the inventions will become apparent to persons skilled in the art upon the reference to the description of the invention. It is, therefore, contemplated that the appended claims will cover such modifications that fall within the scope of the invention.

A puppet having two sides, the two sides reflecting the same character. However, on the first side the character is bearing a face displaying a first emotion such as a smile reflecting happiness, and a second side with the same face except displaying a second emotion such as a frown reflecting sadness. The puppets are used, typically with a script bearing a portion for each side of the puppet, for instructing small children.

BACKGROUND OF THE INVENTION The present invention relates generally to a device for shielding the skin of humans from ambient light to facilitate the performance of certain tests on the skin. In a more specific application, the present invention relates to a device for shielding a spot of the skin of infants who are undergoing phototherapy for the treatment of jaundice. Jaundice is a relatively common occurrence in newborn infants resulting from elevated leves of serum bilirubin. The most common treatment of jaundice or hyperbilirubinemia is the exposure of the infant to phototherapy. This treatment reduces the serum bilirubin concentration. Historically, the only available method for the determination of the serum bilirubin concentration was blood sampling followed by analysis in the laboratory. This, of course, is not only time consuming and relatively expensive, but also requires taking a sample of the infant's blood. A direct relationship exists between a person's skin color or the degree of jaundice and hyperbilirubinemia. This relationship or correlation ultimately led to the development of a cutaneous jaundice meter which utilizes the principles of reflectometry to detect the extent of yellow in the infant's skin which correlates with the level of serum bilirubin. A commercial cutaneous jaundice meter is a hand-held unit having a probe less than one-half inch in diameter which is pressed against the infant's skin. A digital readout provides information with respect to the yellowness of the skin. This jaundice meter is presently indentified by the trademark MINOLTA/AIR-SHIELDS and is distributed by Narco Scientific of Hatboro, Pa. While the above described jaundice meter has been shown to work satisfactorily with newborn infants for the purpose of mass screening for the determination of the degree of jaundice or the level of serum bilirubin, its usefulness has been questioned with respect to infants undergoing phototherapy for the treatment of such conditions. Specifically, for infants undergoing phototherapy, the relationship between skin color and serum bilirubin levels appears to be disrupted. This is believed to be a result of bleaching and/or tanning of the skin which is a normal occurrence during phototherapy and which affects the accuracy of the jaundice meter reading. Thus, unless the above-mentioned cutaneous jaundice meter can be used to accurately estimate the serum bilirubin level during phototherapy, its value is limited. Accordingly, a need exists for a device which would permit the use of such an instrument during phototherapy. SUMMARY OF THE INVENTION The present invention solves the problem outlined above by providing a means which permits the use of a cutaneous jaundice meter for the estimation and monitoring of serum bilirubin levels in infants undergoing phototherapy. The invention is a device which functions to shield a small part of the infant's skin from the effects of phototherapy and to provide access of that small area of skin to the cutaneous jaundice meter for periodic measurements of the intensity of jaundice. As a result, this small area of skin is unaffected by the direct effects of phototherapy such as bleaching or tanning. Thus, the accuracy of the cutaneous jaundice reading, even on infants undergoing phototherapy, is not reduced. More specifically, the device of the present invention includes a first layer of material with at least one of its surfaces having an adhesive coating to permit it to be secured to the skin of the infant undergoing phototherapy. This first layer has an opening or window to provide access to a small area of the infant's skin. This opening or window should be sufficiently large to allow access by the sensing probe of the cutaneous jaundice meter. The device also includes a second layer designed to overlay the first layer including the opening or window. This second layer is designed for selective removal from at least a portion of the first layer to expose the hole or opening and thus provide access to the skin in the area of the opening for measurement by the jaundice meter. This second layer is preferably constructed of a material which will allow the skin exposed by the opening or window to breathe normally. Accordingly, an object of the present invention is to provide a device for shielding the skin to facilitate and improve the accuracy of tests conducted on the skin. Another object of the present invention is to provide a device for shielding the skin to facilitate the use of a cutaneous jaundice meter during treatment of the infant by phototherapy. A further object of the present invention is to provide a device as described above having means for selectively providing access of a small area of skin to a cutaneous jaundice meter. These and other objects of the present invention will become apparent with reference to the drawings, the description of the preferred embodiment and the appended claims. DESCRIPTION OF THE DRAWINGS FIG. 1 is a pictorial view of one embodiment of the device of the present invention. FIG. 2 is a sectional view of the device of the present invention as viewed along the section line 2--2 of FIG. 1. FIG. 3 is a pictorial view of the device of the present invention with the second layer or lid in an up position. FIG. 4 is a pictorial view of a second embodiment of the device of the present invention showing the second layer or lid in an up position. FIG. 5 is a pictorial view showing the device of the present invention as applied to the skin of an infant. DESCRIPTION OF THE PREFERRED EMBODIMENT Reference is first made to FIGS. 1, 2 and 3 showing a first embodiment of the device of the present invention. In these figures, the device is illustrated generally by the reference numeral 10. More specifically, the device includes a first layer 12 having an adhesive bottom surface to permit securing the device 10 to the skin of the infant. The adhesive surface of the layer 12 is removably secured to a release layer 11. In the first embodiment, the first layer 12 is a generally rectangular shape although other shapes will function satisfactorily. The first layer 12 of the first embodiment is constructed of a foam rubber type material. As shown best in FIGS. 2 and 3, the first layer 12 includes a centrally positioned opening or window 20. A second layer 14, opaque to the passage of ambient light, is positioned above the first layer 12 and functions to selectively cover the opening or window 20. This second layer 14 in the embodiment illustrated in FIGS. 1, 2 and 3 is connected at its rearward end 16 to the first layer 12. In the first embodiment, this connection is by means of a plurality of stitches 21 (FIG. 2). A strip of tape or other material 15 is placed above the stitches 21 (FIG. 2) to cover the same. A piece of adhesive back tape or other material 18 is secured to a top surface portion of the second layer 14 and extends outwardly from the second layer 14 to form the forwardly extending tab portion 19. The adhesive backed tab portion 19 is adapted for selective adherence to the top surface of the strip 13 which is secured to the top surface of the forward end of the first layer 12. Because of the securement of the second layer 14 to the first layer 12 at the end 16, the second layer 14 acts as a hinged lid 17 with respect to the first layer 12, thus permitting the forward extending tab 19 to be manually lifted to the position illustrated in FIG. 3. The lifting of the lid 17 in this fashion enables the skin in the area of the opening or window 20 to be exposed for purposes of obtaining a reading or measurement by cutaneous jaundice meter of the type previously described. After the reading has been taken, the lid 17 is placed down over the opening 20 and the adhesive backed tab 19 is secured to the strip 13. In the first embodiment, the second layer is constructed of conventional medical gauze, although it is contemplated that other types of material will also function satisfactorily. It is believed to be important, however, for this material of the second layer to be a material which will allow the skin exposed by the window 20 to breathe in a normal fashion. The distance between the side edges 12a and 12b (FIG. 3) and the side edges of the opening 20 is also of some importance. If this distance is too small, it is believed that some bilirubin can diffuse laterally from the portion of the unprotected skin during phototherapy, thus resulting in inaccurate readings. It is believed that this distance should be at least two and one-half millimeters. To use the device of FIGS. 1, 2 and 3, the device 10 is removed from the release layer 11 by peeling off the adhesive-backed first layer 12. The device 10 is then secured to the skin of the infant in the position desired. In some cases, health professionals prefer to secure the device 10 to the forehead of the infant while others prefer to secure the device 10 to the sternum of the infant 23 as illustrated in FIG. 5. The infant 23 can then be exposed to phototherapy for treatment of its jaundiced condition. During periodic measurements to determine the progress of reducing the bilirubin level by phototherapy, the lid 17 (FIGS. 1, 2 and 3) is raised and a measurement taken by a cutaneous jaundice meter. After measurement, the lid 17 is then placed back over the opening to protect the skin test area from the effects of phototherapy. A second embodiment of the device of the present invention is illustrated in FIG. 4. This embodiment includes a generally annular or doughnut shaped first layer 22 with a central opening or window 24. In this embodiment, the layer 22 includes an adhesive coating both on its bottom surface and its upper surface. The adhesive coating on the bottom surface permits the first layer 22 to be secured to the infant to be tested. The adhesive layer on the upper surface permits the second layer or lid 25 to be selectively secured to the upper surface of the layer 22 to close the opening 24. It should be noted that the stickiness between the bottom surface of the first layer 22 and the skin of the infant should be more aggressive than the stickiness between the upper surface of the first layer 22 and the bottom surface of the lid 25 to prevent the device from being removed from the skin of the infant each time the lid 25 is raised. As illustrated, the second layer or lid 25 is also circular in shape and is fixedly secured to a portion of the first layer 22 at the point 26. The forward edge of the lid 25 includes a tab 27 to facilitate easy lifting of the lid 25. The material from which the lid 25 is constructed is a material which is opaque to the passage of ambient light and will allow the infant's skin to breathe in a normal fashion. It should also be noted that the device of the present invention can be designed to perform dual functions. For example, it could be designed to also serve as an electrode during conduction of EKG tests, thus minimizing the number of patches needed to be placed on the infant. Although the description of the preferred embodiment has been quite specific, it is contemplated that various changes and modifications could be made without deviating from the spirit of the present invention. Accordingly, it is intended that the scope of the present invention be dictated by the appended claims rather than by the description of the preferred embodiment.

A device for shielding a portion of human skin to facilitate the performance of tests on the skin. The device includes a first layer adapted to be secured to the skin to be tested with an opening to permit selective access by a testing instrument. A second layer is positioned above the first layer in a manner permitting selective removal of at least a portion of the second layer to permit access to the skin through the opening in the first layer.

BACKGROUND OF THE INVENTION [0001] Field of the Invention [0002] The present invention relates generally to cup holders. In particular, countertop seated cup holders for food service application wherein a plurality of disposable cups may be stacked and held stable for display and easy access. [0003] Description of the Related Art [0004] A problem in the food service industry has long been the placement of disposable cups for easy access. If stacks of cups are simply left out on an open table, they pose sanitary problems, and are prone to being moved, upset or toppled. [0005] Existing cup holders for this application are either difficult to keep clean, provide inadequate stability or are comparatively expensive. [0006] Many restaurants have spring loaded cup holders recessed into cabinetry which are often located behind the counter for employees to quickly obtain a cup for service. However, they are rarely provided for customers. They are prone to jams, take up a great deal of space, and are costly and require professional installation. They are also difficult to clean and because the mechanism is below countertop level, spills will soil the entire contents of the cup holder, requiring that the cup holder be emptied for cleaning. [0007] Accordingly, there is a continuing need for alternative cup holders. SUMMARY OF THE INVENTION [0008] In an aspect there is provided, a cup rack comprising: [0009] a base providing a surface for abutting support for a plurality of cups; [0010] a cup retainer plate coupled to the base; [0011] a plurality of cup retaining apertures formed within the cup retainer plate, each cup retaining aperture sized to receive a corresponding cup and having a diameter smaller than the largest exterior diameter of the corresponding cup; the cup retainer plate moveable from a first closed position parallel and proximal to the surface for abutting support to a second open position for insertion of cups within the cup retaining apertures. BRIEF DESCRIPTION OF THE DRAWINGS [0012] FIG. 1 is a front perspective view of a 4×2 array cup rack. No cups are shown so that the bare mechanism is visible. [0013] FIG. 2 is a perspective exploded view of the 4×2 array cup rack shown in FIG. 1 , with insertion of mounting cups shown. [0014] FIG. 3 is a front perspective view of a 4×2 array cup rack shown in FIG. 1 with mounting cups in place. [0015] FIG. 4(A) is a cross-section view of the 4×2 array cup rack shown in FIG. 3 along the plane containing the line 4 A- 4 A, in the indicated direction. FIG. 4(B) is a cross-section view of the 4×2 array cup rack shown in FIG. 3 along the plane containing the line 4 B- 4 B, in the indicated direction. [0016] FIG. 5 is a front perspective view of the 4×2 array cup rack shown in FIG. 3 with stacking cups in place. [0017] FIG. 6(A) is a cross-section view of the 4×2 array cup rack in FIG. 5 along the plane containing the line 6 A- 6 A, in the indicated direction. FIG. 6(B) is a cross-section view of the 4×2 array cup rack shown in FIG. 5 along the plane containing the line 6 B- 6 B, in the indicated direction. [0018] FIG. 7(A) is a perspective view of a rotating circular array cup rack, with no cups shown. FIG. 7(B) is a perspective view of the same rotating circular array cup rack, but with mounting cups shown. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0019] Now referring to the drawings, with reference numerals summarized in Table 1 , FIG. 1 illustrates an exemplary arrangement of a cup rack, a periodically spaced 4×2 array, shown generally at 10. No cups are illustrated so that the bare assembly is seen as a retainer plate 18 with cup retaining apertures 20 and fastened to a top planar surface 16 of a base 12 . The cup retainer plate 18 is a rectangular sheet with roughly the same planar dimension as the top planar surface 16 . The top planar surface 16 is the top surface of the hollow rectangular base 12 . An electronic display 50 may be housed on the front face of the base 12 , with supporting electronics recessed into the cavity of the rectangular base 12 . The cavity of the base 12 can be fitted with brackets and stand-offs as needed to mount electronics for specific applications as desired. The rectangular base 12 includes cylindrical feet 14 near each corner of the bottom surface. The ratio of the sides of the base which create the top planar area is 4×2, corresponding to the 4×2 grid arrangement of the cup retainer plate 18 . The cup retaining apertures 20 are circular holes arranged in a 4×2 array in the cup retainer plate 18 . Three circular apertures 22 for receiving threaded fasteners 22 are found centrally in the interstitial regions between each nearest neighbour group of four cup retaining apertures 20 . [0020] FIG. 2 is an exploded view of the cup rack, located generally at 10 that illustrates how the retainer plate 18 is mounted to the top planar surface 16 by threaded fasteners 24 that pass through fastener apertures 22 formed in the retainer plate 18 and are screwed into threaded bores 26 formed in the base 12 at the top planar surface 16 . The threaded fasteners 24 include expanded heads that buttress against the surface surrounding the fastener apertures 22 and thereby fix the retainer plate 18 to the top planar surface 16 at the aligned fastener apertures 22 and threaded bores 26 . The conical hull of the mounting cups 30 can pass vertically through the cup retaining apertures, but the outwardly flanged rims 32 of the mounting cups 30 cannot. Mounting cups 30 are positioned through the cup retaining apertures so that when collapsed, the outwardly flanged rims 32 are held in place by the interference/press fit of the outwardly flanged rims 32 , abutted against the top planar surface 16 and held in place by the cup retainer plate 18 . In the collapsed configuration, the threaded fasteners 24 are tightened to draw the cup retainer plate 18 onto the top planar surface 16 . The outwardly flanged rims 32 of the mounting cups 32 are compressed or trapped in between the top planar surface 16 and the cup retainer plate 18 forming the interference/press fit. [0021] FIG. 3 is an assembled configuration of the cup rack shown in FIG. 2 . The conical hull of each of the mounting cups 30 is positioned through a cup retaining aperture 20 of the cup retainer plate 18 . The cup retainer plate 18 is fastened to the top planar surface 16 pressing the outwardly flanged rims 32 (unseen) between them, holding the mounting cups 30 in place. Two perpendicular planes are identified along line 4 A- 4 A and line 4 B- 4 B in the directions indicated by arrows perpendicular to those lines. The planes divide the cup rack 10 along the radial centres of the rows and columns of the 4×2 array of cup retaining apertures 20 . [0022] FIG. 4(A) is a cross section along the plane indicated by line 4 A- 4 A in FIG. 3 . This is a cross section along a plane dividing the cup rack 10 along the direction where the cup retaining apertures 20 are in columns of two. The top planar surface 16 is the top surface of the base 12 and provides abutting support against the outwardly flanged rims 32 of the mounting cups 30 . The mounting cups 30 are held tight against the top planar surface 16 by the cup retainer plate 18 . [0023] FIG. 4(B) is a cross section along the plane indicated by line 4 B- 4 B in FIG. 3 . This is a cross section along a plane dividing the cup rack 10 along the direction where the cup retaining apertures 20 are in rows of 4 . The top planar surface 16 is the top surface of the base 12 and provides abutting support against the outwardly flanged rims 32 of the mounting cups 30 . The mounting cups 30 are held tight against the top planar surface 16 by the cup retainer plate 18 . [0024] FIG. 5 is identical to FIG. 3 with the addition of stacking cups 40 , and the cross section planes indicated by line 6 A- 6 A and line 6 B- 6 B. The stacking cups 40 are physically identical to the mounting cups 30 , and are stacked vertically, one inside the next, atop the mounting cups 30 . The mounting cups 30 act as stabilizing support for the stacking cups 40 . [0025] Each mounting cup 30 can support a stack of a plurality of stacking cups 40 . The mounting cups 30 are stabilized by the interference/press fit between the cup retainer plate 18 and the top planar surface 16 . [0026] FIG. 6(A) is identical to FIG. 4(A) with the addition of stacking cups 40 atop the mounting cups 30 . The stacking cups 40 are physically identical to the mounting cups 30 , and are stacked vertically, one inside the next, atop the mounting cups 30 . The mounting cups 30 act as stabilizing support for the stacking cups 40 . Each mounting cup 30 can support a stack of a plurality of stacking cups 40 . The mounting cups 30 are stabilized by the interference/press fit between the cup retainer plate 18 and the top planar surface 16 . [0027] FIG. 6(B) is identical to FIG. 4(B) with the addition of stacking cups 40 atop the mounting cups 30 . The stacking cups 40 are physically identical to the mounting cups 30 , and are stacked vertically, one inside the next, atop the mounting cups 30 . The mounting cups 30 act as stabilizing support for the stacking cups 30 . Each mounting cup 30 can support a stack of a plurality of stacking cups 40 . The mounting cups are stabilized by the interference/press fit between the cup retainer plate 18 and the top planar surface 16 . [0028] FIG. 7(A) and (B) illustrate a ‘lazy Susan’ variant of the cup rack shown in FIG. 1-6 , located generally at 100. The cup rack 100 is roughly cylindrical in shape comprising a cylindrical base 112 with a rotating top plate, a circular top planar surface 116 of the rotating top plate and a cylindrical cup retainer plate 118 . The base is a circular hollow cylinder with vertical dimension appropriate to holding the circular cylindrical feet 114 , and includes any suitable bearing mechanism that allows the rotating top plate that provides the top planar surface 116 to rotate freely about the longitudinal axis through the centre of the base 112 . The rotating top plate is connected to the lower portion of the base 112 through mechanical means by which the rotational freedom of the rotating top plate is supported. The cup retainer plate 118 in radial cross section is roughly the same circular dimension as the top planar surface 116 . The cup retainer plate 118 is connected to the top planar surface by threaded fasteners exactly as for the rectangular cup rack shown in FIG. 2 . The threaded fastener apertures 122 are four, and are located near the edge of the cup retainer plate, between pairs of cup retaining apertures 120 . FIG. 7(A) illustrates the cup rack 100 without mounting cups and FIG. 7 (B.) [0029] shows the assembly with mounting cups 130 in place, with the hull of each mounting cup 130 inserted within a cup retaining aperture 120 and the outwardly flanged rim (not shown) of each mounting cup 130 pressed between the rotating top planar surface 116 and the cup retainer plate 118 . [0030] The base 12 of the cup rack 10 illustrated in FIG. 1 to FIG. 6 facilitates mounting of a display in its front face, and has space for supporting electronics to be mounted in its hollow interior cavity. Without loss of generality, the following example configurations are contemplated. The display may be a translucent backlit sign. Alternatively, a computing device comprising a display such as a computer tablet may be mounted to the front face of the base, with optional audio equipment mounted in the hollow interior cavity. Another example configuration may be a digital liquid crystal display/light emitting diode display/organic light emitting diode display panel, driven by a computer mounted in the cavity. [0000] TABLE 1 Summary of Reference Numerals Shown in the Drawings. Reference No. Description 10 Cup rack 12 Base 14 Feet 16 Top planar surface/abutting support of cups 18 Cup retainer plate 20 Cup retaining aperture 22 Fastener aperture 24 Threaded fastener 26 Threaded bore 30 Mounting cup 32 Outwardly flanged rim 40 Stacking cup 100 Rotating Cup rack 112 Base with rotating top plate 114 Feet 116 Top planar surface/abutting support of cups 118 Cup retainer plate 120 Cup retaining aperture 122 Fastener aperture 130 Mounting cup [0031] In operation, the cup rack facilitates stacking of disposable cups with outwardly flanged top rims. Such cups are common to the food service industry and the rims are often formed by rolling the material of the cup outwardly back towards the base of the cup. The rim provides structural support for the cup, as well as a flange upon which to attach a cup lid. The symmetry of these cups allows them to be placed one inside the next forming a stack. The cup rack facilitates such stacking by holding the bottom most cup (the mounting cup) fixed to, in turn, provide support for the remaining (stacking) cups. The difference between what is referred to herein as mounting and stacking cups is only their purpose with respect to the application. There is no physical difference between stacking and mounting cups. Several illustrative variants of the cup rack have been described above. Further illustrative variants and modifications are now described and still further variants, modification and combinations thereof will be recognized by the person of skill in the art. [0032] The cup rack comprises an abutting base surface (also referred to herein as the top planar surface, for descriptions of specific embodiments), and a plate in which there is a plurality of circular apertures (also referred to herein as the cup retainer plate, for descriptions of specific embodiments). The each of the plurality of circular apertures fits over the conical hull of the mounting cup, but is not large enough to allow the mounting cup rim to pass through. The retainer plate is fastened tightly to the abutting base surface, compressing the rim of the mounting cup between them. This mechanism makes stable the mounting cup, facilitating the stacking of further identical cups. [0033] The retainer plate may be coupled to the planar surface of the base with any conventional reversible or removable fastener including for example, bolts, clamps, clips, magnets, hooks, hook and pile, snaps, and the like. [0034] FIG. 2-6 show cups with outwardly flanged rims being used as mounting cups. The cup rack can also be used with cups devoid of any flanged rim as a mounting cup. For example, Styrofoam cups devoid of a flanged rim may be captured within a circular aperture of the retainer plate by a friction fit. The cup rack may be adapted to hold any stackable receptacle for consumable liquids with or without a flanged rim including for example, a coffee cup, a tea cup, a soup cup, a soup bowl, cups or bowls made of materials comprising paper, polymer plastics (eg. polyethylene terephthalate or polylactic acid, or polymer foams (eg., expanded polystyrene foam), cups or bowls comprising disposable, reusable, recyclable, or biodegradable materials, and the like. When the stackable receptacle has a flanged rim the circular apertures can be sized to trap or retain the flanged rim while allowing the remainder of the receptacle to pass through the circular aperture. When the stackable receptacle does not have a flanged rim the circular aperture is sized to trap or retain the rim of the receptacle or a portion proximal to the rim by a friction/interference fit. [0035] Mounting cups and stacking cups may be of the same or substantially the same dimensions. Where the mounting cups and stacking cups are different, typically the mounting cups will be smaller than the stacking cups in that the volume bounded by the exterior dimensions of the mounting cup will be smaller than the volume bound by exterior dimensions of the stacking cup. Generally, if the volume bound by the exterior dimensions of the mounting cup is less than the volume bound by the exterior dimensions of the stacking cup, then the difference between the mounting cup volume and stacking cup volume is less than 10%, more typically less than 5%, 4%, 3%, 2%, 1% or less than any percentage therebetween. [0036] The cup retaining apertures can be any size allowed by manufacturing, but should correspond directly to the size of cup which they are designed to support. The radius of the cup retaining aperture should be such that it fits over conical hull of its respective cup, but the rim of the cup, with or without an outward flange depending on the type of cup being stacked, cannot pass through. [0037] The cup retaining aperture will have a diameter that is smaller than the largest exterior diameter of the cup that it is intended to receive. For cups with conical hulls the largest exterior and interior diameters occur at or proximal to the rim of the cup. For cups without an outwardly extending flange at the rim the difference between the largest exterior and interior diameters is typically the thickness of the cup at its rim. This thickness is variable but typically ranges from 0.05 millimeters to 2 millimeters. For cups that include an outwardly extending flange at the rim the largest exterior diameter is measured across diametrically opposing points of the external edge of the flange and the difference between the largest exterior and interior diameters is greater than the material thickness at the rim of the cup as the radial distance of the flange must be taken into account. Regardless of whether the rim is flanged or not, the cup retaining aperture will be sized to have a diameter less than the largest exterior diameter. The cup retaining aperture will typically be sized to have a diameter that is less than the largest exterior diameter of the cup and greater than or equal to the largest interior diameter of the cup, but for the convenience of a particular application the cup retaining aperture may be less than the largest interior diameter of the cup. As the cup retaining aperture is progressively decreased in diameter to be significantly less than the largest interior diameter of the cup, the cup retaining aperture captures a portion of the conical hull of the cup that is progressively axially distal from the rim and the cup retainer plate can be spaced accordingly from the abutting base surface. Generally, if the cup retaining aperture has a diameter less than the largest interior diameter of the cup, then the difference between the cup retaining aperture diameter and the largest interior diameter of the cup is less than 10%, more typically less than 5%, 4%, 3%, 2%, 1% or less than any percentage therebetween. [0038] The cup retaining aperture need not have a uniform diameter along its axial length. The cup retainer plate is bound by first and second opposing parallel surfaces with the first surface facing the top planar surface when the cup retainer plate is fixed to the base and the second surface providing abutting support for stacking cups on the mounting cup. As shown in the cross-section views of FIG. 4 and FIG. 6 the cup retaining aperture cylindrical sidewall is perpendicular to the first and second surfaces of the cup retainer plate such that the cup retaining aperture provides a uniform or constant diameter at each point along the axial length of the cup retaining aperture from the first surface to the second surface. However, a non-uniform or varying diameter of the cup retaining aperture is also contemplated. For example, the cup retaining aperture may be tapered so that the cup retaining aperture on the second surface of the cup retainer plate is narrower than it is on the first surface of the cup retainer plate. The intention of this design feature would be to increase pressure in the radial directions, securing the cup from motion in the plane of the top planar surface of the base. Another advantage of this feature is that the tapered cup retaining aperture can achieve an interference/press fit of an outwardly extending flange without crushing the flange as the taper provides space for accommodating the radial extension of the flange. Furthermore, in applications where the cup retaining aperture captures the conical hull of the cup proximal to but not at the rim, a tapered cup retaining aperture may provide an improved interference/press fit by substantially matching the angle of the taper to the angle of the conical hull. [0039] A mounting cup captured at or proximal to its rim by a cup retaining aperture constitutes a reversible connection between the mounting cup and the cup retainer plate. The connection between the mounting cup and the cup retainer plate may be further bolstered by a permanent fixative or integral bonding as desired. Integral molding of the mounting cup with the cup retainer plate is also contemplated. However, permanent fixation or integrated connection is not as adaptable to different cup types as a reversible connection. [0040] The cup retaining plate should be roughly the same size as the abutting base. If the cup retaining plate is larger than the abutting base, then the overhung corners superfluously occupy space, and provide a hazard in operation for catching clothing or being bumped by users. If the retaining plate is too small, then area for retaining apertures is not used optimally, and spills may be allowed into the gap between the two plates, making sanitation more difficult. The cup retaining plate will typically be equal or slightly smaller than the abutting planar surface of the base. Generally, if the cup retaining plate has a circumference/perimeter less than the circumference/perimeter of the abutting planar surface of the base, then the difference between the cup retaining plate circumference/perimeter and the circumference/perimeter of the abutting planar surface of the base is less than 10%, more typically less than 5%, 4%, 3%, 2%, 1% or less than any percentage therebetween. [0041] Assembly of the cup rack prior to use can be achieved through any convenient method that results in cups being vertically/axially immobilized within the cup retaining apertures. For example, assembly of the cup rack may involve placing the cups in corresponding appropriately sized cup retaining apertures, and fastening the cup retainer plate onto the top planar surface/abutting support of the cups. In another example, the cups can be placed in appropriate order (corresponding to the configuration of holes on the cup retainer plate) on top of the abutting base surface. The retainer plate is then lowered over the cups, allowing the conical hulls of the cups to pass through the cup retaining apertures. When the cup retainer plate is fully lowered it is resting on the rims of the cups or capturing the conical hull of the cup proximal to or at the rim of the cup. The cup retainer plate is then fastened to the base plate, and tightened to compress the rims, forming an interference fit. Remaining cups may then be stacked on top of the first to a desired height or a height limited by the mechanical structure of the stack. Disassembly of the cup rack may be accomplished by removing the fasteners fixing the retainer plate to the base, then removing the retainer plate, then removing the cups. [0042] Although mounting cups will typically be placed with abutting support on a base surface in conjunction with an interference/press fit in a cup retaining aperture, other means of providing abutting support are also contemplated. For example, a screen may be slidably coupled or coupled by snap fit to the first surface of the cup retainer plate such that the screen may be moved to insert cups within the cup retaining apertures and then once the cups are fully inserted within the cup retaining apertures the screen may be placed in a position to abut the rims of the inserted cups. In one example, the screen may comprise a plurality of apertures sized to allow a cup to fully pass through and be inserted with the screen moveable from a first open position where the screen apertures are aligned with the cup retaining apertures to a second position where the screen apertures are offset from the cup retaining apertures. In the first position the cup passes through the screen aperture and is captured within the cup retaining aperture and in the second position the screen provides an abutting support for the cup captured within the cup retaining aperture. If a screen is used in absence of a prominent base (ie., the base is prominent by having a greater surface area than the cup retainer plate) then the screen becomes the abutting base surface. [0043] In the illustrative variants of the cup rack shown in the drawings, the cup retainer plate is fastened to the base with threaded fasteners. The threaded fasteners may be replaced. Alternatives for fixing and tightening the cup retainer plate to the base include clips, clamps, pins, flanged interference fit, and other reversible fasteners. This includes variations on the fastener, such a nut and bolt fasteners or captive inserts with threaded fasteners. Furthermore, the cup retainer plate may be hingedly coupled to the base with a reversible fastener used to fix the cup retainer plate and the base together so that the cup retainer plate can be moved pivotably from a first fastened position parallel to the top planar surface of the base to a second unfastened position at an angle relative to the top planar surface of the base to allow for clearance to insert cup within the cup retaining apertures. Similarly, the cup retainer plate may be coupled to the base using one or more telescopic shafts with the cup retainer plate and the base connected to opposing ends of the telescopic shaft(s). In yet another illustrative variant, a combination of a pivotable and telescopic coupling may be used, for example a telescopic shaft that can retractably extend from the base with a pivotable coupling of the shaft to the retainer plate at an extended end of the shaft. Yet another variant, includes a slidable coupling of the retainer plate and the base such as may be provided by a tongue and groove or a track and bearing configuration. [0044] The number, shape, size and arrangement of the cup retaining apertures may readily be varied to suit a specific application. Two illustrative variants shown in the drawings, provide a rectangular grid arrangement of four rows and two columns ( FIG. 1 - FIG. 6 ), and a circular arrangement on a rotating base ( FIG. 7 ). Alternatives include, for example, stair-step grids in which rows, columns or individual apertures are arranged at selected relative heights. Configurations may also include storage, stacking and display bays for cup lids, straws and/or other accessories. Variations of the base may be designed for specific deployments, such as placement of water cooler bottles, mounted to soda dispensing machines or fixed to the base of coffee makers. [0045] The cup rack described herein provides several advantages. For example, it is easy to clean around assemblies of the cup rack and to maintain sanitation of the assembly. The assemblies can be seated atop counters so that they are not prone to soiling, and are easily maintained. They require no specialized tools for installation and are easily replicable. The cup rack provides a stable platform for supporting stacks of stackable cups. [0046] For further sanitary consideration, the cup rack may include a sanitary plate or cover that may be positioned to abut and cover the cup retainer plate such that the retainer plate is positioned between the sanitary plate and the abutting planar surface of the base in a parallel alignment. The cup retainer plate will typically have a circumference/perimeter that is equal to or less than the circumference perimeter of the sanitary plate. Generally, if the cup retaining plate has a circumference/perimeter less than the circumference/perimeter of the sanitary plate, then the difference between the cup retaining plate circumference/perimeter and the circumference/perimeter of the sanitary plate is less than 10%, more typically less than 5%, 4%, 3%, 2%, 1% or less than any percentage therebetween. The sanitary plate will comprise a plurality of apertures that are substantially similar in size and co-aligned with the plurality of cup retaining apertures of the cup retainer plate. Typically, an aperture of the sanitary plate will have a diameter equal or less than a corresponding aperture of the cup retainer plate. Generally, if the aperture of a sanitary plate has a diameter less than the diameter of a corresponding cup retaining aperture of the cup retainer plate, then the difference between the sanitary plate aperture diameter and the corresponding cup retaining aperture diameter of the cup retainer plate is less than 10%, more typically less than 5%, 4%, 3%, 2%, 1% or less than any percentage therebetween. Other than apertures that are similar in size and co-aligned with the cup retaining apertures of the cup retainer plate the sanitary plate will be devoid of other apertures and will be substantially continuous and impermeable to liquids. In use, once the cup retainer plate is reversibly fixed to the base plate trapping rims of the mounting cups therebetween the sanitary plate is positioned with circular apertures allowing the hulls of the mounting cups to pass therethrough with the sanitary plate in parallel alignment with the cup retainer plate and a first surface of the sanitary plate abutting and/or covering the second surface of the cup retainer plate. The stacking cups can then be stacked on each of the mounting cups with a rim of the first stacked cup abutting a second surface of the sanitary plate. The purpose of the sanitary plate is to provide a cover for the retainer plate that can be easily placed on or removed from a covering position of the cup retainer plate while keeping the mounting cups in place. Thus, the sanitary plate can easily be removed for cleaning purposes without requiring disassembly of the cup retainer plate and mounting cups. Use of the sanitary plate will significantly decrease the need to clean the retainer plate or any crevice that may exist between the retainer plate and the base in an assembled position. [0047] The sanitary plate may be freely removable from the cup retainer plate in that it simply rests on the cup retainer plate and is not fastened to the cup retainer plate so that it may be manually removed by simply lifting it off of the cup retainer plate. Alternatively, the sanitary plate may be reversibly fastened to the cup retainer plate and/or the base with a reversible fastener such as magnets, clips, snaps, hooks, hook and pile (eg., Velcro) and the like. In examples, where the sanitary plate is coupled to the cup retainer plate using a reversible fastener the force required to remove the sanitary plate from the cup retainer plate will be less than the force required to remove the cup retainer plate from the base so that removal of the sanitary plate does not cause unintended removal of the cup retainer plate. [0048] Optionally, the cup rack may include electronics for signage or advertising displays. This may simply be embedded tablets, or single-board computers with LCD/OLED or other display. The cup rack base may include structures for holding electronics such as a bay, a window or brackets to hold digital displays, tablets and the like. [0049] The base may provide a surface for mounting an electronic display. The cavity of the base can be fitted with brackets and stand-offs as needed to mount electronics for specific applications of mounting an electronic display. For example, a tablet may be seated across an opening formed in a surface of the base communicative with the cavity, set in a grove and held in place by a rotating bracket mounted to the inside of the cavity. If printed circuit boards are needed for electronics, they may be fastened onto standoffs which are threaded into the inner surfaces of the bottom, top or sides of the base. Any convenient mechanism for safely securing an electronic display may be used. [0050] The electronic display may accommodate any type of computing device provided the computing device is configured to display text and/or images. For example, the computing device may be a desktop, laptop, notebook, tablet, personal digital assistant (PDA), PDA phone or smartphone, gaming console, portable media player, and the like. The computing device may be implemented using any appropriate combination of hardware and/or software configured for wired and/or wireless communication over a network. The computing device hardware components such as displays, storage systems, processors, interface devices, input/output ports, bus connections and the like may be configured to run one or more applications to allow, for example, an image to be manipulated from a displayed document, receiving actions and optionally action parameters associated with the image, representing the actions in a graphic overlay at or near the image, and/or a selection of an action in the graphic overlay. [0051] Optionally, the computing device may be networked to a remote server. The server computer may be any combination of hardware and software components used to store, process and/or display images and/or actions associated with the desired implementation of the cup rack. The server computer components such as storage systems, processors, interface devices, input/output ports, bus connections, switches, routers, gateways and the like may be geographically centralized or distributed. The server computer may be a single server computer or any combination of multiple physical and/or virtual servers including for example, a web server, an image server, an application server, a bus server, an integration server, an overlay server, a meta actions server, and the like. The server computer components such as storage systems, processors, interface devices, input/output ports, bus connections, switches, routers, gateways and the like may be configured to run one or more applications. [0052] When a network is used, the network may be a single network or a combination of multiple networks. For example, the network may include the internet and/or one or more intranets, landline networks, wireless networks, and/or other appropriate types of communication networks. In another example, the network may comprise a wireless telecommunications network (e.g., cellular phone network) adapted to communicate with other communication networks, such as the Internet. Typically, the network will comprise a computer network that makes use of a TCP/IP protocol (including protocols based on TCP/IP protocol, such as HTTP, HTTPS or FTP). [0053] The computing device and/or the server may be configured to follow any computer communication standard including Extensible Markup Language (XML), Hypertext Transfer Protocol (HTTP), Java Message Service (JMS), Simple Object Access Protocol (SOAP), Lightweight Directory Access Protocol (LDAP), and the like. [0054] The electronic display and/or the computing device and/or the server computer may accommodate any type of still or moving image file including JPEG, PNG, GIF, PDF, RAW, BMP, TIFF, MP3, WAV, WMV, MOV, MPEG, AVI, FLV, WebM, 3GPP, SVI and the like. Furthermore, a still or moving image file may be converted to any other file without hampering the ability of the computing device and/or server software to communicate and/or process the image. Thus, the electronic display may accommodate any image file type and may function independent of a conversion from one file type to any other file type. [0055] The computing device may allow end user interaction through any convenient user interface element including, for example, a window, a tab, a text box, a button, a hyperlink, a drop down list, a list box, a check box, a radio button box, a cycle button, a datagrid or any combination thereof. Furthermore, the user interface elements may provide a graphic label such as any type of symbol or icon, a text label or any combination thereof. Any desired spatial pattern or timing pattern of appearance of user interface elements may be accommodated. [0056] The cup rack may be arranged in various assembly configurations for customized deployment. The primary mechanism by which the cup rack functions may be applied in arbitrary arrangements in conjunction with a given delivery platform. For example, the mechanism may be applied in a rectangular M x N array atop a podium (such as the 4×2 array illustrated in FIG. 1 ), or an in a circular chain on a rotating platform (that is, the so called lazy Susan, illustrated in FIG. 7 ). The cup rack may be configured in any shape or size as desired. For example, the cup retainer plate and the abutting base surface may be a circle, ellipse, triangle, square, pentagon, hexagon, or any other polygon, irregular shape or a shape including a recognized logo or trademarked shape or design. Furthermore, the abutting base surface need not be horizontal, but will typically not be vertical. The abutting base surface may be any convenient combination of angles including a horizontal portion and an angled portion. Furthermore, the base may include any shape or size of extending back panel, side, panel, front panel, or any combination thereof. For example, a pair of parallel side panels may extend perpendicularly from the abutting base surface to provide a pair of parallel side walls that brackets the abutting base surface. In another example, a back panel may extend perpendicularly from the abutting base surface and optionally join a side wall at each opposing edge of the back panel to form a three sided enclosure that brackets the abutting base surface. The side panels and back panel may be of any desired size or shape and include profiles or shapes that may be circular, square, curved, triangular, and the like. The back panel may be connected to or free of the side panels as desired. The back panels, side panels, or front panels may extend at differing independent lengths or similar lengths from the abutting base surface as desired. The panels will typically extend at perpendicular or substantially perpendicular angles with respect to the abutting base surface. However, other angles may be accommodated including for example, angles greater than 45 degrees. Generally, a parallel orientation of one or more panels to the abutting base surface will be avoided. Video displays as described above may be installed in any of the back, side or front panels with electronic circuitry supported by the back, front and/or side panel and/or within the base. The cup rack and any extending panel may be any size or shape as long as it includes an abutting base surface and a cup retainer plate to achieve an interference/press fit to hold mounting cups in place. [0057] These examples of specific assemblies of the cup rack are for illustrative purposes and are included without intended loss of generalities. [0058] Several variants of the cup rack have been described for illustrative purposes. Still further variants, modifications and combinations thereof are contemplated and will be recognized by the person of skill in the art. Accordingly, the foregoing detailed description is not intended to limit scope, applicability, or configuration of claimed subject matter.

A cup stacking and holding assembly is disclosed with methods of application in standard use and with internal electronics for visual displays. The cup holder assembly may be manufactured in various configurations, all providing a cup rack for convenient and stable stacking of disposable cups. The cup rack may comprise: a base providing a surface for abutting support for a plurality of cups; a cup retainer plate coupled to the base; a plurality of cup retaining apertures formed within the cup retainer plate, each cup retaining aperture sized to receive a corresponding cup and having a diameter smaller than the largest exterior diameter of the corresponding cup; the cup retainer plate moveable from a first closed position parallel and proximal to the surface for abutting support to a second open position for insertion of cups within the cup retaining apertures.

This application claims the benefit of the Provisional application No. 60/323,824 filed Sep. 21, 2001. BACKGROUND OF THE INVENTION The present invention is directed to fire suppression systems, in general, and more specifically to a fire suppression system and a plurality of aerosol generators for dispensing a fire suppressant material, that is substantially void of an ozone depleting material, promptly into the affected storage area, and a solid propellant container preferably for use therein. It is of paramount importance to detect a fire in an unattended, storage area or enclosed storage compartment at an early stage of progression so that it may be suppressed before spreading to other compartments or areas adjacent or in close proximity to the affected storage area or compartment. This detection and suppression of fires becomes even more critical when the storage compartment is located in a vehicle that is operated in an environment isolated from conventional fire fighting personnel and equipment, like a cargo hold of an aircraft, for example. Current aircraft fire suppressant systems include a gaseous material, like Halon® 1301, that is compressed in one or more containers at central locations on the aircraft and distributed through piping to the various cargo holds in the aircraft. When a fire is detected in a cargo hold, an appropriate valve or valves in the piping system is or are activated to release the Halon fire suppressant material into the cargo hold in which fire was detected. The released Halon material is intended to blanket or flood the cargo hold and put out the fire. Heretofore, this has been considered an adequate system. However, the Halon material of the current systems contains an ozone depleting material which may leak from the storage compartment and into the environment upon being activated to suppress a fire. Most nations of the world prefer banning this material to avoid its harmful effects on the environment. Also, Halon produces toxic products when activated by flame. Accordingly, there is a strong desire to find an alternate material to Halon and a suitable fire suppressant system for dispensing it as needed. For cargo holds of aircraft, a fire in the hold indication requires not only a dispensing of the fire suppressant material, but also a prompt landing of the aircraft at the nearest airport. The aircraft will then remain out of service until clean up is completed and the aircraft is certified to fly again. This unscheduled servicing of the aircraft is very costly to the airlines and inconveniences the passengers thereof. The problem is that some activations of the fire suppressant system result from false alarms of the fire detection system, i.e. caused by a perceived fire condition that is something other than an actual fire. Thus, the costs and inconveniences incurred as a result of the dispensing of the fire suppressant material under false alarm conditions could have been avoided with a more accurate and reliable fire detection system. The present invention intends to overcome the drawbacks of the current fire detection and suppressant systems and to offer a system which detects a fire accurately and reliably, generates a fire indication and provides for a quick dispensing of a fire suppressant, which does not include substantially an ozone depleting material, focused within the storage compartment in which the fire is detected. SUMMARY OF THE INVENTION In accordance with one aspect of the present invention, a solid propellant container for exhausting a fire suppressant aerosol comprises: a housing having at least one open side and including a multiplicity of orifices for exhausting the fire suppressant aerosol; a solid propellant disposed inside of the housing; at least one cover mounted to the housing to seal correspondingly the at least one open side thereof; an ignition material coupled to the solid propellant for igniting the solid propellant to produce the fire suppressant aerosol; and at least one baffle integral to the housing to capture non-usable effluent. In accordance with another aspect of the present invention, a fire suppression system for a substantially enclosed area comprises: a plurality of solid propellant aerosol generators disposed about the enclosed area for exhausting a fire suppressant aerosol that is substantially void of an ozone depleting material into the enclosed area, each aerosol generator including an ignition element for igniting the solid propellant thereof; and a fire control unit, each ignition element of the aerosol generators being coupled to the fire control unit which is operative to ignite the solid propellant of at least one aerosol generator utilizing the ignition element thereof to exhaust fire suppressant aerosol into the enclosed area. In accordance with yet another aspect of the present invention, a fire suppression system for a plurality of substantially enclosed areas comprises: a plurality of solid propellant aerosol generators disposed about each enclosed area of the plurality for exhausting a fire suppressant aerosol that is substantially void of an ozone depleting material into at least one enclosed area, each aerosol generator including an ignition element for igniting the solid propellant thereof; and a fire control unit for each enclosed area of the plurality, each fire control unit being coupled to the ignition elements of the aerosol generators of the corresponding enclosed area and is operative to ignite the solid propellant of at least one aerosol generator of the corresponding enclosed area utilizing the ignition element thereof to exhaust fire suppressant aerosol into the corresponding enclosed area. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a sketch of a fire detection and suppression system for use in a storage compartment suitable for embodying the principles of the present invention. FIGS. 2 and 3 are top and bottom isometric views of an exemplary aerosol generator assembly suitable for use in the embodiment of FIG. 1 . FIGS. 4 and 5 are bottom and top isometric views of an exemplary aerosol generator assembly compartment mounting suitable for use in the embodiment of FIG. 1 . FIG. 6 is a block diagram schematic of an exemplary fire detector unit suitable for use in the embodiment of FIG. 1 . FIG. 7 is a block diagram schematic of an exemplary imager unit suitable for use in the embodiment of FIG. 1 . FIG. 8 is a block diagram schematic of an overall fire detection system suitable for use in the application of an aircraft. FIG. 9 is a block diagram schematic of an exemplary fire suppression system suitable for use in the application of an aircraft. FIG. 10 is an isometric view of an exemplary aerosol generator illustrating exhaust ports thereof suitable for use in the embodiment of FIG. 1 . FIG. 11 is an expanded view assembly illustration of the aerosol generator of FIG. 10 . DETAILED DESCRIPTION OF THE INVENTION A sketch of a fire detection and suppression system for use at a storage area or compartment suitable for embodying the principles of the present invention is shown in cross-sectional view in FIG. 1 . Referring to FIG. 1 , a storage compartment 10 which may be a cargo hold, bay or compartment of an aircraft, for example, is divided into a plurality of detection zones or cavities 12 , 14 and 16 as delineated by dashed lines 18 and 20 . It is understood that an aircraft may have more than one cargo compartment and the embodiment depicted in FIG. 1 is merely exemplary of each such compartment. It is intended that each of the cargo compartments 10 include one or more aerosol generators for generating a fire suppressant material. In the present embodiment, a plurality of hermetically sealed, aerosol generators depicted by blocks 22 and 24 , which may be solid propellant in ultra-low pressure aerosol generators, for example, are disposed at a ceiling portion 26 of the cargo compartment 10 above vented openings 28 and 30 as will be described in greater detail herein below. In the present embodiment, the propellant of the plurality of aerosol generators 22 and 24 produces upon ignition an aerosol that is principally potassium bromide. The gaseous products are principally water, carbon dioxide and nitrogen. For aircraft applications, each of the aerosol generators 22 and 24 has a large orifice instead of the conventional sonic nozzles. As a result, the internal pressure during the discharge period is approximately 10 psig. During storage and normal flight the pressure inside the generator is the normal change in pressure that occurs in any hermetically sealed container that is subjected to changes in ambient conditions. Test results of aerosol generators of the solid propellant type are shown in Table 1 below. The concept that is used for Extended Twin Operations (ETOPS) up to 540 minutes is to expend a series of aerosol generators of 3½ lbs each for each 2000 cubic feet. This would create the functional equivalent of an 8% Halon 1301 system. At 30 minutes, the concentration would be reduced to the functional equivalent of 4½% Halon 1301. At that point, another aerosol generator may be expended every 30 minutes. Different quantities of aerosol generators may be used based upon the size of the cargo bay. It is understood that the size and number of the generators for a cargo compartment may be modified based on the size of the compartment and the specific application. TABLE 1 Requirements Of Present Embodiment vs. Halon in 2000 Cubic Feet Suppression Design 30 Minute Threshold Minimum initial Release Fuel Fire 3.5 pounds 4.6 pounds 9.2 pounds Bulk Load Test <2.5 pounds <2.5 pounds <2.5 pounds Container Test 3.5 pounds 4.6 pounds 9.2 pounds Aerosol Can 4.6 pounds Test Halon 25 pounds = 33 pounds = 66 pounds = requirement 3% of Halon 4% of Halon 8% of Halon An exemplary hermetically sealed, aerosol generator 22 , 24 with multiple outlets 25 for use in the present embodiment is shown in the isometric sketch of FIG. 10 . The aerosol generator 22 , 24 may employ the same or similar initiator that has been used in the US Air Force's ejection seats for many years which has a history of both reliability and safety. Its ignition element consists of two independent 1-watt/1-ohm bridge wires or squibs, for example. The aerosol generator 22 , 24 for use in the present embodiment will be described in greater detail herein below in connection with the break away assembly illustration of FIG. 11 . In the top view of FIG. 2 and bottom view of FIG. 3 , the sealed container 22 , 24 is shown mounted to a base 32 by supporting straps 34 and 36 , for example. The bottom of the base 32 which has a plurality of openings 38 and 40 may be mounted to the ceiling 26 over vented portions 28 and 30 thereof to permit passage of the aerosol and gaseous fire suppressant products released or exhausted from the aerosol generator via outlets 25 out through the vents 28 and 30 and into the compartment 10 . The present example employs four aerosol generators located in two places 22 , 24 for compartment 10 which are shown in bottom view in FIG. 4 and top view in FIG. 5 . As shown in FIGS. 4 and 5 , in the present embodiment, each of the four aerosol generators 42 , 44 , 46 and 48 is installed with its base over a respectively corresponding vented portion 50 , 52 , 54 , 56 of the ceiling 26 . Accordingly, when initiated, each of the aerosol generators will generate and release its aerosol and gaseous fire suppressant products through the openings in its respective base and vented portion of the ceiling into the compartment 10 . With the present embodiment, the attainment of 240 or 540 minutes or longer of fire suppressant discharge is a function of how many aerosol generators are used for a compartment. It is expected that the suppression level will be reached in an empty compartment in less than 10 seconds, for example. This time may be reduced in a filled compartment. Aerosol tests demonstrated that the fire suppressant generated by the aerosol generators is effective for fuel/air explosives also. In addition, the use of independent aerosol generator systems for each cargo compartment further improved the system's effectiveness. For a more detailed description of solid propellant aerosol generators of the type contemplated for the present embodiment, reference is made to the U.S. Pat. No. 5,861,106, issued Jan. 19, 1999, and entitled “Compositions and Methods For Suppressing Flame” which is incorporated by reference herein. This patent is assigned to Universal Propulsion Company, Inc. which is the same assignee and/or a wholly-owned subsidiary of the parent company of the assignee of the instant application. A divisional application of the referenced '106 patent was later issued as U.S. Pat. No. 6,019,177 on 1 Feb. 2000 having the same ownership as its parent '106 patent. Referring back to FIG. 1 , as explained above, each cargo compartment 10 may be broken into a plurality of detection zones 12 , 14 and 16 . The number of zones in each cargo compartment will be determined after sufficient testing and analysis in order to comply with the application requirements, like a one minute response time, for example. The present embodiment includes multiple fire detectors distributed throughout each cargo compartment 10 with each fire detector including a variety of fire detection sensors. For example, there may be two fire detectors installed in each zone 12 , 14 and 16 in a dual-loop system. The two fire detectors in each zone may be mounted next to each other, inside pans located above the cargo compartment ceiling 26 , like fire detectors 60 a and 60 b for zone 12 , fire detectors 62 a and 62 b for zone 14 and 64 a and 64 b for zone 16 , for example. In the present embodiment, each of the fire detectors 60 a , 60 b , 62 a , 62 b , 64 a and 64 b may contain three different fire detection sensors: a smoke detector, a carbon monoxide (CO) gas detector, and hydrogen (H 2 ) gas detector as will be described in greater detail herein below. While in the present application a specific combination of fire detection sensors is being used in a fire detector, it is understood that in other applications or storage areas, different combinations of sensors may be used just as well. In addition, at least one IR imager may be disposed at each cargo compartment 10 for fire detection confirmation, but it is understood that in some applications imagers may not be needed. In the present embodiment, two IR imagers 66 a and 66 b may be mounted in opposite top corners of the compartment 10 , preferably behind a protective shield, in the dual-loop system. This mounting location will keep each imager out of the actual compartment and free from damage. Each imager 66 a and 66 b may include a wide-angle lens so that when aimed towards the center or bottom center of the compartment 10 , for example, the angle of acceptance of the combination of two imagers will permit a clear view of the entire cargo compartment including across the ceiling and down the side walls adjacent the imager mounting. It is intended for the combination of imagers to detect any hot cargo along the top of the compartment, heat rise from cargo located below the top, and heat reflections from the compartment walls. Each fire detector 60 a , 60 b , 62 a , 62 b , 64 a and 64 b and IR imagers 66 a and 66 b will include self-contained electronics for determining independently whether or not it considers a fire to be present and generates a signal indicative thereof as will be described in greater detail herein below. All fire detectors and IR imagers of each cargo compartment 10 may be connected in a dual-loop system via a controller area network (CAN) bus 70 to cargo fire detection control unit (CFDCU) as will be described in more detail in connection with the block diagram schematic of FIG. 8 . The location of the CFDCU may be based on the particular application or aircraft, for example. A suitable location for mounting the CFDCU in an aircraft is at the main avionics bay equipment rack. A block diagram schematic of an exemplary fire detector unit suitable for use in the present embodiment is shown in FIG. 6 . Referring to FIG. 6 , all of the sensors used for fire detection are disposed in a detection chamber 72 which includes a smoke detector 74 , a carbon monoxide (CO) sensor 76 , and a hydrogen (H 2 ) sensor 78 , for example. The smoke detector 74 may be a photoelectric device that has been and is currently being used extensively in such applications as aircraft cargo bays, and laboratory, cabin, and electronic bays, for example. The smoke detector 74 incorporates several design features which greatly improves system operational reliability and performance, like free convection design which maximizes natural flow of the smoke through the detection chamber, computer designed detector labyrinth which minimizes effects of external and reflected light, chamber screen which prevents large particles from entering the detector labyrinth, use of solid state optical components which minimizes size, weight, and power consumption while increasing reliability and operational life, provides accurate and stable performance over years of operation, and offers an immunity to shock and vibration, and isolated electronics which complete environmental isolation of the detection electronics from the contaminated smoke detection chamber. More specifically, in the smoke detector, a light emitting diode (LED) 80 and photoelectric sensor (photo diode) 82 are mounted in an optical block within the labyrinth such that the sensor 82 receives very little light normally. The labyrinth surfaces may be computer designed such that very little light from the LED 80 is reflected onto the sensor, even when the surfaces are coated with particles and contamination build-up. The LED 80 may be driven by an oscillating signal 86 that is synchronized with a photodiode detection signal 88 generated by the photodiode 82 in order to maximize both LED emission levels and detection and/or noise rejection. The smoke detector 74 may also include built-in test (BIT), like another LED 84 which is used as a test light source. The test LED 84 may be driven by a test signal 90 that may be also synchronized with the photodiode detection signal 88 generated by the photodiode 82 in order to better effect a test of the proper operation of the smoke detector 74 . Chemical sensors 76 and 78 may be each integrated on and/or in a respective semiconductor chip of the micro-electromechanical system (MEMS)-based variety for monitoring and detecting gases which are the by-products of combustion, like CO and H 2 , for example. The semiconductor chips of the chemical sensors 76 and 78 may be each mounted in a respective container, like a TO-8 can, for example, which are disposed within the smoke detection chamber 72 . The TO-8 cans include a screened top surface to allow gases in the environment to enter the can and come in contact with the semiconductor chip which measures the CO or H 2 content in the environment. More specifically, in the present embodiment, the semiconductor chip of the CO sensor 76 uses a multilayer MEMS structure. A glass layer for thermal isolation is printed between a ruthenium oxide (RuO 2 ) heater and an alumina substrate. A pair of gold electrodes for the heater is formed on a thermal insulator. A tin oxide (SnO 2 ) gas sensing layer is printed on an electrical insulation layer which covers the heater. A pair of gold electrodes for measuring sensor resistance or conductivity is formed on the electrical insulator for connecting to the leads of the TO-8 can. Activated charcoal is included in the area between the internal and external covers of the TO-8 can to reduce the effect of noise gases. In the presence of CO, the conductivity of sensor 76 increases depending on the gas concentration in the environment. The CO sensor 76 generates a signal 92 which is representative of the CO content in the environment detected thereby. It may also include BIT for the testing of proper operation thereof. This type of CO sensor displayed good selectivity to carbon monoxide. In addition, the semiconductor chip of the H 2 sensor 78 in the present embodiment comprises a tin dioxide (SnO 2 ) semiconductor that has low conductivity in clean air. In the presence of H 2 , the sensor's conductivity increases depending on the gas concentration in the air. The H 2 sensor 78 generates a signal 94 which is representative of the H 2 content in the environment detected thereby. It may also include BIT for the testing of proper operation thereof. Integral heaters and temperature sensors within both the CO and H 2 sensors, 76 and 78 , respectively, stabilize their performance over the operating temperature and humidity ranges and permit self-testing thereof. For a more detailed description of such MEMS-based chemical sensors reference is made to the co-pending patent application bearing Ser. No. 09/940,408, filed on Aug. 27, 2001 and entitled “A Method of Self-Testing A Semiconductor Chemical Gas Sensor Including An Embedded Temperature Sensor” which is incorporated by reference herein. This application is assigned to Rosemount Aerospace Inc. which is the same assignee and/or a wholly-owned subsidiary of the parent company of the assignee of the instant application. Each fire detector also includes fire detector electronics 100 which may comprise solid-state components to increase reliability, and reduce power consumption, size and weight. The heart of the electronics section 100 for the present embodiment is a single-chip, highly-integrated conventional 8-bit microcontroller 102 , for example, and includes a CAN bus controller 104 , a programmable read only memory (ROM), a random access memory (RAM), multiple timers (all not shown), multi-channel analog-to-digital converter (ADC) 106 , and serial and parallel I/O ports (also not shown).The three sensor signals (smoke 88 , CO 92 , and H 2 94 ) may be amplified by amplifiers 108 , 110 and 112 , respectively, and fed into inputs of the microcontroller's ADC 106 . Programmed software routines of the microcontroller 102 will control the selection/sampling, digitization and storage of the amplified signals 88 , 92 and 94 and may compensate each signal for temperature effects and compare each signal to a predetermined alarm detection threshold. In the present embodiment, an alarm condition is determined to be present by the programmed software routine if all three sensor signals are above their respective detection threshold. A signal representative of this alarm condition is transmitted along with a digitally coded fire detection source identification tag to the CFDCU over the CAN bus 70 using the CAN controller 104 and a CAN transceiver 114 . Using preprogrammed software routines, the microcontroller 102 may perform the following primary control functions for the fire detector: monitoring the smoke detector photo diode signal 88 , which varies with smoke concentration; monitoring the CO and H 2 sensor conductivity signals 92 and 94 , which varies with their respective gas concentration; identifying a fire alarm condition, based on the monitored sensor signals; receiving and transmitting signals over the CAN bus 70 via controller 104 and transceiver 114 ; generating discrete ALARM and FAULT output signals 130 and 132 via gate circuits 134 and 36 , respectively; monitoring the discrete TEST input signal 124 via gate 138 ; performing built-in-test functions as will be described in greater detail herebelow; and generating supply voltages from a VDC power input via power supply circuit 122 . In addition, the microcontroller 102 communicates with a non-volatile memory 116 which may be a serial EEPROM (electrically erasable programmable read only memory), for example, that stores predetermined data like sensor calibration data and maintenance data, and data received from the CAN bus, for example. The microcontroller 102 also may have a serial output data bus 118 that is used for maintenance purposes. This bus 118 is accessible when the detector is under maintenance and is not intended to be used during normal field operation. It may be used to monitor system performance and read detector failure history for troubleshooting purposes, for example. All inputs and outputs to the fire detector are filtered and transient protected to make the detector immune to noise, radio frequency (RF) fields, electrostatic discharge (ESD), power supply transients, and lightning. In addition, the filtering minimizes RF energy emissions. Each fire detector may have BIT capabilities to improve field maintainability. The built-in-test will perform a complete checkout of the detector operation to insure that it detects failures to a minimum confidence level, like 95%, for example. In the present embodiment, each fire detector may perform three types of BIT: power-up, continuous, and initiated. Power-up BIT will be performed once at power-up and will typically comprise the following tests: memory test, watchdog circuit verification, microcontroller operation test (including analog-to-digital converter operation), LED and photo diode operation of the smoke detector 74 , smoke detector threshold verification, proper operation of the chemical sensors 76 and 78 , and interface verification of the CAN bus 70 . Continuous BIT testing may be performed on a continuous basis and will typically comprise the following tests: LED operation, Watchdog and Power supply ( 122 ) voltage monitor using the electronics of block 120 , and sensor input range reasonableness. Initiated BIT testing may be initiated and performed when directed by a discrete TEST Detector input signal 124 or by a CAN bus command received by the CAN transceiver 114 and CAN controller 104 and will typically perform the same tests as Power-up BIT. A block diagram schematic of an exemplary IR imager suitable for use in the fire detection system of the present embodiment is shown in FIG. 7 . Referring to FIG. 7 , each imager is based on infrared focal plane array technology. A focal plane infrared imaging array 140 detects optical wavelengths in the far infrared region, like on the order of 8-12 microns, for example. Thermal imaging is done at around 8-12 microns since room temperature objects emit radiation in these wavelengths. The exact field-of-view of a wide-angle, fixed-focus lens of the IR imager will be optimized based on the imager's mounting location as described in connection with the embodiment of FIG. 1 . Each imager 66 a and 66 b is connected to and controlled by the CAN bus 70 . Each imager may output a video signal 142 to the aircraft cockpit in the standard NTSC format. Similar to the fire detectors, the imagers may operate in both “Remote Mode” and “Autonomous Mode”, as commanded by the CAN bus 70 . The imager's infrared focal plane array (FPA) 140 may be an uncooled microbolometer with 320 by 240 pixel resolution, for example, and may have an integral temperature sensor and thermoelectric temperature control. Each imager may include a conventional digital signal processor (DSP) 144 for use in real-time, digital signal image processing. A field programmable gate array (FPGA) 146 may be programmed with logic to control imager components and interfaces to the aircraft, including the FPA 140 , a temperature controller, analog-to-digital converters, memory, and video encoder 148 . Similar to the fire detectors, the FPGA 146 of the imagers may accept a discrete test input signal 150 and output both an alarm signal 152 and a fault signal 154 via circuits 153 and 155 , respectively. The DSP 144 is preprogrammed with software routines and algorithms to perform the video image processing and to interface with the CAN bus via a CAN bus controller and transceiver 156 . The FPGA 146 may be programmed to command the FPA 140 to read an image frame and digitize and store in a RAM 158 the IR information or temperature of each FPA image picture element or pixel. The FPGA 146 may also be programmed to notify the DSP 144 via signal lines 160 when a complete image frame is captured. The DSP 144 is preprogrammed to read the pixel information of each new image frame from the RAM 158 . The DSP 144 is also programmed with fire detection algorithms to process the pixel information of each frame to look for indications of flame growth, hotspots, and flicker. These algorithms include predetermined criteria through which to measure such indications over time to detect a fire condition. When a fire condition is detected, the imager will output over the CAN bus an alarm signal along with a digitally coded source tag and the discrete alarm output 152 . The algorithms for image signal processing may compensate for environmental concerns such as vibration (camera movement), temperature variation, altitude, and fogging, for example. Also, brightness and contrast of the images generated by the FPA 140 may be controller by a controller 162 prior to the image being stored in the RAM 158 . In addition, the imager may have BIT capabilities similar to the fire detectors to improve field maintainability. The built-in-tests of the imager may perform a complete checkout of its operations to insure that it detects failures to a minimum confidence level, like around 95%, for example. Each imager 66 a and 66 b may perform three types of BIT: power-up, continuous, and initiated. Power-up BIT may be performed once at power-up and will typically consist of the following: memory test, watchdog circuit and power supply ( 164 ) voltage monitor verification via block 166 , DSP operation test, analog-to-digital converter operation test, FPA operation test, and CAN bus interface verification, for example. Continuous BIT may be performed on a continuous basis and will typically consist of the following tests: watchdog, power supply voltage monitor, and input signal range reasonableness. Initiated BIT may be performed when directed by the discrete TEST Detector input signal 150 or by a CAN bus command and will typically perform the same tests as Power-up BIT. Also, upon power up, the FPGA 146 may be programmed from a boot PROM 170 and the DSP may be programmed from a boot EEPROM 172 , for example. A block diagram schematic of an exemplary overall fire detection system for use in the present embodiment is shown in FIG. 8 . In the example of FIG. 8 , the application includes three cargo compartments, namely: a forward or FWD cargo compartment, and AFT cargo compartment, and a BULK cargo compartment. As described above, each of these compartments are divided into a plurality of n sensor zones or cavities # 1 , # 2 , . . . , #n and in each cavity there are disposed a pair of fire detectors F/D A and F/D B. Each of the compartments also include two IR imagers A and B disposed in opposite corners of the ceilings thereof to view the overall space of the compartment in each case. Alarm condition signals generated by the fire detectors and IR imagers of the various compartments are transmitted to the CFDCU over a dual loop bus, CAN bus A and CAN bus B. In addition, IR video signals from the IR imagers are conducted over individual signal lines to a video selection switch of the CFDCU which selects one of the IR video signals for display on a cockpit video display. In the present embodiment, the CFDCU may contain two identical, isolated alarm detection channels A and B. Each channel A and B will independently analyze the inputs from the fire Detectors and IR imagers of each cargo compartment FWD, AFT and BULK received from both buses CAN bus A and CAN bus B and determine a true fire alarm and compartment source location thereof. A “true” fire condition may be detected by all types of detectors of a compartment, therefore, a fire alarm condition will only be generated if both: (1) the smoke and/or chemical sensors detect the presence of a fire, and (2) the IR imager confirms the condition or vice versa. If only one sensor detects fire, the alarm will not be activated. This AND-type logic will minimize false alarms. This alarm condition information may be sent to a cabin intercommunication data system (CIDC) over data buses, CIDS bus A and CIDS bus B and to other locations based on the particular application. Besides the CAN bus interface, each fire detector and IR imager will have discrete Alarm and Fault outputs, and a discrete Test input as described herein above in connection with the embodiments of FIGS. 6 and 7 . As required, each component may operate in either a “Remote Mode” or “Autonomous Mode”. As shown in the block diagram schematic embodiment of FIG. 8 , the Cargo Fire Detection Control Unit (CFDCU) interfaces with all cargo fire detection and suppression apparatus on an aircraft, including the fire detectors and IR imagers of each compartment, the Cockpit Video Display, and the CIDS. It will be shown later in connection with the embodiment of FIG. 9 that the CFDCU also interfaces with the fire suppression aerosol generator canisters, and a Cockpit Fire Suppression Switch Panel. Accordingly, the CFDCU provides all system logic and test/fault isolation capabilities. It processes the fire detector and IR Imager signals input thereto to determine a fire condition and provides fire indication to the cockpit based on embedded logic. Test functions provide an indication of the operational status of each individual fire detector and IR imager to the cockpit and aircraft maintenance systems. More specifically, the CFDCU incorporates two identical channels that are physically and electrically isolated from each other. In the present embodiment, each channel A and B is powered by separate power supplies. Each channel contains the necessary circuitry for processing Alarm and Fault signals from each fire detector and IR imager of the storage compartments of the aircraft. Partitioning is such that all fire detectors and IR imagers in both loops A and B of the system interface to both channels via dual CAN busses to achieve the dual loop functionality and full redundancy for optimum dispatch reliability. The CFDCU acts as the bus controller for the two CAN busses that interface with the fire detectors and IR imagers. Upon determining a fire indication in the same zone of a compartment by both loops A and B, the CFDCU sends signals to the CIDS over the data buses, for eventual transmission to the cockpit that a fire condition is detected. The CFDCU may also control the video selector switch to send an IR video image of the affected cargo compartment to the cockpit video display to allow the compartment to be viewed by the flight crew. A block diagram schematic of an exemplary overall fire suppression system suitable for use in the present embodiment is shown in FIG. 9 . As shown in FIG. 9 , Squib fire controllers in the CFDCU also monitor and control the operation of the fire suppression canisters, # 1 , # 2 , . . . #n in the various compartments of the aircraft through use of squib activation signals Squib # 1 -A, Squib # 1 -B, . . . , Squib #n-A and Squib #n-B, respectively. Upon receipt of a discrete input from a fire suppression discharge switch on the Cockpit Fire Suppression Switch Panel, the respective squib fire controller fires the initiater in the suppressant canisters, as required. Verification that the initiaters have fired is sent to the cockpit via the CIDS as shown in FIG. 8 . The CFDCU may include BIT capabilities to improve field maintainability. These capabilities may include the performance of a complete checkout of the operation of CFDCU to insure that it detects failures to a minimum confidence level of on the order of 95%, for example. More specifically. the CFDCU may perform three types of BIT: power-up, continuous, and initiated. Power-up BIT will be performed once at power-up and will typically consist of the following tests: memory test, watchdog circuit verification, microcontroller operation test, fire detector operation, IR imager operation, fire suppressant canister operation, and CAN bus interface verification, for example. Continuous BIT may be performed on a continuous basis and will typically consist of the following tests: watchdog and power supply voltage monitor, and input signal range reasonableness. Initiated BIT may be performed when directed by a discrete TEST Detector input or by a bus command and will typically perform the same tests as Power-up BIT. The exemplary aerosol generators 22 , 24 of the present embodiment will now be described in greater detail in connection with the break away assembly illustration of FIG. 11 . The assembly is small enough to mount in unusable spaces in the storage compartment, e.g. cargo hold of an aircraft, and provides an ignition source for the propellant and a structure for dispensing hot aerosol while protecting the adjoining mounting structure of the aircraft, for example, from the hot aerosol. A modular assembly of the aerosol generator supports and protects the fire suppressant propellant during shipping, handling and use by a tubular housing 180 . The modular design also allows the assembly to be used on various sized and shaped compartment or cargo holds by choosing the number of assemblies for each size. This assembly may be mountable within the space between the ceiling of the cargo hold and the floor of the cabin compartment as described in connection with the embodiment of FIG. 1 . In the assembly, the propellant may be supported by sheet metal baffles that capture non-usable effluent and force the hot aerosol to flow through the assembly allowing them to cool before being directed into the cargo hold through several exhaust orifices or ports 25 . These ports 25 are closed by a hermetic seal, which provides the dual purpose of protecting the propellant from the environment as well as the environment from the propellant. An integral igniter is included in the assembly, which meets a 1-watt, 1-amp no-fire requirement. Referring to FIG. 11 , more specifically, the assembly comprises a substantially square tube or housing 180 which may have dimensions of approximately 19″ in length and 4″ by 4″ square, for example. The tube 180 supports the rest of the assembly. Several holes are stamped in one wall of the tube or housing 180 to provide mounting for mating parts and ports 25 that are used to direct the fire suppressant aerosol into the cargo hold. Two extruded propellants 182 which may be approximately 3⅓ pounds, for example, are mounted flat to surfaces of two sheet metal baffles 184 , respectively. The baffles 184 are in turn mounted vertically within the square aerosol generator such that a gap between the top of the baffles 184 and the inside of the tube 180 exists to allow the hot aerosol to flow over the baffles 184 and out the ports 25 in the tube. Two additional baffles 186 cover the sides of the tubular housing 180 . The baffles also capture non-useful effluent. One side of the assembly is closed with a snap-on cap 187 which has a port 188 to secure a through bulkhead electrical connector 190 . The other side of the assembly is also closed with another snap-on end cap 192 . Inside the assembly attached to a face of each of the propellants 182 is a strip of ignition material that is ignited by an igniter. The electrical leads of the igniter are connected to the through bulkhead electrical connector in order to provide the ignition current to the igniter. While the present invention has been described herein above in connection with a storage compartment of an aircraft, there is no intended limitation thereof to such an application. In fact, the present invention and all aspects thereof could be used in many different applications, storage areas and compartments without deviating from the broad principles thereof. Accordingly, the present invention should not be limited in any way, shape or form to any specific embodiment or application, but rather construed in breadth and broad scope in accordance with the recitation of the claims appended hereto.

A fire suppression system for a substantially enclosed area comprises: a plurality of solid propellant aerosol generators disposed about the enclosed area for exhausting a fire suppressant aerosol that is substantially void of an ozone depleting material into the enclosed area. Each aerosol generator including an ignition element for igniting the solid propellant thereof. Each ignition element of the aerosol generators being coupled to a fire control unit which is operative to ignite the solid propellant of at least one aerosol generator utilizing the ignition element thereof to exhaust fire suppressant aerosol into the enclosed area. Each aerosol generator preferably includes a container which comprises: a housing including an orifice for exhausting the fire suppressant aerosol; a solid propellant disposed inside of the housing; at least one cover mounted to the housing to seal correspondingly at least one open side thereof; an ignition material coupled to the solid propellant for igniting the solid propellant to produce the fire suppressant aerosol; and at least one baffle disposed integral to the housing to capture non-usable effluent.

TECHNICAL FIELD The present invention relates to an air-conditioning mechanism for a seat, in particular for a vehicle seat. BACKGROUND OF THE INVENTION In air-conditioned vehicle seats or other seating accommodations having air-circulating layers in the region of seat and/or backrest contact surfaces, the problem often arises in the case of stitched seat covers that the regions of a seat or backrest surface separated from one another by stitchings are unevenly air-conditioned, since the flow connection through the cover stitching furrow is insufficient. In the current state of the art, implementation of cover stitching furrows through a ventilation layer of a knitted spacer fabric is not feasible, either visually or in terms of air-circulation technology. Neither 90° angles nor smooth cushion edges can be formed using known spacer media, so that furrows and cover edges that are made using spacer media do not have a neat appearance. A generally common procedure is to place spacer fabric only in furrow-free regions of the seat and ventilate seat-region surfaces separated from one another by stitching furrows separately from one another in each instance, for example by miniblowers. U.S. Pat. No. 6,619,737 discloses an air-conditionable vehicle seat which has a ventilation layer, through which air is able to flow, located under a cushion part, as well as an air-permeable upper cushion layer located over this ventilation layer. The cushion is covered with a cushion cover and provided with stitching, along which the cushion cover is connected by fastening means with the upper cushion layer. The ventilation layer extends all the way into the side pieces of the cushion so that the side pieces of the cushion subdivided by stitchings of the seat surface can likewise be supplied with air by the blower for the seat surface for ventilation of the seat. At the same time, in order to obtain a sufficient supply of air for the side pieces, the ventilation layer in the region of the stitchings has a thickness that is almost unchanged. A vehicle seat of the type mentioned in U.S. Pat. No. 6,619,737, which has a cushion cover with stitchings, is additionally disclosed in U.S. Pat. No. 6,817,675. Here a cushion cover and an upper cushion layer are fastened along the stitchings by fastening means, also bridging the ventilation layer at a lower cushion part. In both of the cases mentioned, a plurality of blowers is used for ventilation of all seat regions. In addition, an air-conditionable vehicle seat is disclosed in WO 03/101,777 A1. In this case, an air-circulating layer with additional vertical channels is provided, in order also to supply the air-circulating layer with sufficient air-conditioned air through stitched regions of the cover material. SUMMARY OF THE INVENTION The present invention provides an air-conditioned seat with at least one cushion layer subdivided by stitchings or the like, in which a uniform and sufficient supply of air to all air-circulating layers located under a cover material is ensured by as simple as possible construction. In particular, the flow connection through the cover stitching furrows is such that a single ventilation device is sufficient for the ventilation of all seat regions. In one embodiment, an air conditioning mechanism for a vehicle seat is provided. The vehicle seat has at least one cushion with at least one cover and at least two air conditioned zones on a surface facing an occupant, and at least one depression between the zones. The depression has a floor level that is recessed with respect to the air conditioned zones, into which the cover is at least partially drawn in the direction of the floor of the depression. The air conditioned zones and the at least one depression are connected together by an air-permeable connecting mechanism and, the depression, in the transverse direction, is at least partially air-permeable despite the cover. In one example, at least the portion of the cover drawn into the depression is porous, reticulated, perforated, punched or slit. The connecting mechanism can be located between the air conditioned zones essentially on or above the floor level of the at least one depression. In another aspect, an air-conditioning mechanism for a seat, in particular a vehicle seat, provides that at least two air-conditioned zones of a seat and at least one depression located between the air-conditioned zones are connected together permeable to air by at least one connecting mechanism and that the at least one depression in the transverse direction, despite the cover, is at least partially passable by air. In addition, it is advantageous when the at least one connecting mechanism is located between the air-conditioned zones and the at least one depression, essentially on or above the floor level. In the present context, air-conditioned zones are regions of a seat in which at least one air-circulating layer is located below a cover material. Such air-circulating layers and air-distribution layers may for example be spacer or distance layers that for example have knitted spacer fabric. Within these layers an air stream may be generated, for example, by a connected blower, which can act to temper the corresponding seat surface region and/or to carry away moisture diffusing into the seat and the air-circulating layer. In a seat according to the present invention, a largely uniform supply of the air-circulating layers of various air-conditioned regions of the seat with air-conditioned air can be obtained without the depressions lying between them, which for example may be provided with stitchings, resulting in buildup or obstructions in air circulation. In this way, a cover furrow is produced which also ensures air circulation through the furrows into the next cover field. According to one embodiment of the invention, an elongated depression is formed in a cushion core. On both sides of this depression, at an upper side of the cushion core, there is in each instance located an air-distribution layer for the formation of an air-conditioned zone. A connecting mechanism between the air-conditioned zones and the depression is formed by a channel, 1 to 3 cm wide and about 3 to 8 cm long, molded in the cushion core of the seat. It is provided that a plurality of such channels is in each instance formed in the cushion core transverse to the direction of the course of the depression. The floor level of the connecting channels according to the invention may then be located above, below or at the same level as the floor level of the elongated depression. The depth of the connecting channel need only be sufficient to ensure an air-flow connection of an air-circulating layer of an air-conditioned seat zone to an air-circulating layer of an adjacent air-conditioned seat zone. In addition, the connecting channels run outside the regions in which the fastening or anchoring points of the cover anchoring are found. The cover may be anchored by at least one auxiliary mechanism, for example by so-called anchor lugs. In each instance, these anchor lugs are connected at an upper edge with the cover edges drawn into the depression and any cover underlayment present and at a lower edge have devices for anchoring in the direction of the floor level of the depression and for fastening of the anchor lugs in the region of the floor level of the depression. According to one aspect of the invention, these anchor lugs are obtained by punching or for example by selection of an air-permeable textile or nonwoven as lug material in such a way that they present no noticeable flow barrier. In this way, an air stream between the air-distribution layers, which are in each instance located on different sides of the furrow on the upper side of the cushion core, is possible through the channels. In a cover anchoring without anchor lugs, for example by anchoring of the cover material itself, care must likewise be taken to see that the material lying in the region of the connecting channel, for example the cover material, is air-permeable or is made at least partially air-permeable. The air-distribution layers, which for example have knitted spacer fabric, may in each instance, on both sides of the depression or the furrow, reach directly to the depression in the cushion core. However, since known spacer materials harden the edges produced at the furrow and do not permit a free design of the geometric shape of the edge profile, this procedure is not advantageous. Support of the depression edges by material additionally introduced into the edge regions, in particular in the shape of a bead, is advantageous. An additional molded part, for example a square profile, which can be made of sectional foam, preferably is used for support and/or formation of the edge of a depression. Such an additional molded part can be mechanically fastened, for example by cementing or laminating, to the cushion inserts, which also support the air-distribution layers. This ensures simple assembly in the seat structure. An alternative variant is connection of the molded part, for example the profile strip, to the cushion core. Direct molding in the cushion mold foam core is not possible, since removal of such a foam part from the tool is not possible. Cover furrows according to the invention may be designed according to customers' specifications in their height profile and in their haptic properties. These properties are determined by the molded part placed on the cushion insert or on the cushion core. The entire arrangement is relatively simple to make. The steps for installation in the seat are simple and can be performed quickly. The passage of air between the air-conditioned zones of the seat separated by cover furrows, in particular when a plurality of connecting channels according to the invention are provided, is good enough that a single ventilation device, such as a blower located under the seat, suffices to ventilate all regions of the seat. BRIEF DESCRIPTION OF THE DRAWINGS For a more complete understanding of this invention, reference should now be made to the embodiments illustrated in grater detail in the accompanying figures and described below by way of examples of the invention wherein: FIG. 1 shows a schematic sectional representation of the structure of a seat arrangement according to one embodiment of the invention. FIG. 2 shows a schematic top view of the seat arrangement of FIG. 1 . FIG. 3 shows a perspective view and block diagrammatic view of a vehicle seat incorporating an air conditioning system according to an embodiment of the invention. DETAILED DESCRIPTION OF THE INVENTION In the following figures, the same reference numerals are used to refer to the same components. While the present invention is described as an air-conditioning system for use within a vehicle seat, it may be adapted and applied to various systems including other vehicle or non-vehicle systems requiring an air-conditioned surface. In this regard, in the following description, various operating parameters and components are described for several constructed embodiments. These specific parameters and components are included as examples only and are not meant to be limiting. The schematic sectional view of FIG. 1 illustrates the structure of an air-conditioning system for a vehicle seat 10 according to an embodiment of the invention. A blower 12 delivers air into a distribution layer 14 through which air is able to flow. The distribution layer 14 has the task of distributing the air stream 16 through the entire cushion surface and an air-conditioned zone 50 , 52 of the cushion surface, which may be in contact with the passenger; it has for example a spacer fabric uniformly permeable to air in all directions. In the region of the contact surfaces, the air passes through the air-permeable cover superstructure, which is comprised of an air-permeable seat cover 18 , the air-permeable cover underlayment 20 and a textile support 22 of a spacer layer. The textile support 22 and the distribution layer 14 in each instance form a structural unit for a cushion region 50 , 52 . The structural unit is mounted as an insert on the cushion core 24 , and in trough-like recesses in the cushion core. The air stream provides for carrying away moisture in the microclimate between passenger and seat 10 . In the regions strongly blocked by the passenger, back-ventilation of the contact surface results in sufficient air conditioning, moist air diffusing into the seat being carried away from the contact surface by a transverse flow of air in the distribution layer 14 . The cover stitching furrow 26 divides the air-distribution layer 14 as well as the cushion surface into two or more regions 50 , 52 , which in known vehicle seats do not have sufficient flow connection. A cover furrow 26 is produced by an elongated depression 27 in the cushion core 24 running along a straight or curved line, into which the cover 18 is anchored together with the underlayment 20 . Anchoring along this line is effected via an anchor lug 28 , which is sewn to the cover parts. The anchor lug 28 is fastened by a hook 29 to a wire 30 , which is expanded into the cushion core 24 and runs on the floor of the depression 27 . Optionally, clamps, which hold the anchor profile in place at individual points in the course of the depression, may alternatively be set into the cushion core 24 . The anchor lug band 28 is air-permeable; it usually is made of an air-impermeable textile or nonwoven. The air-distribution layer 14 lying on the surface of the cushion core 24 is interrupted in the region of the depression 27 . The depression 27 thus separates two air-conditioned zones 50 , 52 of the seat surface from one another. The present invention provides an airflow connection between the air-conditioned zones 50 , 52 and the depression 27 through the cover stitching furrow 26 . The connection is produced by channels 32 , about 1 to 3 cm wide and about 3 to 8 cm long, formed in the cushion core 24 . The channels 32 are depressions in the cushion core 24 running transverse to the direction of the depression 27 , which are located outside the regions in which the anchor points 34 of the cover anchoring are found. The anchor lug 28 is formed by punching or optionally by selection of an air-permeable textile as anchor material in such a way that it presents no appreciable flow obstruction. In the region of the channels 32 , air is therefore able to flow back and forth virtually unhindered between the air-conditioned zones 50 , 52 . Since known spacer materials are not suitable for the molding of edges, the air-distribution layers 14 in the example shown do not reach as far as the edges of the depression 27 . Instead, the edges at the depression 27 are supported by an additional molded part, in the example shown by a square profile 36 , which can be sectional foam. The course and shape of the cover stitching furrow 26 may thus be designed in any way desired. The profile 36 can be mechanically fastened to the cushion insert made of the textile support 22 and the spacer layer 14 , for example by cementing or laminating. Simple assembly in construction of the vehicle seat 10 is thereby ensured. An alternative variant provides cementing of the profile strip 36 onto the cushion core 24 . However, direct molding in the foam core of the cushion mold may not be possible, since removal of such a foam part from the tool may not be possible. The spacer material 14 is completely immersed in the cushion core 24 in the manner described. Alternatively, the spacer material itself may also form the edges (not represented), which as mentioned, however, is not advantageous in the case of known spacer materials. The schematic representation of FIG. 2 shows a top view of the seat structure of FIG. 1 . There the arrangements of the cover stitching furrow 28 and of the depression 27 in the cushion core 24 , as well as the channels 32 running transverse to the latter, can be clearly seen. The channels 32 permit a virtually unhindered stream of air from one air-conditioned seat region 50 to another air-conditioned region 52 , separated from the first by the cover furrow 26 . The anchor lug 28 , by means of which the cover material in the region of the furrow 26 is drawn into the depression 27 , is fastened at anchor points 34 in the region of the floor level of the depression 27 ; these anchor points 34 lie between the connecting channels 32 in the depression 27 in the cushion core 24 . The height profile and shape of the depressions 27 may be largely freely designed according to customers' specifications, since these properties of the profile strip 36 are determined by the profile strip 36 attached to the cushion insert and the latter may be variously shaped as desired. Not only the transverse furrows of the cover shown, but longitudinal furrows may alternatively be made in the way described. The separation of central parts and side regions of the cushion may likewise be used in the manner described for ventilation, so that complete areal ventilation of the seat contact region becomes possible. Referring now to FIG. 3 , a perspective and block diagrammatic view of a vehicle seat 10 incorporating an air conditioning system 55 according to an embodiment of the present invention is shown. The air conditioning system 55 is electrically coupled to a controller 53 including a power source 54 by way of a connector. In this example, electrical power is transferred to the air conditioning system 55 to activate the fan/blower to convey air to the zones 50 , 52 on either side of the furrow 26 . Because of the inventive seat arrangement, only a single fan/blower is required under one of the sections 50 , 52 . Of course, another air conditioning system could also be incorporated into the backrest to similarly condition that portion of the seat as well. As shown, the system is contained within the seat cover as described above with respect to FIGS. 1 and 2 and is beneath and near the upper surface to provide efficient transfer of air to or from the upper surface. While the invention has been described in connection with one or more embodiments, it is to be understood that the specific mechanisms and techniques which have been described are merely illustrative of the principles of the invention, numerous modifications may be made to the apparatus described without departing from the spirit and scope of the invention as defined by the appended claims.

An air-conditioning system for a seat includes a cushion having a cover and two air-conditioned zones proximate a surface facing a seat occupant, and an elongated depression between the zones, the depression having a floor which is recessed with respect to the zones and into which the cover is at least partially drawn into in the direction of the depression floor, the air-conditioned zones being at least partially distanced from the depression. The zones and the depression are connected by a plurality of air-permeable channels, the channels being located between the air-conditioned zones essentially on or above the depression floor. The depression, in the transverse direction, is at least partially air-permeable, despite the cover.

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 08/440.569 filed on May 15, 1995, now abandoned, which is a continuation of U.S. application Ser. No. 08/356,361 filed Mar. 7, 1995, which is a section 371 application of PCT/GB93/01282, the contents of which are herein incorporated by reference. The present invention relates to polypeptides and their use in the diagnosis and therapy of disorders involving complement activity and various inflammatory and immune disorders. BACKGROUND OF THE INVENTION Constituting about 10% of the globulins in normal serum, the complement system is composed of many different proteins that are important in the immune system's response to foreign antigens. The complement system becomes activated when its primary components are cleaved and the products alone or with other proteins, activate additional complement proteins resulting in a proteolytic cascade. Activation of the complement system leads to a variety of responses including increased vascular permeability, chemotaxis of phagocytic cells, activation of inflammatory cells, opsonization of foreign particles, direct killing of cells and tissue damage. Activation of the complement system may be triggered by antigen-antibody complexes (the classical pathway) or, for example, by lipopolysaccharides present in cell walls of pathogenic bacteria (the alternative pathway). Complement receptor type 1 (CR1) has been shown to be present on the membranes of erythrocytes, monocytes/macrophages, granulocytes, B cells, some T cells, splenic follicular dendritic cells, and glomerular podocytes. CR1 binds to the complement components C3b and C4b and has also been referred to as the C3b/C4b receptor. The structural organisation and primary sequence of one allotype of CR1 is known (Klickstein et al., 1987, J. Exp. Med. 165:1095-1112, Klickstein et al., 1988, J. Exp. Med. 168:1699-1717; Hourcade et al., 1988, J. Exp. Med. 168:1255-1270, WO 89/09220, WO 91/05047). It is composed of 30 short consensus repeats (SCRs) that each contain around 60-70 amino acids. In each SCR, around 29 of the average 65 amino acids are conserved. Each SCR has been proposed to form a three dimensional triple loop structure through disulphide linkages with the third and first and the fourth and second half-cystines in disulphide bonds. CR1 is further arranged as 4 long homologous repeats (LHRs) of 7 SCRs each. Following a leader sequence, the CR1 molecule consists of the N-terminal LHR-A, the next two repeats, LHR-B and LHR-C, and the most C-terminal LHR-D followed by 2 additional SCRs, a 25 residue putative transmembrane region and a 43 residue cytoplasmic tail. SUMMARY OF THE INVENTION Based on the mature CR1 molecule having a predicted N-terminal glutamine residue, hereinafter designated as residue 1, the first four SCR domains of LHR-A are defined herein as consisting of residues 2-58 (residues 3-59 of SEQ ID NO: 29), 63-120 (residues 64-121 of SEQ ID NO: 29), 125-191 (residues 126-192 of SEQ ID NO: 29) and 197-252 (residues 198-253 of SEQ ID NO: 29), respectively, of mature CR1. Hourcade et al., 1988, J. Exp. Med. 168:1255-1270 observed an alternative polyadenylation site in the human CR1 transcriptional unit that was predicted to produce a secreted form of CR1. The MRNA encoded by this truncated sequence comprises the first 8.5 SCRs of CR1, and encodes a protein of about 80 kDa which was proposed to include the C4b binding domain. When a cDNA corresponding to this truncated sequence was transfected into COS cells and expressed, it demonstrated the expected C4b binding activity but did not bind to C3b (Krych et al., 1989, FASEB J. 3:A368; Krych et al. Proc. Nat. Acad. Sci. 1991, 88, 4353-7). Krych et al., also observed a MRNA similar to the predicted one in several human cell lines and postulated that such a truncated soluble form of CR1 with C4b binding activity may be synthesised in humans. In addition, Makrides et al. (1992, J. Biol. Chem. 267 (34) 24754-61) have expressed SCR 1+2 (residues 3-59 and 64-121, respectively, of SEQ ID NO: 29) and 1+2+3+4 (residues 3-59, 64-121, 126-192 and 198-253, respectively of SEQ ID NO: 29) of LHR-A as membrane-attached proteins in CHO cells. Several soluble fragments of CR1 have also been generated via recombinant DNA procedures by eliminating the transmembrane region from the DNAs being expressed (WO 89/09220, WO 91/05047). The soluble CR1 fragments were functionally active, bound C3b and/or C4b and demonstrated Factor I cofactor activity depending upon the regions they contained. Such constructs inhibited in vitro complement-related functions such as neutrophil oxidative burst, complement mediated hemolysis, and C3a and C5a production. A particular soluble construct, sCR1/pBSCR1c, also demonstrated in vivo activity in a reversed passive Arthus reaction (WO 89/09220, WO 91/05047; Yeh et al., 1991, J. Immunol. 146:250), suppressed post-ischemic myocardial inflammation and necrosis (WO 89/09220, WO 91/05047; Weisman et al., Science, 1990, 249:146-1511; Dupe, R. et al. Thrombosis & Haemostasis (1991) 65(6) 695.) and extended survival rates following transplantation (Pruitt & Bollinger, 1991, J. Surg. Res 50:350; Pruitt et al., 1991 Transplantation 52; 868). Furthermore, co-formulation of sCR1/pBSCR1c with p-anisoylated human plasminogen-streptokinase-activator complex (APSAC) resulted in similar anti-haemolytic activity as sCR1 alone, indicating that the combination of the complement inhibitor sCR1 with a thrombolytic agent was feasible (WO 91/05047). Soluble polypeptides corresponding to part of CR1 have now been found to possess functional complement inhibitory, including anti-haemolytic, activity. According to the present invention there is provided a soluble polypeptide comprising, in sequence, one to four short consensus repeats (SCR) selected from SCR 1, 2, 3 and 4 (residues 3-59, 64-121, 126-192 and 198-253, respectively, of SEQ ID NO: 29) of long homologous repeat A (LHR-A) as the only structurally and functionally intact SCR domains of CR1 and including at least SCR3 (residues 126-192 of SEQ ID NO: 29). In preferred aspects, the polypeptide comprises, in sequence, SCR 1, 2, 3 and 4 (residues 3-59, 64-121, 126-192 and 198-253, respectively, of SEQ ID NO: 29) of LHR-A or SCR 1, 2 and 3 (residues 3-59, 64-121 and 126-192, respectively of SEQ ID NO: 29) of LHR-A as the only structurally and functionally intact SCR domains of CR1. It is to be understood that variations in the amino acid sequence of the polypeptide of the invention by way of addition, deletion or conservative substitution of residues, including allelic variations, in which the biological activity of the polypeptide is retained, are encompassed by the invention. Conservative substitution is understood to mean the retention of the charge and size characteristics of the amino acid side chain, for example arginine replaced by histidine. In one aspect, the polypeptide of the invention may be represented symbolically as follows: NH.sub.2 --V1--SCR1--W.sup.1 --SCR2-X.sup.1 --SCR3-Y.sup.1 --OH.sub.--(I) in which SCR1 (residues 3-59 of SEQ ID NO: 29) represents residues 2-58 of mature CR1, SCR2 (residues 64-121 of SEQ ID NO: 29) represents residues 63-120 of mature CR1, SCR3 (residues 126-192 of SEQ ID NO: 29) represents residues 125-191 of mature CR1, and V 1 , W 1 , X 1 and Y 1 represent bonds or short linking sequences of amino acids, preferably 1 to 5 residues in length and which are preferably derived from native interdomain sequences in CR1. In a preferred embodiment of formula (I), W 1 , X 1 and Y 1 represent residues 59-62, 121-124 and 192-196, respectively, of mature CR1 (residues 60-63, 122-125 and 193-197, respectively, of SEQ ID NO: 29) and V 1 represents residue 1 of mature CR1 (residue 2 of SEQ ID NO: 29) optionally linked via its N-terminus to methionine. In another aspect the polypeptide of the invention may be represented symbolically as follows: NH.sub.2 --V.sup.2 --SCR 1--W.sup.2 --SCR2--X.sup.2 --SCR3--Y.sup.2 --SCR4--Z.sup.2 OH (II) in which SCR1 (residues 3-59 of SEQ ID NO: 29), SCR2 (residues 64-121 of SEQ ID NO: 29) and SCR3 (residues 126-192 of SEQ ID NO: 29) are as hereinbefore defined, SCR4 (residues 197-252 of SEQ ID NO: 31) represents residues 197-252 of mature CR1 and V 2 , W 2 , X 2 , Y 2 and Z 2 represents bonds or short linking sequences of amino acids, preferably 1 to 5 residues in length and which are preferably derived from native interdomain sequences in CR1. In preferred embodiments of formula (II), W 2 , X 2 , Y 2 and Z 2 represent residues 59-62, 121-124, 192-196, and residues 253 respectively, of mature CR1 (residues 60-63, 122-125, 193-197 and 254. respectively, of SEQ ID NO: 29)and V 2 represents residue 1 of mature CR1 (residue 2 of SEQ ID NO: 29) optionally linked via its N-terminus to methionine. In one particular embodiment of formula (II) arginine 235 is replaced by histidine. In the preferred embodiment of formula (II), residue 235 is arginine. In one further aspect, the polypeptide of the invention may be represented symbolically as follows: NH.sub.2 --X.sup.3 --SCR3--Y.sup.3 --OH (III) in which SCR3 (residues 126-192 of SEQ ID NO: 29) is as hereinbefore defined and X 3 and Y 3 represent bonds or short linking sequences of amino acids, preferably 1 to 5 residues in length and which are preferably derived from native interdomain sequences in CR1. In a preferred embodiment of formula (III) X 3 represents amino acids 122-124 of mature CR1 (residues 123-125 of SEQ ID NO: 29) optionally linked to methionine at its N-terminus and Y 43 represents amino acids 192-196 of mature CR1 (residues 193-197 of SEQ ID NO: 29). In another further aspect, the polypeptide of the invention may be represented symbolically as follows: NH.sub.2 --X.sup.4 --SCR3--Y.sup.4 --SCR4--Z.sup.4 --OH (IV) in which SCR3 (residues 126-192 of SEQ ID NO: 29) and SCR4 (residues 198-253 of SEQ ID NO: 29) are as hereinbefore defined and X 4 , Y 4 and Z 4 represent bonds or short linking sequences of amino acids, preferably 1 to 5 residues in length and which are preferably derived from native interdomain sequences in CR1. In a preferred embodiment of formula (IV) X 4 represents amino acids 122-124 of mature CR1 (residues 123-125 of SEQ ID NO: 29) optionally linked to methionine at its N-terminus and Y 4 and Z 4 represent amino acids 192-196 and 253 respectively of mature CR1 (residues 193-197 and 254, respectively, of SEQ ID NO: 29). In a further aspect, the invention provides a process for preparing a CR 1 polypeptide according to the invention which process comprises expressing DNA encoding said polypeptide in a recombinant host cell and recovering the product. In particular, the process may comprise the steps of: i) preparing a replicable expression vector capable, in a host cell, of expressing a DNA polymer comprising a nucleotide sequence that encodes said polypeptide; ii) transforming a host cell with said vector; iii) culturing said transformed host cell under conditions permitting expression of said DNA polymer to produce said polypeptide; and iv) recovering said polypeptide. The DNA polymer comprising a nucleotide sequence that encodes the polypeptide also forms part of the invention. The process of the invention may be performed by conventional recombinant techniques such as described in Sambrook et al., Molecular Cloning: A laboratory manual 2nd Edition. Cold Spring Harbor Laboratory Press (1989) and DNA Cloning vols I, II and III (D. M. Glover ed., IRL Press Ltd). The invention also provides a process for preparing the DNA polymer by the condensation of appropriate mono-, di- or oligomeric nucleotide units. The preparation may be carried out chemically, enzymatically, or by a combination of the two methods, in vitro or in vivo as appropriate. Thus, the DNA polymer may be prepared by the enzymatic ligation of appropriate DNA fragments, by conventional methods such as those described by D. M. Roberts et al., in Biochemistry 1985, 24, 5090-5098. The DNA fragments may be obtained by digestion of DNA containing the required sequences of nucleotides with appropriate restriction enzymes, by chemical synthesis, by enzymatic polymerisation, or by a combination of these methods. Digestion with restriction enzymes may be performed in an appropriate buffer at a temperature of 20°-70° C., generally in a volume of 50 ml or less with 0.1-10 mg DNA. Enzymatic polymerisation of DNA may be carried out in vitro using a DNA polymerase such as DNA polymerase 1 (Klenow fragment) in an appropriate buffer containing the nucleoside triphosphates dATP, dCTP, dGTP and dTTP as required at a temperature of 10°-37° C., generally in a volume of 50 ml or less. Enzymatic ligation of DNA fragments may be carried out using a DNA ligase such as T4 DNA ligase in an appropriate buffer at a temperature of 4° C. to 37° C., generally in a volume of 50 ml or less. The chemical synthesis of the DNA polymer or fragments may be carried out by conventional phosphotriester, phosphite or phosphoramidite chemistry, using solid phase techniques such as those described in `Chemical and Enzymatic Synthesis of Gene Fragments--A Laboratory Manual` (ed. H. G. Gassen and A. Lang), Verlag Chemie, Weinheim (1982), or in other scientific publications, for example M. J. Gait, H. W. D. Matthes M. Singh, B. S. Sproat and R. C. Titmas, Nucleic Acids Research, 1982, 10, 6243; B. S. Sproat and W. Bannwarth, Tetrahedron Letters, 1983, 24, 5771; M. D. Matteucci and M. H. Caruthers, Tetrahedron Letters, 1980, 21, 719; M.D. Matteucci and M.H. Caruthers, Journal of the American Chemical Society, 1981, 103, 3185; S. P. Adams et al., Journal of the American Chemical Society, 1983, 105, 661; N. D. Sinha, J. Biernat, J. McMannus and H. Koester, Nucleic Acids Research, 1984, 12, 4539; and H. W. D. Matthes et al., EMBO Journal, 1984, 3, 801. Preferably an automated DNA synthesiser (for example, Applied Biosystems 381 A Synthesiser) is employed. The DNA polymer is preferably prepared by ligating two or more DNA molecules which together comprise a DNA sequence encoding the polypeptide. The DNA molecules may be obtained by the digestion with suitable restriction enzymes of vectors carrying the required coding sequences. The precise structure of the DNA molecules and the way in which they are obtained depends upon the structure of the desired product. The design of a suitable strategy for the construction of the DNA molecule coding for the polypeptide is a routine matter for the skilled worker in the art. In particular, consideration may be given to the codon usage of the particular host cell. The codons may be optimised for high level expression in E. coli using the principles set out in Devereux et al., (1984) Nucl. Acid Res., 12, 387. The expression of the DNA polymer encoding the polypeptide in a recombinant host cell may be carried out by means of a replicable expression vector capable, in the host cell, of expressing the DNA polymer. The expression vector is novel and also forms part of the invention. The replicable expression vector may be prepared in accordance with the invention, by cleaving a vector compatible with the host cell to provide a linear DNA segment having an intact replicon, and combining said linear segment with one or more DNA molecules which, together with said linear segment, encode the polypeptide, under ligating conditions. The ligation of the linear segment and more than one DNA molecule may be carried out simultaneously or sequentially as desired. Thus, the DNA polymer may be preformed or formed during the construction of the vector, as desired. The choice of vector will be determined in part by the host cell, which may be prokaryotic, such as E coli, or eukaryotic, such as mouse C127, mouse myeloma, chinese hamster ovary, fungi e.g. filamentous fungi or unicellular `yeast` or an insect cell such as Drosophila. The host cell may also be in a transgenic animal. Suitable vectors include plasmids, bacteriophages, cosmids and recombinant viruses derived from, for example, baculoviruses or vaccinia. The DNA polymer may be assembled into vectors designed for isolation of stable transformed mammalian cell lines expressing the fragment e.g. bovine papillomavirus vectors in mouse C127 cells, or amplified vectors in chinese hamster ovary cells (DNA Cloning Vol. II D. M. Glover ed. IRL Press 1985; Kaufman, R. J. et al. Molecular and Cellular Biology 5, 1750-1759, 1985; Pavlakis G. N. and Hamer, D. H. Proceedings of the National Academy of Sciences (USA) 80, 397-401, 1983; Goeddel, D.V. et al., European Patent Application No. 0093619, 1983). The preparation of the replicable expression vector may be carried out conventionally with appropriate enzymes for restriction, polymerisation and ligation of the DNA, by procedures described in, for example, Sambrook et al., cited above. Polymerisation and ligation may be performed as described above for the preparation of the DNA polymer. Digestion with restriction enzymes may be performed in an appropriate buffer at a temperature of 20°-70° C., generally in a volume of 50 ml or less with 0.1-10 mg DNA. The recombinant host cell is prepared, in accordance with the invention, by transforming a host cell with a replicable expression vector of the invention under transforming conditions. Suitable transforming conditions are conventional and are described in, for example, Sambrook et al., cited above, or "DNA Cloning" Vol. II, D. M. Glover ed., IRL Press Ltd, 1985. The choice of transforming conditions is determined by the host cell. Thus, a bacterial host such as E.coli, may be treated with a solution of CaCI 2 (Cohen et al., Proc. Nat. Acad. Sci., 1973, 69, 2110) or with a solution comprising a mixture of RbC1, MnC1 2 , potassium acetate and glycerol, and then with 3- N-morpholino!-propane-sulphonic acid, RbC1 and glycerol or by electroporation as for example described by Bio-Rad Laboratories, Richmond, Calif., USA, manufacturers of an electroporator. Mammalian cells in culture may be transformed by calcium co-precipitation of the vector DNA onto the cells or by using cationic liposomes. The invention also extends to a host cell transformed with a replicable expression vector of the invention. Culturing the transformed host cell under conditions permitting expression of the DNA polymer is carried out conventionally, as described in, for example, Sambrook et al., and "DNA Cloning" cited above. Thus, preferably the cell is supplied with nutrient and cultured at a temperature below 45° C. The protein product is recovered by conventional methods according to the host cell. Thus, where the host cell is bacterial such as E. coli and the protein is expressed intracellularly, it may be lysed physically, chemically or enzymatically and the protein product isolated from the resulting lysate. Where the host cell is mammalian, the product is usually isolated from the nutrient medium. Where the host cell is bacterial, such as E. coli, the product obtained from the culture may require folding for optimum functional activity. This is most likely if the protein is expressed as inclusion bodies. There are a number of aspects of the isolation and folding process that are regarded as important. In particular, the polypeptide is preferably partially purified before folding, in order to minimise formation of aggregates with contaminating proteins and minimise misfolding of the polypeptide. Thus, the removal of contaminating E. coli proteins by specifically isolating the inclusion bodies and the subsequent additional purification prior to folding are important aspects of the procedure. The folding process is carried out in such a way as to minimise aggregation of intermediate-folded states of the polypeptide. Thus, careful consideration needs to be given to, among others, the salt type and concentration, temperature, protein concentration, redox buffer concentrations and duration of folding. The exact condition for any given polypeptide generally cannot be predicted and must be determined by experiment. There are numerous methods available for the folding of proteins from inclusion bodies and these are known to the skilled worker in this field. The methods generally involve breaking all the disulphide bonds in the inclusion body, for example with 50 mM 2-mercaptoethanol, in the presence of a high concentration of denaturant such as 8M urea or 6M guanidine hydrochloride. The next step is to remove these agents to allow folding of the proteins to occur. Formation of the disulphide bridges requires an oxidising environment and this may be provided in a number of ways, for example by air, or by incorporating a suitable redox system, for example a mixture of reduced and oxidised glutathione. Preferably, the inclusion body is solubilised using 8M urea, in the presence of mercaptoethanol, and protein is folded, after initial removal of contaminating proteins, by addition of cold buffer. A preferred buffer is 20 mM ethanolamine containing 1 mM reduced glutathione and 0.5 mM oxidised glutathione. The folding is preferably carried out at a temperature in the range 1° to 5° C. over a period of 1 to 4 days. If any precipitation or aggregation is observed, the aggregated protein can be removed in a number of ways, for example by centrifugation or by treatment with precipitants such as ammonium sulphate. Where either of these procedures are adopted, monomeric polypeptide is the major soluble product. If the bacterial cell secretes the protein, folding is not usually necessary. The polypeptide of this invention is useful in the treatment or diagnosis of many complement-mediated or complement-related diseases and disorders including, but not limited to, those listed below. Disease and Disorders Involving Complement Neurological Disorders multiple sclerosis stroke Guillain Barre Syndrome traumatic brain injury Parkinson's disease allergic encephalitis Alzheimer's disease Disorders of Inappropriate or Undesirable Complement Activation haemodialysis complications hyperacute allograft rejection xenograft rejection corneal graft rejection interleukin-2 induced toxicity during IL-2 therapy paroxysmal nocturnal haemoglobinuria Inflammatory Disorders inflammation of autoimmune diseases Crohn's Disease adult respiratory distress syndrome thermal injury including burns or frostbite uveitis psoriasis asthma acute pancreatitis Post-Ischemic Reperfusion Conditions myocardial infarction balloon angioplasty atherosclerosis (cholesterol-induced) & restenosis hypertension post-pump syndrome in cardiopulmonary bypass or renal haemodialysis renal ischemia intestinal ischaemia Infectious Diseases or Sepsis multiple organ failure septic shock Immune Complex Disorders and Autoimmune Diseases rheumatoid arthritis systemic lupus erythematosus (SLE) SLE nephritis proliferative nephritis glomerulonephritis haemolytic anemia myasthenia gravis Reproductive Disorders antibody- or complement-mediated infertility Wound Healing The present invention is also directed to a pharmaceutical composition comprising a therapeutically effective amount of a polypeptide, as above, and a pharmaceutically acceptable carrier or excipient. The present invention also provides a method of treating a disease or disorder associated with inflammation or inappropriate complement activation comprising administering to a subject in need of such treatment a therapeutically effective amount of a polypeptide of this invention. In the above methods, the subject is preferably a human. An effective amount of the polypeptide for the treatment of a disease or disorder is in the dose range of 0.01-100 mg/kg; preferably 0.1 mg-10 mg/kg. For administration, the polypeptide should be formulated into an appropriate pharmaceutical or therapeutic composition. Such a composition typically contains a therapeutically active amount of the polypeptide and a pharmaceutically acceptable excipient or carrier such as saline, buffered saline, dextrose, or water. Compositions may also comprise specific stabilising agents such as sugars, including mannose and mannitol, and local anaesthetics for injectable compositions, including, for example, lidocaine. Further provided is the use of a polypeptide of this invention in the manufacture of a medicament for the treatment of a disease or disorder associated with inflammation or inappropriate complement activation. In order to inhibit complement activation and, at the same time, provide thrombolytic therapy, the present invention provides compositions which further comprise a therapeutically active amount of a thrombolytic agent. An effective amount of a thrombolytic agent is in the dose range of 0.01-10 mg/kg; preferably 0.1-5 mg/kg. Preferred thrombolytic agents include, but are not limited to, streptokinase, human tissue type plasminogen activator and urokinase molecules and derivatives, fragments or conjugates thereof. The thrombolytic agents may comprise one or more chains that may be fused or reversibly linked to other agents to form hybrid molecules (EP-A-0297882 and EP 155387), such as, for example, urokinase linked to plasmin (EP-A-0152736), a fibrinolytic enzyme linked to a water-soluble polymer (EP-A-0183503). The thrombolytic agents may also comprise muteins of plasminogen activators (EP-A-0207589). In a preferred embodiment, the thrombolytic agent may comprise a reversibly blocked in vitro fibrinolytic enzyme as described in U.S. Pat. No. 4,285,932. A most preferred enzyme is a p-anisoyl plasminogen-streptokinase activator complex as described in U.S. Pat. No. 4,808,405, and marketed by SmithKline Beecham Pharmaceuticals under the Trademark EMINASE (generic name anistreplase, also referred to as APSAC; Monk et al., 1987, Drugs 34:25-49). Routes of administration for the individual or combined therapeutic compositions of the present invention include standard routes, such as, for example, intravenous infusion or bolus injection. Active complement inhibitors and thrombolytic agents may be administered together or sequentially, in any order. The present invention also provides a method for treating a thrombotic condition, in particular acute myocardial infarction, in a human or non-human animal. This method comprises administering to a human or animal in need of this treatment an effective amount of a polypeptide according to this invention and an effective amount of a thrombolytic agent. Also provided is the use of a polypeptide of this invention and a thrombolytic agent in the manufacture of a medicament for the treatment of a thrombotic condition in a human or animal. Such methods and uses may be carried out as described in WO 91/05047. This invention further provides a method for treating adult respiratory distress syndrome (ARDS) in a human or non-human animal. This method comprises administering to the patient an effective amount of a polypeptide according to this invention. The invention also provides a method of delaying hyperacute allograft or hyperacute xenograft rejection in a human or non-human animal which receives a transplant by administering an effective amount of a polypeptide according to this invention. Such administration may be to the patient or by application to the transplant prior to implantation. The invention yet further provides a method of treating wounds in a human or non-human animal by administering by either topical or parenteral e.g. intravenous routes, an effective amount of a polypeptide according to this invention. BRIEF DESCRIPTION OF THE FIGURES FIG. 1 depicts plasmid pBROC413. FIG. 2 depicts the construction of plasmid pDB1013-5-4. FIG. 3 depicts the construction of plasmid pDB1018. DETAILED DESCRIPTION OF THE INVENTION General Methods Used In Examples (i) DNA Cleavage Cleavage of DNA by restriction endonucleases was carried out according to the manufacturer's instructions using supplied buffers. Double digests were carried out simultaneously if the buffer conditions were suitable for both enzymes. Otherwise double digests were carried out sequentially where enzyme requiring the lowest salt concentration was added first to the digest. Once that digest was complete the salt concentration was altered and the second enzyme added. (ii) Production of Blunt Ended DNA Fragments The recessed 3' termini of DNA fragments were filled in using the Klenow fragment of DNA polymerase I as described in Sambrook et al (1989). (iii) DNA Purification/Concentration and Analysis Removal of protein contaminants, nucleosides was with phenol/CHCl 3 followed by precipitation with ethanol. DNA was analysed on horizontal agarose gel electrophoresis; both methods are described in Sambrook et al (1989). (iv) DNA Fragment Isolation 1. DNA Purification on DEAE NA45 Membranes DNA fragments were purified from agarose gels by making an incision in the agarose above and just below the required DNA fragment. NA45 membranes from Schleicher & Schuell (Anderman, Great Britain) that had been soaked in TE (10 mM Tris pH 8.0, 1 mM EDTA) were inserted into the incisions and current reapplied to the gel until the DNA fragment was trapped on the lower membrane; higher molecular weight DNA was trapped on the upper membrane. The lower membrane was removed from the gel and the DNA eluted into 0.05M arginine/1M NaCl at 70° C. for 2 hours. The DNA was then concentrated by ethanol precipitation as described in Sambrook et al (1989). 2. Electroelution DNA fragments were excised from agarose gels and DNA extracted by electroelution using the Unidirectional Electroeluter (IBI Ltd., Cambridge, England) according to the manufacturer's instructions. 3. Gel Purification DNA fragments were excised from agarose gels and DNA extracted using the QIAEX gel extraction kit according to the manufacturers instructions (QIAGEN Inc., USA). (v) Plasmid Preparation Large scale plasmid preparation of plasmid DNA was carried out using CsCl as described in Sambrook et al (1989) or using Magic MaxiprepsMAGIC MAXIPREPS®, a medium scale (up to 1 mg) DNA preparation system using pre-packed ion-exchange columns (Promega Corporation, Madison, USA) according to the manufacturers instructions. Mini-plasmid preparations were carried out using either the alkaline lysis method described in Sambrook et al (1989) or Magic Minipreps (Promega Corporation, Madison, USA) according to the manufacturer's instructions. (vi) Introduction of Plasmid DNA into E. coli 1. Plasmids were transformed into E. coli HB101 or E. coli BL21 (DE3) (Studier and Moffat, 1986) that had been made competent using calcium chloride as described in Sambrook et al (1989). 2. Alternatively plasmids were introduced into E.coli DH1 (Low,1968) or E.coli BL21 (DE3) by electroporation using the Gene PulsarGENE PULSAR®, electroporation apparatus for gene transfer, and Pulse Controller PULSE CONTROLLER® (of Bio-Rad, part of the electroporation apparatus (Bio-Rad Laboratories, Richmond, Calif., USA) according to the manufacturer's instructions. (vii) Kinasing of Oligonucleotides Oligonucleotides or annealed oligonucleotides possessing 5' overhangs were kinased using T 4 polynucleotide kinase as described in Sambrook et al (1989). (viii) Annealing and Ligation of Oligonucleotides Oligonucleotides were annealed together by mixing generally equimolar concentrations of the complementary oligonucleotides in 10 mM Tris pH 8.5, 5 mM MgCl 2 and placing at 100° C. for 5 minutes and then cooling very slowly to room temperature. Annealed oligonucleotides with sticky ends were ligated to vector or other oligonucleotides containing complementary sticky ends using T 4 DNA ligase as described in Sambrook et al (1989). (ix) PCR (Polymerase Chain Reaction) Amplification of DNA DNA fragments from ligation reactions or DNA fragments excised and purified from agarose gels were amplified by PCR from two primers complementary to the 5' ends of the DNA fragment. Approximately 0.1-1 mg of ligation reaction or the purified DNA from the agarose gel was mixed in 10 mM Tris pH 8.3 (at 25° C.), 50 mM KCI, 0.1% gelatin; MgCl 2 concentrations were varied from 1.5 mM to 6 mM to find a suitable concentration for each reaction. Both primers were added to a final concentration of 2 μM; each dNTP was added to a final concentration of 0.2 mM. The final reaction volume was either 75 ml or 100 ml, which was overlayed with mineral oil to prevent evaporation. Thermal cycling was then started on a thermal cycler eg. Hybaid Thermal rcactorHYBAID THERMAL REACTOR®, automated device for carrying out the polymerase chain reaction, and a typical example of conditions used was 940° C. 7 mins, 45° C. 2 mins, hold at 45° C. for less than 5 min., and then add 5 units of Taq DNA polymerase (purchased from a commercial source, e.g. Gibco). The DNA fragment was amplified by cycling the temperature at 72° C. 2 mins, 94° C. 1 min and 45° C. 2 min a total of 35 times. (x) DNA Sequencing Using the Double Stranded Method Sequencing was carried out using "Sequenase™" (United States Biochemical Corporation) essentially as described in the manufacturer's instructions. (xi) DNA Sequence Analysis and Manipulation Analysis of sequences were carried out on a digital VAX computer using the GCG package of programmes as described in Devereux et al (1984). (xii) Production of Oligonucleotides 1. Oligonucleotides were synthesised using a Gene Assembler PlusGENE ASSEMBLER PLUS®, automated DNA synthesizer (Pharmacia LKB Biotechnology, Milton Keynes, England) or a 381A Synthesiser (Applied BioSystems) according to the manufacturer's instructions. 2. Oligonucleotide purification was carried out either using MonoQMONO Q®, anion-exchange resin (Pharmacia), as recommended by Pharmacia or by UV shadowing where recovery of synthetic oligonucleotides was by electrophoresis through a denaturing polyacrylamide gel. The oligonucleotides were loaded onto a 12% acrylamide/7M urea gel and run at 1500 V until the oligonucleotide had migrated approximately two thirds of the length of the gel. The DNA was visualised using a hand-held, long-wavelength ultraviolet lamp; and the DNA bands excised. The oligonucleotide was recovered using Sep-Pak C18 reverse phase columns (Waters) as described in Sambrook et al (1989). (xiii) Sodium Dodecyl Sulphate Polyacrylamide Gel Electrophoresis (SDS PAGE) SDS PAGE was carried out generally using the Novex system (British Biotechnology) according to the manufacturer's instructions. Prepacked gels of acrylamide concentrations 14%, 16%, 4-20% or 10-27% were the ones most frequently used. Samples for electrophoresis, including protein molecular weight standards (LMW Kit, Pharmacia) were usually diluted in 1%(w/v)SDS-containing buffer (with or without 5%(v/v) 2-mercaptoethanol), and left at room temperature for about 0.5 to 1 h before application to the gel. (xiv) Alteration of Codon Usage The non random use of synonymous codons has been demonstrated in E. coli and there is some evidence to support the belief that protein production from genes containing non-optimal or minor codons (particularly at the 5' end of the gene) is less efficient than that from genes with no such codons (e.g. Chen an Inouye, 1990). A codon usage table compiled from genes highly expressed in E. coli (supplied as part of the GCG sequence analysis software package, Devereux et al, (1984)) was used to determine the optimal codons for expression in E. coli. All of the first 30 codons of all constructs (where compatible with restriction enzyme sites) were optimised for high level expression. The codons for the seven amino acids: arg, gly, ile, leu, pro, ser, ala were optimised (where compatible with restriction enzyme sites) throughout the coding sequence. (xv) Construction of Vector pBROC413 The plasmid pT7-7 (Tabor, 1990) contains DNA corresponding to nucleotides 2065-4362 of pBR322 and like pBR322 can be mobilized by a conjugative plasmid in the presence of a third plasmid ColK. A mobility protein encoded by ColK acts on the nic site at nucleotide 2254 of initiating mobilization from this point. pT7-7 was digested with LspI and BglII and the protruding 5' ends filled in with the Klenow fragment of DNA Polymerase I. The plasmid DNA fragment was purified by agarose gel electrophoresis, the blunt ends ligated together and transformed into E. coli DH1 by electroporation. The resultant plasmid pBROC413 (FIG.1) was identified by restriction enzyme analysis of plasmid DNA. The deletion in pBROC413 from the LspI site immediately upstream of the .O slashed.10 promoter to the BglII site at nucleotide 434 of pT7-7 deletes the DNA corresponding to nucleotides 2065-2297 of pBR322. The nic site and adjacent sequences are therefore deleted making pBROC413 non mobilizable. (xvi) Haemolytic Assay The anti-haemolytic activity of polypeptides was assessed by measuring the inhibition of complement mediated lysis of sheep erythrocytes sensitised with rabbit antibodies (obtained from Diamedix Corporation, Miami, USA). Human serum diluted 1:125 in 0.1M Hepes/0.15M NaCl pH 7.4 buffer was the source of complement and was prepared from a pool of volunteers essentially as described in (Dacie & Lewis, 1975). Briefly, blood was warmed to 370° C. for 5 minutes, the clot removed and the remaining serum clarified by centrifugation. The serum fraction was split into small aliquots and stored at -196° C. Aliquots were thawed as required and diluted in the Hepes buffer immediately before use. Inhibition of complement-mediated lysis of sensitised sheep erythrocytes was measured using a standard haemolytic assay using a v-bottom microtitre plate format as follows. 50 ml of a range of concentrations (0.01-100 μg/ml but typically 0.05-25 mg/ml) of test protein diluted in Hepes buffer were incubated with 50 ml of the diluted serum for 15 minutes at 37° C. . 100 ml of prewarmed sensitised sheep erythrocytes were added for 1 hour at 37° C. in a final reaction volume of 200 ml. Samples were spun at 300 g at 4° C. for 15 minutes before transferring 150 ml of supernatant to flat bottomed microtitre plates and determining the absorption at 410 nm, which reflects the amount of lysis in each test solution. Maximum lysis was determined by incubating serum with erythrocytes in the absence of any inhibitor from which the proportion of background lysis had been subtracted (determined by incubating erythrocytes with buffer). The background lysis by inhibitor was assessed by incubating inhibitor with erythrocytes and then subtracting that from test samples. Inhibition was expressed as a fraction of the total cell lysis such that IH50 represents the concentration of inhibitor required to give 50% inhibition of lysis. (xvii) C3a RIA Assay Activation of complement pathways can be followed by measuring the release of the anaphylatoxin, C3a and its breakdown product C3a des Arg. Both products can be measured using a competitive radio-immuno assay purchased from Amersham International plc, U. K., (human complement C3a des Arg 125 I!assay, code RPA 518). (a) Alternative Pathway Activation by Zymosan A The alternative pathway of complement was activated with zymosan A, a complex carbohydrate from yeast (Sigma, catalogue number Z-4250). Zymosan A was made 50 mg/ml in Hepes buffer (0.1M Hepes/0.15M NaCl pH 7.4) or in PBS (50 mM sodium phosphate/10M NaCl pH 7.4) and vortexed until a fine suspension had formed. Serum (prepared as described for the haemolytic assay; Method xvi) was preincubated with different concentrations of complement inhibitor diluted in Hepes buffer for 15 mins at 37° C. using the volumes given below. Zymosan A was then vortexed for a few seconds each time before addition to the samples after which samples were incubated for a further 30 mins at 37° C. The zymosan A was then spun down at approximately 11,000 g for 30 seconds at ambient temperature. Typically 100 ml of supernatant were added to an equal volume of precipitating solution provided in the kit and the subsequent supernatant assayed as described in the technical bulletin supplied by Amersham with the C3a des Arg assay RIA kit. Each sample was assayed in duplicate and useful dilutions of the supernatant, to ensure that sample counts were on the standard curve, were found to be 1/50-1/100. EDTA or Futhan were not used in any solutions or tubes as suggested in the technical bulletin. Each sample was counted for 1 minute on an LKB-Wallac 1272 ClinigammaCLINIGAMMA®, automated gamma ray counter for measuring radioactivity. Data was processed using the RiaCalc program for RIA assays as supplied with the Clinigamma. The data was computed essentially as described in the Amersham technical bulletin with the standard curve constructed by non-linear regression fit to the data. The miniaturised assay was carried out essentially as described above but using smaller total volumes for the activation of serum. ______________________________________Volumes of samples added serum inhibitor Zymosan A______________________________________Normal Assay 79 ml 20 ml 21 mlMiniaturised Assay 26.3 ml 6.7 ml 7 ml______________________________________ In the minaturised assay, after activation, typically 25 ml of the sample were precipitated. The assay kit reagent additions were reduced from 50 ml to 10 ml which enabled the assay to be carried out in a U-bottom microtitre plate containing separate detachable wells. The assay was then carried out as described in the technical bulletin using the adjusted volumes until the last dilution in isotonic saline. In this instance 200 ml of saline were added and the plate spun at approximately 2500 g for 12 mins at 4° C. The supernatants from each well were carefully removed by aspiration and the precipitate was washed with a further 300 ml of isotonic saline. The plate was then spun again at about 2500g for 5 mins, 4° C. and the supernatant was discarded. Wells were then counted for 10 mins each on the ClinigammaCLINIGAMMA®, automated gamma ray counter for measuring radioactivity. The data was processed as above. To determine the % inhibition of maximum activation at each inhibitor concentration, a number of controls were carried out with each experiment. These included maximum activation (A) i.e. serum+zymosan A only, background activation (B) i.e. serum +buffer only, and background activation in the presence of inhibitor (C) i.e. serum +inhibitor only. The background activation was generally subtracted from the maximum activation. Similarly the background activation in the presence of inhibitor was subtracted from the value of activated serum in the presence of inhibitor. These values could then be used to determine the % inhibition at each inhibitor concentration. using the following formula: ##EQU1## where D is the value of activation of serum in the presence of inhibitor and zymosan A. The IC50 is defined as the concentration of inhibitor required to reduce maximum activation by 50%. (b) Classical Pathway Activation by Heat Aggregated IgG Activation of the classical pathway by IgG was performed as follows. Human γ-globulin (Sigma, catalogue number G-4386) was made 14 mg/ml in 0.1M Hepes/0.15M NaCl pH 7.4 and heated at 60° C. for 1 hour. Samples of heat aggregated IgG were then stored as small aliquots at -80° C. until required. Serum was activated using heat aggregated IgG using the same volumes as described for the zymosan A normal or miniaturised assay. Preincubation of inhibitor with serum was for 15 mins at 37° C. followed by addition of the heat aggregated IgG. Incubation was continued for a further 45 mins at 37° C. The samples were then assayed directly for C3a levels using either the normal or miniaturised assay. (xviii) C5a RIA Assay Activation of complement pathways can be followed by measuring the release of the anaphylatoxin C5a and its breakdown product C5a des Arg. Both products can be measured using a competitive radio-immuno assay purchased from Amersham International plc, U. K., (human complement C5a des Arg 125 !assay, code RPA 520). The alternative pathway of complement was activated with zymosan A, as described for the C3a RIA assay (Method (xvii)). The assay was carried out in the miniaturised form as described for the C3a assay using the reagents provided in the C5a des-Arg RIA kit. References in the Examples to amino acid numbering relate to the corresponding residues of mature CR1 protein. EXAMPLE 1 Construction of Plasmid pDB1010-D11 Encoding SCR 1+2 Residues 2-125 of SEQ ID NO: 29) General Points A DNA sequence for SCR 1+2 (residues 2-125 of SEQ ID NO: 29) corresponding to amino acid 1 and ending at amino acid 124 of mature human complement receptor 1 was designed such that the 5' end of the gene contained an NdeI site. This site comprises an ATG codon to give the initiating methionine required for the start of mRNA translation and places the gene an optimum distance from the Shine-Dalgarno ribosome binding sequence of pBROC413. The 3' end of the gene finished on two stop codons followed by a HindIII site. Restriction endonucleases that do not cut pBROC413 and that were commercially available were identified. The sequences of the restriction sites recognised by the endonucleases were translated into all three reading frames. The sites that contained rarely used codons for E. coli expression were discarded. The remaining sites were matched with the DNA coding for SCR 1+2 (SEQ ID NOS: 1-8). If the restriction site could be fitted into the DNA sequence so as to preserve the coding sequence and not add a rarely used codon, the DNA sequence was altered to include this restriction site. 10 unique restriction sites were so identified and incorporated. To enable intracellular expression of protein in E. coli, an ATG codon was added to the 5' end of the gene immediately preceding the codon for the first amino acid of mature CR-1. The codon ATG is part of the NdeI restriction site which can be used for cloning into vectors such as pBROC413. The codon corresponding to proline 124 of mature CR-1 has been changed to one encoding glutamine, which also encompasses an EcoRI site. (a) Construction of Plasmid Oligonucleotides coding for SCR 1+2 (SEQ ID NOS: 1-8) (Table 1; 1-8) were synthesised as 4 complementary pairs of 87-101 mers that could be ligated in a unique fashion via complementary 8 bp overhangs between the pairs of oligonucleotides. The four complementary pairs of oligonucleotides were designated Pair A (SEQ ID NOS: 1 and 2) (oligos 1+2)-, Pair B (SEQ ID NOS: 3 and 4) (oligos 3+4), Pair C (SEQ ID NOS: 5 and 6) (oligos 5+6) and Pair D (SEQ ID NOS: 7 and 8) (oligos 7+8). Pair A which corresponded to the 5' end of the gene contained an NdeI restriction site overhang and Pair D contained a HindIII restriction site overhang at the 3' end. All oligonucleotides apart from 1 and 2 were purified on Pharmacia Mono QMONO Q®, anion-exchange resin (Pharmacia), columns prior to use. Oligonucleotide 2 of pair A and oligonucleotide 7 of pair D were kinased before annealing with their unkinased complementary oligonucleotides 1 and 8 respectively. Oligonucleotides pairs B (SEQ ID NOS 3 and 4) and C (SEQ ID NOS: 5 and 6) were annealed first and then kinased. The kinased oligonuleotide pairs were ligated Pair A (approx. 0.1 μg) to Pair B (approx. 0.2 μg) and Pair C (approx. 2 μg) to Pair D (approx. 4 μg). The ligated oligonucleotides (A+B) were in turn ligated to (C+D) to form the gene coding for SCR 1+2 (SEO ID NOS: 1-8). The DNA coding for SCR 1+2 (SEQ ID NOS: 1-8) was amplified by PCR using two oligonucleotides (Table 1; 15 and 16) complementary to the two strands of DNA. Both oligonucleotides contained 5' unmatched ends that contained 6 bp of random sequence followed by the sequence of either NdeI or HindIII restriction sites followed by 18 bp complementary to the gene. Following PCR, a band of approximately 400 bp was visualised on horizontal agarose gel electrophoresis, which was excised and purified on DEAE NA45 membranes. The DNA was then cut with NdeI and HindIII before ligating into pBROC413 that had been cut with the same enzymes. The vector was transformed into E. coli HB 101 made competent with calcium chloride. Mini-plasmid preparations were made and the plasmid DNA was analysed by digestion with NdeI and HindIII. Plasmids containing the correct sized insert, were further subjected to restriction mapping with EcoRI, HpaI, KpnI and SmaI. The plasmids that displayed the correct restriction maps were analysed by DNA sequencing of both strands across the gene coding for SCR 1+2 (SEQ ID NOS: 1-8). Plasmid pDB1010-D11 was identified as having the correct sequence across the gene coding for SCR 1+2 (SEQ ID NOS: 1-8). EXAMPLE 2 Construction, Expression, Purification, Folding and Formulation of MQ1→K196 of CR-1 (SEQ ID NO: 27) (SCR 1+2+3) General Points The DNA coding for SCR 1+2+3 (SEQ ID NO: 33) was constructed by ligating DNA coding for SCR 1+2 (SEQ ID NOS: 1-8) (Example 1a) to DNA encoding SCR 3 (SEQ ID NO: 32). General points relating to SCR 3 coding unit (SEQ ID NO: 32) are presented in Example 9. The SCR 3 coding unit (SEQ ID NO: 32) corresponding to amino acid 122 and ending at amino acid 196 of mature CR1 (residues 123-197 of SEQ ID NO: 29), was designed such that 5' end of the unit contained the EcoRI site at the junction of SCR's 2 & 3 as well as an NdeI site 5' to the EcoRI site. The 3' end of the unit finished on two stop codons followed by a HindIII site. The plasmids containing the SCR 3 coding unit (SEQ ID NO: 32) and the SCR 1+2 coding unit (SEQ ID NOS: 1-8) were digested with EcoRI and HindIII. The SCR 3 coding unit (SEQ ID NO: 32) was isolated and inserted downstream of the SCR 1+2 coding unit (SEQ ID NOS: 1-8) in the EcoRI/HindIII-cut SCR 1+2-containing plasmid, to give a plasmid containing the SCR 1+2+3 coding unit (SEQ ID NO: 33), which corresponds to amino acids 1 to 196 of mature CR1 (residues 2-197 of SEQ ID NO: 29). The addition of the SCR 3 coding unit (SEQ ID NO: 32) through the EcoRI site, converts the codon corresponding to a glutamine at position 124 back to the authentic amino acid (proline) that is found in CR1. (a) Construction of Plasmid pDB1013-5-4 encoding SCR 1+2+3 (SEQ ID NO: 27) Three pairs of oligonucleotides (Table 1; 9-14) encompassing the SCR3 coding sequence (SEQ ID NO: 32) were synthesised. The oligonucleotides were first annealed as pairs (9, 10; 11,12; 13,14) and the middle pair kinased thus allowing the three pairs to be ligated together via 8 base pair overlapping sequences. The 5' end of this trimeric molecule was designed to be complementary to NdeI digested DNA and the 3' end to HindIII digested DNA. This enabled the trimer to be cloned into NdeI/HindIII digested pBROC413 generating pBROC435 (FIG. 2). The identity of pBROC435 was checked by restriction enzyme analysis and confirmed by DNA sequencing. Plasmid DNA from pBROC435 and pDB1010-D11 (Example 1) were both cut with EcoRI and HindIII; the EcoRI/HindIII band of pBROC435 coding for SCR 3 was purified on an DEAE NA45 membrane as was the cut vector pDB1010-D11. The SCR 3 coding unit (SEQ ID NO: 32) was then ligated into pDB1010-D11 to generate pDB1013-5 which was then transformed into calcium chloride competent E. coli HB101. The resulting colonies were analysed by mini-plasmid preparation of DNA followed by restriction mapping. One of the colonies, termed pDB1013-5-4 (FIG. 2), contained the SCR 1+2+3 coding unit (SEQ ID NO: 33). This plasmid was then analysed for expression of the gene product. (b) Expression of SCR 1+2+3 (SEQ ID NO: 27) pDB1013-5-4 was transformed into calcium chloride competent E. coli BL21 (DE3) and resulting colonies analysed by restriction digestion of mini-plasmid DNA preparations. Single colonies were inoculated into universals containing 10 ml of L broth or NCYZM medium and 50 mg/ml ampicillin and allowed to grow overnight at 37° C., 220 r.p.m. The overnight cultures (typically 5 ml) were used to inoculate each of 2 L conical flasks containing 500 mls of NCYZM medium, 150 mg/ml ampicillin; cultures were grown at 37° C., 220 r.p.m. until A 600 was 0.5 absorbance units. Cultures were induced with 1 mM isopropylthioβ-D-galactoside (IPTG) and allowed to grow a further 3 hours under the same conditions. The cultures were centrifuged (approx. 8000 g/10 min) and the supernatants discarded. The cell pellets were stored at -40° C. L broth was 1% (w/v) Bactotryptone, 0.5% (w/v) Bactoyeastextract, 0.5% (w/v) NaCl. NCYZM media was L-broth containing 0.1% (w/v) casamino acids and 0.2%(w/v) MgSO 4 .7H 2 O, pH 7.0. (c) Isolation of Solubilised Inclusion Bodies Frozen cell pellet of E.coli BL21 DE3 (pDB1013-5-4) (1 liter culture) prepared in a similar way to that described in Example 2b. was allowed to thaw at 4° C. for 2 h and was then resuspended in 50 mM Tris/50 mM NaCl/1 mM EDTA/0.1 mM PMSF pH 8.0 (33 ml). The suspension was transferred to a 100 ml glass beaker and sonicated (Heat Systems--Ultrasonics W380; 70 Watts, 50×50% pulse, pulse time=5 sec.). The sonicate was immediately centrifuged (6000 g/4° C./10 min) and the supernatant was discarded. The pellet, containing the inclusion bodies, was resuspended in 20 mM Tris/8 M urea/50 mM 2-mercaptoethanol/1 mM EDTA/0.1 mM PMSF pH 8.5 (100 ml) and left static at room temperature (approx. 23° C.) for 1 h. The resulting solution was centrifuged (approx. 2000 g at 4° C. for 10 min) to remove any material that had failed to solubilise. The supernatant of this spin was retained at -40° C. as the solubilised inclusion body product. (d) Purification of SCR +2+3 (SEQ ID NO: 27) from the Solubilised Inclusion Body A column (i.d., 16 mm; h, 10 mm) of S-Sepharose Fast Flow was prepared and connected into an FPLC (Pharmacia) system. The column was equilibrated with 20 mM Tris/8M urea/1 mM EDTA/50 mM 2-mercaptoethanol pH 8.5. 10 ml of thawed, solubilised inclusion body, prepared as described in Example 2c, was applied to the column and washed through with equilibration buffer. The column was then developed with a linear gradient to 1M NaCl (in equilibration buffer) followed by rinses with 1M NaCl and 2M NaCl (also in equilibration buffer). All the chromatography was at 1.0 ml min -1 and at room temperature. Analysis by SDS PAGE/protein staining of the fractions collected during the chromatography indicated that virtually all the SCR 1+2+3 polypeptide (SEQ ID NO: 27) had absorbed to the column and had been dissociated by the 1M NaCl-containing buffer. The appropriate fractions were stored at -40° C. Subsequent assay for protein content of the peak fraction using the Bradford protein assay and a bovine serum albumin standard showed it contained 2.8 mg protein. (e) Folding S-Sepharose--purified SCR 1+2+3 (SEQ ID NO: 27) that had been purified in a similar way to that described in Example 2d and stored at -40° C. was thawed and 0.4 ml buffer-exchanged into 0.05 M formic acid using Sephaex G25 (P10). The absorbance at 280 nm of the buffer-exchanged solution was determined as 0.52, and, using I=34000 and appropriate correction factors for dilution, the protein concentration of the original preparation (prior to buffer-exchange) was calculated to be 0.6 mg/ml. Based on this figure, 1.7 ml S-Sepharose-purified protein was diluted with 0.85 ml 20 mM Tris/8M urea/50 mM 2-mercaptoethanol/1M NaCl pH 8.5 to give a 0.4 mg/ml solution, on which the folding was carried out. Folding was effected by a series of dilutions, using cold diluent at all times. At t=0 h, 0.8 ml SCR1+2+3 (SEQ ID NO: 27) (0.4 mg/ml) was added to 0.8 ml 20 mM Tris/1M urea/5 mM EDTA/3 mM 2-mercaptoethanol pH 8.0 (`diluent`) in a 30 ml polystyrene universal container. The solution was mixed thoroughly by gentle swirling and left static, capped, in a cold room (approx. 2° to 3° C.). At 1 h, 1.6 ml diluent was added and mixed. At 2 h, 3.2 ml diluent was added and mixed. At 4 h, 6.4 ml diluent was added and mixed. The solution was left a further 20 h in the cold room, then ultrafiltered (YM5, Amicon Ltd) to approx. 1.4 ml. This was buffer-exchanged into 0.1M NH 4 HCO 3 (2.5 ml) using Sephadex G25 (PD 10) in the cold room. The eluate was aliquoted and was stored at -40° C. or lyophilised. The product containing SCR 1+2+3 (SEQ ID NO: 27) was analysed by SDS PAGE, followed by protein staining. In both non-reduced and reduced (with 2-mercaptoethanol 5% (v/v)) samples there was a single major band. The molecular weight of the reduced band, compared to reduced protein standards of known M r , was approx. 24,000. The non-reduced protein (band) had a slightly faster mobility than the reduced protein (band). The product was analysed in a functional haemolytic assay utilising antibody-sensitized sheep erythrocytes (Method (xvi)). The product showed concentration-dependent inhibition of the complement--mediated lysis of the erythrocytes with an IH50 around 0.4 mg/ml. (f) Folding Preparation, folding, processing and analysis were carried out exactly as described in Example 2e except (1) the diluent for the folding was 20 mM ethanolamine (pH 10.0) (2) the folded solution was ultrafiltered to a final volume of 1.55 ml, and (3) the IH50 figure was determined as about 0.6 mg/ml. (4) the recovery of product was approx. 100 per cent. (g) Determination of N-terminal sequence of SCR 1+2+3 (SEQ ID NO: 27) 1 ml samples of growing E.coli BL21 (DE3) containing plasmid pDB1013-5-4 were removed 3 hours post-induction with 1 mM IPTG as described in Example 2b. These samples were spun in an eppendorf centrifuge and the resultant pellets each resuspended in 200ml of reducing buffer (100 mM Tris pH6.8/200 mM dithiothreitol/4% ( w /v) SDS/2% ( w /v) bromophenol blue and 20% ( v /v) glycerol and boiled for 5 minutes. 25 ml samples were applied to a 14% polyacrylamide gel. When the electrophoresis was complete the proteins were transferred to a Problott membranePROBLOTT MEMBRANE®, a membrane for receiving protein by electrophoretic transfer (electroblotting)-(Applied Biosystems) using a Sartoblot electroblotting apparatus (Sartorius) at 0.8 mA/cm 2 for 1 hour 40 mins using CAPS (3- cyclohexylamino!-1-propanesulphonic acid) transfer buffer. After transfer the ProBlott membranePROBLOTT MEMBRANE®, a membrane for receiving protein by electrophoretic transfer (electroblotting),-was stained (0.1 % ( w /v) Coomassie Blue R-250/40% ( v /v) methanol/1% v /v acetic acid) for 20 seconds and destained using 50% ( v /v) methanol. A band corresponding to a M r approx 23,000 protein was excised and the N-terminal sequence determined using a Blott cartridge in an Applied Biosystems 477A Protein Sequencer. The sequence of the first 20 amino acids was found to agree with the predicted sequence except that residue 3 could not be identified by the sequencing protocol used. EXAMPLE 3 Expression and Purification of SCR 1+2+3 (SEQ ID NO: 27) from a Fermentation Vessel (a) Fermentation of E. coli Harbouring the Plasmid pDB1013-5-4 E coli BL21 (DE3): pDB 1013-5-4 was recovered from storage in liquid nitrogen by thawing a vial containing 1 ml of the culture and this was used to inoculate 100 ml of seed medium (NCYZM) containing ampicillin at 75 mg/ml. The primary and secondary seed stage fermentations were carried out in plain 500 ml shake flasks batched with 100 ml aliquots of NCYZM medium. The primary and secondary seed fermentation conditions were as follows: 37° C., 230 rpm on an orbital shaker with a 50 mm throw. The primary seed incubation time was 2 hours. The primary seed culture was used to inoculate secondary seed fermentation medium at 0.1% (v/v). The secondary seed was incubated for 14.5 hours. Two 15 liter Biolafitte fermenters were each batched with 10 liters of NCYZM medium and 0.01% (v/v) Dow Coming DC1510 antifoam. The vessels plus media were sterilised using steam to 121 ° C. for 45 minutes. Ampicillin sterilised by microfiltration (0.2 mm) was added aseptically to the vessel media to a final concentration of 150 mg/ml. The fermenters were inoculated at a level of 3% (v/v) from pooled secondary seed culture. The final stage incubation conditions were 37° C., agitator 400 rpm, airflow 5 l/min (0.5 vvm). The final stage fermentations were sampled aseptically pre-inoculation, at 0 hours and thence every half hour. The samples were monitored for increases in optical density (600 nm). When the OD600 was ≧0.5, IPTG was added to give a final concentration of 1 mM. The fermentations were incubated for a further 3 hours. The cells were recovered by centrifugation using 7000 g for 25 minutes. The total cell yield (wet weight) was 49.8 grammes. (b) Inclusion Body Isolation. Inclusion bodies from 23 g (wet weight) cell pellet were isolated and solubilised essentially as described in Example 2. (c) Purification of denatured SCR 1+2+3 (SEQ ID NO: 27) The volume of solubilised inclusion body from Example 3b was approx. 800 ml. To this viscous solution was added SP-Sepharose FF (100 ml gel bed, water washed and suction dried). The mixture was swirled vigorously and left static for 1 h at room temperature. The supernatant was decanted and stored at -40° C. The remaining slurry was resuspended to a uniform suspension and poured into a glass jacket (i.d., 41.5 mm) and allowed to settle into a packed bed. This packed bed was connected into a low pressure chromatography system at 4° C. and equilibrated with 0.02M Tris/8M urea/0.05M 2-mercaptoethanol/0.001 M EDTA pH 8.5. When the A 280 of the eluate had minimised, the buffer was changed (step-wise) to the equilibration buffer additionally containing 1M NaCl. A single A 280 peak was eluted, in a volume of 90 ml (equivalent to approx. 1 Vt). The solution was clear and colourless and was estimated, by A 280 determination of a buffer-exchanged sample (using an ε=25,000), to contain about 300 mg target protein. By SDS PAGE followed by protein stain the target protein was the major band present. The 90 ml product was stored at -40° C. (d) Folding and Further Purification 18 ml of the above product (nominal 60 mg) was diluted with 12 ml 0.02M Tris/8M urea/1M NaCl/0.05M 2-mercaptoethanol pH 8.5. The product (30 ml) was added as 5 ml aliquots at 1 min intervals to 930 ml freshly prepared, cold 0.02M ethanolamine/0.001M EDTA, with swirling, and left static for 1 h/4° C. Then reduced glutathione was added to 1 mM (by addition of 9.6 ml 0.1M GSH) and oxidised glutathione was added to 0.5 mM (by addition of 9.6 ml 0.05M GSSG). The solution was clear and was left static in the cold for approx. 70 h. The solution was then ultrafiltered using a YM10 membrane to a final retentate volume of about 10 ml; this retentate was cloudy. It was mixed with 90 ml 0.1M NaH 2 PO 4 /1M (NH 4 ) 2 SO 4 pH 7.0 (Buffer A) at room temperature and then centrifuged at 4000 rpm for 20 min. The supernatant was decanted and SCR 1+2+3 protein (SEQ ID NO: 27) isolated by chromatography of the supernatant on Butyl Toyopearl 650 S. The column of Butyl Toyopearl (Vt˜12 ml) was equilibrated with Buffer A. The 100 ml supernatant was applied to the column and the column washed with Buffer A. It was then developed with a linear gradient of 100% Buffer A to 100% 0.1M NaH 2 PO 4 pH 7.0. All the chromatography was at room temperature at approx. 30 cmh -1 . A major A 280 peak was eluted during the gradient. Fractions spanning the peak were analysed by SDS PAGE followed by protein stain. The most concentrated fractions of the peak contained essentially pure SCR 1+2+3 (SEQ ID NO: 27) and were active in the haemolytic assay (Method (xvi)) (IH 50 ˜0.3 mg/ml). They were stored at -40° C. EXAMPLE 4 Formulation of Butyl Toyopearl Purified SCR 1+2+3 (SEQ ID NO: 27). Batches of SCR 1+2+3 (SEQ ID NO: 27) that had been expressed, folded and purified in similar ways to batches described in Examples 2 and 3 and further purified by ammonium sulphate treatment and Butyl Toyopearl chromatography essentially as described in Example 3d were formulated into a useable product as follows. Three such Butyl Toyopearl products were pooled to give a volume of about 31 ml. All 31 ml were buffer-exchanged into 0.05M formic acid (prepared using 0.2μ m-filtered `MilliQ` water) using a column of Sephadex G25. All the chromatography was at 50 cmh -1 at 4° C. The eluate from the column was monitored at 280 nm and the Vo fraction was collected as a single fraction. The bulk of this fraction was lyophilised in aliquots. Analysis of the Vo pool prior to lyophilisation by both SDS PAGE/stain and C8 reverse phase HPLC showed it to be essentially pure target protein. The pool demonstrated anti-haemolytic activity (IH 50 approx. 0.3 mg/ml) and the endotoxin content was low (<1 ng/mg). One of the lyophilised aliquots was shown to be soluble at 10 mg ml 31 1 in phosphate-buffered saline and showed complement inhibitory activity in the haemolytic assay (Method xvi); the IH50 was 0.3 μg/ml. Another of the lyophilised aliquots was examined to determine the disulphide bridge pattern. All six correct (as predicted on the basis of a consensus SCR motif) disulphides were detected. EXAMPLE 5 Effect of SCR 1+2+3 (SEQ ID NO: 27) on IgG-Mediated Activation of the Classical Pathway of Complement, as Measured by C3a Release Inhibition of heat aggregated IgG activated serum was carried out as described in Method (xvii). Heat aggregated IgG activates the classical pathway of complement. Different concentrations (typically 4-1000 mg/ml) of inhibitor were incubated with serum in the presence of heat aggregated IgG and the % inhibition of activation at each concentration was determined. The IC50 of SCR 1+2+3 (SEQ ID NO: 27) was determined as approximately 22 mg/mil indicating that SCR 1+2+3 (SEQ ID NO: 27) can inhibit the classical pathway of complement. EXAMPLE 6 Effect of SCR 1+2+3 (SEQ ID NO: 27) on Zymosan A-Mediated Activation of the Alternative Pathway of Complement, as Measured by Following C3a release. Inhibition of zymosan A activated serum was carried out as described in Method (xvii). Different concentrations of SCR 1+2+3 (SEQ ID NO: 27) (typically in the range 1-1000 μg/ml) were incubated with serum in the presence of zymosan A and the % inhibition of activation at each concentration was determined. From several different experiments the IC50 was determined as 20-40 mg/ml indicating that SCR 1+2+3 (SEQ ID NO: 27) can inhibit the alternative pathway of complement. EXAMPLE 7 Effect of SCR 1+2+3 (SEQ ID NO: 27) on Zymosan A-Mediated Activation of the Alternative Pathway of Complement, as Measured by C5a Release. Inhibition of zymosan A activated serum was carried out as described in Method (xvii) and assayed as described in Method (xviii). Different concentrations of SCR 1+2+3 (SEQ ID NO: 27) (typically in the range 4-700 mg/ml) were incubated with serum in the presence of zymosan A and the % inhibition of activation at each concentration was determined. From several different experiments the IC50 was determined as approximately 20-30 mg/ml, indicating that SCR 1+2+3 (SEQ ID NO: 27) can inhibit the alternative pathway of complement. EXAMPLE 8 Endotoxin Content Determination of Purified, Folded and Formulated SCR 1+2+3 (SEQ ID NO: 27) A batch of final product SCR 1+2+3 (SEQ ID NO: 27) was prepared essentially as described in Example 4 above and was measured for endotoxin content using a method based on the gel-clot reaction of limulus amoebocyte lysate (LAL) (Atlas Bioscan Ltd.). The sensitivity of the assay was 0.125 EU/ml and this was checked by titration against a doubling dilution series prepared from standard E. coli endotoxin supplied with the LAL kit. 10-fold dilutions of˜1.3 mg/ml SCR 1+2+3 protein stock (SEQ ID NO: 27) were tested in quadruplicate for their effect on LAL by adding 10 ml of sample to 10 ml LAL. After 1 h at 37° C. the mixtures were tested for either clotting or remaining liquid. (Solutions that contain at least 0.125 EU endotoxin will clot this LAL preparation.) After taking into account the results of simultaneous tests designed to test for interference, it was concluded that the endotoxin content of the SCR 1+2+3 protein preparation (SEQ ID NO: 27) was<12.5 EU/ml, equivalent to approx.<1 ng/mg protein. EXAMPLE 9 Expression, Folding, Purification, and Formulation of MR122 ->K196 of CR-1 (SEQ ID NO: 28) (SCR 3) General Points The coding sequence (SEQ ID NO: 32) for SCR 3 (SEQ ID NO: 28) corresponding to amino acid 122 and ending at amino acid 196 of mature human complement receptor 1 was designed such that the 5' end of the gene contained an NdeI restriction endonuclease site. This site comprises an ATG start codon to give the initiating methionine required for the start of MRNA translation and allows the placement of the gene an optimum distance from the Shine-Dalgarno ribosome binding site of pBROC413. This codon is followed immediately by the gene coding for SCR 3 (SEQ ID NO: 32) starting with a codon for arginine 122 of mature human complement receptor 1. The 3' end of the gene finishes with a codon for lysine 196 followed by two stop codons followed by a HindIII site. The DNA coding for SCR3 (SEQ ID NO: 32) was modified for optimum codon usage in E. coli as described in the methods. The gene was also altered to incorporate unique restriction endonuclease sites. This was carried out in the following way. Restriction endonucleases that do not cut pBROC413 and were commercially available were identified. The DNA sequence of these restriction endonuclease sites was then translated into all three reading frames and the codon usage examined. Sites that contained codons that are rarely used by E. coli were discarded. The remaining sites were examined for their translated sequence and if that sequence matched with SCR 3 (SEQ ID NO: 28), the restriction site was incorporated into the sequence. (a) Construction of Plasmid pBROC435 Encoding SCR 3 (SEQ ID NO: 28) The construction of pBROC435 is described in Example 2a (b) Expression of SCR 3 (SEQ ID NO: 28) from pBROC435 pBROC435 was transformed by electroporation into E.coli BL21(DE3) and resulting colonies analysed by restriction digestion of mini-plasmid DNA preparations. Single colonies were inoculated into universals containing 10 ml of L broth or NCYZM medium and 50-75 mg/ml ampicillin and allowed to grow overnight at 37° C., 220 r.p.m. Typically 4 ml of overnight cultures were used to inoculate each of 2 L conical flasks containing 500 ml of NCYZM medium, 150 mg/ml ampicillin; cultures were grown at 37° C., 230r.p.m. until A 600 was 0.5 absorbance units. Cultures were induced with 1 mM IPTG and allowed to grow a further 3 hours under the same conditions. The cultures were centrifuged (approx, 8000 g/10 min) and the supernatants discarded. The cell pellets were stored at -40° C. (c) Isolation of Solubilised Inclusion Bodies The frozen cell pellet of E. coli (from 3 1 growth culture in NCYZM) described in Example 9b was allowed to thaw at room temperature for 2 h and was then resuspended in 50 mM Tris/50 mM NaCl/1 mM EDTA/0.1 mM PMSF pH 8.0 (90 ml). The suspension was transferred to a 200 ml glass beaker and sonicated (Heat Systems--Ultrasonics W380; 70 Watts, 50×50% pulse, pulse time=5 sec.). The sonicate was immediately centrifuged (6000 g/4° C./10 min) and the supernatant was discarded. The pellet, containing the inclusion bodies, was resuspended in 20 mM Tris/8M urea/50 mM 2-mercaptoethanol/1 mM EDTA/0.1 mM PMSF pH 8.5 (300 ml) with gentle pipetting to mix. After mixing, the solution was left static at room temperature (approx. 23° C.) for 1 h. The resulting solution was centrifuged (2000 g at 40° C. for 10 min) to remove material that failed to solubilise. The supernatant of this spin was retained at -40° C. as the solubilised inclusion body product. (d) Purification of SCR3 (SEQ ID NO: 28) from the Solubilised Inclusion Body A column (i.d., 32 mm; h, 32 mm) of Q-Sepharose Fast Flow (Pharmacia) was prepared and equilibrated with 20 mM Tris/8M urea/50 mM 2-mercaptoethanol pH 9.0. 200 ml of thawed, solubilised inclusion body, prepared as in Example 9c, was applied to the column and washed through with equilibration buffer. The column was connected to an FPLC system and developed via a stepwise gradient of 0.1, 1.0, 2.0M NaCl (also in equilibriation buffer). All chromatography was at 2.0 ml min -1 and at room temperature. Analysis by SDS PAGE/protein staining of the fractions collected during the chromatography indicated that virtually all the SCR3 (SEQ ID NO: 28) did not bind to the column. Many other proteins had absorbed to the column however and had been dissociated by the 0.1M and 1M NaCl-containing buffers. The purity of SCR3 (SEQ ID NO: 28) in the unadsorbed fraction was estimated to be about 80%. (e) Folding of SCR3 (SEQ ID NO: 28) Q-Sepharose-purified SCR3 (SEQ ID NO: 28) that had been purified as described in Example 9d and stored at -40° C. was thawed and was folded by a series of dilutions, using cold diluent. At t=0, 100 ml 20 mM Tris/1M urea/5mM EDTA/3 mM 2-mercaptoethanol pH 8.0 (diluent) were added to 100 ml SCR3 (SEQ ID NO: 28). At this stage the solution was turbid in appearance. The solution was mixed thoroughly by gentle swirling and left static, capped, in a cold room (2°-3° C.). At 1 h, 200 ml diluent was added and mixed, final volume=400 ml. At 2 h, 400 ml diluent was added and mixed, final volume=800 ml. At 4 h 800 ml of diluent was added and mixed, final volume=1.6 L. The solution was left for a further 20 h in the cold room. The solution now appeared clear, and it was stored at -40° C. in aliquots. (f) Formulation of SCR3 (SEQ ID NO: 28) 50 ml of SCR3 (SEQ ID NO: 28) prepared as in Example 9e were thawed and ultrafiltered to 3.5 ml using a 2000 Da cut-off membrane (Amicon). 2.5 ml of the concentrate was buffer-exchanged into 0.1M NH 4 HCO 3 (3.0 ml) using Sephadex G25 (PD 10). Subsequent analysis for protein content using the molar extinction coefficient of 11000 showed this sample contained approx 0.24 mg/ml. Analysis of this material by SDS PAGE/protein staining indicated that the protein was about 80% pure. Samples reduced with 2-mercaptoethanol had a lower electrophoretic mobility suggesting the presence of disulphide bonds in SCR3 (SEQ ID NO: 28). Analysis of this sample in the haemolytic assay (Method (xvi)) showed it had an IH50 of approx. 10-20 mg/ml. (g) Determination of N-terminal Sequence of Expressed SCR3 (SEQ ID NO: 28 200 ml SCR3 (SEQ ID NO: 28) prepared and formulated in 0.1M NH 4 HCO 3 as in Example 9f was precipitated with 800 ml cold acetone in a cardice/ethanol bath for 60 mins. The sample was then spun in an Eppendorf centrifuge (approx 10,000 g/20 mins) and the resultant pellet resuspended with heating in sample buffer containing 5% (v/v) 2-mercaptoethanol. 30 ml samples were electrophoresed on a 4 to 20% SDS-containing polyacrylamide gradient gel. When the electrophoresis was complete the proteins were transferred to a ProBlott membranePROBLOTT MEMBRANE®, a membrane for receiving protein by electrophoretic transfer (electroblotting)(Applied Biosystems) using an electroblotting apparatus at 200 mA for 2 h using CAPS in 10% methanol/90%H 2 O (v/v)) transfer buffer. After transfer the ProBlott membranePROBLOTT MEMBRANE®, a membrane for receiving protein by electrophoretic transfer (electroblotting), was stained (0.1%(w/v) Coomassie Blue), destained, rinsed and air dried according to the manufacturer's instructions. Sections of the membrane were excised and used for N-terminal sequencing. The sequence of the first 20 amino acids of the major band was as expected for SCR3 (SEQ ID NO: 28) with the exception of residue 5, which could not be identified. (h) Preparation, Folding and Formulation of SCR3 (SEQ ID NO: 28) Preparation and folding were carried out exactly as described in Example 9a-9e. 400 ml of folded SCR3 (SEQ ID NO: 28) was ultrafiltered through a 30 KDa cut-off filter (Amicon) at 4° C. Samples of the ultrafiltrate were processed in two ways. 1. 50 ml were ultrafiltered using a 2 KDa cut-off membrane to a final volume of 3.5 ml and buffer-exchanged into 0.05M formic acid (6.7 ml) using Sephadex G25 (PD10) columns. The total amount of SCR3 (SEQ ID NO: 28) estimated by the absorbance at 280 nm was 0.6 mg. Analysis by SDS PAGE/protein staining indicated that the protein had a purity of about 95%. The sample was freeze-dried and stored at -40° C. 2. 100 ml of the ultrafiltrate were adjusted to pH 5.5 with HCl. The sample was applied to a Mono S column (1 ml) at 1.5 ml min -1 and washed through with equilibration buffer (2 mM Tris.HCl pH 5.5). The column was then developed with a step gradient of 0.1, 1.0 and 2.0M NaCl (also in equilibration buffer). All remaining chromatography was at 1.0 ml min -1 and at room temperature. Analysis by SDS PAGE/protein staining of the fractions collected during the chromatography demonstrated that the major band dissociated at 1M NaCl contained SCR3 (SEQ ID NO: 28) at about 95% purity. EXAMPLE 10 Expression, Folding, Purification and Formulation of MR122-S253 of CR-1 (SEQ ID NO: 31) (SCR 3+4) (a) Construction of Plasmid pDB1019 encoding SCR 3+4 (SEQ ID NO: 31) The DNA coding for SCR 3+4 (SEQ ID NO: 31) was constructed from the plasmids pBROC435 (Example 2) and pDB 1018-1 (Example 11) which carry the genes coding for SCR 3 (SEQ ID NOS: 9-14) and SCR 1+2+3+4 (SEQ ID NOS: 1-8, 9-14 and 21-26) respectively. The SCR 4 coding unit (SEQ ID NOS: 21-26) was excised from pDB 1018-1 and ligated onto the end of the SCR 3 coding unit (SEQ ID NOS: 9-14) in pBROC435. pDB 1018-1 was digested with SpeI and HindIII and separated on a 1% agarose gel. The band which codes for SCR 4 (SEQ ID NOS: 21-26) (˜245 bp) was excised from the gel and purified using the QIAEX extraction kit. Plasmid pBROC435 was also cut with SpeI and HindIII, separated on 1% agarose, excised from the agarose and purified with the QIAEX kit. The SCR 4 coding DNA (SEQ ID NOS: 21-26) was then ligated into the cut pBROC435 plasmid to give pDB1019. This DNA was used to transform E. coli HB 101 made competent with CaCl 2 . Transformants were analysed by restriction analysis using EcoRI and HindIII. Clones carrying the correct sized insert were used for expression studies. (b) Expression of SCR 3+4 (SEQ ID NO: 31) from pDB1019-1C pDB1019 was transformed into E. coli BL21(DE3) made competent with CaCl 2 and the resulting colonies were analysed by restriction digestion of mini-plasmid DNA preparations. Plasmid pDB1019-1C was identified as carrying the correct sized insert. Single colonies of E. coli BL21(DE3) carrying pDB1019-1C were inoculated into ten universals containing 10 mls of NCYZM medium and 75 mg/ml ampicillin and allowed to grow overnight at 37° C., 240 r.p.m. The overnight cultures were then used to inoculate eight 2 L conical flasks (5 ml/flask) containing 500 ml of NCYZM medium, 150 mg/ml ampicillin. Cultures were grown at 37° C., 240 r.p.m. until A 600 was 0.5 absorbance units. At this point cultures were induced with 1 mM IPTG and allowed to grow a further 3 hours under the same conditions. The cultures were centrifuged (approx. 8000 g/10 mins) and the supernatants were discarded. The cell pellets were stored at -40° C. (c) Isolation, Purification, Folding and Formulation of SCR 3+4 (SEQ ID NO: 31 The methods used generally follow those described earlier for the preparation of SCR 1+2+3 -- (SEQ ID NO: 27). Isolation of solubilised inclusion bodies from cell pellet derived from 21 culture was carried out as described in Example 2c. The volume of solubilisate was 200 ml. Some of the contaminating (host) E. coli proteins were removed from the preparation by adsorption onto S-Sepharose, either in a batch process or by column chromatography, using systems similar to those described in Example 2d. The protein present in the unadsorbed fractions was shown by SDS PAGE/stain to contain significant amounts of SCR 3+4 protein (SEQ ID NO: 31). About half of these fractions were ultrafiltered using a YM1 (Amicon) membrane to approx. 35 to 40 ml. This retentate was estimated to contain about 0.3 mg protein/ml (based on A 280 determination of a buffer-exchanged sample, using ε=21,000). 10.5 ml of the retentate was mixed with 325 ml cold 20 mM ethanolamine and left static at 4° C. for 1 hour. Then reduced glutathione was added to 1 mM (by addition of 3.4 ml 100 mM GSH) and oxidised glutathione was added to 0.5 mM (by addition of 3.4 ml 50 mM GSSG). The solution was mixed and left static at 4° C. for ˜72 h. The solution was clear. The solution was then ultrafiltered using a YM1 membrane to a retentate of 5 ml. The retentate was divided in two and buffer-exchanged into either 20 mM ethanolamine or 50 mM formic acid using Sephadex G25 (PD10 columns). Analysis of the formic acid SCR 3+4 product (SEQ ID NO: 31) by reverse phase HPLC and by SDS PAGE followed by protein staining showed only one major protein species (>90% pure). The protein concentration was estimated to be 0.3 mg/ml using A 280 determinations. The product was active in the haemolytic assay (Method (xvi)); the IH50 value was approx. 30 mg/ml EXAMPLE 11 Construction, Expression, Folding, Purification and Formulation of MQ1-S253 of CR-1 (SEQ ID NO: 29) (SCR 1+2+3+4) General Points Two constructs were prepared by making a plasmid encoding SCR 1+2 (SEQ ID NOS: 1-8), incorporating SCR3 (SEQ ID NOS: 9-14) and finally adding SCR4 (SEQ ID NOS: 21-26). The two constructs encoded consensus SCR1 to 4 (SEQ ID NO: 29) and the R235H mutation of SCR1 to 4 (SEQ ID NO: 30) (Example 12). A plasmid containing the SCR 1+2+3+4 coding unit (SEQ ID NOS: 1-8, 9-14 and 21-26) was constructed by adding the DNA encoding SCR 4 (SEQ ID NOS: 21-26) onto the construct coding for SCR 1+2+3 (SEQ ID NO: 33) (Example 2). For convenience of DNA manipulation, the SCR 4 DNA coding unit (SEQ ID NOS: 21-26) was made by synthesising the DNA encoding the last 17 amino acids of SCR 3 (residues 176-192 of SEQ ID NO: 29) followed by the DNA coding for the linker region followed by SCR 4 (residues 198-253 of SEQ ID NO: 29). This DNA started at the SpeI site of the SCR 1+2+3 coding construct (SEQ ID NO: 33) which corresponds to T175 of mature CR-1 followed by the DNA coding for the linker region followed by SCR 4 (residues 198-253 of SEQ ID NO: 29) ending on the codon corresponding to S253 followed by two stop codons and a HindIII site. As for the previous constructs the DNA encoding SCR 4 (SEQ ID NOS: 21-26) was altered for optimised codon usage and restriction sites as previously described in Example 1. This unit of DNA was ligated to the plasmid coding for SCR 1+2+3 (SEQ ID NO: 27) which had been cut with SpeI and HindIII to give a construct coding for SCR 1+2+3+4 (SEQ ID NO: 29). (a) Construction of Plasmid pDB1018 encoding SCR 1+2+3+4 (SEQ ID NO: 29) Oligonucleotides (Table 1; oligos 21-26 coding for SCR4 (SEQ ID NOS: 21-26) were synthesised as 3 complementary pairs of 68-90 mers that could be ligated in a unique fashion via complementary 8 bp overhangs between the pairs of oligonucleotides. The 3 complementary pairs of oligonucleotides were designated Pair E (oligos 21, 22) (SEQ ID NOS: 21 and 22), Pair F (oligos 23, 24) (SEQ ID NOS: 23 and 24) and Pair G (oligos 25, 26) (SEQ ID NOS: 25 and 26). Pair E which corresponds to the 5' end of the gene contained a SpeI restriction site overhang and Pair G contained a Hind III restriction site overhang at the 3' end. All oligonucleotides apart from 22 and 24 were purified by electrophoresis through a denaturing polyacrylamide gel followed by reverse phase chromatography (C 18 ). Oligonucleotides 22, 23, 24 and 25 (SEQ ID NOS: 22-25) were kinased before annealing to their complementary oligonucleotides. The oligonucleotides were ligated pair E (SEQ ID NOS: 21 and 22) to pair F (SEQ ID NOS: 23 and 24) to pair G (SEQ ID NOS: 25 and 26) to form the gene coding for part of SCR3 (residues 126-192 of SEQ ID NO: 29) and the whole of SCR4 (residues 198-253 of SEQ ID NO: 29) which for convenience will be called the SCR4 -- gene (SEQ ID NOS: 21-26) in the subsequent text. The DNA coding for SCR4 (SEQ ID NOS: 21-26) was initially amplified by PCR using two oligonucleotides (Table 1; oligos 17 and 18) (SEQ ID NOS: 17 and 18) complementary to the two strands of DNA. Both oligonucleotides contained 5' unmatched ends that contained 6bp of random sequence followed by the sequence of either SpeI (oligo 17) or HindIII (oligo 18) restriction sites followed by 18 bp complementary to the gene. Following PCR a band of approximately 250 bp was visualised on horizontal agarose gel electrophoresis, which was excised and purified on DEAE NA45 membranes. This DNA was used for a second PCR amplification using nested primers that had been moved inwards by four nucleotides at their 5' ends (Table 1; oligo 19, oligo 20). These oligo's incorporated the SpeI and HindIII restriction sites but now only had 2 nucleotides beyond the end of each restriction site. Following PCR a band of approx. 250 bp was visualised on horizontal agarose gel electrophoresis. This band was excised and purified using the QIAEX agarose gel extraction kit. The DNA for SCR 4 (SEQ ID NOS: 21-26) was blunt-end ligated to itself following kinasing. The multimers formed were visualized by horizontal agarose gel electrophoresis and the bands excised and purified using the QIAEX agarose gel extraction kit. The DNA was then cut with SpeI and HindIII and ligated into pDB1013-5-4 that had been cut with the same enzymes to produce pDB1018 (FIG. 3). The vector was transformed into E.coli HB101 made competent with calcium chloride. Mini-plasmid preparations were made and plasmid DNA analysed by digestion with Nde I, Hind III, Stu I, Spe I and Kpn I. The plasmids with the correct restriction maps were analysed by DNA sequencing of both strands across the gene encoding SCR4 (SEQ ID NOS: 21-26). Two plasmids were selected for further study. pDB1018-1, which encoded MQ1-S253 (SEQ ID NO: 29) (consensus SCR1 to 4) and pDB1018-6, which encoded the R235H mutant of MQ1-S253 (SEO ID NO: 30). The amino acid sequences of the two polypeptides encoded by pDB 1018-1 and pDB 1018-6 are shown in Table 2. Taking the first residue as being the A of the ATG initiating codon, DNA sequencing revealed that residue 600 of pDB1018-6 had been altered from G→A. This is a silent mutation and does not alter the amino acid at this position. (b) Expression of MQ1-S253 (SEQ ID NO: 29) from pDB1018-1 pDB 1018-1, constructed as described in Example 11a, was transformed into calcium chloride competent E.coli BL21(DE3). Single colonies were inoculated into universals containing 10 ml of NZCYM medium and 75 mg/ml ampicillin and allowed to grow overnight at 370° C., 230 r.p.m. 3 ml of overnight culture were used to inoculate each of 8×2 liter conical flasks containing 500 ml of NZCYM medium, 150 mg/ml ampicillin; cultures were grown at 37° C., 230 r.p.m. until A 600 reached 0.5 absorbance units. The cultures were induced with 1 mM 1PTG and allowed to grow for a further 3 hours under the same conditions. The cultures were centrifuged (approx. 7000 g/10 mins/4° C.) and the supernatants discarded. The cell pellets were stored at -40° C. (c) Isolation of Solubilised Inclusion Bodies The frozen cell pellets of E.coli BL21(DE3) (pDB1018-1) each equivalent to 1 liter of culture prepared as described in Example 11b were allowed to thaw at 0-4° C. over 2 hours. The pellets were resuspended in 50 mM Tris/50 mM NaCl/1 mM EDTA/0.1 mM PMSF pH 8.0; 30 ml for each liter pellet. Each suspension was transferred to a 100 ml glass beaker and sonicated (Heat systems--Ultrasonics W380; 70 Watts, 50×50% pulse, pulse time=5 seconds). The sonicates were pooled and immediately centrifuged (6,000 g/4° C./10 mins) and the supernatant discarded. The pellet containing the inclusion bodies was resuspended in 20 mM Tris/8M urea/50 mM 2-mercaptoethanol/1 mM EDTA/0.1 mM PMSF pH 8.5 (400 ml), thoroughly mixed and left static at room temperature (approx. 23° C.) for 1 hour. (d) Purification of MQ1-S253 (SEQ ID NO: 29) from the Solubilised Inclusion Body. 30 ml of S-Sepharose FF that had been washed with deionised water and suction dried was added to the inclusion body solution described in Example 11c, and vigorously shaken for 30 seconds. The S-Sepharose mixture was left static at room temperature (23° C.) for 1.5 hours and then the supernatant was discarded. The remaining slurry was packed into a column (id, 4.1 cm). The column was equilibrated using 20 mM Tris/8M urea/50 mM 2-mercaptoethanol/1 mM EDTA/0.1 mM PMSF pH 8.5 at 60 cmh -1 , 4° C. MQ1-S253 protein (SEQ ID NO: 29) was eluted using the equilibration buffer containing 1M NaCl. Analysis by SDS PAGE/protein staining of the fractions collected during the chromatography indicated that virtually all the target protein had adsorbed to the column and had been dissociated by the 1M NaCl wash. The appropriate fraction was stored at -40° C. (e) Folding and Formulation Based on a molar extinction coefficient of 25,000 and A 280 values determined in 50 mM formic acid, 60 mg of the S-Sepharose purified unfolded protein described in Example 11d was folded and formulated as follows : 8.0 ml of solution (equivalent to 60 mg protein) was diluted with 22 ml cold 20 mM Tris/8M urea/50 mM 2-mercaptoethanol/1M NaCl/1 mM EDTA/0.1 mM PMSF pH8.5, to give 30 ml of a 2.0 mg/ml solution. The 30 ml was diluted rapidly with constant stirring into 930 ml cold (0°-4° C.) freshly prepared 20 mM ethanolamine. The solution was left static at 0°-4° C. for 1 hour. Reduced glutathione was added to 1 mM (by addition of 9.6 ml of 100 mM stock) and then oxidised glutathione was added to 0.5 mM (by addition of 9.6 ml of 50 mM stock). The solution was left static at 0°-4° C. for a further 48 hours and then ultrafiltered using a stirred cell (Amicon) and a YM10 membrane (Amicon, nominal 10,000 Da molecular weight cut-off) to approx. 29 ml. The ultrafiltered retentate was buffer exchanged into 50 mM formic acid using Sephadex G25 (i.d., 26 mm; h, 245 mm Vt, 123 ml) and a flow rate of 50 cmh -1 to a final volume of 40 ml. Using a molar extinction coefficient of 25,000 for the protein 51 mg of protein was recovered. The purified protein gave an IH 50 value (see Method xvi) of approximately 2 mg/ml. (f) Further Purification and Formulation of SCR1+2+3+4 (SEQ ID NO: 29). Folded SCR1+2+3+4 (SEQ ID NO: 29) (nominal 25 mg) in 50 mM formic acid prepared essentially as described in Example 11e was lyophilised. The lyophilisate was resolubilised in 20 mM ethanolamine (10 ml) to give a cloudy solution. The 10 ml were then added to 90 ml 0.1M NaH 2 PO4/1M (NH4) 2 SO4 pH 7.0, thoroughly mixed, and then clarified by centrifugation (4000 rpm/20 min). The supernatant (100 ml) was decanted and was chromatographed on Butyl Toyopearl (exactly as described for SCR1+2+3 in Example 3d). The peak A 280 fractions, eluting at about 100% of the 1M NaCl-containing buffer, were pooled and buffer-exchanged using Sephadex G25 into 50 mM formic acid. The Vo pool (29.5 ml) was lyophilised in aliquots. The purity of the protein was assessed by SDS PAGE followed by protein staining and by C8 reverse-phase HPLC; the protein was estimated to be>95% pure. One of the lyophilised aliquots was resolubilised to 4 mg protein/ml in 0.1M Hepes/0. 15M NaCl pH7.4. The product showed activity in the haemolytic assay (Method (xvi)); the IH50 was calculated to be 0.3 μg/ml. Another of the lyophilised aliquots was examined to determine the disulphide bridge pattern using proteolytic digestion and peptide identification by amino acid sequencing. All eight correct (as predicted on the basis of a consensus SCR motif) disulphides were detected. EXAMPLE 12 Expression, Isolation, Folding and Formulation of Purified MQ1-S253 (R235H) (SEQ ID NO: 30) (a) Expression of MQ1-S253 (R235H) (SEQ ID NO: 30) pDB1018-6 (prepared as described in Example 11a) was transformed into calcium chloride competent E. coli BL21(DE3). Single colonies were inoculated into universals containing 10 mls of NCYZM medium and 50 mg/ml ampicillin and allowed to grow overnight at 37° C., 220 r.p.m. The overnight cultures (approx. 3 ml) were used to inoculate each of 2 l conical flasks containing 500 ml of NCYZM medium, 150 mg/ml ampicillin; cultures were grown at 37° C., 220 r.p.m. until A 600 was 0.5 absorbance units. Cultures were induced with 1 mM IPTG and allowed to grow a further 3 hours under the same conditions. The cultures were centrifuged (approx. 8000 g/10 min/4° C.) and the supernatants discarded. The cell pellets were stored at -40° C. (b) Isolation of Solubilised Inclusion Bodies and Purification of Unfolded MQ1-S253 (R235H) (SEQ ID NO: 30) Frozen cell pellet of E. coli BL21 DE3 (pDB1018-6) (2 liter culture) described in Example 12a was allowed to thaw at 4° C. for 2 h and was then resuspended in 50 mM Tris/50 mM NaCl/1 mM EDTA/0.1 mM PMSF pH 8.0 (66 ml). The suspension was transferred to a 250 ml glass beaker and sonicated (Heat Systems--Ultrasonics W380; 70 Watts, 30×50% pulse time=5 seconds). The sonicate was immediately centrifuged (6000 g/4° C./10 min) and the supernatant was discarded. The pellet, containing the inclusion bodies, was resuspended by vigorous swirling in 20 mM Tris/8 M urea/50 mM 2-mercaptoethanol/1 mM EDTA/0.1 mM PMSF pH 8.5 (200 ml) and left static at room temperature (approx. 23° C.) for 1.5 h. Water-washed, suction-dried S-Sepharose (equivalent to approx. 25 ml packed bed volume) was added to the 200 ml solubilised inclusion body and the mixture swirled vigorously to wet the Sepharose beads thoroughly. The mixture was left static at room temperature for 1 h. The supernatant (approximately 150 ml) was decanted and discarded. The slurry remaining was resuspended to a uniform suspension by swirling and then poured into a 32 mm (i.d.) glass jacket and allowed to settle. The gel bed was connected into a low pressure chromatography system and was equilibrated with 20 mM Tris/8M urea/1 mM EDTA/50 mM 2-mercaptoethanol pH 8.5 at 4° C. until the A 280 baseline stabilised. The column was then developed with equilibration buffer containing 1M NaCl. All the chromatography was at approx. 1 ml min -1 . Analysis by SDS PAGE/protein staining of the fractions collected during the chromatography indicated that most of the MQ1-S253 (R235H) polypeptide (SEQ ID NO: 30) had adsorbed to the column and had been dissociated by the 1M NaCl-containing buffer wash and that the purity of the material was about 90%. A sample of the pool was buffer-exchanged into 50 mM formic acid using Sephadex G25 column to allow some assays to be carried out. Amino acid analysis of the pool of the MQ1-S253 (R235H) (SEQ ID NO: 30)-containing fractions gave a total protein content of about 120 mg. (c) Folding and Formulation of SCR 1+2+3+4 (R235H) (SEQ ID NO: 30) Based on A 280 values and a molar extinction coefficient of 25,000 for the protein in 50 mM formic acid, 20 mg of the S-Sepharose-purified unfolded protein described in Example 12b was folded and formulated as follows. 5.2 ml protein solution (equivalent to 20 mg) was diluted with 4.8 ml cold 20 mM Tris/8M urea/50 mM 2-mercaptoethamol/1M NaCl pH8.5, to yield 10 ml of a 2.0 mg/ml solution. The 10 ml was diluted rapidly with constant stirring into 310 ml freshly prepared, cold (approx. 0°-4° C.) 20 mM ethanolamine. The solution was left static at 0°-4° C. for 1 h. Then reduced glutathione was added to 1 mM (by addition of 2.56 ml 125 mM GSH). Then oxidised glutathione was added to 0.5 mM (by addition of 3.2 ml 50 mM GSSG). The solution was left static, in the cold room (˜2°-3° C.), for a further 48 h. The solution was then ultrafiltered using a stirred cell and a YM10 (nominal 10,000 molecular weight out-off) membrane to approximately 2 ml. The solution was clear. The ultrafiltration cell was washed with approximately 2 ml 20 mM ethanolamine and the wash and the ultrafiltered retentate were pooled to give a final volume of 3.7 ml. 2.2 ml of this solution was buffer-exchanged into 3.2 ml 50 mM formic acid using Sephadex G25 (PD10). The buffer-exchanged material was regarded as the product, and it was stored at -40° C. Analysis of an aliquot of the product showed it contained 1.6 mg protein/ml, that by SDS PAGE under non-reducing conditions a single major band of M r ˜28,000 was present and that N-terminal sequencing of the band (MQXNAPE) was consistent with the expected sequence. In addition the preparation gave an IH 50 value (see Method (xvi)) of approximately 1 mg/ml. IN THE FIGURES FIG. 1 Plasmid pBROC413. bla indicates the ampicillin resistance gene, .O slashed.10 the T7 RNA polymerase promoter and rbs the ribosome binding site. Arrows for .O slashed.10 and bla give the direction of transcription. The polylinker site has been indicated. The plasmid is not drawn to scale and the size is approximate. FIG. 2 illustrates the construction from pDB1010-D11 and pBROC435 of plasmid pDB1013-5-4 coding for SCR 1+2+3 (SEQ ID NO: 27). Plasmid sizes are approximate and are not drawn to scale. FIG. 3 illustrates the construction from pDB1013-5-4 of pDB1018 coding for SCR 1+2+3+4 (SEQ ID NO: 29). Plasmid sizes are approximate and are not drawn to scale. REFERENCES USED IN EXAMPLES OR GENERAL METHODS 1. Chen G-F. and Inouye M. (1990). Suppression of the negative effect of minor arginine codons on gene expression; preferential usage of minor codons within the first 25 codons of the E. coli genes. Nuc.Acids.Res. 18 (6): 1465-1473. 2. Dacie, J. V. & Lewis S. M., (1975) Practical haematology Fifth Edition, Ed. Churchill Livingstone, Edinburgh & New York pp 3-4 3. Devereux, Haeberli and Smithies (1984). A comprehensive set of sequence analysis programmes for the vax. Nuc.Acids.Res. 12(1): 387-395 4. Hourcade D., Miesner D. R., Atkinson J. P. & Holers V. M. (1988). Identification of an alternative polyadenylation site in the human C3b/C4b receptor (complement receptor type 1) transcriptional unit and prediction of a secreted form of complement receptor type 1. J. Exp. Med. 168 1255-1270 5. Low B. (1968). Proc.Natl.Acad.Sci.USA 60:160 6. Sambrook J., Fritsch E. F. and Maniatis J. (1989). Molecular Cloning: A Laboratory Manual 2nd Edition. Cold Spring Harbour Laboratory Press 7. Studier F. W. and Moffat B. A. (1986). J.Mol.Biol 189: 113 8. Tabor S. (1990). Expression using the T7 RNA polymerase/promoter system. In Current Protocols in Molecular Biology (F. A. Ausubel, R. Brent, R. E. Kingston, .D. D. Moore, J. G. Seidman, J. A. Smith and K. Struhl, eds) pp. 16.2.1-16.2.11 Greene Publishing and Wiley-Interscience, New York TABLE 1 OLIGO 1=SEQ ID NO:1 OLIGO 2=SEQ ID NO:2 OLIGO 3=SEQ ID NO:3 OLIGO 4=SEQ ID NO:4 OLIGO 5=SEQ ID NO:5 OLIGO 6=SEQ ID NO:6 OLIGO 7=SEQ ID NO:7 OLIGO 8=SEQ ID NO:8 OLIGO 9=SEQ ID NO:9 OLIGO 10=SEQ ID NO:10 OLIGO 11=SEQ ID NO:11 OLIGO 12=SEQ ID NO:12 OLIGO 13=SEQ ID NO:13 OLIGO 14=SEQ ID NO:14 OLIGO 15=SEQ ID NO:15 OLIGO 16=SEQ ID NO:16 OLIGO 17=SEQ ID NO:17 OLIGO 18=SEQ ID NO:18 OLIGO 19=SEQ ID NO:19 OLIGO 20=SEQ ID NO:20 OLIGO 21=SEQ ID NO:21 OLIGO 22=SEQ ID NO:22 OLIGO 23=SEQ ID NO:23 OLIGO 24=SEQ ID NO:24 OLIGO 25=SEQ ID NO:25 OLIGO 26=SEQ ID NO:26 TABLE 2 Amino Acid Sequences of Proteins, Deduced from the cDNA Constructs. The full deduced sequence of the proteins of the Examples are given as follows: MQ1→K196 of CR-1 is given in SEQ ID NO: 27 MR122→K196 of CR-1 is given in SEQ ID NO: 28 MQ1-S253 of CR-1 is given in SEQ ID NO: 29 The R235H mutant of MQ1-S253 of CR-1 is given in SEQ ID NO: 30 MR122-S253 of CR-1 is given in SEQ ID NO: 31. Coding DNA for SEQ ID NO: 28 is given in SEQ ID NO: 32 Coding DNA for SEQ ID NO: 27 is given in SEQ ID NO: __________________________________________________________________________SEQUENCE LISTING(1) GENERAL INFORMATION:(iii) NUMBER OF SEQUENCES: 33(2) INFORMATION FOR SEQ ID NO:1:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 87 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:1:TATGCAGTGCAACGCTCCGGAATGGCTGCCGTTCGCGCGCCCGACCAACCTGACTGATGA60ATTTGAGTTCCCGATCGGTACCTACCT87(2) INFORMATION FOR SEQ ID NO:2:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 93 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:2:CGTAGTTCAGGTAGGTACCGATCGGGAACTCAAATTCATCAGTCAGGTTGGTCGGGCGCG60CGAACGGCAGCCATTCCGGAGCGTTGCACTGCA93(2) INFORMATION FOR SEQ ID NO:3:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 101 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:3:GAACTACGAATGCCGCCCGGGTTATAGCGGCCGCCCGTTTTCTATCATCTGCCTGAAAAA60CTCTGTCTGGACTGGTGCTAAGGACCGTTGCCGACGTAAAT101(2) INFORMATION FOR SEQ ID NO:4:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 101 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:4:ACGACAAGATTTACGTCGGCAACGGTCCTTAGCACCAGTCCAGACAGAGTTTTTCAGGCA60GATGATAGAAAACGGGCGGCCGCTATAACCCGGGCGGCATT101(2) INFORMATION FOR SEQ ID NO:5:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 101 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:5:CTTGTCGTAATCCGCCAGATCCGGTTAACGGCATGGTGCATGTGATCAAAGGCATCCAGT60TCGGTTCCCAAATTAAATATTCTTGTACTAAAGGTTACCGT101(2) INFORMATION FOR SEQ ID NO:6:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 101 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:6:CCAATCAGACGGTAACCTTTAGTACAAGAATATTTAATTTGGGAACCGAACTGGATGCCT60TTGATCACATGCACCATGCCGTTAACCGGATCTGGCGGATT101(2) INFORMATION FOR SEQ ID NO:7:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 94 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:7:CTGATTGGTTCCTCCAGCGCTACATGCATCATCTCTGGTGATACTGTCATTTGGGATAAT60GAAACACCGATTTGTGACCGAATTCAGTAATAAA94(2) INFORMATION FOR SEQ ID NO:8:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 90 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:8:AGCTTTTATTACTGAATTCGGTCACAAATCGGTGTTTCATTATCCCAAATGACAGTATCA60CCAGAGATGATGCATGTAGCGCTGGAGGAA90(2) INFORMATION FOR SEQ ID NO:9:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 72 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:9:TATGCGAATTCCGTGTGGTCTGCCGCCGACCATCACCAACGGTGATTTCATCTCTACCAA60TCGCGAGAATTT72(2) INFORMATION FOR SEQ ID NO:10:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 78 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:10:CATAGTGAAAATTCTCGCGATTGGTAGAGATGAAATCACCGTTGGTGATGGTCGGCGGCA60GACCACACGGAATTCGCA78(2) INFORMATION FOR SEQ ID NO:11:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 85 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:11:TCACTATGGTTCTGTGGTGACCTACCGCTGCAATCCGGGTAGCGGTGGTCGTAAGGTGTT60TGAGCTCGTGGGTGAGCCGTCCATC85(2) INFORMATION FOR SEQ ID NO:12:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 85 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:12:GTGCAGTAGATGGACGGCTCACCCACGAGCTCAAACACCTTACGACCACCGCTACCCGGA60TTGCAGCGGTAGGTCACCACAGAAC85(2) INFORMATION FOR SEQ ID NO:13:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 79 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:13:TACTGCACTAGTAATGACGATCAAGTGGGCATCTGGAGCGGCCCGGCACCGCAGTGCATC60ATCCCGAACAAATAATAAA79(2) INFORMATION FOR SEQ ID NO:14:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 75 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:14:AGCTTTTATTATTTGTTCGGGATGATGCACTGCGGTGCCGGGCCGCTCCAGATGCCCACT60TGATCGTCATTACTA75(2) INFORMATION FOR SEQ ID NO:15:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 30 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:15:GAGACTCATATGCAGTGCAACGCTCCGGAA30(2) INFORMATION FOR SEQ ID NO:16:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 30 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:16:GTCAGCAAGCTTTTATTACTGAATTCGGTC30(2) INFORMATION FOR SEQ ID NO:17:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 30 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:17:ATCGTAACTAGTAACGACGATCAAGTGGGC30(2) INFORMATION FOR SEQ ID NO:18:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 30 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:18:ATGACTAAGCTTTTATTATGAGCAGCTCGG30(2) INFORMATION FOR SEQ ID NO:19:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 32 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:19:TAACTAGTAACGACGATCAAGTGGGCATCTGG32(2) INFORMATION FOR SEQ ID NO:20:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 33 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:20:CTAAGCTTTTATTATGAGCAGCTCGGGAGTTCC33(2) INFORMATION FOR SEQ ID NO:21:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 81 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:21:CTAGTAACGACGATCAAGTGGGCATCTGGAGCGGCCCGGCACCGCAGTGCATCATCCCGA60ACAAATGCACGCCGCCAAATG81(2) INFORMATION FOR SEQ ID NO:22:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 85 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:22:GTTCTCCACATTTGGCGGCGTGCATTTGTTCGGGATGATGCACTGCGGTGCCGGGCCGCT60CCAGATGCCCACTTGATCGTCGTTA85(2) INFORMATION FOR SEQ ID NO:23:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 90 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:23:TGGAGAACGGTATCCTGGTATCTGACAACCGTTCTCTGTTCTCTTTAAACGAAGTTGTAG60AGTTTCGTTGTCAGCCGGGCTTTGTTATGA90(2) INFORMATION FOR SEQ ID NO:24:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 90 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:24:CGGACCTTTCATAACAAAGCCCGGCTGACAACGAAACTCTACAACTTCGTTTAAAGAGAA60CAGAGAACGGTTGTCAGATACCAGGATACC90(2) INFORMATION FOR SEQ ID NO:25:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 72 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:25:AAGGTCCGCGCCGTGTGAAGTGCCAGGCCTTGAACAAATGGGAGCCGGAACTCCCGAGCT60GCTCATAATAAA72(2) INFORMATION FOR SEQ ID NO:26:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 68 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO:26:AGCTTTTATTATGAGCAGCTCGGGAGTTCCGGCTCCCATTTGTTCAAGGCCTGGCACTTC60ACACGGCG68(2) INFORMATION FOR SEQ ID NO:27:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 197 amino acids(B) TYPE: amino acid(D) TOPOLOGY: linear(ii) MOLECULE TYPE: peptide(v) FRAGMENT TYPE: N-terminal(xi) SEQUENCE DESCRIPTION: SEQ ID NO:27:MetGlnCysAsnAlaProGluTrpLeuProPheAlaArgProThrAsn151015LeuThrAspGluPheGluPheProIleGlyThrTyrLeuAsnTyrGlu202530CysArgProGlyTyrSerGlyArgProPheSerIleIleCysLeuLys354045AsnSerValTrpThrGlyAlaLysAspArgCysArgArgLysSerCys505560ArgAsnProProAspProValAsnGlyMetValHisValIleLysGly65707580IleGlnPheGlySerGlnIleLysTyrSerCysThrLysGlyTyrArg859095LeuIleGlySerSerSerAlaThrCysIleIleSerGlyAspThrVal100105110IleTrpAspAsnGluThrProIleCysAspArgIleProCysGlyLeu115120125ProProThrIleThrAsnGlyAspPheIleSerThrAsnArgGluAsn130135140PheHisTyrGlySerValValThrTyrArgCysAsnProGlySerGly145150155160GlyArgLysValPheGluLeuValGlyGluProSerIleTyrCysThr165170175SerAsnAspAspGlnValGlyIleTrpSerGlyProAlaProGlnCys180185190IleIleProAsnLys195(2) INFORMATION FOR SEQ ID NO:28:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 76 amino acids(B) TYPE: amino acid(D) TOPOLOGY: linear(ii) MOLECULE TYPE: peptide(v) FRAGMENT TYPE: internal(xi) SEQUENCE DESCRIPTION: SEQ ID NO:28:MetArgIleProCysGlyLeuProProThrIleThrAsnGlyAspPhe151015IleSerThrAsnArgGluAsnPheHisTyrGlySerValValThrTyr202530ArgCysAsnProGlySerGlyGlyArgLysValPheGluLeuValGly354045GluProSerIleTyrCysThrSerAsnAspAspGlnValGlyIleTrp505560SerGlyProAlaProGlnCysIleIleProAsnLys657075(2) INFORMATION FOR SEQ ID NO:29:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 254 amino acids(B) TYPE: amino acid(D) TOPOLOGY: linear(ii) MOLECULE TYPE: peptide(v) FRAGMENT TYPE: N-terminal(xi) SEQUENCE DESCRIPTION: SEQ ID NO:29:MetGlnCysAsnAlaProGluTrpLeuProPheAlaArgProThrAsn151015LeuThrAspGluPheGluPheProIleGlyThrTyrLeuAsnTyrGlu202530CysArgProGlyTyrSerGlyArgProPheSerIleIleCysLeuLys354045AsnSerValTrpThrGlyAlaLysAspArgCysArgArgLysSerCys505560ArgAsnProProAspProValAsnGlyMetValHisValIleLysGly65707580IleGlnPheGlySerGlnIleLysTyrSerCysThrLysGlyTyrArg859095LeuIleGlySerSerSerAlaThrCysIleIleSerGlyAspThrVal100105110IleTrpAspAsnGluThrProIleCysAspArgIleProCysGlyLeu115120125ProProThrIleThrAsnGlyAspPheIleSerThrAsnArgGluAsn130135140PheHisTyrGlySerValValThrTyrArgCysAsnProGlySerGly145150155160GlyArgLysValPheGluLeuValGlyGluProSerIleTyrCysThr165170175SerAsnAspAspGlnValGlyIleTrpSerGlyProAlaProGlnCys180185190IleIleProAsnLysCysThrProProAsnValGluAsnGlyIleLeu195200205ValSerAspAsnArgSerLeuPheSerLeuAsnGluValValGluPhe210215220ArgCysGlnProGlyPheValMetLysGlyProArgArgValLysCys225230235240GlnAlaLeuAsnLysTrpGluProGluLeuProSerCysSer245250(2) INFORMATION FOR SEQ ID NO:30:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 254 amino acids(B) TYPE: amino acid(D) TOPOLOGY: linear(ii) MOLECULE TYPE: peptide(v) FRAGMENT TYPE: N-terminal(xi) SEQUENCE DESCRIPTION: SEQ ID NO:30:MetGlnCysAsnAlaProGluTrpLeuProPheAlaArgProThrAsn151015LeuThrAspGluPheGluPheProIleGlyThrTyrLeuAsnTyrGlu202530CysArgProGlyTyrSerGlyArgProPheSerIleIleCysLeuLys354045AsnSerValTrpThrGlyAlaLysAspArgCysArgArgLysSerCys505560ArgAsnProProAspProValAsnGlyMetValHisValIleLysGly65707580IleGlnPheGlySerGlnIleLysTyrSerCysThrLysGlyTyrArg859095LeuIleGlySerSerSerAlaThrCysIleIleSerGlyAspThrVal100105110IleTrpAspAsnGluThrProIleCysAspArgIleProCysGlyLeu115120125ProProThrIleThrAsnGlyAspPheIleSerThrAsnArgGluAsn130135140PheHisTyrGlySerValValThrTyrArgCysAsnProGlySerGly145150155160GlyArgLysValPheGluLeuValGlyGluProSerIleTyrCysThr165170175SerAsnAspAspGlnValGlyIleTrpSerGlyProAlaProGlnCys180185190IleIleProAsnLysCysThrProProAsnValGluAsnGlyIleLeu195200205ValSerAspAsnArgSerLeuPheSerLeuAsnGluValValGluPhe210215220ArgCysGlnProGlyPheValMetLysGlyProHisArgValLysCys225230235240GlnAlaLeuAsnLysTrpGluProGluLeuProSerCysSer245250(2) INFORMATION FOR SEQ ID NO:31:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 133 amino acids(B) TYPE: amino acid(D) TOPOLOGY: linear(ii) MOLECULE TYPE: peptide(v) FRAGMENT TYPE: internal(xi) SEQUENCE DESCRIPTION: SEQ ID NO:31:MetArgIleProCysGlyLeuProProThrIleThrAsnGlyAspPhe151015IleSerThrAsnArgGluAsnPheHisTyrGlySerValValThrTyr202530ArgCysAsnProGlySerGlyGlyArgLysValPheGluLeuValGly354045GluProSerIleTyrCysThrSerAsnAspAspGlnValGlyIleTrp505560SerGlyProAlaProGlnCysIleIleProAsnLysCysThrProPro65707580AsnValGluAsnGlyIleLeuValSerAspAsnArgSerLeuPheSer859095LeuAsnGluValValGluPheArgCysGlnProGlyPheValMetLys100105110GlyProArgArgValLysCysGlnAlaLeuAsnLysTrpGluProGlu115120125LeuProSerCysSer130(2) INFORMATION FOR SEQ ID NO: 32:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 243 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO: 32:CATATGCGAATTCCGTGTGGTCTGCCGCCGACCATCACCAACGGTGATTTCATCTCTACC60AATCGCGAGAATTTTCACTATGGTTCTGTGGTGACCTACCGCTGCAATCCGGGTAGCGGT120GGTCGTAAGGTGTTTGAGCTCGTGGGTGAGCCGTCCATCTACTGCACTAGTAATGACGAT180CAAGTGGGCATCTGGAGCGGCCCGGCACCGCAGTGCATCATCCCGAACAAATAATAAAAG240CTT243(2) INFORMATION FOR SEQ ID NO: 33:(i) SEQUENCE CHARACTERISTICS:(A) LENGTH: 605 base pairs(B) TYPE: nucleic acid(C) STRANDEDNESS: single(D) TOPOLOGY: linear(ii) MOLECULE TYPE: DNA(xi) SEQUENCE DESCRIPTION: SEQ ID NO: 33:CATATGCAGTGCAACGCTCCGGAATGGCTGCCGTTCGCGCGCCCGACCAACCTGACTGAT60GAATTTGAGTTCCCGATCGGTACCTACCTGAACTACGAATGCCGCCCGGGTTATAGCGGC120CGCCCGTTTTCTATCATCTGCCTGAAAAACTCTGTCTGGACTGGTGCTAAGGACCGTTGC180CGACGTAAATCTTGTCGTAATCCGCCAGATCCGGTTAACGGCATGGTGCATGTGATCAAA240GGCATCCAGTTCGGTTCCCAAATTAAATATTCTTGTACTAAAGGTTACCGTCTGATTGGT300TCCTCCAGCGCTACATGCATCATCTCTGGTGATACTGTCATTTGGGATAATGAAACACCG360ATTTGTGACCGAATTCCGTGTGGTCTGCCGCCGACCATCACCAACGGTGATTTCATCTCT420ACCAATCGCGAGAATTTTCACTATGGTTCTGTGGTGACCTACCGCTGCAATCCGGGTAGC480GGTGGTCGTAAGGTGTTTGAGCTCGTGGGTGAGCCGTCCATCTACTGCACTAGTAATGAC540GATCAAGTGGGCTCTGGAGCGGCCCGGCACCGCAGTGCATCATCCCGAACAAATAATAAA600AGCTT605__________________________________________________________________________

Soluble polypeptides are provided that comprise no more than three short consensus repeats (SCR) of Complement Receptor 1, and contain SCR3. DNA molecules encoding such soluble polypeptides, as well as methods, vectors and host cells, also are provided.

BACKGROUND OF THE ART [0001] The present invention relates to a prescription prepared for local injections to treat malignant tumors that are commonly seen in birds and mammals. [0002] The general approach for treating a malignant tumor is to incise the lesion or administer an anti-tumor preparation. However, the incision of the lesion to treat cancer may result in contraction of the portion surrounding the lesion and formation of a cicatrix. In such case, the portion surrounding the lesion does not heal properly and form the same healthy tissues as those prior to the incision. The administration of an anti-tumor preparation is performed to basically prevent the enlargement and spreading of the tumor. In this case, it is difficult for the anti-tumor preparation to act directly on the tumor and decrease the size of the tumor or terminate the tumor. SUMMARY OF THE INVENTION [0003] Accordingly, it is an object of the present invention to provide a local injection prescription that disperses a malignant tumor to decrease the size of the tumor or terminate the tumor by directly injecting the prescription to the lesion. [0004] To achieve the above object, the present invention provides a local injection prescription obtained by dissolving an organic compound, which has a lactone nucleus, in lower alcohol and water. The organic compound contains macrolide. Macrolide includes avermectin. [0005] Further, the organic compound includes phenytoin. [0006] The lower alcohol is an alcohol selected from a group of alcohols represented by the molecular formulas of CH 4 O, C 2 H 6 O, C 3 H 8 O, and C 4 H 10 O. [0007] Lactone is a substance defined as an anhydride of hydroxy acid. Further, lactone is dehydrated and condensed to form the lactone nucleus. Macrolide is one example of an organic compound having the lactone nucleus. Macrolide is the generic term for substances that have a frame using a large lactone nucleus as a chemical structure. Further, macrolide is often included in antibiotics obtained from actinomycetes. Avermectin is one type of macrolide. Natural avermectin is obtained by fermenting actinomycete streptomyces avermitilis. Ivermectin is a widely known avermectin and is 2, 2, 2, 3-dihydroavermectin B1. TABLE 1 R1 R2 R3 A1a C2H5 CH3 A1b CH3 CH3 A2a OH C2H5 CH3 A2b OH CH3 CH3 B1a C2H5 H B1b CH3 H B2a OH C2H5 H B2b OH CH3 H [0008] The administration of macrolide as a substance having the lactone nucleus has shown that macrolide has an anti-tumor feature (Japanese Patent Publication Nos. 7-504913 and 7-504914). However, these observations have not focused on local usage. Although, it may be presumed that the local usage of macrolide as a substance having the lactone nucleus is effective, there have been no prescriptions for macrolide. It is possible to solely use a substance having the lactone nucleus. It is also possible to combine and use two or more substances having the lactone nucleus. [0009] It is preferred that the lower alcohol be monatomic alcohol. Diatomic and triatmoic have high viscosity under normal temperatures and can thus not be solely used. It is further preferred that the monatomic alcohol be one of C 1 to C 4 . It is especially preferred that the lower alcohol be methyl alcohol (CH 4 O) and ethyl alcohol (C 2 H 6 O), which have small molecular weights. Although methyl alcohol may be used, the most preferred lower alcohol is ethyl alcohol since the amount used for local injections is small. Since the molecular weight of lower alcohol is small, lower alcohol easily passes through cell membranes. Further, since alcohol has a hydrophilic group and a hydrophobic group, alcohol may be used as a solvent that easily dissolves a substance having the lactone nucleus such as ivermectin. Additionally, alcohol easily permeates portions of cells having a high water content. In addition, ethanol is administered to treat hepar cancer. This is because alcohol inactivates glycogen, which is the energy source for growing cancer cells. Accordingly, alcohol is optimal for use as a prescription in the present invention. [0010] However, the usage of ethyl alcohol having a high purity is painful when the ethyl alcohol permeates cells. It is thus preferred that the ratio of ethyl alcohol be 35 to 70 weight by percent. Once the alcohol permeates cells, pain is eliminated due to the peripheral nervous system blocking effect. [0011] It is preferred that α-amino acid be mixed with the prescription that is prepared in this manner. A functional group of α-amino acid is represented by the following expression. [0012] Examples of α-amino acid are aminobutyric acid, glutamic acid, and theanine. For example, L-aminobutyric acid is represented by the following expression. [0013] The broken lines indicate that the coupling group relative to carbon (C) is located in a direction downward from the plane of the drawing. The same applies hereafter. [0014] From several observations related to antagonism of L-γ-amino acid having tropism with the GABA receptor of a suppressive nerve cell, it may be assumed that the similar L-α-amino acid has a function that enhances the division of cells. Although this function has not yet been completely understood, it may be assumed that L-α-amino acid suppresses the internal respiration effect of a nerve cell and induces apoptosis. Thus, the local use of L-α-amino acid on a malignant tumor enhances the apoptosis of nerve cells. Further, there have been observations that glutamic acid enhances apoptosis as it stagnates at synapse gaps. Thus, the applicant has prescribed α-amino acid, especially, theanine, which has the above functional group, to treat malignant tumors. [0015] Theanine mainly refers to L-theanine and is represented by the following expression as a chemical substance, which is indicated by γ-ethylamino-L-glutamine. [0016] Theanine is a white crystalline powder known as one of the umami components of tea and has no smell. Further, theanine has been observed as preventing high blood pressure and preventing necrosis of cells due to ischemia. [0017] Glutamic acid is mainly α-amino acid, which is widely known as umami component. For example, Glutamic acid is represented by the following expression. [0018] It is preferred that vitamin B6 be mixed with the prescription that is prepared in this manner. [0019] The prescription according to the present invention is used to treat malignant tumors that are commonly seen in birds and mammals. Malignant tumors include sarcoma, adenoma, skin cancer, and the like. Further, mammals include humans. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0020] A preferred embodiment according to the present invention will now be discussed. In the preferred embodiment, IVOMEC (registered trademark of Merial Ltd.) injection, which is used as an anti-parasite preparation, was used as an ivermectin preparation. The preparation includes 10 mg of ivermectin in 1 ml. [0021] Further, 70 percent ethyl alcohol was used as a solvent. [0022] The solubility of IVOMEC injection and ALEVIATIN injection liquid relative to water and 70 percent ethyl alcohol solution was as shown in the following table. [0023] Table 2 IVOMEC Ethyl Alcohol Injection (70% Solution) Water Dissolubility 1 1 ⊚ 1 ⊚ 1 1 ⊚ 1 1 Δ 1 ◯ 1 1 ⊚ 1 1 1 ⊚ 1 ▴ [0024] Prescription 1, which is described below, was used in example 1. Prescription 1 IVOMEC injection 33.33 volume percent 70 percent ethyl alcohol solution 66.66 volume percent [0025] In example 2, as a basic prescription, the above prescription 1 was mixed with prescription 2, which is described below, and prescription 3 was mixed as required. In prescription 3, pyridoxine chloride was used as vitamin B6. Further, prescription 4 was used when necessary. Estrogen was also used since it is known to be especially effective on tumors near the anus of a male dog dipropionic acid estradiol was used as the estrogen. Prescription 2 L-theanine 33.33 volume percent 35 percent ethyl alcohol solution 66.66 volume percent [0026] 1 ml ampul containing 5 mg of dipropionic acid estradiol as an estrogen [0027] In the following examples, the prescriptions were all directly injected to the lesion. However, the prescriptions may also be injected to the artery that supplies the lesion with blood. EXAMPLE 1 [0028] (No. 1) [0029] Prescription 1 was locally injected to treat anus tumor in a large-size dog (male, weighing about 17 kg). An amount of 1.0 cc per injection was administered once a month for a total of six times. The observations were as shown in Table 3. [0030] (No. 2) [0031] Prescription 1 was locally injected to treat mastadenoma and melanoma in a medium-size dog (female, weighing about 13 kg). An amount of 1.0 cc per injection was administered once a month for a total of three times to the mastadenoma. An amount of 1.0 cc per injection was administered once to the melanoma. The observations were as shown in Table 3. [0032] (No. 3) [0033] Prescription 1 was locally injected to treat vaginal sarcoma in a medium-size dog (female, weighing about 10.5 kg). A total of 0.9 cc, 0.3 cc for each of three locations in the sarcoma, was injected and administered once a month for a total of two times. The observations were as shown in Table 3. [0034] (No. 4) [0035] Prescription 1 was locally injected to treat mastocytoma formed near the groin at the right rear leg in a large-size dog (male, weighing about 22 kg). An amount of 1.0 cc per injection was administered once a month for a total of two times. The observations were as shown in Table 3. [0036] (No. 5) [0037] Prescription 1 was locally injected to treat malignant skin histoma formed near the outer side of the left hip in a small-size dog (female, weighing about 4 kg). An amount of 0.2 cc per injection was administered once a month for a total of two times. The observations were as shown in Table 3. [0038] (No. 6) [0039] Prescription 1 was locally injected to treat subcutaneous lymphoma formed in the back of a small-size dog (female, weighing about 3 kg). An amount of 0.2 cc was injected and administered once a month for a total of two times. The observations were as shown in Table 3. [0040] (No. 7) [0041] Prescription 1 was locally injected to treat the right mammary gland for mastadenoma in a large-size dog (female, weighing about 20 kg). The prescription was injected at three locations of the sarcoma. An amount of 0.5 cc was injected at each of the three locations totaling to 1.5 cc per administration once a month for a total of two times. The observations were as shown in Table 3. [0042] (No. 8) [0043] Prescription 3 was locally injected to treat multiple skin cancer and chondrosarcoma of the entire body and the 16th rib in a large-size dog (male, weighing about 18 kg). An amount of 1.0 cc per injection was administered once a month for a total of two times to treat the multiple skin cancer. An amount of 1.0 cc per injection was administered once a month for a total of three times to treat the chondrosarcoma. The observations were as shown in Table 3. [0044] (No. 9) [0045] Prescription 1 was locally injected to treat osteosarcoma in the rear left femur of a medium-size dog (male, weighing about 15 kg). An amount of 1.0 cc per injection was administered once. The observations were as shown in Table 3. [0046] (No. 10) [0047] Prescription 1 was locally injected to treat folliculus pili cellular tumor in the neck and left back-side hip of a large-size dog. An amount of 0.5 cc was injected to the sarcoma at one location and an amount of 0.7 cc was injected to the sarcoma at another location. A total of 1.5 cc was administered once a month for a total of two times. The observations were as shown in Table 3. [0048] (No. 11) [0049] Prescription 1 was locally injected to treat upper jaw sinus sarcoma of the nasal cavity upper jaw sinus in a cat (male, weighing about 3 kg). An amount of 0.5 cc per injection was administered once a month for a total of three times. The observations were as shown in Table 3. [0050] (No. 12) [0051] Prescription 1 was locally injected to treat lymphoma of the rear right groin in a small-size dog (male, weighing about 5 kg) once. The observations were as shown in Table 3. TABLE 3 No. Observation Results 1 Completely healed 2 Both completely healed 3 Completely healed 4 Completely healed 5 Completely healed 6 Completely healed 7 Reduced to ⅔ in first month 8 Both completely healed 9 Completely healed 10 Completely healed 11 Reduced to ½ in fourth month 12 Reduced to ½ in first month EXAMPLE 2 [0052] (No. 1) [0053] A 1 ml ampul of prescription 4 was locally injected to an anus tumor of a middle-size dog (male, weighing about 12 kg). An ampul of prescription 4 mixed with equally mixed prescriptions 1 and 3 was also locally injected. A total amount of 19 ml, which consists of 4.5 ml of prescription 1, 4.5 ml of prescription 3, and 1 ml of prescription 4, per injection was administered once every month for a total of two times. The observations were as shown in Table 4. [0054] (No. 2) [0055] A 0.8 ml ampul of prescription 4 was locally injected to an anus tumor of a middle-size dog (male, weighing about 12 kg). An ampul of prescription 4 mixed with equally mixed prescriptions 1 and 3 was also locally injected. A total amount of 13 ml, which consists of 1.5 ml of prescription 1, 1.5 ml of prescription 3, and 10 ml of prescription 4, per injection was administered once every month for a total of three times. The observations were as shown in Table 4 [0056] (No. 3) [0057] An ampul of prescription 4 was mixed with equally mixed prescriptions 1 and 3 and locally injected to an adiposis cell tumor of a large-size dog (male, weighing about 27 kg). A total amount of 15 ml, which consists of 2.5 ml of prescription 1, 2.5 ml of prescription 3, and 10 ml of prescription 4, per injection was administered once every month for a total of four times. The observations were as shown in Table 4 [0058] (No. 4) [0059] Prescriptions 1 and 3 were equally mixed and locally injected to an adiposis cell tumor of a large-size dog (male, weighing about 40 kg). A total amount of 3 ml, which consists of 1.5 ml of prescription 1 and 1.5 ml of prescription 3, per injection was administered once every month for a total of five times. The observations were as shown in Table 4 [0060] (No. 5) [0061] Prescriptions 1 and 3 were equally mixed and locally injected to an adiposis cell tumor of a middle-size dog (female, weighing about 15 kg). A total amount of 0.8 ml, which consists of 0.4 ml of prescription 1 and 0.4 ml of prescription 3, per injection was administered once every month for a total of four times. The observations were as shown in Table 4 [0062] (No. 6) [0063] Prescriptions 1 and 3 were equally mixed and locally injected to a trichoepithelioma of a small-size dog (female, weighing about 3 kg). A total amount of 5 ml, which consists of 2.5 ml of prescription 1 and 2.5 ml of prescription 3, per injection was administered once every month for a total of two times. The observations were as shown in Table 4 [0064] (No. 7) [0065] Prescriptions 1 and 3 were equally mixed and locally injected to tongue cancer of a honey parrot (male, weighing about 0.4 kg). A total amount of 0.8 ml to 1 ml, which consists of 0.4 ml to 0.5 ml of prescription 1 and 0.4 ml to 0.5 ml of prescription 3, per injection was administered once every month for a total of five times. The observations were as shown in Table 4 TABLE 4 No. Observation Results 1 Tumor diameter reduced from 11.4 mm to 9 mm, volume reduced by ½ 2 Completely healed 3 Reduced to ⅙ by third month 4 Reduced and cut off, tumor did not occur again 5 Completely healed 6 Completely healed 7 Completely healed

A local injection prescription that disperses a malignant tumor to decrease the size of the tumor or terminate the tumor. The local injection prescription is produced by dissolving an organic compound having a lactone nucleus in lower alcohol and water.

BACKGROUND OF THE INVENTION The present invention relates to an apparatus for aiding medical treatments in the blood circulation system of a patient, and in particular for minimizing unintended injury during the treatment, while preventing the circulation of embolic debris, or blood clots, resulting from such treatments. The invention is primarily, but not exclusively, concerned with providing protection in connection with procedures like those for implanting a prosthetic heart valve. The invention utilizes some components disclosed in co-pending Application No. PCT/US2012/61038, the disclosure of which is incorporated herein by reference. There are known procedures, known as transcatheter aortic valve implantation (TAVI), in which a prosthetic heart valve is implanted at the site of a defective native valve, or of a previously implanted defective prosthetic valve. In these procedures, the new prosthetic valve and its guiding structure are introduced by a transcutaneous catheterization technique. For example, the valve and delivery components will be introduced through an incision in the groin or arm and along a blood vessel path to the desired location. Such a procedure is disclosed, for example, in U.S. Pat. No. 7,585,321, which issued to Alan Cribier on Sep. 8, 2009, the entire disclosure of which is incorporated herein by reference. Such valves and their associated guiding devices are marketed by Medtronic and by Edwards Lifesciences, one example of the Edwards valves being marketed under the trade name Sapien. Although such prosthetic valves have been used successfully to provide a replacement for stenotic native heart valves or defective prosthetic valves, it is difficult with known implantation procedures to guide the prosthetic valve to its intended location with sufficient accuracy to avoid traumatizing body tissue around the implantation site. BRIEF SUMMARY OF INVENTION The present invention provides an apparatus and procedure that guide a medical device to an implantation site more accurately. To this end, apparatus according to the invention for carrying out a medical procedure at a site in a patient's blood circulatory system, comprises: a first assembly having an outer diameter and including a device to be implanted in the circulatory system; a tubular sheath surrounding the first assembly and having a first diameter; a hollow tube having a second diameter, distal and proximal ends, and an axial length between the distal and proximal ends, the hollow tube being open at both ends; a pressure transducer, or sensor, disposed at the proximal end of the hollow tube for detecting the pressure in the tube; and a filter that is collapsible into the sheath and expandable upon being deployed out of the sheath for blocking debris and passing blood in the circulatory system, at the site of the medical procedure, the filter having, when deployed, a radially expanded generally conical or frustoconical form with a large diameter end, a small diameter end opposite to the large diameter end, and a side surface extending between the large diameter end and the small diameter end, the filter: comprising a flexible filter material covering the side surface and having pores dimensioned to prevent the passage of debris therethrough while allowing the passage of blood, and having a first opening at the large diameter end, a second opening at the small diameter end, and a third opening in the flexible filter material at the side surface, each opening having a respective diameter, wherein: the diameter of the second opening is substantially equal to the first diameter such that the second opening forms a seal with the sheath when the sheath extends into the filter through the second opening; the hollow tube is insertable, via the distal end, into the filter through the third opening; and the diameter of the third opening is substantially equal to the second diameter. According to preferred embodiments of the invention, the hollow tube is controllable to displace the distal end in directions transverse to the axial length of the hollow tube, the hollow tube is a steerable catheter, the first assembly is a transaortic valve implantation assembly and the device to be implanted in the circulatory system includes a prosthetic valve. A valve implantation procedure according to the present invention may include the following basic steps: the sheath with the retracted filter is introduced into the aorta toward the existing aortic valve and the filter is deployed out of the sheath and allowed to expand radially with the large diameter end facing the existing aortic valve, so that the filter obturates the aorta, preferably upstream of the coronary arteries; the hollow tube is introduced through the third opening to bring its distal end into the region enclosed by the expanded filter, thus blocking the third opening; the tubular sheath is introduced into the aorta and brought to a position in which its distal end is in contact with the first opening of the filter in a manner to assure that debris produced during valve implantation will flow into the tubular sheath and will thus be prevented from flowing into blood vessels communicating with the aorta;. then the distal end of the hollow tube will be displaced across the aorta, as by manipulating the proximal end of the hollow tube or by operating a known steering mechanism associated with the hollow tube, while monitoring the pressure of blood expelled through the existing aortic valve with the aid of the pressure transducer, to bring the distal end of the hollow tube to a desired location where the systolic blood pressure has a maximum value; then the valve implantation assembly is guided, as with the aid of fluoroscopic observation, to cause the prosthetic valve to be advanced alongside the distal end of the hollow tube, when the hollow tube is at the desired location, into the desired implantation position, aligned with the existing aortic valve, and the prosthetic valve is deployed into its desired implanted state; and finally, after a period of time to complete removal of any debris produced during the implantation procedure, all components of the apparatus are removed from the patient's body. By introducing the prosthetic valve at a location corresponding to maximum blood pressure, trauma to the aortic wall, which could generate clots and other debris, is prevented, or at least minimized. According to the invention, there may be provided, together with the filter and blocking device, a stent or stent graft that is preliminarily deployed against the inner wall of the blood vessel, e.g., the aorta, to prevent trauma during introduction of the filter. The components of embodiments of the invention may be conveyed to the treatment site along various blood vessel paths and may be introduced via respectively different paths. For example, if the components are to be positioned in, or pass through, the aorta, one component can be introduced through an incision in a groin and the associated femoral artery, and another component can be introduced through an incision in an arm and the associated subclavian artery. Other introduction locations can also be used. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a cross-sectional view relating to a preferred embodiment of the invention. FIG. 2 is a view, partly in cross section and partly perspective, showing a variation of the preferred embodiment of the invention. FIG. 3 is a cross-sectional detail view of a housing assembly that forms a component of the preferred embodiment and that will be located outside the patient's body. DETAILED DESCRIPTION OF THE INVENTION Details of the invention are shown in FIGS. 1-3 . The illustrated embodiment is composed essentially of: an assembly 60 ( FIG. 2 ) that includes a guide sheath 68 and a valve implantation system 66 ( FIG. 2 ); a filter 80 and associated control wires 82 ; and a small diameter tube, or catheter, 89 ( FIG. 2 ). According to this embodiment, components 60 and 80 , to be described below, are introduced into the aorta along the same path, for example along the femoral artery via an incision made in the groin and then into the aorta, or through a subclavian artery, as described earlier herein. Catheter 89 ( FIG. 2 ) can be introduced along a different path, for example the radial artery of one arm. The components shown in FIG. 1 include a guidewire 62 that is introduced first into the ascending aorta, preferably to a point close to the valve that is to be replaced. Then, guidewire 62 is used to introduce an optional first sheath 64 , the distal end of which is also brought to a point in the ascending aorta, after which guidewire 62 may be withdrawn, and a sheath 68 is introduced into sheath 64 . Sheath 64 is not provided in the embodiment of FIG. 2 and sheath 68 may be brought, while being guided by guidewire 62 , to the desired point in the descending aorta. Sheath 68 houses filter 80 , held in a radially compressed state in sheath 68 . Control wires 82 extend through sheath 68 to a proximal location outside of the patient's body. These wires are used to control the desired relative axial movements between filter 80 and sheath 68 . Filter 80 has a generally cylindrical structure with a small diameter end, at the top of the filter in FIG. 2 , and a large diameter end, at the bottom of the filter in FIG. 2 . According to a presently preferred embodiment of the invention, the large diameter end of filter 80 is formed to have a generally oval shape with a major diameter of about 40 mm and a minor diameter of the order of 30 mm. This allows the lower end of the filter to better conform to the somewhat oval shape of a normal aorta. Of course, the dimensions of filter 80 can be varied to conform to aortas having different sizes, for example in children, and shapes. Filter 80 has a form that may be defined by an outwardly bowed arcuate generatrix of rotation about the longitudinal axis of filter 80 such that the wall of the filter bows outwardly, as shown in FIG. 2 . The framework of the illustrated embodiment is composed of a plurality of wires, or a single wire, including a ring 84 at the small diameter end, a series of longitudinal struts, or ribs, 87 , and a circular or oval nitinol ring 86 extending around the large diameter end. Rings 84 and 86 are bonded, or otherwise secured, to the upper and lower ends, respectively, of ribs 87 . The sides of filter 80 are covered with a suitable filter fabric having a pore size of, for example, 110 μm. Filters composed of a framework of wires of memory metal, e.g. nitinol, can be constructed to present a radial expansion/radial compression ratio of 8:1, or more. Therefore, they can be deployed in a sheath or tube having an inner diameter preferably equal to or greater than ⅛ the desired expanded diameter of the large diameter end of the filter. After sheath 68 has been brought to its desired position in the aorta, close to the defective heart valve, at least approximately where the lower end of filter 80 is to be deployed. Then, sheath 68 can be retracted while filter 80 is held in place by acting on control wires 82 . As filter 80 thus exits the lower end of sheath 68 , the filter expands, due to the properties of the memory metal wires 84 , 86 , 87 , while it is being deployed to bring it to the desired position and configuration to trap debris. Then, sheath 68 may be withdrawn from the patient's body or left in place at a distance from the deployed filter. Filters having a nitinol frame can generally expand radially by a maximum factor of 8 and filter 80 is dimensioned so that in the deployed, or expanded, state, the diameter of the small diameter end can be in the range of 18-26 mm, but can have a smaller diameter if smaller diameter valve implantation systems are developed, and the maximum diameter of the large diameter end can be of the order of 35-40 mm. After filter 80 has been thus deployed sheath 68 can be brought into the position shown in FIG. 2 to form a seal with ring 84 , and a transaortic valve implantation system 66 will be introduced through sheath 68 and then through the small diameter end of filter 80 . Typically, introduction of system 66 will be aided by a guidewire such as guidewire 62 shown in FIG. 1 , which can be introduced in order to guide system 66 past the defective heart valve. System 66 encloses an assembly 70 carrying the prosthetic valve to be implanted The side of filter 80 is provided with an opening defined by a small diameter ring 88 , preferably secured to a strut 87 . Ring 88 may be made of nitinol wire. Filter fabric is not present in the region enclosed by ring 88 , which thus delimits an opening. Ring 88 is dimensioned to receive a small diameter tube, or catheter, 89 , which may have a diameter of the order of 3-7 Fr., preferably 3 Fr., and is preferably dimensioned to achieve a sufficiently close fit with ring 88 to prevent the escape of debris from the region enclosed by filter 80 . Tube 89 may be of a type known as a “pigtail” catheter. Tube 89 will be inserted into ring 88 after filter 80 has been deployed at the desired location. To aid insertion of tube 89 , a guidewire (not shown) may be introduced, for example through the right radial artery or the right femoral artery, and then passed through ring 88 into the region enclosed by filter 80 . The guidewire may have a diameter of 0.5 Fr. Then, tube 89 is passed over the guidewire and through ring 88 , also into the region enclosed by filter 80 . Tube 89 may be employed to inject a contrast fluid that facilitates visualization of the surgery site, such as the aorta and the aortic valve. Such an operation will be further described below. In addition, the distal end of tube 89 can be provided with radiopaque markers to enable its position to be determined fluoroscopically. Then, system 66 will be operated in a known manner to implant the prosthetic valve. During implantation of the heart valve, debris will be released and this debris will be confined by filter 80 and can be carried off with blood through sheath 68 to a suction device located outside of the patient's body. This blood and debris can pass through a conventional device, such as a Coulter counter, which detects and counts the debris particles. Suction will be continued until the output of the measuring device indicates that no further debris is present in the blood flow. After such an indication has been produced, filter 80 can be withdrawn, by acting on the control wires 82 , into sheath 68 and all components can then be withdrawn from the patient's body. Tube 89 may be connected to a suction device outside the patient's body to also suction debris, inevitably accompanied by blood, through tube 89 . Outside of the patient's body, debris can be filtered out of the blood and the blood can be returned to the patient's circulatory system, as will be described subsequently herein. However, according to the present invention, tube 89 is provided at its proximal end, outside the patient's body, with a pressure sensor, and the proximal end of tube 89 is manipulated, or displaced, manually by the physician according to principles known in the medical field to displace the open distal end of tube 89 across the region in front of the existing aortic valve in order to identify the location of the maximum pressure of blood being expelled through the existing aortic valve. This identification of the location may be achieved by fluoroscopically observing one or more radiopaque markers provided at the distal end of tube 89 . After this location has been determined, the position of the distal end of tube 89 is used to guide the prosthetic valve of assembly 70 toward the location of maximum blood pressure, thereby enabling the valve to be introduced and implanted at a location that minimizes trauma. If some lateral displacement of the distal end portion of tube 89 needs to be done, one possibility is to first introduce tube 89 into the aorta, with the pressure sensor removed, and through the opening delimited by ring 88 , to provide a bend in a portion of the guidewire that extends from its distal end, and introduce the guidewire into tube 89 so that the end portion is in registry with a corresponding distal portion of tube 89 , and manipulate the guidewire, including possibly rotating it, to move the distal portion of tube 89 to the desired location across the aortic valve, all under fluoroscopic observation of a radiopaque marker or markers on the distal end portion of tube 89 . Then, the guidewire is removed and the proximal end of tube 89 is connected to the pressure sensor to provide a pressure indication that confirms the position of the distal end of tube 89 . Tube 89 may be advanced in and out of the aortic valve, thus entering and exiting the left ventricle. This will give a foolproof method of placing the prosthetic valve implantation device at the desired spot and minimize trauma to the heart. FIG. 3 is a cross-sectional view showing one possible connection and supporting arrangement for the proximal ends of sheath 68 and system 66 with valve implantation assembly 70 their proximal ends being outside of the patient's body. This arrangement includes a housing 102 secured to the proximal end of sheath 68 so that the region enclosed by sheath 68 communicates with the region enclosed by housing 102 . An outlet conduit 106 extends from the region enclosed by housing 102 to a suction filter device 108 that separates debris from blood and is connected to return the filtered blood to an artery or vein. The debris outlet may be coupled to the above-mentioned suction device. Housing 102 is provided with a pair of seals 110 through each of which a respective guidewire 82 passes. Housing 102 is also provided with an annular seal 114 through which assembly 66 passes. Assembly 66 , in turn, is provided, at its proximal end, with an annular seal 118 through which device 70 extends. While the description above refers to particular embodiments of the present invention, it will be understood that many modifications may be made without departing from the spirit thereof. The accompanying claims are intended to cover such modifications as would fall within the true scope and spirit of the present invention. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, rather than the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

Apparatus for carrying out a medical procedure at a site in a patient's blood circulatory system, including a device to be implanted in the circulatory system, a sheath surrounding device and having a first diameter; a hollow tube having a second diameter and having a pressure transducer at its proximal end, and a filter that is collapsible into the sheath and is expandable out of the sheath for blocking debris and passing blood in the circulatory system.

CROSS REFERENCE TO RELATED APPLICATIONS This is a continuation of application Ser. No. 08/727,171 filed Sep. 30, 1996 now abandoned, which is a continuation of application Ser. No. 08/375,468 filed on Jan. 20, 1995 now abandoned, which is a continuation of application Ser. No. 08/039,378 filed on Mar. 30, 1993 now abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a catheter for diagnostic procedures such as transillumination or for therapeutic procedures such as inducing localized hyperthermia and/or photodynamic therapy in a patient and, more particularly, to a catheter for the transluminal or intersitial delivery of heat to tissue. 2. Prior Art The use of light sources such as lasers has become common in the medical industry. As new, higher power light sources are created providing wavelengths useful for medical applications, the indications for use have increased dramatically. One such application is the delivery of diffuse light energy in energy densities sufficient to cause hyperthermia (elevated tissue temperature), photocoagulation (to weld or destroy tissue depending upon the degree of temperature increase), inducing a photodynamic/photobiological effect or performing diagnostic transillumination for imaging tissue. Current art light delivery devices are available to either diffuse or focus light in a forward direction to effect a light/tissue interaction. One limitation of these devices is that the tissue being heated develops a temperature gradient which is greatest at the interface closest to the light delivery system and decreasing with the depth of the tissue as described by thermal and light diffusion theory. Certain medical applications require a temperature field much different than this model. Adjunctive hyperthermia, the use of deep heating modalities to treat hyperproliferating cells such as tumors, is finding increasing use for synergistically improving the effectiveness of Photodynamic Therapy (PDT), chemotherapy and radiative therapy in cancer treatment. Unfortunately, current hyperthermia devices for intraluminal delivery are not able to deliver localized heat to a target tissue located adjacent to a tubular tissue without damaging the luminal wall of the tubular tissue. In addition to the above described thermal field problem, prior art intraluminal, optically-induced hyperthermia devices cannot sufficiently couple the light energy out to the target tissue. As the light energy or power in the delivery device increases, the greater the chance that the delivery device will fail. Cooling the delivery device also permits the efficient coupling of the light energy out of the delivery device enabling the operation of the light guide at much greater power levels. It is, therefore, desirable that a catheter is available which provides intraluminal delivery of light to a target tissue adjacent to the lumen which produces a thermal gradient which is substantially uniform in the target tissue or at least not excessive at the interface which is closest to the delivery device and which has the capacity to handle high power when required. SUMMARY OF THE INVENTION It is an object of this invention to provide a catheter for the transluminal delivery of optical energy to target tissue adjacent to a tubular tissue member without undue heating of the wall of the tubular tissue immediately adjacent the catheter. It is yet another aspect of this invention to provide a catheter for delivering light to target tissue adjacent to a tubular tissue to provide therapeutic hyperthermia which device has the capacity for high power. It is yet another object of this invention to provide a catheter that can provide hyperthermia to tissue completely surrounding a tubular tissue. These and other aspects of the invention can best be understood by examining the drawings and turning to the description of the preferred embodiments. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 15 is a cross-sectional view of a prostate gland surrounding the urethra. FIG. 16A is a cross-sectional view of a prostate gland showing the transluminal insertion of a side firing catheter into the urethra to irradiate the prostate. FIG. 16B shows the temperature distribution in the tissue immediately surrounding the urethra. FIG. 17A is a cross-sectional view of the prostate gland with a more or less cylindrical diffuser tip inserted into the urethra. FIG. 17B shows the light distribution in the tissue surrounding the diffuser tip. FIG. 18A is a cross-sectional view of the prostate gland showing a catheter according to the present invention inserted into the urethra and the cooling balloon is inflated. FIG. 18B shows the temperature distribution in the tissue surrounding the cooled diffuser tip of FIG. D1. FIG. 1 is a schematic view of a hyperthermia catheter according to the present invention. FIG. 2 is a cross-sectional view of the distal balloon taken along section line 2--2 of FIG. 1. FIG. 3 is a cross-sectional view of the distal catheter body taken along section line 3--3 of FIG. 1. FIG. 4 is an end-on view of the proximal end of the catheter FIG. 1. FIG. 5 is a close-up view of the distal end of the catheter including the balloon shown in FIG. 1. FIG. 6 is a longitudinal cross-sectional view of the distal end of the catheter shown in FIG. 5. FIG. 7 is yet another embodiment of a high power light diffuser catheter. FIG. 8 is a cross-sectional view of the distal balloon taken at section line 8--8 of FIG. 7. FIG. 9 is a cross-sectional view of the catheter body along section line 9--9 in FIG. 7. FIG. 10 is an end-on view of the proximal catheter. FIG. 11 is a longitudinal cross-sectional view of the first embodiment of the catheter shown in FIG. 7. FIG. 12 is a cross-sectional view of a second preferred embodiment of the balloon portion of the catheter shown in FIG. 7. FIG. 13 is a longitudinal cross-sectional of a third preferred embodiment of the balloon shown in FIG. 7. FIG. 14 is a longitudinal cross-sectional view of yet another embodiment of the distal tip of the hyperthermia catheter including the balloon shown in FIG. 7. DETAILED DESCRIPTION OF THE INVENTION Various medical procedures require the delivery of light energy to a target tissue causing a photoreaction (photochemical, photothermal, photoplasma, or photophysical). One such treatment involves the photocoagulation of the prostate tissue to treat Benign Prostate Hypertrophy (BPH). This malady is characterized by the uncontrolled proliferation of cells which make up the prostate gland in men. In its severe states it restricts the flow of fluids through the urethra. Lastly, it is also associated with a high incidence of prostate cancer. Turning now to FIG. 15, the prostate is a gland which is generally toroidal in shape and surrounds the urethra. As the hypertrophy of the prostate cells occurs, the prostate swells and begins to constrict the urethra, thus restricting the flow of fluids through this tubular tissue. To treat this malady, surgical procedures such as TransUrethral Resection of the Prostate (TURP) are employed. Side effects include, incontinence, frequency of urination and impotence. Recently hyperthermia has been employed as a treatment for BPH. A catheter is introduced intraluminally into the urethra. Light is delivered by a focusing fiber optic designed to emit light in a 45-90 degree direction to the axis of the catheter. This type of device creates temperature gradients in the irradiated tissue which is greatest at the interface closest to the delivery device. Referring to FIGS. 16A and 16B, the maximum temperature (T m ) occurs at the urethra wall (D uw ). If a catheter is placed in the urethra of a patient as shown in FIG. 16A, the resultant temperature gradient will appear as illustrated in FIG. 16B. Obviously, this will damage the healthy urethra to a greater extent compared to the diseased prostate. By replacing the side firing light delivery device shown in FIG. 16A with a 360 degree cylindrical light diffusing device as shown in FIG. 16A, the therapy can be uniformly performed radially thus heating the entire prostate if needed. The device can also be partially shielded when heating the whole prostate is not desired. Using a cylindrical diffuser does not overcome the problem of heating the urethra to a greater extent than the prostate as previously discussed. Referring to FIG. 17B, T m again occurs at a distance D uw , the urethra wall. Since T m is greater than the coagulation temperature, T c (or any other desired heating level), the urethra will coagulate before the prostate gland as is the case with the side firing system. If a balloon is added to the device shown in FIG. 17A (see FIG. 18A) and cooling liquid is flowed through the balloon, the tissue at the interface, that is: the urethra wall; will be cooled by the flowing liquid, producing a temperature gradient as illustrated in FIG. 18B. The temperature between D uw and D p is below the threshold temperature for coagulation, T c . The area between the prostate, D p , and D bt , the distance to where the bulk tissue beyond the prostate begins, reaches a temperature which is above the coagulation threshold, T c . The maximum temperature, Tm is achieved well within the prostate. The same type of balloon can be added to side firing systems to cool the tissues of the urethra causing deeper heating profiles. The balloon and coolant are, of course, optically transparent to the wavelengths used for inducing hyperthermia in the target tissue. Such a system may also be used for transilluminating the surrounding tisue for diagnostic purposes by keeping the maximum temperature T m below the coagualtion threshold T c . T c indicates the threshold temperature where coagulation occurs. If the temperature can be maintained below this threshold in both the urethral tissue and the non-target tissue beyond the prostate, the coagulation will be limited to the prostate, where it is intended. In addition to cooling the non-target urethral tissue, the fluid serves to cool the catheter diffuser tip allowing the device to be driven to much higher power levels without failure. FIG. 1 illustrates the first preferred embodiment of a catheter, generally indicated at 10, employing the high power light diffuser. The distal portion of the catheter is surrounded by an optically clear, inflatable balloon 11 which is fitted to the catheter body 12. The internal components of the catheter body 12 are separated into three channels at the 3-way adapter 13. The fiber optic array (not shown) is directed into a bundle encased in a polymer tube 14 which delivers the bundle to the fiber optic connector 15. This connector 15 ultimately is coupled to the light source (not shown). The center arm of the 3-way adapter 13 houses the guidewire lumen 16 which is capped with a hemostasis valve 17. The third arm 18 of the 3-way adapter 13 provides an inlet for cooling fluid. The fluid is introduced through the infusion port 18 where it enters a dedicated channel (not shown) which in turn supplies the distal balloon 11 with cooling fluid while inflating the balloon 11. The fluid then enters a second dedicated channel (not shown) and returns the fluid to the 3-way adapter 13 where it is directed to the output port 19. The fluid is then directed from the output port 19 to an external closed loop chiller (not shown) where it is cooled and returned to the infusion port (18). FIG. 2 illustrates the cross-sectional view of the distal balloon 11 taken at section line 2--2 in FIG. 1. The central guidewire lumen 16 is surrounded by the internal tube 24. The diffusing medium 23 is encased between the optically reflective internal tube 24 and the optically clear external tube 22. The balloon 11 is inflated with the inflation and coaling medium 21 and is concentrically located around the guidewire lumen 16. The optically clear fluid barrier tube 25 separates the inflation medium 21 into influx and effluent. FIG. 3 illustrates the cross-sectional view of the distal catheter body 12 taken at 3--3 in FIG. 1. The guidewire lumen 16 is surrounded by the internal tube 24 which in turn is surrounded by an array of fiber optics 33 which in turn is surrounded by the external tube 22 which in turn is surrounded by the dedicated infusion channel 32 which is surrounded by the fluid barrier 25 which in turn is surrounded by the dedicated output channel 31 which in turn is surrounded by the catheter body 12. FIG. 4 is an end on view of the proximal end of the catheter 10. The fiber optic bundle 34 or a fused facsimile is housed in the stainless steel or similar material connector. FIG. 5 is a close up view of the balloon 11 shown in FIG. 1. The distal tip of the catheter 10 incorporates a rounded tip 51 for the atraumatic delivery of the device through the lumen of a tubular tissue such as the urethra or bronchus. The rounded tip 51 surrounds the guidewire lumen 16. Underlying the balloon 11 is the catheter body 12. FIG. 6 is a cross-sectional view of the optically clear balloon 11 shown in FIG. 5. The rounded tip 51 creates the introducer funnel 61 which leads into the guidewire lumen 16. After the diffuser tip 23 is positioned intraluminally adjacent to the target tissue, the balloon 11 is inflated with a transparent inflation medium 21 which is supplied to the balloon through the dedicated infusion channel 32. The inflation medium exits the balloon through the dedicated output channel 31. The two channels are separated by a fluid barrier 25 except at a distal end to create a an opening 35. Light communication is achieved via an optical waveguide such as fiber optics 33 which conducts light from a source (not shown) such as a laser to the diffuser 23. The diffuser 23 is enclosed between an internal optically reflective tube (24) and the external optically clear tube 22. FIG. 7 is a second embodiment of the high power light diffuser (70). The distal balloon 11 is attached to the catheter body 12 which in turn is connected to the 3-way adapter 13. The single fiber optic (not shown) is directed to the polymer tube (14) which in turn directs the single fiber optic to the fiber optic connector 15. The remaining two arms of the 3-way adapter 13 provide an infusion port 18 and an output port 19 for the inflation medium 21 connected by an external closed loop chiller (not shown). FIG. 8 illustrates the cross-sectional view of the distal balloon 11 taken at 8--8 in FIG. 7. The central diffusing medium 82 is surrounded by the optically clear diffuser sheath 81 which in turn is surrounded by the optically clear inflation medium 21 which in turn is surrounded by the optically clear balloon 11. The inflation medium 21 is separated into influx and effluent by the optically clear fluid barrier 25. FIG. 9 illustrates a cross-sectional view of the catheter body 12 taken at 9--9 in FIG. 7. The centrally located single fiber optic 91 is surrounded by the diffusing medium 82 which n turn is surrounded by the diffuser sheath 81 which in turn is surrounded by the dedicated infusion channel 32 which in turn is surrounded by the optically clear fluid barrier 25 which in turn is surrounded by the dedicated output channel 31 which in turn is surrounded by the catheter body 12. FIG. 10 is an end on view of the proximal catheter 70. The single fiber optic 91 is surrounded by epoxy 101 which in turn is surrounded by the fiber optic connector 15. FIGS. 11-14 represent four embodiments of the distal balloon shown in FIG. 7. FIG. 11 is a cross-sectional view of the distal catheter shown in FIG. 7. The distal hemispherical tip 111 allows for the atraumatic delivery of the device. The balloon 11 is inflated with the inflation medium 21 which is delivered to the balloon 11 through the dedicated infusion channel 32 and exits the balloon 11 through the dedicated output channel 31. The two channels are separated by the optically clear fluid barrier 25. The balloon is attached proximally to the catheter body 12. Light communication is provided via the single fiber optic 91 from the source (not shown) to the diffusing medium 82. FIG. 12 is a cross-sectional view of the distal catheter shown in FIG. 7. The distal tip is identical to that shown in FIG. 11 with the exception that the hemispherical tip (111 in FIG. 11) is replaced with a conical tip 121 for interstitial insertion of the device. FIG. 13 is a cross-sectional view of the distal catheter shown in FIG. 7. The distal tip is identical to that shown in FIG. 12 with the exception of a fluid (gas or liquid) gap 131 placed between the fiber optic 91 and the diffusing medium 82. FIG. 14 is a cross-sectional view of the distal catheter shown in FIG. 7. The distal tip is identical to that shown in FIG. 12 with the exception of replacing the continuous gradient diffusing medium (82 in FIG. 12) with multiple discrete diffusing segments. The diffusing segment 141 closest to the fiber optic 91 has the lowest concentration of scattering centers in elastomer substrate (as low as zero) of all the segments. The second segment 142 has the next lowest concentration of scatter centers in elastomer substrate. The same trend continues with the third segment 143 and the fourth (now shown), etc. While it is not shown, an outer layer of elastomer or elastomer plus scattering centers may be used to create the desired optical output of the device. The catheter may be used for inducing hyperthermia in prostate tissue as follows: 1. The catheter is advanced through the urethra until the balloon and underlying diffuser are positioned in the urethra adjacent to and centered within the prostate (the target tissue). 2. The balloon is inflated to intimately contact the internal wall of the urethra. 3. The inflation of the balloon is maintained by circulating a cooling fluid through the catheter to and from the interior chamber of the balloon. The fluid exits the catheter where it is transported to an external chiller. After the fluid has been cooled to body temperature or slightly below body temperature, the fluid is returned to the balloon through the catheter. This process continues in a closed loop. 4. Light is then delivered to the tip and emitted radially (focused or diffused) to the target tissue. 5. Following coagulation or lower level heating of the prostate tissue, the light is extinguished, the fluid is terminated thus deflating the balloon, and the delivery device is removed from the urethra. While the utility of the device has been demonstrated using the hyperthermia treatment of BPH as an example, it should not be construed that this device is limited to that application. The use of this device to adjunctively treat other hyperproliferative cells such as esophageal tumors with PDT or selective hyperthermia or a combination of the two is an obvious extension of the utility of the cooled catheter. The same device in a spherical geometry could be used to treat bladder cancer, or illuminating the tissue surrounding the cavity remaining after the resection of a tumor or other mass. BPH can also be treated with PDT. Since studies show that photosensitizers are concentrated in the deeper tissues of the prostate, the incorporation of a cooling means around the diffused tip would facilitate the procedure by allowing the diffuser to be driven at higher powers and by providing more efficient and safer hyperthermia simultaneously with PDT, which has shown a strong synergism. In addition to the aforesaid therapeutic applications red light is particularly useful for performing transillumination of tissue for diagnostic purposes. This is due to the relative lucency of blood and tissue to light at longer wavelengths. Such light must be delivered at a power level sufficient to penetrate the tissue under investigation and be detected. Light delivery tips suitable for transillumination may be placed beneath the skin. A transparent balloon surrounding the diffuser tip may then be inflated with a cooling fluid to expand against the surrounding tissue. Cooling the tissue adjacent to the diffuser tip by thermal contact with the heat-conducting fluid circulating through the interior of the transparent balloon will permit the delivery of transilluminating light at greater power levels without tissue destruction. In this regard, a material having good heat conduction characteristics is a preferred material for balloon wall construction. Representative and preferred embodiments of the invention having been described and illustrated, it is to be understood that, within the scope of the appended claims, various changes can be made therein. Hence, the invention can be practiced in ways other than those specifically described herein. For example, the catheter may be used for interstitial induction of hyperthermia in a target tissue when it is necessary or desirable to prevent overheating of the tissue immediately adjacent to the diffusive light source. It is clear that the principal of using a transparent heat conducting balloon around a light delivery diffuser tip to cool the adjacent tissue during photoirradiation can be applied to a variety of geometries. As a further example; if, following the excision of a tissue, it is advantageous to photoirradiate the tissue surrounding the excised tissue. A transparent balloon of any suitable shape can be inserted into the void space left by the excised tissue and filled with a volume of coolant sufficient to expand the balloon against the surrounding walls. A light diffuser tip positioned within the interior of the inflated balloon may then be used to photoirradiate the surrounding tissue.

A catheter and a method for using the catheter for the transluminal hyperthermic treatment of target tissue is presented. The catheter comprises an elongate tubular member having two coolant circulating lumens and an optical waveguide coextensive therewith, the proximal end of the optical waveguide being adapted to receive light from a light source and the distal end of the optical waveguide terminating in a diffuser tip. The diffuser tip provides a means for radially distributing treatment light from the light source to tissue adjacent to the distal tip of the catheter to heat the tissue. A transparent, inflatable balloon surrounds the diffuser tip. The inflatable balloon permits the flow of an optically transparent coolant around the diffuser tip to cool the tissue immediately adjacent to the diffuser tip to prevent overheating. A method of using the device for the transurethral treatment of benign prostate hypertrophy is presented as an example.

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a divisional of U.S. patent application Ser. No. 10/037,974 filed on Nov. 9, 2001, now U.S. Pat. No. 6,962,599 which is a continuation-in-part of U.S. patent application Ser. No. 09/710,692 filed on Nov. 10, 2000 now U.S. Pat. No. 6,589,267. The disclosures of the above applications are incorporated herein by reference. DISCUSSION OF THE INVENTION The present invention relates to an external counterpulsation apparatus and method for controlling the same and, more particularly, to such an external counterpulsation apparatus and method for controlling the same having improved efficiency and utility. External counterpulsation is a noninvasive, atraumatic means for assisting and increasing circulation in patients. External counterpulsation uses the patient's physiological signals related to their heart cycle (e.g., electrocardiograph (ECG), blood pressure, blood flow) to modulate the inflation and deflation timing of sets of compressive cuffs wrapped around a patient's calves, lower thighs and/or upper thighs, including the lower buttocks. The cuffs inflate to create a retrograde arterial pressure wave and, at the same time, push venous blood return from the extremities to reach the heart at the onset of diastole. The result is augmented diastolic central aortic pressure and increased venous return. Rapid, simultaneous deflation of the cuffs produces systolic unloading and decreased cardiac workload. The end results are increased perfusion pressure to the coronary artery during diastole, when the heart is in a relaxed state with minimal resistant to blood flow; reduced systolic pressure due to the “sucking effect” during cuff deflation; and increased cardiac output due to increased venous return and reduced systolic pressure. Under normal operating conditions, when the heart contracts and ejects blood during systole, the aortic and coronary perfusion pressure increases. It should also be noted that the workload of the heart is proportional to the systolic pressure. However, during systole the impedance to coronary flow also increases significantly due to the contracting force of the myocardium, thereby restricting coronary blood flow. Also, during diastole, the myocardium is in a relaxed state, and impedance to coronary flow is significantly reduced. Consequently, although the diastolic perfusion pressure is much lower than systolic pressure, the coronary blood flow during diastole accounts for approximately eighty (80) percent of the total flow. The historical objectives of external counterpulsation are to minimize systolic and maximize diastolic pressures. These objectives coalesce to improve the energy demand and supply ratio. For example, in the case of patients with coronary artery disease, energy supply to the heart is limited. External counterpulsation can be effective in improving cardiac functions for these patients by increasing coronary blood flow and therefore energy supply to the heart. During a treatment session, the patient lies on a table. Electronically controlled inflation and deflation valves are connected to multiple pairs of inflatable devices, typically adjustable cuffs, that are wrapped firmly, but comfortably, around the patient's calves, lower thighs, and/or upper thighs, including the buttocks. The design of the cuffs permits significant compression of the arterial and venous vasculature at relative low pneumatic pressures (200-350 millimeters Hg). The earlobe pulse wave, finger pulse finger or temporal pulse wave is used as a timing signal to give the appropriate time for application of the external pressure so that the resulting pulse produced by external pressure in the artery can arrive at the root of the aorta just at the closure of the aortic valve. Thus, the arterial pulse wave is divided into a systolic period and a diastolic period. The earlobe pulse wave, finger pulse wave or temporal pulse wave signals, however, may not reflect the true pulse wave from the great arteries such as the aorta. According to the present invention, there are two factors that should be taken into account to determine the appropriate deflation time of all the inflatable devices: (1) release of all external pressure before the next systole to produce maximal systolic unloading, i.e., the maximum reduction of systolic pressure; (2) maintenance of the inflation as long as possible to fully utilize the whole period of diastole so as to produce the longest possible diastolic augmentation, i.e., the increase of diastolic pressure due to externally applied pressure. One measurement of effective counterpulsation is the ability to minimize systolic pressure, and at the same time maximize the ratio of the area under the diastolic wave form to that of the area under the systolic wave form. This consideration can be used to provide a guiding rule for determination of optimal deflation time. Furthermore, the various existing external counterpulsation apparatuses only measure the electrocardiographic signals of the patient to guard against arrhythmia. Because counterpulsation applies pressure on the limbs during diastole, which increases the arterial pressure in diastole and makes it higher than the systolic pressure, the blood flow dynamics and physiological parameters of the human body may vary. Some of these variations are beneficial. An external counterpulsation apparatus according to the invention generally includes a plurality of inflatable devices adapted to be received about the lower extremities of the patient, a source of compressed fluid in communication with the plurality of inflatable devices, and a fluid distribution assembly interconnecting the source of compressed fluid and the inflatable devices. The fluid distribution assembly includes a selectively operable inflation/deflation valve interconnected between each of the inflatable devices and the source of compressed fluid. The fluid distribution assembly distributes compressed fluid from the source of compressed fluid to the inflation/deflation valve and operates each inflation/deflation valve to sequentially inflate and deflate each of the inflatable devices. Each inflation/deflation valve has in input in fluid communication with the source of compressed fluid, an inflation/deflation port in fluid communication with one of the inflatable devices, and a deflation exhaust port in fluid communication with the atmosphere. The deflation exhaust port is normally open so as to exhaust compressed fluid upon loss of power to the external counterpulsation apparatus. The source of compressed may include a compressor and a power ramp-up device. The power ramp-up device, upon startup of the apparatus, converts electrical power to the compressor from 110/120 VAC 50/60 Hz to three-phase 220 VAC at a variable frequency. The power ramp-up device also increases the electrical power to a preselected full power level over a period of approximately three to five seconds. In an external counterpulsation apparatus according to the invention, a treatment table is provided upon which the patient Is situated during the treatment. The treatment table includes a main portion and an articulating portion selectively adjustable to a plurality of angulated positions relative to the main portion. The treatment table further includes a motor-driven elevation assembly actuable to selectively raise and lower the treatment table to a plurality of different elevated positions. The treatment table further includes a plurality of wheels allowing the treatment table to be selectively moved between a plurality of locations. The treatment table may further include an inflation/deflation valve mounted to the treatment table and movable therewith. The inflation/deflation valve selectively inflates and deflates an inflatable device attachable to the patient. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a block diagram of an external counterpulsation apparatus according to the present invention. FIG. 2 is a block diagram of an external counterpulsation apparatus according to the present invention. FIG. 3 is a block diagram of an external counterpulsation apparatus according to the present invention. FIGS. 4A and 4B are partial schematic diagrams of a portion of the fluid distribution assembly according to the present invention, illustrating fluid pipes connected to a semiconductor cooling device and air-conditioner cooling evaporator, respectively. FIG. 5 is a diagrammatic view of an external counterpulsation apparatus according to the present invention. FIG. 6 is a diagrammatic representation of fluid flow of the external counterpulsation apparatus of FIG. 5 . FIG. 7 is another flow diagram of fluid flow of the external counterpulsation apparatus according to the present invention. FIG. 8 is a control diagram for the external counterpulsation apparatus of FIGS. 5 through 7 . FIGS. 9A and 9B are diagrammatic representations of inflation and deflation of inflatable cuff devices of the present invention, coordinated with the associated portions of the patient's ECG. FIG. 10 is a graphic representation of the relationship between the patient's ECG, the valve opening signals and the inflatable cuff device inflation pressure waveforms during operation of the external counterpulsation apparatus of FIGS. 5 through 9 . FIGS. 11A and 11B are graphic representations of possible inflation time advances and delays and possible deflation time advances and delays. FIGS. 12 through 18 illustrate an exemplary inflation/deflation valve for use in an external counterpulsation apparatus according to the present invention. FIGS. 19 through 22 illustrate a pressure regulator assembly for use in an external counterpulsation apparatus according to the present invention. FIG. 23 is a block diagram depicting a computer system for monitoring and recording the treatment of a patient using an external counterpulsation device in accordance with the present invention. FIG. 24 illustrates an exemplary treatment control screen for the enhanced computer system of the present invention. FIG. 25 illustrates an exemplary main menu control screen for the enhanced computer system of the present invention. FIG. 26 illustrates an exemplary patient information screen for the enhanced computer system of the present invention. FIG. 27 illustrates an exemplary site information screen for the enhanced computer system of the present invention. FIG. 28 diagrammatically illustrates initiation timing logics for the inflation/deflation valves of an external counterpulsation apparatus according to the present invention. FIG. 29 is a diagrammatic representation of exemplary timing for the inflation/deflation valves and the air pressure waveforms in the inflatable devices of the external counterpulsation apparatus according to the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A detailed description of varied and merely exemplary embodiments of the present invention follows with reference to the accompanying drawings. One skilled in the art will readily recognize that the principles of the invention are equally applicable to other embodiments and applications. FIG. 1 is a block diagram of a first exemplary embodiment of an external counterpulsation apparatus according to the present invention, wherein a controller 10 controls the gas compressor 20 and set of solenoid valves 24 . The compressor can be of rotary vane, piston, diaphragm or blower type. One suitable compressor is a scroll-type compressor as described in U.S. Pat. No. 5,554,103, commonly assigned and incorporated herein by reference, which essentially consists of two scroll basin with very narrow gaps between them; with one scroll basin adapted to rotate at very high speed (3,000 rpm) while the other scroll basin remains stationary. The clenching of the scroll basins compresses the air radially inwardly toward the center and the compressed air comes out of the center shaft. During operation, the compressor 20 operates to produce pressurized gas, such as pressurized air, which is sent into the positive pressure reservoir 22 via a cooling means 21 . A pressure-limiting valve 23 is provided on the reservoir 22 , which keeps the internal pressure of the reservoir 22 constant. For this variation of the invention, the opening and closing of the set of solenoid valves 24 is, controlled by the inflation and deflation driving signals generated by the controller 10 . The set of solenoid valves 24 may include a number of two-position, three-way solenoid valves corresponding to the number of inflatable devices 25 . When a valve is in the first of the two positions, it inflates the inflatable device; when it is in the second of the two positions, it deflates the inflatable device, under control of the control system. Other valve assemblies, including those disclosed below, may be used in accordance with the invention. Each inflatable device. 25 may include a balloon or air bladder surrounded by a cuff, or may be unitary in structure. The inflatable devices 25 may include cuffs wrapped tightly around the lower limbs with inflatable devices 25 put in between the cuffs and the body. When compressed gas is injected into the inflatable devices 25 , the cuff will also expand and extend outward, due to the elasticity and extensibility of its material. Suitable cuff and balloon apparatuses shown and described in U.S. Pat. No. 5,554,103, are incorporated herein by reference. More or fewer inflatable devices 25 may be used, but three are shown here for explanation purposes. For example, more devices may be used to improve the fit, and thus the effectiveness of counterpulsation. FIG. 2 illustrates another external counterpulsation apparatus according to the present invention. In this variation, a control signal generated by the controller 10 signals the compressor 20 to compress gas into the positive pressure reservoir 22 after being cooled by the cooling means 21 . A pressure-limiting valve 23 is provided on the positive pressure reservoir to keep its internal pressure constant. A negative pressure reservoir 26 connected to the inlet of the compressor 20 is a source of negative pressure. The control system 10 controls the opening and closing of the set of solenoid valves 24 by issuing inflation and deflation control signals in accordance with the results of detection. When the set of solenoid valves 24 are in the first position, they inflate the inflatable devices 25 , when they are in the second position, they deflate the inflatable devices 25 . The gas discharged from the inflatable devices is discharged into the negative pressure reservoir 26 via the set of solenoid valves 24 , and then returns to the compressor 20 . As there may be leakage during the circulation of gas, which may affect the amount of gas output from the compressor 20 , a pressure-limiting valve 27 is provided to adjust the negative pressure in the negative pressure reservoir 26 . When the negative pressure exceeds a certain value, the pressure-limiting valve 27 is opened to inject a certain amount of gas into the negative pressure reservoir 26 . FIG. 3 illustrates another external counterpulsation apparatus according to the present invention, wherein the controller 10 generates control signals and the compressor 20 operates to produce two portions of pressurized gas, one portion of pressurized gas is sent to the positive pressure reservoir 29 , while another is sent into the positive pressure reservoir 22 via the cooling means 21 and a throttle valve 28 . The pressure limiting valve 23 is operative to adjust the pressure inside the reservoir 22 . The reference numeral 30 indicates a two-position-five-way solenoid valve or two two-position-three-way solenoid valves, 31 indicates a mono-directional throttle valve, 35 indicates a cylindrical gas distribution means or cylinder, 37 is a partition, and 36 indicates a piston. When an inflation driving signal is issued by the controller 10 , the solenoid valve 30 opens to the first of the two positions, and the gas flow is introduced into the portion I of the cylinder from the reservoir 29 via the solenoid valve 30 and the throttle governor 31 to push the piston from a first towards a second end of the cylinder 35 . A space portion III is formed by the piston 36 and the cylinder 35 and is always in communication with the reservoir 22 . Vents for the inflatable devices 25 are situated in sequence in the cylinder 35 , the inflatable devices 25 being sequentially inflated as the piston 36 moves towards the second end of the cylinder 35 . When a deflation signal is issued by the controller 10 , the solenoid valve 30 is moved to its second position, and the gas in the reservoir 29 enters portion 11 of the cylinder 35 via the solenoid valve 30 to push the piston 36 back to the first end of the cylinder 35 . At that time, the gas in portion I is discharged via the solenoid valve 30 , and the gas in the inflatable devices 25 is discharged to the negative pressure reservoir 26 . In order to speed of deflation, a solenoid valve 34 is also opened at the same time and the gas discharged from the inflatable device 25 is discharged to both negative pressure reservoirs 26 , 33 . Negative pressure reservoir 33 is kept at a negative pressure by the input portion of compressor 32 . Discharged gas is also sent to the reservoir 22 by the output portion of the compressor 32 . During the deflation phase, in such an embodiment, if the pressurized inflatable devices 25 is simply exhausted into the atmosphere, exhaustion of the inflatable devices may not be completed, with the residual gas pressing on the tissue mass surrounded by the inflatable devices, reducing the much needed vascular space in the body to receive the volume of blood ejected by the heart. This can reduce the ability of external counterpulsation to unload systolic blood pressure and reduce cardiac workload. The addition of negative pressure reservoirs 26 , 33 serve to more rapidly evacuate the pressurized gas in the inflatable devices 25 , thereby ensuring complete absence of pressure on the lower extremities, enabling the vasculature that has been previously compressed and emptied during the diastolic period to act as a source of suction to help the heart eject blood and unload systolic blood pressure. In addition, the negative pressure reservoirs 26 , 33 ensure the smooth operation of the solenoid valves 30 , 34 and prevent the leakage of large volumes of pressurized gas exhausting into the atmosphere. This closed gas system also reduces noises generated by the opening and closing of solenoid valves and movement of air from escaping the system. It should be noted, however, that a negative pressure reservoir might not necessarily be required in each variation, embodiment or application of the present invention. Furthermore, during normal operation of external counterpulsation, there is always some leakage of compressed air from the inflatable device 25 during the inflation period. To compensate for this leakage and to ensure there is adequate air supplied to the compressor 20 for producing air pressure in the range of five (5) to fifteen (15) psi, leakage compensation might be required, such as the use of a vacuum limiting valve, a vacuum pump, or compressor, or some combination thereof. An example of the leakage compensation means is a vacuum limiting valve 27 connected to the negative pressure reservoir 26 , set at approximately negative 100 mm Hg. When the negative pressure reservoir is less than approximately 100 mm Hg, the vacuum-limiting valve 27 is open and air is sucked into the reservoir 26 to provide more air to the intake of the compressor 20 . One variation of the present invention includes a gas cylindrical distribution system 35 , as shown in FIG. 3 , including a syringe-type system to push a piston in one direction to provide sequential inflation of the inflatable devices 25 , with the inflatable devices 25 furthest from the heart being inflated first. The inflatable device openings are placed on both sides of the cylinder, connecting to the left and right limbs as well as buttock. The number of inflatable devices can be two (2) to eight (8) or more on each side, but more or fewer may be used. This is achieved by connecting the inflatable devices 25 furthest from the heart to the portion of the cylinder closest to the piston 36 , as the piston 36 moves from left to right as shown in FIG. 3 . This gas distribution system uses compressed air to move the piston 36 back and forth along cylinder 35 , producing a quiet operation without requiring much power. The solenoid valve 30 is a normally open valve to portion 11 of the cylinder 35 , thereby connecting portion 11 to the positive pressure reservoir 29 in case of power failure, moving the piston 36 to the left in FIG. 3 , exposing all the inflatable devices 25 to the negative pressure reservoir 26 , thereby deflating all inflatable devices 25 and reducing the possibility of inducing trauma to the patient. When air is compressed, heat will be generated. In external counterpulsation, approximately twenty-five (25) cubic feet of air is compressed to five (5) to fifteen (15) psi pressure, generating a gas with temperature reaching as high as seventy (70) to ninety (90) degrees Celsius, depending on the environment and efficiency of the compressor. When compressed gas with such high temperature is sent to the inflatable devices 25 , which are in close contact with the patient's skin, it may produce abrasion or burn to the skin, or at least, an uncomfortable feeling to the patient. Therefore, in some embodiments of the invention, cooling the compressed air is preferred. In general, any means of cooling can be utilized in this invention, including exposing to the atmosphere a long piece of coil or metal pipe connecting the compression means to the positive pressure reservoir, blowing air through a coil of metal pipe carrying the heated gas, water cooling such as that used in the radiator of automobile, running cooling water, or air conditioner, for examples. Further cooling examples are shown in FIGS. 4A and 4B which are partial schematic diagrams of the fluid distribution assembly of the external counterpulsation apparatus according to the present invention, illustrating a gas pipe 39 connected to a cooling means. The pipe 39 may be associated with fans 38 and/or heat isolation materials 40 , as shown in FIG. 4A , wherein cooling means 21 includes semiconductor-type heat isolation materials 40 . In FIG. 4B , the cooling means is an evaporator, i.e., fluid-cooled tubing. Alternatively, the cooling means 21 can be a fan, as shown in FIG. 2 . Any other suitable cooling mechanism can be used. Beginning with FIG. 5 , another embodiment of the external counterpulsation apparatus according to the invention is illustrated and described. External counterpulsation apparatus 201 includes three component assemblies, namely, a control console assembly 202 , a treatment table assembly 204 , and an inflation/deflation assembly 206 . The control console assembly 202 is mounted for mobility from one location to another upon wheels 214 , and similarly the treatment table assembly 204 is mounted for mobility from one location to another upon wheels 216 . As used herein the term “wheels” includes casters, rollers, track-type belts, or other lockable and unlockable wheel-type devices configured for allowing the components to be “wheeled” from one location to another and then locked in order to maintain the desired position or location. The control console assembly 202 generally includes a user interface device, such as a computer monitor or touch screen 220 , and a cabinet or housing 222 , in which various components described below are located and housed. The treatment table assembly 204 generally includes an upper surface 205 on an articulating portion 226 and a horizontal portion 228 , with the articulating portion 226 being hingedly or otherwise pivotally interconnected with the horizontal portion 228 for adjustment (either manually or by way of a power drive) to a plurality of angulated positions relative to the horizontal portion 228 . In this regard, it should be noted that the angulated position of the articulating portion 226 relative to the horizontal portion 228 is preferably limited to an angle 230 that is thirty (30) degrees above the horizontal. Thus, by way of the motor-driven elevation assembly 224 and the articulating portion 226 of the treatment table assembly 204 , a patient receiving treatment can be easily positioned or situated on the upper surface 205 , elevated to a desired treatment height, and made comfortable by adjusting the articulating portion 226 relative to the horizontal main portion 228 . In this regard, it should be noted that the motor-driven elevation assembly 224 preferably includes a limiting switch or other limiting device (not shown) that limits the elevation of the top or upper surface of the horizontal main portion 228 of the treatment table between heights of twenty-four (24) inches and thirty-six (36) inches from the floor or other surface upon which the treatment table assembly 204 is situated. FIGS. 6 and 7 are schematic or diagrammatic representations of the compressed gas flow arrangement for the external counterpulsation apparatus 201 generally including the control console 202 , treatment table 204 , and inflation/deflation assembly 206 . The control console 202 preferably includes an air intake/filter assembly 232 , a muffler 233 , which can be located before or after a compressor 234 (as shown in contrast in FIGS. 6 and 7 ), a tank 236 , a pressure sensor 238 , a pressure relief valve 240 , and a pressure regulator 242 . The pressure sensor 238 is preferably a pressure transducer, but can be any pressure or temperature sensoring device. A temperature sensor 239 may also be included, as shown in FIG. 7 . A hose connection assembly 244 is used for quick connecting and disconnecting the above-described components with those mounted on, or otherwise associated with, the treatment table assembly 204 . Such treatment table assembly components include a valve manifold 246 , as shown in FIG. 7 , a number of inflation/deflation valves 248 , 250 and 252 , each with an associated pressure transducer/sensor 254 , 256 , and 258 , respectively. A connect/disconnect assembly 260 is provided for quick and easy connection and disconnection of the inflation/deflation valves 248 , 250 and 252 with their associated inflatable devices 208 , 210 , and 212 , respectively, of the inflation/deflation assembly 206 . FIG. 8 diagrammatically illustrates the electrical/logic/control interconnections of the various components of the external counterpulsation apparatus 201 . The control console assembly 202 includes a power supply 264 that feeds power to a computer assembly 219 , which includes a CPU and the user interface monitor 220 , as well as other input provisions such as a keyboard and touch screen; as well as to the compressor 234 , by way of a power switch panel 213 , transformer 215 , and power module 266 , which includes a power converter and ramp-up assembly. The power module 266 converts electrical power to the compressor from 110/120 VAC 50/60 Hz to three-phase 220 VAC at a variable frequency and increases the electrical power to a preselected full power level over a period preferably of approximately three (3) to approximately five (5) seconds. At the onset of external counterpulsation treatment for the patient, electrical power is required to power the three sets of inflation/deflation valves 248 , 250 , 252 , as well as to provide the base line requirement of electrical energy to the computer 219 , the user interface monitor 220 , and other electronics associated with the external counterpulsation apparatus 201 . This can result in a power surge of up to or even exceeding 30 amperes. This power requirement is too high for most normal house power supply systems. Therefore, the power module 266 includes a variable frequency drive transistorized inverter (e.g., Mitsubishi Model FR-E520-1.5K) to slowly ramp up the power supply to the compressor 234 over the above-mentioned preferred period of approximately three (3) to five (5) seconds. The power module 266 converts 110/220 VAC 50/60 Hz line input and converts it to three-phase 220 VAC and with variable frequencies, starting at zero (0) Hz and up to a preset frequency (e.g., 72 Hz). Thus, the operation of the compressor 234 is independent of the input line's frequency, and there is no sudden power surge required to start the compressor 234 . In terms of user friendliness, various related functions of the system 201 are grouped for easy and logical operation. All patient-related inputs (patient ECG, finger plethysmography, patient call button, etc.) are located in one location, namely on a patient input panel 209 associated with the treatment table assembly 204 . Outputs, such as printer outputs, patient signals, outputs, service signals, outputs, etc., are also grouped in one location, preferably as part of an output module 211 on the control console assembly 202 . Operator inputs for purposes of adjusting performance of the apparatus 201 , are all on the touch screen display of the user interface monitor 220 , and include inflation/deflation timings, magnitude of pressure applied, and other important data discussed below, including the display of the patient's ECG, graphic representations of the inflation/deflation timings, plethysmogram (ear lobe, finger, temporal, etc.) for monitoring appropriate timing adjustment and other operational factors. A keyboard 217 also may be provided. All inputs and outputs are preferably communicated through signal module 219 . All of the above-described controls and features are configured and calculated to provide for sequential pressurization of the patient's lower limbs, beginning at the most distal area at which the inflatable device 208 is applied, followed by an intermediate area at which the inflatable device 210 is positioned, and ending with the pressurization by the inflatable device 212 at the upper end of the patient's leg or the buttock area. This sequence is indicated graphically in FIGS. 9A and 9B , with the exhausting of all pressure to the inflatable devices 208 , 210 and 212 occurring near the end of the ECG cycle, as illustrated in FIG. 9B . This relationship is also graphically illustrated in FIG. 10 , which juxtaposes the ECG signal 277 , the valve opening signals 283 and the inflatable cuff device pressure waveforms 285 . As illustrated in FIGS. 11A and 11B , the inflation time can be advanced or delayed by the operator between certain minimums and maximums. FIGS. 12 through 18 illustrate an exemplary inflation/deflation valve 248 , which should be regarded as typical for the inflation/deflation valve 250 and 252 as well. The inflation/deflation valve 248 (and 250 and 252 ) is preferably a rotary actuable butterfly-type valve, which can be actuated pneumatically or in the preferred embodiment electrically by the respective operators 289 on opposite ends of a body portion 288 for controlling the rotatable rotors 290 . Attached to the rotors 290 are butterfly valve elements 292 , 294 which open and close the compressed gas or compressed air inlet 295 and the inflation/deflation port 296 , which is connected to the respective or associated inflatable cuff devices 208 , 210 , or 212 , with the butterfly valve element 294 being rotatable actuable to open and close fluid communication between the inflation/deflation port 296 and a deflation exhaust port 297 . The quick-acting operators 290 are respectively actuated and controlled by way of the control system described herein, in order to provide for proper inflation and deflation timing and sequential operation of the inflatable devices 208 , 210 , 212 . The butterfly valve elements 292 , 294 and their associated rotors 290 are preferably rotatable through a maximum rotation angle of approximately 60 degrees between open and closed positions. A larger or smaller rotation angle is within the scope of the invention. The inflation passageway through each of the butterfly valve openings between the input port 295 and the inflation/deflation port 296 is more restricted than the deflation passageway between the inflation/deflation port 296 and the deflation exhaust port 297 , with the restriction being approximately twenty (20) to thirty (30) percent larger on the deflation side than on the inflation side in order to allow deflation of the inflatable devices 208 , 210 , 212 at the same rate as the inflation rate, owing to the fact that the inflation has a higher pressure gradient between the compressed gas at the input 295 and the inflation/deflation port 296 when compared with the pressure gradient between the inflation port 296 and the deflation exhaust port 297 . The butterfly valve elements 292 , 294 , along with their associated rotors 290 are driven by a rotary solenoid using fifteen (15) volt DC continuous power or twenty-seven (27) volt DC, fifty milliseconds pulse, dropping back to a fifteen (15) volt holding voltage. This lower power consumption is important not only, to reduce the overall electrical power requirement, but to reduce the heat output. For safety and other quick-acting purposes, the deflation butterfly valve element 294 is normally open (such as in a power-off condition) and the inflation butterfly valve element 292 is normally closed. Thus, in the case of a power loss, the inflation valve element 292 will be closed and the deflation valve element 294 will open to allow air from the inflatable cuff devices to deflate and exhaust to atmospheric pressure. Each of the butterfly valve elements 292 and 294 can be opened from approximately fifty (50) to three hundred (300) milliseconds, and are preferably open from one hundred (100) milliseconds to two hundred (200) milliseconds, to allow compressed air from the above-mentioned reservoir to be admitted to the inflatable devices during the onset of a diastole. As mentioned above, the timing and opening times of the inflation valves are variable in order to correctly correspond with the patient's heart rate, but preferably not less than approximately one hundred (100) milliseconds duration. At the end of a diastole, the deflation butterfly valve element 294 opens (even without electrical power) for a period of approximately fifty (50) to three hundred (300) milliseconds and preferably one hundred twenty (120) to two hundred twenty (220) milliseconds. It is desirable to make the period of opening of the deflation butterfly valve element 294 variable according to the heart rate, but with an opening time of not less than approximately one hundred twenty (120) milliseconds during normal operation. It should be noted that it would be possible to use three-way valves, as discussed above. It is important, however, to prevent cross-overleakage if such three-way valves are used when switching from the inflation port to the deflation port and vice versa. As illustrated in FIGS. 19 and 20 , the exemplary pressure regulator assembly 242 is a proportional-control pressure-relief valve, preferably providing for an adjustment range of approximately one (1) to approximately ten (10) psi for the tank 236 discussed above. Upon startup of the external counterpulsation apparatus 201 , a pressure regulation chamber 502 is vented to atmosphere. Once the compressor comes on and begins to pressurize the tank 236 , a control or load valve 504 of the pressure regulator assembly 242 remains open to an exhaust port 506 , providing for minimum tank pressure built-up. The flow of fluid to the pressure control chamber is controlled by the load valve 504 . When the load valve 504 is energized, compressed fluid will flow through a pathway 508 connecting the pressure regulation chamber 502 to a pressure control chamber 510 . As shown in FIG. 23 , the pressure control chamber 510 and pressure regulation chamber 502 are separated by a pair of diaphragms 518 . As long as the pressure in the pressure regulation chamber 502 is lower than the pressure in the pressure control chamber 510 , there is no fluid leak through the pressure exhaust port 506 . When the operator-selected pressure is reached, the load valve 504 is closed, pressure continues to build up in the reservoir and the pressure regulation chamber 502 will push a reservoir control piston 512 against the bias of spring 514 , opening the exhaust port 506 and leak the build-up pressure to atmosphere. When the pressure drops to the operator-selected pressure, i.e., the pressure in the pressure control chamber 510 , the reservoir control piston 512 will move back into cylinder 516 , closing the pressure exhaust port 506 . When the operator wants to lower the selected pressure, a bleed valve 518 is opened, leaking fluid from the pressure control chamber 510 , lowering its pressure, and the reservoir control piston 512 will again move against the bias of spring 514 , exposing the pressure regulation chamber 502 to the atmosphere through the exhaust port 506 , and thereby lowering the pressure in the pressure regulation chamber 502 . The bleed valve 518 is open to atmosphere via port 522 . FIG. 24 illustrates a similar embodiment, differing chiefly in that a single diaphragm 520 separates the control chamber 510 and the pressure regulation chamber 502 . When the rotary solenoid inflation/deflation valves open, a sudden drop in tank 236 pressure occurs. This sudden drop Is sensed by the dome diaphragm which instantly moves down closing the servo vent valve. Immediately, the pressure regulation chamber 502 pressure builds, causing the load valve 504 to close so that the compressor 234 can make up for the sudden tank pressure drop below the desired preset level. If operation of the subsequent inflatable cuff devices causes a drop in the tank pressure, the load valve 504 stays closed so that the tank pressure can recover to the desired preset pressure level in the shortest possible time. When the inflatable cuff devices 208 , 210 and 212 are exhausted, the tank pressure recovers quickly due to the fact that the compressor is constantly providing pressurized gas into the tank. When the desired tank pressure set point is reached, the dome diaphragm, sensing the increased tank pressure, moves up, thus opening the pressure exhaust port and reducing the pressure regulation chamber pressure to a value that holds the load valve open at a position that maintains the tank pressure at the desired preset level and exhausts the compressor flow into a muffler and exhaust system. Preferably the dome control solenoids operate at 24 volt DC 0.6 watts each. The orifice is preferably 0.031 inch in diameter, and the load and bleed valves are two-way two position solenoids, with the bleed valve preferably being a three-way two position solenoid. The load valve is preferably a two-way normally closed solenoid, using 24 volt DC to increase dome pressure. The bleed valve is a two-way normally closed solenoid, using 24 volt DC to decrease dome pressure. A power failure causes the vent port to open and vents the dome pressure, which correspondingly vents the tank pressure. In use, the operator can adjust magnitude of external counterpulsation treatment pressure to be applied to the patient using digital or analog means, as best shown in FIG. 22 . The output is either a digital voltage signal or a voltage proportional to the selected pressure. When the operator begins treatment of a patient, the source of compressed fluid, i.e., compressor 234 , is activated, sending compressed fluid through a valve, such as a solenoid valve or servo or proportional valve, which is controlled by computer 219 . The computer 219 compares the output from the pressure transducer in the reservoir (in analog form and translates to digital form using a analog-to-digital converter) and the operator-selected treatment pressure, and then controls the valve to direct compressed fluid to the reservoir to increase the pressure in the reservoir to the operator-selected level or vent the compressed fluid to atmosphere. When the inflation valve opens, pressure in the reservoir drops and the computer 219 closes the valve to atmosphere and directs compressed fluid to the reservoir to maintain its pressure at or near the operator-selected level. The computer 219 also provides damping means so that the pressure in the reservoir does not run-away in a wild swing to a high or low pressure, but maintains the pressure in the reservoir to within 10-20 mm Hg of the operator-selected level or set point. FIG. 23 depicts a computer system 318 for monitoring and recording the treatment of a patient who is receiving treatment from the external counterpulsation device of the present invention. As previously described, the computer system 318 is used to control the operations of the external counterpulsation device. The computer system 219 is further operable to monitor and record information associated with the treatment of the patient. More specifically, the computer system 318 includes a patient database 320 for storing demographic information for one or more patients; a patient treatment database 324 for storing treatment information for one or more patients; a site database 324 for storing information regarding the site of the patient treatment; and the computer 219 . For illustration purposes, the computer 219 is a personal computer (PC) having an associated user interface 220 , such as a touch screen monitor and keyboard. In this case, the data structures are defined in a storage device associated with the personal computer (e.g., an internal hard drive). More specifically, the data structure for the patient database may include patient identification, such as a number; patient name; patient address; patient medical history, including physician name, disease history, and emergency contact information; image data, such as magnetic resonance images, x-ray images, CAT scan images, etc.; hemodynamic data, such as blood pressure and blood flow information in waveform and data formats; and laboratory test results. The data structure for the patient treatment database may include patient identification; treatment time, such as inflation time, deflation time, and cumulative treatment time; ECG data (in waveform and data formats); plethysmograph data; applied pressure data (for a specific treatment session and cumulative); ECG electrode position; and ECG electrode type. The data structure for the site database may include site identification, such as a number; site name; site address; physician name; device operator name or ID; external counterpulsation device type; and external counterpulsation system configuration. As is mentioned or described in detail below, the user interface 220 is preferably a touch screen for easy monitoring of patient treatment status, treatment parameters, and other relevant data, and provides the capability for adjustment to control operation. As shown in FIG. 24 , the user Interface 220 or touch screen display includes patient data in the upper left hand portion of the display, which is in communication with the patient's data base allowing an operator to create a patient file for each new patient and allowing the system or apparatus 201 to track the accumulated treatment time for proper dosage for the patient. Ease of initiation and termination of operation is accomplished with three buttons on the top line of the display, namely a start button 336 for initiation and continuation of treatment; a standby button 338 that can be used to place the external counterpulsation apparatus 201 on “hold”, whenever the patient needs to rest, use a restroom, or otherwise temporarily pause the treatment, and to then resume when the patient returns to complete the treatment session; and an exit button 340 to stop treatment. The treatment timing function does not run when the standby button is selected, thus allowing it to keep track of total treatment time. The exit button 340 is provided to stop the treatment session for a particular patient and to record the elapsed treatment time in the patient database for use in future treatment sessions. An ECG display is included with timing markers 352 and bars 350 superimposed on or adjacent the ECG signal 342 for easy identification of inflation and deflation timing, which is illustrated by the graphic inflation/deflation timing markers and bars. The timing markers 352 are amplitude signals superimposed on the ECG signal 342 , and should not be misinterpreted as noise. Further, the markers 352 can be turned “on” or “off” for easier identification of the ECG signal 342 . The timing bars identify a trigger signal 353 , which can be checked against the ECG's R-wave, as well as the inflation and deflation times, which demonstrate the period of the cardiac cycle when external pressure is applied. This enables operators to easily identify and verify that they are not inflating the inflatable devices 208 , 210 , 212 during the cardiac systole, when the heart is pumping or ejecting blood. The user interface 220 also includes digital display of inflation and deflation time 358 , digital display of the magnitude of external pressure applied 370 , digital display of the intended treatment period 360 . The default treatment period is preferably 60 minutes. Inflation time, deflation time, magnitude of pressure applied, and treatment period can be manually adjusted by the operator. Digital display of the elapsed treatment time is also provided at 362 and the three pairs of inflatable devices can individually be turned “on” or “off” at 372 , which condition is easily identified and displayed in the lower right hand of the display screen. Further, the inflatable devices can be triggered on every heartbeat, or every other, at 374 . Moreover, control of printer functions is provided at 376 , including a five (5) second chart or continuous chart. A freeze-display option is provided at 378 , whereby a user can freeze the screen for extended examination. FIGS. 24 through 27 illustrate some exemplary control screens that help to better understand the functionality of the enhanced computer system 320 . As shown in FIG. 25 , a main menu screen 326 allows the operator to select from one of four options: (a) patient information, (b) site information, (c) ECP Treatment, or (d) system diagnostics. The patient information and site information options allow the operator to enter patient information and clinical site information, respectively, into the system. The ECP treatment option allows the operator to monitor and control the treatment of a patient; whereas the system diagnostic option allows the operator to simulate treatment of a patient for purposes of training the operator and/or testing the equipment of the external counterpulsation device. Referring to FIG. 26 , the patient information screen 328 permits the operator to input and/or edit demographic information for one or more patients. The patient demographic information may include (but is not limited to) the patient's name, address, phone number, sex, date of birth and other documentation relating to the medical treatment of the patient (e.g., medication, disease history, etc.). Once this information is entered for a new patient, it may be stored into the patient data structure 320 . Each new patient may also be assigned a randomly generated patient identification number that is stored in the patient data structure 320 . Similarly, the site information screen 330 permits the operator to input and/or edit information relating to the clinical site as shown in FIG. 28 . The site information may include (but is not limited to) the clinical site's name, address, phone number, facsimile number, and the name of the physician associated with the clinical site. The site information is stored in the site information data structure 324 . FIG. 24 , as discussed above, illustrates the primary treatment control screen 332 for monitoring and controlling the patient's treatment as provided by the external counterpulsation device of the present invention. Patient treatment information is prominently displayed in the center of the user interface. The upper waveform 342 is an electrocardiogram (ECG) signal taken from the patient. As will be apparent to one skilled in the art, the R wave portion of the ECG signal is typically used to monitor the cardiac cycle of the patient. The lower waveform 344 is a pressure signal indicative of the blood pressure of the patient. The pressure signal is also used to monitor the cardiac cycle of the patient as well as to monitor the counterpulsation waves being applied to the patient by the external counterpulsation device in a preferred embodiment, the pressure signal is further defined as a plethysmograph waveform signal as received from a finger plethysmograph probe. Two amplitude adjustment switches 346 and 348 are positioned just to the right of each of these waveforms which allow the operator to adjust the resolution at which the signals are viewed. Timing bars 350 are simultaneously displayed between the upper and lower waveforms. The timing bars 350 indicate when the inflation/deflation cycle is being applied to the patient by the external counterpulsation system. More specifically, the timing signal includes a timing bar for each inflation/deflation cycle, where the leading edge of the timing bar corresponds to the initiation of inflation and the trailing edge of the timing bar corresponds to the initiation of deflation. Further, the timing bars 350 include the trigger signal 353 , which indicates the time at which the inflation/deflation cycle is triggered. The safety and effectiveness of the external counterpulsation therapy depends on the precise timing of the inflation/deflation cycle in relation to the cardiac cycle of the patient. For instance, an arterial wall with significant calcium deposits (hardened artery) will transmit the external pressure pulse up the aorta faster than an elastic vasculature. Therefore, the inflation valves should be opened later for a calcified artery than for a normally elastic artery. Because it is difficult to measure the elasticity of the arterial wall, the operator may have to manually adjust the proper timing of the inflation valves by imposing the requirement that the arrival of the external pulse at the root of the aorta be after the closure of the aortic valves. The enhanced display of the three patient treatment signal enables the operator to more accurately adjust the timing of the inflation valves. This is one exemplary way in which the computer system of the present invention improves the patient treatment provided by the external counterpulsation device. To further improve the monitoring of the timing of the inflation/deflation cycle in relation to the cardiac cycle of the patient, timing markers 352 may be superimposed over the ECG signal. The timing markers 352 appear for each interval of an QRS wave on the ECG signal. The markers appear as high-frequency noise superimposed on the ECG wave to indicate inflation and deflation in relation to the ORS wave. As will be apparent to one skilled in the art, the amplitude of the signals are adequately sized so that the markers will not be misinterpreted as noise associated with the ECG signal. The timing markers switch 354 allows the operator to turn on/off the display of the timing markers 352 on the screen. The treatment control screen 332 also provides the switches for adjusting the timing of the inflation/deflation cycle. The inflation adjustment switch 356 allows the operator to adjust the setting of the time for the start of sequential inflation as it is measured relative to the R peak of the ECG signal. Each press of the left arrow causes the inflation to occur some predefined time increment earlier (e.g., ten (10) milliseconds); whereas the right arrow causes the inflation to occur some predefined time increment later. The current setting of the inflation start time is displayed on the middle window of the switch 356 . Likewise, the deflation adjustment switch 358 allows the operator to adjust the setting of the time for the start of deflation as it is measured relative to the R peak of the ECG signal. Deflation may be simultaneous or sequential. In addition, the treatment time for the patient is monitored and controlled by two additional interfaces. The treatment setting switch 360 allows the operator to set the time for the patient treatment. Again, each press of the left arrow causes an increase in the treatment time by some predefined time increment (e.g., one (1) minute) and each press of the down arrow decreases the treatment time by the same predefined time increment. The current setting of the treatment time is displayed on the middle window of the switch 360 . An elapsed treatment time display 362 shows the elapsed time of the current treatment session. Other patient treatment information may also be displayed and/or adjusted through the use of the treatment control screen 332 . For instance, a heart rate display 364 may show the heart rate of the patient and a diastolic/systolic ratio display 368 may show the peak ratio and the area ratio of the plethysmograph signal. These displays may be updated periodically, such as upon freezing the display or polling every predefined time period, or may be updated in real time. Additionally, a pressure adjustment switch 370 may be provided to allow the operator to adjust the inflation pressure of the compressed air. It is envisioned that other patient treatment information may be displayed and/or adjusted through various user interfaces as provided on the treatment control screen 332 . FIG. 28 is a block diagram or flow chart summarizing the procedures of the initiation operation and the automatic set up of the inflation/deflation logic for the external counterpulsation apparatus 201 . The opening of the inflation/deflation valves are performed by a power switch circuit which reads the values of T 1 and T 2 from memory. Even though the inflation time T 1 appears to be relatively short, i.e., less than one-half of the R-R interval, it represents the time at which the inflation signal is being sent to the power switching circuit to initiate opening of the inflation valves. It takes approximately twenty (20) milliseconds for the valves to fully open, approximately another thirty (30) milliseconds for the air pressure to arrive at the inflatable devices 208 , 210 , 212 , approximately another seventy (70) milliseconds to reach full inflation pressure, and approximately an additional two hundred (200) to three hundred (300) milliseconds for the applied pressure wave to travel from the peripheral vasculature of the legs and thighs to the root of the aorta. By that time, the systolic period would have already passed. For example, take a heart rate of sixty (60) beats per minute, the systolic time is approximately four hundred (400) to five hundred (500) milliseconds per beat. Therefore, for the applied pulse wave to arrive at the root of the aorta at the time the aortic valve closes, the inflation signal should start at about one hundred fifty (150) to two hundred (200) milliseconds after the R wave. In addition, it can be shown that the deflation time happens approximately one hundred sixty (160) milliseconds before the next R wave. Deflation valves for the lower leg and thigh cuffs open to the atmosphere for a duration of one hundred twenty (120) milliseconds. Because the decay time T 4 is eighty (80) milliseconds at the most for the inflatable device pressure to drop to zero (0), there is no residual pressure existing in the cuffs at the beginning of the next systolic phase, giving the peripheral vascular bed ample time to refill during cardiac systole. During the operation stage following the initiation stage, the values of T 1 and T 2 will be stored in memory and used to control the inflation/deflation timing. However, the memory will be updated with every new heartbeat using the updated TR to calculate the new T 1 and T 2 and stored in memory replacing the old T 1 and T 2 . In addition, the CPU will interrogate every ten (10) milliseconds a flag in one of the registers to determine if any of the manual adjustment buttons have been pushed. The inflation/deflation adjustment buttons 356 , 358 are located on the front panel (screen) for advancing or retarding the inflation or deflation times. Each depression of the inflation advance button will trigger the CPU to compare the vale (TR-T 1 ) to 200 ms. If (TR-T 1 ) is larger than two hundred (200) milliseconds, then T 1 will be lengthened by ten (10) milliseconds. This is done by adding ten (10) milliseconds to C 1 which has been initially set at approximately two hundred ten (210) milliseconds as used in T 1 =(12.65*TR+C.−300) milliseconds. The same logic is applied to limit the ability of advancing T 1 to approximately two hundred (200) milliseconds or less before the next R wave, in order to prevent the inflation valve of the lower leg cuffs from opening so late that not enough time remains for the deflation valves to open before the next R wave; keeping in mind the facts that the inflation valve for the thigh cuffs opens approximately fifty (50) milliseconds after T 1 and remains open for approximately another one hundred (100) milliseconds, leaving only approximately fifty (50) milliseconds for the pair of deflation valves to open before the next R wave. Since the logic used in controlling the manual adjustment of the deflation valves sets a limit for the deflation to open no later than approximately thirty (30) milliseconds before the next R wave, it is clear that the deflation valves will have to open to the atmosphere within approximately thirty (30) milliseconds after the inflation valve of the thigh cuffs is closed. The other manual inflation/deflation adjustment buttons 356 , 358 work on the same principle; that is, with each depression of one of the buttons, the CPU will check the conditions limiting the timing of the valves, and if the limits are not reached, then the timing for the inflation/deflation valves can be advanced or retreated by subtracting or adding ten (10) milliseconds to C 1 or C 2 of the above equation and the equation T 2 =(TR-C 2 ) milliseconds. The formula used in calculating T 1 is given by: T 1 =(12.65*√{square root over ( T R )} +C 1 −300) ms where the constant 12.65 is used instead of 0.4 when converting the unit of TR from seconds to milliseconds, and C 1 is a constant that is initially assigned with a value equal to two hundred ten (210) milliseconds. However, this value can be changed later by manual adjustment. The factor three hundred (300) milliseconds has been experimentally determined to be equal to the approximate maximum time it takes for the applied external pressure wave to travel from the lower leg to the aortic valves. After T 1 has been determined, it is comprised with a value of one hundred fifty (150) milliseconds. If T 1 is less than one hundred fifty (150) milliseconds, it is then set to one hundred fifty (150) milliseconds. If T 1 is larger than one hundred fifty (150) milliseconds, then the calculated value will be used. These procedures guarantee that the inflation valves will not open in less than one hundred fifty (150) milliseconds after the R wave. Even when T 1 is set at one hundred fifty (150) milliseconds, the leading edge of the pressure wave will not arrive at the aortic root until approximately three hundred fifty (350) milliseconds after the R wave, taking into account the time required for the pulse to travel up from the peripheral vasculature to the root of the aorta. Once the value of T 1 has finally been determined, it is used to calculate T 2 using the following formula: T 2=( TR−C 2) ms where the constant C 2 is initially set at one hundred sixty (160) milliseconds and can be increased or decreased later by manual adjustment. From this equation, it is clear that the deflation valves open one hundred sixty (160) milliseconds before the next R wave. C 2 , however, can be increased or decreased manually to achieve an optimal hemodynamic effect. The logic used in the timing of the inflation/deflation valves fulfill two basic criteria: (1) the inflation valves must not be opened so that the pressure pulse wave reaches the root of the aorta during systole, forcing the aortic valve to close prematurely, thereby creating systolic loading; and (2) the deflation valves must be opened to the atmosphere before the next R wave to allow enough time for the air pressure in the cuffs to decay to zero so that there is no residual pressure causing a tourniquet effect. Finally, the inflation/deflation valves will not be operational when the heart rate is higher than one hundred twenty (120) beats per minute or lower than thirty (30) beats per minute. The inflation/deflation valve timing logic controls the timing of external pressure applied to the lower legs and thighs of the patient. A diagram of how the inflation/deflation valves are connected to the compressor and air tank is shown in FIG. 9 . The inflation/deflation timing logic is divided into two main parts: (1) the initiation stage upon power up during which the inflation/deflation times are set up automatically; and (2) the operation stage during which the inflation and deflation time can be adjusted manually. The operations of these timing logic systems are controlled by a microprocessor, and no signal will be sent out to the inflation/deflation valve power supply when the heart rate is higher than one hundred twenty (120) beats per minute or lower than thirty (30) beats per minute. As shown, there are three (3) inflation valves and three (3) deflation valves. One pair of inflation/deflation valves are for the calves, one pair for the lower thighs, and one pair for the upper thighs. The valves are normally open, and selectively closed when energized. Upon receipt of a signal from the inflation/deflation timing control, electrical power to the inflation valves will be switched on for a period of one hundred (100) milliseconds and will open them to the air tank. Similarly, upon receipt of the deflation valve signal, power to the deflation valves will be switched on for a period of one hundred twenty (120) milliseconds and will open the lower leg and thigh cuffs to the atmosphere. In addition, two safety valves can be provided, each of them located between the inflation valve and the cuffs. The safety valves are normally open to air. These two optional valves (not shown) are independent of the logic controlling the inflation/deflation valves. They are installed in case of power failure so that pressure remaining in the leg and thigh cuffs can be vented to the atmosphere automatically. During initiation stage when power is turned on, the computer 214 of the control console 202 will start a series of initiation procedures. The first step is to maintain the deflation valves open to atmosphere. Each deflation valve will remain open for one hundred twenty (120) milliseconds, or long enough to relieve all the air pressure from the leg and thigh cuffs. The computer 219 will then look for the input of the electrocardiogram (ECG) and determine the presence of the QRS complex. If the QRS complex is not detected, the inflation/deflation valves 208 , 210 , 212 will not be activated and the external counterpulsation will not start. The inflation valves will remain open to atmosphere; no compressed gas will enter the inflatable devices 208 , 210 , 212 from the tank 236 . After the detection of four (4) complete R-R intervals, the CPU will determine their average (TR), and will update TR by taking the mean of the last TR and the new R-R interval. Meanwhile, the two constants used for the calculation of inflation time T 1 and deflation time T 2 will be initiated with the values C 1 =210 milliseconds and C 2 =160 milliseconds. Definitions of T 1 and T 2 and other variables are shown diagrammatically in the example of FIG. 29 . They are: TR(R-R interval): average R-R interval in ms. T 1 (inflation time): interval from R wave to the opening of lower leg inflation valve in ms. Note that the inflation valve for the thigh cuffs open twenty to seventy milliseconds, and preferably fifty milliseconds after T 1 . In addition, inflation valves are normally closed. However, they will be opened for a duration of one hundred milliseconds or more when energized. TD(duration time): interval between the opening of the lower leg inflation valve and the opening of the deflation valves for both the lower legs and thighs in milliseconds. T 2 (deflation time): interval from R wave to the opening of, the deflation valves in milliseconds. Note that the deflation valves for both lower leg and thigh cuffs are normally open to the atmosphere, but are selectively closed when energized. This opening time has been experimentally determined to be approximately at least forty (40) milliseconds longer than the pressure decay time T 4 . T 3 (pressure rise time): interval between the time when the air pressure in the lower leg or thigh cuffs is zero (0) and the time when it reaches equilibrium with the pressure in the reservoir. This value has been measured experimentally under many different situations with various cuff sizes and is equal to approximately fifty (50) milliseconds. T 4 (pressure decay time): interval for the air pressure in the cuffs to drop to zero when the deflation valves are opened to the atmosphere. The value of T 4 has been determined in a variety of situations with various cuff sizes and has an average value of eighty (80) milliseconds. A diagrammatic representation of the time for inflation/deflation valves and air pressure waveforms for the three pair of cuffs shown in FIG. 29 . The patient electrocardiogram (ECG) using a 3-lead system is digitized and the R-R interval TR determined. The R-wave is then used as a triggering signal. The inflation time T 1 for the lower leg cuffs is calculated according to the square root formula of Bazett (see FDA 510(K) submission K882401, incorporated herein by reference): T 1 =(12.65*√{square root over ( T R )} +C 1 −300) ms where C 1 is a constant with an initial value of two hundred ten (210) milliseconds. The inflation time can be adjusted manually, and the adjustment changes the C 1 value. Therefore application of external pressure to the body begins with the lower leg T 1 milliseconds after the ORS complex. Inflations of the lower thigh cuffs begin approximately twenty (20) to seventy (70) milliseconds, and preferably fifty (50) milliseconds after the inflation of the lower leg cuffs, and the upper thigh cuffs will be inflated approximately twenty (20) to seventy (70) milliseconds, and preferably fifty (50) milliseconds after the lower thigh cuffs. The initial value assigned to T 1 (as discussed above) is based on the square root formula of Bazett (Heart 7:353,1920) which approximates the normal Q-T interval of the ECG as the product of a constant (0.4) times the square root of the R-R interval measured in seconds. The Q-T interval is measured from the beginning of the QRS complex to the end of the T wave. It represents the duration of ventricular electrical systole and varies with the heart rate; it can be used to approximate the hemodynamic systolic interval. The foregoing discussion discloses and describes merely exemplary embodiments of the present invention for purposes of illustration. One skilled in the art will readily recognize from such discussion, and from the accompanying drawings and claims, that various changes, modifications, and variations can be made therein without departing from the principles, spirit or scope of the invention as defined in the following claims.

A method of controlling an external counterpulsation apparatus includes selecting a patient treatment pressure; outputting a signal corresponding to the selected treatment pressure; detecting a pressure of a compressed fluid reservoir; comparing the selected treatment pressure to the compressed fluid reservoir pressure; and controlling a pressure regulator valve based on a difference between the patient treatment pressure and the compressed fluid reservoir pressure. The compressed fluid reservoir pressure may be decreased when the compressed fluid reservoir pressure is greater than a preset difference from the patient treatment pressure, particularly by venting the compressed fluid reservoir to atmosphere. The compressed fluid reservoir pressure may be necessary when the compressed fluid reservoir pressure is less than a preset difference from the patient treatment pressure, particularly by operating a compressor.

CROSS REFERENCE TO RELATED APPLICATION The present application claims the priority of U.S. Provisional Application No. 60/719,322, filed Sep. 21, 2005. BACKGROUND AND SUMMARY The present invention relates to an apparatus and method for determining and displaying functional residual capacity data and other pulmonary parameters, such as positive end expiratory pressure (PEEP) data, for patients breathing with the aid of a mechanical ventilator, such as a critical care ventilator. The invention also determines and displays relationships between these and other parameters. Functional residual capacity (FRC) is the gas volume remaining in the lungs after unforced expiration or exhalation. Several methods are currently used to measure functional residual capacity. In the body plethysmography technique, the patient is placed in a gas tight body box. The patient's airway is sealingly connected to a breathing gas conduit connected to the exterior of the body box. By measuring lung pressures and pressures in the box, at various respiratory states and breathing gas valve flow control conditions, the functional residual capacity of the patient can be determined. Another technique for measuring functional residual capacity is the helium dilution technique. This is a closed circuit method in which the patient inhales from a source of helium of known concentration and volume. When the concentration of helium in the source and in the lungs has reached equilibrium, the resulting helium concentration can be used to determine the functional residual capacity of the patient's lungs. A further technique for determining functional residual capacity is the inert gas wash-out technique. This technique is based on a determination of the amount of gas exhaled from the patient's lungs and corresponding changes in gas concentrations in the exhaled gas. The gas used for the measurement is inert in the sense that it is not consumed by metabolic activity during respiration. While a number of gases may be used for such a measurement of functional residual capacity, it is convenient to use nitrogen for this purpose. In a straightforward example in which the patient is initially breathing air, the lung volume forming the functional residual capacity of the lung will contain nitrogen in the same percentage as air, i.e. approximately 80%, the remaining 20% of air being oxygen. In a wash-out measurement, the subject commences breathing gases in which oxygen is at a different concentration than 20%. For example, the patient commences breathing pure oxygen. With each breath, nitrogen in the lungs is replaced by oxygen, or, stated conversely, the nitrogen is “washed out” of the lungs by the oxygen. While the breathing of pure oxygen could continue until all nitrogen is washed out of the lungs, in most cases, the breathing of oxygen continues until the nitrogen concentration in the exhaled breathing gases falls below a given concentration. By determining the volume of inert gas washed out of the lungs, and knowing the initial concentration of the inert gas in the lungs, the functional residual capacity of the lungs may be determined from these quantities. Methods for determining functional residual capacity in this manner are well known and are described in such literature as The Biomedical Engineering Handbook, CRC Press, 1995, ISBN 0-8493-8346-3, pp. 1237-1238, Critical Care Medicine, Vol. 18, No. 1, 1990, pp. 8491, and the Yearbook of Intensive Care and Emergency Medicine, Springler, 1998, ISBN 3-540-63798-2, pp. 353-360. By analogy to the above described wash out measurement technique, it is also possible to use a wash in of inert gas for measurement of functional residual capacity. Such a method and apparatus is described in European Patent Publication EP 791,327. The foregoing methods are used with spontaneously breathing patients and are typically carried out in a respiratory mechanics laboratory. But in many cases, patients that could benefit from a determination of functional residual capacity are so seriously ill as to not be breathing spontaneously but by means of a mechanical ventilator, such as a critical care ventilator. This circumstance has heretofore proven to be a significant impediment in obtaining functional residual capacity information from such patients. Additionally, the patient's illness may also make it impossible or inadvisable to move the patient to a laboratory or into and out of a body box for the determination of functional residual capacity. It would therefore be highly advantageous to have an apparatus and method by which the functional residual capacity of mechanically ventilated patients could be determined. It would be further advantageous to associate the apparatus for carrying out the determination of functional residual capacity with the ventilator to reduce the amount of equipment surrounding the patient and to facilitate set up and operation of the equipment by an attending clinician. Such apparatus would also enable the determination of functional residual capacity to be carried out at the bedside of the patient, thus avoiding the need to move the patient. A single determination of functional residual capacity provides important information regarding the pulmonary state of the patient. However, it is often highly desirable from a diagnostic or therapeutic standpoint to have available trends or changes in the functional residual capacity of a patient over time. It would also be helpful to be able to relate functional residual capacity to other pulmonary conditions existing in the lungs or established by the ventilator and to changes in these conditions. For example, it is known that the pressure established by the ventilator in the lungs at the end of expiration, the positive end expiratory pressure or PEEP, affects the functional residual capacity of the lungs. Typically, an increase in PEEP increases functional residual capacity. There are two components to the increased functional residual capacity as PEEP is increased. One component is due to stretching of the lung by the increased pressure. A second component, particularly in diseased lungs, occurs from the effect of PEEP during breathing by the patient. As a patient expires, the pressure in the lungs drops until it approaches airway pressure. As the pressure within the lungs drops, the alveoli or air sacs in the lungs deflate. If alveolar sacs collapse completely, more pressure is required upon inspiration to overcome the alveolar resistance and re-inflate the alveolar sacs. If this resistance cannot be overcome, the volume of such sacs are not included in the functional residual capacity of the patient's lungs. By applying PEEP in the patient's airway, the additional pressure in the patient's lungs keeps more of these alveolar sacs from completely collapsing upon expiration and, as such, allows them to participate in ventilation. This increases the functional residual capacity of the patient's lungs and the increase is often described as “recruited volume.” Volume reductions are termed “de-recruitments.” However, setting the PEEP too high can cause excessive lung distension. There may also be compression of the pulmonary bed of the lung, loading the right side of the heart and reducing the blood volume available for gas exchange. Either of these circumstances present the possibility of adverse consequences to the patient. Still further, action such as performing a suction routine, administering a nebulized medication, or changing the ventilation parameters of the ventilator can also influence functional residual capacity and it would be helpful to be able to easily determine the effect of such actions on functional residual capacity. An apparatus and method that would possess the foregoing characteristics and that would easily and cogently make such information available would be highly beneficial in conveniently obtaining a full understanding of the pulmonary condition of the patient and how the patient is reacting to the mechanical ventilation and to any associated therapeutic measures. The clinician could then carry out appropriate action beneficial to the patient in a timely and informed manner. BRIEF DESCRIPTION OF THE PRESENT INVENTION An embodiment of the present invention comprises an apparatus and method that achieves the desired, highly advantageous features noted above. Thus, with the present invention the functional residual capacity of a mechanically ventilated patient may be determined at the bedside of the patient without the need to move the patient to a laboratory. By associating the apparatus with the ventilator, only a single device need be employed to both ventilate the patient and determine functional residual capacity. The determined functional residual capacity may be advantageously displayed in conjunction with earlier determinations and in conjunction with other pulmonary conditions, such as PEEP. Changes, or trends, in functional residual capacity over time may thus be discerned, along with changes in the other pulmonary conditions. Additionally, the apparatus and method provides a log of events having the potential to impact the functional residual capacity of the patient and/or its accurate determination. Such events may include suctioning the patient, administering a nebulized medication to the patient, performing a lung recruitment maneuver, and altering the PEEP or other ventilator parameters. The apparatus may also automate functional residual capacity measurement in conjunction with these types of events. For example, it is desirable to provide that functional residual capacity measurements be automatically conducted immediately before and after nebulized drug therapy in order to precisely gauge the effect of the nebulization treatment. The foregoing provides an attending clinician with significant information for assessing the state of, and trends in, the functional residual capacity of the patient, as well as the relationship between the patient's residual capacity and the other factors, so that the clinician can fully discern the functional residual capacity condition of the patient. Further features of the apparatus and method of the present invention will be apparent from the following detailed description, taken in conjunction with the associated drawing. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a general diagram of a mechanical ventilator and associated apparatus for ventilating a patient. FIG. 2 shows an endotracheal tube with a tracheal pressure sensor suitable for use in the present invention. FIG. 3 shows a ventilator display unit presenting an initial display screen for use in the present invention. FIG. 4 is a chart showing the relationship among a plurality of screens employed in the present invention. FIG. 5 shows a display screen for displaying functional residual capacity data and related data. FIG. 6 shows a display for use in scaling the display shown in FIG. 5 . FIG. 7 is a flow chart showing the steps for carrying out a measurement of functional residual capacity in accordance with a method of the present invention. FIG. 8 shows a display displaying a log of events and actions that may impact the determination of functional residual capacity. FIG. 9 shows a display showing spirometry data. FIG. 10 shows a display for making setup adjustments for the screen shown in FIG. 9 . FIG. 11 shows a tabular display displaying fictional residual capacity values with periodically obtained ventilator operating data and/or patient condition data. FIG. 12 shows a graphic display displaying functional residual capacity values with periodically obtained ventilator operating data and/or patient condition data. DETAILED DESCRIPTION The Mechanical Ventilator and Airway Gas Module FIG. 1 shows mechanical ventilator 10 for providing breathing gases to patient 12 . Ventilator 10 receives air in conduit 14 from an appropriate source, not shown, such as a cylinder of pressurized air or a hospital air supply manifold. Ventilator 10 also receives pressurized oxygen in conduit 16 also from an appropriate source, not shown, such as a cylinder or manifold. The flow of air in ventilator 10 is measured by flow sensor 18 and controlled by valve 20 . The flow of oxygen is measured by flow sensor 22 and controlled by valve 24 . The operation of valves 20 and 24 is established by a control device such as central processing unit 26 in the ventilator. The air and oxygen are mixed in conduit 28 of ventilator 10 and provided to inspiratory limb 30 of breathing circuit 32 . Inspiratory limb 30 is connected to one arm of Y-connector 34 . Another arm of Y-connector 34 is connected to patient limb 36 . During inspiration, patient limb 36 provides breathing gases to lungs 38 of patient 12 . Patient limb 36 receives breathing gases from the lungs of the patient during expiration. Patient limb 36 may include components such as a humidifier for the breathing gases, a heater for the breathing gases, a nebulizer, or a water trap (not shown). The breathing gases expired by patient 12 are provided through patient limb 36 and Y-connector 34 to expiratory limb 46 of breathing circuit 32 . The expired breathing gases in expiratory limb 46 are provided through valve 54 and flow sensor 56 for discharge from ventilator 10 . Valve 54 may be used to establish the PEEP for patient 12 . Patient limb 36 includes gas flow and pressure sensor 57 which may be of the type shown in U.S. Pat. No. 5,088,332. A pair of pressure ports and lines 58 , 60 are placed on either side of a flow restriction in the sensor and the pressure difference developed across the flow restriction is used by flow measurement unit 62 in gas module 64 to measure gas flow in patient limb 36 . One of the pressure lines is connected to pressure measurement unit 66 to measure the pressure in patient limb 36 . Sensor 57 also provides for a gas sampling line 68 which is connected to gas analyzer 70 . Gas analyzer 70 may measure the amount of oxygen and carbon dioxide in the breathing gases. Knowing the amounts of oxygen and carbon dioxide in the breathing gases enables the amount of nitrogen to be determined as the total amount of breathing gas less the amounts of carbon dioxide and oxygen. Respiratory and metabolic gas module 64 may comprise that made and sold by GE Healthcare as a Datex-Ohmeda MCOVX gas module. The output of gas module 64 is provided in data bus 72 to central processing unit 74 in ventilator display unit 76 . Central processing unit 26 in ventilator 10 is also connected to central processing unit 74 via data bus 78 . The Endotracheal Tube To obtain an accurate indication of the pressure in lungs 38 of the patient 12 , endotracheal tube 90 shown in FIG. 2 may be used. Endotracheal tube 90 has end 92 for connection to patient limb 36 . In use, endotracheal tube 90 extends through the mouth and into the trachea of patient 12 to provide an airway passage to lungs 38 . Endotracheal tube 90 includes pressure sensor catheter 94 that extends from end 96 to provide a pressure sampling point that is close to lungs 38 of patient 12 when the endotracheal tube is inserted in the patient and can thus obtain a highly accurate indication of the pressure in the lungs. An intermediate portion of catheter 94 may lie within endotracheal tube 90 . The proximal portion exits the endotracheal tube and is connected via A-A to a pressure transducer and to an auxiliary input to ventilator display unit 76 . The pressure obtained from catheter 94 is termed Paux. While FIGS. 1 and 2 show a connection to ventilator display unit 76 for this purpose, the connection may, alternatively, be to gas module 64 . An endotracheal tube of the type shown in FIG. 2 is described in U.S. Pat. No. 6,315,739. Ventilator Display Unit Display unit 76 of ventilator 10 receives information from the ventilator and gas module 64 and is used by the clinician to control, via data bus 78 , the pneumatic control components of ventilator 10 that deliver breathing gases to patient 12 . Additionally, central processing unit 74 in display unit 76 carries out the determination of functional residual capacity, recruited/de-recruited volumes, and other quantities employed in the present invention. It will be appreciated that other CPU configurations, such as a single CPU for the ventilator and its display unit may be used, if desired. Ventilator display unit 76 includes user interface 100 and display 102 . Display 102 is shown in greater detail in FIG. 3 . Display 102 is divided into a number of display portions 102 a - g for displaying inputted, sensed, and computed information. Display portions 102 a through 102 f relate primarily to the operation of ventilator 10 and the ventilation of patient 12 and are discussed briefly below. Display screen portion 102 g displays information and relationships in accordance with the present invention, as described in detail below. Display portion 102 a provides for the display of operating information of ventilator 10 . The portion shows the type of ventilation being performed by ventilator 10 , in the exemplary case of FIG. 3 , synchronized, intermittent, mandatory ventilation, or SIMV-volume controlled ventilation. Portion 102 a also provides a display of operating information inputted into ventilator 10 including the percentage of oxygen for the breathing gases, tidal volume (TV), breathing rate, inspiration time (T insp ), amount of positive end expiratory pressure (PEEP) and the pressure limit (P limit ) set for the volume controlled ventilation. To input these operating parameters into ventilator 10 , an appropriate one of buttons 104 a through 104 f is actuated. Control knob 106 is rotated to enter a desired value for the selected option and pressed to confirm the new parameter value. Further ventilator functions may be controlled by pressing a button that controls a specialized function such as ventilator setup button 73 that establishes other ventilation modes for patient 12 , spirometry button 75 for showing and controlling the display of spirometry information, 100% 0 2 button 77 , nebulizer button 79 , and procedures button 80 that controls specialized procedures for ventilator 10 . Display portion 102 b of display 102 shows airway pressure data as measured from sensor 57 . Portion 102 c shows textual information relating to the flow of breathing gases to the patient obtained from sensor 57 , and portion 102 d shows pressure data from catheter 94 in the endotracheal tube 90 during ventilation of patient 12 . Portion 102 e of display 102 shows the information in portions 102 b , 102 c , and 102 d in graphic form and includes an indication of certain other operating information, such as the mode of ventilation SIMV-VC, and whether certain features of the present invention are operational or not. Display portion of 102 shows additional data as selected by the clinician. In the example of FIG. 3 end tidal CO 2 (E t CO 2 ), lung compliance, expiratory alveolar minute volume (MVe(alv)), respiratory rate, total positive end expiratory pressure, and inspiratory alveolar minute volume (MVi(alv)) are being shown. Display portion 102 a - f remain generally unchanged as the present invention is practiced although, as noted above, the clinician may select the information to be shown in certain portions, such as portion 102 f. Display Screen of Present Invention Display screen 102 g is the part of display 102 employed in the present invention. As shown in FIG. 4 and in FIGS. 5 , 6 , 8 , 9 , and 10 , the content of this screen will change, depending on the inventive feature being utilized, the different content in screen 102 g being identified as 102 g 1 , 102 g 2 , 102 g 3 , etc. in the appropriate figures of the drawing. In general, each screen 102 g will include a menu or control portion 108 , a graphic portion 110 and tabular portion 112 . For this purpose, graphic portion 110 contains a pair of orthogonal axes by which data can be graphically presented. The clinician may navigate and control the screen using control knob 106 . Control knob 106 is rotated to scroll through the menu options displayed in menu portion 108 , depressed to select a menu option, rotated again to establish a numerical value for the selected option when appropriate, and depressed again to enter the value into ventilator display unit 76 or to confirm selection of the menu option. FIG. 3 shows an initial content for screen 102 g relating to spirometry. As hereinafter noted, spirometry illustrates the relationship between inspired gas volumes and the pressure in the lungs as the patient breathes. The graphic form of the data is normally in a loop, one portion of which is formed during inspiration and the other portion of which is formed during expiration in the manner shown in FIG. 9 . The tabular portion 112 provides fields in which various obtained and computed ventilation and lung properties may be displayed. Menu portion 108 allows the clinician to select a number of options with respect to the display and use of the information shown in graphic and tabular portions 110 and 112 . Menu portion 108 also allows the clinician to select a further screen at 116 for adjusting the scaling for the abscissa and ordinate of graph 110 and the setup for spirometry measurements at 118 . From menu portion 108 , the clinician may also select screens that allow the functional residual capacity (FRC) features of the present invention and the spirometry features of the present invention to be carried out by selecting items 120 and 122 , respectively. The spirometry features of the present invention are identified by applicant as SpiroDynamics or the abbreviation SpiroD. FIG. 4 shows the architecture of the screens 102 g used in the present invention. As noted above, the spirometry screen shown in FIG. 3 as screen 102 g 1 is the initial screen appearing as screen 102 g . Also as noted above, associated with this screen are screens for spirometry scaling and spirometry setup By means of menu items 120 and 122 , the clinician can select either a screen relating to functional residual capacity, namely screen 102 g 2 shown FIG. 5 or a screen relating to SpiroDynamics comprising screen 102 g 3 of FIG. 9 . The screen format of FIG. 5 is termed “FRC INview.” The view of FIG. 9 is termed “spiroD”. The FRC INview showing of 102 g 2 includes screen shown in FIG. 6 that allows for scaling of the quantities shown graphically in FIG. 5 . A further selection on the FRC INview screen allows the clinician to select the FRC log screen shown in FIG. 8 as screen 102 g 4 . FRC Determination and Display The flow chart of FIG. 7 shows a method of the present invention for determining and displaying functional residual capacity information for patient 12 . The clinician uses a screen in the format of 102 g 2 of FIG. 5 . It is assumed that the clinician has previously established an oxygen percentage for the breathing gases to be provided by ventilator 10 using button 104 a , control knob 106 and screen region 102 a , at step 200 . In the example shown in FIG. 3 , the oxygen percentage is 50%. Ventilator 10 can be operated with the set percentage of oxygen to provide breathing gases to patient 12 at step 202 . As noted above, in order to determine the functional residual capacity of patient 12 by a gas wash-out/wash-in technique, it is necessary to alter the composition of the breathing gases supplied to patient 12 . To this end, the clinician sets a different level for the oxygen content of the breathing gases. This is performed by selecting the FRC 0 2 field 206 in menu portion 108 of screen 102 g 2 and appropriately establishing the FRC 0 2 value. The amount of change may be an increase or decrease from the previously set level established at step 200 ; however it must be an amount sufficient to perform the functional residual capacity analysis. A change of at least 10% is preferable in order to obtain an accurate indication of the functional residual capacity. To ensure that appropriate oxygen concentrations are supplied to patient 12 it is usually desired to increase the oxygen level and, unless the current oxygen level is very high (greater than 90%), a default setting of a 10% increase over the current setting may be provided. The level of oxygen set by the clinician “tracks” changes made in the oxygen content of the breathing gases at the ventilator, as for example by actuating button 104 a . Thus, for example, if the ventilator oxygen is originally 50% as shown in FIG. 3 , and the FRC 02 shown in FIG. 5 is 60%, if the ventilator oxygen setting is later changed to 70%, the FRC 02 amount will automatically move to 80%. Lowering the ventilator oxygen setting, however, will not result in lowering the FRC 02 amount, thereby avoiding the possibility of low oxygen breathing gases for the patient. The alteration of the oxygen content of the breathing gases is carried out in step 208 of FIG. 7 . For exemplary purposes, below, an alteration in the form of an increase to 75% O 2 is shown in FIG. 5 . Next, the clinician must select the frequency, or interval, at which the functional residual capacity measurements will be carried out. This is performed at step 210 . A single functional residual capacity determination by the present method may be selected by the appropriate field 212 in menu 108 . Alternatively, a series of FRC determinations or cycles may be selected, with a series interval, set in field 214 , between each determination. The interval is typically between one and twelve hours in increments of one hour but may be more frequent. The time when the next functional residual capacity determination begins is shown in field 248 . Alternatively, functional residual capacity measurements can be set to occur automatically in conjunction with certain procedures controlled by ventilator 10 , such as immediately prior and/or after a period of nebulized drug therapy, recruitment maneuvers, a suction procedure, or a change in ventilator setting. Functional residual capacity measurement may be initiated, terminated, delayed, interrupted, or prevented in accordance with the occurrence of events, such as those noted above, that may affect the accuracy of the functional residual capacity measurement. For example, a functional residual capacity measurement may be terminated for a high oxygen procedure for patient 12 and then resumed or started after a “lock out” period. The initial or base line amount of nitrogen in the expired breathing gases is determined at step 216 . As noted above this may be determined by subtracting the amounts of oxygen and carbon dioxide, as determined by gas analyzer 70 , from the total amount of the breathing gases, as determined using flow measurement unit 62 . While the present invention is described using nitrogen as the inert gas, it will be appreciated that other inert gas may also be used. For example, the breathing gases for patient 12 may include the inert gas helium and amounts of helium expired by the patient could be used in a functional residual capacity measure in the manner described herein. To commence the determination of functional residual capacity, breathing gases having the increased amount of oxygen shown in data field 206 are provided to patient 12 in step 218 . The increased percentage of oxygen in the breathing gases will wash a portion of the nitrogen or other inert gas out of lungs 38 of patient 12 with each breath of the patient. The amount of breathing gases inspired and expired by patient 12 with each breath, i.e. the tidal volume, is a lung volume that is in addition to the residual volume of the lungs found after expiration. The tidal volume is also smaller than the residual volume. For a healthy adult a typical tidal volume is 400-700 ml whereas the residual volume or functional residual capacity is about 2000 ml. Therefore, only a portion of the nitrogen in the lungs 38 of patient 12 is replaced by the increased amount of oxygen with each breath. The amount of nitrogen washed out of the lungs in each breath is determined by subtracting the amount of oxygen and carbon dioxide from the amount of breathing gases expired by patient 12 during each breath obtained using flow measurement unit 62 . See step 220 . Knowing the amounts of expired breathing gases, the initial amount of expired nitrogen and the amount expired in each expiration by patient 12 , a functional residual capacity quantity can be determined for each successive breath in steps 222 a , 222 b . . . 222 n . Any inert gas wash out/wash in functional residual capacity measurement technique may be used, a suitable technique for determining functional residual capacity for use in the present invention being described in U.S. Pat. No. 6,139,506. The functional residual capacity quantity as determined after each successive breath, will tend to increase as nitrogen continues to be washed out of the lungs of the patient by the increased oxygen in the breathing gases. This results from the fact that the breathing gases that are inspired by patient 12 , i.e., the tidal volume, are not fully equilibrated inside the entire functional residual capacity volume before being exhaled by the patient. In particular, functional residual capacity volume that lies behind intrinsic lung resistance does not mix as quickly with inspired gases compared to functional residual capacity volume that is pneumatically connected to the trachea through a lower resistance path. As such, the magnitude of breath-to-breath increases in functional residual capacity that are noted are an indication of the amount of intrinsic resistance within the lung gas transfer pathways. Thought of another way, additional functional residual capacity volume that is registered many breaths into the functional residual capacity measurement procedure is lung volume that is not participating well in the gas transfer process. As the determination of functional residual capacity proceeds, the determined values for functional residual capacity for the breaths are displayed in graphic portion 110 of screen 102 g 2 as a capacity or volume curve 224 in steps 226 a , 226 b . . . 226 c at the end of the determination for each breath. This confirms to the clinician that the determination of functional residual capacity is working properly. Also, as curve 224 forms from left to right, the shape of the curve is an indication to the clinician of the intrinsic resistance and quality of ventilation of lung functional residual capacity, as discussed above. In the example shown, the clinician can appreciate that patient 12 has a homogeneously ventilated lung volume, as indicated by the qualitative flatness of the functional residual capacity curve, with a lung residual capacity of about 2500 ml. The scaling of graph 110 of FIG. 5 may be automatically altered to provide a scale appropriate to the fictional residual capacity data being shown. It will be appreciated that, if desired, the data relating breath number to the corresponding functional residual capacity value can also be displayed in tabular form in the display of ventilator display unit 76 . This could comprise a column containing the breath numbers and a column containing the corresponding functional residual capacity values. Mechanical ventilator 10 continues to supply breathing gases having increased oxygen concentration for x number of breaths, for example, 20 breaths. A final value for functional residual capacity is determined at the end of the x breaths at step 228 and volume or capacity curve 224 extends to this breath to show the final determination of functional residual capacity at the end of 20 breaths. Thereafter, at step 230 the concentration of oxygen in the breathing gases is altered to the original level of, for example 50%, set at step 200 and ventilator 10 is operated at step 232 to repeat steps 216 - 228 to make a second determination of functional residual capacity with this alteration of the oxygen concentration in the breathing gases. It will be appreciated that this determination uses a wash-in of nitrogen, rather than a wash-out. This second determination is graphed and displayed in graphic portion 110 as graph 234 , in the same manner as graph 224 , described above. The values for the two final functional residual capacity determinations are shown in data field 237 of tabular portion 112 of screen 102 g 2 in step 236 . In the example shown, these values are 2500 and 2550 ml. For future use, the final determination of functional residual capacity made in step 232 is compared to that determined in step 228 . This is carried out at step 238 . It is then determined, in step 240 , whether the difference between the two determinations of functional residual capacity is less or greater than some amount, such as 25%. If the difference is less than 25%, the two values are averaged and will be subsequently displayed in text form in data field 245 in step 244 when the determination becomes part of the chronological record following a later functional residual capacity determination. If the difference between the two values for the functional residual capacity is greater than some amount, such as than 25%, both the final value determined at step 228 and the final value determined in step 232 will be displayed by step 246 in data field 245 of FIG. 5 and in the graph 110 . This display of the functional residual capacity determination informs the clinician that the accuracy of the functional residual capacity determination is questionable. The final value(s) for the functional residual capacity are preferably displayed in tabular portion 112 of screen 102 g 2 along with additional associated data such as the time and date at which functional residual capacity was determined, or the values of PEEPe and PEEPi existing when the functional residual capacity determination was made. PEEPe is the end expiratory pressure established by ventilator 10 . PEEPi, also known as auto PEEP, is the intrinsic end expiratory pressure and is a measurement in pressure of the volume of gas trapped in the lungs at the end of expiration to the PEEPe level. While the determination of functional residual capacity has been described as being carried out for a given number of breaths, such as 20, it can be terminated sooner if it is apparent that the functional residual capacity measurement has become stable on a breath-to-breath basis. This can be conveniently determined by measuring the O 2 content of the expired breathing gases at the end of the patient's expirations, that is, the end tidal oxygen level. When the amount of oxygen in the expired breathing gases remains unchanged for a predetermined number of breaths, it is an indication that the wash out/wash in the inert gas is complete and that the functional residual capacity determination can be terminated. Thereafter, if a series of functional residual capacity determinations has been selected at step 210 , steps 218 through 246 are repeated after the time interval indicated in data field 214 with the start of the functional residual capacity determination occurring at the time displayed in data field 248 . The predetermined time interval may be overridden or the functional residual capacity determination terminated by appropriate commands from the clinician entered into menu 108 . The volume curves, such as 224 , 234 , and functional residual capacity data, such as that in field 237 , generated in the course of successive functional residual capacity determinations are saved by ventilator display unit 76 and, as such, can be compared to data from previous or subsequent functional residual capacity determinations. This comparison requires that a previous determination of functional residual capacity be selected as a reference curve using the time at which it was obtained as identified in data field 250 . When a reference curve is selected, an indication is made in data field 250 and that functional residual capacity curve is displayed as the reference curve 252 . Curve 252 shows a lung that is not well ventilated. Further indication of the reference curve and reference curve values may be made by a color indication for this data, different from that of the other functional residual capacity data in graph 110 and table 112 . The result is a visual indicator that can easily be referred to by the clinician to quickly assess improvement or deterioration in the functional residual capacity condition of patient 12 over time. In the example shown in FIG. 5 , there has been an increase in the functional residual capacity of patient 12 for each eight hour interval. Also, it is common practice to alter, usually increase, the PEEP to improve ventilation of lungs 38 of patient 12 by opening areas of the lung that are not being properly ventilated. Tabulating the actual measured values for PEEPe and PEEPi, along with the corresponding functional residual capacity determination, as shown in FIG. 5 , allows the clinician to see the effect, if any of applied PEEPe therapy on the volume of the functional residual capacity of the patient's lungs, as well as on the intrinsic PEEP. As also shown in FIG. 5 , a history of a certain number of functional residual capacity determinations and PEEP pressures are shown in table 112 to present trends and the history of these quantities. In the example shown there, an increase in PEEPe has resulted in an increase in functional residual capacity of patient 12 . FRC Events Log Certain clinical or other events can affect the value for functional residual capacity determined from the method steps shown in FIG. 7 . Such events may include performing a suction routine on patient 12 to remove accumulated secretions, administering a nebulized medication, changing the ventilation mode, or changing one or more ventilation parameters, such as tidal volume (TV), breath rate, PEEP, or other parameter. By selecting the FRC Log field 253 in menu 108 of screen 102 g 2 shown in FIG. 5 , screen 102 g 4 of FIG. 8 will be shown to provide a log of the events that may effect functional residual capacity in data field 254 along with the time(s) and date(s) the event took place. The log also includes the time, date and value of any periodic functional residual capacity determinations made in the manner described above. The clinician may scroll through the events of the log using control knob 106 to review the functional residual capacity event history in relation to the measured values of functional residual capacity to determine if specific actions had a positive or negative effect on the determined functional residual capacity for the patient. Trends Log Display The functional residual capacity value(s) determined in the above manner can also be provided in conjunction with a tabular and/or graphic display of periodic ventilator operating data and/or patient condition data, as shown in FIGS. 11 and 12 . For example, the display may show ventilator and/or patient data existing at points of time spaced at five minute intervals. Such a display is helpful in documenting and identifing trends in the treatment and condition of the patient over time and hence is termed a “Trends” log. A tabular trends log 300 is shown in FIG. 11 showing numerical data values obtained at five minute intervals for a period of an hour in tabulation field 302 . The data columns exemplarily show a plurality of airway pressure conditions in columns 304 , 306 and 308 , including PEEP in column 308 . As functional residual capacity determinations become available, they can be entered in the trends tabulation in column 310 , as at 312 . While tabulation field shows data for one hour, data for a much longer period, such as 14 days, may be stored in a memory in ventilator 10 or display unit 76 . Cursor 314 allows the clinician to scroll through the stored data to display data from a desired time period. Tabulation field 302 is accompanied by an appropriate menu 316 operable by control knob 106 for selecting desired data to be shown and other properties of the trends log display. FIG. 12 shows a graphical trends log display 320 in which functional residual capacity data 322 is graphically shown for a period of time, such as three hours, along with other data from ventilator 10 or patient 12 , such as respiratory rate (RR) 324 . The same menu 316 may be used with this display. The trends log displays may be placed in screen portion 102 g by actuating an appropriate button in display unit 76 such as vent setup button 73 or spirometry button 75 . Spirometry Display It may also be helpful for the clinician to have a better idea of how much of an increase in functional residual capacity is due to distension of the lung by increased PEEP and how much is due to making previously closed alveolar sacs available, i.e., opening of the lung by “recruitment” of lung volume. Such information can be obtained using the spirometry aspects of the present invention, as shown in the SpiroD screen 102 g 3 of FIG. 9 . In general, spirometry is used to determine the mechanics of a patient's lungs by examining relationships between breathing gas flows, volumes, and pressures during a breath of a patient. A commonly used relationship is that between inspired/expired breathing gas flows and volumes that, when graphed, produces a loop spirogram. The size and shape of the loop is used to diagnose the condition of the lung. A relationship also exists between inspired/expired gas volumes and pressure in the lungs. In the past, a problem with the use of this relationship has been that pressure has been measured at a point removed from the lungs so that the measured pressure may not be an accurate reflection of actual pressure in the lungs thus lessening the diagnostic value of the pressure-volume loop. Through the use of catheter 94 extending from endotracheal tube 90 shown in FIG. 2 , a far more accurate indication of lung pressure is obtained. For a healthy lung, a graph of the relationship between volume and pressure is roughly an elongated, narrow loop of positive uniform slope. That is, constant increments of inspired volume increase lung pressure by constant increments. The loop is formed because there remains some amount of lung resistance below the pressure sensing point at the end of catheter 94 . In a diseased lung, the loop may be wider and may also reflect a non-linear lung volume pressure relationship. For such a lung, the volume-pressure relationship over the course of an inspiration/expiration may be in a form such as that shown in FIG. 9 by 420 , and a curve illustrating the volume-pressure relationship resulting from a mathematical computation using loop data is plotted, as shown in FIG. 9 by reference numeral 422 . The curve 422 shown in FIG. 9 in often termed a “dynostatic curve” and is used for diagnostic purposes. A typical dynostatic curve is shown in FIG. 9 to contain a middle portion of somewhat linear positive slope and a pair of inflection points separating end portions of differing slopes. The dynostatic curve and its generation is described in Practical Assessment of Respiratory Mechanics by Ola Stenqvist, British Journal of Anesthesia 91(1), pp. 92-105 (2003) and “The Dynostatic Algorithm in Adult and Paediatric Respiratory Monitoring” by Soren Sondergaard, Thesis, University Hospital, Gothenburg University, Sweden (2002). In graph 110 of FIG. 9 , the abscissa of the graph is lung pressure measured at the end of catheter 94 connected to the auxiliary input A of ventilator display unit 76 and is termed “Paux”. The ordinate is scaled in volume of breathing gases inspired/expired by patient 12 . It will be appreciated that this volume comprises the tidal volume for the patient. The tidal volume moves into and out of the lungs in a manner that can be described as being “above” the functional residual capacity. That is, for normal breathing, a patient starts a breath with the volume of the lungs at the functional residual capacity which may, for example be 2000 ml. During inhalation, the volume of the lungs increases by the tidal volume of, for example 500-700 ml, and during exhalation, the volume of the lungs decreases by approximately that amount. The same situation occurs when a patient is being provided with breathing gases from a mechanical ventilator, such as ventilator 10 . It must thus be appreciated that the ordinate of the graph 110 in FIG. 9 is scaled in the relative volume of inspiration/expiration for which the origin of the graph is zero, not in absolute volume that would also take into consideration functional residual capacity and for which the origin of a graph would be the amount of the functional residual capacity. The scaling of graph 110 of FIG. 9 may be automatically altered to provide a scale appropriate to the spiromety data being shown. With PEEP applied to patient 12 by ventilator 10 , there will be a movement of the graph away from the origin of the axes along the abscissa. The graph will move right by the amount of the PEEP, i.e. the lung pressure at the end of expiration by patient 12 . The menu portion 108 of SpiroD screen 102 g 3 shown in FIG. 9 allows the user to open up a set up menu, shown in FIG. 10 that allows the clinician to turn a purge flow through catheter 94 on or off to zero the Paux sensor connected to catheter 94 when the purge flow is on and endotracheal tube 90 has been inserted in patient 12 . The SpiroD set-up menu also allows the clinician to set the scaling for the graphical portions of the display. A “Paux Alarm” screen, reached from the SpiroD setup screen of FIG. 10 , allows the clinician to set appropriate alarms for patient lung pressure, as sensed by catheter 94 . Various other selections on menu 108 of screen 102 g 3 of FIG. 9 allow the clinician to save the current data and to view this information as a first or second reference for use and display with subsequently obtained data. Up to a given number of loops, for example, six loops and curves, may be saved for analytical purposes. The “erase reference” option allows the user to determine which information to save and which to delete. The “SpiroD loops” and “SpiroD curves” menu items may be turned on or off. Selecting “on” for both the curve and loop will display both the loop and the curve at once in the manner shown in FIG. 9 . For easier comparison among loops and curves obtained at various times, either the loop or curve showing may be turned “off.” The “cursor” option allows the clinician to scroll along the horizontal axis and display the actual pressure and volume measurements associated with the loops or curves that are displayed. For the graphical showing of graph 110 of the screen 102 g 3 in FIG. 9 , volumes and pressures are obtained from sensor 57 and catheter 94 and the spirometry data, computed and displayed for every third breath if the respiratory rate is less than some desired number, for example, 15 breaths per minute. If the respiratory rate is greater than that number, every fifth breath used. The loop 420 for a complete inspiratory/expiratory breathing cycle is displayed in the graph of screen 102 g 3 of FIG. 9 . The dynostatic curve 422 is then calculated for display in graph 110 . Various compliance values for the patient's lungs are shown in the table 112 of screen 102 g 3 of FIG. 9 . Compliance can be seen as the amount by which the volume of the lung increases for an incremental increase in lung pressure. The data necessary to determine compliance can be obtained from sensor 57 and gas module 64 . Compliance is represented by the slope of dynostatic curve 422 . It is an indication of the stiffness or elasticity of the lung. In a stiff lung, an incremental increase in pressure results in a smaller increase in volume over a lung that is more elastic and the slope of the curve 422 is more horizontal. In an elastic lung, the reverse is true. To aid the clinician in analyzing the lungs of patient 10 , the compliance is computed at the beginning, middle, and end of the respiratory cycle of the patient. As shown in the example in FIG. 9 , the middle portion of dynostatic curve 422 indicates a portion of greater compliance than the end portions. The table of the screen sets out numerical values. Ordinarily, the highly compliant, middle portion of curve 422 shown in FIG. 9 is that in which the lung is most effectively ventilated. The table 112 of display 102 g 3 of FIG. 9 also shows the peak pressure achieved in the lungs during the breath, the PEEP pressure, and the airway resistance, Raw. The airway resistance is the pressure drop experienced by breathing gas flow of the lungs and is expressed in units of pressure per unit of flow. Airway resistance can also be determined with data from sensor 57 and gas module 64 in a manner described in the Stenqvist reference noted above. Various alternatives and embodiments are contemplated as being within the scope of the following claims particularly pointing out and distinctly claiming the subject matter regarded as the invention.

A ventilator for ventilating a patient has means integrated therewith for carrying out a determination of the functional residual capacity of the patient using an inert gas wash in/wash out technique. To this end, the ventilator operates to alter the inert gas content of breathing gases provided to the patient. The amount of inert gas expired by the patient is obtained and used to determine functional residual capacity on a breath-by-breath basis. A graph of the functional residual capacities for a given number of breaths is produced. Thereafter, the inert gas levels in the breathing gases are returned to the original levels and further functional residual capacity determinations and a graph of same provided. The functional residual capacity information may also be provided in tabular form. A log of functional residual capacity determinations and ventilator settings or patient treatments affecting same may also be provided.

BACKGROUND OF THE INVENTION This invention relates to devices for the fixation of fractured bones and in particular to a device for the fixation of fractures involving long bones, such as subtrochanteric and intertrochanteric fractures of the femur. The successful fixation of any fractured long bone is generally dependent upon two basic considerations. First, the fracture site should be rigidly maintained in compression to stimulate bone repair; and second, shear, rotational and angular stresses at the fracture site should be minimized (and if possible eliminated) as such stresses inhibit bone union. In fractures involving the proximal aspect of the femur, for example, these considerations are particularly important due to the considerable magnitude and complex distribution of the forces to which this region is subjected. (Loads up to four times body weight may be transmitted through this region during the gait cycle.) Heretofore, the fixation of fractures of the proximal femur has typically been attempted by the insertion of a hip compression screw, usually comprising a lag screw to be secured in the femoral head, a compression plate cooperable with the lag screw to be secured to the femoral shaft and a compression screw for attaching the compression plate to the lag screw and applying a compressive force therebetween. Such devices have also been more generally used for the fixation of fractures in which one major fragment is mostly cancellous and the other fragment is primarily cortical (e.g., supracondylar fractures of the distal femur). Although prior hip compression devices are effective for the fixation of certain types of fracture configurations involving the proximal femur (more specifically, certain intertrochanteric fracture configurations), there are many fracture configurations for which these devices perform poorly or are ineffective. For example, in the case of subtrochanteric fractures of the proximal femur (as well fractures in other regions such as supracondular fractures of the distal femur), prior hip compression devices can allow significant shear, rotational and angular forces to occur while failing to provide the desired compressive forces at the fracture site. In practice, such characteristics may lead to a loss of reduction, nonunion or malunion of the fractured bone and even breakage of the device subsequent to insertion. The present invention overcomes these deficiencies and other disadvantages of the prior art. SUMMARY OF THE INVENTION In accordance with the present invention, an axial compression device is provided whereby longitudinally adjacent segments of a fractured long bone may be placed and maintained in rigid axial compression and whereby shear, rotational and angular forces at the fracture site are minimized. More particularly, according to one of its broader aspects, the invention provides an axial compression device for the fixation of a fractured bone (such as a femur wherein both subtrochanteric and intertrochanteric fractures are present) having a first bone fragment, a second bone fragment disposed transverse to the first bone fragment and a third bone fragment disposed longitudinally of the first bone fragment, which comprises first means adapted to be secured to the second bone fragment, second means cooperable with the first means for applying a compressive force between the first and second bone fragments, and third means adapted to be secured to the third bone fragment and cooperable with the second means for applying a compressive force between the first and third bone fragments. As will be described hereinafter in connection with a preferred form of the invention, the first means may comprise a lag screw, the second means may comprise an angled slide member having a first leg adapted to be connected to the lag screw and a second leg, and the third means may comprise a retaining member adapted to be slidably coupled to the second leg of the angled slide member. In another of its broad aspects, the invention provides an axial compression device for the fixation of a fractured bone (such as a femur wherein a subtrochanteric fracture is present) having a first bone fragment and a second bone fragment disposed longitudinally thereof, which comprises shaft means adapted to be secured within the first bone fragment, retaining means adapted to be secured to the second bone fragment, and an angled slide member having a first leg and a second leg, the first leg being adapted to be connected to the shaft means, the second leg being cooperable with the retaining means for applying a compressive force between the first and second bone fragments. According to yet another broad aspect of the invention, an assembly is provided for use in an axial compression device for the fixation of a fractured bone of the last mentioned type, which comprises retaining means adapted to be secured to the second bone fragment and an angled slide member having a first leg and a second leg, the first leg being adapted to be connected to the first bone fragment, the second leg being cooperable with said retaining means for applying a compressive force between the first and second bone fragments. The features and advantages of the invention will be further understood from the following description of the preferred embodiment taken in connection with the accompanying drawing. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is an elevation view shown partly in section of an axial compression device according to the invention applied to the proximal aspect of a right femur, and FIG. 2 is an exploded perspective view of the axial compression device of FIG. 1. DESCRIPTION OF THE PREFERRED EMBODIMENT FIGS. 1 and 2 illustrate a preferred axial compression device in accordance with the present invention. For the purposes of example only, the device is shown particularly adapted for the fixation of a fractured femur wherein both a subtrochanteric fracture and an intertrochanteric fracture are present. FIG. 1 depicts a right femur in such condition. More specifically, the femur in FIG. 1 includes three bone fragments: a fragment denoted by the reference letter A, a fragment transverse to fragment A and denoted by the reference letter B, and another fragment disposed longitudinally of fragment A and denoted by reference letter C. As indicated in the drawing, the intertrochanteric fracture appears between bone fragment A (which includes the greater and lesser trochanters) and bone fragment B (which includes the femoral head). The subtrochanteric fracture appears between bone fragment A and bone fragment C (which includes the upper portion of the femoral shaft). It is to be understood, of course, that while the invention will hereinafter be explained in connection with the multiply fractured femur just described, an axial compression device according to the invention may (as will be apparent from the ensuing discussion) be employed for the fixation of a variety of fracture configurations such as a subtrochanteric fracture alone or a supracondylar fracture of the distal femur. Referring now to FIG. 2, it will be seen that the illustrated embodiment of the invention comprises shaft means such as a lag screw 10, slide means such as an angled slide member 20 and retaining means such as a barrelled side plate (retaining member) 40. These components are preferably made from a substantially rigid material of low biologic reactivity such as stainless steel, carbon fiber or one of the various cobalt alloys used for surgical purposes (as are the remaining components of the device to be discussed later). The lag screw 10 includes a cylindrical shaft portion 12 and is adapted to be secured to a bone fragment. in this case fragment B. in the standard manner by means of a threaded head portion 14. It will be appreciated that when the lag screw is threaded into position in bone fragment B, the lag screw shaft 12 will be secure within bone fragment A. For reasons which will soon be apparent, the lag screw shaft 12 is provided with a threaded axial bore 16 and a longitudinal groove or keyway 18a on its outer surface. With continued reference to FIG. 2, it will further be observed that the angled slide member 20 comprises a first leg 22 and a second leg 24 (both of substantially cylindrical cross section in the form shown) disposed at an angle relative to each other. The particular orientation of legs 22 and 24 will naturally vary depending upon the particular fracture configuration to be treated but will typically be an angle in the range of 90°-150°. The first leg 22 of the angled slide member has an axial bore 26 through its length which is adapted at one end (the end opposite the vertex of slide member 20) to receive the lag screw shaft 12. Leg 22 may thus be inserted into the femur proximally of the subtrochanteric fracture for engagement with the lag screw shaft 12 as shown in FIG. 1. To ensure proper alignment of the lag screw shaft 12 and bore 26, the bore includes an inwardly projecting key 18b for cooperation with the previously mentioned keyway 18a on the outer surface of lag screw shaft 12. The opposite end of bore 26 is adapted to receive a compression screw 60. Preferably, bore 26 also includes an intermediate portion 28 of reduced diameter which forms a shoulder 30 within the bore which serves as a stop for the head of compression screw 60. The shaft of compression screw 60 is adapted to pass through the reduced diameter portion 28 for engagement with the threaded axial bore 16 in the lag screw shaft 12. It will therefore be appreciated that by threading the compression screw 60 into the threaded axial bore 16, the lag screw 10 and the first leg 22 of the angled slide member may be drawn tightly together to apply a compressive force between the bone fragments A and B (i.e., across the intertrochanteric fracture surface). To prevent any shifting of the lag screw shaft 12 within leg 22 of the angled slide member once compression screw 60 has been threaded in place, and more particularly, to prevent lateral displacement of the intertrochanteric fracture fragments A and B on the subtrochanteric fragment C with weight bearing, locking means such as a locking screw 62 is inserted rearward of screw 60 in bore 26. As shown in FIG. 1, the bore 26 is adapted to threadably receive locking screw 62 rearward of compression screw 60 so that the locking screw 62 may be threaded into firm abutment against the head of the screw 60. Of course, any of a variety of locking elements (such as a keyed metal disk which is rotated into a locked position within bore 26) could be used in place of locking means for the described purpose. To complete the fixation of the fractured bone shown in FIG. 1, the barrelled side plate 40 and the second leg 24 of the angled slide member are coupled in a manner now to be described. In accordance with the preferred form of the invention shown, barrelled side plate 40 is a retaining member of substantially cylindrical configuration which is adapted to be attached to bone fragment C by means of fixation screws 64. Fixation screws 64 thread into bone segment C through holes such as 50 in projecting flanges 48 on the body of the barrelled side plate 40. Similarly to the first leg 22 of the angled slide member, the barrelled side plate 40 includes an axial bore 42 through its length. The bore 42 is adapted at one of its ends (the upper end as shown in the drawing) to slidably (or, more specifically, telescopically) receive the second leg 24 of the angled slide member. Bore 42 is further adapted at its opposite end to receive an additional compression screw 66. Appropriate alignment between the second leg 24 of the angled slide member and the barrelled side plate 40 is ensured by a key 32b which projects into bore 42 for cooperation with a longitudinal groove or keyway 32a on the outer surface of the second leg 24. In practice, the key 32b and keyway 32a may be arranged with different rotational alignments to permit the application of varying degrees of torsion to longitudinally adjacent bone fragments such as fragments A and B. Preferably, as was the case with bore 26, the bore 42 in barrelled side plate 40 includes an intermediate portion 44 of reduced diameter that forms a shoulder 46 within the bore which acts as a stop for the head of compression screw 66 as is shown in FIG. 1. The shaft of compression screw 66 is adapted to pass through the reduced diameter portion 44 for engagement with a threaded axial bore 34 in the second leg 24 of the angled slide member (see FIG. 1). Thus it will be apparent that by threading the compression screw 66 into the threaded axial bore 34, the second leg 24 of the angled slide member and the barrelled side plate 40 will be drawn tightly together. This action, of course, serves to apply a compressive force between the bone segments A and C (i.e., across the subtrochanteric fracture site). It should be noted that in the case of compression screw 66, it is preferable not to provide a locking screw or the like as was done in connection with compression screw 60. This permits rearward movement of the compression screw 66 within bore 42 so that additional dynamic compressive loading may occur at the subtrochanteric fracture site with weight bearing, thereby further enhancing the healing process. From the preceding discussion it will be appreciated that by virtue of the invention, rigid fixation of the multiply fractured femur in FIG. 1 is achieved in conformity with the basic considerations set forth at the outset hereof. More specifically, the cooperable assembly of the slide member 20 and the side plate 40 provide the desired compressive force at the subtrochanteric fracture site while shear, rotational and angular stresses at the fracture site are substantially eliminated as a result of the general geometry of the axial compression device. A similar effect is achieved at the intertrochanteric fracture site by the cooperative relationship of the lag screw 10 and the slide member 20. While a preferred form of the invention has been shown and described, it will be appreciated by those skilled in the art that numerous modifications may be made according to the principles of the invention, the scope of which is defined in the appended claims. For example, it may be desirable in various situations to use components of different configurations from those shown (i.e., components of non-cylindrical cross section). In addition, it may be beneficial in some situations to provide additional fixation means whereby the slide member may be attached directly to one of the fractured bone fragments. It may further be desirable for certain applications to include a ratcheting mechanism for the slide member and compression slide to prevent disengagement thereof.

An axial compression device for the fixation of a fractured bone comprises an assembly including a lag screw and a retaining member secured to bone fragments on opposite sides of a fracture and an angled slide member adapted to be connected to the lag screw and cooperable with the retaining member for providing a compressive force between the bone fragments. The lag screw and angled slide member are especially adapted to achieve simultaneous fixation of a secondary fracture which may also be present.

CROSS-REFERENCE TO RELATED APPLICATIONS The instant application is a US non-provisional Application based on U.S. provisional application No. 61/167,725, filed Apr. 8, 2009, the disclosure of which is hereby expressly incorporated by reference hereto in its entirety. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates generally to needle safety systems for injection devices, e.g., hypodermic syringes, IV infusion sets, etc., such as are utilized for injection of medicament into the body tissues of human and animal patients. More specifically, this invention relates to a needle safety system having a body, a safety shield, a needle, and a system for causing the safety shield to move from a retracted position to an extended position. The extended position preferably prevents the possibility of inadvertent needle pricks and/or prevents subsequent use or re-use of the system. This invention also relates to single-use needle units which automatically deploy the safety shield over the needle when cause to do so and/or activated by the user. This invention also relates to an IV infusion needle which can be used only once and have a built-in safety system which cannot be easily overridden by a user thereof. 2. Discussion of Background Information The following devices relate to similar devices: U.S. Pat. No. 5,591,138 to VAILLANCOURT; U.S. Pat. No. 5,403,286 to LOCKWOOD, Jr.; U.S. Pat. No. 7,428,773 to NEWBY et al.; U.S. Pat. No. 7,413,560 to CHONG et al.; U.S. Pat. No. 7,322,963 to GOH; U.S. Pat. No. 7,150,725 to WILKINSON; U.S. Pat. No. 7,144,387 to MILLERD; U.S. Pat. No. 6,375,640 to TERAOKA; D452,000 to CRAWFORD et al; U.S. Pat. No. 5,498,241 to FABOZZI; U.S. Pat. No. 6,210,371 to SHAW; U.S. Pat. No. 5,376,080 to PETRUSSA; U.S. Pat. No. 5,267,977 to FEENEY, Jr.; U.S. Pat. No. 5,242,401 to COLSKY; and U.S. Pat. No. 5,167,635 to HABER et al. The entire disclosure of each of these documents is hereby expressly incorporated by reference in their entireties. The invention provides improvements over such devices such as using a more user friendly and/or less costly and/or more safe safety system. SUMMARY OF THE INVENTION According to one non-limiting aspect of the invention there is provided a needle device comprising a body, a needle shield movable relative to the body, a needle at least partially arranged in the body, and a safety system that at least one of causes the needle shield to move to an extended position when activated by a user, releasably retains the needle shield in a retracted position after the user moves the needle shield to the retracted position, prevents a user from triggering the device, locks the needle shield in a fully extended position, prevents the needle shield from being retained in a retracted position after a user moves the needle shield towards the retracted position, non-releasably retains the needle shield in a fully extended position after being activated by a user, and utilizes two separate re-use prevent mechanisms. The device may be a single-use needle device. The body may be generally cylindrically shaped. The needle shield may be generally cylindrically shaped. The body may comprise a one-piece member. The needle shield may comprise a one-piece member. The body and the needle shield may each comprise a synthetic resin material. The needle may comprise a generally cylindrical hollow needle. The needle may comprise at least one of metal and stainless steel. The body may comprise at least one releasable retaining member which releasably retains the needle shield in a retracted position. The body may comprise plural releasable retaining members which releasably retains the needle shield in a retracted position. The body may comprise at least one non-releasable retaining member which non-releasably retains the needle shield in a fully extended position. The body may comprise at least one non-deflectable retaining member which non-releasably retains the needle shield in an extended position. The body may comprise plural non-releasable retaining members which lock the needle shield in an extended position. The device may further comprise a trigger device that is structured and arranged to cause movement of the needle shield from the retracted position to the fully extended position. The device may further comprise a trigger device that is structured and arranged to lock to the body after the device is triggered. The needle shield may be movable from an initial position that is intermediate the fully extended position and the retracted position to the retracted position and then to the fully extended position. The needle shield may be movable to the retracted position from an initial position that is intermediate the fully extended position and the retracted position. The device may further comprise a trigger that selectively releases at least one locking member which releasably retains the needle shield in the retracted position. The device may further comprise a biasing member structured and arranged to move the needle shield from the retracted position to the fully extended position. The device may further comprise a helical compression spring structured and arranged to move the needle shield from the retracted position to the fully extended position. The device may further comprise a helical compression spring structured and arranged to maintain the needle shield in an initial position. The safety system may cause the needle shield to move to the extended position when activated by a user. The safety system may releasably retain the needle shield in the retracted position after the user moves the needle shield to the retracted position. The safety system may prevent a user from triggering the device. The safety system may lock the needle shield in the fully extended position. The safety system may prevent the needle shield from being retained in the retracted position after a user moves the needle shield towards the retracted position. The safety system may non-releasably retain the needle shield in the fully extended position after being activated by a user. The safety system may utilize two separate re-use prevent mechanisms. The device may further comprise a connecting interface for allowing the device to be mounted to an injection or sampling device. The connecting interface may have a Luer-Lok configuration. The device may further comprise a system preventing the user from inadvertently moving the needle shield to the retracted position from an initial position. The system preventing the user from inadvertently moving the needle shield to the retracted position from the initial position may at least one of require the user to rotate unthread the needle shield from the body and require the user to remove a removable use prevention device. The invention also provides for a single-use needle device comprising a body, a needle shield movable relative to the body, a needle at least partially arranged in the body, and a safety system that at least two of causes the needle shield to move to an extended position when activated by a user, releasably retains the needle shield in a retracted position after the user moves the needle shield to the retracted position, prevents a user from triggering the device, locks the needle shield in a fully extended position, prevents the needle shield from being retained in a retracted position after a user moves the needle shield towards the retracted position, non-releasably retains the needle shield in a fully extended position after being activated by a user, and utilizes two separate re-use prevent mechanisms. The invention also provides for an IV infusion needle device comprising a body, a needle shield movable relative to the body, a needle at least partially arranged in the body, and a safety system that at least one of causes the needle shield to move to an extended position when activated by a user, releasably retains the needle shield in a retracted position after the user moves the needle shield to the retracted position, prevents a user from triggering the device, locks the needle shield in a fully extended position, prevents the needle shield from being retained in a retracted position after a user moves the needle shield towards the retracted position, non-releasably retains the needle shield in a fully extended position after being activated by a user, and utilizes two separate re-use prevent mechanisms. The invention also provides for a method of using the device described above, wherein the method comprises moving the needle shield from an initial position to the retracted position, causing the needle shield to move to a fully extended position whereby the needle shield projects out beyond a needle tip, and at least one of preventing the needle shield from moving back to the initial position and preventing the needle shield from being retained in the retracted position. The invention also provides for a needle device comprising at least one feature shown in at least one the drawings of the instant application. Other exemplary embodiments and advantages of the present invention may be ascertained by reviewing the present disclosure and the accompanying drawing. BRIEF DESCRIPTION OF THE DRAWINGS The present invention is further described in the detailed description which follows, in reference to the noted plurality of drawings by way of non-limiting examples of exemplary embodiments of the present invention, in which like reference numerals represent similar parts throughout the several views of the drawings, and wherein: FIG. 1 shows a side cross-section view of a first non-limiting embodiment of the device according to the invention. The needle portion is not shown in cross-section. The deflectable retaining member and the deflectable releasable locking member arranged behind the needle is not shown for clarity. FIG. 1 shows the device with the needle shield in an initial position and with the device being in a ready-to-use configuration; FIG. 2 shows the device of FIG. 1 with the needle shield being releasably locked in the retracted position after it is moved by the user to the retracted position; FIG. 3 shows the device of FIG. 2 in a triggered position after a trigger sleeve is moved to a triggering position that will allow the needle shield to move forwardly; FIG. 4 shows the device of FIG. 3 after the needle shield has moved to a fully extended position and become non-releasably locked therein. The trigger sleeve is also non-releasably locked to the body. In this configuration, the device is rendered unusable and can be safely handled and discarded; FIG. 5 shows the device of FIG. 1 with the needle shield and trigger sleeve removed; FIG. 6 shows the device of FIG. 5 , but no longer in cross-section; FIG. 7 shows a side view of the needle shield used in the embodiment of FIG. 1 ; FIG. 8 shows a side cross-section view of the needle shield of FIG. 7 ; FIG. 9 shows a front end view of the needle shield of FIG. 7 ; FIG. 10 shows a rear end view of the needle shield of FIG. 7 ; FIG. 11 shows a cross-section view of a needle shield biasing spring used the device of FIG. 1 ; FIG. 12 shows a front end view of a trigger sleeve used the device of FIG. 1 ; FIG. 13 shows a side cross-section view of a trigger sleeve used the device of FIG. 1 ; FIG. 14 shows a side cross-section view of a second non-limiting embodiment of the device according to the invention. The needle portion is not shown in cross-section. The deflectable releasable locking member arranged behind the needle is not shown for clarity. FIG. 14 shows the device with the needle shield in an initial position and with the device being in a ready-to-use configuration. This embodiment is similar to the device of FIGS. 1-13 except that the needle shield and body has a tapered proximal end and the device utilizes a retaining ring to axially retain the trigger sleeve; FIGS. 15 and 16 show partial side cross-section views of another non-limiting embodiment of the device. The deflectable members arranged behind the needle are not shown for purposes of clarity. This embodiment is similar to the device of FIGS. 1-13 except that the body utilizes a visual indicator to inform the user that the device has been used, i.e., that the needle shield has moved to the fully extended position and/or become non-releasably locked in this position and/or has already been used. FIG. 15 shows the device with the needle shield in an initial position. FIG. 16 shows the device after the needle shield has moved to a fully extended position and become non-releasably locked therein; FIG. 17 shows a side cross-section view of another non-limiting embodiment of the device. The deflectable releasable locking member arranged behind the needle is not shown for clarity. This embodiment is similar to the device of FIGS. 1-13 except that it additionally utilizes a use prevention device or wrapping which must be removed by the user before the user can move the needle shield to the retracted position; FIG. 18 shows a side cross-section view of another non-limiting embodiment of the device according to the invention. The needle portion is not shown in cross-section. The deflectable releasable locking member arranged behind the needle is not shown for clarity. FIG. 18 shows the device with the needle shield in an initial position and with the device being in a ready-to-use configuration. This embodiment is similar to the device of FIGS. 1-13 except that the needle shield threadably engages the body so as to prevention use of the device until the user rotates the needle shield. The threads also prevent the user from inadvertently moving the needle shield to the fully extended position; FIG. 19 shows the device of FIG. 18 after the needle shield is unthreaded (unlocked) and moved by the user to the retracted position and is releasably retained therein; FIG. 20 shows the device of FIG. 19 after the needle shield has moved to an intermediate position just prior to the fully extended position wherein it will become non-releasably locked therein. Although not shown, in this position the trigger sleeve is also non-releasably locked to the body; FIG. 21 shows the device of FIG. 20 after the needle shield has been threaded towards the forward end and moved to a fully extended position by the user rotating the needle shield in a direction opposite that use to allow the user to move it to the retracted position. The needle shield has become non-releasably locked therein; FIGS. 22 and 23 show side cross-section views of another non-limiting embodiment of the device. The deflectable releasable locking member arranged behind the needle is not shown for clarity. This embodiment is similar to the device of FIGS. 1-13 except that the needle shield has a very short needle guide and the body is configured to cause a side cocking of the needle shield when it moved to the fully extended position. FIG. 22 shows the device with the needle shield in an initial position. FIG. 23 shows the device after the needle shield has moved to a fully extended position and become non-releasably locked therein. The side cocked configuration of the needle shield shown in FIG. 23 provides an indication to the user that the device has already been used and prevents re-use because the opening is no longer aligned with the needle; FIG. 24 shows a side cross-section view of another non-limiting embodiment of the device. The deflectable releasable locking member arranged behind the needle is not shown for clarity. This embodiment is similar to the device of FIGS. 1-13 except that the initial position of the needle shield is the same as the fully retracted position and the device lacks mechanism for non-releasably locking the needle shield in the extended position; FIG. 25 shows a side cross-section view of another non-limiting embodiment of the device. This embodiment is similar to the device of FIG. 24 except that the trigger sleeve is removed so that the device can be triggered by the user depressing the releasably locking devices; FIG. 26 shows a side cross-section view of another non-limiting embodiment of the device. The deflectable releasable locking member arranged behind the needle is not shown for clarity. This embodiment is similar to the device of FIGS. 1-13 except that a rear or distal end of the device utilizes a connecting interface or configuration allowing the device to be connected to a sample and/or injection device; FIG. 27 shows a partial side cross-section view of another non-limiting embodiment of the device. This embodiment is similar to the device of FIG. 26 except that a trigger spring is utilized; and FIGS. 28-30 show various views of another non-limiting embodiment of the device. In FIG. 28 , the deflectable releasable locking member arranged behind the needle is not shown for clarity. This embodiment is similar to the device of FIGS. 1-13 except that a rear or distal end of the device utilizes a connecting interface or configuration allowing the device to be connected to a tube of an IV infusion set and a distal area which can receive a butterfly member. FIG. 30 shows an end view of the butterfly member. DETAILED DESCRIPTION OF THE INVENTION Referring now to the drawings and first to FIGS. 1-13 which shows a first embodiment of an injection device 1 . In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. The device 1 includes an elongate generally cylindrical body or barrel 10 having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device 1 also utilizes an axially movable and retractable safety sleeve 30 arranged at a proximal end of the body 10 and an axially movable trigger sleeve 40 arranged at an area of a distal end of the body 10 . Finally, the device 1 utilizes a spring 50 which is configured to bias the axially movable and retractable safety sleeve 30 towards an extended position covering the puncturing end of the needle N. Referring to FIG. 1 , the device 1 is shown in an initial or ready-to-use position. In this position, the needle shield 30 covers the proximal end of the needle N owing to the fact that the spring 50 biases the needle shield 30 towards the extended position. This position is maintained by contact between the distal flange 34 of the needle shield 30 and a plurality of deflectable projections 14 . The position or configuration shown in FIG. 1 is, in embodiments, that which can be utilized when the device 1 is packaged. Referring to FIG. 2 , the device 1 is shown in a usable or using position. In this position, the needle shield 30 is retracted by the user (applying the equivalent of a force F sufficient to compress the spring 50 ) to expose the proximal end of the needle N. This occurs when the user moves the needle shield 30 back in a manner which compresses the spring 50 . This retracted position is maintained by locking engagement between the distal flange 34 of the needle shield 30 and a plurality of deflectable locking members 15 . The position or configuration shown in FIG. 2 is, in embodiments, that which can be utilized when the device 1 , i.e., the puncturing end of the needle N, is injected. Referring to FIG. 3 , the device 1 is shown in a post-use position. In this position, the needle shield 30 is ready to be released from the retracted by the user (applying the equivalent of a force F sufficient to move the trigger sleeve 40 ) and to move to a fully extended position (shown in FIG. 4 ) covering the proximal end of the needle N. This occurs when the user moves the trigger sleeve 40 forward in a manner which causes inward deflection of the locking members 15 (occurring also when the inside diameter of the flange 34 engages with tapered surfaces 15 b ) which in turn causes the members 15 to disengage and/or unlock from the flange 34 . This triggering position in effect releases the locking engagement between the distal flange 34 of the needle shield 30 and a plurality of deflectable locking members 15 . The position or configuration shown in FIG. 3 is, in embodiments, that which can be utilized immediately after the device 1 is used so that the device 1 will be rendered safe to handle and dispose. Referring to FIG. 4 , the device 1 is shown in a final disposable position. In this position, the needle shield 30 has been automatically moved to the fully extended position by the spring 50 as soon as the device is triggered (see FIG. 3 ). As is apparent from a fair comparison of FIGS. 1 and 4 , the spring 50 has caused the flange 34 to move forward of the deflectable members 14 . The members 14 were thus to caused to deflect inwardly (as the flange 34 moved over them and slidably engaged with their tapered surfaces). The members 14 then spring back to an original position. The flange 34 thus cones to rest against a distal surface 13 (see FIGS. 5 and 6 ) of the shoulder 12 of the body 10 . In this position, the needle shield 30 is non-removably locked in the fully extended position. This is due to the fact that the members 14 prevent substantial axial movement of the needle shield 30 relative to the body 10 . This occurs because the members 14 each have an outer projecting portion that extends outwardly more than an inner diameter of the flange 34 . In this position, the device 1 has been rendered single-use since the user no longer has the ability to retract the needle shield 30 . Thus, locking the needle shield 30 in the fully extended position provides a first level of safety in preventing re-use of the device 1 and allows the user to handle the device 1 without fear of being pricked by the needle N. The device 1 , however, also provides a second level of safety in regards to rendering the device single-use and/or providing an indication to the user that the device has already been used. This additional level of safety relates to the fact that the trigger sleeve 40 is non-releasably locked in the triggering position. This is due to the fact that the members 15 prevent substantial axial movement of the trigger sleeve 40 relative to the body 10 . This occurs because the members 15 each have an outer projecting portion that extends into a groove 41 (see FIG. 13 ) outwardly more than an inner diameter 43 of the trigger sleeve 40 . As is apparent from a fair comparison of FIGS. 1 , 3 and 4 , during triggering, the members 15 were caused to deflect inwardly (as the tapered surface 42 moves over the projections 15 a of the members 15 . The members 15 then spring back to an original position with the projections seated within the groove 41 . The trigger sleeve 40 thus becomes non-releasably axially locked in the position shown in FIG. 4 . The two safety systems described above are ensured because the user has no readily apparent mechanism to releasing the locking engagement between the body 10 and the needle shield 30 and between the body 10 and the trigger sleeve 40 . Referring to FIGS. 5 and 6 , the body 10 is, in embodiments, a one-piece integrally formed member having a generally cylindrical main section 11 , a generally cylindrical proximal section 12 , an annular stop surface or shoulder 13 which is contacted by the flange 34 of the needle shield 30 in the fully extended position, four equally circumferentially spaced (i.e., arranged 90 degrees apart) deflectable retaining members 14 (for purposes of clarity the one behind the needle N in FIG. 5 is now shown), four equally circumferentially spaced (i.e., arranged 90 degrees apart) deflectable locking members 15 (for purposes of clarity the one behind the needle N in FIG. 5 is now shown), a retaining flange or shoulder 16 which limits axial movement of the trigger sleeve 40 , a generally cylindrical proximal space 17 sized and configured to receive therein the spring 50 and to allow for inward deflection of the members 14 , and an another generally cylindrical space 18 sized and configured to allow for inward deflection of the members 15 . The members 14 have a tapered section which is contacted by the flange 34 of the needle shield 30 when in the position shown in FIG. 1 and can deflect inwardly and return or spring back to an original or relaxed position (see e.g., FIG. 5 ). The members 15 have a tapered section 15 b which is contacted by the flange 34 of the needle shield 30 when moved to the retracted position shown in FIG. 2 and a projection 15 a which is contacted by the tapered surface 42 of the trigger sleeve 40 (see FIGS. 3 and 13 ) when moved to the triggering position shown in FIG. 3 , and can deflect inwardly (see e.g., FIG. 3 ) and return or spring back to an original or relaxed position (see e.g., FIG. 5 ). In embodiments, the device can utilize as few as two equally spaced members 14 and 15 and as many as ten of each. Referring to FIGS. 7-10 , the needle shield 30 is, in embodiments, a one-piece integrally formed member having an annular proximal end 31 , a generally cylindrical main section 33 , a generally cylindrical inner guide sleeve section 36 , an annular stop flange 34 , a generally cylindrical inner space 32 sized and configured to receive therein the needle N, and a generally cylindrical main space 35 sized and configured to receive therein the shoulder portion 12 of the body 10 . In embodiments, the surface 33 can have a friction increasing portion, e.g., a knurl, a texture, etc., to make it easier to be gripped by a user. Referring to FIG. 11 , the spring 50 is, in embodiments, a one-piece integrally formed member having the form of a helical compression spring which, in embodiments, is made of spring steel. Referring to FIGS. 12 and 13 , the trigger sleeve 40 is, in embodiments, a one-piece integrally formed member having an annular proximal and distal ends, a tapered section 42 , a generally cylindrical inner groove 41 , a generally cylindrical inner surface 43 sized and configured to slidably engage with a comparably sized surface of the body 10 , and a generally cylindrical main outer surface 44 . In embodiments, the surface 44 can have a friction increasing portion, e.g., a knurl, a texture, etc., to make it easier to be gripped by a user. Referring now to FIG. 14 which shows another embodiment of an injection device 1 ′. In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the previous embodiment, the device 1 ′ includes an elongate generally cylindrical body or barrel 10 ′ having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device 1 ′ also utilizes an axially movable and retractable safety sleeve 30 ′ arranged at a proximal end of the body 10 ′ and an axially movable trigger sleeve 40 ′ arranged at an area of a distal end of the body 10 ′. Finally, the device 1 ′ utilizes a spring 50 ′ which is configured to bias the axially movable and retractable safety sleeve 30 ′ towards an extended position covering the puncturing end of the needle N. The deflectable member 14 ′ and 15 ′ arranged behind the needle N are not shown for clarity. This embodiment is similar to the device of FIGS. 1-13 except that the needle shield 30 ′ and body 10 ′ have comparable tapered proximal ends TPE and the device 1 ′ optionally utilizes a separate retaining ring RR to axially retain the trigger sleeve 40 ′. Referring now to FIGS. 15 and 16 , which show another embodiment of an injection device 1 ″. In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the first embodiment, the device 1 ″ includes an elongate generally cylindrical body or barrel 10 ″ having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device 1 ″ also utilizes an axially movable and retractable safety sleeve 30 ″ arranged at a proximal end of the body 10 ″ and an axially movable trigger sleeve 40 ″ arranged at an area of a distal end of the body 10 ″. Finally, the device 1 ″ utilizes a spring 50 ″ which is configured to bias the axially movable and retractable safety sleeve 30 ″ towards an extended position covering the puncturing end of the needle N. The deflectable member 14 ″ and 15 ″ arranged behind the needle N are not shown for clarity. This embodiment is similar to the device of FIGS. 1-13 except that the body 10 ″ utilizes a visual indicator 60 to inform the user that the device 1 ″ has been used, i.e., that the needle shield 30 ″ has moved to the fully extended position and/or become non-releasably locked in this position and/or has already been used. FIG. 15 shows the device 1 ″ with the needle shield in an initial position (similar to FIG. 1 ). FIG. 16 shows the device 1 ″ after the needle shield 30 ″ has moved to a fully extended position and become non-releasably locked therein. In the fully extended position, the visual indicator 60 is now visible whereas it was previously covered by a distal portion of the needle shield 30 ″ in FIG. 15 . In embodiments, the visual indicator 60 is a colored band, i.e., a narrow section of having a color that is different from that of the surface 11 ″. Other forms of visual indication can also be utilized which are not visible in the configuration of FIG. 15 , but are visible in the configuration of FIG. 16 . Referring now to FIG. 17 , which show another embodiment of an injection device 1 ′″. In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the first embodiment, the device 1 ′″ includes an elongate generally cylindrical body or barrel 10 ′″ having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device 1 ′″ also utilizes an axially movable and retractable safety sleeve 30 ′″ arranged at a proximal end of the body 10 ′″ and an axially movable trigger sleeve 40 ′″ arranged at an area of a distal end of the body 10 ′″. Finally, the device 1 ′″ utilizes a spring 50 ′″ which is configured to bias the axially movable and retractable safety sleeve 30 ′″ towards an extended position covering the puncturing end of the needle N. The deflectable member 14 ′″ and 15 ′″ arranged behind the needle N are not shown for clarity. This embodiment is similar to the device of FIGS. 1-13 except that it additionally utilizes a removable retaining member 70 arranged on the body 10 ′″. The member 70 serves to inform the user that the device 1 ′″ has not yet been used and also prevents accidental rearward movement of the needle shield 30 ′″. In order to use the device 1 ′″, the user first removes the member 70 and then uses the device in the same way as described above regarding the embodiment of FIGS. 1-13 . FIG. 17 shows the device 1 ′″ with the needle shield in an initial position (similar to FIG. 1 ). In embodiments, the member 70 is a colored adhesive wrap, i.e., a narrow section of adhesive tape having a color that is different from that of the surface 11 ′″. Other forms of the member 70 can also be utilized which prevent rearward axial movement of the needle shield 30 ′″ until removed. The member 70 has a protruding free end 71 which can be gripped by the user to allow for unwrapping from the surface 11 ′″. Referring now to FIGS. 18-21 , which show another embodiment of an injection device 1 IV . In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the first embodiment, the device 1 IV includes an elongate generally cylindrical body or barrel 10 IV having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device 1 IV also utilizes an axially movable and retractable safety sleeve 30 IV arranged at a proximal end of the body 10 IV and an axially movable trigger sleeve 40 IV arranged at an area of a distal end of the body 10 IV . Finally, the device 1 IV utilizes a spring 50 IV which is configured to bias the axially movable and retractable safety sleeve 30 IV towards an extended position covering the puncturing end of the needle N. The deflectable member 14 IV and 15 IV arranged behind the needle N are not shown for clarity. Referring to FIG. 18 , the device 1 IV is shown in an initial or ready-to-use position. In this position, the needle shield 30 IV covers the proximal end of the needle N owing to the fact that the spring 50 IV biases the needle shield 30 IV towards the extended position and because external thread of section 36 IV threadably engage with internal threads arranged on a proximal end of the body 10 IV . This position is thus maintained by both contact between the distal flange 34 IV of the needle shield 30 IV and a plurality of deflectable projections 14 IV , but mainly as a result of the engagement between external thread of section 36 IV and internal threads arranged on a proximal end of the body 10 IV . The position or configuration shown in FIG. 18 is, in embodiments, that which can be utilized when the device 1 IV is packaged and ensures that the needle shield 30 IV cannot substantially move axially forwards or backwards relative to the body 10 IV . Referring to FIG. 19 , the device 1 IV is shown in a usable or using position. In this position, the needle shield 30 IV is retracted by the user (applying the equivalent of a force F sufficient to compress the spring 50 IV ) to expose the proximal end of the needle N. This occurs when the user moves the needle shield 30 IV back in a manner which compresses the spring 50 IV . This retracted position is maintained by locking engagement between the distal flange 34 IV of the needle shield 30 IV and a plurality of deflectable locking members 15 IV . The position or configuration shown in FIG. 19 is, in embodiments, that which can be utilized when the device 1 IV , i.e., the puncturing end of the needle N, is injected. In order to cause rearward movement of the needle shield 30 IV , the user first rotates the needle shield 30 IV relative to the body 10 IV in a first rotation direction which causes the threaded engagement between the needle shield 30 IV and the body 10 IV to disengage. Then, the user causes rearward movement of the needle shield 30 IV as in the embodiment shown in FIG. 2 . Referring to FIG. 20 , the device 1 IV is shown in a post-use and triggered position. In this position, the needle shield 30 IV has been released from the retracted by the user (applying the equivalent of a force F sufficient to move the trigger sleeve 40 IV ) and to move to an intermediate position just short of the fully extended position (shown in FIG. 21 ) covering the proximal end of the needle N. This occurs when the user moves the trigger sleeve 40 IV forward in a manner which causes inward deflection of the locking members 15 IV which in turn causes the members 15 IV to disengage and/or unlock from the flange 34 . This triggering position in effect releases the locking engagement between the distal flange 34 IV of the needle shield 30 IV and a plurality of deflectable locking members 15 IV . The position or configuration shown in FIG. 20 is, in embodiments, that which can be utilized immediately after the device 1 IV is used so that the device 1 IV will be rendered somewhat safer to handle. Referring to FIG. 21 , the device 1 IV is shown in a final disposable position. In this position, the needle shield 30 IV , which was automatically moved to the position shown in FIG. 20 by the spring 50 IV , is moved to the fully extended position first by the user rotating the needle shield 30 IV relative to the body 10 IV in a second opposite direction to cause engagement of the threads. Once the threads disengage with one another, the spring 50 IV will automatically cause the needle shield 30 IV to move to the fully extended position shown in FIG. 21 . As is apparent from a fair comparison of FIGS. 18 and 21 , the spring 50 IV has caused the flange 34 IV to move forward of the deflectable members 14 IV . The members 14 IV were thus to caused to deflect inwardly (as the flange 34 IV moved over them and slidably engaged with their tapered surfaces). The members 14 IV then spring back to an original position. The flange 34 IV thus cones to rest against a distal surface of the shoulder 12 IV of the body 10 IV . In this position, the needle shield 30 IV is non-removably locked in the fully extended position. This is due to the fact that the members 14 IV prevent substantial axial movement of the needle shield 30 IV relative to the body 10 IV . This occurs because the members 14 IV each have an outer projecting portion that extends outwardly more than an inner diameter of the flange 34 IV . In this position, the device 1 IV has been rendered single-use since the user no longer has the ability to retract the needle shield 30 IV . Should this locking engagement fail, the user will still be prevented from moving the needle shield 30 IV to the retracted position by the threads (unless the user deliberately rotates the needle shield 30 IV in a manner which causes engagement between the threads. Thus, locking the needle shield 30 IV in the fully extended position provides a first level of safety in preventing re-use of the device 1 IV and allows the user to handle the device 1 IV without fear of being pricked by the needle N. The device 1 IV , however, also provides a second level of safety in regards to rendering the device single-use and/or providing an indication to the user that the device has already been used. This additional level of safety relates to the fact that the trigger sleeve 40 IV is non-releasably locked in the triggering position in a manner similar to that described above regarding FIG. 4 . The two, or more accurately three, safety systems described above are ensured because the user has no readily apparent mechanism to releasing the locking engagement between the body 10 IV and the needle shield 30 IV and between the body 10 IV and the trigger sleeve 40 IV . Referring now to FIGS. 22 and 23 , which show another embodiment of an injection device 1 V . In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the first embodiment, the device 1 V includes an elongate generally cylindrical body or barrel 10 V having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device 1 V also utilizes an axially movable and retractable safety sleeve 30 V arranged at a proximal end of the body 10 V and an axially movable trigger sleeve 40 V arranged at an area of a distal end of the body 10 V . Finally, the device 1 V utilizes a spring 50 V which is configured to bias the axially movable and retractable safety sleeve 30 V towards an extended position covering the puncturing end of the needle N. The deflectable member 14 V and 15 V arranged behind the needle N are not shown for clarity. This embodiment is similar to the device of FIGS. 1-13 except that the body 10 V utilizes a proximal shoulder 12 V which has upper and lower stop surfaces that result in the needle shield 30 V assuming a side cocked position (because of the different axial locations of stop surfaces 13 V a and 13 V b) when it moves to the fully extended position (see FIG. 23 ). This provides an indication to the user that the device has already been used. It also prevents the user from moving the needle shield 30 V back to a retracted position. FIG. 22 shows the device 1 V with the needle shield 30 V in an initial position (similar to FIG. 1 ). FIG. 23 shows the device 1 V after the needle shield 30 V has moved to a fully extended position and become cocked and non-releasably locked therein. In the fully extended position, the visual indication is provided by the cocked configuration of the needle shield 30 V . Referring now to FIG. 24 which shows another embodiment of an injection device 1 VI . In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the previous embodiment, the device 1 VI includes an elongate generally cylindrical body or barrel 10 VI having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device 1 VI also utilizes an axially movable and retractable safety sleeve 30 VI arranged at a proximal end of the body 10 VI and an axially movable trigger sleeve 40 VI arranged at an area of a distal end of the body 10 VI . Finally, the device 1 VI utilizes a spring 50 VI which is configured to bias the axially movable and retractable safety sleeve 30 VI towards an extended position covering the puncturing end of the needle N. Unlike the previous embodiments, however, this embodiment utilizes no deflectable members to retain the needle shield 30 VI in the fully extended position, and, in fact, the original position of the needle shield is the same as the final extended position. The deflectable member 15 VI arranged behind the needle N is not shown for clarity. This embodiment is otherwise similar to the device of FIGS. 1-13 . Referring now to FIG. 25 which shows another embodiment of an injection device 1 VII . In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the previous embodiment, the device 1 VII includes an elongate generally cylindrical body or barrel 10 VII having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device 1 VII also utilizes an axially movable and retractable safety sleeve 30 VII arranged at a proximal end of the body 10 VII . Finally, the device 1 VII utilizes a spring 50 VII which is configured to bias the axially movable and retractable safety sleeve 30 VII towards an extended position covering the puncturing end of the needle N. Unlike the previous embodiments, however, this embodiment utilizes no deflectable members to retain the needle shield 30 VII in the fully extended position, and, in fact, the original position of the needle shield is the same as the final extended position. Also, unlike the previous embodiments, this embodiment utilizes no an axially movable trigger sleeve. Instead, the user directly depresses the deflectable members 15 VII to cause the needle shield 30 VII to move to the fully extended position from the retracted position. The deflectable member 15 VII arranged behind the needle N is not shown for clarity. This embodiment is otherwise similar to the device of FIG. 24 . Referring now to FIG. 26 which shows another embodiment of an injection device 100 . In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the previous embodiment, the device 100 includes an elongate generally cylindrical body or barrel 110 having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device 100 also utilizes an axially movable and retractable safety sleeve 130 arranged at a proximal end of the body 110 and an axially movable trigger sleeve 140 arranged at an area of a distal end of the body 110 . Finally, the device 100 utilizes a spring 150 which is configured to bias the axially movable and retractable safety sleeve 130 towards an extended position covering the puncturing end of the needle N. The deflectable member 114 and 115 arranged behind the needle N are not shown for clarity. This embodiment is similar to the device of FIGS. 1-13 except that it additionally includes a connecting interface CI for connecting the device 100 to an injection device. In embodiments, the interface IC is a luer-lok or luer lock type interface. Referring now to FIG. 27 which shows another embodiment of an injection device 100 ′. In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the previous embodiment, the device 100 ′ includes an elongate generally cylindrical body or barrel 110 ′ having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device 100 ′ also utilizes an axially movable and retractable safety sleeve 130 ′ arranged at a proximal end of the body 110 ′ and an axially movable trigger sleeve 140 ′ arranged at an area of a distal end of the body 110 ′. Finally, the device 100 ′ utilizes a spring 150 ′ which is configured to bias the axially movable and retractable safety sleeve 130 ′ towards an extended position covering the puncturing end of the needle N. The deflectable member 114 ′ and 115 ′ arranged behind the needle N are not shown for clarity. This embodiment is similar to the device of FIG. 27 except that it additionally includes a spring 80 for biasing the trigger sleeve 140 ′ towards a forward position. In embodiments, the interface IC′ is a luer-lok or luer lock type interface. Referring now to FIGS. 28-30 , which shows another embodiment of an injection device 1000 . In embodiments, the device is a device for injecting an IV needle. In embodiments, the device is an injection device that can be coupled to a device for injection or obtaining a fluid sample. In embodiments, the device is used in combination with other devices in the context of healthcare delivery and/or the medical profession. As with the previous embodiment, the device 1000 includes an elongate generally cylindrical body or barrel 1010 having a needle N retained therein. The needle N is hollow and has a proximal end that is configured for puncturing and a distal end for discharging or receiving fluid. The device 1000 also utilizes an axially movable and retractable safety sleeve 1030 arranged at a proximal end of the body 1010 and an axially movable trigger sleeve 1040 arranged at an area of a distal end of the body 1010 . Additionally, the device 1000 utilizes a spring 1050 which is configured to bias the axially movable and retractable safety sleeve 1030 towards an extended position covering the puncturing end of the needle N. The deflectable member 1014 and 1015 arranged behind the needle N are not shown for clarity. This embodiment is similar to the device of FIGS. 1-13 except that it additionally includes a connecting interface CI″ for connecting the device 1000 to a fluid injection and/or removing device. In embodiments, the interface IC″ includes an arrangement allowing a tube or tubing T to connect the device 1000 to the fluid container (not shown). The device 1000 also utilizes an axially retained removable butterfly member 90 arranged at a distal end of the body 1010 . A non-limiting embodiment of the butterfly member is shown in FIG. 30 . In embodiments, other butterfly members, whether conventional or otherwise, can be utilized with the devices disclosed herein such as that shown in FIG. 28 . The devices described herein can also utilize one or more features disclosed in prior art documents expressly incorporated by reference in pending U.S. patent application Ser. No. 11/616,196 (Publication No. 2008/0154212). This application/publication and the documents expressly incorporated therein is hereby expressly incorporated by reference in the instant application. Furthermore, one or more of the various parts of the device(s) can preferably be made as one-piece structures by e.g., injection molding, when doing so reduces costs of manufacture. Non-limiting materials for most of the parts include synthetic resins such as those approved for syringes, blood collection devices, or other medical devices. Furthermore, the invention also contemplates that any one or all disclosed features of one embodiment may be used on other disclosed embodiments, to the extent such modifications function for their intended purpose. It is noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention. While the present invention has been described with reference to an exemplary embodiment, it is understood that the words which have been used herein are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present invention in its aspects. Although the present invention has been described herein with reference to particular means, materials and embodiments, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims.

A needle device includes a body, a needle shield movable relative to the body, a needle at least partially arranged in the body, and a safety system that at least one of causes the needle shield to move to an extended position when activated by a user, releasably retains the needle shield in a retracted position after the user moves the needle shield to the retracted position, prevents a user from triggering the device, locks the needle shield in a fully extended position, prevents the needle shield from being retained in a retracted position after a user moves the needle shield towards the retracted position, non-releasably retains the needle shield in a fully extended position after being activated by a user, and utilizes two separate re-use prevent mechanisms. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.

FIELD OF THE INVENTION The present invention is directed to external programming machines that communicate with active implantable medical devices and exchange data therewith. BACKGROUND OF THE INVENTION The invention will be mainly described in the case of a cardiac pacemaker, but this is only one example of an implementation of the present invention, which is applicable in a far more general manner to a very great variety of "active implantable medical devices." Active implantable medical devices are defined, for example, by the Jun. 20, 1990 Directive 90/385/CCE of the European Community Council, to include, in addition to cardiac pacemakers, defibrillators and/or cardiovertors, diffusion/infusion pumps of medical substances, cochlear implants, implanted biological collectors, etc. These devices (hereafter collectively designated "implants"), once put in place in a patient, that is, implanted, are programmed (and typically also reprogrammable to one extent or another) by an external programming device to perform the intended function in a desired manner. The external device is typically called a "programmer" and generally is a microcomputer equipped with a programming head placed in proximity with the site of the implant. The programmer can read, by way of electromagnetic transmission (wireless telemetry) through the programming head the data stored in the implant. For example, the programmer can read the parametric data, biological signals that have been recorded by the implant, events diagnosed by the implant, etc. The programmer typically also is able to send parametric data to the implant so as to re-program it, that is to say to modify some parameters of implant functioning, and may be able to send programming instructions to the implant to reconfigure its software. The term "parametric data" should be understood to mean and include the parameters used to program and/or control the functioning of the implant, which parameters may be predetermined at the time of construction of the implant or programmed/programmable values based on the intended use of the device, and also are referred to herein as "data". The known programmers are specific to a given type of implant, or to a family of implants of the same manufacture. Consequently, each time a new implant is placed on the market, it is generally required to provide a corresponding update of the applicable programmers. In addition, even in the absence of placement on the market of a new implant, improvements are regularly obtained that can require an update of the programmer software. These updates are particularly delicate. Indeed, for self-evident security reasons, all updates have to be released according to a very strict protocol: The protocol typically require a visit to the responsible health center or clinic where the programmer is maintained so that a qualified person can then change the program and recover the prior program. This visit is completed with a writing and signature of various certification documents, etc. These procedures are burdensome and costly. As a result, one typically avoids to follow them too often (for example, no update may be made in the case of a minor modification of the software). In addition, the security procedures, as complete as they are, do not eliminate totally the risk of an absence of an appropriate update. For example, a programmer that could not be located by the manufacturer will not be updated. Nor do the procedures avoid the risks of operating during the update transition periods, and, especially, the less appropriate utilization of an obsolete version of the software. The reference to "obsolete" should be understood to mean simply a prior version that has been made obsolete by the update being implemented. OBJECTS AND SUMMARY OF THE INVENTION One of the objects of the present invention is, therefore, to remedy to these difficulties, by proposing a new concept of programmer whose software can be updated in an entirely automatic manner, without human intervention, thereby reducing, if not eliminating the burden, costs, and risks associated with current update procedures. The invention relies on an implementation of the notion of an "object" in the software sense of the term, that is to say a structural element in the broadest sense of the term (data, constructors, destructors and methods), allowing the software to manage and to display data in a very structured manner. In particular, the access to data is released in general only by methods appropriate to the object. This allows to protect the object data against exceeding a predetermined range and to render the software particularly reliable. The concept of "heritage" or "inheritance" also facilitates the design of the software, with one object being able to inherit another object. This allows the one object to use directly the methods of the other object and simplify the structure of each with respect to updating by modification or addition of the one object, as will be explained. Examples of such software objects and their applications to the field of cardiac pacemakers will be described below. In a general manner, one will be able to refer to the published literature on this subject of use of object programming, for example, the work of Max Bouche, "La demarche objet--Concepts et outils," AFNOR, 1994, (The Step Object--Concepts and Tools, AFNOR, 1994), as well as the documentation of typical "object oriented" programming languages such as C++. Broadly, the invention is directed to (i) storing in the implant object oriented software, allowing it to define the display, the processing, and the programming of its data by an external programmer; (ii) comparing in the programmer a list of objects that the programmer contains to the list of objects that the implant contains; and (iii) downloading from the implant to the programmer objects in the implant that are missing in the programmer or more recent relative to the version of the object that is in the programmer, thereby to update the software of the programmer. Proceeding in this manner, which is described in more detail hereafter, provides at least four major advantages as compared to the prior art updating procedures: security, economy, simplification of the programming, and standardization. Security All programmers are equipped with a basic minimum software, that is to say, objects allowing it to establish communication with an implant, and to manage connections between objects in the implant and objects in the programmer. Such a basic programmer will therefore able to read any implant and its objects, even if the implant has been developed well after the programmer and contains objects not previously in the programmer. Consequently, the operator of the programmer no longer will be unable to read and re-program the functions of a recent implant model in accordance with the present invention, if he has a compatible programmer, however old it may be. In addition, each parameter has its proper mode of management, defined by software in the implant, which controls the capture of these parameters by the programmer, and which is defined in a given object. Thus, the programmer will not capture false parameter values because they are no longer controlled by an object pre-existing in the programmer but rather by a object issued from the implant. Economy The expense of updating a programmer is considerably reduced and becomes required only for important equipment changes, (namely new generations of programmers, hardware changes telemetry heads, etc.). One also avoids all of the expense of the classic security procedures that go with the known update changes: manufacture of diskettes and manuals for the update, dispatching a qualified operator to each programmer site, signature of a register certifying the update, recovery of the old diskettes, etc. Simplification of the Programming The evolution and updating of the programmer software is performed automatically in a manner that is transparent to the user of the programmer. Only very general functions will be needed to complete management of the basic objects, and the list of objects furnished will, at the end, be completed by the new or additional objects defined in each new implant. Standardization The flexibility of the implementation of the present invention allows the creation of a standard allowing all programmers to read compatibly any implant, regardless of its model or manufacturer. Each manufacturer will be able to define the graphic display aspect of its programmer, the possibilities of data management, supplementary calculations, etc. in a manner that will maintain a certain originality and product distinctiveness, but, with the basic objects being defined in an identical manner, the reading of a "foreign" implant now becomes perfectly possible. One can thus envisage the realization of a universal programmer, which until now was excluded not only for reasons of cost and complexity, but also for security reasons (namely, the damages from unforeseen incompatibility risks). One particular aspect of the invention is directed to a system comprising, on the one hand, an implant of the active implantable medical device type, and, on the other hand, an external programmer, in which: The programmer has a software composed of an number of software objects; the implant has a memory containing, on the one hand, parametric data concerning the functioning of the implant, and, on the other hand, a number of software objects necessary for the functioning of a programmer in connection with the aforementioned parametric data of the implant; a bi-directional connection between the programmer and the implant to exchange information allowing particularly the selective transfer of all or part of the aforementioned parametric data and one or more of the aforementioned objects of the implant to the programmer; and the programmer has a programming capability to command the downloading from the implant of at least a part of the aforementioned objects contained in the implant memory and to add and/or to substitute these objects to the objects defined in the programmer software. More preferably, the programmer downloads as much or as many of the implant objects as is necessary to become fully compatible with the implant. As a result the system is able to update the programmers. Preferably, the updating procedure occurs automatically when the programmer is placed in communication with the implant. Advantageously, the programmer capability for updating operates to: establish a list of objects that are found in the implant, more preferably a list which includes the version of the objects found; compare the established list to the objects in the programmer software; command the downloading from the implant of those objects absent in the programmer software and to add these objects to the programmer software; and/or command the downloading from the implant of those object for which the version present in the programmer software is prior to that found in the implant, and to replace therewith the objects in the software. As a result, when an updated programmer is next in communication with a similar implant, the comparision of ojects in the implant to the programmer finds all of the current versions of the objects in the programmer, and no downloading is needed. Other aspects of the invention are separately directed, as independent products, on the one hand, to the implant, and on the other hand, to the programmer, respectively implementing the appropriate one of the aforementioned characteristics. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a block diagram of a system for reprogramming a programmer in accordance with the present invention; and FIG. 2 is flow diagram for updating the programmer of the system of FIG. 1. DETAILED DESCRIPTION OF THE INVENTION One is going now to describe an example of an implementation in accordance with a preferred embodiment of the invention with reference to FIGS. 1 and 2. As previously indicated, the software of the programmer 300, as well as that of the implant 200, is organized in object oriented software "objects." In the case of an implant 200 which is a cardiac pacemaker, one can represent by one object each element (parameter) of the pacemaker that is programmable or simply displayable on the screen 350 of a programmer or printable on a printer (not shown). Thus, a curve giving the cardiac frequency as a function of time can be represented by a particular software object called "CARDIAC FREQUENCY," that inherits from a more general object, which one can call "CURVE," and comprises a sequence of data corresponding to a curve, with its format, its title, a method of display, a method of printing, etc. The term "format" refers to the scales in abscissa (X-axis) and ordinate (Y-axis). The programmer 300 for its part has an object "CONNECTION ADMINISTRATOR" that can call data corresponding to the cardiac frequency stored in the pacemaker, by applying transfer data protocols, compression/decompression, etc. as necessary. The programmer 300 will then be able to display a window on the programmer screen 350 presenting the cardiac frequency data, with the help of the object CURVE, allowing all presently available display related functions: zooming, moving in the window, measuring the data displayed with the help of cursors, etc. These functions are understood to be performed in the conventional manner. The concept of the invention is based on three fundamental hypotheses. First, the programmer software is "open," that is to say that it can be modified by receiving and incorporating new objects concerning data, the display of data, the processing of data, and the programming of the implant. These objects can come from the implant (according to the characteristic of the invention), from a diskette or from any other computer support in itself known (e.g., ROM change, a modem or file transfer), for example, by the preliminary loading of the CONNECTION ADMINISTRATOR object. Second, the implant 200 stores all objects needed by it to define the programmer display, the data processing, and the programming of data contained in or acquired by the implant. It should be noted that the size of the objects in the implant software can be relatively reduced, to the extent that they inherit from other objects are already present in the programmer. For example, the programmer object CURVE generally defines the display and management of a curve, and therefore the implant software object CARDIAC FREQUENCY need only map the particular features of the data to be displayed to the object CURVE. The object CURVE then manages the actual processing and/or display. Third, the versions of objects are dated (for example, by a version number and/or a date code) and any more recent version replaces a prior version in the programmer. Developments of objects is thus to be released by imposing an "upward" compatibility, that is to say, the more recent version remains compatible with all data exchanges relative to older versions. In the beginning of the exchange of data between an implant 200 and a programmer 300 (step 10, FIG. 2), the programmer 230 systematically calls a block called List-Of-Objects that is a repertory of available objects in the implant (step 20, FIG. 2). This can be done automatically, preferably as soon as a valid communication link 400 is established (step 20, FIG. 2). This List-Of-Objects is maintained in the implant. Preferably, the List-Of-Objects also includes the version of each object in the implant. More preferably, the List-Of-Objects includes a table containing an object number and object name (and optionally a description). The programmer 300 then compares the codes of these implant objects with the objects already known (e.g., an available list of objects in the programmer software 320, which is preferably dynamically managed and safeguarded in a configuration file) (step 30, FIG. 2). If one or more of these objects is unknown to the programmer, it calls the object CONNECTION ADMINISTRATOR and commences a procedure of downloading the unknown objects so as to complete its software and to adapt the programmer to the implant (steps 50 and 70, FIG. 2). The programmer configuration file is then updated (step 80, FIG. 2). The procedure of downloading and updating automatically occurs for each unknown object (step 50, FIG. 2), by the programmer utilizing the CONNECTION ADMINISTRATOR object that inherits the object being downloaded. The CONNECTION ADMINISTRATOR sends a code, e.g., a number of the object, to the pacemaker and the pacemaker returns a block of corresponding information to the programmer. A similar procedure is performed for objects that, although present in the software of the programmer, correspond to a version that is older than the one contained in the implant (step 70, FIG. 2). After this updating phase, the programmer has all of the objects needed to be compatible with the implant, and can call all data (235 or 236) contained in the implant, to display the desired results, re-program the implant, etc. in the conventional manner (step 90, FIG. 2). Thus, in the case of an implant having the object CARDIAC-FREQUENCY being read by a programmer not knowing that object, the programmer identifies the object in the List-Of-Objects provided by the pacemaker. The programmer then asks the implant to transfer the object, which it does, and the programmer adds it to its program. The call to the constructor of the object also allows to reserve a memory zone to receive later the curve of frequency, the selection of a display window and the initialization of various variables, associated with the object. The code (or number) of the object CARDIAC-FREQUENCY then comes to be added to the dynamic list of available objects maintained in the software of the programmer. When the programmer operator wants to display the curve, it calls on the programmer the corresponding window. The program then tests the presence of the curve in memory, and, if no curve exists, it commences a reading of the cardiac frequency data stored in the pacemaker. The curve is then displayed in a window having the classic display adjustment controls (gain, zoom, moving), measure (cursors) and possibly printing these various functions all being managed by the general object CURVE already present in the programmer. One is going now to describe two detailed examples of pacemaker objects: an object NOMINAL FREQUENCY (programmed fixed value); and an object RESPIRATORY FREQUENCY (data which varies in the course of the time). The description of objects can be released under any of several forms, which can be summarized as three cases: (1) machine code, (2) precompiled code and (3) metalanguage: The machine code or firmware is linked to the processor to allow a long term usage. The precompiled code (such as the old fashioned "P-code") is extremely effective, being able to describe all data and methods of the new objects. However, it remains large in size, and is thus less adapted to be used with implants having low memory capacity. The metalanguage specifies only the value of variables belonging to parent objects that are predetermined by the programmer. The volume of data is thereby extremely reduced as compared to the other cases. Most of data of an implant can be contained in a description in the form of a metalanguage, but the recourse to a precompiled code should remain accessible for the integration with original objects. In the examples described here, the chosen language is a metalanguage, which gives a reduced size of the objects and a total independence from the programming language. On the other hand, it can only make reference to the basic objects of the programmer, without being able to make them directly progress. The limits are reached only when a completely new concept will not be able to be integrated by the programmer, with the result that the development of the basic objects has to be extremely well released to avoid the too frequent occurrence of this type of incident that would impose a traditional software update of programmers. EXAMPLE 1 Object: NOMINAL FREQUENCY The nominal frequency (also known as a base frequency), which is an essential parameter of all cardiac pacemakers, can be represented by an object described in the following manner: 1. object number: a unique code is associated with the object, for example, eight characters (two letters for the manufacturer, four letters for the object and two digits for the number of version). This allows to choose a code both unique and easily decipherable. 2. object ANCESTOR: a number for this object provides the code of the object ANCESTOR, that is the only object that already resides in this case in the programmer and allows the programmer to manage all processes of display, capture, printing and storing of a numerical value. This object inherits, of course, at a minimum, a more general object that is the CONNECTION ADMINISTRATOR. As it concerns a programming by predetermined steps, the values are coded in number of steps. This datum occupies five characters. The next data provides the parameters of the object ANCESTOR: (a) descriptive sentence (100 characters) accompanying the numerical value at the display (for example, twenty characters of text for a total of a hundred characters for twenty characters in five different languages). (b) unit of measure (10 characters). (c) values of the minimum, the maximum and the nominal value (16 characters): the limit is resident in the object ANCESTOR so as to prevent the capture of a numerical value out of the limits. These limits are updated by the maximum and the minimum and the nominal values replace the values previously present in the object during a call of a method of "placement to the nominal" which inherit all programmable objects. The step increment can be defined as a constant, logarithmic, or inverse function value in order to accommodate to the various cases existing in pacemakers. (d) reference window (5 characters): Each datum to be displayed in one of the screens of the programmer, that can contain one or more windows. Each window is defined by the pacemaker with at least a title, a format (one column, two columns, etc.) and actions that one can execute (displacement, call to a momentary reading or continuous reading of the pacemaker, local menu, etc.) (e) position in the reference window (5 characters): This provides column, height, etc., that can summarize in the form of a number to five digits: The first gives the column, the three following give an order of priority in relation to the others; the nucleus of screen-management places them from high to low by order of priority. The totality of the data for this object occupy therefore 56 characters in monolingual mode and 136 characters in a multilingual mode. EXAMPLE 2 Object: RESPIRATORY FREQUENCY In the case of a pacemaker analyzing the respiratory frequency, the acquired data can be stored for periods of several hours, several days and even several months. The object can be described in metalanguage in the following manner (Those terms already described are not repeated except as noted): (1) number of object (8 characters) (2) object ANCESTOR (5 characters) It concerns a curve generator in frequency as a function of time f(t) possessing a vertical scale and a horizontal scale, a format of data and a display mode (line, minimum--maximum, etc.), methods of scale change, display and printing. This object belongs to the objects residing in the programmer. The next data give the parameters of the object ANCESTOR: (a) descriptive sentence (20 characters for each language, or 100 characters in 5 language multilingual mode): (b) unit of measure (10 characters). (c) format of data (5 characters): continuation of numerical values (an integer) (8, 16, 24 or 32 bits), real, etc. This format is a resident object that inherits the object CONNECTION ADMINISTRATOR so as to render it capable to manage the transfer of data between the pacemaker and the programmer. (d) time period separating each datum, (4 characters): period in milliseconds, coded by a four byte word allowing thus a dynamic range of time of between 1 ms and 1137 hours. (e) vertical scale description (12 characters): low value, high value, step increment. (f) reference window (5 characters): same as in the case of the nominal frequency. (g) position in the reference window (5 characters): as for the nominal frequency, the display of the graph positions according to a certain order of priority; the number of columns and the number of displayed elements are taken into account by the window to grant to each the available maximum place: thus, a window with one column containing only one curve displays the former on all the available surface, a window with two columns and four curves displays each on a quarter of the total surface, area etc. The totality of these data occupies therefore 74 characters in monolingual mode and 154 characters in a five language multilingual mode. One can thus describe in the same general manner all of the necessary parameters for the functioning of the pacemaker. In the case of a relatively complicated cardiac pacemaker, comprising for example 20 curves stored in memory and 50 programmable parameters, the total size of objects is thus, in multilingual mode, 50×136=6800 characters for parameters and 20×154=3080 characters for curves, for a total of 9880 characters. To this it is necessary to add the block List-of-Objects that will be transmitted to the programmer beforehand to perform the update, which is 70×8=540 bytes. The total size reserved to the storing of objects in the pacemaker reaches, therefore, approximately 10 Kb in the case of the most complex (for example, a DDD rate responsive pacemaker of the most recent generation). Advantageously, these elements can be easily introduced in a ROM circuit of the pacemaker, without entailing over-consumption, so that this circuit is not activated. One skilled in the art will appreciate that the present invention can be practiced by other than the described embodiments, which are presented for purposes of illustration and not of limitation.

A system and methods for the automatic update of the software of an external programmer implant is that is used to program and configure an active implantable medical device implant and acquire data obtained by the implant. The programmer comprises software composed of an assembly of software objects. The implant comprises a memory containing parametric data for the functioning of the implant and an assembly of software objects necessary for the functioning of the programmer in connection with the aforementioned of parametric data. The programmer and the implant communicate bi-directionally. The automatic updating preferably occurs by the programmer reading of the memory of the implant, establishing a list of objects that are found in the implant with their respective versions, comparing the list to the objects (and their versions) that are in the programmer software, downloading from the implant of those objects which are not found in the programmer software and adding these objects to the programmer software; and/or downloading from the implant those objects in the programmer software whose version is prior to the version of the object found in the implant, and to replace the programmer software objects, with the more current version.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit, under 35 U.S.C §119(e)(1), of U.S. provisional patent application No. 61/153,277 filed on Feb. 17, 2009, titled: “Medical Device for Placement of Continuous Regional Anesthesia Catheters,” the disclosure of which is herein incorporated by reference. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH [0002] Not Applicable. FIELD OF INVENTION [0003] The invention relates generally to medical devices that enable the placement of catheters into body of an organism, and more specifically to medical devices designed to assist the placement of regional anesthesia catheters for continuous infusion of local anesthetics. BACKGROUND [0004] Regional anesthesia catheters are hollow body flexible catheters that are designed to be placed next to a nerve or nerve plexus of the human body, and kept in place for up to a few days. Liquid medicine is injected into proximal end of the catheter. The medication then exits from distal end of the catheter and is deposited around the nerve that is intended to be anesthetized. The dispersal of medication around the nerve causes the area innervated by that nerve to become anesthetized. In current anesthesia practice, hollow shaft metal needles are used to place such catheters into position. [0005] Such needles are covered with an electrically insulating covering over the outer surface of most of their length, except the tip and proximal end. An electric impulse sent to the needle is conveyed axially down to the tip of the needle and not radially to surrounding tissues. This allows for more precise placement of the needle tip. A stimulating wire is attached to the proximal end of the needle and is used to connect the needle to an electric supply source or so-called a nerve stimulator device. The distal end of the needle is placed through the skin of the patient and is advanced toward the target nerve. The amount of electric impulse that is sent toward the needle tip is gradually decreased as the needle advances into the patient's body, which helps to localize the target nerve. A muscle contraction at a specific low current verifies the proximity of the needle tip to that nerve. Next, the catheter is placed through needle. [0006] Needles and catheters come in different gauges and lengths, and it is imperative to use catheters with matching needles. Catheters are either stimulating or non-stimulating. Non-stimulating catheters are composed of an elongated hollow body and generally are similar to epidural catheters. Stimulating catheters generally have a hollow body and means for conveying electric current from the proximal end of the catheter to its distal tip. Only a small portion of the distal and proximal ends of the catheter are electrically exposed, while the body is electrically nonconductive. This allows for precise placement of catheter tip next to a nerve. [0007] These days some practitioners use ultrasound devices to visualize the target nerve and place the needle tip, followed by the catheter tip, next to the target nerve. Practitioners may choose to perform the procedure, using ultrasound alone, or they may employ ultrasound and a nerve stimulator simultaneously. In current practice, however, the majority of practitioners prefer to use nerve stimulators. [0008] Placement of regional anesthesia catheters is done using strict sterile techniques to avoid catheter and needle contamination, and thus patient infection. For example, the skin area were the needle and catheter will be inserted into the patient is prepped and extensively draped. The long resilient catheter is always prone to contamination from surrounding objects. It is also necessary for the practitioner to wear a mask, hat and sterile gloves and even sterile gown in some instances. An assistant is needed to help open sterile packages, connect and disconnect stimulating wires of needle and catheter to nerve stimulator, and operate the nerve stimulator. The assistant will help utilize the ultrasound device as well, if one is used. SUMMARY [0009] The current invention is directed to a device that: Reduces chance and frequency of catheter and needle contamination. Reduces time needed to place the catheter adjacent to the target nerve. Eliminates need for an assistant in most parts of a procedure. Eliminates the need for anesthesia provider to wear hat, mask, sterile gloves, and gown. Eliminates the need to drape insertion site. Reduces risk of needle injury to medical staff because the needle is housed safely in a protective covering. [0016] In this invention, a metal hollow shaft needle is manufactured to a size that is almost twice as long as commercially-available similar needles. The needle is electrically insulated throughout most of its length, on the outer surface, except its proximal end and distal tip. The needle's proximal end may be attached to a stimulating wire which is adapted to allow it to be connected to a nerve stimulator device. The proximal portion of the needle shaft is permanently placed inside a plunger and the plunger is placed inside a housing. The plunger is situated inside the housing so that it can slide up and down the housing with friction. A removable protective cap is placed over distal end of the housing to ensure sterility. [0017] In the present invention, a stimulating regional anesthesia catheter is preloaded inside the needle. The catheter tip may be electrically in touch with electrically conductive inside surface of the needle. A protective sheath made of clear collapsible plastic covers most of the length of the catheter, which is left proximal to the needle. The sheath has a proximal hub and a distal hub and is secured and sealed at the peripheral ends of the hubs. The distal hub is attached to the proximal end of the needle, while the proximal hub is placed around the proximal end of catheter, leaving a small portion of the catheter (approx. 1-2 cm.) out. A regional anesthesia catheter adaptor is attached to the sheath's proximal hub in a releasable manner. This adaptor accepts and rigidly maintains the catheter's proximal end. It has components to electrically connect the nerve stimulator to the catheter's proximal end and provides fluid access into the interior lumen of the catheter for injection of liquid medicine using a syringe or infusion pump. [0018] After prepping the insertion site, the catheter adaptor is connected to a nerve stimulator device. The housing distal protective cap is removed and the distal end of the housing is placed over the insertion site. The needle is then advanced toward the target nerve by advancing the plunger into the housing. At this time, the catheter is manipulated, through the catheter sheath, to bring the catheter's tip into electrical contact with the inside lumen of the needle. The anesthesia provider can operate the nerve stimulator to send a decreasing amount of electric impulse to the catheter tip, and simultaneously advance the needle tip through the patient's body towards the target nerve. After the needle tip is placed in close proximity to the target nerve, the catheter is pushed through the catheter sheath by the practitioner and advanced until the desired length of the catheter's distal end exits beyond the needle tip. [0019] At this point, any satisfactory muscle contraction is a result of direct stimulation of the nerve by the catheter's tip and will confirm that the catheter tip has been correctly placed near the target nerve. Next, the proximal end of the catheter is released from the catheter adaptor to free the catheter, and then the needle is withdrawn while the catheter is maintained in place. Finally, the catheter adaptor is detached from the sheath's proximal hub and securely reattached to the catheter's proximal end. Care should be taken not to touch and contaminate the proximal end of the catheter and the distal part of the adaptor. At this time the catheter should be properly secured to the patient. [0020] In an alternative method of using this embodiment, a first impulse is sent to the needle using the needle's stimulating wire. The catheter is advanced beyond the needle's distal tip, then a second impulse is sent to the catheter to verify the catheter's correct placement. [0021] In alternative embodiments, a non-stimulating catheter is used. In non-stimulating catheter embodiments, the needle may be comprised of components that connect the needle to a supply source of electricity. BRIEF DESCRIPTION OF DRAWINGS [0022] FIG. 1 is a side elevational view of a prior art needle. [0023] FIG. 2 is a side sectional view of a needle and plunger inside the housing according to an embodiment. [0024] FIG. 2A is a side sectional view of a needle and plunger according to an embodiment. [0025] FIG. 2B is a side sectional view of a housing according to an embodiment. [0026] FIG. 2C is a side sectional view of a beveled distal end of a housing according to an embodiment. [0027] FIG. 3 is a side sectional view of a regional anesthesia catheter placed inside covering sheath according to an embodiment. [0028] FIGS. 4A and 4B are side elevational views of a catheter adaptor according to an embodiment. [0029] FIG. 5 is a side sectional view of a fully-assembled invention according to an embodiment. [0030] FIG. 6 is a side sectional view of one embodiment of the invention having a stylet placed inside needle. [0031] FIG. 6A is a side sectional view of a plunger and needle, with the plunger having a side slot for insertion of the stylet, according to an embodiment. [0032] FIG. 6B is a side sectional view of a stylet according to one embodiment of the invention. [0033] FIG. 7 is a side sectional view of one embodiment of the housing with side longitudinal slot. [0034] FIG. 7A is a side sectional view of one embodiment of the needle with curved proximal end. [0035] FIG. 7B is a side sectional view of one embodiment of the invention with the needle placed inside the housing and with the curved proximal end of the needle placed inside side slot. [0036] FIG. 8 is a side sectional view of one embodiment of the invention fully assembled with schematic depiction of switch pad and nerve stimulator device (NS). [0037] FIG. 9A is a side sectional view of one embodiment of the invention with distal conduit in the released position. [0038] FIG. 9B is a side sectional view of one embodiment of the invention with distal conduit in the locked position. DETAILED DESCRIPTION [0039] Referring to FIG. 1 , a conventional hollow shaft metal needle 11 is shown. These needles are well known to prior art. They are made in different lengths and gauges suitable for intended use. The needle shown in FIG. 1 has a shaft 12 , a proximal end 16 and a distal tip 15 . The tip 15 may be straight or beveled, or it may be made with an angle at the end of the straight shaft 12 . The proximal end 16 is provided with a hub 18 . The stimulator wire 14 has a first end attached to proximal end 16 and a second end adapted to connect to nerve stimulator device using connection plug 17 . Using a nerve stimulator, electric impulse is sent through connection plug 17 , which conveys the impulse to tip 15 . [0040] Needles, such as the one shown in FIG. 1 , are usually manufactured with a shaft 12 that is covered with electrically non-conductive material on its outer surface, except along its proximal end 16 and its tip 15 , which are not coated with the non-conductive material. This allows for precise placement of the tip 15 next to a nerve. A stylet (not shown) may be placed inside the shaft 12 . In such an embodiment, the stylet is removed after the needle tip 15 penetrates the patient's body. Stylets are generally used to facilitate needle insertion into the patient's body and to prevent body tissues from plugging needle lumen. [0041] Referring to FIG. 2 , a hollow shaft metal needle 11 is made almost twice as long as commercially-available, similar needles. The needle 11 has a shaft 12 , a proximal end 16 , and a tip 15 . Using standard industry methods that are well known in the art, the shaft 12 is coated with a thin layer of non-conductive material over the shaft's 12 outer surface; the tip 15 and the proximal end of the shaft 16 are not coated. The tip 15 may be straight or beveled or it may make an angle with the shaft 12 . The proximal section of the needle 11 is permanently and coaxially placed inside the plunger 6 . The plunger 6 has a proximal end 7 , a distal annular ring 8 , a thumb rest 28 , and an entry hub 18 . The plunger 6 divides the shaft 12 into sections 2 and 4 . Section 2 is coaxially disposed within the plunger 6 . The hub 18 is in fluid communication and provides access to the inside of the lumen of the needle shaft 12 and the needle tip 15 . [0042] The proximal end 16 may be attached to a stimulating wire 14 which is adapted to connect the needle 11 to a electric supply source. The plunger 6 is placed inside the housing 10 . The housing 10 preferably has a cylindrical body. It has a distal end 20 , a proximal end 23 , and a distal conduit 22 . The housing 10 has a length that allows the needle 11 to be withdrawn completely inside the housing 10 . The inner diameter of the conduit 22 is slightly larger than the outer diameter of the needle 11 , and the inner diameter of the conduit 22 will guide the needle 11 out of the distal end of the housing 10 . A finger flange 24 may be attached to the proximal end 23 of the housing 10 . [0043] Minimal friction exists between the distal annular ring 8 and the housing 10 . The proximal end 23 of the housing 10 may be provided with anterior and posterior inner annular stop rings 26 . These rings 26 will maintain the needle 11 completely inside the housing 10 in such a way that the needle tip 15 will rest inside the conduit 22 at a position slightly proximal to the distal end of the conduit 22 . Slight force should be needed to move the annular ring 8 passed the annular stop rings 26 in either direction. The distal end 20 of the housing 10 may be beveled almost 30-45 degrees, this conforms to the angle with which the needle 11 will penetrate the patient's body. Except for the needle 12 , which is preferably made of metal, the other component parts of the embodiment of the invention depicted in FIG. 2 can be made of any solid material, preferably plastic. The annular ring 8 may alternatively be made of a soft elastic material like plastic or rubber. [0044] Marks may be placed along the plunger 6 , the needle 11 , or the housing 10 to help the user determine the depth of penetration of the needle 11 . This could be accomplished by applying alternating colors of specific length to the outer surface of the plunger 6 , the needle 11 , or the housing 10 , or alternatively marking lines of different thickness along the outer surface of the plunger 6 , the needle 11 , or the housing 10 . In an alternative embodiment, the needle 11 can be attached to the distal end of the plunger 6 instead of being coaxially placed within the plunger 6 . In this embodiment an axial central conduit should exist within the plunger 6 to provide fluid communication between the hub 18 and the needle 11 and to allow catheter placement into the needle 11 . [0045] In one embodiment of the present invention shown in FIG. 9 , a catheter assembly is shown with a locking mechanism. The locking mechanism is accomplished by constructing the conduit 22 out of a soft but resilient material. The anesthesia provider can lock the needle 11 in position by simply pinching the conduit 22 between his/her fingers. Upon the release of the pressure created by the provider's fingers, the conduit 22 will resume its straight shape and free the needle 11 from its locked position. This locking mechanism may be used during the advancement of the catheter through the needle 11 , so the needle 11 can be maintained in its position. [0046] Referring to FIG. 3 , a conventional stimulating regional anesthesia catheter is shown placed inside of a protective sheath. As described earlier, only the distal tip and the proximal end of the stimulating catheter are electrically exposed. The catheter has a proximal end 63 , a distal tip 65 , and a body 61 . The catheter has means to convey electric impulse from the proximal end 63 to the distal tip 65 . Any electric current sent through the proximal end 63 will only travel axially through the body 61 and exit from the distal end 65 . This allows for precise placement of the catheter tip next to a target nerve. The catheter cover sheath 68 is made of thin clear plastic and is attached to the distal hub 67 and the proximal hub 62 as shown in FIG. 3 . The sheath 68 is attached to periphery of hubs 67 and 62 in a sealed and secured way to maintain the sterility of the catheter 61 . [0047] Referring to FIG. 3 , the sheath 68 is manufactured of adequate length as to when fully expanded, to cover the catheter 61 over its length beginning adjacent to the needle 12 and continuing until just before the proximal end 63 of the catheter 61 which is placed inside a catheter adaptor. The distal hub 67 is attached to an entry hub 18 of the plunger 6 . This attachment may be permanent or, preferably releasable but secured, like a Luer fitting, or a male-female connection, or any other way known to prior art. It is important that this connection does not come apart accidentally during the catheter placement procedure, which may render the catheter 61 exposed and subject to outside contamination. [0048] Alternatively, as explained earlier, the catheter 61 can be a non-stimulating catheter. In embodiments assembled using a non-stimulating catheter, the proximal end 63 of the catheter 61 may be maintained by a catheter adaptor attached to a proximal hub 62 , or, alternatively, it may be left free inside the catheter sheath 68 . This is because electrical stimulation of the catheter, during catheter placement, is not needed when a non-stimulating catheter is used. The catheter adaptor can be attached/reattached to the catheter's 61 proximal end 63 after the catheter 61 is placed correctly and the needle is removed from the patient's body. [0049] Referring to FIGS. 4A and 4B , a generic catheter adaptor 71 is shown. These adaptors generally have a first part 72 and a second part 74 . The first part 72 has a front end 76 and rear end 78 . The front end 76 has space in it to accept and firmly grasp the proximal end 63 of the catheter 61 . This provides for an electrical connection between the catheter 61 and the catheter adaptor 71 , and provides for fluid communication with the catheter 61 . FIG. 4A shows the catheter adaptor 71 in the released position. In FIG. 4B , part 74 has moved in relation to part 72 , which puts the catheter adaptor 71 in the locked position, which locks the proximal end 63 of the catheter in place. The rear end 78 of the catheter adaptor 71 is shaped to accept syringes of local anesthetics or infusion pumps for purposes of injecting liquid medicine through the catheter adaptor 71 into catheter lumen. [0050] The rear end 78 of the catheter adaptor 71 is covered by a removable protective cap to maintain sterility. The catheter adaptor 71 depicted in FIGS. 4A and 4B has a stimulating wire 73 and a connecting plug 75 . The connecting plug 75 is used to connect the catheter adaptor 71 to an electric supply source. The front end 76 of the adaptor 71 is connected securely, but releasably, to the proximal hub 62 of the sheath 68 . This can be done, for example, with Luer fitting connections or any similar manner known to prior art. Accidental disconnection of the adaptor 71 from the proximal hub 62 during catheter placement can render the catheter 61 contaminated. [0051] Referring to FIG. 5 , an embodiment of the catheter system is shown fully assembled. A protective cap (not shown) should cover the distal end 20 . The protective cap needs to be removed just prior to needle insertion. A second cap (not shown) should cover the rear end 78 of the catheter adaptor 71 . This should be removed in order to introduce local anesthetics into the catheter adaptor 71 and into the catheter lumen. As shown in FIG. 5 , no areas of either the catheter or the needle are exposed. [0052] By preloading the catheter and placing the parts of the catheter system in protective sheaths, the anesthesia provider can touch and operate the entire catheter system unit without the need to wear sterile gloves or use extensive protective draping; a simple preparation of the insertion site will suffice. A pair of clean gloves will be needed to cover the anesthesia provider's hands. The provider will join the connection plug 75 to a nerve stimulator (not shown here), then he/she will place the distal end 20 of the housing 10 against the insertion site. [0053] Referring to FIG. 5 , the needle 11 is advanced toward the targeted nerve by advancing the plunger 6 through the housing 10 . Advancing the plunger 6 fully inside the housing 10 will cause the needle 11 to protrude out of the distal end 20 of the housing 10 the same length as similar commercially available needles. The anesthesia provider can operate the nerve stimulator simultaneously with the catheter system. The catheter is manipulated until its tip 15 comes in contact with the electrically conducting interior lumen of the needle 11 . This will electrically couple the nerve stimulator to the needle tip 15 . When the needle tip 15 is verified to be adequately close to the target nerve, the catheter 61 is grasped through the catheter sheath 68 and advanced inside the needle 11 . [0054] Marks on the catheter 61 will show the practitioner when the catheter tip 65 exits out of the needle tip 15 and loses electric contact with it. A satisfactory muscle twitch observed after this point in time is the result of direct stimulation of the target nerve by the catheter tip 65 , which means correct placement of the catheter tip 65 within the nerve sheath. When an adequate length of the catheter 61 is placed adjacent to the nerve, the proximal end 63 of the catheter 61 is released from the adaptor 71 . This allows the catheter end to move freely inside the sheath 68 . The catheter 61 is then further fed through the plunger hub 18 , while the needle 11 is simultaneously removed from the patient. [0055] Care must be taken not to withdraw the catheter 61 while the needle 11 is being removed. When the needle tip 15 is out of the patient, the catheter 61 is held by the hand at a point distal to the needle tip 15 . The proximal portion of catheter 61 is then pulled out of the sheath 68 and the needle 11 . Care should be taken not to touch and contaminate the proximal end 63 of the catheter 61 , and the front end 76 of the catheter adaptor 71 . These two portions need to be reconnected in a sterile manner. [0056] In some embodiments of the present invention, marks may be placed along the catheter 61 at a distance that is almost one inch away from the proximal end 63 to warn the practitioner of the eminent exit of the proximal end 63 out of the needle 11 , so accidental contamination of the catheter end 63 can be avoided. The adaptor 71 at this point is released from the proximal hub 62 and reconnected to the proximal end 63 . Next, the needle 11 is pulled completely into the housing 10 and is disposed of safely. Lastly, the catheter 61 is secured to the patient properly. [0057] In an alternative embodiment, a first electric impulse is sent from a source of electricity to the needle tip 15 using the needle's stimulating wire 14 . The needle tip 15 is positioned next to the nerve and the catheter 61 is then advanced, through the catheter sheath 68 and through the needle 11 , to a point beyond the needle 11 tip. When the catheter 61 has been advanced to a point beyond the needle 11 tip, a second electric impulse is sent to the catheter tip 65 using the stimulating wire 73 of the catheter adaptor 71 to verify correct catheter placement. Then, the catheter proximal end 63 is freed from catheter adaptor, the needle 11 is removed, and the catheter's 61 proximal end is reattached to catheter adaptor. [0058] In one embodiment, the invention is made the same way as described above, but instead of a stimulating catheter 61 , a non-stimulating one is preloaded inside the needle 11 lumen and covered by a protective cover sheath 68 . The proximal end of the catheter 61 may be grasped by a catheter adaptor, or it may be left free inside catheter sheath 68 . In this embodiment, an electric impulse is sent to the needle 11 tip using the needle's 11 stimulating wire 14 , the needle 11 tip is then positioned near the target nerve, and the catheter 61 is then advanced through the catheter sheath 68 and through the needle 11 , to a point beyond the needle's 11 tip. The needle 11 is removed and catheter adaptor is attached/reattached to the catheter's 61 proximal end. Correct positioning of the catheter tip can be verified by visualizing the catheter tip, using an ultrasound device, or by injecting doses of local anesthetics into the catheter lumen and around the nerve and confirming the occurrence of a nerve block. [0059] In another embodiment, the needle 11 is manufactured as a hollow shaft metal needle without insulating covering over the outside surface and without a stimulating wire 14 . A non-stimulating catheter 61 is preloaded inside the needle 11 and covered with a protective sheath 68 , in the same way as in other embodiments. The catheter's 61 proximal end 63 may be grasped by a catheter adaptor or it may be left free inside the catheter sheath 68 . [0060] In various embodiments, an ultrasound device may be used to visualize the target nerve and the needle 11 as the needle 11 travels through the patient's skin and into the body, and to place needle tip 15 in a position that is close to that target nerve. In embodiment described above, using ultrasound device, the needle tip 15 is placed next to a nerve, then the catheter 61 is advanced through the catheter sheath 68 and through the needle 11 , and extrudes through and beyond the needle tip 15 . The needle 11 is removed from the patient's body and the catheter adaptor 71 is attached/reattached to the catheter's proximal end 63 . Correct positioning of the catheter tip 65 can be verified by visualizing the catheter 61 through the use of an ultrasound device, or by injecting doses of local anesthetics into the catheter lumen and around the target nerve and confirming the occurrence of a nerve block. [0061] In an embodiment of the invention assembled using a non-stimulating catheter 61 , a non-stimulating catheter adaptor 71 may be used. While a stimulating catheter adaptor 71 is comprised of components that allow a nerve stimulator device to be connected to the catheter's proximal end 63 to send electrical impulses to the catheter 61 , a non-stimulating catheter adaptor 71 is devoid of such components. However, similar to a stimulating catheter 61 , a non-stimulating catheter 61 will tightly grasp the catheter's proximal end 63 and provide for fluid access into the catheter lumen. [0062] In other embodiments, one or more orifices may be provided along the section 2 of the needle 11 . Space should exist between this portion of the needle 11 and the interior lumen of the plunger 6 . The plunger 6 should be made of clear plastic. In this embodiment, if accidental intravascular entry happens, blood will enter into the open space inside the plunger 6 and can be seen by the anesthesia provider. Exit holes may be placed, preferably on the proximal end of the plunger 6 , to allow air to exit as blood flows in. In this embodiment, it is necessary that the catheter tip 65 be placed proximal to the orifices so as not to block the flow of blood if intravascular entry happens. [0063] In the embodiment depicted in FIG. 6 , the invention may include a stylet 50 . A stylet 50 is comprised of an elongated body made of metal or preferably plastic. The stylet 50 may be removably placed inside a hollow needle. Stylets are designed to facilitate insertion of a needle into a patient's body and also prevent skin or other tissue materials from plugging the needle's relatively large bore. In FIG. 6 , the plunger 6 is comprised of a proximal portion 6 a , a middle portion 6 b , and a distal portion 6 c . The section 2 of the needle 11 also has a proximal portion 2 a and a distal portion 2 b. [0064] Needle portions 2 a and 2 b are connected by a metal plate 6 b (p), which runs through the middle portion 6 b of the plunger 6 . The middle portion 6 b of the plunger 6 is an enlarged space that is in fluid communication with needle portions 2 a and 2 b . The middle portion 6 b of the plunger 6 not only allows for the insertion or withdrawal of the stylet 50 , it will also allow blood to freely flow into the plunger 6 in case the needle 11 accidentally pierces a vein or artery when the stylet 50 is removed. The internal diameters of portions 2 a and 2 b are the same as the internal diameter of the entire needle 11 . The needle 11 again is electrically insulated on its outer surface, except its tip 15 and proximal end 16 . The proximal end 16 may be connected to a stimulating wire 14 . [0065] Any electric current coming through needle portion 2 a , either through the wire 14 or by way of contact with the catheter tip 65 , will exit only from the tip 15 . The middle portion 6 b of the plunger 6 also has a slot 6 b (s). This slot 6 b (s) is designed to allow insertion of the stylet 50 . FIG. 6B depicts a stylet 50 designed to fit the embodiment shown in FIG. 6 . It has a body 52 , a tip 58 and a knob 54 and a plug 56 . The stylet 50 can be inserted and withdrawn through slot 6 b (s) of the middle portion 6 b . The plug 56 is sized to fit snugly into slot 6 b (s) and the knob 54 can be grabbed by the practitioner so the stylet 50 can be inserted or withdrawn. When fully advanced, the stylet tip 58 will reach the needle tip 15 and will be flush with the needle tip 15 . [0066] In one embodiment shown in FIGS. 7 through 7B , the housing 10 is provided with a longitudinal side slot 21 . The side slot 21 runs on the side of the housing 10 , from the proximal end 23 to just above the conduit 22 . It is sized to fit the needle 11 . In this embodiment, the proximal end 23 of the needle 11 is curved and faces outward as is shown in FIG. 7A . This curve allows the needle hub 18 to maintain its position just next to and out of the housing 10 . This positioning allows the practitioner to grab the hub 18 in order to advance the needle 11 through the housing 10 by way of sliding the needle alongside the slot 21 . An annular ring 8 is placed around needle 11 at a place between the curved and straight portions of the needle 11 . As in the other embodiment of the invention shown in FIG. 5 , the catheter 61 is preloaded inside needle 11 and is covered with the sheath 68 . The distal hub 67 is attached to the hub 18 as it is in other embodiments of the invention. As can be seen in FIG. 7B , by providing a slot 21 , the needle 11 and the catheter system can be made much shorter than other embodiments without sacrificing the actual needle length available to penetrate the patient's body. [0067] In an alternative embodiment shown in FIG. 8 , the invention comprises a switch pad 30 . While the switch pad 30 can be any size and shape, the switch pad 30 is preferably similar in size, shape and structure to a regular ECG pad. An electric impulse is sent to the needle 11 by way of contact with catheter tip 65 . Alternatively, the needle 11 can be connected to the nerve stimulator directly using a needle wire 14 and then the catheter is connected to the nerve stimulator by disconnecting the nerve stimulator from the needle and attaching it to catheter 61 through the catheter adaptor 71 . [0068] The switch pad 30 allows the task of electrically stimulating the needle 11 and/or the catheter 61 quickly and/or single-handedly. The switch pad 30 is made of soft plastic or a similar non-conductive material. The switch pad 30 has a top surface 30 a and a bottom surface 30 b . The bottom surface 30 b is covered with a layer of adhesive material which enables the switch pad 30 to be temporarily attached to the patient's body. A knob 31 is affixed into the switch pad 30 . The knob 31 is constructed of a conductive material. The knob 31 has a cylindrical top portion 31 a and a disc-shaped bottom portion 31 b . The knob 31 is positioned into the switch pad 30 in such a way that the cylindrical top portion 31 a sits perpendicularly on the top surface 30 a while the disc-shaped bottom portion 31 b is attached to and is substantially flush with the bottom surface 30 b of the switch pad 30 . The 31 b portion is covered with a layer of conductive gel to facilitate its electric connection to the patient's body. [0069] Attaching the switch pad 30 to a patient's body will provide an electrical connection between the patient's skin and the knob 31 . The knob 31 will function as a ground connection between the patient body and a nerve stimulator device. The switch pad 30 is further comprised of knobs 33 and 35 . These knobs 33 , 35 are made of conductive material, but they are electrically isolated in such way that no connection exits between the two knobs 33 , 35 , or between the two knobs 33 , 35 and the bottom surface 30 b. [0070] The stimulating wire 14 of the needle 11 and the wire 73 of the catheter adaptor 71 can be attached to the knobs 33 , 35 using standard alligator clips. As is shown in FIG. 8 , a metal pivot 37 is provided on the top surface 30 a . A metal bar 39 is attached to the pivot 37 in such a way that it can move between the two knobs 33 , 35 . The metal bar 39 maintains a constant electrical connection to the pivot 37 . A dent or slot may be provided on the side of knobs 33 , 35 to hold the metal bar 39 snugly in position in order to provide a reliable electrical connection. As is shown in FIG. 8 , wires from the nerve stimulator can be connected to the knob 31 and the pivot 37 using alligator clips. [0071] Referring to FIG. 8 , at the beginning of the catheter placement procedure, wires 14 and 73 are connected to knobs 33 and 35 . The needle 11 is electrically stimulated. Thereafter, when the catheter 61 is advanced through the needle 11 and placed into position near the target nerve, the anesthesia provider can then switch to catheter stimulation by moving the metal bar 39 from its position against knob 33 to a position against knob 35 . Alternatively, the switch pad 30 may only have knob 37 and knob 31 . Knob 31 provides a grounding connection. The second wire of the nerve stimulator is attached to the knob 37 using an alligator clip. Then the anesthesia provider can switch from needle stimulation to catheter stimulation and vise versa by attaching wires 14 and 73 to the knob 37 in an alternating fashion. [0072] Other embodiments of the invention comprise a sealing diaphragm around catheter 61 . The sealing diaphragm may be needed if the anesthesia provider wishes to inject liquids like normal saline into the catheter 61 , before the catheter 61 is advanced through the needle 11 , to facilitate catheter 61 advancement within the nerve sheath. In this embodiment, a sealing diaphragm may be provided around the catheter 61 at the level of the hub 67 or the hub 18 . The function of the sealing diaphragm is to prevent liquid from flowing back inside the sheath 68 . The catheter tip is advanced to the position of the needle tip 15 , then liquid is injected into catheter 61 through catheter adaptor to exit from catheter tip and be deposited in the nerve sheath.

A medical device for placement of regional anesthesia catheters. The device comprises a hollow shaft needle, a plunger attached to the posterior end of the needle, a housing dimensioned so that plunger can slide inside the housing with friction, a regional anesthesia catheter preloaded inside the needle, a protective cover sheath covering the catheter, and a catheter adaptor attached to posterior end of the sheath and the catheter. The medical device allows a practitioner to quickly and effectively place a regional anesthesia catheter inside an organism without the use of an assistant, and with minimal risk of contaminating the catheter before it enters the organism's body. At the end, the needle is withdrawn inside the housing and disposed.

BACKGROUND OF THE INVENTION [0001] Chemometrics is the science of relating measurements made on a chemical system or process to the state of the system via application of mathematical and statistical methods. It is used many times to predict the properties, such as chemical composition, of structures based on their spectral response. [0002] One application concerns the assessment of the state of blood vessel walls such as required in the diagnosis of atherosclerosis. This is an arterial disorder involving the intimae of medium- or large-sized arteries, including the aortic, carotid, coronary, and cerebral arteries. Atherosclerotic lesions or plaques can contain complex tissue matrices, including collagen, elastin, proteoglycans, and extracellular and intracellular lipids with foamy macrophages and smooth muscle cells. In addition, inflammatory cellular components (e.g., T lymphocytes, macrophages, and some basophiles) can also be found in these plaques. [0003] Disruption or rupture of atherosclerotic plaques appears to be the major cause of heart attacks and strokes, because, after the plaques rupture, local obstructive thromboses form within the blood vessels. [0004] Near infrared (NIR) spectroscopy can be used to measure and mathematical, including statistical, techniques applied to extract information from the NIR spectral data. Mathematical and statistical manipulations such as linear and non-linear regressions of the spectral band of interest and other multivariate analysis tools are available for building quantitative calibrations as well as qualitative models for discriminant analysis. [0005] For example, in one specific spectroscopic application used in the identification of atherosclerotic lesions or plaques, an optical source, such as a tunable laser, is used to access or scan a spectral band of interest, such as a scan band in the near infrared of 750 nanometers (nm) to 2.5 micrometers (μm). The generated light is used to illuminate tissue in a target area in vivo using a catheter. Diffusely reflected light resulting from the illumination is then collected and transmitted to a detector system, where a spectral response is resolved. The response is used to assess the state of the tissue. [0006] The environment in which the spectra are collected, however, creates problems. Due to the presence of intervening fluid, such as blood in the case of probes inserted into blood vessels, the spectral signals related to the properties of the tissue can be overwhelmed. Thus, robust discriminant methods must be used to extract the spectra of the vessel walls in the presence of noise sources. Further, the movement of the intervening fluid due to the heart's pumping action coupled with an inability to well control the probe head's distance from the region of interest on the blood vessel wall further work contrary to the precision required to enable accurate assessment of the vessel's state. [0007] At a more macro level, the devices used to collect the spectra and natural variation between individuals provides added challenges. Discriminant methods must be robust against drift in the spectrometer and manufacturing differences between the, typically, disposable probes or catheters. The models based on the discriminant methods must be easily transferable and updatable and account for the drift and differences. Further, the discriminant methods must be able to compensate for nature individual-to-individual deviations in blood constituents and manifestations of the disease state. SUMMARY OF THE INVENTION [0008] Spectra collected from most spectroscopic instruments are inherently local in nature owing to contributions from absorption, emission, the instrument, and measurement environment events occurring at different locations and with different localizations in both time (wavelength) domain and frequency. [0009] Well-established algorithms based on direct application of regression by partial least squares (PLS) or principal component regression (PCR) are the most widely used methods for multivariate calculation. These algorithms globally explain spectral variance by using latent variables (or principal components) only in either the time (wavelength) or frequency domain, although separate variable selection by genetic algorithms or by other means can be used as a way of isolating localized effects in these modeling methods. [0010] Without efficient isolation of localized effects, more global latent variables (or principal components) than necessary or desirable may have to be used to explain the local sources of variance in the time and frequency domains. As a consequence, the regression and discriminant models can be invalidated by the non-calibrated variation that is normally contributed from the fluctuation of sampling conditions. Significant baseline variation in near infrared (NIR) spectra, for example, can arise as a result of the heart's pumping action, intervening fluid, blood cell passing, blood distance variation, and catheter bending, all of which can degrade and even corrupt the discriminant analysis. [0011] Mathematical transformations, the most widely-used one of which is the Fourier Transform (FT), translate signals from one domain to another domain. The FT, for example, transforms the NIR spectra that exist in the time domain (wavelength) to the frequency domain. Spectral features in wavelength domain are no longer local after the transformation, however. Instead, they are globally represented in frequency domain. [0012] Wavelet transform (WT) is another form of mathematical transformation. It is similar to the traditional FT in that it takes a spectrum from a wavelength domain and represents it in the frequency domain. The WT, however, is distinguished from the FT by the fact that it not only dissects spectra into their frequency components in frequency domain, but it also varies the scale at which the frequency components are analyzed with a matched resolution. In other words, the WT allows spectra to be analyzed locally in both wavelength and frequency domains. [0013] When applied to the spectral analysis of blood vessels, dual domain methods, such as WT, enable the spectral signals from blood vessels to be analyzed simultaneously according to frequency and wavelength. Specifically, Dual-Domain Regression Analysis (DDRA) and Dual-Domain Discrimination Analysis (DDDA) in combination with wavelet transform (WT) or other time-frequency transformation methods enable the modeling of signals simultaneously in both domains. This provides a mechanism for isolating and modeling the non-interesting variation in spectra, making the system and analysis method more robust against variations in instrument and environmental conditions, e.g., broad-band spectral variation contributed from water, heart motion, blood cell move, catheter bend variation, and other non-interesting interferences, while some other noises contributed from the laser speckle phenomenon in middle frequency range, due to constructive and destructive interference as using a tunable laser as the light source. This provides higher sensitivity and specificity, compared with other models currently being used. [0014] Consequently, in general, according to one aspect, the invention features a method for optically analyzing blood vessel walls. The method comprises receiving optical signals from the vessel walls and resolving a spectrum of optical signals to generate spectral data. [0015] In a typical implementation, the optical signal is tracked in time to obtain the spectrum. This is because the spectral response is usually obtained by detecting the response as a tunable source, illuminating the region of interest, is scanned over a spectral scan band or while a spectrometer analyzes the response of the region of interest, which is illuminated by a broadband source with array detectors. Alternatively FT-NIR systems can be used for spectrum acquisition. [0016] According to the invention, the spectral data are partitioned into their frequency components in frequency domain. And the data are represented in both wavelength and frequency domains, which is defined as dual-domain spectra. The term “dual-domain” is used here because the spectra possess local features in both wavelength and frequency domains. [0017] In the typical embodiment, this partition is achieved by applying the wavelet prism, which in one example involves the use of the Mallat pyramid algorithm for wavelet decomposition and application of the individual wavelet reconstruction afterwards. In other embodiments, other transform techniques and frequency filters, such as low-pass, high-pass, and band pass filter, can be applied to dissect the spectral information in the wavelength domain into dual-domain spectra. It is beneficial to note that those transform techniques should be designed to ensure that the dual-domain spectra are mutually orthogonal in Hilbert space. Ideally, the transformation process should be perfect or approximately perfect. [0018] In any event, according to the invention, the dual-domain spectral data are then used to analyze the vessel walls. In the typical embodiment, the spectral data are used to analyze a disease state of blood vessels walls such as the presence of atherosclerotic plaques, and their state. [0019] In some examples, dual domain regression analysis is used, such as with dual domain discrimination models. In some cases, the spectral data are preferably preprocessed before the dual domain transformation. [0020] In other examples, regression analysis is used, such as with single domain discrimination models. However, in this example, the spectral data are preferably preprocessed by transforming the spectral data into dual-domain spectral data and then removing the undesired spectral variation by applying a signal correction operation to, such as low-frequency components of the dual-domain spectral data to reduce noise. [0021] In general according to another aspect, the invention can also be characterized in the context of a system for optically analyzing blood vessel walls. This system comprises a detector system for receiving optical signals from the vessel walls and a spectrometer for resolving a spectrum of the optical signals in wavelength to generate spectral data. An analyzer then transforms the spectral data into dual-domain spectral data and uses the dual-domain spectral data to analyze the vessel walls. [0022] The above and other features of the invention including various novel details of construction and combinations of parts, and other advantages, will now be more particularly described with reference to the accompanying drawings and pointed out in the claims. It will be understood that the particular method and device embodying the invention are shown by way of illustration and not as a limitation of the invention. The principles and features of this invention may be employed in various and numerous embodiments without departing from the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0023] In the accompanying drawings, reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale; emphasis has instead been placed upon illustrating the principles of the invention. Of the drawings: [0024] FIG. 1 is a schematic diagram illustrating the application of a wavelet prism to the collected near infrared (NIR) spectra according to the present invention; [0025] FIG. 2 is a schematic diagram illustrating the dual domain spectra, showing the absorption both as a function of frequency and wavelength, illustrating the expansion of the data into the frequency and wavelength domains according to the present invention; [0026] FIG. 3 is a plot of a NIR spectra simulating the contribution of three factors, the signal of interest, baseline variation, and high frequency noise; [0027] FIG. 4 is a plot of spectral variation as a function of wavelet scale illustrating the location of the analytical signal in the frequency domain; [0028] FIG. 5A is a schematic block diagram illustrating the spectroscopic catheter system to which the present invention is applicable; [0029] FIG. 5B is a cross-sectional view of the catheter head positioned for performing spectroscopic analysis on a target region of a blood vessel; [0030] FIG. 6 is a schematic block diagram illustrating the calibration step of a dual-domain Mahalanobis discriminator according to one embodiment of the present invention; [0031] FIG. 7 is a schematic block diagram illustrating the prediction step of the dual-domain Mahalanobis discriminator; [0032] FIG. 8 shows the application of the dual domain partial least squares discrimination algorithm to the dual domain data set to obtain the discrimination algorithm model according to the present invention; [0033] FIG. 9 illustrates the application of the partial least squares dual domain discrimination algorithm according to one embodiment of the present invention; [0034] FIG. 10 schematically illustrates the generated dual domain partial least squares discrimination analysis DDPLS-DA model according one embodiment of the present invention; [0035] FIG. 11 is a plot of accuracy as a function of model factors showing the decreased number of model factors associated with the dual domain analysis of the present invention; and [0036] FIG. 12 is a plot of mean sensitivity and specificity as a function of blood distance between the catheter head and the target area of the vessel wall, illustrating the insensitivity achieved by the present invention relative to this blood distance. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0037] FIG. 1 illustrates the partitioning of spectral data that were acquired from a blood vessel. [0038] Specifically, a set of near infrared (NIR) spectra are shown in the graph inset 116 . In the current embodiment, these spectra were collected from a region, or regions, of interest on the interior of a patient's blood vessel, such as the coronary artery. Specifically, the plot shows mean-centered absorbance as a function of wavelength in nanometers (nm) covering a scan band of 600 to 2300 nm. In some implementations, the scan band is represented in time corresponding to the capture or resolving device's time to scan over the band of interest to collect each spectrum. [0039] The spectra exhibit a large degree of variability between individual scans. Some of this variability is due to signals from the regions of interest. However, most of variability is due to the combined effects of noise sources in the time and frequency domains. [0040] A wavelet prism algorithm 112 splits a time-domain spectra into a set of dual-domain spectra. In one example, an implementation of the Mallat pyramid algorithm coupled with wavelet reconstruction is used. [0041] In some implementations some prefiltering or pre-scaling is applied to the spectral data prior transformation into the dual-domain space, such as mean centering. More generally, preprocessing is applied as described in U.S. patent application Ser. No. 10/426,750, filed on Apr. 30, 2003, entitled Spectroscopic Unwanted Signal Filters for Discrimination of Vulnerable Plaque and Method Therefor, by Marshik-Geurts, et al., this application being incorporated herein in its entirety by this reference. [0042] FIG. 2 shows a set of wavelet representations 114 A- 114 G of the original data by action of the wavelet prism decomposition 112 on the original spectra. [0043] Specifically, it illustrates the local nature of the transformed data. The data now show the absorption both as a function of wavelength and as a function of frequency in wavelet scales. The localized variation in the spectral data is expanded into the frequency domain. Specifically, each of the separate plots 114 A- 114 G shows how the spectral data are distributed in two domains. The plot 115 illustrates the total distribution of the spectra over frequency domain. [0044] This decomposition of the response matrix X for m samples measured at p spectral wavelengths, using a wavelet prism in the current embodiment, can be formulated as: X ≈ ∑ k = 1 l + 1 ⁢ X k ⁢   ⁢ where ⁢ ⁢ X 1 = G T ⁢ D 1 ⁢ ⁢ X 2 = H T ⁢ G T ⁢ D 2 ⁢ ⁢ … ⁢ ⁢ X 1 = H T ⁢ H T ⁢   ⁢ … ⁢   ⁢ H T ︸ 1 - 1 ⁢ G T ⁢ D 1 ⁢ ⁢ X 1 + 1 = H T ⁢ H T ⁢   ⁢ … ⁢   ⁢ H T ︸ 1 ⁢ A 1 ( 1 ) [0045] The decomposition at the wavelet scale (level) l yields a m×p×(l+1) dual-domain, spectral cubic X including l+1 frequency components {X 1 , X 2 , . . . , X 1 , X l+1 }. The matrices D 1 , D 2 , . . . , D k , . . . , D 1 , and A obtained by wavelet decomposition using the Mallat algorithm denote the wavelet coefficients. H and G are a low-pass and a high-pass filter, respectively, and are determined by the specific mother wavelet used in the transform. [0046] For the other methods of generating dual-domain spectra, the time-frequency transform and decomposition are implemented by optimizing a set of basis vectors with the available a priori knowledge about analytes of interest and interferants, to maximize the separation between the various sources. [0047] In the current embodiment, the decomposition differs from that often used since there is no wavelength compression with increasing scale. This permits examination and selective removal of certain local features with restricted frequency characteristics. [0048] As shown in FIG. 2 , “baseline-like” aspects of the spectra (low-frequency components and noise), which are mainly related to the blood distance variation, heart motion, and catheter curvature difference, are more concentrated in the lowest-frequency approximation component 114 G and comprise a majority, approximately 98%, of total spectral variance in many instances. The high-frequency noise, which may mostly result from the modal hopping of the laser light source, can be found in the low-scale representations 114 A and 114 B. These high frequency components comprise small spectral variance of the dual-domain spectra produced by the decomposition. They often contain little contribution from the spectral variation caused by the chemical or physical properties of interest when compared with the components in the frequency ranges that describe most typical spectral peaks. [0049] FIG. 3 shows a set of simulated spectra, which include the analytical signal (the graph insert 118 ), broad band baseline (the 119 ), and high-frequency noise. Each spectrum with more than 2000 wavelength points is collected in 5 milliseconds. [0050] FIG. 4 is a plot of spectral variance of the simulated spectra as a function of wavelet scale that spans most of the frequency region. It illustrates the localization of various sources in the frequency domain. [0051] Generally, the total spectra 128 (solid point) can be decomposed into three type of sources, signal 123 (dash and hollow point), high frequency noise 125 (dotted line and solid point), and baseline or low frequency noise 124 (dotted line hollow square). [0052] Only the frequency domain has been shown here in FIG. 4 . The x-axis is the wavelet scale, corresponding to frequency domain, from 1 (high frequency) to 13 (low). The y-axis is in arbitrary units, which indicates spectral variation. [0053] A large value means large portion of spectral intensity contributed into the total spectra 128 . [0054] The baseline is located around 11 and higher levels on the wavelet scale, while high frequency noise has a significant contribution to the total spectra via the low frequency domain (1˜4 level). The signal of interest is mostly located in the middle range of frequencies. Therefore the signal of interest can be usually extracted by using frequency filtering techniques. [0055] It should be noted, however, that simple spectral filtering will not match the performance of the dual domain approach. This is because, while the sources are localized in frequency domain, the noise is distributed over the whole frequency domain. That is to say, the noise contribution is not zero at the frequency location where signal is present. Thus, the frequency-based filters will also remove the signal of interest, which translates to lost information. [0056] A linear transform such as the wavelet decomposition preferably conserves the relationship of property to spectra through the decomposition. Therefore, the frequency components in dual-domain spectra obtained by wavelet prism decomposition may be modeled separately at different frequency scales, if a linear relationship between the raw spectra and the target property exists. As a result, it is possible to implement a regression or discrimination analysis on the dual-domain spectra produced from a wavelet prism decomposition of a set of spectra over the entire wavelength and frequency domains at the same time, providing a way to isolate local information without significant information loss. [0057] The dual-domain approach, however, will keep all of the spectral variation and do the processing in the model calibration step, which will decrease the chance of information loss and increase the chance of extracting the interesting information. [0058] It is important to mention that, the dual-domain approach can also be used to do signal correction in preprocessing step, which will increase the chance of separating the interest information from the undesired variation. [0059] FIG. 5A shows an optical spectroscopic catheter system 50 for blood vessel analysis, to which the present invention is applicable, in one embodiment. [0060] The system 50 generally comprises a probe, such as catheter 56 , a spectrometer 40 , and analyzer 42 . [0061] In more detail, the catheter 56 includes an optical fiber or optical fiber bundle. The catheter 56 is typically inserted into the patient 2 via a peripheral vessel, such as the femoral artery 10 . The catheter head 58 is then moved to a desired target area, such as a coronary artery 18 of the heart 16 or the carotid artery 14 . In the embodiment, this is achieved by moving the catheter head 58 up through the aorta 12 . [0062] When at the desired site, radiation is generated. In the current embodiment, optical illuminating radiation is generated, preferably by a tunable laser source 44 and tuned over a range covering one or more spectral bands of interest. In other embodiments, one or more broadband sources are used to access the spectral bands of interest. In either case, the optical signals are coupled into the optical fiber of the catheter 56 to be transmitted to the catheter head 58 . [0063] In the current embodiment, optical radiation in the near infrared (NIR) spectral regions is used. Exemplary scan bands include 1000 to 1450 nanometers (nm) generally, or 1000 nm to 1350 nm, 1150 nm to 1250 nm, 1175 nm to 1280 nm, and 1190 nm to 1250 nm, more specifically. Other exemplary scan bands include 1660 nm to 1740 nm, and 1630 nm to 1800 nm. In some implementations, the spectral response is first acquired for a full spectral region and then bands selected within the full spectral region for further analysis. [0064] However, in other optical implementations, scan bands appropriate for fluorescence and/or Raman spectroscopy are used. In still other implementations, scan bands in the visible or ultraviolet regions are selected. [0065] In the current embodiment, the returning, diffusely-reflected light is transmitted back down the optical fibers of the catheter 56 to a splitter or circulator 54 or in separate optical fibers. This provides the returning radiation or optical signals to a detector system 52 , which can comprise one or multiple detectors. [0066] A spectrometer controller 60 monitors the response of the detector system 52 , while controlling the source or tunable laser 44 in order to probe the spectral response of a target area, typically on an inner wall of a blood vessel and through the intervening blood or other unwanted signal sources. [0067] As a result, the spectrometer controller 60 is able to collect spectra by monitoring the time varying response of the detector system 52 . When the acquisitions of the spectra are complete, the spectrometer controller 60 then provides the data to the analyzer 42 . [0068] With reference to FIG. 5B , the optical signal 146 from the optical fiber of the catheter 56 is directed by a fold mirror 122 , for example, to exit from the catheter head 58 and impinge on the target area 22 of the artery wall 24 . The catheter head 58 then collects the light that has been diffusely reflected or refracted (scattered) from the target area 22 and the intervening fluid 108 and returns the light 102 back down the catheter 56 . [0069] In one embodiment, the catheter head 58 spins as illustrated by arrow 110 . This allows the catheter head 58 to scan a complete circumference of the vessel wall 24 . In other embodiments, the catheter head 58 includes multiple emitter and detector windows, preferably being distributed around a circumference of the catheter head 58 . In some further examples, the catheter head 58 is spun while being drawn-back through the length of the portion of the vessel being analyzed. [0070] However the spectra are resolved from the returning optical signals 102 , the analyzer 42 , transforms the data to obtain the dual domain data set. From here, an assessment of the state of the blood vessel wall 24 or other tissue of interest is made from collected spectra. This assessment is made using, for example, Dual-Domain Regression Analysis (DDRA) and Dual-Domain Discrimination Analysis (DDDA), in some exemplary embodiments. [0071] The collected spectral response is used to determine whether the region of interest 22 of the blood vessel wall 24 comprises a lipid pool or lipid-rich atheroma, a disrupted plaque, a vulnerable plaque or thin-cap fibroatheroma (TCFA), a fibrotic lesion, a calcific lesion, and/or normal tissue in the current application. In another example, the analyzer makes an assessment as to the level of medical risk associated with portions of the blood vessel, such as the degree to which portions of the vessels represent a risk of rupture. This categorized or even quantified information is provided to an operator via a user interface 70 , or the raw discrimination or quantification results from the collected spectra are provided to the operator, who then makes the conclusion as to the state of the region of interest 22 . [0072] In one embodiment the information provided is in the form of a discrimination threshold that discriminates one classification group from all other spectral features. In another embodiment, the discrimination is between two or more classes from each other. In a further embodiment the information provided can be used to quantify the presence of one or more chemical constituents that comprises the spectral signatures of a normal or diseased blood vessel wall, or the vulnerability index that is defined as the measure of the risk of heart attack. [0073] The dual domain analysis can be used to address the relative motion between the catheter head 58 and the vessel wall 24 . Movement in the catheter head 58 is induced by heart and respiratory motion. Movement in the catheter head 58 is also induced by flow of the intervening fluid 108 , typically blood. The periodic or pulse-like flow causes the catheter head 58 to vibrate or move as illustrated by arrow 104 . Further, the vessel or lumen is also not mechanically static. There is motion, see arrow 106 , in the vessel wall 24 adjacent to the catheter head 58 . This motion derives from changes in the lumen as it expands and contracts through the cardiac cycle. Other motion could be induced by the rotation 110 of the catheter head 58 . Thus, the relative distance between the optical window 48 of catheter head 58 and the region of interest 22 of the vessel 24 is dynamic. [0000] Regression Analysis [0074] The regression analysis on a dual-domain spectral set is a two-step procedure, done in a way similar to that used for regular (single-domain) regression methods. The first step is to establish a dual-domain model in a calibration set between the dependent m×1 vector y (the property) and a set of independent variables contained in a dual-domain spectral cubic X {X k , k=1, 2, . . . , 1 +1}. The second step is to predict values for the dependent properties based on a prediction set X u ={X T 1,u . . . X T l+1,u } T . [0075] Consider the dual-domain regression model y = ∑ k = 1 l + 1 ⁢ X k ⁢ β k + e ⁢   ⁢ E ⁡ ( e ) = 0 , Cov ⁡ ( e ) = σ 2 ⁢ I ( 2 ) where β k is the p×1 regression coefficient vector for the frequency component at the kth scale in the dual-domain spectra, e denotes an m×1 error vector, and E(·) and Cov(·) are the expectation and covariance, respectively. The goal of the dual-domain regression analysis is to calculate the regression coefficients β={β 1 , . . . , β l+1 } with the lowest associated prediction error. Principal Component Regression (PCR), Partial Least Squares (PLS), continuum regression (CR), ridge regression (RR), and regression with a maximum likelihood criterion or a Bayesian information criterion are common approaches useful for the regression step. [0076] In dual-domain PCR (DDPCR), the regression vector is determined by β ^ DD ⁢   ⁢ PCR = AGR ⁢   ⁢ min β DDPCR ∈ R ⁢ [ Σ ⁡ ( y - y ^ ) 2 ] ( 3 ) [0077] Exact solution of the equations (2) or (3) for the optimal model defined there is not straightforward. However, satisfactory performance may be obtained by an approximate solution for this model. [0078] Consider dual-domain regression using PCR. To find an approximate solution to equation 3, several steps are involved. In this case, a separate PCR on each frequency component of the dual-domain spectra is first performed with respect to an analytical target, the dependent vector y, and the PCR regression vector obtained is then weighted according to the predictive ability of each frequency domain component for the target. The frequency component with highest linear relationship to the analytic target will gain the highest weight. Cross-validation methods are preferably employed here for the PCR models of frequency components to extract this frequency distribution. [0079] The singular value decomposition (SVD) of the kth frequency component of the dual-domain spectra X , X k , is expressed by X k =U k Σ k V k T . The matrix U k represents the m×q k matrix of eigenvectors for X k X k T , V k symbolizes the p×q k matrix of eigenvectors for X k T X k , and Σ k denotes the q k ×q k diagonal matrix of singular values (σ i,k ) equal to the square root of the eigenvalues of X k X k T and X k T X k . Note that the rank, q k , of X k will vary with scale. The PCR modeling approach is to include the first d eigenvectors (d≦q k ) pertinent in modeling the prediction property, where d represents the prediction rank. A general form of the DDPCR regression vector {circumflex over (β)} k,DDPCR for the kth frequency scale is expressed by β ^ k , DDPCR = g k ⁡ [ ∑ i = 1 d ⁢ ( σ i , k - 1 ⁢ u i , k T ⁢ y ) ⁢ v i , k ] = g k ⁢ β ^ k , PCR ( 4 ) where {circumflex over (β)} k, PCR is separately estimated by regular PCR for the frequency component at the kth scale. The scalar term, g k , that is typically associated with the frequency distribution of the analytic target over frequency domain, is the weight for the kth scale determined by the receiver operating characteristic—area under curve (ROC-AUC) analysis or cross-validation (CV) of the calibration set (for medical diagnosis discrimination) according to g k = AUC k / ∑ k = 1 l + 1 ⁢ AUC k ( 5 ⁢ a ) g k = s k 2 / ∑ k = 1 l + 1 ⁢ s k 2 ( 5 ⁢ b ) g = AGR ⁢   ⁢ max g ∈ R ⁢ ( FOM ) ( 5 ⁢ c ) [0080] In equation 5a, AUC k denotes the area obtained from the receiver operating characteristics curve under area (ROC-AUC) analysis in the calibration set for kth scale, while s k in equation 5b is the reciprocal of the cross-validation error. In addition, this coefficient term, g (g k , k=1, 2, . . . , l+1), can be optimized by maximizing the value in Figure of merit (FOM), according to equation 5c. FOM is defined to measure the performance of predicting vulnerability for a risk of heart attack. [0081] In the prediction step, an unknown sample x T u is first decomposed by the WP algorithm, followed by multiplication of the frequency components x T k,u (k=1,2, . . . 1, 1+1) with the kth regression vector according to y ^ u = ∑ k = 1 l + 1 ⁢ x k , u T ⁢ β ^ k , DDPCR ( 6 ) [0082] Similarly, for dual-domain regression using PLS (DDPLS), CR (DDCR), RR (DDRR), an approximate solution to equation (2) can be obtained as {circumflex over (β)} k, DD-RGN =g k {circumflex over (β)} k, RGN , where RGN=PLS, CR, RR,   (7) where {circumflex over (β)} k, RGN is computed separately by regular regression analysis on the kth-scale frequency component, and the weight g k for the kth scale is estimated by the ROC-AUC analysis, cross-validation of the calibration set, or optimization method. [0083] It should be clear that because the weighting of the regression defined in equations (4) and (7) combines the sets of latent variables generated from the separate analyses of the wavelet decompositions at different scales, there will be only a single set of latent variables produced from DDRA, just as in regular regression analysis (e.g., PLS or PCR). However, the weighted latent variables produced by DDPCR and DDPLS, in general, will differ from those produced by conventional PCR and PLS, respectively, because of the weighting of the sets of latent variables. A performance comparison with those from PCR or PLS done in terms of latent variables from each method can be done to see if there is benefit to the dual domain analysis, even though the variables used in the comparison are not directly equivalent. Such a comparison is analogous to those done, for example, between PLS and PCR. [0000] Discrimination Analysis [0084] In another implementation, a multivariate regression technique is built distinguishing the differences between two classifications or other classification schemes of interest. In a current implementation, the regression technique used is PLS-DA. The PLS-DA model is based upon maximizing the separation of the information based upon the groups to be distinguished. A threshold is established by a classifier providing the mechanism for separating samples from all other groups or samples. The classifier can also provide the calculated results of the scores from the model. [0085] In another embodiment, a calibration model based upon machine learning techniques is built distinguishing the differences between two classifications schemes, or more, of interest. The classification is provided by the application of the machine learning system approach that determines which combinations of the measurements are sufficient to distinguish between the classes. These methods can be applied as non-linear or linear separators. In one embodiment, artificial neural networks are used and the method is fine tuned by changing the number of degrees of freedom or dimensionality of the model. In another embodiment, support vector machines form hyper-planes between the assigned classes and in general attempt to maximize the separation between the two closest points in each classification group. [0086] In a further, preferred, embodiment, Mahalanobis classifiers (discriminators) are used on the dual-domain spectra. As opposed to the weights strategy used in Equations 4, 5, and 7, the dual-domain Mahalanobis discriminators automatically account for the scale differences between frequency components. They provide a curved or linear boundary surface (threshold) in the high-dimension Hilbert space to improve the discrimination decision making. Basically in these methods, as shown in FIG. 6 , a set of parallel multivariate regression models are established separately on the frequency components in dual-domain spectra, The estimation of sensitivity (positive, e.g., LP and DP) samples in calibration set, Ŷ p , is used to compute the Mahalanobis distance (MD), according to MD 2 =( Ŷ p −m Ŷ p )′ C Ŷ p −1 ( Ŷ p −m Ŷ p )   (8) where m Ŷ p is the mean of Ŷ p , and C Ŷ p is the covariance matrix of Ŷ p . The Mahalanobis distances of specificity samples (negative, e.g., Fibrotic (F13) and Calcific (CAL) are also calculated by using the covariance matrix C Ŷ p and the estimation of specificity samples Ŷ n . The ROC analysis is then conducted on both two groups' MDs to determine the discrimination threshold for the final dual-domain Mahalanobis discriminator. [0087] As shown in FIG. 7 , in the prediction step of unknown spectra X u , are passed through the wavelet prism (WP), the parallel models are applied to the partitioned spectra, leading to a set of prediction scores ŷ u,k (k=1,2, . . . , l+1), following by calculation of Mahalanobis Distance. [0088] FIG. 8 shows the strategy used in the current embodiment. The dual domain (DD) PLS-DA algorithm 160 is applied to the dual domain transformed data sets 114 A- 114 G. Spectra are then separated into two classification groups using the dual domain discrimination model 162 . In current examples, one group is the Lipid Pool (LP) and Disrupted Plaque (DP) sample prediction results and the other is for Fibrotic (FIB) and Calcific (CAL) sample prediction, according to one classification scheme. In another embodiment, the scheme distinguishes between vulnerable plaques or thin-cap fribroatheroma (TCFA) and non-vulnerable plaques or non-TCFA. [0089] The core of the PLS-DA algorithm for the dual domain analysis currently used is a spectral decomposition step performed via either the NIPALS or the SIMPLS algorithm. [0090] FIG. 9 is a diagram representing the NIPALS decomposition of the spectral information represented by the X matrix 310 and the binary classification information represented by the Y matrix 320 . [0091] X 310 is the spectra data matrix, Y 320 is the binary component information matrix, S and U are the resultant scores matrix 326 , 328 from the spectral and component information respectively and LVx 322 and LVy 324 are the loading scores of latent variables (LV) for spectra and information, respectively. The other nomenclature is for the number of spectra (n), the number of data points (p), the number of components (c), and the number of final principal components (f). [0092] Once the first decomposition is made resulting in a LV and scores for each of the X and Y matrices, the resultant scores matrix for the spectral information (S) 326 is swapped with the scores matrix containing the binary classification information (U) 328 . The latent variable information from LVx and LVy 322 , 324 are then subtracted from the X and Y matrices 310 , 320 , respectively. These newly reduced matrices are then used to calculate the next LV and score for each round until enough LVs are found to represent the data. Before each decomposition round, the new score matrices are swapped and the new LVs are removed from the reduced X and Y matrix. [0093] The final number of latent variables arrived at from the PLS decomposition (see f) are highly correlated with the group classification information due to the swapped score matrices. The LVx and LVy matrices contain the highly correlated variation of the spectra with respect to the two groups used to build the model. The second set of matrices, S and U, contain the actual scores that represent the amount of each of the principle component variation that are present within each spectrum. [0094] The scores from the U matrix and X-block weights are used to calculate the regression coefficients for each frequency components. According to Equations 7 and 5, the final dual-domain discrimination model is established, as represented in FIG. 10 . The threshold was set using the model discrimination indices for the LP and DP scores as one group and those for the FIB and CAL as the other group according to one classification scheme for the blood vessels. For predictions, an unknown spectrum was dissected by wavelet prism, followed by a prediction according to Equation 6, leading to the DDPLS-DA discrimination index. If this resultant value is above the threshold of the model then that sample is said to be either a member of the LP and/or DP class. [0095] FIG. 11 illustrates the improved performance associated with the dual domain partial least squares discrimination analysis DDPLS-DA, as opposed to convention single domain PLS-DA algorithms. In the figure, x-axis is the latent variable number used in models, while y-axis presents the mean value of sensitivity of specificity, corresponding to the discrimination performance. Two curves, 410 and 411 , are the cross-validation results for PLS-DA (dotted line and hollow square) and DDPLS-DA (solid and hollow circle), respectively. This suggests that DDPLS-DA needs fewer latent variables than the regular PLS-DA. [0096] The other two curves, 414 and 415 , show the results from the blind validation for both methods. The DDPLS-DA provided improved performance in terms of decreasing the LV number required and significantly enhancing the sensitivity and specificity. On other hand, the 411 and 415 from DDPLS-DA models almost overlap, while the 410 and 414 diverge when the latent variables is larger than 6. This implies that the regular PLS-DA models suffered from over-fitting and DDPLS-DA models performed consistently. Compared with regular PLS-DA, DDPLS-DA, therefore, is more robust and easier to maintain, update, or transfer, and is able to be applied to a broader number of situations. [0097] In addition, FIG. 12 illustrates the mean sensitivity/specificity as a function of blood distance between the catheter head 58 and the target area 22 . The plot, 417 , shows the general insensitivity of the dual domain partial least squares discrimination algorithm to distances between 0 and 1.5 millimeters. In contrast, the conventional single domain PLS discrimination algorithm, as shown in plot 416 , exhibits a sharp fall off from approximately 0.98 to 0.9 when distances in excess of 1 millimeter are encountered. [0000] Dual Domain Preprocessing [0098] Referring back to FIG. 1 , a wavelet prism algorithm 112 splits a time-domain spectra into a set of dual-domain spectra. As shown in FIG. 2 , “baseline-like” aspects of the spectra (low-frequency components and noise), which are mainly related to the blood distance variation, heart motion, and catheter curvature difference, are located in the lowest-frequency approximation component 114 G and comprise a majority, approximately 98%, of total spectral variance in many instances. These lowest-frequency components often contain little contribution from the spectral variation caused by the chemical or physical properties of interest. [0099] It is thus possible to establish an operational filter with the available a priori knowledge between analytes of interest and interferants, to maximize the retrieval of the signal of interest from this particular frequency region with a less signal damage and loss, compared with the regular preprocessing methods in single domain. [0100] The subsequently applied regression analysis or discrimination models are either regular single domain methods or dual-domain modeling, according to the invention. The generalized least square (GLS) and orthogonal signal correction have been successfully used as the preprocessing to correct the spectral variation of blood and instrument in single domain. The higher performance of signal correction can be expected when they are applied in dual-domain spectra. [0101] While this invention has been particularly shown and described with references to typical embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims. Specifically, it is important to note that the use of dual domain techniques described here as pre-processing is independent of the use of dual domain as a chemometric analysis technique. That is, either approaches, or both together can be applied to the spectroscopic data from the vessel walls.

A method for optically analyzing blood vessel walls comprises receiving optical signals from the vessel walls and resolving a spectrum of optical signals in wavelength to generate spectral data. The spectral data is then transformed into the frequency domain. In the preferred embodiment, this transformation is achieved by applying wavelet decomposition. In other embodiments other transform techniques such as Fourier analysis is applied. The spectral data in the frequency domain are then used to analyze the vessel walls. In the typical embodiment, the spectral data are used to analyze a disease state of blood vessels walls such as the presence of atherosclerotic plaques, and their state. Dual domain method enables the spectral signals from blood vessels to be analyzed simultaneously according to frequency and wavelength (time). Dual-Domain Regression Analysis (DRDA) and Dual-Domain Discrimination Analysis (DDDA) in combination with wavelet transform (WT) enable the modeling of signals simultaneously in both domains. This provides a mechanism for isolating the non-interesting variation in spectra, making the system and analysis method more robust against variations in instrument and environmental conditions, e.g., broad-band spectral variation contributed from water, heart motion, and other non-interesting interferences. This provides higher sensitivity and specificity when compared with other models currently being used.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation application of U.S. patent application Ser. No. 13/955,817, entitled “Applicator Assembly” dated Jul. 31, 2013, which claims the benefit of U.S. Provisional Patent Application No. 61/677,861, filed Jul. 31, 2012, entitled “Applicator Assembly,” which are incorporated herein by reference in their entirety. BACKGROUND [0002] People may desire easier and more effective ways to apply cosmetics. Accordingly there is a need for improved systems and methods to address these issues. SUMMARY [0003] A makeup brush for use with a motorized handle has a substantially cylindrical body portion defining a first end, a second end, a blind bore formed in the first end, an outer wall that extends from the first end to the second end, and a coupling assembly formed at the second end that is configured for coupling the body portion to a motorized handle. An applicator is at least partially received in the blind bore and coupled therein. At least one finger grip is formed on the outer wall proximate to the first end and extends radially outward from the outer wall. The at least one finger grip is configured to enable a user to releasably couple the body portion adjacent a motorized handle without the user having to touch the applicator. In various embodiments, the blind bore has a solid bottom wall that separates the bore from the coupling assembly. [0004] A makeup brush for use with a rotating motorized handle comprises (a) a body portion comprising (1) a first end having a recess formed therein; (2) a second end comprising a coupling assembly that is configured to releasably couple the body portion to a rotating motorized handle; and (3) an outer wall that extends between the first end and the second end; (b) a plurality of bristles at least partially received in the recess and coupled therein; and (4) at least one finger grip formed on the outer wall of the body portion. In various embodiments, the at least one finger grip is configured to allow a user to grasp the body portion without having to grasp the plurality of bristles when attaching or removing the body portion from a rotating motorized handle. [0005] In yet another embodiments, a makeup brush comprises (a) a body portion comprising (1) a first end having a recess formed therein, the recess comprising a bottom wall intermediate the first end and the second end; (2) a second end comprising a coupling assembly that is configured to releasably couple the body portion to a motorized handle where the bottom wall is solid and separates the recess from the coupling assembly; and (b) an applicator is at least partially received in the recess and coupled therein. BRIEF DESCRIPTION OF THE DRAWINGS [0006] Various embodiments of an applicator assembly are described below. In the course of this description, reference will be made to the accompanying drawings, which are not necessarily drawn to scale, and wherein: [0007] FIGS. 1 A 1 - 1 B 12 show a first embodiment of an applicator cup for use with a makeup brush, or other suitable applicator, such as one of the makeup brushes that are described in U.S. patent application Ser. No. 13/087,212, entitled “Cosmetic Applicator Systems,” which was filed on Apr. 14, 2011, and which is hereby incorporated by reference in its entirety. These figures show the applicator cup with various alternative attachment recesses and, in one embodiment, an attachment shaft. In these embodiments, the applicator cup includes no finger grip adjacent its upper portion. The various structural features of the applicator cup are described in greater detail below. [0008] FIGS. 2 A 1 - 2 B 12 show a second embodiment of an applicator cup with various alternative attachment recesses and, in one embodiment, an attachment shaft. In these embodiments, the applicator cup includes two small finger grips adjacent its upper portion that, in various embodiments, are dimensioned to allow a user to grasp the applicator cup without touching an applicator that is positioned adjacent the applicator cup. [0009] FIGS. 3 A 1 - 3 B 12 show a second embodiment of an applicator cup with various alternative attachment recesses and, in one embodiment, an attachment shaft. In these embodiments, the applicator cup includes a single finger grip that extends circumferentially around (e.g., partially or entirely circumferentially around) its upper portion. In various embodiments, this finger grip is dimensioned to allow a user to grasp the applicator cup without touching an applicator that is positioned adjacent the applicator cup. [0010] FIGS. 4A-4G show exemplary handles for use with an applicator cup, such as the applicator cups shown in FIGS. 1 A 1 - 1 B 12 , FIGS. 2 A 1 - 2 B 12 , and FIGS. 3 A 1 - 3 B 12 . [0011] FIGS. 5A-5H is an illustration of a motorized brush support and a plurality of cosmetic brushes, according to a particular embodiment. DETAILED DESCRIPTION [0012] Various embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which various relevant embodiments are shown. The invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Like numbers refer to like elements throughout. Applicator Cup [0013] An applicator cup 100 , 200 and 300 according to various embodiments are shown in FIGS. 1 A 1 - 1 B 12 , 2 A 1 - 2 A 12 and 3 A 1 - 3 A 12 , respectively. As shown in these figures, the applicator cup 100 , 200 and 300 may comprise a substantially cylindrical (e.g., cylindrical), at least partially hollow, cup body portion 110 , 210 and 310 that includes a side wall 115 , 215 , and 315 , a top face 120 , 220 and 320 , and a bottom face 130 , 230 and 330 , respectively. In particular embodiments, the cup body portion 110 , 210 and 310 may have a substantially circular (e.g., circular) cross section. The cup body portion 110 , 210 and 310 may define, in various embodiments, an applicator-receiving recess 140 , 240 , and 340 adjacent (e.g., extending through) the cup's top face 120 , 220 and 320 and an attachment recess adjacent (e.g., extending through) the cup's bottom face 130 , 230 and 330 , respectively. In some embodiments, such as the embodiments shown in FIGS. 2 A 1 - 2 B 12 , the applicator cup 200 includes at least one finger grip 225 A- 225 G disposed adjacent the cup's top face 220 A- 220 G. The finger grip 225 A- 225 G may be, for example, a protrusion that extends outwardly from the cup body portion's outer surface. [0014] Cup [0015] As shown in FIG. 1 A 1 , the cup's body portion 110 may be substantially cylindrical (e.g., cylindrical) with a diameter between, for example, about 20 mm and about 40 mm. In particular embodiments, the cup's body portion 110 may have a diameter of about 29.4 mm. In various embodiments, the cup's body portion 110 may have a height between about 20 mm and about 40 mm. In particular embodiments, the cup's body portion 110 has a height of 31.8 mm. In the embodiment shown in FIGS. 1A , the cup's body portion 110 defines a top 120 and bottom face 130 and defines a beveled edge on the outer circumference of the edge of the cup's bottom face 130 . In other embodiments, the cup's body portion 110 may define any other suitable edge (e.g., round or square) on the outer circumference of the edge of the cup's bottom face 130 . [0016] Applicator-Receiving Recess [0017] In the embodiments shown in FIGS. 1 A 1 , 2 A 1 and 3 A 1 , the cup's body portion 110 , 210 and 310 defines an applicator-receiving recess 140 , 240 , and 340 that is substantially centered (e.g., centered) relative to the cup's top face 120 , 220 and 320 . In the embodiments shown in these figures, the applicator-receiving recess 140 , 240 , and 340 is substantially cylindrical (e.g., cylindrical) and has a diameter that is between about 15 mm and 39 mm. In particular embodiments, the applicator-receiving recess 140 , 240 , and 340 has a diameter of about 28.1 mm. In certain embodiments, the applicator-receiving recess 140 , 240 , and 340 has a diameter that is about 0.5 mm less than the cup's diameter. In the embodiments shown in these figures, the applicator-receiving recess 140 , 240 , and 340 is between about 18 mm and 39 mm deep. In particular embodiments, the applicator-receiving recess 140 , 240 , and 340 is about 24 mm deep. In other embodiments, the applicator-receiving recess 140 , 240 , and 340 may be any depth suitable for housing an applicator. [0018] In various embodiments, the cup's body portion 110 , 210 and 310 may be adapted to maintain an applicator at least substantially within (e.g., within) the respective applicator-receiving recess 140 , 240 , and 340 . The applicator may, for example, comprise a brush, sponge, or any other suitable applicator for applying either a liquid or powder substance (e.g., such as cosmetics, makeup, lotion, sunblock, sunscreen, moisturizer, foundation, concealer, eye shadow, blush, bronzer, cream, or any other appropriate substance). In various embodiments, an applicator may be adapted for applying substances in a plurality of forms (e.g., liquid, powder, or any other suitable form). In particular embodiments, the applicator is adapted to apply cosmetics or lotions while rotating. The applicator may, for example, be adapted to substantially maintain its shape and structure after repeated use. [0019] The applicator may include a brush comprising bristles of any suitable length (e.g., between about 10 mm and about 80 mm). The bristles may be made of any suitable material (e.g., natural or synthetic material). [0020] Attachment Recess [0021] As shown in FIGS. 1 A 1 - 1 B 12 , the cup's body portion 110 B- 110 F may define one or more attachment recesses (e.g., attachment recesses 150 B- 150 F, respectively) that are suitable for use in attaching the applicator cup 110 B- 110 F to a handle when the cup's body portion 110 B- 110 F is attached to the handle. The handle may, for example, be a motorized handle or any other handle suitable for use in applying cosmetics. Referring briefly to FIG. 4A-4C , an exemplary handle 400 and an exemplary motorized handle 450 are shown. [0022] As may be understood from FIGS. 1 A 1 - 1 B 12 , the attachment recess 150 B- 150 F may be defined adjacent the cup's respective bottom face 130 B- 130 F. The attachment recess 150 B- 150 F may be sized to receive a corresponding portion (e.g., a rotating portion) of a motorized handle when the applicator cup 100 A- 100 F is attached to the motorized handle. In various embodiments, the engagement between this portion of the motorized handle and the applicator cup 100 A- 100 F causes the applicator cup 100 A- 100 F to rotate when the motorized handle's rotating portion rotates. In particular embodiments, the applicator cup 100 A- 100 F may define an attachment recess that is between about 2 mm deep and about 14 mm deep. [0023] FIGS. 1 A 1 - 1 B 11 show various embodiments of the applicator cup 100 A- 100 G having different attachment recess configurations 150 B- 150 F. These exemplary embodiments are described more fully below: [0024] No Attachment Recess [0025] In particular embodiments, the applicator cup 110 may define no attachment recess (See applicator cup 110 A in FIGS. 1 A 1 , 1 A 2 , 1 A 5 and 1 A 8 ). In such embodiments, the applicator cup 110 may be adapted to be attached to a brush without the use of an attachment recess. [0026] Figure Eight [0027] The brush cup 100 B shown in FIGS. 1 A 3 , 1 A 6 and 1 A 9 defines an attachment recess 150 B that is substantially centered (e.g., centered) adjacent the cup's bottom face 130 B, and that has a profile that includes two at least partially overlapping circles. [0028] Multi-Hole [0029] The brush cup 100 C shown in FIGS. 1 A 4 , 1 A 7 and 1 A 10 defines four attachment recesses 150 C whose profiles are substantially circular (e.g., circular). The attachment recesses 150 C are defined in an outer portion of the cup's bottom face 130 C. In the embodiment shown in this figure, the cup 110 C defines the four attachment recesses 150 C that are substantially evenly-spaced (e.g., evenly-spaced) about a circle having a radius that is substantially centered (e.g., centered) on the cup's bottom face 130 C. In other embodiments, the cup 110 C may define any other suitable plurality of attachment recesses (e.g., two, three, etc.). [0030] Multi-Sided [0031] The brush cup 100 D shown in FIGS. 1 B 1 , 1 B 5 and 1 B 9 defines an attachment recess 150 D that is substantially centered (e.g., centered) adjacent the cup's bottom face 130 D, and that has a profile that is substantially octagonal (e.g., octagonal). In various embodiments, the cup 110 D may define an attachment recess that is substantially centered (e.g., centered) adjacent the cup's bottom face 130 D. In this embodiment, the profile of the attachment recess is that of a shape with any suitable number of sides (e.g., triangular, square, pentagonal, hexagonal, heptagonal, etc.) [0032] Cross [0033] The brush cup 100 E shown in FIGS. 1 B 2 , 1 B 6 and 1 B 10 defines two attachment recesses 150 E that are substantially rectangular (e.g., rectangular) and substantially perpendicular (e.g., perpendicular) to one another (e.g., so that the recesses 150 E cooperate to form a cross). In this embodiment, the two attachment recesses are each substantially parallel (e.g., parallel) to a radius of the cup's bottom face 130 E. [0034] Serpentine [0035] In the embodiment 100 F shown in FIGS. 1 B 3 , 1 B 7 and 1 B 11 , the cup 110 F defines an attachment recess 150 F that is substantially S-shaped (e.g., S-shaped). [0036] Shaft [0037] In particular embodiments, such as the embodiment 100 G shown in FIGS. 1 B 4 , 1 B 8 and 1 B 12 , the cup 110 G comprises an attachment shaft 150 G (rather than an attachment recess). In the embodiment shown in this figure, the attachment shaft 150 G extends substantially perpendicularly (e.g., perpendicularly) from and is substantially centered relative to the cup's bottom face 130 G. In the embodiment 100 G shown in this figure, the attachment shaft 150 G has a profile that is substantially octagonal (e.g., octagonal) and that extends about 7 mm from the cup's bottom surface. In other embodiments, the attachment shaft 150 G may extend between about 3 mm and about 15 mm from the cup's bottom surface. [0038] In various embodiments, the attachment shaft 150 G may have any other suitable profile. [0039] For example, the attachment shaft 150 G may have a profile that is similar to any of the profiles of the attachment recesses described above (e.g., figure eight, multi-hole, multi-sided, cross, or serpentine). [0040] Finger grip [0041] In various embodiments, such as the embodiment shown in FIGS. 2 A 1 - 2 B 12 , the cup' body portion 210 A- 210 G may comprise at least one finger 225 A- 225 G grip that extends radially outward from the cup's outer surface. In the embodiment shown in FIGS. 2A-2B , the cup's body portion 210 A- 210 G comprises two finger grips 225 A- 225 G that are disposed on opposing faces adjacent the cup's upper portion 220 A- 220 G. In various embodiments, the finger grips 225 A- 225 G may have a width (between the portion of the finger grip that engages the rest of the cup, and the outer portion that a user would engage when using the finger grip to lift the cup) between about 5 mm and 15 mm. In particular embodiments, the finger grips 225 A- 225 G may have a width of about 7 mm. In various embodiments, the finger grips 225 A- 225 G have a height of between about 4 mm and about 15 mm. In particular embodiments, the finger grips 225 A- 225 G have a height of about 9.6 mm. [0042] It should be understood that finger grips 225 A- 225 G may, for example, have any width and height suitable for allowing a user to grip the applicator cup's body portion 210 A- 210 G using the finger grips 225 A- 225 G (e.g., by squeezing their thumb and index finger against the respective finger grips in order to lift or move the cup). In particular embodiments, the finger grips 225 A- 225 G may be of a suitable size and shape to maintain the user's fingers spaced apart from the applicator when handling the applicator cup. [0043] In certain embodiments, such as the embodiment shown in FIGS. 3 A 1 - 3 B 12 , the applicator cup body portions 310 A- 310 G may comprise a finger grip 325 A- 325 G that extends along substantially the entire circumference of the cup's outer surface. In the embodiment shown in these figures, the finger grip 325 A- 325 G is disposed adjacent the cup's upper portion 320 A- 320 G. [0044] In various embodiments, the finger grips may be adapted to allow a user to insert the applicator cup 200 A- 200 G or 300 A- 300 G into, or remove it from, a motorized handle substantially without touching the applicator so that a lower portion 322 of the finger grip is adjacent the motorized handle ( FIG. 4A-4G ). In particular embodiments, the applicator cup 210 A- 210 G is configured to enable a user to use the applicator cup 210 A- 210 G in conjunction with the motorized handle to apply cosmetics. In various embodiments, the applicator cup 210 A- 210 G is configured to rotate at a speed of between about 92 and about 489 revolutions per minute when used in conjunction with the motorized handle. In particular embodiments, the motorized handle may be configured to apply a torque of between about 6 and about 34 ounce inches. In various embodiments, the motorized handle may be configured to enable the user to adjust the speed of the motorized handle's motor. In other embodiments, the motorized handle may be configured to enable a user to adjust a torque that the motorized handle applies to the applicator cup 210 A- 210 G when the applicator cup 210 A- 210 G is being used in conjunction with the motorized handle. [0045] In particular embodiments, the finger grips 225 A- 225 G may be adapted to allow the user to move, install, uninstall, and/or otherwise use the applicator cup 200 A- 200 G substantially without touching any of the substance that is to be applied with the applicator (e.g., makeup, lotion, liquid foundation, powder foundation, concealer, eye shadow, blush, bronzer, or any other substance that may be applied with the applicator). In various embodiments, the applicator may be adapted for longer use as a result of avoiding exposure to contaminants (e.g., oils) on the user's hands. Exemplary Use [0046] The applicator cup described above may be utilized as part of a method of applying any of a plurality of cosmetics or other substances to a user's skin. The user may first select an applicator assembly that includes: (1) an applicator cup; and (2) an applicator that is installed in the applicator cup, so that the applicator extends beyond the end of the applicator cup's top face. The applicator may be, for example, a particular brush or sponge that is suitable for applying the particular cosmetic, or other substance to the user's skin. Suitable substances include both powder or liquid substances, for example, lotion, liquid foundation, powder foundation, concealer, eye shadow, blush, bronzer, or any other suitable substance. The user may then pick up the applicator assembly by lifting it via the finger grips on the sides of the applicator cup. [0047] Next, the user may attach the applicator assembly, attachment recess side first, to a suitable handle. The handle may, for example, be a motorized handle or any other handle suitable for applying cosmetics or other substances (e.g., a non-motorized handle). The handle may define a substantially circular (e.g., circular) recess with a diameter that is sufficiently large to allow the applicator assembly to be easily inserted into the recess and to rotate within the recess, and that is sufficiently small to allow the applicator assembly to fit snuggly within the recess once inserted. While inserting the cup into the handle's recess, the user may align the cup's attachment recess(es) with the handle's corresponding attachment protrusion(s). In particular embodiments, when the applicator assembly is installed on the handle, the attachment protrusion(s) may extend from the handle into the handle's recess(es). In various embodiments, such as in the case of a makeup brush assembly that includes a motorized handle, the attachment protrusions may be adapted to rotate about an axis, which may, for example, be substantially centered (e.g., centered) within and run substantially perpendicular to (e.g., perpendicular to) the handle's recess. An example of a suitable handle for use with the applicator assembly is described in U.S. patent application Ser. No. 13/087,212, entitled “Cosmetic Applicator Systems,” which was filed on Apr. 14, 2011, and which—as noted above—is hereby incorporated by reference in its entirety. [0048] As illustrated in FIG. 5A-5H , a motorized brush support (such as the motorized handle 450 discussed above with reference to FIG. 4A-4G ) may be compatible with a set of cosmetic brushes 520 for applying a cosmetic to a surface area such as the face. The motorized brush support 450 , as shown, includes a base portion (in this case, a handle 510 ), a head assembly 530 and a coupling assembly 532 . The coupling assembly 532 may extend away from the head assembly 530 , as shown, or it may be integrated within the head assembly 530 . In some embodiments, each of the cosmetic brushes 520 A- 520 G may include a connector 522 A- 522 G, respectively, for attaching to or otherwise engaging with the coupling assembly 532 . The connector 522 A- 522 G may extend below the base of a brush, as shown, or it may be integrated within the base of the brush. The connector 522 A- 522 G may include any type of connector or fastening mechanism that fits or otherwise engages with the coupling assembly 532 . Any of a variety of combinations of connectors 522 A- 522 G and coupling assemblies 532 known to those skilled in the art may be used. [0049] Any of a variety of cosmetic brushes (such as one or more specialty makeup brushes) may be collected in a set 520 for use with any particular application. In an exemplary embodiment, the set of cosmetic brushes 520 , as illustrated, may include one or more of the following brush types: a Liquidator Brush 520 A, a Powder Foundation Brush 520 B, an Under-Eye Concealer Brush 520 C, an Upper Eyelid Shadow Brush 520 D, a Blush Blaster Brush 520 E, a Disco Shine Brush 520 F, and a Bronzer Brush 520 G. [0050] The Liquidator Brush 520 A may be used to apply and distribute a liquid or cream foundation. The Powder Foundation Brush 520 B may be used to apply and distribute a powder foundation or base. The Under-Eye Concealer Brush 520 C may be used to apply and distribute a concealer compound under the eyes and other areas, as desired. The Upper Eyelid Shadow Brush 520 D may be used to apply and distribute a shadow compound to the upper eyelids. The Blush Blaster Brush 520 E may be used to apply and distribute a blush compound to the “S zone” or cheeks and other areas, as desired. The Disco Shine Brush 520 F may be used to apply and distribute a decorative compound such as a colored powder or glitter to any area. The Bronzer Brush 520 G may be used to apply and distribute a bronzing compound to any area. In use, any of the set of brushes 520 may be used to apply, distribute, and blend any of these compounds to any area of the face. [0051] The cosmetic brushes in a set 520 may include any number of different brush types. A brush may include a base, a collection of bristles, and a ferrule or other component for holding the bristles to the base. The bristles may be made of natural animal hair, synthetic fibers, or a blend. The base of the brush, in some embodiments, may be made of different materials, in various colors. The brush may include one or more words or indicia correlated to a particular manufacturer, product name, trademark, business, or social cause. The set of brushes 520 may be color coded or otherwise grouped by a visible feature that indicates to the user each brush's intended use and/or its association with a particular set of brushes. Each cosmetic brush may be characterized by its particular features; for example, its overall size and shape, the shape of its base, the ferrule type, the bristle composition (natural, synthetic or blend, for example), the bristle length, the bristle color, the shape of each bristle end (rounded or blunt, smooth or rough, for example), the overall shape made by all the bristles together (fan-shaped, cone-shaped, flat, rounded, pointed, and the like), the bristle spacing and density (measured, for example, in bristles per square inch) and the bristle stiffness (from rigid bristles like a toothbrush, to bristles as limp as cotton thread). For example, in the context of face makeup, a first cosmetic brush (such as The Liquidator Brush 520 A illustrated in FIG. 5B ) may be relatively large in size, flat across the end of the bristles, and relatively rigid in stiffness. A second cosmetic brush (such as The Upper Eyelid Shadow Brush 520 D illustrated in FIG. 5E ) may be relatively small in size, rounded in shape across the end, and softer in stiffness. [0052] The user may then apply makeup using the handle and applicator cup assembly by, for example, placing cosmetic on the applicator, activating the motorized handle, and applying cosmetic to the desired area of the body using the rotating applicator). When the user wishes to apply makeup using a different applicator, the user may simply detach the current applicator assembly from the handle, attach a new applicator assembly to the handle, and proceed as described above. Other Suitable Uses [0053] Stand-Alone Applicator Cup [0054] In particular embodiments, an applicator cup such as the applicator cup described above may be utilized as a stand-alone applicator (e.g., may be suitable for applying a substance without attaching the applicator cup and applicator to a separate handle). In such embodiments, a user may apply a substance (e.g., makeup, cosmetic, lotion, cream, or other suitable substance) by installing an appropriate applicator in the applicator cup, and applying the substance by gripping the applicator cup (e.g., using their fingers). [0055] Applicator Cup Combined with Recess-Free Handle [0056] In particular embodiments, the applicator cup is adapted for use with a suitable handle that does not define a recess for accepting the applicator cup. In such embodiments, the applicator cup may be adapted to attach to an end of the handle such that the applicator cup is at least partially exposed (e.g., fully exposed) when attached to the handle. [0057] Upright Storage [0058] In particular embodiments, the applicator cup is adapted to stand substantially upright (e.g., upright) on its bottom face when placed, for example, on a flat support surface (e.g., a counter, table, or other suitable surface). In such embodiments, an applicator installed in the applicator cup may sit upright within the applicator cup's applicator-receiving recess when the applicator cup is standing on its bottom face. In particular embodiments, placing the applicator cup in a position in which the applicator cup is standing on its bottom face may at least substantially (e.g., substantially) protect the integrity of the installed applicator (e.g., by allowing the applicator to stand in a rested, upright position in which the applicator does not come into contact with the support surface (e.g., as the applicator would if it were rested, for example, on its side)). Conclusion [0059] Many modifications and other embodiments of the invention will come to mind to one skilled in the art to which this invention pertains having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. For example, as will be understood by one skilled in the relevant field in light of this disclosure, the invention may take form in a variety of different mechanical and operational configurations. As a particular example, in certain embodiments, the applicator cup may be sufficiently thick to allow a user to grip the cup substantially without touching the applicator. Therefore, it is to be understood that the invention is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for the purposes of limitation.

A makeup brush for use with a motorized handle has a substantially cylindrical body portion defining a first end, a second end, a blind bore formed in the first end, an outer wall that extends from the first end to the second end, and a coupling assembly formed at the second end that is configured for coupling the body portion to a motorized handle. An applicator is at least partially received in the blind bore and coupled therein. At least one finger grip is formed on the outer wall proximate to the first end and extends radially outward from the outer wall. The at least one finger grip is configured to enable a user to releasably couple the body portion adjacent a motorized handle without the user having to touch the applicator. In various embodiments, the blind bore has a solid bottom wall that separates the bore from the coupling assembly.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a food sterilizing apparatus capable of successively carrying out steps of sterilizing and cooling food contained in rigid containers. 2. Prior Art Conventionally, solid ingredients of nourishing preparations containing both solid and liquid such as stew and sold as preservable food in retort pouches are sterilized on a batch basis in sterilizing vessels before being retrieved for packaging. For example, Japanese Patent Publication No. 56-121468 discloses a sterilizing apparatus for producing sterilized solid food where granular solid food is mixed with liquid serving as a heat transmitting medium, heated, sterilized and then separated again from the liquid. However, the apparatus has drawbacks that it requires cumbersome operations of mixing solid with liquid before heating and sterilizing the food and pumping out the liquid after the completion of sterilization and that the solid food is liable to be broken as the container of the apparatus is rotated while the food is heated for sterilization. Japanese Patent Publication No. 50-88251 discloses a sterilizing apparatus for sterilizing food in containers comprising a sterilizing chamber provided with inlet and outlet ports and a conveyor belt running through the inlet and outlet ports such that containers containing food are sequentially moved into the chamber by the conveyor belt and the food in the containers is heated and sterilized while moving in the chamber between the inlet and outlet ports. However, a major drawback of the apparatus is that the sterilizing chamber is not sealed and therefore the sterilizing effect of the apparatus is inevitably insufficient. Japanese Patent Publication No. 49-71177 discloses a boiling/sterilizing apparatus comprising a boiler tank provided with an inlet air lock and an outlet air lock, a boiling/sterilizing chamber and an endless conveyor belt arranged below the boiling/sterilizing chamber. However, the apparatus has a major drawback that the sterilizing chamber cannot be sealed off for effective sterilizing operation because an endless conveyor belt is arranged inside the tank. Japanese Patent Publication No. 51-42391 discloses a high temperature sterilizing apparatus comprising a vessel divided into a plurality of continuously arranged chambers, wherein any two adjacent chambers are separated from each other by a partition wall that can be moved for opening and closing. However, a major drawback of the apparatus is that a plurality of mutually independent conveyors have to be arranged within the each chambers to make the overall configuration of the apparatus rather complicated. Japanese Patent Publication No. 5-30952 discloses a high temperature sterilizing apparatus comprising a heating/sterilizing chamber, a cooling chamber and an air blower arranged within a housing and an endless conveyor belt running through the chambers and the blower and extending to the outside of the housing. However, the apparatus has a major drawback that the heating/sterilizing chamber, the cooling chamber and the air blower cannot be efficiently designed because of the endless conveyor belt running therethrough. In view of the above identified problems of existing food sterilizing apparatuses, the object of the invention is to provide a food sterilizing apparatus having a simple configuration and capable of completely and efficiently sterilizing food. SUMMARY OF THE INVENTION According to the invention, the above object is achieved by providing a food sterilizing apparatus for sterilizing food contained in rigid containers characterized in that it comprises a food supplying section, a linear cylindrical heater, a linear cylindrical cooler and a delivery section, each having inlet and outlet ports arranged respectively at the upstream and downstream ends thereof, any two adjacent ones of said component sections being connected in parallel or rectangularly with each other at the respective outlet and inlet ports thereof with a sealing gate interposed therebetween, said component sections being further provided with respective pushers disposed at the upstream end thereof for moving rigid food containers downstream, each of said pushers having a stroke at least equal to the width of a rigid container. Now, the present invention will be described in greater detail by referring to the accompanying drawings that illustrate preferred embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic view of a first embodiment of food sterilizing apparatus according to the invention, illustrating its configuration. FIG. 2 is a schematic view of a second embodiment of food sterilizing apparatus according to the invention, illustrating its configuration. DETAILED DESCRIPTION OF THE INVENTION In FIG. 1, schematically illustrating a first preferred embodiment of the invention, a food sterilizing apparatus generally denoted by reference numeral 1 comprises a linear cylindrical food supplying section 4 held in communication with a deaerator 2, a linear cylindrical heater 8 arranged in parallel with the linear cylindrical food supplying section 4 with a pressure control chamber 44 interposed therebetween, said pressure control chamber 44 being laterally defined by a first gate valve 6 and a fourth gate valve 42, a linear cylindrical cooler 16 arranged in parallel with the linear cylindrical heater 8 with a second gate valve 10 interposed therebetween and a discharge section 24 arranged in parallel with the linear cylindrical cooler 16 with a pressure control chamber 62 interposed therebetween, said pressure control chamber 62 being laterally defined by a third gate valve 20 and a fifth gate valve 60. The linear cylindrical food supplying section 4 has an internal length of about 60cm and is provided at an end thereof with a pusher 30 for axially and longitudinally pushing and moving forward rigid food containers and at the opposite end thereof with another pusher 32 for pushing and moving rigid food containers in a direction of a right angle to the axis of the food supplying section 4, said pusher 32 being so designed as to extend and push rigid food containers through the first gate valve 6 into a pressure control chamber 44 arranged upstream relative to the linear cylindrical heater 8. The linear cylindrical food supplying section 4 is also provided at the downstream inner end thereof with a turn table 36 for rotating rigid food containers by 90°. The linear cylindrical heater 8 has an internal length of about 180 cm and is connected to a steam heater 40 and provided at the upstream end thereof with a pressure control chamber 44 laterally defined by a fourth gate valve 42 and a pusher 46 for pushing and moving forward rigid food containers through a fourth gate valve 42. Rigid food containers such as retainers filled with food may be arranged in a line such that the front end retainer of the line is pushed into the next processing step by pushing and moving forward the rear end retainer of the line. The linear cylindrical heater 8 is provided at the downstream end thereof with a pusher 47 for pushing rigid food containers in a direction of a right angle to the axis of the heater 8, said pusher 47 being so designed as to extend and push rigid food containers through a second gate valve 10 into a linear cylindrical cooler 16. The pressure control chamber 44 is in the inside with a turn table 48 for rotating rigid food containers by 90°. Likewise, the linear cylindrical heater 8 is also provided at the downstream inner end thereof with a similar turn table 49 for rotating rigid food containers by 90°. The linear cylindrical cooler 16 has an internal length of about 180 cm and is connected to a cooling device 50 and provided at the upstream end thereof with a pusher 52 for pushing and moving forward rigid food containers. The linear cylindrical cooler 16 is additionally provided at the downstream end thereof with another pusher 54 pushing rigid food containers in a direction of a right angle to the axis of the cooler 16, said pusher 54 being so designed as to extend and push rigid food containers through a third gate valve 20 into a pressure control chamber 62 disposed upstream relative to the discharge section 24. The linear cylindrical cooler 16 is additionally provided at the upstream and downstream ends thereof with respective turn tables 56, 57 for rotating rigid food containers by 90°. The discharge section 24 has an internal length of about 60 cm and is provided at the upstream end thereof with a pressure control chamber 62 laterally defined by a fifth gate valve 60 and a pusher 66 for pushing and moving forward rigid food containers through a fifth gate valve 60. The discharge section 24 is additionally provided at the downstream end thereof with a conveyor device 68 for conveying food in rigid food containers. The pressure control chamber 62 is provided in the inside with a turn table for rotating rigid food containers by 90°. The first embodiment of food sterilizing apparatus according to the invention and having a configuration as described above operates in a manner as follows. Food contained in containers, for example, retainers are fed to the linear cylindrical food supplying section 4 and the deaerator 2 is driven to feed steam to the retainers from the bottom and draw the steam upward in order to remove any air existing among particles of the food in the retainers. Thereafter, two retainers containing food are pushed and moved at a time by the pusher 30 onto the turn table 36, which is then rotated by 90°. Subsequently, the first gate valve 6 is opened and the two retainers on the turn table 36 are pushed and moved onto the turn table 48 by the pusher 32. The extended pusher 32 is then retracted to the original position and the turn table 48 is rotated by 90° so that the longitudinal axis of the two retainers on the turn table 48 is aligned with the axis of the linear cylindrical heater 8. At this stage of operation, both the first and fourth gate valves 6 and 42 are closed. Steam is then fed into the pressure control chamber 44 under this condition until the inner pressure of the pressure control chamber 44 becomes equal to that of the linear cylindrical heater 8., When the inner pressures of the pressure control chamber 44 and the linear cylindrical heater 8 are made equal to each other, the fourth gate valve 42 is opened and the retainers on the turn table 48 are pushed and moved into the linear cylindrical heater 8 by the pusher 46. Then, the fourth gate valve 42 is closed and the steam heater 40 is driven to heat and sterilize the food in the retainers. Meanwhile, the inner pressure of the pressure control chamber 44 is regulated to become equal to that of the linear cylindrical food supplying section 4 and two other retainers are fed into the pressure control chamber 44 from the linear cylindrical food supplying section 4 and placed on the turn table 48, which is then rotated by 90° so that the longitudinal axis of the two retainers on the turn table 48 is aligned with the axis of the linear cylindrical heater 8 and the retainers are made ready to move into the linear cylindrical heater 8. Thereafter, the fourth gate valve 42 is opened again and the retainers on the turn table 48 are pushed and moved into the linear cylindrical heater 8 by the pusher 46 until the two retainers at the other end of the linear cylindrical heater 8 are moved onto the turn table 49 located at the downstream end of the linear cylindrical heater 8, whereby the turn table 49 is rotated by 90° . In this manner, as the retainers in the linear cylindrical heater 8 are gradually moved forward through the latter, the food contained in the retainers are heated and sterilized to meet predetermined requirements of sterilization. As retainers are moved onto the turn table 49, the second gate valve 10 is opened, and the retainers on the table 49 are pushed and moved onto the turn table 56 located in the linear cylindrical cooler 16 by the pusher 47. Note that the inner pressure of the linear cylindrical heater 8 and that of the linear cylindrical cooler 16 are maintained equal to each other at this stage of operation. Thereafter, the turn table 56 is rotated by 90° along with the retainers held thereon, which retainers are then pushed and moved further into the linear cylindrical cooler 16 by the pusher 52. Meanwhile, the food contained in the retainers in the linear cylindrical cooler 16 are cooled by the cooling device 50 as they move though the cooler 16. In this way, additional food retainers are fed onto the turn table 56 and pushed and moved into the linear cylindrical cooler 16 by the pusher 52 so that the retainers in the linear cylindrical cooler 16 are sequentially moved onto the turn table 57 located at the downstream end of the linear cylindrical cooler 16. The food contained in the retainers are incessantly cooled while they move through the linear cylindrical cooler 16. Then, the turn table 57 is rotated by 90° along with the two retainers held thereon and the third gate valve 20 is opened so that they may be moved onto the turn table 69 by the pusher 54. Note that, at this stage of operation, the inner pressure of the pressure control chamber 62 is made equal to that of the linear cylindrical cooler 16. Thereafter, the third gate valve 20 is closed and the inner pressure of the pressure control chamber 62 is regulated to become equal to that of the discharge section 24. Meanwhile, the turn table 69 is driven to rotate by 90° along with the retainers held thereon and then the fifth gate valve 60 is opened so that the retainers on the turn table 60 may be pushed and moved into the discharge section 24 by the pusher 66. At the same time, the retainers in the discharge section 24 are sequentially moved onto the conveyor device 68 as they are pushed and moved forward by newly fed retainers. FIG. 2 schematically illustrates the configuration of a second embodiment of food sterilizing apparatus according to the invention. Note that the components that are substantially identical with those of the first embodiments are denoted respectively by the same reference numerals prefixed by one hundred and will not be described any further. The food sterilizing apparatus 100 of the second embodiment comprises a linear cylindrical food supplying section 104 held in communication with a deaerator 102, a linear cylindrical heater 108 arranged at a right angle to the linear cylindrical food supplying section 104 with a pressure control chamber 144 interposed therebetween, said pressure control chamber 144 being laterally defined by a first gate valve 106 and a fourth gate valve 142, a linear cylindrical cooler 116 arranged at a right angle to the linear cylindrical heater 108 with a second gate valve 110 interposed therebetween and a discharge section 124 arranged in parallel with the linear cylindrical cooler 116 with a pressure control chamber 162 interposed therebetween, said pressure control chamber 162 being laterally defined by a third gate valve 120 and a fifth gate valve 160. The linear cylindrical food supplying section 104 has an internal length of about 60 cm and is provided at an end thereof with a pusher 130 for axially pushing and moving forward rigid food containers and at the opposite end thereof with a pressure control chamber 144 that has a pusher 146 for pushing and moving rigid food containers in a direction of a right angle to the axis of the linear cylindrical food supplying section 104. The pusher 146 extends and moves rigid food containers through the first gate valve 142 into the linear cylindrical heater 108. The pressure control chamber 144 contains in the inside a turn table 136 for rotating rigid food containers by 90°. The linear cylindrical heater 108 has an internal length of about 180 cm and is connected to a steam heater 140 and provided at the downstream end thereof with a pusher 152 for pushing rigid food containers in a direction of a right angle to the axis of the heater 108 and a turn table 149 such that the rigid food containers fed in by the pusher 146 are eventually rotated by 90° by the turn table 149 and then pushed and moved through the second gate valve 110 into the linear cylindrical cooler 116 by the pusher 152 as the latter extends. The linear cylindrical cooler 116 has an internal length of about 180cm and is connected to a cooling device 150 and provided at the downstream end thereof with a pusher 154 pushing rigid food containers in a direction of a right angle to the axis of the cooler 116, said pusher 154 being so designed as to extend and push rigid food containers through a third gate valve 120 into a pressure control chamber 162, The linear cylindrical cooler 116 is additionally provided at the downstream end thereof with a turn tables 157 for rotating rigid food containers by 90°. The pressure control chamber 162 has therein a turn table 169 for rotating rigid food containers by 90° and a pusher 166 for pushing and moving rigid food containers into the discharge section 124. The discharge section 124 has an internal length of about 60 cm and is provided at the downstream end thereof with a conveyor device 168 for conveying the food in the rigid food containers coming out from the apparatus. ADVANTAGE OF THE INVENTION A food sterilizing apparatus according to the invention is advantageous in that it has a simple configuration and can completely and efficiently sterilize food.

A food sterilizing apparatus has a simple configuration and can completely and efficiently sterilize food. The food sterilizing apparatus is designed to sterilize food contained in rigid food containers and comprises a food supplying section, a linear cylindrical heater, a linear cylindrical cooler and a discharge section, each having inlet and outlet ports arranged respectively at the upstream and downstream ends thereof, any two adjacent ones of said component sections being connected in parallel or rectangularly with each other at the respective outlet and inlet ports thereof with a sealing gate interposed therebetween, said component sections being further provided with respective pushers disposed at the upstream end thereof for moving rigid food containers downstream, each of said pushers having a stroke at least equal to the width of a rigid container.

CROSS-REFERENCE TO RELATED APPLICATIONS/PATENTS This application is a continuation of prior application Ser. No. 11/438,891, filed May 23, 2006, now abandoned, the entirety of which is incorporated herein by reference. In addition, this application contains subject matter which is related to the subject matter of the following applications. Each of the below listed applications is hereby incorporated herein by reference in its entirety: “Surgical Spacer,” by Anderson (U.S. patent application Ser. No. 11/438,940); and “Systems and Methods for Adjusting Properties of a Spinal Implant,” by Trieu et al. (U.S. patent application Ser. No. 11/439,006). TECHNICAL FIELD The present invention generally relates to surgical spacers for spacing adjacent body parts. More particularly, the present invention relates to surgical spacers having a flexible container for containing a material that is compressible during end use, the container being substantially impermeable to the material, and a structure for controlling at least part of a shape of the container when containing the material. BACKGROUND OF THE INVENTION The human spine is a biomechanical structure with thirty-three vertebral members, and is responsible for protecting the spinal cord, nerve roots and internal organs of the thorax and abdomen. The spine also provides structural support for the body while permitting flexibility of motion. A significant portion of the population will experience back pain at some point in their lives resulting from a spinal condition. The pain may range from general discomfort to disabling pain that immobilizes the individual. Back pain may result from a trauma to the spine, the natural aging process, or the result of a degenerative disease or condition. Procedures to address back problems sometimes require correcting the distance between spinous processes by inserting a device (e.g., a spacer) therebetween. The spacer, which is carefully positioned and aligned within the area occupied by the interspinous ligament, after removal thereof, is sized to position the spinous processes in a manner to return proper spacing thereof. Dynamic interspinous spacers are currently used to treat patients with a variety of indications. Essentially, these patients present a need for distraction of the posterior elements (e.g., the spinal processes) using a mechanical device. Current clinical indications for the device, as described at SAS (Spine Arthroplasty Society) Summit 2005 by Guizzardi et al., include stenosis, disc herniation, facet arthropathy, degenerative disc disease and adjacent segment degeneration. Marketed interspinous devices include rigid and flexible spacers made from PEEK, titanium or silicone. Clinical success with these devices has been extremely positive so far as an early stage treatment option, avoiding or delaying the need for lumbar spinal fusion. However, all devices require an open technique to be implanted, and many require destroying important anatomical stabilizers, such as the supraspinous ligament. Current devices for spacing adjacent interspinous processes are preformed, and are not customizable for different sizes and dimensions of the anatomy of an interspinous area of an actual patient. Instead, preformed devices of an approximately correct size are inserted into the interspinous area of the patient. Further, the stiffness or flexibility of the devices must be determined prior to the devices being inserted into the interspinous area. Thus, a need exists for improvements to surgical spacers, such as those for spacing adjacent interspinous processes. SUMMARY OF THE INVENTION Briefly, the present invention satisfies the need for improvements to surgical spacers by providing shape control. A flexible container is provided that is fillable in situ to a desired amount, with a structure for at least part of the container providing shape control thereto. An optional conduit coupled to the container allows for filling of the container, for example, by injecting a material into the container. The present invention provides in a first aspect, a surgical spacer. The surgical spacer comprises a flexible container for containing a material that is compressible during end use, wherein the container is substantially impermeable to the material. The surgical spacer further comprises a structure for at least part of the container when containing the material, wherein the structure controls at least part of a shape of the surgical spacer. The present invention provides in a second aspect, an interspinous spacer. The interspinous spacer comprises a flexible container for containing an injectable material that is compressible during end use, wherein the container is substantially impermeable to the injectable material. The interspinous spacer further comprises a conduit coupled to the container for accepting the injectable material, and a structure for at least part of the container when containing the material, wherein the structure has a shape during end use to fit between adjacent spinous processes. The present invention provides in a third aspect, a method of controlling at least part of a shape of a surgical spacer. The surgical spacer comprises a flexible container for containing a material that is compressible during end use, wherein the container is substantially impermeable to the material. The surgical spacer further comprises a structure for at least part of the container when containing the material. The method comprises creating the structure with at least one material for controlling at least part of a shape of the surgical spacer during end use. The present invention provides in a fourth aspect, a method of spacing adjacent spinous processes. The method comprises providing an interspinous spacer, the interspinous spacer comprising a flexible container for containing an injectable material that is compressible during end use, wherein the container is substantially impermeable to the injectable material. The interspinous spacer further comprises a conduit coupled to the container for accepting the injectable material, and a structure for at least part of the container when containing the material, wherein the structure has a shape during end use to fit between adjacent spinous processes. The method further comprises implanting the interspinous spacer between adjacent spinous processes, and injecting the injectable material into the container through the conduit such that the shape is achieved. Further, additional features and advantages are realized through the techniques of the present invention. Other embodiments and aspects of the invention are described in detail herein and are considered a part of the claimed invention. BRIEF DESCRIPTION OF THE DRAWINGS The subject matter which is regarded as the invention is particularly pointed out and distinctly claimed in the claims at the conclusion of the specification. The foregoing and other objects, features, and advantages of the invention are apparent from the following detailed description taken in conjunction with the accompanying drawings in which: FIG. 1 depicts adjacent vertebrae of the lumber region of a human spinal column. FIG. 2 depicts a more detailed view of a portion of a human spinal column including the vertebrae of FIG. 1 . FIG. 3 depicts the spinal column portion of FIG. 2 after implantation and filling of one example of an interspinous spacer in accordance with an aspect of the present invention. FIG. 4 is a partial cut-away view of one example of an unfilled surgical spacer with the container in the structure, in accordance with an aspect of the present invention. FIG. 5 depicts an example of a surgical spacer with integrated container and structure, in accordance with an aspect of the present invention. FIG. 6 is a cross-sectional view of one example of a surgical spacer with external container, in accordance with an aspect of the present invention. FIG. 7 depicts one example of the construction of a structure for use with one example of a surgical spacer, in accordance with another aspect of the present invention. FIG. 8 depicts another example of a surgical spacer with integrated container and structure, in accordance with another aspect of the present invention. FIG. 9 depicts one example of a structure for a surgical spacer including at least one substantially inflexible shaped member, in accordance with another aspect of the present invention. FIG. 10 depicts another example of a structure for a surgical spacer including at least one substantially inflexible shaped member, in accordance with another aspect of the present invention. FIG. 11 depicts still another example of a structure for a surgical spacer including a supra-structure, in accordance with another aspect of the present invention. FIG. 12 depicts a portion of a surgical spacer with a structural mesh coupled at least one least one substantially inflexible shaped member, in accordance with another aspect of the present invention. DETAILED DESCRIPTION OF THE INVENTION A surgical spacer of the present invention can be formed in situ during a procedure. The spacer includes the following basic aspects: a flexible container, and a structure for at least part of the container that controls at least part of the shape of the surgical spacer. The flexible container can be filled or injected through an optional conduit after placement. Further, the structure may be folded or otherwise reduced in size prior to use in some aspects. Together with an unfilled container, in some aspects, the spacer can create a smaller footprint during implantation. Once filled, the structure provides support and containment for the container, as well as providing shape control for at least part of the spacer. FIG. 1 depicts adjacent vertebrae 100 , 102 of the lumbar region of a human spinal column. As known in the art, each vertebrae comprises a vertebral body (e.g., vertebral body 104 ), a superior articular process (e.g., superior articular process 106 ), a transverse process (e.g., transverse process 108 ), an inferior articular process (e.g., inferior articular process 110 ), and a spinous process (e.g., spinous process 112 ). In addition, between vertebral bodies 104 and 114 is a space 116 normally occupied by an intervertebral disc (see FIG. 2 ), and between spinous processes 112 and 118 is a space 120 normally occupied by an interspinous ligament (see FIG. 2 ). FIG. 2 depicts the vertebrae of FIG. 1 within an area 200 of the lumbar region of a human spine. As shown in FIG. 2 , spinous processes 112 and 118 are touching and pinching interspinous ligament 202 , calling for spacing of the spinous processes. FIG. 3 depicts spinous processes 112 and 118 after spacing with an interspinous spacer 300 in accordance with one aspect of the present invention. As shown in FIG. 3 , interspinous ligament 202 has been removed in a conventional manner prior to insertion of spacer 300 . Although shown in its filled state, in this example, spacer 300 is implanted in its unexpanded state, as described more fully below. The spacer is filled with a material described below through a conduit 302 after implantation. For example, the material may be injected into the spacer through the conduit (e.g., a one-way valve). Prior to implantation and filling, measurement of the space between the interspinous processes and determination of the spacer size and desired amount of filling can be performed. Conventional methods can be used, such as, for example, the use of templates, trials, distractors, scissor-jacks or balloon sizers. FIG. 4 depicts a partially cut-away view of one example of a spacer 400 , in accordance with one aspect of the present invention. As shown in FIG. 4 , the spacer comprises an unfilled container 402 inside a structure 404 . Preferably, the container is in an evacuated state during implantation and prior to being filled. Where a valve (e.g., a one-way valve) is coupled to the container, the container is preferably evacuated prior to or during the process of coupling the valve thereto. In the present example, the structure is outside the container. However, as will be described in more detail below, the container can be outside the structure, or the container and structure can be integrated. In addition, although the structure is shown to be roughly H-shaped to fit between adjacent spinous processes, the structure can have any shape necessary for the particular surgical application. For example, the structure could instead have a roughly cylindrical shape to replace an intervertebral disc. As another example, the structure could be spherically or elliptically shaped to replace part of the intervertebral disc, for example, the nucleus pulpous, leaving the rest of the disc intact. Further, although the structure is shown enveloping the container, the structure could be for only a portion of the container, depending on the particular application. For example, it may be desired to prevent bulging of the container only in a particular area. Coupled to the container is an optional conduit 406 for accepting a material that is compressible during end use. The structure provides support for and containment of the container when filled. The container is flexible and substantially impermeable to the material it will be filled with. However, depending on the application, the container may be permeable to other materials, for example, it may be air and/or water permeable. In the present example, the container takes the form of a bag or balloon, but can take other forms, so long as flexible and substantially impermeable to the material it will be filled with. Thus, the container must be substantially impermeable to the filling material, for example, in a liquid state during filling and prior to curing. Examples of container materials include silicone, rubber, polyurethane, polyethylene terephthalate (PET), polyolefin, polycarbonate urethane, and silicone copolymers. Conduit 406 accepts the material being used to fill the container. Preferably, the conduit comprises a one-way valve, however, a two-way valve is also contemplated, as another example. The conduit can comprise any material suitable for implanting, for example, various plastics. Also preferably, the conduit is constructed to be used with a delivery system for filling the container, such as, for example, a pressurized syringe-type delivery system. However, the delivery system itself forms no part of the present invention. As noted above, the conduit is optional. Other examples of how to fill the container comprise the use of a self-sealing material for the container, or leaving an opening in the container that is closed (e.g., sewn shut) intraoperatively after filling. Using a curable material to fill the container may also serve to self-seal the container. In use, the container is filled with a material that is compressible during end use. The compressibility characteristic ensures that the material exhibits viscoelastic behavior and that, along with the structure, the spacer can accept compressive loads. Of course, the degree of compressibility will depend on the particular application for the surgical spacer. For example, if a spacer according to the present invention is used between adjacent spinous processes, the spacer would need to accept compressive loads typically experienced in the posterior region of the spine, for example, up to about 80 shore A. In other words, the spacer is preferably capable of resisting compressive motion (or loads) with a stiffness of about 40 to about 240 N/mm (newtons per millimeter). The material is preferably injectable, and may be compressible immediately or after a time, for example, after curing. For purposes of the invention, the compressibility characteristic is necessary during end use, i.e., after implantation. Materials that could be used include, for example, a plurality of beads (e.g., polymer beads) that in the aggregate are compressible, or materials that change state from exhibiting fluid properties to exhibiting properties of a solid or semi-solid. Examples of such state-changing materials include two-part curing polymers and adhesive, for example, platinum-catalyzed silicone, epoxy, polyurethane, etc. As noted above, the structure provides support for and containment of the container when filled, as well as at least partial shape control of the spacer. The structure comprises, for example, a structural mesh comprising a plurality of fibers and/or wires 408 . Within the structural mesh are shape-control fibers and/or wires 410 . In one example, shape control is provided by wires of a shape-memory alloy (e.g., Nitinol). The shape-memory alloy wire(s) can be coupled to the structural mesh (inside or outside), or weaved into the mesh (i.e., integrated). Coupling can be achieved, for example, by stitching, twisting, or closing the wire on itself. Alternatively, shape control can be provided by other wires or fibers that do not “give” in a particular direction, for example, metal or metal alloys (e.g., tantalum, titanium or steel, and non-metals, for example, carbon fiber, PET, polyethylene, polypropalene, etc.). The shape-memory alloy can be passive (e.g., superelastic) or active (e.g., body-temperature activated). The use of metal, metal alloy or barium coated wires or fibers can also improve radiopacity for imaging. The remainder of the structure can take the form of, for example, a fabric jacket, as shown in FIG. 4 . Although the shape-memory alloy wires make up only a portion of the structural mesh of FIG. 4 , it will be understood that there could be more such wires, up to and including comprising the entirety of the mesh. The fabric jacket in this example contains and helps protect the container from bulging and damage from forces external to the container, while the shape-memory alloy provides shape control of the spacer in a center region 412 . The fibers of the jacket comprise, for example, PET fabric, polypropylene fabric, polyethylene fabric and/or steel, titanium or other metal wire. Depending on the application, the structure may be permeable to a desired degree. For example, if bone or tissue growth is desired to attach to the structure, permeability to the tissue or bone of interest would be appropriate. As another example, permeability of the structure may be desired to allow the material used to fill the container to evacuate air or water, for example, from the container, in order to prevent bubbles from forming inside. Where a mesh is used, for example, the degree of permeability desired can be achieved by loosening or tightening the weave. Although the structure is shown in a roughly H-shape in the example of FIG. 4 , it will be understood that in practice, the structure can be made to be folded, unexpanded, or otherwise compacted. This is particularly true where, for example, the structure comprises a fabric or other easily folded material. A folded or unexpanded state facilitates implantation, allowing for a smaller surgical opening, and unfolding or expansion in situ upon filling of the container. Further, the structure can have a different final shape, depending on the shape-control material used. For example, the shape-memory wires in FIG. 4 may be in their inactive state, whereupon activation by body temperature causes contraction thereof, making the spacer of FIG. 4 “thinner” than shown in the center region. One example of the construction of a structural mesh 700 for use as one example of a structure of the present invention will now be described with reference to FIG. 7 . Two roughly cylindrical members 702 and 704 are sewn together around a periphery 706 of an opening along a side (not shown) in each. Each member in this example comprises a fabric mesh (e.g., fabric mesh 714 ) similar in composition to the fabric jacket of FIG. 4 . Interwoven with the fabric are a plurality of shape-memory alloy wires both horizontally (e.g., wire 716 ) and vertically (e.g., wire 718 ). An opening 708 is created in one of the members for accepting the container, for example, by laser cut. In one example, a conduit described above would poke through opening 708 . The ends of the cylindrical members (e.g., end 710 ) are then trimmed and sewn shut, as shown in broken lines (e.g., lines 712 ) in FIG. 7 . FIG. 5 depicts an outer view of another example of a surgical spacer 500 in accordance with an aspect of the present invention. A container conduit 501 is shown pointing outward from an opening 503 . As shown, the structure 502 delimits the final shape of the spacer, in this example, a rough H-shape. The structure comprises a mesh 504 of shape-memory alloy wire, that is soaked through with a dispersion polymer 506 (e.g., silicone). The dispersion polymer (after curing) acts as the container and is shown filled in FIG. 5 . This is one example of the container and the structure being integral. Although the mesh of FIG. 5 is described as being all shape-memory alloy wire, it will be understood that, like FIG. 4 , the shape-memory alloy could only form a part of the structure. FIG. 6 is a cross-sectional view of another example of a surgical spacer 600 in accordance with the present invention. Surgical spacer 600 is similar to the spacer of FIG. 5 , except that instead of being soaked in a dispersion polymer, a structural mesh 602 of a shape-memory alloy wire is coated with a dispersion polymer (e.g., silicone) 604 or other curable liquid appropriate for the container material, creating an outer container. The coating can be done in a conventional manner, for example, by dip molding on the outside of the mesh. FIG. 8 depicts another example of a surgical spacer 800 with an integrated container and structure, in accordance with another aspect of the present invention. The container and structure in the example of FIG. 8 both comprise a single layer 802 of rubber that is thick enough for a given application to perform the functions of both the container and structure (including shape control). Such a rubber shell would be able to return to its original shape when unconstrained. In addition, spacer 800 preferably includes a conduit 804 (preferably, a one-way valve) for filling internal space 806 . The material can be any of the filling materials described above, for example, silicone. Where the spacer is used, for example, to space adjacent spinous processes, the thickness of layer 802 is preferably in the range of about 0.2 mm to about 2.5 mm. A layer of rubber of that thickness will contain the material chosen, and, when filled, will sufficiently maintain the shape of the spacer for the intended use. In an alternate aspect, the rubber shell of FIG. 8 can be augmented with internal, external, or integrated features to further control shape. Examples of such features include thread, wires (e.g., metal, including shape-memory alloys), cables, tethers, rings or a mesh. FIG. 9 depicts one example of a structure for a surgical spacer including at least one substantially inflexible shaped member, in accordance with another aspect of the present invention. The substantially inflexible member(s) are used to achieve at least part of a preformed shape for a given application. Structure 900 comprises blades 902 and 904 that are substantially inflexible and are substantially straight. In one example, the blades comprise metal, such as, for example, a nickel-titanium alloy. The blades provide a specific shape for at least part of the surgical spacer. Coupling the blades is, for example, a structural mesh 906 . The structure can be paired with any of the types of containers described herein. In addition, the structural mesh can take any of the forms described herein. For example, the structural mesh could take the form of a PET fabric mesh, with or without other shape-enhancing elements (e.g., shape-memory alloy fabric or wire). In one example, the mesh covers the blades. In another example, the mesh is coupled at a periphery of the blades. As shown in the example of FIG. 12 , a portion of a surgical spacer 1200 comprises a blade 1202 and structural mesh 1204 . At the periphery 1206 of the blade, the mesh is coupled to the blade by stitching through a plurality of holes (e.g., hole 1208 ). Similarly, FIG. 10 depicts another example of a structure 1000 including at least one substantially inflexible shaped member. In this example, there are two substantially inflexible shaped members 1002 and 1004 , each being roughly U-shaped. In one example, the U-shaped members comprise metal blades, such as, for example, nickel-titanium alloy blades. Coupling the blades is, for example, a structural mesh 1006 similar to that described above with respect to FIG. 9 . In addition, as also noted above with respect to FIG. 9 , the structure of FIG. 10 can be paired with any of the containers described herein. FIG. 11 depicts still another example of a structure 1100 for a surgical spacer, in accordance with another aspect of the present invention. In this example, the structure comprises a supra-structure 1102 coupled to a main structure 1104 . The main structure need not provide shape control, since that is provided by the supra-structure, however, it could also provide shape control. For example, the main structure could provide shape control in one or more directions, while the supra-structure provides shape control in one or more other directions. Of course, the supra-structure could provide shape control uniformly, e.g., if added to all surfaces. In one example, the main structure comprises a fabric mesh (e.g., PET fabric) with or without added shape memory control fibers or wires. In one example, shown inset in FIG. 11 , supra-structure 1102 comprises a plurality of interlocking links 1106 , the links comprising, for example, a shape-memory alloy. The links could provide resistance to expansion in one or more directions or uniformly, and/or could allow pliability, permitting deformation in one or more directions. The supra-structure can be loosely or rigidly coupled to the main structure, for example, via loops, hooks, stitches or frictional mechanisms. Of course, the supra-structure could instead be coupled to an inside 1108 of the main structure in another example. As with other embodiments herein, the shape-memory alloy can be passive (e.g., superelastic) or active (e.g., body-temperature activated). Although preferred embodiments have been depicted and described in detail herein, it will be apparent to those skilled in the relevant art that various modifications, additions, substitutions and the like can be made without departing from the spirit of the invention and these are therefore considered to be within the scope of the invention as defined in the following claims.

A surgical spacer comprising first and second hollow support members, a flexible container, and a compressible material disposed in the container is disclosed. The first and second support members each have an exterior and an interior cavity. The exteriors of the first and second support members are affixed together and the interior cavities of the first and second support members are connected via a connecting opening. The container is disposed in the interior cavities and extends through the connecting opening. In addition, the container is substantially impermeable to the compressible material. The first and second support members are more rigid than the flexible container. A combination of the first and second support members controls the shape of the flexible container, with the compressible material disposed therein, in response to a compressive load applied to an exterior of the spacer.

BACKGROUND OF THE INVENTION 7 relates to a process for producing a The present invention salad oil which is a useful liquid oil from a specified oil or fat obtained by treating palm oil. Solid fats which are in solid form at ambient temperature are usually converted into liquid oils to make the use thereof convenient. Solid oils such as palm oil are recently mass-produced and the quantity thereof will be increased in future. Therefore, development of new effective utilization of them is eagerly demanded. However, use of the solid fats per se is limited. Under these circumstances, it will be quite significant to produce a liquid salad oil from palm oil which is a solid fat. Various processes were generally tried for liquefying solid fats. The most simple process comprises merely mixing a solid fat with a liquid oil. However, this process is not so effective, since the amount of the solid fat which can be incorporated into the liquid oil is limited to an extremely small amount in order to obtain the intended oil. This process is, therefore, not effective. Another known process comprises fractionating a solid fat to take a low-melting point fraction, but it will be apparent from, for example, oleins obtained by fractionation of palm oil that even the low-melting point fraction tends to be in solid form in seasons other than summer and thus the product thus obtained is only a semi-liquid oil. Under these circumstances, various processes based on transesterification reaction with lipase were recently proposed For example, Japanese Patent Unexamined Published Application (hereinafter referred to as "J. P. KOKAI") No. Sho 61-293389 discloses transesterification of palm oil and an odorless liquid starting oil with lipase, taking advantage of 1,3-specificity. However, this process is not always satisfactory, since the amount of palm oil which can be incorporated is only 50% at the most. J. P. KOKAI Nos. Sho 49-107304 and 64-81899 describe a process wherein a liquid oil is incorporated into an oil obtained from palm oil by fractionation and transesterification of them is conducted. However, the obtained oil has an insufficient cooling resistance. SUMMARY OF THE INVENTION Summary A primary object of the present invention is to provide a process for efficiently producing a salad oil from palm oil which is a solid fat without posing the above-described problems. This and other objects of the present invention will be apparent from the following description and Examples. The present invention was completed on the basis of a finding that a salad oil can be efficiently produced by treating palm oil to produce an oil or fat having specified characteristics, homogeneously mixing the oil or fat with a liquid edible oil having another composition and subjecting them to a 1,3-specific transesterification between fatty acid residues constituting the oil or fat and fatty acid residues constituting the liquid edible oil and that the above-described object can be thus efficiently attained. The present invention provides a process for producing a salad oil which comprises transesterifying a mixture of (A) an oil or fat produced from palm oil and having the following characteristics: ______________________________________iodine value: 55 to 75constituent fatty acids:palmitic acid: 30 to 42% by weightoleic acid: 42 to 48% by weightlinoleic acid: 11 to 20% by weighttripalmitin: 2% by weight or lessopen-tube melting point: 5 to 25° C.______________________________________ and (B) a liquid edible oil other than the component (A) in a weight ratio of 5:95 to 95:5 with immobilized lipase having 1,3-specificity in the absence of solvent and then fractionating the product in the absence of solvent. DESCRIPTION OF THE PREFERRED EMBODIMENTS The oils and fats (A) having the above-described characteristics are preferably those having an iodine value of 57 to 75, amount of palmitic acid residue of 30 to 40% (by weight; the same shall apply hereinafter) and open-tube melting point of 5 to 25%. The oils and fats used as component (A) in the present invention are produced from palm oil by dry fractionation or solvent fractionation method under conditions controlled so that the above-described characteristics will be obtained. It is important in the present invention that the oil or fat having the above-described characteristics is used. When a starting oil having characteristics not within the above-described ranges is used, the object of the invention cannot be attained. The iodine value, fatty acid composition and open-tube melting point are determined according to standard oil and fat analysis methods (edited by Yukagaku Kyokai) and the amount of tripalmitin is determined according to high-performance liquid chromatography. The immobilized lipase having 1,3-specificity usable in the present invention include, for example, Lipozyme (a product of Novo Co.) which is produced by immobilizing a lipase having 1,3-specificity derived from Mucor Miehei by using an ion exchange resin as carrier. The immobilized lipase usable in the present invention is not limited to Lipozyme but any lipase having 1,3-specificity which is carried on a known carrier is usable. The liquid edible oils usable as the component (B) in the present invention include soybean oil, rape seed oil, cotton seed oil, corn oil, safflower oil, rice oil, sunflower oil and sesame oil. They can be used either singly or in the form of a mixture of two or more of them. Both oil components (A) and (B) used in the present invention may be refined oils, bleached oils and deodorized oils. The weight ratio of the oil or fat used as the component (A) to the liquid edible oil used as the component (B) in the present invention is 5:95 to 95: 5, preferably 55:45 to 90:10 in order to attain the object of the present invention which is to produce a liquid oil having a cooling resistance satisfying the standard of salad oils (the Japanese Agricultural Standard that it is not clouded after leaving to stand at 0° C. for 5.5 h). A salad oil can be produced in a quite satisfactory yield in an practically and economically advantageous manner by subjecting the mixture of the substances in the above-described weight ratio to the transesterification. Namely, when the amount of the palm oil or fat in the starting mixture exceeds 95 parts for 5 parts of the liquid edible oil in the mixture, the salad oil cannot be recovered in a satisfactory yield in the subsequent fractionation step. When the ratio of the oil or fat to the liquid edible oil is higher than 55:45, the salad oil can be produced in an economically more advantageous manner. The transesterification reaction in the present invention is conducted at about 60° C. to 80° C., particularly at around 70° C. From a commonsense point of view, a high temperature is desirable for increasing the reaction (transesterification reaction) velocity However, an excessively high temperature will pose a problem of deactivation. It is desirable in the present invention that the homogeneous oil mixture is formulated so that it will be saturated with water at the reaction temperature. By the saturation with water, the amount of free fatty acids by-produced in the course of the reaction can be kept small and the activity of the immobilizedlipase can be kept for a quite long period of time. The transesterification can be conducted either batchwise or continuously in the present invention. However, the continuous process wherein a column filled with the immoblized lipase is used is suprior from the viewpoints of apparatus and efficiency. When the transesterification reaction is conducted batchwise, heating at a relatively high temperature for a long period of time is required in order to sufficiently conduct the reaction particularly when a solid fat is used and, in addition, the amount of free fatty acids formed by the hydrolysis (side reaction) is increased, while the heating time is shorter and the amount of the by-produced fatty acids is small in the continuous process. In the present invention, the solid fat is separated by fractionation from the modified product thus produced. The fractionation is conducted in the absence of solvent, which is one of the characteristic features of the present invention. To produce the salad oil intended in the present invention (i.e. salad oil which is not clouded after leaving to stand at 0° C. for 5.5 h according to the Japanese Agricultural Standard), the reaction mixture is slowly cooled to 3° C. to 10° C., preferably around 5° C. to precipitate the solid components from the mixture and the solid fat is fractionated by filtration by an ordinary method. According to the present invention, the relative amount of the starting material derived from palm oil can be increased to an extent larger than that of ordinary processes and the salad oil produced by the present invention has a satisfactory cooling resistance. The following Examples will further illustrate the present invention. EXAMPLE 1 40% of an oil or fat produced by dry fractionation of palm oil and having an iodine value of 58.0, palmitic acid content of 39.8%, oleic acid content of 42.5%, linoleic acid content of 11.2%, tripalmitin content of 0.2% and open-tube melting point of 21.6° C. was homeneously mixed with 60% of rape seed oil. 360 g/h of the mixture was passed through a 1 l column filled with 300 g of Lipozyme (immobilized lipase of Novo Co.) to conduct the transesterification. The reaction product obtained in the initial stage (72 h) was taken out and then about 5 kg of the reaction product in the next stage was taken, dried and slowly cooled to 5° C. in 48 h and crystals thus formed were filtered out at that temperature. The yield of the liquid oil was 87%. Even when the liquid oil was cooled to 0° C. in ice/water for 30 h, it was not clouded to suggest that it had a sufficient cooling resistance as that required of the salad oil. COMPARATIVE EXAMPLE 1 40 % of palm oil having an iodine value of 5.1, palmitic acid content of 44.0%, oleic acid content of 39.2%, linoleic acid content of 10.2%, tripalmitin content of 9.4% and open-tube melting point of 35° C. was homeneously mixed with 60% of the same rape seed oil as that used in Example 1. After the transesterification and slow cooling conducted in the same manner as that of Example 1, the liquid oil was obtained (yield: 78%). When it was cooled in the same manner as that of Example 1, it was clouded after 17 h. COMPARATIVE EXAMPLE 2 40 % of the same oil produced from palm oil as that used in Example I was homogeneously mixed with 60% of the same rape seed oil as that used in Example 1. The mixture was slowly cooled to 5° C. in 48 h and then filtered at that temperature. The yield of the liquid was 58% which was far lower than that obtained in Example 1 and this process is practically unsatisfactory. EXAMPLE 2 60 % of the same oil derived from palm oil as that used in Example 1 was homogeneously mixed with 40% of the same rape seed oil as that used in Example 1. 360 g/h of the mixture was passed through a 1 l column filled with 300 g of Lipozyme (immobilized lipase of Novo Co.) to conduct the transesterification. The reaction product obtained in the initial stage (72 h) was taken out and then about 5 kg of the reaction product in the next stage was taken, dried and slowly cooled to 5° C. in 48 h and crystals thus formed were filtered out at that temperature. The yield of the liquid oil was 70%. Even when the liquid oil was cooled to 0° C. in ice/water for 5.5 h, it was not clouded to suggest that it had a sufficient cooling resistance as that required of the salad oil. COMPARATIVE EXAMPLE 3 60 % of the same oil derived from palm oil as that used in Example 1 was homogeneously mixed with 40% of the same rape seed oil as that used in Example 1. The mixture was cooled to 5° C. in 48 h. No liquid oil could be obtained by filtration. EXAMPLE 3 A salad oil was prepared by the same method as in Example 1 except that rape seed oil was replaced by soybean oil. As a result, the yield of the liquid salad oil was 84 %. Even when the liquid oil was cooled to 0° C. in ice/water for more than 5.5 h, it was not clouded to : suggest that it had a sufficient cooling resistance as that required of the salad oil. EXAMPLE 4 A salad oil was prepared by the same method as in Example 1 except that rape seed oil was replaced by corn oil. As a result, the yield of the liquid salad oil was 85 %. Even when the liquid oil was cooled to 0° C. in ice/water for more than 5.5 h, it was not clouded to suggest that it had a sufficient cooling resistance as that required of the salad oil. COMPARATIVE EXAMPLE 4 40 % of the same oil derived from palm oil as that used in Example 1 was homogeneously mixed with 60 % of the same soybean oil as that used in Example 3. The mixture was cooled to 5° C. in 48 h. As a result, the yield of the liquid oil was 59%. COMPARATIVE EXAMPLE 5 40 % of the same oil derived from palm oil as that used in Example 1 was homogeneously mixed with 60 % of the same corn oil as that used in Example 4. The mixture was cooled to 5° C. in 48 h. As a result, the yield of the liquid oil was 55%.

A process for producing a salad oil comprises transesterifying a mixture of (A) an oil or fat produced from palm oil and having the following characteristics: ______________________________________ iodine value: 55 to 75constituent fatty acids:palmitic acid: 30 to 42% by weightoleic acid: 42 to 48% by weightlinoleic acid: 11 to 20% by weighttripalmitin: 2% by weight or lessopen-tube melting point: 5 to 25° C.______________________________________ and (B) a liquid edible oil other than the component (A) in a weight ratio of 5:95 to 95:5 with immobilized lipase having 1,3-specificity in the absence of solvent and then fractionating the product in the absence of solvent. Thereby, the salad oil can be efficiently derived from palm oil which is a solid oil and the relative amount of the starting material obtained from palm oil in the salad oil can be increased. The thus-produced salad oil has a satisfactory cooling resistance.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/968,664, which was filed on Mar. 21, 2014 and titled “External Control and Balance of a Lower Extremity Orthotic Device for Transportation”. The entire content of this application is incorporated by reference. BACKGROUND OF THE INVENTION [0002] The present invention pertains to powered orthotic devices and, more particularly, to relocating powered orthotic devices when the devices are not being worn. [0003] Orthotic systems, such as human exoskeletons, are being used to restore, rehabilitate, enhance and protect human muscle function. These exoskeletons are systems of actuated braces that apply forces to the appendages of an exoskeleton wearer or user. In a rehabilitation setting, exoskeletons are typically operated by a physical therapist who uses one or more of a plurality of possible input arrangements to sends commands to an exoskeleton control system. The exoskeleton control system receives intent commands from the exoskeleton operator (e.g., the physical therapist) and then performs desired actions accordingly. In order to properly execute these desired actions, the exoskeleton control system utilizes a range of sensors placed throughout the exoskeleton to sense the exoskeleton's state. Thereafter, the exoskeleton control system prescribes and controls trajectories in the joints of the exoskeleton. These trajectories can be prescribed as position based, force based or a combination of both methodologies, such as through an impedance controller. [0004] During rehabilitation, although the trajectories of the actuated braces of the exoskeleton are controlled by the exoskeleton control system and commands from the physical therapist to the exoskeleton control system, the wearer of the exoskeleton makes significant contributions to the locomotion of the exoskeleton, particularly with regards to balancing both themselves and the exoskeleton, as well as to maneuvering and turning the exoskeleton. As such, exoskeletons are mostly ineffective or incapable of balancing or turning themselves when not worn by a person. In a number of situations, it is desirable for someone, such as a physical therapist, to move an exoskeleton that is not being worn, such as prior to or after a rehabilitation session. However, the substantial weight and size of the exoskeleton makes the lifting and carrying of the exoskeleton awkward and inconvenient for anyone to execute over even short distances. As the exoskeleton is a locomotive device, the capacity exists for the actuated braces of an unworn exoskeleton to assist in the movement of the exoskeleton. Therefore, it would be desirable to develop a device and method that allows a physical therapist, or other operator, to utilize the locomotive capabilities of an unworn exoskeleton in order to relocate the exoskeleton. SUMMARY OF THE INVENTION [0005] Disclosed herein are devices and methods that allow a physical therapist, or other operator, wishing to move an unworn exoskeleton, to provide for the balance of the unworn exoskeleton, while simultaneously utilizing a control system and actuated braces of the exoskeleton to propel the unworn exoskeleton. In other words, the exoskeleton walks by taking steps forward, as commanded by the operator using any of a plurality of input arrangements, while the operator balances and steers the exoskeleton by physically guiding the exoskeleton using a handle or other interaction surface of the exoskeleton. [0006] In particular, the present invention is directed to an ambulatory exoskeleton and a method of relocating the ambulatory exoskeleton. The exoskeleton comprises a control system which can be selectively entered into or exited from an unworn propulsion mode to enable controlled movement of the exoskeleton in the unworn propulsion mode. The control system is configured to control the exoskeleton in at least two different modes, with one mode constituting the unworn propulsion mode, used when the exoskeleton is not worn by a user, and another mode constituting a worn propulsion or default mode, used when the exoskeleton is worn by a user. [0007] Preferably, the control system controls the exoskeleton using a first set of parameters in the unworn propulsion mode and a second, different set of parameters in the default mode. The first set of parameters is optimized for use in controlling the exoskeleton when the exoskeleton is not worn by a user, and the second set of parameters is optimized for use in controlling the exoskeleton when the exoskeleton is worn by a user. In particular, each of the first and second sets of parameters includes safety parameters, with the safety parameters of the first set being relaxed relative to the safety parameters of the second set. [0008] In one embodiment, the control system is caused to enter or exit the unworn propulsion mode through a button, switch or other activation member, the position of which is selectively determined by a physical therapist or other operator when the exoskeleton is not being worn. In one form of the invention, after entering the unworn propulsion mode, an activation portion of the control system then determines whether the exoskeleton is actually being worn by a user. In a particular embodiment, the determination of whether the exoskeleton is worn by a user is based on a measurement of a motor current required by an actuated brace of the exoskeleton in order for the exoskeleton to stand. In accordance with the invention, movement of the exoskeleton following entry into the unworn propulsion mode can be controlled in various ways. In one embodiment, once use of the exoskeleton in the unworn propulsion mode is established, the exoskeleton automatically takes a step forward. In another embodiment, movement in the unworn propulsion mode is established through a portion of the control system that determines an angle of a shank of the exoskeleton. For instance, when the angle of the shank reaches a predetermined value, the control system causes the exoskeleton to take a step forward. In yet another embodiment, the exoskeleton further comprises a handle, and the control system causes the exoskeleton to move based on a force applied to the handle. [0009] Additional objects, features and advantages of the invention will become more readily apparent from the following detailed description of preferred embodiments thereof when taken in conjunction with the drawings wherein like reference numerals refer to common parts in the several views. BRIEF DESCRIPTION OF THE DRAWINGS [0010] FIG. 1 is a side view of an exoskeleton and a wearer thereof in accordance with the present invention; [0011] FIG. 2 is a side view of the exoskeleton with a physical therapist or other operator balancing and controlling the unworn exoskeleton as the exoskeleton steps forward; [0012] FIG. 3 is a flow diagram showing one embodiment of a process by which the exoskeleton enters an unworn propulsion mode, is relocated by a physical therapist and then exits the unworn propulsion mode; [0013] FIG. 4 is a flow diagram showing another embodiment of a process by which the exoskeleton enters the unworn propulsion mode, is relocated by a physical therapist and then exits the unworn propulsion mode; and [0014] FIG. 5 is a flow diagram showing still another embodiment of a process by which the exoskeleton enters the unworn propulsion mode, is relocated by a physical therapist and then exits the unworn propulsion mode. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0015] Detailed embodiments of the present invention are disclosed herein. However, it is to be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various and alternative forms. The figures are not necessarily to scale, and some features may be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to employ the present invention. [0016] Concepts were developed to provide an operator with a way to activate, control, balance and direct the actuated walking movement of an unworn ambulatory exoskeleton (i.e., an exoskeleton not currently worn by a patient or other person). An exemplary ambulatory exoskeleton is illustrated in FIG. 1 , with the exoskeleton shown being worn by a patient in a physical therapy setting. With continued reference to FIG. 1 , an exoskeleton 100 has a torso portion 105 and leg supports (one of which is labeled 110 ). Exoskeleton 100 is used in combination with a pair of crutches, a left crutch 115 of which includes a lower, ground engaging tip 120 and a handle 125 . In connection with this embodiment, through the use of exoskeleton 100 , a patient (or, more generally, a wearer or user) 130 is able to walk. In a manner known in the art, torso portion 105 is configured to be coupled to a torso 135 of patient 130 , while the leg supports are configured to be coupled to the lower limbs (one of which is labeled 140 ) of patient 130 . Additionally, actuators, interposed between portions of the leg supports 110 , as well as between the leg supports 110 and torso portion 105 , are provided for shifting of the leg supports 110 relative to torso portion 105 to enable movement of the lower limbs 140 of patient 130 . In some embodiments, torso portion 105 can be quite small and comprise a pelvic link (not shown), which wraps around the pelvis of patient 130 . In the example shown in FIG. 1 , the actuators are specifically shown as a hip actuator 145 , which is used to move a hip joint 150 in flexion and extension, and as knee actuator 155 , which is used to move a knee joint 160 in flexion and extension. The actuators 145 and 155 are controlled by a controller (or CPU) 165 in a plurality of ways known to one skilled in the art of exoskeleton control, with controller 165 being a constituent of an exoskeleton control system. Although not shown in FIG. 1 , various sensors are in communication with controller 165 so that controller 165 can monitor the orientation of exoskeleton 100 . Such sensors can include, without restriction, encoders, potentiometers, accelerometer and gyroscopes, for example. As certain particular structure of an exoskeleton for use in connection with the present invention can take various forms and is known in the art, it will not be detailed further herein. [0017] Previously disclosed devices and methods have provided ways for a patient to balance or assist in the balance of an ambulatory exoskeleton worn by the patient. However, novel devices and methods are required for an unworn exoskeleton device to walk while being balanced and directed by a physical therapist or other operator. In order for the unworn exoskeleton to assist in its own propulsion while being balanced and directed by, for instance, a physical therapist, the exoskeleton control system is first signaled or commanded to enter an “unworn propulsion mode”. The unworn propulsion mode is distinct from a default mode which is designated for when the exoskeleton is worn by a patient. In addition to facilitating relocating of the unworn exoskeleton by the physical therapist, the unworn propulsion mode is preferably optimized for the absence of a patient (i.e., the exoskeleton control system controls the exoskeleton according to different parameters). Once the exoskeleton is in the unworn propulsion mode, the actuated braces of the exoskeleton cause the exoskeleton to take steps, thereby resulting in a walking motion, with the step rate and timing controlled as described below, while the physical therapist assists in the balancing of the exoskeleton until the point at which the physical therapist commands the exoskeleton to cease walking. One can visualize such a device as being akin to a person walking a hand truck, where the person operating the device can control its motion almost effortlessly without bearing the weight of the device. [0018] A first embodiment of the invention comprises an exoskeleton with a handle mounted on the back of the exoskeleton and an activation member, such as a button, toggle switch or the like, as an input means in proximity to the handle. The activation member is in communication with the exoskeleton control system and, upon signaling the exoskeleton control system through the activation member by a physical therapist, the exoskeleton control system enters the unworn propulsion mode. When the exoskeleton control system enters the unworn propulsion mode, the exoskeleton is balanced by the physical therapist using the handle, and the physical therapist is able to command the exoskeleton to take steps forward using control inputs. In one rather simple implementation, the exoskeleton automatically takes steps forward at a constant rate until the activation member is deselected by the physical therapist. In another embodiment, the physical therapist uses a control pad as an activation member to command each step. In a further embodiment, the exoskeleton makes use of sensed operational parameters of the exoskeleton in connection with controlling the exoskeleton. For instance, the shank angle of the forward leg in double stance is a consistent indicator of when the exoskeleton is prepared to take a step with the rear leg. Therefore, in one embodiment of the invention, when the leg support shank of the forward leg (during double stance) is leaned forward sufficiently, this parameter is used to indicate a desire to take a step and the powered orthotics controller initiates a step with the rear leg. Other operational parameters could also be employed, including those described in PCT Application No. PCT/US2013/033472, titled “Human Machine Interface for Lower Extremity Orthotics”, which is hereby incorporated by reference. In some embodiments, the exoskeleton can also walk backwards when the angle of the rear shank decreases during double stance, in which case the forward leg enters a swing phase and takes a backwards step. This embodiment has utility when maneuvering the exoskeleton in tight spaces. [0019] At this point it should be recognized that there are many ways to measure operational parameters of an exoskeleton, including the leg support shank angle with respect to the ground. For example, in addition to measuring the shank angle directly with an inertial measurement unit (IMU), in some embodiments it is possible to measure the torso orientation with an IMU and the relative angles at the hip and knee and use the combination of these measurements to produce a shank angle. In another example, if the terrain is generally known, it is possible to measure the ankle angle to estimate the shank angle. In yet other embodiments, it is sufficient to measure the general position of the torso relative to the foot, and multiple measurements are combined to estimate this relative orientation. Further, it is important to understand that this control system method is particularly advantageous in connection with the present invention because it allows the physical therapist to indirectly, but intuitively, control the walking speed of the exoskeleton. If the physical therapist pushes the torso of the exoskeleton forward, the device will pivot about the ankle, thereby increasing the shank angle and, upon reaching a predetermined shank angle, triggering the step. The faster the physical therapist pushes the exoskeleton torso forward, the sooner the shank angle will reach the threshold, the sooner the exoskeleton will take the next step and the faster the exoskeleton will walk. In some embodiments, the speed of the swing is tied to the rate that the exoskeleton steps are triggered (or the speed of the shank motion), such that the speed of the leg swinging forward can also be increased as the physical therapist pushes the exoskeleton to walk faster. [0020] A depiction of the first embodiment is shown in FIG. 2 , in which a physical therapist 200 uses his hands to grasp a handle 205 that is attached to exoskeleton 100 . The interaction of physical therapist 200 with handle 205 allows physical therapist 200 to exert force on exoskeleton 100 and thereby both guide and balance exoskeleton 100 . When physical therapist 200 activates a button 210 , exoskeleton 100 begins to take steps forward, which is shown in this case by a step in progress. During this stepping process, physical therapist 200 continues to balance exoskeleton 100 by exerting force on handle 205 . Although a single handle is shown in FIG. 2 , exoskeleton 100 can include multiple handles. Alternatively, handle 205 can be omitted, and physical therapist 200 can grasp other portions on the rear of exoskeleton 100 , with such portions optionally being configured to facilitate grasping. [0021] In other embodiments, the exoskeleton can estimate how hard the physical therapist is pushing on the handle, either with a force sensor in the handle, measuring the motion of the torso or measuring how much current is consumed in hip actuation, and use this information to choose when and how fast to take a step. It is important to note that some of these embodiments, such as monitoring the current in the hip actuation and measuring the motion of the torso, would not require any additional sensing beyond that which would already be required to operate the exoskeleton. As a result, these embodiments advantageously add only software to the device and would not increase the cost or complexity of the exoskeleton. In some embodiments, the exoskeleton can consider if the force applied by the physical therapist is directed to one side or the other and chose to take repeated steps on one leg in order to facilitate turning. In a further embodiment, the exoskeleton can estimate the vertical component of the force applied by the physical therapist and use this information to choose when to sit or stand (e.g., standing when the exoskeleton is sitting and the physical therapist pulls up on the handle or sitting when the exoskeleton is standing and the physical therapist pushes down on the handle). In yet another embodiment, the exoskeleton can monitor the roll angle of the torso and take multiple steps on the same side to facilitate turning when the torso is leaned to one side. In still another embodiment, the physical therapist can shake the torso, which results in the exoskeleton taking short, rapid steps in place to facilitate turning and maneuvering of the exoskeleton in tight quarters. [0022] A diagram illustrating the first embodiment is provided in FIG. 3 . The physical therapist 200 grasps the handle 205 of the unworn exoskeleton 100 (step 300 ), and, by use of the handle 205 , the physical therapist 200 balances the exoskeleton 100 into a standing position (step 305 ). At this point, the physical therapist 200 presses the button 210 (step 310 ), which causes the exoskeleton control system 165 to enter the unworn propulsion mode (step 315 ). As a result, the exoskeleton 100 takes steps forward at a constant rate (step 320 ), during which time the physical therapist 200 continues balancing the walking exoskeleton 100 (step 325 ) until such point that the physical therapist 200 again presses the button 210 (step 330 ). This causes the exoskeleton 100 to cease stepping (step 335 ) and signals the exoskeleton control system 165 to exit the unworn propulsion mode (step 340 ). [0023] As an example of the first embodiment, consider a physical therapist working in a clinical setting with an exoskeleton. At the beginning of the day, prior to the arrival of patients, the physical therapist may wish to move the exoskeleton from a storage or battery charging area to a therapy area that is across a room or down a hall. When the physical therapist wishes to move the exoskeleton from one of these locations to the other, the physical therapist grasps a handle on the back of the exoskeleton and lifts or balances the exoskeleton into a position suitable for walking. The physical therapist then steers the exoskeleton device in the direction that the physical therapist wishes the exoskeleton device to walk and pushes the button on the exoskeleton that directs the exoskeleton control system to enter the unworn propulsion mode. As a result, the exoskeleton takes steps forward at a constant rate while being balanced by the physical therapist who steers the exoskeleton, as needed, until such time as the physical therapist wishes the exoskeleton to stop walking. At that point, the physical therapist again pushes the same button on the exoskeleton, which commands the exoskeleton to stop taking steps forward and to exit the unworn propulsion mode. The exoskeleton completes the last motion in progress (i.e., finishing any step being taken) and returns to a standing position. The physical therapist can repeat this process any number of times until satisfied with the final location of the exoskeleton. [0024] Another exemplary embodiment of the invention comprises an exoskeleton with a handle mounted on the back of the exoskeleton and an activation member in the form of a control pad in communication with the exoskeleton control system. The control pad has a selectable option that, upon selection by a physical therapist, signals the exoskeleton control system to enter the unworn propulsion mode. When the exoskeleton control system enters the unworn propulsion mode, the exoskeleton is balanced by the physical therapist using the handle and the physical therapist is able to command the exoskeleton to take steps forward using the control pad to command each step. Optionally, the control pad can include additional controls for commanding the exoskeleton to turn, step backward, stand or sit, for example. Alternatively, as described above, the exoskeleton can be commanded to perform such actions based on the force applied to the handle (or other appropriate inputs) by the physical therapist. [0025] As an example of this embodiment, again consider a physical therapist working in a clinical setting with an exoskeleton wherein the physical therapist wishes to move the exoskeleton from one area to another. Here, the physical therapist selects an option on the exoskeleton control pad that directs the exoskeleton control system to enter the unworn propulsion mode. As a result, the exoskeleton takes steps forward, as commanded by the physical therapist via the exoskeleton control pad, while being balanced by the physical therapist who steers the exoskeleton, such as through one or more handles as needed, until such time as the physical therapist wishes the exoskeleton to stop walking. At that point, the physical therapist selects an option on the exoskeleton control pad that commands the exoskeleton to stop taking steps forward and to exit the unworn propulsion mode. The exoskeleton then completes the last motion in progress (i.e., finishing any step being taken) and returns to a standing position. The physical therapist can repeat this process any number of times until satisfied with the final location of the exoskeleton. [0026] A further aspect of the invention comprises an exoskeleton with a handle mounted on the back of the exoskeleton and an input means in communication with the exoskeleton control system, wherein the input means has a selectable option that, upon selection by a physical therapist, signals the exoskeleton control system to cause the exoskeleton to stand. Upon standing, the exoskeleton control system automatically measures the motor currents to the actuated braces required for the exoskeleton to stand. Based on these motor currents, the exoskeleton control system estimates the weight of the exoskeleton wearer. In the case of an unworn exoskeleton, the exoskeleton control system would estimate that the exoskeleton wearer weighs nothing, which indicates to the exoskeleton control system that the exoskeleton is unworn. Of course, there are many other ways known in the art to estimate the weight of the user (i.e., whether a user is present) that would also work in determining that the exoskeleton is unworn, such as force sensors in the feet or in appropriate links of the exoskeleton. In the case in which the exoskeleton control system has determined that the exoskeleton is unworn, the exoskeleton control system can be programmed to automatically enter into the unworn propulsion mode. When the exoskeleton control system enters the unworn exoskeleton propulsion mode, the exoskeleton is balanced by the physical therapist using the handle, and the physical therapist is able to command the exoskeleton to take steps forward using any of control means known to one skilled in the art, including the methods described in PCT Application No. PCT/US2013/033472 (referenced above). [0027] A block diagram illustrating this embodiment is provided in FIG. 4 . The physical therapist first commands the exoskeleton to stand using the input means (step 400 ), such as one or more force sensors as activation member(s) actuated when the physical therapist grasps a handle to balance the unworn exoskeleton. As the exoskeleton stands, the exoskeleton control system estimates the motor current required for the exoskeleton to stand (step 405 ), and the exoskeleton control system uses this motor current data to determine the weight of the exoskeleton wearer, which is zero in this example since the exoskeleton is unworn (step 410 ). Upon determining that the exoskeleton wearer weighs nothing and, therefore, that the exoskeleton is unworn, the exoskeleton automatically enters the unworn propulsion mode (step 415 ), at which point the exoskeleton measures the shank angle of the forward exoskeleton leg (step 420 ). When the forward leg reaches the correct shank angle, the exoskeleton control system commands the exoskeleton to take a step forward (step 425 ), while the physical therapist continues to use the handle to balance the exoskeleton. Walking of the exoskeleton then proceeds by a repetition of shank angle determination and step execution (i.e., steps 420 and 425 ). When the physical therapist stops pushing the torso of the exoskeleton, the exoskeleton will stop taking steps. To terminate the walking process, the physical therapist uses the input means to command the exoskeleton to exit the unworn propulsion mode (step 430 ), thereby preventing further steps. [0028] As an example of this embodiment, consider a physical therapist working in a clinical setting with an exoskeleton. At the end of the workday, the physical therapist wishes to move the exoskeleton from a physical therapy room to a storage or battery charging area in another location. The physical therapist grasps a handle on the back of the exoskeleton and balances the exoskeleton while using an input means to command the exoskeleton to stand. The exoskeleton stands using force from the motors in the actuated exoskeleton joints while relying on the physical therapist for balance. Upon standing, the exoskeleton determines, based on joint currents, that it is unworn and enters into an unworn propulsion mode. The physical therapist steers the exoskeleton in the direction that the physical therapist wishes the exoskeleton device to walk and then shifts the balance of the exoskeleton slightly forward, resulting in a change in measured shank angle for the forward exoskeleton leg. When this shank angle reaches a particular point, the exoskeleton control system determines that a step should be executed and the exoskeleton takes a step forward. The physical therapist continues to balance the exoskeleton during execution and completion of the step. By using this process, the physical therapist can affect not only the balance of the unworn exoskeleton but also use the exoskeleton balance in controlling the exoskeleton to take steps forward in a walking process. The physical therapist uses these controls to command the exoskeleton to takes steps forward, with the exoskeleton walking while being balanced by the physical therapist who steers the exoskeleton, as needed, until such time as the physical therapist wishes the exoskeleton to stop walking. At that point, the physical therapist provides input to command the exoskeleton to stop taking steps forward and to exit the unworn propulsion mode. The exoskeleton then completes the last motion in progress (i.e., finishing any step being taken) and returns to a standing position. The physical therapist can repeat this process any number of times until satisfied with the final location of the exoskeleton. [0029] A block diagram illustrating a further embodiment is provided in FIG. 5 . The physical therapist 200 selects the unworn propulsion mode of sitting exoskeleton 100 (step 500 ), and, by use of the handle 205 , physical therapist 200 lifts exoskeleton 100 slightly (step 505 ). At this point, exoskeleton 100 detects the upward force and stands up (step 510 ). Then, physical therapist 200 pushes exoskeleton 100 forward (step 515 ). As a result, the exoskeleton 100 takes steps forward (step 520 ) until physical therapist 200 returns exoskeleton 100 to a neutral position (step 525 ), resulting in exoskeleton 100 corning to a stop (step 530 ). If the physical therapist 200 then pushes exoskeleton 100 forward (step 515 ), exoskeleton 100 begins stepping again (step 515 ). If, instead, the physical therapist 200 leans exoskeleton 100 backwards (step 535 ), then exoskeleton 100 sits (step 540 ) and exits the unworn propulsion mode (step 545 ). [0030] In yet another embodiment, when an exoskeleton includes sufficient actuation, sensors and control to walk without assistance from a human, the exoskeleton can transport itself to a new location without need of physical interaction with a human. For example, a user can put the exoskeleton into the unworn propulsion mode and designate the location to which the exoskeleton should walk on a device such as a tablet computer or via a voice command. As a result, the exoskeleton will stand, walk to the specified location, sit and then exit the unworn propulsion mode. Optionally, the exoskeleton can wait for a command from the user before sitting and exiting the unworn propulsion mode. Of course, if the exoskeleton's storage position does not involve sitting, the standing and sitting steps can be omitted. [0031] In general then, an exoskeleton in accordance with the present invention includes a control system; an input means for causing the control system to enter or exit an unworn propulsion mode; and a means for controlling movement of the exoskeleton in the unworn propulsion mode. As described above, the input means for causing the control system to enter or exit the unworn propulsion mode can be various different activation members, such as a button, switch or control pad, or an automatic determination that the exoskeleton is unworn. Additionally, the means for controlling movement of the exoskeleton in the unworn propulsion mode can be a manual input controller, such as a handle or control pad, or an automatic control, such as a determination of an angle of a shank of the exoskeleton. However, one skilled in the art should recognize that there are a variety of means by which an operator can cause the control system to enter or exit the unworn propulsion mode and control movement of the exoskeleton in this mode. For example, a joystick can be used to control the exoskeleton's movement, any employed buttons, switches or other activation members can be physical or digital. In addition, either means can be provided on a device separate from the exoskeleton (especially if the exoskeleton if able to balance itself without the aid of the operator). [0032] In all embodiments, upon the exoskeleton control system entering the unworn propulsion mode, some of the parameters of the exoskeleton controlled by the exoskeleton control system are preferably changed or relaxed relative to the control parameters of an exoskeleton being worn by a person (i.e., when the exoskeleton control system is in the default mode). In the case of an unworn exoskeleton, it can be easier for the therapist to maneuver the exoskeleton upon relaxation of certain parameters. In addition, as an unworn exoskeleton is substantially lighter, easier for the physical therapist to maneuver and does not contain a patient, safety is of reduced concern such that certain safety related parameters can be relaxed (although the safety of the physical therapist should still be considered). For example, the coronal plane measurement discussed in PCT Application No. PCT/US2013/033472 (discussed above) would not need to be required to take a step. [0033] Although the above embodiments have been discussed primarily in the environment of clinical rehabilitation, the present invention can equally well be applied to exoskeletons used in the home, where family members or caregivers may wish to maneuver an exoskeleton when it is not in use. Further, the present invention can be applied to exoskeletons used by able-bodied people to help such users maneuver their exoskeletons when they are not being worn. [0034] Based on the above, it should be readily apparent that the present invention provides a device and method that allows an operator to utilize the locomotive capabilities of an exoskeleton to relocate the exoskeleton when the exoskeleton is not being worn. Although described with reference to preferred embodiments, it should be readily understood that various changes or modifications could be made to the invention without departing from the spirit thereof. In general, the invention is only intended to be limited by the scope of the following claims.

An ambulatory exoskeleton can be selectively operated in at least two different modes, with one mode constituting an unworn propulsion mode, used when the exoskeleton is not worn by a user, and another mode constituting a default or worn propulsion mode, used when the exoskeleton is worn by a user. With this arrangement, a physical therapist, or other operator, wishing to move an unworn exoskeleton, can balance the unworn exoskeleton, while simultaneously utilizing a control system and actuators of the exoskeleton to propel the unworn exoskeleton. Therefore, the exoskeleton walks by taking steps forward, as commanded by the operator using any of a plurality of input arrangements, while the operator balances and steers the exoskeleton by physically guiding the exoskeleton using a handle or other interaction surface of the exoskeleton.

CROSS-REFERENCE TO RELATED APPLICATIONS The present utility patent application is a continuation-in-part of U.S. patent application Ser. No. 11/983,503, filed Nov. 9, 2007. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not Applicable. THE NAMES OF THE PARTIES TO A JOINT RESEARCH OR DEVELOPMENT Not Applicable. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a cover, and more particularly to a cover fit onto a container with a sliding air tight fit, the cover having an air release valve to allow escape of air from the container when the cover is pressed onto the container with the air release valve held open during the installation to release air from the container to create a vacuum seal with at least a partial vacuum in the container with the cover fully installed on the container with a tight vacuum seal fit and the cover only releasable for removal by opening the air release valve to admit air back into the container to break the vacuum seal and allow a user to slide the cover off with the air release valve held open. 2. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 1.98 Closed containers keep items fresher within the container with a vacuum or partial vacuum within the container so that there is less air in the container to cause contained items to spoil, thereby preventing or prolonging spoilage. Prior art containers fail to provide a simple vacuum closure with a sliding cover rather than a threaded cover and a simple air release valve rather than a vacuum pump. The closest prior art of which applicants are aware is their prior U.S. Pat. No. 5,397,024 to Wu et al. The cover includes a valve depressible inward of the cover for allowing air to flow inward or outward of the cover. However, the valve assembly includes a screw secured to the plug rod and engaged with the cover for preventing the valve assembly from disengaging from the cover. The screw is normally made of metal and may not be easily threaded into place. In addition, the screw which is made of metal material may not closely enclose the opening of the cover such that a rubber ring and a gasket are required to be engaged on the screw for engaging with the cover so as to enclose the opening. Furthermore, the inner thread of the plug rod may be easily damaged by the metal screw. The present invention has arisen to mitigate and/or obviate the afore-described disadvantages of the conventional covers for containers. Another related prior art U.S. Pat. No. 5,697,510, issued Dec. 16, 1997 to Wang et al., provides a container including a cover engaged on an open top. A channel and an opening are formed in the cover. A knob is slidably engaged in the channel and includes a tube having a pair of shoulders. A plug has a pair of hooks engaged into the tube and engaged with the shoulders so as to secure the plug to the tube. A spring is biased between the knob and the plug for biasing the knob partially outward of the cover and for forcing the plug against the cover to enclose the orifice. The plug can be made of plastic material instead of metal material. The prior art patents fail to provide a means for carrying the container or means for stacking a number of the containers or means for securely locking the cover on the container body. What is needed is a cover fit precisely over a container with an air-tight sliding fit and an air release valve to create a vacuum seal fit with a vacuum or partial vacuum in the container by installing the cover thereon and a twist lock for the top with a top handle and adjacent air release valve to carry the container by the top handle. BRIEF SUMMARY OF THE INVENTION The primary object of the present invention is to provide a cover fit precisely over a container with an air-tight sliding fit and an air release valve to create a vacuum or partial vacuum in the container by installing the cover thereon. A related object of the present invention is to provide a container cover with a cylindrical interior wall and a precisely matching cylindrical exterior face around a container opening to receive the cover, the cylindrical exterior face having a slightly angled truncated conical tapered upper portion with a smaller diameter adjacent to a top rim of the container opening and extending outwardly down to a straight vertical cylindrical surface spaced apart from the rim to allow the cover to slip easily over the rim down onto the mating cylindrical portion wherein the air release valve is required to install the cover over the outer cylindrical portion of the container sleeve. Another object is to provide a cover and container further comprising a twist lock for the top with a top handle and adjacent air release valve to carry the container by the top handle. An alternate object of the present invention is to provide a cover having a sliding vacuum fit on a container wherein an air release valve is positioned on a side of the cover adjacent to the top and the top of the cover is flat so that several covered containers can be stacked together. A further object of the present invention is to provide a plurality of modular cradles for the containers to form a rack system for stacking a number of the vacuum sealed containers vertically. Another objective of the present invention is to provide a cover of a container which includes no screw therein. In brief, a cover for a container fits with a sliding air tight fit over the container body with an inner cover sleeve adjacent to the cover opening forming an air tight slidable fit with an outer container sleeve around the top opening of the container. The cover has an air release valve to allow escape of air from the container when the cover is pressed onto the container body with the air release valve held open during the installation to release air from the container to create a vacuum seal fit with at least a partial vacuum in the container with the cover fully installed on the container. The cover is only releasable for removal by opening the air release valve to admit air back into the container to break the vacuum and allow a user to slide the cover off with the air release valve held open. A handle positioned adjacent to the air release valve enables a user to remove and install the cover with a single hand gripping the handle and pressing the air release valve with a thumb of the same hand. To further secure the cover at least a pair of protrusions extending from opposite sides of the container sleeve engage mating L-shaped openings in a bottom edge of the cover to lock the cover in place. Special dual sided cradles engage a top of a vacuum sealed container below each cradle and a bottom of a vacuum sealed container above each cradle so that a series of cradles are used to vertically stack a number of vacuum sealed containers. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS These and other details of the present invention will be described in connection with the accompanying drawings, which are furnished only by way of illustration and not in limitation of the invention, and in which drawings: FIG. 1 is an exploded perspective view of the vacuum sealed container of the present invention with the container body, cover, and air release valve components all aligned for assembly; FIG. 2 is a perspective view of the vacuum sealed container of FIG. 1 with the cover on the container body showing the locking element; FIG. 3 is a partial cross sectional view of the vacuum sealed container of the present invention taken through 3 - 3 of FIG. 5 with the cover sealed on the container body; FIG. 4 is a partial cross sectional view of the vacuum sealed container of the present invention taken through 3 - 3 of FIG. 5 with the cover removed from the container body showing the combined pressing of the air release valve and the rotary motion of the cover to release the lock mechanism; FIG. 5 is a perspective view of the vacuum sealed container of the present invention showing a hand of a user simultaneously gripping the handle and pressing the air release valve with a single hand; FIG. 6 is a perspective view of one of the cradles of the stacking system of the present invention used for stacking a vertical array of the vacuum sealed containers of the present invention; FIG. 7 is a perspective view of a stacked vertical array of the vacuum sealed containers of the present invention using the cradles of FIG. 6 ; FIG. 8 is a perspective view of an alternate embodiment of the vacuum sealed container of the present invention having a flat topped cover with the vacuum release valve on the side of the cover adjacent to the top; FIG. 9 is a partial cross-sectional view of the cover of FIG. 8 aligned for installation on a container having a tapered conical upper portion of the cylindrical sleeve around the top opening of the container; FIG. 10 is a partial cross-sectional view of the cylindrical flat top cover of FIG. 8 installed on the container having a tapered conical upper portion of the cylindrical sleeve around the top opening of the container; FIG. 11 is a partial cross-sectional view of the cover of FIG. 1 having a top handle and top pressure release button, the cover aligned for installation on a container having a tapered conical upper portion of the cylindrical sleeve around the top opening of the container; FIG. 12 is a partial cross-sectional view of the cylindrical cover of FIG. 1 having a top handle and top pressure release button, the cover installed on the container having a tapered conical upper portion of the cylindrical sleeve around the top opening of the container. DETAILED DESCRIPTION OF THE INVENTION In FIGS. 1-12 , a vacuum sealed container 9 comprises a container body 10 including an open top 11 encircled by an outer body sleeve 12 and a cover 20 engaged on top of the container body 10 for enclosing the open top of the container body with a vacuum seal. The cover 20 comprises an air release valve 30 in an upper portion of the cover above the container body and an interior cover sleeve 22 structured to mate with the outer body sleeve 12 with an airtight force fit over the mating outer body sleeve so that it is necessary to open the air release valve to slide the cover onto the container body releasing air through the air release valve 30 to create a vacuum seal, producing at least a partial vacuum in the container, with the cover fully installed on the container body as in FIGS. 2 , 3 , 5 , 8 , 10 , and 12 , and so that it is necessary to open the air release valve 30 to admit air into the container to release the vacuum seal to enable the cover 20 to be removed from the container body 10 as in FIGS. 1 , 4 , 9 , and 11 . In FIG. 1 , exploded detail A, the air release valve with a knob 30 comprises a channel 21 formed in the cover and an air opening 211 formed through the cover, the opening communicating with the channel so that air can pass through the channel into the container. The knob 30 slidably engaged in the channel has a top portion normally protruding above the top of the cover for engaging the knob to activate the air valve, as shown in FIG. 3 . A hollow tube 31 extends from the knob into the channel 21 . The hollow tube has side wall openings 311 . The knob 30 includes four projections 33 for engaging with the cover 20 so as to prevent the knob 30 from engaging into the channel 21 of the cover 20 . A bottom plug 40 engages the upper knob 30 through the air opening 211 , the bottom plug having a flat top surface for covering the air opening to block the air. A shaft 41 extends upwardly from the bottom plug with an expanded partially tapered head 411 on the top of the shaft 41 . The shaft 41 is inserted into the hollow tube 31 of the knob 30 and the head 411 snaps out into the side wall openings 311 to lock the bottom plug 40 to the knob 30 through the air opening 211 to allow the plug 40 to be quickly and easily secured to the knob 30 . A coil spring 35 is engaged on the tube 31 and is biased between the knob 30 and the plug 40 so as to bias the knob 30 partially outward of the cover 20 and so as to force the plug 40 against the cover 20 for enclosing the orifice 211 , as shown in FIG. 3 , to normally seal the opening through the cover to prevent air from passing therethrough until the plug is pushed by a user to release the plug and admit the air through the opening. In operation, as shown in FIG. 4 , when the knob 30 is depressed inward of the channel 21 , the plug 40 is disengaged from the opening 211 such that the opening 211 is opened and such that air is allowed to flow inward or flow outward of the cover. It is to be noted that the plug 40 can be easily made by molding processes and can be made with plastic materials instead of metal material that is used for making the typical fastening screw. In addition, the plug 40 can be easily and quickly secured to the knob 30 . Furthermore, the plug 40 itself is good enough to be used for closely enclosing the opening 211 . The biasing means biased between the knob and the plug for biasing the knob partially outward of the cover and for forcing the plug against the cover is preferably a spring 35 but may be a different type of biasing means. The cover 20 is further locked onto the container body 10 by at least one protrusion 13 on a side of the outer body sleeve 12 interlocking with at least one mating L-shaped opening 23 on a bottom edge of the cover 20 to mate with the protrusion. As the cover 20 is installed on the container body 20 , while activating the air release valve 30 , a vertical edge portion 24 of each of the L-shaped openings 23 engages the mating protrusion 13 and as the protrusion reaches a horizontal portion 25 of the L-shaped opening 23 the cover is turned to fully insert the protrusion in the horizontal portion to lock the cover 20 onto the container 10 to enable the container to be lifted by the cover, as in FIG. 5 . The cover 20 is turned in an alternate direction to align the vertical edge portion 24 of the L-shaped opening 23 with the protrusion 13 and the cover lifted while activating the air release valve 30 to remove the cover 20 from the container body 10 , as shown in FIG.4 . A handle 50 extends out from the top of the cover 20 with a gripping space 51 between the handle 50 and the cover to grip the handle to maneuver the cover 20 onto and off of the container body 1 O. The handle 50 is positioned adjacent to the air release valve 30 so that the air release valve 30 may be activated by a hand of a user holding the handle 50 , as in FIG. 5 with the finger's of the user around the handle and the thumb of the user pushing the air release valve 30 . The handle 50 on the cover 20 is also used to lift the container with the cover locked on, as in FIG. 5 . In FIGS. 6 and 7 , the vacuum sealed container 9 further comprises a rack 70 for vertically stacking a plurality of the vacuum sealed containers, as in FIG. 7 , with each oriented horizontally in a vertical stacked array. The rack 70 comprises a plurality of container supports 60 , each container support 60 comprising a pair of horizontally spaced mating cradles 61 interconnected by a pair of dowels 62 or other means for rigidly interconnecting the cradles 61 . Each of the cradles 61 comprises an elongated member having a top surface 64 for engaging and supporting a bottom of a vacuum sealed container 9 and a bottom surface 65 for resting on a top of a vacuum sealed container 9 so that a container support is positioned under a bottom vacuum sealed container and between each adjacent vacuum sealed container in the vertical stacked array, as shown in FIG. 7 . Each of the container supports further comprises a container edge support 63 protruding from a back edge of one of the cradles 61 . The container edge support 63 configured to receive and support a bottom edge of one of the vacuum sealed containers to prevent each vacuum sealed container 9 from sliding off a back of the stacked array, as in FIG. 7 , so that the covers 20 may be installed on and removed from the container bodies 10 to access contents of the vacuum sealed containers 9 while remaining in the vertical stacked array. In FIG. 8 , the cover of FIG. 1 has a top handle 50 and top pressure release button 30 . The cover is aligned for installation on a container 10 A having a tapered conical upper portion 12 A of the cylindrical sleeve around the top opening rim 11 of the container 10 A to allow the cover 20 to slip easily over the rim 11 down past the tapered conical upper portion 12 A onto the mating cylindrical portion 12 B wherein the air release valve 30 is required to install the cover over the outer cylindrical portion 12 B of the container sleeve. In FIG. 9 the cylindrical cover 20 of FIG. 8 is installed on the container 10 having the tapered conical upper portion 12 A of the cylindrical sleeve 12 B. In FIG. 10 , an alternate embodiment of the vacuum sealed container 9 A of the present invention has a vacuum release valve 30 on the side of the cover 20 A adjacent to the top and a flat top surface 7 so that the covered containers may be stacked on top of each other with a bottom 8 of one container 10 resting on a top 7 of the cover 20 of another covered container 9 A. In FIG. 11 , the cover 20 A of FIG. 10 is aligned for installation on a container 10 A having a tapered conical upper portion 12 A of the cylindrical sleeve 12 B around the top opening rim 11 of the container 10 A to allow easy insertion of the container cover 20 A with a cylindrical interior wall 22 and a precisely matching cylindrical exterior cylindrical sleeve 12 B around the container opening to receive the cover. The exterior face cylindrical sleeve 12 B has a slightly angled truncated conical tapered upper portion 12 A with a smaller diameter adjacent to a top rim 11 of the container opening and expanding outwardly down to a straight vertical cylindrical surface 12 B spaced apart from the rim 11 to allow the cover to slip easily over the rim 11 down over the tapered upper portion 12 A onto the mating cylindrical portion 12 B wherein the air release valve is required to install the cover over the outer cylindrical portion of the container sleeve. In FIG. 12 , the flat top cover of FIG. 10 is installed over the container sleeve. The vacuum sealed containers 9 may be made in a variety of sizes including large 10 liter size containers to house any desired contents to maintain the contents in a fresh condition due to the vacuum seal. Although this invention has been described with a certain degree of particularity, it is to be understood that the present disclosure has been made by way of example only and that numerous changes in the detailed construction and the combination and arrangement of parts may be resorted to without departing from the spirit and scope of the invention as hereinafter claimed.

A cover for a container fits with a sliding air tight fit over the container body. A cover air release valve allows escape of air from the container when removing and installing the cover to create a vacuum seal fit. A handle positioned adjacent to the air release valve enables a user to remove and install the cover with a single hand gripping the handle and pressing the air release valve. Protrusions extending from opposite sides of the container sleeve engage mating L-shaped openings in a bottom edge of the cover to lock the cover in place. Special dual sided cradles engage a top of a vacuum sealed container below each cradle and a bottom of a vacuum sealed container above each cradle so that a series of cradles are used to vertically stack a number of vacuum sealed containers.

CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 60/504,506, filed on Sep. 19, 2003, the entire disclosure of which is incorporated herein by reference. BACKGROUND 1. Technical Field The present disclosure relates to surgical apparatus for facilitating the insertion of surgical instruments into a body cavity of a patient and, more particularly, to surgical apparatus adapted to facilitate the insertion of an expansion assembly (i.e., a trocar) through a radially expandable dilation assembly and into the body cavity of the patient. 2. Background of Related Art Minimally invasive surgical procedures are performed throughout the body and generally rely on obtaining percutaneous access to an internal surgical site using small diameter tubes (typically 5 to 12 mm), usually referred to as cannulas, which provide access through the skin of the patient and open adjacent the desired surgical site. A viewing scope is introduced through one such cannula, and the surgeon operates using instruments introduced through other appropriately positioned cannulas while viewing the operative site on a video monitor connected to the viewing scope. The surgeon is thus able to perform a wide variety of surgical procedures requiring only a few 5 to 12 mm punctures through the patient's skin, tissue, etc. adjacent the surgical site. Certain minimally invasive surgical procedures are often named based on the type of viewing scope used to view the area of the body which is the operative site. For example, laparoscopic procedures use a laparoscope to view the operative site and are performed in the interior of the abdomen through a small incision. Such laparoscopic procedures typically require that a gas, such as carbon dioxide, be introduced into the abdominal cavity. This establishes pneumoperitoneum wherein the peritoneal cavity is sufficiently inflated for the insertion of trocars into the abdomen. Pneumoperitoneum is established through the use of a special insufflation needle, called a Veress needle, which has a spring-loaded obturator that advances over the sharp tip of the needle as soon as the needle enters the abdominal cavity. This needle is inserted through the fascia and through the peritoneum. Generally, the surgeon relies on tactile senses to determine the proper placement of the needle by recognizing when the needle is inserted through the fascia and then through the peritoneum. After establishing pneumoperitoneum, the next step in laparoscopic surgery involves the insertion of a trocar, obturator or trocar/obturator assembly into the abdominal cavity. Preferably, the cannulas used in laparoscopic procedures should be readily sealable to inhibit the leakage of the insufflation gas from the abdominal cavity, in particular, should be designed to inhibit leakage from the region between the external periphery of the trocar and the abdominal wall. In order to reduce the amount of insufflation gas which escapes from the abdominal cavity, a radially expandable access system has been developed to provide improved sealing about the periphery of the cannula. A system for performing such a function is commercially available from United States Surgical, a division of Tyco Healthcare, Ltd. under the trademark VERSASTEP™. Certain aspects of the expandable access system are described in commonly assigned U.S. Pat. Nos. 5,431,676; 5,814,058; 5,827,319; 6,080,174; 6,245,052 and 6,325,812, the entire contents of which are expressly incorporated herein by reference. As disclosed therein, the expandable access system includes a sleeve having a sleeve body, typically made up of a radially expandable braid covered by an elastomeric layer. The braid initially has an inner diameter of about 2 mm and an outer diameter of about 3.5 mm. In use, passage of a surgical instrument (i.e., trocar, cannula, obturator, etc.) through the expandable access system causes radial expansion of the sleeve, typically to a final diameter of 5 mm, 10 mm or 12 mm. However, the sleeve can be expanded to any necessary diameter in order to accommodate the particular surgical instrument. The expandable access system further includes a handle affixed to a proximal end of the sleeve, the handle including a passage formed therein for the introduction of surgical instruments, through the handle, into the sleeve body. A method of use of the expandable sealing apparatus includes inserting a pneumoperitoneum needle through the radially expandable sleeve body of the expandable access system to thereby form a needle/sleeve assembly. The needle/sleeve assembly is then introduced through the patient's abdomen by engaging the sharpened distal end of the pneumoperitoneum needle, protruding from the distal end of the sleeve body, against the body tissue of the body cavity and advancing the needle/sleeve assembly into the body cavity until the needle/sleeve assembly extends across the layers of the body tissue thereby forming an incision in the body tissue. The pneumoperitoneum needle is then removed from the body of the sleeve. A cannula, having a diameter smaller than the opening in the handle and larger than the lumen of the sleeve, is then introduced through the opening in the handle and into the abdomen of the patient. As a result, due to radial expansion of the sleeve by the trocar, the incision is subsequently also radially expanded. Cannulas used in laparoscopic procedures include a valve at a proximal end thereof in order to permit passage of a trocar, viewing scope or other surgical instrument therethrough while simultaneously inhibiting escape of insufflation gas from the abdominal cavity. Accordingly, there exists a need for an expansion assembly insertion apparatus which facilitates and enhances control of the insertion of and expansion assembly into the axial lumen of a radially expandable dilation assembly and into the abdominal cavity of the patient. SUMMARY Apparatus for forming and enlarging a percutaneous penetration are disclosed. According to one aspect of the present disclosure, the apparatus includes an elongate dilation member including a radially expandable member having a proximal end with a handle, a distal end, and an axial lumen with a first cross-sectional area; and an elongate expansion member including a tubular element having a distal end, a proximal end with a handle, and an axial lumen with a second cross-sectional area which is larger than the first cross-sectional area. The distal end of the expansion member is configured for facilitating insertion of the tubular element through the axial lumen of the dilation member. The apparatus further includes an advancing apparatus having a first arm with a first engaging feature for engaging the handle of the dilation member; a second arm with a second engaging feature for engaging the handle of the expansion member; and an operation member. The first arm and the second arm are connected so that operation of the operation member approximates the first engaging feature and the second engaging feature together. It is envisioned that the radially expandable member includes a braided sleeve. It is further envisioned that the radially expandable member includes a splittable sheath. Desirably, the operation member is attached to the second arm. The second arm may include a passage for receiving the first arm. The operation member may be pivotally attached to the second arm and may have a pivotal link engaging the first arm so that upon pressing the operation member, the link moves the first arm proximally. Desirably, the first arm extends parallel to the longitudinal axes of the dilation member and the expansion member. It is contemplated that the first arm and the second arm may include inter-engaging ratchet teeth. It is further contemplated that the first arm and the second arm may be pivotally attached so that pressing the operation member toward the first arm approximates the first engaging feature and second engaging feature together. According to another aspect of the present disclosure, an apparatus for facilitating the insertion of an expansion assembly distally through a radially expandable dilation assembly into a body cavity of a patient is provided. The apparatus includes a handle; and a trigger operatively coupled to the handle. The trigger is pivotable between a first position, spaced a distance from the handle, and a second position, in close proximity to the handle. The apparatus further includes a spine member having a proximal end and a distal end. The spine member is slidably received within the handle and is axially moveable relative to the handle upon a manipulation of the trigger from the open position to the closed position. The apparatus further includes an actuation mechanism in operative engagement with the handle, the trigger and the spine member. The actuation mechanism is releasably engagable with the spine member and, when engaged with the spine member, axially moves the spine member relative to the handle upon movement of the trigger to the closed position. The apparatus further includes an expansion assembly retaining structure operatively coupled to the handle for holding the expansion assembly in place; and a yoke provided at the distal end of the spine member for maintaining the dilation assembly aligned with the expansion assembly. Desirably, manipulation of the trigger towards the handle incrementally approximates the yoke toward the expansion assembly retaining structure. It is envisioned that the yoke defines a distal clevis and a proximal clevis. Accordingly, tabs extending from opposite sides of a handle of the dilation assembly are positionable between the distal clevis and the proximal clevis. It is further envisioned that the expansion assembly retaining structure includes at least one C-shaped cuff configured to operatively engage a handle of the expansion assembly in a snap-fit manner. The actuation mechanism may include a driving lever operatively supported on the spine member; a linkage member having a first end pivotally connected to the trigger and a second end slidably received within the handle and pivotally connected to the driving lever; and a compression spring disposed between the driving lever and an inner surface of the handle. The compression spring desirably biases the driving lever to an orientation orthogonal to the spine member. Accordingly, actuation of the trigger toward the handle causes the driving lever to pivot and bind against the spine member. The actuation mechanism may further include a braking lever operatively supported on the spine member, a first end of braking lever is pivotally positioned within a recess formed in the handle; and a spring member disposed between braking lever and a surface formed in the handle, wherein the spring member biases a free end of the braking lever in a distal direction. It is envisioned that the proximal end of the spine member may extend from a proximal end of the handle. The apparatus may include an elongate dilation assembly operatively associatable with the yoke. The elongate dilation assembly may include a handle, a radially expandable tubular sheath having a proximal end connected to the handle, a distal end, and defining an axial lumen with a first cross-sectional area. The apparatus may further include an elongate expansion assembly operatively connectable to the at least one cuff. The expansion assembly may include a tubular element having a distal end, a proximal end with a handle, and an axial lumen with a second cross-sectional area which is larger than the first cross-sectional area of the elongate dilation assembly. According to another aspect of the present disclosure, a kit for providing access to a target surgical site is provided. The kit includes a radially expandable dilation assembly; a pneumoperitoneum needle assembly; a stylet; an expansion assembly; an obturator; an expansion assembly insertion apparatus for forming and enlarging a percutaneous penetration; and a package for enclosing the radially expandable dilation assembly, the pneumoperitoneum needle assembly, the stylet, the expansion assembly, the obturator, and the expansion assembly insertion apparatus. The kit may further include a package insert including at least one of instructions on use and warnings of use. Other features and advantages of the disclosed trocar insertion apparatus will appear from the following description in which the preferred embodiment has been set forth in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the detailed description of the embodiments given below, serve to explain the principles of the disclosure. FIG. 1 is a side elevational view of a radially expandable dilation assembly for sealing a percutaneous opening in a patient; FIG. 2 is a side elevational view of a pneumoperitoneum needle component of the dilation assembly, shown with a stylet removed from a tubular needle body; FIG. 3 is a partly separated side elevational view of a cannula assembly of an elongate expansion assembly; FIG. 4 is a side elevational view of an obturator component for use with the elongate expansion assembly of FIG. 3 ; FIG. 5 is a perspective view of an expansion assembly insertion apparatus, in accordance with the present disclosure, having an expansion assembly and a dilation assembly operatively mounted thereto; FIG. 6 is a cross-sectional side elevational view of the fixed handle and trigger of the expansion assembly insertion apparatus, taken along the longitudinal axis thereof, illustrating an exemplary actuation mechanism; FIGS. 7-10 illustrate use of the expansion assembly insertion apparatus in connection with the dilation assembly of FIG. 1 and the expansion assembly of FIG. 2 for facilitating insertion of the expansion assembly in to the dilation assembly; and FIG. 11 illustrates a kit including a radially expandable dilation assembly, a pneumoperitoneum needle, a cannula assembly, an obturator and an insertion apparatus present in a package. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Preferred embodiments of the presently disclosed expansion assembly insertion 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. Referring now in detail to the drawing figures, as seen in FIG. 1 , a radially expandable dilation assembly is generally designated with the reference numeral 10 . Radially expandable dilation assembly 10 includes a tubular sheath 12 having a proximal end 14 , a distal end 16 and an axial lumen 15 extending therethrough. Axial lumen 15 defines a longitudinal axis “X” and further defines a first cross-sectional area extending therethrough. Proximal end 14 is tapered radially outward in the proximal direction and is secured to a handle 18 . Handle 18 includes an aperture 20 extending therethrough and interconnected with lumen 15 of tubular sheath 12 . Tubular sheath 12 may be made from any material which is capable of receiving an expansion assembly to effect radial expansion of sheath 12 , as described in more detail hereinafter. Sheath 12 preferably includes an inelastic braid covered by an elastic membrane, as described in commonly assigned U.S. Pat. No. 5,431,676, the full disclosure of which is incorporated herein by reference. Suitable expandable sleeves 10 may be obtained commercially from United States Surgical, a division of Tyco Healthcare, Ltd., as part of the STEP™ introducer system. A pneumoperitoneum needle assembly 30 including a tubular needle 32 and a stylet 34 is illustrated in FIG. 2 . Tubular needle 32 includes a hub 36 having a male bayonet connector 38 at a proximal end thereof. Preferably, stylet 34 is spring loaded in a proximal connector 40 which includes a male bayonet fitting 42 . Male bayonet fitting 42 is receivably coupled to female bayonet fitting (not illustrated) of hub 36 . An insufflation valve 44 is connected to the proximal end of stylet 34 and a port 46 is formed in a distal end thereof. Port 46 permits the introduction of insufflation gas through valve 44 to be released through stylet 34 . In use, stylet 34 is mounted within needle 32 with bayonet fitting 42 attached to hub 36 . The distal end of stylet 34 in turn extends from a distal end 48 of needle 32 such that stylet 34 will retract into needle 32 when needle assembly 30 is engaged against tissue, as described in more detail below. Referring now to FIG. 3 , an expansion assembly 50 is shown and described. Expansion assembly 50 includes an expansion member 52 (i.e., a cannula tube) and a proximal hub 54 . Expansion member 52 includes a threaded connector 56 at its proximal end which can be removably secured to a fitting 58 in the distal end of proximal hub 54 . Preferably, expansion member 52 defines a second cross-sectional area which is larger than the first cross-sectional area of tubular sheath 12 . With reference to FIG. 4 , an obturator 70 including a shaft 72 having a tapered distal end 74 (see also FIGS. 5 , 8 , and 9 ) and a handle 76 is shown and described. As will be described in greater detail below, obturator 70 is intended to be placed within a central lumen of cannula assembly 50 in order to facilitate insertion of expansion assembly 50 into radially expandable dilation assembly 10 . Turning now to FIG. 5 , an expansion assembly insertion apparatus in accordance with the present disclosure, having an expansion assembly 50 and a dilation assembly 10 operatively mounted thereto, is shown generally as reference numeral 100 . Insertion apparatus 100 includes a proximally extending fixed handle 102 , a trigger 104 pivotably coupled to fixed handle 102 at pivot pin 118 , and a distally extending spine member 106 . Spine member 106 has a distal end 108 and a proximal end 110 defining a longitudinal axis “X”′ . Proximal end 110 of spine member 106 is slidably received within fixed handle 102 through an aperture 102 a formed in a distal end of fixed handle 102 . While a generally rectangular cross-section for spine member 106 has been depicted it is contemplated that spine member 106 can have a circular, elliptical, square or other polygonal cross-section. Distal end 108 of spine member 106 is provided with a yoke or engaging feature 112 operatively coupled thereto. Yoke 112 defines a U-shaped clevis 114 having a pair of legs 116 , 117 . Preferably, clevis 114 includes a distal pair of legs 116 a , 117 a and a proximal pair of legs 116 b , 117 b . Legs 116 , 117 define an axis which is substantially parallel to the longitudinal “X′” axis of spine member 106 . In use, U-shaped clevis 114 of yoke 112 receives handle 18 of dilation assembly 10 therein. In particular, handle 18 includes a pair of diametrically opposed tabs 18 a , 18 b wherein either tab 18 a or 18 b is positioned between distal and proximal legs 116 a and 116 b while the other of tab 18 a or 18 b is positioned between distal and proximal legs 117 a and 117 b. As best seen in FIG. 6 , fixed handle 102 includes an actuation mechanism for the mechanical operation of insertion apparatus 100 . The actuation mechanism includes a linkage member 120 having a first end 120 a which is pivotably coupled to trigger 104 at a pivot point 122 and a second end 120 b which is slidably received within fixed handle 102 and pivotably coupled to a driving lever 130 . Driving lever 130 is located and/or suspended on spine member 106 which passes through an aperture or opening 132 formed in driving lever 130 . A compression spring 134 disposed between driving lever 130 and an inner surface of fixed handle 102 urges driving lever 130 in a distal direction and to remain orthogonal relative to spine member 106 . The force of spring 134 urges trigger 104 against a backing member 126 , via linkage member 120 , of fixed handle 102 thus providing a standby condition. In the standby condition, driving lever 130 is positioned substantially perpendicular to the direction of motion, indicated by the arrow “P”, of spine member 106 when in operation. Motion of trigger 104 about the pivot pin 118 causes spine member 106 to move against the bias of spring 134 , as will be described in greater detail below. The actuation mechanism further includes a braking lever 136 having an opening 138 through which spine member 106 passes. One end 140 of braking lever 136 is pivotably positioned in a recess 142 formed in fixed handle 102 such that braking lever 136 may pivot within constraints defined by the surfaces of recess 142 and by the binding of braking lever 136 with spine member 106 when the edges of opening 138 in braking lever 136 engage the surfaces of spine member 106 . At least one compression spring 144 is disposed between a wall 146 in fixed handle 102 and braking lever 136 . Spring 144 effectively biases the free end of braking lever 136 distally away from driving lever 130 . The biased position of braking lever 136 is limited by the binding and/or cocking interference between opening 138 of braking lever 136 and the surfaces of spine member 106 . In the embodiment illustrated in FIG. 6 , braking lever 136 extends in the direction of fixed handle 102 so that its distal end 148 can be suitably gripped by the thumb of a user. It should be noted that in the standby position illustrated in FIG. 6 , driving lever 130 is substantially perpendicular to the longitudinal “X′” axis of spine member 106 , whereas the portion of braking lever 136 which engages spine member 106 is transversely oriented to the longitudinal “X′” of spine member 106 at a slight angle. In this condition, if a force is applied to yoke 112 ( FIG. 5 ) in the direction indicated by arrow “P”, slide member 106 is free to move through fixed handle 102 . Since braking lever 136 is free to pivot against the bias of spring 144 when force is applied on yoke 112 , in the direction of arrow “P”, braking lever 136 presents no obstacle to the motion of spine member 106 and yoke 112 and thus may be advanced continuously through fixed handle 102 . However, in the standby position, as illustrated in FIG. 6 , if a force is applied to yoke 112 in the direction opposite to the direction indicated by arrow “P”, the edges of opening 138 in braking lever 136 bind against the surfaces of spine member 106 and it is not possible to withdraw the moving yoke 112 further away from fixed handle 102 . Compression of spring 144 , by pressing on braking lever 136 with a finger in the direction of the arrow “P”, allows withdrawal of spine member 106 and yoke 112 to be extended away from fixed handle 102 . Compression of spring 144 brings distal end 148 of braking lever 136 into perpendicularity with the direction of intended motion of spine member 106 , and thus spine member 106 is then free to slide in either direction through opening 136 in braking lever 136 . The preferred method of use of expansion assembly insertion apparatus 100 is to squeeze trigger 104 (toward fixed handle 102 ) to incrementally advance spine member 106 and yoke 112 through fixed handle 102 . When trigger 104 is squeezed, pivoting occurs about pivot pin 118 and second end 120 b of linkage member 120 also moves substantially in the direction of arrow “P”. This causes driving lever 130 to pivot about its first end 131 so that driving lever 130 is no longer perpendicular to the direction “P” of intended motion of spine member 106 . Pivoting of driving lever 130 compresses spring 134 and also causes the end edges of aperture 132 , formed in driving lever 130 to bind against the surfaces of spine member 106 . Binding occurs because driving lever 130 is no longer perpendicular to the direction “P” of intended motion of spine member 106 . Further motion of trigger 104 causes driving lever 130 to translate in the direction of arrow “P”. This motion further compresses spring 134 and in the process, by means of the binding and/or cocking interference between driving lever 130 and spine member 106 , advances spine member 106 and its connected yoke 112 through fixed handle 102 . The maximum distance of advancement of yoke 112 , with one squeeze of trigger 104 , is limited to when spring 134 is fully compressed or trigger 104 strikes the surface of fixed handle 102 . After trigger 104 is fully pivoted about pivot pin 118 , release of trigger 104 causes the return of trigger 104 to the stand by condition due to spring 134 urging driving lever 130 to a perpendicular position and pressing linkage member 120 into trigger 104 . Returning to FIG. 5 , fixed handle 102 is further provided with at least one, preferably a pair of resilient C-shaped cuffs 124 affixed to a distal end thereof. Cuffs 124 define a longitudinal axis which is substantially aligned with the axis of clevis 114 defined by legs 116 , 117 . In use, cuffs 124 are configured to receive proximal hub 54 of cannula assembly 50 therein by a snap-fit type engagement. In addition, fixed handle 102 is provided with a backing member 126 as described above. Backing member 126 preferably extends transversely from fixed handle 102 beyond the longitudinal axis of cuffs 124 . Accordingly, in operation, backing member 126 preferably acts as a stop for a proximal end surface of expansion assembly 50 when expansion assembly 50 is mounted to expansion assembly insertion apparatus 100 . While insertion apparatus 100 has been shown and described herein as including a trigger 104 for incrementally approximating clevis 114 toward cuffs 124 , it is envisioned and within the scope of the present disclosure that any operation member may be used to accomplish that same function. For example, the operation member may include a ratchet mechanism, a screw drive, a pneumatic drive or the like to advance clevis 114 toward cuffs 124 . Referring now to FIGS. 7-10 , a preferred method of operation of expansion assembly insertion apparatus 100 , will be described. Initially, as seen in FIG. 7 , the radially expandable dilation assembly 10 , having pneumoperitoneum needle assembly 30 inserted therein, is introduced through a patient's abdomen “A” (or other body location) by engaging sharpened distal end 48 of needle assembly 30 against the tissue of the patient's abdomen “A” and advancing the sleeve/needle combination forward until tubular sheath 12 of dilation assembly 10 extends across the tissue of abdomen “A”. Needle assembly 30 is then removed, and an expansion assembly 50 including an obturator 70 disposed therewithin is introduced through tubular sheath 12 of dilation assembly 10 , with the aid of expansion assembly insertion apparatus 100 thereby resulting in radial expansion of tubular sheath 12 (see FIG. 9 ). In particular, yoke 112 of insertion apparatus 100 is preferably first hooked onto handle 18 of dilation assembly 10 as described above. Next, expansion assembly 50 , including obturator 70 , is loaded into insertion apparatus 100 by coupling proximal hub 54 of expansion assembly 50 to cuffs 124 as described above. Finally, insertion apparatus 100 is actuated by repeatedly squeezing trigger 104 , as described above, in order to incrementally advance expansion assembly 50 and obturator 70 through dilation assembly 10 . As expansion assembly 50 and obturator 70 are moved distally through tubular sheath 12 , dilation assembly 10 is radially expanded from the first cross-sectional area to the second cross-sectional area. Finally, as illustrated in FIG. 10 , obturator 70 is removed from expansion member 52 , leaving an access channel through abdominal wall “A” for the introduction of a variety of other surgical instruments through the access channel. An ergonomic feature of insertion apparatus 100 is the substantially longitudinally oriented fixed handle 102 and trigger 104 . In other words, fixed handle 102 is preferably aligned with the longitudinal axis of spine member 106 while trigger 104 is preferably pivotable to a closed position which is substantially aligned with the longitudinal axis of spine member 106 . Thus, the longitudinal axis of insertion apparatus 100 is oriented in a substantially orthogonal direction with respect to the longitudinal axis of the forearm of the surgeon. Accordingly, the application of the insertion force by the surgeon preferably occurs by the surgeon gripping fixed handle 102 and trigger 104 and pivoting his forearm about his elbow such that is hand travels in a direction substantially co-linear with the longitudinal axis of insertion apparatus 100 . Turning now to FIG. 11 , an exemplary package or “kit” containing various combinations of system components is illustrated. Providing such kits is a particularly convenient way to facilitate inventory maintenance of the components necessary to reconstruct the access systems of the present disclosure. It will be appreciated, of course, that complete systems could be sold in kits, as well as each of the individual components can be sold in their own kits. In many cases, it will be desirable to combine the pairs of components or multiple pieces of a single component together in one package, particularly where the components are sized to match each other. The kits will include conventional package elements, typically pouches, envelopes, trays, boxes, foam inserts and other containers of a type commonly used for sterile or non-sterile packaging of surgical instruments. The packages will typically also include a “package insert P” which is a written instruction sheet with instructions on use, warnings, etc. As seen in FIG. 11 , an exemplary kit 200 , for providing access to a target surgical site, includes a package 202 , typically non-sterile since the reusable components can be subsequently sterilized and at least one of the following items: a radially expandable dilation assembly 10 ; a pneumoperitoneum needle assembly 30 ; a stylet 34 ; an expansion assembly 50 ; and an obturator 70 . Kit 200 further includes an expansion assembly insertion apparatus 100 . Although the foregoing disclosure has been described in some detail by way of illustration and example, for purposes of clarity or understanding, it will be obvious that certain changes and modifications may be practiced within the scope of the appended claims.

Apparatus for forming and enlarging a percutaneous penetration are disclosed. The apparatus includes an elongate dilation member including a radially expandable member having a first cross-sectional area; and an elongate expansion member including a tubular element having a second cross-sectional area which is larger than the first cross-sectional area. The apparatus further includes an advancing apparatus having a first arm with a first engaging feature for engaging the handle of the dilation member; a second arm with a second engaging feature for engaging the handle of the expansion member; and an operation member; the first arm and the second arm being connected so that operation of the operation member approximates the first engaging feature and the second engaging feature together.

[0001] This application claims priority from U.S. Provisional Patent Application Serial No. 60/382,874, filed on May 22, 2002. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to a method of manufacturing two brassieres from a single blank, and the resultant brassieres. More particularly, the present invention relates to a method of manufacturing a single seamless, circularly knit bra blank that has two individually integrated knitted seamless double layer brassieres in the same blank. The present method provides for minimization of the steps in the manufacturing process by completing some manufacturing steps during formation of the blank. Moreover, the present method provides for reduced manufacturing time by simultaneously knitting two double layer brassieres in one blank. [0004] The brassiere blank has a first portion or brassiere having both an inner and outer layer of fabric formed in a cylindrical shaped blank. The first portion is seamlessly joined to the top edge of a second portion or brassiere, also having inner and outer fabric layers formed in the same cylindrical shaped blank. [0005] 2. Description of the Prior Art [0006] The use of generally cylindrical blanks in the manufacturing of double layer brassieres is known. For example, U.S. Pat. No. 6,125,664 to Browder, Jr., entitled BRASSIERE, BRASSIERE BLANK AND METHODS OF MAKING SAME describes the use of a cylindrical blank to form one double layer brassiere. A blank is formed followed by the knitting of a welt band in the mid section of the blank. A lower torso part is then pulled upward, over the welt band and matched against the upper torso part. One double layer brassiere is then formed by stitching and knitting. SUMMARY OF THE INVENTION [0007] It is an object of the invention to provide a method of manufacturing two double layer circular knit brassieres from a single blank. [0008] It is another object of the present invention to provide a single blank, which includes four layers from which two double layer circular knit brassieres may be manufactured. [0009] It is still another object of the present invention to provide a single blank having two fold lines to fold each of the two outer layers over a separate one of the inner layers of the brassiere. [0010] It is yet another object of the present invention to provide a blank for forming two circular knit brassieres with each brassiere having an anchoring chest band hidden from view. [0011] It is still yet another object of the present invention to provide a blank containing two individual two-ply brassiere garments, each having discretely placed integrally knitted support elements or features on the inner fabric layer. Specifically, in the central gore area between the breast cups, and to include the areas under and encircling the breast cups. [0012] It is a further object of the present invention to provide a method of manufacturing a double layer circular knit brassiere having a mock terry or true sinker produced terry loop stitch construction knitted into at least the lining layer of the brassiere or between the outer and inner layer of the brassiere. [0013] It is still a further object of the present invention to provide for the inclusion of an arcuate underwire support under the breast cups placed either on the inner fabric layer or, if desired, between the inner and outer layers. [0014] These and other objects and advantages of the present invention will be achieved by a method according to the present invention. The method provides for forming a single blank used for making two brassieres on a circular knitting machine. The method includes forming an inner layer of material, forming anchoring chest bands at both ends of the blank on the inner layer material, forming outer layer material sections integrally knitted to and extending from each of the bands, and joining the edge of the outer material, opposite the chest anchoring bands, to the inner layer by a stitch line created by a transfer of held loops during the completion of knitting of each of two turned welts that include two double-ply bras within the blank. [0015] A blank is also provided having two upper torso parts, with each part having an inner layer, outer layer, and a hidden chest anchoring band. The outer layer of each part has a fold line adjacent the anchoring chest band. The edge of the outer fabric layer, opposite the hidden anchoring chest band, is integrally knitted to the inner layer. The two individual upper torso two-ply parts are continuously knitted and connected to a single layer of either an inner or an outer layer material. The single blank exits the circular knitting machine fully assembled as two connected two-ply brassieres. BRIEF DESCRIPTION OF THE DRAWINGS [0016] The above and other objects, advantages and benefits of the present invention will be understood by reference to the detailed description provided below and the accompanying drawings. [0017] [0017]FIG. 1 is a perspective view of a blank according to one embodiment of the present invention; [0018] [0018]FIG. 2 is a perspective view of the front of the upper torso part of FIG. 1; [0019] [0019]FIG. 3 is a perspective view of the back of the upper torso part of FIG. 1; and [0020] [0020]FIG. 4 is a perspective view of one embodiment of a double layer brassiere formed according to the present invention. DETAILED DESCRIPTION OF THE INVENTION [0021] Referring to the drawings, and in particular to FIG. 1, there is provided a blank according to a first embodiment of the present invention generally represented by reference numeral 10 . The blank 10 is formed in a cylindrical shape. [0022] The blank 10 is preferably formed on a circular weft knitting machine. Preferably, the circular knit machine has a computerized electronic needle and yarn feed selection system, such as circular knit machine Model No. SM8-8, or SM8-83 as manufactured by Santoni® of Brescia, Italy. The blank 10 is a generally cylindrical tube having four layers that, upon manufacture, will correspond to portions of two double layer brassieres. [0023] The blank 10 includes an first upper torso two-ply portion 12 and a second upper torso two-ply portion 14 . The upper torso two-ply portion 12 and upper torso two-ply portion 14 are seamlessly joined by an area 24 of, inner or outer, single layer material. [0024] The two ply of the first upper torso portion 12 includes an inner ply or layer of material 16 and an outer ply or layer of material 18 separated by an anchoring chest band 20 , which is preferably a single layer band. Preferably, a fold line 34 forms in the outer material layer 18 , adjacent the band 20 . The edge of the outer layer 18 , opposite the single layer band 20 is knitted to the inner layer 16 at a stitch line 22 during the completion of forming and closing a first turned welt. The second upper torso portion 14 has an inner layer of material 26 and an outer layer of material 28 separated by a second anchoring chest band 30 . Preferably, a fold line 36 is formed in the outer material layer 28 , adjacent the chest anchoring band 30 . The edge of the outer layer 28 , opposite the band 30 , is integrally knitted to the inner layer 26 at a stitch line 32 during the completion of forming a second turned welt. [0025] The blank 10 is manufactured by the circular knitting machine and exits the knitting machine completely assembled, as shown for example in FIG. 1. No additional blank 10 assembly or manual folding operations or steps are required. The method of forming a single blank used for making two double layer brassieres on a circular knitting machine, includes forming an inner layer of material, forming anchoring chest bands at both ends of the inner layer material, forming outer layer material sections extending from each anchoring chest band, and joining the edge of the outer material, opposite the hidden anchoring chest band, to the inner layer by a stitch line created by the transfer of held loops during the completion of forming each of two individual long turned welts or brassieres interconnected during knitting. Each long turned welt includes a two-ply brassiere and is integrally knitted so as to form one single blank. [0026] The blank 10 is ready for further manufacturing steps, such as dyeing, finishing, and/or boarding to form two double layer circular knit brassieres. The manufacturing steps may be completed with the blank 10 fully assembled, upon exiting the circular knitting machine, or the upper and lower portions 12 , 14 of the blank can be separated by removing the gap 24 of inner material. Preferably, the maximum number of manufacturing steps are performed with the upper and lower portions 12 , 14 of blank 10 not separated, which reduces handling and manufacturing costs for each brassiere. [0027] The inner layers 16 , 26 are material suitable for an inner layer of a brassiere, such inner layers 16 , 26 are preferably formed with yarns selected for softness, comfort and wicking properties. The inner layers 16 , 26 include yarns with one or any combination of stitches, such as plain, knit, miss, or tuck, to provide body comfort and support to the wearer. A miss stitch is also known as a float stitch. The inner layers 16 , 26 are preferably made of either textured nylon having a relatively high number of fine denier filaments or a microfiber having about 20 to about 120 denier or spun yarn, such as cotton, in the size range of about 40/1's to about 60/1's cotton count. Such yarn provides softness, comfort and desired moisture wicking properties. Additionally, the inner fabric layers 16 , 26 are formed using an elastomeric stretch yarn such as spandex in combination with said nylon or cotton non-stretch yarns. [0028] The outer fabric layers 18 , 28 may include the same or different yarn combinations and constructions as the inner fabric layers 16 , 26 . [0029] The knit construction of inner layers 16 , 26 , which form the respective inner fabric layers of the two brassieres, may be any combination of conventional knit stitches, such as plain, knit, miss or tuck, with the potential of additional yarns or knit constructions, such as a true sinker produced terry loop, added in strategically engineered areas to provide both support or lift, as well as moisture wicking properties, thereby increasing wearer comfort. Such strategic areas are, for example, under the breast cups or in a the center gathered panel area between breast cups. [0030] The outer layers 18 , 28 include material suitable for an outer layer of a respective brassiere. The outer layers 18 , 28 are preferably made of synthetic continuous multifilament flat or textured polymer or spun yarn. The outer layers 18 , 28 preferably also have an elastomeric yarn, such as bare spandex or spandex, that is covered with a textured multifilament nylon yarn. The combination of yarns forms a fabric that may contain a spun yarn, such as cotton, in the range about 40/1's to about 60/1's count or synthetic continuous multifilament flat or textured yarn, such as nylon, in a range between 10 to about 200 denier, and preferably from about 60 to about 120 denier. [0031] The outer layers 18 , 28 of each brassiere are formed on a circular knitting machine using one or any combination of knit stitches. Such stitches may include, but are not limited to, plain, knit, miss or tuck stitches. The outer fabric layers 18 , 28 may have a plain appearance or, optionally, may have unique aesthetic and recognizable knitted-in characteristics including, but not limited to, a Jacquard pattern design, geometric, stylized logo, abstract, or other designs or patterns such as florals. [0032] The inner layers 16 , 26 may also include patterning (not shown) that outlines the shape of each brassiere. The patterning defines parts of the brassiere to be cut and formed, such as the breast cups, neckline and/or straps. [0033] The central gore area between the breast cups, the area under the cups, and the lower area encircling the cups, can also be knitted with discretely placed engineered shorter stretch zones in order to give added support and shaping as well as comfort to the wearer. [0034] The anchoring chest bands preferably are welt bands, 20 , 30 that may include materials that are denser than the outer material layers 16 , 26 . A fold line for the outer material layers 16 , 26 is located adjacent the chest anchoring bands 20 , 30 . For example, the first upper torso part 12 includes a fold line 34 for the outer layer material 18 adjacent the first single layer anchoring chest band 20 . For example, the second upper torso part 14 includes a fold line 36 for the outer layer material 28 adjacent the second single layer chest band 30 . The fold lines 34 , 36 result in brassieres having a straight smooth edge at the bottom of each brassiere. The fold lines 34 , 36 may be formed by any method known in the art such as, by way of example, by adding stitches in the fold area or by dropping stitches in the fold area. [0035] In another embodiment of the invention, the anchoring chest bands 20 , 30 may also be formed by adding in, during the circular knitting process, additional heavier denier bare spandex elastomeric yarn, or less preferably, a nylon covered spandex yarn thereby causing a greater fabric density in the welt bands 20 , 30 portions than the fabric and yarn density used to form the inner layers 16 , 26 and the outer layers 18 , 28 . The single layer anchoring chest bands 20 , 30 are included in the inner layers of essentially both long turned welt two-ply bras. In addition, the welt bands 20 , 30 are hidden from view by the outer layer of the bra garment. [0036] The manufacturing of a single blank 10 having four material layers, which may be formed into two double layer brassieres, allows for an increase in efficiency and cost savings in the manufacturing process. The manufacturing process results in a single blank 10 including a first upper torso part 12 and second upper torso part 14 that may each be further manufactured to form two double layer circular knit brassieres. The handling of one blank 10 decreases handling and manufacturing costs. [0037] After the blank 10 is formed, the blank is removed from the circular knitting machine to be further processed through the steps of knitting, dyeing, finishing and/or boarding. Handling of one blank 10 further reduces costs, since the blank may be dyed without being separated. [0038] The manufacturing steps to form two brassieres from the single blank 10 will be illustrated herein using the first upper torso part 12 . Similar manufacturing steps will be performed, on second upper torso part 14 , to form the second brassiere. [0039] Referring now to FIG. 2 to 4 , a brassiere 60 , shown in FIG. 4 may be formed from the upper part or brassiere 12 shown in FIGS. 2 and 3. The outer layer 18 may be joined to the inner layer 16 of the upper part 12 to form brassiere 60 . The outer layer 18 may include patterning that defines the breast cups 40 , straps 42 , 44 , and the neckline of brassiere 60 . The patterning on outer layer 18 defines outer removable sections 48 , 50 to define arm holes 62 , 64 of brassiere 60 . The patterning also defines a front removable section 52 and a rear removable section 54 that defines a neckline 66 of brassiere 60 . The patterning is dependent on the style of brassiere 60 . For example, the brassiere 60 could be patterned as a strapless brassiere. Also, the straps could be attached later in the manufacturing process. [0040] The arm holes 62 , 64 of brassiere 60 are formed by joining inner and outer layers 16 , 18 by knitting or stitching along patterning defining arm holes 62 , 64 and then removing the outer removable sections 48 , 50 from upper torso part 12 . The neckline 66 and straps 68 , 70 of brassiere 60 can then be formed by joining inner and outer layer 16 , 18 of upper torso section 12 along the pattern defining the inner edge of straps 68 , 70 and neckline 66 , followed by removing front section 52 and the back section 54 , to form double layer brassiere 60 . The brassiere 60 includes an anchoring chest band 72 , which is shown in FIG. 4 as a hidden band. The band 72 is adjacent inner material 76 and is inside the brassiere 60 , covered by outer layer material 74 , and thus hidden from view. [0041] Further manufacturing steps may also be taken on the torso parts 12 , 14 , such steps including forming lower edges along the bottom edge of the chest anchoring bands 20 , 30 . For example, a rigid flat or textured nylon yarn feed knitting with a knit and miss pattern technique, and simultaneously, a spandex stretch yarn using a knit and tuck stitch combination technique may be used to form a decorative scallop edge treatment for the bra bottom edge, or a mini turned welt may be formed to create yet another smooth beaded edge treatment. Other manufacturing steps include adding an underwire and/or adding a front closure or rear closure to each brassiere. [0042] In yet a further embodiment of the present invention, the blank 10 may include a terry loop stitch construction knitted into the brassiere. The terry loop may be a true terry loop or mock terry loop. The terry loop may be knitted into the inner layer of the brassiere so that the terry loop contacts the brassiere wearer, or the terry loop may be knitted between the lining layer and outer layer. The terry loop stitch construction may be knitted into any portion of the brassiere, such as, the breast cups, the straps, and/or the entire brassiere. Two brassieres may then be manufactured from a single blank resulting in an essentially triple layer brassiere, or a double layer brassiere that includes a terry loop layer. The terry loop stitch construction includes a hydrophylic yarn of any suitable material, such as cotton, textured microdenier nylon, or a synthetic continuous multifilament textured nylon having substantial wickable moisture moving properties. [0043] The present invention having been thus described with particular reference to the preferred forms thereof, it will be obvious that various modifications may be made therein without departing from the spirit and scope of the present invention.

The present invention relates to a method of manufacturing a single knit tubular blank, and the resultant blank and products. The method provides two circular knit brassieres each having first and second layers, thereby minimizing the steps in the process of manufacturing.

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] The present application claims the benefit of U.S. Provisional Patent Application 61/914,470 to Tuval, filed Dec. 11, 2013, entitled “Curved catheter.” [0002] The present application is related to: [0003] U.S. patent application Ser. No. 14/405,144 to Tuval, which is the US National Phase of International Patent Application PCT/IL2013/050495 to Tuval (published as WO 13/183060), filed Jun. 6, 2013, entitled “Prosthetic renal valve,” which claims priority from U.S. Provisional Patent Application 61/656,244 to Tuval, filed Jun. 6, 2012, entitled “Prosthetic renal valve;” and [0004] International Patent Application PCT/IL2014/050289 to Schwammenthal (published as WO 14/141284), filed Mar. 13, 2014, entitled “Renal pump,” which claims priority from (a) U.S. Provisional Patent Application 61/779,803 to Schwammenthal, filed Mar. 13, 2013, entitled “Renal pump,” and (b) US Provisional Patent Application 61/914,475 to Schwammenthal, filed Dec. 11, 2013, entitled “Renal pump.” [0005] All of the above-listed applications are incorporated herein by reference. FIELD OF EMBODIMENTS OF THE INVENTION [0006] Some applications of the present invention generally relate to medical apparatus. Specifically, some applications of the present invention relate to apparatus and methods associated with placing a medical device in one or more of a subject's renal vessels. BACKGROUND [0007] Catheters are medical tools that are used for cardiovascular, urological, gastrointestinal, neurovascular, and ophthalmic applications. Catheters may be inserted blood vessels, such as to provide access to the blood vessel to medical devices or tools. Catheters are typically flexible tubes that are inserted into a patient's body via an access port and advanced, over a guidewire, to a desired location inside the subject's body. SUMMARY OF EMBODIMENTS [0008] In accordance with some applications of the present invention, a catheter is placed into a renal vessel of a subject by being inserted into the subject's vasculature via a vessel of the subject's groin. The catheter defines a continuous tube that defines a lumen therethrough, and a medical device is inserted into the subject's body via the catheter lumen. The continuous tube defined by the catheter typically defines at least a first portion, a second portion, a third portion, a fourth portion, and a fifth portion thereof, each of the portions of the catheter typically defining a shape having given characteristics. [0009] The catheter is typically shaped such that both (a) when the catheter is placed into a renal vessel that is ipsilateral with respect to the vessel of the groin via which the catheter is inserted, and (b) when the catheter is placed into a renal vessel that is contralateral with respect to the vessel of the groin via which the catheter is inserted, the catheter is stabilized by portions of the catheter contacting inner walls of the blood vessels of the subject at at least two points. Typically, one of the portions of the catheter stabilizes the catheter by contacting an inner wall of an iliac vessel of the subject, and another one of the portions of the catheter stabilizes the catheter by contacting an inner wall of the vena cava, or the aorta of the subject. Further typically, the catheter is stabilized by portions of the catheter contacting inner walls of the blood vessels of the subject at the at least two points (a) before the catheter is retracted such as to release the device from the distal end of the catheter, and (b) subsequent to the catheter having been retracted, such as to release the device from the distal end of the catheter. [0010] There is therefore provided, in accordance with some applications of the present invention, apparatus including: [0011] a medical device that is configured to be inserted into a body of a subject; and [0012] a catheter that defines a continuous tube that defines a lumen therethrough, the medical device being configured to be inserted into the subject's body via the catheter, the continuous tube including at least first, second, third, fourth, and fifth portions thereof, [0013] the first portion being disposed at a first end of the catheter and being shaped, when the catheter is in a non-constrained configuration, to define a cylindrical portion of the tube that defines a generally straight central longitudinal axis; [0014] the second portion being disposed adjacent to the first portion and being shaped, when the catheter is in the non-constrained configuration, to define a curved cylindrical portion of the tube, a curvature of the second portion being such that a central longitudinal axis of the second portion defines a curve that is concave in a given direction, and that curves outwardly away from the central longitudinal axis of the first portion; [0015] the third portion being disposed between the second and the fourth portions and being shaped, when the catheter is in the non-constrained configuration, to define a curved cylindrical portion of the tube, a curvature of the third portion being such that a central longitudinal axis of the third portion defines a curve that is convex in the given direction, and that curves inwardly toward the central longitudinal axis of the first portion, such that the central longitudinal axis of the third portion meets the central longitudinal axis of the first portion, [0016] the fourth portion being disposed between the third and the fifth portions of the tube, and being shaped, when the catheter is in the non-constrained configuration, to define a curved cylindrical tube, a curvature of the fourth portion being such that a central longitudinal axis of the fourth portion defines a curve that is concave in the given direction, and that curves away from the central longitudinal axis of the first portion, [0017] the fifth portion being disposed at a second end of the catheter the fifth portion being shaped, when the catheter is in the non-constrained configuration, to define a curved cylindrical tube, a curvature of the fifth portion being such that a central longitudinal axis of the fifth portion defines a curve that is concave in the given direction, and that curves inwardly toward the central longitudinal axis of the first portion. [0018] For some applications, the continuous tube defined by the catheter further includes a sixth portion disposed between the second and third portions of the tube, the sixth portion of the tube defining a cylindrical portion of the tube that defines a generally straight central longitudinal axis, when the catheter is in the non-constrained configuration. [0019] For some applications, a flexibility of at least a distal tip of the fifth portion is greater than a flexibility of each of the first, second, third, and fourth portions. [0020] For some applications, at least a tip of the fifth portion is atraumatic. [0021] For some applications, when the catheter is in the non-constrained configuration, a radius of curvature of the second portion is greater than 50 mm. For some applications, when the catheter is in the non-constrained configuration, the radius of curvature of the second portion is less than 250 mm. [0022] For some applications, when the catheter is in the non-constrained configuration, a radius of curvature of the third portion is greater than 20 mm. For some applications, when the catheter is in the non-constrained configuration, the radius of curvature of the third portion is less than 100 mm. [0023] For some applications, when the catheter is in the non-constrained configuration, a radius of curvature of the fourth portion is greater than 10 mm. For some applications, when the catheter is in the non-constrained configuration, the radius of curvature of the fourth portion is less than 80 mm. [0024] For some applications, when the catheter is in the non-constrained configuration, a radius of curvature of the fifth portion is greater than 50 mm. For some applications, when the catheter is in the non-constrained configuration, the radius of curvature of the fifth portion is less than 250 mm. [0025] For some applications, when the catheter is in the non-constrained configuration, a ratio of a radius of curvature of the second portion to a radius of curvature of the third portion is greater than 1.5:1. For some applications, when the catheter is in the non-constrained configuration, the ratio of the radius of curvature of the second portion to the radius of curvature of the third portion is less than 4:1. [0026] For some applications, when the catheter is in the non-constrained configuration, a length of the second portion of the tube, measured along the longitudinal axis of the second portion, is at least twice the length of the medical device. For some applications, the length of the second portion of the tube is at least 3 times the length of the medical device. [0027] For some applications, a length of the third portion of the tube, measured along the longitudinal axis of the third portion, is at least twice the length of the medical device. For some applications, the length of the third portion of the tube is at least 3 times the length of the medical device. [0028] For some applications, when the catheter is in the non-constrained configuration a length of the second portion, measured along the longitudinal axis of the second portion, is greater than 20 mm. For some applications, when the catheter is in the non-constrained configuration, the length of the second portion is less than 50 mm. [0029] For some applications, when the catheter is in the non-constrained configuration, a length of the third portion, measured along the longitudinal axis of the third portion, is greater than 40 mm. For some applications, when the catheter is in the non-constrained configuration, the length of the third portion is less than 100 mm. [0030] For some applications, when the catheter is in the non-constrained configuration, a length of the fourth portion, measured along the longitudinal axis of the fourth portion, is greater than 20 mm. For some applications, when the catheter is in the non-constrained configuration, the length of the fourth portion is less than 50 mm. [0031] For some applications, when the catheter is in the non-constrained configuration, a length of the fifth portion, measured along the longitudinal axis of the fifth portion, is greater than 20 mm. For some applications, when the catheter is in the non-constrained configuration, the length of the fifth portion is less than 50 mm. [0032] For some applications: [0033] the catheter is configured to be: inserted into the subject's body via a blood vessel of a groin of the subject, and advanced distally such that the fifth portion of the catheter is inserted into a renal vessel that is contralateral to the blood vessel of the subject's groin; and [0036] the medical device is configured to be deployed inside the contralateral renal vessel by the catheter being retracted proximally, subsequent to insertion of the fifth portion of the catheter into the contralateral renal vessel. [0037] For some applications, when the fifth portion of the catheter is disposed inside the renal vessel and prior to deploying the medical device by the catheter being retracted proximally, the second portion is configured to stabilize the catheter by contacting an inner wall of an iliac vessel of the subject. [0038] For some applications, when the fifth portion of the catheter is disposed inside the renal vessel, and prior to deploying the medical device by the catheter being retracted proximally, the third portion is configured to stabilize the catheter by contacting an inner wall of a vessel of the subject selected from the group consisting of: a vena cava of the subject, and an aorta of the subject. [0039] For some applications, when the fifth portion of the catheter is disposed inside the renal vessel, and prior to deploying the medical device by the catheter being retracted proximally, the fourth portion is configured to stabilize the catheter by contacting an inner wall of the renal vessel. [0040] For some applications, subsequent to deployment of the device in the contralateral renal vessel by the catheter having been retracted proximally, the second portion is configured to stabilize the catheter by contacting an inner wall of an iliac vessel of the subject. [0041] For some applications, subsequent to deployment of the device in the contralateral renal vessel by the catheter having been retracted proximally, the third portion is configured to stabilize the catheter by contacting an inner wall of a vessel of the subject selected from the group consisting of: a vena cava of the subject, and an aorta of the subject. [0042] For some applications, subsequent to deployment of the device in the contralateral renal vessel by the catheter having been retracted proximally, the fourth portion is configured to stabilize the catheter by contacting an inner wall of the renal vessel. [0043] For some applications: [0044] the catheter is configured to be: inserted into the subject's body via a blood vessel of a groin of the subject, and advanced distally such that the fifth portion of the catheter is inserted into a renal vessel that is ipsilateral to the blood vessel of the subject's groin; and [0047] the medical device is configured to be deployed inside the contralateral renal vessel by the catheter being retracted proximally, subsequent to insertion of the fifth portion of the catheter into the ipsilateral renal vessel. [0048] For some applications, when the fifth portion of the catheter is disposed inside the renal vessel, and prior to deploying the medical device by the catheter being retracted proximally, the second portion is configured to stabilize the catheter by contacting an inner wall of an iliac vessel of the subject. [0049] For some applications, when the fifth portion of the catheter is disposed inside the renal vessel, and prior to deploying the medical device by the catheter being retracted proximally, the third portion is configured to stabilize the catheter by contacting an inner wall of a vessel of the subject selected from the group consisting of: a vena cava of the subject, and an aorta of the subject. [0050] For some applications, when the fifth portion of the catheter is disposed inside the renal vessel, and prior to deploying the medical device by the catheter being retracted proximally, the fourth portion is configured to stabilize the catheter by contacting an inner wall of the renal vessel. [0051] For some applications, subsequent to deployment of the device in the ipsilateral renal vessel by the catheter having been retracted proximally, the second portion is configured to stabilize the catheter by contacting an inner wall of an iliac vessel of the subject. [0052] For some applications, subsequent to deployment of the device in the ipsilateral renal vessel by the catheter having been retracted proximally, the third portion is configured to stabilize the catheter by contacting an inner wall of a vessel of the subject selected from the group consisting of: a vena cava of the subject, and an aorta of the subject. [0053] For some applications, subsequent to deployment of the device in the ipsilateral renal vessel by the catheter having been retracted proximally, the fourth portion is configured to stabilize the catheter by contacting an inner wall of the renal vessel. [0054] For some applications, in the non-constrained configuration of the catheter, the catheter defines a span in a direction that is perpendicular to the longitudinal axis of the first portion that is greater than 20 mm. [0055] For some applications, in the non-constrained configuration of the catheter, the catheter defines a span in the direction that is perpendicular to the longitudinal axis of the first portion that is greater than 40 mm. [0056] For some applications, in the non-constrained configuration of the catheter, the catheter defines a span in the direction that is perpendicular to the longitudinal axis of the first portion that is less than 70 mm. [0057] For some applications, in the non-constrained configuration of the catheter, the catheter defines a span in the direction that is perpendicular to the longitudinal axis of the first portion that is less than 60 mm. [0058] For some applications, in the non-constrained configuration of the catheter, the catheter defines a length measured along the longitudinal axis of the first portion, from a location at which the longitudinal axis of the second portion begins to curve away from the longitudinal axis of the first portion until the longitudinal axis of the third portion meets the longitudinal axis of the first portion that is greater than 80 mm. For some applications, the length is greater than 100 mm. For some applications, the length is less than 250 mm. For some applications, the length is less than 150 mm. [0059] For some applications, the medical device includes a radially-expandable impeller disposed inside a radially-expandable cage. [0060] For some applications, a length of cage, measured along a longitudinal axis of the cage, when the cage is in a radially expanded configuration, is between 17 mm and 26 mm. [0061] There is further provided, in accordance with some applications of the present invention, a method including: [0062] inserting a catheter into a body of a subject via a vein of a groin of the subject, and [0063] advancing the catheter distally such that: a distal end of the catheter is disposed inside a renal vein of the subject, and respective stabilizing portions of the catheter stabilize the catheter by being in contact with inner walls of, respectively, an iliac vein of the subject, and a vena cava of the subject; and [0066] subsequently, deploying a medical device inside the renal vein by retracting the distal end of the catheter, such that the distal end of the catheter is in a retracted state, in which the respective stabilizing portions of the catheter still stabilize the catheter by being in contact with the inner walls of, respectively, the subject's iliac vein and the subject's vena cava. [0067] For some applications, advancing the catheter distally includes advancing the catheter distally such that a further stabilizing portion of the catheter stabilizes the catheter by being in contact with an inner wall of the renal vein. [0068] For some applications, retracting the distal end of the catheter includes retracting the distal end of the catheter, such that while the distal end of the catheter is in its retracted state, a further stabilizing portion of the catheter stabilizes the catheter by being in contact with an inner wall of the renal vein. [0069] For some applications, advancing the catheter distally such that the distal end of the catheter is disposed inside the subject's renal vein includes advancing the catheter distally such that the distal end of the catheter is disposed inside a renal vein of the subject that is contralateral to the vein of the subject's groin via which the catheter is inserted. [0070] For some applications, advancing the catheter distally such that the distal end of the catheter is disposed inside the subject's renal vein includes advancing the catheter distally such that the distal end of the catheter is disposed inside a renal vein of the subject that is ipsilateral to the vein of the subject's groin via which the catheter is inserted. [0071] For some applications, the method further includes operating the medical device, inside the renal vein, while the catheter is disposed inside a body of the subject in its retracted state, such that the catheter supports the medical device during its operation. [0072] For some applications, deploying the device includes deploying a radially-expandable impeller that is disposed inside a radially-expandable impeller cage, and operating the medical device includes rotating the impeller. [0073] There is further provided, in accordance with some applications of the present invention, a method including: [0074] inserting a catheter into a body of a subject via an artery of a groin of the subject, and [0075] advancing the catheter distally such that: a distal end of the catheter is disposed inside a renal artery of the subject, and respective stabilizing portions of the catheter stabilize the catheter by being in contact with inner walls of, respectively, an iliac artery of the subject, and an aorta of the subject; and [0078] subsequently, deploying a medical device inside the renal artery by retracting the distal end of the catheter, such that the distal end of the catheter is in a retracted state, in which the respective stabilizing portions of the catheter still stabilize the catheter by being in contact with the inner walls of, respectively, the subject's iliac artery and the subject's aorta. [0079] For some applications, advancing the catheter distally includes advancing the catheter distally such that a further stabilizing portion of the catheter stabilizes the catheter by being in contact with an inner wall of the renal artery. [0080] For some applications, retracting the distal end of the catheter includes retracting the distal end of the catheter, such that while the distal end of the catheter is in its retracted state, a further stabilizing portion of the catheter stabilizes the catheter by being in contact with an inner wall of the renal artery. [0081] For some applications, advancing the catheter distally such that the distal end of the catheter is disposed inside the subject's renal artery includes advancing the catheter distally such that the distal end of the catheter is disposed inside a renal artery of the subject that is contralateral to the artery of the subject's groin via which the catheter is inserted. [0082] For some applications, advancing the catheter distally such that the distal end of the catheter is disposed inside the subject's renal artery includes advancing the catheter distally such that the distal end of the catheter is disposed inside a renal artery of the subject that is ipsilateral to the artery of the subject's groin via which the catheter is inserted. [0083] For some applications, the method further includes operating the medical device, inside the renal artery, while the catheter is disposed inside a body of the subject in its retracted state, such that the catheter supports the medical device during its operation. [0084] For some applications, deploying the device includes deploying a radially-expandable impeller that is disposed inside a radially-expandable impeller cage, and operating the medical device includes rotating the impeller. [0085] The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS [0086] FIG. 1 is a schematic illustration of a catheter, in accordance with some applications of the present invention; [0087] FIGS. 2A-B are schematic illustrations of the catheter being inserted via a vein of a subject's groin, a distal end of the catheter being placed into a renal vein of the subject that is ipsilateral to the vein of the groin, in accordance with some applications of the present invention; [0088] FIGS. 2C-D are schematic illustrations of portions of the catheter, respectively before and after a medical device has been deployed inside the ipsilateral renal vein, via the distal end of the catheter, in accordance with some applications of the present invention; [0089] FIG. 2E is a schematic illustration of a catheter that has been inserted, via an artery of a subject's groin, such that a distal end of the catheter is placed into a renal artery of the subject that is ipsilateral to the artery of the groin, in accordance with some applications of the present invention; [0090] FIGS. 3A-B are schematic illustrations of a catheter being inserted via a vein of a subject's groin, a distal end of the catheter being placed into a renal vein of the subject that is contralateral to the vein of the groin, in accordance with some applications of the present invention; [0091] FIGS. 3C-D are schematic illustrations of portions of the catheter, respectively before and after a medical device has been deployed inside the contralateral renal vein, via the distal end of the catheter, in accordance with some applications of the present invention; and [0092] FIG. 3E is a schematic illustration of a catheter that has been inserted, via an artery of a subject's groin, such that a distal end of the catheter is placed into a renal artery of the subject that is contralateral to the artery of the groin, in accordance with some applications of the present invention. DETAILED DESCRIPTION OF EMBODIMENTS [0093] Reference is now made to FIG. 1 , which is a schematic illustration of a catheter 20 , in accordance with some applications of the present invention. Catheter 20 defines a continuous tube that defines a lumen therethrough. A medical device 50 ( FIG. 2D ) is typically inserted into the subject's body via the catheter lumen. The continuous tube defined by catheter 20 typically defines at least a first portion 22 , a second portion 24 , a third portion 26 , a fourth portion 28 , and a fifth portion 30 thereof. For some applications, the continuous tube additionally defines a sixth portion 32 having characteristics as described hereinbelow. Alternatively or additionally, the continuous tube defines one or more different additional portions. [0094] Typically, in a non-constrained configuration of the catheter (i.e., in the absence of any force being applied to the catheter), each of the portions of the catheter defines a shape having characteristics as described hereinbelow. For some applications, the catheter is made from a polymer, a polymer that is reinforced with a braided or coiled metal or alloy, a metal, and/or an alloy (such as nitinol). The catheter is shape set (e.g., by shape setting the catheter in a mold, by steam shaping, and/or by mechanical shape setting), such that the shape of each of the portions has the described characteristics. [0095] First portion 22 of catheter 20 is disposed at a first, proximal end of the catheter. When the catheter is in the non-constrained configuration, the first portion typically defines a cylindrical portion of the tube that defines a generally straight central longitudinal axis 23 . [0096] As used in the present application, including in the claims, a “central longitudinal axis” of a structure is the set of all centroids of cross-sectional sections of the structure along the structure. Thus the cross-sectional sections are locally perpendicular to the central longitudinal axis, which runs along the structure. (If the structure is circular in cross-section, the centroids correspond with the centers of the circular cross-sectional sections.) [0097] Second portion 24 is typically disposed adjacent to the first portion. When the catheter is in the non-constrained configuration, the second portion is typically shaped to define a curved cylindrical portion of the tube. The curvature of the second portion is such that a central longitudinal axis 25 of the second portion defines a curve that is concave in a given direction, and that curves outwardly away from the central longitudinal axis of the first portion. For example, as shown in FIG. 1 the curve is concave in the direction in which arrow 34 is pointing. [0098] For some applications, when the catheter is in the non-constrained configuration, a radius of curvature R 2 of second portion 24 is greater than 50 mm, and/or less than 250 mm, e.g., 50 mm-250 mm. Typically, a length of the second portion of the tube (measured along central longitudinal axis 25 of the second portion) is at least twice the length (e.g., at least 3 times the length) of medical device 50 ( FIG. 2D ), which is configured to be placed inside the subject's body, via the catheter. For some applications, when the catheter is in the non-constrained configuration, the length of the second portion of the tube is greater than 20 mm, and/or less than 50 mm, e.g., 20 mm-50 mm. [0099] Third portion 26 of catheter 20 is disposed between the second and the fourth portions. When the catheter is in the non-constrained configuration, the third portion is shaped to define a curved cylindrical portion of the tube. The curvature of the third portion is typically such that a central longitudinal axis 27 of the third portion defines a curve that is convex in the given direction (in the example shown, in the direction of arrow 34 ), and that curves inwardly toward the central longitudinal axis of the first portion. Further typically, the curvature of the third portion is such that the central longitudinal axis of the third portion meets central longitudinal axis 23 of the first portion. For example, as shown in FIG. 1 , central longitudinal axis 27 of the third portion meets central longitudinal axis 23 of the first portion at point 36 . [0100] For some applications, when the catheter is in the non-constrained configuration, a radius of curvature R 3 of third portion 26 is greater than 20 mm, and/or less than 100 mm, e.g., 20 mm-100 mm. For some applications, when the catheter is in the non-constrained configuration, a ratio of radius of curvature R 2 of the second portion to radius of curvature R 3 of the third portion is greater than 1.5:1, and/or less than 4:1, e.g., 1.5:1-4:1. [0101] Typically, a length of the third portion of the tube (measured along central longitudinal axis 27 of the third portion) is at least twice the length (e.g., at least 3 times the length) of medical device 50 ( FIG. 2D ), which is configured to be placed inside the subject's body, via catheter 20 . For some applications, when the catheter is in the non-constrained configuration, the length of the third portion of the tube is greater than 40 mm, and/or less than 100 mm, e.g., 40 mm-100 mm. [0102] Fourth portion 28 is disposed between the third and the fifth portions of the tube. When the catheter is in the non-constrained configuration, the fourth portion typically defines a curved cylindrical tube. The curvature of the fourth portion is typically such that a central longitudinal axis 29 of the fourth portion defines a curve that is concave in the given direction (in the example shown, in the direction of arrow 34 ), and that curves away from central longitudinal axis 23 of first portion 22 . [0103] For some applications, when the catheter is in the non-constrained configuration, a radius of curvature R 4 of fourth portion 28 is greater than 10 mm, and/or less than 80 mm, e.g., 10 mm-80 mm. For some applications, when the catheter is in the non-constrained configuration, a length of the fourth portion of the tube (measured along central longitudinal axis 29 of the fourth portion) is greater than 20 mm, and/or less than 50 mm, e.g., 20 mm-50 mm. [0104] Fifth portion 30 is disposed at a second end of the catheter. When the catheter is in the non-constrained configuration, the fifth portion is typically shaped to define a curved cylindrical tube. The curvature of the fifth portion is typically such that a central longitudinal axis 31 of the fifth portion defines a curve that is concave in the given direction (in the example shown, in the direction of arrow 34 ), and that curves inwardly toward central longitudinal axis 23 of first portion 22 . For some applications, at least a distal tip 37 of the fifth portion of the continuous tube defined by the catheter is greater than a flexibility of each of the first, second, third, and fourth portions. [0105] For some applications, when the catheter is in the non-constrained configuration, a radius of curvature R 5 of fifth portion 30 is greater than 50 mm, and/or less than 250 mm, e.g., 50 mm-250 mm. For some applications, when the catheter is in the non-constrained configuration, a length of the fifth portion of the tube (measured along central longitudinal axis 31 of the fifth portion) is greater than 20 mm, and/or less than 50 mm, e.g., 20 mm-50 mm. [0106] As described hereinabove, for some applications, the tube defined by catheter 20 further defines a sixth portion 32 , disposed between the second and third portions of the tube. For some applications, when the catheter is in the non-constrained configuration, the sixth portion of the tube defines a cylindrical portion of the tube that defines a generally straight central longitudinal axis. For some applications, a length of the sixth portion (measured along the central longitudinal axis of the sixth portion) is greater than 10 mm, and/or less than 100 mm, e.g., 10 mm-100 mm. [0107] Typically, in the non-constrained configuration of the catheter (i.e., in the absence of any force being applied to the catheter), the catheter defines a span SP in a direction that is perpendicular to longitudinal axis 23 of first portion 22 that is greater than 20 mm (e.g., greater than 40 mm), and/or less than 70 mm (e.g., less than 60 mm), e.g., 20 mm-70 mm (e.g., 40 mm to 60 mm). Further typically, in the non-constrained configuration of the catheter (i.e., in the absence of any force being applied to the catheter), the catheter defines a length L 1 , measured along longitudinal axis 23 of first portion 22 , from where the second catheter begins to curve until point 36 at which longitudinal axis 27 of third portion 26 meets longitudinal axis 23 of first portion 22 that is greater than 80 mm (e.g., greater than 100 mm), and/or less than 250 mm (e.g., less than 150 mm), e.g., 80 mm-250 mm (e.g., 100 mm to 150 mm). Typically, when the fifth portion of the catheter is placed inside a renal vessel of the subject, as described hereinbelow, length L 1 corresponds to the distance from where the second portion of the catheter contacts the wall of an iliac vessel, until the renal vessel. [0108] Reference is now made to FIGS. 2A-B , which are schematic illustrations of catheter 20 being inserted into the subject's vasculature via a vein of a subject's groin (right femoral vein 40 , in the example shown). A distal end of the catheter is advanced into a renal vein of the subject that is ipsilateral to the vein of the groin (e.g., right renal vein 42 , in the example shown), in accordance with some applications of the present invention. For some applications, in order to insert the distal end of the catheter into the renal vein, the distal end of the catheter is first placed into the subject's vena cava 44 , downstream of (i.e., distal to) the renal vein. The catheter is inserted such that due to the curvature of the catheter, the distal tip of the catheter pushes against the inner wall of the vena cava on the ipsilateral side of the vena cava, as shown in FIG. 2A . The catheter is then retracted proximally, such that when the distal tip of the catheter passes the opening to the renal vein, the distal tip of the catheter enters the renal vein. When the distal tip has entered the renal vein, the catheter is then advanced, such that the distal tip of the catheter is disposed inside the renal vein in the vicinity of the subject's kidney 46 , as shown in FIG. 2B . [0109] As described hereinabove, typically, at least distal tip 37 of the fifth portion of the continuous tube defined by catheter 20 (i.e. the distal tip of the catheter) is greater than a flexibility of each of the first, second, third, and fourth portions of the catheter. For some applications, the distal tip of the fifth portion (i.e. the distal tip of the catheter) is thus configured to be atraumatic. For some applications, the tip being atraumatic reduces a likelihood of an injury being caused to the inner wall of the vena cava, during the insertion of the catheter, relative to if the distal tip of the catheter were not atraumatic. For some applications, the distal tip of the catheter is made of a more flexible material (e.g., a more flexible polymer) than that of the remainder of the catheter, and/or a reinforcing material (e.g., a braided or coiled metal or alloy) that reinforces the remainder of the catheter is not present in the distal tip of the catheter, or is made to be more flexible in the distal tip of the catheter. [0110] For some applications, a control unit 48 disposed outside the subject's body is coupled to medical device 50 ( FIG. 2D ), and is configured to control the functioning of the medical device. For example, the medical device may be a pump, and the control unit may control the functioning of the pump, by rotating a portion of the pump via a motor 49 . Typically, the control unit includes any type of processor (such as a computer processor) configured to execute the actions described herein. Further typically, a user interacts with the control unit via a user interface 51 , which typically includes any type of user interface configured to receive inputs from a user and/or to provide outputs to the user (including but not limited to keyboards, displays, pointing devices, etc.). [0111] Reference is now made to FIGS. 2C-D , which are schematic illustrations of portions of catheter 20 , respectively before and after a medical device 50 has been deployed inside renal vein 42 , via the distal end of the catheter, in accordance with some applications of the present invention. Typically, medical device 50 is self expandable. For example, medical device 50 may be a self expandable valve, a self expandable stent, and/or a self-expandable pump. For some applications, medical device 50 is a blood pump that includes a radially-expandable impeller disposed inside a radially-expandable impeller cage, e.g., as described with reference to 12Ai-22Cii of WO 14/141284 to Schwammenthal, which is incorporated herein by reference. For such applications, control unit 48 typically controls the functioning of the pump, by rotating the impeller of the pump via motor 49 . Typically, the medical device is deployed inside the renal vein by retracting the distal end of catheter 20 , such that the medical device self expands, as shown in the transition from FIG. 2C to FIG. 2D . [0112] Typically, during deployment of medical device 50 inside renal vein (i.e., during retraction of catheter 20 from the position shown in FIG. 2C to the position shown in FIG. 2D ), second portion 24 of the catheter is configured to stabilize the catheter by contacting an inner wall of an iliac vein 52 of the subject. Further typically, subsequent to the deployment of the medical device inside the renal vein, second portion 24 of the catheter is configured to stabilize the catheter by contacting the inner wall of iliac vein 52 , as shown in FIG. 2D . In this manner, second portion 24 acts as a stabilizing portion of the catheter. For some applications, the device is temporarily placed inside the subject's renal vein, in order to provide an acute treatment to the subject. The catheter remains in place inside the subject's vasculature during the treatment, and the second portion of the catheter provides stabilization to the catheter by contacting the inner wall of iliac vein 52 , as shown in FIG. 2D . Subsequent to the treatment being terminated, device 50 is withdrawn from the subject's renal vein via the catheter. [0113] As described hereinabove, the length of second portion 24 of the tube defined by catheter 20 is typically at least twice the length (e.g., at least 3 times the length) of medical device 50 . Typically, the second portion is thus configured to contact the inner wall of iliac vein 52 both (a) before the catheter has been retracted such as to release the device from the distal end of the catheter (as shown in FIG. 2C ), and (b) subsequent to the catheter having been retracted at least by the length of the device, such as to release the device from the distal end of the catheter (as shown in FIG. 2D ). [0114] As described hereinabove, for some applications, medical device 50 is a blood pump that includes a radially-expandable impeller disposed inside a radially-expandable impeller cage, e.g., as described with reference to 12Ai-22Cii of WO 14/141284 to Schwammenthal, which is incorporated herein by reference. For such applications, the length of the cage, measured along the longitudinal axis of the cage, and when the cage is in a radially expanded configuration, is typically greater than 17 mm, less than 26 mm, and/or between 17 and 26 mm. For some applications, the length of second portion 24 of the tube defined by catheter 20 is at least 30 mm (e.g., at least 50 mm), and/or less than 80 mm (e.g., less than 65 mm). [0115] Typically, during deployment of medical device 50 inside renal vein (i.e., during retraction of catheter 20 from the position shown in FIG. 2C to the position shown in FIG. 2D ), third portion 26 of the catheter is configured to stabilize the catheter by contacting an inner wall of the subject's vena cava 44 . Further typically, subsequent to the deployment of the medical device inside the renal vein, third portion 26 of the catheter is configured to stabilize the catheter by contacting the inner wall of the vena cava, as shown in FIG. 2D . In this manner, third portion 26 acts as a stabilizing portion of the catheter. As described hereinabove, the length of the third portion of the tube defined by catheter 20 is typically at least twice the length (e.g., at least 3 times the length) of medical device 50 . Typically, the third portion is thus configured to contact the inner wall of vena cava 44 both (a) before the catheter has been retracted such as to release the device from the distal end of the catheter (as shown in FIG. 2C ), and (b) subsequent to the catheter having been retracted at least by the length of the device, such as to release the device from the distal end of the catheter (as shown in FIG. 2D ). [0116] As described hereinabove, for some applications, medical device 50 is a blood pump that includes a radially-expandable impeller disposed inside a radially-expandable impeller cage, e.g., as described with reference to 12Ai-22Cii of WO 14/141284 to Schwammenthal, which is incorporated herein by reference. For such applications, the length of the cage, measured along the longitudinal axis of the cage, is typically greater than 17 mm, less than 26 mm, and/or between 17 and 26 mm. For some applications, the length of third portion 26 of the tube defined by catheter 20 is at least 30 mm (e.g., at least 50 mm), and/or less than 80 mm (e.g., less than 65 mm). [0117] For some applications, during at least a portion of the deployment of medical device 50 inside renal vein 42 , fourth portion 28 of the catheter is configured to stabilize the catheter by contacting an inner wall of the subject's renal vein. For example, as shown in FIG. 2C , prior to the retraction of catheter 20 such as to deploy device 50 , the fourth portion stabilizes the catheter by contacting the inner wall of the renal vein. In this manner, fourth portion 28 acts as a stabilizing portion of the catheter. For some applications, fourth portion 28 of the catheter is configured to stabilize the catheter by contacting an inner wall of the subject's renal vein even after the device has been deployed by the catheter having been retracted proximally. Alternatively, fourth portion 28 of the catheter is configured not contact the inner wall of the subject's renal vein after the device has been deployed by the catheter having been retracted proximally, as shown in FIG. 2D . [0118] Reference is now made to FIG. 2E , which is a schematic illustration of catheter 20 , the catheter having been inserted into the subject's vasculature via an artery of a subject's groin (right femoral artery 60 , in the example shown). A distal end of the catheter is advanced into a renal artery of the subject that is ipsilateral to the artery of the groin (e.g., right renal artery 62 , in the example shown). For some applications, generally similar techniques to those described hereinabove with reference to FIGS. 2A-2D are performed on the arterial side of the subject's vasculature, mutatis mutandis. For some applications, when catheter 20 is used on the arterial side of the subject's vasculature, during at least a portion of the procedure (a) second portion 24 of the catheter stabilizes the catheter by contacting an inner wall of an iliac artery 64 of the subject, (b) third portion 26 of the catheter stabilizes the catheter by contacting an inner wall of an aorta 66 of the subject, and (c) fourth portion 28 of the catheter stabilizes the catheter by contacting an inner wall of renal artery 62 . Typically, both before and after the catheter is retracted such as to release device 50 inside the renal artery, (a) second portion 24 of the catheter stabilizes the catheter by contacting the inner wall of iliac artery 64 , and (b) third portion 26 of the catheter stabilizes the catheter by contacting the inner wall of aorta 66 . [0119] Reference is now made to FIGS. 3A-B , which are schematic illustrations of catheter 20 being inserted via a vein of a subject's groin (right femoral vein 40 , in the example shown), a distal end of the catheter being advanced into a renal vein of the subject that is contralateral to the vein of the groin (e.g., left renal vein 72 , in the example shown), in accordance with some applications of the present invention. [0120] For some applications, in order to insert the distal end of the catheter into renal vein 72 , the distal end of the catheter is first placed into the subject's vena cava 44 , downstream of (i.e., distal to) the renal vein. The catheter is inserted such that due to the curvature of the catheter, the distal tip of the catheter pushes against the inner wall of the vena cava on the contralateral side of the vena cava, as shown in FIG. 3A . The catheter is then retracted proximally, such that when the distal tip of the catheter passes the opening to the renal vein, the distal tip of the catheter enters the renal vein. When the distal tip has entered the renal vein, the catheter is then advanced, such that the distal tip of the catheter is disposed inside the renal vein in the vicinity of the subject's kidney 46 , as shown in FIG. 3B . As described hereinabove with reference to FIGS. 2A-B , typically, the tip of catheter 20 being atraumatic reduces a likelihood of an injury being caused to the inner wall of the vena cava, during the insertion of the catheter, relative to if the distal tip of the catheter were not atraumatic. [0121] Reference is now made to FIGS. 3C-D , which are schematic illustrations of portions of catheter 20 , respectively before and after medical device 50 has been deployed inside renal vein 72 , via the distal end of the catheter, in accordance with some applications of the present invention. Typically, during deployment of medical device 50 inside renal vein 72 (i.e., during retraction of catheter 20 from the position shown in FIG. 3C to the position shown in FIG. 3D ), second portion 24 of the catheter is configured to stabilize the catheter by contacting an inner wall of iliac vein 52 . Further typically, subsequent to the deployment of the medical device inside the renal vein second portion 24 of the catheter is configured to stabilize the catheter by contacting the inner wall of iliac vein 52 , as shown in FIG. 3D . As described hereinabove, with reference to FIGS. 2C-D , for some applications, the device is temporarily placed inside the subject's renal vein, in order to provide an acute treatment to the subject. The catheter remains in place inside the subject's vasculature during the treatment, and the second portion of the catheter provides stabilization to the catheter by contacting the inner wall of iliac vein 52 , as shown in FIG. 3D . Subsequent to the treatment being terminated, the device is withdrawn from the subject's renal vein via the catheter. [0122] As described hereinabove with reference to FIGS. 2C-D , the length of the second portion of the tube defined by catheter 20 is typically at least twice the length (e.g., at least 3 times the length) of medical device 50 . Typically, the second portion is thus configured to contact the inner wall of iliac vein 52 both (a) before the catheter has been retracted such as to release the device from the distal end of the catheter (as shown in FIG. 3C ), and (b) subsequent to the catheter having been retracted at least by the length of the device, such as to release the device from the distal end of the catheter (as shown in FIG. 3D ). [0123] As described hereinabove, for some applications, medical device 50 is a blood pump that includes a radially-expandable impeller disposed inside a radially-expandable impeller cage, e.g., as described with reference to 12Ai-22Cii of WO 14/141284 to Schwammenthal, which is incorporated herein by reference. For such applications, the length of the cage, measured along the longitudinal axis of the cage, is typically greater than 17 mm, less than 26 mm, and/or between 17 and 26 mm. For some applications, the length of second portion 24 of the tube defined by catheter 20 is at least 30 mm (e.g., at least 50 mm), and/or less than 80 mm (e.g., less than 65 mm). [0124] Typically, during deployment of medical device 50 inside renal vein 72 (i.e., during retraction of catheter 20 from the position shown in FIG. 3C to the position shown in FIG. 3D ), third portion 26 of the catheter is configured to stabilize the catheter by contacting an inner wall of the subject's vena cava 44 . Further typically, subsequent to the deployment of the medical device inside the renal vein, third portion 26 of the catheter is configured to stabilize the catheter by contacting the inner wall of the vena cava, as shown in FIG. 3D . As described hereinabove, the length of the third portion of the tube defined by catheter 20 is typically at least twice the length (e.g., at least 3 times the length) of medical device 50 . Typically, the third portion is thus configured to contact the inner wall of vena cava 44 both (a) before the catheter has been retracted such as to release the device from the distal end of the catheter (as shown in FIG. 3C ), and (b) subsequent to the catheter having been retracted at least by the length of the device, such as to release the device from the distal end of the catheter (as shown in FIG. 3D ). [0125] As described hereinabove, for some applications, medical device 50 is a blood pump that includes a radially-expandable impeller disposed inside a radially-expandable impeller cage, e.g., as described with reference to 12Ai-22Cii of WO 14/141284 to Schwammenthal, which is incorporated herein by reference. For such applications, the length of the cage, measured along the longitudinal axis of the cage, is typically greater than 17 mm, less than 26 mm, and/or between 17 and 26 mm. For some applications, the length of third portion 26 of the tube defined by catheter 20 is at least 30 mm (e.g., at least 50 mm), and/or less than 80 mm (e.g., less than 65 mm). [0126] For some applications, during at least a portion of the deployment of medical device 50 inside renal vein 72 , fourth portion 28 of the catheter is configured to stabilize the catheter by contacting an inner wall of the subject's renal vein. For example, as shown in FIG. 3C , prior to the retraction of catheter 20 such as to deploy device 50 , the fourth portion stabilizes the catheter by contacting the inner wall of the renal vein. For some applications, fourth portion 28 of the catheter is configured to stabilize the catheter by contacting an inner wall of the subject's renal vein even after the device has been deployed by the catheter having been retracted proximally, as shown in FIG. 3D . [0127] Reference is now made to FIG. 3E , which is a schematic illustration of catheter 20 , the catheter having been inserted into the subject's vasculature via an artery of a subject's groin (right femoral artery 60 , in the example shown). A distal end of the catheter is advanced into a renal artery of the subject that is contralateral to the artery of the groin (e.g., right renal artery 82 , in the example shown). For some applications, generally similar techniques to those described hereinabove with reference to FIGS. 3A-3D are performed on the arterial side of the subject's vasculature, mutatis mutandis. For some applications, when catheter 20 is used on the arterial side of the subject's vasculature, during at least a portion of the procedure (a) second portion 24 of the catheter stabilizes the catheter by contacting an inner wall of an iliac artery 64 of the subject, (b) third portion 26 of the catheter stabilizes the catheter by contacting an inner wall of an aorta 66 of the subject, and (c) fourth portion 28 of the catheter stabilizes the catheter by contacting an inner wall of renal artery 82 . Typically, both before and after the catheter is retracted such as to release device 50 inside the renal artery, (a) second portion 24 of the catheter stabilizes the catheter by contacting the inner wall of iliac artery 64 , and (b) third portion 26 of the catheter stabilizes the catheter by contacting the inner wall of aorta 66 . [0128] It is noted that, in accordance with the above description of catheter 20 , the catheter is shaped such that both (a) when the catheter is placed into a renal vessel that is ipsilateral with respect to the vessel of the groin via which the catheter is inserted, and (b) when the catheter is placed into a renal vessel that is ipsilateral with respect to the vessel of the groin via which the catheter is inserted, the catheter is stabilized by portions of the catheter contacting inner walls of the blood vessels of the subject at at least two points. Typically, the second portion of the catheter stabilizes the catheter by contacting an inner wall of an iliac vessel of the subject, and the third portion stabilizes the catheter by contacting an inner of the vena cava or the aorta of the subject. Further typically, the catheter is stabilized by portions of the catheter contacting inner walls of the blood vessels of the subject at the at least two points (a) before the catheter is retracted such as to release the device from the distal end of the catheter, and (b) subsequent to the catheter having been retracted such as to release the device from the distal end of the catheter. [0129] It is noted that, for some applications, catheter 20 is used for the insertion of a medical device therethrough that provides a therapy (e.g., renal denervation) to a renal vessel (e.g., a renal artery or a renal vein). Subsequent to providing the therapy, the device is withdrawn from the renal vessel via the catheter. Catheter 20 provides stabilization during the advancement of the device, during the withdrawal of the device, and/or during the provision of the therapy by (a) second portion 24 of the catheter stabilizing the catheter by contacting an inner wall of an iliac vessel of the subject, (b) third portion 26 of the catheter stabilizing the catheter by contacting an inner wall of vena cava 44 or aorta 66 of the subject, and, optionally, (c) fourth portion 28 of the catheter stabilizing the catheter by contacting an inner wall of the renal vessel, in accordance with the techniques described hereinabove. [0130] Although catheter 20 is described hereinabove as being inserted via a femoral blood vessel, for some applications, catheter 20 is inserted through a different peripheral vessel in the subject's groin, e.g., the iliofemoral vein. Alternatively or additionally, the catheter is inserted via a vein of the arm (e.g., a brachial, or antecubital vein), the chest (e.g., the subclavian vein), or the neck (e.g., the jugular vein). For some applications, catheter 20 is inserted into the hepatic vein. [0131] In general, in the specification and in the claims of the present application, the term “proximal” and related terms, when used with reference to a device or a portion thereof, should be interpreted to mean an end of the device or the portion thereof that, when inserted into a subject's body, is typically closer to a location through which the device is inserted into the subject's body. The term “distal” and related terms, when used with reference to a device or a portion thereof, should be interpreted to mean an end of the device or the portion thereof that, when inserted into a subject's body, is typically further from the location through which the device is inserted into the subject's body. [0132] It will 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 and methods are described including inserting a catheter into a subject's body via a vein of the subject's groin. The catheter is advanced distally such that a distal end of the catheter is disposed inside the subject's renal vein. Respective stabilizing portions of the catheter stabilize the catheter by being in contact with inner walls of, respectively, an iliac vein of the subject, and a vena cava of the subject. Subsequently, a medical device is deployed inside the renal vein by retracting the distal end of the catheter, such that the distal end of the catheter is in a retracted state, in which the respective stabilizing portions of the catheter still stabilize the catheter by being in contact with the inner walls of, respectively, the subject's iliac vein and the subject's vena cava. Other applications are also described.

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] This application is a continuation-in-part of U.S. patent application Ser. No. 10/641,284 filed on Aug. 15, 2003, which claims the benefit of U.S. Provisional Patent Application No. 60/403,361 filed on Aug. 15, 2002, and this application also claims the benefit of U.S. Provisional Patent Application No. 60/426,420, filed on Nov. 15, 2002. The full disclosure of each of these applications is incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention relates to a stent-graft for use as a prosthetic within a body vessel to support the vessel, and particularly, to a stent-graft having improved longitudinal structural flexibility and graft wear that can be used within a body vessel such as the aorta to support and facilitate the repair of the vessel. BACKGROUND OF THE INVENTION [0003] An abdominal aortic aneurysm (AAA) is a very common deteriorating disease typically manifested by a bulbous weakened section and expansion of the aorta vessel wall at a region between the aorto-renal junction and the aorto-iliac junction. These aneurysms can result from accidents, atherosclerosis, high blood pressure or inherited disease. Aneurysms affect the ability of the vessel lumen to conduct fluids, and may at times be life threatening, for instance when rupture of the vessel wall occurs. Ruptured abdominal aortic aneurysms—which can cause massive internal bleeding—kill about 6,000 Americans a year. [0004] A traditional treatment for repairing an aneurysm is to surgically remove part or all of the aneurysm and replace it with a synthetic graft or patch. But, in this procedure, the graft is put in place by threading a tiny plastic tube through a small incision in the groin and into a femoral artery. A spring-loaded stent graft, covered with a sheath, is loaded on the tip of the tube. The stent graft provides a new, more secure channel for blood within the blood vessel. Using X-ray images, the medical team guides the graft to the diseased section of the blood vessel and then pulls back the sheath. The self-expanding spring action fixes the graft to the inside vessel wall, and the tube is withdrawn from the femoral artery and the groin. [0005] When the aneurysm is proximate the opening of another vessel, such as the renal artery, it can be difficult to anchor a conventional expandable stent-graft within the aorta. Additionally, the neck above the aneurysm can be short and tortuous. Conventional expandable stent-grafts may include anchors such as that disclosed in U.S. Pat. No. 6,334,869 to Leonhardt et al., which is incorporated herein by reference. These conventional, expandable stent-grafts with anchoring stent portions are commonly referred to as “suprarenal” stent-grafts. However, these suprarenal stent grafts do not conform to, or follow, the contour of the region of the aneurysm. As a result, these conventional tubular stent grafts can be too stiff for effective use at the site of an aortic aneurysm. [0006] In cases where the aneurysm involves the ipsilateral and contralateral iliac vessels extending from the aorta, it is known to provide a generally Y-shaped bifurcated stent graft having a primary limb joining with an ipsilateral limb and a contralateral limb. An example of such a stent graft, and elements for surgically implanting the stent graft, are described in U.S. Pat. No. 5,387,235 to Chuter, which is incorporated herein by reference. The surgical procedure taught by Chuter involves either surgical isolation of the femoral vessels in the groin to provide direct access to the vessels, or percutaneous entry through both ipsilateral and contralateral femoral arteries. However, these stent grafts experience the same lack of longitudinal flexion that are experienced by the above-discussed conventional stent grafts. SUMMARY OF THE INVENTION [0007] The present invention relates to a stent-graft with increased longitudinal flexibility relative to conventional stent-grafts. Longitudinal flexibility as used herein relates to the flexibility of the stent-graft structure (or portions thereof) to move relative to its major, longitudinal axis of extension. The stent-graft is deployed within a body lumen such as the aorta for supporting the lumen and repairing luminal aneurysms. In a preferred embodiment, the stent-graft is located and expanded within a blood vessel to repair aortic aneurysms. [0008] An aspect of the present invention includes a rail stent-graft comprising an elongated stent assembly including at least one vessel support element that is positionable on a first side of a junction of at least two vessels. The rail stent-graft also includes an elongated stent-graft assembly comprising at least one vessel support element and at least one graft element. The stent-graft assembly is positionable on a second side of the junction of the at least two vessels. The rail stent-graft assembly further includes at least one rail element extending between the stent assembly and the stent-graft assembly. Each of these assemblies is moveable along and relative to the at least one rail element. BRIEF DESCRIPTION OF THE DRAWINGS [0009] The present invention will be even better understood with reference to the attached drawings, in which: [0010] FIG. 1 is a partial schematic illustration of a descending aorta; [0011] FIG. 2 illustrates a rail stent-graft according to an embodiment of the present invention positioned with a descending aorta; and [0012] FIG. 3 is a schematic view of the rail stent-graft shown in FIG. 2 . DETAILED DESCRIPTION OF THE INVENTION [0013] Referring to the figures where like numerals indicate the same element throughout the views, FIG. 1 shows an aorta 12 joined to renal arteries 14 and 15 at aorto-renal junctions (intersection) 16 , and having an aortic aneurysm 18 below the aorto-renal junctions 16 . As is known, an aortic aneurysm 18 includes a weakened and expanded vessel wall at the diseased region of the aorta 12 . As shown in FIG. 2 , the rail stent-graft 10 according to the present invention is deployed within the aorta 12 so that at least a stent-graft assembly 50 is located in the region of the aneurysm 18 and acts as a prosthetic device for relieving blood flow pressure against the weakened vessel wall by acting as a fluid conduit through the region of the aneurysm 18 . [0014] As illustrated in FIG. 2 , the rail stent-graft 10 according to the present invention comprises the stent-graft assembly 50 including a graft portion 100 and a stent portion 200 . The stent-graft assembly 50 can include the structure of the stent-grafts discussed in U.S. patent application Ser. No. 10/641,284 filed on Aug. 15, 2003, which is fully incorporated herein by reference. The rail stent-graft 10 also comprises a rail stent assembly 300 that is spaced from the stent-graft assembly 50 so that these two assemblies can be positioned on opposite sides of an intersection of two vessels. The rail stent assembly 300 can include any of the rail stents discussed in U.S. patent application Ser. No. 10/100,986 filed on Mar. 20, 2002, and U.S. Provisional patent application Ser. No. 60/426,366, filed on Nov. 15, 2002, which are both fully incorporated herein by reference. As illustrated, the rail stent assembly 300 can be positioned and anchored above the junction 16 in order to locate the assemblies 50 , 300 of the rail stent-graft 10 at their respective desired positions within the aorta 12 . As discussed below, elongated rail elements 80 extend between the assemblies 50 and 300 . Any number of rails 80 that do not hinder the desired longitudinal flexibility of the stent-graft 10 can be used between the assemblies 50 , 300 and within these assemblies 50 , 300 . [0015] The stent portion 200 of the stent-graft assembly 50 includes a plurality of spaced, circumferential support elements (hoops) 222 . Each circumferential support element 222 is generally annular in shape. In a preferred embodiment, each circumferential support element 222 has a sinusoidal or otherwise undulating form. Each circumferential support element 222 is made from a flexible, biocompatible material (i.e., from a material that is, for example, non-reactive and/or non-irritating). In one embodiment, each circumferential support element 222 is made from medical-grade metal wire formed as a closed loop (i.e., as an annular hoop) in a known manner, including, for example, micro-welding two ends of a wire segment together. Stainless steel, metal alloys, shape-memory alloys, super elastic alloys and polymeric materials used in conventional stents are representative examples of materials from which circumferential support elements 222 can be formed. The alloys can include NiTi and Nitinol. The polymers for circumferential support elements 222 may, for example, be bioabsorbable polymers so that the stent can be absorbed into the body instead of being removed. [0016] As shown in FIG. 2 , the support elements 222 are freely mounted on elongated rails elements 80 (herein after “rails”) such that the support elements 222 can move along the rails 80 . The rails 80 extend along the length of the stent-graft 10 between the outermost peaks of terminal support elements 222 at a first end 54 and the innermost peaks of the terminal support element 222 at a second end 56 . As illustrated, the terminal support elements 222 can extend beyond the terminal ends of the graft-portion 100 . [0017] The graft portion 100 , illustrated in FIGS. 2 and 3 , is formed of well known biocompatible materials such as woven polyester including that available under the trademark “DACRON”, porous polyurethane, and Polytetrafluroethylene (PTFE). In a preferred embodiment, the biocompatible material is expanded Polytetrafluroethylene (ePTFE). Methods for making ePTFE are well known in art, and are also described in U.S. Pat. No. 4,187,390 issued to Gore on Feb. 5, 1980, which is incorporated herein by reference. [0018] The graft portion 100 can be secured to the rails 80 and the stent portion 220 as illustrated in the U.S. patent application Ser. No. 10/641,284, filed on Aug. 15, 2003, which has been fully incorporated herein by reference. For example, the stent-graft portion 100 can include a plurality of circumferentially extending rings that are spaced from each other along the length of the graft portion 100 . These rings eliminate the need to suture the stent portion 200 to the graft portion 100 . Additionally, these rings can receive the rails 80 so that the rings and the stent-graft section can move along and relative to the rails 80 . [0019] The rails 80 can have any form. For example, the rails 80 can be solid cylindrical members, such as wires or extrusions with circular, elliptical or other known cross sections. Alternatively, the rails 80 can be ribbons or spring wires. Additionally, the rails 80 are desirably sufficiently flexible to accommodate bends, curves, etc. in a blood vessel. Rails 80 may be made from, for example and without limitation the following biocompatible materials: metals, metallic alloys including those discussed above, glass or acrylic, and polymers including bioabsorbable polymers. The rails 80 can also include any of the materials discussed in the U.S. patent application Ser. No. 10/100,986, filed on Mar. 20, 2002, and U.S. Provisional Patent Application Ser. No. 60/426,366, filed on Nov. 15, 2002, which have been incorporated herein by reference. [0020] The rails 80 can be passed or “snaked” through the circumferential support elements 222 as discussed in U.S. patent application Ser. No. 10/641,284. Additionally, the rails 80 can be passed through the stent portion 200 and the graft portion 100 as discussed below. [0021] In the embodiment illustrated in FIGS. 2 and 3 , the circumferential support elements 222 include apertures through which the rails 80 extend as shown. The support elements 222 slide along the rail(s) 80 so that the stent-graft assembly 50 can conform to the shape of the aorta or other blood vessel. It is also contemplated that the terminal support elements 222 can move along the rails 80 if, for example, the rail elements form a closed loop or include terminal stop members. [0022] The rail stent assembly 300 includes a plurality of vessel support elements 322 that, like vessel support elements 222 , are mounted for free movement along the rails 80 and relative to the rails 80 . These vessel support elements can be substantially the same as vessel support elements 222 discussed above. Therefore, the above-discussion regarding vessel support elements 222 is also applicable to vessel support elements 322 and will not be repeated. The adjacent vessel support elements 322 can be secured to each other by a bridge element. Providing at least one bridge element between adjacent support elements 322 increases the structural integrity of the stent-graft 10 because it helps to keep the support elements 322 distributed along the length of the rail stent portion 300 while still offering increased longitudinal flexibility. Alternatively, adjacent vessel support elements 322 can be free of any connection to each other and move independently along the rail(s) 80 . [0023] As previously discussed, the rails 80 are desirably sufficiently flexible to accommodate bends, curves, etc. in a blood vessel and can have any of the configurations discussed in U.S. patent application Ser. No. 10/100,986 and U.S. Provisional Patent Application Ser. No. 60/426,366. The ability of the support elements 322 to move along and independent of the rails 80 allows the rail stent section 300 to conform to the contour of a vessel by shortening along the inner radius of a vessel curve and maintaining a longer arc along the outer radius of the vessel curve. This conformability of the rail stent assembly 300 creates an effective seal with the vascular wall of the aorta above the renal artery junction 16 . Similarly, as discussed above, the stent-graft assembly 50 is also capable of experiencing this conformability to the shape of the aorta below the junction 16 and thus is capable of forming a seal with the lower part of the descending aorta. [0024] As shown in FIG. 2 , the rails 80 extend between the rail stent assembly 300 and the stent-graft assembly 50 . The space 90 between the rail stent assembly 300 and the stent-graft assembly 50 is aligned with the junction 16 and formed by stops on the rail(s) 80 . Specifically, each rail 80 can include a mechanical deformation or stop member, such as a weld that restrict the support elements 222 , 322 from traveling along the rail and entering the open space 90 . Alternatively, the rails may be free of any type of stop for either the rail stent assembly 300 and/or the stent-graft assembly 50 . [0025] The stent-graft assembly 60 can include a bifurcated region 65 as shown in FIG. 2 . In a preferred embodiment, the bifurcated region permits the stent-graft assembly 60 to be used in cases where involvement of one or both iliac vessels 11 and 13 is present. The bifurcated region 65 of the stent-graft 60 has a generally Y-shape and extends from the primary section 62 of the stent-graft assembly 60 that is located within the aorta 12 . The bifurcated region includes a first limb 64 for location within a vessel such as the ipsilateral iliac vessel 11 , and a second limb 66 for location within another vessel such as the contralateral iliac vessel 13 . These limbs 64 , 66 meet at a graft limb junction 63 . Each limb 64 , 66 is generally similar in construction to the primary section 60 . Both limbs utilize the rail stent-graft technology discussed above with respect to the primary section 62 . For example, the limbs 64 , 66 each include a graft portion 100 having a graft material that can be secured relative to a stent portion 200 that includes a plurality of vessel support elements 222 . The graft portion 100 and stent portion 200 of each limb 64 , 66 are moveable between the ends of the rails 80 that support them. The term “bifurcation” is not limiting to the number of limbs that can found in this region of the stent-graft 10 . Instead, the bifurcated region 65 could include more than two limbs. [0026] The present invention also includes introducing an agent into a body using the above-discussed stent-graft 10 . In a preferred embodiment, the agent(s) is carried by one or more of the rails 80 or the graft portion 100 and released within the body over a predetermined period of time. For example, these stents can deliver one or more known agents, including therapeutic and pharmaceutical drugs, at a site of contact with a portion of the vasculature system or when released from a carrier as is known. These agents can include any known therapeutic drugs, antiplatelet agents, anticoagulant agents, antimicrobial agents, antimetabolic agents and proteins. These agents can also include any of those disclosed in the above mentioned U.S. Provisional Patent Application No. 60/426,366, U.S. Pat. No. 6,153,252 to Hossainy et al., and U.S. Pat. No. 5,833,651 to Donovan et al., all of which are hereby incorporated by reference in their entirety. Local delivery of these agents is advantageous in that their effective local concentration is much higher when delivered by the stent than that normally achieved by systemic administration. [0027] Thus, while there have been shown and described and pointed out fundamental novel features of the present invention as applied to preferred embodiments thereof, it will be understood that various omissions and substitutions and changes in the form and details of the devices illustrated, and in their operation, and in the method illustrated and described, may be made by those skilled in the art without departing from the spirit of the invention as broadly disclosed herein.

A rail stent-graft with increased longitudinal flexibility and sealing properties that is deployable within a body lumen, such as the aorta, for repairing an aneurysm. The rail stent-graft includes an anchoring assembly for securing the rail stent-graft to a portion of the vessel above a junction with another vessel.

BACKGROUND [0001] The percussion examination is an integral portion of every general physical exam of the thorax and many specialty exams including the pulmonary exam and the abdominal exam. The percussion exam is used to identify a variety of normal anatomical landmarks and to identify pathological conditions such as ascites, pulmonary infiltrates, and organomegally. The standard percussion exam is performed by placing one hand with spread fingers on the patient. One finger of the other hand is used to strike one finger of the hand on the patient in a brisk swinging motion. The resulting tapping action results in an audible sound which may be characterized as “tympanic”, “resonant”, “dull”, or a variety of other variations. These sounds are then used to identify the boundaries of organs or the presence of abnormalities. [0002] The sound heard from the standard method of percussion is often very faint and therefore very difficult to interpret. In addition to being difficult to hear, the quality may be affected by the characteristics of the examiner's fingers themselves and the examiner's personal exam technique. The standard exam consists of multiple taps on the patient used for point to point comparison of the changes in sound at different places on the patient. Therefore, variations in the technique from one tap to another or one physician to another may affect the results of the exam. SUMMARY [0003] A small device clips onto the end of a stethoscope and aids during the percussion portion of a physical exam of the thorax or abdomen. The device is essentially a small mechanical “tapper” which is operated by pressing a small plunger with the index finger of the hand holding the end of the stethoscope onto the patient's body. During a normal percussion exam, the physician taps on the abdomen or thorax with a finger from one hand hitting a finger of the other hand placed on the body. The very faint sounds heard from this action can be classified as “tympanic, dull, resonant, etc” and help to diagnose organomegaly, ascities, lung infiltrates and other anatomy and abnormalities. This device aids in the exam by amplifying the percussion sounds heard because it is used together with the stethoscope. It also allows for one hand operation so this exam can be easily combined with the auscultation portion of the regular physical exam. [0004] In some embodiments, the device includes a base adapted to be clipped to the head of the stethoscope with a hammer support extending over a patient, and a hammer supported by the hammer support and actuated by a user to tap on the patient. The hammer may include a finger pad that is depressed by the user to actuate the hammer, and a flared piston head piece that taps on the patient when the user depresses the finger pad. The finger pad and the head piece can be made from stainless steel. In certain embodiments, the hammer includes a main piston body positioned within a casing that is supported by the hammer support. The casing may be made from stainless steel, while the piston body may be made from brass. [0005] Some embodiments can have a spring positioned around at least a portion of the main piston body and within the casing. In such embodiments, the spring acts to return the hammer to its starting position after being actuated by the user. The spring can be a stainless steel compression spring. The base can be secured to the head of the stethoscope with a set-screw. [0006] Some embodiments may have one or more of the following advantages. The device greatly improves acoustics due to its design and use in conjunction with the stethoscope. In addition, the device allows for a one-hand percussion examination which will allow the healthcare professional to use the other hand for other purposes and to access portions of the body which may be more difficult to reach with two hands. This device conveniently attaches to the stethoscope and therefore is easy to carry and use. The spring-loaded piston provides a regular tapping action and may allow for a more astute diagnose of differences in the acoustic response from one point to another on the patient. BRIEF DESCRIPTION OF THE DRAWINGS [0007] The foregoing and other objects, features and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. [0008] [0008]FIG. 1 is a perspective view of a stethoscope head with a medical percussion device in accordance with the invention; [0009] [0009]FIG. 1A is a perspective view of the medical percussion device of FIG. 1; [0010] [0010]FIG. 2 is a top view of the medical percussion device of FIGS. 1 and 1A; [0011] [0011]FIG. 2A is a cross-sectional view of the medical percussion device along the line 2 A- 2 A of FIG. 2; [0012] [0012]FIG. 2B is a bottom view of the medical percussion device of FIGS. 1 and 1A; [0013] [0013]FIG. 2C is an end view of the medical percussion device along the line 2 C- 2 C of FIG. 2; [0014] [0014]FIG. 2D is an end view of the medical percussion device along the line 2 D- 2 D of FIG. 2; [0015] [0015]FIG. 2E is a close-up view of the medical percussion device in the region 2 E of FIG. 2A; [0016] [0016]FIG. 3 is a cross-sectional view of an alternative embodiment of the medical percussion device; and [0017] [0017]FIGS. 4A and 4B illustrate a sequence of steps for using the medical percussion device in accordance with the invention. DETAILED DESCRIPTION OF THE INVENTION [0018] A description of preferred embodiments of the invention follows. [0019] Referring to FIGS. 1, 1A, and 2 - 2 D, there is shown a medical percussion device 10 , which is a ring-shaped device approximately 2 inches in diameter constructed from either metal or plastic. It has two aspects to its design: a base portion 12 and a hammer-action assembly 14 . [0020] The base portion 12 is designed to attach to a stethoscope 16 (FIG. 1) and is shaped like an open-ended ring so that it can slip around the head of the stethoscope. The base 12 includes a screw clamp, such as a set-screw 18 , to help hold the percussion device 10 securely in place on the stethoscope head 16 . [0021] The base portion 12 is made from surgical grade stainless steel and is machined from one solid piece of metal. The base portion 12 has two smaller holes (one is threaded) on the two “tails” so that the stainless steel thumb screw 18 can be fed through this part in order to secure the base 12 to the stethoscope-head 16 . The other side of the base piece 12 has a wide threaded hole to accommodate the hammer-action assembly 14 described below. The hammer-action assembly 14 screws into the base 12 at this larger hole. [0022] Referring now to FIG. 2E, the hammer-action assembly 14 includes a piston assembly 19 having a metal piston 20 with detachable (screw in) flared head 22 and a detachable (screw in) finger pad 24 , a spring 26 , and a casing tube made from two parts 28 and 30 . The flared head 22 of the piston comes into contact with the patient's skin as the piston is pressed by an examining medical professional. The finger pad 24 is the portion of the hammer-action assembly 14 that is depressed by the physician during the percussion exam. The spring 26 acts to return the depressed piston 20 to its starting position. [0023] The casing tube 28 and 30 covers the three pieces of the piston 20 , 22 , and 24 and holds the spring 26 in place. The casing tube 28 and 30 is made from two pieces of stainless steel rod which are both first drilled through to accommodate the piston 20 . Then, a recess is created in each rod by milling down the center of each rod and leaving a lip on the end of each piece so that once attached together, the spring 26 and piston 20 will be secured inside the casing 28 and 30 via this ledge. To attach the two pieces of the casing 28 and 30 to one another, one piece is turned down a small amount and threaded while the other piece is bored out a small amount and tapped. These two rods join at this threaded joint. In addition, the outer edge of the casing 30 is threaded to mate with the tapper base 12 . [0024] As mentioned above, the piston assembly 19 is made from three pieces 20 , 22 , and 24 . The finger pad piece 24 is made of stainless steel by turning down a stainless steel rod on the lathe to create a flat surface for the finger to press followed by a shaft. The last few millimeters of the shaft are further turned down and then threaded to create the joint between the finger pad piece 24 and the main piston body 20 . [0025] The main piston body 20 is made from brass. Brass is used because it has self-lubricating properties while still maintaining an appreciable density (as opposed to Teflon). The main piston body 20 is made by first drilling and tapping either end of a brass rod in order to create a mating threaded hole for the finger pad 24 and piston head 22 . Then either end of the brass rod is turned down on the lathe to a diameter which will fit through the holes created in the casing tube. [0026] The piston head piece 22 is made from stainless steel rod which is turned down on a lathe. The head itself is made round and smooth because it will come into contact with the patient. The shaft is further turned down and threaded at the last few millimeters in order to mate the shaft of the piston head 22 to the threaded hole in the piston body piece 20 described above. [0027] The spring 26 is a stainless steel compression spring without modification. [0028] The hammer-action assembly 14 is formed by aligning the piston body 20 into the top half 28 of the casing piece. Then the spring 26 is slid over the bottom portion of the piston body 20 and is compressed as the bottom half 30 of the casing is mated to the top half 28 and securely screwed together. Next, the finger pad 24 and piston head 22 are mated to the threaded holes of the piston body 20 which are protruding out of the casing pieces. [0029] The hammer-action assembly 14 can then be screwed into place on the tapper base piece 12 by mating the threaded portion of the bottom half of the casing 30 to the threaded hole of the base piece 12 . Finally, the stainless steel set-screw 18 can be pressed into the holes in the tails of the base piece 12 . [0030] Referring now to FIG. 3, there is shown an alternative embodiment of the percussion device 10 with pieces made from a die-casting or from a plastic injection molding process, so that the part count may be reduced from eight to four total pieces. In this embodiment, the base piece 12 , upper casing 28 , and lower casing 30 may all be combined into two symmetrically split pieces, of which one is shown in FIG. 3, which meet and are assembled around the piston 19 . The piston 19 may be formed from a single piece (reducing it from 3 pieces to 1 piece). In this design, the spring 26 is first positioned on the piston 19 . Then the piston 19 and spring 26 are placed in one half of the combined base-casing part. Finally, the other symmetrical base-casing part is mated to the identical half and the two are sealed together with a bonding material. The stainless steel set-screw 18 is pushed into the holes at the tails of the base 12 as described above. If the base-casing combined part is made from plastic, the set-screw may not be necessary as the plastic may be flexible enough to allow for a tight fit without a set-screw. [0031] In use, as illustrated in FIGS. 4A and 4B, the mechanical percussion device 10 attaches to the head of the stethoscope 16 and is designed to be used in conjunction with the stethoscope. While the healthcare professional is listening to the thorax or abdomen with the stethoscope, the percussion device 10 may be used by depressing the spring-loaded piston 19 with the index finger, F (FIG. 4B), of the same hand that holds the stethoscope head 16 against the patient's skin, S. The resonant sounds of the body cavity will be distinctly audible through the stethoscope earpieces. The topologic pattern of percussion and comparative percussion techniques described in clinical medicine texts such as “Bates' Guide to Physical Examination and History Taking, 8th edition,” by Lynn S. Bickley and Peter G. Szilagyi, Lippincott Williams & Wilkins, Philadelphia, 2003, the entire contents of which are incorporated herein by reference, may still be followed with the percussion device 10 . The piston may be repeatedly depressed and released to created a consistent and regular tapping action that will aid in diagnoses. [0032] While this invention has been particularly shown and described with references to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims. For instance, the shape and feel of the device can be different than that described above. Any suitable material can be used to make the various parts of the percussion device. The hammer action can implement different types of mechanical mechanisms, such as, tube bearing, weighted pivot, rolling weight, and bow action snap-back mechanisms. Other types of designs for different finger motions for the mechanical action are contemplated, as well, such as, for example, angled piston motion, rolling motion, or a camera trigger motion with a button on the edge of the device rather than on the back of the device. Moreover, an electronic or electromagnetic actuator can be used in place of the manual device.

A mechanical tapper clips onto the end of a stethoscope. The device is operated by pressing a small plunger with the index finger of the hand holding the end of the stethoscope onto the patient's body to aid the percussion portion of a physical exam.

CROSS-REFERENCE TO RELATED APPLICATIONS This patent application is a continuation of a patent application entitled “Stabilization of Arsenic-Contaminated Materials,” application Ser. No. 09/099,738, filed Jun. 18, 1998, now U.S. Pat. No. 6,254,312, issued Jul. 3, 2001. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not-applicable. BACKGROUND OF THE INVENTION The present invention relates to methods for treating an arsenic-contaminated waste matrix to stabilize the arsenic and reduce arsenic leaching to contaminant acceptable levels. Arsenic, which is carcinogenic in its inorganic form, is identified in the Resource Conservation Recovery Act (RCRA) as a hazardous metal and is reportedly the third most common regulated inorganic contaminant found at Superfund sites. Specific sources of hazardous waste containing arsenic include: pesticides and herbicides [MSMA (monosodium methane arsonate), cacodylic acid (dimethyl arsinic acid), sodium arsenite, lead arsenate)], ammonia still lime sludge from coking operations, veterinary pharmaceuticals [(RCRA waste listing K084) wastewater treatment sludge, (K101) distillation tar residue from distillation of aniline-based compounds, (K102) residue from use of activated carbon for decolorization], arsenic sulfide (D004) generated from phosphoric acid purification, and wood preservative manufacturing wastes. Other anthropogenic sources of arsenic include: coal-burning fly ash from energy production copper, lead and zinc smelter operations gold mining operations, and glass manufacturing and cotton gin processing. While arsenic, like other metals, exhibits a positive valence state, in aqueous materials it usually exists not as a solitary cationic species but as an oxy-anion, typically in a mixture of a trivalent (+3), reduced form (arsenite, AsO 3 3− ) and/or a pentavalent (+5) oxidized form (arsenate, AsO 4 3− ). As a result, technologies that effectively treat other cationic metals are typically not effective for stabilizing arsenic. The ability of arsenic to change oxidation state under certain environmental conditions poses a challenge to treatment methods because the different oxidation states have different mobilities in the environment. Arsenite is usually more mobile than arsenate. Also, arsenic is amenable to numerous chemical and biological transformations in the environment, which can result in increased mobility. The mobility of arsenic can be controlled by redox conditions, pH, biological activity and adsorption/desorption reactions. Arsenic stabilization chemistry is complex and is influenced significantly by the chemical speciation of arsenic (valence state, inorganic vs. organic, etc.), the oxidation-reduction potential and acidity/alkalinity of the waste matrix, and the presence of other metals, counter ions, and complexing ligands. Arsenic is often present in waste with lead or chromium. Typical techniques for stabilizing these metals (e.g., treating with phosphate to stabilize lead, or treating with reducing agents to stabilize chromium) can undesirably increase arsenic leachability from wastes. When arsenic and chromium are found in together in the same waste matrix, the contaminants are typically present as chromated copper arsenate (CCA). According to the U.S. Environmental Protection Agency, slag vitrification at 1,100 to 1,400° C. is the Best Demonstrated Available Treatment (BDAT) for arsenic. In a vitrification process, all forms of arsenic are converted to arsenic oxide, which reacts with other glass-forming constituents and becomes immobilized in the glass formed. In most arsenic stabilization situations, vitrification is impractical, however, because of the high energy costs and a secondary problem of volatilizing arsenic to cause air pollution. Other known detoxification technologies include chemistries that involve solidification or chemical stabilization. “Solidification” is defined by US EPA as a technique that encapsulates the waste in a monolithic solid of high structural integrity. The encapsulation may be effected by fine waste particles (microencapsulation) or by a large block or container of wastes (macroencapsulation). Solidification does not necessarily involve a chemical interaction between the wastes and the solidifying reagents, but may mechanically bind the waste into the monolith. Contaminant migration is restricted by decreasing the surface area exposed to leaching and/or by isolating the wastes within an impervious capsule. “Stabilization” refers to those techniques that reduce the hazard potential of a waste by converting the contaminants into their least soluble, mobile, or toxic form. The physical nature and handling characteristics of the waste are not necessarily changed by stabilization. These definitions appear on page 2 of Conner, J. R., Chemical Fixation and Solidification of Hazardous Wastes , Van Nostrand Reinhold, New York (1990), which is incorporated herein by reference in its entirety. U.S. Pat. No. 5,037,479 (Stanforth) discloses a method for treating solid hazardous waste containing unacceptable levels of leachable metals such as lead, cadmium and zinc, which includes the steps of mixing the solid waste with at least two additives, a pH buffering agent and an additional agent which is a salt or acid containing an anion that forms insoluble or non-leachable forms of the leachable metal, each agent being selected from a specified group of agents. U.S. Pat. No. 5,202,033 (Stanforth et al.) discloses a method for treating solid hazardous waste containing unacceptable levels of leachable metals such as lead, cadmium, arsenic, zinc, copper and chromium, which includes the steps of mixing the solid waste in situ with a phosphate source or a carbonate source or ferrous sulfate. An additional pH controlling agent is optionally added under conditions which support reaction between the additive and pH controlling agent and the metals, to convert the metals to a relatively stable non-leachable form. U.S. Pat. No. 5,430,235 (Hooykaas et al.) discloses a process for solidifying an arsenic-contaminated matrix as a rock-hard product using high dosages of a clay material, an iron salt, a manganese salt, an oxidizer, and a hydraulic binder such as Portland cement. The process disclosed in U.S. Pat. No. 5,430,235 has several disadvantages. Because of the requirement for a hydraulic binder, the process includes a curing period of 7 days or longer. The process also results in significant bulking (volume increase) of the treated waste materials. If dosage levels are lower than those identified as preferred, it is difficult to achieve solidification. U.S. Pat. No. 5,347,077 (Hooykaas et al.) discloses a process for solidifying contaminated soil, sediment or sludge that may contain arsenic by adding iron, manganese, aluminum salts and Portland cement at dosages of 20 percent by weight and higher. Again, the process requires a curing period and has the additional disadvantage of high bulking after treatment. Hooykaas et al. use an oxidizing agent to oxidize organic matter, since it is difficult to solidify the waste matrix in the presence of organic matter. U.S. Pat. No. 5,252,003 (McGahan) discloses a process for controlling arsenic leaching from waste materials by adding iron (III) ions and magnesium (II) ions, preferably in the form of iron (III) sulfate and magnesium oxide. U.S. Pat. No. 4,723,992 (Hager) discloses a process for fixing pentavalent arsenic in soil by adding metal salts or iron, aluminum, or chromium and a weak organic acid. U.S. Pat. No. 5,130,051 (Falk) discloses a process for encapsulating waste that contains toxic metals, including arsenic, by adding a mixture of alkaline silicate and magnesium oxide, and, optionally, borax, a concentrated acid, a reducing agent, and fly ash at high dosage rates. The iron (ferric) sulfate treatment process is ineffective against reduced forms of arsenic and does not provide long-term stability of treated wastes because, under certain natural conditions, the ferric ions may be reduced to ferrous form, thereby remobilizing the arsenic. The solidification processes require very high additive dosages with resultant high bulking of the treated waste. None of the known technologies discloses a process for cost-effectively and permanently stabilizing arsenic in contaminated soil, sediment, or sludge where the arsenic can be present in trivalent and pentavalent states, and in both organic and inorganic forms. The patents mentioned in the Background of the Invention are specifically incorporated herein by reference in their entirety. BRIEF SUMMARY OF THE INVENTION The present invention provides a method for stabilizing an arsenic-contaminated waste matrix and reducing the leaching of arsenic to acceptable levels. A major objective of the invention is to provide a method for treating an arsenic-contaminated waste matrix that contains arsenic in both the reduced (arsenite) and/or the oxidized (arsenate) form. Other objectives of the invention include efficiently treating both organic and inorganic arsenic compounds, providing long-term, permanent treatment of arsenic, providing treatment with low bulking potential, and providing a treatment method that is cost-effective and easy to conduct. In the method of the present invention, an agent for controlling oxidation-reduction (redox) potential (ORP), an agent for controlling pH, and an agent for adsorption and coprecipitation of the arsenic are mixed with the arsenic-contaminated material. The sum of the amounts of added ORP control agent, pH control agent and adsorption-coprecipitation agent are insufficient to cause the waste matrix to solidify without adding a binding agent of the type identified by Hooykaas. The ORP control agent and the pH control agent are added in amounts that will vary with the amount of contaminants present, but in any event, in amounts sufficient to bring most (at least about 50%) of the contaminating arsenic into its higher oxidized state. The arsenite/arsenate transition is controlled by adjusting the redox potential and pH in a coordinated manner. For example, see Vance, D. B., “Arsenic: Chemical Behavior and Treatment,” National Environmental Journal 60-64 (May/June 1995), incorporated by reference herein in its entirety, which includes charts that depict the speciation of arsenic under various conditions. Agents for adsorbing and coprecipitating arsenic, such as ferric iron, are also known. Id. Although the chemicals used in the stabilization process can have a higher unit cost, the package cost is lower than that of solidification methods because the chemicals are used in small amounts. The ORP control agent, pH control agent and adsorption-coprecipitation agent can each be added to between 0.01 and 10 percent of the waste matrix, by weight. The invention will be more fully understood upon consideration of the following detailed description. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS Not applicable. DETAILED DESCRIPTION OF THE INVENTION The invention describes a cost-effective, low-bulking, permanent method for stabilizing an arsenic-contaminated waste matrix wherein the method comprises the steps of incorporating an ORP control agent, a pH control agent, and an adsorption-coprecipitation agent. The types and additive rates of these component chemistries will depend on arsenic speciation and concentration, the waste matrix, and on the overall treatment objectives. A goal achieved by the method of the present invention is to bring the level of leachable arsenic to no higher than the maximum acceptable Toxicity Characteristic Leaching Procedure (TCLP) toxicity level of 5 mg/L dictated by RCRA. The same level would be set as the criterion for TCLP-arsenic in the proposed Universal Treatment Standard (UTS). The leachable arsenic as measured by the TCLP test can be reduced to a level below the maximum acceptable toxicity level of 5.0 mg/L, e.g., 0.5 mg/L, and perhaps lower. The arsenic-contaminated materials can include, but are not limited to, sediment, soil, sludge and industrial wastes. The method is a low-bulking method, by which it is intended that after practicing the method the waste matrix volume is preferably no more than 10% greater, and more preferably no more than 5% greater, than before stabilization. In a first embodiment of the method, each of the three agents is a separate class of chemical compound. In a second embodiment, a single chemical additive can act as two components in the treatment. An alternative would be that the chemical species added initially as one component of the chemistry may react with a waste matrix to produce a second component of the chemistry. In another embodiment, under suitable conditions, one chemical compound added to a specific waste matrix can serve the function of all three components in the disclosed arsenic stabilization method. The ORP control agent can increase or decrease the redox potential of the waste matrix depending upon the arsenic speciation and presence of other metal contaminants. It is desirable to reduce the mobility by providing conditions where most (at least about 50%, preferably 60 to 95%, more preferably 80 to 95%) of the arsenic compounds are present in the higher oxidized (arsenate) state. For example, if a substantial fraction of arsenic is present in the arsenite form and no other major heavy metal oxy-anions are present in the waste, an oxidizing ORP agent is selected to increase the redox potential of the waste matrix. This can be complicated by the presence of other heavy metal oxy-anions, such as hexavalent chromium, in the waste matrix. If the waste contains arsenic and another such heavy metal compound, the leaching potential of both the arsenic and the other heavy metal is decreased by lowering the redox potential of the waste matrix using a reducing ORP control agent. In this situation the ORP is reduced enough to convert chromium from its hexavalent state to less mobile trivalent state while the ORP would still be in the range for arsenic to be present most in its less mobile pentavalent state. The oxidizing ORP control agent can be any compound that increases the redox potential of the waste matrix, although the compound is preferably one that has insignificant environmental impact upon the matrix. Suitable oxidizing ORP control agents include potassium permanganate, sodium chlorate, sodium perchlorate, calcium chlorite or another chlorinated oxidizing agent, sodium percarbonate, sodium persulfate, sodium perborate, potassium persulfate, hydrogen peroxide, magnesium peroxide, or another peroxide compound, compounds of multivalent elements at their higher oxidation state (e.g., ferric sulfate), gaseous oxygen, and ozone. The reducing ORP control agents can be any compound that decreases the redox potential of the waste matrix, although the compound is preferably one that has insignificant environmental impact upon the matrix. Suitable reducing ORP control agents include ferrous sulfate, sulfur dioxide, sodium bisulfite, sodium metabisulfite, or the like. In the presence of the adsorption-coprecipitation agent, the pH of the waste matrix controls the leaching potential of arsenic in conjunction with the redox potential of the waste. The pH control agent is selected to raise or lower the pH of the waste matrix depending on the original acidity/alkalinity of the waste and the treatment objectives, in accordance with the diagrams shown in Vance, supra. The pH control agents for raising pH can be any compound that raises the pH, without significant environmental impact, and can include magnesium oxide or hydroxide, calcium oxide or hydroxide, barium oxide or hydroxide, reactive calcium carbonate, sodium hydroxide, dolomitic lime, limestone (high calcium or dolomite), and the like. The pH control agents for lowering pH can be any compound that lowers the pH, without significant environmental impact, and can include sulfuric acid, phosphoric acid, another mineral acid, or ferric sulfate, ferric chloride, aluminum sulfate, aluminum chloride, and like acidic compounds. A suitable adsorption-coprecipitation agent can react with arsenic to form an insoluble arsenic compound or can immobilize arsenic on its surface by chemical adsorption. The adsorption-coprecipitation agent can be, but is not limited to, ferric sulfate, aluminum sulfate, activated alumina, or manganese dioxide. The chemical additives, which can be in a solid state, aqueous slurry, or in solution, are thoroughly mixed with the waste matrix to be stabilized. The stabilization method can be performed in situ using conventional earth-moving equipment such as a back hoe, tiller, or drag line, or ex situ by blending the additives with the waste matrix in a mechanical device, such as a pugmill or a cement mixer. In a typical practice of the method for stabilizing arsenic and reducing arsenic leachability, the ORP control agent is mixed first with the waste matrix, followed by the adsorption-coprecipitation agent and then the pH control agent. Alternatively, all three components can be added simultaneously to, and mixed with, the waste matrix. The additive dosage requirements typically total less than 10-15 percent of the weight of the waste matrix. This is a major advantage over solidification methods, which require 20-30 percent or higher dosages of additives, including cement-like materials. If the additives are mixed uniformly with the waste, no curing step is required. This is another significant advantage over solidification systems which typically requiring curing periods of one week or more. The present invention will be more fully understood upon consideration of the following Examples which are intended to be exemplary and not limiting. EXAMPLE 1 TABLE 1 Additive (wt %) Untreated Treatment ORP control — — — — 0.5 (potassium permanganate) pH control — — 1 1 1 (magnesium oxide) Ads/Coprecip — 5 5 10 5 (ferric sulfate) TCLP (mg/L) 26.0 17.0 2.4 1.9 0.75 An arsenic-contaminated river sediment contained 14,000 mg/kg dry weight total arsenic and was determined to contain hazardous levels of arsenic, with a screening TCLP-arsenic concentration of 26.0 mg/L. The sediment was treated with a 3-component treatment chemistry according to the present invention. In this trial, shown in Table 1, the ORP control agent (potassium permanganate) was added at 0.5 percent by weight. The pH control agent (magnesium oxide) was added at 1 percent by weight. The adsorption-coprecipitation (Ads/Coprecip) agent (ferric sulfate) was added at 5 percent by weight. The sediment treated according to the invention was nonhazardous and had a screening TCLP-arsenic concentration of 0.75 mg/L. In controls, ferric sulfate alone (5 percent by weight) reduced the screening TCLP-arsenic concentration to 17.0 mg/L, while magnesium oxide (1 percent by weight) with ferric sulfate (5 percent by weight) reduced the screening TCLP-arsenic concentration to 2.4 mg/L, respectively. At a higher dosage of ferric sulfate (10 percent by weight) with magnesium oxide (1 percent by weight), treatability of the sediment improved marginally, reducing the screening TCLP-arsenic concentration to 1.9 mg/L. EXAMPLE 2 TABLE 2 Additive (wt %) Untreated Treatment ORP control — —  5 — — 5 (potassium permanganate) pH control —  5 — — 5 5 (magnesium oxide) Ads/Coprecip — —  5  5 5 (ferric sulfate) TCLP (mg/L) 290 220 160 69 14.0 1.1 Arsenic-contaminated soil containing 10,100 mg/kg dry weight arsenic had a screening TCLP-arsenic concentration of 290 mg/L. This contaminated soil was treated with the additives described in Example 1, either singly or in combination. Separate treatment with 5 percent by weight dosages of potassium permanganate, magnesium oxide, or ferric sulfate gave screening TCLP-arsenic concentrations of 160 mg/L, 220 mg/L, and 69 mg/L, respectively. When magnesium oxide and ferric sulfate were mixed with the soil at 5 percent by weight each, the screening TCLP-arsenic concentration was reduced to 14.0 mg/L. When potassium permanganate, magnesium oxide, and ferric sulfate were added at 5 percent by weight each, the soil was rendered nonhazardous with a screening TCLP-arsenic concentration of 1.1 mg/L. The present invention is not intended to be limited by the foregoing, but rather to encompass all such variations and modifications as come within the scope of the following claims.

A method for stabilizing arsenic in a waste matrix includes the steps of combining with the waste matrix an agent for controlling the oxidation-reduction potential of the matrix, an agent for controlling the pH of the matrix and an agent for adsorbing or coprecipitating the arsenic in the matrix.

CROSS REFERENCE TO RELATED APPLICATION This application is a continuation of U.S. application Ser. No. 10/701,855 filed Nov. 5, 2003 (issued as U.S. Pat. No. 6,969,474); which is a continuation of U.S. application Ser. No. 09/777,335 filed Feb. 6, 2001 (issued as U.S. Pat. No 6,652,765); which is a continuation of U.S. patent application Ser. No. 09/259,432 filed Mar. 1, 1999 (issued as U.S. Pat. No. 6,491,723); which is a continuation of U.S. patent application Ser. No. 08/607,903 filed Feb. 27, 1996 (issued as U.S. Pat. No. 5,876,453); which is a continuation-in-part of pending U.S. patent application Ser. No. 08/351,214, filed Nov. 30, 1994, (now abandoned) for “Implant Surface Preparation.” FIELD OF THE INVENTION The present invention relates to processes for improving the surfaces of devices to be surgically implanted in living bone, and to implant devices having the improved surfaces. BACKGROUND OF THE INVENTION The success of prosthetic devices surgically implanted in living bone depends substantially entirely on achieving and maintaining an enduring bond between the confronting surfaces of the device and the host bone. Surgical procedures for preparing living bone to receive a surgically implanted prosthetic device have been known for twenty years or more, but considerable controversy remains concerning the ideal properties of the surface of the device which confronts the host bone. It is known through clinical experience extending over several decades that titanium and its dilute alloys have the requisite biocompatability with living bone to be acceptable materials for use in making surgically implantable prosthetic devices, when the site of installation is properly prepared to receive them. There is, however, less certainty about the ideal physical properties of the surfaces of the prosthetic devices which confront the host bone. For example, the endosseous dental implant made of titanium enjoys sufficient predictable success to have become the artificial root most frequently chosen for restoring dentition to edentulous patients, but that success depends in part on the micromorphologic nature of the surface of the implant which comes in contact with the host bone. Because there is no standard for the surface micromorphology of dental implants, the surfaces of commercial implants have a wide range of available textures. It is known that osseointegration of dental implants is dependent, in part, on the attachment and spreading of osteoblast-like cells on the implant surface. It appears that such cells will attach more readily to rough surfaces than to smooth surfaces, but an optimum surface for long-term stability has not yet been defined. Wilke, H. J. et al. have demonstrated that it is possible to influence the holding power of implants by altering surface structure morphology: “The Influence of Various Titanium Surfaces on the Interface Strength between Implants and Bone”, Advances in Biomaterials , Vol. 9, pp. 309–314, Elsevier Science Publishers BV, Amsterdam, 1990. While showing that increased surface roughness appeared to provide stronger anchoring, these authors comment that it “cannot be inferred exclusively from the roughness of a surface as shown in this experiment. Obviously the shear strength is also dependent on the kind of roughness and local dimensions in the rough surface which can be modified by chemical treatment.” Buser, D. et al., “Influence of Surface Characteristics on Bone Integration of Titanium Implants”, Journal of Biomedical Materials Research , Vol. 25, pp. 889–902, John Wiley & Sons, Inc., 1991, reports the examination of bone reactions to titanium implants with various surface characteristics to extend the biomechanical results reported by Wilke et al. The authors state that smooth and titanium plasma sprayed (“TPS”) implant surfaces were compared to implant surfaces produced by alternative techniques such as sandblasting, sandblasting combined with acid treatment, and plasma-coating with HA. The evaluation was performed with histomorphometric analyses measuring the extent of the bone-implant interface in cancellous bone. The authors state, “It can be concluded that the extent of bone-implant interface is positively correlated with an increasing roughness of the implant surface.” Prior processes that have been used in attempts to achieve biocompatible surfaces on surgically implantable prosthetic devices have taken many forms, including acid etching, ion etching, chemical milling, laser etching, and spark erosion, as well as coating, cladding and plating the surface with various materials, for example, bone-compatible apatite materials such as hydroxyapatite or whitlockite or bone-derived materials. Examples of U.S. patents in this area are U.S. Pat. Nos. 3,855,638 issued to Robert M. Pilliar Dec. 24, 1974 and 4,818,559 issued to Hama et al. Apr. 04, 1989. A process of ion-beam sputter modification of the surface of biological implants is described by Weigand, A. J. et al. in J. Vac. Soc. Technol ., Vol. 14, No. 1, January/February 1977, pp. 326–331. As Buser et al. point out (Ibid p. 890), the percentage of bone-implant contact necessary to create sufficient anchorage to permit successful implant function as a load-bearing device over time remains unclear. Likewise, Wennerberg et al., “Design and Surface Characteristics of 13 Commercially Available Oral Implant Systems”, Int. J. Oral Maxillofacial Implants 1993, 8:622–633, show that the different implants studied varied considerably in surface topography, and comment: “Which of the surface roughness parameters that will best describe and predict the outcome of an implant is not known” (p. 632). Radio-frequency glow-discharge treatment, also referred to as plasma-cleaning (“PC”) treatment, is discussed in Swart, K. M. et al., “Short-term Plasma-cleaning Treatments Enhance in vitro Osteoblast Attachment to Titanium”, Journal of Oral Implantology , Vol. XVIII, No. 2 (1992), pp. 130–137. These authors comment that gas plasmas may be used to strip away-organic contaminants and thin existing oxides. Their conclusions suggest that short-term PC treatments may produce a relatively contaminant-free, highly wettable surface. U.S. Pat. No. 5,071,351, issued Dec. 10, 1991, and U.S. Pat. No. 5,188,800, issued Feb. 23, 1993, both owned by the assignee of the present application, describe and claim methods and means for PC cleaning of a surgical implant to provide a contact angle of less than 20 degrees. Copending application Ser. No. 08/149,905, filed Nov. 10, 1993, owned by the assignee of the present application, describes and claims inventions for improving the surfaces of surgically implantable devices which employ, among other features, impacting the surface with particles of the same material as the device to form the surface into a desired pattern of roughness. SUMMARY OF THE INVENTION It is a primary object of the present invention to produce an implant surface having a roughness that is substantially uniform over the area of the implant that is intended to bond to the bone in which the implant is placed. It is a further object of this invention to provide an improved surgically implantable device having on its surface a substantially uniform micromorphology. It is another object of the invention to provide a process or processes for manufacturing such improved implant devices. It is an additional object of the invention to provide such improved implant devices which can be manufactured without contaminating the surfaces thereof. It is a more specific object of the invention to provide an improved etch-solution process that will result in a substantially uniform surface topography on surgically implantable devices. In accordance with the present invention, the foregoing objectives are realized by removing the native oxide layer from the surface of a titanium implant to provide a surface that can be further treated to produce a substantially uniform surface texture or roughness, and then performing a further, and different, treatment of the resulting surface substantially in the absence of unreacted oxygen. The removal of the native oxide layer may be effected by any desired technique, but is preferably effected by immersing the implant in hydrofluoric acid under conditions which remove the native oxide quickly while maintaining a substantially uniform surface on the implant. The further treatment is different from the treatment used to remove the native oxide layer and produces a desired uniform surface texture, preferably acid etching the surface remaining after removal of the native oxide layer. To enhance the bonding of the implant to the bone in which it is implanted, a bone-growth-enhancing material, such as bone minerals, hydroxyapatite, whitlockite, or bone morphogenic proteins, may be deposited on the treated surface. The implant is preferably maintained in an oxygen-free environment following removal of the native oxide layer, in order to minimize the opportunity for oxide to re-form before the subsequent treatment is performed. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a diagrammatic sectional view taken through a body of titanium covered with a layer of native oxide; FIG. 2 is the same section shown in FIG. 1 after impacting the surface with a grit; FIG. 3 is the same section shown in FIG. 2 after bulk etching with an acid etch; FIG. 4 is the same section shown in FIG. 2 after first removing the native oxide and then bulk etching with an acid; FIGS. 5A and 5B are scanning electron micrographs (“SEMs”) of two titanium dental implants prepared in accordance with the present invention; FIGS. 6A and 6B are SEMs of the same implants shown in FIGS. 5A and 5B , at a higher magnification level; FIG. 7 is a graph of the results of an Auger electron spectroscopic analysis of a titanium surface that has been exposed to air; FIGS. 8A and 8B are SEMs of two titanium dental implants prepared in accordance with the present invention; and FIGS. 9A and 9B are SEMs of the same implants shown in FIGS. 8A and 8B , at a higher magnification level. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Turning now to the drawings, and referring first to FIG. 1 , a titanium body 10 which has been exposed to air has on its outer surface 12 an irregular layer 14 of an oxide or oxides of titanium which form naturally. This oxide layer 14 is referred to herein as the “native oxide” layer, and typically has a thickness in the range from about 70 to about 150 Angstroms. The native oxide layer that forms naturally on titanium when it is exposed to air is actually a combination of different oxides of titanium, including TiO, TiO 2 , Ti 2 O 3 and Ti 3 O 4 . The concentration of these oxides in the titanium body diminishes with distance from the surface of the body. The oxide concentration may be measured in an Auger spectrometer. Auger electron spectroscopy (AES) measures the energy of Auger electrons produced when an excited atom relaxes by a radiationless process after ionization by a high energy electron, ion or x-ray beam. The spectra of a quantity of electrons emitted as a function of their energy reveal information about the chemical environment of the tested material. One of the major uses of AES is the depth profiling of materials, to reveal the thickness (depth) of the oxide layer on the surfaces of materials. These Auger electrons lie in an energy level that extends generally between the low energy level of the emission of secondary electrons up to the energy of the impinging electron beam. In this region, small peaks will occur in the spectra at certain energy levels that identify the existence of certain elements in the surface. As used herein, the term “native oxide layer” refers to the layer which extends from the surface of the material to the depth at which the energy of the peak-to-peak oxygen profile as measured in an Auger electron spectrometer decreases by one-half. For example, in the peak-to-peak oxygen profile reproduced in FIG. 7 , the thickness of the native oxide layer was 130 Angstroms, which is the depth at which the oxygen profile dropped to half its maximum intensity. Thus, removal of a 130-Angstrom layer from the surface of the titanium body would remove the native oxide layer. FIG. 2 depicts the surface 12 of the titanium body 10 after being grit blasted to achieve initial roughening, as described in more detail below. The oxide layer 14 is still present, but it has a rougher surface than in its original state depicted in FIG. 1 . FIG. 3 depicts the grit-blasted surface 12 of the titanium body 10 after it has been bulk etched in an etching acid. The etched area 16 where the native oxide layer 14 has been removed by the etching acid exhibits a much finer roughness, but in areas where the oxide layer remains, the initial roughness depicted in FIG. 2 also remains. FIG. 4 depicts the grit-blasted surface 12 of the titanium body 10 after it has been etched in a first acid to remove the native oxide layer 14 , and then in a second acid to produce the desired topography on the surface 16 produced by the first acid treatment. As described in more detail below, the preferred surface topography has a substantially uniform, fine roughness over the entire surface 16 . Among the processes previously used to improve the surfaces of dental implants made of titanium is that of etching the surface with an acid, such as a mixture of two parts (by volume) sulfuric acid and one part (by volume) muriatic acid. It has been found that such acid treatments do not etch an oxidized implant surface uniformly or consistently from one region to another. According to one aspect of the present invention, the native oxide layer is removed from the surface of a titanium implant prior to the final treatment of the surface to achieve the desired topography. After the native oxide layer is removed, a further and different ‘treatment of the surface is carried out in the absence of unreacted oxygen to prevent the oxide layer from re-forming until after the desired surface topography has been achieved. It has been found that this process permits the production of unique surface conditions that are substantially uniform over the implant surface that is so treated. Removal of the native oxide layer can be effected by immersing the titanium implant in an aqueous solution of hydrofluoric (HF) acid at room temperature to etch the native oxide at a rate of at least about 100 Angstroms per minute. A preferred concentration for the hydrofluoric acid used in this oxide removal step is 15% HF/H 2 O. This concentration produces an etch rate of approximately 200–350 Angstroms per minute at room temperature, without agitation, so that a typical native oxide layer having a thickness in the range from about 70 to about 150 Angstroms can be removed in about one-half minute. Other suitable etching solutions for removing the native oxide layer, and their respective etch rates, are: 50% HF−etch rate˜600 to 750 Angstroms/min. 30% HF−etch rate˜400 to 550 Angstroms/min. 10% HF−etch rate˜100 to 250 Angstroms/min. A 100% HF was found to be difficult to control, and the etch rate was not determined. The preferred 15% HF solution allows substantially complete removal of the native oxide layer with minimum further consumption of the titanium surface after the implant is removed from the solution. The native oxide layer may be removed by the use of other acids, or by the use of techniques other than acid etching. For example, the Swart et al. article cited above mentions the use of plasma cleaning to remove thin oxides. Regardless of what technique is used, however, it is important to remove substantially all the native oxide from the implant surface that is intended to interface with the living bone, so that the subsequent treatment of that surface produces a substantially uniform surface texture to promote uniform bonding to the living bone. The native oxide layer is preferably removed from substantially the entire bone-interfacing surface of the implant. In the case of screw-type, such as implent 10 , illustrated in FIG. 12 , dental implants, the bone-interfacing surface typically includes the entire implant surface beyond a narrow collar region 14 on the side wall of the implant at the gingival end thereof. This narrow collar region 14 preferably includes the first turn of the threaded portion 16 , of the implant. It is preferred not to etch the gingival end 17 itself, as well as the narrow 16 collar region 14 , because these portions of the implant are normally fabricated with precise dimensions to match abutting components which are eventually attached to the gingival end 12 of the implant. Moreover, it is preferred to have a smooth surface on that portion of a dental implant that is not embedded in the bone, to minimize the risk of infection. The treatment that follows removal of the native oxide layer must be different from the treatment that is used to remove the native oxide layer. A relatively aggressive treatment is normally required to remove the oxide layer, and such an aggressive treatment does not produce the desired uniform surface texture in the resulting oxide-free surface. Thus, after the native oxide layer has been removed, the resulting implant surface is immediately rinsed and neutralized to prevent any further attack on the implant surface. The surface is then subjected to the further, and different, treatment to produce a desired uniform surface texture. For example, the preferred further treatment described below is a relatively mild acid-etching treatment which forms a multitude of fine cone-like structures having relatively uniform, small dimensions. Because of the prior removal of the native oxide layer, even a mild second treatment of the implant surface can produce a substantially uniform effect over substantially the entire bone-interfacing surface of the implant. Prior to removing the native oxide layer, the oxide-bearing surface may be grit blasted, preferably with grit made of titanium or a dilute titanium alloy. As is taught in the aforementioned copending U.S. patent application Ser. No. 08/149,905, the use of a grit made of titanium avoids contaminating the surface of a titanium implant. Thus, for a dental implant made of commercially pure (“CP”) titanium, the blasting material may be CP B299 SL grade titanium grit. The preferred particle size for this grit is in the range from about 10 to about 60 microns (sifted), and the preferred pressure is in the range from about 50 to about 80 psi. The surface treatment that follows removal of the native oxide layer from the implant surface may take several forms, singly or in combination. The preferred treatment is a second acid etching step, using an etch solution (“Modified Muriaticetch”) consisting of a mixture of two parts by volume sulfuric acid (96% by weight H 2 SO 4 , 4% by weight water) and one part by volume hydrochloric acid (37% by weight HCl, 63% by weight water) at a temperature substantially above room temperature and substantially below the boiling point of the solution, preferably in the range from about 60° C. to about 80° C. This mixture provides a sulfuric acid/hydrochloric acid ratio of about 6:1. This preferred etch solution is controllable, allowing the use of bulk etch times in the range from about 3 to about 10 minutes. This solution also can be prepared without the risk of violent reactions that may result from mixing more concentrated HCl solutions (e.g., 98%) with sulfuric acid. This second etching treatment is preferably carried out in the absence of unreacted oxygen, and before the implant surface has been allowed to re-oxidize, following removal of the native oxide layer. Of course, the implants may be kept in an inert atmosphere or other inert environment between the two etching steps. The second etching step produces a surface topography that includes many fine projections having a cone-like aspect in the sub-micron size range. Because of the fine roughness of the surface, and the high degree of uniformity of that roughness over the treated surface, the surface topography produced by this process is well suited for osseointegration with adjacent bone. As illustrated by the working examples described below, the final etched surface consists of a substantially uniform array of irregularities having peak-to-valley heights of less than about 10 microns. Substantial numbers of the irregularities are substantially cone-shaped elements having base-to-peak heights in the range from about 0.3 microns to about 1.5 microns. The bases of these cone-shaped elements are substantially round with diameters in the range from about 0.3 microns to about 1.2 microns, and spaced from each other by about 0.3 microns to about 0.75 microns. The SEMs discussed below, and reproduced in the drawings, illustrate the surface topography in more detail. The acid-etched surface described above also provides a good site for the application of various materials that can promote bonding of the surface to adjacent bone. Examples of such materials are bone-growth-enhancing materials such as bone minerals, bone morphogenic proteins, hydroxyapatite, whitlockite, and medicaments. These materials are preferably applied to the etched surface in the form of fine particles which become entrapped on and between the small cone-like structures. The bone-growth-enhancing materials are preferably applied in the absence of oxygen, e.g., using an inert atmosphere. The roughness of the surface to which these materials are applied enhances the adherence of the applied material to the titanium implant. The uniformity of the rough surface enhances the uniformity of the distribution of the applied material, particularly when the material is applied as small discrete particles or as a very thin film. A preferred natural bone mineral material for application to the etched surface is the mineral that is commercially available under the registered trademark “BIO-OSS”. This material is a natural bone mineral obtained from bovine bone; it is described as chemically comparable to mineralized human bone with a fine, crystalline biological structure, and able to support osseointegration of titanium fixtures. The invention will be further understood by reference to the following examples, which are intended to be illustrative and not limiting: EXAMPLE NO. 1 A batch of 30 screw-type cylindrical implants made of CP titanium were grit blasted using particles of CP B299 SL grade titanium grit having particle sizes ranging from 10 to 45 microns, at a pressure of 60 to 80 psi. After grit-blasting, native oxide layer was removed from the implant surfaces by placing 4 implants in 100 ml. of a 15% solution of HF in water at room temperature for 30 seconds. The implants were then removed from the acid, neutralized in a solution of baking soda, and placed in 150 ml. of “Modified Muriaticetch” (described above) at room temperature for 3 minutes. The implants were then removed from the acid, neutralized, rinsed and cleaned. All samples displayed very similar surface topographies and a high level of etch uniformity over the surface, when compared with each other in SEM evaluations. Consistency in the surface features (peaks and valleys) was also observed. The SEMs in FIGS. 5A , 5 B, 6 A and 6 B show the surfaces of two of the implants, Sample A-1 and Sample A-4, at magnifications of 2,000 and 20,000. It will be observed that the surface features over the areas shown are consistent and uniform. The scale shown on the X20,000 photographs is 1 micron=0.564 inch. At this magnification the surfaces appear to be characterized by a two-dimensional array of cones ranging in height (as seen in the SEMs) from about 0.17 inch to about 0.27 inch; the base diameters of these cones varied from about 0.17 inch to about 0.33 inch. Converting these numbers to metric units on the above-mentioned scale (1 micron=0.564 inch) yields: cone height range (approx.)=0.30 to 0.50 micron cone base diameter range (approx.)=0.30 to 0.60 micron. The same degree of uniformity was found in all the samples, and from sample to sample, at magnifications of 2,000 and 20,000, as compared with similar samples subjected to bulk etching without prior removal of the native oxide, as described in EXAMPLE NO. 2 below. EXAMPLE NO. 2 Four of the implants that had been grit blasted as described in EXAMPLE NO. 1 above were placed in 150 ml. of “Modified Muriaticetch” for 10 minutes. The implants were then removed, neutralized, rinsed and cleaned. SEM photographs taken at magnifications of 2,000 and 20,000 showed that the bulk etch solution failed to remove the native oxide layer after 10 minutes in the etch solution. The failure to remove the native oxide layer (100–150 Angstrom units thick) resulted in a non-uniformly etched surface, as depicted in FIG. 3 . In areas of the implant surfaces where the native oxide was removed, the topography was similar to that observed on the implants in EXAMPLE NO. 1. EXAMPLE NO. 3 The procedure of this example is currently preferred for producing commercial implants. A batch of screw-type implants made of CP titanium were immersed in a 15% solution of HF in water at room temperature for 60 seconds to remove the native oxide layer from the implant surfaces. A plastic cap was placed over the top of each implant to protect it from the acid. The implants were then removed from the acid and rinsed in a baking soda solution for 30 seconds with gentle agitation. The implants were then placed in a second solution of baking soda for 30 seconds, again with agitation of the solution; and then the implants were rinsed in deionized water. Next the implants were immersed in another solution of two parts by volume sulfuric acid (96% by weight H 2 SO 4 , 4% by weight water) and one part by volume hydrochloric acid (37% by weight HCl, 63% by weight water) at 70° C. for 5 minutes. The implants were then removed from the acid and rinsed and neutralized by repeating the same steps carried out upon removal of the implants from the HF. All samples displayed very similar surface topographies and a high level of etch uniformity over the surface, when compared with each other in SEM evaluations. Consistency in the surface features (peaks and valleys) was also observed. The SEMs in FIGS. 8A , 8 B, 9 A and 9 B show the surfaces of two of the implants, Sample 705MB and Sample 705MC, at magnifications of 2,000 and 20,000. It will be observed that the surface features over the areas shown are consistent and uniform. The scale shown on the X20,000 photographs is 1 micron=0.564 inch. At this magnification the surfaces appear to be characterized by a two-dimensional array of cones ranging in height (as seen in the SEMs) from about 0.17 inch to about 1.128 inch; the base diameters of these cones varied from about 0.17 inch to about 1.128 inch. Converting these numbers to metric units on the above-mentioned scale (1 micron=0.564 inch) yields: cone height range (approx.)=0.30 to 0.20 microns cone base diameter range (approx.)=0.30 to 0.20 microns. The same degree of uniformity was found in all the samples, and from sample to sample, at magnifications of 2,000 and 20,000, as compared with similar samples subjected to bulk etching without prior removal of the native oxide, as described in EXAMPLE NO. 2 above.

The surface of a device that is surgically implantable in living bone is prepared. The device is made of titanium with a native oxide layer on the surface. The method of preparation comprises the steps of removing the native oxide layer from the surface of the device and performing further treatment of the surface substantially in the absence of unreacted oxygen.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. application Ser. No. 11/166,817 filed on Jun. 24, 2005 the entire disclosure of which is incorporated by reference in its entirety. FIELD OF THE INVENTION [0002] This invention relates to the treatment of acne vulgaris, commonly known simply as “acne.” Acne is a disease of the skin in which the pilosebaceous structures of the skin become inflamed, leading to the formation of comedones, pustules and nodules. Acne can lead to permanent scarring in severe cases. [0003] It is generally believed that acne arises when hyperkeratosis of the pilosebaceous structure wholly or partially blocks the opening of the structure, resulting in comedones filled with sebum, keratin, and Propionibacterium acnes . These lesions are commonly identified as acne. P. acnes naturally occurs in normal skin, but is especially and characteristically present in acne lesions. It is believed that metabolic byproducts and waste from P. acnes within the pilosebaceous structures cause or contribute to the inflammation of acne lesions. [0004] Conventional acne treatments have taken many forms. Topical keratolytic agents, such as salicylic acid are sometimes used. Keratolytic agents are thought to encourage the opening up of blocked pilosebaceous structures, thereby reducing conditions that are favorable to inflammation. Benzoyl peroxide, an anti-microbial, remains a popular and effective treatment. Topical antibiotics, such as clindamycin, which are effective against P. acnes , have also been used with a view towards preventing the formation of metabolic byproducts from this organism. Topical retinoids such as tretinoin have also been used in the treatment of acne. [0005] Systemic (i.e. non-topical) treatments for acne include the use of oral antibiotics in more serious cases. These treatments are directed towards the reduction in the amount P. acnes in the skin, especially the pilosebaceous structures, and seek to reduce the inflammation caused by waste materials and metabolic byproducts from these organisms. Tetracycline antibiotics are most commonly used for this purpose. These include tetracycline, minocycline and doxycycline. Erythromycin is also sometimes used. [0006] Standard oral minocycline therapy for acne in pediatric patients calls for the administration of a 4 mg/kg initial loading dose, and a 2 mg/kg dose every 12 hours thereafter. This results in a dose of 6 mg/kg on the first day of treatment and a 4 mg/kg dose each day thereafter. In adults, a 200 mg initial dose is followed by a 100 mg dose every 12 hours thereafter. In a typical patient, this results in about a 4.5 mg/kg dose on the first day of treatment, and 3.0 mg/kg dose each day thereafter. [0007] In cases where acne does not respond to oral antibiotic treatment, oral isotretinoin is sometimes used. While effective, isotretinoin is also powerfully teratogenic, and women of childbearing age are required to use multiple methods of contraception while taking the drug. [0008] While oral tetracycline antibiotics remain a highly favored and widely used treatment for more serious cases of acne, it is not without side effects. Vestibular side effects, including extreme dizziness and concomitant nausea, can be so severe as to result in discontinuance of tetracycline therapy. Long term use can sometimes result in vaginal candidisis, esophageal erosions and in antibiotic resistant infections. [0009] Some recent research has indicated that very low doses of oral tetracycline can result in some improvement of acne even though the dose of tetracycline is too low to have an antibiotic effect. This observation has been attributed to an anti-inflammatory effect of tetracycline compounds. This effect has been reported to have been observed even where a chemically modified tetracycline that have no antibiotic properties are used. The use of tetracycline antibiotics at a dose too low to have an antibiotic effect or the use of modified tetracycline having no antibiotic properties as treatments for acne has never been approved by any drug regulatory agency. SUMMARY OF THE INVENTION [0010] According to the present invention, a method is provided for the treatment of acne in which an antibiotically effective dose of an oral tetracycline, such as minocycline, is provided. This dose is approximately 1 milligram per kilogram of body weight (1 mg/kg), without an initial loading dose of antibiotic. This antibiotic dosing regimen has been found to be as effective as a conventional dosing regimen incorporating a significant initial loading dose and higher subsequent doses. However, the dosing method of the current invention produces far fewer side effects. [0011] In another aspect of this invention, the oral tetracycline is provided in a dosage form that provides for the continued release of the antibiotic between doses, as opposed to an immediate or nearly immediate release of the drug. DETAILED DESCRIPTION OF THE INVENTION [0012] According to the present invention, acne vulgaris is treated by the use of an oral tetracycline antibiotic, preferably minocycline. This antibiotic is administered in an antibiotically effective amount of approximately 1.0 milligram per kilogram of body weight per day (1.0 mg/kg/day). While this may be accomplished by the use of divided doses, it is preferred that the tetracycline antibiotic be delivered in a single daily dose. This treatment regime is initiated without a loading dose, and is continued until resolution or substantial resolution of the patient's acne. The course of treatment typically lasts 12 to up to 60 weeks, but will be adjusted according to the disease status and other medical conditions of each patient in the exercise of ordinary good clinical judgment by the patient's health care provider. [0013] Controlled, double-blinded studies were undertaken to determine the effectiveness of this invention. Treatment of 473 patients with acne was undertaken according to the present invention. Placebos were provided to 239 patients. The effectiveness of the invention in treating acne vulgaris is shown in Table 1. TABLE 1 Total Lesion Counts Total Lesions Total Lesions (as Percent of Baseline) Baseline (mean) 169.3 100 Day 28 (mean) 134.0 78 Day 56 (mean) 119.3 69 [0014] TABLE 1 Total Lesion Counts Total Lesions Total Lesions (as Percent of Baseline) Day 84 (mean) 112.3 66 [0015] Inflammatory Lesion Counts Inflammatory Inflammatory Lesions (as Lesions Percent of Baseline) Baseline (mean) 77.4 100 Day 28 (mean) 52.1 66 Day 56 (mean) 44.3 56 Day 84 (mean) 41.9 53 [0016] While effective as a treatment for acne, this resulted in almost no side effects above those observed with a placebo, as shown in Table 2. TABLE 2 % Subjects with Adverse Events Minocycline Placebo At least One Adverse Event 56.2 54.1 At Least One Serious 0.4 0 Adverse Event Blood/Lymphatic System 0.3 0.3 Disorders Cardiac Disorders 0.3 0 Ear and Labyrinth Disorders 3.6 3.3 Endocrine Disorders 0.3 0 Eye Disorders 2.2 2.7 Gastrointestinal Disorders 21.2 26.1 General Disorders and 13.8 10.4 Administrative Site Conditions Immune System Disorders 0.7 2.5 Infections and Infestations 9.3 11.0 Laboratory Blood 0.7 1.1 Abnormalities Metabolism and Nutrition 0.6 0.3 Disorders Musculoskeletal and 4.6 3.6 Connective Disorders Neoplasms Benign, 0.1 0 Malignant and Unspecified Nervous System Disorders 29.2 25.8 Psychiatric Disorders 6.4 7.1 Renal and Urinary Disorders 0.3 0.5 Reproductive System and 0.7 0.3 Breast Disorders Respiratory, Thoracic and 5.3 6.9 Mediastinal Disorders Skin and Subcutaneous 8.6 7.1 Tissue Disorders Vascular Disorders 1.0 0.3 [0017] The effectiveness of this invention can be seen by comparing the above efficacy data with published data on the effectiveness of conventional tetracycline treatments for acne in the reduction of total acne lesions and in the reduction of inflammatory lesions. See, e.g. Hersel & Gisslen, “Minocycline in Acne Vulgaris: A Double Blind Study,” Current Therapeutic Research, 1976. [0018] Because of the variations in body weight encountered in clinical practice, in the actual practice of this invention it is not practical to provide every patient with exactly 1 mg/kg/day of oral tetracycline antibiotic. However, it is acceptable to approximate this dose by providing the patient with from 0.5 to 1.5 mg/kg/day although from 0.7 to 1.3 mg/kg/day is preferred, and 1.0 mg/kg/day is ideal. [0019] While it can be effective to provide the oral tetracycline antibiotic in divided doses taken over the course of a day (e.g. twice or three times a day), it is preferable to provide the oral tetracycline antibiotic in a dosage form that releases the antibiotic slowly during the course of a day so that once-a-day dosing is possible. While delayed release dosage forms are known in the art, the formulation of them is far from predictable and the selection of a specific delayed release formulation is accomplished more by trial and error than by mathematical prediction based on known properties of delay release agents. No delayed release product useful in the present invention has been known heretofore. [0020] It has been discovered that the ratio of fast dissolving carriers to slow dissolving carriers in the core caplet is important in obtaining a dissolution profile that enables once-a-day dosing in accordance with the present invention. By keeping the ratio of these components within a certain range, one may obtain this result. [0021] The fast dissolving carrier is any binder, vehicle, or excipient that quickly dissolves in an aqueous physiological medium, such as gastric fluid, thereby tending to quickly release the active ingredient. Lactose, its salts and hydrates are good examples of such components. It has been observed that sometimes a portion of the fast dissolving components are formulated in a manner that results in the complete or partial encapsulation or inclusion or coating of these fast-dissolving materials in granules of slow-dissolving materials. These encapsulated materials are excluded from the calculation of the above mentioned ratio of fast-dissolving to slow dissolving components. [0022] A slow dissolving carrier is any binder, vehicle, or excipient that dissolves slowly over the course of hours and perhaps a day, thereby slowing the release of the active ingredient. Examples of such components are polyvinyl pyrrolidone, polyvinyl acetate, microcrystalline cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, or waxy or lipid-based tableting agents such as magnesium stearate or calcium stearate. Outer “enteric” coatings are excluded from this amount when calculating the above-mentioned ratio. [0023] Insoluble carriers are binders, vehicles, or excipients that are practically insoluble in physiological fluids, such as gastric fluid, and includes compounds, such as silicon dioxide and talc. [0024] While the exact formulation of these dosage forms can vary, it has been observed that it is advantageous to formulate them so that the ratio of fast dissolving carriers to slow dissolving carriers is from 0.30 to 0.50, and preferably from 0.35 to 0.45. A ratio of about 0.36 to 0.40 is particularly preferable. [0025] Dosage forms, such as capsules, tablets, and caplets that release 25 to 52% of the antibiotics within 1 hour, 53 to 89% in 2 hours, and at least 90% within 4 hours are suited to the once-a-day dosage regimen contemplated by the current inventories. More preferably, 30 to 52% of the antibiotic is released within 1 hour, 53 to 84% within 2 hours, and at least 85% within 4 hours. [0026] Alternatively, the oral tetracycline antibiotic may be delivered in a dosage form that releases the antibiotic in such a way that the maximum blood concentration of the antibiotic (C max ) is reached at about 3.5 hours after administration (T max ). In actual practice of the invention, the C max should be reached between 2.75 and 4.0 after administration, more preferably between 3.0 and 3.75 after administration. [0027] As examples of such a once-a-day formulation, one may use the following: 135 mg Caplet Quantity Component (mg) Minocycline (as 145.8 hydrochloride) (dry weight) Lactose 107.4 Monohydrate (intragranular) Lactose 43.8 Monohydrate (extragranular) Total Lactose 151.2 Monohydrate HPMC 94 Silicon Dioxide 3 Mg. Stearate 6 [0028] 45 mg Caplet Quantity Component (mg) Minocycline (as 48.6 hydrochloride) (dry weight) Lactose 192.2 Monohydrate (intragranular) Lactose 42.2 Monohydrate (extragranular) Total Lactose 234.40 Monohydrate HPMC 108 Silicon Dioxide 3 Mg. Stearate 6 [0029] Each of these components is combined in a conventional fashion, compressed in a tabletting apparatus, and then provided in a conventional manner with a suitable coating, such as, without limitation Opadry II and optional coloring.

A method for treatment of acne with tetracyclines is provided. A lower sustained dose and no loading dose is employed, with an optional once-a-day dosing regimen.

TECHNICAL FIELD [0001] The invention is in the field of oxidatively coloring hair, specifically, an improved method that permits oxidatively coloring dark hair to a lighter color without the associated drawbacks. BACKGROUND OF THE INVENTION [0002] It is always difficult and challenging to oxidatively color hair to a lighter color than the base hair shade, particularly when the base hair shade is black or very dark brown. There are basically two functions taking place in an oxidative hair color process: lifting and color deposit. Lifting involves bleaching melanin from the hair. Color deposit occurs when the oxidative dyes then impart color to the bleached hair strands. In order to oxidatively color hair to at least two shades lighter than the base hair shade it is critical that both lift and color deposit be optimal. [0003] There are oxidative hair color kits on the market that purport to provide high lift and color deposit in one step. For example, L'Oréal Superior Preference® les True Brunettes is an oxidative hair color kit that the manufacturer states is for use in coloring dark hair to an ultra-lightening brown with no brassiness; and L'Oréal Féria Hi-Lift Browns a kit that the manufacturer advertises is suitable for lightening the color of very dark hair to a lighter brown shade. However, both kits provide for a one step process, e.g. the oxidative hair color is combined with a 30 volume developer and used to color the hair. The lifting and color deposit occurs in one step. While the process is generally effective, when lifting and coloring occur in one step the degree of lift (or lightening) is often not optimal. In addition, such processes generally provide color deposit that tends to be very ashy with purple or green tones. This occurs because the manufacturers of such colorants incorporate these shades to counteract the brassiness that sometimes occurs. [0004] Further, even with kits like this it is difficult to obtain a final hair color that is more than two levels over the base hair color shade. Such products are also generally not acceptable for use on gray hair since they provide a tone that tends to be green or purple. [0005] Salons have procedures for oxidatively coloring hair to a lighter shade that are completed in two steps. In the first step the hair is oxidatively colored with a high lift composition to remove melanin, followed by a second oxidative color procedure where an oxidative dye and developer are combined and the mixture is used to color the hair. However, this two step procedure involves application of oxidative compositions in both steps, which in turn may produce color that is less than optimal. [0006] Accordingly, there is a need to provide an oxidative hair color method and compositions for lightening dark hair that will provide lightening that is up to, or greater than 2 levels more than the base hair color shade, but without brassiness and the other drawbacks associated with the traditional one step processes. [0007] It is an object of the invention to provide a method for oxidatively coloring hair to a shade more than one or two levels lighter than the base hair color shade. [0008] It is a further object of the invention to provide a method for oxidatively coloring dark hair to a lighter hair color. [0009] It is a further object of the invention to provide a two step high lift method for oxidatively coloring hair to achieve hair color with improved vibrancy and reduced brassiness. [0010] It is a further object of the invention to provide a two step high lift hair coloring method where the color deposit is true and vibrant. SUMMARY OF THE INVENTION [0011] The invention is directed to a two step high lift method for oxidatively coloring hair comprising a first step of applying to the hair a color lifting mixture for a period of time sufficient to lift the hair, followed by a second step of applying an inactivated oxidative dye composition for a period of time sufficient to color the hair. [0012] The term “lift” means lightening. The term “high lift” when used herein means that the method of the invention is capable of lightening hair at least one to two levels above the base hair shade, preferably at least two levels. [0013] The invention is further directed to a method for improving color vibrancy and reducing brassiness of oxidatively colored hair comprising treating the hair with a two step high lift method comprising a first step of applying to the hair a hair lifting mixture for a period of time sufficient to lift the hair, followed by a second step of applying an inactivated oxidative dye composition for a period of time sufficient to color the hair. DETAILED DESCRIPTION [0014] The method of the invention comprises the use of certain compositions according to certain procedures. [0000] I. The Compositions Used in the Method [0015] A. The Lifting Mixture [0016] In order to achieve the lifting required in the first step of the invention process, the hair is treating with a lifting mixture. The lifting mixture is prepared immediately prior to use by combining an aqueous oxidizing agent composition and a hair lifting composition. When the two are combined the aqueous oxidizing agent composition activates the lifting composition such that the mixture is then operable to “lift” or bleach melanin from the hair fibers. [0017] 1. Aqueous Oxidizing Agent (or Developer) Composition [0018] The developer or aqueous oxidizing agent composition in its simplest form is an aqueous solution of hydrogen peroxide. Preferably it comprises from about 1-99%, preferably 10-99%, more preferably 60-97% of water, and about 5-25%, preferably 6-20%, more preferably 7-15% by weight of the total composition of hydrogen peroxide. Developer compositions are generally sold in the form of 10, 20, 25, 30, or 40 volume hydrogen peroxide. The 20 volume hydrogen peroxide developer composition comprises 6% by weight of hydrogen peroxide. The 25 volume hydrogen peroxide developer composition contains about 7.5% of hydrogen peroxide and the 30 volume hydrogen peroxide developer composition about 9%, and the 40 volume developer about 12% hydrogen peroxide, with all weight percentages by weight of the total composition of hydrogen peroxide. [0019] In the preferred embodiment of the invention, the developer composition used has a higher relative percentage of hydrogen peroxide, specifically about 25 to 30 volume or higher. Preferably, the aqueous oxidizing agent composition comprises from about 25 to about 50, preferably from about 25 to 40 volume hydrogen peroxide. [0020] If desired, the developer composition may contain a variety of other ingredients that enhance the aesthetic properties and contribute to more efficient coloring of hair. Preferred developer compositions for use with the inactivated oxidative dye composition in the method of the invention, when combined with the oxidative dye composition, form a composition very similar in consistency to a shampoo. Suggested developer compositions preferably comprise: [0021] 0.5-25% hydrogen peroxide, [0022] 0.1-10% of a conditioner, [0023] 0.01-5% of a thickener, and [0024] 1-99% water. [0025] (a). Conditioners [0026] The developer composition may contain one or more conditioners that exert a conditioning effect on hair. If present such conditioners may range from about 0.1-30%, preferably from about 0.5-25%, more preferably from about 1-20% by weight of the total composition of one or more conditioners. Examples of suitable conditioning ingredients include, but are not limited to those set forth below. [0027] (i). Cationic Silicones [0028] As used herein, the term “cationic silicone” means any silicone polymer or oligomer having a silicon backbone, including polysiloxanes, having a positive charge on the silicone structure itself. Cationic silicones that may be used in the developer compositions of the invention include those corresponding to the following formula, where the ratio of D to T units, if present, are greater than about 80 D units to 1 T unit: (R) a G 3-a -Si—(—OSiG 2 ) n -(-OSiGb(R 1 ) 2-6b ) m —O—SiG 3-a (R 1 ) a in which G is selected from the group consisting of H, phenyl, OH, C 1-10 alkyl, and is preferably CH 3 ; and a is 0 or an integer from 1 to 3, and is preferably 0; b is 0 or 1, preferably 1; the sum n+m is a number from 1 to 2,000 and is preferably 50 to 150; n is a number from 0 to 2000, and is preferably 50 to 150; and m is an integer from 1 to 2000, and is preferably 1 to 10; R is a C 1-10 alkyl, and R 1 is a monovalent radical of the formula C q H 2q L in which q is an integer from 2 to 8 and L is selected from the groups: in which R 2 is selected from the group consisting of H, phenyl, benzyl, a saturated hydrocarbon radical, and is preferably an alkyl radical containing 1-20 carbon atoms; and A- is a halide, methylsulfate, or tosylate ion. [0029] Preferably the developer comprises one or more conditioners that exert a conditioning effect on hair. A variety of conditioners are suitable including cationic polymers, oily conditioning agents, fatty alcohols, proteins, and so on. A combined total weight of conditioners ranges from about 0.1-25%, preferably 0.5-20%, more preferably 1-15% by weight of the total composition. [0030] (ii). Cationic Polymers [0031] A variety of cationic polymers are suitable for use in the developer composition such as quaternary derivatives of cellulose ethers or guar derivatives, copolymers of vinylpyrrolidone, polymers of dimethyldiallyl ammonium chloride, acrylic or methacrylic polymers, quaternary ammonium polymers, and the like. [0032] (aa). Quaternary Derivatives of Cellulose [0033] Examples of quaternary derivatives of cellulose ethers are polymers sold under the tradename JR-125, JR-400, JR-30M. Suitable guar derivatives include guar hydroxypropyl trimonium chloride. [0034] (bb). Copolymers of Vinylpyrrolidone [0035] Copolymers of vinylpyrrolidone having monomer units of the formula: wherein R 1 is hydrogen or methyl, preferably methyl; y is 0 or 1, preferably 1 R 2 is O or NH, preferably NH; R is C x H 2x where x is 2 to 18, or —CH 2 —CHOH—CH 2 , preferably C x H 2x where x is 2; R 4 is methyl, ethyl, phenyl, or C 1-4 substituted phenyl, preferably methyl; and R 5 is methyl or ethyl, preferably methyl. [0042] (cc). Polymers of Dimethyldiallylammonium Chloride [0043] Homopolymers of dimethyldiallylammonium chloride or copolymers of dimethyldiallylammonium chloride and acrylamide are also suitable. Such compounds are sold under the tradename MERQUAT by Calgon. [0044] (dd). Acrylic or Methacrylic Acid Polymers [0045] Homopolymers or copolymers derived from acrylic or methacrylic acid, selected from monomer units acrylamide, methylacrylamide, diacetone-acrylamide, acrylamide or methacrylamide substituted on the nitrogen by lower alkyl, alkyl esters of acrylic acid and methacrylic acid, vinylpyrrolidone, or vinyl esters are suitable for use. [0046] (ee). Polymeric Quaternary Ammonium Salts [0047] Also suitable are polymeric quaternary ammonium salts of cellulose and other polymers, including but not limited to Polyquaternium 10, 28 31, 33, 34, 35, 36, 37, and 39. [0048] (ff). Diquaternary Polydimethylsiloxanes [0049] Also suitable are diquaternary polydimethylsiloxanes such as Quaternium-80, sold by Goldschmidt Corporation under the tradename ABIL-Quat 3272. [0050] Examples of other cationic polymers that can be used in the compositions of the invention are disclosed in U.S. Pat. Nos. 5,240,450 and 5,573,709, which are hereby incorporated by reference. [0051] Particularly preferred are conditioners Polyquaternium 10 and Polyquaternium 28. Polyquaternium-10 is the polymeric quaternary ammonium salt of hydroxyethyl cellulose reacted with trimethyl ammonium substituted epoxide. Polyquaternium-28 is the polymeric quaternary ammonium salt consisting of vinyl pyrrolidone and dimethylaminopropyl methacrylamide monomers. [0052] (gg). Oily Conditioning Agents [0053] Also suitable are a variety of oily materials that provide good conditioning effect to hair. Suitable oils are liquid at room temperature and may comprise esters, hydrocarbons, and the like. Preferably the composition comprises 0.001-20%, more preferably 0.005-15%, most preferably 0.01-10% by weight of the total composition of such oils. Particularly preferred oily conditioning agents are oils extracted from vegetable sources, specifically meadowfoam seed oil. [0054] (hh). Nonionic Silicones [0055] Also suitable as conditioning agents are one or more silicones. Suitable silicone hair conditioning agents include volatile or nonvolatile nonionic silicone fluids, silicone resins, and silicone semi-solids or solids. [0056] Volatile silicones are linear or cyclic silicones having a measurable vapor pressure, which is defined as a vapor pressure of at least 2 mm. of mercury at 20° C. Examples of volatile silicones are cyclic silicones having the general formula: where n=3-7. [0057] Also, linear volatile silicones that may be used in the compositions of the invention have the general formula: (CH 3 ) 3 Si—O—[Si(CH 3 )—O] n —Si(CH 3 ) 3 where n=0-7, preferably 0-5. [0058] Also suitable are nonvolatile silicone fluids including polyalkyl siloxanes, polyaryl siloxanes, polyalkylaryl siloxanes, polyether siloxane copolymers, amine-functional silicones, and mixtures thereof. Such silicones have the following general formula: wherein R and R′ are each independently alkyl, aryl, or an alkyl substituted with one or more amino groups, and x and y are each independently 0-100,000, with the proviso that x+y equals at least one and A is siloxy endcap unit. Preferred is where A is methyl, R is methyl, and R′ is an alkyl substituted with at least two amino groups, most preferably an amine-functional silicone having the formula: which is known by the CTFA name trimethylsilylamodimethicone. [0059] Another type of silicone conditioning agent is a silicone polymer having the following general formula: wherein R, R′ and R″ are each independently a C 1-10 straight or branched chain alkyl or phenyl, and x and y are such that the ratio of (RR′R″) 3 SiO 1/2 units to SiO 2 units is 0.5 to 1 to 1.5 to 1. [0060] Preferably R, R′ and R″ are a C 1-6 alkyl, and more preferably are methyl and x and y are such that the ratio of (CH 3 ) 3 SiO 1/2 units to SiO 2 units is 0.75 to 1. Most preferred is this trimethylsiloxy silicate containing 2.4 to 2.9 weight percent hydroxyl groups, which is formed by the reaction of the sodium salt of silicic acid, chlorotrimethylsilane, and isopropyl alcohol. The manufacture of trimethylsiloxy silicate is set forth in U.S. Pat. Nos. 2,676,182; 3,541,205; and 3,836,437, all of which are hereby incorporated by reference. Trimethylsiloxy silicate as described is available from Dow Corning Corporation under the tradename Dow Corning 749 Fluid, which is a blend of about 40-60% volatile silicone and 40-60% trimethylsiloxy silicate (trimethylated silica). The fluid has a viscosity of 200-700 centipoise at 25 0 C., a specific gravity of 1.00 to 1.10 at 25° C., and a refractive index of 1.40-1.41. [0061] (b). Thickeners [0062] The developer composition may contain one or more thickeners that assist in maintaining an increased viscosity of the final composition resulting from mixture of the hair dye and the developer compositions. The amount of thickening agent if present is about 0.001-5%, preferably about 0.005-4%, more preferably about 0.005-3% by weight of the total composition. [0063] A variety of thickening agents are suitable including those mentioned above with respect to the oxidative dye composition, in addition to low melting point waxes, carboxyvinyl polymers, and the like. Also suitable are a variety of water soluble anionic thickening polymers such as those disclosed in U.S. Pat. No. 4,240,450, which is hereby incorporated by reference. Suggested ranges of such polymers are about 0.01-5%, preferably 0.05-4%, more preferably 0.1-3% by weight of the total developer composition. Examples of such anionic polymers are copolymers of vinyl acetate and crotonic acid, graft copolymers of vinyl esters or acrylic or methacrylic acid esters, cross-linked graft copolymers resulting from the polymerization of at least one monomer of the ionic type, at least one monomer of the nonionic type, polyethylene glycol, and a crosslinking agent, and the like. Preferred are acrylate copolymers such as steareth-10 allyl ether acrylate copolymer. [0064] (c). Other Ingredients [0065] (i). Nonionic Surfactants [0066] The developer composition may contain one or more nonionic surfactants. Suitable nonionic surfactants are the same as those mentioned below with respect to the alkalizing composition, and in the same amount. [0067] (ii). Chelating Agents [0068] The developer composition may contain one or more chelating agents as described herein with respect to the oxidative dye composition, and in the same ranges by weight. [0069] The aqueous oxidizing agent composition may contain one or more additional ingredients including but not limited to humectants, preservatives, botanicals, fatty acids, fatty alcohols, or mixtures thereof [0070] 2. The Lifting Composition [0071] The lifting composition may comprise a persulfate bleach composition in particulate or semi-solid form, an alkalizing composition, or the combination of both. The term “alkalizing composition” means a composition that is typically used in high lift blonding processes. Such compositions typically contain no oxidative dyes or minimal oxidative dyes. If oxidative dyes are present they are those that are used in level 9, light blonde, or level 10, high lift blond oxidative hair color shades. [0072] (a). Alkalizing Composition [0073] The alkalizing composition comprises from about 0.1-99%, preferably from about 0.5-95%, more preferably from about 1-90% water, and from about 0.1-99%, preferably from about 0.5-95%, more preferably from about 1-90% by weight of the total composition of one or more oils. Suitable oils include those set forth above in the developer composition as conditioners or oily conditioning agents. The alkalizing composition may also contain other ingredients such as pH adjusters, botanicals, humectants, nonionic surfactants, fatty alcohols, fatty acids, and the like. In the event where the alkalizing composition contains oxidative dyes, they are dyes that are typically used in Level 9 or 10 oxidative hair color, including those noted in the tables set forth herein. [0074] (i). Alkalizing Agent [0075] The alkalizing composition preferably contains one or more alkalizing agents preferably in a range of about 1-5% based on the total weight of the alkalizing composition. The term “alkalizing agent” means an ingredient that is capable of imparting alkalinity (e.g. a pH of greater than 7) to the alkalizing agent composition. Suitable alkalizing agents include ammonium hydroxide, metal hydroxides, alkanolamines, sodium silicate, metal carbonates, sodium metasilicate, and mixtures thereof. Suitable metal hydroxides and carbonates include alkali metal and alkaline earth metal hydroxides or carbonates. Examples of such metal hydroxides include sodium, potassium, lithium, calcium, magnesium and so on. A particularly preferred alkaline earth metal hydroxide is sodium hydroxide. Suitable alkanolamines include mono-, di-, and trialkanolamines such as monoethanolamine (MEA), diethanolamine (DEA), triethanolamine (TEA), 2-aminobutanol, aminoethyl propanediol, aminomethyl propanediol, bis-hydroxyethyl tromethamine, diethanolamine, diethyl ethanolamine, diisopropanolamine, dimethylamino methylpropanol, dimethyl MEA, isopropanolamine, methylethanolamine, mixed isopropanolamines, triisopropanolamine, tromethamine, and mixtures thereof. A particularly preferred alkanolamine is MEA. [0076] Most preferred are alkalizing agents that contain ammonium hydroxide in combination with a second alkalizing agent such as an alkanolamine. [0077] (ii). Fatty Acids or Fatty Alcohols [0078] The alkalizing composition may contain one or more fatty acids or fatty alcohols and if so suggested ranges are about 0.001-15%, preferably 0.005-10%, most preferably 0.01-8% by weight of the total composition. If fatty acids are present they may react with the alkalizing agent to form soap in situ, which provides a more shampoo-like character to the alkalizing composition when it is combined with the developer and applied to hair. Fatty acids are of the general formula RCOOH wherein R is a straight or branched chain, saturated or unsaturated C 6-30 alkyl. Suitable fatty alcohols are those of the general formula R—OH where R is as set forth for the fatty acid. [0079] Examples of suitable fatty acids include oleic acid, stearic acid, myristic acid, linoleic acid, and so on. Particularly preferred is oleic acid. [0080] Suitable fatty alcohols include stearyl alcohol, cetearyl alcohol, cetyl alcohol, or mixtures thereof. [0081] (iii). Conditioners [0082] Various hair conditioning agents, such as those mentioned for use in the developer composition, are also suitable for use in the alkalizing composition. If present such conditioners are suitable in the same percentage ranges as set forth for the developer. [0083] (iv). Surfactants [0084] (aa). Nonionic Surfactants [0085] Nonionic surfactants may be present in the alkalizing composition. If so, suggested ranges are from about 0.01-10%, preferably about 0.05-8%, more preferably about 0.1-7% by weight of the total composition. Suitable nonionic surfactants include alkoxylated alcohols or ethers, alkoxylated carboxylic acids, sorbitan derivatives, and the like. [0086] (1). Alkoxylated Alcohols or Ethers [0087] Suitable alkoxylated alcohols, or ethers, are formed by the reaction of an alcohol with an alkylene oxide, usually ethylene or propylene oxide. Preferably the alcohol is a fatty alcohol having 6 to 30 carbon atoms, and a straight or branched, saturated or unsaturated carbon chain. Examples of such ingredients include steareth 2-30, which is formed by the reaction of stearyl alcohol and ethylene oxide where the number of repeating ethylene oxide units is 2 to 30; Oleth 2-30 which is formed by the reaction of oleyl alcohol and ethylene oxide where the number of repeating ethylene oxide units is 2 to 30; Ceteareth 2-100, formed by the reaction of a mixture of cetyl and stearyl alcohol with ethylene oxide, where the number of repeating ethylene oxide units in the molecule is 2 to 100; Ceteth 1-45 which is formed by the reaction of cetyl alcohol and ethylene oxide, and the number of repeating ethylene oxide units is 1 to 45, and so on. Particularly preferred are Steareth-21, which is the reaction product of a mixture of stearyl alcohol with ethylene oxide, and the number of repeating ethylene oxide units in the molecule is 21, and Oleth-20 which is the reaction product of oleyl alcohol and ethylene oxide wherein the number of repeating ethylene oxide units in the molecule is 20. [0088] (2). Alkoxylated Carboxylic Acids [0089] Also suitable as the nonionic surfactant are alkyoxylated carboxylic acids, which are formed by the reaction of a carboxylic acid with an alkylene oxide or with a polymeric ether. The resulting products have the general formula: where RCO is the carboxylic ester radical, X is hydrogen or lower alkyl, and n is the number of polymerized alkoxy groups. In the case of the diesters, the two RCO— groups do not need to be identical. Preferably, R is a C 6-30 straight or branched chain, saturated or unsaturated alkyl, and n is from 1-100. [0090] (3). Sorbitan Derivatives [0091] Also suitable are various types of alkoxylated sorbitan and alkoxylated sorbitan derivatives. For example, alkoxylation, in particular, ethoxylation, of sorbitan provides polyalkoxylated sorbitan derivatives. Esterification of polyalkoxylated sorbitan provides sorbitan esters such as the polysorbates. Examples of such ingredients include Polysorbates 20-85, sorbitan oleate, sorbitan palmitate, sorbitan sesquiisostearate, sorbitan stearate, and so on. [0092] (bb). Anionic Surfactants [0093] If desired the alkalizing composition may contain one or more anionic surfactants. Together with the soap formed by the reaction of the fatty acid and alkanolamine or metal hydroxide, the ingredients provide the composition with the characteristics of shampoo. Preferred ranges of anionic surfactant, if present, are from about 0.1-25%, preferably 0.5-20%, more preferably 1-15% by weight of the total composition. [0094] (1). Alkyl and Alkyl Ether Sulfates [0095] Suitable anionic surfactants include alkyl sulfates or alkyl ether sulfates generally having the formula ROSO 3 M and RO(C 2 H 4 O) x SO 3 M wherein R is alkyl or alkenyl of from about 10 to 20 carbon atoms, x is 1 to about 10 and M is a water soluble cation such as ammonium, sodium, potassium, or triethanolamine cation. [0096] (2). Sulfate Derivatives [0097] Another type of anionic surfactant which may be used in the compositions of the invention are water soluble salts of organic, sulfuric acid reaction products of the general formula: R 1 —SO 3 -M wherein R 1 is chosen from the group consisting of a straight or branched chain, saturated aliphatic hydrocarbon radical having from about 8 to about 24 carbon atoms, preferably 12 to about 18 carbon atoms; and M is a cation. Examples of such anionic surfactants are salts of organic sulfuric acid reaction products of hydrocarbons such as n-paraffins having 8 to 24 carbon atoms, and a sulfonating agent, such as sulfur trioxide. [0098] (3). Isethionic Acid Derivatives [0099] Also suitable as anionic surfactants are reaction products of fatty acids esterified with isethionic acid and neutralized with sodium hydroxide. The fatty acids may be derived from coconut oil, for example. [0100] (4). Succinates or Succinimates [0101] In addition, succinates and succinimates are suitable anionic surfactants. This class includes compounds such as disodium N-octadecylsulfosuccinate; tetrasodium N-(1,2-dicarboxyethyl)-N-octadecylsulfosuccinate; and esters of sodium sulfosuccinic acid e.g. the dihexyl ester of sodium sulfosuccinic acid, the dioctyl ester of sodium sulfosuccinic acid, and the like. [0102] (5). Olefin Sulfonates [0103] Other suitable anionic surfactants include olefin sulfonates having about 12 to 24 carbon atoms. The term “olefin sulfonate” means a compound that can be produced by sulfonation of an alpha olefin by means of uncomplexed sulfur trioxide, followed by neutralization of the acid reaction mixture in conditions such that any sultones which have been formed in the reaction are hydrolyzed to give the corresponding hydroxy-alkanesulfonates. The alpha-olefin from which the olefin sulfonate is derived is a mono-olefin having about 12 to 24 carbon atoms, preferably about 14 to 16 carbon atoms. [0104] (6). Beta-Alkoxy Alkane Sulfonates [0105] Other classes of suitable anionic organic surfactants are the beta-alkoxy alkane sulfonates or water soluble soaps thereof such as the salts of C 10-20 fatty acids, for example coconut and tallow based soaps. Preferred salts are ammonium, potassium, and sodium salts. [0106] (7). N-Acyl Amino Acids [0107] Still another class of anionic surfactants include N-acyl amino acid surfactants and salts thereof (alkali, alkaline earth, and ammonium salts) having the formula: wherein R 1 is a C 8-24 alkyl or alkenyl radical, preferably C 10-18 ; R 2 is H, C 1-4 alkyl, phenyl, or —CH 2 COOM; R 3 is CX 2 — or C 1-2 alkoxy, wherein each X independently is H or a C 1-6 alkyl or alkylester, n is from 1 to 4, and M is H or a salt forming cation as described above. Examples of such surfactants are the N-acyl sarcosinates, including lauroyl sarcosinate, myristoyl sarcosinate, cocoyl sarcosinate, and oleoyl sarcosinate, preferably in sodium or potassium forms. [0108] (cc). Amphoteric or Zwitterionic Surfactants [0109] Also suitable for use in the alkalizing composition are amphoteric or zwitterionic surfactants. Examples of amphoteric surfactants that can be used are generally described as derivatives of aliphatic secondary or tertiary amines wherein one aliphatic radical is a straight or branched chain alkyl of 8 to 18 carbon atoms and the other aliphatic radical contains an anionic group such as carboxy, sulfonate, sulfate, phosphate, or phosphonate. [0110] (v). Botanicals [0111] It may be desired to include one or more botanicals in the alkalizing composition. Suitable botanicals include various extracts such as hypnea musciformis, gellidiela acerosa, sargassum filipendula, and so on. [0112] 2. Persulfate Bleach Composition [0113] Also suitable as the lifting composition is a persulfate bleach composition. The bleach composition may be in the form of a powder, paste, cream, or liquid. The persulfate composition generally comprises a mixture of persulfate compounds which are capable of bleaching the hair, particulate fillers, and, if desired, inorganic particulate colorants. The persulfate composition may be found in the powdered particulate form, or in the form of a cream or paste as described in U.S. Pat. No. 5,888,484; and U.S. Pat. No. 6,613,311, both of which are hereby incorporated by reference in their entirety. [0114] (a). Persulfates [0115] The persulfate composition comprises about 15-65%, preferably about 20-60%, more preferably about 25-55% by weight of the total persulfate composition of one or more inorganic persulfates which may be alkali metal or alkaline earth metal persulfates, or ammonium persulfate. [0116] (b). Alkalizing Agents [0117] The persulfate composition preferably contains one or more alkalizing agents. Preferred alkalizing agents are one or more inorganic salts as set forth herein. Suggested ranges of inorganic salts are from about 0.1-40%, preferably about 0.5-35%, preferably about 1-30% by weight of the total composition. [0118] (c). Particulate Fillers [0119] The persulfate composition also preferably comprises one or more particulate fillers. Preferably, the persulfate composition comprises about 5-60%, preferably about 8-55%, more preferably about 10-50% by weight of the total persulfate composition of the particulate fillers. The term “particulate filler” means a generally inert particulate having a particle size of about 0.1-250 microns. The particulate fillers provide volume and, when mixed with the persulfates, dilute the persulfate particles. A variety of particulate fillers are suitable including inorganics, inorganic salts, hydrophilic colloids, carbohydrates, soaps, alkyl sulfates, and the like. [0120] (i) Inorganics [0121] Examples of inorganics include silica, hydrated silica, alumina, attapulgite, bentonite, calcium oxide, chalk, diamond powder, diatomaceous earth, fuller's earth, hectorite, kaolin, mica, magnesium oxide, magnesium peroxide, montmorillonite, pumice, talc, tin oxide, zeolite, zinc oxide, and the like. [0122] (ii) Hydrophilic Colloids [0123] Examples of suitable hydrophilic colloids include hydroxyethylcellulose, locust bean gum, maltodextrin, methylcellulose, agar, dextran, dextran sulfate, gelatin, pectin, potassium alginate, sodium carboxymethylchitin, xanthan gum, and the like. [0124] (iii) Carbohydrates [0125] Examples of suitable carbohydrates include sugars such as glucose, sucrose, maltose, xylose, trehelose, and derivatives thereof, in particular sugar esters of long chain, C 14-30 fatty acids, as well as dextrins, cellulosics, and derivatives thereof. [0126] (iv) Soaps and Alkyl Sulfates [0127] Examples of soaps and alkyl sulfate particles that may act as particulate fillers include the aluminum, sodium, and potassium salts of fatty acids such as aluminum distearate, aluminum isostearate, aluminum myristate, calcium behenate, calcium stearate, calcium behenate, magnesium stearate, magnesium tallowate, potassium palmitate, potassium stearate, potassium oleate, sodium stearate, sodium oleate, sodium myristate, sodium palmitate, and the like. Suitable alkyl sulfates include sodium lauryl sulfate, sodium cetyl sulfate, sodium myristyl sulfate, sodium octyl sulfate, and the like. [0128] (d). Inorganic Colorants [0129] If desired, the persulfate composition may comprise about 0.01-2%, preferably about 0.05-1%, more preferably about 0.1-1% by weight of the total persulfate composition of an inorganic colorant. The inorganic colorant is preferably in the particulate form and will provide a subtle coloration to the powder composition to make it more aesthetically pleasing for commercial purposes. Particularly preferred for use in the bleach composition is ultramarine blue. [0130] B. The Inactivated Dye Composition [0131] In the method of the invention, in the second step, an inactivated dye composition is applied to the hair. The term “inactivated” means that the dye composition has not been combined with an aqueous oxidizing agent composition in a pre-mix prior to application to the hair. Rather, according to the method of the invention, the hair is first treated with the lifting mixture obtained by combining the aqueous oxidizing agent and the lifting composition for the requisite period of time. Thereafter, the inactivated dye composition is applied on top of the lifting mixture already on the hair. [0132] The inactivated dye composition may be in a liquid, solid, or semi-solid form. It may be in a shampoo, conditioner, or any other type of composition form. The inactivated dye composition generally contains at least one oxidative primary intermediate that is operable to color hair when in the oxidized or activated form, which occurs when the inactivated dye composition is applied to the hair on top of the developer composition. The composition generally comprises from about 0.01-35%, preferably from about 0.1-25%, more preferably from about 0.5-20% by weight of the total composition of at least one oxidative dye; and from about 0.01-95%, preferably about 0.05-95%, preferably about 0.1-85% by weight of the total composition of water. The composition may be in the form of a solution or emulsion. If the latter, the emulsion generally comprises from about 0.01-95%, preferably about 0.05-85%, more preferably about 0.1-80% by weight of the total composition of water and about 0.01-80%, preferably about 0.1-65%, preferably about 0.5-50% by weight of the total composition of an oily phase. The first composition may comprise a variety of other ingredients as further described herein. [0133] 1. Oxidative Dyes [0134] (a). Primary Intermediates. [0135] The inactivated oxidative dye composition comprises at least one primary intermediate and, optionally, at least one coupler for the formation of oxidative dyes. It is noted that the primary intermediates and optional couplers that are found in the inactivated dye composition are generally selected to impart the desired color to the hair. This is in contrast to the optional oxidative dyes that may be found in the lightening mixture, which are selected to impart maximum bleaching or lifting of the hair. [0136] Suitable ranges of primary intermediates are about 0.0001-6%, preferably about 0.0005-5.5%, more preferably about 0.001-5% by weight of the total composition. Such primary intermediates are well known for use in hair color, and include ortho or para substituted aminophenols or phenylenediamines, including para-phenylenediamines of the formula: wherein R 1 and R 2 are each independently hydrogen, C 1-6 alkyl, or C 1-6 alkyl substituted with one or more hydroxy, methoxy, methylsulphonylamino, aminocarbonyl, furfuryl, unsubstituted phenyl, or amino substituted phenyl groups; R 3 , R 4 , R 5 , and R 6 are each independently hydrogen, C 1-6 alkyl, C 1-6 alkoxy, halogen, or C 1-6 alkyl substituted with one or more hydroxy or amino groups. [0137] Specific examples of suitable primary intermediates include para-phenylenediamine, 2-methyl-1,4-diaminobenzene, 2,6-dimethyl-1,4-diaminobenzene, 2,5-dimethyl-1,4-diaminobenzene, 2,3-dimethyl-1,4-diaminobenzene, 2-chloro-1,4-diaminobenzene, 2-methoxy-1,4-diaminobenzene, 1-phenylamino-4-aminobenzene, 1-dimethylamino-4-aminobenzene, 1-diethylamino-4-aminobenzene, 1-bis(beta-hydroxyethyl)amino-4-aminobenzene, 1-methoxyethylamino-4-aminobenzene, 2-hydroxymethyl-1,4-diaminobenzene, 2-hydroxyethyl-1,4-diaminobenzene, 2-isopropyl-1,4-diaminobenzene, 1-hydroxypropylamino-4-aminobenzene, 2,6-dimethyl-3-methoxy-1,4-diaminobenzene, 1-amino-4-hydroxybenzene, and derivatives thereof, and acid or basic salts thereof. [0138] Preferred primary intermediates are p-phenylenediamine, p-aminophenol, o-aminophenol, N,N-bis(2-hydroxyethyl)-p-phenylenediamine, 2,5-diaminotoluene, their salts and mixtures thereof. [0139] (b). Color Coupler [0140] The inactivated oxidative dye composition may optionally comprise from about 0.0001-10%, more preferably about 0.0005-8%, most preferably about 0.001-7% by weight of the total oxidative composition of one or more color couplers. Suitable color couplers include, for example, those having the general formula: wherein R 1 is unsubstituted hydroxy or amino, or hydroxy or amino substituted with one or more C 1-6 hydroxyalkyl groups, R 3 and R 5 are each independently hydrogen, hydroxy, amino, or amino substituted with C 1-6 alkyl, C 1-6 alkoxy, or C 1-6 hydroxyalkyl group; and R 2 , R 4 , and R 6 are each independently hydrogen, C 1-6 alkoxy, C 1-6 hydroxyalkyl, or C 1-6 alkyl, or R 3 and R 4 together may form a methylenedioxy or ethylenedioxy group. Examples of such compounds include meta-derivatives such as phenols, catechol, meta-aminophenols, meta-phenylenediamines, and the like, which may be unsubstituted, or substituted on the amino group or benzene ring with alkyl, hydroxyalkyl, alkylamino groups, and the like. Suitable couplers include m-aminophenol, 2,4-diaminotoluene, 4-amino, 2-hydroxytoluene, phenyl methylpyrazolone, 3,4-methylenedioxyphenol, 3,4-methylenedioxy-1-[(beta-hydroxyethyl)amino]benzene, 1-methoxy-2-amino-4-[(beta-hydroxyethyl)amino]benzene, 1-hydroxy-3-(dimethylamino)benzene, 6-methyl-1-hydroxy-3 [(beta-hydroxyethyl)amino]benzene, 2,4-dichloro-1-hydroxy-3-aminobenzene, 1-hydroxy-3-(diethylamino)benzene, 1-hydroxy-2-methyl-3-aminobenzene, 2-chloro-6-methyl-1-hydroxy-3-aminobenzene, 1,3-diaminobenzene, 6-methoxy-1,3-diaminobenzene, 6-hydroxyethoxy-1,3-diaminobenzene, 6-methoxy-5-ethyl-1,3-diaminobenzene, 6-ethoxy-1,3-diaminobenzene, 1-bis(beta-hydroxyethyl)amino-3-aminobenzene, 2-methyl-1,3-diaminobenzene, 6-methoxy-1-amino-3-[(beta-hydroxyethyl)amino]-benzene, 6-(beta-aminoethoxy)-1,3-diaminobenzene, 6-(beta-hydroxyethoxy)-1-amino-3-(methylamino)benzene, 6-carboxymethoxy-1,3-diaminobenzene, 6-ethoxy-1-bis(beta-hydroxyethyl)amino-3-aminobenzene, 6-hydroxyethyl-1,3-diaminobenzene, 1-hydroxy-2-isopropyl-5-methylbenzene, 1,3-dihydroxybenzene, 2-chloro-1,3-dihydroxybenzene, 2-methyl-1,3-dihydroxybenzene, 4-chloro-1,3-dihydroxybenzene, 5,6-dichloro-2-methyl-1,3-dihydroxybenzene, 1-hydroxy-3-amino-benzene, 1-hydroxy-3-(carbamoylmethylamino)benzene, 6-hydroxybenzomorpholine, 4-methyl-2,6-dihydroxypyridine, 2,6-dihydroxypyridine, 2,6-diaminopyridine, 6-aminobenzomorpholine, 1-phenyl-3-methyl-5-pyrazolone, 1-hydroxynaphthalene, 1,7-dihydroxynaphthalene, 1,5-dihydroxynaphthalene, 5-amino-2-methyl phenol, 4-hydroxyindole, 4-hydroxyindoline, 6-hydroxyindole, 6-hydroxyindoline, 2,4-diamionphenoxyethanol, and mixtures thereof. [0141] Preferred couplers include resorcinol, 1-naphthol, 2-methylresorcinol, 4-amino-2-hydroxy toluene, m-aminophenol, 2,4-diaminophenoxyethanol, phenyl methylpyrazolone, their salts, or mixtures. [0142] In the haircolor industry, haircolor is classified into one of ten levels as follows:  1 = very black  2 = bright black  3 = very dark brown  4 = dark brown  5 = medium brown  6 = light brown  7 = dark blonde  8 = medium blonde  9 = light blonde 10 = high lift blonde [0143] Set forth in the table below is a non-limiting example of the primary intermediates and the color couplers that may be used in various shades of hair color. Other primary intermediates and couplers may be used in addition to, or in lieu of, those set forth in the Table and nothing herein shall be construed to limit the invention to only those primary intermediates and couplers set forth. Level 1 - Very Black Level 2 - Bright Black Primary Primary Intermediates Couplers Intermediates Couplers p-phenylenediamine m-aminophenol p-phenylene- resorcinol diamine p-phenylenediamine resorcinol 2-chloro-P- sulfate phenylene- diamine sulfate 2-chloro-phenylene 4-amino-2-hydroxy o-aminophenol diamine sulfate toluene p-aminophenol 4-chlororesorcinol o-aminophenol m-aminophenol HCL 2,4-diaminophenoxy ethanol m-phenylenediamine sulfate [0144] Level 3 - Very Dark Brown Level 4 - Dark Brown Primary Primary Intermediates Couplers Intermediates Couplers p-phenylenediamine resorcinol p-phenylenediamine resorcinol N,N-bis(2-hydroxy- 1-naphthol N,N-bis(2- 1-naphthol ethyl)-P-phenylene- hydroxyethyl)-P- diamine sulfate phenylene diamine sulfate m-amino- p-aminophenol m-aminophenol phenol phenyl methyl pyrazolone o-aminophenol 4-amino-2- hydroxytoluene [0145] Level 5 - Medium Brown Level 6 - Light Brown Primary Primary Intermediates Couplers Intermediates Couplers p-phenylenediamine resorcinol p-phenylenediamine resorcinol N,N-bis(2-hydroxy- 1-naphthol N,N-bis(2-hydroxy- 1-naphthol ethyl)-P-phenylene ethyl)-P-phenylene diamine sulfate diamine sulfate p-aminophenol m-aminophenol p-aminophenol m-amino- phenol o-aminophenol phenyl methyl phenyl pyrazolone methyl pyrazolone 2-methyl- 4-amino-2- resorcinol hydroxy toluene 4-amino- 2-methyl- 2-hydrox- resorcinol toluene [0146] Level 7 - Dark Blonde Level 8 - Medium Blonde Primary Primary Intermediates Couplers Intermediates Couplers p-phenylenediamine resorcinol p-phenylenediamine resorcinol N,N-bis(2-hydroxy- 1-naphthol N,N-bis(2- 1-naphthol ethyl)-P-phenylene hydroxyethyl)-P- diamine sulfate phenylenediamine sulfate p-aminophenol phenyl p-aminophenol m-aminophenol methyl pyrazolone o-aminophenol phenyl methyl pyrazolone 4-amino-2- hydroxytoluene [0147] Level 9 - Light Blonde Level 10 - High Lift Blonde Primary Primary Intermediates Couplers Intermediates Couplers p-phenylenediamine resorcinol p-phenylenediamine resorcinol N,N-bis(2- 4-amino- N,N-bis(2-hydroxy- 1-naphthol hydroxyethyl)-P- 2-hydroxy ethyl)-P-phenylene- phenylenediamine toluene diamine sulfate sulfate p-aminophenol phenyl methyl phenyl pyrazolone methyl pyrazolone o-aminophenol 2-methyl- 2-methyl- resorcinol resorcinol 1-naphthol [0148] The inactivated oxidative dye composition may also contain a variety of other ingredients such as surfactants, conditioners, humectants, pigments, and the like. [0149] 2. Surfactants [0150] The inactivated oxidative dye composition may comprise one or more surfactants that may assist in maintaining the composition in the emulsion form if it is an emulsion, or aid in the foaming or cleansing capability of the composition if it is in the shampoo form. Suitable surfactants include anionic surfactants, nonionic surfactants, amphoteric surfactants, and the like. If present, surfactants may range from about 0.001-50%, preferably about 0.005-45%, more preferably about 0.1-40% by weight of the first composition. [0151] (a) Nonionic Surfactants [0152] Suggested ranges of nonionic surfactant, if present, are about 0.01-10%, preferably about 0.05-8%, more preferably about 0.1-7% by weight of the total oxidative composition. Suitable nonionic surfactants include alkoxylated alcohols or ethers, alkoxylated carboxylic acids, sorbitan derivatives, and the like. [0153] Suitable alkoxylated alcohols, or ethers, are formed by the reaction of an alcohol with an alkylene oxide, usually ethylene or propylene oxide. Preferably the alcohol is a fatty alcohol having 6 to 30 carbon atoms, and a straight or branched, saturated or unsaturated carbon chain. Examples of such ingredients include steareth 2-30, which is formed by the reaction of stearyl alcohol and ethylene oxide where the number of repeating ethylene oxide units is 2 to 30; Oleth 2-30 which is formed by the reaction of oleyl alcohol and ethylene oxide where the number of repeating ethylene oxide units is 2 to 30; Ceteareth 2-100, formed by the reaction of a mixture of cetyl and stearyl alcohol with ethylene oxide, where the number of repeating ethylene oxide units in the molecule is 2 to 100; Ceteth 1-45 which is formed by the reaction of cetyl alcohol and ethylene oxide, and the number of repeating ethylene oxide units is 1 to 45, and so on. [0154] Also suitable as the nonionic surfactant are alkyoxylated carboxylic acids, which are formed by the reaction of a carboxylic acid with an alkylene oxide or with a polymeric ether. The resulting products have the general formula: where RCO is the carboxylic ester radical, X is hydrogen or lower alkyl, and n is the number of polymerized alkoxy groups. In the case of the diesters, the two RCO— groups do not need to be identical. Preferably, R is a C 6-30 straight or branched chain, saturated or unsaturated alkyl, and n is from 1-100. [0155] Also suitable are various types of alkoxylated sorbitan and alkoxylated sorbitan derivatives. For example, alkoxylation, in particular, ethoxylation, of sorbitan provides polyalkoxylated sorbitan derivatives. Esterification of polyalkoxylated sorbitan provides sorbitan esters such as the polysorbates. Examples of such ingredients include Polysorbates 20-85, sorbitan oleate, sorbitan palmitate, sorbitan sesquiisostearate, sorbitan stearate, and so on. [0156] (b) Anionic Surfactants [0157] If desired the first composition may contain one or more anionic surfactants. Preferred ranges of anionic surfactant are about 0.01-25%, preferably 0.5-20%, more preferably 1-15% by weight of the total oxidative composition. Suitable anionic surfactants include alkyl and alkyl ether sulfates generally having the formula ROSO 3 M and RO(C 2 H 4 O) x SO 3 M wherein R is alkyl or alkenyl of from about 10 to 20 carbon atoms, x is 1 to about 10 and M is a water soluble cation such as ammonium, sodium, potassium, or triethanolamine cation. [0158] Another type of anionic surfactant which may be used in the compositions of the invention are water soluble salts of organic, sulfuric acid reaction products of the general formula: R 1 —SO 3 -M wherein R 1 is chosen from the group consisting of a straight or branched chain, saturated aliphatic hydrocarbon radical having from about 8 to about 24 carbon atoms, preferably 12 to about 18 carbon atoms; and M is a cation. Examples of such anionic surfactants are salts of organic sulfuric acid reaction products of hydrocarbons such as n-paraffins having 8 to 24 carbon atoms, and a sulfonating agent, such as sulfur trioxide. [0159] Also suitable as anionic surfactants are reaction products of fatty acids esterified with isethionic acid and neutralized with sodium hydroxide, or fatty acids reacts with alkanolamines or ammonium hydroxides. The fatty acids may be derived from coconut oil, for example. Examples of fatty acids also include lauric acid, stearic acid, oleic acid, palmitic acid, and so on. [0160] In addition, succinates and succinimates are suitable anionic surfactants. This class includes compounds such as disodium N-octadecylsulfosuccinate; tetrasodium N-(1,2-dicarboxyethyl)-N-octadecylsulfosuccinate; and esters of sodium sulfosuccinic acid e.g. the dihexyl ester of sodium sulfosuccinic acid, the dioctyl ester of sodium sulfosuccinic acid, and the like. [0161] Other suitable anionic surfactants include olefin sulfonates having about 12 to 24 carbon atoms. The term “olefin sulfonate” means a compound that can be produced by sulfonation of an alpha olefin by means of uncomplexed sulfur trioxide, followed by neutralization of the acid reaction mixture in conditions such that any sultones, which have been formed in the reaction are hydrolyzed to give the corresponding hydroxy-alkanesulfonates. The alpha-olefin from which the olefin sulfonate is derived is a mono-olefin having about 12 to 24 carbon atoms, preferably about 14 to 16 carbon atoms. [0162] Other classes of suitable anionic organic surfactants are the beta-alkoxy alkane sulfonates or water soluble soaps thereof such as the salts of C 10-20 fatty acids, for example coconut and tallow based soaps. Preferred salts are ammonium, potassium, and sodium salts. [0163] Still another class of anionic surfactants include N-acyl amino acid surfactants and salts thereof (alkali, alkaline earth, and ammonium salts) having the formula: wherein R 1 is a C 8-24 alkyl or alkenyl radical, preferably C 10-18 ; R 2 is H, C 1-4 alkyl, phenyl, or —CH 2 COOM; R 3 is CX 2 — or C 1-2 alkoxy, wherein each X independently is H or a C 1-6 alkyl or alkylester, n is from 1 to 4, and M is H or a salt forming cation as described above. Examples of such surfactants are the N-acyl sarcosinates, including lauroyl sarcosinate, myristoyl sarcosinate, cocoyl sarcosinate, and oleoyl sarcosinate, preferably in sodium or potassium forms. [0164] (c). Cationic, Zwitterionic or Betaine Surfactants [0165] Certain types of amphoteric, zwitterionic, or cationic surfactants may also be used as the amphiphilic surface active material. Descriptions of such surfactants are set forth in U.S. Pat. No. 5,843,193, which is hereby incorporated by reference in its entirety. [0166] Amphoteric surfactants that can be used in the compositions of the invention are generally described as derivatives of aliphatic secondary or tertiary amines wherein one aliphatic radical is a straight or branched chain alkyl of 8 to 18 carbon atoms and the other aliphatic radical contains an anionic group such as carboxy, sulfonate, sulfate, phosphate, or phosphonate. [0167] Suitable amphoteric surfactants may be imidazolinium compounds having the general formula: wherein R 1 is C 8-22 alkyl or alkenyl, preferably C 12-16 ; R 2 is hydrogen or CH 2 CO 2 M, R 3 is CH 2 CH 2 OH or CH 2 CH 2 OCH 2 CHCOOM; R 4 is hydrogen, CH 2 CH 2 OH, or CH 2 CH 2 OCH 2 CH 2 COOM, Z is CO 2 M or CH 2 CO 2 M, n is 2 or 3, preferably 2, M is hydrogen or a cation such as an alkali metal, alkaline earth metal, ammonium, or alkanol ammonium cation. Examples of such materials are marketed under the tradename MIRANOL, by Miranol, Inc. [0168] Also suitable amphoteric surfactants are monocarboxylates or dicarboxylates such as cocamphocarboxypropionate, cocoamphocarboxypropionic acid, cocamphocarboxyglycinate, and cocoamphoacetate. [0169] Other types of amphoteric surfactants include aminoalkanoates of the formula R—NH(CH 2 ) n COOM or iminodialkanoates of the formula: R—N[(CH 2 ) m COOM] 2 and mixtures thereof; wherein n and m are 1 to 4, R is C 8-22 alkyl or alkenyl, and M is hydrogen, alkali metal, alkaline earth metal, ammonium or alkanolammonium. Examples of such amphoteric surfactants include n-alkylaminopropionates and n-alkyliminodipropionates, which are sold under the trade name MIRATAINE by Miranol, Inc. or DERIPHAT by Henkel, for example N-lauryl-beta-amino propionic acid, N-lauryl-beta-imino-dipropionic acid, or mixtures thereof. [0170] Zwitterionic surfactants are also suitable for use in the compositions of the invention. The general formula for such surfactants is: wherein R 2 contains an alkyl, alkenyl or hydroxy alkyl radical of from about 8 to about 18 carbon atoms, from 0 to about 10 ethylene oxide moieties and 0 or 1 glyceryl moiety; Y is selected from the group consisting of nitrogen, phosphorus, and sulfur atoms; R 3 is an alkyl or monohydroxyalkyl group containing about 1 to 3 carbon atoms; X is 1 when Y is a sulfur atom, and 2 when Y is a nitrogen or phosphorus atom; R 4 is an alkylene or hydroxyalkylene of from about 1 to about 4 carbon atoms, and Z is a radical selected from the group consisting of carboxylate, sulfonate, sulfate, phosphonate, and phosphate groups. [0171] Zwitterionic surfactants include betaines, for example higher alkyl betaines such as coco dimethyl carboxymethyl betaine, lauryl dimethyl carboxymethyl betaine, lauryl dimethyl alphacarboxyethyl betaine, cetyl dimethyl carboxymethyl betaine, lauryl bis-(2-hydroxyethyl)carboxymethyl betaine, stearyl bis-(2-hydroxypropyl)carboxymethyl betaine, oleyl dimethyl gamma-carboxylethyl betaine, and mixtures thereof. Also suitable are sulfo- and amido-betaines such as coco dimethyl sulfopropyl betaine, stearyl dimethyl sulfopropyl betaine, and the like. [0000] 3. Polar Solvents [0172] The inactivated oxidative dye composition may also comprise a variety of polar solvents other than water, including mono-, di-, or polyhydric alcohols, and similar water soluble ingredients. If present, such polar solvents may range from about 0.01-25%, preferably about 0.05-15%, more preferably about 0.1-10% by weight of the first composition of polar solvent. Examples of suitable monohydric alcohols include ethanol, isopropanol, benzyl alcohol, butanol, pentanol, ethoxyethanol, and the like. Examples of dihydric, or polyhydric alcohols, as well as sugars and other types of humectants that may be used include glucose, fructose, mannose, mannitol, malitol, lactitol, inositol, and the like. Suitable glycols include propylene glycol, butylene glycol, ethylene glycol, polyethylene glycols having from 4 to 250 repeating ethylene glycol units, ethoxydiglycol, and the like. Many of these types of alcohols also serve also serve as penetration enhancers, meaning that they enhance penetration of primary intermediates and couplers into the hair shaft by virtue of their tendency to act as humectants and swell the hair shaft. Ethoxydiglycol is a particularly good penetration enhancer and is the preferred polar solvent. [0173] In the preferred embodiment of the invention the composition comprises water in addition to one or more polar solvents, which are dihydric alcohols. In the preferred compositions, about 0.001-20%, preferably about 0.005-10%, more preferably about 0.001-8% by weight of the total composition comprises a non-aqueous polar solvent. [0174] 4. Chelating Agents [0175] The inactivated oxidative dye composition may also contain 0.0001-5%, preferably 0.0005-3%, more preferably 0.001-2% of one or more chelating agents which are capable of complexing with and inactivating metallic ions in order to prevent their adverse effects on the stability or effects of the composition. In particular, the chelating agent will chelate the metal ions found in the water and prevent these ions from interfering with the deposition and reaction of the dye with the hair fiber surface. Suitable chelating agents include EDTA and calcium, sodium, or potassium derivatives thereof, HEDTA, sodium citrate, TEA-EDTA, and so on. [0176] 5. pH Adjusters [0177] It may also be desirable to add small amounts of acids or bases to adjust the pH of the first composition to the desired pH range of greater than about 7.0 to 12.0. Suitable acids include hydrochloric acid, phosphoric acid, erythorbic acid, and the like. Suitable bases include sodium hydroxide, potassium hydroxide, and the like. Also suitable are primary, secondary, or tertiary amines or derivative thereof such as aminomethyl propanol, monoethanolamine, and the like. Suggested ranges of pH adjusters are from about 0.00001-8%, preferably about 0.00005-6%, more preferably about 0.0001-5% by weight of the total composition. [0178] 6. Preservatives [0179] The inactivated oxidative dye composition may also contain one or more preservatives. Suggested ranges are about 0.0001-8%, preferably 0.0005-7%, more preferably about 0.001-5% by weight of the total composition. Suitable preservatives include methyl, ethyl, and propyl paraben, hydantoins, and the like. [0180] In the preferred method of the invention the inactivated oxidative dye composition is in the form of a liquid such as a shampoo or conditioner composition. [0000] II. The Method [0181] A. The First Step [0182] The method for coloring hair is in two steps. In the first step the hair is treated with the lifting mixture, which is prepared by combining the aqueous oxidizing agent and the lifting composition. In the case where the lifting composition in the lifting mixture comprises a persulfate bleach composition, from about 1 to 2 parts, preferably about 1.5 parts, aqueous oxidizing agent composition are combined with 0.5 to 2 parts, preferably about 1.0 parts persulfate bleach composition. In the case where the lifting mixture is an alkalizing composition, from about 1 to 2 parts aqueous oxidizing agent composition and about 0.5 to 2 parts alkalizing composition are combined to form the lifting mixture which is then applied to the hair. The proportions mentioned may vary depending on the type of hair, the hair length, and the desired properties. [0183] The lifting mixture is applied to the hair strands ensuring that all hair strands are coated. The lifting mixture is left on the hair for a period of time necessary to achieve adequate lifting. In general, this period of time is from about 10-45 minutes, preferably from about 15-35 minutes, more preferably about 20 minutes. Thereafter, preferably, additional lifting mixture is added to the root area of the hair and the composition is left for an additional period of time ranging from about 5 to 15 minutes, preferably about 10 minutes. [0184] Then, the inactivated oxidative dye composition is applied to the hair on top of the lifting mixture and massaged into the hair for a period of time ranging from about 1 to 15, preferably from about 1 to 8, most preferably about 2 minutes. [0185] The mixture is rinsed well from the hair with water. If desired the hair may be treated with standard shampoo and conditioner. [0186] Hair colored according to the two step method of the invention exhibits improved vibrancy and color tone. In addition, dark hair can be lightened more than one or two levels above the base hair shade. In general, the method of the invention permits oxidative coloring of the hair where the hair is lightened from one to five, preferably from two to four levels above the base hair color shade. [0000] III. Kits [0187] The compositions necessary to practice the method of the invention may be present in kit form, such as retail kits. Such kits generally contain a carton or box for holding the various kit components. The kit will contain one receptacle containing an aqueous oxidizing agent composition, a second receptacle containing the lifting composition, and a third receptacle containing the inactivated dye composition. If desired, the kit may contain other ingredients such as printed documents (like instructions, discount coupons, etc.), gloves, and so on. [0188] The invention will be further described in connection with the following examples which are set forth for the purposes of illustration only. EXAMPLE 1 [0189] A 30 volume developer for use in the method of the invention was prepared as follows: Ingredient w/w % Water QS Methyl paraben 0.05 EDTA 0.02 Mineral oil 0.60 Cetearyl alcohol/ceteareth-20 4.50 Lauramide MEA 0.01 Cetearyl alcohol 0.20 Cyclomethicone/trimethylsiloxysilicate (50:50) 0.01 Amodimethicone/C11-15 Pareth-7, Laureth-9, 2.00 Trideceth-12, glycerin, water Hydrogen peroxide (35% aqueous solution) 26.00 Steareth-10 allyl ether/acrylates copolymer 0.10 Disodium phosphate 0.03 Phosphoric acid 0.028 [0190] The composition was prepared by combining the ingredients and mixing well. The composition was stored in a plastic container. EXAMPLE 2 [0191] Alkalizing compositions were prepared as follows: w/w % Ingredient A B Water QS QS Erythrobic acid 0.20 0.20 Sodium sulfite 0.50 0.50 Ethoxydiglycol 5.00 5.00 Tetrasodium EDTA 0.80 0.80 Ethanolamine 3.00 3.00 Hypnea Musciformis Extract, Gelligiela Acerosa 0.80 0.80 Extract, Sargassum Filipendula Extract, Sorbitol Sodium benzotriazolyl butylphenol sulfonate, 0.50 0.50 buteth-3, tributyl citrate P-phenylendiamine 0.001 — 1-naphthol 0.002 — P-aminophenol — 0.01 Resorcinol — 0.01 Ammonium lauryl sulfate 2.00 2.00 Oleic acid 12.50 12.50 Cetearyl alcohol 4.00 4.00 Cetearyl alcohol, polysorbate-60 2.00 2.00 Oleth-20 1.00 1.00 Steareth-21 0.70 0.70 Limananthes Alba (meadowfoam) seed oil 0.75 0.75 Oleyl alcohol 0.40 0.40 Polyquaternium-10 0.20 0.20 Polyquaternium-28 0.50 0.50 Mica, titanium dioxide 0.30 0.30 Hydrolyzed wheat protein 0.50 0.50 Fragrance 1.25 1.25 Ammonium hydroxide (28%) 13.00 13.00 [0192] The compositions were prepared by combining the ingredients and mixing well. The compositions were stored in brown glass containers. EXAMPLE 3 [0193] A lifting composition in the form of a persulfate bleach was prepared as follows: w/w % Potassium persulfate 45.00 Sodium persulfate 5.00 Sodium metasilicate 11.50 Silica 2.00 Hydrated silica 2.00 Sodium stearate 10.67 EDTA 2.00 Hydroxyethylcellulose 3.09 Sodium lauryl sulfate 2.00 Sodium chloride 5.00 Sucrose 7.16 Ultramarine blue 0.08 Sodium silicate 4.50 EXAMPLE 4 [0194] Split head tests were conducted on a salon panelist having dark brown hair having from about 10 to 70 gray hairs on her whole head. The developer composition of Example 1, 1.5 parts, and the alkalizing composition A from Example 2, 1 part, were combined to form a lifting mixture which was applied to strands of hair on the left side of the head, generally avoiding the root area for 20 minutes. Additional lifting mixture was then applied to the root area for an additional 10 minutes. An inactivated oxidative dye composition having the following formula was applied on the left side over the lifting mixture for 2 minutes. Ingredient % by weight Water QS Citric acid 0.001 Erythrobic acid 0.50 Sodium sulfite 0.50 Ethoxydiglycol 2.00 P-Phenylenediamine 2.00 M-aminophenol 0.80 Resorcinol 1.10 4-amino-2-hdroxytoluene 0.10 Hydroxypropylmethylcellulose 0.30 Tetrasodium EDTA 0.30 Sodium lauryl sulfate (30% aqueous solution) 10.00 Sodium laureth sulfate (28% aqueous solution) 20.00 Cocamidopropyl betaine 4.00 Ethanolamine 2.50 Isostearic acid 6.00 Lauramide DEA 2.00 Fragrance 0.75 [0195] After the color mixture was rinsed from the hair with lukewarm water until the water ran clear, a hair conditioner of the following formula was applied for two minutes, then rinsed out with water. Ingredient w/w % Water QS Methyl paraben 0.20 Propyl paraben 0.05 Panthenol 0.01 Behentrimonium chloride 4.00 Glycerin 5.00 Cetearyl alcohol 6.00 Mango seed butter 0.10 Amodimethicone, cetrimonium chloride, trideceth-12 3.30 Sodium benzotriazolyl Butylphenol Sulfonate, Buteth-3, 0.005 Tributyl Citrate Fragrance 0.50 Cholesteryl oleyl carbonate, cholesteryl chloride, 0.01 cholesteryl nonanoate Isostearyl lactate, diisostearyl malate, triisostearyl 0.01 citrate, isostearyl glycolate Citric acid 0.015 Methylchloroisothiazolinone, methylisothiazolinone 0.04 Polyethylene terephthalate, acrylates copolymer 0.30 [0196] The right side of the head was treated with L'Oréal Féria Hi-Lift Browns™. The ingredient listing on this product is reproduced below: [0197] Shimmering Colour Permanent Haircolour Gel Ingredients: Water, Trideceth-2 Carboxamide MEA, Propylene Glycol, Hexylene Glycol, PEG-2 Oleamine, Ammonium Hydroxide, Polyglyceryl-4-Oleyl Ether, Oleyl Alcohol, Alcohol Denat., Polyglyceryl-2-Oleyl Ether, Oleic Acid, Sodium Diethylaminopropylcocoaspartamide, Pentasodium Pentetate, Fragrance, Ammonium Acetate, Sodium Metabisulfite, Phenyl Methyl Pyrazolone, Resorcinol, Erythorbic Acid, P-Phenylenediamine, 2,4-Diaminophenoxyethanol HCL, m-Aminophenol, Hydroxypropyl Bis(N-Hydroxyethyl-p-Phenylenediamine)HCL. [0000] Shimmering Colour Developing Creme Ingredients: Water, Hydrogen Peroxide, Cetearyl Alcohol, Trideceth-2 Carboxamide MEA, Ceteareth-30, Glycerin, Pentasodium Pentetate, Sodium Stannate, Tetrasodium Pyrophosphate. [0198] Colour Hydrator No Build-Up Deep Conditioner Ingredients: Water, Cetearyl Alcohol, Glycerin, Behentrimonium Chloride, Euphorbia Cerifera (Candelilla) Wax, Amodimethicone, Cetyl Esters, Isopropyl Alcohol, Fragrance, Methylparaben, Trideceth-12, Chlorhexidine Dihydrochloride, Cetrimonium Chloride. [0199] The other half head was treated according to package instructions. The bottle of Shimmering Colour Permanent Haircolour Gel was poured into the Shimmering Colour Developing Creme and mixed well. The majority of the composition was immediately applied to unwashed dry hair for 20 minutes, covering only the ends of the hair and avoiding the roots. The remaining portion of the composition was then applied to the hair roots for 10 minutes. After 30 minutes the mixture was rinsed from the hair with lukewarm water until the rinse water was clear. The Colour Hydrator No Build-Up Deep Conditioner was applied to hair for two minutes, then rinsed out with water. [0200] A trained salon evaluator evaluated the results on both sides. The color tone, evenness of color, lift, and color vibrancy in the hair treated with the method of the invention was better than these same properties on the half head treated with the L'Oréal product. EXAMPLE 5 [0201] A salon panelist having dark brown hair with about 10 to 70 gray hairs on the entire head was recruited for this study. A split head test was conducted. The left side of the head was treated with a lifting mixture obtained by combining about 1.5 parts of the developer composition of Example 1 and about 1 part of alkalizing composition A from Example 2. The developer composition was applied to the hair strands, avoiding the root area, and left for 20 minutes. Additional lifting mixture was then applied to the root area for 11 minutes. The inactivated oxidative dye composition as set forth in Example 2 was applied for 2 minutes. The mixture was rinsed from the hair with lukewarm water until the water ran clear. Hair conditioner as set forth in Example 4 was applied to the hair for 2 minutes, then rinsed out with water. [0202] The other half head was treated with L'Oréal New Ultra-Lightening for Dark Hair Only Superior Preference® les True Brunettes, Level 3 permanent hair color UL53 (ultra light beige brown) following the package instructions. The ingredient listing for the products in the kit are set forth below: [0203] Color Gel Ingredients: Water, Trideceth-2 Carboxamide MEA, Propylene Glycol, Hexylene Glycol, PEG-2 Oleamine, Ammonium Hydroxide, Polyglyeryl-4-Oleyl Ether, Oleyl Alcohol, Alcohol Denat., Polyglyceryl-2-Oleyl Ether, Oleic Acid, Sodium Diethylaminopropyl Cocoaspartamide, Pentasodium Pentetate, Ammonium Acetate, Fragrance, Sodium Metabisulfite, Resorcinol, P-Phenylenediamine, m-Aminophenol, Phenyl Methyl Pyrazolone, Erythorbic Acid, P-Aminophenol, 2-Methylresorcinol, Hydroxypropyl Bis(N-Hydroxyethyl-p-Phenylenediamine) HCL, 2,4-Diaminophenoxyethanol HCL, 2-Methyl-5-Hydroxyethyl-Aminophenol, p-Methylaminophenol sulfate. [0000] Color Optimizing Creme Ingredients: Water, Hydrogen Peroxide, Cetearyl Alcohol, Trideceth-2 Carboxamide MEA, Ceteareth-30, Glycerin, Pentasodium Pentetate, Sodium Stannate, Tetrasodium Pyrophosphate. [0204] Care Supreme® Conditioner Ingredients: Water, Cetearyl Alcohol, Glycerin, Behentrimonium Chloride, Euphorbia Cerifera (candelilla) wax, Amodimethicone, Cetyl Esters, Isopropyl Alcohol, Fragrance, Methylparaben, Camphor Benzalkonium Methosulfate, Trideceth-12, Chlorhexidine, Dihydrochloride, Cetrimonium Chloride, PPG-5-Ceteth-20, Oleth-10, Disodium Cocoamphodipropionate, Lecithin, Phosphoric Acid, Tocopherol, Ethyl Hexyl Salicylate, Phenoxyethanol, Ethyl Paraben. [0205] A trained salon evaluator assessed the difference between the half heads. The color tone, evenness of color, lift, and color vibrancy in the hair treated with the method of the invention was better than these same properties on the half head treated with the L'Oréal product. [0206] While the invention has been described in connection with the preferred embodiment, it is not intended to limit the scope of the invention to the particular form set forth but, on the contrary, it is intended to cover such alternatives, modifications, and equivalents as may be included within the spirit and scope of the invention as defined by the appended claims.

A two step high lift method for oxidatively coloring hair comprising a first step of applying to the hair a lifting mixture comprised of an aqueous oxidizing agent composition and a lifting composition to the hair for a period of time sufficient to lift the hair, followed by a second step of applying an inactivated oxidative dye composition for a period of time sufficient to color the hair, and a method for improving color vibrancy and tone, evenness of color, and reducing brassiness in high lift oxidatively colored hair.

BACKGROUND OF THE INVENTION While the prior are is replete with toy or mechanical animal devices, as can be seen by reference to U.S. Pat. Nos. 2,095,646; 2,218,065; 2,801,104; 2,988,847 and 3,997,157; these devices fall far short of duplicating the motions of the "mechanical bull", that was prominently featured in the movie "Urban Cowboy". The actual rodeo training device that was depicted in the movie, formed the subject matter of U.S. Pat. No. 3,997,979, and this device has subsequently enjoyed its own commercial success, and as a result of popular demand, can be found in numerous night spots throughout the country. The mechanical motions, that distinguish the actual device from the prior art toys, are the combination of rotary and reciprocal movements, on a continuous and/or sequential basis. All of the prior art toy mechanical animals seem to have either a solely vertical reciprocal motion or a solely rotary motion. Neither of these motions alone produces a visual effect, which even remotely resembles the actual rodeo training device, upon which the present invention is based. Due to the widespread popularity enjoyed by the mechanical bull, it is surprising that to date no one has been able to develop a toy, which closely simulates the movements of the actual device. As a result of the foregoing, the device which forms the basis of the present invention was developed, and the end result is a toy mechanical bull which closely approximates the combined rotary and reciprocal movements employed in the actual device. SUMMARY OF THE INVENTION An object of the present invention is the provision of a toy mechanical bull, whose movements closely approximate the movements of an actual rodeo training device. Another object of the present invention is to provide simplified actuating mechanisms, that will produce vertical and reciprocal movements in a toy, to simulate the movements of a mechanical bull. Still another object of the present invention is to provide a toy mechanical bull, that can be used in conjunction with a doll figure, to reproduce the actual results produced by a living or mechanical bull, when ridden by a human rider. Yet another object of the present invention is to provide means on a toy mechanical bull, that will cooperate with means adapted to be secured to a doll figure, to releasably secure the doll figure on the toy mechanical bull. A further object of the present invention is the provision of a toy mechanical animal that produces simultaneous rotary and reciprocal movements. These and other objects, advantages, and novel features of the invention will become apparent from the detailed description which follows when viewed in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1, is a perspective view of the toy mechanical bull used conjunction with a doll figure. FIG. 2, is a cross-sectional view showing the internal mechanisms of the toy mechanical bull. FIG. 3, is a detail view showing the cooperation releasable securing means on the toy mechanical bull and the doll figure used in conjunction therewith. FIG. 4, is a detail view of the power supply connection to the upper actuating motor employed in the device. FIG. 5, is a detail view of the vertical reciprocal actuator mechanism. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT As can be seen by reference to FIG. 1, the toy mechanical bull, which forms the basis of the present invention, is designated generally as 10. The toy mechanical bull, hereinafter referred to as the device 10, further comprises a housing 20, a vertical support column 40, and a simulated miniature animal body 60, operatively connected to one another. The housing 20, forms a base for the device 10, and in the preferred embodiment, is in the form of an elongated rectangular enclosure 21, which may be fabricated from either metal, plastic, or other suitable rigid materials. The enclosure 21, is further provided with a plurality of support legs 22, on its lower surface. In addition, the enclosure 21, further provides a housing for the power supply 80, and at least a portion of the actuating mechanism 100. Referring now to FIG. 2, it can be seen that the power supply 80, in the preferred embodiment, comprises a pair of 9 v batteries 81, with the appropriate electrical leads 82, connected thereto. It should be appreciated at this juncture, that this invention also contemplates the use of an external source of electrical current to power the device 10, and should not be limited to the battery operated operation illustrated and described. Turning now to the operative connection between the housing 20, the support column 40, and the miniature animal body 60; it can be seen that the vertical support housing 40, is provided with apertured insulated internal partitions 41, which frictionally engage an insulated jacket 42' which is disposed about an electrically conductive elongated rod member 42. The lower end of the rod member 42, is received in a suitably dimensioned aperture 24, in the floor of the enclosure 21; and the remainder of the rod 42, projects through the central aperture 23, in the base 20, and a substantial vertical distance into the support column 40. The miniature animal body is in turn connected to the vertical support column 40, by virture of the linkages 50, and 70, depicted in FIGS. 2 and 5. Linkage 50, comprises an elongated lever arm 51, which is pivotally connected on one end to a pivot rod 43, secured between the free ends of a U-shaped horizontal bracket 44, disposed on the lower portion of the vertical support column 40. The other end of the lever arm 51, is likewise pivotally secured to a pivot rod 61, disposed in the forward portion of the miniature animal body 60. The linkage 70, on the other hand, comprises an elongated contoured crank lever 71, supported by a pair of vertically projecting ear members 45, formed on the upper surface of the vertical support column 40. The ends of the crank lever 71, extend into either side of the miniature animal body 60, proximate its midpoint, and are rotatably disposed therein. The vertical support column 40, is further provided with an insulated curved skirt member 46, on its lower end, and a motor support bracket 47, on its upper end. The skirt member 46, serves the dual function of insulating the vertical support column 40, from the base 20, and also providing an aesthetically pleasing appearance to the device, as the base and column rotate with respect to one another. The motor support bracket 47, is provided to support one of the actuating motors, that forms part of the actuating mechanism 100, that will now be described in detail. The actuating mechanism 100, comprises a pair of small electric motors 101 and 102, connected to the power supply 80. The motor 101, imparts the rotary movement, and the motor 102, imparts the vertical reciprocal movement, to the device 10. Motor 101, is mounted on the floor of the enclosure 21, and is provided with an output shaft 103, which cooperates with a first pinion wheel 48, rotatably secured to the elongated rod member 42. As the output shaft 103, rotates, it will impart a rotary motion to the pinion wheel 48, via frictional engagement therewith. This rotary motion is in turn imparted to the vertical support column 40. Motor 102, is also provide with an output shaft 104, which cooperated with a second pinion wheel 74, rigidly secured to the crank arm 71. As the output shaft 104, rotates, it will impart a rotary motion to the pinion wheel 74, via frictional engagement therewith. This rotary motion will have a vertical reciprocal component, which will be imparted to the miniature animal body, by virtue of the linkage assemblied 50 and 70, to produce the simulated "bucking" action of the device. As shown in FIG. 2, a pair of standard electrical leads 82, forms the electrical connection between the power source 80, and motor 101. The electrical connection between the power source 80, and motor 102, presents some unusual problems due to the relative rotation between the miniature animal body 60, and the base member 20. As can best be seen by reference to FIG. 4, the conductive rod member 42, is provided with an insulated jacket 42', extending along most of its length, which leaves both ends of the rod exposed. The first pinion wheel 48, is further provided with an electrically conductive hub (48'), which is insulated from the conductive rod member 42, via the jacket 42', and which frictionally engages a spring biased conductive washer 49. In order to connect the positive and negative terminals of the power source 80, to the appropriate terminals on the motor 102, brush contacts must be established between the relatively rotating components. To accomplish this task the electrical lead from the positive terminal of the battery is in contact with the exposed lower end of the conductive rod member 42, and the electrical lead from the negative terminal of the motor 102, is in brushing contact with the upper surface of the conductive hub 48'. The electrical lead to the negative terminal of the battery is likewise in contact with the underside of the conductive washer 49, to complete the electrical circuit. In addition, to the aforementioned features, the miniature animal body 60, is further provided with releasable securing means 200. These releasable securing means 200, are fabricated from Velcro, and comprise a "hard" Velcro securing means 201, in the form of a saddle, rigidly secured to the miniature animal body, and a "soft" Velcro securing means, in the form of chaps, which are adapted to be secured to the lower torso of a doll figure 203 (shown in phantom), to releasably secure the doll figure to saddle portion 201, of the miniature animal body. One of the unexpected benefits derived from the use of Velcro fasteners is that, as opposed to other releasable fastening means, the Velcro fasteners allow the doll figure to pitch back and forth on the miniature animal body, in much the same manner as a person would react, to the movements of a live or mechanical animal. This result is produced by the disengagement and re-engagement of different portions of the chaps 202, with different portions of the saddle 201, as a result of the motions of the miniature animal body 60, in several planes. It should also be particularly noted, that no other releasable fastening means produces quite the same effect, and the employment of Velcro features is considered to be crucial to this invention. The ultimate result produced, by the motions of the device 10, with regard to the doll figure 203, is that the releasable securing means will eventually totally disengage, and the doll figure 203, will be "bucked" or "thrown" from the miniature mechanical animal. This visual effect will not only be enjoyable for children but will also produce fond memories for adults whom have ridden a living animal or a mechanical simulation thereof. Having thereby disclosed the subject matter of this invention, it should be obvious that many substitutions, modifications and variations are possible in light of the above teachings. It is therefore to be understood that the invention as taught and described, is only to be limited to the extent of the breadth and scope of the appended claims.

A toy mechanical bull having rotary and reciprocal movements used in conjunction with a doll figure having releasable securing means adapted for cooperation with complementary releasable securing means on the toy mechanical bull, wherein the rotary and reciprocal movements of the toy mechanical bull will disengage the releasable securing means resulting in a simulation of a mechanical bull throwing a rider from its back.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a Divisional Application of U.S. patent application Ser. No. 11/926,012, now U.S. Pat. No. 8,355,800, filed Oct. 28, 2007, for Coating Package for an Implantable Device, which is a Divisional Application of U.S. patent application Ser. No. 11/206,484, now U.S. Pat. No. 7,894,911, filed Aug. 17, 2005, which is a Divisional Application of U.S. patent application Ser. No. 09/515,373, now abandoned, filed Feb. 29, 2000, which claims the benefit of U.S. Provisional Application No. 60/125,873, filed Mar. 24, 1999. TECHNICAL FIELD OF INVENTION The present invention relates to electrical stimulation of the retina to produce artificial images for the brain. It relates to electronic image stabilization techniques based on tracking the movements of the eye. It relates to telemetry in and out of the eye for uses such as remote diagnostics and recording from the retinal surface. The present invention also relates to electrical stimulation of the retina to produce phosphenes and to produce induced color vision. The present invention relates to hermetically sealed electronic and electrode units which are safe to implant in the eye. BACKGROUND Color perception is part of the fabric of human experience. Horner (c. 1100 b.c.) writes of “the rosy-fingered dawn”. Lady Murasaki no Shikibu (c. 1000 a.d.) uses word colors (“purple, yellow shimmer of dresses, blue paper”) in the world's first novel. In the early nineteenth century Thomas Young, an English physician, proposed a trichromatic theory of color vision, based on the action of three different retinal receptors. Fifty years later James Clerk Maxwell, the British physicist and Hermann von Helmholtz, the German physiologist, independently showed that all of the colors we see can be made up from three suitable spectral color lights. In 1964 Edward MacNichol and colleagues at Johns Hopkins and George Wald at Harvard measured the absorption by the visual pigments in cones, which are the color receptor cells. Rods are another type of photoreceptor cell in the primate retina. These cells are more sensitive to dimmer light but are not directly involved in color perception. The individual cones have one of three types of visual pigment. The first is most sensitive to short waves, like blue. The second pigment is most sensitive to middle wavelengths, like green. The third pigment is most sensitive to longer wavelengths, like red. The retina can be thought of a big flower on a stalk where the top of that stalk is bent over so that the back of the flower faces the sun. In place of the sun, think of the external light focused by the lens of the eye onto the back of the flower. The cones and rods cells are on the front of the flower; they get the light which has passed through from the back of the somewhat transparent flower. The photoreceptor nerve cells are connected by synapses to bipolar nerve cells, which are then connected to the ganglion nerve cells. The ganglion nerve cells connect to the optic nerve fibers, which is the “stalk” that carries the information generated in the retina to the brain. Another type of retinal nerve cell, the horizontal cell, facilitates the transfer of information horizontally across bipolar cells. Similarly, another type of cell, the amacrine facilitates the horizontal transfer of information across the ganglion cells. The interactions among the retinal cells can be quite complex. On-center and off-center bipolar cells can be stimulated at the same time by the same cone transmitter release to depolarize and hyperpolarize, respectively. A particular cell's receptive field is that part of the retina, which when stimulated, will result in that cell's stimulation. Thus, most ganglion cells would have a larger receptive field than most bipolar cells. Where the response to the direct light on the center of a ganglion cells receptive field is antagonized by direct light on the surround of its receptive field, the effect is called center-surround antagonism. This phenomenon is important for detecting borders independent of the level of illumination. The existence of this mechanism for sharpening contrast was first suggested by the physicist Ernst Mach in the late 1800's. More detailed theories of color vision incorporate color opponent cells. On the cone level, trichromatic activity of the cone cells occurs. At the bipolar cell level, green-red opponent and blue-yellow opponent processing systems of the center-surround type, occur. For example, a cell with a green responding center would have a annular surround area, which responded in an inhibiting way to red. Similarly there can be red-center responding, green-surround inhibiting response. The other combinations involve blue and yellow in an analogous manner. It is widely known that Galvani, around 1780, stimulated nerve and muscle response electrically by applying a voltage on a dead frog's nerve. Less well known is that in 1755 LeRoy discharged a Leyden jar, i.e., a capacitor, through the eye of a man who had been blinded by the growth of a cataract. The patient saw “flames passing rapidly downward.” In 1958, Tassicker was issued a patent for a retinal prosthetic utilizing photosensitive material to be implanted subretinally. In the case of damage to retinal photoreceptor cells that affected vision, the idea was to electrically stimulate undamaged retinal cells. The photosensitive material would convert the incoming light into an electrical current, which would stimulate nearby undamaged cells. This would result in some kind of replacement of the vision lost. Tassicker reports an actual trial of his device in a human eye. (U.S. Pat. No. 2,760,483). Subsequently, Michelson (U.S. Pat. No. 4,628,933), Chow (U.S. Pat. Nos. 5,016,633; 5,397,350; 5,556,423), and De Juan (U.S. Pat. No. 5,109,844) all were issued patents relating to a device for stimulating undamaged retinal cells. Chow and Michelson made use of photodiodes and electrodes. The photodiode was excited by incoming photons and produced a current at the electrode. Norman et al. (U.S. Pat. No. 5,215,088) discloses long electrodes 1000 to 1500 microns long designed to be implanted into the brain cortex. These spire-shaped electrodes were formed of a semiconductor material. Najafi, et al., (U.S. Pat. No. 5,314,458), disclosed an implantable silicon-substrate based microstimulator with an external device which could send power and signal to the implanted unit by RF means. The incoming RF signal could be decoded and the incoming RF power could be rectified and used to run the electronics. Difficulties can arise if the photoreceptors, the electronics, and the electrodes all tend to be mounted at one place. One issue is the availability of sufficient area to accommodate all of the devices, and another issue is the amount of power dissipation near the sensitive retinal cells. Since these devices are designed to be implanted into the eye, this potential overheating effect is a serious consideration. Since these devices are implants in the eye, a serious problem is how to hermetically seal these implanted units. Of further concern is the optimal shape for the electrodes and for the insulators, which surround them. In one embodiment there is a definite need that the retinal device and its electrodes conform to the shape of the retinal curvature and at the same time do not damage the retinal cells or membranes. The length and structure of electrodes must be suitable for application to the retina, which averages about 200 microns in thickness. Based on this average retinal thickness of 200 microns, elongated electrodes in the range of 100 to 500 microns appear to be suitable. These elongated electrodes reach toward the cells to be activated. Being closer to the targeted cell, they require less current to activate it. In order not to damage the eye tissue there is a need to maintain an average charge neutrality and to avoid introducing toxic or damaging effects from the prosthesis. A desirable property of a retinal prosthetic system is making it possible for a physician to make adjustments on an on-going basis from outside the eye. One way of doing this would have a physician's control unit, which would enable the physician to make adjustments and monitor the eye condition. An additional advantageous feature would enable the physician to perform these functions at a remote location, e.g., from his office. This would allow one physician to remotely monitor a number of patients remotely without the necessity of the patient coming to the office. A patient could be traveling distantly and obtain physician monitoring and control of the retinal color prosthetic parameters. Another version of the physician's control unit is a hand-held, palm-size unit. This unit will have some, but not all of the functionality of the physician's control unit. It is for the physician to carry on his rounds at the hospital, for example, to check on post-operative retinal-prosthesis implant patients. Its extreme portability makes other situational uses possible, too, as a practical matter. The patient will want to control certain aspects of the visual image from the retinal prosthesis system, in particular, image brightness. Consequently, a patient controller, performing fewer functions than the physician's controller is included as part of the retinal prosthetic system. It will control, at a minimum, bright image, and it will control this image brightness in a continuous fashion. The image brightness may be increased or decreased by the patient at any time, under normal circumstances. A system of these components would itself constitute part of a visual prosthetic to form images in real time within the eye of a person with a damaged retina. In the process of giving back sight to those who are unable to see, it would be advantageous to supply artificial colors in this process of reconstructing sight so that the patient would be able to enjoy a much fuller version of the visual world. In dealing with externally mounted or externally placed means for capturing image and transmitting it by electronic means or other into the eye, one must deal with the problem of stabilization of the image. For example, a head-mounted camera would not follow the eye movement. It is desirable to track the eye movements relative to the head and use this as a method or approach to solving the image stabilization problem. By having a method and apparatus for the physician and the technician to initially set up and measure the internal activities and adjust these, the patient's needs can be better accommodated. The opportunity exists to measure internal activity and to allow the physician, using his judgment, to adjust settings and controls on the electrodes. Even the individual electrodes would be adjusted by way of the electronics controlling them. By having this done remotely, by remote means either by telephone or by the Internet or other such, it is clear that a physician would have the capability to intervene and make adjustment as necessary in a convenient and inexpensive fashion, to serve many patients. SUMMARY OF INVENTION The objective of the current invention is to restore color vision, in whole or in part, by electrically stimulating undamaged retinal cells, which remain in patients with lost or degraded visual function arising, for example, from Retinitis Pigmentosa or Age-Related Macular Degeneration. This invention is directed toward patients who have been blinded by degeneration of photoreceptors; but who have sufficient bipolar cells, or other cells acting similarly, to permit electrical stimulation. There are three main functional parts to this invention. One is external to the eye. The second part is internal to the eye. The third part is the communication circuitry for communicating between those two parts. Structurally there are two parts. One part is external to the eye and the other part in implanted within the eye. Each of these structural parts contains two way communication circuitry for communication between the internal and external parts. The structural external part is composed of a number of subsystems. These subsystems include an external imager, an eye-motion compensation system, a head motion compensation system, a video data processing unit, a patient's controller, a physician's local controller, a physician's remote controller, and a telemetry unit. The imager is a video camera such as a CCD or CMOS video camera. It gathers an image approximating what the eyes would be seeing if they were functional. The imager sends an image in the form of electrical signals to the video data processing unit. In one aspect, this unit formats a grid-like or pixel-like pattern that is then ultimately sent to electronic circuitry (part of the internal part) within the eye, which drives the electrodes. These electrodes are inside the eye. They replicate the incoming pattern in a useable form for stimulation of the retina so as to reproduce a facsimile of the external scene. In an other aspect of this invention other formats other than a grid-like or pixel like pattern are used, for example a line by line scan in some order, or a random but known order, point-by-point scan. Almost any one-to-one mapping between the acquired image and the electrode array is suitable, as long as the brain interprets the image correctly. The imager acquires color information. The color data is processed in the video data processing unit. The video data processing unit consists of microprocessor CPU's and associated processing chips including high-speed data signal processing (DSP) chips. In one aspect, the color information is encoded by time sequences of pulses separated by varying amounts of time; and, the pulse duration may be different for various pulses. The basis for the color encoding is the individual color code reference ( FIG. 2 a ). The electrodes stimulate the target cells so as to create a color image for the patient, corresponding to the original image as seen by the video camera, or other imaging means. Color information, in an alternative aspect, is sent from the video data processing unit to the electrode array, where each electrode has been determined to stimulate preferentially one of the bipolar cell types, namely, red-center green-surround, green-center-red-surround, blue-center-yellow-surround, or yellow-center-blue-surround. An eye-motion compensation system is an aspect of this invention. The eye tracker is based on detection of eye motion from the corneal reflex or from implanted coils of wire, or, more generally, insulated conductive coils, on the eye or from the measurement of electrical activity of extra-ocular muscles. Communication is provided between the eye tracker and the video data processing unit by electromagnetic or acoustical telemetry. In one embodiment of the invention, electromagnetic-based telemetry may be used. The results of detecting the eye movement are transmitted to a video data processing unit, together with the information from the camera means. Another aspect of the invention utilizes a head motion sensor and head motion compensation system. The video data processing unit can incorporate the data of the motion of the eye as well as that of the head to further adjust the image electronically so as to account for eye motion and head motion. The internal structural part which is implanted internally within the eye, is also composed of a number of subsystems. These can be categorized as electronic circuits and electrode arrays, and communication subsystems, which may include electronic circuits. The circuits, the communication subsystems, and the arrays can be hermetically sealed and they can be attached one to the other by insulated wires. The electrode arrays and the electronic circuits can be on one substrate, or they may be on separate substrates joined by an insulated wire or by a plurality of insulated wires. This is similarly the case for a communication subsystem. A plurality of predominately electronic substrate units and a plurality of predominately electrode units may be implanted or located within the eye as desired or as necessary. The electrodes are designed so that they and the electrode insulation conform to the retinal curvature. The variety of electrode arrays include recessed electrodes so that the electrode array surface coming in contact with the retinal membrane or with the retinal cells is the non-metallic, more inert insulator. Another aspect of the invention is the elongated electrode, which is designed to stimulate deeper retinal cells by penetrating into the retina by virtue of the length of its electrodes. A plurality of electrodes is used. The elongated electrodes are of lengths from 100 microns to 500 microns. With these lengths, the electrode tips can reach through those retinal cells not of interest but closer to the target stimulation cells, the bipolar cells. The number of electrodes may range from 100 on up to 10,000 or more. With the development of electrode fabrication technology, the number of electrodes might rage up to one million or more. Another aspect of the invention uses a plurality of capacitive electrodes to stimulate the retina, in place of non-capacitive electrodes. Another aspect of the invention is the use of a neurotrophic factor, for example, Nerve Growth Factor, applied to the electrodes, or to the vicinity of the electrodes, to aid in attracting target nerves and other nerves to grow toward the electrodes. Hermetic sealing is accomplished by coating the object to be sealed with a substance selected from the group consisting of silicon carbide, diamond-like coating, silicon nitride and silicon oxide in combination, titanium oxide, tantalum oxide, aluminum nitride, aluminum oxide, zirconium'oxide. This hermetic sealing aspect of the invention provides an advantageous alternative to glass coverings for hermetic seals, being less likely to become damaged. Another feature of one aspect of the structural internal-to-the-eye subsystems is that the electronics receive and transmit information in coded or pulse form via electromagnetic waves. In the case where electromagnetic waves are used, the internal-to-the-eye implanted electronics can rectify the RF, or electromagnetic wave, current and decode it. The power being sent in through the receiving coil is extracted and used to drive the electronics. In some instances, the implanted electronics acquire data from the electrode units to transmit out to the video data processing unit. In another aspect the information coding is done with ultrasonic sound. An ultrasonic transducer replaces the electromagnetic wave receiving coil inside the eye. An ultrasonic transducer replaces the coil outside the eye for the ultrasonic case. By piezoelectric effects, the sound vibration is turned into electrical current, and energy extracted therefrom. In another aspect of the invention, information is encoded by modulating light. For the light modulation case, a light emitting diode (LED) or laser diode or other light generator, capable of being modulated, acts as the information transmitter. Information is transferred serially by modulating the light beam, and energy is extracted from the light signal after it is converted to electricity. A photo-detector, such as a photodiode, which turns the modulated light signal into a modulated electrical signal, is used as a receiver. Another aspect of the structural internal-to-the-eye subsystems of this invention is that the predominately electrode array substrate unit and the predominately electronic substrate unit, which are joined by insulated wires, can be placed near each other or in different positions. For example, the electrode array substrate unit can be placed subretinally and the electronic substrate unit placed epiretinally. On a further aspect of this invention, the electronic substrate unit can be placed distant from the retina so as to avoid generating additional heat or decreasing the amount of heat generated near the retinal nerve system. For example, the receiving and processing circuitry could be placed in the vicinity of the pars plana. In the case where the electronics and the electrodes are on the same substrate chip, two of these chips can be placed with the retina between them, one chip subretinal and the other chip epiretinal, such that the electrodes on each may be aligned. Two or more guide pins with corresponding guide hole or holes on the mating chip accomplish the alignment. Alternatively, two or more tiny magnets on each chip, each magnet of the correct corresponding polarity, may similarly align the sub- and epiretinal electrode bearing chips. Alternatively, corresponding parts which mate together on the two different chips and which in a fully mated position hold each other in a locked or “snap-together” relative position. Now as an element of the external-to-the-eye structural part of the invention, there is a provision for a physician's hand-held test unit and a physician's local or remote office unit or both for control of parameters such as amplitudes, pulse widths, frequencies, and patterns of electrical stimulation. The physician's hand-held test unit can be used to set up or evaluate and test the implant during or soon after implantation at the patient's bedside. It has, essentially, the capability of receiving what signals come out of the eye and having the ability to send information in to the retinal implant electronic chip. For example, it can adjust the amplitudes on each electrode, one at a time, or in groups. The hand-held unit is primarily used to initially set up and make a determination of the success of the retinal prosthesis. The physician's local office unit, which may act as a set-up unit as well as a test unit, acts directly through the video data processing unit. The remote physician's office unit would act over the telephone lines directly or through the Internet or a local or wide area network. The office units, local and remote, are essentially the same, with the exception that the physician's remote office unit has the additional communications capability to operate from a location remote from the patient. It may evaluate data being sent out by the internal unit of the eye, and it may send in information. Adjustments to the retinal color prosthesis may be done remotely so that a physician could handle a multiple number of units without leaving his office. Consequently this approach minimizes the costs of initial and subsequent adjustments. BRIEF DESCRIPTION OF THE DRAWINGS The above and other features and advantages of the invention will be more apparent from the following detailed description wherein: FIG. 1 a shows the general structural aspects of the retina color prosthesis system; FIG. 1 b shows the retina color prosthesis system with a structural part internal (to the eye), with an external part with subsystems for eye-motion feedback to enable maintaining a stable image presentation, and with a subsystems for communicating between the internal and external parts, and other structural subsystems; FIG. 1 c shows an embodiment of the retina color prosthesis system which is, in part, worn in eyeglass fashion; FIG. 1 d shows the system in FIG. 1 c in side view; FIG. 2 a shows an embodiment of the color I coding schemata for the stimulation of the sensation of color; FIG. 2 b represents an embodiment of the color I conveying method where a “large” electrode stimulates many bipolar cells with the color coding schemata of FIG. 2 a; FIG. 2 c represents an embodiment of the color II conveying method where an individual electrode stimulates a single type of bipolar cell; FIG. 3 a represents an embodiment of the telemetry unit including an external coil, an internal (to the eye) coil, and an internal electronic chip; FIG. 3 b represents an embodiment of the telemetry unit including an external coil, an internal (to the eye) coil, an external electronic chip, a dual coil transfer unit, and an internal electrode array; FIG. 3 c shows and acoustic energy and information transfer system; FIG. 3 d shows a light energy and information transfer system; FIG. 4 represents an embodiment of the external telemetry unit; FIG. 5 shows an embodiment of an internal telemetry circuit and electrode array switcher; FIG. 6 a shows a monopolar electrode arrangement and illustrates a set of round electrodes on a substrate material; FIG. 6 b shows a bipolar electrode arrangement; FIG. 6 c shows a multipolar electrode arrangement; FIG. 7 shows the corresponding indifferent electrode for monopolar electrodes; FIG. 8 a depicts the location of an epiretinal electrode array located inside the eye in the vitreous humor located above the retina, toward the lens capsule and the aqueous humor; FIG. 8 b shows recessed epiretinal electrodes where the electrically conducting electrodes are contained within the electrical insulation material; a silicon chip acts as a substrate; and the electrode insulator device is shaped so as to contact the retina in a conformal manner; FIG. 8 c is a rendering of an elongated epiretinal electrode array with the electrodes shown as pointed electrical conductors, embedded in an electrical insulator, where an pointed electrodes contact the retina in a conformal manner, however, elongated into the retina; FIG. 9 a shows the location of a subretinal electrode array below the retina, away from the lens capsule and the aqueous humor. The retina separates the subretinal electrode array from the vitreous humor; FIG. 9 b illustrates the subretinal electrode array with pointed elongated electrode, the insulator, and the silicon chip substrate where the subretinal electrode array is in conformal contact with the retina with the electrodes elongated to some depth; FIG. 10 a shows a iridium electrode that comprises a iridium slug, an insulator, and a device substrate where this embodiment shows the iridium slug electrode flush with the extent of the insulator; FIG. 10 b indicates an embodiment similar to that shown in FIG. 10 / 12 a , however, the iridium slug is recessed from the insulator along its sides, but with its top flush with the insulator; FIG. 10 c shows an embodiment with the iridium slug as in FIG. 10 / 12 b ; however, the top of the iridium slug is recessed below the level of the insulator; FIG. 10 d indicates an embodiment with the iridium slug coming to a point and insulation along its sides, as well as a being within the overall insulation structure; FIG. 10 e indicates an embodiment of a method for fabricating and the fabricated iridium electrode where on a substrate of silicon an aluminum pad is deposited; on the pad the conductive adhesive is laid and platinum or iridium foil is attached thereby; a titanium ring is placed, sputtered, plated, ion implanted, ion beam assisted deposited (IBAD) or otherwise attached to the platinum or iridium foil; silicon carbide, diamond-like coating, silicon nitride and silicon oxide in combination, titanium oxide, tantalum oxide, aluminum nitride, aluminum oxide or zirconium oxide or other insulator will adhere better to the titanium while it would not adhere as well to the platinum or iridium foil; FIG. 11 a depicts a preferred electrode where it is formed on a silicon substrate and makes use of an aluminum pad, a metal foil such as platinum or iridium, conductive adhesive, a titanium ring, aluminum or zirconium oxide, an aluminum layer, and a mask; FIG. 11 b shows an elongated electrode formed on the structure of FIG. 11 a with platinum electroplated onto the metal foil, the mask removed and insulation applied over the platinum electrode; FIG. 11 c shows a variation of a form of the elongated electrode wherein the electrode is thinner and more recessed from the well sides; FIG. 11 d shows a variation of a form of the elongated electrode wherein the electrode is squatter but recessed from the well sides; FIG. 11 e shows a variation of a form of the elongated electrode wherein the electrode is a mushroom shape with the sides of its tower recessed from the well sides and its mushroom top above the oxide insulating material; FIG. 12 a shows the coil attachment to two different conducting pads at an electrode node; FIG. 12 b shows the coil attachment to two different conducting pads at an electrode node, together with two separate insulated conducting electrical pathways such as wires, each attached at two different electrode node sites on two different substrates; FIG. 12 c shows an arrangement similar to that seen in FIG. 12 / 16 d , with the difference that the different substrates are very close with a non-conducting adhesive between them and an insulator such as aluminum or zirconium oxide forms a connection coating over the two substrates, in part; FIG. 12 d depicts an arrangement similar to that seen in FIG. 12 / 16 c ; however, the connecting wires are replaced by an externally placed aluminum conductive trace; FIG. 13 shows a hermetically sealed flip-chip in a ceramic or glass case with solder ball connections to hermetically sealed glass fit and metal leads; FIG. 14 shows a hermetically sealed electronic chip as in FIG. 18 with the addition of biocompatible leads to pads on a remotely located electrode substrate; FIG. 15 shows discrete capacitors on the electrode-opposite side of an electrode substrate; FIG. 16 a shows an electrode-electronics retinal implant placed with the electrode half implanted beneath the retina, subretinally, while the electronics half projects above the retina, epiretinally; FIG. 16 b shows another form of sub- and epi-retinal implantation wherein half of the electrode implant is epiretinal and half is subretinal; FIG. 16 c shows the electrode parts are lined up by alignment pins or by very small magnets; FIG. 16 d shows the electrode part lined up by template shapes which may snap together to hold the parts in a fixed relationship to each other; FIG. 17 a shows the main screen of the physician's (local) controller (and programmer); FIG. 17 b illustrates the pixel selection of the processing algorithm with the averaging of eight surrounding pixels chosen as one element of the processing; FIG. 17 c represents an electrode scanning sequence, in this case the predefined sequence, A; FIG. 17 d shows electrode parameters, here for electrode B, including current amplitudes and waveform timelines; FIG. 17 e illustrates the screen for choosing the global electrode configuration, monopolar, bipolar, or multipolar; FIG. 17 f renders a screen showing the definition of bipolar pairs (of electrodes); FIG. 17 g shows the definition of the multipole arrangements; FIG. 18 a illustrates the main menu screen for the palm-sized test unit; FIG. 18 b shows a result of pressing on the stimulate bar of the main menu screen, where upon pressing the start button the amplitudes A 1 and A 2 are stimulated for times t 1 , t 2 , t 3 , and t 4 , until the stop button is pressed; FIG. 18 c exhibits a recording screen that shows the retinal recording of the post-stimulus and the electrode impedance; FIG. 19 a - c show the physician's remote controller that has the same functionality inside as the physician's controller but with the addition of communication means such as telemetry or telephone modern; and FIG. 20 shows the patient's controller unit. DESCRIPTION OF THE PREFERRED EMBODIMENTS The following description is of the best mode presently contemplated for carrying out the invention. This description is not to be taken in a limiting sense, but is merely made for the purpose of describing the general principles of the invention. The scope of the invention should be determined with reference to the claims. Objective The objective of the embodiments of the current invention is a retinal color prosthesis to restore color vision, in whole or in part, by electrically stimulating undamaged retinal cells, which remain in patients with, lost or degraded visual function. Embodiments of this retinal color prosthesis invention are directed toward helping patients who have been blinded by degeneration of photoreceptors and other cells; but who have sufficient bipolar cells and the like to permit the perception of color vision by electric stimulation. By color vision, it is meant to include black, gray, and white among the term color. General Description Functionally, there are three main parts to an embodiment of this retinal color prosthesis invention. See FIG. 1 a . FIG. 1 a is oriented toward showing the main structural parts and subsystems, with a dotted enclosure to indicate a functional intercommunications aspect. The first part of the embodiment is external ( 1 ) to the eye. The second part is implanted internal ( 2 ) to the eye. The third part is means for communication between those two parts ( 3 ). Structurally there are two parts. One part is external ( 1 ) to the eye and the other part ( 2 ) is implanted within the eye. Each of these structural parts contains two way communication circuitry for communication ( 3 ) between the internal ( 2 ) and external ( 1 ) parts. The external part of the retinal color prosthesis is carried by the patient. Typically, the external part including imager, video data processing unit, eye-tracker, and transmitter/receiver are worn as an eyeglass-like unit. Typical of this embodiment, a front view of one aspect of the structural external part ( 1 ) of the color retinal prosthesis is shown in FIG. 1 c and a side view is shown in FIG. 1 d , ( 1 ). In addition, there are two other units which may be plugged into the external unit; when this is done they act as part of the external unit. The physician's control unit is not normally plugged into the external part worn by the patient, except when the physician is conducting an examination and adjustment of the retinal color prosthetic. The patient's controller may or may not be normally plugged in. When the patient's controller is plugged in, it can also receive signals from a remote physician's controller which then acts in the same way as the plug-in physician's controller. Examining further the embodiment of the subsystems of the external part, see FIG. 1 b . These include an external color imager ( 111 ), an eye-motion compensation system ( 112 ), a head-motion compensation system ( 131 ), a processing unit ( 113 ), a patient's controller ( 114 ), a physician's local controller ( 115 ), a physicians hand-held palm-size pocket-size unit ( 130 ), a physician's remote controller ( 117 ), and a telemetry means ( 118 ). The color imager is a color video camera such as a CCD or CMOS video camera. It gathers an image approximating what the eyes would be seeing if they were functional. An external imager ( 111 ) sends an image in the form of electrical signals to the video data processing unit ( 113 ). The video data processing unit consists of microprocessor CPU's and associated processing chips including high-speed data signal processing (DSP) chips. This unit can format a grid-like or pixel-like pattern that is sent to the electrodes by way of the telemetry communication subsystems ( 118 , 121 ). See FIG. 1 b . In this embodiment of the retinal color prosthesis ( FIG. 1 b , ( 121 )), these electrodes are incorporated in the internal-to-the eye implanted part. These electrodes, which are part of the internal implant ( 121 ), together with the telemetry circuitry ( 121 ) are inside the eye. With other internally implanted electronic circuitry ( 121 ), they cooperate with the electrodes so as to replicate the incoming pattern, in a useable form, for stimulation of the retina so as to reproduce a facsimile perception of the external scene. The eye-motion ( 112 ) and head-motion ( 131 ) detectors supply information to the video data processing unit ( 113 ) to shift the image presented to the retina ( 120 ). There are three preferred embodiments for stimulating the retina via the electrodes to convey the perception of color. Color information is acquired by the imaging means ( 111 ). The color data is processed in the video data processing unit ( 113 ). First Preferred Color Mode Color information (See FIG. 2 a ), in the first preferred embodiment, is encoded by time sequences of pulses ( 201 ) separated by varying amounts of time ( 202 ), and also with the pulse duration being varied in time ( 203 ). The basis for the color encoding is the individual color code reference ( 211 through 217 ). The electrodes stimulate the target cells so as to create a color image for the patient, corresponding to the original image as seen by the video camera, or other imaging means. Using temporal coding of electrical stimuli placed (cf. FIG. 2 b , 220 , FIG. 2 c , 230 ) on or near the retina ( FIG. 2 b and FIG. 2 c , 221 , 222 ) the perception of color can be created in patients blinded by outer retinal degeneration. By sending different temporal coding schemes to different electrodes, an image composed of more than one color can be produced. FIG. 2 shows one stimulation protocol. Cathodic stimuli ( 202 ) are below the zero plane ( 220 ) and anodic stimuli ( 203 ) are above. All the stimulus rates are either “fast” ( 203 ) or “slow” ( 202 ) except for green ( 214 ), which includes an intermediate stimulus rate ( 204 ). The temporal codes for the other colors are shown as Red ( 211 ), as Magenta ( 212 ), as Cyan ( 213 ), as Yellow ( 215 ), as Blue ( 216 ), as Neutral ( 217 ). This preferred embodiment is directed toward electrodes which are less densely packed in proximity to the retinal cells. Second Preferred Color Mode Color information, in a second preferred embodiment, is sent from the video data processing unit to the electrode array, where each electrode has been determined by test to stimulate one of a bipolar type: red-center green-surround, green-center-red-surround, blue-center-yellow-surround, or yellow-center-blue-surround. In this embodiment, electrodes which are small enough to interact with a single cell, or at most, a few cells are placed in the vicinity of individual bipolar cells, which react to a stimulus with nerve pulse rates and nerve pulse structure (i.e., pulse duration and pulse amplitude). Some of the bipolar cells, when electrically, or otherwise, stimulated, will send red-green signals to the brain. Others will send yellow-blue signals. This refers to the operation of the normal retina. In the normal retina, red or green color photoreceptors (cone cells) send nerve pulses to the red-green bipolar cell which then pass some form of this information up to the ganglion cells and then up to the visual cortex of the brain. With small electrodes individual bipolar cells can be excited in a spatial, or planar, pattern. Small electrodes are those with tip from 0.1 μm to 15 μm, and which individual electrodes are spaced apart from a range 8 μm to 24 μm, so as to approximate a one-to-one correspondence with the bipolar cells. The second preferred embodiment is oriented toward a more densely packed set of electrodes. Third Preferred Color Mode A third preferred mode is a combination of the first and of the second preferred modes such that a broader area coverage of the color information encoded by time sequences of pulses, of varying widths and separations and with relatively fewer electrodes is combined with a higher density of electrodes, addressing more the individual bipolar cells. First Order and Higher Effects Regardless of a particular theory of color vision, the impinging of colored light on the normal cones, and possibly rods, give rise in some fashion to the perception of color, i.e., multi-spectral vision. In the time-pulse coding color method, above, the absence of all, or sufficient, numbers of working cones (and rods) suggests a generalization of the particular time-pulse color encoding method. The generalization is based on the known, or partly known, neuron conduction pathways in the retina. The cone cells, for example, signal to bipolar cells, which in turn signal the ganglion cells. The original spatial-temporal-color (including black, white) scheme for conveying color information as the cone is struck by particular wavelength photons is then transformed to a patterned signal firing of the next cellular level, say the bipolar cells, unless the cones are absent or don't function. Thus, this second level of patterned signal firing is what one wishes to supply to induce the perception of color vision. The secondary layer of patterned firing may be close to the necessary primary pattern, in which case the secondary pattern (S) may be represented as P*(1+ε). The * indicates matrix multiplication. P is the primary pattern, represented as a matrix P = [ p 11 p 1 ⁢ j p k ⁢ ⁢ 1 p kj ] where P represents the light signals of a particular spatial-temporal pattern, e.g., flicker signals for green. The output from the first cell layer, say the cones, is then S, the secondary pattern. This represents the output from the bipolar layer in response to the input from the first (cone) layer. If S=P*(1+ε), where 1 represents a vector and ε represents a small deviation applied to the vector 1, then S is represented by P to the lowest order, and by P*(1+ε) to the next order. Thus, the response may be seen as a zero order effect and a first order linear effect. Additional terms in the functional relationship are included to completely define the functional relationship. If S is some non-linear function of P, finding S by starting with P requires more terms then the linear case to define the bulk of the functional relationship. However, regardless of the details of one color vision theory or another, on physiological grounds S is some function of P. As in the case of fitting individual patients with lenses for their glasses, variations of parameters are expected in fitting each patient to a particular temporal coding of electrical stimuli. Scaling Data from Photoreceptors to Bipolar Cells As cited above, Greenberg (1998), indicates that electrical and photic stimulation of the normal retina operate via similar mechanisms. Thus, even though electrical stimulation of a retina damaged by outer retinal degeneration is different from the electrical stimulation of a normal retina, the temporal relationships are expected to be analogous. To explain this, it is noted that electrical stimulation of the normal retinal is accomplished by stimulating the photoreceptor cells (including the color cells activated differentially according to the color of light impinging on them). For the outer retinal degeneration, it is precisely these photoreceptor cells which are missing. Therefore, the electrical stimulation in this case proceeds by way of the cells next up the ladder toward the optic nerve, namely, the bipolar cells. The time constant for stimulating photoreceptor is about 20 milliseconds. Thus the electrical pulse duration would need to be at least 20 milliseconds. The time constant for stimulating bipolar cells is around 9 seconds. These time constants are much longer than for the ganglion cells (about 1 millisecond). The ganglion cells are another layer of retinal cells closer to the optic nerve. The actual details of the behavior of the different cell types of the retina are quite complicated including the different relationships for current threshold versus stimulus duration (cf. Greenberg, 1998). One may, however, summarize an apparent resonant response of the cells based on their time constants corresponding to the actual pulse stimulus duration. In FIG. 2 , which is extrapolated from external-to-the-eye electrical stimulation data of Young (1977) and from light stimulation data of Festinger, Allyn, and White (1971), there is shown data that would be applicable to the photoreceptor cells. One may scale the data down based on the ratio of the photoreceptor time constant (about 20 milliseconds) to that of the bipolar cells (about 9 milliseconds). Consequently, 50 milliseconds on the time scale in FIG. 2 now corresponds to 25 milliseconds. Advantageously, stimulation rates and duration of pulses, as well as pulse widths may be chosen which apply to the electrode stimulation of the bipolar cells of the retina. Eye Movement/Head Motion Compensation In a preferred embodiment, an external imager such as a color CCD or color CMOS video camera ( 111 ) and a video data processing unit ( 113 ), with an external telemetry unit ( 118 ) present data to the internal eye-implant part. Another aspect of the preferred embodiment is a method and apparatus for tracking eye movement ( 112 ) and using that information to shift ( 113 ) the image presented to the retina. Another aspect of the preferred embodiment utilizes a head motion sensor ( 131 ) and a head motion compensation system ( 131 , 113 ). The video data processing unit incorporates the data of the motion of the eye as well as that of the head to further adjust the image electronically so as to account for eye motion and head motion. Thus electronic image compensation, stabilization and adjustment are provided by the eye and head movement compensation subsystems of the external part of the retinal color prosthesis. Logarithmic Encoding of Light In one aspect of an embodiment ( FIG. 1 b ), light amplitude is recorded by the external imager ( 111 ). The video data processing unit uses a logarithmic encoding scheme ( 113 ) to convert the incoming light amplitudes into the logarithmic electrical signals of these amplitudes ( 113 ). These electrical signals are then passed on by telemetry ( 118 ), ( 121 ), to the internal implant ( 121 ) which results in the retinal cells ( 120 ) being stimulated via the implanted electrodes ( 121 ), in this embodiment as part of the internal implant ( 121 ). Encoding is done outside the eye, but may be done internal to the eye, with a sufficient internal computational capability. Energy and Signal Transmission Coils The retinal prosthesis system contains a color imager ( FIG. 1 b , 111 ) such as a color CCD or CMOS video camera. The imaging output data is typically processed ( 113 ) into a pixel-based format compatible with the resolution of the implanted system. This processed data ( 113 ) is then associated with corresponding electrodes and amplitude and pulse-width and frequency information is sent by telemetry ( 118 ) into the internal unit coils, ( 311 ), ( 313 ), ( 314 ) (see FIG. 3 a ). Electromagnetic energy, is transferred into and out from an electronic component ( 311 ) located internally in the eye ( 312 ), using two insulated coils, both located under the conjunctiva of the eye with one free end of one coil ( 313 ) joined to one free end of the second coil ( 314 ), the second free end of said one coil joined to the second free end of said second coil. The second coil ( 314 ) is located in proximity to a coil ( 311 ) which is a part of said internally located electronic component, or, directly to said internally located electronic component ( 311 ). The larger coil is positioned near the lens of the eye. The larger coil is fastened in place in its position near the lens of the eye, for example, by suturing. FIG. 3 b represents an embodiment of the telemetry unit temporally located near the eye, including an external temporal coil ( 321 ), an internal (to the eye) coil ( 314 ), an external-to-the-eye electronic chip ( 320 ), dual coil transfer units ( 314 , 323 ), ( 321 , 322 ) and an internal-to-the-eye electrode array ( 325 ). The advantage of locating the external electronics in the fatty tissue behind the eye is that there is a reasonable amount of space there for the electronics and in that position it appears not to interfere with the motion of the eye. Ultrasonic Sound In another aspect the information coding is done with ultrasonic sound and in a third aspect information is encoded by modulating light. An ( FIG. 3 c ) ultrasonic transducer ( 341 ) replaces the electromagnetic wave receiving coil on the implant ( 121 ) inside the eye. An ultrasonic transducer ( 342 ) replaces the coil outside the eye for the ultrasonic case. A transponder ( 343 ) under the conjunctiva of the eye may be used to amplify the acoustic signal and energy either direction. By piezoelectric effects, the sound vibration is turned into electrical current, and energy extracted therefrom. Modulated Light Beam For the light modulation ( FIG. 3 d ) case, a light emitting diode (LED) or laser diode or other light generator ( 361 ), capable of being modulated, acts as the information transmitter. Information is transferred serially by modulating the light beam, and energy is extracted from the light signal after it is converted to electricity. A photo-detector ( 362 ), such as a photodiode, which turns the modulated light signal into a modulated electrical signal, is used as a receiver. A set of a photo-generator and a photo-detector are on the implant ( 121 ) and a set is also external to the eye Prototype-Like Device FIG. 4 shows an example of the internal-to-the-eye and the external-to-the eye parts of the retinal color prosthesis, together with a means for communicating between the two. The video camera ( 401 ) connects to an amplifier ( 402 ) and to a microprocessor ( 403 ) with memory ( 404 ). The microprocessor is connected to a modulator ( 405 ). The modulator is connected to a coil drive circuit ( 406 ). The coil drive circuit is connected to an oscillator ( 407 ) and to the coil ( 408 ). The coil ( 408 ) can receive energy inductively, which can be used to recharge a battery ( 410 ), which then supplies power. The battery may also be recharged from a charger ( 409 ) on a power line source ( 411 ). The internal-to-the eye implanted part shows a coil ( 551 ), which connects to both a rectifier circuit ( 552 ) and to a demodulator circuit ( 553 ). The demodulator connects to a switch control unit ( 554 ). The rectifier ( 552 ) connects to a plurality of diodes ( 555 ) which rectify the current to direct current for the electrodes ( 556 ); the switch control sets the electrodes as on or off as they set the switches ( 557 ). The coils ( 408 ) and ( 551 ) serve to connect inductively the internal-to-the-eye ( 500 ) subsystem and the external-to-the patient ( 400 ) subsystem by electromagnetic waves. Both power and information can be sent into the internal unit. Information can be sent out to the external unit. Power is extracted from the incoming electromagnetic signal and may be accumulated by capacitors connected to each electrode or by capacitive electrodes themselves. Simple Electrode Implant FIG. 6 a illustrates a set of round monopolar electrodes ( 602 ) on a substrate material ( 601 ). FIG. 7 shows the corresponding indifferent electrode ( 702 ) for these monopolar electrodes, on a substrate ( 701 ), which may be the back of ( 601 ). FIG. 6 b shows a bipolar arrangement of electrodes, both looking down onto the plane of the electrodes, positive ( 610 ) and negative ( 611 ), and also looking at the electrodes sideways to that view, positive ( 610 ) and negative ( 611 ), sitting on their substrate ( 614 ). Similarly for FIG. 6 c where a multipole triplet is shown, with two positive electrodes ( 621 ) and one negative electrode, looking down on their substrate plane, and looking sideways to that view, also showing the substrate ( 614 ). Epiretinal Electrode Array FIG. 8 a depicts the location of an epiretinal electrode array ( 811 ) located inside the eye ( 812 ) in the vitreous humor ( 813 ) located above the retina ( 814 ), toward the lens capsule ( 815 ) and the aqueous humor ( 816 ); One aspect of the present embodiment, shown in FIG. 8 b , is the internal retinal color prosthetic part, which has electrodes ( 817 ) which may be flat conductors that are recessed in an electrical insulator ( 818 ). One flat conductor material is a biocompatible metallic foil ( 817 ). Platinum foil is a particular type of biocompatible metal foil. The electrical insulator ( 818 ) in one aspect of the embodiment is silicone. The silicone ( 818 ) is shaped to the internal curvature of the retina ( 814 ). The vitreous humor ( 813 ), the conductive solution naturally present in the eye, becomes the effective electrode since the insulator ( 818 ) confines the field lines in a column until the current reaches the retina ( 814 ). A further advantage of this design is that the retinal tissue ( 814 ) is only in contact with the insulator ( 818 ), such as silicone, which may be more inactive, and thus, more biocompatible than the metal in the electrodes. Advantageously, another aspect of an embodiment of this invention is that adverse products produced by the electrodes ( 817 ) are distant from the retinal tissue ( 814 ) when the electrodes are recessed. FIG. 8 c shows elongated epiretinal electrodes ( 820 ). The electrically conducting electrodes ( 820 ) says are contained within the electrical insulation material ( 818 ); a silicon chip ( 819 ) acts as a substrate. The electrode insulator device ( 818 ) is shaped so as to contact the retina ( 814 ) in a conformal manner. Subretinal Electrode Array FIG. 9 a shows the location of a subretinal electrode array ( 811 ) below the retina ( 814 ), away from the lens capsule ( 815 ) and the aqueous humor ( 816 ). The retina ( 814 ) separates the subretinal electrode array from the vitreous humor ( 813 ). FIG. 9 b illustrates the subretinal electrode array ( 811 ) with pointed elongated electrodes ( 817 ), the insulator ( 818 ), and the silicon chip ( 819 ) substrate. The subretinal electrode array ( 811 ) is in conformal contact with the retina ( 814 ) with the electrodes ( 817 ) elongated to some depth. Electrodes Iridium Electrodes Now FIG. 10 will illuminate structure and manufacture of iridium electrodes ( FIGS. 10 a - e ). FIG. 10 a shows an iridium electrode, which comprises an iridium slug ( 1011 ), an insulator ( 1012 ), and a device substrate ( 1013 ). This embodiment shows the iridium slug electrode flush with the extent of the insulator. FIG. 10 b indicates an embodiment similar to that shown in FIG. 10 a , however, the iridium slug ( 1011 ) is recessed from the insulator ( 1012 ) along its sides, but with its top flush with the insulator. When the iridium electrodes ( 1011 ) are recessed in the insulating material ( 1012 ), they may have the sides exposed so as to increase the effective surface area without increasing geometric area of the face of the electrode. If an electrode ( 1011 ) is not recessed it may be coated with an insulator ( 1012 ), on all sides, except the flat surface of the face ( 1011 ) of the electrode. Such an arrangement can be embedded in an insulator that has an overall profile curvature that follows the curvature of the retina. The overall profile curvature may not be continuous, but may contain recesses, which expose the electrodes. FIG. 10 c shows an embodiment with the iridium slug as in FIG. 10 b , however, the top of the iridium slug ( 1011 ) is recessed below the level of the insulator; FIG. 10 d indicates an embodiment with the iridium slug ( 1011 ) coming to a point and insulation along its sides ( 1021 ), as well as a being within the overall insulation structure ( 1021 ). FIG. 10 e indicates an embodiment of a method for fabricating the iridium electrodes. On a substrate ( 1013 ) of silicon, an aluminum pad ( 1022 ) is deposited. On the pad the conductive adhesive ( 1023 ) is laid and platinum or iridium foil ( 1024 ) is attached thereby. A titanium ring ( 1025 ) is placed, sputtered, plated, ion implanted, ion beam assisted deposited (IBAD) or otherwise attached to the platinum or iridium foil ( 1024 ). Silicon carbide, diamond-like coating, silicon nitride and silicon oxide in combination, titanium oxide, tantalum oxide, aluminum nitride, aluminum oxide or zirconium oxide ( 1012 ) or other insulator can adhere better to the titanium ( 1025 ) while it would not otherwise adhere as well to the platinum or iridium foil ( 1024 ). The depth of the well for the iridium electrodes ranges from 0.1 μm to 1 mm. Elongated Electrodes Another aspect of an embodiment of the invention is the elongated electrode, which are designed to stimulate deeper retinal cells, in one embodiment, by penetrating the retina. By getting closer to the target cells for stimulation, the current required for stimulation is lower and the focus of the stimulation is more localized. The lengths chosen are 100 microns through 500 microns, including 300 microns. FIG. 8 c is a rendering of an elongated epiretinal electrode array with the electrodes shown as pointed electrical conductors ( 820 ), embedded in an electrical insulator ( 818 ), where the elongated electrodes ( 817 ) contact the retina in a conformal manner, however, penetrating into the retina ( 814 ). These elongated electrodes, in an aspect of this of an embodiment of the invention may be of all the same length. In a different aspect of an embodiment, they may be of different lengths. Said electrodes may be of varying lengths ( FIG. 8 , 817 ), such that the overall shape of said electrode group conforms to the curvature of the retina ( 814 ). In either of these cases, each may penetrate the retina from an epiretinal position ( FIG. 8 a , 811 ), or, in a different aspect of an embodiment of this invention, each may penetrate the retina from a subretinal position ( FIG. 9 b , 817 ). One method of making the elongated electrodes is by electroplating with one of an electrode material, such that the electrode, after being started, continuously grows in analogy to a stalagmite or stalactite. The elongated electrodes are 100 to 500 microns in length, the thickness of the retina averaging 200 microns. The electrode material is a substance selected from the group consisting of pyrolytic carbon, titanium nitride, platinum, iridium oxide, and iridium. The insulating material for the electrodes is a substance selected from the group silicon carbide, diamond-like coating, silicon nitride and silicon oxide in combination, titanium oxide, tantalum oxide, aluminum nitride, aluminum oxide or zirconium oxide. Platinum Electrodes FIG. 11 ( a - e ) demonstrates a preferred structure of, and method of, making, spiked and mushroom platinum electrodes. Examining FIG. 11 a one sees that the support for the flat electrode ( 1103 ) and other components such as electronic circuits (not shown) is the silicon substrate ( 1101 ). An aluminum pad ( 1102 ) is placed where an electrode or other component is to be placed. In order to hermetically seal-off the aluminum and silicon from any contact with biological activity, a metal foil ( 1103 ), such as platinum or iridium, is applied to the aluminum pad ( 1102 ) using conductive adhesive ( 1104 ). Electroplating is not used since a layer formed by electroplating, in the range of the required thinness, has small-scale defects or holes which destroy the hermetic character of the layer. A titanium ring ( 1105 ) is next placed on the platinum or iridium foil ( 1103 ). Normally, this placement is by ion implantation, sputtering or ion beam assisted deposition (IBAD) methods. Silicon carbide, diamond-like coating, silicon nitride and silicon oxide in combination, titanium oxide, tantalum oxide, aluminum nitride, aluminum oxide or zirconium oxide ( 1106 ) is placed on the silicon substrate ( 1101 ) and the titanium ring ( 1105 ). In one embodiment, an aluminum layer ( 1107 ) is plated onto exposed parts of the titanium ring ( 1105 ) and onto the silicon carbide, diamond-like coating, silicon nitride and silicon oxide in combination, titanium oxide, tantalum oxide, aluminum nitride, aluminum oxide or zirconium oxide ( 1106 ). In this embodiment the aluminum ( 1107 ) layer acts as an electrical conductor. A mask ( 1108 ) is placed over the aluminum layer ( 1107 ). In forming an elongated, non-flat, electrode ( FIG. 11 b ), platinum is electroplated onto the platinum or iridium foil ( 1103 ). Subsequently, the mask ( 1108 ) is removed and insulation ( 1110 ) is applied over the platinum electrode ( 1109 ). In FIG. 11 c , a platinum electrode ( 1109 ) is shown which is more internal to the well formed by the silicon carbide, diamond-like coating, silicon nitride and silicon oxide in combination, titanium oxide, tantalum oxide, aluminum nitride, aluminum oxide or zirconium oxide and its titanium ring. The electrode ( 1109 ) is also thinner and more elongated and more pointed. FIG. 11 d shows a platinum electrode formed by the same method as was used in FIGS. 11 a , 11 b , and 11 c . The platinum electrode ( 1192 ) is more internal to the well formed by the silicon carbide, diamond-like coating, silicon nitride and silicon oxide in combination, titanium oxide, tantalum oxide, aluminum nitride, aluminum oxide or zirconium oxide and its titanium ring as was the electrode ( 1109 ) in FIG. 11 c . However it is less elongated and less pointed. The platinum electrode is internal to the well formed by the silicon carbide, diamond-like coating, silicon nitride and silicon oxide in combination, titanium oxide, tantalum oxide, aluminum nitride, aluminum oxide or zirconium oxide and its titanium ring; said electrode whole angle at it's peak being in the range from 1° to 120°; the base of said conical or pyramidal electrode ranging from 1 micron to 500 micron; the linear section of the well unoccupied by said conical or pyramidal electrode ranging from zero to one-third. A similar overall construction is depicted in FIG. 11 e . The electrode ( 1193 ), which may be platinum, is termed a mushroom shape. The maximum current density for a given metal is fixed. The mushroom shape presents a relatively larger area than a conical electrode of the same height. The mushroom shape advantageously allows a higher current, for the given limitation on the current density (e.g., milliamperes per square millimeter) for the chosen electrode material, since the mushroom shape provides a larger area. Inductive Coupling Coils Information transmitted electromagnetically into or out of the implanted retinal color prosthesis utilizes insulated conducting coils so as to allow for inductive energy and signal coupling. FIG. 12 b shows an insulated conducting coil and insulated conducting electrical pathways, e.g., wires, attached to substrates at what would otherwise be electrode nodes, with flat, recessed metallic, conductive electrodes ( 1201 ). In referring to wire or wires, insulated conducting electrical pathways are included, such as in a “two-dimensional” “on-chip” coil or a “two-dimensional” coil on a polyimide substrate, and the leads to and from these “two-dimensional” coil structures. A silicon carbide, diamond-like coating, silicon nitride and silicon oxide in combination, titanium oxide, tantalum oxide, aluminum nitride, aluminum oxide or zirconium oxide ( 1204 ) is shown acting as both an insulator and an hermetic seal. Another aspect of the embodiment is shown in FIG. 12 d . The electrode array unit ( 1201 ) and the electronic circuitry unit ( 1202 ) can be on one substrate, or they may be on separate substrates ( 1202 ) joined by an insulated wire or by a plurality of insulated wires ( 1203 ). Said separate substrate units can be relatively near one another. For example, they might lie against a retinal surface, either epiretinally or subretinally placed. Two substrates units connected by insulated wires may carry more electrodes than if only one substrate with electrodes was employed, or it might be arranged with one substrate carrying the electrodes, the other the electronic circuitry. Another arrangement has the electrode substrate or substrates placed in a position to stimulate the retinal cells, while the electronics are located closer to the lens of the eye to avoid heating the sensitive retinal tissue. In all of the FIGS. 12 a , 12 b , and 12 c , a coil ( 1205 ) is shown attached by an insulated wire. The coil can be a coil of wire, or it can be a “two dimensional” trace as an “on-chip” component or as a component on polyimide. This coil can provide a stronger electromagnetic coupling to an outside-the-eye source of power and of signals. FIG. 12 c shows an externally placed aluminum (conductive) trace instead of the electrically conducting wire of FIG. 12 d . Also shown is an electrically insulating adhesive ( 1208 ) which prevents electrical contact between the substrates ( 1202 ) carrying active circuitry ( 1209 ). Hermetic Sealing Hermetic Coating All structures, which are subject to corrosive action as a result of being implanted in the eye, or, those structures which are not completely biocompatible and not completely safe to the internal cells and fluids of the eye require hermetic sealing. Hermetic sealing may be accomplished by coating the object to be sealed with silicon carbide, diamond-like coating, silicon nitride and silicon oxide in combination, titanium oxide, tantalum oxide, aluminum nitride, aluminum oxide or zirconium oxide. These materials also provide electrical insulation. The method and apparatus of hermetic sealing by aluminum and zirconium oxide coating is described in a U.S. patent application Ser. No. 08/994,515, now U.S. Pat. No. 6,043,437. The methods of coating a substrate material with the hermetic sealant include sputtering, ion implantation, and ion-beam assisted deposition (IBAD). Hermetic Box Another aspect of an embodiment of the invention is hermetically sealing the silicon chip ( 1301 ) by placing it in a metal or ceramic box ( 1302 ) of rectangular cross-section with the top and bottom sides initially open ( FIG. 13 ). The box may be of one ( 1302 ) of the metals selected from the group comprising platinum, iridium, palladium, gold, and stainless steel. Solder balls ( 1303 ) are placed on the “flip-chip”, i.e., a silicon-based chip that has the contacts on the bottom of the chip ( 1301 ). Metal feedthroughs ( 1304 ) made from a metal selected from the group consisting of radium, platinum, titanium, iridium, palladium, gold, and stainless steel. The bottom cover ( 1306 ) is formed from one of the ceramics selected from the group consisting of aluminum oxide or zirconium oxide. The inner surface ( 1305 ), toward the solder ball, ( 1303 )) of the feed-through ( 1304 ) is plated with gold or with nickel. The ceramic cover ( 1306 ) is then attached to the box using a braze ( 1307 ) selected from the group consisting of: 50% titanium together with 50% nickel and gold. Electronics are then inserted and the metal top cover (of the same metal selected for the box) is laser welded in place. Separate Electronics Chip Substrate and Electrode Substrate In one embodiment of the invention ( FIG. 14 ), the chip substrate ( 1401 ) is hermetically sealed in a case ( 1402 ) or by a coating of the aluminum, zirconium, or magnesium oxide coating. However, the electrodes ( 1403 ) and its substrate ( 1404 ) form a distinct and separate element. Insulated and hermetically sealed wires ( 1405 ) connect the two. The placement of the electrode element may be epiretinal, while the electronic chip element may be relatively distant from the electrode element, as much distant as being in the vicinity of the eye lens. Another embodiment of the invention has the electrode element placed subretinally and the electronic chip element placed toward the rear of the eye, being outside the eye, or, being embedded in the sclera of the eye or in or under the choroid, blood support region for the retina. Another embodiment of the invention has the electronic chip element implanted in the fatty tissue behind the eye and the electrode element placed subretinally or epiretinally. Capacitive Electrodes A plurality of capacitive electrodes can be used to stimulate the retina, in place of non-capacitive electrodes. A method of fabricating said capacitive electrode uses a pair of substances selected from the pair group consisting of the pairs iridium and iridium oxide; and, titanium and titanium nitride. The metal electrode acts with the insulating oxide or nitride, which typically forms of its own accord on the surface of the electrode. Together, the conductor and the insulator form an electrode with capacitance. Mini-capacitors ( FIG. 15 ) can also be used to supply the required isolating capacity. The capacity of the small volume size capacitors ( 1501 ) is 0.47 microfarads. The dimensions of these capacitors are individually 20 mils (length) by 20 mils (width) by 40 mils (height). In one embodiment of the invention, the capacitors are mounted on the surface of a chip substrate ( 1502 ), that surface being opposite to the surface containing the active electronics elements of the chip substrate. Electrode/Electronics Component Placement In one embodiment ( FIG. 16 a ), the internal-to-the-eye implanted part consists of two subsystems, the electrode component subretinally positioned and the electronic component epiretinally positioned. The electronics component, with its relatively high heat dissipation, is positioned at a distance, within the eye, from the electrode component placed near the retina that is sensitive to heat. An alternative embodiment shown in FIG. 16 b is where one of the combined electronic and electrode substrate units is positioned subretinally and the other is located epiretinally and both are held together across the retina so as to efficiently stimulate bipolar and associated cells in the retina. An alternative embodiment of the invention has the electronic chip element implanted in the fatty tissue behind the eye and the electrode element placed subretinally or epiretinally, and power and signal communication between them by electromagnetic means including radio-frequency (RF), optical, and quasi-static magnetic fields, or by acoustic means including ultrasonic transducers. FIG. 16 c shows how the two electronic-electrode substrate units are held positioned in a prescribed relationship to each other by small magnets. Alternatively the two electronic-electrode substrate units are held in position by alignment pins. Another aspect of this is to have the two electronic-electrode substrate units held positioned in a prescribed relationship to each other by snap-together mating parts, some exemplary ones being shown in FIG. 16 d. Neurotrophic Factor Another aspect of the embodiment is the use of a neurotrophic factor, for example, Nerve Growth Factor, applied to the electrodes, or to the vicinity of the electrodes, to aid in attracting target nerves and other nerves to grow toward the electrodes. Eye-Motion Compensation System Another aspect of the embodiment is an eye-motion compensation system comprising an eye-movement tracking apparatus ( FIG. 1 b , 112 ); measurements of eye movement; a transmitter to convey said measurements to video data processor unit that interprets eye movement measurements as angular positions, angular velocities, and angular accelerations; and the processing of eye position, velocity, acceleration data by the video data processing unit for image compensation, stabilization and adjustment. Ways of eye-tracking ( FIG. 1 b , 112 ) include utilizing the corneal eye reflex, utilizing an apparatus for measurements of electrical activity where one or more coils are located on the eye and one or more coils are outside the eye, utilizing an apparatus where three orthogonal coils placed on the eye and three orthogonal coils placed outside the eye, utilizing an apparatus for tracking movements where electrical recordings from extra-ocular muscles are measured and conveyed to the video data processing unit that interprets such electrical measurements as angular positions, angular velocities, and angular accelerations. The video data processing unit uses these values for eye position, velocity, acceleration to compute image compensation, stabilization and adjustment data which is then applied by the video data processor to the electronic form of the image. Head Sensor Another aspect of the embodiment utilizes a head motion sensor ( 131 ). The basic sensor in the head motion sensor unit is an integrating accelerometer. A laser gyroscope can also be used. A third sensor is the combination of an integrating accelerometer and a laser gyroscope. The video data processing unit can incorporate the data of the motion of the eye as well as that of the head to further adjust the image electronically so as to account for eye motion and head motion. Physician's Local Control Unit Another aspect includes a retinal prosthesis with (see FIG. 1 b ) a physician's local external control unit ( 115 ) allowing the physician to exert setup control of parameters such as amplitudes, pulse widths, frequencies, and patterns of electrical stimulation. The physician's control unit ( 115 ) is also capable of monitoring information from the implanted unit ( 121 ) such as electrode current, electrode impedance, compliance voltage, and electrical recordings from the retina. The monitoring is done via the internal telemetry unit, electrode and electronics assembly ( 121 ). An important aspect of setting up the retinal color prosthesis is setting up electrode current amplitudes, pulse widths, and frequencies so they are comfortable for the patient. FIGS. 17 a - c and FIGS. 18 a - c illustrate some of the typical displays. A computer-controlled stimulating test that incorporates patient response to arrive at optimal patient settings may be compared to being fitted for eyeglasses, first determining diopter, then cylindrical astigmatic correction, and so forth for each patient. The computer uses interpolation and extrapolation routines. Curve or surface or volume fitting of data may be used. For each pixel, the intensity in increased until a threshold is reached and the patient can detect something in his visual field. The intensity is further increased until the maximum comfortable brightness is reached. The patient determines his subjective impression of one-quarter maximum brightness, one-half maximum brightness, and three-quarters maximum brightness. Using the semi-automated processing of the patient-in-the-loop with the computer, the test program runs through the sequences and permutations of parameters and remembers the patient responses. In this way apparent brightness response curves are calibrated for each electrode for amplitude. Additionally, in the same way as for amplitude, pulse width and pulse rate (frequency), response curves are calibrated for each patient. The clinician can then determine what the best settings are for the patient. This method is generally applicable to many, if not all, types of electrode based retinal prostheses. Moreover, it also is applicable to the type of retinal prosthesis, which uses an external light intensifier shining upon essentially a spatially distributed set of light sensitive diodes with a light activated electrode. In this latter case, a physician's test, setup and control unit is applied to the light intensifier which scans the implanted photodiode array, element by element, where the patient can give feedback and so adjust the light intensifier parameters. Remote Physician's Unit Another aspect of an embodiment of this invention includes (see FIG. 1 b ) a remote physician control unit ( 117 ) that can communicate with a patient's unit ( 114 ) over the public switched telephone network or other telephony means. This telephone-based pair of units is capable of performing all of the functions of the of the physician's local control unit ( 115 ). Physician's Unit Measurements, Menus and Displays Both the physician's local ( 115 ) and the physician's remote ( 117 ) units always measure brightness, amplitudes, pulse widths, frequencies, patterns of stimulation, shape of log amplification curve, electrode current, electrode impedance, compliance voltage and electrical recordings from the retina. FIG. 17 a shows the main screen of the Physician's Local and Remote Controller and Programmer. FIG. 17 b illustrates the pixel selection of the processing algorithm with the averaging of eight surrounding pixels chosen as one element of the processing. FIG. 17 c represents an electrode scanning sequence, in this case the predefined sequence, A. FIG. 17 d shows electrode parameters, here for electrode B, including current amplitudes and waveform timelines. FIG. 17 e illustrates the screen for choosing the global electrode configuration, monopolar, bipolar, or multipolar. FIG. 17 f renders a screen showing the definition of bipolar pairs (of electrodes). FIG. 17 g shows the definition of the multipole arrangements. FIG. 18 a illustrates the main menu screen for the palm-sized test unit. FIG. 18 b shows a result of pressing on the stimulate bar of the (palm-sized unit) main menu screen, where upon pressing the start button the amplitudes A 1 and A 2 are stimulated for times t 1 , t 2 , t 3 , and t 4 , until the stop button is pressed. FIG. 18 c exhibits a recording screen that shows the retinal recording of the post-stimulus and the electrode impedance. FIGS. 19 a , 19 b , and 19 c show different embodiments of the Physician's Remote Controller, which has the same functionality inside as the Physician's Local Controller but with the addition of communication means such as telemetry or telephone modem. Patient's Controller Corresponding to the Physician's Local Controller, but with much less capability, is the Patient's Controller. FIG. 20 shows the patient's local controller unit. This unit can monitor and adjust brightness ( 2001 ), contrast ( 2002 ) and magnification ( 2003 ) of the image on a non-continuous basis. The magnification control ( 2003 ) adjusts magnification both by optical zoom lens control of the lens for the imaging means ( FIG. 1 , 111 ), and by electronic adjustment of the image in the data processor ( FIG. 2 , 113 ). While the invention herein disclosed has been described by means of specific embodiments and applications thereof, numerous modifications and variations could be made thereto by those skilled in the art without departing from the scope of the invention set forth in the claims.

The present invention is an implantable electronic device formed within a biocompatible hermetic package. Preferably the implantable electronic device is used for a visual prosthesis for the restoration of sight in patients with lost or degraded visual function. The package is formed from a thin film of hermetic biocompatible material to minimize the size of the implanted device.

FIELD OF THE INVENTION [0001] This invention relates generally to sunscreen application products, including wipes for the application of sunscreen. BACKGROUND OF THE INVENTION [0002] Sunscreens are substances or compositions applied to the skin to protect the skin from sunburn caused by the sun's ultraviolet rays. When uniformly applied to the body, sunscreens can be highly effective in protecting against sunburn. However, sunscreen failure can occur when areas of the body are missed because the sunscreen is hard to see or visualize after being applied or rubbed onto the skin. Children are at greater risk of sunburn than adults, since coverage on children's skin is more likely to be incomplete, uneven or inconsistent. A color indicator has been added to some sunscreens, making it visibly noticeable when being applied to the skin. The coloration substantially disappears when the sunscreen emulation dries after it is spread on the skin and is rubbed out. Examples of such colored sunscreens are described in U.S. Pat. Nos. 6,290,936; 6,146,618; and 6,099,825, which are incorporated by reference. [0003] Though the colored tints are helpful in providing full distribution of sunscreen, the do not address the mess associated with the application. Because of the substantial mess involved in applying sunscreen, a need arises for another method of dispensing the sunscreen emulsion. Ideally, an improved application method can also incorporate tints to allow even distribution. SUMMARY OF THE INVENTION [0004] In its preferred form, the present invention comprises a colored sunscreen wipe. The wipe is impregnated with colored sunscreen to allow an ideal amount of sunscreen to be dispersed over the skin, at the same time leaving the hands of the applier free of excess sunscreen. The need for colored sunscreen wipes arises especially when traveling, or at the beach or pool, and when access to a source of water for cleaning the hands after application is limited. The wipe also allows only the necessary amount of sunscreen to be applied evenly to the skin, thus eliminating wasteful amounts of sunscreen in the application process. BRIEF DESCRIPTION OF THE DRAWINGS [0005] The preferred and alternative embodiments of the present invention are described in detail below with reference to the following drawings. [0006] FIG. 1 is a top plan view of a preferred wipe; [0007] FIG. 2 is an end view of a preferred wipe containing sunscreen; [0008] FIG. 3 is a perspective view of a preferred wipe container; [0009] FIG. 4 is a perspective view of an alternate preferred wipe container; [0010] FIG. 5 is a side view of a preferred method for folding and interleaving wipes in a container; and [0011] FIG. 6 is a flow diagram for a preferred method of using a sunscreen wipe. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0012] The preferred embodiment of the present invention relates to a swatch of fibrous materials incorporating a desired amount of sunscreen, ideally with a colored tint. The wipes reduce the amount of wasted sunscreen emulsion applied to the skin and facilitate even coverage to protect the skin from ultraviolet radiation. According to one embodiment, the wipes are folded and arranged in a stacked configuration inside a suitable container for consumer sale. [0013] FIG. 1 shows an exemplary preferred wipe 10 , comprising a swatch of fibrous material 16 . The swatch can be formed from cotton or other materials commonly associated with “cloth,” or may alternatively be formed from paper or pulp-based materials commonly associated with paper towels and baby wipes. Likewise, the swatch may be formed from a blend of various materials, so long as it remains relatively flexible. Ideally, the swatch is capable of absorbing and holding a sufficient amount of sunscreen. In certain embodiments, however, the sunscreen is principally not absorbed into the swatch, but rather remains substantially atop the swatch. [0014] As indicated in FIG. 1 , the swatch preferably is “quilted,” meaning that it includes a plurality of generally raised regions 14 and depressed regions 12 . The quilting enables the swatch to hold a greater amount of sunscreen in order to cover a larger area. [0015] FIG. 2 illustrates an end view of the wipe depicted in FIG. 1 . Thus, the wipe of FIG. 2 comprises a swatch 16 having a plurality of raised regions 14 and depressed regions 12 . A layer of sunscreen 20 is shown on the top portion of the wipe, with a relatively greater amount of sunscreen retained within the depressed regions. In some embodiments, the top and bottom of the wipe will be substantially symmetrical, with a layer of sunscreen on either side. In alternate embodiments, however, an additional material is applied to or incorporated into the swatch to inhibit the sunscreen from migrating from the top surface 24 to the bottom surface 26 . Thus, in one embodiment a generally sunscreen-impenetrable layer 22 is provided on the bottom surface 26 so that the bottom surface of the wipe remains dry. The inhibiting layer may be formed from plastic, rubber, fluoropolymers, nylon, or other materials. In alternate embodiments, a similar layer is woven into the wipe, or the wipe is formed from less absorbent materials such that the layer of sunscreen on top surface 24 of the swatch is inhibited from flowing toward the bottom surface 26 . [0016] The wipes contain a sunscreen emulsion solution which is absorbed into or rests on top of one side of the wipes. The sunscreen may be a standard white color or, in some embodiments, may contain a colored tint. The amount of the sunscreen solution contained in each wet wipe may vary depending upon the type and composition of the sunscreen (e.g. waterproof, SPF 2, SPF 50, etc.). [0017] The sunscreen emulsion that is impregnated into the wipe can contain a water-soluble color dye (color indicator) in an amount sufficient to enable the sunscreen to be readily visualized (i.e. colored) when initially applied to the skin, such that when the sunscreen emulsion dries after being spread on the skin or is rubbed into the skin using one's hand or fingers, the color substantially disappears. One or more water-soluble dyes can be employed in the composition, preferably in an amount ranging from about 0.0005 to about 0.5% by weight of the sunscreen composition. A suitable water-soluble color dye is a blend of Ext. DC violet #2(95%) and Ext. DC red #3 (5%). [0018] The sunscreen compositions can also contain a sun screening effective amount of one or more oil-soluble or water-soluble sun screening UV_A and UV_B actives. Water is employed in the sunscreen in amounts effective to form the emulsion and solubilize the ingredients. A waterproofing agent may also be added to provide waterproofing characteristics to the emulsion. Suitable waterproofing agents include copolymers derived from polymerization of octadecene-1 and malefic anhydride. [0019] The colored (or uncolored) sunscreen wipes may be dispensed in any number of boxes or bags, such as those shown in FIGS. 3 and 4 . Thus, as one example, a dispenser box 30 may be used, including a container body 32 and dispenser lid 34 having a slot to enable a wipe 10 to be removed through the dispenser lid 34 . A substantially air-tight, resealable lid 36 is also provided to allow the wipes to stay saturated with the colored sunscreen. In the form of FIG. 4 , a similar dispenser package is provided in a cylindrical shape. Either of the packaging types of FIGS. 3 and 4 may be used without the dispenser lids. [0020] In yet another embodiment, one or more wipes is provided in individually-wrapped packages. In this form, a single wrap is folded multiple times to form a pocket-sized square (or other shape), then sealed in a water-tight and air-tight package that can be opened for individual use. Such a package may also include two or more wipes in a single package. [0021] When using a dispenser package with wipes or facial tissues, it is common to fold the wipe or tissues in an overlapping arrangement in which pulling one wipe from the package will urge an adjacent wipe out of the package with it. In one embodiment, such as that shown in FIG. 3 , a similar folding arrangement is used for the sunscreen wipes. [0022] In an embodiment in which the wipes contain sunscreen on a top surface 24 and have a substantially dry bottom surface 26 , it is useful to store the wipes within a container such that the sunscreen on the top surface of a wipe does not contaminate the dry and clean bottom surfaces of other wipes. A preferred arrangement for accomplishing this result is to fold the wipes before interleaving them within the container. Thus, as shown in FIG. 5 , a plurality of wipes 10 are folded generally in half so that the dry bottom surface 26 faces outward and the wet sunscreen-containing top surface faces inward. Only the bottom surfaces of adjacent wipes contact one another, thereby ensuring that each wipe is removed from the container with one wet side and one dry side. In addition, if the wipes are arranged within the container such that the folded end 50 emerges from the container before the open end, it will better ensure that the sunscreen does not dry out, even if the top lid 36 is removed or not used. [0023] As shown in FIG. 5 , a C-folded arrangement is used for interleaving adjacent wipes. Certainly a Z-folded or other arrangement may be used to enable a continuous flow of wipes to emerge from the package, one at a time. [0024] In an alternative configuration, the wet wipes may take the form of continuous webs of material which include perforations to separate the individual wet wipes and which are wound into rolls and packaged in plastic containers. An example of such a container is shown in FIG. 4 , and described more fully in U.S. Pat. Nos. 6,613,729 and 6,696,070. [0025] A preferred method for using the sunscreen wipe is shown in FIG. 6 . Initially, a wipe is removed from a package containing one or more wipes in a first step 60 . The wipe is unfolded 62 if necessary (depending on the packaging method) to expose the sunscreen-containing top surface. In the embodiment having a substantially dry side and a substantially wet side, the dry side is placed against the palm of the hand with the wet side exposed. This allows the sunscreen to be applied 64 by rubbing the wipe against the skin wherever sunscreen is desired. If the sunscreen includes a colored tint, the user will readily be able to determine whether the coverage has been even. Finally, when the sunscreen is sufficiently, applied, the wipe is discarded 66 . [0026] The colored sunscreen wipe will allow the consumer to use the sunscreen emulsion within a convenient wet wipe, thus achieving maximum possible uniformity of application to the skin with the least amount of mess possible. [0027] While the preferred embodiment of the invention has been illustrated and described, as noted above, many changes can be made without departing from the spirit and scope of the invention. Accordingly, the scope of the invention is not limited by the disclosure of the preferred embodiment. Instead, the invention should be determined entirely by reference to the claims that follow.

The invention relates to a product comprising a wet wipe and a sunscreen (colored or white) emulsion. The sunscreen emulsion is impregnated into the wet wipe resulting in the even spread of the colored sunscreen with more convenience, and significantly reducing the mess and waste normally resulting from the application of emulsions by hand.

FIELD OF THE INVENTION [0001] The present invention relates to golf club heads, more specifically to golf club heads with striking faces that have been modified with laser radiation. The primary feature of these laser surface modified golf club heads is improved performance and playability with an improvement in the feel received by the golfer. BACKGROUND OF THE INVENTION [0002] In recent years, there have been a large number of technological innovations in the field of golf club construction in an effort to improve the performance of the clubs. Many of these innovations have focused on optimizing the weight distribution within the golf club's head in order to correct for off-center hits, thereby expanding the “sweet spot”. These innovations have resulted in golf clubs with dramatic performance improvements that have received excellent success in the marketplace. Similarly, the configuration of the golf clubs has also been modified to optimize the “spin” imparted to the golf ball during impact, since this spin can be utilized to better control the ball. [0003] More recently, golf club manufacturers have shifted their focus to improving the golf club's “feel”. Although the feel is a rather individual and subjective characteristic, most golfers equate it with a comfortable sensation received through the hands during contact with the golf ball. Many golf club manufacturers have improved the feel of golf clubs by incorporating secondary materials into the primary material of the golf club's construction. Some of these multiple material systems have received an excellent reception in the golf club marketplace. There are additional methods, such as the one described in the current invention, which can also be utilized to improve a golf club's performance and feel. [0004] An alternative process to tailor the properties of a material is through the application of a laser (Light Amplification through Stimulated Emission of Radiation). Laser surface modification provides an opportunity to specifically tailor the surface of a material to have unique properties when compared to those of the unmodified bulk material. Laser radiation can be used to focus a very intense source of heat in a small area. Some examples of modified surface properties include an increased surface hardness, a decreased surface hardness, and an increased surface roughness. A decrease in surface hardness or an increase in surface hardness from a laser treatment is possible in different materials depending on their chemical structure. In some non-heat treatable iron alloys, for example, the laser radiation can be used to reduce the internal residual stresses, thereby reducing the surface hardness. In heat-treatable alloys, on the other hand, the thermal energy provided by the laser can increase the hardness by changing the crystalline structure of the material. In most instances, there will also be a change in the surface topography of the laser surface modified material. Specifically, the roughness of the surface will increase. A final example of a beneficial change in the surface structure of a material through the application of laser radiation is the creation of a periodic pattern of raised or depressed features on the golf club. [0005] The difference in these properties is a result of the specific material to be modified by the laser. The increased surface hardness can be particularly beneficial in golf club applications where it is desired to have the ball rebound from the golf club with as much initial velocity as possible, resulting in a ball that travels a great distance. A decreased surface hardness, on the other hand, can be particularly beneficial in the case of a golf club application where a soft feel is required. Additionally, a golf club hitting face with a periodic array of features can advantageously put an increased amount of spin on the golf ball. Finally, an increased surface roughness on the hitting face of the golf club is particularly desirable in the case of a golf club where it is desired to impart a large degree of spin on the golf ball. [0006] Laser surface modification has been used extensively in different areas of materials science for joining two or more materials, annealing materials to relieve internal stresses, and sintering powders into a unitary mass. These techniques have been used for a wide variety of industrial applications where it is important to have specific properties of the materials, such as high surface hardness, low surface hardness, or resistance to particular types of wear. In the computer disk drive industry, for example, it has been shown that a laser can be used to modify the surface structure of the hard disk in a manner that benefits the wear properties of the disk drive. Examples of laser application to hard disk drives can be seen in the prior art of Wong, et al. in U.S. Pat. No. 6,117,499 and Baernboim, et al. in U.S. Pat. No. 6,103,990. Additional examples of laser applications are evidenced in the prior art of Herren, et al. in U.S. Pat. No. 5,030,551, which details a process for laser marking ceramics and glasses, and Horng et al. in U.S. Pat. No. 5,322,436 which details a process for creating a laser engraved mark on an orthodontic band. There are many additional examples in the prior art, detailing the apparatus for delivering the laser radiation to a work piece. Excellent examples can be found in U.S. Pat. Nos. 5,338,915, 4,156,124, and 4,797,532. Although there are many industrial examples of the use of laser radiation for the benefit of specific applications, there is an absence of said laser processing in application to golf equipment. [0007] The prior art in golf club construction and engineering is significant. Thorne and Poplaski, in U.S. Pat. No. 5,800,285, describe a method for producing artwork on a golf club with a photochemical engraving technique. The application of a laser in this process is intended to change the structure of a photoresist chemical, thereby allowing a separate compound to chemically etch the exposed areas. This process is fundamentally different than the one described in the present patent application where the laser is modifying the material composing the striking face of the golf club. The primary purpose of Thorne's process is to create a customized pattern such as letters, numbers, symbols, or scorelines, thus it is not primarily focused on functionally modifying the surface. In addition, this patent primarily describes an alternative process for detailing the head of a golf club, when compared to traditional metal casting or metal stamping. Finally, Thorne and Poplaski's patent is focused only on metallic materials, which is dissimilar from the laser modification process which applies equally well to all classes of materials. [0008] There are additional methods described in the prior art on golf clubs constructed of multiple materials. For example, Chen in U.S. Pat. No. 5,403,007, describes a golf club with a metal body and a ceramic or titanium hitting face. Similarly, Buck in U.S. Pat. No. 5,779,560, describes a golf club head comprised of a metal head with an insert comprised of a fiber-reinforced composite. Anderson, in U.S. Pat. Nos. 5,024,437 and 5,261,663, describes an insert made of a softer material such as a forged carbon steel to improve the feel of the club during impact. Further attempts to improve the feel of a golf club were proposed by Krumme in U.S. Pat. No. 5,807,190 wherein individual pieces of a secondary material (“pixels”) were incorporated into the striking face of the club. Similarly, Igarashi, in U.S. Pat. No. 5,407,202, proposed a golf club incorporating a high strength, low weight material such as titanium for the striking face of a golf club. An additional method to improve the performance of golf clubs was proposed by Mahaffey in U.S. Pat. No. 5,827,131 including multiple-layer inserts for the golf club hitting surface. Additional attempts have been made to improve the performance and feel, such as U.S. Pat. No. 5,154,425 which describes a golf club head composed of a material which is a composite of metal and ceramic components. [0009] Many of these methods, however, require very expensive processing techniques and can lead to a substantial number of internal interfaces between the dissimilar materials. These internal interfaces are sources of potential manufacturing defects, as well as interruptions to the vibrations translated to the golfer. It is the vibrations transmitted to the golfer that provide the pleasant feel. In the current invention, on the other hand, the laser surface modified material is substantially the same as the base material, with a slight functional, structural, or topographical modification. SUMMARY OF THE INVENTION [0010] With the present invention, it has been found that a laser can be used to modify the surface structure of a material. The changes can include modification of the crystalline structure of the material, changes to the surface roughness, changes in the surface chemistry of the chemical elements, or can, in some cases, transform a crystalline material into a non-crystalline (i.e., amorphous) material. [0011] In one aspect, the present invention provides a surface with a greatly increased roughness, thereby dramatically increasing the frictional coefficient of the material. An increase in the level of the friction on the surface of a club hitting face can positively impact the performance of the club by changing the manner in which the golf ball interacts with the club during striking. The increased friction between the golf club and the ball imparts a high degree of spin to the ball during the contact. This high degree of spin can be particularly advantageous in the application of golf clubs with a high degree of loft since it allows control over the golf ball after it lands in the desired location. [0012] In a golf putting application, the present invention can be particularly advantageous due to the high friction between the ball and the putter's surface. This high friction causes the ball to immediately roll in a forward direction, as opposed to the problem of skidding evidenced by many of the prior art putters. [0013] In many applications for golf clubs, the surface modification will be limited to specific areas on the club hitting face. The present invention can be used for a number of different clubs, including putters, irons, specialty clubs, and drivers. Specialty clubs can include any club used for chipping, hitting out of deep rough, hitting out of wet grass, or hitting out of any hazard, such as, but not limited to sand bunkers. [0014] Although the preferred location of the laser surface modified material is on the hitting face, it can also be used on any surface of the club, such as the face nearest the ground when the ball is being struck. Again, surface material properties can be altered to increase the performance of the golf club. [0015] Non-limiting examples of some materials that may be included in laser surface modification processing include steel alloys, stainless steel alloys, titanium alloys, aluminum and its alloys, aluminum oxide, zirconium dioxide, silicon carbide, silicon nitride, polymeric materials, and rubber compounds. [0016] In a major aspect, the present invention provides a method of manufacture for a laser surface modified material. The manufacturing method typically includes treating the material surface with laser radiation. Nonlimiting examples of laser types include carbon dioxide, yttrium aluminum garnet (YAG), or any type of solid-state semiconductor laser. Typical laser power for a carbon dioxide laser ranges from 5-5000 Watts. The focused spot size is typically in the range of 125 microns (0.005 inches). [0017] One tremendous advantage of the present invention is the multiple methods to functionally modify the surface structure of the material. In one instance, for example, a heat treatable steel alloy can increase in hardness from the thermal energy provided by the laser. In another example, the laser beam can increase the surface roughness of a material. In yet another example, lasers can be used to anneal a metallic alloy to remove residual stresses and decrease the hardness of the material. Each one of these properties can benefit different applications for the striking face of a golf club. In one instance, a softer metallic alloy on the striking face of a golf club delivers a better feel to the player. In another instance, an increase in the surface roughness of the striking face of a golf club provides an increase in the amount of advantageous spin that can be applied to a golf ball. Although the previous examples have focused on metallic materials, the technique for laser surface modification applies equally well to natural materials such as wood, as well as synthetic materials comprising the classes generally known as polymers and ceramics. [0018] The type and power of the laser depends on the type of material to be treated. For a given material, an increase in laser power will increase the depth of penetration into the material. In general, any laser will cause a small change in the surface structure of a material. In the case of the present invention, however, the power must reach a threshold that depends on the type of material, to give the benefits described for the striking face of a golf club. [0019] An alternative embodiment for the laser surface modification process can be applied to golf clubs that are composed of multiple materials. For example, the laser surface modified material can be used on the hitting surface of the golf clubs, In an alternative embodiment, a secondary material that is inserted into the primary golf club material, can be treated with laser surface modification. BRIEF DESCRIPTION OF THE DRAWINGS [0020] [0020]FIG. 1 is a scanning electron microscope image of an aluminum oxide surface that has been modified with laser radiation. [0021] [0021]FIG. 2 is a scanning electron microscope image of a titanium alloy surface that has been modified with laser radiation. [0022] [0022]FIG. 3 is a high magnification scanning electron microscope image of a titanium alloy surface that has been modified with laser radiation. [0023] [0023]FIG. 4 is a schematic showing a putter with a laser surface modified striking face. [0024] [0024]FIG. 5 is a schematic showing an iron with a laser surface modified striking face. [0025] [0025]FIG. 6 is a schematic showing a driver with a laser surface modified striking face. [0026] [0026]FIG. 7 is a cross-sectional view of putter with a laser surface modified striking face. The depth of penetration of the laser modified material is indicated on the drawing. [0027] [0027]FIG. 8 is a cross-sectional view of a driver with a laser surface modified striking face. The depth of penetration of the laser modified material is indicated on the drawing. [0028] [0028]FIG. 9 is a cross-sectional view of an iron club with a laser surface modified striking face. The depth of penetration of the laser modified material is indicated on the drawing. DETAILED DESCRIPTION OF THE INVENTION [0029] With the present invention, it has been found that a laser can be used to advantageously modify properties such as crystallinity, hardness, ductility, elasticity and topography of the surface of a material. These modifications can be particularly beneficial in the case of golf club applications. [0030] Non-limiting examples of some materials that may be included in laser surface modification processing include steel alloys, stainless steel alloys, titanium alloys, aluminum and its alloys, aluminum oxide, zirconium dioxide, silicon carbide, silicon nitride, polymeric materials, and rubber compounds. [0031] Nonlimiting examples of laser types include gas lasers, such as Helium-Neon, Helium-Cadmium, Copper vapor, gold vapor, carbon dioxide, nitrogen, argon ion, krypton ion, Excimer, a liquid dye laser, diode laser, free electron laser, or x-ray laser, yttrium aluminum garnet (YAG), Excimer, diode-laser, or any type of solid state semiconductor laser. [0032] The head of the golf club can be manufactured through one of the methods well known in the prior art. Some examples include casting, forging, and powder metallurgical methods. A typical casting process, for example, consists of heating a metal alloy above its melting temperature, thereby rendering a liquid metal. The club can be cast into a hollow ceramic mold with the dimensions that are desired in the finished piece. Alternatively, a unitary mass of a ductile metal alloy can be forced into a mold cavity while in a solid state, as in the forging process. After one of these initial forming processes, the club can be finished by sand blasting, plating, or some other surface finishing treatment, dependent on the finish desired for the club. Furthermore, the specific demarcations on the golf club, such as the company logo or the club number, can be highlighted with paint for aesthetic purposes. [0033] In the current invention, the golf club head produced by any of the above processes will then be subjected to laser surface modification. In a typical process, the laser beam will be focused onto the surface of the material to be treated. The laser beam is turned on by means of an electronic controller that initiates the laser power. In a general laser process, the laser beam is emitted from the laser cavity and manipulated by a series of lenses and mirrors to be focused onto the working surface of the material to be modified. In a preferred embodiment, the laser is pulsed on and off from 1 to 200 times per second. Each one of these individual laser pulses modifies the surface of the material in a very localized region, typically 0.1-100 microns. It is particularly advantageous to move either the laser beam or the material to be modified, in an effort to modify the surface of the material in a large pattern. Several commercially available laser systems have a computer-controlled table for mounting the sample. The sample is then moved with the computer software, thereby inscribing a pattern onto the surface of the sample. In most instances for the present invention, the spacing between the individual laser pulses is very small, thereby making the pattern indistinct. In other embodiments of the current invention, individual pulses are separated by an area of 1 to 10 times the size of the pulse, in order to produce a periodic area of surface features. [0034] There are several elements of the laser process that can be varied to modify the degree of surface modification. Some examples include ambient atmosphere and temperature, pulse period, pulse width, gas pressure, and cone size. Each of these variables can be tuned for the specific material to be modified. The type and power of the laser depends on the type of material to be treated. For a given material, an increase in laser power will increase the depth of penetration into the material. In general, any laser will cause a small change in the surface structure of a material. In the case of the present invention, however, the power must reach a threshold that depends on the type of material, to give the benefits described for the striking face of a golf club. In some instances, sufficient laser power can be applied to golf club causing a localized melting of the surface material. This melting process can produce unique new material characteristics when the surface is re-solidified. [0035] An alternative embodiment for the laser surface modification process can be applied to golf clubs composed of multiple materials. It is well known in the prior art that multiple materials can be beneficially incorporated into a single golf club to improve the performance and feel. A secondary material, generally referred to as an insert, can be modified similar to a golf club composed of a single material. The laser settings must be adjusted to an appropriate level depending on the material in the insert. Too much laser power can cause excessive damage to the material, while too little laser power can cause no beneficial effect. [0036] In a major aspect, the present invention provides golf clubs with surfaces that have been modified with laser radiation. The following examples should serve to provide sufficient information to allow anyone skilled in the art to reproduce the current invention. EXAMPLE 1 Ceramic Material [0037] Is A commercially available aluminum oxide (Al 2 O 3 ) material (AD-996, CoorsTek, Inc., Golden, CO) with a thickness of 0.025 inches was selected for the laser surface modification experiments. The aluminum oxide substrate was placed on an anodized aluminum fixture on a carbon dioxide (CO 2 ) laser system with computer-controlled position head and manually adjusted laser settings (Epilog Laser, Golden, Colo.). The laser was operated in a raster mode with powers ranging from 2.5 Watts to 25 Watts and speeds of 2.5 inches per second to 25 inches per second. The surface of the material was characterized with a scanning electron microscope (840-JXA, JEOL Instruments, Ltd.) at an accelerating voltage of 15 kV and a probe current of 3×10 −10 amps. FIG. 1 shows the SEM image of the surface of the aluminum oxide material clearly highlighting the microfeatures on the surface. Additionally, the crystalline material has been changed to an amorphous material, as evidenced by the smooth region within the laser surface modified region. EXAMPLE 2 Titanium Alloy [0038] A commercially available titanium alloy (Ti—6Al—4V, Titanium Industries, Inc.) was selected for the laser surface modification experiments. The titanium material was placed on a xy-fixture on a Nd:YAG laser (Hobart MM1200) system with computer-controlled z-height head and manually adjusted laser settings. The laser was operated in a continuous wave mode with powers ranging from 100 Watts to 1200 Watts and material speeds of 1 inch per second to 10 inches per second. The laser surface modification experiments were conducted in a variety of different atmospheres, including air, methane, nitrogen, and argon. The surface of the material was characterized with a scanning electron microscope (840-JXA, JEOL Instruments, Ltd.) at an accelerating voltage of 15 kV and a probe current of 3×10 −10 amps. FIG. 2 shows a low magnification scanning electron microscope image of the surface of the laser modified titanium alloy. The raised horizontal features are the result of melted and re-solidified material that was treated under the laser beam. FIG. 3 shows a higher magnification scanning electron microscope image of the surface of the laser modified titanium alloy, indicating the presence of the laser microfeatures. EXAMPLE 2 Titanium Metal [0039] A commercially pure titanium metal (CP-Grade II, Titanium Industries, Inc.) was selected for the laser surface modification experiments. The tubular titanium material was placed on an anodized aluminum fixture on a carbon dioxide (CO2) laser system with computer-controlled position head and manually adjusted laser settings (Epilog Laser, Golden, Colo.). The laser was operated in a raster mode with powers ranging from 2.5 Watts to 25 Watts and speeds ranging from 2.5 inches per second to 25 inches per second. A black paint coating was applied to the surface to increase the heat absorbed by the material. The laser surface modification experiments were conducted in air at ambient temperatures. EXAMPLE 3 Stainless Steel Alloy [0040] A stainless steel material (17-4PH alloy, ARMCO Steel Corporation) in a solution-treated condition was selected for the laser surface modification experiments. The stainless steel material was placed on a xy-fixture on a Nd:YAG laser (Hobart MM1200) system with computer-controlled z-height head and manually adjusted laser settings. The laser was operated in a continuous wave mode with powers ranging from 100 Watts to 1200 Watts and material speeds of 1 inch per second to 10 inches per second. The laser surface modification experiments were conducted in a variety of different atmospheres, including air, methane, nitrogen, and argon. The hardness of the laser modified coating was measured by cutting the sample transverse to the laser surface, mounting in a resin material (polyoxybenzylmethylenglycolanhydride, trade name Bakelite), and polishing with silicon carbide and diamond abrasives. The hardness was then measured on the surface layer and bulk material showing an increase from 350+/−6 to 400+/−5 on a Brinell hardness scale. EXAMPLE 4 Polymeric Material [0041] A commercially available polymer material (ethylene/methacrylic acid copolymer, Trade Name: Surlyn, Dupont Packaging and Industrial Polymers, Inc.) was selected for the laser surface modification experiments. A block of the polymeric material was placed on an anodized aluminum fixture on a carbon dioxide (CO2) laser system with computercontrolled position head and manually adjusted laser settings (Epilog Laser, Golden, Colo.). The laser was operated in a raster mode with powers ranging from 2.5 Watts to 25 Watts and speeds of 2.5 inches per second to 25 inches per second. Material was selectively ablated from the surface of the polymer to form a two dimensional periodic array of microfeatures ranging in size from 50 to 1000 microns. [0042] Golf Club Construction [0043] After the surface of the material of the golf club head has been modified with the laser, the club head can be attached to a shaft. Typical shaft materials can be composed of aluminum alloys, titanium alloys, graphite reinforced polymers, or chrome-coated steel. The final stage of the golf club assembly is to secure a grip to the opposite end of the club from the club head. Typical grips are composed of molded rubber or leather. [0044] Referring now to FIG. 4, a golf putter is indicated with a laser surface modified region 2 , a club head 4 , and a golf shaft 6 . The laser surface modified region can be any size relative to the putter head, but will typically occupy 30-90% of the region on the hitting face. Referring now to FIG. 5, a golf driver is indicated with a laser surface modified region 8 , a club head 10 , and a golf shaft 12 . The laser surface modified region can be any size relative to the driver head, but will typically occupy 25-95% of the region on the hitting face. Referring now to FIG. 6, a golf iron is indicated with a laser surface modified region 14 , a club head 16 , and a golf shaft 18 . The laser surface modified region can be any size relative to the iron head, but will typically occupy 25-95% of the region on the hitting face. FIGS. 7 - 9 show cross-sectional views of the three different clubs with laser surface modified striking faces. The depth of the laser surface modification 20 for the putter 22 in FIG. 7 can vary from 0.001-1000 micrometers. The depth of the laser surface modification 24 for the driver 26 in FIG. 8 can vary from 0.001-1000 micrometers. The depth of the laser surface modification 28 for the putter 30 in FIG. 9 can vary from 0.001-1000 micrometers.

Lasers are useful for many types of materials processing, including annealing, texturing, hardening, patterning, cutting, welding, and joining. A method is provided for modifying the surface finish and structure of any material, with said materials being used in the construction of golf clubs. The surface modified materials have properties that lead to increased performance of the golf clubs. A secondary benefit is an improved material structure leading to a better feel for the golfer.

SUMMARY OF THE INVENTION The present invention relates to the use of esters of L-carnitine and acyl L-carnitine with hydroxyacids for producing pharmaceutical compositions which contain such esters as active ingredients, suitable to be topically applied For the treatment of dermatoses. Particularly preferred are the esters of the following hydroxyacids: α-hydroxybutyric acid α-hydroxyisobutyric acid β-hydroxybutyric acid γ-hydroxybutyric acid α-hydroxyisocaproic acid α-hydroxyisovaleric acid malic acid, and tartronic acid. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferably, the acyl group is C 1-5 alkanoyl, particularly acetyl, propionyl, butyryl, isobutyryl, valeryl and isovaleryl. Encompassed by the compounds to be used according to the present invention are both the inner salts and the salts of the aforesaid esters with pharmacologically acceptable acids. Pharmaceutically acceptable salts of the compound according to the invention include, in addition to the inner salts, all pharmaceutically acceptable salts which are prepared by the addition of acid to L-carnitine, and which do not give rise to undesirable toxic or collateral effects. The formation of pharmaceutically acceptable acid addition salts is well known in pharmaceutical technology. Non-limiting examples of suitable salts include the chloride, bromide, orotate, acid aspartate, acid citrate, acid phosphate, fumarate, acid fumarate, actate, maleate, acid maleate, acid oxalate, acid sulfate, glucose phosphate, tart rate and acid tartrate salts. The esters of L-carnitine and the aforesaid alkanoyl L-carnitine with β-hydroxybutyric acid and the pharmacologically acceptable salts thereof are known compounds. For instance, EP 0443996 A1 discloses the activity of these esters in inhibiting neuronal degeneration (as it occurs e.g. in Alzheimer's dementia and Parkinson's disease) and liver proteolysis and in the treatment of coma. Also the esters of L-carnitine and the aforesaid alkanoyl L-carnitine with γ-hydroxybutyric acid and the pharmacologically acceptable salts thereof are known compounds (see e.g. EP 429403 A2 and EP 442850 A1). These esters are endowed with the same pharmacological properties as the β-hydroxybutyric acid esters. On the other hand, the esters of L-carnitine and aforesaid alkanol L-carnitines with hydroxyacids other than β- and γ-hydroxybutyric acid are novel compounds. Their preparation can be carried out similarly to that of the known esters which is disclosed in the aforesaid European patent applications with only slight modifications which, depending on the selected hydroxyacid, will be apparent to any average-skilled expert in organic synthesis. The preparation of some of the esters suitable for the dermatologic use acceding to the present invention is hereinbelow described. EXAMPLE 1 Preparation of the ester of L-carnitine with gamma-hydroxybutyric acid (ST 701). Step a: Preparation of the benzyl ester of gamma-bromobutyric acid. Gamma-bromobutyric acid (3.3 g; 0.02 moles) was suspended in benzyl alcohol (15 mL). The suspension was cooled to 0° C. and thionyl chloride (8 mL; 0.01 moles) was slowly added dropwise thereto. The resulting mixture was kept at room temperature for 16 hours, then concentrated under vacuum for removing the thionyl chloride and distilled For removing the benzyl alcohol. The distillation residue was shown to be the title compound. TLC exane 6--AcOEt4 R f =0.8 NMR CDCl 3 δ 7.2(5H,s,aromatic); 5.0(2H,s,CH 2 -benzyl) 3.3(2H,t,CH 2 COO); 2.6-2.0(4H,m,BrCH 2 CH 2 ) Step b: Preparation of L-carnitine ester with benzyl gamma-bromobutyrate Carnitine inner salt (0.8 g; 0.005 moles) was suspended in 10 mL anhydrous dimethyl formamide. Benzyl ester of gamma-bromobutyric acid (1.3 g; 0.005 moles) was added to the suspension. The resulting reaction mixture was kept under stirring at 60° C. for 48 hours under a nitrogen stream and then distilled under vacuum till complete solvent removal; 1.3 g of residue were obtained which was shown to be the title compound. TLC CHCLl 3 4.2-H 2 O 1.1-Isopr OH 0.7-CH 3 COOH 1.1 MetOH 2.8 R F =0.8 NMR D 2 Oδ 7.4(5H,s,aromatic); 5.2(2H,s,CH 2 -benzyl); 4.6(1H,m,C HOH); 4.2(2H,m,O--CH 2 ); 3.6(2H,m,N+Ch 2 ); 3.3(9H,s,(CH 3 ) 3 N+); 3.0 (2H,d,CH--C H.sub. 2 COO); 2.6(2H,m,CH 2 C H.sub. 2 COO); 2.0(2H,m,CH 2 C H.sub. 2 CH 2 ). Step c: Preparation of the ester of L-carnitine bromide with gamma-hydroxybutyric acid. The compound of step b (1.3 g) was dissolved in 20 mL of a 1:1 H 2 O:EtOH mixture. The resulting solution was hydrogenated in the presence of 150 mg 10% Pd/C at 3 atmospheres of hydrogen for 2 hours. The mixture was filtered and concentrated under vacuum. 1 g of the title compound was obtained. TLC as in step b R F =0.6 Step d: Preparation of the ester of L-carnitine chloride with gamma-hydroxybutyric acid (ST 701). The compound of step c (1 g) was eluted on 30 mL of AMBERLITE IRA 402 strongly basic resin activated to Cl - form. The eluate was lyophilized. A highly hygroscopic solid was obtained. NMR (D 2 O):δ 4.2(2H.t.--CH 2 O--); 3.5(2H,d,--N+Ch 2 --); 3.2(9H,s,(CH 3 ) 3 N+); 2.0(2H,d,CH 2 COO); 2.4(2H,m,C H.sub. 2 COOH); 2.0(2H,m,C H.sub. 2 --CH 2 COOH). ##STR1## HPLC Spherisorb column--SCX 5M Eluant KH 2 PO 4 0.005M--CH 3 CN (35-65); pH=4.2 Flow rate 1 ml/min Detector UV 205 nm ST 701 R T =7.8 Carnitine R T =10.02 0.5% ##STR2## EXAMPLE 2 Preparation of the ester of acetyl L-carnitine with γ-hydroxybutyric acid (ST 793) Step a: Preparation of the benzyl ester of γ-bromobutyric acid (ST 793). γ-bromobutyric acid (3.3 g; 0.02 moles) was suspended in benzyl alcohol (15 mL). The suspension was cooled to 0° C. and thionyl chloride (8 mL; 0.01 moles) was slowly added dropwise thereto. The resulting mixture was kept at room temperature for 16 hours, then concentrated under vacuum to remove the unreacted thionyl chloride and distilled to remove the benzyl alcohol. The distillation residue was purified by silica gel chromatography using hexane-AcOEt 98:2 as eluant. TLC hexane R F =0-2 NMR CDCl 3 δ 7.2(5H,s,aromatic); 5.0(2H,s,CH 2 -benzyl) 3.3(2H,t,CH 2 COO); 2.6-2.0(4H,m,BrCH 2 CH 2 ) Step b: Preparation of the ester of acetyl L-carnitine with benzyl γ-bromobutyrate. Acetyl L-carnitine inner salt (1.62 g; 0.008 moles) was suspended in 12 mL anhydrous dimethylformamide. γ-bromobutyric acid benzyl ester (2.05 g; 0.008 moles) was added to the suspension. The resulting reaction mixture was kept under stirring for 24 hours under a nitrogen stream. Ethyl ether was then added till complete precipitation of a compound which was filtered off. 3.43 g of the title compound were thus obtained. TLC CHCl 3 4.2-H 2 O 1.1-Isopr OH 0,7-Ch 3 COOH 1.1 MetOH 2.8 R F =0.8 HPLC Column μ Bondapack C18 eluant KH 2 PO 4 0.05M--CH 3 CN 70-30 Flow rate 1 mL/min R t 12.9 NMR D 2 O δ 7.4 (5H,s,aromatic); 5.6(1H,m, ##STR3## 5.2(2H,s,CH 2 -benzyl); 4.4-4.0(4H,m,N+CH 2 ,OCH 2 ) 3.5(9H,s,(CH 3 ) 3 N+); 3.2(2H,d,CH--CH 2 COO); 2.3(2H,m,CH 2 CH 2 COO); 2.0(5H,m+,CH 2 CH 2 CH 2 ;COCH 3 ) Step c: Preparation of the ester of acetyl L-carnitine bromide with γ-hydroxybutyric acid. The compound of the step b (1 g) was dissolved in 20 mL absolute ethanol. The resulting solution was hydrogenated in the presence of 100 mg 10% Pd7C at 3 atmospheres of hydrogen concentrated under vacuum. 0.75 g of the title compound were obtained. Yeld 98%. TLC as in step b R F =0.7 Step d: Preparation of the ester of acetyl L-carnitine with γ-hydroxybutyruic acid inner salt. The compound of step c (1 g) was eluted on 30 mL of a strongly basic resin AMBERLITE IRA 402 activated in HCO 3 - form. The eluate was lyophilized. A highly hygroscopic solid was obtained. NMR (D 2 O): δ 5.6(1H,m, ##STR4## 4.2(2H,t,--CH 2 O); 3.7(2H,d,--N+CH 2 --); 3.2(9H,s,(CH 3 ) 3 N+); 2.8(2H,d,CH 2 COO); 2.3-2.0(5H,m+s,CH 2 COOH+COCH 3 ); 1.8(2H,m,CH 2 CH 2 COOH) ##STR5## HPLC Column spherisorb--SCX 5M Eluant KH 2 PO 4 0.005M--CH 3 CN (35-65); pH=4.2 Flow-rate 1 mL/min Detector UV 205 nm Rt=8.83 TLC as in step b R F =0.5 EXAMPLE 3 Preparation of the ester of isovaleryl L-carnitine chloride with β-hydroxybutyric acid (ST 687) Step a: Preparation of the benzyl ester of β-hydroxybutyric acid 1. β-hydroxybutyric acid sodium salt (1.2 g; 0.01 moles) was suspended in benzyl bromide (6 mL; 0.05 moles) 18 crown-6 (0.264 g) dissolved in 7 mL acetonitrile was added to the mixture. The resulting solution was partly concentrated under a nitrogen stream and then kept under stirring at 80° C. for 90 minutes. To the cooled solution a mixture hexane-H 2 O was added. The separated and dried organic phase was concentrated and then distilled under vacuum for removing the excess benzyl bromide. 1.1 g of solid residue were obtained which was identified to be the title compound. Yield 56%. TLC CHCl 3 9--MetOH 1 R F =0.8 Gas chromatography: column HP 1 25 m; inner diameter 0.32 mm; film thickness 0.33 μm carrier (He) flow-rate: 1 mL/min. Make up gas 40 mL/min Splitting ration 40 mL/min Injector 220° C. Detector (Fid) 280° C. Column temperature 120° C., 15° C./min 250° C. Rt=9.36 compound Rt=4.84 no benzyl bromide NMR CDC 3 δ 7.3(5H,s,benzyl); 5.2(2H,s,CH 2 -benzyl); 4.2(1H,m,CH); 2.8(1H,s,broadOH); 2.5(2H,d,CH 2 COO); 1.2(3H,d,CH 3 ) Step b: Preparation of the acid chloride of isovaleryl L-carnitine chloride 2. Thionyl chloride (7.7 mL; 0.1 moles) was added to isovaleryl L-carnitine chloride (10 g; 0.035 moles). The resulting mixture was kept at room temperature for 4 hours, then concentrated under vacuum to remove the thionyl chloride excess. The residue was washed three times with anhydrous ethyl ether. The raw reaction product thus obtained was used in the subsequent step without further purification. Step c: Preparation of the ester of isovaleryl L-carnitine choride with β-hydroxybutyric acid benzyl ester 3. The acid chloride of isovaleryl L-carnitine chloride (0.035 moles) of step b was dissolved in anhydrous tetrahydrofuran (25 mL). To the resulting solution the β-hydroxybutyric acid benzyl ester (7 g; 0.035 moles) of step a was added. The reaction mixture was kept at 25° C. under stirring overnight. Ethyl ether was then added thereto till complete precipitation. The solid thus obtained was filtered off and washed with ethyl ester. 14 g of the title compound were obtained. Yield 89%. NMR D 2 O δ5.7(5H,m,benzyl); 5,5(1H,m,--CH--); 5.2(1H,m,COOCH); 5.0(2H,s,CH 2 benz.) 3.8(2H,m,NCH 2 ); 3.2(9H,s,(H 3 ) 3 N+); 2.8-2.5(4H,dd,CH 2 --COOCHCH 2 COO);2.2(2H,d,OCOCH 2 ) 1.8(1H,m, ##STR6## 1.2(3H,d,CH--CH 3 ); 0.8(6H,d, ##STR7## Step d: Preparation of the ester of isovaleryl L-carnitine chloride with β-hydroxybutyric acid The compound of step c (14 g; 0.031 moles) was dissolved in H 2 O-ethanol 1:1 (100 mL) and hydrogenated in the presence of 1,5 g 10% Pd/C at 4 atmospheres for two hours. The reaction mixture was filtered, the filtrate concentrated to dryness under vacuum and the residue crystallized from acetone-ethyl ether. 10 g of a hygroscopic compound were obtained. TLC chloroform 4.2 IsoprOH 0.7 MeOH 2.8 H 2 O1 AcOH 1.1 Rf=0.7 ##STR8## NMRD 2 O δ 5.7(1H,m, ##STR9## 5.3(1H,m,--COOCH--); 3.8(2H,m,N+CH 2 ) 3.2(9H,s,(CH 3 ) 3 N+); 2.8(2H,d,CH 2 --COO); 2.6(2H,d,CH 2 COOH); 2.2(2H,d,OCOCH 2 );1.8(1H,m, ##STR10## 1.2(3H,d,CHCH 3 ); 0.8(6H,d, ##STR11## HPLC Column μ Bondapack-C18 Eluant KH 2 PO 4 0.05M--CH 3 CN (85-15) Detector UV λ=205 nm Flow-rate 1 ml/min Rt=14-16 (the diasteroisomers are shown) ______________________________________Elementary Analysis for C.sub.15 H.sub.30 NO.sub.6 Cl C H N______________________________________calc. 50.6 8.4 3.9found 48.93 8.36 3.49______________________________________ The dermatoses which are suitably treated with the compositions of the present invention are in particular ichthyosis, psoriasis and those dermatoses which are induced by a defective keratinization, such as dandruff, ache and palmar and plantar hyperkeratosis. Ichthysosis is a dermatosis characterized by generalized dryness, harshness and scaling of the skin. It may occur as a hereditary disease present at birth, or as a metabolic disorder associated with hypothyroidism or with the intake of drugs (such as butyrophenols) inhibiting lipid synthesis, or as a paraneoplastic syndrome, manifestation of a tumor process involving internal organs. Xeroderma, the mildest form of ichthyosis is neither congenital nor associated with systemic abnormalities. It usually occurs on the lower lees of middle-aged or older patients, most often in cold weather and in patients who bathe frequently. There may be mild to moderate itching and an associated dermatitis due to detergents or other irritants. The inherited ichthyoses, all characterized by excessive accumulation of scale on the skin surface, are classified according to clinical, genetic, and histologic criteria. Known treatments of and form of ichthyosis comprise topically applying to the skin hydrating emollients. Furthermore, salicylic acid or vitamin A-containing ointments have been widely used. A keratolytic agent particularly effective in removing the scale in ichthyosis vulgaris, lamellar ichthyosis and sex-linked ichthyosis contains 6% salicylic acid in a gel composed of propylene glycol, ethyl alcohol, hydroxypropylene cellulose and water. Further known drugs for the treatment of this disorder include: 50% propylene glycol in water, hydrophilic petrolatum and water (in equal parts), and cold cream and an a-hydroxy acid (e.g. lactic and pyruvic acid) in various bases. In lamellar ichthyosis, 0.1% tretinoin (vitamin A acid; retinoic acid) cream has been utilized. None of these treatments has been found satisfactorily effective. Hyperkeratosis is a thickening of the stratum corneum of the skin. The treatment of choice is the topical application of drugs containing urea, propylene glicol or salicylic acid. Also in this case, none of the known treatment has proved to be satisfactorily effective. It has now been found that the compounds of the present invention, when topically applied as solutions, lotions, creams or ointments containing from 0,01% to 20%, preferably from 1% to 15% and most preferably from 2 to 10% by weight of at least one of the foregoing compounds, are potently effective in achieving complete remission of ichthyotic conditions in humans and in healing psoriasis and those disorders brought about by an altered keratinization, such as dandruff, acne and palmar and plantar hyperkeratosis. It has also been found that, if the solutions, creams or ointments of the invention are applied regularly on a daily basis, within about two to three weeks the effected skin areas will return to normal conditions. The compounds according to the invention are prepared via a process whose steps are illustrated in the following reaction scheme, wherein R, R 1 and X have the previously defined meanings. In order to prepare the compositions of this invention, at least one of the esters according to the invention is preferably dissolved in water or ethanol initially. The solution thus prepared may be admixed in the conventional manner with commonly available ointment bases such as hydrophilic ointment (USP) or petrolatum (USP). The water or ethanol used to dissolve the compounds according to this invention may range in concentration of from 1 to 30%, by volume, of the total composition. The compounds of this invention may also be formulated in a solution or lotion form. For instance, an ester according to the invention is dissolved directly in a mixture of water, ethanol and propylene glicol (40:40:20 by weight). Some examples of the formulation are hereinbelow described: Formulation 1:5% Solution 5 grams of an ester according to the invention were dissolved in 5 mL of water and the resulting solution admixed with 40 mL of ethanol and 20 mL of propylene glycol. Sufficient water was added to make 100 mL of formulation. Formulation 2:5% Ointment 5 grams of an ester according to the invention were admixed with 95 grams of USP grade hydrophilic ointment, until an uniform consistency resulted.

Dermatosis is treated by a method comprising topically applying an effective amount of an ester of L-carnitine or an acyl L-carnitine with a hydroxy carboxylic acid selected from the group consisting of α-hydroxybutyric acid, α-hydroxyisocaproic acid, α-hydroxyisovaleric acid, malic acid and tartronic acid, to a patient in need thereof.

This is .Iadd.a Reissue of application Ser. No. 458,451, filed Jan. 17, 1983, U.S. Pat. No. 4,460,585, which is .Iaddend.a continuation-in-part application of Ser. No. 280,816, filed July 6, 1981, now abandoned. FIELD OF THE INVENTION This invention relates to .[.s-triazin-2-one and thione.]. .Iadd.3- and 5-ureido-1,2,4-triazoles and 3- and 5-thioureido-1,2,4-triazoles .Iaddend.compounds, processes for their preparation, intermediates useful in their preparation, pharmaceutical compositions and methods for influencing physiological function, such as blood pressure, in humans and animals. REPORTED DEVELOPMENTS 1,3,5-triazine compounds are known to possess a broad spectrum of biological activity. The 4,6-diamino-1,2-dihydro-2-triazines have been reported to be effective as antimalarial, antitumor, antihelminthic and antibacterial agents as well as active agents against coccidiosis in chicks and against murine toxoplasmosis. See Heterocyclic Compounds, Volume 7, John Wiley & Sons, 1961 (Elderfield ed.) Chapter 8, "S-Triazines." The antiherbicidal activity of 1-alkyl-4-alkylamino-1,2-dihydro-2-triazin-2-ones and thiones has been reported in U.S. Pat. No. 3,585,197 to Seidel et al. Recently, 1-aryl-1,2-dihydro-1,3,5-triazin-2-ones (thione) and their pharmaceutical uses have been reported in U.S. Pat. No. 4,246,409 to Douglas et al. S-Triazin-2- ones (thiones) which are substituted by hydrazinyl groups in the 4-position have not been previously reported. SUMMARY OF THE INVENTION This invention relates to a class of .[.s-triazine.]. .Iadd.3- and 5-ureido-1,2,4-triazole .Iaddend.compounds according to Formula I wherein: .Iadd.R x and R z are either NHC (X) NHR 1 or R 6 , provided that R x and R z are not both either NHC (X) NHR 1 or R 6 ; .Iaddend. X is oxygen or sulfur; R 1 is aryl, substituted aryl, .[.aralkyl,.]. heterocyclic .[.,.]. .Iadd.or .Iaddend.substituted heterocyclic .[., heterocyclic lower alkyl, or substituted heterocyclic lower alkyl.].; R 4 is hydrogen, alkyl, cycloalkyl, alkenyl, alkynyl, alkanoyl, carboalkoxy, carbamoyl, alkyl carbamoyl, aryl, aroyl, aralkyl, heterocyclic, substituted heterocyclic, halo alkyl, or halo alkanoyl; R 6 is hydrogen, alkyl, cycloalkyl, alkenyl, alkynyl or aralkyl; .[.and the pharmaceutically acceptable acid addition salts thereof..]. .Iadd.or a pharmaceutically acceptable salt thereof..Iaddend. This invention relates also to processes for the preparation of compounds of Formula I and intermediate compounds useful in these processes. Compounds within the scope of Formula I possess pharmaceutical activity, including cardiovascular activity, such as blood pressure lowering activity, and are useful in methods of treating physiological disorders, such as hypertension, in humans and animals. DETAILED DESCRIPTION OF THE INVENTION Depending upon the specific substitution, compounds of Formula I above may be present in enolized or tautomeric forms. Certain of the compounds can also be obtained as hydrates or in different polymorphic forms. The structures used herein to designate novel compounds are intended to include the compound along with its alternative or transient states. The nomenclature generally employed to identify the novel .[.triazine.]. .Iadd.triazole .Iaddend.derivatives as disclosed herein is based upon the ring structure shown in Formula I with the .[.triazine.]. ring positions numbered .[.counter.].clockwise beginning with the nitrogen having the .[.R 1 .]. .Iadd.R 4 .Iaddend. substitution. Compounds of this invention which are preferred include those wherein: X is oxygen or sulfur; R 1 is phenyl or substituted phenyl; R 4 is hydrogen, lower alkyl, lower alkanoyl, carboloweralkoxy, phenyl, or benzoyl; R 6 is hydrogen or lower alkyl; and the pharmaceutically acceptable acid addition salts thereof. A subclass of these compounds, of particular interest, includes compounds according to Formula I wherein: X is oxygen or sulfur; R 1 is phenyl or phenyl in which one or more of the phenyl hydrogens has been replaced by the same or different substituents selected from the group consisting of halo or lower alkyl; R 4 is hydrogen; R 6 is hydrogen or methyl; and the pharmaceutically acceptable acid addition salts thereof. Another class of preferred compounds is where: R 1 is phenyl, 2-halophenyl, 3-halophenyl, 4-halophenyl, 3,4-dihalophenyl, 3-trihalomethylphenyl or 2,6-diloweralkylphenyl; R 4 is lower alkanoyl, benzoyl, or carboloweralkoxy; R 6 is hydrogen; and the pharmaceutically acceptable acid addition salts thereof. A further preferred class of compounds is where: R 1 is phenyl or substituted phenyl; R 4 is methyl; and R 6 is hydrogen; provided that when R 1 is substituted phenyl the phenyl substituent is either 3- or 4-halo, or 3-trihalo alkyl; and the pharmaceutically acceptable acid addition salts thereof. A special embodiment of these preferred classes of compounds is where: R 1 is phenyl substituted in either the meta or para positions by a halogen, for example, chloro; or where R 1 is phenyl substituted in either or both of the meta or para positions by chloro when R 4 is other than methyl. Another special embodiment of these preferred classes of compounds is where: R 1 is phenyl, 4-loweralkyl phenyl or 4-loweralkoxy phenyl; R 6 is hydrogen; and R 4 is phenyl; and the pharmaceutically acceptable acid addition salts thereof. An embodiment of this invention, of particular interest, is a .[.4-hydrazinyl triazinone.]. .Iadd.ureido triazole .Iaddend.according to Formula I wherein R 1 is a heterocyclic ring. The most preferred heterocyclic ring is pyridyl, and the exemplary subclass of the compounds according to this invention which includes the pyridyl ring is shown below in Formulae .[.II-IV..]. .Iadd.II-V. .Iaddend. ##STR2## wherein: n is zero to four; R is alkyl, alkoxy, halo, cyano, amino, carbamoyl, alkylamino, or dialkylamino; and X, R 4 and R 6 are as defined above. The most preferred compounds according to this invention are listed in the following Table I. TABLE I______________________________________Name M.P.______________________________________4-acetylhydrazino-1-phenyl-1,2-dihydro- 158° C.1,3,5-triazin-2-one4-ethoxycarbonylhydrazino-1-phenyl-1,2- 165-167° C.dihydro-1,3,5-triazin-2-one4-hydrazino-1-phenyl-1,2-dihydro-1,3,5- >245° C.triazin-2-one4-methylhydrazino-1-phenyl-1,2-dihydro- 182.5-133° C.1,3,5-triazin-2-one4-acetylhydrazino-1-(4-chlorophenyl)- 176-178° C.1,2-dihydro-1,3,5-triazin-2-one4-benzoylhydrazino-1-(4-chlorophenyl)- 193-195° C.1,2-dihydro-1,3,5-triazin-2-one1-(4-chlorophenyl)-4-ethoxycarbonyl- 194-195° C.hydrazino-1,2-dihydro-1,3,5-triazin-2-one1-(4-chlorophenyl)-4-hydrazino-1,2- >250° C.dihydro-1,3,5-triazin-2-one1-(4-chlorophenyl)-4-methylhydrazino- 228-231° C.1,2-dihydro-1,3,5-triazin-2-one4-acetylhydrazino-1-(3-chlorophenyl)- 140-144° C.1,2-dihydro-1,3,5-triazin-2-one1-(3-chlorophenyl)-4-hydrazino-1,2- >250° C.dihydro-1,3,5-triazin-2-one1-(3-chlorophenyl)-4-methylhydrazino- 219-221° C.1,2-dihydro-1,3,5-triazin-2-one4-hydrazino-1-(4-methylphenyl)-1,2- >250° C.dihydro-1,3,5-triazin-2-one1-(4-methylphenyl)-4-phenylhydrazino- 196° C.1,2-dihydro-1,3,5-triazin-2-one1-(2,6-dichlorophenyl)-4-hydrazino- >250° C.1,2-dihydro-1,3,5-triazin-2-one4-acetylhydrazino-1-(2-chlorophenyl)- 210° C.1,2-dihydro-1,3,5-triazin-2-one1-(2-chlorophenyl)-4-hydrazino-1,2- >250° C.dihydro-1,3,5-triazin-2-one1-(3,4-dichlorophenyl)-4-hydrazino >250° C.1,2-dihydro-1,3,5-triazin-2-one4-acetylhydrazino-1(3-dichlorophenyl)- 183-185° C.4-methylhydrazino-1-(3-triflouromethyl- 199-201° C.phenyl)-1,2-dihydro-1,3,5-triazin-2-one4-acetylhydrazino-1-(3-trifluoromethyl- 142.5-164° C.phenyl)-1,2-dihydro-1,3,5-triazin-2-one4-hydrazino-6-methyl-1-phenyl-1,2- >250° C.dihydro-1,3,5-triazin-2-one1-(4-methylphenyl)-4-phenylhydrazino- 196° C.1,2-dihydro-1,3,5-triazin-2-one1-(4-methoxyphenyl)-4-phenylhydrazino- 170.5-171.5° C.1,2-dihydro-1,3,5-triazin-2-one3-[3-(1-phenylureido)]-1,2,4-triazole >245° C.1-methyl-5-[3-(1-phenylureido)]-1,2,4-triazole 182.5-183° C.3-[3-(1-(4-chlorophenyl)ureido)]-1,2,4-triazole >250° C.3(5)-[3-(1-(4-chlorophenyl)ureido)]-1-methyl-1,2,4- 228-231° C.triazole3-[3-(1-(3-chlorophenyl)ureido)]-1,2,4-triazole >250° C.3(5)-[3-(1-(3-chlorophenyl)ureido)]-1-methyl-1,2,4- 219-221° C.triazole3-[3-(1-(4-methylphenyl)ureido)]-1,2,4-triazole >250° C.5-[3-(1-(4-methylphenyl)ureido)]-1-phenyl-1,2,4- 196° C.triazole3-[3-(1-(2,6-dichlorophenyl)ureido)]-1,2,4-triazole >250° C.3-[3-(1-(2-chlorophenyl)ureido)]-1,2,4-triazole >250° C.3-[3-(1-(3,4-dichlorophenyl)ureido)]-1,2,4-triazole >250° C.1-methyl-3(5)-[3-(1-(3-trifluoromethylphenyl)- 199-201° C.ureido)]-1,2,4-triazole1-methyl-3(5)-[3-(1-phenylureido)]-1,2,4-triazole >250° C.5-[3-(1-(4-methoxyphenyl)ureido)]-1-phenyl-1,2,4- 170.5-171.5° C.triazole______________________________________ As employed above and throughout the disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meanings: "Alkyl" means a saturated aliphatic hydrocarbon which may be either straight- or branched-chain. Preferred are lower alkyl groups which have up to about 6 carbon atoms, including methyl, ethyl and structural isomers of propyl, butyl, pentyl and hexyl. "Cycloalkyl" means a saturated cyclic hydrocarbon, preferably having about 3 to about 6 carbon atoms, which may also be substituted with a lower alkyl group. "Carbamoyl" means a radical of the formula ##STR3## where R may be hydrogen or lower alkyl. "Alkenyl" means an unsaturated aliphatic hydrocarbon which may include straight or branched chains. Preferred groups have up to about 6 carbon atoms and may be vinyl and any structural and geometric isomers of propenyl, butenyl, pentenyl, and hexenyl. "Alkynyl" means an unsaturated aliphatic hydrocarbon containing one or more triple bonds. Preferred groups contain up to about 6 carbon atoms and include ethynyl, propynyl, butynyl, pentynyl, and hexynyl. "Aryl" means a radical of an aromatic group. The preferred aromatic groups are phenyl and substituted phenyl. "Substituted phenyl" means a phenyl group in which one or more of the hydrogens has been replaced by the same or different substituents including halo, lower alkyl, halo lower alkyl, amino, acylamino, hydroxy, phenyl lower alkoxy, lower alkanoyl, carboloweralkoxy, acyloxy, cyano, halo lower alkoxy or lower alkyl sulfonyl. "Aralkyl" means lower alkyl in which one or more hydrogens is substituted by aryl (preferably phenyl or substituted phenyl). Preferred groups are benzyl or phenethyl. "Heterocyclic" or "heterocyclic ring" means a cyclic or bicyclic system having 1 to 3 hetero atoms which may be nitrogen, oxygen or sulfur, including oxazolidinyl, thiazolidinyl, pyrazolidinyl, imidazolidnyl, piperidyl, piperazinyl, thiamorpholinyl, 1-pyrrole, 2-pyrrole, 3-pyrrole, 2-furan, 3-furan, 2-thiophene, 3-thiophene, 2-tetrahydrothiophene, 3-tetrahydrothiophene, 1-imidazole, 2-imidazole, 4-imidazole, 5-imidazole, 2-oxazole, 4-oxazole, 5-oxazole, 2-thiazole, 4-thiazole, 5-thiazole, 1-pyrazole, 3-pyrazole, 4-pyrazole, 5-pyrazole, 1-pyrrolidine, 2-pyrrolidine, 3-pyrrolidine, 2-pyridyl, 3-pyridyl, 4-pyridyl, 2-pyrimidine, 4-pyrimidine, 5-pyrimidine, 6-pyrimidine, 2-purine, 6-purine, 8-purine, 9-purine, 2-quinoline, 3-quinoline, 4-quinoline, 5-quinoline, 6-quinoline, 7-quinoline, 8-quinoline, 1-isoquinoline, 3-isoquinoline, 4-isoquinoline, 4-isoquinoline, 5-isoquinoline, 6-isoquinoline, 7-isoquinoline, 8-isoquinoline, carbazole, trimethyleneethylenediaminyl, ethyleneiminyl and morpholinyl; "Substituted heterocyclic" or "substituted heterocyclic ring" means a heterocycle in which one or more of the hydrogens on the ring carbons have been replaced by substituents as given above with respect to substituted phenyl. Preferred heterocyclic rings are pyridyl, pyrimidyl, pyrazolyl, imidazolyl, furyl, thienyl, oxazolyl, thiazolyl, piperidyl, morpholinyl, oxazolidinyl, thiazolidinyl, pyrazolidinyl, imidazolidinyl, piperazinyl, thiamorpholinyl, trimethyleneethylenediaminyl and ethyleneiminyl. The terms "halo" and "halogen" include all four halogens, namely, fluorine, chlorine, bromine and iodine. The halo alkyls, halophenyl and halo-substituted pyridyl include groups having more than one halo substituent which may be the same or different such as trifluoromethyl, 1-chloro-2-bromo-ethyl, chlorophenyl, 4-chloropyridyl, etc. "Acyloxy" means an organic acid radical of lower alkanoic acid such as acetoxy, propionoxy, and the like. "Lower alkanoyl" means the acyl radical or a lower alkanoic acid, including acetyl, propionyl, butyryl, valeryl, and stearoyl. "Alkoxy" means the oxy radical of an alkyl group, preferably a lower alkyl group, such as methoxy, ethoxy, n-propoxy, and i-propoxy. "Aroyl" means a radical of the formula ##STR4## wherein R is aryl. Preferred aroyl groups include benzoyl and substituted benzoyl. The preferred "halo lower alkyl" group is trifluoromethyl. The preferred "halo lower alkanoyl" group is trifluoroacetyl. The compounds of this invention may be prepared by the general synthesis according to .[.Scheme I:.]. .Iadd.Schemes I and II: .Iaddend. ##STR5## A 1-R 1 -substituted-4-alkyl isobiuret is cyclized to the corresponding 1-R 1 -6-R 6 -4-alkoxy-1,2-dihydro-1,3,5-triazin-2-one by treatment with an R 6 substituted cyclizing reagent. The group in the 4-position of the isobiuret, shown as O-alkyl, may be any suitable group which is capable of being displaced upon treatment of the cyclized product with a hydrazinyl reagent. The alkoxy groups, as shown in Scheme I, are preferred. Condensation of the 4-alkoxy triazinone with an appropriately substituted hydrazine produces the .[.4-hydrazino.]. .Iadd.ureido-triazole compound .Iaddend..[.adduct.]. according to Scheme II: ##STR6## Alternatively, the 4-methoxy-s-triazinone may be reacted with unsubstituted hydrazine thereby producing the .[.4-hydrazinyl triazinone.]. .Iadd.triazole wherein R 4 is hydrogen and .Iaddend.which may be treated with an appropriate alkylating or acylating reagent such as an alkyl halide, alkyl triflate, alkanoyl halide, such as, benzyol halide, methyl halide, acetyl chloride, benzoylchloride, and result in the desired R 4 substitution. .Iadd.Although the applicants do not wish to be bound by any particular theory, the process according to this invention may proceed by a number of mechanisms, one of which is described in Scheme III, below..Iaddend. ##STR7## .Iadd.wherein: X, R 1 , R 4 and R 6 are as previously defined. The hydrazine compound attacks the s-triazine starting material at the 6-position forming an addition product which undergoes a ring opening and recyclizes with the elimination of the leaving group, L, thereby forming the triazole compound of the present invention. It is believed that addition of the hydrazine reagent to the 6-position of the s-triazine is favored when the R 1 group is capable of stabilizing a negative charge resulting from the rupture of the 1,6-carbon-nitrogen bond of the triazine intermediate. When R 1 is an aryl group, it is believed that the energy level of the transition state involved in breaking the carbon-nitrogen bond is lowered by charge distribution and resonance. The reaction is presumably driven to completion by the ejection of a good leaving group and the intramolecular cyclization to form the aromatic 1,2,4-triazole. In contrast, as disclosed in U.S. Pat. No. 4,406,897, when an aryl group is present in the 6.Iaddend.-position of the s-triazinone and not in the 1-position, the addition at the 4-position is favored and the hydrazine compound simply displaces the 4-leaving group of the starting material as shown in Scheme IV, below. ##STR8## The .[.triazinthione.]. .Iadd.thioureido-triazole .Iaddend.compounds according to this invention are prepared by the same general route by utilizing the corresponding isothiobiuret as starting material. The isobiuret (isothiobiuret) starting material may be prepared by any manner known to those skilled in the art. One process for the synthesis of these particular isobiurets (isothiobiuret) comprises the treatment of an O-alkylisourea (isothiourea), such as O-methyl-isourea, with an appropriately substituted isocyanate (isothiocyanate) according to Scheme .[.III.]. .Iadd.V.Iaddend.: ##STR9## For example, O-methyl isourea may be prepared in situ by neutralizing O-methyl isourea hydrogen sulfate with one equivalent of base, such as sodium hydroxide, in a polar nonaqueous solvent, such as, THF or ethanol. The reaction media is dried before adding the isocyanate by addition of a drying agent such as sodium sulfate (Na 2 SO 4 ). The isocyanate is added to the reaction media dropwise and the isobiuret recovered by extraction and recrystallization. The isocyanate may be prepared from primary alkyl amines or anilines by methods known to those in the art (e.g., reaction with phosgene or thiophosgene in the customary manner). The cyclizing reagent may consist of an activated form of an acid amide or ortho ester or acyl derivative such as a Vilsmier reagent which will bring about acylation and ring closure of the isobiuret or isothiobiuret to give the corresponding s-triazinone or thione of the type described above. The cyclizing reagent employed in the reaction can be any cationic reagent system capable of generating in the reaction mixture a stabilized carbonium ion having the oxidation state of an acid or acid amide. Since the cationic carbon is incorporated into the ring the choice of reagent will determine the R 6 substitution in the compounds of Formula I above. Thus, in the case of a dialkyl carboxylic acid amide dialkyl acetal, such as, dialkyl formamide dialkyl acetal, R 6 is hydrogen and the resulting triazine is unsubstituted in the 6-position; in the case where the acetamide derivative is used as the cyclizing reagent, R 6 is methyl and the resulting triazine is substituted in the 6-position, and so on. In general, the preferred cyclizing reagents are the ortho esters of carboxylic acids of the Formula .[.V.]. .Iadd.VI.Iaddend.: ##STR10## wherein: R 6 is hydrogen, or lower alkyl; and each of R 10 through R 12 are lower alkyl or halo lower alkyl. Exemplary ortho esters include triethylorthoformate and trimethylorthoacetate. Additional cyclizing reagents include the carboxylic acid amide dialkyl acetals, such as, dialkyl formamide dialkyl acetal, preferably, dimethyl formamide dimethyl acetal; dialkyl acetamide dialkyl acetals, preferably, dimethyl acetamide dimethyl acetal; dialkyl propionamide dialkyl acetal, preferably, dimethyl propionamide dimethyl acetal. Other carboxylic acid amide derivatives can also be used including substituted derivatives. Other methylidene derivatives that can be used as the cyclizing reagent include the combination of an N,N-disubstituted carboxylic acid amide and any strong alkylating agent, preferably a strong methylating agent. Any of the strong alkylating agents known in the art such as methyliodide, methylfluorosulfonate, alkylmethane sulfonates, e.g., methylmethanesulfonate, and alkyl or dialkyl sulfates, e.g., dimethylsulfate can be suitably employed though dimethylsulfate is preferred owing to its ready availability. A cyclizing reagent of particular interest is a DMF-dimethylsulfate complex. Reagents of the type shown in Formula .[.V.]. .Iadd.VI .Iaddend.above are stable products which are commercially available or can be prepared in advance. The cyclizing reaction can be carried out by simply combining the reactants in a suitable solvent at room temperature with stirring. The reaction time can be shortened by heating the reaction mixture or by using elevated pressure or both. The solvent selected should have a relatively high boiling point and low vapor pressure in order to permit the reaction mixture to be heated above 100° C. Dimethylformamide is a convenient solvent to use, particularly where the cyclizing reagent is a dimethylformamide derivative, though other organic solvents can also be used. The solvents that can be used include saturated and unsaturated hydrocarbons, aromatic solvents, alcohols such as methanol and ethanol, halogenated hydrocarbons such as chloroform, carbon tetrachloride, ethylene chloride, or others such as methyl acetate, ethyl acetate, acetonitrile, acetone, ether, acetamide, tetrahydrofuran and the like. Suitable mixtures of solvents can also be used. The reaction is preferably carried out under substantially anhydrous conditions though the presence of water can be tolerated. If small amounts of water are present, the effect can be offset by using an excess of the cyclizing reagent. In carrying out the cyclizing reaction, the cyclizing reagent is preferably used in slight excess of the amount required as the stoichiometric equivalent of the isobiuret or isothiobiuret starting material. Reagent systems employing dimethyl sulfate are prepared as necessary for the cyclization or can be formed in situ in the reaction mixture by adding the reagent components to the reaction vessel in a suitable solvent or solvent mixture. When carrying out the cyclizing reaction with a reagent of the type shown in Formula .[.V.]..Iadd.VI.Iaddend., it is preferred to use as starting material an acid addition salt of the isobiuret or isothiobiuret or alternatively, if the free base is used, then an acid, preferably a mineral acid such as hydrochloric acid, can be added to the reaction mixture. When a reagent system comprising a carboxylic acid amide and a strong alkylating agent is employed, the reagent is itself acidic and the reaction proceeds readily with the free base as starting material. In such instances it may be advantageous to add a proton scavenging solvent such as a tertiary amine, e.g., triethylamine or cyclic amines such as pyridine. Other miscible solvents can be used along with the preferred amines e.g., solvents such as triethanolamine, acetonitrile, ethanol, etc., though dimethyl formamide is preferred. The conversion of most isobiurets and isothiobiurets to the corresponding s-triazine derivative can be achieved in from less than about 20 minutes to about 5 hours at temperatures on the order of 100° C. to 120° C. Higher or lower temperatures can be used if desired, and the reaction can be carried out at room temperature. In most cases the cyclized end product can be recovered by filtering after direct crystallization from the reaction mixture particularly where the solvent has been chosen to facilitate recovery of the end product. Where the product does not readily crystallize, the novel .[.s-triazinone.]. derivatives can be conventiently isolated in the pure form by solvent extraction using any of the usual organic solvents which are not miscible with water such as: the hydrocarbons, for example, hexane; the chlorinated hydrocarbons, for example, chloroform or carbon tetrachloride; the aromatic solvents such as benzene, xylene, toluene, o-chloro-toluene and the like; ethers such as dioxane; ketones such as 2-pentanone, etc. The .[.s-triazinone.]. product is extracted into the solvent layer generally after stripping the solvent or concentrating the reaction mixture then shaking with an extracting composition of water and solvent and removing the solvent component, leaving the by-product in the aqueous layer. The product is recovered by evaporating off the solvent. If desired, the product can be further purified by recrystallizing from a suitable organic solvent such as those noted above. The selection of solvent is not critical and generally those solvents which are most readily available will be employed. The compounds of this invention may be readily converted to their nontoxic acid addition salts by customary methods in the art. The nontoxic salts of this invention are those salts the acid component of which is pharmacologically acceptable in the intended dosages. Such salts would include those prepared from inorganic acids, and organic acids, such as, higher fatty acids, high molecular weight acids, etc. Exemplary acids include hydrochloric acid, hydrobromic acid, sulfuric acid, nitric acid, phosphoric acid, methane sulfonic acid, benzene sulfonic acid, acetic acid, propionic acid, malic acid, succinic acid, glycolic acid, lactic acid, salicylic acid, benzoic acid, nicotinic acid, phthalic acid, stearic acid, oleic acid, abietic acid, etc. It is well known in the pharmacological arts that nontoxic acid addition salts of pharmacologically active amine compounds do not differ in activities from their free base. The salts merely provide a convenient solubility factor. Other salts, for example, quarternary ammonium salts, are prepared by known methods for quarternizing organic nitrogen compounds. The following example shows the synthetic preparation of .[.the hydrazinyltriazone.]. .Iadd.a mixture of the 3- and 5-ureido triazole .Iaddend.compounds described herein. It is to be construed as an illustration of the preparation of the compounds and not as limitations thereof. EXAMPLE I Preparation of .[.4-methylhydrazinyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one.]. .Iadd.1-methyl-3(5)-[3-(1-phenylureido)]-1,2,4-triazole .Iaddend. A. 4-Methyl-1-phenyl isobiuret 41.45 g of aqueous NaOH are added to a stirred suspension of O-methylisourea hydrogen sulfate (44.33 g) in 400 ml of THF while being cooled. After stirring at RT for 15 minutes, 200 g of anhydrous Na 2 SO 4 are added to the reaction mixture with continued stirring for one hour. Phenyl isocyanate (31.30 g) dissolved in THF (150 ml) is then added dropwise over a period of two hours. The mixture is filtered, concentrated, and the product crystallized from ethylacetate and hexane, to afford 41.10 g of the isobiuret, m.p. 86°-88° C. B. 4-Methoxy-1-phenyl-1,2-dihydro-1,3,4-triazin-2-one 4-methyl-1-phenyl isobiuret (41.08 g) is dissolved in 212 ml of triethylorthoformate. The solution is heated to 110°-115° C. for approximately four hours with a stream of N 2 being passed over the reaction mixture to flush out evolved ethanol and the reaction mixture allowed to cool overnight. The reaction product is filtered, washed with hexane, and recrystallized from toluene, affording 16.43 g of the triazinone, m.p. 171°-173° C. .[.4-Methylhydrazinyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one.]. .Iadd.1-Methyl-3(5)-[3-(1-phenylureido)]-1,2,4-triazole .Iaddend. 2.4 ml of methylhydrazine dissolved in 10 ml of absolute ethanol are added to a suspension of 4-methoxy-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one (4.60 g) in 100 ml of absolute ethanol and stirred for one hour. The solid product is filtered, washed with ether and dried to give 3.10 g (63.1%) of .[.4-methylhydrazino-1-phenyl-s-triazin-2-one.]. .Iadd.a mixture of 1-methyl-3(5)-[3-(1-phenylureido)]-1,2,4-triazole.Iaddend., m.p. 219° C. .Iadd.D. 1-Methyl-5-(3-(1-phenylureido))-1,2,4-triazole.Iaddend. .Iadd.The solid mixture of Step C. above is purified and affords 1-methyl-5-(3-(1-phenylureido))-1,2,4-triazole, m.p. 182.5°-183° C. .Iaddend. The isobiurets listed in Table II may be substituted for 4-methyl-1-phenyl isobiuret in Example 1 to prepare the corresponding 4-methoxy-s-triazones in Table III. TABLE II 4-methyl-1-benzyl isobiuret 4-methyl-1-(2-methylphenyl)-isobiuret 4-methyl-1-(2-ethylphenyl)-isobiuret 4-methyl-1-(2,6-dimethylphenyl)-isobiuret 4-methyl-1-(2,6-diethylphenyl)-isobiuret 4-methyl-1-(2-chlorophenyl)-isobiuret 4-methyl-1-(3-chlorophenyl)-isobiuret 4-methyl-1-(4-chlorophenyl)-isobiuret 4-methyl-1-(2-chloro-6-bromophenyl)-isobiuret 4-methyl-1-(3,4-dihydroxyphenyl)-isobiuret 4-methyl-1-(3,4-dichlorophenyl)-isobiuret 4-methyl-1-(3,4-dimethoxyphenyl)-isobiuret 4-methyl-1-(3,5-dichlorophenyl)-isobiuret 4-methyl-1-(3,4-diacetoxyphenyl)-isobiuret 4-methyl-1-(3,4-diethoxyphenyl)-isobiuret 4-methyl-1-(2-pyridyl)-isobiuret 4-methyl-1-(3-pyridyl)-isobiuret 4-methyl-1-(4-pyridyl)-isobiuret 4-methyl-1-[2-(3-methylpridyl)]-isobiuret 4-methyl-1-[2-(4-methoxypyridyl)]-isobiuret 4-methyl-1-[2-(5-methylpyridyl)]-isobiuret 4-methyl-1-[2-(5-methylpyridyl)]-isobiuret 4-methyl-1-[2-(3-chloropyridyl)]-isobiuret 4-methyl-1-[2-(4-chloropyridyl)]-isobiuret 4-methyl-1-[2-(3-carbomethoxypyridyl)]-isobiuret 4-methyl-1-[2-(3-cyanopyridyl)]-isobiuret 4-methyl-1-[2-(3-methoxypyridyl)]-isobiuret TABLE III 4-methoxy-1-benzyl-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(4-chloropheny)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(2-chloro-6-bromophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(3,5-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(3,4-diacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(3,4-diethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(2-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(3-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-(4-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-[2-(3-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-[2-(4-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-[2-(5-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-[2-(3-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-[2-(4-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-[2-(3-carbomethoxypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-[2-(3-cyanopyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-methoxy-1-[2-(3-methoxypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one The .[.4-hydrazino-s-triazinones.]. .Iadd.ureido-triazoles .Iaddend.of Table IV may be prepared from the corresponding 4-methoxy-s-triazinones disclosed in Table III. .Iadd.The use of 3(5) in the compounds listed below designates that the substituent which it precedes is located at either the three or five position of the 1,2,4-triazole ring, e.g. 3(5)-[3-(1-benzylureido)]-1-methyl-1,2,4-triazole designates two compounds 3-[3-(1-benzylureido)]-1-methyl-1,2,4-triazole and 5-[3-(1-benzylureido)]-1-methyl-1,2,4-triazole. .Iaddend. TABLE IV .[.4-hydrazino-1-benzyl-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(2-chloro-6-bromophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(3,4-hydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(3,5-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(3,4-diacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(3,4-diethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(2-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(3-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-(4-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-[2-(3-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-[2(4-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-[2-(5-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-[2-(3-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-[2-(4-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-[2-(3-carbomethoxypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-[2-(3-cyanopyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-1-[2-(3-methoxypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-benzyl-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(2-chloro-6-bromophenyl)-1,2-dihydro-1,3,5-triazin-2-on 4-methylhydrazino-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(3,5-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(3,4-diacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(3,4-diethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(2-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(3-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-(4-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-[2-(3-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-[2-(4-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-[2-(5-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-[2-(3-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-[2-(4-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-[2-(2-chloro-6-bromophenyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-[2-(3-cyanopyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-1-[2-(3-methoxypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-1-benzyl-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(2-methyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(2-chloro-6-bromophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(3,5-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(3,4-diacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(3,4-diethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(2-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(3-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-(4-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-([2-(3-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-[2-(4-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-[2-(5-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-[2-(3-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-[2-(4-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-[2-(3-carbomethoxypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-[2-(3-cyanopyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-acetylhydrazino-1-[2-(3-methoxypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-benzyl-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(2-chloro-6-bromophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(3,5-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(3,4-diacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-3,4-diethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(2-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(3-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-(4-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-[2-(3-methypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-[2-(4-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-[2-(5-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-[2-(3-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-[2-(4-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-[2-(3-carbomethoxypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-[2-(3-cyanopyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-trifluoromethylhydrazino-1-[2-(3-methoxypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1benzyl-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(2-chloro-6-bromophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(3,5-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(3,4-diacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(3,4-diethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(2-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(3-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(4-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-[2-(3-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-[2-(4-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-[2-(5-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-[2-(3-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-[2-(4-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-[2-(3-carbomethoxypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-[2-(3-cyanopyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-[2-(3-methoxypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-benzyl-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(1,2-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-1-(2-chloro-6-bromophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-(3,5-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-(3,4-diacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-(3,4-diethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-(2-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-(3-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-(4-pyridyl)-1,2,-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-[2-(3-methylpyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-[2-(4-methylpyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-[2-(5-methylpyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-[2-(3-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-[2-(4-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-[2-(3-carbomethoxypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-[2-(3-cyanopyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-1-[2-(3-methoxypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-benzyl-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(2-chloro-6-bromophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(3,5-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(3,4-diacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(3,4-diethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(2-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-1-(3-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allyhydrazino-1-(4-pyridyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allyhydrazino-1-[2-(3-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-allyhydrazino-1-[2-(4-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-allyhydrazino-1-[2-(5-methylpyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-allyhydrazino-1-[2-(3-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-allyhydrazino-1-[2-(4-chloropyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-allyhydrazino-1-[2-(3-carbomethoxypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-allyhydrazino-1-[2-(3-cyanopyridyl)]-1,2-dihydro-1,3,5-triazin-2-one 4-allyhydrazino-1-[2-(3-methoxypyridyl)]-1,2-dihydro-1,3,5-triazin-2-one.]. .Iadd.3-[3-(1-(2-methylphenyl)ureido)]-1,2,4-triazole 3-[3-(1-(2-ethylphenyl)ureido)]-1,2,4-triazole 3-[3-(1-(2,6-dimethylphenyl)ureido)]-1,2,4-triazole 3-[3-(1-(2,6-diethylphenyl)ureido)]-1,2,4-triazole 3-[3-(1-(2-chlorophenyl)ureido)]-1,2,4-triazole 3-[3-(1-(3-chlorophenyl)ureido)]-1,2,4-triazole 3-[3-(1-(4-chlorophenyl)ureido)]-1,2,4-triazole 3-[3-(1-(2-chloro-6-bromophenyl)ureido)]-1,2,4-triazole 3-[3-(1-(3,4-dihydroxyphenyl)ureido)]-1,2,4-triazole 3-[3-(1-(3,4-dichlorophenyl)ureido)]-1,2,4-triazole 3-[3-(1-(3,4-dimethoxyphenyl)ureido)]-1,2,4-triazole 3-[3-(1-(3,5-dichlorophenyl)ureido)]-1,2,4-triazole 3-[3-(1-(3,4-diacetoxyphenyl)ureido)]-1,2,4-triazole 3-[3-(1-(3,4-diethoxyphenyl)ureido)]-1,2,4-triazole 3-[3-(1-(2'-pyridyl)ureido)]-1,2,4-triazole 3-[3-(1-(3'-pyridyl)ureido)]-1,2,4-triazole 3-[3-(1-(4'-pyridyl)ureido)]-1,2,4-triazole 3-[3-(1-(2'-(3'-methylpyridyl))ureido)]-1,2,4-triazole 3-[3-(1-(2'-(4'-methylpyridyl))ureido)]-1,2,4-triazole 3-[3-(1-(2'-(5'-methylpyridyl))ureido))-1,2,4-triazole 3-[3-(1-(2'-(3'-chloropyridyl))ureido)]-1,2,4-triazole 3-[3-(1-(2'-(4'-chloropyridyl))ureido)]-1,2,4-triazole 3-[3-(1-(2'-(3'-carbomethoxypyridyl))ureido)]-1,2,4-triazole 3-[3-(1-(2'-(3'-cyanopyridyl))ureido)]-1,2,4-triazole 3-[3-(1-(2'-(3'-methoxypyridyl))ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(2-methylphenyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(2-ethylphenyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(2,6-dimethylphenyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(2,6-diethylphenyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(2-chlorophenyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(3-chlorophenyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(4-chlorophenyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(2-chloro-6-bromophenyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(3,4-dihydroxyphenyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(3,4-dichlorophenyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(3,4-dimethoxyphenyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(3,5-dichlorophenyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(3,4-diacetoxyphenyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(3,4-diethoxyphenyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(2'-pyridyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(3'-pyridyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(4'-pyridyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(2'-(3'-methylpyridyl))ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(2'-(4'-methylpyridyl))ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(2'-(5'-methylpyridyl))ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(2'-(3'-chloropyridyl))ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(2'-(4'-chloropyridyl))ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(2-chloro-6-bromophenyl)ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(2'-(3'-cyanopyridyl))ureido)]-1,2,4-triazole 1-methyl-3(5)-[3-(1-(2'-(3'-methoxypyridyl))ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(2-methylphenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(2-ethylphenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(2,6-dimethylphenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(2,6-diethylphenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(2-chlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(3-chlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(4-chlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(2-chloro-6-bromophenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(3,4-dihydroxyphenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(3,4-dichlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(3,4-dimethoxyphenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(3,5-dichlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(3,4-diacetoxyphenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(3,4-diethoxyphenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(2'-pyridyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(3'-pyridyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(4'-pyridyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(2'-(3'-methylpyridyl))ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(2'-(4'-methylpyridyl))ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(2'-(5'-methylpyridyl))ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(2'-(3'-chloropyridyl))ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(2'-(4'-chloropyridyl))ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(2'-(3'-carbomethoxypyridyl))ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(2'-(3'-cyanopyridyl))ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(2'-(3'-methoxypyridyl))ureido)]-1,2,4-triazole .Iaddend. The general synthesis described above may be utilized to prepare the .[.4-hydrazino-triazinones.]. .Iadd.ureido-triazoles .Iaddend.in Table V. .[.TABLE V.]. .[.4-hydrazino-6-methyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-methyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-methyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-methyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-methyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-methyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-methyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-methyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-methyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-methyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-methyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-methyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-methyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-methyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-methyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-methyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-methyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-methyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-methyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-methyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-methyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-methyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-methyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-methyl-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-methyl-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-methyl-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-methyl-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-methyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-methyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-methyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-methyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-methyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-methyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allyhydrazino-6-methyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-methyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-methyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-methyl-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-methyl-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-methyl-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-methyl-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-methyl-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-methyl-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allyhydrazino-6-methyl-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-methyl-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-methyl-1-(3,4-dimethoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-methyl-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-methyl-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydraxzino-6-methyl-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-methyl-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-methyl-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-methyl-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-methyl-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-methyl-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-methyl-1-(3,4-dihydroxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-methyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-methyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-methyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-methyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-methyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-methyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-methyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-methyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-methyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-methyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-methyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-methyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-methyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-methyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-methyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-methyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-methyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-methyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-methyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-methyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-methyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-methyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-methyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-methyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-methyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-methyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-methyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-methyl-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-methyl-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-methyl-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-methyl-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-methyl-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-methyl-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allyhydrazino-6-methyl-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-methyl-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-methyl-1-(2,6-diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-methyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-methyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-methyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-methyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-methyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-methyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-methyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-methyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-methyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-ethyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-ethyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-ethyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-ethyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-ethyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-ethyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-ethyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-ethyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-ethyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-ethyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-ethyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-ethyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-ethyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-ethyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-ethyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-ethyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-ethyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-ethyl-1-(2-methylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-ethyl-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-ethyl-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-ethyl-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-ethyl-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-ethyl-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-ethyl-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-ethyl-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-ethyl-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-ethyl-1-(2-ethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-ethyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-ethyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-ethyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-ethyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-ethyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-ethyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-ethyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-ethyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-ethyl-1-(2-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-ethyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-ethyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-ethyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-ethyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-ethyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-ethyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-ethyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-ethyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-ethyl-1-(4-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-ethyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-ethyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-ethyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-ethyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-ethyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-ethyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-ethyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-ethyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-ethyl-1-(3,4-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-1-ethyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-ethyl-1-phenyl-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-ethyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-ethyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-ethyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-ethyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-ethyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-ethyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-ethyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-ethyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-ethyl-1-(3-chlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-ethyl-1-(3,4-ditrifluoroacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-ethyl-1-(3,4-ditrifluoroacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-ethyl-1-(3,4-ditrifluoroacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-ethyl-1-(3,4-ditrifluoroacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-ethyl-1-(3,4-ditrifluoroacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-ethyl-1-(3,4-ditrifluoroacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-ethyl-1-(3,4-ditrifluoroacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-ethyl-1-(3,4-ditrifluoroacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-ethyl-1-(3,4-ditrifluoroacetoxyphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-ethyl-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-ethyl-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-ethyl-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-ethyl-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-ethyl-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-ethyl-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-ethyl-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-ethyl-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-ethyl-1-(2,6-dimethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-ethyl-1-(diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-ethyl-1-(diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-ethyl-1-(diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-ethyl-1-(diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-ethyl-1-(diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-ethyl-1-(diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-ethyl-1-(diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-ethyl-1-(diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-ethyl-1-(diethylphenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-hydrazino-6-ethyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-methylhydrazino-6-ethyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-ethylhydrazino-6-ethyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propylhydrazino-6-ethyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-phenylhydrazino-6-ethyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-benzylhydrazino-6-ethyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-allylhydrazino-6-ethyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-propargylhydrazino-6-ethyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one 4-pyridylhydrazino-6-ethyl-1-(2,6-dichlorophenyl)-1,2-dihydro-1,3,5-triazin-2-one.]. .Iadd.3-[3-(1-phenylureido)]-5-methyl-1,2,4-triazole 1-methyl-3(5)-methyl-5(3)-[3-(1-phenylureido)]-1,2,4-triazole 1-ethyl-3(5)-methyl-5(3)-[3-(1-phenylureido)]-1,2,4-triazole 1-propyl-3(5)-methyl-5(3)-[3-(1-phenylureido)]-1,2,4-triazole 1-phenyl-3-methyl-5-[3-(1-phenylureido)]-1,2,4-triazole 1-pyridyl-3-methyl-5-[3-(1-phenylureido)]-1,2,4-triazole 3-[3-(1-(2-methylphenyl)ureido)]-5-methyl-1,2,4-triazole 1-methyl-3(5)-methyl-5(3)-[3-(1-(2-methylphenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-methyl-5(3)-[3-(1-(2-methylphenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-methyl-5(3)-[3-(1-(2-methylphenyl)ureido)]-1,2,4-triazole 1-phenyl-3-methyl-5-[3-(1-(2-methylphenyl)ureido))-1,2,4-triazole 1-pyridyl-3-methyl-5)-[3-(1-(2-methylphenyl)ureido)]-1,2,4-triazole 3-[3-(1-(2-ethylphenyl)ureido)]-5-methyl-1,2,4-triazole 1-methyl-3(5)-methyl-5(3)-[3-(1-(2-ethylphenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-methyl-5(3)-[3-(1-(2-ethylphenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-methyl-5(3)-[3-(1-(2-ethylphenyl)ureido)]-1,2,4-triazole 1-phenyl-3-methyl-5-[3-(1-(2-ethylphenyl)ureido)]-1,2,4-triazole 1-pyridyl-3-methyl-5-[3-(1-(2-ethylphenyl)ureido)]-1,2,4-triazole 3-[3-(1-(2-chlorophenyl)ureido)]-5-methyl-1,2,4-triazole 1-methyl-3(5)-methyl-5(3)-[3-(1-(2-chlorophenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-methyl-5(3)-[3-(1-(2-chlorophenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-methyl-5(3)-[3-(1-(2-chlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-3-methyl-5-[3-(1-(2-chlorophenyl)ureido)]-1,2,-triazole 1-pyridyl-3-methyl-5-[3-(1-(2-chlorophenyl)ureido)]-1,2,4-triazole 3-[3-(1-(3,4-dimethoxyphenyl)ureido)]-5-methyl-1,2,4-triazole 1-methyl-3(5)-methyl-5(3)-[3-(1-(3,4-dimethoxyphenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-methyl-5(3)-[3-(1-(3,4-dimethoxyphenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-methyl-5(3)-[3-(1-(3,4-dimethoxyphenyl)ureido)]-1,2,4-triazole 1-phenyl-3-methyl-5-[3-(1-(3,4-dimethoxyphenyl)ureido)]-1,2,4-triazole 1-pyridyl-3-methyl-5-[3-(1-(3,4-dimethoxyphenyl)ureido)]-1,2,4-triazole 3-[3-(1-(3,4-dihydroxyphenyl)ureido)]-5-methyl-1,2,4-triazole 1-methyl-3(5)-methyl-5(3)-[3-(1-(3,4-dihydroxyphenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-methyl-5(3)-[3-(1-(3,4-dihydroxyphenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-methyl-5(3)-[3-(1-(3,4-dihydroxyphenyl)ureido)]-1,2,4-triazole 1-phenyl-3-methyl-5-[3-(1-(3,4-dihydroxyphenyl)ureido)]-1,2,4-triazole 1-pyridyl-3(5)-methyl-5(3)-[3-(1-(3,4-dihydroxyphenyl)ureido)]-1,2,4-triazole 3-[3-(1-chlorophenyl)ureido)]-5-methyl-1,2,4-triazole 1-methyl-3(5)-methyl-5(3)-[3-(1-(3-chlorophenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-methyl-5(3)-[3-(1-(3-chlorophenyl)ureido))-1,2,4-triazole 1-propyl-3(5)-methyl-5(3)-[3-(1-(3-chlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-3-methyl-5-[3-(1-(3-chlorophenyl)ureido)]-1,2,4-triazole 1-pyridyl-3(5)-methyl-5(3)-[3-(1-(3-chlorophenyl)ureido)]-1,2,4-triazole 3-[3-(1-(4-chlorophenyl)ureido)]-5-methyl-1,2,4-triazole 1-methyl-3(5)-methyl-5(3)-[3-(1-(4-chlorophenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-methyl-5(3)-[3-(1-(4-chlorophenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-methyl-5(3)-[3-(1-(4-chlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-3-methyl-5-[3-(1-(4-chlorophenyl)ureido)]-1,2,4-triazole 1-pyridyl-3(5)-methyl-5(3)-[3-(1-(4-chlorophenyl)ureido)]-1,2,4-triazole 3-[3-(1-(3,4-dichlorophenyl)ureido)]-5-methyl-1,2,4-triazole 1-methyl-3(5)-methyl-5(3)-[3-(1-(3,4-dichlorophenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-methyl-5(3)-[3-(1-(3,4-dichlorophenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-methyl-5(3)-[3-(1-(3,4-dichlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-3-methyl-5-[3-(1-(3,4-dichlorophenyl)ureido)]-1,2,4-triazole 1-pyridyl-3-methyl-5-[3-(1-(3,4-dichlorophenyl)ureido)]-1,2,4-triazole 3-[3-(1-(2,6-diethylphenyl)ureido)]-5-methyl-1,2,4-triazole 1-methyl-3(5)-methyl-5(3)-[3-(1-(2,6-diethylphenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-methyl-5(3)-[3-(1-(2,6-diethylphenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-methyl-5(3)-[3-(1-(2,6-diethylphenyl)ureido)]-1,2,4-triazole 1-phenyl-3-methyl-5-[3-(1-(2,6-diethylphenyl)ureido)]-1,2,4-triazole 1-pyridyl-3-methyl-5-[3-(1-(2,6-diethylphenyl)ureido)]-1,2,4-triazole 3-[3-(1-(2,6-dichlorophenyl)ureido)]-5-methyl-1,2,4-triazole 1-methyl-3(5)-methyl-5(3)-[3-(1-(2,6-dichlorophenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-methyl-5(3)-[3-(1-(2,6-dichlorophenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-methyl-5(3)-[3-(1-(2,6-dichlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-3-methyl-5-[3-(1-(2,6-dichlorophenyl)ureido)]-1,2,4-triazole 1-pyridyl-3-methyl-5-[3-(1-(2,6-dichlorophenyl)ureido)]-1,2,4-triazole 3-[3-(1-phenylureido)]-5-ethyl-1,2,4-triazole 1-methyl-3(5)-ethyl-5(3)-[3-(1-phenylureido)]-1,2,4-triazole 1-ethyl-3(5)-ethyl-5(3)-[3-(1-phenylureido)]-1,2,4-triazole 1-propyl-3(5)-ethyl-5(3)-[3-(1-phenylureido)-1,2,4-triazole 1-pyridyl-3-methyl-5-[3-(1-(2,6-diethylphenyl)ureido)]-1,2,4-triazole 13-[3-(1-(2,6-dichlorophenyl)ureido)]-5-methyl-1,2,4-triazole 1-methyl-3(5)-methyl-5(3)-[3-(1-(3,6-dichlorophenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-methyl-5(3)-[3-(1-(2,6-dichlorophenyl)ureido))-1,2,4-triazole 1-propyl-3(5)-methyl-5(3)-[3-(1-(2,6-dichlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-3-methyl-5-[3-(1-(2,6-dichlorophenyl)ureido)]-1,2,4-triazole 1-pyridyl-3-methyl-5-[3-(1-(2,6-dichlorophenyl)ureido)]-1,2,4-triazole 3-[3-(1-phenylureido)]-5-ethyl-1,2,4-triazole 1-methyl-3(5)-ethyl-5(3)-[3-(1-phenylureido)]-1,2,4-triazole 1-ethyl-3(5)-ethyl-5(3)-[3-(1-phenylureido)]-1,2,4-triazole 1-propyl-3(5)-ethyl-5(3)-[3-(1-phenylureido)]-1,2,4-triazole 1-phenyl-3-ethyl-5-[3-(1-phenylureido)]-1,2,4-triazole 1-pyridyl-3-ethyl-5-[3-(1-phenylureido)]-1,2,4-triazole 3-[3-(1-(2-methylphenyl)ureido)]-5-methyl-1,2,4-triazole 1-methyl-3(5)-ethyl-5(3)-[3-(1-(2-methylphenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-ethyl-5(3)-[3-(1-(2-methylphenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-ethyl-5(3)-[3-(1-(2-methylphenyl)ureido)]-1,2,4-triazole 1-phenyl-3-ethyl-5-[3-(1-(2-methylphenyl)ureido)]-1,2,4-triazole 1-pyridyl-3-ethyl-5-[3-(1-(2-methylphenyl)ureido)]-1,2,4-triazole 3-[3-(1-(2-ethylphenyl)ureido)]-5-methyl-1,2,4-triazole 1-methyl-3(5)-ethyl-5(3)-[3-(1-(2-ethylphenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-ethyl-5(3)-[3-(1-(2-ethylphenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-ethyl-5(3)-[3-(1-(2-ethylphenyl)ureido)]-1,2,4-triazole 1-phenyl-3-ethyl-5-[3-(1-(2-ethylphenyl)ureido)]-1,2,4-triazole 1-pyridyl-3-ethyl-5-[3-(1-(2-ethylphenyl)ureido)]-1,2,4-triazole 3-[3-(3-(1-(2-chlorophenyl))ureido)]-5-ethyl-1,2,4-triazole 1-methyl-3(5)-ethyl-5(3)-[3-(1-(2-chlorophenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-ethyl-5(3)-[3-(1-(2-chlorophenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-ethyl-5(3)-[3-(1-(2-chlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-3-ethyl-5-[3-(1-(2-chlorophenyl)ureido)]-1,2,4-triazole 1-pyridyl-3-ethyl-5-[3-(1-(2-chlorophenyl)ureido)]-1,2,4-triazole. 3-[3-(1-(4-chlorophenyl)ureido)]-5-ethyl-1,2,4-triazole 1-methyl-3(5)-ethyl-5(3)-[3-(1-(4-chlorophenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-ethyl-5(3)-[3-(1-(4-chlorophenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-ethyl-5(3)-[3-(1-(4-chlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-3-ethyl-5-[3-(1-(4-chlorophenyl)ureido)]-1,2,4-triazole 11-pyridyl-3-ethyl-5)-[3-(1-(4-chlorophenyl)ureido))-1,2,4-triazole 3-[3-(1(3,4-dichlorophenyl)ureido)]-5-ethyl-1,2,4-triazole 1-methyl-5(3)-[3-(1-(3,4-dichlorophenyl)ureido)]-1,2,4-triazole 1-ethyl-5(3)-[3-(1-(3,4-dichlorophenyl)ureido)]-1,2,4-triazole 1-propyl-5(3)-[3-(1-(3,4-dichlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(3,4-dichlorophenyl)ureido)]-1,2,4-triazole 1-pyridyl-5-[3-(1-(3,4-dichlorophenyl)ureido)]-1,2,4-triazole 1-pyridyl-3-ethyl-5-[3-(1-phenylureido)]-1,2,4-triazole 3-[3-(1-(3-chlorophenyl)ureido)]-5-ethyl-1,2,4-triazole 1-methyl-3(5)-ethyl-5(3)-[3-(1-(3-chlorophenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-ethyl-5(3)-[3-(1-(3-chlorophenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-ethyl-5(3)-[3-(1-(3-chlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-3-ethyl-5-[3-(1-(3-chlorophenyl)ureido)]-1,2,4-triazole 1-pyridyl-3-ethyl-5-[3-(1-(3-chlorophenyl)ureido)]-1,2,4-triazole 3-[3-(1-(3,4-ditrifluoroacetoxyphenyl)ureido)]-5-ethyl-1,2,4-triazole 1-methyl-5(3)-[3-(1-(3,4-ditrifluoroacetoxyphenyl)ureido)]-1,2,4-triazole 1-ethyl-5(3)-[3-(1-(3,4-ditrifluoroacetoxyphenyl)ureido)]-1,2,4-triazole 1-propyl-5(3)-[3-(1-(3,4-ditrifluoroacetoxyphenyl)ureido)]-1,2,4-triazole 1-phenyl-5-[3-(1-(3,4-ditrifluoroacetoxyphenyl)ureido)]-1,2,4-triazole 1-pyridyl-3-ethyl-5-[3-(1-(3,4-ditrifluoroacetoxyphenyl)ureido)]1,2,4-triazole 3-[3-(1-(2,6-dimethylphenyl)ureido)]-5-ethyl-1,2,4-triazole 1-methyl-3(5)-ethyl-5(3)-[3-(1-(2,6-dimethylphenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-ethyl-5(3)-[3-(1-(2,6-dimethylphenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-ethyl-5(3)-[3-(1-(2,6-dimethylphenyl)ureido)]-1,2,4-triazole 1-phenyl-3-ethyl-5-[3-(1-(2,6-dimethylphenyl)ureido)]-1,2,4-triazole 1-pyridyl-3-ethyl-5-[3(1-(2,6-dimethylphenyl)ureido)]-1,2,4-triazole 3-[3-(1-(2,6-diethylphenyl)ureido)]-5-ethyl-1,2,4-triazole 1-methyl-3(5)-ethyl-5(3)-[3-(1-(3,6-diethylphenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-ethyl-5(3)-[3-(1-(2,6-diethylphenyl)ureido)]1,2,4-triazole 1-propyl-3(5)-ethyl-5(3)-[3-(1-(2,6-diethylphenyl)ureido)]-1,2,4-triazole 1-phenyl-3-ethyl-5-[3-(1-(2,6-diethylphenyl)ureido)]-1,2,4-triazole 1-pyridyl-3-ethyl-5-[3-(1-(2,6-diethylphenyl)ureido)]-1,2,4-triazole 3-[3-(1-2,6-dichlorophenyl)ureido)]-5-ethyl-1,2,4-triazole 1-methyl-3(5)-ethyl-5(3)-[3-(1-(2,6-dichlorophenyl)ureido)]-1,2,4-triazole 1-ethyl-3(5)-ethyl-5(3)-[3-(1-(2,6-dichlorophenyl)ureido)]-1,2,4-triazole 1-propyl-3(5)-ethyl-5(3)-[3-(1-(2,6-dichlorophenyl)ureido)]-1,2,4-triazole 1-phenyl-3-ethyl-5-[3-(1-(2,6-dichlorophenyl)ureido)]-1,2,4-triazole 1-pyridyl-3-ethyl-5-[3-(1-(2,6-dichlorophenyl)ureido)]-1,2,4-triazole As mentioned above, the 4-methoxy-s-triazinone may be reacted with unsubstituted hydrazine thereby producing the ureido triazole (wherein R 4 is hydrogen) which may be treated with an appropriate alkylating reagent such as an alkyl halide, alkyl triflate, alkanoyl halide, such as benzoyl halide, methyl halide, acetyl chloride, benzoylchloride, and result in the desired R 4 substitution. The following table lists the melting points of the acylation products obtained from the reaction of the listed starting materials. ______________________________________ Melting PtStarting Materials of Product______________________________________3-[3-(1-phenylureido)]-1,2,4-triazole and 158° C.acetyl chloride3-[3-(1-phenylureido)]-1,2,4-triazole and 165-167° C.ethyl chloroformate3-[3-(1-phenylureido)]-1,2,4-triazole and 176-178° C.acetyl chloride3-[3-(1-(4-chlorophenyl)ureido)]-1,2,4-triazole and 193-195° C.benzoyl chloride3-[3-(1-(4-chlorophenyl)ureido)]-1,2,4-triazole and 194-195° C.ethyl chloroformate3-[3-(1-(3-chlorophenyl)ureido)]-1,2,4-triazole and 140-144° C.acetyl chloride3-[3-(1-(3-chlorophenyl)ureido)]-1,2,4-triazole and 210° C.acetyl chloride3-[3-(1-(3,4-dichlorophenyl)ureido)]-1,2,4-triazole 183-185° C.and acetyl chloride3-[3-(1-(3-trifluoromethylphenyl)ureido)]-1,2,4- 142.5-164° C.triazole and acetyl chloride______________________________________ The .[.hydrazinyl.]. .Iadd.ureido triazole .Iaddend.compounds which possess blood pressure-lowering activity can be used as antihypertensive agents by oral, parenteral or rectal administration. Orally they may be administered as tablets, aqueous or oily syspensions, dispersible powders or granules, emulsions, hard or soft capsules, or syrups or elixers. Parenterally they may be administered as a salt in solution which pH is adjusted to physiologically accepted values. Aqueous solutions are preferred. Compositions intended for oral use may be prepared according to any method known to the art for the manufacture of pharmaceutical compositions, and such compositions may contain one or more inert carrier agents including excipients, such as sweetening agents, flavoring agents, coloring agents, preserving agents and the like, in order to provide a pharmaceutically elegant and palatable preparation. The dosage regimen in carrying out the methods of this invention is that which ensures maximum therapeutic response until improvement is obtained, and thereafter the minimum effective level which gives relief. Thus, in general, the dosages are those that are therapeutically effective in the alleviation of hypertensive disorders. The therapeutically effective doses correspond to those dosage amounts found effective in tests using animal models which are known to correlate to human activity. In general, it is expected that daily doses between about 5 mg/kg and about 300 mg/kg (preferably in the range of about 10 to about 50 mg/kg/day), will be sufficient to produce the desired therapeutic effect, bearing in mind, of couse, that in selecting the appropriate dosage in any specific case, consideration must be given to the patient's weight, general health, age, the severity of the disorder, and other factors which may influence response to the drug. Various tests in animals have been carried out to show the ability of the compounds of this invention to exhibit reactions that can be correlated with activity in humans. These tests involve such factors as their blood pressue-lowering effect and determination of their toxicity. It has been found that the preferred compounds of this invention, when tested in the above situation, show a marked blood pressure-lowering activity. Determination of Antihypertensive Activity A description of the test protocol used in the determination of the antihypertensive activity of the compounds of this invention follows: (a) Male TAC spontaneously hypertensive rats (SHR's), eleven weeks old, weighing 200-220 grams, are chosen for testing. The average systolic blood pressure (as measured below) should be 165 mmHg or above. Any rat not initially meeting this criterion is not utilized. (b) A Beckman dynograph is balanced and calibrated using a Beckman indirect blood pressure coupler. A mercury monometer is placed on one arm of the glass "T" tube. The known pressure head in the tail cuff is synchronized with the recorder output so that 1 mm pen deflection=5 mmHg. Any correction is made using the chart calibration screw on the pressure coupler. The pulse amplitude is controlled by the pre-amplifier using a 20 v/cm setting. The rats are prewarmed in groups of five for twenty minutes to dilate the tail artery from which the arterial pulse is recorded. After prewarming, each rat is placed in an individual restraining cage with continued warming. When the enclosure temperature has been maintained at 35° C. for 5 minutes, recordings are started. The tail cuff is placed on the rat's tail and the rubber bulb of the pneumatic tail cuff transducer is taped securely to the dorsal surface of the tail. When the rat's pulse reaches maximum amplitude and is unwavering, the cuff is inflated and the air slowly released. A reading of systolic blood pressure is read at the point of the chart when the first deflection appears on the chart recording while the air in the cuff is being released. The exact point of the systolic blood pressure reading is where the first deflection forms a 90° angle to the falling cuff pressure base line. After obtaining nine or ten consistent readings, the average of the middle five readings is calculated. (c) Three groups of twenty rats receive the test compound at doses of about 25 mg/kg per os. A fourth group of twenty control rats receive distilled water. Statistical comparisons of systolic pressure (four hours ater the first dose and sixteen hours after the second dose) are made on a daily basis using the Student t test for dependent variables (see, E. Lord, Biometrika, 34, 56 (1947)), with the predose observations serving as baseline values for each rat. This testing method is known to correlate well with antihypertensive activity in humans and is a standard test used to determine antihypertensive properties. Accordingly, .[.hydrazine triazinones.]. .Iadd.ureido-triazoles .Iaddend.which show effectiveness in the test can be considered to be active antihypertensive agents in humans.

##STR1## This invention relates to .[.1-aryl-4-hydrazinyl-1,2-dihydro-1,3,5-triazin-2-ones and 2-thiones.]. .Iadd.3.Iaddend.- .Iadd.and 5.Iaddend.-.Iadd.[3.Iaddend.-(.Iadd.1.Iaddend.-.Iadd.arylureido.Iaddend.)]-.Iadd.1,2,4.Iaddend.-.Iadd.triazoles and 3.Iaddend.- .Iadd.and 5.Iaddend.-.Iadd.[3.Iaddend.-(.Iadd.1.Iaddend.-(.Iadd.arylthioureido.Iaddend.)]-.Iadd.triazoles .Iaddend.of Formula I, processes for their preparation, isobiuret and 4-alkoxy-s-triazinone preparative intermediates, and methods of treating physiological disorders in humans and animals, in particular, cardiovascular disorders, including hypertension.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates generally to a child's riding device for one or more children, and more particularly to a multi-use swing that is connectable to a frame in a number of different configurations to oscillate through various paths. 2. Prior Art Simple swings have been used for many years and are particularly enjoyed by children of all ages. More complicated swings having more than the conventional two suspension lines have also been used by adults as, for example, the traditional "porch swing". Swings which are capable of relatively intricate maneuvers and oscillations are also known in the prior art. For example, Williams U.S. Pat. No. 2,325,456 describes a swing which comprises a horizontal bar suspended at spaced apart ends by an outwardly disposed chain. The bar is swingable both endwise and sideways to produce a combination of upward and sideways twists similar to the movement of a bucking bronco. It is common knowledge that with the urbanization and the resultant decrease in farmland, children have fewer and fewer opportunities for physical exercise, muscular development, and coordination development. Operators of children's playgrounds have also noted the scarcity of available equipment which is at the same time both safe and enjoyable for use by children. However, no prior art swings have the flexibility and features which allows the user to be creative and develop their own uses. The need exists for a flexible swing for both home use and playground equipment that can be simply and inexpensively constructed which will furnish both younger and older children exercise, exciting play, and opportunities for physical development. SUMMARY OF INVENTION It is the object of the present invention to provide a novel swing for children. Another object of the present invention is to provide a swing with multiple options and uses provided by a plurality of suspension links that can be selected by the user to oscillate through many different paths of travel. Another object of the present invention is to provide a swing that can be operated safely without contacting structures. Another object of the present invention is to provide a swing that may be simultaneously used by more than one person. Another object of the present invention is to provide a swing which is simple in design, inexpensive to manufacture, rugged in construction, easy to use and efficient in operation. Satisfaction of these objects in accordance with the spirit of this invention a multi-use swing is herein provided that is simultaneously swingable, tilting and/or rotatable and may be used by more than one person if desired. As will be understood in connection with the disclosure herein, the swing provides a seat which can be used by one or more persons to rotate, travel in a figure "eight" path, travel in a conventional to and fro oscillation as well as additional configurations. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of one embodiment of the swing of the present invention; FIG. 2 is a perspective view of the seat portion of the swing of the present invention; FIG. 3 is a perspective view of one embodiment of one of the suspension links of the swing of the present invention; FIG. 4 is a vertical section of a portion of the attachment means for the swing of the present invention; FIG. 5 is a bottom plan view of the suspension platform of the present invention; FIG. 6 is a diagrammatic representation of a number of possible connections between the seat and the support platform; and FIG. 7 is a rigid yoke for connection to the ends of the seat of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 illustrates one embodiment of the swing contemplated by the present invention, generally designated 10. In this embodiment, the swing includes a frame 12, a support platform 14, a base or lower plate 15 and a pair of stabilizers 16 to prevent the swing from overturning. A seat 20 is supported from the platform 14 by a plurality of suspension links 22. The frame 12 includes a ladder element 16 on at least one end. The frame includes a pair of substantially vertical more inwardly tilted posts 24 on each end and a pair of horizontal post elements 28 connected to the upper ends of the post 24. A plurality of ladder rungs 30 between the posts 24 on one end enable the user to climb up onto the top of the support platform 14 as described hereinafter. A pair of hand rails 34 or supports are provided for added safety. In the preferred embodiment of the present invention, a slide 40 is connected on one end of the frame 12 to provide a playful exit from the platform 13. In this form of the invention, it is not be necessary to include the ladder rungs at the end which incorporate the slide because access would be had by climbing the ladder 16 at the opposite end of the frame 12. In an alternative embodiment, the frame 12 may be connected to a conventional "swing-set" at right angles thereto. Referring to FIG. 2, the seat 20 may take various shapes but is shown here to be generally oval or rounded in shape, being substantially longer in the longitudinal direction of the swing as mounted in FIG. 1. Preferably, the seat is made of a durable, soft, resilient fabric such as vinyl or the like which is easily and readily cleaned. The seat 20 may be formed of a top panel 42, and a bottom panel 44 46 which are sewn together at the seams 50 and filled with a semi-rigid, flexible material, like foam rubber or the like. Although the seat portion 20 may be rigid, for safety reasons flexibility is desirable. The seat 20 also includes a plurality of circumferential handles 52 to be used as holding points for the user. Referring to FIG. 4, the support platform 14 includes a plurality of eye bolts 56a-56g which are secured through apertures in the platform 14 by nuts 58 and washers 60. In the preferred embodiment, the support platform has at least seven eyes labeled 56a-56g which are laid out in the pattern as shown in the bottom plan view of FIG. 5. In the preferred embodiment, the central eye bolts 56g and 57 in the top and bottom supports is releasably, rotatably mounted by a lockable thrust bearing 59. The eye bolts 56a-g are connected by a varying plurality of suspension links 22 to the connection points on the seat. The suspension links 22, as shown in FIG. 3, each include a clip 64 at the top end connected by a flexible fabric-type strap or strand 66 to a connector, generally designated 70. The connector 70 is a conventional snap-on type plastic connector having a male portion 72 and a female portion 74. In use, the male portion 72 is inserted into the female portion 74 and the prong elements 76 snap outwardly through the apertures 78 in the female portion to securely lock the connector together. A female connector portion 74 is connected to the seat at positions a-h by a small strap portion 66 so it may hang free when not in use. This type of connector allows for easy changeability for configurations of the various suspension links. In the preferred embodiment, the female portions 74 are attached by a strap portion 66 directly to the seat portion 42 such as at the points labeled a, b and c. Similarly, connector portions 74 are connected at points d, e and f on the other side of the seat (not shown) and at points g and h at the opposite end of the seat 42. The swing has the flexibility to be used in many different combinations of suspension links 22 between the seat 20 and the supports 14 and 15. To facilitate movement of the hooks 64 between the eye-bolts 56, a plurality of access holes 60 permit access from the top. Six of the connection combinations are shown schematically in FIG. 6 wherein each pair represents the points that are connected between the eyes 56a-g on the support platform 14 and the connection points a through h on the seat. The top set is arranged with six support elements 22 so that it can support four or more people for group play. In this configuration, the eyes 56b and 56d are each connected to two points a and d and c and b on the seat. The connection points a and d on the seat are connected by supports 22 to the eye 56b on the support platform and similarly the points c and f are connected by a support 22 to the eye 56d. The respective end eyes 56a and 56e are connected to the end points g and h on the seat. In this manner, several users can swing in a generally traditional fashion and significantly can be supported by the six supports 22. The next pair going down in FIG. 6 shows an arrangement where the seat is transverse with respect to the platform 24 and the points b and e on the seat 42 are connected to the eyes 56b and 56d or 56a and 56e. In this setup, two children can use the swing as a "tilting board" or teeter totter which can pivot about the b e axis and also swing to and fro. In a third form of the tilt board, if all of the supports 22 are connected to the center eye-ring 56g, the users cannot only tilt, but can rotate in a merry-go-round fashion about the central top support. In this case, the bearing 59 can be left free to permit rotation or locked to a winding and then unwinding of the seat 20. Moving down to the next pair, four supports 22 are used to connect the eyes 56b and 56d to the four connections a, c, d and f on the seat portion 22. The center support 56G is also connected to each end of the seat at G and H. In this setup, the seat will have much less or little ability to tilt back and forth because of the stability added by the additional supports near the end connection points. As an alternative, or fourth configuration, a rigid connection element 80 such as that shown in FIG. 7, can be connected between the central eye 56g and the end connection points g and h on the seat. With this additional rigid support 80, the arms 82 will engage the support 14 to prevent the swing from inadvertently traveling over the top of the support. This connection allows the seat to safely swing through a very large arc of travel. The next configuration has six support links 22 connecting the center eye 56g to the points a, c, d, f, g and h on the seat. In addition, in this configuration, the points g and h are connected by two additional supports to the eye 57 on the lower base or plate 15. In this fashion, the seat will remain essentially in a single plane but can be rotated in a round table or carousel fashion and be used as an ordinary carousel. In another variant, the seat 22 may be supported in a vertical orientation as shown in the bottommost pair between the eye 56g and the end connection point g for swinging and rotating simultaneously. Two or more persons can "hang on" to the handles 52 on the seat in this configuration. Alternatively, the bottom point f on the seat can be connected to the lower eye 57 to reduce the to and fro swinging action while permitting rotation. Obviously, with the present structure as described and with simple modifications or additional connection points provided to the seat and the upper and lower supports, many different types of motion can be generated and therefore no unnecessary limitations should be understood from the foregoing description as many modifications will be obvious to those skilled in the art.

A swing apparatus that can be used in many different configurations includes a "seat" portion for supporting a child or other user for swinging travel in a selective variety of paths. The swing includes a frame which supports the seat by one or more flexible or rigid support links for movement in a plurality of paths. The links can be selectively connected to a number of different suspension points on the frame and, similarly, on a number of different connection points on the seat to provide many different configuration or uses to provide multiple paths of travel for the seat.

This is a continuation of application Ser. No. 08/301,116, filed Sep. 6, 1994, now U.S. Pat. No. 5,427,870 issued Jun. 27, 1995, and further a continuation-in-part of application Ser. No. 08/058,438, filed May 7, 1993, now U.S. Pat. No. 5,454,922. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a dispensing device, in particular a device where the active fluid is oxygen or nitrogen gas which has been released from a solid state electrochemical cell, and where the pressure increase resulting from the release of such gas pushes fluid from a bladder within a pressure-tight chamber through an outlet in a steady continuous flow until the fluid contents of the bladder are exhausted. 2. State of the Art Richter in U.S. Pat. No. 3,894,538 disclosed a device for dispensing medicines to man or beast. The medicine was contained in a flexible container which became compressed as fluid was electro-osmotically or electrolytically introduced into an adjacent flexible chamber. The rate of medicine discharge was regulated by using a potentiometer. Maget in U.S. Pat. No. 4,522,698 disclosed electrochemical prime movers. Embodiments of the invention include a device for dispensing pharmaceuticals to a human body over a substantial period of time at a sustained very low rate, where a battery provides the driving force to transport an electrochemically active gas from a precharged chamber to a second chamber through an ion-exchange membrane. Oxygen from air was disclosed as moving across an ion-exchange membrane to pressurize a chamber. Pressure in a chamber increases as electroactive gas transports across the membrane, this increase in pressure drives a piston which forces the contained pharmaceutical fluid to flow through an outlet. The invention requires electrodes which are electrically conductive and act as catalyst to convert molecules to ions; titanium-palladium alloy or palladium black are recommended materials. A controller is utilized to control the magnitude and time pattern of current and voltage applied to the membrane as well as to turn current on and off. To function, the invention requires either exposure to air or precharging with an electroactive gas. Maget in U.S. Pat. No. 4,886,514 disclosed electrochemically driven drug dispensers. A potential from an external power source drives an electrochemically active gas such as hydrogen or oxygen to be transported across a membrane from a fixed volume chamber to a chamber which has a variable volume. The volume of the chamber varies by either flexing am expansible diaphragm type wall or by displacing a sliding wall, said wall is shared by a second variable volume chamber which contains a fluid drug to be administered. As the electrochemically active gas is transported to the first variable volume chamber, the drug is forced out of the second variable volume chamber through an outlet. Countering the electrochemical transport of gas across the membrane, the gas diffuses in the opposite direction across the membrane in accordance to the pressure gradient and diffusivity properties of the membrane. A controller compensates for the gas diffusion rate and varies the voltage and current to achieve the desired drug delivery rate in a steady or intermittent mode. To function, the invention requires precharging with an electroactive gas. Maget et al. in U.S. Pat. No. 4,902,278 disclosed a fluid delivery micropump. The pump utilizes an air-actuated battery in a fixed closed circuit with an electrochemical cell which drives the transport of oxygen in air across a membrane. The transport applies external pressure to a collapsible reservoir filled with fluid, as a result, fluid is expelled from the reservoir through an outlet. The membrane is preferably a Nation material (a perfluoro sulfonic polymer) which has been coated with platinum black/10% Teflon. Electrodes are preferably titanium screens. To control the current, a resistor is utilized. The device is activated by removing a protective peel tab to expose air inlet ports to the battery cathode. A disadvantage of this type of system is that shelf life of the device is dependent on the integrity of the seals which prevent air leakage to the battery. If the seals are not perfect, the battery will slowly discharge before the desired time of use. To function, the invention requires exposure to air. The prior art includes several devices which are capable of performing the general function of the device presently disclosed; however, the prior art has not satisfied a demand which exists for a device which 1) has a design which can dispense a fluid over a nearly constant rate for an extended period of time, 2) has a simple design which is conducive to fabrication, 3) does not require exposure to air, fluid or the precharging of an electrochemically active gas to function, 4) does not utilize polymeric ion-exchange membranes which typically must remain hydrated to some degree to function and which are affected by humidity, which can cause changes in conductivity, gas flow and dispensing rates. SUMMARY OF THE INVENTION An invention is disclosed which provides a self-powered, low cost device which has a long shelf life and which dispenses a fluid at a slow, steady, predictable rate over an extended period of time. The fluid itself may have beneficial attributes or it may contain chemicals or nutrients which provide a benefit or which inhibit something undesirable to a system or living organism. The fluid can be delivered to a specific site through appropriate tubing and connections, or the fluid can be delivered to an external portion of the device where it is allowed to evaporate into a room, vehicle, container or other environment surrounding the dispenser. The dispenser may be embodied in a form intended to be stationary, sitting upon something or hung from something, or may be embodied in a form to be worn on a person or animal in the form of a pendant, a clothing attachment, a collar attachment for an animal, or in a form to be hung from a tree or other type of plant. A significant aspect of the invention is that some embodiments of the gas-generating electrochemical cell also act as a battery so that a separate power source is not required, in contrast to prior art devices. The present device is delivered to consumers in a disabled condition so that no drain on the battery or electroactive components occurs when the device is on the shelf, waiting to be used. Activation occurs when the consumer completes an electric circuit. This may be accomplished in various ways, for example, by snapping electronically conducting components of the device together or by removing a temporary insulator from between two electronic contacts. In addition, the user typically unseals the fluid sack outlet by removing a plug, or by cutting or by puncturing the sack. Thus, neither the power supply nor the fluid contents will be compromised before the device is to be utilized. A novel solid state electrochemical cell releases oxygen or nitrogen gas which is the working substance, i.e., pumping gas in the device. Released gas flows into a gas-tight chamber which encloses a flexible bladder containing the fluid to be dispensed. As gas is transported into a gas-tight chamber, the resulting increase in pressure compresses the bladder such that the fluid flows through an outlet to the desired destination or to a site on the dispenser where the fluid can evaporate or disperse. Oxygen is a suitable pressurizing gas and can be electrochemically released from a solid anode material of the general form A x O y . The value of x is 1 to 3 and y is 1 to 4. Nitrogen also may be a suitable pressurizing gas. It can be electrochemically released from a solid anode material of the general form A'.sub.α N 62 . The value of α is 1 to 3 and β is 1 to 3. In each of the above instances, an ion migrates across a suitable ion conducting electrolyte. The migrating ion may be, respectively, A ions or A' ions. A is a cation such as silver, copper and the like in a positive valence state, while A' is an alkali metal such as sodium, lithium and the like in a positive valence state. The migrating ion (cation) allows the anion (O -2 or N -3 ) to combine with a similar anion to form a gas (O 2 or N 2 ) concomitant with the release of electrons. At the cathode, several possibilities may occur, examples include ones in which the migrated cations are reduced to their elemental state, or where a solid material R 2 wherein R is a halogen is ionizable to R - , or solid material, R', where R' is a group VIB element reducible to R' -2 or where cathode material CR x is reduced to C+XR - . A typical CR x is a fluorocarbon such as a CF x which is readily available. In the above formulas, X and x are equivalent and have a value of about 0.8 to about 1.2. The driving force powering the device is either provided by the electrochemical reactions occurring during operation of the cell, or by a battery. The micropumps of the instant invention are characterized by a fluid dispensing chamber wherein the chamber has a fluid reservoir and a gas space. The gas space and fluid reservoir are separated by a flexible material, e.g., a membrane or a bladder, such that as the gas space expands due to incoming gas, the fluid reservoir is caused to shrink which causes fluid, generally liquid, to be discharged from a discharge port in the reservoir. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a plot of current density versus time of an Ag 2 O/S cell; FIG. 2 shows a plot of current versus time of an Ag 2 O/I 2 cell; FIG. 3 shows a plot of current versus time of two Li 3 N/I 2 cells; FIG. 4 shows a plot of current versus time of a Li 3 N/CF x cell; FIG. 5 is a perspective sectional view of a fluid dispensing micropump embodying features of the present invention; FIG. 6 shows a perspective sectional view of an embodiment of the invention which is a variation of what was shown in FIG. 1; FIG. 7 shows a perspective sectional view of an embodiment of the invention which features a battery integrated into the design; FIG. 8A schematically illustrates an electrochemical cell of the invention in a pre-discharged condition; FIG. 8B schematically illustrates a discharging cell; and FIG. 8C schematically illustrates a cell which does not require a discrete electrolyte member. DETAILED DESCRIPTION OF THE INVENTION The instant invention employs anode materials wherein an electrochemical decomposition occurs at the anode to release an anion such as O -2 or N -3 which, upon release of electrons, combine to form O 2 and N 2 gases which can be used for pressurizing purposes. The anode materials generally comprise a compound formed of a metal cation, typically monovalent, and a divalent or trivalent anion such as O -2 or N -3 . The cathode material is one which electrochemically reacts with the cation species from the anode material after its transport through an appropriate electrolyte. The electrolyte maybe solid, liquid or a solid dissolved in a liquid. If the electrolyte is not solid, a separator such as the microporous separators used in the battery industry may be used to prevent direct contact of the anode and cathode materials. If a separator is used, electrolyte is absorbed into the pores of the separator. Battery separators are typically a microporous sheet of polyolefin such as ethylene vinyl alcohol copolymers having a pore size less than 1.0 micron. The copolymer has a linear-type olefin portion with a vinyl alcohol content of between 20 and 90%. The alcohol portion may also be hydrolyzed. Other typical battery separators include those described in the patent literature such as cellophane with a grafted polymer U.S. Pat. No. 3,330,702; cellulosic material or paper coated with a resin U.S. Pat. Nos. 3,893,871 and 3,976,502; cellophane with a grafted copolymer U.S. Pat. No. 3,330,702; methacrylic acid-divinyl benzene copolymer U.S. Pat. No. 3,684,580; phenol-resorcinol-formaldehyde resin U.S. Pat. No. 3,475,355; and polyacrylamide U.S. Pat. No. 3,018,316. Several examples of a polyolefin-homo or copolymer film with fillers are U.S. Pat. Nos. 3,870,586; 3,955,014; 3,985,580; and U.S. Pat. No. 4,024,333. The use of polytetrofluoroethylene is described in U.S. Pat. No. 3,475,222 and U.S. Pat. No. 3,661,645, while other polyvinyl compositions are found in U.S. Pat Nos. 3,585,081; 3,766,106; 3,875,270 and 3,907,601. Silicone rubber-vinyl copolymer is still yet another example of a battery separator described in U.S. Pat. No. 3,585,081. The gas producing electrochemical cell is sealed from the external environment. Since no gaseous materials are involved in the cathode chamber, the cathode or cathode current collector need not be porous. A preferred cathode is one which is sealed from the environment and has a combination of properties such that unreacted cathode and reacted cathode materials have adequate ionic and/or electronic conductivity such that the voltage drop across the zone does not increase significantly relative to the rest of the cell as the cell discharges. Suitable cathodes are set forth in the following examples. In prior gas producing cells, it was typical for the cathode and anode chamber to contain an element common to each. For example, in Maget patent ('698), the cathode contained O 2 and the anode contained oxygen in combined form, H 2 O, to form an O 2 /H 2 O redox couple with a proton transported through an electrolyte so that the reaction on opposite sides of the electrolyte were the reverse of one another. The total redox energy involved is zero, however, because of internal cell resistance, electrode polarization, and differences in oxygen partial pressure, a battery (power source) had to be used in such cells. Also, in such a cell, a gas is present at both electrodes, thereby requiring porous electrodes. In the instant invention, many cells have completely different materials, i.e., no common elements, in the cathode and anode chambers. Thus, in many instances a net energy production (positive voltage) occurs so that the cell is self-powered. The device disclosed herein is particularly distinguished from the prior art in that the device can function while completely sealed from its external environment, excluding the outlet port through which the fluid will be dispensed, and without requiring an internal reservoir of gas to be pumped. Unlike the devices described in the prior art, an organic ion-exchange membrane is not utilized in this device, and since the device is sealed, this device is not sensitive to changes in ambient humidity. Also, the device does not rely on access to air or other gas to operate. Further, because the device is simply structured and is comprised of readily available, easily fabricated materials, it is disposable. The following examples illustrate different possibilities of the device where the anode and cathode couple, in effect, create a galvanic cell such that an additional battery is not required: EXAMPLE 1 An example of an oxygen releasing, solid, self-driving cell is one in which the active anode material is Ag 2 O and the active cathode material is solid I 2 or a combination solid I 2 and poly(2-vinylpyridene) (P2VP) or poly 2 vinylquinoline (P2VQ) which combine to form a material both electronically and ionically conductive. Several silver ion conductors are suitable as solid electrolytes for this application including Ag 4 RbI 5 , AgI/Al 2 O 3 and Ag-Nasicon; however the preferred electrolyte in this case is AgI which reactively forms at the interface between the anode (Ag 2 O) and cathode (I 2 ) layers. This electrolyte forms spontaneously as an interfacial reaction, requires no preparation, and conforms to any irregularities in the interface. The electrochemical reactions are: ______________________________________Anodic: Ag.sub.2 O → 2Ag.sup.+ + 1/2O.sub.2 + 2e.sup.-Cathodic: 2Ag.sup.+ + I.sub.2 + 2e.sup.- → 2AgIOverall: Ag.sub.2 O + I.sub.2 → 2AgI + 1/2O.sub.2______________________________________ Such a cell has a standard potential, E°, of 0.96 V; therefore, in this case, no battery or other applied voltage source is required to drive the process. Once the electrical circuit is completed between the cathode and the anode, electrons and ions begin to flow and the device is operable. Other materials which would release oxygen when properly coupled with I 2 include Na 2 O, K 2 O, Na 2 O 2 , Ag 2 O 2 , K 2 O 2 , Rb 2 O and Rb 2 O 2 . A cell of this type is schematically illustrated in FIG. 8. The cell remains dormant until an electron conductor is connected between the anode and cathode materials. EXAMPLE 2 Another example of an oxygen releasing, solid cell which is self-driving is one in which the anode material is Ag 2 O and the cathode material is solid S or a combination of solid S and Ag 2 S which together form a material both electronically and ionically conductive. A suitable electrolyte is Ag 4 RbI 5 . The electrochemical reactions are: ______________________________________Anodic: Ag.sub.2 O → 2Ag.sup.+ + 1/2O.sub.2 + 2e.sup.-Cathodic: 2Ag.sup.+ + S + 2e.sup.- → Ag.sub.2 SOverall: Ag.sub.2 O + S → Ag.sub.2 S + 1/2O.sub.2______________________________________ Such a cell has a standard potential, E°, of 0.16 V. Other materials which could be used in the place of S are Se and Te. EXAMPLE 3 An example of a nitrogen releasing, solid, self-driving cell is one in which the anode material is Li 3 N and the cathode material is solid I 2 or a combination of solid I 2 and poly(2-vinylpyridene) which combine to form a material both electronically and ionically conductive. Several lithium ion conductors are suitable as solid electrolytes for this application including LiI/Al 2 O 3 and Li-Nasicon; however, the preferred electrolyte in this case is LiI which forms at the interface between the anode and cathode layers. This electrolyte, similarly to AgI, forms spontaneously, requires no preparation, and conforms to any irregularities in the interface. The electrochemical reactions are: ______________________________________Anodic: Li.sub.3 N → 3Li.sup.+ + 1/2N.sub.2 + 3e.sup.-Cathodic: 3Li.sup.+ + 3/2I.sub.2 + 3e.sup.- → 3LiIOverall: Li.sub.3 N + 3/2I.sub.2 → 3LiI + 1/2N.sub.2______________________________________ Such a cell has a standard potential, E°, of 2.16 V; therefore, in this case, no battery or other applied voltage source is required to drive the process. Once the anode and cathode are electronically connected, the cell will begin to function. EXAMPLE 4 Another example of a nitrogen releasing, solid, self-driving cell is one in which the anode material is NaN 3 and the cathode material is solid I 2 or a combination of solid I 2 and poly(2-vinylpyridene) which combine to form a material both electronically and ionically conductive. Several sodium ion conductors are suitable as solid electrolytes for this application including NaI/Al 2 O 3 and Nasicon; however the preferred electrolyte in this case is NaI which forms at the interface between the anode and cathode layers. This electrolyte forms spontaneously, requires no preparation, and conforms to any irregularities in the interface. The electrochemical reactions are: ______________________________________Anodic: NaN.sub.3 → Na.sup.+ + 3/2N.sub.2 + e.sup.-Cathodic: Na.sup.+ + 1/2I.sub.2 + e.sup.- → 3LiIOverall: NaN.sub.3 + 1/2I.sub.2 → NaI + 1/2N.sub.2______________________________________ Such a cell has a standard potential, E°, of 4.05 V; therefore, in this case, no battery or other applied voltage source is required to drive the process. The following examples illustrate different possibilities of the device where the solid anode and cathode couple require an applied voltage to drive the gas releasing reaction, such an applied voltage can be provided by one or more batteries: EXAMPLE 5 Another example of a nitrogen releasing cell which is self driving is one in which the anode material is Li 3 N and the cathode material is polycarbon monofluoride of CF x (where x is 0.8 to 1.2). An example of such a material is a product of Allied Chemical under the trade name Accuflor™. A suitable electrolyte is a 1:1 mixture of ethylene glycol dimethyl ether and propylene carbonate containing 1M LiBF 4 . This electrolyte is used with a thin microporous separator comprised of polypropylene or polyolefin. Such a separator is electronically insulative but has high ion permeability. The cell is similar to the Li-CF x battery described in Modem Battery Technology by C. D. S. Tuck, pp. 337-348, except that in the case of this invention, the lithium anode is replaced by a lithium nitride anode so that gas is released electrochemically as the cell discharges. The electrochemical reactions are: ______________________________________Anodic: x Li.sub.3 N → 3x Li.sup.+ + x/2 N.sub.2 + 3x e.sup.-Cathodic: 3x Li.sup.+ + 3 CF.sub.x + 3x e.sup.- → 3x LiF + 3 COverall: x Li.sub.3 N + 3 CF.sub.x → 3x LiF + 3 C + x/2______________________________________ N.sub.2 Such a cell has a standard potential, E°, of approximately, 2.7 V; therefore, in this case, no battery or other applied voltage source is required. EXAMPLE 6 Another example of a oxygen releasing cell which is self driving is one in which the anode material is Ag 2 O and the cathode material is polycarbon monofluoride of CF x (where x is 0.8 to 1.2). An example of such a material is a product of Allied Chemical under the trade name Accuflor™. A suitable electrolyte is 1:1 mixture of ethylene glycol dimethyl ether and propylene carbonate containing 1M AgBF 4 . This electrolyte is used with a thin microporous separator comprised of polypropylene or polyolefin. EXAMPLE 7 Another example of a oxygen releasing cell which is self driving is one in which the anode material is a paste consisting of Ag 2 O silver nitrate and sodium hydroxide solution and the cathode material is a paste consisting of solid S, carbon, and silver nitrate, and where the anode and cathode are separated by a solid polymer electrolyte which has been exchanged with silver ion containing solution such as silver nitrate. EXAMPLE 8 An example of an oxygen releasing, solid cell which is not self-driving and which would require a battery or other applied voltage source is one in which the anode material is Cu 2 O and the cathode material is porous copper or graphite or carbon. Several copper ion conductors are suitable as solid electrolytes for this application including Rb 4 Cu 16 I 7 Cl 13 or Cu-Nasicon or a mixture of CuI and Al 2 O 3 . The electrochemical reactions are: ______________________________________Anodic: Cu.sub.2 O → 2Cu.sup.+ + 1/2O.sub.2 + 2e.sup.-Cathodic: 2Cu.sup.+ + 2e.sup.- → 2CuOverall: Cu.sub.2 O → 2Cu + 1/2O.sub.2______________________________________ Such a cell has a standard potential, E°, of -0.77 V. Other oxygen releasing solid couples include Cu 2 O/I 2 , Li 2 O/I 2 , Na 2 O/S, K 2 O 2 /S. Regardless of whether the cell is self-driven or driven with a battery or other applied voltage source, the rate of fluid dispensing is directly proportional to the rate of oxygen or nitrogen, in the above stated examples, released at the anode which is directly proportional to the electrical current. The electrical current required to dispense the fluid is very low, about 183 μA per ml fluid per day at standard conditions for the oxygen releasing cells mentioned above assuming no leakage occurs from the gas chamber. To determine actual fluid delivery at conditions other than standard for those cells, the following relationship can be used: ml actual per day=0.00349×Z×C×T/P; where: Z=Number of electrons which must pass though the device circuit per molecule of gas released. Typically Z=4 for O 2 release, Z=6 for N 2 release. C=Current in μA (microamps), T=Temperature in degrees K P=Pressure in Torr Many applications involving concentrated chemicals will require substantially less than 1 ml per day to be effective, thus total current flow in the range of five to 500 μA would be typical for this device although the device is not limited to this range. Such a current range would provide fluid delivery ranges from 0.03-2.7 ml per day. Thus, this device is effective when operating at low current densities. If a self-driven cell is selected, resistors and controllers to restrict or otherwise control current flow may be utilized or may be avoided by adjusting cement density through cell design. Without complicating the present device, several strategies can be taken to make adjustments in construction such that the desired substance dispensing rate is achieved. Some strategies relate to adjustments which would affect the current density and hence the rate of fluid flow. The area of the electrolyte surface can be predetermined or the thickness of the electrolyte may be varied in a particular cell to give a desired gas discharge rate and consequently a desired fluid flow. The rate of cell discharge can be increased by adding constituents to the anode which would improve the electronic and ionic conductivity. For example, the addition of Ag 2 S and/or RbAg 4 I 5 to the anode has been found to dramatically improve cell discharge rates. A combination of 20% by weight of each was very effective. Other concentrations are also effective. Addition of electrolytes dissolved in non-aqueous electrolytes to either anode or cathode have similar effects and help prevent polarization. The addition to the anode of a small amount of oxygen evolution catalyst such as 0.5% RuO2 or IrO2 can increase the discharge rate by an order of magnitude. Larger and smaller amounts of these oxides also may be effectively used. Further advantages of the invention will become apparent from the drawings and more detailed description below. FIG. 1 shows a plot of current density versus time of a Ag 2 O/S cell. Finely divided AgI (40%) and high surface area Al 2 O 3 (60% by weight) were heated to 500° C. to form a very ionically conductive electrolyte. A small amount of this electrolyte was pressed to form a thin membrane in a 0.625" diameter die. An anode mixture of Ag 2 O powder, graphite powder, and AgI+Al 2 O 3 electrolyte was added to one side of the membrane, a cathode mixture of sulfur powder, graphite powder, and AgI+Al 2 O 3 electrolyte was added to the other side of the membrane. The entire cell was pressed into a three layer pellet at a pressure of 78,000 psi. A perforated stainless steel plate was used for the anode contact and an un-perforated stainless steel plate was used for the cathode contact. Total height of the cell was about 0.25 inches. The cell circuit was completed by contacting an electronic resistor to the anode and cathode contacts. A resistor of approximately 10000 ohms was used in the circuit. FIG. 2 shows a plot of current versus time of a Ag 2 O/I 2 cell where the anode was approximately 60% Ag 2 O, 20% Ag 2 S, 20% Ag 4 RbI 5 and 0.5% RuO 2 while the cathode was 6.7% P2VP with the balance consisting of I 2 . Percents stated are percents by weight. The cathode mixture was heated slightly to form a semi-plastic paste. First the anode mixture was pressed in a 0.75" diameter die at about 20,000 psi. The electrolyte between the anode and cathode was AgI which formed in situ when the anode and cathode were pressed together. The reaction continues until a continuous, impervious layer of AgI is formed, which sets as a separator between the reactive materials. A perforated stainless steel plate was used for the anode contact and an unperforated stainless steel plate was used for the cathode contact. Total height of the cell was about 0.2". The cell circuit was completed by contacting an electronic resistor to the anode and cathode contacts. Resistors of 10000 ohms, 5000 ohms and 1000 ohms were used in the circuit. FIG. 3 shows a plot of current versus time of two Li 3 N/I 2 cells. In the first cell approximately 33% graphite powder was mixed with a balance of Li 3 N. Some of this mixture was pressed in a 0.75" diameter die at approximately 20,000 psi. A cathode mixture of 5% P2VP with balance I 2 was mixed in a ball mill with alumina balls overnight. This cathode mixture was not heated. Some of this mixture was pressed onto the cathode. A continuous, thin LiI electrolyte layer formed in situ between the anode and cathode when they were pressed together. A perforated stainless steel plate was used for the anode contact and an unperforated stainless steel plate was used for the cathode contact. Total height of the cell was about 0.2". The cell circuit was completed by contacting an electronic resistor of 16,200 ohms to the anode and cathode contacts. In a second Li 3 N/I 2 cell, approximately 33% graphite powder was mixed with a balance of Li 3 N powder. Some of this mixture was pressed in a 0.75" diameter die at approximately 20,000 psi. Next a layer of Li 3 N powder without graphite was pressed onto the previous layer. On this layer was pressed a cathode mixture of 5% P2VP with balance I 2 which had been mixed in a ball mill with alumina balls overnight. A thin, continuous LiI electrolyte layer formed spontaneously in situ between the anode and cathode when they were pressed together. Again, a perforated stainless steel plate was used for the anode contact and an un-perforated stainless steel plate was used for the cathode contact. Total height of the cell was about 0.2". The cell circuit was completed by contacting an electronic resistor of 10000 ohms to the anode and cathode contacts. FIG. 4 illustrates the current versus time characteristics for a Li 3 N--CF x all in which the anode material was a mixture of 75 wt % lithium nitride (Li 3 N, Aldrich, Milwaukee, Wis,) and 25 wt % carbon black (Vulcan). To prepare anode material, powders of Li3N and carbon were dry mixed in a ball mill under N 2 atmosphere, and then passed through a sieve with a mesh size of 200 microns before pressing into anode pellet (15 mm dia.×3 mm thick). Cathode material was a mixture of 77 wt % carbon monofluoride (CF x , x between 0.8 to 1.2, Allied Signal Chemicals, Morristown, N.J.), 13 wt % carbon black (Vulcan), and 10 wt % poly-tetrafluoroethylene (PTFE, Aldrich, Milwaukee, Wis.). For preparing the cathode material, powders of CFx, PTFE and carbon were slurried in an isopropanol solution. The slurry was well mixed, heated at 90° C. to coagulate PTFE, and then dried at 100° C. and passed through a sieve with a mesh size of 200 microns before pressing into a cathode pellet (15 mm dia.×5 mm thick). Liquid electrolyte was 1M lithium fluoroborate (LiBF 4 , Fluka, Buchs, Switzerland) dissolved in a 1:1 mixture of ethylene glycol dimethyl ether (Aldrich, Milwaukee, Wis.) and propylene carbonate (Aldrich, Milwaukee, Wis.). Separator material was a hydrophobic microporous polyolefin membrane (Pall RAI Manufacturing Company, Hauppauge, N.Y.). Nickel mesh was used as current collectors. For purposes of illustration of the present invention, an embodiment of the solid electrolyte fluid dispensing micropump is shown in FIG. 5. Pump housing 1 is fabricated of a chemically resistant and electronically conductive material such as 304 or 316 stainless steel. Gas passages 3 or holes are perforated through the pump housing 1. Anode material 2 is pressed into the pump housing 1. Anode material 2 is comprised of an oxidized compound of the general formula A x O y such as Ag 2 O or a nitride compound of the general formula A'.sub.α N.sub.β combined with other constituents which improve electronic and ionic conductivity and which are electrocatalysts. On top of said anode material, solid electrolyte material 4 is pressed or otherwise forms spontaneously when anode and cathode materials are contacted as indicated hereinabove. The composition of said solid electrolyte material is selected based on the cation A or A' which is to be conducted. For example, AgI mixed with Al 2 O 3 or Ag 4 RbI 5 or Ag-Nasicon could be selected to conduct Ag +1 cations, or AgI, an Ag + conductor will form spontaneously when Ag 2 O is contacted with I 2 to form an electrolytic interface. Cathode material 5 comprised of solid halogen material such as I 2 mixed with poly(2-vinylpyridene), or S mixed with Ag 2 S and Ag 4 RbI 5 , is pressed into the cathode cap 14 which is an electronic conductor such as 304 or 316SS. A spacer 6 comprised of an electrically insulating material separates the cathode material 5 and cathode cap from the pump housing 1. The cathode cap 14 and the spacer 6 are crimped by the pump housing 1 to form a seal. The gas shell 7 is attached to the pump housing 1. The gas chamber 8 is bounded by the gas shell 7 and the pump housing 1. Within said gas chamber is a fluid sack 9 which contains the fluid to be dispersed 10. Said fluid sack is made of a flexible material, such as Barex or ethylene vinyl alcohol film, which has adequate corrosion properties for said fluid. Said fluid sack has an outlet 11 which passes through said gas shell and is sealed thereto. The fluid sack is preferably a polymeric, filmy, material impervious to both the pressurizing gas molecules and the fluid material. The fluid sack outlet 11 may be very simple or may have a fitting for the attachment of tubing, or may have an attachment suitable for promoting evaporation of the fluid into the surrounding air. Said fluid sack be may sealed from the external environment before the time of activation with a plug 12, clip or other means, or may have a sealed portion which protrudes through said outlet which is cut off or punctured by the user at the time of activation. Contact clip 13 fabricated of an electronic conductor completes the electrical circuit between said anode contact and said cathode contact after activation by the user. At the time of activation, cations migrate from said anode material to said cathode material to form compound AR, AR x/2y or A'R.sub.α/3β which remain with cathode material 5. Gas is released from anode material 2, passes through gas passages 3, and enters gas chamber 8. As gas enters said gas chamber, the pressure increases, forcing fluid 10 to be dispensed from fluid sack 9. The thickness of said electrolyte and the cross-sectional area of the active electrochemical cell formed by this device are selected so that the desired fluid dispensing rate is achieved. Optionally, an electronic resistor (not shown) may be placed between the contact clip 13 and cathode cap 14 to modulate the current and dispensing rate to a lower level if desired. FIG. 6 shows a perspective sectional view of an embodiment of the invention which is a variation of what was shown in FIG. 1. Those features similar to features in FIG. 1 are similarly numbered. In this embodiment, contact clip 17 is stationary. The device is activated by the user by pressing on tab 18 which inverts to make contact with cathode 5. Another feature variation is shown in this embodiment; a fluid sack 9 is sealed at the outlet 19. At the time of activation, the user cuts or punctures said outlet so that the fluid 10 contained can be dispensed as the device operates. FIG. 7 shows a perspective sectional view of an embodiment of the invention which features a battery integrated into the design. Those features similar to features in FIGS. 1 and 2 are similarly numbered. Pump housing 22 is fabricated of a chemically resistant and electronically conductive material. Into said pump housing is pressed anode material 2 comprised of a chemically inert, electronically conductive material such as graphite or carbon fibers mixed with an oxidized compound of the general formula, A x O y or A'.sub.αN 62 such as Cu 2 O. A solid electrolyte material 4 is pressed onto the anode material 2. The composition of said solid electrolyte material is selected based on the cation A or A' which is to be conducted. For example, Rb 4 Cu 16 I 7 Cl 13 , CuI mixed with Al 2 O 3 , or Cu-Nasicon could be selected to conduct Cu +1 cations. Cathode material 20, comprised of an electronic conductor such as graphite fiber or copper or reducible material such as I 2 or S mixed with an electronic conductor and ionic conductor, is pressed against solid electrolyte 4. A spacer 27 comprised of an electrical insulator prevents contact between the cathode 20 and the pump housing 22. Said pump housing also encloses a button cell 21, such as a silver oxide or alkaline cell, which are readily available commercial cells. The negative pole of said button cell contacts the cathode 20. Spacer 28 comprised of an electrical insulator prevents contact between the button cell 21 and the pump housing 22. The cathode cap 14 and the spacer 28 are crimped by the pump housing 22 to form a seal. Optionally, spacer 27 and spacer 28 may be integrated into one pan. The contact clip 23 completes the circuit after an electronic insulating pull tab 24 is removed by the user at the time of activation. Fluid to be dispensed 10 is contained between a flexible diaphragm 25 and outer shell 26. The gas chamber 8 into which gas is electrochemically introduced is bounded by the diaphragm 8, the gas shell 7, and the pump housing 22. FIGS. 8A, 8B and 8C are schematics of general examples of the electrochemical portion of the device, where the cathode includes a reducible material. The figures include regions Z1, Z2, Z'2, Z3, Z'4, Z4, Z5 interfaces Z1/Z2, Z2/Z'2, Z'2/Z3, Z3/Z'4, Z'4/Z4, Z4/Z5. FIG. 8A represents a pre-discharged cell. FIG. 8B represents a discharging cell. FIG. 8C represents a cell which does not require an electrolyte in addition to the anode and cathode since the reaction product formed serves the function of the electrolyte. Z1 is the anode current collector and must be an electronic conductor, preferably porous. It may also have a porous inner layer and a nonporous outer layer with a single port or multiple ports to allow escape of released oxygen or nitrogen gas at particular locations. Z1 material must be non-reactive with material Z2 and the oxygen or nitrogen which will be released. Z2 is the anode and must include the gas releasing compound, either A x O y or A'.sub.α N 62 , and must be an ionic conductor or a mixed conductor. If A x O y or A'.sub.α N.sub.β are ionically conductive and have low electronic conductivity, then material Z2 may consist entirely of those compounds and may be non-porous; in this case, oxidation will occur at the Z1/Z2 interface, A or A' ions will migrate through layers Z2 and Z3 through the Z2/Z3 and Z3/Z4 interfaces. When this occurs, the thickness of the Z2 layer decreases and it is desirable to have the entire assembly in compression to maintain contact. This may be achieved through utilization of one or more springs. If A x O y or A'.sub.α N.sub.β are not ionic conductors, a material which has lower tendency to oxidize relative to A x O y or A'.sub.α N.sub.β but which is ionically conductive must be added to material Z2, in addition, an electronic conductor must be added, usually, the electronic conductivity will be higher than the ionic conductivity which results in initial oxidation at the Z2/Z3 interface. As oxidation of A x O y or A'.sub.α N.sub.β occurs, a zone Z' is formed where A x O y or A'.sub.α N.sub.β has been consumed but includes the ionic and electronic conducting materials which had been added to material Z2. Oxidation continues at the Z2/Z'2 interface as electrons are conducted through Z2 and cations are conducted through Z'2. Oxygen or nitrogen permeates through Z2 and Z1, thus layer Z2 must be porous enough to allow this permeation. Permeation can also be enhanced if necessary by providing small channels in the Z2 material. Z5 the cathode current collector and is a non-porous electronic conductor which is non reactive with material Z4. Z4 is the cathode and includes a reducible material. It must either be an anionic conductor, or mixed conductor. Electrons are provided at the Z5/Z4 interface which ultimately reduce the material in Z4 to anions. Usually, electrons are conducted through Z4, initially anions are formed at the Z3/Z4 interface where cations and anions form a reaction product and create a new layer Z'4. Subsequently, anions may be formed at the Z4/Z'4 interface. Z'4 material must be either conductive to cations so that reaction product forms at the Z4/Z'4 interface, otherwise Z'4 must be conductive to anions so that reaction product forms at the Z3/Z'4 interface. Z3 is the electrolyte, a layer which is conductive to either cations or anions but which is an electronic insulator. This layer is necessary if both Z2, Z2' (if formed), Z4', and Z4 are all electronic conductors. If any one of those layers is electronically insulating, then layer Z3 is unnecessary since the insulating layer functions as an electrolyte. An electrolyte referred to herein above as Ag-Nasicon, Li-Nasicon or other Nasicon material is a metal super ion conductor, and has the general formula Me.sub.(1+x) Zr 2 Si x P.sub.(3-x) O 12 wherein Me is a metal such as silver, lithium, sodium, copper and the like. The sodium ion version is referred to as Nasicon, which was the earliest material developed. Other cation conductors are referred to as Li-Nasicon, Ag-Nasicon, etc. These metals are monovalent cations in ionic form. Such electrolytes are solid, ceramic-type materials which are well known cation (positive metal ions) conductors, having been used in sodium-sulfur batteries and similar electrochemical cells in which transport of a metal ion from an anode chamber to cathode chamber was desired. In the above-stated formula, the value of x is equal to or less than 3 and equal to or greater than 0. A typical value for x is 2. The various Nasicon-type materials used in the instant examples had a value for x of about 2. Although the instant invention is illustrated with a fluid dispensing portion consisting of a flexible membrane or flexible sack, it is to be understood that the invention may include pistons, bellows or other components which may be moved by a pressurized gas to dispense fluids, typically liquids, from a dispenser to the external environment.

A self-contained device which continuously dispenses a packaged fluid is disclosed. The device is particularly suited for applications where several months may lapse before performance is manually initiated, after which a consistent steady flow is required for an extended period until the packaged fluid is exhausted. The device is particularly suited for applications where ease of fabrication is important. The device utilizes an electrochemicalIy-generated gas, such as oxygen or nitrogen, to pressurize the packaged fluid to dispense it. Oxygen can be electrochemically released from a solid anode material of the general form AxOy as A ions migrate across a suitable ion-conducting electrolyte. Alternatively, nitrogen can be the pressurizing gas wherein it is electrochemically released from a solid, anode material of the general form A'.sub.α N.sub.β where A' is a cation, as A' ions migrate across a suitable ion-conducting electrolyte. At the cathode, several possibilities may occur, either the migrated cations are reduced to their elemental state, or a solid material, R 2 , where R is a halogen, is reduced to R - , or solid material, R', where R' is a group VIB element other than oxygen is reduced to R' -2 , or solid material CR x , is reduced to C+XR - . The released gas, oxygen or nitrogen, pressurizes a chamber resulting in fluid contained in a flexible bladder within the chamber to be forced through an outlet. Depending on the selection of anode and cathode materials, the device will be self driven or else will require a battery to provide a driving force.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a new and improved exercise and therapy device and method of using it. More particularly, the present invention relates to a device which enables a selective therapeutic exercise regimen by providing a selective tension controlling mechanism attached to a rotatable dish-shaped exercise and therapy platform that will react to the operator's shifting of weight. 2. Description of the Related Art Today's modern occupations are primarily sedentary and non-physical in nature. Time constraints require more home or office based exercise devices and because of increased urbanization, space requirements for an exercise apparatus are often limited. In addition, therapy of joint related injuries may require time consuming and expensive visits to facilities which maintain complex equipment for exercising and rehabilitation of various parts of the body. The physical benefits of compact rotational exercise and therapy devices designed for individual use in the home or office are well known. Examples of different types and kinds of arrangements and techniques for utilizing exercise and therapy devices are disclosed in U.S. Pat. Nos. 5,879,276, 5,813,958, 5,683,337, 5,582,567 and 5,399,140. In general, the structure and function of most rotational exercise and therapy devices involve platforms having either horizontal rotation about an axis or vertical rotation about an axis. A limited number of exercise and therapy devices provide some restricted and limited horizontal and vertical rotation. Some of the rotational exercise and therapy devices require motorization and others provide for adjustable resistance mechanisms. Rotational exercise and therapy devices providing for limited horizontal and vertical rotation are known in the prior art. Such a device is described in U.S. Pat. No. 5,879,276. The operator causes movement through jumping and twisting movements. These jumping and twisting movements may exacerbate a pre-existing condition in joint injuries undergoing a therapeutic regimen on such a device. Additionally, in order for the operator to benefit from continuous movement, the entire platform spins 360°. The spinning motion could result in disorientation of the operator and loss of balance critical to safe operation of a rotational exercise and therapy device. If used by the operator, the hand rail provided for safety in such a case would cause the operator to have to stop the rotation of the platform in one direction and cause it to move in the opposite direction through jumping and twisting movements, again unsuitable for certain joint injuries undergoing rehabilitative therapy. There is no mechanism provided for this device which would allow for tension control of the rotating platform. Such tension control would provide for selective resistance applied to the platform and would be useful for exercising different muscle groups. Therefore, it would be highly desirable to have a new and improved device and method for making same for rotational exercise and therapy which would allow continuous movement of a platform in horizontal and vertical rotation, which includes a safety hand rail, which would respond to slight changes in the operator's center of gravity, and which would also allow for selective resistance to free movement. The device described in U.S. Pat. No. 5,813,958 addresses the problem of irritation of an existing injury due to jumping as described in the previous invention by providing a motorized platform supported on a universal joint which provides for limited horizontal and vertical rotation. This device provides for no adjustment or control by the operator during the exercise and limits the requirements of the body for spontaneous adjustments in balance and muscular contractions which are part of injury therapy and exercise. In addition, the motorized mechanism and universal joint would make the device very expensive to own and operate. It would require skilled maintenance and would be unaffordable for many people requiring therapy and those wishing to have a versatile low cost exercise device. Again, this device does nothing to address the problem of an adjustable tension mechanism for restricting free movement and selectively exercising certain muscle groups. Therefore, it would be highly desirable to have a new and improved device and method for making same for rotational exercise and therapy which would be inexpensive to manufacture, respond to slight changes in the operator's center of gravity and which would also allow for selective resistance to free movement. U.S. Pat. No. 5,683,337 describes a device that addresses the problem of tension control. However, the device has a platform that rotates horizontally and not vertically, so that the operator cannot achieve maximum therapy for selected joint musculature. In addition, the platform must be stopped in its rotation and started again in the opposite direction instead of requiring the operator to make spontaneous adjustments in balance and muscular contractions which are part of injury rehabilitation therapy and exercise. The device also lacks a safety hand rail to provide needed support for operators undergoing injury therapy. A safety hand rail makes further injury much less likely. Therefore, it would be highly desirable to have a new and improved device and method for rotational exercise and therapy which would allow continuous movement of a platform in horizontal and vertical rotation in conjunction with a safety hand rail which would respond to slight changes in the operator's center of gravity. U.S. Pat. No. 5,582,567 describes a device that has a platform that provides vertical rotation from side to side but does not provide for horizontal rotation. The device does provide safety hand rails. However, this inventive apparatus does not provide tension control. Therefore, it would be highly desirable to have a new and improved device and method for making same for rotational exercise and therapy which would allow continuous movement of a platform in horizontal and vertical rotation, respond to slight changes in the operator's center of gravity, and allow for selective resistance to free movement. Finally, U.S. Pat. No. 5,399,140 provides for a platform that does have limited vertical and horizontal rotation but has no tension control mechanism or support bars. In addition, the device is mechanically complicated with many parts which could require frequent repair or mandate numerous adjustments. Therefore, it would be highly desirable to have a new and improved device and method for making same for rotational exercise and therapy which is inexpensive to manufacture and maintain, which includes a safety hand rail, and which would also allow for selective resistance to free movement when reacting to weight shifts by an operator undergoing exercise or rehabilitative therapy for an injury. SUMMARY OF THE INVENTION Therefore, the principal object of the present invention is to provide a new and improved device and method for making same, for rotational exercise and therapy which would allow continuous movement of a rotatable dish-shaped exercise and therapy platform in horizontal and vertical rotation. This continuous movement in a horizontal and vertical rotation provides a continuous change in the angle of joints at the ankles, subtarsal joints, knee joints and hip joints. Associated with changes in these joint angles will be muscular contractions around these joints for stability, balance and change of direction. Muscular involvement is also necessary for stabilization of the vertebral column, particularly the lumbar spine. It is a further object of the present invention to provide such a new and improved device and method for making same, for rotational exercise and therapy, with a safety hand rail. The safety hand rail would aid in balance for those whose injuries or other medical conditions might cause the operator to lose balance during the performance of therapy and exercise routines. The primary purpose of the safety hand rail is to assist the operator in maintaining a vertical position of the pelvis, torso and head, as the lower extremity moves with the dish-shaped rotatable platform. It is a further object of the present invention to provide such a new and improved device and method for making same, for rotational exercise and therapy, which would respond to slight changes in the operator's center of gravity. As the operator shifts weight while operating the novel exercise and therapy device, in order for the muscular contractions to occur, the mechano-receptors of the joints, the muscles and tendons must signal the muscular system to contract through the central nervous system. The inventive instant device reacts to these shifts in weight and center of gravity and allows for greatly improved exercise and therapy regimens. It is yet a further object of the present invention to provide such a new and improved device and method for making same, for rotational exercise and therapy, which would also allow for selective resistance to free movement of the dish-shaped platform by providing a tensioning mechanism. Because of the varying degrees of difficulty that the device enables, there is a wide range of applications including but not limited to rehabilitation of ankle injuries, knee injuries and hip injuries which includes strengthening and proprioception, strengthening of lower back and hip muscles, balance training for the elderly, neuromuscular re-education for the lower extremity, sport specific training for snowboarding, surfing, skiing and other sports, and cardiovascular conditioning. It is yet a further object of the present invention to provide such a new and improved device and method for making same, for rotational exercise and therapy, which would be inexpensive to manufacture and maintain. The design of the device provides a simple, yet effective means by which to provide rotational exercise and therapy without complex motorization or mechanization. Since the present invention lacks complex mechanisms and motorization and is considerably less expensive to manufacture, the initial cost to procure this device is relatively low, and repairs to the device are inexpensive and required much less frequently. Briefly, the above and further objects of the present invention are realized by providing a new and improved exercise and therapy device and method of making it. More particularly, the present invention relates to a device which enables a selective therapeutic exercise regimen by providing a tensioning mechanism attached to a horizontally and vertically rotatable dish-shaped exercise and therapy platform, provided with a safety hand rail to aid in maintaining balance and a vertical posture for the operator. The rotatable dish-shaped exercise and therapy platform will react to changes in the operator's weight shifts and center of gravity placed upon it. When this novel multi-rotational aspect of the rotatable dish exercise and therapy platform responds to subtle changes in the operator's center of gravity, movement of the dish-shaped platform will occur. These changes trigger muscular contractions around the joints of the operator responding to the rotation of the platform while the tensioning mechanism allows for selective resistance to the free movement of the platform enabling exercise and therapy routines for various muscle groups. BRIEF DESCRIPTION OF THE DRAWINGS The above mentioned and other objects and features of this invention and the manner of attaining them will become apparent, and the invention itself will be best understood by reference to the following description of the embodiment of the invention in conjunction with the accompanying drawings, wherein: FIG. 1 is a perspective view of the novel exercise and therapy device constructed in accordance with the present invention; FIG. 2 is a perspective view of the novel exercise and therapy device according to the present invention, with the removable stationary step platform removed; FIG. 3 is an exploded perspective view of an exercise and therapy device according to the present invention showing the separate elements of the device; FIG. 4 is a side elevational view of the novel exercise and therapy device according to the present invention, with the removable stationary step platform removed; FIG. 5 is a front elevational view of the novel exercise and therapy device according to the present invention; FIG. 6 is a front elevational view of the novel exercise and therapy device according to the present invention, with the removable stationary step platform in place; FIG. 7 is a close up side elevational view of one embodiment of the lower tensioning cable attachment to the bottom of the lower curved surface of the rotatable dish exercise and therapy platform, according to the present invention; and FIG. 8 is a close up side elevational view of another embodiment of the lower tensioning cable attachment to the bottom of the lower curved surface of the rotatable dish exercise and therapy platform according to the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings, and more particularly to FIG. 1 thereof, there is shown a new exercise and therapy device 10 which is constructed in accordance with the present invention. The new exercise and therapy device 10 is used to efficiently, effectively and economically provide exercise and therapy by providing selective exercise regimens to various muscle groups. Referring to FIG. 1, the novel exercise and therapy device 10 is composed of four primary components. The first being the rotatable portion of the unit which includes the dish exercise and therapy platform 12 which has an upper flat surface 14 for receiving an operator and a lower curved surface 16 which is in frictional contact with a roller array or system, for example, a plurality of ball bearings, here only one of which is shown, ball bearing 22 . Preferably three or more roller means or ball bearings are used to construct the device. The second component of the novel exercise and therapy device 10 is the ball bearing housing base support portion comprised of a plurality of ball bearing housings, only one of which is shown here, ball bearing housing 32 . An equal number of ball bearing housings must be used, therefore preferably three or more. A bearing support frame 40 , is supported by and held above the supportive base 52 by base support blocks, only two of which are shown (partially visible), base support blocks 42 and 44 . The third component of the novel exercise and therapy device 10 is the tensioning mechanism 50 comprised of an upper coated tensioning cable 62 , held close to a hand rail 76 by one or more cable retaining straps 66 , an upper tensioning cable retaining bracket 68 , notched tensioning adjustment mechanism 72 , and tensioning adjustment mechanism handle 74 . Other parts of the tensioning mechanism 50 are better illustrated in FIGS. 2 and 3 below. The fourth component is the safety feature of the novel exercise and therapy device 10 is comprised of the hand rail 76 , and the removable stationary step platform 82 . Turning now to FIG. 2 to illustrate the novel exercise and therapy device 10 and especially to show the tensioning mechanism 50 in greater detail, the removable stationary step 82 , as shown in FIG. 1, has been removed. Now visible are a bare tensioning cable 54 , tensioning spring 56 , and lower tensioning cable retaining bracket 58 . The upper coated tensioning cable 62 is directly attached to the lower bare tensioning cable 54 and tensioning spring 56 as its bare cable portion passes through the lower tensioning retaining bracket 58 (the plastic coating stops at the lower bracket 58 ). Also exposed by the removal of the stationary step platform 82 , is another ball bearing housing 34 and associated ball bearing 24 in direct contact with the lower curved surface 16 of the rotatable dish-shaped platform 12 . Referring now to FIG. 3, this exploded view of the novel exercise and therapy device 10 better illustrates all of the elemental parts of the four primary construction components. The first being the rotatable portion of the unit which includes the dish exercise and therapy platform 12 which has an upper flat surface 14 for receiving an operator and a lower curved surface 16 which is in frictional contact with a plurality of ball bearings 22 , 24 , 26 and 28 (spaced apart) preferably three or more. The second component of the novel exercise and therapy device 10 is the ball bearing housing base support portion comprised of a plurality of ball bearing housings 32 , 34 , 36 and 38 (spaced apart) preferably three or more, a bearing support frame 40 , base support blocks 42 , 44 , 48 and 46 and a base 52 . The third component of the novel exercise and therapy device 10 is the tensioning mechanism 50 comprised of a bare tensioning cable 54 , tensioning spring 56 , lower tensioning cable retaining bracket 58 , coated tensioning cable 62 , pulley 64 , cable retaining straps 66 , upper tensioning cable retaining bracket 68 , notched tensioning adjustment mechanism 72 , and tensioning adjustment mechanism handle 74 . The fourth component is the safety feature of the novel exercise and therapy device 10 which is comprised of the hand rail 76 , the handrail screws 78 for affixing the hand rail 76 to the supportive base 52 , and the removable stationary step platform 82 . Considering now the novel exercise and therapy device 10 in greater detail with reference to FIG. 3, the components making up the rotatable portion of the exercise and therapy device 10 are simply and readily manufactured and assembled. The dish exercise and therapy platform 12 having a flat upper surface 14 to receive an operator. This flat upper surface 14 can be coated or roughened to enable better gripping and non-skid operation. The rotatable dish exercise and therapy platform 12 also has a lower curved surface 16 which is in frictional contact with a plurality of ball bearings 22 , 24 , 26 and 28 (spaced apart) preferably three or more. The second primary component of the new exercise and therapy device 10 is the base support. The plurality of ball bearings 22 , 24 , 26 and 28 (spaced apart) preferably three or more are each housed within ball bearing housings 32 , 34 , 36 and 38 which are fixedly attached by a variety of means (including screws and adhesives) to the bearing support frame 40 . The bearing support frame 40 is fixedly attached to a plurality of base support blocks 42 , 44 , 46 , 48 preferably four or more in number which are permanently afixed to the base 52 by a variety of means (including screws and adhesives). The third primary component of the new exercise and therapy device 10 is the unique tensioning mechanism 50 . The distal end of the bare tensioning cable 54 is attached to the lower surface of the rotatable dish exercise and therapy platform 16 (explained in greater detail below, see FIGS. 7 and 8 ), and runs through a pulley 64 which is afixed to the base 52 of the new exercise and therapy device 10 , but also the pulley 64 is allowed to swivel about its central axis. The proximal end of the bare tensioning cable 54 is attached to one end of a tensioning spring 56 . The other end of the tensioning spring 56 is attached to the bare portion of a coated tensioning cable 62 by passing that bare portion of cable through the lower tensioning cable retaining bracket 58 . The coated tensioning cable 62 is supported on the hand rail 76 by cable retaining straps 66 and the distal end of the coated tensioning cable 62 is attached to a notched tensioning adjustment mechanism 72 through an upper tensioning cable retaining bracket 68 which is attached to the middle of the upper portion of the safety hand rail 76 . The tension on the coated tensioning cable 62 is adjusted by means of a tensioning adjustment mechanism handle 74 . When the tensioning adjustment mechanism handle 74 is placed in the notch to the furthest away from the upper tensioning cable retaining bracket 68 , the greatest amount of tension is placed upon the dish 12 at the distal end of the unique tensioning mechanism 50 and the rotatable dish exercise and therapy platform 12 is virtually set motionless at this setting allowing the operator to safely move onto and off of the removable stationary step platform 82 as well as onto and off of the rotatable exercise and therapy platform 12 . Referring now to FIG. 4, a side view is illustrated and, as in FIG. 2 above, the removable stationary step platform is taken away to better show detail. Also, in this figure, an embodiment of the exercise and therapy device 10 having only three ball bearings within three ball bearing housings is shown, whereas all prior figures have shown four. Ball bearings 102 , 104 , and 106 are set within ball bearing housings 112 , 114 , and 116 . These are fixedly attached to the ball bearing housing support frame 140 which in turn is set upon supportive base 52 using three or more support blocks, here only base support blocks 142 and 144 are shown. These base support blocks 142 and 144 hold the bearing support frame 140 above the upper flat surface of the supportive base 52 . The bearing support frame 140 being elevated in this way, enables the bare lower tensioning cable (not shown) to be attached to the lower curved surface 16 of the exercise and therapy dish platform 12 , and run over to the lower tensioning cable retaining bracket 58 in an unobstructed fashion. This is essential to the proper functioning of the tensioning mechanism 50 . Referring now to FIG. 5 and FIG. 6, the fourth primary component of the novel exercise and therapy device 10 is the safety feature which includes the safety hand rail 76 which is afixed to the base 52 by means of the hand rail screws 78 (not shown, but see FIG. 3 ). Other suitable means may also be used for affixing the hand rail 76 to the base 52 . The safety hand rail 76 provides a means by which the operator may maintain balance during the process of moving from the removable stationary step platform 82 to the rotatable dish and therapy platform 12 and during the exercise and therapy regimen which begins after the tensioning adjustment mechanism handle 74 is adjusted to the desired tension setting. The safety hand rail 76 also serves to support the coated tensioning cable 62 which is attached to the hand rail 76 by a plurality of cable retaining straps 66 . It is also contemplated that another embodiment of the exercise and therapy device, as described herein, may have the tensioning cable run inside of the hand rail, in which case the safety hand rail would be constructed of rigid hollow tubing. In this way, the tensioning cable would be out of sight, and out of the way of the operator. The safety hand rail 76 further serves the purpose of providing a base for mounting the notched tensioning adjustment mechanism 72 and the tensioning adjustment mechanism handle 74 in such a position as to provide convenient accessibility to the operator during use of the exercise and therapy device 10 . Another element of safety is provided by use of the removable stationary step platform 82 , here shown in place on the apparatus in FIG. 6 and removed to show greater detail in FIG. 5 . Having a firm stationary platform 82 to mount and dismount from the rotatable dish exercise and therapy platform 12 is essential to safety as the movable platform 12 may be in a low tension configuration and cause the operator to stumble or fall upon mounting. By using the stationary step platform 82 and the hand rail 76 together to balance and brace the operator, the chance of a sudden loss of balance is nearly entirely eliminated during use of the exercise and therapy device 10 . In this way the safety elements of the novel device work together to insure accident free use. Referring now to FIG. 7, one embodiment of the means by which the bare lower tensioning cable 54 is attached to the lower curved surface of the rotatable dish exercise and therapy platform 16 is shown in detail. The threaded eye hook 84 is secured to the lower curved surface of the rotatable dish exercise and therapy platform 16 by means of an internal mounting nut 86 and an external mounting nut 88 . The eye hook then receives the looped end 98 of the bare tensioning cable 54 . The loop is secured by means of a cable crimp 95 . Turning now to FIG. 8, this figure illustrates another means of attachment for the bare tensioning cable 54 to the lower curved surface of the rotatable dish exercise and therapy platform 16 in detail. The eye hook 94 is attached by a welded or soldered connection 96 to the lower curved surface of the rotatable dish exercise and therapy platform 16 , and receives the distal end of the bare tensioning cable 54 forming a loop 98 secured by a cable crimp 95 . When in use for exercise or therapy regimen, the novel exercise and therapy device 10 is placed on a floor, deck or other suitable flat surface. The operator steps upon the removable stationary step platform 82 , adjusts the tensioning adjustment mechanism handle 74 to maximum tension and steps upon the flat surface of the rotatable dish exercise and therapy platform 12 . At this setting, the lower curved surface of the rotatable dish exercise and therapy platform 16 frictionally engages the plurality of ball bearings 22 , 24 , 26 and 28 as the tensioning mechanism places the greatest torque upon the rotatable dish exercise and therapy platform 12 . When the tensioning mechanism is adjusted by the operator by moving the tensioning adjustment mechanism handle 74 toward the left side of the notched tensioning adjustment mechanism 72 , the friction is reduced and the operator's shifting center of gravity moves the rotatable dish exercise and therapy platform 12 with less force applied, about a vertical axis of rotation 162 and a horizontal axis of rotation 164 (as shown in FIG. 4 ). The adjustment of amount of tension on the rotatable dish exercise than therapy platform 12 determines the amount of force exerted by the operator required to cause rotation of the rotatable dish exercise and therapy platform 12 and allows the operator to exercise a variety of muscle groups at differing exertion levels. Additionally, adjustment of the tensioning mechanism 50 can be used to compensate for differing individuals total body weight, thereby creating optimal conditions for a productive exercise workout session or therapy session for that particular individual. Finally, the novel exercise and therapy device 10 can be configured to utilize three or more ball bearings such as the four ball bearings shown in FIG. 3, ball bearings 22 , 24 , 26 and 28 to allow for greater or lesser surface area contact between the lower surface of the rotatable dish exercise and therapy platform 16 thus allowing for greater or less frictional contact. The greater the frictional contact, the greater the amount of force required to cause rotation when the tensioning mechanism is activated. FIG. 4 is an example of another embodiment of the novel exercise and therapy device 10 that utilizes three ball bearings. Not just ball bearings can be employed for this purpose, as other roller-type mechanisms are also contemplated. It should be understood, however, that even though these numerous characteristics and advantages of the invention have been set forth in the foregoing description, together with details of the structure and function of the invention, the disclosure is illustrative only, and changes may be made in detail, especially in matters of shape, size, chemistry and arrangement of parts within the principal of the invention to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed.

A new and improved exercise and therapy device and method of making same is provided. The present invention relates to a device which enables a selective therapeutic exercise regimen by providing a tensioning mechanism attached to a horizontally and vertically rotatable platform, provided with a safety hand rail to aid in maintaining balance and a vertical posture for the operator. The dish-shaped platform will react to changes in the operator's weight shifts and center of gravity placed upon it. When this novel multi-rotational aspect of the platform responds to subtle changes in the operator's center of gravity, movement of the dish-shaped platform will occur. These changes trigger muscular contractions around the joints of the operator responding to the rotation of the platform while the tensioning mechanism allows for selective resistance to the free movement of the platform enabling exercise and therapy routines for various muscle groups. Inexpensive manufacturing and maintenance costs will be associated with the production of this simple and effective design thus making the device readily accessible to more people.

FIELD OF THE INVENTION The present invention generally relates to apparatus, systems and methods for manufacturing food, more specifically angular patties, sausages or other proteinaceous products of variable texture for animal consumption. BACKGROUND OF THE INVENTION A large and growing number of households have pets. Studies have shown that pet owners often treat their pets as they treat close friends and relatives. Owners include pets in holiday celebrations, and often refer to themselves as the parents of their pets. Such affinity is tangibly demonstrated in the rapid growth of a multibillion dollar pet industry with an increasing demand for pet products that mimic human products. Health conscious consumers are also demanding higher quality pet food that is not only closer in ingredient quality to human food, but also looks less processed and more natural. However, conventional pet food producers seldom focus on the visual impact of pet food that heightens aesthetic appeal to a purchaser, even if they integrate advanced ingredients more commonly found in food produced for human consumption. Meat patties and related products for both human and animal consumption are commonly made using forming processes and systems, including a forming or mold plate and knockout cups. Typically, a meat emulsion is conveyed into cavities on a mold plate, and knocked out with cups that travel in a direction perpendicular to the process. Usually, patty forming plates have cavities with vertical sides which require vertically reciprocating knockout cups. With multiple cavities and knockout cups, the typical forming machine processes large quantities of food in an hour, and produce products that have the familiar disc-like shape of frozen hamburger patties. There have been some minor variations to this traditional process for meat patties, particularly for human consumption, where patties having more natural and irregular edges are formed, to cater to the demand of high end restaurants and their patrons. These newer techniques have been produced by forming meat under pressure in an irregularly shaped die cavity followed, by pressing the top and bottom surfaces together. Processes used for human grade food are rarely suitable for the pet food market which has different requirements. For instance, human grade sausages or patties are usually designed for relatively short shelf lives. Pet food, on the other hand, is engineered to be stored (if necessary) for eighteen months after manufacturing before it is consumed, and therefore requires a substantially longer shelf life. Human grade sausage patties, once opened, become stale in less than a week unless refrigerated. Pet treats, however, are expected to last for up to three months after the package is opened, without refrigeration. The delay in the storage and consumption of pet foods requires more careful ingredient selection, preservation of freshness with antioxidants, processing that avoids insects and rancidity, careful packaging and storage. Since high moisture meat products tend to spoil quickly, such products are usually sold in cans in the pet food market, and are more typical as cat food. Pet food or kibble with low moisture content (typically less than 10%), are dry and hard, and less palatable to pets. Semi-moist pet food, typically having moisture content between 15 and 30%, is very popular with animals since it has a texture and palatability that is closest to meat. However, as discussed, semi-moist pet food is difficult to store in a stable condition, without canning or refrigeration, for long periods. Skinned sausage links for human consumption are made from beef, veal, pork, lamb, poultry and wild game, using a unique blend of old procedures and newer, highly-mechanized processes, However, the basic procedure of stuffing meat into casings to make sausages still remains commercially viable today. Skinned sausages are generally perceived to be of even higher quality than formed sausage patties for human consumption. Skinned sausages are typically sliced only after they are cooked, otherwise maintenance of slice integrity is difficult. When sliced, typically by hand before a meal, the sausages are typically cut into angular slices. Hand slicing further conveys to consumers the impression of premium quality and more personalized food preparation. There is no economical process that can produce high volumes of sliced sausages that appear to have been sliced off the sausage log for human consumption, much less for pet food consumption. Thus, neither conventional pet food manufacturing processes nor traditional food production techniques used for human consumption can meet the requirements of cost-effectively manufacturing slices of semi-moist, shelf-stable, meat patties that appear to have been cut at an angle from a conventional round skinned sausage log. Moreover, there are no economic methods for forming such angled sausage slices in a continuous manufacturing process. SUMMARY OF THE INVENTION Illustrative embodiments of the present invention include apparatus, systems and methods for manufacturing slices of reconstituted food products that appear to have been cut from a previously whole food product at an angle. Particularly, the disclosed invention is useful for manufacturing a sliced sausage, meat or other proteinaceous product that appears to have been cut at an angle from a whole, skinned sausage. In one illustrative embodiment, the present invention utilizes knockout cavities and knockout cups that are angled, to develop an animal treat that looks similar to human grade skinned sausage log that has been sliced at an angle, and the exposed faces of the sausage patty reveal the product ingredients such as beef muscle chunks, rice, or apples. Shown herein, as another illustrative embodiment, is a manufacturing process for making portions to be finished into angled pet treats comprising: (a) providing a ground mix of proteinaceous material, flavor enhancers and preservatives to a forming chamber comprising: a fixed base surface, a fixed top surface, and a movable intermediate section insertable between said base and top surfaces, said intermediate section having a plurality of die cavities that each have a central axis oblique to the surface of said intermediate plate, said top surface having a plurality of feeder holes that overlap at least partially with said die cavities, (b) filling said plurality of die cavities via said feeder holes with said foodstuff, thereby forming a plurality of portions in shapes and dimensions that generally correspond to the shapes and dimensions of said die cavities, (b) moving said intermediate section containing said plurality of portions out of said chamber, (c) forcibly ejecting said portions with a plurality of longitudinal elements that reciprocate in and out of said die cavities along said central axis, thereby forming angled pet treats. While embodiments of the present invention are described primarily with respect to pet food products and pet sausage treats in particular, it should be appreciated that the disclosed apparatus, systems and methods may be applied to the cost-effective production of a broad range of food products, whether intended for pet or human consumption. It will be appreciated by those skilled in the art that the foregoing brief description and the following detailed description are exemplary and explanatory only, and are not intended to be restrictive thereof or limiting the invention. Thus, the accompanying drawings, referred to herein and constituting a part hereof, illustrate only preferred embodiments of the invention, and, together with the detailed description, serve to explain the principles of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an overall process schematic for making patties with angled edges, according to an illustrative embodiment of the invention. FIG. 2 is an illustration of the basic configuration of a conventional knockout forming system typically employed in the prior art. FIG. 3A-D is an illustration of the operation of a standard patty forming system typically employed in the prior art. FIG. 4 details an angled knockout system, according to an illustrative embodiment of the invention. FIGS. 5A-B , 6 A-B, and 7 A-B, show angled patties formed and knocked out at 60.degree., 45.degree., and 30.degree., respectively, according to an illustrative embodiments of the invention. FIGS. 8A-B , 9 A-B, 10 A-B, and 11 A-B, show angled sausage patties of various geometric and non-geometric (irregular) shapes according to an illustrative embodiment of the invention. FIG. 12A-12B show perspective views of a knockout system configuration that is designed to evacuate angled patty product away from the forming equipment, according to an illustrative embodiment of the invention. FIGS. 13A and 13B show perspective views of a knockout system configuration that is designed to evacuate angled patty product toward the forming equipment, according to an illustrative embodiment of the invention. FIGS. 14A , 14 B and 14 C show perspective views of a knockout system configuration that is designed to evacuate angled patty product parallel to the forming equipment, according to an illustrative embodiment of the invention. FIGS. 15A and 15B show a mechanism for implementing angular knockout cups using an actuator mechanism mounted at an angle to enable a reciprocating knockout action at any desired angle, according to an illustrative embodiment of the invention. FIGS. 16A , 16 B and 16 C show a mechanism for implementing angular knockout cups using a vertical actuator mechanism working in conjunction with a hinged mechanism to enable a reciprocating knockout action at any desired angle, according to an illustrative embodiment of the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Illustrative and alternative embodiments and operational details of apparatus, systems and methods to manufacture a plurality of angled patties and/or sausage treats of varying texture in a continuous process will be discussed in detail below with reference to the figures provided. The subject invention is generally relevant to any edible food product produced at least in part through extrusion, including apparatus, systems and methods for making such products. One preferred product, however, is an edible food product for animal consumption, more particularly an angled sausage treat for pets containing meat and/or meat analogs. In one illustrative embodiment of the invention shown in FIG. 1 , frozen blocks of muscle meat, organs or any appropriate proteinaceous material are processed through a first grinder ( 100 ) containing a grinding plate with openings that are 1/16″ to 1″ in diameter, preferably approximately ⅜″, resulting in an output that has large chunks of meat. The ground meat is batched and mixed in a mixer ( 120 ), typically a ribbon flight mixer or a sigma blade mixer or a solid screw mixer. Dry and liquid ingredients ( 110 ) are added to the meat batch in the mixer. The mixed batch may also be processed with a second grinder ( 130 ) containing a grinding plate ideally with ⅜″ diameter openings, or otherwise with openings between 1/16″ and 1,″ that assists in the consistent mixing of both longitudinal grains and smaller chunks of meat in such a way that the resultant meat emulsion can be extruded easily. This additional grinding step, if used, can also contribute to the appearance and texture of the final angled patty or sausage product. Note also that while the grinding and mixing steps described herein are a preferred embodiment, similar results can also be attained by separately sourcing pre-ground (and pre-mixed) proteins and other ingredients, and then using this externally sourced ground mix as the starting raw material to carry out the rest of the process steps described in FIG. 1 and below. The ground meat emulsion is fed into the hopper of a patty former ( 140 , and explained in further detail infra) which in turn fills a knockout plate ( 150 ) located proximately. Once the knockout plate is filled, the plate extends beyond the hopper walls to the knockout area. The product is knocked out ( 160 ) and collected on trays. The trays are fed then into an oven dryer ( 170 ). If a continuous belt is used, then the belt feeds directly into the oven. The angled patties are dried ideally at between 140° and 180° F., but anywhere between 130° and 250° F., for several hours, ideally in the range of 4-6 hours. The temperature and drying profile is important to prevent the generation of skin or shriveling of meat in the product. After drying, the sausage patties are cooled ( 180 ) for 1-4 hours at ambient temperature before continuing to packaging ( 190 ). A non-ambient air cooling operation may also be used. Before describing the patty former and knockout system used in the process of FIG. 1 ( 140 , 150 ) of the present invention, it is helpful to first discuss conventional approaches of the prior art in some more depth. A typical prior art knockout system used in a standard patty former is illustrated in FIG. 2 , and incorporates knockout cavities ( 220 ) that fill perpendicular to the face of the knockout plates or surfaces ( 200 ). Concurrently, the knockout cups ( 210 ) travel along a vertical central axis ( 220 ) that is perpendicular to the face of the knockout plate as well. FIG. 3A-3D shows a typical sequence of operations of such a standard patty forming operation in more detail. The patty former contains two stationary plates or surfaces ( 300 A and 305 A) between which an intermediate “knockout” section or plate ( 315 A) is positioned. The knock out plate can move in and out of the forming chamber. The knockout plate contains a plurality of holes that serve as molding dies or cavities for the meat emulsion that is fed from the top of the patty former. The molding dies are vertical cylindrical holes with sides that are perpendicular to the top and bottom faces of the knockout plate, which are used to produce cylindrical, disc-shaped patties. The top stationary plate ( 305 A) also has a plurality of feeder holes, with each feeder hole in the stationary plate aligning with a corresponding mold cavity in the knockout plate. When the meat emulsion is fed under pressure ( 310 A) through the forming chamber ( 301 A), it enters through the feeder holes ( 320 A) of the top plate ( 305 A) into the mold cavities of the knockout plate ( 315 A). After the meat is pressed and formed into the mold cavities of the knockout plate, pressure is released, and FIG. 3B shows the knockout plate moved horizontally ( 300 B) out of the chamber, positioning the formed patties ( 310 B) below the knockout plate ( 320 B). The pieces of formed patties ( 330 C) are then forced/knocked out ( FIG. 3C ) through the motion ( 300 C) of vertical plungers (also known as knockout cups or rods) ( 310 C) that travel perpendicular ( 320 C) to the face of the knockout plates ( 315 A or 320 B). The patties then fall to a conveyor ( 340 C) below for further processing. Following the “knockout” segment ( FIG. 3C ), the knockout cups and knockout plate return to their positions ( 300 D, 310 D). While the die cavities ( 220 or 310 B) normally have vertical sidewalls, sometimes the side walls are also slightly tapered outward toward the bottom to facilitate quick product release when the product is eventually punched out by the knockout cups, so that the diameter of the hole at the bottom of the die is slightly larger than the diameter of the hole of the top of the cavity. While the outward tapering coupled with the vertical knock enables a quicker release of the patties during knockout, the resulting end-product still has sides generally perpendicular to the top and bottom, in the familiar disc-shape of hamburger patties. Unlike the conventional method of the prior art discussed in the preceding paragraph, FIG. 4-FIG . 16 details significant modifications and improvements of the traditional forming process to produce meat or other proteinaceous products with angled edges, in accordance with an illustrative embodiment of the present invention. Starting with FIG. 4 , in order to simulate an angled cut, the walls of the fill cavities ( 420 ) and path of travel ( 430 ) (along the central axis ( 420 )) for the longitudinal knockout members or cups ( 410 ) are modified to an angle ( 440 ), which can generally be varied 10°-80° from the face of the knockout plate, but is preferably within 30°-60°. The resulting products ( FIG. 5A-FIG . 7 A) have elongated faces ( 500 A- 700 A) and angled sides ( 500 B- 700 B), similar to product that is hand cut from an extruded log or a sausage product for humans that is hand sliced after cooking, exposing the surface. It will be apparent to one skilled in the art that while the intermediate section is described herein as a plate, it can be of other shapes as well, so long as the intermediate section is capable of reciprocating in and out of the patty chamber. Likewise, the top and bottom plates also can also be sections of varying shapes and sizes, so long as the top surface of the bottom section, and the bottom surface of the top section, can be aligned with the top and bottom surfaces of the intermediate section in such a way that the intermediate section can still move in and out of the chamber, and the feeder holes in the top section at least partially align with the die cavities of the intermediate section. The knockout cup and cavity system shown in FIG. 4 can also be designed to aid the formation of angled meat patties that look like sliced skinned sausage logs. This is done by taking advantage of the shear and frictional forces created by an angular knockout system. Since the formed meat in the cavities is no longer pushed out through downward vertical force and is instead squeezed through an angular hole, there is more frictional and shear forces that the plunger (knockout cup) has to overcome. Referring to FIG. 4 , the plunger travelling in the direction ( 430 ) encounters more resistance in the “acute angle” half of the cavity ( 480 ) when the meat is pushed out, and relatively less resistance in the “obtuse angle” side ( 470 ). This additional resistance (as compared with less resistance for the vertical systems of the prior art described supra) enables the end product to appear raised around the patty edges. In other words, the frictional and shear forces of the angled plunger can be utilized, if necessary, to create an “overhang” at the edges of the patties, giving it a more natural “skinned sausage slice” look. While the plunger diameter must be less than the diameter of the cavity, even this difference can be emphasized as another variable that determines the quality of the “skinned slice” look. Higher the difference between the diameter of the plunger and the diameter of the cavity, thicker is the “skin” formed by shear at the end of the sausage, but these differences in diameter cannot be too large or the plunger will just jab through the middle of the patty. Typically the diameter of the plunger is adjusted to within about 10% of the diameter of the cavity. Further, this plunger is also designed in a way where the contact face of the plunger ( 480 to 470 ) is usually at an angle ( 450 ) to the face of top face of the mold plate ( 400 )—in other words the contact face is often designed to be parallel to the horizontal top face of the mold plate ( 400 ). This enables the plunger to first contact the molded meaty material at ( 480 ) and, as it pushes its way through, also contact the material at ( 470 ), eventually pushing the whole product out. Because of the differential force between the two corners ( 470 and 480 ), the overhanging skin is also more pronounced at one side of the log, making the appearance of the final product closer to the appearance of a sliced skinned sausage log. Depending on the dimensions and features of the product required, and the type of ingredients and process conditions used, this plunger contact angle ( 450 ) is varied from about 5°-50°. Chunks of muscle meat, rice, etc. (ingredient alternatives for a preferred embodiment) are discussed further in TABLE 1 below, and are also visible on the surface of the patties. Adjusting the initial moisture content of the blend of proteinaceous material and the temperature and length of the drying operation further contributes to either a wrinkled or smooth appearance of the product. For example, the skin formed on the sides and top as a result of slow drying can further enhance the appearance of the quality of human grade sausage pieces cut from whole sausages. The angled cavity-knockout system may also incorporate the shapes of circles, ellipses, triangles, squares, non-geometric shapes and other irregular shapes ( FIG. 8-11 ). In a production setting, the knockout system would incorporate as many as 2 to 200 cavities with reciprocating knockout cups (similar to the 36 cup production system shown in FIG. 12A-12B ). As one skilled in the art will recognize, there are many possible ways for implementing production grade systems containing multiple die cavities for operation with multiple knockout members. Much of this will depend on space, and desired process and engineering considerations. For instance, the knockout assembly can be arranged to evacuate angled patties that drop to the conveyor (see FIG. 1 , 150 - 160 ) in different configurations. The knockout cups can be angled away from the forming equipment ( FIG. 12A , FIG. 12B ), or towards the forming equipment ( FIG. 13A , FIG. 13B ), or parallel to the forming equipment ( FIG. 14A , FIG. 14B ). FIG. 1 , ( 150 ), can also be considered as an angled knockout system that is parallel to the forming equipment ( 140 ), similar to FIG. 14 . There are also many possible mechanisms for implementing multiple knockouts at an angle, and a few of these are illustrated in FIG. 15 and FIG. 16 . FIG. 15 involves mounting an actuator ( 1500 A) in the angle ( 1510 A) of desired angular reciprocating motion ( 1520 A). The knockout elements are attached to a mounting plate ( 1500 B) would ultimately be directed by the actuator to ensure an angular reciprocating action. Another solution, FIG. 16 , incorporates a vertical actuator ( 1600 B) working with a hinged mechanism ( 1610 B, 1620 B). The vertical motion ( 1630 B) of the vertical actuator ( 1600 B) is translated to a rotation of the hinge mechanism which drives the knockout assembly ( 1640 B) in the direction ( 1650 B), in the desired oblique angle ( 1660 B) for the patties. Other solutions may include the use of cam systems or multiple actuators (not shown). Note also that it is possible to produce products where the cavities and plungers vary in size so that the products cumulatively produced during a process run appear to be of varying shapes and sizes, thereby simulating a product mix that has a more random and natural look. While the foregoing description explains the manufacturing process used to make the product, it is also important to note, as will be evident to one skilled in the art, that the type and relative proportions of ingredients used in making the product also plays a role in the texture, semi-moistness and appetizing appearance of the final product. In particular, the increased proportion of meat used in this process helps develop a rough texture that appears more like human grade sausage. Two recipes (A and B) are shown below to demonstrate some typical proportions of proteins and other ingredients used in the beginning of the process ( FIG. 1 at mixer 120 ) to make an angled sausage or patty treat for animal consumption (numbers below are in weight percent): Component Recipe A Recipe B Meat/Animal Protein 62% 59% Plant Protein  6% 10% Starches 15% 20% Flavors 15% 10% Preservatives  2%  1% TOTAL 100%  100%  While the recipes above are specific, TABLE 1 below illustrates the broader ranges of composition of the key components that can be used in conjunction with the process described herein to make angled proteinaceous food treats for animal consumption. Some of these combinations would also be useful for making long-lasting products for human consumption, as will be appreciated by one skilled in the art. Note that many of these starting ingredients (e.g., beef or chicken or vegetables) inherently contain water. TABLE 1 Category Typical examples/comments Proportion (wt. %) Proteins Chicken, beef, pork, turkey, venison, duck, 40-70%  etc., or a combination. Premium and lower grade meats, or offal, could also be used. Meat analogs such as soy or vegetable protein can also be used for developing more healthy snacks. Flours/Starch/ Wheat, soy, corn, tapioca, etc., or a 0-20% Carbohydrates combination Vegetables/Fruits Apples, banana, sweet potato, cranberry,   10% carrots, peas, etc., or a combination Flavor enhancers Sugar, salt, garlic, onion, digests. 5-20% Preservatives Potassium sorbate, sorbic acid, butylated 0.01-5%   hydroxyanisole (BHA), butylated hydroxytoluene (BHT), mixed tocopherols, calcium propionate, zinc propionate, rosemary extract, citric acid, sodium erythobate, Accelerated testing studies have also indicated that recipes A and B produce pet treats that are shelf stable for at least 18 months, maintaining a stabilized intermediate moisture content (15-30% by weight, usually 18-26%), and stabilized water activity (Aw ranging from 0.60 to 0.78, usually 0.65-0.75%) without refrigeration under normal conditions of storage in homes or stores that are reasonable and expected for the packaged pet foods industry. The ingredient mix, within the composition ranges in TABLE 1 provided above, can also be adjusted as needed by one skilled in the art to ensure that similar stabilized moisture content and water activity is achieved to create final packaged products that are semi-most and shelf-stable for at least 18 months. It will be apparent to one skilled in the art that the final shape and texture of the end products, and their size and thickness distributions, whether for animal or human consumption, can be pre-designed and/or manipulated on-the-fly during the manufacturing process by pre-selecting and/or dynamically adjusting various process variables. These variables include, but are not limited to, the following: 1. Having a range of repeating and/or irregular patterns, sizes and shapes of the knockout cups to develop an assortment of product sizes and shapes in a process run ( FIG. 5A , 10 A, 11 A, 8 A). 2. In addition to the drying conditions described above, the angle of the knockout, which in conjunction with the composition of the mix (see 3 below), are important in optimizing the “wrinkled edges with skin” appearance and grainy texture of the final product. A vertical knockout system imparts almost the same uniform force across the patty, whereas the oblique knockout has more variation in the imparted force across the “slice” of the sausage, particularly a sharper difference in force between the edges of the slice and the center that is caused by differential shearing, which in turn is typically a function of the oblique angle, the speed of the knockout cups, the materials and composition of the patty blend, the temperature and pressure during compaction of the patties. 3. Speed of the reciprocating angled knockout cups can be adjusted along with the speed of the conveyor to create differences in the product appearance. For instance at relatively slower speeds, the knockout cup will stretch the meat out more “gently” before dislodging it into the angular slice, thereby creating more differential stress between the center and the edges, and this results in more of a pulled or torn look that would be created by a person using a blunter knife on a sausage log. 4. Variations in composition within the ranges prescribed in Table 1. For instance, increasing the meat concentrations and lowering or eliminating carbohydrates will increase the leathery, grainy or wrinkled texture of the product. Note that increasing the ratio of premium muscle meat to lower grade meat (including offal), will also increase the natural wholesome look, but this must be balanced with commercial considerations such as cost and consumer preferences. To some extent, the composition can also be adjusted dynamically during processing by adding multiple feed points, each independently controllable, instead of the fixed set of dry ingredients ( 110 ) suggested by in FIG. 1 . While the invention has been described in conjunction with specific embodiments, it is evident that many alternatives, modifications, permutations and variations will become apparent to those skilled in the art in light of the foregoing description. Accordingly, it is intended that the present invention embraces all such alternatives, modifications and variations as fall within the scope of the claims below.

Apparatus, systems and methods are disclosed for manufacturing slices of sausages that appear to have been cut from a conventional round sausage log at an angle. An illustrative embodiment provides a manufacturing process for making portions to be finished into angled pet treats comprising: (a) providing a ground mix of proteinaceous material, flavor enhancers and preservatives to a forming chamber comprising: a fixed base surface, a fixed top surface, and a movable intermediate section insertable between said base and top surfaces, said intermediate section having a plurality of die cavities that each have a central axis oblique to the surface of said intermediate plate, said top surface having a plurality of feeder holes that overlap at least partially with said die cavities, (b) filling said plurality of die cavities via said feeder holes with said foodstuff, thereby forming a plurality of portions in shapes and dimensions that generally correspond to the shapes and dimensions of said die cavities, (b) moving said intermediate section containing said plurality of portions out of said chamber, (c) forcibly ejecting said portions with a plurality of longitudinal elements that reciprocate in and out of said die cavities along said central axis, thereby forming angled pet treats.

DOMESTIC PRIORITY Under 35 USC 119(e) [0001] This application claims the benefit and priority of U.S. Provisional Application Ser. No. 61/173,487 filed Apr. 28, 2009, entitled “New Oral Formulations for Tetrapyrrole Derivatives” by Susanna Grate et al., which is incorporated by reference herein. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention Present invention generally relates to drug formulation. In particular it relates to an oral formulation of tetrapyrrole compounds and their derivatives, to be used in the photodynamic therapy (PDT), Antimicrobial Photodynamic therapy (APDT) and even for photodiagnosis purpose. This formulation will be administered orally. [0003] 2. Invention Disclosure Statement [0004] Photosensitizers are compounds which can be photoactivated by irradiation of specific wavelength matching the absorption spectrum of the photosensitizer. Photosensitizers are used in Photodynamic Therapy (PDT) treatment, a novel method used initial in treating cancer and now found to be effective in treating other medical problems also. PDT method is used to treat different kinds of cancers including proliferating and non-proliferating types, Benign Prostate Hyperplasia (BPH), other Inflammatory conditions, cosmetic applications and others. Generally photosensitizers are administered to patient systemically and topically, which both have their own merits and demerits. [0005] In general, photosensitizers are now delivered topically or intravenously. Especially, the intravenous delivery poses problems for the medical treatment as many photosensitizers are hydrophobic or amphiphilic substances which are non-soluble in water. Sometimes the photosensitizers are administered in alcoholic solution (ethanol, propylene glycol) as e.g. the photosensitizer temoporfin. However, the alcohol content can induce pain during administration and alcohol as a solubilizing agent in general is not feasible for certain groups of patients. Therefore, there have been efforts to formulate hydrophobic photosensitizers in a way that renders them water-soluble. These approaches include many different carrier systems such as liposomes, nanoparticles, quantum dots, or carrier systems based on inorganic materials. Of special interest in this respect are carrier systems based on highly biocompatible materials such as lipids, proteins or biocompatible polymers. There are a number of such carrier systems known in the art (F. L. Primo, P. P. Macaroff, Z. G. M. Lacava, R. B. Azevedo, P. C. Marais, A. C. Tedesco, Binding and photophysical studies of biocompatible magnetic fluid in biological medium and development of magnetic nanoemulsion: A new candidate for cancer treatment. J. Magnetism Magn. Mater., 2007, 310, 2838-2840; patent application WO 06133271A2; A. J. Gomes, C. N. Lunardi, A. C. Tedesco, Characterization of biodegradable poly(D,L-lactide-co-glycolide) nanoparticles loaded with bacteriochlorophyll-a for photodynamic therapy, Photomed. Laser Surg., 2007, 25, 428-435; E. Ricci-Junior, J. M. Marchetti, Preparation, characterization, photocytotoxicity assay of PLGA nanoparticles containing zinc(II) phthalocyanine for photodynamic therapy use, J. Microencapsul., 2006, 23, 523-538; E. Ricci-Junior, J. M. Marchetti, Zinc(II) phthalocyanine loaded PLGA nanoparticles for photodynamic therapy use, Int. J. Pharm., 2006, 310, 187-195; V. Saxena, M. Sadoqi, J. Shao, Polymeric nanoparticulate delivery system for indocyanine green: Biodistribution in healthy mice, Int. J. Pharm., 2006, 308, 200-204; A. Vargas, B. Pegaz, E. Debefve, Y. Konan-Kouakou, N. Lange, J.-P. Ballini, H. van den Bergh, R. Gurny, F. Delie, Improved photodynamic activity of porphyrin loaded into nanoparticles: an in vivo evaluation using chick embryos, Int. J. Pharm., 2004, 286, 131-145; Y. N. Konan, M. Berton, R. Gurny, E. Allémann, Enhanced photodynamic activity of meso-tetra(4-hydroxyphenyl)porphyrin by incorporation into sub-200 nm nanoparticles, Eur. J. Pharm. Sci., 2003, 18, 241-249; Y. N. Konan, R. Cerny, J. Favet, M. Berton, R. Gurny, E. Allémann, Preparation and characterization of sterile sub-200 nm meso-tetra(4-hydroxyphenyl)porphyrin loaded nanoparticles for photodynamic therapy, Eur. J. Pharm. Biopharm., 2003, 55, 115-124; A. Vargas, M. Eid, M. Fanchaouy, R. Gurny, F. Delie, In vivo photodynamic activity of photosensitizer-loaded nanoparticles: Formulation properties, administration parameters and biological issues involved in PDT outcome, Eur. J. Pharm. Biopharm., 2008, 69, 43-53; B. Pegaz, E. Debefve, F. Borle, J.-P. Ballini, H. Van den Bergh, Y. N. Kouakou-Konan, Encapsulation of porphyrins and chlorins in biodegradable nanoparticles: The effect of dye lipophilicity on the extravasation and the photothrombic activity. A comparative study, J. Photochem. Photobiol. B: Biology, 2005, 80, 19-27; patent application WO 97010811A1 and patent application WO 03097096A1). However, these water-soluble carrier systems were developed for intravenous administration. They have not yet been evaluated for their potential for oral administration. [0006] Oral administration is one of the easiest routes for drug administration and is particularity useful for patient compliance. The main hurdles faced in oral administration of drugs include biological barriers which makes it difficult for poorly water soluble drug molecules to be administered orally. Commonly the drug size, its bioavailability, the solubility and stability makes it difficult to pass through the biological barriers like the intestinal mucosa and gut epithelium. To overcome these biological barriers drug development and manufacturing units have found novel methods of formulation using more efficient delivery systems. Newer drug delivery systems are formulated to avoid the drug being accumulated in non-targeted site such as spleen and liver thus increasing dramatically the drug half life in the circulatory system. This is difficult in some cases, as well as undesirable if it is the liver for example which contains cancerous tissue. [0007] Oral drug delivery system development has been fostered by the need to deliver medications to patients more efficiently and with fewer side effects. The oral route is found to be the most convenient route of drug administration. The oral and other therapeutic systems in human use have been validated as concepts for controlled continuous drug release which can minimize the daily dose or the number of doses of a drug required to maintain the required therapeutic effect, while minimizing unwanted pharmacological effects. Oral drug delivery systems in particular have required innovation in material science to provide biocompatible materials during prolonged contact with body tissues, bioengineering methods to develop drug delivery modules, and clinical pharmacology studies for elucidation of drug pharmacokinetics under conditions of continuous controlled drug administration. [0008] Oral drug delivery systems/methods provide the possibility to maintain therapeutically optimum drug concentrations in plasma and target organs; and therefor eliminate the need for frequent single dose administration. Many pharmaceutical active agents used as medicines and supplements need to be stabilized and protected against degradation or oxidation activity using suitable carrier systems. The effectiveness of such agents may be improved by increasing their solubility in body fluids or by masking their unwanted properties (such as toxicity, odor, taste and other characteristics) before reaching the target organ using drug delivery systems. [0009] Oral administration of unstable, insoluble and bad tasting active agents would require a delivery system which can stabilize the drug, avoid precipitation, and prevent early degradation. It also calls for a system which can improve the solubility. A system to mask the bad taste, reduce toxicity and side effects. Drug formulation units use different means to achieve these characteristics by using carrier system like nano-capsule, microspheres, liposomes, and pegylation. These carrier systems are made of biocompatible polymers, lipids or even natural/synthetic proteins. Natural stable proteins/lipids have been used because of their less immunogenic properties, and additionally can be used for specific targeting. [0010] Drug delivery systems have been widely used to administer drugs with high molecular weight, having low solubility and permeability and having high susceptibility to enzymatic action in the GIT. Examples of macromolecules include peptides, proteins, nucleotides, sugars, etc. In prior art we see many such examples of using drug delivery systems for oral administration. [0011] In U.S. Pat. No. 7,432,369 by Williams et al., discloses pyridyl-substituted Porphyrin compounds and their effective amount used in treating various disorders. They also discuss the method of administrating the drug which include oral route along with other well established methods. Composition for oral administration of their invention include tablets, lozenges, aqueous or oily suspensions, granules, powders, emulsions, capsules, syrups or elixirs. The method of formulating the oral formulation is not discussed. [0012] Prasad, et al., in their U.S. Pat. No. 7,364,754 disclose a certain ceramic based nanoparticle agents for encapsulating hydrophobic photosensitizers used in PDT methods. Such nanoparticles entrapping drug/dyes can be administrated orally, parenterally or topically. The specific photosensitizer used here is 2-devinyl-2-(1-hexyloxyethyl)pyropheophorbide. [0013] Robinson in his U.S. Pat. No. 6,376,483 discloses use of bacteriochlorins and bacteriopurpurins and their production methods. In his disclosure he describes the oral administration of this active agents using inert diluent or with assimilable edible carrier, or it may be enclosed in hard or soft shell gelatin capsules, or compressed into tablets or incorporated directly in food. This patent basically describes new routes for synthesis of bacteriochlorins and bacteriopurpurins from symmetrical and asymmetrical mesodiacrylate porphyrins and their uses in PDT treatment. [0014] In U.S. Patent Application No. 2007/0237827 by Sung et al., disclose a oral formulation consisting of biodegradable nanoparticles encapsulating therapeutically active agents like HMG-CoA reductase inhibitors, erythropoietin etc., to be orally delivered showing effective paracellular permeability. This patent does not discuss photosensitizer, but relates to nanoparticles as carrier for hydrophilic protein having high molecular weight which cannot easily be absorbed in the gut and also to prevent the proteases activity on the enclosed proteineous drug. [0015] Harel in his U.S. patent Application No. 2008/044481 discloses use of microparticles for oral administration of bioactive agents like drug, protein, vitamins, probiotic organism etc. The encapsulation material can be made of oil, polysaccharides, proteins, synthetic polymers or combination of these. [0016] In publication WO 2007/122613, by Yoav D. Livney et al., the inventors describe a method of encapsulating hydrophobic compounds including nutrients, therapeutic and cosmetic compounds and their administration via food and beverages. Especially used milk protein casein for the encapsulation. [0017] Generally photosensitizers in the prior art are administrated systemically or topically, depending on the place of treatment and drug properties. The solubility, molecular size and stability are certain factors used to decide the mode of administration. The present invention provides a oral formulation which can be easily administered to the patient through the oral route without any complication such as pain due to needle pricks, or staining of skin due to local application etc. Present invention aims to provide a formulation which can be easily absorbed by the gastrointestinal tract. OBJECTIVES AND BRIEF SUMMARY OF THE INVENTION [0018] It is an objective of the present invention to provide a suitable formulation of photosensitizer for oral administration, which can deliver the therapeutic drug dosage required for photodynamic therapy and antimicrobial photodynamic therapy treatment to the target organ or body region. [0019] It is also an objective of the present invention to provide a suitable oral formulation using a carrier system encapsulating photosensitizer which is stable in the gastrointestinal tract. [0020] It is yet another objective, to provide a suitable oral formulation which increases the bioavailability of the drug to ensure sufficient accumulation at the target site. [0021] It is the still another objective, of the present invention to provide oral formulation of photosensitizer which can be administered in the form of a tablet; a capsule; a liquid fill; a powder; a paste; a syrup etc. [0022] It is also another objective of the present invention to provide oral formulation using carrier system comprising of lipids, conventional liposomes, pegylated liposomes, thermodynamically stable nano-emulsions, Alpha-feto Protein (AFP), BSA (Bovine Serum Albumin), Hydrosoles, Self-Micro-Emulsifying-Drug-Delivery-Systems (SMEDDS), fat emulsion system, nanoparticles and other known suitable carriers. [0023] It is further objective of the present invention to provide oral formulation, which can be easily adhered on the gastrointestinal tract mucosa, where the drug subsequently will be absorbed. [0024] Briefly stated, present invention discloses a method of formulating photosensitive agents for oral administration during photodynamic therapy (PDT) and Antimicrobial photodynamic therapy (APDT) treatment. The oral formulated photosensitizers show increased solubility and permeability, thus improving the bioavailability of photosensitizers at the treatment site. An orally administrated photosensitizer is suitable formulated for mucosal adhesion and absorption via gastrointestinal mucosal membranes. Present invention of oral formulation uses lipids and known proteins as carriers for photosensitizer by oral route. Carriers known for encapsulating photosensitizer include conventional liposome, pegylated liposome, nanoemulsion, nanocrystrals, nanoparticles, fatty emulsions, lipidic formulation, hydrosols, SMEDDS, Alpha-Feto protein (AFP), and Bovine-Serum-Albumin (BSA), fatty emulsions and nanoparticles. The oral formulation in case of a hydrophobic photosensitizer in the present invention is stabilized using suitable surfactant/solubilizers thus preventing aggregation of the drug in the stomach and until it is absorbed in the duodenum and the small intestine. This formulation can be administered in the form of liquid, capsules, tablets, powder, paste or gel. Thus formulated drug can be administered orally as one single dose or in multiple doses before administering PDT. It is one of the embodiments of this invention to use Temoporfin (m-THPC) as a photosensitizer in the oral formulations. This compound is especially suitable to be administered orally because there is no known enzyme system in the mammalian body which can metabolize Temoporfin. So, Temoporfin can reach the blood system unchanged and fully active after absorption of the formulation in the gastrointestinal tract. [0025] The above, and other objects, features and advantages of the present invention will become apparent from the following description to be read in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF FIGURES [0026] FIG. 1 : examples of tetra-pyrrole skeletons in the molecules useful in photodynamic therapy. [0027] FIG. 2 : A graph depicting florescence measured in a in female NMRI nu/nu mice bearing a HT29 tumor after oral application of FOSLIPOS. [0028] FIG. 3 : Structure of BLC6066 a Photosensitive agent DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0029] Administration by the oral route is the most common and preferred method by which drugs are presented for systemic effects. In general orally taken drugs usually involve incorporating the drug into a tablet or a capsule. The tablet contains a variety of other substances apart from the drug itself, the drug needs to be compatible with these other substances. That means the chemical and physical property of the active agent needs to be well understood to choose the right inert ingredients and excipients for formulation. Other oral dosage forms comprise liquids (solutions, suspensions, and emulsions), semi-solids (pastes), and solids (tablets, capsules (soft and Hard), powders, granules, premixes and others. [0030] Preformulation steps involve the characterization of a drug's physical, chemical, and mechanical properties in order to choose which other ingredients should be used in the preparation. Factors such as particle size, polymorphism, pH, and solubility of the active agent are taken into consideration, as all of these can influence bioavailability and hence the activity of a drug. The drug must be combined with inert additives by a method which ensures that the quantity of drug present is consistent in each dosage unit e.g. each tablet/capsules. The dosage should have a uniform appearance, with an acceptable taste, tablet hardness, or capsule disintegration. [0031] Orally administered photosensitizer undergoes dissolution followed by absorption through a biological membrane into systemic circulation. The main processes effecting the oral bioavailability of a drug are dissolution, permeability, enzymatic metabolism in the gastrointestinal membranes and hepatic extraction. [0032] In the present invention of oral formulation for photosensitizer the term ‘photosensitizer’ used herein general includes a photosensitive compound which can be photoactivated using suitable wavelength. It includes tetrapyrroles and their derivative compounds of porphyrins, chlorins (such as Chlorophyll derivatives as well as synthetic chlorins such as temoporfin, m-tetrahydroxyphenylchlorin (mTHPC)), bacteriochlorins, corroles and phthalocyanines. It also includes tautomers in all cases and their metallates and salts. The present invention involves tetrapyrrole macrocycle having the structure shown in the FIG. 1 [0033] Preferably photosensitizers having reduced porphyrins such as dihydroporphyrins in which saturated carbon atoms are located at the non-fused carbon atoms of one of the pyrrole rings. The parent compound of this series is called chlorin, which, defined in terms of the unsubstituted porphyrin ring, is 17,18-dihydroporphyrin. [0034] Tetrahydroporphyrins in which the saturated carbon atoms are located at nonfused carbon atoms of two diagonally opposite pyrrole rings are bacteriochlorins: tetrahydroporphyrins with adjacent pyrrole rings reduced in this way are called isobacteriochlorins. [0035] The tetrapyrrole compound of present invention is formulated into one of the following forms, but not limited, thereto, to tablet, capsule, liquid fill capsule, powder, liquid, gel or paste form. The formulation method of present invention uses required inert ingredient from among those which are chemically compatible with the preselected photosensitizer. [0036] Dosage forms suitable for oral administration include, by way of example and without limitation, pharmaceutically acceptable emulsions, solutions, suspensions, syrups and elixirs. As mentioned, in addition to the photosensitizer, the dosage forms may contain inert diluents commonly used in the art such as water or other solvents, solubilizing agents and emulsifiers. Besides inert diluents, the oral compositions may also include adjuvants such as wetting agents, emulsifying and suspending agents, crystallization inhibitors, preservatives, pH buffering agents, sweetening, flavouring and odor masking agents. [0037] Pharmaceutically acceptable means the inert materials, compositions, and dosage forms which are suitable for use in tissues of human beings or animals without causing excessive toxicity, allergic response, or complication, commensurate with a reasonable benefit/risk ratio. [0038] Pharmaceutically acceptable carriers or delivery systems useful in this disclosure include conventional as well as novel systems known in the art of drug delivery systems. [0039] In general, dosage form of present invention includes: photosensitizer; and pharmaceutical acceptable excipient/carrier, further including fillers, binders, disintegrants, lubricants, glidants, wetting agents, buffering agent, absorption accelerator and others depending on the drug dosage form. Tablet Form [0040] In general a tablet formulation of tetrapyrrole compounds and its derivates will have: Required percentage of the photosensitizer (active agent), certain percentage of surfactant, fillers, disintegrants, lubricants, glidants, binders, absorption accelerator, solution retarding agents, wetting agents, absorbents; buffering agent and small percentage of compounds which ensure easy disintegration, to avoid aggregation, and dissolution of the tablet in the gut region. The use of surfactant helps to stabilize the hydrophobic photosensitizer and avoid aggregation. [0042] The disintegration time can be modified for a rapid effect or for sustained release. Special coatings can make the tablet resistant to the stomach acids such that it only disintegrates in the duodenum as a result of a more alkaline pH or specific enzyme action, or can cause a restricted diffusion from the tablet to the gut. Tablets can also be coated with sugar to disguise the taste. Some tablets are designed with an osmotically active core, surrounded by an impermeable membrane with a pore in it. This allows the drug to percolate out from the tablet at a constant rate as the tablet moves through the digestive tract. In one of the embodiments, mTHPC is used as a preferred photosensitizer which does not form metabolites once inside the body hence are resistant to enzymatic and other biochemical activity in vivo. ((Ref: Hony Cai et al, Biomedical Chromatography 13: pg. 354-359 (1999) and Biomedical Chromatography 13: pg. 184-186 (1999). In “The Pharmacokinetic behaviour of the photosensitizer m-THPC in mice and men by Martijn Triesscheijn et al; Cancer Chemother Pharmacol 60: Pg. 113-122 (2007) pharmacokinetics of mTHPC and its pharmacokinetic behaviour is related when bound to lipoproteins in vivo. The study reports that neither lipoprotein levels nor cholesterol metabolism affects the pharmacokinetics of mTHPC in Plasma. [0043] In the present invention the examples of tablet core include but are not limited to maize starch, pregelatinized starch, sodium starch glycollate, povidone, glycerol dibehenate, magnesium stearate, lactose monohydrate, powdered cellulose, pregelatinized maize starch, colloidal anhydrous silica, microcrystalline cellulose, hydroxypropyl cellulose, indigo carmine aluminium lake, crospovidone, silica, colloidal anhydrous/Colloidal silicon dioxide etc. [0044] Suitable film coating materials/compositions include but are not limited to hypromellose, glycerol triacetate, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), ethylcellulose, polyvinyl alcohol—partly hydrolized titanium dioxide, lecithine, xanthane gum. Capsule Form [0045] In one of the embodiments, a capsule, a gelatinous envelope is used to enclose the photosensitizer formulation. Capsules can be designed to remain intact for some hours after ingestion in order to delay absorption. They may also contain a mixture of slow- and fast-release particles to produce rapid and sustained absorption in the same dose. The two main types of capsules are hard-shelled capsules, used for dry, powdered ingredients, and soft-shelled capsules, used for oils and for active ingredients that are dissolved or suspended in oil. Both of these classes of capsule are made both from gelatine and from plant-based gelling substances like carrageenans and modified forms of starch and cellulose. [0046] The Capsule shell materials used in present invention include but are not limited to hypromellose, ethylcellulose, lactose monohydrate, magnesium stearate. hypromellose, hydroxypropyl methylcellulose acetate succinate, Sucrose, sugar spheres, talcum, titanium dioxide, triethyl citrate, povidone, silica, colloidal anhydrous/colloidal silicon dioxide, polysorbate 20, etc. [0047] Further the capsule shell material can contain pharmaceutically acceptable coloring agents for example titanium dioxide, yellow iron oxide, red iron oxide, gelatin, sodium lauryl sulfate, indigo carmine, yellow iron oxide and edible white ink. Still further the capsule shell material can contain pharmaceutically acceptable printing ink which includes but is not limited to shellac, lecithin (soya), simethicone, red iron oxide, and hydroxypropyl cellulose. Liquid Fill Capsules (Soft and Hard Capsules) [0048] In yet another embodiment, liquid filled capsules are used; as they improve the bioavailability of hydrophobic photosensitizer by promoting absorption. Liquid filling is particularly suitable in products containing highly potent and cytotoxic compounds due to the simplified manufacturing process and in products that exhibit low solubility or poor bioavailability in other formats. The solubilizing agents include but are not limited to Poly ethylene gycol/macrogols (Trade name Lutrol® (BASF AG)) Liquid Form-Foslipos Formulation [0049] The term ‘Foslipos’ of the present invention means a lipid formulation encapsulating hydrophobic photosensitizer by forming liposomal vesicles with no added saccharide and which is not freeze dried. Lipids have an ability to solubilize hydrophobic drugs, thus lipid-based drug delivery systems have been proven to improve drug absorption and dissolution rates in the gastrointestinal tract. [0050] Liposomal vesicles used in the present invention are composed of phospholipids, preferably synthetic phospholipids are phosphatidyl cholines; such as dipalmitoylphosphatidyl choline (DPPC), dimyristoyl phosphatidyl choline (DMPC), distearoyl phosphatidyl choline (DSPC), and phosphatidyl glycerol; such as dipalmitoyl glycerol (DPPG), distearoyl phosphatidyl glycerol (DSPG) and dimyristoyl phosphatidyl glycerol (DMPG). [0051] Foslipos focuses on the lipid bilayer as transport compartment. In this way, the photosensitizer resides within the membrane, the photosensitizing agents are effectively targeted to their place of action but the luminal part inside the liposome particle stays free for the inclusion of other substances, including drugs that may have a beneficial effect on the therapy. The liquid liposomal formulation of photosensitizer in this invention is never freeze dried unlike the conventional liposomal formulation, nevertheless it has a long, stable viable shelf life which makes the drug commercially interesting. Pegylated Liposomal Formulation-Liquid Form [0052] Hydrophobic photosensitizer and typically two or more synthetic phospholipids and at least one pegylated phospholipid are dissolved in an alcoholic solution. The solution is then dried under vacuum using a rotary evaporator. The mixture is then passed through a homogenizer filter system using a final pore size of 100 nanometers. During rehydration the water is supplemented with monosaccharides. The filtrate is collected, filled into vials and optionally freeze dried. [0053] Pegylated liposomal formulation was prepared using synthetic phospholipids. The phospholipids used in this invention preferably include DPPC (dipalmitoyl phosphatidyl choline), DPPG (dipalmitoyl phosphatidyl glycerol) and DSPE (pegylated distearoyl phosphatidyl ethanolamine), all of which are produced synthetically. [0054] In another embodiment of the present invention an oral formulation can be produced in liquid form where the a mixture of the photosensitizer and lipofundin can be administered through oral route. Thermodynamically Stable Nano and Self Emulsifying Microemulsion Drug Delivery System (SMEDDS) [0055] In another embodiment an oral formulation of nano and micro-emulsion is employed for oral administration of photosensitizer. An emulsion is a liquid system in which one liquid is dispersed in a second, immiscible liquid (with or without emulsifiers), usually in droplets. SMEDDS (micro-emulsions system) are thermodynamically stable carrier system of hydrophobic drug shaving prolonged shelf life. Present formulations of micro-emulsion formulation are prepared using non-toxic, non-irritant and pharmaceutically acceptable ingredients. [0056] The term SMEDDS (self emulsifying microemulsion drug delivery system) is defined as isotropic mixtures of oil, surfactant, cosurfactant and drug that rapidly form oil in water microemulsion when exposed to aqueous media or gastrointestinal fluid under conditions of gentle agitation or digestive motility that would be encountered in GI tract. The term SMEDDS is used in its conventionally accepted sense as a non-opaque or substantially non-opaque colloidal dispersion comprising water and organic components including hydrophobic (lipophilic) organic components. SMEDDS are identifiable as possessing one or more of the following characteristics. They are formed spontaneously or substantially spontaneously when their components are brought into contact, that is without substantial energy supply, e.g. in the absence of heating or the use of high shear equipment or other substantial agitation. They exhibit thermodynamic stability. They are monophasic. They are substantially non-opaque, i.e. are transparent or opalescent when viewed by optical microscopic means. In their undisturbed state they are optically isotropic. SMEDDS comprise a dispersed or particulate (droplet) phase, the particles of which are of a size less than 200 nm, hence they exhibit optical transparency. The pharmaceutical and cosmetic industries are expressing an ever increasing demand for compositions free from an aqueous phase, in order to facilitate their packaging in the form of hard gelatin capsules, tablets and plasters. The compositions known at the present time for the manufacture of hard gelatin capsules, in particular the ones described in the above documents, are unable to meet the need, since the presence of water contained in these mixtures is incompatible with the technique employing hard gelatin capsules. [0057] The invention solves these problems. It relates to an orally administrable composition, in particular for pharmaceutical or cosmetic use, comprising a lipophilic phase, at least one surfactant and at least one cosurfactant which, mixed and in the presence of physiological fluid, form a microemulsion facilitating dissolution in situ and improving the bioavailability of the active principles. Preparation of Formulation in General: [0058] This orally administrable composition capable of forming a microemulsion, comprising at least: [0059] an active principle, [0060] a lipophilic phase consisting of a mixture of fatty acid esters and glycerides, [0061] a surfactant (SA), [0062] a cosurfactant (CoSA), [0063] a solvent, [0064] a hydrophilic phase, [0065] is characterized: in that the lipophilic phase consists of a mixture of C 8 to C 18 polyglycolized glycerides having a hydrophilic-lipophilic balance (HLB) of less than 16, this lipophilic phase representing from 1 to 75% of the total weight of the composition; in that the surfactant (SA) is chosen from the group comprising saturated C 8-C 10 polyglycolized glycerides and oleic esters of polyglycerol, this surfactant also having an HLB of less than 16; in that the cosurfactant (CoSA) is chosen from the group comprising lauric esters of propylene glycol, oleic esters of polyglycerol and ethyl diglycol; in that the SA/CoSA ratio is between 0.3 and 8; and in that the hydrophilic phase of the final microemulsion is supplied after ingestion by the physiological fluid of the digestive milieu. [0066] In one another embodiment of the invention microemulsions as Self-Micro-Emulsifying-Drug-Delivery-Systems (SMEDDS) formulation can include varying amounts of photosensitizer as active agent preferably Temoporfin (mTHPC), while the excipient employed includes a non-limiting list of examples such as: macrogolglycerolhydroxystearate 40, polyethoxylated castor oil, Cremophor®EL (sold by BASF). Polyethyleneglycole 300, Polyethyleneglycole 400, d-alpha-tocopheryl-polyethyleneglycol-1000-succinate: TPGS® (sold by Estman), Caprylocaproyl Macrogolglycerides (Polyoxylglycerides): Labrasol®, Propylene Glycol Monocaprylate/Propylene Glycol Caprylate Capryol® 90, Diethylene Glycol Monoethyl Ether: Transcutol, Oleoyl Macrogolglycerides (Polyoxylglycerides)/Linoleoyl Macrogolglycerides (Polyoxylglycerides): Labrafil®, Lauroyl Macrogolglycerides (Polyoxylglycerides)/Stearoyl Macrogolglycerides (Polyoxylglycerides): Gelucire®, Glyceryl Mono-Linoleate: Maisine®, Propylene Glycol Dicaprylocaprate/Medium Chain Triglycerides: Labrafac®, Propylene Glycol Monolaurate/Propylene Glycol Laurate: Lauroglycol®, Glyceryl Mono-Oleate: Peceol®, Polyglyceryl Oleate: Plurol Oleicque® (all sold by Gattefossé SAS, St. Priest, France); Mono, -Diglycerides: Capmul® MCM, Mixed Diesters of caprylic/capric acids on propylene glycol: Captex®200, Triglycerides of caprylic/capric acid: Captex®355, Polyglycerol oleate: Caprol® MPGO, Oleic esters on Decaglycerol: Caprol® PGE-860, Ethoxylated coconut glycerol esters: Acconon®CO-7, Ethoxylated caprylic/capric glycerol esters: Acconon®CC-6 (All sold by ABITEC Corporation) and other recrystallation inhibitors, bioavailability enhancers, surfactants, emulsifiers, ethanol and water, to be mixed in several different regimes. These formulations will finally be administered filled in soft gelatine capsules. In the duodenum and small intestine the SMEDDS formulation after contact with the intestinal fluid will form single layered micelles sized to about 200 nm suitable to be absorbed easily onto the mucosa for the following uptake in the body. Nanosuspensions [0067] An alternative to the aforementioned way to solubilize highly unsoluble drugs is the reduction of the particle size, which leads to an increased surface area and therefore the dissolution rate increases. However, micronization alone is not sufficient to attain the desired bioavailability for these kind of drugs. Nanonisation has shown to provide higher bioavailability of drugs if the particle size is in the sub-micrometer size range (Müller et al., 1998, 2001] because it increases drug dissolution rate and the saturation solubility of the compound. There are different methods described in the literature for reducing the particle size of drug particles to a nanometer range, for example precipitation ([Trotta et al., 2001], jet milling, pearl milling (Liversidge and Conzentino, 1995) and high-pressure homogenization (Müller & Keck, 2004). [0068] To transform aqueous dispersions into dry powder, one can use lyophilization and spray drying procedures. Spray drying usually requires high temperature in the process, which is not suitable for thermolabile drugs. In such cases, lyophilization is the most suitable procedure. In the lyophilization process, a cryoprotective agent such as mannitol, trehalose or sucrose is added to the solution to avoid particle aggregation after reconstitution of the system. O/W Emulsion Formulation [0069] In another embodiment of the present patent the formulation principle to be administered orally is a mixture of oil and fat compounds with mTHPC. Such emulsions containing soya oil, medium-chain triglycerides, glycerol, egg lecithin, α-Tocopherol, sodium oleate and water in different concentrations are used clinically as a calory sources in i.v. nutrition. Hot-Melt-Extrusion Formulation [0070] In another embodiment of the present invention the formulation principle to be administered orally is a mixture of biocompatible polymers blended with suitable excipients with mTHPC. These mixtures will be molten up homogenously, extruded through a single or twin-screw extruder to form solid dispersions of the API. [0071] These solid dispersions show higher solubility rates of the API due to higher grades of wettability and bioavailability, thus improving the drug release in the GIT. Suitable polymers could be chosen non-exclusively out of the group of “basic butylated methacrylate copolymer (aPMMA)”, Copovidone (COP), Polyethylene glycol-polyvinyl alcohol copolymer (PEG-PVA), Eudragit-variants and other polymers and excipients know to experts in the field of the invention. Nanocrystal Formulation [0072] In another embodiment of the present invention the active drug compound could be administered perorally in a nanocrystal formulation. Extremely fine grinded drug, for example Temoporfin, would be stabilized by surfactants and finally spray-dried to retain their large surface which facilitates resorption in the gastrointestinal tract stably. Powdered Form-Liposome Encapsulated Photosensitizer [0073] In one of the embodiment of the present invention, photosensitizers are encapsulated into a liposome for oral administration. Liposomal vesicles can improve the solubility of hydrophobic photosensitizers to be administrated orally. [0074] Liposomes were prepared according to the following general procedure: [0075] The hydrophobic photosensitizer and typically two or more synthetic phospholipids are dissolved in alcoholic solution. The solution is then dried under vacuum using a rotary evaporator. The mixture is then passed through a homogenizer filter system using a final pore size of 100 nanometers. The rehydration water is supplemented with monosaccharides. The filtrate is collected, filled into vials and optionally freeze dried. [0076] The synthetic Phospholipids such as phosphatidyl choline can be one or more synthetic cholines such as dipalmitoyl phosphatidyl choline (DPPC), dimyristoyl phosphatidyl choline (DMPC), distearoyl phosphatidyl choline (DSPC). Suggested glycerols include dipalmitoyl phosphatidyl glycerol (DPPG) and dimyristoyl phosphatidyl glycerol (DMPG). Certain phospholipids used here in required ratio can stabilize the liposomal formulation and protect it from gastrointestinal tract degradation action. [0077] Thus formulated liposome encapsulating photosensitizer is in the form of dry powder which can formulated into a tablet or can be encapsulated into a hard capsule for oral administration. Nanoparticles as a Drug Carrier System [0078] The oral formulation may also involve nanoparticles on which the photosensitizer is absorbed, in which the photosensitizer is included or to which the photosensitizer is covalently attached. In a preferred formulation the nanoparticles are formed from biodegradable materials such as human serum albumin (HSA) or Poly(lactide-co-glycolide) (PLGA), as is known in the art. Alpha Fetoprotein (AFP) as Carrier System- [0079] Alpha-fetoprotein (AFP) is used as a oncoshuttle in this formulation to target photosensitizer to the tumor cells. AFP is used as an oncoshuttle since most cancers express AFP receptors (AFPR), and hence are target specific. AFP is a large glycoprotein consisting of a polypeptide chain containing about 600 amino acids and a large heterogeneous carbohydrate moiety. AFP molecules contain 15 disulphide bonds. Whereas the disulphide bonds determine the tertiary structure, the carbohydrates confer the molecule with special binding properties. [0080] Preparation of the formulation can be divided into three parts: [0081] 1) unloading the AFP-protein [0082] 2) binding of the drug substance to the protein [0083] 3) isolation of the protein-drug-complex and preservation [0084] As the protein is only available with bound lipophilic substances (for instance fatty acids), these substances have too be liberated from the protein to allow subsequent binding of the drug molecules. [0085] Step 1. Unloading can be achieved with any organic solvent, which does not disturb the protein structure but will dissolute the lipophilic substances. Therefore watery solution of primary and secondary alcohols or polyalcohols can be used. After unloading, the AFP has to be purified by ultrafiltration. [0086] Step 2. The loading procedure requires a solvent which is able to dissolve the drug substance and has to be removed after the incubation time. Removal can be performed by freeze drying or evaporation. [0087] Step 3. The unbound drug substance has to be removed by ultrafiltration and the solution has to be stabilized. Bovine-Serum-Albumin (BSA) as Carrier System [0088] A natural protein such as Bovine-Serum-Albumin (BSA) is used in the present invention to encapsulate the photosensitizer for oral administration. The amino acid sequence of AFP has significant homologies to Bovine-Serum-Albumin. The peculiarity of albumin-like proteins is the presence of three structurally homologous domains formed by two alpha-helical globin-like subdomains. Therefore, BSA can also be used as an effective carrier in PDT. BSA is large globular protein with 17 disulphide bonds. The preparation procedure of BSA formulations is as follows: [0089] Preparation of the formulation can be divided into three parts: [0090] 1) unloading the BSA-protein [0091] 2) binding of the drug substance to the protein [0092] 3) isolation of the protein-drug-complex and preservation [0093] As the protein is only available with bound lipophilic substances (for instance fatty acids and other lipids), these substances have too be liberated from the protein to allow subsequent binding of the drug molecules. [0094] Step 1. Unloading can be achieved with any organic solvent, which does not disturb the protein structure but will dissolve the lipophilic substances. Therefore watery solution of primary and secondary alcohols or polyalcohols can be used. After unloading, the BSA has to be purified by ultrafiltration. [0095] Step 2. The loading procedure requires a solvent which is able to dissolute the drug substance and has to be removed after the incubation time. Removal can be performed by freeze drying or evaporation. [0096] Step 3. The unbound drug substance has to be removed by ultrafiltration and the solution has to be stabilized. [0097] Present formulation methods do not limit to the above mentioned carrier systems and formulations, but it can be used with other carriers suitable for oral formulation like microspheres, polymers, micelles, hydrosoles, apasomes, and niosomes and novel technical devices like iPills etc. [0098] The disclosed orally formulated photosensitizer is administered orally for treating different types of cancerous conditions such as head and neck cancer, prostate cancer, skin cancers and others, it also further includes proliferating and non-proliferating disorders, and other disease conditions such as BPH, dysplasia, Barrett's Oesophagus, Age Related Macular Degeneration, vascular diseases, inflammatory disorders and bacterial and viral infections. It can further be used for cosmetic application of PDT such as skin rejuvenation, acne treatment, scare and wrinkle removal, hair removal, fat reduction and cellulite treatment. It is also used in antimicrobial photodynamic therapy for treating microbial infections; such as viri, bacteria, fungi, protozoan parasites and prions. Further PDT applications include dental problems and others. The present formulation is not limited to above mentioned examples alone but can be extended to other human and animal disorders which can be treated using photodynamic therapy (PDT). [0099] In general PDT treatment method using the present oral administration of photosensitizer involves single administration of photosensitizer via oral route followed by illumination. Further embodiment also involves use of multiple oral administration of photosensitizer followed by single illumination regime or multiple light illumination regime. The multiple oral dosages can be given daily or weekly or as required depending on the disease condition and location. The optimal drug dosage within the tissue can be ensured by measuring fluorescence before the irradiation. Such optimized treatment regime minimizes light sensitivity and maximizes usage of the drug while at the same time limiting necrosis and causing sequential killing of the target tissues. Such optimized multiple treatment regimes also help to induce immune action in the body initiating immune response against targeted cell for long. Depending on the disease condition the above treatment regime may be repeated as required after a short gap. [0100] Further it can also be used for diagnostic purpose by orally administrating a low dosage. The term ‘low’ here means to say a effective dosage that is normal lower than the general administrated effective therapeutic dosages. The term ‘Diagnostic’ means a material useful for testing for the presence or absence of a active agent or disease, and/or a agent that enhances tissue imaging. The term ‘effective’ here means an oral dosage of a diagnostic or therapeutic agent that is useful for producing a desired effect. [0101] In another possible embodiment, tetrapyrrole derivative formulations for oral administration of the present invention are used as non-PDT therapeutic agents or as anti-cancer chemotherapeutic agents without application of light/radiation. The action of the drug in the absence of the light energy is referred to as dark toxicity. The drug here acts as a cytotoxic agent acting directly on the cells. The oral formulated tetrapyrrole of the present invention is adminstered to the patient as a single dose or preferably as a multiple dose. Here the cytotoxic effect is directly dependent of the drug concentration in use and hence needs to be carefully supervised by a physician. This application would be useful for the inactivation of cancer cells, bacteria, fungi and parasites and infectious prions. Determination of Dark Toxicity [0102] Dark toxicity effect of 2,3-Dihydro-2,3-dihydroxy-15,20-dihexyl-5,10-bis(4-carboxy-phenyl)porphyrin (BLC 6066) (refer FIG. 3 ) in different cell lines like MG 82, HT29 and J774A1 was determined by incubating the cell culture with different increasing concentration of BLC6066 in the range of 2 to 10 μmM for about 24 hrs. Cells incubated in the concentration of 10 μM of BLC 6066 showed definite toxicity in human cells, plus strong dark toxicity towards bacteria cells. [0103] The present invention is further illustrated by the following examples, but is not limited thereby. Example 1 FOSLIPOS—A Liposome Based Oral Formulation of a Hydrophobic Photosensitizer for Orally Administered [0104] Foslipos (lipid based formulation of mTHPC, containing DPPC and DPPG) [0105] Drug Dosage: 300 μg mTHPC [0106] Studies were performed using adult female athymic NMRI nu/nu mice (Harlan Winkelmann GmbH, Germany). Six to eight-week old mice weighing 22-24 g were inoculated subcutaneously into the left hind thigh with a suspension of HT29 human colorectal carcinoma cells (0.1 ml of 8×10 7 cells/ml in 5% glucose). Experiments were performed 10 days later, when tumors reached a surface diameter of about 5-8 mm, and a thickness of 2-3 mm in height. [0107] Foslipos (300 μg mTHPC drug dosages) was administered by gavage. Immediately after application fluorescence of the skin was measured by a fiber spectrometer (Jeti GmbH Jena). Excitation wavelength was 415 nm, emission wavelength 652 nm. Fluorescence of the skin was measured at different time points after administration (0 h, 1 h, 2 h, 4 h, 6 h, 8 h, 25 h, 31 h and 49 h). High fluorescence values could be measured for the Foslipos from 24 h after oral application (refer FIG. 2 ). [0108] HPLC Analysis [0109] Animals were sacrificed 50 hours after oral application of Foslipos (three mice each time point). Immediately after the animals were killed the plasma, liver, spleen, colon, tumor, skin and skeletal muscle were dissected, weighed and stored at −70° C. All tissue samples were reduced to small pieces by cutting with a scalpel, weighed and freeze dried (Christ Freeze drying system Alpha 1-4 LSC). The resulting powdered tissue was weighed and approx. 10-20 mg was transferred in to a 2.0 ml reaction tube and 1.5 ml of methanol: Dimethyl sulfoxide (DMSO) (3:5, v:v) was added. The samples are mixed for five seconds using a vortex mixer (Merck Eurolab, MELB 1719) operating at 2,400 rpm and then incubated at 60° C. under continuous shaking for at least 12 hours. All samples were centrifuged at 16,000 g (Microfuge, Heraeus, Germany) for five minutes. 1 ml of each supernatant was transferred to a HPLC vial for HPLC analysis. [0110] HPLC analysis of the sample shows higher Foslipos accumulation in tumor cells compared to other tissues readings. [0111] Having described preferred embodiments of the invention with reference to the accompanying drawings, it is to be understood that the invention is not limited to the precise embodiments, and that various changes and modifications may be effected therein by skilled in the art without departing from the scope or spirit of the invention as defined in the appended claims.

Oral formulations and method of formulating photosensitive agents for oral administration during photodynamic therapy (PDT) and Antimicrobial photodynamic therapy (APDT) treatment are presented. The oral formulated photosensitizers show increased solubility and permeability, thus improving the bioavailability of photosensitizers at the treatment site. An orally administered photosensitizer is suitably formulated for mucosal adhesion and absorption via gastrointestinal mucosal membranes. Oral formulation provided herein use lipids and known proteins as carriers for photosensitizers by oral route. Carriers for encapsulating preselected photosensitizers include conventional liposomes, pegylated liposomes, nanoemulsions, nanocrystrals, nanoparticles, fatty emulsions, lipidic formulations, hydrosols, SMEDDS, Alpha-Feto protein (AFP), and Bovine-Serum-Albumin (BSA), fatty emulsions, hot-melt-extrudates and nanoparticles. The oral formulation, in case of a hydrophobic photosensitizer in the present invention, is stabilized using suitable surfactants/solubilizers thus preventing aggregation of the drug in the stomach and until it is absorbed in the duodenum and the small intestine. Oral formulations can be administered in the form of liquid, capsule, tablet, powder, paste or gel. Formulated drugs can be administered orally as one single dose or in multiple doses before administering PDT. In one embodiment Temoporfin (m-THPC) is used as a photosensitizer in the oral formulations. Temoporfin like many hydrophobic photosensitizers are especially suitable to be administered orally because there is no known enzyme system in the mammalian body which can metabolize Temoporfin or similar photosensitizers. Temoporfin can reach the blood system unchanged and fully active after absorption of the formulation in the gastrointestinal tract.

CROSS REFERENCES TO RELATED APPLICATIONS [0001] This application claims priority to provisional application No. 60/976,175 filed on Sep. 28, 2007, the entire disclosure of which is hereby incorporated by reference. TECHNICAL FIELD [0002] This invention relates to a protective mouthguard for use by athletes that incorporates a color customizable feature, allowing users to customize the visible color of the mouthguard. BACKGROUND OF THE INVENTION [0003] Existing mouthguards are generally horseshoe or U-shaped, with inner and outer walls that form a trough or channel for the upper or lower teeth. The mouthguards are typically made of a type of resin, usually a thermoplastic that softens in boiling water allowing the user to customize the mouthguard to fit the user's mouth, while still maintaining shock absorbing properties. The mouthguards are generally produced using an injection molding process, during which the resin is injected at high pressure into a mold, which is the inverse of the product's shape. The mold is typically made from metal and precision-machined to form the features of the desired part. In the molding process, the design of the mold must account for the ability to remove the molded product from the mold without damaging or distorting the molded product. [0004] As many mouthguards are worn in team sports, it would be advantageous to have mouthguards that colored with the appropriate team colors. During the manufacturing process, a colorant, such as dye, can be added after the resin to produce different colors for the separate pieces that are injection molded. [0005] This form of color customization has some major disadvantages with regards to the production and mass manufacturing of the product. Each time the colorant is added, the entire injection molding process is lengthened, which in turn increases production costs. In addition, because a different colorant has to be used if different colored pieces are desired, the process is further lengthened, and a continuous process cannot be maintained. Since the colorization of the mouthguard must be done during the manufacturing process, any commercial mass manufacturer must accurately predict the amount of mouthguard that will sell for each color and make the right amount for each. Such a prediction is not practical. Any pre-colored mouthguards that have the wrong team colors will not be bought by the users. SUMMARY OF THE INVENTION [0006] This invention solves the aforementioned problems by allowing the mouthguard user to color customize the mouthguard post-production and purchase. The mouthguard incorporates several different means in which a color piece or tab is secured to a designated area of the mouthguard, and is visible from the outside of the mouthguard. [0007] In general, the invented mouthguard is U-shaped to fit the shape of the user's mouth, with optional inner and outer walls creating a trough for the user's teeth. The mouthguard is made of a type of thermoplastic that will soften when heated to allow the user to fit the mouthguard to his mouth. The mouthguard has locations in which a color tab can be inserted that will be visible when the user has the mouthguard in his mouth. The locations can be slots in the mouthguard that will hold the color tab securely with appropriately placed holes to reveal the colored tabs. [0008] The use of the color tab/insert in the mouthguard provides an advantage over the use of coloration in the injection molding process. Because the color customization occurs after production of the mouthguard, the manufacturer can continuously produce one model per mold without any interruptions to the process. In addition, users of the mouthguard can switch the color tabs/inserts if they so choose, whereas the colorization during the injection molding process is permanent. [0009] The mouthguard may also include an optional tether located and extending out from the bottom of the mouthguard. The tether may be composed of the same material as the mouthguard. The tether will have an area directly attached to the tray bottom that will tear at a predetermined pull force for a desired tear away feature. The area could be thinner material or have perforations to weaken the area. Other means of affecting the area to ensure that the area will break before any other section of the tether can be used and still be within the scope of the invention. The tether piece will then thicken as it extends outward toward the wearer's facemask. Behind the area where the tether is designed to breakaway is a hole in the mouthguard. The hole is oval in shape while the tether is cylindrical or vice versa. The difference will allow the tether to have a friction fit within the hole. Once the tether is torn away, this creates a blind or invisible hole that is revealed so the user can replace the tether with a friction type fit, round tongue to oval shaped hole. [0010] The opposite side of the tether will feature a wrap around detail to attach to the users facemask found on most protective helmets. The wrap around detail involves a ratcheted system that will keep the tether loop created by looping the mouthpiece through the tether end opening and when pulled tight using the elastomer coefficient of friction characteristics and a mating mechanical ratcheted detail keeping the loop tightly wound around the user's facemask. The wrap around feature will have a pull away or break free force greater than that of the thin tear away area molded next to the tray bottom. BRIEF DESCRIPTION OF DRAWINGS [0011] FIG. 1 shows a perspective view of the invented mouthguard in accordance with one embodiment of the invention. [0012] FIG. 2 shows a perspective view of the same embodiment with the components separated from each other. [0013] FIG. 3 shows a front view of the same embodiment with the customizable color insert in the mouthguard. [0014] FIG. 4 shows a bottom view of the same embodiment. [0015] FIG. 5 shows a top view of the same embodiment. [0016] FIG. 6 shows a side view of the same embodiment. [0017] FIG. 7 shows a cross-sectional view of the bottom tray of the mouthguard of FIG. 1 along the lines A-A. [0018] FIG. 8 shows a cross-sectional view of the mouthguard of FIG. 1 along the lines B-B. [0019] FIG. 9 shows a front view of the color insert. [0020] FIG. 10 shows a cross-sectional view of the invented mouthguard in accordance with another embodiment of the mouthguard. [0021] FIG. 11 shows a perspective view of another embodiment with the components separated from each other. [0022] FIG. 12 shows a front view of yet another embodiment. [0023] FIG. 13 shows a top view of the same embodiment. [0024] FIG. 14 shows a side view of the same embodiment. [0025] FIG. 15 shows a perspective view of yet another embodiment. [0026] FIG. 16 shows a perspective view of yet another embodiment. [0027] FIG. 17 shows a perspective view of yet another embodiment. [0028] FIG. 18 shows a perspective view of yet another embodiment. [0029] FIG. 19 shows a perspective view of yet another embodiment. [0030] FIG. 20 shows a perspective view of yet another embodiment DETAILED DESCRIPTION [0031] For the purposes of understanding the invention, reference will now be made to the embodiments illustrated in the drawings. It will be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates. [0032] FIGS. 1-8 depict one embodiment of the invention. The invented mouthguard 100 is composed of a base unit 102 and tether 104 . The base unit 102 is U-shaped to conform to a user's mouth and the tether 104 extends from the front of the mouthguard. On the top surface, base unit 102 has a trough 112 running along the inside of the U-shape to fit the user's upper teeth. In this embodiment, base unit 102 is comprised of three different portions: (1) a bottom tray 106 , (2) a top piece 108 and (3) a color insert 110 . [0033] The three components of the base unit are configured to fit together. The bottom tray 106 is U-shaped and will be sized to fit into the user's mouth. The bottom tray 106 has a double outer wall 116 (composed of inner wall 124 and outer wall 118 ) that can extend along the front of the mouthguard. If desirable, the double wall 116 can extend along the entire outside labial perimeter of the mouthguard, continuously or in sections. The inner and outer walls 124 , 118 are placed closed together so that a thin space or slot exists between the two in which the color insert 110 can be placed. The outer wall 118 of the double wall 116 has holes 122 that reveal the color insert 110 when it is placed in the slot 120 . The holes in this embodiment are in the shape of an “X” and an “O”, though the invention is not limited to these shapes. [0034] Inner wall of the double wall has a “trap door” that encloses the slot to ensure that the color insert 110 is firmly set within the slot 120 . The trap door can be seen in detail in FIG. 7 . FIG. 7 is a cut-away depiction of the bottom tray 106 along lines A-A. As can be seen, outer wall 118 is a straight wall with holes 122 in it. Inner wall 124 has a lip 126 that projects toward outer wall 118 . Once the color strip is placed in the slot between the inner and outer walls, the projecting lip 126 will prevent the color insert from coming out of the slot. The location of projecting lip 126 is shown on inner wall, but it could easily be located on outer wall. [0035] Top piece 108 is also in a U-shape to conform to the user's mouth. Top piece 108 can have the trough 112 on its upper surface and the bottom surface will conform to the upper surface of the bottom tray 106 . Top piece 108 will also have a lip 114 that will come on top of the double wall 116 . Lip 114 will help to seal the slot 120 and prevent color insert 110 from coming out of the slot 120 . [0036] A typical color tab/insert can be seen in FIG. 9 . It is made of a firm yet malleable material, such as plastic or rubber, and can come in different forms, such as, but not limited to, stickers, decals, or just plain tabs. It can be of all various colors, but is not limited to a solid color as it may include patterns of different sorts as well. This provides an additional advantage over existing mouthguards. With the current molding process, it would be difficult, if not impossible, to incorporate elaborate patterns of any sort, let alone mass produce mouthguards with such patterns. For commercialization purposes, a multitude of different colored inserts can be inexpensively manufactured and packaged with a single mouthguard product. [0037] Each component of base unit 102 can be easily manufactured using injection molding techniques. Other techniques, such as extrusion blow molding, injection blow molding, compression molding, thermal forming or cast pour molding process lost core molding can also be used. Bottom tray 106 can be composed of a relatively material that has some durability and flexibility, such as a thermoplastic elastomer (TPE). Bottom tray 106 will be molded first. Double wall 116 , slot 120 , holes 122 and lip 126 are all moldable features and mouthguard bottom tray 106 is easily removed from the mold. Bottom tray 106 will be capable of accepting a second shot of a softer, pliable material, such as ethylene vinyl acetate (“EVA”), on top of it to create top piece 108 during the injection molding process. In this process, the top piece will conform to the shape of the bottom tray 106 and the lip 114 can be shaped to cover both inner and outer walls 118 , 124 of the bottom tray 106 . Color insert 110 can be easily manufactured in numerous colors and colored patterns to be included with the base unit 102 . It will be evident to one of skill in the art that any appropriate materials can be used for both the top and bottom pieces. [0038] To custom color the mouthguard, the user will choose the appropriately colored color insert 110 that corresponds to the team colors. In order to add the color insert 110 , the user must pull up the outer lip 114 of the top piece 108 and slide the insert into the slot 120 . The lip 114 will naturally return back to its original shape and cover both the tops of the inner and outer walls. Alternatively, the color strip can be placed into the slot 120 through appropriate openings in the side or bottom of the mouthguard. [0039] After inserting the color insert 110 , the user will custom fit the mouthguard by boiling the mouthguard in water. This boiling process will soften the top piece 108 . Afterwards, the mouthguard is placed in the user's mouth and the user will bite down onto the mouthguard to conform the mouthguard to the teeth. After the mouthguard has cooled, the top piece 108 will be cured and fitted to the user's teeth. In addition, the top piece 108 will be forced against the double wall 116 and on top of the double wall 116 to seal the slot closed. [0040] The configuration of the top piece 108 and the double wall 116 is best seen in FIG. 8 . FIG. 8 shows a cross-sectional view of the two components along line B-B. As can be seen in the detailed figure, the inner wall 124 and outer wall 118 are pressed against one another. This occurs, in part, from the pressure from the user biting down on the mouthguard during the customization process and the resilience of the top piece 108 after being cured through the boil and bite process. [0041] FIGS. 10-11 depict another embodiment that is a similar to the embodiment described above. Similar to that embodiment, the mouthguard base unit 201 comprises a top piece 202 , a bottom tray 203 and color insert 204 . The bottom tray 203 has a single outer wall 207 instead of a double wall. Single outer wall 207 has holes or revealed sections 206 in the front. Top piece 202 has an indented section 210 in the front of it to accommodate the color insert 204 . Color insert 204 will be placed in between the single outer wall 207 of bottom tray 203 and indented section 210 of the top piece 202 . During the customization process in which the mouthguard is boiled and custom fitted to the user's teeth, the color insert will be secured in between the top piece and the bottom tray. [0042] FIGS. 12-14 depict another embodiment in which the top piece 302 does not completely overlay the bottom piece 303 . The top piece 302 only has an outer wall that ends in a lip 307 . Only the front teeth come into contact with the top piece 302 at a bite portion 308 . The back teeth come into contact with the trough 304 of the bottom piece 303 . The bottom piece still has the holes 310 in the front of its outer wall 305 . The color insert can be seen through these holes 310 , as shown in FIG. 12 . [0043] FIG. 15 depicts another embodiment. Unlike the embodiments described above, this embodiment is made of only one piece. Similar to the bottom piece of the first embodiment, this mouthguard 401 has a double outer wall 402 and an inner wall 403 that form a trough 404 for the user's teeth. The double wall 402 creates a slot 406 in which the color insert will fit. The outermost wall of the double wall 402 contains the holes 405 , and the color insert will be visible through these holes. [0044] FIG. 16 depicts another embodiment that is similar to the previously described embodiment. In this embodiment, the slot 506 created by the double wall 502 extends all the way to the rear of the mouthguard 501 . This allows the option of adding holes all along the outer wall, in addition to the holes 505 in the front, and using a longer color insert to sit in the slot. The insert will then be visible through these additional holes all along the outer wall. [0045] FIG. 17 depicts yet another embodiment that comprises just one piece 601 . It has an outer wall 602 and an inner wall 603 , forming a trough 604 for the user's teeth. In the outer wall 602 , there is a removable section 605 that contains the holes 606 . This creates a recess or compartment 607 within the front wall of the mouthguard in which the color insert is to be placed. After the color insert is placed in the recess, the removable section is fit back into the recess, thereby firmly securing the color insert. [0046] FIG. 18 depicts yet another embodiment that is made of only one piece 701 . The outer wall 702 has a slot 705 cut out in which the color insert 707 is inserted in from the side. The front of the outer wall 702 has holes 706 that penetrate to the back wall of the slot 705 . Once the color insert 707 is inserted into the slot 705 , the color will be clearly visible. [0047] Another means in which this invention can realize the advantage of mass production and easier customization by the user is to generally have a color strip attached to the outer surface of the labial wall of the mouthguard. This can be accomplished in a number of ways. Two such ways are depicted in FIGS. 19 and 20 . Again, like the embodiments described above, these two embodiments are made of only one piece. However, on the outer surface of the outer wall are protrusions 805 and 905 , respectively, on which the color tabs will be attached. These protrusions take the shapes of knobs 805 and Ts 905 , respectively. With respect to the knobs 805 , the color tab 806 will have holes 807 to fit around the knobs, and that are spaced appropriately apart to allow the tab 806 to fit tightly against the face of the outer wall 802 . The Ts 905 of the other embodiment perform a similar function of securing the color tab 906 to the body 901 . The color tab 906 will likely have to be of greater thickness than the tabs/inserts of the previous embodiments so that it may include the sister connections 907 to the T-shaped protrusions 905 . Another means to accomplish this may be done by using a decal or sticker to stick to the front of the labial wall of the mouthguard, thereby eliminating the need for protrusions on the outer wall. [0048] The present invention may be embodied in other specific forms without departing from the spirit or general characteristics thereof; therefore, the embodiments described herein are to be considered in all respects illustrative and not restrictive. The scope of the invention is to be indicated by the appended claims, rather than by the foregoing description.

This invention relates to a protective mouthguard for use by athletes that incorporates a color customizable feature, allowing users to customize the visible color of the mouthguard. The invented protective mouthguard has a u-shaped base that will fit inside of a user's mouth. The front surface of the mouthguard can be visible when the mouthguard is worn by the user inside of his mouth. A colorable strip is placed inside a cavity in the front wall of the mouthguard and is visible through holes that are placed in the front wall.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention pertains to animal feeders, and more particularly, to portable livestock feeding methods and devices. 2. Prior Art Agri-economics has become of critical importance in recent years. This is particularly true of the beef cattle industry, but generally applies to all livestock-oriented endeavors. The rancher, dairyman, or the like is continually faced with rising operating costs, while the prices paid for his products have not kept pace. Additionally, the rancher has been unable to take full advantage of "economics of size." One of the prime reasons for this situation is the necessity of feeding pre-cut, dried fodder or hay to the livestock. While the requirements for feeding pre-cut feed are dependent upon climate, almost all locations in the U.S. require that cattle and other livestock be fed at least part of the year. In northern states, such as Wyoming and Montana, feeding may be required as much as nine months of the year. Feeding is a costly and time-consuming operation. The economics of, for example, the beef cattle industry could be greatly improved if the manpower required in performing the feeding task and/or the amount of waste normally associated with feeding could be minimized. Attempts to minimize the manpower required in performing the feeding task by employing large, stationary feeding "pavilions" have generally not met with success. Many such devices have been introduced, such as large feeding troughs, conveyor devices, and the like. However, in general, these devices have had inherent drawbacks. First, many are mechanically complicated, making the use of such devices for the small rancher almost prohibitive in terms of initial purchase as well as maintenance and upkeep. Second, they require that a large number of cattle be fed in a very confined area which leads to sanitary and disease problems. Third, huge quantities of feed are placed in these devices where the cattle, even when restrained by stanchions, have almost unrestrained access to the loose fodder. Thus the feeding cattle broadcast or spill or otherwise dump a large fraction of the feed on the ground where it is trampled and soiled. The trampled and soiled feed cannot be eaten and is therefore wasted. Thus, most large installations waste a large percentage of the fodder purchased. In addition to the inherent drawbacks, stationary feeding installations also prevent the rancher from taking advantage of natural pasture grass which, although not sufficient to support a total herd at certain times of the year, is ofttimes of sufficient quantity to substantially supplement the pre-cut feed. Thus, in addition to wasting a great deal of the pre-cut feed, more of the feed has to be fed for a longer period of time, when stationary feeding installations are used. Portable feeding methods and devices are also known. One of the simplest methods involves merely broadcasting or breaking baled hay on the ground. While this method alleviates some problems associated with stationary feeding installations, such as sanitary and disease problems, the waste is enormous. Small, portable feeding devices have been constructed over the years, but none to date has been totally effective in eliminating waste while still allowing substantially large volumes of feed to be efficiently fed to the livestock. For example, some portable feeding devices provide elevated racks communicating with troughs such that gravity forces the feed contained in the rack into the trough as the animals feed. See, for example, U.S. Pat. No. 329,029 to Dye. Although the rack provides a means for placing greater amounts of feed in the feeder, the troughs still allow the feeding livestock unrestricted access to the feed. Other attempts involve the use of stanchions to form an elevated periphery around a feeder box to allow the livestock limited access to the feed contained within the box. While these devices sufficiently restrain the cattle from wasting the feed, the volume of accessible feed is small. The animals only have access to that amount of feed which can be reached by extending the length of their necks through the stanchions and down into the trough. Thus, such portable feeders, while diminishing waste, require frequent and costly refilling. A more recent portable feeding device is disclosed in U.S. Pat. No. 3,802,394 issued to Mahler Apr. 9, 1974. This device incorporates a feeder and a means for wetting the pre-cut feed with a liquid food supplement by dipping restrained feed in a trough of the supplement located below the confined feed. Specifically, this device incorporates a rotatable, volumed chamber, bounded in part by a stationary mesh wall. Loose fodder is placed into the rotatable volume. The volume is then varied by means of hinged, solid partitions which are manually manipulated in angular relationship one to the other. This action simultaneously compacts the feed and urges the feed toward the stationary meshed wall. While this device allows the cattle limited access to the feed, thus preventing a substantial amount of waste, the volume of feed that can be fed is limited. In addition, the device must be manually manipulated from time to time, to maintain compaction of the feed, thus requiring constant attendance. Additionally, because the solid partitions are hinged about a common axis, confinement of the volume can only be accomplished by rotating the partitions in angular relation, one to the other. Thus, the livestock cannot gain access to a retained residual of feed which remains within the container. The present invention substantially alleviates the problems associated with heretofore-known portable feeders by allowing livestock continuous, limited access to the outer wall of a large mass of contained, compacted feed until the mass is substantially depleted; while preventing the feeding livestock from obtaining unrestricted access to the feed mass. The method and apparatus of the present invention allows for the substantially waste-free feeding of large quantities of pre-cut feed and preferably baled or compacted feed at virtually any desired location. In addition, the apparatus of the instant invention is economical to maintain, has few moving parts, requires no outside energy source other than the feeding cattle, requires essentially no maintenance, and is virtually indestructible. SUMMARY OF THE INVENTION In accordance with the broader aspects of the invention, there is provided at least one movably supported, perforated barrier which forms a confining segment of a mobile container such that the barrier is continuously urged against a volume of feed confined within the container by the action of livestock feeding through the perforated barrier. Thus the feeding livestock have continual, limited access to the outer wall of the feed mass, but are unable to gain unrestricted access to the total volume of feed. According to one embodiment, the station comprises a roofed, mobile, rectangular-shaped, variable volume hopper, adapted for confining fibrous feed and being formed by a pair of spaced-apart upstanding opposing end walls and at least one rigid, mesh-covered panel movably suspended interior the opposing end walls such that the combined action of gravity and livestock feeding through the mesh urge the suspended panel continuously against the outer wall of confined feed until the confined feed is substantially totally consumed. In preferred forms of the apparatus, each opposing end wall has fixedly attached thereto at least one sloping track. The rigid, mesh-covered panel is movably suspended on opposing sloping tracks by means of a pair of support rods which are fixedly attached to the upper portion of the panel such that the support rods extend beyond the longitudinal dimension of the panel. Each rod engages one of the opposing tracks by resting on the top surface thereof. Thus suspended, the panel may be articulated outwardly and upwardly in an arc for efficient and expeditious loading of the feeding station. The method of the invention comprises continuously urging a movably suspended, perforated barrier, having perforations of sufficient size for livestock to secure fibrous feed material therethrough, against a volume of confined fibrous feed material by the combined action of gravity and livestock feeding through the perforated barrier. BRIEF DESCRIPTION OF THE DRAWINGS The advantages of the present invention will be readily apparent and appreciated by those of ordinary skill in the art as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanied drawings in which: FIG. 1 is a perspective view of a preferred embodiment of the novel portable animal feeding station; FIG. 2 is a sectional end view of the apparatus taken through 2--2 in FIG. 1; FIG. 3 illustrates an end view of the apparatus showing the articulation of the panel for loading; FIG. 4 illustrates an end view of the apparatus with the panel in its fully articulated and recessed position for loading; FIG. 5 illustrates preferred means for movably suspending the meshed panels on the sloped track; and FIG. 6 illustrates a top view, with the roof removed, showing the mesh-covered, suspended panels in their extended position as they appear when the feeder is full, and a phantom representation of the panels in their collapsed position as they appear when the feeder has been emptied. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawings wherein like reference characters designate like or corresponding parts throughout the several views, there is illustrated in FIG. 1 a portable animal feeding station of the present invention. The feeding station, which for purposes of description is generally designated by reference numeral 10, has a mesh-covered, ractangular-shaped variable volume enclosure or hopper 12 which is fixedly supported upon a pair of skids 14a and 14b; and carries, mounted thereon and covering the top portion thereof, a roof 16. A removable pull bar 18 is attached to one end of the hopper 12. The hopper 12 is formed by a rectangular base plate 20 containing, respectively, fixedly attached at each corner thereof, four upstanding posts 22a, 22b, 22c and 22d. Fixedly attached between upstanding posts 22a and 22b, and 22c and 22d, which form opposing ends of hopper 12, are support members 24a and 24b. Upstanding posts 22a and 22b, support member 24a and the end portion of rectangular base plate 20 form one end wall which is covered with wire mesh. Likewise, upstanding posts 22c and 22d, support member 24b and the other end portion of rectangular base plate 20 form an opposing end wall which is covered with wire mesh. Fixedly mounted between upstanding posts 22a and 22b, and 22c and 22d are v-shaped tracks 26a and 26b, respectively. The apex of v-shaped tracks 26a and 26b are supportedly attached to the center of support members 24a and 24 b, respectively. Fixedly attached to one longitudinal side of base plate 20 and the lower portion of upstanding posts 22b and 22c is a rigid, mesh-covered restraining partition 28a. Likewise, fixedly attached to the opposite longitudinal side of base plate 20 and the lower portion of upstanding posts 22a and 22d is a rigid, mesh-covered restraining partition 28b. The restraining partitions 28a and 28b are of sufficient height to prevent animals entering the confinement, yet not of such a height to restrict consumption of the confined feed. A height of about 18 inches measured from the ground has been found sufficient. The remaining portion of each longitudinal side of hopper 12 is formed by a pair of movably suspended, articulating, perforated panels 30a and 30b. Each panel 30b and 30b is a rigid, mesh-covered, rectangular frame having elongated dimensions slightly less than the distance between upstanding posts 22b and 22c, and 22a and 22d, respectively; and being of a height such that the bottom longitudinal portion of each panel 30a and 30 b does not contact the upper longitudinal portion of respective restraining partitions 28a and 28b. Fixedly attached to the upper longitudinal portion of panels 30a and 30b, respectively, are elongated support rods 32a and 32b. The support rods 32a and 32b extend, on each end, substantially beyond the longitudinal dimension of panels 30a and 30b, respectively; and, thus beyond each end wall of hopper 12. The extended portions of each support rod, 32a and 32b, engage the v-shaped tracks 26a and 26 b by movably resting on the top surface thereof, as shown in FIG. 5. Thus, each panel 30a and 30b hangs movably suspended, by means of elongated support rods 32a and 32b engaging appropriate portions of opposing v-shaped tracks 26a and 26b. Restraining pins 34a, 34b, 34c, and 34d (not shown) are slidingly mounted in brackets attached to respective upstanding posts 22 (a-d). The restraining pins slidingly engage the outward facing bottom portion of panels 30a and 30b to restrain the panels from articulating when feeding station 10 is in operation, as will be more particularly described hereinafter. In operation, the empty feeding station is pulled to an appropriate location in a pasture or the like by means of removable pull bar 18, preferably behind a truck loaded with baled hay or fodder. Once in position, the removable pull bar 18 is removed and one panel (30a or 30b) is articulated upwardly about the appropriate support rod (32a or 32b), as shown in FIG. 3. The panel is then pushed completely back in the direction of arrow 36 and further articulated into a recessed position, as shown in FIG. 4. A latch means 38 is provided on the roof 16 for securely fastening the panel in the recessed position for loading. It will be realized that while both panels are adapted for articulation and positioning for loading, only one panel at a time can assume the recessed position for loading, as shown in FIG. 4. Baled hay or fodder is stacked either longitudinally or widthwise on the ground within the dimension of the confines of hopper 12. As can be seen in the figures, the total confines, i.e. the width, length, and height dimensions of the feeding station, can be completely filled with compressed fodder or hay. As each bale is placed or stacked within the confines of hopper 12, the baling wire or other restraining feature used to bale the hay is severed. Once the hopper 12 is filled, the articulated panel is unlatched and returned to its hanging position. Preferably, restraining pins 34 a-d are then positioned to engage the outward facing bottom portion of each panel. Although not critical to the invention, the restraining pins are provided to prevent outward articulation of the movable, suspended panels by feeding livestock. Normally, the panels are of sufficient weight to prevent such articulation and thus the restraining pins are not needed. Once the pins are in place, the filled feeding station is operable. As the cattle feed by pulling the confined feed material through the wire mesh, the panels are continually urged against the remaining wall of the feed in the hopper. As shown in FIG. 2, as the feed is eaten, the panels are urged along the v-shaped tracks 26a and 26b toward the center of hopper 12 and thus toward one another. As a smaller and smaller volume of feed is confined between the panels (30a and 30b), some seepage or spillage can occur underneath the bottom longitudinal portion of each panel. Restraining partitions 28a and 28b prevent the livestock from trampling or soiling this spillage; but, allow the animals to consume this spillage by feeding between the positioned panel and the corresponding restraining partition. FIG. 5 shows the movement of one end of the elongated support rod 32b along the top surface of the v-shaped track 26b as the animals consume the feed. The sloping configuration of the track utilizes gravity to maintain the panel against the outer wall of feed. Thus, as the livestock feed, urging the movably suspended panel against the outer wall of confined feed, gravity acts on the panel to create a compressive force maintaining the feed in a compact mass between the movably suspended panels. As the feeding station is emptied, the panels progressively move inwardly, finally coming to rest proximate one another in the center of the hopper 12, as shown in phantom in FIG. 6. The hopper 12 of the instant invention need not contain a floor. Thus, the feed is loaded within the confines of hopper 12 and is supported directly on the ground beneath the confine. In another embodiment, as shown in FIG. 2, the feeding station 10 may employ a floor 40 which is integrally formed as a portion of the hopper 12. In accordance with this embodiment, the hopper 12 can be filled at any location, for example, proximate a hay stack, and moved to a particular location. This embodiment thus alleviates the need for separately transporting the feeding station and the feed to the desired location. Additionally, in accordance with this embodiment, the feeding station may be used to store feed until an apropriate time for use. Thus, it will be realized that the loaded station may be pulled to a desired location and cordoned off, or heavy plastic sheets may be placed over the meshed walls to prevent livestock access to the feed. In this manner, the station provides a convenient device for storing the feed until needed. It should be noted that in accordance with this embodiment, wherein a flooring is provided, the length of the panels and the slope of the tracks must be adjusted such that the panels traveling along the tracks do not at any point engage the flooring, thus stopping the panels from further movement toward the center of the hopper. The slope of the tracks is not particularly critical; however, preferably the slope is sufficient to urge the panel snugly against the mass of feed. It will be realized by the skilled artisan that the weight of the panel will, to some extent, determine the slope required to gravitationally maintain the panel against the feed. It has been found that tracks having no slope can be utilized in accordance with the invention, since the feeding animals exert sufficient force to urge the panels against the feed without the gravitational force. However, this embodiment is not preferred, since it allows the confined feed a greater opportunity to "mound" of its own weight. It will be appreciated that the feeding station, as depicted in the figures, is completely symmetrical. However, the feeding station of the instant invention can be configured so as to have only one movable panel. When this is done, the width of the feeding station must be somewhat reduced, since the restraining partition restricts the total movement of the livestock in reaching the feed. Preferably, the feeding station is completely mesh-enclosed such that cattle have access to the feed from any side, thus allowing more cattle to feed simultaneously without interfering with one another. The movement of the panels and the force of gravity tend to compact the confined feed so that it is urged toward the ends of the feeding station and thus against the inner side of the mesh covering opposing end walls of the hopper. If desired, the end walls of the hopper can be solid partitions or walls to prevent over-exposure of the feed to the elements. The size of mesh openings or perforations for a particular feeding situation will depend upon the livestock to be fed and the feed employed. Generally, the mesh openings should be of sufficient size to allow easy access to the feed material, but not be so large as to allow the animal to pull large quantities of the feed material from the hopper. Preferably, a mesh having a grid opening of about 6 inches square is sufficient when pre-cut, baled hay is used as the feed material. This opening size has been found to allow access to the feed, while providing sufficient restraint to prevent waste. The material from which the feeding station is constructed is not critical. Any material which is durable and weather-resistant is sufficient. When lighter materials are utilized, however, added weight to the bottom of the hanging panels may be required so that they function normally and cannot be articulated by, for example, an animal grabbing the mesh in its teeth and moving backwards. The roof is provided totally for convenience. As is well known, the roof prevents feed contained within the feeding station from undue exposure to weather such as rain, snow and the like which hampers the feeding, as well as enhancing spoilage of the feed. Preferably, the roof employs a slight overhang which may be extended to any desired practical length. one of the particularly advantageous aspects of the instant feeding station is that the roof need not be removed in order to load the feeding station. Additionally, the height of the feeding station is preferably such that a man can walk underneath the roof overhang. Thus, even very substantial overhangs will not interfere with either the feeding, loading, or transporting of the station. It will be noted that the preferred feeding station can be loaded with equal ease from either side. A particularly unique aspect of this invention is the manner in which the panels articulate and then can be forced back and recessed parallel to the roof and latched thereto for loading. In this manner, the roof need not be removed. Additionally, a separate supporting means is not required in order to hold the panel in the articulated position in loading the station. The pull bar 18 is removed prior to allowing the livestock to feed from the station. This is to provide easy access to the feed and prevent the animals from injuring themselves on the protruding bar. A collapsible or retractable bar may also be utilized. The suspension means may be any known in the art which provides movable suspension of the panel. For example, a u-shaped, "grooved" type track can be utilized with, for example, a mating roller surface which is rotatably connected to the panel by means of bearings, sleeves and the like. Other means for movably suspending the panels will be readily apparent to the skilled artisan. The elongated support rod resting upon the top portion of the track is preferred for simplicity. Additionally, the mechanism requires essentially no maintenance. It has been found that even if the elongated support rod becomes slightly rusted, the pressure of the feeding livestock on the panel is sufficient to cause the panel to move and engage the feed as required. Preferably, the elongated supports extend beyond the tracks, and thus beyond the end of opposing end walls of the hopper, as is shown in detail in FIG. 5. During feeding, the panel can become slightly askew on the tracks because, for example, animals feed at one end of the panel or the other. This condition will quickly right itself. However, the support rods need be of sufficient length to prevent the skewed panel from falling off the track. The hopper is fixedly mounted on runners or skids to afford mobility of the station. It will be realized by those skilled in the art, any means or method known for transporting large objects may be utilized to afford portability of the station. If advantageous, the feeding station of the instant invention can be permanently mounted on a vehicle having a self-contained motor means. While the invention has been explained in relation to its preferred embodiments, it is to be understood that various modifications thereof will become apparent to those skilled in the art upon reading the specification and is intended to cover such modifications as fall within the scope of the appended claims.

Disclosed is a novel, portable, animal feeding station which provides livestock, at virtually any desired location, waste-free access to fibrous feed material in quantities heretofore unobtainable with a portable unit. Compacted fibrous feed is charged into a rectangular-shaped, variable volume hopper formed by a pair of upstanding stationary, spaced-apart, opposing end walls and a pair of movably suspended mesh-covered side panels. The side panels are movably suspended on sloping tracks mounted interior the end walls such that the panels are positioned by gravity against the confined feed mass. Feeding livestock are able to grasp the fibrous feed through the mesh according to their need, and in doing so forcibly urge the panel, along the sloping tracks, against the remaining feed mass. Thus, the livestock have continuous limited access to the outer wall of the feed mass, until the mass is depleted; but are unable to obtain unrestricted access to the feed which would enable the animals to scatter and waste it.

This application is a continuation of U.S. patent application Ser. No. 09/232,101 filed Jan. 15, 1999, now U.S. Pat. No. 6,231,528. FIELD OF THE INVENTION The invention pertains generally to apparatus and method for therapeutically treating musculoskeletal tissue in vivo. In particular, the invention pertains to the combined use of biophysical and biochemical stimuli for therapeutically treating bone and other musculoskeletal tissue in vivo. More particularly, the invention pertains to the combined use of ultrasound and a bone growth factor for therapeutically treating bone in vivo. BACKGROUND OF THE INVENTION In recent years, various attempts have been made to stimulate bone growth. These approaches have not been particularly successful, and as a consequence have not as yet received broad acceptance by either the professional (i.e., medical) or lay (i.e., patient) community. Further, this lack of effectiveness has resulted in a reluctance of the third-party payer community (e.g., insurance companies and HMO's) to offer reimbursement, so that commercialization of such stimulation technologies has been stalled. A number of issued patents disclose methods and apparatuses to biophysically treat bone and other musculoskeletal tissue. For example, Kaufman et al., U.S. Pat. No. 5,309,808 disclose apparatus and method for therapeutically treating and/or quantitatively evaluating bone tissue in vivo, by subjecting bone to an ultrasonic signal pulse of finite duration, and involving a composite sine-wave signal consisting of plural discrete frequencies. These frequencies are spaced in the ultrasonic region to approximately 2 MHz; the excitation signal is repeated substantially in the range 1 to 1000 Hz. In a closely related patent, Kaufman et al., U.S. Pat. No. 5,458,130, the same inventors extend the apparatus and method to the treatment to musculoskeletal tissue in general. In another patent by the same inventors, Kaufman et al., U.S. Pat. No. 5,547,459 disclose apparatus and method for therapeutically treating bone tissue in vivo, by subjecting bone to an ultrasonic sinusoidal signal pulse peculiarly modulated by a sinusoidal signal with a frequency between about 0 Hz and 25 kHz. Duarte, U.S. Pat. No. 4,530,360 discloses apparatus and a method of using ultrasonic energy for therapeutic treatment of bone tissue in vivo, using a pulsed sine wave at substantially a single frequency within the range 1.3 to 2.0 MHz, and at a pulse repetition rate of 100 to 1000 Hz. McLeod et al., U.S. Pat. Nos. 5,103,806 and 5,191,880 disclose methods for promotion of growth bone tissue and the prevention of osteopenia, using mechanical loading of the bone tissue. In both patents, the inventors apply a mechanical load to the bone tissue at a relatively low level on the order of between about 50 and about 500 microstrain, peak to peak, and at a relatively high frequency in the range of about 10 and 50 hertz. Bassett et al., U.S. Pat. No. 4,928,959 disclose method and device for providing active exercise treatment for a patient suffering from a bone disorder. A patient is subjected to an impact load in order to stimulate bone growth, with an impact load sensor being used to monitor the treatment strength. Numerous other patents disclose methods for stimulating bone growth relying on the generation of electromagnetic signals. For example, Ryaby et al. U.S. Pat. Nos. 4,105,017 and 4,315,503 describe methods for promoting bone healing in delayed and nonunion bone fractures, using an asymmetric pulsed waveform. In U.S. Pat. No. 4,993,413, McLeod et al. disclose method and apparatus for inducing a current and voltage in living tissue to prevent osteoporosis and to enhance new bone formation. They disclose the use of a symmetrical low frequency and low intensity electromagnetic signal substantially in the range of 1-1000 Hertz. In Liboff et al., U.S. Pat. No. 5,318,551 (and others), methods are disclosed which incorporate the combined use of a static and time-varying magnetic field to stimulate bone healing and growth. Specific amplitudes and frequencies are disclosed for optimal enhancement of bone growth, based on the theory of “ion-cyclotron resonance.” Non-biophysical methods, i.e., methods which use a biochemical compound (or generically a “bone growth factor”) to stimulate bone growth have also been described. For example, Ammann et al., U.S. Pat. No. 5,604,204 disclose method for inducing bone growth using a bone growth factor composition known as TGF-β, in an animal, locally at a bone site where skeletal tissue is deficient. The TGF-β is contained in a “pharmaceutically acceptable carrier” in an amount effective to induce bone growth at the bone site. Dunstan et al., U.S. Pat. No. 5,656,598 disclose method involving therapeutic (biochemical) compositions for the prevention and treatment of pathological conditions involving bone and dental tissue. The invention achieves its objectives by administering a fibroblast growth factor (FGF-1) to an animal or human in need of such treatment. Oppermann et al., U.S. Pat. Nos. 5,354,557 and 5,814,604, disclose methods involving osteogenic devices. (The use of the term “devices” should be understood to denote a biochemical compound or bone growth factor in an appropriate matrix for delivery to the bone.) The osteogenic devices are comprised of a matrix containing substantially pure naturally-sourced mammalian osteogenic protein. They also disclose DNA and amino acid sequences for novel polypeptide chains useful as subunits of dimeric osteogenic proteins, and methods of using the osteogenic devices to mimic the natural course of endochondral bone formation in mammals. The inventors also disclose methods of producing osteogenic proteins using recombinant DNA technology. Balazs et al., U.S. Pat. No. 5,128,326, disclose systems based on hyaluronans derivatives, as well as methods for preparing same. Such systems are useful for treatment of cartilage tissue. Falk et al., U.S. Pat. No. 5,792,753 disclose a pharmaceutical composition which contains a drug that inhibits prostaglandin synthesis, and also contains an amount of a form of hyaluronic acid. The composition is topically administered to the skin and is useful for the treatment of cartilage as it relates to arthritis. Wang et al., U.S. Pat. No. 5,4,877,864, disclose human and bovine bone and cartilage inductive (biochemical) factors. Such factors may be produced by recombinant techniques and may be useful for treatment of various musculoskeletal tissue defects. The prior art, exemplified by the references that have been briefly discussed, have used either biophysical or biochemical approaches, to promote bone growth, bone ingrowth and bone healing, or other musculoskeletal tissue healing or growth. In either case, that is, in the biophysical approach (including for example, ultrasound methods), or in the biochemical approach (including, for example, bone growth factors such as TFG-β), treatment has not been effective enough to lead to widespread use. However, the present inventors have discovered how to dramatically enhance the efficacy of such therapeutic methods for bone growth and other musculoskeletal tissue healing, taking advantage of the uniquely synergistic nature associated with the two basic approaches. BRIEF STATEMENT OF THE INVENTION It is accordingly an object of the invention to provide an improved method and apparatus for therapeutically treating bone and other musculoskeletal tissue in vivo, whereby to promote bone and other musculoskeletal tissue healing, growth and ingrowth. Another object is to meet the above object, such that bone and musculoskeletal tissue healing, growth and ingrowth may be more efficiently and more effectively treated than heretofore. A specific object is to take advantage of the synergistic properties associated with combined application of biochemical and biophysical treatment methods whereby to achieve the indicated objectives. A further specific object is to take advantage of the synergistic properties associated with biochemical and biophysical treatment methods whereby to achieve much shorter total treatment times, shortening both daily treatment times and the total number of daily treatments required. A further specific object is to achieve the above objects with a specially chosen set of ultrasonic signals, designed with respect to a mathematical model for evaluating the displacement associated with a biochemical compound. It is a general object to achieve the foregoing objects with apparatus components that are for the most part commercially available. Briefly stated, the invention in its presently preferred form achieves the foregoing objectives by injecting through skin overlying a bone to be treated, a biochemical compound containing an osteogenic protein (i.e., a bone growth factor). Soon after this injection, the bone is iteratively subjected to an ultrasonic signal of finite duration, consisting of frequency components in the ultrasonic region to approximately 10 MHz, delivered by a transducer placed on skin overlying the bone; the excitation signal is repeated in the range of 1 to 1000 Hz. The exposure time for ultrasonic therapy is chosen to be in the range of 1 minute to 1 hour, for 1 to 3 times a day, for a period of days as necessary for healing or for promoting bone growth or bone ingrowth. In the presently preferred embodiment of the invention, a single ultrasound treatment lasting for 15 minutes is applied within one hour of the injection of the bone growth factor, and achieves the indicated objectives. In the currently preferred embodiment, the ultrasonic signal is generated by a pulser to which the transducer is connected. The pulser emits a negative going narrow square pulse of about −300 volts; the duration of the pulse itself is about 0.3 microseconds. The transducer emits an ultrasound signal with a center frequency of about 3 MHz, and of about 1 microsecond in duration, thereby creating a broadband exponentially damped 3 MHz sinusoidal signal. The signal is repeated at a repetition rate of 4,500 Hz. In the presently preferred embodiment, the ultrasound interacts with the bone growth factor in such a way as to enhance in a positive fashion the bone healing, bone growth and bone ingrowth processes. This combined effect of the ultrasound therapy in the presence of the bone growth factor produces a synergistically enhanced response, namely one that is many times more effective than that which would be produced by having either agent acting alone. In this way, the present invention, besides offering much enhanced bone healing, bone growth and bone ingrowth results, also benefits from significantly shorter treatment periods, both from reductions in the total daily treatment time, but even more importantly, from dramatic reductions in the total number of days required for treatment, which result from application of the methods disclosed herein. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an electrical-circuit diagram schematically showing the interconnected relation of components of apparatus of the invention. FIG. 2 is a set of acoustic ultrasonic signals used for stimulation of bone growth and healing for several of the currently preferred embodiments. FIG. 3 is an electrical-circuit diagram schematically showing the interconnected relation of components of apparatus of an alternative embodiment of the invention. FIG. 4 is a schematic diagram illustrating the interrelationships of several alternative embodiments of the invention. FIG. 5 is another schematic diagram illustrating the interrelationships of several other alternative embodiments of the invention. DETAILED DESCRIPTION OF THE INVENTION The invention will be described in detail for a presently preferred embodiment, in conjunction with the accompanying drawings. The invention is shown in FIG. 1 in application to interconnected components for constructing apparatus for performing methods of the invention, namely for therapeutically treating bone in vivo, whereby to stimulate bone growth, bone ingrowth and bone healing. These components are, in general, commercially available from different sources and will be identified before providing detailed description of their total operation. In FIG. 1, the bone locale 10 to be treated is shown surrounded by soft tissue 11 and skin 9 and to be placed next to an ultrasonic transducer 12 , and obtainable from Panametrics, Inc., Waltham, Mass.; suitably, the transducer 12 may be Panametrics “Videoscan” part number V318-SU, having a nominal element size of ¾″ diameter, and rated for 1 MHz. As shown, transducer 12 is used for signal launching, in which the launched signal is transmitted through standard ultrasonic couplant (not shown), through the skin, soft tissue and into the bone tissue. The ultrasound couplant may suitably be obtained from Parker Laboratories, Incorporated, of Orange, N.J. In this way the ultrasound transducer may be understood to be acoustically coupled to the skin 9 . Basic operation is governed by computer means 14 , which may be a PC computer, such as the “400 MHz Pentium II” available from Gateway 2000, Inc., North Sioux City, S.Dak.; as its designation suggests, this computer contains a 400 MHz clock-pulse generator, and an Intel Pentium II processor, with provision for keyboard instruction at 14 ′. An electrical function-generator card 15 is relied upon to generate an excitation signal which is supplied to the launch transducer 12 , via power amplifier means 17 . The power amplifier is suitably Model No. 240L, an RF power amplifier product of EIN, Inc., Rochester, N.Y. This product provides a 50 dB gain, over the range 20 kHz to 10 MHz. The excitation signal generated by card 15 is a negative pulse signal, of about 0.3 seconds in duration; after input of this signal to power amplifier 17 , the value of the output signal from the power amplifier 17 is approximately −300 volts. Card 15 may suitably be a waveform synthesizer product of Quatech, Inc., Akron, Ohio, identified by Quatech part No. WSB-100. This waveform synthesizer provides generation of analog signals independent of the host computer 14 , allowing full processor power to be used for other tasks, including calculation of waveform data; it has the capacity to generate an output signal comprising literally thousands of points in the indicated frequency range. The computer 14 , card 15 , and power amplifier 17 may be understood to comprise an ultrasound pulser 44 (shown within the dashed line in FIG. 1 ); however its present embodiment as described herein has much more flexibility than conventional ultrasound pulsers because of the wide range of electrical excitation signals that may be realized. (It should nevertheless be understood that a conventional ultrasound pulser may also be utilized in the present invention, as shown in FIG. 3.) A needle syringe 18 is also shown and contains 20 milliliters of a bone growth factor 27 . In the presently preferred embodiment of the invention, the bone growth factor 27 is TGF-β. This bone growth factor may suitably be obtained from Genentech, Inc., of South San Francisco, Calif. Finally, general signal-processing/display/storage software, for the signal processing control and operation of the computer is not shown but will be understood to be a CD-ROM loaded at 19 into the computer; this software is suitably MATLAB 5, available from The MathWorks, Inc., Natick, Mass. Further software, also not shown include the Signal Processing, Optimization and Statistics Toolboxes, also available from MathWorks, as well as C++ Version 5, available from the Microsoft Corporation, Bothell, Wash. In the presently preferred embodiment of this invention and with additional reference to FIGS. 1 and 2, soft tissue 11 surrounding bone locale 10 is injected through skin 9 , with a bone growth factor 27 using syringe 18 . An ultrasound transducer 12 , connected to an ultrasound pulser 44 , is placed next to bone locale 10 with surrounding soft tissue 11 and skin 9 , with sufficient ultrasound gel to insure efficient acoustic coupling. An ultrasound signal is transmitted from transducer 12 , passes through skin 9 , soft tissue 11 , and into the bone locale 10 . The transmitted ultrasound signal is generated by pulsing the transducer with a 0.3 microsecond duration −300 volt square wave. With particular reference to FIG. 2 (A), this produces an ultrasound signal with a center frequency of about 3 MHz, and of about 1 microsecond in duration, thereby creating a broadband exponentially damped 3 MHz sinusoidal signal, 6 . This signal is repeated at a frequency of 4,500 Hz. In the presently preferred embodiment of the invention, the ultrasound signal is applied within 10 minutes of the injection of the bone growth factor, for an initial ultrasound treatment time of 15 minutes. Subsequently, two 15 minute ultrasound treatments per day are applied, for 7 days total. It should be understood that in the presently preferred embodiment subsequent ultrasound treatments are applied without any additional injections of the bone growth factor. In most cases, ultrasound treatments lasting no more than 1 week to 2 weeks will achieve the indicated objectives regarding bone healing, bone growth and bone ingrowth; in many cases, only the single initial ultrasound treatment is required to achieve the indicated objectives. The preceding description has proceeded on the basis that a biophysical stimulus, that is, ultrasound, when used in conjunction with application of a biochemical compound, that is, a bone growth factor, can dramatically improve the bone healing properties many times over that which would be obtained by using either factor alone. The basis for the above statement is rooted in a fundamental insight which led the present inventors to their current invention. This insight is that ultrasound interacts in such a way as to directly modify the velocities and displacements of the molecules of the biochemical compound. This modification or “stirring” of the bone growth factor molecules, which includes an induced drifting of the molecules towards the surface of the bone, provides a multiplicative enhancement of the direct effects of the ultrasound and bone growth factor when each acts individually. This effect is further enhanced through a small but present local heating phenomenon and associated increase in local blood flow, induced by the ultrasound, that affects in a beneficial way the biochemically treated soft tissue and bone. It is therefore useful to describe in more detail the basis for the synergistic behavior arising from application of ultrasound in conjunction with use of a bone growth factor. A basic principle of the present invention is that the normal diffusion process of the molecules of a bone growth factor can be enhanced by the external ultrasound exposure. This in turn can produce higher concentrations of the bone growth factor molecules in a shorter time in regions to be treated. It should be further understood that these higher concentrations of bone growth factor lead to increases in the associated binding of the bone growth factors or messengers to their target cells in the bone, and thus to enhanced activity. The enhanced activity may also be produced through an induced microstirring, or displacements induced on the bone growth factor molecules by the external ultrasound. The basic equations for describing the above interactions are given by: M      v l  t = M     β     ( v a - v l ) + N ( 1 ) and φ≡−D∇c+c ( v a −{overscore (v)} )  (2) In Eqs. 1-2, it should be understood that c=c(x,y,z,t) is the concentration of the bone growth factor at time, t, and spatial coordinates (x, y, z) (i.e., the number of bone growth factor molecules per cubic meter at time, t, and spatial coordinates (x, y, z)), v i is the velocity of the i-th molecule, β is the collision frequency of Langevin, M is the mass of the molecule, V a is the velocity of the particles of the medium in which the bone growth factor molecules are moving, N is random (thermal) noise force, D is the diffusion coefficient associated with the molecules, {overscore (v)} is the ensemble mean velocity of the molecules, and Φ is the molecule flux density in units of number of molecules per squared meter second. It should also be understood that Mβ(v a −v i ) is the individual drag force acting on a single particle, and Mβ(v a −{overscore (v)}) is the average drag force. The corresponding contribution to the flux density is equal to c·average drag force/(Mβ)≡c (v a −{overscore (v)}). In the case of a spherical molecule (or messenger) of radius, R 0 , moving in a medium of viscosity, η), then Mβ=6ΠηR 0 . The random force contributes to the diffusion a term −D ∇c, where D=kT/(6ΠηR 0 ), where k is Boltzmann's constant and T is the temperature in degrees Kelvin. Another relationship which can be obtained from the definition of the molecule flux is: φ=c{overscore (v)}  (3) Then, equating Eq. 2 with Eq. 3 leads to the following two equations: V _ ≅ V a 2 - D 2  ∇    ln     c     and ( 4 ) Φ ≅ c     V a 2 - D 2  ∇    c ( 5 ) It should be understood that, v a , the acoustic velocity of the medium particles, can be computed from the linear solution of the elastic wave equation. Such a solution is widely known in the art, and a commercial software package even exists for computing it. This software, Wave2000, may suitably be obtained from CyberLogic, Inc., located in New York, N.Y. Two additional equations required to solve for the concentration c=c(x,y,z,t) of the bone growth factor molecules (or messengers) are the continuity equations: ∇ .     Φ = - ∂ c ∂ t + K -  c B - K +     ( s - c B )     c ( 6 ) 0 = - ∂ c B ∂ t - K -     c B + K +     ( s - c B )     c ( 7 ) In Eqs. 6 and 7, s is assumed to be the concentration of binding sites for the bone growth factor molecules, c B is assumed to be the volume concentration of bound messengers, and K + and K − are the adsorption and desorption rate “coefficients,” respectively. Solving Eq. 6 for c B and substituting it in Eq. 7, the following equation can be derived: ( K - + cK + ) 2  [ ∇ · Φ + ∂ c ∂ t ] + [ ∂   ∂ t     ( ∇ · Φ ) + ∂   2  c ∂ t 2 + K +     s     ∂ c ∂ t ]     K - + [ ∂   ∂ t     ( ∇ · Φ ) + ∂   2  c ∂ t 2 ]     cK + - [ ∇ · Φ + ∂ c ∂ t ]     K +     ∂ c ∂ t = 0 ( 8 ) Finally, the divergence of the flux, ∇·Φ, can be expressed as ∇ · Φ = 1 2     ∇ c · v a + 1 2     c     ∇ · v a - D 2     ∇ 2  c ( 9 ) It should be understood that by substituting Eq. 9 into Eq. 8, a partial differential equation for the concentration of bone growth factor molecules, at time, t, and at spatial coordinates, (x,y,z), is obtained. Solution may be obtained by a number of ways known in the art. In the presently preferred embodiment, the method of finite differences is used. A suitable reference for this technique may be found in the book Numerical Recipes in FORTRAN The Art of Scientific Programming , Second Edition, by William H. Press, Saul A. Teukolsky, William T. Vetterling and Brian P. Flannery, published by Cambridge University Press, Cambridge, England in 1992, and which is incorporated by reference hereinto. The concentration, c, and flux, Φ (as computed according to Eq. 5), are thus affected by an external ultrasound input, through the induced motion of the medium particles, as represented by a non-zero value for v a . It is to be understood that this results in synergistic enhancements of bone healing, bone growth and bone ingrowth effects. It is useful to provide further analysis of the basis by which the synergistic behavior with the biophysical and biochemical inputs may be obtained. To do this, a consideration of the one-dimensional case is given. The basic equations then reduce to: ∂ c ∂ t = D 2     ∂   2  c ∂ z 2 - 1 2     ∂ ( v a     c ) ∂ z     and ( 10 ) Φ = c     v a 2 - D 2     ∂ c ∂ z ( 11 ) Therefore, in the one-dimensional case, and with the further simplifying assumptions that K + =K − =s=0, the concentration, c, of the molecules of the bone growth factor is obtained by solving Eq. 10. Eq. 11 may then be solved for the molecule flux, Φ, in the presence (v a ≠0) and in the absence (v a =0) of ultrasound exposure. It should be further pointed out that the external ultrasound waveform is responsible for inducing motion of the particles of the propagation medium (i.e., the soft tissue and bone), as represented through the velocity, v a . It is this particle motion that gives rise to the enhanced effects of the combined stimulations, through the non-linear interactions with the bone growth factor molecules. Thus, different ultrasound waveforms will in general give rise to distinct effects in terms of the bone healing, bone growth and bone ingrowth. It has been pointed out supra that algorithms (i.e., computer software) exist for the evaluation of the induced medium particle velocity. Alternatively, under some simplifying assumptions, analytic expressions for the medium velocity, v a , may also be described. One such example is given by v a = v 0      - α     z     sin     ω     ( t - z v p ) ( 12 ) In Eq. 12, v 0 is the induced particle motion of the medium (i.e., soft tissue) at the surface (i.e., the outer layer of the skin), α is the attenuation of the medium, ω is the radian frequency, z is the depth at which the velocity is being evaluated and z=0 is the outer skin surface, and v p is the velocity of the ultrasound wave within the medium. It should be appreciated that in this characterization any discontinuities in the medium have been ignored, i.e., a semi-infinite uniform half-space is assumed. Yet another example of a particle velocity, v a , is given by v a = v 0      - α     z     ∑ n = 0 ∞     f     ( t - nT - z v g ) ( 13 ) In Eq. 13, 1/T is the repetition rate of the signal waveform, f(.), and v g is the group velocity of the ultrasound wave. In the case of no dispersion, the group velocity, v g , is equal to the phase velocity, v p . In cases of dispersion, the value of the group velocity, v g , may most suitably be chosen to be at the nominal center frequency of the waveform, f(.). It should be understood, however, that in the characterization as described in Eq. 13, the dispersion is assumed to be negligible. In other cases, it may be most suitable to compute the full solution to the elastic wave equation, as disclosed supra, in order to evaluate the particle velocity at any point in the medium. It should be understood that any functional description for the ultrasound waveform, f(.), can be utilized in the present invention. In the presently preferred embodiment, f(.) is an exponentially damped sinusoid of 3 MHz, repeating at 4.5 kHz=1/T. However, any waveform, including but not limited to continuous sine, pulsed sine, broadband finite-duration, as well as amplitude and frequency modulated ultrasound signals can be utilized in realizing the objectives of the invention. It should also be pointed out that in the case of a semi-infinite or infinite medium, the value of v 0 can be computed from the following expression: I a = 1 2     ρ d     v p     v 0 2 ( 14 ) In Eq. 14, ρ d is the medium (tissue) density, and I a is the acoustic (ultrasound) power intensity in Watts per square meter that enters the tissue at z=0, that is, that enters the skin surface. An excellent reference for explaining the relationship between acoustic intensity and medium velocity may be found in the book entitled Physical Principles of Medical Ultrasonics , by C. R. Hill, published by Halsted Press, New York, in 1986, and which is incorporated by reference hereinto. The preceding has described an analytic basis for the synergistic effects which are induced by combined application of ultrasound and biochemical compounds, as discovered by the present inventors. It should be further appreciated that other mechanisms by which the ultrasound imput can dramatically enhance the activity of the bone growth factor exist as well. As one such example, the external ultrasound input can affect directly the binding constants K + and K − , leading to enhanced bone healing results. Additionally, increased local blood circulation due to application of ultrasound can significantly improve the bone healing, bone growth and bone ingrowth effects of a bone growth factor. An excellent reference for these effects induced on blood flow and temperature can be found in the book Therapeutic Heat and Cold, Fourth Edition , edited by Justus F. Lehmann and published by Williams and Wilkins of Baltimore, Md. in 1990, and incorporated by reference hereinto. It should be understood that it is the combination of ultrasound with bone growth factors that produces the enhanced bone healing, bone growth and bone growth results. Another embodiment of the invention involves the combined use of ultrasound with skin surface application of a bone growth factor, for treating a bone fracture. In this embodiment, the bone growth factor is not injected through the skin; instead, it is non-invasively applied to the skin surface overlying the bone to be treated. The ultrasound transducer is immediately placed onto the skin where the bone growth factor was applied, and energized by the ultrasound pulser. Thus it should be understood that a prescribed amount of a biochemical compound is placed on the skin overlying the bone to be treated in a living body, and that the ultrasound transducer, connected to an ultrasound pulser, is acoustically coupled to the skin and produces an ultrasound signal within the bone. In this embodiment of the invention, the applied ultrasound, through the mechanism as described hereinabove, i.e., through the effects on diffusion of the bone growth factor molecules, serves to transfer or transport the bone growth factor through the skin and soft tissue and deliver it to the bone to be treated. In this alternative embodiment of the invention, and with additional reference to FIG. 2 (B), a specially designed ultrasound signal is utilized for the first ultrasound treatment, that is the ultrasound treatment immediately after the bone growth factor is applied to the skin outer surface. The ultrasound signal consists of a relatively high intensity 250 mW/cm 2 (SATA) continuous sinusoid of approximately 1 MHz frequency applied for 5 minutes, and then followed for an additional 5 minutes at 150 mW/cm 2 (SATA), and ending with 20 additional minutes at 15 mW/cm 2 (SATA). Subsequent ultrasound treatments are carried out using the 15 mW/cm 2 (SATA) continuous sinusoid at 1 MHz frequency for 20 minutes two times per day for 2 weeks total. The selected ultrasound signal serves to both transport the bone growth factor through the skin and to synergistically enhance its associated bioactivity and bioeffectiveness. It should therefore be understood that in addition to the transporting of the bone growth factor through the skin, that this embodiment also has associated with it synergistic enhancements in the healing effects, as described hereinabove for the embodiment of the invention in which the bone growth factor was injected through the skin. In this alternative embodiment, injection by syringe or any other invasive means is avoided; the bone growth factor is “pushed” or “conveyed” through the intact skin to the bone. Further, synergistic enhanced response is also realized by the action of the ultrasound in conjunction with the bone growth factor, not only through direct effects on diffusion, but also through associated local increases in blood flow, temperature increases, as well as effects on the adsorption and desorption rate coefficients. It should be appreciated that although ultrasound is one biophysical stimulus that can synergistically interact with and enhance the bioeffectiveness of a bone growth factor, other biophysical stimuli also can be utilized. In one such alternative embodiment of the invention, acoustic energy, but not ultrasonic, i.e., mechanical energy having only frequencies below approximately 20,000 cycles per second, is used to stimulate bone growth. In this alternative embodiment, a vibrating platform is used to generate dynamic displacements in bone tissue throughout the body. Such a vibrating platform is well known in the art, and may suitably be Model No. 4060-15, obtainable from the Bertec Corporation, of Columbus, Ohio. This model is capable of producing vertical displacements having a frequency content of up to 1800 Hz. This biophysical input, that is a mechanical input having sub-ultrasonic frequency components, has been previously described to have osteogenic capabilities, that is to promote bone healing, growth and ingrowth. An example of such a method is given in the two patents by McLeod et al., U.S. Pat. Nos. 5,103,806 and 5,191,880, which are incorporated by reference hereinto. In these patents, the inventors disclose methods for promotion of growth of bone tissue and the prevention of osteopenia, using mechanical loading of the bone tissue. In the present alternative embodiment of the invention, the effects of the biophysical (i.e., mechanical) input are dramatically enhanced by combining this treatment with a biochemical one, namely, a therapeutic drug. In this alternative embodiment, the drug may suitably be Fosamax, available from Merck & Co., Inc., Whitehouse Station, N.J. It should be understood that in this embodiment both the biophysical (i.e., mechanical) and biochemical (i.e., drug) inputs are systemically applied. Thus, the synergistically enhanced response occurs throughout the skeleton, and most importantly the therapeutic benefit includes, but is not limited to, the hips and spine. In the present embodiment of the invention, the mechanical stimulus is applied for about 10 minutes twice a week, ideally about 2 hours after ingestion by the patient of his or her first Fosamax dose that morning; the benefits obtained under the prescribed regimen are much more dramatic increases in bone mass and marked reductions in bone loss, as well as significant reductions in the total number of biophysical (i.e., mechanical) treatments required per week and reductions by half in the required dosage of Fosamax, in contrast to that which is required without synergistic biochemical and biophysical treatment. The reduction in drug dosage is particularly beneficial as it reduces the potential for side-effects. Although in the alternative embodiment of the invention as disclosed in the preceding paragraph, mechanical energy (that is, vibrations inducing displacements and strains) was combined with biochemical treatment with Fosamax, it should be understood that any drug which stimulates bone growth, or inhibits bone loss, or acts on both such aspects of bone physiology and metabolism, may be utilized. Such drugs can include any biochemical compound, such as estrogen or estrogen-like compounds, bisphophonates, calcitonins, fluorides, anabolic bone agents, anti-resorptive drugs, selective estrogen receptor modulators, PTH or other therapeutic peptides, or any bone growth factor. It should be further understood that although in the present alternative embodiment of the invention as described in the preceding paragraph that the biophysical input (i.e., mechanical force) and biochemical compound (i.e., drug) are both systemically applied, local treatments are also considered to be within the scope of the present invention. The local nature of the treatments can be understood to be associated with either the mechanical stimulus or the biochemical stimulus, or with both. The synergistic effects due to the externally induced vibratory motion of the bone and soft tissue in combination with application of the biochemical compound are responsible for the enhanced bone healing, bone growth and bone ingrowth results. It should therefore be additionally understood that a variety of mechanical stimulation methods may be utilized in alternative embodiments of the present invention. For example, another method and apparatus for generating mechanical energy in a living body is described by Bassett et al., U.S. Pat. No. 4,928,959 and which is incorporated by reference hereinto; they disclose method and device for providing active exercise treatment for a patient suffering from a bone disorder, in which a patient is subjected to an impact load in order to stimulate bone growth, with an impact load sensor being used to monitor the treatment strength. Such methods also benefit greatly from their synergistic combination with biochemical compounds according to the invention as disclosed herein. While the alternative embodiments as described in the preceding two paragraphs have focussed on the combined use of mechanical energy at sub-ultrasonic frequencies with biochemical compounds for treating bone loss (as in osteoporosis or osteopenia), bone fracture healing can be treated as well. Thus, in yet a further alternative embodiment of the invention, bone fracture healing is therapeutically treated by combining a mechanical stimulus together with a bone growth factor. In the present embodiment, a bone fixator enabled with “dynamization” is used to treat a bone fracture. Dynamization is a method by which a certain amount of mechanical energy is provided to a bone fracture site, in an effort to accelerate or otherwise optimize the healing process. An apparatus for providing such stimuli to a bone fracture is disclosed in a patent by Faccioli et al., U.S. Pat. No. 5,320,622, and which is included by reference hereinto. In the present embodiment, a fibroblast growth factor, FGF-1, is injected into the fracture site preferably within 5 days of the occurrence of the fracture, and mechanical stimulation via dynamization is applied continuously starting 5 additional days after application of the bone growth factor. The bone growth factor, FGF-1, is suitably available from Rhone-Poulenc Rorer Pharmaceuticals, Inc., of Collegeville, Pa. In the present embodiment, bone healing at the fracture site is significantly enhanced due to the synergistic interaction of the combined application of mechanical stimulation and bone growth factor. It should be further understood that mechanical stimulation at a fracture site can be achieved not just with “dynamization” as described in the preceding paragraph, but also with induced localized vibrations, as for example with a dynamic vibration shaker, or by induced systemic vibrations, as for example with a vibrating platform; in either case, the vibrations are to be understood to be applied in conjunction with use of a bone growth factor, in order to achieve the objectives of enhanced bone healing and bone growth. For example, in one yet additional alternative embodiment of the invention, a vibration shaker generates relatively high frequency local displacements in a fractured limb. Such a vibration shaker may suitably be Model No. V-102, available from Ling Dynamic Systems, Inc., of Yalesville, Conn. This shaker can generate mechanical vibrations at frequencies of more than 1000 Hertz, and in conjunction with application of a locally applied bone growth factor, can dramatically enhance the fracture healing process, over that obtainable with application of either stimuli individually. In this present alternative embodiment of the invention, the bone growth factor is FGF-1, suitably available from Rhone-Poulenc Rorer Pharmaceuticals, Inc., of Collegeville, Pa. With additional reference to FIG. 4, it should thus be understood that mechanical (i.e., acoustic, vibrational) stimulation, either at ultrasonic or below ultrasonic frequencies, whether applied locally or systemically, when used in conjunction or combination with a biochemical compound (i.e., a bone growth factor), whether applied locally or systemically (including topical skin application or injection), can dramatically and significantly enhance the bone healing, bone growth and bone ingrowth processes, through a powerful synergistic interaction, as discovered by the present inventors. It should additionally be understood that such methods and apparatti can find use not only in bone fracture healing (in fresh, delayed and non-union fractures) and in treatment for osteoporosis and osteopenia, but also for treatment in the case of orthopaedic implants, for example to promote bone ingrowth around an artificial hip or knee. The disclosed invention can also find use for promoting osteoconduction and osteoinduction around not only orthopaedic implants, but for incorporation of bone grafts as well. Such bone grafts include but are not limited to autologous, bone bank, collagen based, as well as non-bone graft materials. It should be understood that the bone graft materials may be treated directly with a bone growth factor, before being placed into a patient. Subsequently, ultrasound treatment is used to synergistically enhance the amount of bone ingrowth into and around the biochemically treated implant. In one such alternative embodiment of the invention, a non-bone graft material, most suitably Pro Osteon 500R, available from Interpore Cross International of Irvine, Calif., is treated first with an autologous bone growth factor, suitably platelet-derived growth factor, and surgically implanted into the patient. A low intensity (20 mW/cm 2 SATA) ultrasound continuous sine signal at 3 MHz is then applied every other day for thirty minutes for a period of 3 weeks. The effect of the growth factor in combination with the ultrasound results in dramatically enhanced bone ingrowth, biomechanical stability and resorption of the non-bone graft material. A related but alternative embodiment of the invention utilizes a bone graft substitute known as NOVOS, suitably available from Stryker Biotech, of Natick, Mass. NOVOS contains type I bone collagen and Osteogenic Protein-1 (OP-1), and, in this alternative embodiment, is surgically implanted into a non-union fracture. The osteogenic proteins are described by Kuberasampath et al., U.S. Pat. No. 5,840,325, which is incorporated by reference hereinto. A low intensity (20 mW/cm 2 SATA) ultrasound continuous sine signal at 3 MHz is then applied every other day for thirty minutes, starting within 24 hours from the time of the implant, for a period of 3 weeks. The combination of the ultrasound with OP-1 treated collagen (i.e., NOVOS) results in dramatically enhanced bone healing and consolidation at the fracture site. As yet one further embodiment of the invention, electromagnetic field (“EMF”) energy is used as a biophysical input, in synergistic conjunction with a bone growth factor. In this alternative embodiment, mechanical energy is not employed; instead, an electromagnetic applicator is used to treat a bone which is also treated with a bone growth factor. The electromagnetic applicator is most suitably a “pulsed electromagnetic field (“PEMF”) applicator, as available from Orthofix International N.V., located in Curacao, Netherlands; this applicator is described by Erickson et al., U.S. Pat. No. 5,195,941, and which is included by reference hereinto. (In this embodiment, and with additional reference to FIG. 4, it is to be understood that the ultrasound transducer and ultrasound pulser shown in FIG. 1 are replaced by the PEMF stimulator.) In this alternative embodiment, TGF-β is injected with a syringe into the soft tissue overlying a non-union bone fracture. The PEMF applicator is applied to the fractured limb on the same day, within 1 hour of the injection of the bone growth factor, for a total treatment time of 1.5 hours. Subsequently, the PEMF is applied daily for 1.5 hours for approximately 2 weeks, in order that healing of the non-union may be stimulated sufficiently to go on to heal fully, through the synergistic interaction of the external electromagnetic field (i.e., the PEMF) with the bone growth factor (i.e., the TGF-β). It should be understood that the synergistic bone healing response is achieved, in the case of electromagnetic stimulation, largely through direct effects on the K + and K − adsorption and desorption rate coefficients, respectively; however, effects on diffusion and blood flow also are mechanisms through which enhanced effects on bone healing, bone growth and bone ingrowth occur. It should be further appreciated that any type of electromagnetic field applicator or signal may be utilized in conjunction with application of a bone growth factor, each either locally or systemically applied. The electromagnetic field energy may further be understood to be applied either inductively, capacitively or through electrodes in contact with the living body. It should be appreciated that the various biophysical modalities, that is, ultrasonic, mechanical (at sub-ultrasonic frequencies) and electromagnetic energies, can be utilized with a variety of signal waveforms (i.e., temporal characteristics), including continuous sinusoid, pulsed sinusoid, broadband repetitive pulses; and amplitude-modulated and frequency-modulated waveforms. It is, however, to be understood that such application of biophysical signals with specific temporal characteristics are to be utilized in conjunction with a biochemical compound or bone growth factor in order that the indicated objectives can be achieved. It should also be appreciated that the biochemical compound may often be contained in a convenient matrix which is biocompatible and which is used as a “vehicle” to carry the “active” bone growth factor or component. As one such example, TGF-β may be mixed with a basic ultrasound couplant or gel, and the mixture applied to the skin. The gel or matrix serves a dual purpose in this case: (i) as a convenient means to maintain the growth factor in a confined region; and (ii) to efficiently couple the ultrasound signal from an ultrasound transducer to the skin. While the previously disclosed embodiments of the invention have focused on enhancing bone healing, bone growth and bone ingrowth, it should nevertheless be understood that the methods disclosed herein can find therapeutic application not only to bone but to other musculoskeletal tissues as well. For example, in an alternative embodiment of the invention, osteoarthritis at the knee is treated through the combined application of ultrasound with a biochemical compound. In the present alternative embodiment, and with additional reference to FIG. 1, a 3.5 MHz continuous sinusoidal signal having a spatial-average temporal-average power intensity of 15 mW/cm 2 is applied to the skin overlying the knee to be treated. In FIG. 1, the cartilage is not shown but understood to be adjacent to bone 10 . In the present embodiment, the biochemical compound is most suitably Synvisc, available from Biomatrix, Inc., of Ridgefield, N.J. It should be understood that Synvisc is injected into the cartilage of the knee to be treated using syringe 18 . The knee is then treated with ultrasound, which together with the biochemical treatment (that is, the Synvisc), leads to significantly enhanced reductions in pain and improved function, as compared with that obtained using either (i.e., the ultrasound or biochemical) treatment alone. In the presently preferred alternative embodiment, only one ultrasound treatment (that is, one treatment in conjunction with only one injection of Synvisc) is used, with dramatic improvements in pain relief and function achieved. It should therefore be understood that all of the previous variations of the invention as disclosed hereinabove for applications to bone apply as well to musculoskeletal tissue in general. Therefore, and with additional reference to FIG. 5, application of a biophysical stimulus or input in conjunction with application of a prescribed amount of a biochemical compound to a living body can be understood to lead to synergistically enhanced musculoskeletal tissue healing, growth and repair. Further, it should be appreciated that the musculoskeletal tissue can include not only bone, but ligament, tendon and cartilage, as well. Moreover, the biophysical stimulus can be applied locally or systemically, and be of either electromagnetic field energy or mechanical energy at sub-ultrasonic frequencies (i.e., vibrational) or at ultrasonic frequencies. The biochemical compound can itself be applied locally or systemically as well (e.g., be injected through or topically applied to the skin), and can be understood to be comprised of any substance or class of substances that can interact biochemically with the musculoskeletal tissue to be treated. This interaction is enhanced synergistically through application of the biophysical stimulus, through effects on diffusion, blood flow, temperature and adsorption and desorption rate coefficients, as described hereinabove. It should also be generally appreciated that the amount of biochemical compound prescribed will be a function of the type of compound and the particular therapeutic application; however, amounts utilized are generally much less when biophysical inputs are employed according to the methods as disclosed herein, in comparison to that required when biochemical compounds alone are utilized. With additional reference to FIG. 5, and in particular to the portion shown by the dashed arrows, it should be understood that the application of a biochemical compound to the musculoskeletal tissue, i.e., to bone, ligament, cartilage or tendon, can also be achieved non-invasively by concurrent application of ultrasound. In such an alternative embodiment, a prescribed amount of a biochemical compound is applied to the skin; that is, a prescribed amount of the biochemical compound is placed on the skin overlying the musculoskeletal tissue to be treated. An ultrasound transducer is then acoustically coupled to the skin overlying the musculoskeletal tissue to be treated, and connected to an ultrasound pulser, so that an ultrasound signal is produced within the musculoskeletal tissue. The action of the ultrasound causes the biochemical compound to be transported to the musculoskeletal tissue being treated, without the need for invasive needle injection. Additionally, the ultrasound interacts in a synergistic fashion with the biochemical compound to obtain enhanced therapeutic effects on the musculoskeletal tissue. Finally, it is important to emphasize that the disclosed invention and its various embodiments rely on the concurrent use of a biophysical stimulus with a biochemical one. This concurrent or conjunctive use is a crucial aspect of the present invention, as it is the basis by which the indicated objectives of synergistically enhanced musculoskeletal tissue healing and growth are achieved. It should be further appreciated that such concurrent or conjunctive use of the biophysical and biochemical stimuli in the context of the current invention may be carried out in a number of ways. For example, the biophysical stimuli can be applied almost immediately (e.g., within several minutes) after the biochemical compound is injected, ingested or otherwise utilized. Alternatively, the biophysical stimuli can be applied after a more significant period of time has elapsed after utilization or application of the biochemical compound. However, the best results are obtained when the biophysical stimulus is applied within twenty-four (24) hours after application of the biochemical treatment. However, good results are also obtained when the biophysical stimulus is applied as many as three (3) months after application of the biochemical treatment. Thus the present invention should be understood to include both long and short time periods between application of the biochemical compound and subsequent application or applications of the biophysical stimuli, so that the meaning of the terms “concurrent,” “conjunctive,” “combined with” or “in combination with” should be understood in this relatively broad sense. It should lastly be additionally understood that “pre-biochemical treatment” with a biophysical stimuli, that is, application of the biophysical stimulus before utilization of a biochemical stimuli, which serves to “condition” the musculoskeletal tissue, in addition to “post-biochemical treatment” with a biophysical stimuli, can lead to enhanced musculoskeletal tissue healing and growth as well. While several embodiments of the present invention have been disclosed hereinabove, it is to be understood that these embodiments are given by example only and not in a limiting sense. Those skilled in the art may make various modifications and additions to the preferred embodiments chosen to illustrate the invention without departing from the spirit and scope of the present contribution to the art. Accordingly, it is to be realized that the patent protection sought and to be afforded hereby shall be deemed to extend to the subject matter claimed and all equivalence thereof fairly within the scope of the invention. It will be seen that the described invention meets all stated objectives as to therapeutic treatment in vivo of bone tissue specifically and musculoskeletal tissue in general, with specific advantages that include but are not limited to the following: (1) Significantly enhanced healing effects due to the concurrent use of a biophysical stimulus with a biochemical stimulus; (2) Capability to avoid invasive (e.g., needle injection) for delivery of bone growth and other biochemical factors to the treated musculoskeletal tissue; (3) Achievement of a dramatic reduction in the required treatment, including both in terms of number of minutes per treatment and even more importantly also the number of total treatments required; (4) Synergistic response due to the conjunctive use of a biophysical and biochemical stimuli, leading to much more enhanced effects over that which would be obtained using only one of the stimuli; (5) Description of specific biophysical stimuli, including ultrasonic, mechanical and electromagnetic, that may be used to achieve dramatically enhanced healing and growth, when used in conjunction with a biochemical compound; (6) Description of a mathematical model to characterize the synergistic interaction of ultrasonic and biochemical stimuli, which may be used in the design of signals with maximal healing effects; (7) The convenience and practicality of a much more effective method for therapeutically treating bone and other musculoskeletal tissue, allowing in many cases even one single combined application/treatment to achieve the indicated objectives; (8) Reduction in the potential for side-effects from drugs, because of the smaller doses typically required; (9) Greater acceptance by the medical and patient communities, and also by third-party-payers, because of its enhanced effectiveness; and (10) The nature of the apparatus as described here serves best the purposes of further exploration for obtaining maximally effective signals and dosage regimens that can be correlated for the indicated objectives. The embodiments of the invention as described above can explore a wide range of experimental configurations. Their use is expected to lead to the development of compact and efficient apparatus for obtaining the indicated objectives. For example, a compact electronic analog implementation can easily be constructed if economy and simplicity are the primary objectives. Other systems which rely on combined analog and digital electronics are more expensive, yet can be more flexible in terms of the range of applications which can be addressed (e.g., systems for a single therapeutic application to bone fracture healing, versus systems for therapeutic applications to a variety of musculoskeletal tissues and disorders). Further, systems can either be built as a stand-alone unit or as part of a PC-based system.

Non-invasive therapeutic treatment of bone in vivo using ultrasound in conjunction with application of a biochemical compound or bone growth factor is performed by subjecting bone to an ultrasound signal supplied to an ultrasound transducer placed on the skin of a bony member, and involving a repetitive finite duration signal consisting of plural frequencies that are in the ultrasonic range to 20 MHz. Concurrent with application of the ultrasound is the utilization of a bone growth factor applied to the skin of a bony member before stimulation with ultrasound. Ultrasonic stimulation is operative to transport the bone growth factor to the bone and then to synergistically enhance the interaction of the bone growth factor with the bone, whereby to induce healing, growth and ingrowth responses. In another embodiment, a vibrational or mechanical input together with a biochemical compound enhances both bone fracture healing and treats osteoporosis.

BACKGROUND AND SUMMARY OF THE INVENTION This invention relates to an athletic shoe having a shock-absorbing running sole that has at least one component incorporated into the body of the sole so as to modify its mechanical properties of stiffness, shock absorbency and the like, as well as to a process for manufacturing said athletic shoe. An athletic shoe having a sole representing one form of the above-explained type running sole is known from U.S. Pat. No. 4,297,796. In the case of this athletic shoe, a netting or open mesh structure made of stretch-resistant threads or similar means is connected to the top side of a flexibly deformable sole layer. The netting or mesh structure is also folded down around the periphery of the sole layer. The netting structure has the purpose of distributing the shock stresses which, in individual sections, such as in the section of the heel or in the section of the ball, are especially high, over a larger area. An athletic shoe of this type, after the manufacture, cannot be changed as far as its shock-absorbing characteristics are concerned, and, while the netting structure may serve a shock distributing function, it does not provide a means for varying the shock absorbency of localized portions of the sole. It is also known, such as from U.S. Pat. Nos. 2,885,797; 4,364,188 and 4,364,189, as well as German Offenlegungsschrift (Laid-Open patent application) No. 29 04 540, to be able to vary the shock absorbency of localized portions of a resilient sole or sole layer (such as the midsole of a running shoe) by the subsequent incorporation of plugs of a harder material into openings formed in the otherwise homogeneous material of the body of the resilient sole. While such a technique provides a high degree of flexibility in adapting the stiffness and shock absorbency of various parts of a given sole to the needs of a given runner, it is not well suited to mass production of large numbers of soles, nor is there any load distributing effect when individual plugs are utilized. Furthermore, if a mere friction fit is used to hold the plugs in place, they may become dislodged during use, particularly in areas of the sole that are highly flexed. On the other hand, if adhesives are used, a permanent bond results that precludes re-adapting the sole to subsequent needs, not to mention the fact that the fastening procedure can be messy and time-consuming. On the other hand, if the insert plugs were to be incorporated or molded-in during formation of the body of the resilient sole, the costs and/or complexity of the molds required for every single size and/or combination of characteristics of the shoe would be dramatically increased. This invention has an objective of adapting the stiffness and shock absorbency of a resilient sole or sole layer, particularly individual sections of the sole to the shock stress respectively experienced thereby. Furthermore, the invention seeks to attain this objective both from the mass manufacture standpoint as well as from that of enabling the shock-absorbing characteristics to be subsequently adapted to the individual physical needs of the user or to the specific type of sport for which the shoe incorporating the sole is to be used. According to preferred embodiments of the invention, these objectives are achieved by a process and athletic shoe wherein an openwork structure, such as a meshwork or netting, is embedded into at least a portion or portions of a resilient sole during molding thereof, and plugs of a harder material than the body of the sole are inserted vertically into openings of the openwork structure, prior to and/or subsequent to molding of the sole about the openwork structure. In spite of the use of a uniform material for the midsole, the invention makes it possible to give the different sections of the running sole different shock-absorbing characteristics according to anticipated stressing thereof. When using exchangeable plugs, it is possible that the user may find and adjust the blend of shock-absorbing characteristics that is optimal for him or her, and may still be able, according to the different running conditions, as in the case of a hard or soft ground or similar conditions, to adapt the shock-absorbing characteristics in the different sections of the sole. Moreover, by appropriate shaping of the insert plugs, an interlocking engagement with the openwork structure can be achieved that will effectively hold subsequently inserted plugs in place within the sole without the use of adhesives; while, in the situation where the plugs are to be embedded during manufacture of the sole, they can be pre-assembled into the openwork to form pre-assmebled units in any number of combinations, thereby enabling a standardized mold to form soles possessing numerous different characteristics. These and further objects, features and advantages of the present invention will become more obvious from the following description when taken in connection with the accompanying drawings which show, for purposes of illustration only, several embodiments in accordance with the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a diagrammatic view from the top of a running sole of an athletic shoe illustrating an example of a pattern of high and maximum shock stresses as may be imposed during running; FIG. 2 shows a sole incorporating openwork structures for shock-absorbing elements in a sole; FIGS. 3 and 4 show an enlarged representation of the details X and Y, respectively, of FIG. 2, illustrating openwork structures with square and round mesh openings; FIG. 5 shows a cross section through a sole showing (in elevation) different embodiments of shock-absorbing plugs embedded therein; FIGS. 6 and 7 show possible close arrangements for upper supporting surfaces of the shock-absorbing plugs; and FIG. 8 shows, in cross section, a sole having shock-absorbing plugs with springy projecting arms (the plugs being shown in elevation). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In FIG. 1, a running sole of an athletic shoe, especially for longer-distance running, has the reference numeral 1. During running, especially high shock stresses occur in the section of the heel 2 and in the section of the ball 3. The darker sections, where the points are close to one another, represent the sections that are particularly highly stressed. In order to be able to reduce these shock stresses of the heel and of the ball of the foot more effectively than previously and in order to avoid, in the midsole 7, a "wearing-through", an intermediate support 4, in the form of an openwork structure (diagrammatically shown in FIG. 2), is provided in the running sole 1, within the midsole 7, and at least in the sections 2, 3 (FIG. 1); but, preferably, also in the adjacent zones 21, 31, at or around the heel and ball, plugs being provided or being able to be provided so as to serve as a shock-absorbing means. The openwork structure preferably has a mesh form as shown in the circular sections of FIGS. 3 and/or 4, which show an enlarged section of the circles X, Y of FIGS. 1 and 2. In FIG. 3, the openings 5 in the mesh are square, and in FIG. 4 they are circular. The spacing of the openings 5 may be selected according to the desired distribution of pressure. Advantageously, the intermediate support 4 consists of a punched-out section of netting. Alternatively, the support 4 and its openings 5 may be punched-out or otherwise made in a suitable manner from a full strip of solid material, either at the same time or first the support 4 and subsequently the openings 5. Furthermore, openings 5 may be provided at all points or only in preferred zones where shock-absorbing means are to be inserted later. While the intermediate support 4 may be formed of flexible yet stretch-resistant netting, material, especially a woven material, such as of nylon or other synthetic fibers, it is preferred that the intermediate support be formed of a layer of an elastic, but relatively rigid, i.e., shape-sustaining material, such as polyurethane or another foamed material. The intermediate support 4 is provided approximately in the area of the middle third of the softly elastic, preferably volume-compressible midsole 7. Preferably, midsole 7 consists of a highly porous material, such as foamed polyurethane or another softly elastic plastic foam, as is known for use in the midsole layer of the sole of a running shoe. The material of the midsole 7 may preferably be molded around the intermediate support 4, or the midsole may be formed in two parts, the parts being fastened to the intermediate support 4 on opposite sides thereof, preferably by gluing. The plugs 6 may be inserted into the intermediate support 4 before or after its attachment to the midsole 7. FIG. 5 shows a selection of possible shock-absorbing means, preferably developed as plug 6, and their arrangement in the openwork structure forming intermediate support 4, as well as the arrangement of the intermediate support 4 in the running sole or midsole 7. The form of the plugs 6 is such that they can, preferably, exchangeably snap into an opening 5 in the openwork support structure. Preferably, they have the shape of two cones or pyramids arranged on top of one another and tapering toward the bottom in the direction of the outer sole 12. In this connection, see plugs 61, 62, 63 and 64 in FIG. 5. This configuration results in larger upper bearing surfaces 8, which ensure a large-surface exposure toward the insole 9, located above midsole 7, so as to act to eliminate peak stress points. These plugs may be in direct contact with the insole 9 (plug 64) or they may be separated therefrom by a portion of the midsole 7 (plugs 61-63). Approximately in the lower part of the center third, up to half the height of the plug, the plugs 6 have a catch groove 10, preferably in the form of a surrounding ring-shaped groove, by means of which they can snap into an opening 5 in the openwork structure 4. If required for a better fixing, a catch bead 11 may be provided above groove 10 to engage the openwork intermediate support 4. Instead of the catch groove 10, or in addition, other catching and/or clamping elements may also be provided for the fastening of the plug 6 to the intermediate support 4. The lower part of the plug pointing, toward the outer sole 12 may be shaped to have a blunt bottom (see plugs 67--67) and may end at a distance from the inside surface 13 of the outer sole 12, as in the case of plug 64, or it may extend to the inside surface 13 of the outer sole 12, as in the case of plugs 63, 65, or it may project to the outside running surface 14 of outer sole 12 and, itself, serve as a part of the running surface, as in the case of plug 66. Finally, the plugs, like plugs 66 and 67, may also be subsequently insertable through an opening 15 of the running sole 12, in which case the opening 15 may also be closed off from the outside by means of a blind plug 16, where the subsequently inserted plugs do not extend to surface 14. When the plugs 6 are to be inserted subsequently from above, the insole 9 is attached so that it can be removed. This may be achieved, for example, by having the insole simply rest upon the midsole, or by means of catch or snap elements or by means of burr-type closure strips of the type known under the trademark "Velcro", which are provided between the insole 9 and the midsole 7, or the lasting fold of the material of the upper of the athletic shoe (not shown). In order to be able to easily remove the plugs 6, a recess 17 may be provided at an end for the insertion of an extraction screw, tool or similar means. The plugs 64 to 66 could, for example, be subsequently inserted from above. In order to achieve a distribution of pressure on the insole 9, that is as uniform as possible, the bearing surfaces 8 may be developed in such a way that plugs 6, fitted into adjacent openings 5 in the openwork, touch one another or are at least very close together, as this is shown in diagram form in FIGS. 6 and 7 for round or square bearing surfaces 8. A corresponding situation is also shown in FIG. 5 concerning plugs 61, 62, 63. The plugs 6 consist of a suitable, shock-absorbing material that is harder than that of the midsole 7, preferably of an elastic unfoamed or only slightly foamed material, such as nylon, polyurethane, polyethylene, polypropylene or a similar material. A very even shock distribution can be achieved when, according to FIG. 8, the plugs 6 are developed in such a way that, when viewed from the direction of the intermediate support 4, they each have at least two springy arms 18 projecting diagonally toward the periphery of the sole 1, at least toward one side. When such arms 18 are provided, the plugs 6 are practically anchored in the midsole 7 and reinforce this midsole 7 over a wider area. These springy arms 18 may, according to the plug 681 (shown on the left in FIG. 8), be aligned toward the bottom in the direction of the outer sole 12 or, as in the case of the center plug 682, toward the top and inner sole 9. Still further, as in the case of the right plug 863, arms 18 may project toward the top and toward the bottom. The manufacture of a running sole 1 having the plugs 6, according to the invention, takes place, for example, by first manufacturing an intermediate support 4 in the form of an openwork having the openings 5 in at least zones 2 and 3, and preferably also in zones 21 and 23. Subsequently, according to the desired shock-absorption or required location, plugs 6 of one or more of the above-noted types are inserted into the openings 5 in the openwork intermediate support 4, said plugs 6 having a suitable hardness, i.e., are made of a material that is harder than that of the midsole 7, and being inserted in a desired pattern either by hand or machine to form an insert pre-assembly. Subsequently, the pre-assembly of the intermediate support 4 and plugs 6 is surrounded by a softly elastic midsole material so that it becomes embedded therein, for example, by molding or casting. The outer sole 12 is then attached, unless it has been molded onto the midsole at the same time, as may also an upper part (that is shown in the drawings). A conventional heel wedge may also be attached to, or be shaped as one piece with, the midsole 7, or may, preferably, be molded thereon. It is advantageous for the sections 2, 3 of the running sole 1, that are highly or maximally stressed, to have plugs 6 that are made of material that is less hard and/or less dense than that of the adjacent sections 21, 31 in the heel and ball area. This results in the important effect that the highly or maximally stressed sections of the running sole 1 have a shock-absorbing characteristic that is softer than that of the adjacent sections 21, 31, where the supporting effect of the plugs 6 is more extensive. Plugs 6, of a material of varying hardness and/or density, are advantageously provided in such a way that, in the inside (medial) section of the ball, plugs 6 are provided which are less hard and/or less dense than those in the outside (lateral) section of the ball. A similar effect of controlling the degree of shock absorbing may also be achieved by the fact that the peg density, i.e., the number of plugs per cm 2 , in the highly or maximally stressed sections 2, 3, is less than that in the adjacent sections 21, 31. By means of the plugs 6, provided in the preferred zones 2, 3, and 21, 31, of the running sole in the intermediate support 4, the "aging process" of the material of the midsole 7 is also favorably affected and even significantly delayed. That is, conventionally used foamed midsole materials, generally, lose about 50% of their shock-absorbing qualities during approximately the first 300 km of running, because the individual cell walls permanently buckle. This effect occurs especially in the highly stressed areas of the running sole 1. By means of the arrangement of the plugs 6, the stress to which the foamed midsole 7 is subjected in these sections, 2, 3 and 21, 31, is reduced and, thus, the deforming effect on the cell walls of the foamed material of the midsole 7 is decreased. The elasticity or the compressibility of the midsole 7, therefore, will be maintained much longer than is the case in the known arrangements. The intermediate support 4 may also be subdivided into several segments, for example, one segment for the heel and another segment for the ball. It is also possible to arrange more than one intermediate support 4 in the section of the midsole 7 in order to still improve the alignment of the plugs 6 approximately normal to the level of the running sole 1. A special advantage of the present invention is the fact that the shock-absorbing effect along the running sole 1 can be controlled and optimized corresponding to the specific requirements of the individual parts of the sole, without the manufacture of such running soles requiring extremely expensive molds, because the "shock-absorbing profile" over the whole area of the running sole 1 can be determined and even subsequently adapted by means of the intermediate support 4 and the specifically selected plugs 6. Therefore, construction of the injection or casting molds need only be determined by the profile of the running sole 12 and the thickness and shape of the midsole 7. Moreover, since the plugs of at least a given portion of the sole are interlocked within a common support structure, a cooperative load distributing effect is achieved to a certain extent, even when the plugs are not very closely spaced. Also, this interlocking relationship between the support structure and the plugs facilitates manufacture by allowing numerous different pre-assemblies to be created in an inexpensive manner, while simplifying the process of locating and holding of the plugs within a mold in comparison to the use of a multitude of individual plugs. While I have shown and described various embodiments in accordance with the present invention, it is understood that the same is not limited thereto, but is susceptible of numerous changes and modifications as known to those skilled in the art, and I, therefore, do not wish to be limited to the details shown and described herein, but intend to cover all such changes and modifications as are encompassed by the scope of the appended claims.

An athletic shoe having a shock-absorbing running sole which has at least one intermediate support extending at least approximately in parallel with a major plane of the running sole. The intermediate openwork support is disposed in a softly elastic midsole provided between an insole and a running sole. For obtaining a targeted reduction of shock stresses occurring to a varying degree in the individual sole sections, plugs are inserted into the openwork support. The plugs are made of a material that is harder than that of the midsole and are disposed vertically with respect to the noted major plane thereof, at least in the sections that are highly or maximally stressed during the running and possibly also in the adjacent zones.

[0001] This is a continuation of application Ser. No. 10/230140, filed Aug. 29, 2002. BACKGROUND OF THE INVENTION [0002] This invention relates to the field of orthopedic spinal fusion surgery and particularly to the process of interarticular facet fixation or fusion, serving to stabilize adjacent vertebral elements, thereby facilitating the development of bony union between them and thus long term spinal stability. [0003] Of all animals possessing a backbone, human beings are the only creatures who remain upright for significant periods of time. From an evolutionary standpoint, this erect posture has conferred a number of strategic benefits, not the least of which is freeing the upper limbs for purposes other than locomotion. From an anthropologic standpoint, it is also evident that this unique evolutionary adaption is a relatively recent change and as such has not benefitted from natural selection as much as have backbones held in the horizontal attitude. As a result, the stresses acting upon the human backbone (or “vertebral column”), are unique in many senses, and result in a variety of problems or disease states that are peculiar to the human species. [0004] The human vertebral column is essentially a tower of bones held upright by fibrous bands called ligaments and contractile elements called muscles. There are seven bones in the neck or cervical region, twelve in the chest or thoracic region, and five in the low back or lumbar region. There are also five bones in the pelvis or sacral region which are normally fused together and form the back part of the pelvis. This column of bones is critical for protecting the delicate spinal cord and nerves, and for providing structural support for the entire body. [0005] Between the vertebral bones themselves exist soft tissue structures—discs—composed of fibrous tissue and cartilage which are compressible and at as shock absorbers for sudden downward forces on the upright column. More importantly, the discs allow the bones to move independently of each other to permit functional mobility of the column of spinal vertebrae. Unfortunately, the repetitive forces which act on these intervertebral discs during repetitive day-to-day activities of bending, lifting and twisting cause them to break down or degenerate over time. [0006] Presumably because of humans' posture, their intervertebral discs have a high propensity to degenerate. Overt trauma, or covert trauma occurring in the course of repetitive activities disproportionately affect more highly mobile areas of the spine. Disruption of a disc's internal architecture leads to bulging, herniation or protrusion of pieces of the disc and eventual disc space collapse. Resulting mechanical and even chemical irritation of surrounding neural elements (spinal cord and nerves) cause pain, attended by varying degrees of disability. In addition, loss of disc space height relaxes tension on the longitudinal spinal ligaments, thereby contributing to varying degrees of spinal instability. [0007] While various types of spinal fusion operations have been developed, most procedures involving the articular facets have focused either on the passive grafting of bone between facet surfaces denuded of their synovium, or mechanical fixation of the facet joint with a simple screw. In the former case, additional instrumented fixation of the spine is required to prevent dislodgement of the bone grafts from between the articular surfaces of the joint and in the latter case, the procedure is largely adjunctive since its long term success is usually dependent upon bony union occurring elsewhere between the adjacent vertebral elements being fused, i.e., interbody or inter-transverse postero-lateral fusions. SUMMARY OF THE INVENTION [0008] An object of this invention to provide for a facet fixation device that can be utilized either directly in a stand alone facet fusion procedure or as an adjunctive fixator to be utilized when other forms of spinal fusion are employed, e.g., as back up for an anterior fusion. It is also the object of this invention to provide for deployment of the device either radiographically or through endoscopically assisted minimally invasive approaches. [0009] To achieve these objectives, the invention provides a device having opposable jaws bearing teeth or pointed tips to grasp, clasp, crimp or hold the articular surfaces of a single facet joint, thereby immobilizing the joint. The resultant inhibition of mobility serves to facilitate bony union or fusion of the involved spinal elements either directly at the facet joint or at some other chose point between the involved vertebral segments. [0010] The clasping action of the opposable jaws is achieved by a screw- or ratchet-type mechanism that allows for varying degrees of opposition while simultaneously inhibiting unwarranted or undesirable separation or expansion of component elements. In the simplest version, a metal structure approximating the function of a staple can be crimped together to achieve fixation of the facet joint. [0011] In primary facet fusion, the device is to be applied after a wafer of bone has been placed between the articular surfaces of the facet joint suitably prepared by decortication. As an adjunctive fixator, the device may be applied radiographically or endoscopically to an intact facet joint thereby inhibiting movement at the joint site until fusion is achieved elsewhere. [0012] In either scenario, the salient feature of the device is the opposable nature of the component elements that function as jaws to bite and hold the separate articular components of the facet joint thereby serving to immobilize them. The jaws of the device in turn have pointed tips or teeth that engage the cortical surfaces of the joint as the jaws are mechanically closed. Unidirectional closure of the fixation device is achieved either through a screw or a ratchet mechanism which prevents opening of the jaws or disengagement of the teeth once the desired degree of crimping has been achieved. BRIEF DESCRIPTION OF THE DRAWINGS [0013] In the accompanying drawings, [0014] FIG. 1 is a top plan view of a spinal facet fixation device embodying the invention; [0015] FIG. 2 is a front elevation thereof; and [0016] FIG. 3 is a side elevation thereof. [0017] FIG. 4 is a top plan view of a second form of the invention; [0018] FIG. 5 is a front elevation thereof; and [0019] FIG. 6 is a side elevation thereof. [0020] FIG. 7 is a top plan view of a third form of the invention; [0021] FIG. 8 is a front elevation thereof; and [0022] FIG. 9 is a side elevation thereof. [0023] FIGS. 10 and 11 show a three-finger version of the device shown in FIGS. 1-3 . [0024] FIGS. 12 and 13 show the device of FIG. 1 being applied to hold superior and inferior articular facets together. [0025] FIGS. 14 and 15 show, respectively, a spinal facet staple, and the staple being crimped over a pair of spinal facets. DESCRIPTION OF THE PREFERRED EMBODIMENT [0026] The spinal facet fixation device shown in FIGS. 1-3 comprises a base member 10 having a threaded post 12 affixed at its center and extending perpendicularly therefrom. A nut 16 having an integral or captive washer 18 thereon is threaded onto the post. [0027] A pair of pivot pins 20 , 22 are affixed to the bottom of the base, equally offset from the center. The ends of the pins fit within holes (not shown) formed in respective jaws 24 , 26 . Each of the jaws has one or more curved fingers 30 , each terminating at a pointed tip 32 . [0028] The upper surface of each jaw has an upwardly protruding cam 34 ( FIG. 3 ) designed to bear against the washer. When the nut 18 is turned clockwise, it advances down the post, and the washer 16 , bearing against the cams 34 on either side, forces the jaws to pivot downward, bringing their pointed tips 32 closer together. [0029] To draw a facet joint together, a surgeon places the pointed tips of the jaws against neighboring facets ( FIG. 12 ), and then tightens the nut, whereupon the jaws draw the facets more closely together ( FIG. 13 ) and retain them thus. [0030] An alternative form of the invention is shown in FIGS. 4-6 . Here, the jaws have inwardly extending cam followers 34 ′ rather than the upwardly protruding cam surface 34 of the first embodiment. The post 12 ′ in this instance has a rounded head 13 at its bottom; its threaded shaft extends through a threaded collar 15 on the base. The threads may be left-handed, if desired, in which case the head moves upward when the nut us turned clockwise, raising the cam followers and levering the fingers downward to grasp the facets. Other variations on the details of the actuating mechanism will occur to those of ordinary skill. [0031] A third form of the invention is shown in FIGS. 7-9 . In this case, the jaws are hinged on along an axis by a single pin 20 ″. The threaded actuator and cams have been replaced by a ratchet segment 40 having raked teeth which permit the jaws to be drawn together, but does not permit them to spread apart thereafter. One end of the segment is fixed to the jaw 24 ; the other passes through a slot 42 on the jaw 26 so that its teeth catch against the side of the slot. This type of device is closed with a tool such as forceps. [0032] The number of fingers on each jaw may be varied, depending on the intended application. In the examples illustrated in FIGS. 1-9 , each jaw each had two fingers. As an exemplary variation, FIGS. 10 and 11 show the device of FIGS. 1- 3 , modified to have only one finger on one of the jaws, two fingers on the other. The exact shape of the fingers, and the geometry of their tips, may also be selected according to preference and intended use. [0033] The invention can also be practiced with a spinal facet staple 50 , illustrated in FIGS. 14 and 15 . The staple has a center portion 52 extending between opposed arms 54 , each of which has an elbow 56 subtending an obtuse angle A. The obtuse angles face one another so that the tips 58 are directed along axes which, if extended, would intersect. In use, the staple is placed with a suitable crimping tool (not shown) so that the tips engage neighboring spinal facets. Then the tool is manipulated to apply sufficient inward force to the elbows to crimp (permanently deform) the center portion as illustrated in FIG. 15 , drawing the facets toward one another, and holding them together after the tool is released. [0034] Since the invention is subject to modifications and variations, it is intended that the foregoing description and the accompanying drawings shall be interpreted as only illustrative of the invention defined by the following claims.

A spinal facet fixation device includes a pair of jaws hinged on a common base. A threaded actuator bears against a cam surface on the jaws to draw the points of the jaws together. A surgeon applies the opposed points to respective facets of vertebral elements, and then tightens the actuator to draw the facets together.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to the field of dental hygiene and more particularly to dental prophylaxis procedure. 2. Description of the Related Art A principal task of all dental hygienists and many dentists is giving patients a dental prophylaxis. Dental prophylaxis is the cleaning of teeth by first scraping away built-up plaque, tartar and calculus, and then polishing the teeth surfaces. Prophylaxis is routinely performed to enhance the appearance of a patient's teeth and also impede reformation of plaque and calculus. The dental prophylaxis procedure requires utilizing various dental instruments, some of which are pointed and extremely sharp. During a prophylaxis, these instruments are continually being coated with blood and debris, so that the dental care provider must frequently wipe the instruments to clean them. One method presently used to clean instruments is simply to wipe them on the patient's bib. Not only is this method unprofessional and messy, it is also potentially hazardous to the patient because a careless motion could result in a sharp point penetrating the bib and puncturing the skin. A second method is to wipe instruments on a pile of tissue or cotton placed on a tray. This method is not widely used because contact between an instrument and the tissue or cotton sufficient to ensure adequate cleaning of both edges of the instrument cannot be easily or reliably achieved. Increasing instrument tip pressure against the pile generally results in the unsecured pile sliding over the tray surface. In a third method the dental care provider holds cotton balls, tissue, or gauze pads in the palm of one hand while probing the patient's mouth with an instrument held in the other. This method presently is in widest use because the provider can quickly and efficiently clean instruments. However, the method is potentially hazardous to the provider because he or she risks a puncture wound as well as the invasion of life threatening or otherwise harmful viruses and bacteria. The Center for Disease Control has recommended that this method be discontinued, but has yet to propose a substitute method. OBJECTS OF THE INVENTION Accordingly, it is a primary object of the present invention to provide a method for repetitively cleaning dental instruments during a prophylaxis procedure which eliminates the possibility of nicking or puncturing a patient while a dental care provider cleans an instrument. Another object of the invention is to provide a method for repetitively cleaning dental instruments during a prophylaxis procedure which eliminates the possibility of nicking or puncturing the provider. A further object of the invention is to provide a device for repetitively cleaning dental instruments during a prophylaxis procedure that is simple, reliable, and easy to use. Yet another object of the invention is to provide a device that is simple and inexpensive to manufacture. Other objects of the invention will become evident when the following description is considered with the accompanying drawings. SUMMARY OF THE INVENTION The above and other objects are met by the present invention, a device which includes a generally planar array of substantially parallel cylindrical rolls of a material absorbent to blood and other fluids such as cotton, foam or gauze, wherein contiguous pairs of rolls are attached along their tangent lengths so as to form a cusp-shaped crevice or groove between and along each pair of contiguous rolls. The rolls are rigidly attached to the upper surface of a planar adhesive strip. A roll surface has a relatively rough and porous texture rather than a smooth and nonporous texture, and the rolls are sufficiently firm to resist deflection from a pressure or force such as may be applied by the tip, edge or blade of a dental instrument. The lower surface of the adhesive strip is covered by a peel-off strip which, when removed, exposes adhesive on the lower surface which serves to securely attach the device to a metal, porcelain or plastic surface. Each device is packaged in a sterile wrapper, similar to packaging used for adhesive bandages. Before beginning work on a patient, the provider removes a device from its wrapper, peels off the protective strip, and adhesively attaches the device to a dental tray. As an instrument becomes fouled with blood, saliva and debris particles while work proceeds on the patient, the provider wipes the instrument tip on the roll surfaces as often as needed to keep the tip clean. An instrument having a sharp blade or edge is cleaned by sliding the instrument head one or several times through an inter-roll crevice, the process being similar to a knife blade being pulled through a sharpener. A first preferred embodiment includes two rolls made from a stiff absorbent foam, stiff gauze, or tightly-rolled cotton. A second preferred embodiment includes three rolls made from cotton or linen. A third preferred embodiment includes four rolls made from tightly-rolled cotton. A fourth preferred embodiment includes five rolls made from a stiff absorbent foam, tightly-rolled cotton, or linen. A more complete understanding of the present invention and other objects, aspects and advantages thereof will be gained from a consideration of the following description of the preferred embodiments read in conjunction with the accompanying drawings provided herein. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a first preferred embodiment. FIG. 1a is a top perspective view of the FIG. 1 embodiment. FIG. 2 is an exploded perspective view of the FIG. 1 embodiment. FIG. 3 is an end elevational view of the FIG. 1 embodiment. FIG. 4 is a perspective view of a second embodiment. FIG. 5 is a perspective view of a third embodiment. FIG. 6 is a perspective view of a fourth embodiment. DESCRIPTION OF THE PREFERRED EMBODIMENT I. INTRODUCTION While the present invention is open to various modifications and alternative constructions, the preferred embodiments shown in the drawings will be described herein in detail. It is to be understood, however, there is no intention to limit the invention to the particular forms disclosed. On the contrary, it is intended that the invention cover all modifications, equivalences and alternative constructions falling within the spirit and scope of the invention as expressed in the appended claims. II. FIRST PREFERRED EMBODIMENT Referring to FIGS. 1, 1a, 2 and 3, a device 10 according to a first embodiment includes first and second generally cylindrical rolls 12 and 14 having a convexly-shaped upper surface 16, 18, respectively, and a convexly-shaped lower surface 20, 22, respectively, the surfaces 16, 20 and 18, 22 determined with respect to a common generally horizontal median plane. Upper surfaces 16, 18 include along the roll length an interior portion 16A, 18A, respectively. In any particular device sample, rolls 12, 14 are fabricated from the same material and have generally the same length and diameter. As best shown in FIG. 3, the rolls are transversely compressed and rigidly connected along their lengths in an interface area 24 generally orthogonal to and symmetric about the median plane, so as to form a cusp-shaped crevice (or groove) 26. The device 10 further includes a generally planar adhesive strip 30 including an upper adhesive surface 32 and a lower adhesive surface Surfaces 20, 22 of rolls 12, 14, respectively, are rigidly attached to the surface 32. A peel-off strip 36 is attached to the adhesive surface 34. Removing strip 36 from surface 34 exposes the adhesively coated surface 34. The rolls generally have a common length in a range from about 1-inch to about 3-inches, and a common diameter in a range from about 1/8-inch to about 1-inch. In one embodiment, the rolls 12, 14 are each about 1-inch long and about 1/4-inch diameter, and are made from a stiff absorbent foam having a porous, rough surface texture such as open-celled urethane, or from tightly-rolled cotton such as is commonly used in dentistry. Alternatively, the rolls are each about 2-inches long and about 1/2-inch diameter, and are made from the stiff absorbent foam. Alternatively, the rolls are each about 3-inches long and about 1/2-inch diameter, and are made from a stiff gauze. Regardless of the material used to fabricate the rolls, the rolls are sufficiently firm to resist deflection from a downward pressure such as may be applied by the tip of a dental instrument or from a lateral force tending to increase separation between interior surface portions 16A, 18A as the blade or edge of a dental instrument is drawn through the crevice 26. III. SECOND PREFERRED EMBODIMENT Referring to FIG. 4, a device 50 according to a second embodiment includes first, second and third generally cylindrical rolls 52, 54 and 56 having convexly-shaped upper surfaces 58, 60, 62, respectively, and convexly-shaped lower surfaces 64, 66, 68, respectively, wherein the surfaces 58, 64, and 60, 66, and 62, 68, are determined with respect to a common generally horizontal median plane. Upper surfaces 58, 60, 62 include along the roll length interior portions 58A, 60A and 60B, and 62A, respectively. In any particular device sample, the rolls 52, 54, 56 are fabricated from the same material and have generally the same length and diameter. Similar to the first embodiment, the rolls are transversely compressed and contiguous rolls are rigidly connected along their tangent lengths to form a cusp-shaped crevice. Thus, rolls 52 and 54 are connected along an interface 70 to form a crevice 72 between interior surface portions 58A and 60A, and rolls 54 and 56 are connected along an interface 74 to form a crevice 76 between interior surface portions 60B and 62A. The device 50 further includes a generally planar adhesive strip 80 including an upper adhesive surface 82 and a lower adhesive surface 84. Surfaces 64, 66, 68 of rolls 52, 54, 56, respectively, are rigidly attached to the surface 82. A peel-off strip 86 (not shown) is attached to the adhesive surface 84. Removing strip 86 from surface 84 exposes the adhesively coated surface 84. In one construction, the rolls 52, 54, 56 are each about 1-inch long and about 1-inch diameter, and are made from stiff cotton. Alternatively, the rolls 52, 54, 56 are each about 3-inches long and about 3/4-inch diameter, and are made from linen. Regardless of the material used to fabricate the rolls, the rolls are sufficiently firm to resist deflection from a downward pressure such as may be applied by the tip of a dental instrument or from a lateral force tending to increase separation between interior surface portions 58A, 60A, or 60B, 62A as the blade or edge of a dental instrument is drawn through crevice 72 or 76, respectively. IV. THIRD PREFERRED EMBODIMENT Referring to FIG. 5, a device 100 according to a third embodiment includes first, second, third and fourth generally cylindrical rolls 102, 104, 106, 108 having convexly-shaped upper surfaces 110, 112, 114, 116, respectively, and convexly-shaped lower surfaces 118, 120, 122, 124, respectively, wherein the surfaces 110, 118, and 112, 120, and 114, 122, and 116, 124, are determined with respect to a common generally horizontal median plane. Upper surfaces 110, 112, 114, 116 include along the roll length interior portions 110A, 112A and 112B, 114A and 114B, and 116A, respectively. In any particular device sample, the rolls 102, 104, 106, 108 are fabricated from the same material and have generally the same length and diameter. Similar to the first embodiment, the rolls are transversely compressed and contiguous rolls are rigidly connected along their tangent lengths to form a cusp-shaped crevice. Thus, rolls 102 and 104 are connected along an interface 130 to form a crevice 132, rolls 104 and 106 are connected along an interface 134 to form a crevice 136, and rolls 106 and 108 are connected along an interface 138 to form a crevice 140. The device 100 further includes a generally planar adhesive strip 150 including an upper adhesive surface 152 and a lower adhesive surface 154. Surfaces 118, 120, 122, 124 of rolls 102, 104, 106, 108, respectively, are rigidly attached to the surface 152. A peel-off strip 160 (not shown) is attached to the adhesive surface 154. Removing strip 160 from surface 154 exposes the adhesively-coated surface 154. In an illustrative construction, the rolls 102, 104, 106, 108 are each about 21/2 inches long and about 1-inch diameter, and are made from tightly-rolled cotton. The rolls are sufficiently firm to resist deflection from a downward pressure such as may be applied by the tip of a dental instrument or from a lateral force tending to increase separation between interior surface portions 110A, 112A, or 112B, 114A, or 114B, 116A, as the blade or edge of a dental instrument is drawn through crevice 132, 136, or 140, respectively. V. FOURTH PREFERRED EMBODIMENT Referring to FIG. 6, a device 170 according to a fourth embodiment includes first, second, third, fourth and fifth generally cylindrical rolls 172, 174, 176, 178, 180 having convexly-shaped upper surfaces 182, 184, 186, 188, 190 respectively, and convexly-shaped lower surfaces 192, 194, 196, 198, 200, respectively, wherein the surfaces 182, 192, and 184, 194, and 186, 196, and 188, 198, and 190, 200, are determined with respect to a common generally horizontal median plane. Upper surfaces 182, 184, 186, 188, 190 include along the roll length interior portions 182A, 184A and 184B, 186A and 186B, 188A and 188B, and 190A, respectively. In any particular device sample, the rolls 172, 174, 176, 178, 180 are fabricated from the same material and have generally the same length and diameter. Similar to the first embodiment, the rolls are transversely compressed and contiguous rolls are rigidly attached along their tangent lengths to form a cusp-shaped crevice. Thus, rolls 172 and 174 are connected along an interface 202 to form a crevice 204, rolls 174 and 176 are connected along an interface 206 to form a crevice 208, rolls 176 and 178 are connected along an interface 210 to form a crevice 212, and rolls 178 and 180 are connected along an interface 214 to form a crevice 216. The device 170 further includes a generally planar adhesive strip 220 including an upper adhesive surface 222 and a lower adhesive surface 224. Surfaces 192, 194, 196, 198, 200 of rolls 172, 174, 176, 178, 180, respectively, are rigidly attached to the surface 222. A peel-off strip 230 (not shown) is attached to the adhesive surface 224. Removing strip 230 from surface 224 exposes the adhesively-coated surface 224. In one construction, the rolls 172, 174, 176, 178, 180 are each about 3-inches long and about 1/8-inch diameter, and are made from a stiff absorbent foam, tightly-rolled cotton, or linen. The rolls are sufficiently firm to resist deflection from a downward pressure such as may be applied by the tip of a dental instrument or from a lateral force tending to increase separation between interior surface portions 182A, 184A, or 184B, 186A, or 186B, 188A, or 188B, 190A, as the blade or edge of a dental instrument is drawn through crevice 204, 208, 212, or 216, respectively. VI. METHOD OF USE To use the device 10, 50, 100, or 170, a dental care provider, before beginning work on a patient, removes the device from its protective wrapper, peels off the strip 36, 86, 160, 230, respectively, and presses the adhesive surface 34, 84, 154, 224, respectively, onto the surface of a dental tray so that the device is firmly attached to the tray. Typically, the tray is made from porcelain, aluminum or stainless steel. While working on the patient's mouth with a dental instrument, as the instrument becomes fouled with blood, saliva and debris, the provider cleans the instrument by wiping its tip on the upper roll surfaces and/or sliding a fouled blade or edge one or more times through the cusp-shaped crevice between two contiguous rolls.

A device for repetitively cleaning the tips, edges and blades of dental instruments during prophylaxis. A first embodiment includes two substantially parallel, contiguous rolls made from a rough, absorbent material and attached to an adhesive strip including a lower surface which adhesively attaches to a dental tray. Second, third and fourth embodiments include, respectively, three, four and five substantially parallel, contiguous rolls.

FIELD OF THE INVENTION [0001] This invention relates generally to a mobile sink assembly. More specifically, the present invention relates to a portable or mobile sink assembly utilizing injection molded plastic structural panels having integrally formed connectors. The sink assembly is capable of being packaged and shipped in a knock-down state and assembled into a secure and decorative sink and enclosure assembly without additional fasteners. BACKGROUND OF THE INVENTION [0002] Portable or mobile sinks are very convenient for use wherever access to a water supply and drain facilities are not readily available. Portable sinks have been used in the past to facilitate the preparation of food outdoors and to provide washing and cleaning facilities for patients in nursing homes and hospitals who do not have ready access to conventional washing facilities. It is also very beneficial if there is an area adjacent the sink that can be used to store items related to the washing or cleaning to be done in the sink. DESCRIPTION OF THE PRIOR ART [0003] An example of a portable sink is U.S. Pat. No. 5,465,438 which discloses a mobile sink unit for use in a nursing home. The unit includes a fresh water reservoir, a gray water reservoir, a faucet assembly including a control valve, and a soap dispenser. The majority of the space in the sink enclosure is occupied by the fresh water tank and the gray water tank. Any items to be stored must be kept on the top surface of the enclosure. This area is very small as can be seen in the drawings. The enclosure cabinet is formed from an open frame which is overlaid with a sheet material. This type of structure is not subject to being knocked down for shipment and assembly by the consumer at their location. [0004] U.S. Pat. No. 6,349,715 discloses another type of mobile sink. This sink is used in conjunction with a mobile cooking device. A water supply is connected to the lower portion of the device to supply water to the faucet adjacent the sink. The used water from the sink drains away from the device through an outlet hose. The device comprises a housing formed of front, back, side top and bottom walls which are permanently attached. This construction is also not subject to being knocked down for shipment and assembly by the consumer. [0005] Another type of portable sink is disclosed in U.S. Pat. No. 6,836,910. This sink is connected to a water supply to provide water for the sink. The drain empties onto the surface on which the sink is placed. This can lead to a messy and unhealthy situation. The sink enclosure has a drawer for storage but this does not provide a large amount of storage space. SUMMARY OF THE INVENTION [0006] The present invention provides a portable or mobile sink assembly formed from a plurality of injection molded plastic panels having integrated connectors. The panels and other components are capable of being packaged and shipped in a knock-down state and constructed to form an aesthetically pleasing sink and enclosure. The integrated connection of the side wall panels, back wall panel, front wall panel, bottom panel and sink components simplifies the construction of the sink assembly. The panels are formed from injection molded plastic so as to interlock with one another without the need for separate fasteners or connectors. This assembly incorporates a minimum number of components by integrally forming the connectors into the injection molded panels. The panels are then snapped together to complete the assembly. This construction eliminates the need for separate connectors or fasteners to assemble the sink assembly. Injection molding allows the panels to be formed with a single wall having integral cross-bracing, ribs and gussets for increased rigidity when compared to blow molded or rotationally molded assemblies. The same side wall and bottom panel components can be used to create a variety of different assemblies useful for outdoor entertaining or cookouts. The assembly of these components requires minimal hardware and a minimum number of hand tools. [0007] The base, front wall and back wall panels have integrally formed, outwardly projecting bosses for interlocking engagement with the left and right side wall panels. The left and right side wall panels are constructed with integrally formed, inwardly contoured sockets for interlocking, cooperative engagement with the bosses formed on the base, front wall and back wall panels. The engagement between the bosses and sockets serve to connect the panels together into a rigid and weather resistant assembly. [0008] The lower surface of the base panel includes a plurality of integrally formed bosses which are constructed and arranged to cooperate with casters to allow for easy movement of the sink assembly. [0009] Accordingly, it is an objective of the instant invention to provide a mobile sink assembly composed of panels with integral connectors. [0010] It is a further objective of the instant invention to provide a mobile sink assembly composed of panels formed by injection molding which provide increased structural integrity of the assembly. [0011] It is yet another objective of the instant invention to provide a mobile sink assembly wherein the side wall panels, front wall panel, back wall panel, bottom panel and sink are integrally interlocked without the use of separate fasteners or connectors. [0012] It is a still another objective of the invention to provide a mobile sink assembly constructed of modular panels which has an aesthetically pleasing appearance. [0013] It is still a further objective of the invention to provide a mobile sink assembly which is capable of being packaged and shipped in a knock-down state and constructed into a secure assembly at a desired site. [0014] Other objects 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 front perspective view of the sink assembly of the instant invention with a lid on the sink. [0016] FIG. 2 is a front perspective view of the sink assembly of the instant invention with the lid removed from the sink. [0017] FIG. 3 is an exploded view of the sink assembly shown in FIG. 1 . [0018] FIG. 4 is a front planar view of the sink assembly of the instant invention. [0019] FIG. 5 is a cross-sectional view taken along line 5 - 5 of FIG. 4 . [0020] FIG. 6 is a front perspective view of the sink assembly with the faucet in the raised position. [0021] FIG. 7 is a rear perspective view of the sink assembly of the instant invention. [0022] FIG. 8 is a rear planar view of the sink assembly. [0023] FIG. 9 is a bottom view of the sink assembly. DETAILED DESCRIPTION OF THE INVENTION [0024] 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 embodiment with the understanding that the present disclosure is to be considered an exemplification of the invention and is not intended to limit the invention to the specific embodiments illustrated. [0025] FIGS. 2 and 3 illustrate perspective and exploded views of the sink assembly, generally referenced as 10 , according to a preferred embodiment of the invention. In this preferred, albeit non-limiting, embodiment of the invention the sink assembly is formed from a plurality of panels connected together. These panels include a base panel 100 , a right side panel 200 , a left side panel 300 , a back panel 400 , a front panel 500 , and the sink 600 . In the preferred embodiment the panels and the sink are formed of, but not limited to, a suitable plastic such as polystyrene, polypropylene, or polyethylene, through the process of injection molding. The result is that the panels which form the sink assembly are formed as unitary single wall panels with integral connectors and cross bracing. The sink 600 may be formed from materials other than injection molded plastics. These materials include, but are not limited to, cast plastics, fiberglass and metal. [0026] The base panel is formed with a top surface 104 , a bottom surface 106 , a front edge 108 , a back edge 110 , a left edge 112 and a right edge 114 ( FIGS. 3 and 9 ). Integrally formed along the left and right base panel edges are a plurality of bosses 116 for attaching the base panel to the left and right side panels. The bosses 116 extend outwardly from each edge to cooperate with integrally formed sockets 210 which extend inwardly along the bottom portions 206 and 306 of the right and left side panels respectively. Although only socket 210 of the left side panel is shown another integrally formed socket 210 extends along the bottom portion 306 of the right side panel. The bosses and sockets are constructed and arranged so that the bosses 116 matingly engage the sockets 210 thereby securing the panels together in a perpendicular and inter-fitting engagement. Detent or spring lock fasteners 118 are integrally formed on the bosses 116 . Apertures 208 are formed in the end portions of sockets 210 ( FIG. 3 ). The spring lock fasteners 118 cooperate with the apertures 208 to secure the bosses in the sockets. Those skilled in the art can appreciate that the spring lock fasteners 118 and socket apertures 208 can be used throughout the sink assembly to mount or secure components to one another and facilitate assembly of the sink assembly from an unassembled state without the use of tools. The overlapping boss 116 and socket 210 arrangement increases the structural integrity of the sink assembly by preventing panels 200 , 300 , 400 and 500 from bowing or bending inwardly or outwardly and thus, adversely affecting the appearance or operation of the sink assembly. Also, integrally formed on the bottom of the base panel are ribs 202 and gussets 107 which add structural rigidity and strength to the base panel ( FIG. 9 ). [0027] As shown in FIG. 3 the left side panel is configured with a first edge 312 and a second edge 314 . Both edges include integrally formed elongated sockets 210 extending inwardly in a linear fashion along each edge. The sockets 210 are generally constructed and arranged to cooperate with the bosses 116 provided along an edge of the back panel 400 and the front panel 500 . The top edge of the left side panel is provided with an upstanding lip 315 integrally formed thereon. The lip cooperates with an underside portion of the sink 600 to facilitate their mechanical connection. The interior surface of the left side panel is provided with integrally formed ribs 202 which add structural rigidity and strength to the panel. [0028] The right side panel is configured with a first edge 212 and a second edge 214 . Both edges include integrally formed elongated sockets 210 extending inwardly in a linear fashion along each edge. The sockets 210 are generally constructed and arranged to cooperate with the bosses 116 provided along an edge of the back panel 400 and the front panel 500 . The top edge of the right side panel is provided with an upstanding lip 215 integrally formed thereon. The lip cooperates with an underside portion of the sink 600 to facilitate their mechanical connection. The interior surface of the right side panel is provided with integrally formed ribs 202 (not shown) which add structural rigidity and strength to the panel. [0029] The outer surface of the panels 200 , 300 , 400 and 500 are constructed as generally smooth and have a plurality of inwardly curved grooves 230 integrally formed thereon for added strength, structural integrity and aesthetic appearance. The insides of the panels 200 and 300 are provided with strengthening ribs 202 and seen in FIG. 3 . The ribs add to the structural integrity provided by the grooves 230 . This increase in structural integrity prevents the panels 200 , 300 , 400 and 500 from bowing or bending inwardly or outwardly, adversely affecting the appearance or operation of the sink assembly. As illustrated herein these features are achieved by injection molding. Injection molding offers significant strength and stability advantages over blow-molding or rotational molding as utilized in the prior art. In this manner the sink assembly of the present invention is capable of handling a significant amount of weight and abuse as compared to prior art sink assemblies. [0030] The front panel 500 is attached to the left 300 and right 200 side panels by inserting the bosses 116 , of the front panel, into the sockets 210 , of the left and right side panels, until the spring lock fasteners 118 integrally formed on the bosses 116 engage the apertures 208 in the sockets of the left and right side panels. [0031] Located below the front panel 500 is a door 502 which provided access to a storage area. The storage area comprises the space below the sink 600 , above the base panel 100 , between the right and left side panels 200 and 300 and between the front and back panels 500 and 400 . This area may be used for the storage of items used in conjunction with the sink or for other cleaning purposes. The door 502 is hingedly mounted to the base panel and front panel by hinge pins 504 integrally formed on the door. The hinge pins fit into and cooperate with apertures 506 integrally formed in the base panel and front panel to permit pivotal opening and closing of the door. A handle 508 may also be provided on the door to assist the opening and closing thereof. The outer surface of the door 502 is constructed as generally smooth and has a plurality of inwardly curved grooves 230 integrally formed thereon for added strength, structural integrity and aesthetic appearance. These are similar to grooves 230 formed in the side, back and front panels. [0032] The base panel 100 is attached to the right 200 and left 300 side panels by inserting the bosses 116 , integrally formed on the base panel, into sockets 210 , integrally formed in the side panels, until the spring lock fasteners 118 engage the apertures 208 in the sockets of the left and right side panels ( FIG. 3 ). The back panel 400 is attached to the right and left side panels by inserting the elongated bosses 116 , integrally formed on the back panel, into the sockets 210 , integrally formed in the side panels, until the spring lock fasteners 118 engage the apertures 208 in the sockets of the left and right side panels. The front panel 500 is attached to the right and left side panels by inserting the elongated bosses 116 , integrally formed on the front panel, into sockets 210 , integrally formed in the side panels, until the spring lock fasteners 118 engage the apertures 208 in the sockets of the left and right side panels. It will be appreciated that the purpose of the elongated bosses 116 are to align the two joined panels in a perpendicular relationship and to facilitate their mechanical connection. This results in high structural integrity and reliable operation. [0033] Referring to FIG. 3 the attachment of the sink 600 will now be described. A plurality of independently formed bosses 120 are inserted into the sockets 210 formed at the upper ends of the first and second edges of the right and left side panels. The spring lock fasteners 118 on the bosses 120 engage the apertures 208 formed in the sockets 210 . The sink is then placed over the top portion of the bosses which extend upwardly beyond the ends of the sockets 210 of the side panels. These top portions of the bosses are inserted into sockets 210 (not shown) formed on the underside of the sink at each corner thereof. Spring lock fasteners 118 on the top portion of the bosses engage apertures 208 (not shown) formed in the sockets 210 formed in the sink. As shown in FIG. 3 , each boss 120 has two spring lock fasteners 118 formed thereon, thereby assuring that each boss will be securely attached to both the side panel and the sink. An underlying portion of the sink is constructed and arranged to cooperate with the upstanding lips 215 , 315 , 415 and 515 of the right, left, back and front panels to align the joined elements in a perpendicular relationship and facilitate their mechanical connection. As a result the sink is securely attached to the other panels. When the sink 600 is formed by injection molding or casting, the sockets 210 are formed simultaneously therewith. The socket may also be machined or cut out of a previously cast or molded sink. Further, if the sink is formed from metal the sockets may be attached subsequently, as by welding, for example. [0034] The sink also includes a faucet 602 to supply water from a source to the sink. The faucet is pivoted between an upright, operative position as shown in FIG. 6 and a folded, inoperative position as shown in FIG. 3 . A water control valve 603 is located in the sink and separate from the faucet, as shown in FIG. 3 . A drain 604 is provided at the lowermost portion of the sink to remove the contents of the sink ( FIG. 5 ). A drain hose (not shown) connects the drain to the outside of the sink assembly through an aperture 402 provided in a lower portion of the back panel 400 . As shown in FIG. 1 , a cover 606 is constructed and arranged to cover the sink bowl so that the top portion of the sink assembly may be employed as a work surface or storage area. The cover 606 is stored on the back panel when the sink is in use ( FIG. 7 ). [0035] Referring now to FIGS. 3, 7 and 8 the back panel has integrally formed bosses 116 along the length of the left and right edges thereof. The bosses have spring lock fasteners 118 integrally formed thereon. The back panel is attached to the left and right side panels by inserting the bosses 116 , of the back panel, into the sockets 210 , of the left and right side panels, until the spring lock fasteners 118 engage the apertures 208 formed in the sockets 210 . The back panel is provided with an aperture 402 through which a drain hose may be positioned. The opposite end of the drain hose is connected to the drain 604 of the sink to provide a means to drain the fluids from the sink. The back panel is also provided with a fitting 404 which is connectable to a source of water. The fitting is also connected to the faucet 602 via a means not shown. [0036] A storage area for the sink cover 606 is provided on the back panel. Clips 608 ( FIGS. 7 and 8 ) are positioned on the back panel to hold the sink cover in a vertical position adjacent the panel. The clips 608 located on the upper portion of the back panel are flexible or spring type clips. The sink top is held in its storage position by these clips and can be released therefrom by flexing the clips. [0037] The perpendicular side, back, front and base panels are brought into an overlapping relationship wherein the bosses 116 enter the corresponding sockets 210 in the right and left side panels respectively. The result is a mechanically secure connection between the panels. The overlapping edges between the panels as described above provides a secure connection, snap-together assembly and offers several advantages. First, the design allows the panels to be connected without the need for separate connectors. Second, the design creates a positive lock which prevents separation of the panels. Third, the design maintains alignment of the panels in the same plane and prevents bowing or bending of either panel relative to each other. [0038] Referring now to FIGS. 3, 4 and 5 casters 122 and caster bosses 124 are illustrated. The casters include a stem 126 that is constructed and arranged to cooperate with an aperture integrally formed into the lower surface of the base panel. To attach the caster to the sink assembly, the stem 126 is inserted into the aperture of the boss 124 until a retaining ring snaps into a corresponding groove formed in the aperture. This results in a mechanically secure connection. The casters are also provided with a manually engagable and releasable lock 130 to prevent the sink assembly from unwanted moves on sloped and uneven surfaces. The lock prevents rotation of the casters when in its engaged position and permits free rotation of the casters when in its disengaged position. [0039] Referring to FIGS. 7 and 8 , a shelf 710 is hingedly mounted on one or both side panels of the sink assembly. Each shelf is provided with two hinges 724 and 726 . These hinges are formed separately from the shelf and attached thereto with fasteners. The portion of the hinge which engages the side panel is not attached thereto with fasteners. Hinge 724 is provided with a fixed pin. A portion of the pin extends beyond the hinge. Hinge 726 is provided with a slidable pin. The slidable pin is biased to its extended position by a spring. The portions of the fixed pin and slidable pin which extend beyond the hinges engage apertures 734 formed in the edge portions of the side panels ( FIG. 6 ). This provides a means to attach the shelves to the side panels. Each shelf is also provided with a plurality of supports hingedly mounted to a lower surface of the shelf. If removal of the shelf is desired, the slidable pin is retracted into the hinge which in turn disengages the pin from aperture 734 in the side panel. The shelf can now be pivoted downwardly disengaging the fixed pin from aperture 734 in the side panel and totally disengaging the shelf from the sink assembly. The location of the apertures 734 are identical on both the left and right side panels so that the same shelf may be mounted on either side of the sink assembly. [0040] 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. [0041] 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. [0042] 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 present invention provides a sink assembly formed from a plurality of injection molded plastic panels having integrated connectors which are capable of being packaged and shipped in a knock-down state and constructed to form an aesthetically pleasing sink assembly. The integrated connection of the side walls, front, back, and bottom panels and sink components simplifies the sink assembly construction. The panels are formed of injection molded plastic to interlock with one another without the need for fasteners or connectors. The system incorporates a minimum number of connectors by integrally forming the connectors into the panels which are snapped together to complete the assembly.

BACKGROUND OF THE INVENTION This invention relates generally to crop harvesting and threshing machines, more commonly known as combines, and more particularly to the type of combine commonly referred to as an axial flow type of combine. The axial flow type of combine is characterized by having the crop material pass axially through an elongate housing which has a separate casing therein that surrounds each threshing and separating apparatus or rotor. The crop material is passed spirally rearward about the rotors contained within each casing. Specifically, the invention is concerned with providing a structure that is easily removed from the side frame of the combine to permit quick and convenient access to the rotor area. This access unit or rotor access module permits the operator to service the rotor and its underlying concaves in a minimum of time and without the need for any special tools or assistance. This invention is equally applicable to an axial flow type of combine utilizing either a single threshing or separating rotor, multiple threshing and separating rotors, or any comparable apparatus utilized for rotary threshing and separation. Conventional combines pass the crop material to be threshed between a rotary cylinder and a stationary concave in a direction that is normal to the axis of the rotating cylinder and parallel with the longitudinal axis of the combine frame. In this system much of the grain contained in the crop material fed to the cylinder and the concave passes through the concave as threshed grain. The remainder of the material is conveyed to separating elements of the combine that traditionally include reciprocating or oscillating straw walkers, grain pans and chaffer sieves. Because of the combined effect of the transverse orientation of the rotary cylinder and the single pass of crop material about the cylinder during threshing, there is less of an urgent need to have convenient and rapid access to the threshing area. Since the threshing concave and cylinder extends transversely across the width of a conventional combine, access at one particular relatively narrow point in either side or both sides of the combine permits servicing of the entire width of the concave and threshing cylinder. Combines of the axial flow type, in contrast, utilize single or dual threshing and separating apparatus, such as rotors, that permit the crop material to pass over the concave during the threshing process three or more times. The concaves run from front to rear and generally underlie a single or dual rotor system that is parallel to the longitudinal axis of the combine. This longer area of contact between the rotors and the concaves of necessity requires a larger access area for the operator when servicing the rotors and the concaves. This need for convenient access to the rotor and concave area in the relatively recently commercially developed axial flow types of combines was early recognized by the designers of these machines. Relatively elongated access plates were provided on the sides of the frames of some of these early axial flow type of combines to permit a substantial portion of the threshing area to be serviced at one time. However, simply having access to the threshing and separating area of the axial flow combines did not solve the entire problem since the concaves still had to be serviced in a restricted area, as well as having to be removed in order to reach the rotor. Different approaches were attempted to provide easily removable concave sections underlying the threshing portion of the rotors. One of these early approaches requires that the header and infeed housing mounted to the front portion of the combine be removed entirely from the combine base unit before the concave sections are slid forwardly out of their mountings. Another approach involves the utilization of linkages which permit the forward portion of the concave to be pivoted toward the side of the machine to remove it from the rotor casing. This solved the problem of providing an easy way to change the wire inserts in the concave sections, but did little to improve accessibility to the rotor and the remaining portions of the concaves. None of the aforementioned approaches provided a technique that would permit easy access to the rotor and the remaining concaves for servicing. Additionally, when concave extensions were utilized the separate fasteners utilized to hold them in place in the rotor casings had the potential to come loose and fall out or merely fail because of the high level of vibrational activity in the area surrounding the rotating rotors. The foregoing problems are solved with the design of the machine comprising the present invention by providing a rotor access module that is removably insertable through the frame of a combine into the rotor casing with an interior portion that cooperates with the existing concaves as an integral part of the rotor casing during the threshing and separating cycle when it is fully inserted and when removed from the casing and the frame provides easy access to the rotor and concaves for servicing. SUMMARY OF THE INVENTION It is an object of the present invention to provide in a combine of the axial flow type an access unit that is easily removable from the side frame of a combine to permit easy servicing of the threshing and separating rotor and the concaves underlying the rotor. It is a further object of the present invention to provide a simple, and low cost access unit that is modular in form and which includes grates which serve as an extension of the concaves on its innermost portion to aid in the threshing and separation of the crop material. It is a feature of the present invention that there are provided deflectors attached to the access unit or module which serve to evenly distribute the threshed grain across the grain receiving surface or grain pan which underlies the threshing and separating rotors. It is an advantage of the present invention that the rotor area and the concaves are easily accessible for servicing without the need for any special tools. It is a further advantage of the present invention that the rotor access module is relatively simple of design and low cost in nature. It is another advantage of the present invention that the means to secure the extension of the concaves in place in the rotor casing are not easily susceptible to failure since the extension is part of a unitary module that is inserted and removed as a unit. These and other objects and advantages are obtained by providing a rotor access module in a crop harvesting and threshing machine of the type utilizing at least one axial flow threshing and separating rotor within a generally cylindrical elongate casing such that the access module is removably insertable through the side of the harvesting and threshing machine into the rotor casing and has threshed grates attached to the portion of the module closest the rotor so that when inserted the module serves to aid in the threshing and separating of the grain from the crop material and when removed provides easy access to the threshing and separating apparatus. BRIEF DESCRIPTION OF THE DRAWINGS The advantages of this 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: FIG. 1 is a side elevation view of a crop harvesting and threshing machine illustrating the location of the rotor access module on the frame; FIG. 2 is an enlarged partial front elevation view of the rotor casings taken along the section line 2--2 of FIG. 1 showing the rotor access module inserted through the frame and forming an extension of the concave section of the rotor casing; FIG. 3 is an enlarged partial side elevation view of the rotor casing taken along the section line 3--3 of FIG. 2 showing the interior view of the rotor access module with the grates forming the extension part of the threshing concave; and FIG. 4 is a perspective view of the rotor access module removed from the combine showing the deflectors and grating attached to the unit. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIG. 1, there is shown a combine 10 in a side elevational view with the location of the rotor access module illustrated and indicated generally by the numeral 11. As can be seen, the combine 10 has a mobile frame mounted to a pair of primary driving wheels 12 in front and a pair of smaller steerable wheels 14 in the rear. The combine is powered by an engine (not shown), usually a diesel engine of high horsepower. The engine is mounted to the upper portion of the combine in a suitable fashion and, by means of drive belts or sprocket driven chains, is drivingly connected to the operational components of the combine. Still referring to FIG. 1, the combine 10 has an infeed housing 15 with a crop elevator, indicated generally by the numeral 16, fastened to its front. Combine 10 has a main frame or housing, indicated generally by the numeral 18, that internally supports the two threshing and separating rotors 19, only one of which is partially shown in FIG. 1. The operator's cab 20 extends forwardly over the front of the main frame 18 and is atop the infeed housing 15. A rear housing 21 encloses the rear of the combine 10 and covers the discharge beater and discharge grate assembly, both of which are not shown. The main frame 18 also supports a grain pan 22 and grain cleaning means, not shown. The grain pan 22 collects the threshed and cleaned grain and moves it to a grain trough 24, which spans the width of the combine along the bottom of the frame. The trough is open-topped and has an auger, not shown, rotatably mounted therein to convey the cleaned grain through a grain transfer chute, also not shown, which carries the grain upwardly into the grain tank 25. When it is necessary to unload the full grain tank 25 an unloading auger, not shown, is pivoted within an unloading auger tube 28. Tube 28 is movable between inboard and outboard positions with respect to the longitudinal axis of the combine and is effective to discharge the threshed and cleaned grain from the grain tank to the receiving vehicle or container. Unthreshed grain, commonly known as tailings, is collected in trough 26 and is returned in a conventional manner to the rotors 19 for rethreshing. The cleaning system within the combine functions to take unthreshed grain which remains in the crop material, separate it from the cleaned grain and the chaff, and direct it into this tailings trough 26. Both of the rotors 19 are enclosed in individual elongate and generally cylindrical rotor casings 29, best illustrated in fragmentary fashion in FIG. 2. Both the rotors 19 and the rotor casings 29 are divided into infeed areas, threshing areas and separating areas. The infeed areas are shown generally by the areas defined by the numeral 30 in FIG. 1. The threshing areas, partially illustrated in FIG. 1, run immediately rearwardly of the infeed areas to a point indicated generally by the numeral 31. The separating areas are shown generally by the numeral 32 in FIG. 1. The infeed areas 30 are located generally in the forward portion of the rotor casings 29 adjacent the infeed housing 15. The pairs of auger flighting mounted on the infeed portion of each of the rotors 19 spiral about the rotors and serve to deliver the stream of crop material brought from the header through the infeed housing 15 via the crop elevator 16 rearwardly into contact with the rasp bars 34, see briefly FIG. 2, that are fastened to and generally define the threshing portions of the rotors 19. The structure thus far has been described generally since it is old and well-known in the art. This structure and the interrelationships between the various operating components of a combine are described in greater detail in U.S. Pat. No. 3,626,472, issued Dec. 7, 1971; 3,742,686, issued July 3, 1973; and 3,995,645 issued Dec. 7, 1976; all to Rowland-Hill, hereinafter specifically incorporated by reference in their entirety, insofar as they are consistent with the instant disclosure. Looking now at FIG. 2, rotor casings 29 are supported by structural members of the main frame 18. A support beam 35 has mounted thereagainst a side frame sheet 36. The rotor casings 29 are anchored to support beam 35 by casing bracket member 38. Bracket member 38 has a shelf type portion 39 which serves as a support for the rotor casing cover 40. The lower portion 37 of bracket member 38 is arcuate in shape and forms a portion of the generally cylindrical periphery of the rotor casing 29. On the underside of the rotor casing cover 40 is a transport fin 41 which assists in guiding the crop material rearwardly as the crop material is spiralled about each rotor 19. The support bracket 42 adjoins and supports each of the rotor casing covers 40 and is mounted at its bottommost portion to dividing member 44. The support bracket 42 is curved to conform to the generally cylindrical shape of each of the rotor casings 29 beneath the casing covers 40. Mounted to dividing member 44 within each rotor casing 29 is a guide member 45. Guide member 45 is suitably shaped to also conform to the generally cylindrical contour of the interior of each of the rotor casings 29. The lower portion of each casing 29 is adjustably mounted to a separate linkage and sub-frame apparatus. Dividing member 44 is securely fastened to bracket member 50 which is mounted to the concave cradle linkage, indicated generally by the numeral 47, via the front hinge shaft 48. The concave cradle linkage 47 is essentially the sub-frame that supports the concaves beneath the rotors 19. This cradle linkage is generally an H-shaped configuration with the front hinge shaft 48 and the rear hinge shaft 49 (see briefly FIG. 3) forming a pair of parallel transverse cross bars. A longitudinal central bar, not shown, connects the two so that the entire cradle linkage lies beneath the rotors 19 and the two concave assemblies, indicated generally by the numeral 46, and within the side frame sheets 36. The two concave assemblies 46 underlie the rotors 19, one assembly per rotor. Each concave assembly 46, as seen in FIGS. 2 and 3, has a concave weld assembly 51 which is supported at its outer edges by front and rear pivotal support linkages 54. The length of each of the support linkages 54 is adjustable by turnbuckles 52. Turnbuckles 52 are mounted about their respective front and rear hinge shafts, 48 and 49, by collars 53. Studs 55 connect the turnbuckles 52 to the collars 53. As best seen in FIG. 2, each concave assembly 46 includes a plurality of threshing bars 56, extending longitudinally along the length of the combine 10, and a plurality of transversely curved rods 58 which pass through apertures 43, see briefly FIG. 3, in the bars 56. Each concave assembly further comprises front and rear curved concave weld assemblies 51. Attached to the outermost portion of each concave assembly 46 is a spacer member 57. On the interior sides of each of the rotor casings 29 and on the adjacent sides of each of the concave assemblies 46, the concave weld assemblies 51 are supported on pivot pins 59. Pins 59 insert through apertures in the bracket 50 of the front portion of the combine and through a similarly oriented bracket, not shown, at the rear of the concave cradle linkage 47. A rotor access module 11 inserts through one of the side frame sheets 36 to form a concave extension 60, supplementing the concave assembly 46. Spacer member 57 of FIG. 2 ensures a close fitting between the concave extension 60 and the concave assembly 46 to prevent unthreshed crop material and chaff from passing therebetween and falling into the grain pan 22. As seen in FIGS. 2, 3 and 4, the rotor access module 11 includes an exterior covering member 61, which is fastened to side frame sheet 36 by a plurality of appropriate fasteners 62. Module 11 has a handle 64 attached to the cover plates 61 to facilitate removal from the combine. As best seen in FIGS. 2 and 4, the access module 11 has side members 65 appropriately fastened to the cover plate 61. Appropriately fastened to the opposing side plates 65 are concave extension threshing bars 66 and 67. An intermediate support plate 68 connects the access module cover plate 61 and the concave extension and threshing bars 66 and 67. Bars 66 are aligned in parallel fashion while bar 67 is generally horizontal so that it mates with the bottom of the angular portion 37 of bracket member 38, best seen in FIG. 2. A series of apertures 69 are punched or otherwise suitably placed within each of the extension threshing bars 66 such that rod-like members 70 may be inserted through a correspondingly aligned aperture in each of the extension threshing bars. The combined effect of the rod-like members 70 is to provide an auxiliary threshing and separating surface or extension of the concaves which permits the grain to be threshed by the threshing bars 66 and then separated from the remaining crop material to pass through the spaces provided between the rod-like members 70 and the threshing bars 66. As best seen in FIG. 4, the rotor access module 11 also has a pair of deflector plates 71 and 72 hingedly mounted to side plates 65 and intermediate support plate 68. The forward and rearward ends of deflector plates 71 and 72 have triangularly shaped guide plates 74 attached to prevent the threshed crop material from passing over the edges of the deflector plates 71 and 72 and falling on other than the grain pan 22. Deflector plates 71 and 72 are hingedly mounted to the rotor access module 11 by rotatable shafts 75 and 76 held within sleeves 78 and 79, respectively. Deflector plates 71 and 72 are adjustably positioned via the adjustment assembly, indicated generally by the numeral 80 in FIG. 2. There is an adjustment assembly 80 for each deflector plate 71 and 72. The adjustment assemblies 80 comprise adjustment rods 81 and 82, as seen in FIG. 4, slidably mounted within collars 84 and 85, all of which pass through the cover plate 61. Adjustment rods 81 and 82 are fastened to cross members 86 and 87, respectively. Cross members 86 and 87 are slidably movable within paired tracks 89 and 90. In operation the combine 10 moves across a field of crop material where the header gathers the crop material and consolidates it. The crop material is transferred from the header upwardly into the infeed area 30 by the crop elevator 16 within the infeed housing 15. The crop material is thus brought into contact with the counter-rotating rotors 19 in the infeed area 30 and passes rearwardly into the rotor casings 29. The crop material is successively passed through the threshing area 31 and the separating area 32. The rasp bars 34, mounted to the rotors 19, cooperate with the concave assemblies 46 and the concave extensions 60 of the rotor access modules 11 to thresh the grain and partially separate if from the crop material. Deflector plates 71 and 72 are positioned via the deflector plate adjustment assemblies 80 to catch the threshed grain as it passes through the threshing bars 66 and 67 and rod-like members 70 of the concave extensions 60 to guide the grain onto the grain pan 22. When it is necessary to service the rotors 19 or the concave assembly 46, the rotor access module 11 is removed from the side frame sheet 36 and the rotor casing 29 by removing the rotor access module cover plate fasteners 62. This permits the entire access module 11 to be slidably removed from the combine and the operator to have access into the critical threshing area within each casing. It should also be noted that the rotor access module 11 could also be fastened to the frame side sheet 36 in varying manners that could add to the functional effectiveness of the rotors 19 and the convenience of the combine 10 in general. For example, the fasteners 62 could have shims or spacers inserted over them and between the frame side sheet 36 and the module cover plate 61 to effectively position the entire module 11 further out from the centerline of the combine 10. This will move the concave extension 60 outwardly also, thereby creating more clearance between the threshing bars 66 and the rotors 19. This can be desirable in certain crops such as rice or maize where a flailing action rather than a rubbing action is more effective. Also, the module 11 could be hingedly fastened to the frame side sheet 36 so the module 11 could be easily pivoted out of the casing 29 and secured by a latching mechanism to the frame side sheet 36 in a convenient manner. While the preferred structure in which the principles of the present invention have been incorporated is shown and described above, it is to be understood that the invention is not to be limited to the particular details thus presented, but, in fact, widely different means may be employed in the practice of the broader aspects of this invention. The scope of the appended claims is intended to encompass all obvious changes in the details, materials and arrangements of parts which will occur to one of ordinary skill in the art upon a reading of this disclosure.

In a crop harvesting and threshing machine of the type utilizing axial flow threshing and separation, there is provided an access unit to the threshing and separating apparatus which is removably insertable through the side of the harvesting and threshing machine into the rotor casing. The access unit has threshing grates attached to the portion nearest the threshing and separating apparatus so that when inserted the access unit serves to aid in the threshing and separating of the grain from the crop material and when removed provides easy access to the threshing and separating apparatus.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present application is a continuation of the U.S. application Ser. No. 10/717,925, filed Nov. 23, 2003, which claims priority to Provisional Patent Application No. 60/428,281, filed Nov. 22, 2002, whose disclosure is hereby incorporated by reference in its entirety into the present disclosure. FIELD OF THE INVENTION [0002] The present invention is generally related to tremor control, and more particularly, is related to an apparatus and methods for the electrical stimulation of the brain through skin surface stimulation of the peripheral nervous system for the treatment of movement disorders. BACKGROUND OF THE INVENTION [0003] In the last decade, the use of deep brain stimulation (DBS) has demonstrated dramatic improvement in symptoms associated with movement disorders, including symptoms from Parkinson's disease (PD), Essential Tremor (ET) and dystonia. [0004] Essential Tremor is an involuntary movement, such as a shaking movement that is repeated over and over. Essential Tremor usually affects the hands and head, although occasionally the feet or torso may also be affected. Essential tremor, which sometimes runs in families, is one of the most common types of tremor. It causes shaking that is most noticeable when a person is performing a task like lifting a cup or pointing at an object. The shaking does not occur when the person is not moving. The tremor may also affect the person's voice. Medication can help reduce the shaking. Tremors can also be caused by conditions or medications that affect the nervous system, including Parkinson's disease, liver failure, alcoholism, mercury or arsenic poisoning, lithium, and certain antidepressants. [0005] Instead of destroying the overactive cells that cause symptoms from PD, for example, DBS instead temporarily disables the cells by firing rapid pulses of electricity between four electrodes at the tip of a lead. The lead is permanently implanted and connected to a pacemaker controller installed beneath the skin of the chest. [0006] DBS utilizes electrodes that are usually implanted in one of three regions of the brain: the thalamic nucleus ventralis intermedius (Vim), the internal globus pallidus (GPi), and the subthalamic nucleus (STN) ( FIG. 1 ). Some studies have shown that DBS has the best effect on tremors, when the Vim is stimulated. Rigidity and gait disturbances have shown improvements with stimulation of GPi and STN. The parameters of 130-185 Hz, 60 ms pulse width and 2.5 to 3.5 volts are most commonly utilized for DBS stimulation. DBS stimulation is typically pulsed intermittent stimulation having an on cycle of about a few seconds up to a minute, then an off cycle for about 30 seconds to several minutes. [0007] The challenge of DBS is the obvious drawback of having to undergo a neuro-surgical procedure and also to have the result of one or two electrodes implanted deep within the structures of the brain. [0008] The present invention achieves tremor control through brain stimulation without the use of the invasive DBS electrodes. Stimulation of peripheral nerves results in the excitation of some area of the brain (Thalmus, sub-cortical and Cortical areas). The stimulation of sites on the surface of the skin produces effects of tremor control which are similar to the effects achieved by DBS for limited amounts of time. Surface stimulation is achieved through the use of surface electrodes that are currently used for Muscle Stimulation or TENS. Following a 30-60 minute stimulation time, there is a residual decrease in tremor of at least 30-60 minutes. The device can be worn under the clothing and activated while the decreased tremor period is desired. [0009] PET (Positron Emission Tomography) scans, a molecular medical imaging procedure that uses small amounts of radioactive pharmaceuticals to make images of the body's metabolic activity, Magnetoencephalography (MEG) scans and fMRI scans can be used to identify appropriate peripheral surface stimulation sites. Various types of stimulation can be used including TENS, Neuro-Muscular Stimulation, Ultra Sound, Interferential Stimulation, PEMF, EMF, and various types of mechanical stimulation. [0010] Thus, a heretofore unaddressed need exists in the industry to address the aforementioned deficiencies and inadequacies associated with a neuro-surgical procedure and the implantation of at least one electrode deep within the structures of the brain. SUMMARY OF THE INVENTION [0011] Embodiments of the present invention provide an apparatus and methods for surface electrical stimulation of the peripheral nervous system at predetermined peripheral stimulation sites for the treatment of movement disorders. [0012] In a preferred embodiment, the peripheral stimulation sites, which are linked to specific areas of the brain, are initially traced using dermatome maps and then verified using PET scans, MEG scans, fMRI or other neural imaging devices. The electrical stimulator may utilize an interferential current that has a base medium frequency alternating current between 1 KHz and 100 KHz. An interferential current is set up between two circuits that are arranged in a cross-pattern on the subject's targeted area of stimulation. Where the circuits superimpose in a cross-pattern, the resultant beat frequency will be the difference between the frequencies of the two circuits and will usually range between 0-250 Hz and can be dynamic, and the amplitude will be additive and greater than either circuit alone. [0013] Digital signal processors (DSPs) are used for improving the accuracy and reliability of digital signals that are used extensively in the communications field. Digital signal processing works by standardizing or clarifying the output of a digital signal. In this embodiment, the digital signal processor is used to shape multiple pulsatile waveforms to approximate the output of a sine-wave generator. In another embodiment of the invention, the digital signal processor is replaced with a field-programmable gate array (FPGA). A FPGA is an integrated circuit that can be programmed in the field after it is manufactured and therefore allows users to adjust the circuit output as the needs change. Both the DSP and the FPGA process a digital signal into a pseudo-sine-wave current waveform from the digital pulses generated by a pulse generator. The pseudo-sine-wave current waveform is transmitted through surface electrodes at a targeted area creating an interferential current. [0014] The electrical stimulator may also use a standard TENS or NeuroMuscular stimulation waveform. Such devices produce a pulsatile current with a square wave output, an amplitude range from 0-150 mA and a phase duration (pulse width) range of 1-500 μsec. The frequency of such devices can range from 1 pulse per second (pps) to 2500 pps. The devices can be set to various duty cycles (on and off times) from as little as 1 second to 30 minutes on, and an off time as little as 1 second to as long as several minutes. The device can also be set to a continuous output without a duty cycle. The device may utilize as little as one pair of electrodes, or multiple sets may be more effective depending on the condition of the patient. [0015] Once identified, the peripheral stimulation sites are stimulated with the surface electrical stimulation device. [0016] Other systems methods, features and advantages of the present invention will be or become apparent to one skilled in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the present invention, and be protected by the accompanying claims. BRIEF DESCRIPTION OF THE DRAWINGS [0017] Many aspects of the invention can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present invention. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the several views. [0018] FIG. 1 is a drawing of the potential stimulation sites in the brain for deep brain stimulation for movement disorders; [0019] FIG. 2 is a drawing of a perspective view of an interferential current set up by two circuits; [0020] FIG. 3 is a drawing of a perspective view of an interferential current pattern indicating the current intensity level and area of beat frequency formation; and [0021] FIG. 4 is a drawing of a stimulator with surface electrodes positioned at peripheral stimulation sites. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0022] A preferred embodiment of the invention and modifications thereof will now be described with reference to the drawings. [0023] FIG. 1 shows the potential stimulation sites in the brain for deep brain stimulation via surface stimulation of the peripheral nervous system. Using dermatome maps (not shown) of the peripheral nervous system, which can then be confirmed by PET scans (not shown) of the brain, peripheral surface stimulation sites 410 on a subject's skin surface are determined ( FIG. 4 ). The stimulation of the peripheral surface stimulation sites 410 on the surface of the skin produces effects of tremor control which are similar to the effects achieved by DBS for limited amounts of time. The excited peripheral nerves would in turn excite similar, but not necessarily, the same areas of the brain that are currently stimulated by DBS. [0024] FIG. 2 shows a stimulator 200 for the electrical stimulation of the peripheral nerves for tremor control at the peripheral surface stimulation sites utilizing an interferential current 210 that has a base medium frequency alternating current between 1K-100 KHz. Such a stimulator 200 is shown, for example, in U.S. Pat. No. 6,393,328, issued on May 21, 2002 to the assignee of the present application. Other TENS, Neuromuscular stimulation devices, Ultrasound, Pulsed Electromagnetic Field generators, EMF generators and mechanical stimulation devices can also be utilized (not shown). [0025] The interferential current 210 is set up between two circuits 218 , 220 , 418 , 420 that are arranged in a cross-pattern. A first pair of surface electrodes 208 , 209 are positioned on a subject's skin surface at the peripheral surface stimulation site 410 on one set of diagonal corners of a targeted area 114 , 314 (see FIG. 3 ). The targeted area is the peripheral nerve and surrounding area to be stimulated. A second pair of surface electrodes 209 , 309 , and 408 , is then positioned at the other set of diagonal corners of the targeted area 114 , 314 . A digital signal processor 202 is connected to the first and second pairs of surface electrodes 208 , 209 ; 308 , 309 ; and 408 . When a signal-generating source 204 is connected to the digital signal processor 202 , a sine-wave-like waveform signal output 206 is created. The digital signal processor 202 improves the accuracy and reliability of the digital signals. The digital signal processor 202 processes the multiple pulses from the signal generating source 204 to approximate a sine-wave (pseudo-sine-wave or sine-wave-like). The digital signal processor 202 generates individual pulses 206 of differing widths and resultant amplitudes. When those differing pulses 206 are driven into a transformer (not shown), the pseudo-sine-wave is produced. [0026] A pulse generator 204 is connected to the input of the digital signal processor 202 and supplies a pulsed digital signal output 216 to the digital signal processor 202 . The digital signal 216 is processed by the digital signal processor 202 to create a first circuit 218 and a second circuit 220 at the first and second pairs of surface electrodes 208 , 209 ; 308 , 309 ; and 408 , respectively. Where the first and second circuits 218 , 220 superimpose, the resultant beat frequency (which is preferably between 1 and 250 beats/second) will be the difference between the frequencies of the two circuits, and the amplitude will be additive and greater than either circuit alone ( FIG. 3 ). [0027] Modulating the outputs of the first and second circuits 218 , 410 , 220 , 420 increases the area of the targeted stimulation ( FIG. 4 ). The depth of modulation can vary from 0 to 100% and depends on the direction of the currents established by the first and second circuits 218 , 418 , 220 , 420 . When the first and second circuits 218 , 418 , 220 , 420 intersect at 90°, the maximum resultant amplitude and the deepest level of modulation is half-way between the two circuits (45° diagonally). (See FIG. 3 ). The area of stimulation can be augmented by modulation of the amplitudes of the outputs of the two circuits. [0028] FIG. 4 shows the stimulator 200 , 400 positioned to stimulate the two pairs of electrodes 208 , 209 ; 308 , 309 ; and 408 , at the predetermined peripheral surface stimulation sites 410 . One pair of electrodes may be utilized if we are utilizing NMES or TENS outputs and it is deemed effective due to the condition, and predetermined with Neural Imaging studies. [0029] In an alternative embodiment, as described above, the digital signal processor may be replaced with the FPGA. Whereas DSP processors typically have only eight dedicated multipliers at their disposal, a higher end FPGA device can offer up to 224 dedicated multipliers plus additional logic element-based multipliers as needed. That allows for complex digital signal processing applications such as finite impulse response filters, forward error correction, modulation-demodulation, encryption and applications such as utilized in the present invention. [0030] It should be emphasized that the above-described embodiments of the present invention, particularly, any “preferred” embodiments, are merely possible examples of implementations, merely set forth for a clear understanding on the principles of the invention. Many variations and modifications may be made to the above-described embodiment(s) of the invention without departing substantially from the spirit and principles of the invention. All such modifications and variations are intended to be included herein within the scope of this disclosure and the present invention, and protected by the following claims.

Apparatus and methods for non-invasive electrical stimulation of the brain through skin surface stimulation of the peripheral nervous system as a treatment for movement disorders. Skin surface electrodes are positioned at predetermined peripheral surface stimulation sites on the skin surface using a variety of neural imaging techniques. A pulsatile electrical current is generated at the stimulation sites through a variety of standard electrical stimulation devices. Stimulation of the peripheral surface stimulation sites translates to electrical stimulation of a specific area of the brain.

FIELD OF THE INVENTION [0001] The present application relates generally to patient-manipulable devices for ameliorating incontinence. BACKGROUND OF THE INVENTION [0002] Urinary incontinence can have a variety of causes. Such incontinence results when the urethral sphincter does not close sufficiently to block urine flow through the urethra. A second urinary sphincter malady is urinary retention, which can be caused by spinal cord injury. Urinary retention is the outcome of the urethral sphincter not voluntarily relaxing and opening to allow the urethra to open, causing a state of permanent urinary retention. Particularly in the case of males, there is not much real estate with which to work on the urethra since the prostate surrounds a portion of the urethra, dividing the sphincter muscle into two, whereas for females the sphincter extends along the urethra from the bladder to near where it opens to the outside of the body. [0003] A common treatment for incontinence is simply inserting a catheter into the urethra. Not only is this an uncomfortable nuisance for the patient, it entails the risk is that of urinary tract infections (UTI), which increase in frequency with the number of catheterizations required. [0004] Another treatment which is useful for males only is the use of a so-called artificial urinary sphincter/urethral cuff, in which a working fluid can inflate a cuff that is implanted around the urethra. The working fluid is infused and removed from the cuff pumped by squeezing a pump surgically located in the scrotum. Not only can this device not be used in females, it entails the risk of injury to the scrotum, and patients find it a nuisance to feel for the pump in the scrotum. Moreover, fine tuning the relatively cumbersome cuff to the patient is not possible. [0005] For females, pubovaginal slings made of tissue have been provided in which titanium screws are placed in the pelvic bone on both the sides of the urethra. These screws are attached to sutures that support a strip of tissue that is passed beneath the urethra to support the urethra and the bladder, so that the leakage does not occur during coughing, sneezing, laughing or other physical activities. This procedure does not allow for patient control, and entails a risk of perforation of the urethra or bladder neck due to elevated pressure. A similar approach with similar problems is the use of tension-free vaginal tape in which a “hammock” is wrapped around a portion of the abdominal muscle instead of held in place by screws. There is a risk of perforation of the urethra or bladder neck due to elevated pressure, and the device does not compensate for change due to movement of the abdominal muscles due to weight loss or gain, which could lead to stresses that could cause serious damage. Or, ligaments can be attached to a sagging bladder neck and urethra that have dropped abnormally low in the pelvic area, but as understood herein, this procedure caries many of the risks noted above, and also the risk of tearing/bleeding at the sutures attached to the vaginal wall. SUMMARY OF THE INVENTION [0006] Accordingly, a device includes a pressure element formed with a pressure surface juxtaposable with the urethral sphincter of a patient. An actuator extends away from the pressure element and is engaged therewith. The actuator can be manipulable by the patient from outside the body of the patient to move the pressure element between a retracted position, in which the pressure surface exerts no more than a first pressure on the urethral sphincter, and an advanced position, in which the pressure surface exerts at least a second pressure on the urethral sphincter. The second pressure is greater than the first pressure, such that in the advanced position incontinence is ameliorated. [0007] In an example embodiment, the actuator includes a magnet and a coupler coupling the magnet to the pressure element. In this embodiment, the magnet is movable within the patient by a patient-held actuator magnet moved by the patient outside the patient's body. The pressure surface is established by a distal end of the pressure element for contacting the urethral sphincter, and if desired the pressure surface can be a continuous curved surface. If desired, a spring may be coupled to the pressure element to bias the pressure element toward the advanced position, and an adjustment mechanism can be coupled to the spring to establish a compression of the spring. [0008] As set forth further below, a distal urethra closure establishes, along with the pressure surface, an enclosure in which the urethra can be received. The distal urethra closure may be detachable from the device to permit a surgeon to position the pressure surface next to the urethral sphincter. The distal urethra closure can then be engaged with the device to hold the urethra within the enclosure. Or, the distal urethra closure may hinge on the device between an open configuration, in which the urethra may pass into the enclosure, and a closed configuration, in which the urethra may not pass into the enclosure. [0009] In alternate examples, the pressure surface is established by opposed arms each defining a distal end with at least one arm being hinged on the device. The distal ends are distanced from each other in an open configuration to permit the urethra to pass between the arms. Also, the distal ends can be juxtaposed with other in a closed configuration to prevent the urethra from passing between the arms. In this embodiment, the arms can terminate at the respective distal ends. On the other hand, in a sub-embodiment each arm loops back on itself at the respective distal end such that each arm forms a slot into which a portion of the urethral sphincter can be received, such that the urethral sphincter is urged to open the urethra in the open configuration to alleviate urinary retention and such that the urethral sphincter is urged to close in the closed configuration to alleviate incontinence. [0010] In yet another non-limiting example the pressure element includes first and second curved arms that criss-cross each other to form a bight into which the urethral sphincter can be positioned. The pressure surface is defined by portions of inner surfaces of the arms bordering the bight. Distal ends of the pressure actuator are engageable with bone structure in the patient. In this embodiment, the actuator includes a manipulator tab positionable under the skin of the patient to permit the patient to urge the arms against the bone structure, thereby enlarging the bight. The manipulator tab is releasable by the patient to permit the arms under material bias to move to shrink the bight around the urethra. [0011] In another aspect, a method includes implanting a device in the retropubic space of a patient, with a manipulator member of the device juxtaposed with the top of the pubic symphysis and with the device extending between the pubis and the bladder toward the urethra. The method includes engaging a pressure element of the device with the urethral sphincter. The device has a configuration in which the device applies pressure to the urethral sphincter to alleviate incontinence. [0012] In another aspect, an assembly includes an implantable device configured to contact the urethral sphincter. The device includes a reciprocatingly arranged slidable pressure element to selective apply pressure to the urethral sphincter responsive to manipulation from outside the body to alleviate incontinence, with no portions of the device extending outside the body. [0013] In another aspect, an implantable device is configured to contact the urethral sphincter. The device includes a C-shaped inflatable cuff defining a longitudinally open slit and central channel. The cuff has a deflated configuration, in which the slit is large enough to accept the urethra of a patient therethrough into the central channel, and an inflated configuration in which the slit is not large enough to allow the urethra to pass therethrough and the cuff exerts surrounding pressure on the urethral sphincter to ameliorate the effects of incontinence. A movable actuator selectively urges the cuff toward the inflated configuration. [0014] The details of the present invention, both as to its structure and operation, can best be understood in reference to the accompanying drawings, in which like reference numerals refer to like parts, and in which: BRIEF DESCRIPTION OF THE DRAWINGS [0015] FIG. 1 is a perspective view showing a first embodiment of the device engaged with a male's urethral just below the prostate gland; [0016] FIG. 2 is a perspective view of a first embodiment with the outer surface transparent to illustrate interior components, with the distal urethra closure in the closed configuration and the pressure element midway between the advanced position and retracted position; [0017] FIG. 3 is a perspective view of the first embodiment with the distal urethra closure in the open configuration and the pressure element in the retracted position; [0018] FIG. 4 is a perspective view of the distal part of a second embodiment with the outer surface transparent to illustrate interior components, showing a distal urethra closure that is detachable from the device to permit a surgeon to position the pressure surface next to the urethral sphincter, with the distal urethra closure then being engageable with the device as shown to hold the urethra within the enclosure; [0019] FIG. 5 is a perspective view of a third embodiment showing a pressure element established by opposed curved arms; [0020] FIG. 6 is a perspective view of a fourth embodiment showing a pressure element established by opposed curved arms each of which loops back on itself at the respective distal end such that each arm forms a slot into which a portion of the urethral sphincter can be received, such that the urethral sphincter is urged to open the urethra in the open configuration to alleviate urinary retention and such that the urethral sphincter is urged to close in the closed configuration to alleviate incontinence; [0021] FIG. 7 is a perspective view of a fifth embodiment in which the pressure element includes first and second curved arms that criss-cross each other to form a bight into which the urethral sphincter can be positioned; [0022] FIG. 8 is a perspective view of the fifth embodiment showing the distal ends of the pressure actuator engaged with the pelvis of the patient such that when the patient presses the manipulator tab, which is positioned under the skin of the patient, the arms are urged against the pelvis, thereby enlarging the bight, with the manipulator tab being releasable by the patient to permit the arms under material bias to move to shrink the bight around the urethra; [0023] FIG. 9 is a perspective of a sixth embodiment of a pressure element established by an inflatable cuff; [0024] FIG. 10 is a front elevational view of the embodiment shown in FIG. 9 in the inflated configuration; [0025] FIG. 11 is a side elevational view of the embodiment shown in FIG. 9 ; and [0026] FIG. 12 is a front elevational view of the embodiment shown in FIG. 9 in the deflated configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0027] Referring initially to FIG. 1 , a device 10 includes a fluidless pressure element assembly 12 engaged with the urethral sphincter 14 of a patient, just below the prostate gland 16 . An actuator 18 of the device 10 extends away from the pressure element assembly 12 to form an elongated, relatively thin device 10 , and as described further below, the actuator 18 can be manipulated by the patient from outside the body of the patient to move the pressure element assembly 12 between a retracted position, in which a pressure surface of the pressure element assembly 12 exerts no more than a first pressure on the urethral sphincter and preferably exerts no pressure at all on the sphincter, and an advanced position, in which the pressure surface exerts pressure on the urethral sphincter such that in the advanced position incontinence is ameliorated. [0028] In the example shown, when implanted the device 10 occupies the retropubic space, extending from the top of the pubic symphysis through the space between the pubis 20 and the bladder 22 , down towards the urethra. Present principles recognize that the retropubic space has certain advantages. It is relatively ‘open’, being occupied by only soft tissue. Also, the pelvis protects the device 10 from accidental damage due to force exerted on the outside of the body near to it. The retropubic space can be accessed surgically either from above (over top of pubis) or below (up through the perineum). [0029] In an embodiment described below, in which the actuator 18 includes a magnet, the magnet resides in the end above the pubic symphysis, near the abdominal wall, and is located such that if a magnet with sufficiently large ‘pull’ is held up to the abdomen outside the body in the vicinity of the device magnet, sufficient force is exerted by the exterior magnet to attract the device magnet and actuate the device. If desired, the actuator end of the device with the internal magnet may be fixed to the back of the pubis (e.g., by suturing) to prevent damage to the urethra due to undesired movement of the device body caused by movement or pull of internal magnet. [0030] A minimally invasive implantation procedure can be employed when placing and tuning the device 10 . The slim profile of the device would allow the device to pass through a relatively small opening. The exterior housing of the device 10 can be made of a biocompatible material such as but not limited to Salubria. [0031] FIG. 2 shows details of an example embodiment of the device 10 . As shown, the actuator 18 includes a biocompatible housing 24 with a magnet enclosure 26 configured to closely receive a permanent magnet 28 therein. The magnet 28 can slide within the enclosure 26 under the influence of a magnetic force from a patient-holdable actuator magnet 30 located outside the body. [0032] In the example shown, the permanent magnet 28 is parallelepiped-shaped as is the enclosure 26 , and the magnet 28 can slide from a rear wall 32 of the enclosure 26 to a front wall 34 . The width and depth of the enclosure 26 may be slightly larger than the width and depth of the magnet 28 . If desired, a magnetic or non-magnetic extension 36 can be provided on a front face of the magnet 28 and can slide in an extension enclosure 38 that is contiguous to the enclosure 26 which holds the permanent magnet 28 . As was the case with the magnet 28 /enclosure 26 , the extension enclosure 38 is but marginally larger in width and thickness than the extension 36 , so that the enclosures 26 , 38 closely bear the respective magnet 28 /extension 36 as the magnet 28 and extension 36 slide together along the longitudinal axis of the device 10 between the retracted and extended positions under the influence of the actuator magnet 30 . [0033] A coupler couples the magnet 28 to the pressure element assembly 12 . In the embodiment shown, the coupler is established by two elongated axially stiff wires, lines, or rods 40 that extend through an elongated connector segment 42 of the housing 26 from the extension 36 to a slidable pressure element 44 of the pressure element assembly 12 . A distal end 46 (which may be a continuous curved surface such as concave as shown) of the pressure element 44 establishes a pressure surface that faces the urethral sphincter surrounding the urethra when the device 10 is implanted as shown in FIG. 1 . [0034] In the example shown, a leaf or more preferably coil spring 48 is disposed in the housing 24 in compressive contact with the pressure element 44 to bias the pressure element 44 toward an advanced position, in which the pressure element 44 exerts a pressure on the urethral sphincter which is greater than the pressure exerted by the pressure element 44 on the sphincter when the pressure element 44 is in a retracted position away from the sphincter. Note that in the retracted position, the pressure element 44 may exert little or no pressure on the sphincter and urethra. In any case, it may now be readily appreciated that when a person moves the actuator magnet 30 outside the body and relatively closely spaced from the permanent magnet 28 (typically separated only by a few centimeters of soft tissue), the magnetic coupling between the magnets enables a person to move the permanent magnet and, hence, the pressure element 44 between the advanced and retracted positions to respectively close off the urethra to ameliorate incontinence, and to permit the urethra to open to pass urine. [0035] If desired, an adjustment mechanism 50 may be coupled to the spring 48 to establish a compression of the spring and hence a preloading of the compressive force exerted by the pressure element 44 on the urethra, to “fine tune” the operation of the device to the particular physiology of the patient. In the example shown, the adjustment mechanism 50 is a set screw threadably engaged with the housing 24 in contact with the spring 48 . A surgeon may advance or retract the set screw by rotating it as appropriate to establish a clinically appropriate compression preload on the pressure element 44 . [0036] In non-limiting examples, a catheter-borne pressure sensor can be used to measure pressure within the urethra while a tool such as an Allen wrench is used to adjust the screw depth until the desired pressure was attained. This ensures that the device did not exert over-pressure, which could cause damage to the sphincter and/or urethra, or under-pressure, defined as pressure too low to reliably maintain continence. In embodiments in which permanent retention is an issue, the spring 48 may be dispensed with. [0037] In cross-reference to FIGS. 2 and 3 , a distal urethra closure establishes, along with the pressure surface 46 of the pressure element 44 , an enclosure 54 in which the urethra can be received. In one example, the distal urethra closure includes first and second curved closure arms 56 that are hingedly engaged with the housing 24 between an open configuration ( FIG. 3 ), in which the urethra may pass into the enclosure 54 , and a closed configuration ( FIG. 2 ), in which the urethra may not pass into (or out of) the enclosure 54 . The surgeon manually moves the arms 56 to the open configuration, advances the device 10 to the urethra until the urethra is positioned in the enclosure 54 , and then closes the arms. The arms may be held closed by a friction fit between the arms and the housing, solvent bonding applied by the surgeon, sutures, a clip structure on one arm engaging a recess in the other arm, or other suitable closure methods. [0038] Alternatively, FIG. 4 illustrates a unitary closure element 58 that is detachable from the device to permit a surgeon to position the pressure surface next to the urethral sphincter, with the distal urethra closure then being engageable with the device to hold the urethra within the enclosure. In the embodiment shown, channels in the closure element 58 can be engaged with complementarily-shaped and -sized pins 60 in the housing, with two pins on each side as shown in the example embodiment of FIG. 4 . A friction fit between the closure element 58 and pins 60 (or other appropriate fixation structure) can be used to hold the closure element 58 onto the housing of the device as shown in FIG. 4 . [0039] Refer now to FIGS. 5 and 6 , which show respective alternate embodiments that in all essential respects are identical to that shown in FIGS. 2 and 3 with the following exceptions. In FIG. 5 , a pressure element of a device 100 is established by opposed curved arms 102 each defining a respective distal end 104 , with at least one arm and preferably both arms 102 being hinged on a housing 106 of the device 100 . When the permanent magnet in a magnet housing 108 of the device 100 is retracted (away from the urethra), the arms 102 are retracted into a distal opening 110 of the housing 106 with the outer surfaces of the arms 102 riding against the periphery of the opening 110 , which urges the arms 102 to pivot so that the distal ends 104 move toward each other to establish a closed configuration to trap the urethra between the arms. On the other hand, when the magnet is moved toward the urethra the arms 102 move outward, pivoting under, e.g., the influence of material bias as they clear the opening 110 to an open configuration in which the distal ends 104 are distanced from each other to establish an open configuration to permit the urethra to pass between the arms. In FIG. 5 , the arms 102 terminate at the respective distal ends 104 . [0040] In contrast, FIG. 6 shows a device 200 which is substantially identical to the device 100 shown in FIG. 5 except that each of two arms 202 loops back on itself at a respective distal end 204 such that each arm 202 forms a respective slot 206 . A portion of the urethral sphincter can be received in the slots 206 with the urethra itself remaining in a central enclosure 108 . This is possible because the urethral sphincter is horseshoe-shaped and does not completely surround the urethra. With the device 200 , the urethral sphincter can be urged to open the urethra by moving the permanent magnet toward the urethra to cause the arms 202 to pivot open, pulling the sphincter outwardly from the urethra. This alleviates urinary retention. Also, the urethral sphincter is urged to close when the arms are pulled away from the urethra to alleviate incontinence. [0041] FIGS. 7 and 8 illustrate yet another alternate incontinence relief device 400 that can be engaged with the urethral sphincter to close it off. In the device 400 , which may be made of a single unitary piece of biocompatible plastic, a pressure element is established by first and second curved flexible arms 402 that criss-cross each other to form a bight 404 into which the urethral sphincter can be positioned. A pressure surface is defined by portions 406 of inner surfaces of the arms bordering the bight. [0042] Distal free ends 408 of the arms 402 can be engaged with bone structure in the patient such as the pelvis. Opposite the free ends 408 , a solid, preferably rectilinear manipulator tab 410 is coupled to the arms 402 and may be positioned under the skin of the patient to permit the patient to urge the arms 402 against the bone structure, thereby enlarging the bight 408 . The manipulator tab can then be released by the patient to permit the arms 402 under material bias to move to shrink the bight 408 around the urethra to alleviate incontinence. [0043] In the specific example shown, the arms 402 are coupled to opposed outer edges of the tab 410 . The arms 402 extend inwardly from the tab, crossing each other at 412 , then curve in respective convex segments 414 to establish the bight 404 , crossing each other again at 416 and continuing to extend away from each other along distal segments 418 to the distal ends 408 . Because they are flexible, a surgeon can pull the distal segments 418 of the arms 402 away from each other sufficiently to pass the urethra between the arms into the bight 404 , at which point the arms are released to move back toward each other, closing the bight and trapping the urethra therein. The tab 410 is surgically located above the pubic symphysis, similar to the previous embodiments, such that pressure with a finger or palm on the lower abdomen exerts pressure on the tab 410 . The resulting mechanical deflection causes the arms 402 bow outwards, relaxing the pressure on the urethra and allowing for normal voiding. [0044] It may now be appreciated that the devices herein require no mechanical or electrical connections outside the patient while avoiding infections that can be caused by catheters. Not only do the devices assist in alleviating incontinence, but they also do not destroy anything in the body. Beneficially, implantation may be done clinically without the need for the patient to spend the night at a hospital, and the chance for infection is much lower because nothing crosses the boundary between the inside and outside of the body since there is no way for infection to get in. The implanted device has an adjustability quality because it assists the sphincter as set when implanted, so it will provide the appropriate pressure required to prevent incontinence. [0045] FIGS. 9-12 show an alternate device 500 that is established by a C-shaped inflatable cuff 502 defining a longitudinally open slit 504 and central channel 506 . The cuff 502 has a deflated configuration ( FIG. 12 ), in which the slit 504 is large enough to accept the urethra of a patient therethrough into the central channel 506 . Also, the cuff 502 has an inflated configuration ( FIGS. 9 and 10 ) in which the slit 504 is not large enough to allow the urethra to pass therethrough and the cuff 502 exerts an even, surrounding pressure on the urethral sphincter to ameliorate the effects of incontinence. A reciprocatingly arranged actuator 507 such as a magnet can be moved to selectively urge the cuff 502 toward the inflated configuration. As was the case with the previous embodiments, the actuator is manipulable by the patient from outside the body of the patient to move the cuff 502 . [0046] As shown, a rigid plastic or metal C-shaped support 508 surrounds the cuff 502 in contact with the cuff such that inflation of the cuff does not change the outer diameter of the cuff, being constrained by the support 508 , but only causes the inner diameter of the cuff to decrease. A cylindrical or rectilinear inflatable tube 510 may be in fluid communication with the cuff 502 , extending away from the cuff through an opening in the support 508 as shown. The actuator 507 bears against the tube 510 to urge fluid in the tube into the cuff and thereby urge the cuff toward the inflated configuration. [0047] In operation, the surgeon advances the cuff in the deflated configuration around the urethral sphincter through the slot 504 . The cuff 502 and tube 510 are then inflated with a working fluid such as a flowable silicone used in breast implants or saline. The amount of inflation is as clinically necessary to close the urethra of the particular patient. Subsequent movement of the actuator 507 (e.g., by moving a magnet outside the body to move a magnetic-based actuator 507 ) against the tube 510 squeezes the tube, urging fluid from the tube into the cuff 502 to cause it to clamp down on the urethral sphincter. In alternate structural cooperation the actuator 507 may be moved to relieve pressure on the tube and, hence, on the cuff to facilitate voiding by the patient. [0048] While the particular PATIENT-MANIPULABLE DEVICE FOR AMELIORATING INCONTINENCE is herein shown and described in detail, it is to be understood that the subject matter which is encompassed by the present invention is limited only by the claims.

An implantable device arranged to contact the urethral sphincter allows for manipulation of the device from outside the body by the patient.

CROSS REFERENCE TO RELATED APPLICATION This application is a continuation of U.S. patent application Ser. No. 11/734,674, filed Apr. 12, 2007, now allowed, which is a continuation of U.S. application Ser. No. 09/983,810, filed Oct. 26, 2001, now U.S. Pat. No. 7,226,459. The prior applications are incorporated herein by reference in their entirety. TECHNICAL FIELD This invention relates to rotary cutting surgical instruments, and more particularly, to a reciprocating rotary surgical instrument for cutting semi-rigid tissue. BACKGROUND Conventional arthroscopic surgical instruments generally include an outer tube and an inner member that rotates or translates axially within the outer tube. The outer tube and inner member may interact to create shear forces that cut tissue. This type of cutting is generally used to cut soft tissue, such as muscle, ligaments, and tendons. SUMMARY In one aspect, a surgical instrument includes a cutting member with an implement for cutting tissue, and a drive coupled to the cutting member to simultaneously rotate and translate the cutting member in response to a force applied to the drive. One or more of the following features may be included in the surgical instrument. The drive is configured such that the cutting member reciprocates. The drive includes a drive member attached to the cutting member. The drive member includes a helical groove. The drive includes a translation piece disposed in the groove such that rotary driving of the drive member results in simultaneous reciprocation of the drive member relative to the translation piece. In the illustrated embodiment, the drive includes an inner drive hub coupled to the drive member. The inner drive hub defines a slot and the drive member includes a key received in the slot rotary coupling the drive member to the inner drive hub such that the drive member rotates with the inner drive hub while being free to translate relative to the inner drive hub. The helical groove includes a left-hand threaded helical channel. The helical groove includes a right-hand threaded helical channel. The cutting member is attached to the drive member to move rotatably and axially with the member. The implement is a chamfered cutting edge at a distal end of the cutting member. The chamfered edge is a straight cutting edge. Alternatively, the chamfered edge is an angled cutting edge. The instrument includes an outer tubular member. The cutting member is received within the outer member. The outer member includes a cutting window disposed proximate to a tip of the outer member. The cutting window is an opening in the outer member exposing the cutting member to tissue. The cutting window has a U-shaped proximal end and a saddle-shaped distal end. The saddle-shaped distal end of the cutting window includes a hook. The translation piece includes a follower received within the groove and a sealing cap over the follower. The follower is free to swivel relative to the sealing cap. The follower has an arched bridge shape. The translation piece is coupled to the drive member such that the translation piece is disposed in the helical groove and swivels to follow the helical groove as the drive member rotates. In another aspect, a method of cutting tissue includes positioning an outer member such that tissue is located within the outer member, engaging the tissue with an inner member received within the outer member, and simultaneously rotating and translating the inner member to cut the tissue. One or more of the following features may be included. The translating is reciprocating. The outer member is oriented tangentially to the tissue. In another aspect, a method of cutting tissue includes providing a surgical instrument having an outer member and an inner member received within the outer member for movement relative to the outer member, and applying a tangential cutting force to the tissue with the inner member to mechanically cut the tissue. In another aspect, a method of cutting tissue includes applying a tangential cutting force to tissue with a member, and mechanically driving the member to undergo simultaneous rotation and translation. The method may include that the translation is reciprocation. The cutting edge of conventional arthroscopic surgical instruments, such as rotary shears, have difficulty initiating a cut into semi-rigid tissue tend to bounce away from the tissue. Toothed edge geometry somewhat ameliorates this problem because the “teeth” attempt to pierce the tissue to initiate a cut. However, the efficiency of using “teeth” is limited and the limitations are more evident when cutting large volumes of semi-rigid tissue, such as meniscus or intrauterine fibroid tissue. The simultaneous rotating and reciprocating inner member of the surgical instrument of the invention overcomes these difficulties. The tangential approach to the tissue in the method of the invention limits the tendency of the instrument to bounce away from the tissue. In particular, the instrument and method provide a higher resection rate to shorten procedure length, during, e.g., fibroid and polyp resection. The details of one or more implementations are set forth in the accompanying drawings and the description below. Other features will be apparent from the description and drawings, and from the claims. DESCRIPTION OF DRAWINGS FIG. 1A is a side view and 1 B is a cross-sectional view taken along 1 B- 1 B in FIG. 1A of a reciprocating rotary surgical instrument. FIG. 2A is a top view, FIG. 2B is a cross-sectional view taken along 2 B- 2 B in FIG. 2A , FIG. 2C is a distal end view, and FIG. 2D is a proximal end view of the inner drive hub of the reciprocating rotary surgical instrument of FIG. 1 . FIG. 3A is a top view, FIG. 3B is a side view, FIG. 3C is a cross-sectional view taken along 3 C- 3 C in FIG. 3A , and FIG. 3D is a proximal end view of the helical member of the reciprocating rotary surgical instrument of FIG. 1 . FIG. 4A is a top view, FIG. 4B is a cross-sectional view taken along 4 B- 4 B in FIG. 4A , and FIG. 4C is a distal end of the outer hub of the reciprocating rotary surgical instrument of FIG. 1 . FIG. 5A is an exploded view, FIG. 5B is a partial cutaway view, and FIGS. 5C and 5D are side views of the translation piece and the helical member of the surgical instrument of FIG. 1 . FIG. 6A is a side view, FIG. 6B is a cross-sectional view taken along 6 B- 6 B in FIG. 6A , and FIG. 6C is a top view of the follower of the translation piece of the reciprocating rotary surgical instrument of FIG. 1 . FIG. 7A is a top view and FIG. 7B is a cross-sectional view taken along 7 B- 7 B of FIG. 7A of the cap for the follower of the translation piece of the reciprocating rotary surgical instrument of FIG. 1 . FIG. 8A is a top view and FIG. 8B is a side view of the outer member of the reciprocating rotary surgical instrument of FIG. 1 . FIG. 9 is a side view of the inner member of the reciprocating rotary surgical instrument of FIG. 1 . FIG. 10 illustrates a reciprocating rotary surgical instrument of FIG. 1 in use to cut tissue. FIG. 11 is a side view of an alternate implementation of the inner member of a reciprocating surgical instrument. Like reference symbols in the various drawings indicate like elements. DETAILED DESCRIPTION As shown in FIGS. 1A and 1B , a cutting device 100 includes a driving end 110 and a cutting end 190 . The driving end 110 is located at the proximal end of the cutting device 100 . The cutting end 190 is located at the distal end of the cutting device 100 . At the driving end 110 , there is an inner drive hub 130 with a drive coupler 120 , and an outer hub 140 . The drive coupler 120 mounts into a rotary driver (not shown), which turns the drive coupler 120 causing a helical member 150 and the inner drive hub 130 to rotate. For instance, the rotary driver is Dyonics Power Handpiece, No. 725355. The inner drive hub 130 with the drive coupler 120 is, for example, a component of Smith & Nephew disposable arthroscopic surgical instrument, No. 7205306. The helical member 150 is located within the inner drive hub 120 and the outer hub 140 . The helical member 150 and a translation piece 145 are coupled together such that rotation of the helical member 150 causes linear translation of the helical member 150 , as described further below. The cutting device 100 includes an elongated inner member 185 and an elongated outer member 186 , as shown in FIG. 1B . The inner member 185 is tubular with a hollow interior 184 . The inner member 185 is fixed to the helical member 150 for axial and rotary motion therewith. The outer member 186 is also tubular with a hollow interior 187 . The inner member 185 is received inside the outer member 186 . The outer member 186 is fixed to the outer hub 140 and does not move. The outer member 186 includes a tip 188 , which is blunt, i.e., the corners are rounded. At the cutting end 190 , the outer member 186 defines a cutting window 170 through a wall 186 a of the outer member 186 . Referring to FIGS. 2A-2D , the inner drive hub 130 includes the drive coupler 120 , a lumen 136 , an aspiration opening 132 , and a slot 134 . The drive coupler 120 extends from the proximal end of the inner drive hub 130 and mounts in the rotary driver. Debris from the cutting end 190 of the cutting device 100 is aspirated through the aspiration opening 132 . The slot 134 is disposed in a wall 131 of the inner drive hub 130 . The slot 134 is like a track along one side of the inner drive hub 130 . The slot 134 of the inner drive hub 130 is coupled with a key 152 of the helical member 150 (see FIG. 4B ) so that rotation of the inner drive hub 130 causes the helical member 150 to rotate while allowing the helical member 150 to move axially relative to the inner drive hub 130 , e.g., the key 152 axially slides along the slot 134 . Referring to FIGS. 3A-3D , the helical member 150 of the cutting device 100 is formed of a lubricious material in a tubular shape with a through lumen 159 . The inner member 185 is disposed within the helical member 150 and fixed therein, for example, by epoxy, injection-molded, or over-molded plastic. The helical member 150 includes the key 152 and two helical channels 156 , 158 disposed thereon. As shown in FIG. 3B , the key 152 is shaped like a fin and is located at the proximal end of the helical member 150 . The key 152 mates with the slot 134 of the inner drive hub 130 . The two helical channels 156 , 158 are disposed on a distal portion of the exterior surface of the helical member 150 . One helical channel 156 is right-hand threaded; the other helical channel 158 is left-hand threaded. The pitch of the helical channels may be different or the same. The length of the distal portion of the helical member 150 with helical channels 156 , 158 is longer than the length of the cutting window 170 . The helical channels 156 , 158 are smoothly blended together at their ends to form a continuous groove so that there is a smooth transition from one helical channel to the other helical channel at each end of the distal portion of the helical member 150 . The helical member 150 and the inner drive hub 130 are mechanically driven by the rotary driver. The helical member 150 also moves in an axial direction, e.g., reciprocates, as a result of the interaction of the translation piece 145 with the helical channels 156 , 158 , as described below. Referring to FIGS. 4A-4C , the outer hub 140 of the cutting device 100 is formed of hard plastic and does not move. An example of an outer hub is a component of Smith & Nephew disposable arthroscopic surgical instrument, No. 7205306, modified with a cutout 144 for receiving the translation piece 145 . The cutout 144 is disposed within a wall of the outer hub 140 , for example, centrally, as in FIG. 4B , and aligned with the helical member. The translation piece 145 is located in the cutout 144 of the outer hub 140 . As shown in FIG. 1B , the outer member 186 is disposed within the outer hub 140 and fixed therein by a coupling 144 using, for example, epoxy, glue, insert molding, or spin-welding. Referring to FIG. 5A , the translation piece 145 includes a follower 145 a and a cap 145 b . Having the two helical channels 156 , 158 in conjunction with the slot/key 134 , 152 coupling of the inner drive hub 130 and the helical member 150 , the rotary driver only needs to rotate in one direction and does not require reversal of the rotational direction upon the translation piece 145 reaching the end of one of the helical channels 156 , 158 . Referring to FIGS. 6A-6C , the follower 145 a includes a cylindrical head 145 a 1 and two legs 145 a 2 . As shown in FIGS. 5B-5D , the legs 145 a 2 form an arch and rest in the channels of the double helix 156 , 158 formed in the distal portion of the exterior surface of the helical member 150 . The arch of the legs 145 a 2 is dimensionally related to the diameter described by the helical channels 156 , 158 of the helical member 150 . Referring particularly to FIGS. 5C and 5D , as the helical member 150 and the inner drive hub 130 are mechanically driven by the rotary driver (not shown), the follower 145 a follows the helical channels 156 , 158 , swiveling as the follower 145 a smoothly transitions from helical channel to helical channel 156 , 158 at the ends of the distal portion of the helical member 150 having the helical channels 156 , 158 . The coupling of the follower 145 a to the helical channels 156 , 158 causes the helical member 150 to also translate. Thus, the inner member 185 simultaneously rotates and reciprocates to cut the tissue. Referring to FIGS. 7A and 7B , the cap 145 b of the translation piece 145 covers the follower 145 a to provide a seal to allow sufficient suction to remove aspirated debris. Also, the cap 145 b is a separate piece from the follower 145 a in order to allow the follower 145 b to swivel. As shown in FIGS. 8A and 8B , the outer member cutting window 170 has a generally oblong shape. The proximal end 172 of the cutting window 170 is U-shaped and the distal end 173 has a saddle shape that forms a hook 174 . The distal end 173 is chamfered to provide a sharp edge. The hook 174 pierces the targeted tissue to hold the tissue as the inner member 185 cuts. Also, the shape of the cutting window 170 eliminates galling between the inner and outer members 185 , 186 , and dulling of the cutting edge of the inner member 185 . The cutting window 170 is disposed proximate to the tip 188 of the outer member 186 . The cutting window 170 exposes the inner member 185 over a length L. FIG. 9 shows that the inner member 185 is generally tubular with hollow interior 187 . Aspiration of debris occurs through the hollow interior 187 of the inner member 185 , and through the lumen of the helical member to the aspiration opening 132 of the inner drive hub 130 . The distal end 183 of the inner member 185 is chamfered to a sharp edge 187 for cutting. The inner member 185 simultaneously rotates about its axis and translates along its axis to cut tissue. The cutting surface of the distal end 183 of the inner member 185 shears the tissue. For example, referring to FIG. 10 , the cutting device 100 is placed tangentially against the targeted tissue such that the cutting window 170 exposes the inner member 185 to the tissue. As the inner member 185 rotates and translates, as shown by the arrows, the tissue within the cutting window catches on the hook 174 to initiate the cut and then the cutting edge 183 of the inner member 185 shears the tissue as the inner member 185 advances to cut the tissue. The cut is completed as the cutting edge 183 of the inner member 185 advances beyond the hook 174 of the cutting window 170 within the outer member 186 . FIG. 11 shows an alternative implementation of the inner member. The distal end 283 of the inner member 285 may be angled to a chamfered point so that the cut in the targeted tissue is initiated on one side and then extends across the width of the tissue. Similarly, when the cutting device is placed tangentially against the targeted tissue, the rotating and translating inner member 285 shears the tissue to be cut. A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made. For example, instead of a double helical channel, the helical member may include a single helical channel with a retractable follower and spring, or possibly, attraction and repelling forces of magnets or a solenoid could enable the rotating and reciprocating movements. Also, alternatively, the inner and outer members may have a cross-sectional shape other than circular. Additionally, the shape of the hook of the outer member may be modified in order to improve grasping of the tissue or grasping a larger volume of tissue. Accordingly, other implementations are within the scope of the following claims.

A surgical instrument includes a cutting member with an implement for cutting tissue, and a drive coupled to the cutting member to simultaneously rotate and translate the cutting member in response to a force applied to the drive. A method of cutting tissue includes positioning an outer member such that tissue is located within the outer member, engaging the tissue with an inner member, and simultaneously rotating and translating the inner member to cut the tissue. A tangential cutting force is applied to the tissue with the inner member to mechanically cut the tissue. The inner member is mechanically driven to undergo simultaneous rotation and translation.

This is a continuation of application Ser. No. 584,102, filed Feb. 27, 1984, now abandoned. FIELD OF THE INVENTION This invention pertains to a method for improving the efficacy of ancrod treatment in mammals by administration of neuraminidase treated ancrod. More specifically, the invention pertains to a method of overcoming biological resistance to the administration of ancrod in mammals. BACKGROUND OF THE INVENTION For some years, it has been known that the venom of certain snakes, specifically pit vipers, e.g., Ankistrodon rhodostoma, contains a component which can be used as an anticoagulant. It is also known that an isolated fraction of the venom of Ankistrodon rhodostoma, hereinafter referred to as "ancrod", having a thrombin-like action functions to enzymatically degrade fibrinogen into inactive fibrinopeptides. Fibrinogen has two important physiologic functions: (1) it is required for the formation of a stable fibrin clot, and (2) it is a primary determinant of the viscosity of plasma and, hence, blood viscosity. Degraded fibrinogen, in the form of inactive fibrinopeptides, is cleared from the circulation by the action of the reticuloendothelial system and/or the fibrinolytic system. The resultant reduction in plasma fibrinogen concentration is paralleled by an increase in fibrin degradation product (FDP) concentration. Thus, in an individual not previously exposed to ancrod, e.g., through prior treatment or snake bite, administration is accompanied by a fall in plasma fibrinogen concentration and a parallel increase in FDP concentration. The therapeutic efficacy of ancrod arises from its ability to increase blood flow. In patients with a variety of vascular diseases, controlled reduction in fibrinogen concentration lowers the plasma viscosity and decreases the tendency of red cells to form aggregates. The overall effect is a reduction in blood viscosity and, hence, an increased blood flow, throughout the circulatory system. It has long been known that repeated ancrod administration results in the formation of anti-ancrod substances presumably similar to antibodies) which, after approximately 45-60 days of continued therapy, achieve a sufficiently high titer to negate the beneficial effects of further ancrod administration. Clinically, the emergence of so-called "resistance" to ancrod is manifested by the return of symptoms attributable to reduced blood flow, e.g., pain, ulceration, and the like in the case of peripheral vascular disease. Biochemically, plasma fibrinogen concentration returns to pre-treatment levels and is accompanied by increased plasma and blood viscosity. Because this ancrod resistance arises in most patients after they have received the drug for a relatively brief period, the usefulness of the drug as an effective treatment for various circulatory disorders has been severely limited. One way of overcoming ancrod resistance is disclosed in the assignee's U.S. patent application Ser. No. 428,694, filed Sept. 30, 1982 by Letcher, now abandoned. The Letcher application discloses that resistance to ancrod can be reduced by performing plasmapheresis on the patient's blood when symptoms of ancrod resistance are observed. After plasmapheresis, effective ancrod treatment can be resumed. It has now been unexpectedly discovered that biological resistance to ancrod therapy in mammals can be successfully overcome by treating the ancrod with neuraminidase. DETAILED DESCRIPTION OF THE INVENTION Ancrod is a glycoprotein, having a molecular weight of about 38,000 (mean-value). The glycoprotein comprises approximately 36% carbohydrate, about 28% of the carbohydrate is sialic acid. Ancrod enzymatically catalyzes the hydrolysis of fibrinogen, a protein normally present in blood plasma. The ancrod-catalyzed hydrolysis yields inactive fibrinopeptides. These fibrinopeptides form in filaments by end-to-end polymerization. The filaments are quickly eliminated from the circulation by the action of the reticuloen-dothelial system and/or fibrinolytic system. Ancrod can be termed an anticoagulant because its action on fibrinogen prevents the cross linking of fibrin molecules, needed to form a blood clot. Ancrod and thrombin are alike in that both enzymes hydrolyze fibrinogen. However, only thrombin produces fibrin, a clot precursor. Ancrod's ability to cause the removal of fibrinogen from the bloodstream, rather than its disruption of the blood coagulation pathway, makes it therapeutically efficacious. If all of the patient's fibrinogen were removed from the blood, coagulation would be impossible; however, reduction to 10 or 15 percent of normal concentration causes a substantial reduction in blood viscosity and also keeps the blood coagulation pathway intact. Before it is used to therapeutically induce hypofibrinogenaemina (low plasma fibrinogen concentration), ancrod is desireably purified and isolated from the other venom fractions. It is particularly important to remove those venom fractions containing the hemorrhagic factor. If the hemorrhagic factor is not removed from the viper venom and is administered with ancrod, toxic effects could result. Several methods for isolating ancrod are known. Perhaps the best known method entails two separate ion-exchange chromatography procedures; see Esnouf and Tunnah, Brit. J. Haemat., 13:581-590 (1967). U.S. Pat. No. 3,743,722, issued July 3, 1973, describes a method for isolating ancrod by affinity chromatography. Agmatine-coupled agarose is used to pack the column. Agmatine (decarboxylated arginine) is a competitive inhibitor of ancrod. Ancrod is trapped in the column until almost all of the other protein materials are eluted, provided a proper sodium chloride gradient is used as the eluant. U.S. Pat. No. 3,819,605, issued June 25, 1974, describes a similar method using a modified agarose bed and eluting with a benzamidine solution. U.S. Pat. No. 3,879,369, issued on Apr. 22, 1975, describes yet another chromatographic isolation method. In this system the viper venom is placed on an agmatine-coupled agarose bed, washed with sodium chloride, and eluted with guanidine hydrochloride. Once the ancrod is purified and isolated from the viper venom it can be administered to the patient to cause therapeutic defibrination. In patients with obliterative atherosclerotic vascular disease, plaques form on the interior surface of the larger arteries and arterioles. These obstructions reduce the flow of nutrient blood to the distal organs. Thus, for example, in one form of peripheral vascular disease, atheromatous plaques in the large arteries and arterioles of the extremities reduce blood flow below the level necessary for normal physiologic function, a condition known as ischemia. Symptomatically, this pathologic process is heralded by pain when the metabolic demands of the affected muscle cannot be met by increasing blood flow. Ancrod treatment, possessing the ability to reduce blood viscosity and hence increase blood flow, is indicated in patients with a variety of vascular diseases. By way of non-limiting example, these diseases include moderate and severe chronic circulatory disorders of peripheral arteries, e.g., arteriosclerosis obliterans, thromboangiitis obliterans, diabetic microangiopathy and Raynaud's phenomenon; particularly in the following stages of Fontaine's classification (a scale grading the severity of peripheral vascular disease from stage I to stage V): advanced stage II (intermittent claudication with short walking distance), stage III (rest pain) and early stage IV (ulcers, small necroses). Other diseases that may be alleviated with ancrod therapy include those associated with mononuclear cell infiltration of the blood vessel walls, e. g., so-called "vasculitis". In general, any disorder of the circulatory system manifested by a fibrinogen concentration greater than 50% higher than normal can be effectively treated by the administration of ancrod. Clinical improvement is usually evident within two weeks of continual ancrod therapy. Ancrod is administered in 0.5 to 2.5, but preferably 1.0 to 2.0, and ideally 1.5 Twyford units per kilogram of body weight per day. Potency of ancrod is assayed in vitro by comparing the abilities of ancrod and a standard solution of thrombin to clot a solution of human fibrinogen. (One Twyford unit of ancrod will clot the fibrinogen solution in the same time as does 1 NIH-unit of thrombin.) Ancrod is generally administered by subcutaneous injection on a daily basis. The drug can also be administered by intravenous injection although this route is preferably used only with hospitalized patients. Ancrod can also be administered orally if it is protected from gastric digestion. This is usually accomplished by administering the drug in a hard shell dosage form (e.g., a capsule, tablet, pill or beadlet) that is surrounded with a capsular (enteric) coating, allowing release in the intestine where the environment is less destructive to protein. Suitable enteric coating materials are well known in the art and include shellac-stearic acid-tolu balsam; cellulose acetate phthalate-tolu balsam-shellac; shellac-castor oil; ammoniated shellac cellulose acetate phthalates with or without plasticizer and dusting powder(s). Fibrinogen concentration in normal human subjects is altered by climate and altitude changes. The concentration at sea level ranges from approximately 200 to 400 mg/dl (milligrams of fibrinogen per deciliter of plasma). The concentration range for the disease state is more variable and can have a considerably higher limit. Therefore, individual dosages should be determined for each patient, and should be adjusted to reduce fibrinogen concentration to 70-100 mg/dl. Improvement in patients with peripheral vascular disease is manifested by an improved exercise tolerance, absence of rest pain, healing of superficial skin ulcers, and the like. Recent reports allege that short term (e.g., less than 45 days) ancrod therapy can be used to prevent myocardial infarction in patients with crescendo angina because it improves blood flow in the coronary arteries. Unfortunately, due to the antigenic nature of ancrod, repeated administration in mammals, particularly humans, results in the formation of anti-ancrod substances resembling antibodies. After approximately 45-60 days of therapy, these antibody like substances achieve a sufficiently high titer to neutralize the beneficial effects of further ancrod administration. As noted above, clinically, the emergence of ancrod resistance is manifested by the return of symptoms attributable to reduced blood flow, e.g., pain, ulceration, and the like. Biochemically, plasma fibrinogen concentration returns to pre-treatment levels and is accompanied by increased plasma and blood viscosities. Biological resistance to ancrod is monitored indirectly by measuring the patient's plasma fibrinogen concentration. Resistance to ancrod is encountered when the patient's plasma fibrinogen concentration rises to between about 75 and 100 percent of pretreatment levels. Resistance can also be monitored by measuring the patient's plasma or blood viscosity, which varies with fibrinogen concentration. Measurement of fibrin degradation product (FDP) concentration, indicative of the activity of ancrod in hydrolysing fibrinogen, is another means for monitoring resistance. It has now been unexpectedly discovered that resistance to prolonged ancrod therapy can be successfully prevented by administering ancrod which has been subjected to incubation with neuraminidase. The sialic acids comprise a family of amino sugars containing 9 or more carbon atoms. The sialic acids appear to be regular components of all types of mucoproteins, mucopolysaccharides and certain mucolipids, as well as glycoproteins. See, e.g., Merck Index, 10th Edition, 1983, Ref. 8320. Neuraminidase is an enzyme having wide distribution in micro-organisms and animal tissues Neuraminidase hydrolyses neuraminic acid residues including the sialic acid residues associated with the ancrod g-ycoprotein. With the exception of residues blocked by steric hindrance, neuraminidase can remove all of the susceptible residues by utilizing prolonged incubation with ancrod. In order to illustrate the present invention, reference is made to the following examples which, however, are not intended to limit the invention in any respect. EXAMPLE 1 Ancrod was treated with neuraminidase utilizing the following procedure. 1 0 mg. of freeze-dried type VI neuraminidase purchased from Sigma Chemical Co. was added to 77 Twyford units of ancrod obtained from Twyford Pharmaceuticals, in phosphate buffered saline, pH 6.8, so that neuraminidase content was 5% of the total protein in solution by weight. The mixture was allowed to incubate at room temperature (20° C.) for approximately 4 hours. The neuraminidase-treated ancrod (NTA) was isolated from the cleaved neurominic acid residues and neuraminidase by gel filtration chromatography using Sephadex G100, obtained from Pharmacia, in a column equilibrated with 2.5 mM phosphate buffered saline at pH 6.8. The removal of neuraminic acid residues from the NTA was verified by polyacrylamide gel electrophoresis. The NTA has a markedly reduced mobility at pH 8.2 compared with untreated ancrod. The isolated NTA was then lyophilized, redissolved in 1 ml. phosphate buffered saline, pH 6.8, and 70 Twyford units were obtained. In order to determine the relative activity of NTA versus native ancrod the activity of both was tested against the synthetic substrate N-α-benzoyl-L-arginine ethyl ester. EXAMPLE 2 25 ul of native ancrod (1.9 Twyford units) were added to 2 ml of 10 mM Tris buffer, pH 8.5, containing 0.625 mM synthetic substrate. The rate of increase in absorbance at 253 nm at various time intervals was measured using a Cary 219 spectrophotometer. Reaction rates measured at different enzyme concentrations verified that there is a linear relationship between enzyme concentration and the observed velocity of the reaction. 1 ml of ancrod (77 Twyford units) was mixed with 0.9 units of neuraminidase and allowed to react at room temperature (20° C.) for 4 hours. One unit of neuraminidase is defined as the amount required to liberate 1.0 uM of N-acetyl neuraminic acid per minute, at pH 5.0 and 37° C. using bovine submaxillary mucin as substrate. Aliquots of this reaction mixture were removed at time intervals listed below and the activity measured as shown below. ______________________________________TIME (MIN) RATE (O.D./MIN) % CONTROL ACTIVITY______________________________________0 .022 1002 .021 955 .020 9112 .020 9123 .020 9158 .020 91120 .020 91400 .020 91______________________________________ The results above show that the NTA has esterase activity almost equal to that of native ancrod. Native ancrod and NTA were then compared for coagulant activity with human fibrinogen. EXAMPLE 3 10 ul of ancrod (77 Twyford units/ml) were added to a 1 ml solution of human fibrinogen obtained from Pacific Hemostasis Inc., La Jolla, Calif., at 1 mg/ml in 50 mM phosphate buffered saline at pH 7.0. The mixture was then observed for the time necessary to generate a clot. The clot end point was defined as the point at which a clot was first visually detectable. Native ancrod was able to clot the fibrinogen in 21±3 seconds (95% confidence level). The procedure was repeated using NTA instead of native ancrod. The NTA clotted the fibrinogen in 23±4 seconds. These results indicate that NTA maintains essentially full fibrinolytic activity compared to native ancrod. EXAMPLE 4 In order to determine the cross reactivity, if any, of NTA and native ancrod, an Ouchterlony immunoprecipitation assay was performed with a 1% agar plate. The central well was filled with serum from a patient currently undergoing ancrod therapy and demonstrating resistance to ancrod. In three equidistant radially placed wells (15 mm from the central well) were placed respectively: commercial ancrod, NTA, and native ancrod isolated from snake venom. As expected, the commercial ancrod and ancrod isolated from snake venom showed the characteristic crescent indicative of cross reaction between the serum from an ancrod resistant patient and the two types of ancrod. Suprisingly, the NTA region showed very little cross reactivity, indicating very little cross over reactivity between ancrod and NTA antibodies. EXAMPLE 5 The experiment of example 4 was carried out using serum from a New Zealand White Rabbit immunized with NTA and Freund's complete adjuvant. 1 ml of NTA (1.5 mg NTA) was thoroughly mixed with 1 ml of Freund's complete adjuvant. 0.5 ml was injected intramuscularly into each hind leg and the remainder was injected subcutaneously into the back. After 4 weeks, the procedure was repeated, using Freund's incomplete adjuvant rather than complete adjuvant. The three outer wells contained commercial ancrod, NTA and ancrod isolated from snake venom, respectively. Only the NTA region showed any cross reactivity, indicating that NTA antibodies do not cross react with native ancrod. These experiments show the potential value of the present invention in reducing clinical resistance to ancrod. The results of the cross reactivity studies indicate that it is likely that NTA administered after resistance has been established to native ancrod will be effective and not be met with resistance from ancrod antibodies. Conversely, if NTA is administered initially, native ancrod could be administered after NTA resistance becomes manifest. Alternatively, both ancrod and NTA can be administered simultaneusly or concurrently. The routes of administration for NTA are the same as those for untreated ancrod described above. NTA can be administered in the same dosage forms as native, untreated ancrod described above. Individual dosages should be determined for each patient and should be adjusted to reduce fibrinogen concentration to 70-100 mg/dl. Typically, this is accomplished by administering between 0.5 and 2.5 Twyford units of NTA per day.

Disclosed is a pharmaceutically effective agent and method of use, comprising ancrod which has been incubated with neuraminidase. The neuraminidase-treated ancrod (NTA) can be substituted for ancrod in ancrod therapy, when immunological resistance to the latter has become manifest. Conversely, NTA can be administered initially, and ancrod substituted therefor after NTA resistance becomes manifest.

This application is a divisional of U.S. application Ser. No. 09/892,613, filed on Jun. 27, 2001, now U.S. Pat. 7,321,026, the contents of which are hereby incorporated by reference into this application. Throughout this application, various references are referred to within parenthesis. Disclosures of these publications in their entireties are hereby incorporated by reference into this application to more fully describe the state of the art to which this invention pertains. FIELD OF THE INVENTION The present invention relates to novel methods in re-engineering, or reshaping antibodies with clinical indications (both therapeutic and diagnostic). The method combines the use of recombinant technology and, stepwise and systemic approaches in re-designing antibody sequences. The invention particularly provides for antibodies which are modified to be less immunogenic than the unmodified counterpart when used in vivo. BACKGROUND OF THE INVENTION Monoclonal antibodies (Mabs) have become the most successful protein drugs being used for the treatment of a variety of diseases, including cancers, transplantation, viral infection, etc. However, the concept of magic bullet took more than 25 years to realize, because there were problems associated with the use of monoclonal antibodies. One of the main problems stems from the original source of most monoclonal antibodies, which are of rodent and murine origin. Repeated injections of these foreign proteins into human would inevitably result in the elicitation of host immune responses against the antibodies: the so-called human anti-mouse antibody (HAMA) responses. Although earlier attempts to use the techniques of molecular engineering to construct chimeric antibodies (for example, mouse variable regions joined to human constant regions) were somewhat effective in mitigating HAMA responses, there remains a large stretch of murine variable sequences constituting ⅓ of the total antibody sequence that could be sufficiently immunogenic in eliciting human anti-chimeric antibody (HACA) responses. A more advanced improvement in antibody engineering has recently been utilized to generate humanized antibodies in which the complementarity determining regions (CDR's) from a donor mouse or rat immunoglobulin are grafted onto human framework regions (for example, EPO Publication No. 0239400, incorporated herein by reference). The process is called “humanization”, or “CDR-grafting”. The original concept of humanization describes the direct grafting of CDR's onto human frameworks, reducing the non-human sequences to less than 5%, and thereby the HAMA and HACA responses. However, direct replacement of framework sequences without further modifications can result in the loss of affinity for the antigen, sometimes as much as 10-fold or more (Jones et al., Nature, 321:522-525, 1986; Verhoyen et al., Science, 239:1534-1536, 1988). To maintain the affinity of the CDR-grafted or humanized antibody, substitutions of a human framework amino acid of the acceptor immunoglobulin with the corresponding amino acid from a donor immunoglobulin at selected positions will be required. The positions where the substitution takes place are determined by a set of published criteria (U.S. Pat. No. 5,85,089; U.S. Pat. No. 5,693,762; U.S. Pat. No. 5,693,761; incorporated herein by reference). However, the presence of murine amino acids within stretches of human framework sequences can be immunogenic in the generation of new T- and B-cell epitopes. Moreover, the identification of the proper framework amino acids to be replaced can sometimes be difficult, further reducing the chances of success in humanization without significant impacts on the specificity and affinity of the humanized antibody. New and improved means for producing re-engineered immunoglobulin with reduced or eliminated immunogenicity while maintaining the specificity and affinity of the parent antibody are therefore needed. Preferably, the re-engineered immunoglobulin should contain no FR amino acid substitutions from the parent antibody, which can be a likely source of immunogenic epitopes for T- or B-cells. However, the approach also offers flexibility in the sequence design where few murine residues or a stretch of murine sequences can be included in the final design, with the ultimate goal of reducing immunogenicity while maintaining specificity and affinity of the resultant antibody for human uses. The present invention describes the methods and approaches in fulfilling these goals. SUMMARY OF THE INVENTION The present invention relates to novel methods for re-engineering immunoglobulin chains having generally one or more complementarity determining regions (CDR's) from a donor immunoglobulin and portions of framework sequences from one or more human, or primate immunoglobulins. The preferred methods comprise first dividing the framework sequences from immunoglobulins of all species into compartmentalized subregions of FR1, FR2, FR3, and FR4, according to the Kabat Database (Kabat et al. Sequences of proteins of immunological interest. Maryland: US Department of Health and Human Services, NIH, 1991), and comparing the individual FR's, instead of the whole framework, in the variable region amino acid sequence subregions of the parent immunoglobulin to corresponding sequences in a collection of human, or primate immunoglobulin chains, and selecting the appropriate human or primate FR's with the highest degree of homology to replace the original FR's of the parent immunoglobulin (framework- or FR-patching). The human FR's can be selected from more than one human or primate immunoglobulin sequences. A collection of human or primate immunoglobulin sequences can be obtained from different databases (for example, Kabat database, National Biomedical Research Foundation Protein Identification Resource, Brookhaven Protein Data Bank, internet, etc.). The individual FR sequences selected from human or primate immunoglobulins will typically have more than 60% homology to the corresponding parent FR sequences. Although high overall homology will be an important criteria for selecting the FR's for patching, lesser homology FR's will be used if the homology of sequences directly flanking the CDR's or at loop positions where contact(s) with the antigen binding site is (are) determined experimentally or predicted via computer modeling. The parent immunoglobulin whose FR's are to be patched may be either a heavy chain or light chain. A patched light and heavy chain can be used to form a complete FR-patched immunoglobulin or antibody, having two light/heavy chain pairs, with or without partial or full-length human constant regions. The individual FR's chosen for patching a parent immunoglobulin chain (applies to both heavy and light chains) should: (1) preferably have amino acid sequences immediately adjacent to the CDR's identical to that of the parent immunoglobulin chain; (2) have amino acid sequences immediately adjacent to the CDR's conservatively similar in structure to, if not completely identical to, that of the parent immunoglobulin chain; (3) preferably have identical amino acid at corresponding FR position of the parent immunoglobulin predicted to be within about 3Å of the CDR's (or the effective antigen-binding site) in a three-dimensional immunoglobulin model and capable of interacting with the antigen or with the CDR's of the parent or FR-patched immunoglobulin; (4) have amino acid conservatively similar in structure to amino acid at corresponding FR position of the parent immunoglobluin predicted to be within about 3Å of the CDR's (or the effective antigen-binding site) in a three-dimensional immunoglobulin model and capable of interacting with the antigen or with the CDR's of the parent or FR-patched immunoglobulin. Each of the heavy and light chains of the FR-patched immunoglobulin will typically comprise FR's sourced from one or more human or primate immunoglobulins according to any one or all of the selection criteria. The FR-patched heavy and light chains of the present invention, when combined into an intact antibody, antibody fragment, or antibody-based derivatives (for example single-chain antibody, diabodies, etc.), will be substantially non-immunogenic in humans and retain substantially the same affinity and properties (for example internalization upon binding) as the parent immunoglobulin to the antigen. These affinity levels should vary within the range of 4-fold, and preferably within about 2 fold of the parent immunoglobulin's original affinity to the antigen. Similar principles apply to re-engineer, or patch, parent immunoglobulins of one species with the FR's from a different species. People skilled in the art of protein and/or molecular engineering will be able to adopt the design and principle of the present invention to produce FR-patched immunoglobulins, or derivatives thereof. Once designed, there exist a variety of techniques in constructing the FR-patched immunoglobulin sequence, for example, by site-directed mutagenesis, and gene-synthesis. The assembled FR-patched sequences will be subcloned into expression vectors containing the appropriate immunoglobulin constant heavy and light chains for transfection in producer cell lines. Different cell systems can be used for the production of the FR-patched immunoglobulins, including bacterial, yeast, insect, and mammalian cells. Alternatively, the immunoglobulins can be produced in the milks of transgenic or transomatic animals, or as stored proteins in transgenic plants. The present invention offers an improved and novel methods, that are relatively easy (no need to identify important FR amino acid interacting with the CDR's) and highly flexible (freedom to match, and change if necessary, individual FR's) in generating immunoglobulins with reduced or eliminated immunogenicities without sacrificing binding affinity and the likelihood of introducing new T- and B-cell epitopes resulting from the introduction of parent immunoglobulin's framework amino acids into the human FR's. The FR-patched antibodies will be suitable for human use in treating a variety of disease, either used singly or repeatedly, at low (less than 10 mg/m 2 ) or high (more than 100 mg/m 2 ) doses, in naked forms or as fusion or chemical conjugates, used alone, or in conjunction with other immunoglobulins or treatment modalities. DETAILED DESCRIPTION OF THE FIGURES FIG. 1A and FIG. 1B . Amino acid sequences (single-letter code) of the heavy chain (VH)(A) and light chain (VL)(B) variable regions of the murine anti-CD22 antibody, RFB4. CDR's are boxed. (SEQ ID NO. 33 and 34) FIG. 2A and FIG. 2B . Comparison of the compartmentalized framework sequences (FR's) of the heavy chain (A) and light chain (B) variable regions of RFB4, with the different human FR's of the highest homology. The FR1, FR2, FR3, and FR4 are indicated. The CDR's are boxed. The bracketed italic next on the left of the FR sequence indicates the source of the human FR. Amino acids in the human FR's that are different from that of the corresponding murine FR's are in bold. (SEQ ID NO. 35-46) FIG. 3A and FIG. 3B . The final designed sequences (single-letter code) of the heavy chain (A) and light chain (B) variable regions of the FR-patched antibody, hpRFB4. CDR's are boxed. Amino acids in the human FR's that are different from that of the original murine FR's are in bold. (SEQ ID NO. 47-48) FIG. 4 . Predicted SDS-PAGE analysis of purified cRFB4 and hpRFB4 under both reducing and non-reducing conditions. FIG. 5 . Predicted flow cytometry analyses on the binding specificity and affinity of cRFB4 and hpRFB4 on Raji cells. FIG. 6 . Predicted competition binding assay comparing the binding affinity between cRFB4 and hpRFB4. An irrelevant antibody was used as a control. FIG. 7A and FIG. 7B . Amino acid sequences (single-letter code) of the heavy chain (A) and light chain (B) variable regions of the murine anti-CD20 antibody, 1F5. CDR's are boxed. (SEQ ID NO. 49-50) FIG. 8A and FIG. 8B . Comparison of the compartmentalized framework sequences (FR's) of the heavy chain (A) and light chain (B) variable regions of 1F5 with the different human FR's of the highest homology. The FR1, FR2, FR3, and FR4 are indicated. The CDR's are boxed. The bracketed italic next on the left of the FR sequence indicates the source of the human FR. Amino acids in the human FR's that are different from that of the corresponding murine FR's are in bold. (SEQ ID NO. 51-67) FIG. 9A and FIG. 9B . The final designed sequences (single-letter code) of the heavy chain (A) and light chain (B) variable regions of the FR-patched antibody, hp1F5. CDR's are boxed. Amino acids in the human FR's that are different from that of the original murine FR's are in bold. Murine FR's not replaced by human sequences are underlined. (SEQ ID NO. 68-69) FIG. 10 . Amino acid sequence of an alternative design of FR-patched variable regions for 1F5 (Alternative Design). CDR's are boxed. Human framework amino acids that differ from that of the corresponding murine frameworks are in bold. A. The heavy chain variable region (VH) amino acid sequence of FR-patched 1F5 (Alternative Design); (SEQ ID NO. 70) B. The light chain variable region (VL) amino acid sequence of FR-patched 1F5 (Alternative Design). (SEQ ID NO. 71) DETAILED DESCRIPTION OF THE INVENTION The present invention aims to establish novel approaches in the design of immunoglobulin with high degree of homology to human or primate sequences through a process named “framework (FR) patching”. The FR-patched immunoglobulin (patched immunoglobulin thereafter) will have substantially reduced, or eliminated immunogenicity when used in human, and carry most or all of the characteristics of a human immunoglobulin such as the ability to target specific antigens, and effector functions (for example, complement fixation, ADCC, etc.), while maintaining the specificity and affinity of the parent immunoglobulin against a specific antigen. The patched immunoglobulin will comprise a heavy and light chain, of which, the respective variable region will contain sequences representing FR1, CDR1, FR2, CDR2, FR3, CDR3, and FR4, according to Kabat's classification (Kabat et al., op. cit.). At least one of the four FR's of each parent immunoglobulin chain containing one or more complementary determining regions (CDR's) will be replaced, or “patched” with, a corresponding human or primate FR. When two or more FR's of the parent immunoglobulin chain are to be replaced, they can be patched with corresponding FR's either from the same human or primate immunoglobulin, or from different human or primate immunoglobulin within the same subgroup or in different subgroups, or from a combination of human and primate immunoglobulins. The patched immunoglobulins will be expressed in appropriate host system for large-scale production at typical pharmaceutical margins, and used in humans at appropriate formats or combinations to treat or detect a wide range of human diseases. To ensure a better understanding of the present invention, several definitions are set forth. As used herein, an “immunoglobulin” refers to a protein consisting of one or more polypeptides substantially encoded by immunoglobulin genes. A typical immunoglobulin protein contains two heavy chains paired with two light chains. A full-length immunoglobulin heavy chain is about 50 kD in size (approximately 446 amino acids in length), and is encoded by a heavy chain variable region gene (about 116 amino acids) and a constant region gene. There are different constant region genes encoding heavy chain constant region of different isotypes such as alpha, gamma (IgG1, IgG2, IgG3, IgG4), delta, epsilon, and mu sequences. A full-length immunoglobulin light chain is about 25 Kd in size (approximately 214 amino acids in length), and is encoded by a light chain variable region gene (about 110 amino acids) and a kappa or lambda constant region gene. Naturally occurring immunoglobulin is known as antibody, usually in the form of a tetramer consisting of two identical pairs of immunoglobulin chains, each pair having one light and one heavy chain. In each pair, the light and heavy chain variable regions are together responsible for binding to an antigen, and the constant regions are responsible for the effector functions typical of an antibody. Immunoglobulin may be in different forms, either naturally occurring, chemically modified, or genetically-engineered, such as Fv (Huston et al., Proc. Natl. Acad. Sci. USA. 85:5879-5833; Bird et al., Science 242:423-426, 1988), diabodies, mini-antibodies, Fab, Fab', F(ab') 2 , bifunctional hybrid antibodies (Lanzavecchia et al., Eur. J. Immunol. 17:105, 1987) (See, generally, Hood et al., “Immunology”, Benjamin, NY, 2 nd ed. 1984; Hunkapiller and Hood, Nature 323:15-16, 1986). The variable region of both the heavy and light chain is divided into segments comprising four framework sub-regions (FR1, FR2, FR3, and FR4), interrupted by three stretches of hypervariable sequences, or the complementary determining regions (CDR's), as defined in Kabat's database (Kabat et al., op. cit.), with the CDR1 positioned between FR1 and FR2, CDR2 between FR2 and FR3, and CDR3 between FR3 and FR4. Without specifying the particular sub-regions as FR1, FR2, FR3 or FR4, a framework region, as referred by others, represents the combined FR's within the variable region of a single, naturally occurring immunoglobulin chain. As used herein, a FR represents one of the four sub-regions, and FR's represents two or more of the four sub-regions constituting a framework region. The sequences of the framework regions of different light or heavy chains are relatively conserved within a species. The framework region of an antibody is the combined framework regions of the constituent light and heavy chains and serves to position and align the CDR's. The CDR's are primarily responsible for forming the binding site of an antibody conferring binding specificity and affinity to an epitope of an antigen. Parent antibody is an antibody of a particular species, for example, murine, which is to be re-engineered, re-shaped, or in this invention, FR-patched into a form, sequence, or structure, appropriate for use in a different species, for example, human, with reduced or minimized immunogenicity. Chimeric antibodies are antibodies whose variable regions are linked, without significant sequence modifications from the parent V-region sequences, to the corresponding heavy and light chain constant regions of a different species. Construction of a chimeric antibody is usually accomplished by ligating the DNA sequences encoding the variable regions to the DNA sequences encoding the corresponding constant chains. The most common types of chimeric antibodies are those containing murine variable regions and human constant regions. In this case, the expressed hybrid molecule will have the binding specificity and affinity of the parent murine antibody, and the effector functions of a human antibody. Most importantly, ⅔ of the amino acids of the recombinant protein are of human origin, a reduced or insignificant immunogenicity is therefore expected when used in human, as in the case of the therapeutic chimeric antibody C2B8 (or RITUXIMAB) (Davis et al., J. Clin. Oncol. 17:1851-1857, 1999; Coiffier et al., Blood 92:1927-1932, 1998; McLaughlin et al., J. Clin. Oncol. 16:2825-2833, 1998). A “humanized” immunoglobulin is generally accepted as an immunoglobulin comprising a human framework region and one or more CDR's from a non-human immunoglobulin (Jones et al., op. cit; Verhoeyen et al., op. cit; Riechmann et al., op. cit.). The non-human immunoglobulin providing the CDR's is called the “donor” and the human immunoglobulin providing the framework is called the “acceptor”. Usually, as has been used and referred to by others, an acceptor is derived from a single human immunoglobulin species. To maintain the affinity of the “humanized” immunoglobulin, donor amino acid residues may have to be incorporated in the framework region of the acceptor immunoglobulin. There is a set of criteria for selecting a limited number of amino acids within the acceptor immunoglobulin for conversion into donor sequences, as published in a series of publications (U.S. Pat. No. 5,85,089; U.S. Pat. No. 5,693,762; U.S. Pat. No. 5,693,761; incorporated herein by reference). The humanized immunoglobulins may or may not contain constant regions. A humanized heavy chain immunoglobulin is a humanized immunoglobulin comprising a corresponding human heavy chain constant region, and a humanized light chain immunoglobulin is a humanized immunoglobulin comprising a corresponding human light chain constant region. A humanized antibody is an antibody comprising a humanized light chain and a humanized heavy chain immunoglobulin. A successful humanized antibody will have to have the following characteristics: (1) significantly reduced, and preferably eliminated, immunogenicity resulting from the humanized sequences, allowing multiple injection of the humanized antibody for human uses; (2) minimally perturbed immunoreactivity including specificity and affinity (within 3-fold) against the original antigen; (3) capable of inducing human effector functions such as complement fixation, complement-mediated cytotoxicity, antibody-dependent cell cytotoxicity, etc. Direct grafting of donor CDR's onto human acceptor framework without further sequence modifications, will likely result in substantial loss of antigen affinity. Although the introduction of selected donor amino acids to acceptor framework regions will somehow rectify the problem, and most of the time, improve affinity, however, the approach is tedious, requiring sometimes the assistance of computer modeling in identifying the appropriate framework amino acid to mutate, and lack flexibility in the choice of acceptor human frameworks in an all-or-none mode. Most importantly, it is likely to introduce potential new immunogenic epitopes by retaining parent “donor” residues in the human “acceptor” framework. The present invention addresses these problems and creates a novel approach with increased flexibility and simplicity in generating a FR-patched antibody that is not immunogenic or is low in immunogenicity, yet having retained most or all of the original affinity against a specific antigen, as in the parent antibody. Since most of the immune responses against a chimeric or humanized immunoglobulin will be directed against epitopes in the variable regions, without intending to be bound by theory, the principle by which the invention comes about will be illustrated by, but not limited to, using the variable region as the example. There exist at least two kinds of epitopes contributing to the immunogenicity against a protein. The so-called “T cell epitopes” are short peptide sequences released during the degradation of proteins within cells and subsequently presented by molecules of the major histocompatability complexes (MHC) in order to trigger the activation of T cells. For peptides presented by MHC class II, such activation of T cells can then give rise to an antibody response by direct stimulation of B cells to produce such antibodies. A detailed analysis of the structure of a humanized variable region reveals the unavoidable existence of stretches of potentially immunogenic CDR's. These CDR's physically and functionally compartmentalize the rest of the framework sequences into four sub-regions, namely, the FR1, FR2, FR3, and FR4 (Kabat et al., op. cit.). Since T cell epitopes are linear continuous short peptides, the presence or absence of such epitopes in each FR compartments should have no correlation to each other, whether the different FR's are derived from the same or different frameworks. The introduction of donor framework residues to the acceptor framework region using the humanization approach of Queen et al. (U.S. Pat. No. 5,85,089; U.S. Pat. No. 5,693,762; U.S. Pat. No. 5,693,761; incorporated herein by reference) will have the possibility of generating new, immunogenic T cell epitopes, resulting in the elicitation of immune responses against the humanized antibody, particularly antibody responses against the idiotypic region formed by the donor CDR loops. It is uncommon to have between 3 to 7 donor amino acids incorporated into each humanized immunoglobulin chain, greatly increasing the chances of emergency for new T cell epitopes. Similarly, these donor-derived residues embedded within the human framework can form new immunogenic B-cell epitopes recognizable by antibodies. While it is well-established that re-introduction of donor residues to the acceptor framework is important in maintaining the original antigen affinity of the humanized immunoglobulin, ideally, it would be preferable if humanization can be accomplished by direct grafting of donor CDR's onto acceptor framework without additional modification and loss of affinity. The present invention provides a new approach in reducing or eliminating the immunogenicity of immunoglobulins whose affinity against the specific antigen is maintained within three fold of its original level. The approach is flexible, versatile, simple, and does not usually require sophisticated computer modeling analysis (although it does not preclude its being used). It deals with the problem of reciprocal relation between reducing immunogenicity and maintaining affinity in humanizing an antibody with the previous and available methodologies. Using an immunoglobulin variable region as example, a set of criteria and principles will be followed in FR-patching the sequence. The criteria may be used singly, or when necessary in combination, to achieve reduced or eliminated immunogenicity, and the desired affinity or other characteristics. In humanizing an immunoglobulin variable region by FR-patching, the parent immunoglobulin amino acid sequences are compartmentalized into FR1, CDR1, FR2, CDR2, FR3, CDR3, and FR4 according to the classification of Kabat et al. (opt. cit.). Each of the compartmentalized FR's will be dealt with separately and used to align with the corresponding FR segments found in all databases, available either in the public domain, commercial entities, or private possession (for example the Kabat database, opt. cit.; the National Biomedical Research Foundation Protein Identification Resource). An immunoglobulin can be patched with FR's from more than one immunoglobulin sources. Preferably, human FR segments with the highest degree of homology (>60%) to the corresponding parent FR's will be used. However, amino acids in the FR's adjacent to one or more of the 3 CDR's in the primary sequence of the immunoglobulin chain may interact directly with the antigen (Amit et al., Science, 233:747-753, 1986, which is incorporated herein by reference) and selecting these amino acids identical to the human FR's with lesser homology will be used according to the criteria set forth below. A human FR1 will be used when it has the highest homology to the parent FR1, preferably 100%, at three or more amino acids immediately adjacent to CDR1. A human FR2 will be used when it has the highest homology to the parent FR2, preferably 100%, at three or more amino acids at both ends immediately adjacent to the flanking CDR1 and CDR2. A human FR3 will be used when it has the highest homology to the parent FR3, preferably 100%, at three or more amino acids at both ends immediately adjacent to the flanking CDR2 and CDR3. A human FR4 will be used when it has the highest homology to the parent FR4, preferably 100%, at three or more amino acids immediately adjacent to CDR3. In case human FR's with 100% homology at three or more amino acids adjacent to the CDRs cannot be identified, FR's with the closest homology at these positions containing conservatively similar amino acids, such as, gly, ala; val, ile, leu; asp, glu; asn, gln; ser, thr; lys, arg; and phe, tyr; will be selected. Preferably, human FR's whose amino acids at positions known to be close to, or have interactions with the CDR's/antigen binding site (Chothia and Lesk, J. Mol. Biol. 196:901, 1987; Chothia et al., Nature 342:877, 1989, and Tramontano et al., J. Mol. Biol. 215:175, 1990, all of which are incorporated herein by reference), either based on computer modeling (see Levy et al., Biochemistry 28:7168-7175, 1989; Bruccoleri et al., Nature 335:564-568, 1988; Chothia et al., Science 233:755-758, 1986, all of which are incorporated herein by reference), crystal structure, published information, or prior experience, which are identical, or conservatively similar to that of the parent FR's will be selected. FR-patching does not preclude the introduction of parent amino acids at corresponding positions of a patched FR where necessary, or the inclusion of FR's in the immunoglobulin from different species such as different primates, murine, etc, when available databases fail to produce a satisfactory FR that meet the above criteria. The primary goal is to produce antibodies with reduced, preferably, eliminated immunogenicity without substantial loss of affinity. The approach increases the chances of success in this regard, with significant improvements over other methods in terms of flexibility, simplicity, and ease of operation. FR-patched antibodies carrying human constant sequences will be able to induce human immune effector functions such as complement-mediated cytotoxicity (CM) or anti-body-dependent cellular cytotoxicity (ADCC), upon binding to the target antigens. Moreover, when injected in human for therapeutic or diagnostic purposes, antibodies patched with human FR's are expected to be non-immunogenic, i.e., will not elicit antibody responses against the injected protein, allowing for multiple injections into human patients if necessary for achieving maximum clinical benefits. Non-human antibodies have been reported to have significantly shorter circulation half-lives than that of human antibodies (Shaw et al., J Immunol. 138:4534-4538, 1987). The patched antibodies, carrying mostly human sequences, will presumably have an extended half-life reminiscent to naturally occurring human antibodies. In the construction of a FR-patched immunoglobulin, sequence design for the variable regions of the immunoglobulin will be done using the criteria and principles illustrated above. The designed FR-patched variable region sequence will be assembled using a variety of standard recombinant techniques well known to those skilled in the art. Preferably, the designed sequence, usually of a size of about 350 base pairs, will be gene-synthesized (Leung et al., Molecular Immunol. 32:1413-1427, 1995; Daugherty et al., Nucl. Acid Res. 19:2471-2476; DeMartino et al., Antibody Immunoconj. Radiopharmaceut. 4:829, 1991; Jones et al., op. cit., all of which are incorporated herein by reference), or the individual FR's can be introduced to replace the parent FR's by methods of site- or oligonucleotide-directed mutagenesis (Gillman and Smith, Gene 8:81-97, 1979; and Roberts et al., Nature 328:731-734; both of which are incorporated herein by reference). The DNA segment encoding the FR-patched immunoglobulin will be joined to DNA sequences encoding the human heavy and light chain regions in DNA expression vectors suitable for bacterial propagation and expression in different host cells. There are a variety of DNA vectors suitable for expression in a variety of host cell systems. Appropriate DNA vectors can be chosen for the expression of the FR-patched immunoglobulins. Typically, a suitable expression control DNA sequence is linked operably to DNA segments encoding the immunoglobulin chains. Preferably, the expression control sequences will be eukaryotic promoter systems in vectors capable of transforming or transfecting eukaryotic host cells, but control sequences for prokaryotic hosts may also be used. The sequence encoding the FR-patched heavy and light immunoglobulin chains can be incorporated into one single DNA expression vector, or into separate heavy and light chain expression vectors. In the latter case, host cells will have to be simultaneously incorporated with both vectors in order to produce a FR-patched antibody with the properly paired heavy and light chain polypeptides. In general, a leader sequence allowing the transportation of the immunoglobulin polypeptide into the Golgi apparatus for later secretion is included at the N-terminal end of each immunoglobulin chain for expression in eukaryotic host cells. Once the vector has been incorporated into the appropriate host, the host is maintained under conditions suitable for high level expression of the nucleotide sequences, and, as desired, the collection and purification of the humanized light chains, heavy chains, light/heavy chain dimers or intact antibodies, binding fragments, single chain antibody (sFv), diabodies, or derivatives thereof, or other immunoglobulin forms may follow (see Beychok, Cells of Immunoglobulin Synthesis, Academic Press, NY, 1979, which is incorporated herein by reference). It is a well-known fact that there are different human constant regions for the heavy and light chains. A particular isotype will have specific effector characteristics that can be chosen for use for different purposes. Human constant region DNA sequences can be isolated in accordance with well known procedures from a variety of human cells, but preferably immortalized B-cells (see, Kabat op. cit. and WP87/02671). The CDR's for producing the immunoglobulins of the present invention will be similarly derived from monoclonal antibodies capable of binding to the predetermined antigens, such as CD22 and CD20, for example, and produced by well known methods in any convenient mammalian source including, mice, rat, rabbits, or other vertebrate, capable of producing antibodies. Suitable source cells for the constant region and framework DNA and secretion, can be obtained from a number of sources such as the American Type Culture Collection (“Catalogue of Cell Lines and Hybridomas,” sixth edition, 1988, Rockville, Md., USA, which is incorporated herein by reference). DNA expression vectors containing the coding sequences for the FR-patched immunoglobulin chains operably linked to an expression control sequence (including promoter and enhancers) are typically replicable in the host organisms either as episomes or as an integral part of the host chromosomal DNA. Selectable markers such as tetracycline, neomycin, beta-lactamase, etc., are included in the vector to allow detection of cells transformed with the DNA vectors (see, for example, U.S. Pat. No. 4,704,362, which is incorporated herein by reference). Bacterial hosts are suitable for propagating the DNA vectors as well as expressing the incorporated immunoglobulin DNA. For example, E. coli is the most commonly used prokaryotic host used for cloning the DNA sequence for the present invention. Other microbial hosts that are useful for the same purposes include, as examples, bacilli (for example Bacillu subtilus ), and other enterobacteriaceae (for example Salmonella, Serratia ), and various Pseudomonas species. Expression of cloned sequences in these hosts require the presence of expression control sequences compatible with the host cell (for example an origin of replication), and functional promoters to be included in the DNA vector. Example of well-known promoter system include, but not limited to, tryptophan (trp) promoter system, beta-lactamase promoter system, phage lambda promoter system, etc. These promoters are responsible for controlling expression, or transcription, of the functional gene sequence downstream of the promoter system, which contains, in addition to all necessary motifs, and optionally with an operator sequence, ribosome binding site sequences and the like, necessary for transcription initiation and translation. Similarly, other microbes, such as yeast, may also be used for expression. For example, a preferred host will be Saccharomyces , which is a suitable host for expression vectors containing the appropriate expression control elements, such as promoters, including 3-phosphoglycerate kinase or other glycolytic enzymes, and an origin of replication, termination sequences and the like as desired. Eukaryotic host cells of invertebrate origin can be used. For example, insect cells, such as hi-5, SF9, SF21. Appropriate expression vectors containing convenient cloning sites, promoters, termination sequences, etc., that are important for high-level expression in the host cells are available commercially (Invitrogen, San Diego, Calif.). Preferably, mammalian tissue cell culture may be used to express and produce the polypeptides of the present invention (see, Winnacker, “From Genes to Clones,” VCH Publisher, NY, N.Y., 1987, which is incorporated herein by reference). The most commonly used mammalian host cells are Chinese Hamster Ovary (CHO) cell lines, various COS cell lines, HeLa cells, and myeloma cell lines such as SP2/0 cell lines, NS0 cell lines, YB2/0 cell lines, etc, and transformed B-cells or hybridomas. These cell lines are capable of conferring the right glycosylation at appropriate site such as amino acid 297 at the heavy chain CH2 domain, and secreting full-length immunoglobulins, and are the host cell system of choice for this particular invention. Similar to expression vectors for other host cells, a eukaryotic cell expression vector will contain the appropriate expression control sequences including promoter (for example, those derived from immunoglobulin genes, metallothionine gene, SV40, Adenovirus, cytomegalovirus, Bovine Papilloma Virus, and the like), enhancers, usually with a leader sequence for directing the expressed polypeptide to the Golgi apparatus for glycosylation and export, the DNA segments of interest (for example, the heavy and light chain encoding sequences and expression control sequences), a termination codon, other necessary processing information sites (such as ribosome binding sites, RNA splice sites, a polyadenylation sequence, and transcriptional terminator sequences), and a selection marker (such as mutant Dhfr, glutamine synthetase (GS), hygromycin, neomycin) (see Kellems, “Gene Amplification in mammalian cells”, Marcel Dekker Inc., NY, N.Y., 1993; which is incorporated herein by reference). There exist a plethora of established and well-known methods for introducing the vectors containing the DNA segments of interest into the host cell, either transiently or stably integrated into the host cell genome. They include, but not limited to, calcium chloride transfection, calcium phosphate treatment, electroporation, lipofection, etc. (See, Maniatis et al., Molecular Cloning: A Laboratory Manual, Cold Spring Harbor Press, 1982; which is incorporated herein by reference). Identification of host cells incorporated with the appropriate expression vector will be achievable typically by first growing cells under selection pressure in accordance with the selectable marker used in the vector, and detection of secreted proteins, for example, the whole antibodies containing two pairs of heavy and light chains, or other immunoglobulin forms of the present invention, by standard procedures such as ELISA and Western analysis. Purification of the expressed immunoglobulin can be purified according to standard procedures of the art, including ammonium sulfate precipitation, affinity columns, column chromatography, gel electrophoresis and the like (see, generally, R. Scopes, “Protein Purification”, Springer-Verlag, NY, 1982). Substantially pure immunoglobulins of at least about 90 to 95% homogeneity are preferred, and 98 to 99% or more homogeneity most preferred, for pharmaceutical uses. Once purified, partially or to homogeneity as desired, the polypeptides may then by used therapeutically (including extracorporeally) or in developing and performing assay procedures, immunofluorescent stainings, and the like (See, generally, Immunological Methods Vols I and II, Lefkovits and Pernis, eds., Academic Press, New York, N.Y., 1979 and 1981). The antibodies of the present invention will typically find use individually, or in combination with other treatment modalities, in treating diseases susceptible to antibody-based therapy. For example, the immunoglobulins can be used for passive immunization, or the removal of unwanted cells or antigens, such as by complement mediated lysis, all without substantial adverse immune reactions (for example anaphylactic shock) associated with many prior antibodies. A preferable usage of the antibodies of the present invention will be the treatment of diseases using their naked forms (naked antibodies) at dosages ranging from 50 mg to 400 mg/m 2 , administered either locally at the lesion site, subcutaneously, intravenously, and intramuscularly, etc. Multiple dosing at different intervals will be performed to achieve optimal therapeutic or diagnostic responses, for example, at weekly intervals, once a week, for four weeks. Usage of the antibodies derived from the present invention can be combined with different treatment modalities, such as chemotherapeutic drugs (for example CHOP, Dox, 5-Fu, . . . etc), radiotherapy, radioimmunotherapy, vaccines, enzymes, toxins/immunotoxins, or other antibodies derived from the present invention or others. The antibodies of the present invention, if specific for the idiotype of an anti-tumor antibody, can be used as tumor vaccines for the elicitation of Ab3 against the tumor antigen. Numerous additional agents, or combinations of agents, well-known to those skilled in the art may also be utilized. Additionally, the antibodies of the present invention can be utilized in different pharmaceutical compositions. The antibodies can be used in their naked forms, or as conjugated proteins with drugs, radionuclides, toxins, cytokines, soluble factors, hormones, enzymes (for example carboxylesterase, ribonuclease), peptides, antigens (as tumor vaccine), DNA, RNA, or any other effector molecules having a specific therapeutic function with the antibody moiety serving as the targeting agents or delivery vehicles. Moreover, the antibodies or antibody derivatives, such as antibody fragments, single-chain Fv, diabodies, etc. of the present invention can be used as fusion proteins to other functional moieties, such as, antibodies or antibody derivatives of a different invention (for example as bispecific antibodies), toxins, cytokines, soluble factors, hormones, enzymes, peptides, etc. Different combinations of pharmaceutical composition, well-known to those skilled in the art may also be utilized. FR-patched antibodies of the present invention can also be used for in vitro purposes, for example, as diagnostic tools for the detection of specific antigens, or the like. The following examples are offered by way of illustration, not by limitation. EXPERIMENTAL In designing the amino acid sequence of the FR-patched immunoglobulin chain, the murine variable region sequence (applies to both VH and VL) was compartmentalized into FR1, CDR1, FR2, CDR2, FR3, CDR3, and FR4, according to Kabat's classification (Kabat et al., op. cit.). Selection of the individual FR's for patching was in accordance to the guidelines as described previously. A human FR1 will be used when it has the highest homology to the parent FR1, preferably 100%, at three or more amino acids immediately adjacent to CDR1. A human FR2 will be used when it has the highest homology to the parent FR2, preferably 100%, at three or more amino acids at both ends immediately adjacent to the flanking CDR1 and CDR2. A human FR3 will be used when it has the highest homology to the parent FR3, preferably 100%, at three or more amino acids at both ends immediately adjacent to the flanking CDR2 and CDR3. A human FR4 will be used when it has the highest homology to the parent FR4, preferably 100%, at three or more amino acids immediately adjacent to CDR3. In case human FR's with 100% homology at three or more amino acids adjacent to the CDRs cannot be identified, FR's with the closest homology at these positions containing conservatively similar amino acids, such as, gly, ala; val, ile, leu; asp, glu; asn, gln; ser, thr; lys, arg; and phe, tyr; will be selected. Preferably, human FR's whose amino acids at positions known to be close to, or have interactions with the CDR's/antigen binding site (Chothia and Lesk, op. cit.; Chothia et al., op. cit., and Tramontano et al., op. cit.), either based on computer modeling (see Levy et al., Biochemistry op. cit.; Bruccoleri et al., op. cit.; Chothia et al., op. cit.), crystal structure, published information, or prior experience, which are identical, or conservatively similar to that of the parent FR's will be selected. In case where a particular human FR satisfying all the above is unavailable, and direct patching results in the loss of affinity or specificity, murine residues considered to have interactions with the antigen binding site, or contribute to the final affinity of the antibody, will be introduced back to the best available FR. Alternatively, the particular FR with no matching human counterpart will be retained and used in its murine composition without modification; the final FR-patched sequence will contain a mixture of human and murine FR's. For the purpose of illustration, two murine anti-B cell antibodies will be FR-patched using the approach as described herein in this invention. EXAMPLE 1 FR-Patched Anti-CD22 Antibody Design of Genes for FR-Patched Anti-CD22 Light and Heavy Chain The heavy and light chain sequence of a murine anti-CD22 antibody, RFB4 (Li et al., Cell Immunol. 118:85, 1989; Mansfield et al., Blood 90:2020-2026, 1997) is used as an example to illustrate the approach of using FR-patching to reduce or eliminate immunogenicity of the re-engineered antibody. The sequences of the heavy (a) and light chain (b) variable region for the murine antibody are shown in FIG. 1 . Patching of the individual FRs for the heavy chain variable region for RFB4 was done as follows: a. FR1: the FR1 sequence of the murine VH was compared with the FR1 sequences of human VH from the Kabat's database (Kabat et al., op. cit.). Although human FR1 of the highest sequence homology is preferred, particular emphasis on the sequence closest to the CDR1 was taken. There are three FR1 sequences that are of high homology to the murine FR1. They are, namely, EIK, RF-SJ1, and WAS. The FR1 with the highest overall homology with the five residues closest to the CDR1 identical to the murine parent is EIK, however, there is a missing residue in position 12, which can create potential problems affecting the immunoreactivity of the resultant antibody. The preferred FR1 picked for the patching was therefore from WAS. First, except at position 28, the third closest residue to CDR1, a whole stretch of 11 amino acids next to the CDR1 is identical to the murine parent. In position 28, a serine residue is found instead of an alanine in the murine sequence. Since serine is considered as a hydroxylated version of alanine, the change is conservative. Moreover, residues that are different between the human and murine are relatively similar in characteristics. For example, valine and leucine in position 5, lysine and glutamine at position 13, lysine and arginine at position 19, and alanine and serine at position 28. Therefore, human sequence from WAS was chosen for patching the FR1 of the anti-CD22 antibody ( FIG. 2A ). b. FR2: by the same token and based on the degree of homology, the human WAS sequence is chosen for patching the FR2 of the anti-CD22 antibody ( FIG. 2A ). c. FR3: with the sequences closest to the CDR2, and CDR3 being identical, and the high degree of homology, the human GAL sequence was selected for patching the FR3 of the anti-CD22 antibody ( FIG. 2A ). d. FR4: there are many human FR4 with the sequence closest to the CDR3 being identical, and a high degree of homology to the murine parent. In this example, the human DOB sequence was selected for patching the FR4 of the anti-CD22 antibody ( FIG. 2A ). The final design of the FR-patched VH sequence ( FIG. 3A ) for the anti-CD22 antibody is composed of the human WAS FR1 and FR2, and the GAL FR3 and DOB FR4, replacing the original VH FR's of the anti-CD22 antibody. There is no single mutation or re-introduction of murine FR residues in the final design of the FR-patched sequence. Using a similar strategy, the sequence design for the FR-patched light chain (VL) was done as follows: a. FR1: human JOH was chosen for patching the FR1 of the murine VL. It has a high degree of sequence homology and the stretch of 8 amino acids adjacent to the CDR1 being identical to the parent sequence ( FIG. 2B ). b. FR2: human Vd'CL was chosen for patching the FR2 of the murine VL, for similar reasons. More than 4 identical sequences are adjacent to the CDR1, and CDR2 ( FIG. 2B ). c. FR3: human WES was chosen for patching the FR3 of the murine VL. FR3 has the longest sequence, and the sequence homology between WES and the murine FR3 is high, with the sequences flanking the CDR2 and CDR3 being identical ( FIG. 2B ). d. FR4: human RZ was chosen for patching the FR4 of the murine VL, for similar reasons ( FIG. 2B ). The final design of the FR-patched VL sequence ( FIG. 3B ) for the anti-CD22 antibody is composed of the human JOH FR1, Vd'CL FR2, WES FR3, and RZ FR4, replacing the original VL FR's of the anti-CD22 antibody. Once again, there is no single mutation or re-introduction of murine FR residues in the final design of the FR-patched sequence. Construction of the FR-Patched Heavy and Light Chain Genes The designed heavy and light chain variable region sequences of the FR-patched antibody are assembled by a combination of oligonucleotide synthesis and PCR using a variety of published methods (Leung et al., op. cit.; Daugherty et al., op. cit.; DeMartino et al., op. cit.; Jones et al., op. cit.). To construct the FR-patched heavy chain variable region sequence (SEQ ID no. 1), the full DNA sequence is divided into two halves: the N-terminal half and the C-terminal half. Both are constructed separately by PCR and the complete variable region sequence is formed by joining the N- and C-terminal halves at the KpnI site. The N-terminal half is constructed as follows: a N-template (SEQ ID no. 3) is a synthetic sense-strand oligonucleotide (111-mer) encoding amino acids 14-50 of the VH region (SEQ ID no. 2). The template is PCR-amplified by two primers: The 5′ Primer (SEQ ID no. 4) is a synthetic sense-strand oligonucleotide (57-mer) encoding amino acids 1-19 of the VH region. The 3′ end of the primer overlaps with the 5′ end of the template by 18 nucleotides. The 3′ Primer (SEQ ID no. 5) is a synthetic anti-sense-strand oligonucleotide (48-mer) encoding amino acids 43-59. The primer overlaps with the template by 21 nucleotides. The N-template (SEQ ID no. 3) is PCR-amplified using the 5′ and 3′ primer set (SEQ ID no. 4 & 5) using standard techniques and procedures. The C-terminal half is constructed as follows: a C-template (SEQ ID no. 6) is a synthetic sense-strand oligonucleotide (132-mer) encoding amino acids 68-111 of the VH region (SEQ ID no. 2). The template is PCR-amplified by two primers: The 5′ Primer (SEQ ID no. 7) is a synthetic sense-strand oligonucleotide (60-mer) encoding amino acids 55-74 of the VH region. The 3′ end of the primer overlaps with the 5′ end of the template by 21 nucleotides. The 3′ Primer (SEQ ID no. 8) is a synthetic anti-sense-strand oligonucleotide (58-mer) encoding amino acids 105-123 of the VH region. The primer and the template overlap by 21 nucleotides. The C-template (SEQ ID no. 6) is PCR-amplified using the 5′ and 3′ primer set (SEQ ID no. 7 & 8) using standard techniques and procedures. For the construction of the full-length FR-patched RFB4 VH domain, the N-template (SEQ ID no. 3, 111-mer), C-template (SEQ ID no. 6, 132-mer), and their respective 5′- and 3′ primers (SEQ ID no. 4 & 5 for N-template, and SEQ ID no. 7 & 8 for C-template), are synthesized on an automated Applied Biosystem 380B DNA synthesizer (Foster City, Calif.). The oligonucleotides are desalted by passing through a CHROMOSPIN-10™ column (Clonetech, Palo Alto, Calif.). The oligonucleotides are adjusted to a final concentration of 20 μM. One μl of template oligonucleotides at various dilutions (10×, 100×, 1000× and 10000×, etc.) are mixed with 5 μl of their corresponding flanking primers in the presence of 10 μl of 10×PCR Buffer (500 mM KCl, 100 mM Tris.HCl buffer, pH 8.3, 15 mM MgCl2) and 5 units of AMPLITAQ™ DNA polymerase (Perkin Elmer, Applied Biosystems Division, Foster City, Calif.). This reaction mixture is adjusted to a final volume of 100 μl and subjected to 30 cycles of PCR reaction consisting of denaturation at 94° C. for 1 minute, annealing at 50° C. for 1 minutes, and polymerization at 72° C. for 1 minute. The PCR reaction mixtures are analyzed under 2% agarose gel electrophoresis. The highest template dilution that gives rise to sufficiently abundant product of the right size will be chosen for further processing. Double-stranded PCR-amplified products for the N- and C-templates are gel-purified, restriction-digested with KpnI. The restricted N- and C-double stranded DNA are ligated at the KpnI site, and the ligated products are subjected to another round of PCR amplification using the 5′ primer for the N-template (SEQ ID no. 4) and the 3′ primer for the C-template (SEQ ID no. 8). The PCR product with a size of ˜350 is directly cloned into the TA cloning vector (Invitrogen, San Diego, Calif.). The sequence of the cloned fragment is confirmed by Sanger's method (Sanger et al., PNAS 74:5463-5467, 1977) to be identical to the designed VH sequence. The confirmed sequence is used to replace the VH sequence of a heavy chain expression vector containing an IgH promoter, an Ig enhancer, a human IgG1 constant region genomic sequence, and a selectable marker, gpt. The final heavy chain expression vector is designated as hpRFB4pSMh. To construct the FR-patched light chain variable region sequence (SEQ ID no. 9), the full length VL variable region sequence is divided into two halves. The N-terminal and C-terminal halves are assembled separately by PCR and joined together via the SpeI site. The N-terminal half is constructed as follows: a N-template (SEQ ID no. 11) is a synthetic sense-strand oligonucleotide (108-mer) encoding amino acids 11-46 of the VL region (SEQ ID no. 10). The template is PCR-amplified by two primers: The 5′ Primer (SEQ ID no. 12) is a synthetic sense-strand oligonucleotide (51-mer) encoding amino acids 1-17 of the VL region. The 3′ end of the primer overlaps with the 5′ end of the template by 21 nucleotides. The 3′ Primer (SEQ ID no. 13) is a synthetic anti-sense-strand oligonucleotide (40-mer) encoding amino acids 40-53. The primer overlaps with the template by 18 nucleotides. The N-template (SEQ ID no. 11) is PCR-amplified using the 5′ and 3′ primer set (SEQ ID no. 12 & 13) using standard techniques and procedures. The C-terminal half is constructed as follows: a C-template (SEQ ID no. 14) is a synthetic sense-strand oligonucleotide (120-mer) encoding amino acids 59-98 of the VL region (SEQ ID no. 10). The template is PCR-amplified by two primers: The 5′ Primer (SEQ ID no. 15) is a synthetic sense-strand oligonucleotide (49-mer) encoding amino acids 50-65 of the VL region. The 3′ end of the primer overlaps with the 5′ end of the template by 21 nucleotides. The 3′ Primer (SEQ ID no. 16) is a synthetic antisense-strand oligonucleotide (48-mer) encoding amino acids 92-107 of the VL region. The primer and the template overlap by 21 nucleotides. The C-template (SEQ ID no. 14) is PCR-amplified using the 5′ and 3′ primer set (SEQ ID no. 15 & 16) using standard techniques and procedures. For the construction of the FR-patched RFB4 VL domain, the N-template (SEQ ID no. 11, 108-mer), C-template (SEQ ID no. 14, 120-mer), and their respective 5′- and 3′ primers (SEQ ID no. 12 & 13 for N-template, and SEQ ID no. 15 & 16 for C-template), are synthesized on an automated Applied Biosystem 380B DNA synthesizer. The oligonucleotides are desalted by passing through a CHROMOSPIN-10™ column (Clonetech). The oligonucleotides are adjusted to a final concentration of 20 μM. One μl of template oligonucleotides at various dilutions (10×, 100×, 1000× and 10000×, etc.) are mixed with 5 μl of their corresponding flanking primers in the presence of 10 μl of 10×PCR Buffer (500 mM KCl, 100 mM Tris.HCl buffer, pH 8.3, 15 mM MgCl2) and 5 units of AMPLITAQ™ DNA polymerase (Perkin Elmer). This reaction mixture is adjusted to a final volume of 100 μl and subjected to 30 cycles of PCR reaction consisting of denaturation at 94° C. for 1 minute, annealing at 50° C. for 1 minutes, and polymerization at 72° C. for 1 minute. The PCR reaction mixtures are analyzed under 2% agarose gel electrophoresis. The highest template dilution that gives rise to sufficiently abundant product of the right size will be chosen for further processing. Double-stranded PCR-amplified products for the N- and C-templates are gel-purified, restriction-digested with SpeI. The restricted N- and C-double stranded DNA are ligated at the SpeI site, and the ligated products are subjected to another round of PCR-amplification using the 5′ primer for the N-template (SEQ ID no. 12) and the 3′ primer for the C-template (SEQ ID no. 16). The PCR product with a size of ˜320 is directly cloned into the TA cloning vector (Invitrogen). The sequence of the cloned fragment is confirmed by Sanger's method (Sanger op. cit.) to be identical to the designed VL sequence. The confirmed sequence is used to replace the VL sequence of a light chain expression vector containing an IgH promoter, an Ig enhancer, a human kappa constant region genomic sequence, and a selectable marker, hyg. The final light chain expression vector is designated as hpRFB4pSMk. Expression and Affinity of FR-Patched Antibody The expression plasmids hpRFB4pSMh and hpRFB4pSMk are linearized and co-transfected into mouse Sp2/0 cells. Cells transfected with the plasmids are selected in the presence of mycophenolic acid and/or hygromycin B conferred by the gpt and hyg genes on the plasmids by standard methods. Cells surviving selection are tested for human antibody secretion using ELISA methods. Clones that are identified to be secreting human antibody are expanded for production in 500 ml roller bottles. Antibodies are purified using standard protein A columns. The purified antibody is analyzed in a SDS-PAGE gel under both reducing and non-reducing conditions (Predicted results shown in FIG. 4 ). The affinity of the FR-patched antibody (hpRFB4) is first evaluated by flow cytometry. Raji cells (5×10 5 ) are incubated with 1 μg of either purified hpRFB4 or chimeric RFB4 (cRFB4) in a final volume of 100 μl of PBS supplemented with 1% FCS and 0.01% (w/v) sodium azide (PBS-FA). cRFB4 differs from hpRFB4 in the variable region sequences which are derived directly from the murine parent without modifications. The mixtures are incubated for 30 minutes at 4° C. and washed three times with PBS to remove unbound antibodies. The binding levels of the antibodies to Raji cells are assessed by the addition of a 20× diluted FITC-labeled, goat anti-human IgG1, Fc fragment-specific antibodies (Jackson ImmunoResearch, West Grove, Pa.) in a final volume of 100 μl in PBS-FA, and incubating for 30 minutes at 4° C. The mixture is washed three times with PBS and fluorescence intensities are measured by a FACSCAN fluorescence-activated cell sorter (Becton Dickinson, Bedford, Mass.) (Predicted results shown in FIG. 5 ) The predicted results indicate that both antibodies bind well to Raji cells with similar affinity. To compare the affinity of the antibody before and after re-engineering the VH and VL sequences of RFB4, a competitive binding assay is performed. Fixed amount (10× dilution from stock) of FITC-conjugated RFB4 (Ancell Corporation, Bayport, Minn.) is mixed with varying concentrations of either cRFB4 or hpRFB4. The mixtures are added to Raji cells in a final volume of 100 μl in PBS-FA, and incubated for 30 minutes at 4° C. After washing three times with PBS, the fluorescence intensities of Raji cells bound with the FITC-RFB4 are measured by FASCAN (Becton Dickinson, Bedford, Mass.). The predicted results indicate that FR-patching of the RFB4 sequence does not have significant effects on the affinity of the re-engineered antibody (Predicted results shown in FIG. 6 ). EXAMPLE 2 FR-Patched Anti-CD20 Antibody Design of Genes for FR-Patched Anti-CD20 Light and Heavy Chain. The heavy and light chain sequence of a murine anti-CD20 antibody, 1F5 (Shan et al. 1999. J Immunol. 162:6589-6595) is used as an example to illustrate the approach of using FR-patching to reduce or eliminate immunogenicity of the re-engineered antibody. The sequences of the heavy and light chain variable region for the murine antibody are shown in FIG. ( 7 ). In designing the amino acid sequence of the FR-patched immunoglobulin for 1F5, the same set of rules as described previously applies. However, there are always situations when no appropriate FR's fulfill all the above-mentioned requirements. The FR-patching approach offers a great degree of flexibility allowing the introduction of murine residues in the problematic FR's, or alternatively, inclusion of the original murine FR's without modifications. The resultant FR-patched antibody will presumably have significantly reduced immunogenicity compared to a murine or chimeric antibody. An anti-CD20 antibody, 1F5, is used as an example for FR-patching to illustrate these points. Patching of the individual FR's of the 1F5 VH sequence was done as follows: a. FR1: the FR1 sequence of the murine VH was compared with the FR1 sequences of human VH from the Kabat's database (Kabat et al., op. cit.). Human FR1 of the highest sequence homology is preferred, particularly at the sequences closest to the CDR1. The human FR1 sequence from LS2'′CL has close to 80% of sequence homology to that of the murine anti-CD20 antibody, and the 10 residues adjacent to the CDR1 are identical to the murine parent sequence. Therefore, the human FR1 sequence from LS2'CL was chosen for patching the FR1 of the anti-CD20 antibody ( FIG. 8A ) b. FR2: the FR2 sequence of the human NEWM was chosen for patching the FR2 sequence of the anti-CD20 antibody. It should be noted that although the third residue of the NEWM FR2 closest to the CDR1 is not identical to that of the murine parent sequence, it is a conserved K to R conversion ( FIG. 8A ). c. FR3: human heavy chain FR3 sequences with satisfactorily high sequence homology and identical sequences adjacent to the CDR2 and CDR3 could not be identified. Although the human FR3 from 783C'CL exhibited 78% of sequence homology, the residues flanking the CDR2 are drastically different, despite the differences being conserved. For example, the K, A, and L at positions 57, 58 and 60 (Kabat's numbering, Kabat et al., op. cit.) which are the 1 st , 2 nd , and 4 th residues closest to the CDR2 are replaced by the conserved human residues R, V and I, respectively. Nevertheless, the high number of changes in proximity to the CDR2, albeit conservative, could result in significant conformational changes at the antigen binding site. Without risking the loss of affinity, and as an illustration on the flexibility of the FR-patching approach, the FR3 would not be patched with any of the human FR's. Instead, the murine FR3 sequence was retained in this particular antibody ( FIG. 8A ). d. FR4: there are many human FR4 with the sequence closest to the CDR3 being identical, and a high degree of homology to the murine parent. In this example, the human 4G12'CL sequence was selected for patching the FR4 of the anti-CD20 antibody ( FIG. 8A ). The final design of the FR-patched VH sequence ( FIG. 9A ) for the anti-CD20 antibody is composed of the human LS2'CL FR1, NEWM FR2, murine 1F5 FR3 and 4G12'CL FR4, replacing the original VH FR's of the murine anti-CD20 antibody. An alternative design will be a patched VH containing the murine CDRs embedded in human LS2'CL FR1, NEWM FR2, 783C'CL FR3, and 4G12'CL FR4 ( FIG. 10A ). For the purpose of illustration, the construction of the former version will be described below. Using a similar strategy, the sequence design for the FR-patched light chain was constructed as follows: a. FR1: human BJ19 was chosen for patching the FR1 of the murine VL. This is the human FR1 sequence with the highest homology to the murine parent (61%). Moreover, some of the human residues that are different from that of the murine are conserved. For example, the E to D, and K to R conversions at positions 18 and 19, respectively, are conserved changes ( FIG. 8B ). b. FR2: although there is a human FR2, MOT, that was found to be of high sequence homology (73%) to the murine FR2, the Tryptophan at position 32 (Kabat's numbering, Kabat et al., op. cit.), the 3 rd residues closest to the CDR2, was replaced by a non-conservative Valine in the MOT FR2 sequence. This replacement potentially might have a significant effect on the final conformation of the antigen binding site. It was therefore determined that the murine FR2 of the VL domain would remain in the design of the FR-patched antibody ( FIG. 8B ). c. FR3: human WES was chosen for patching the FR3 of the murine VL. FR3 has the longest sequence, and the sequence homology between WES and the murine FR3 is 71%, with the three human residues flanking the CDR2 and CDR3 being identical to that of the murine ( FIG. 8B ). d. FR4: human λ FR4 sequence from NIG-58 was chosen for patching the FR4 of the murine VL, for similar reasons. The sequences are 72% homologous to the stretch of 7 residues adjacent to the CDR3 being identical between the human and murine ( FIG. 8B ). The final design of the FR-patched VL sequence ( FIG. 9B ) for the anti-CD20 antibody is composed of the human BJ19 FR1, murine 1F5 FR2, WES FR3, and NIG-58 FR4, replacing the original VL FR's of the anti-CD20 antibody. An alternative design of FR-patched VL will be composed of the human BJ19 FR1, MOT FR2, WES FR3, and NIG-58 FR4, forming the scaffold supporting the CDR loops ( FIG. 10B ). For the purpose of illustration in this application, only the construction of the former FR-patched VL will be described below. Construction of the FR-Patched Heavy and Light Chain Genes The designed heavy and light chain variable region sequences of the FR-patched antibody are assembled by a combination of oligonucleotide synthesis and PCR using a variety of published methods. To construct the FR-patched heavy chain variable region sequence (SEQ ID no. 17), the full DNA sequence is divided into two halves. The N-terminal half and the C-terminal half are constructed separately by PCR and the complete variable region sequence is formed by joining the N- and C-terminal halves at the SpeI site. The N-terminal half is constructed as follows: a N-template (SEQ ID no. 19) is a synthetic sense-strand oligonucleotide (1 14-mer) encoding amino acids 12-49 of the VH region (SEQ ID no. 18). The template is PCR-amplified by two primers: The 5′ Primer (SEQ ID no. 20) is a synthetic sense-strand oligonucleotide (57-mer) encoding amino acids 1-19 of the VH region. The 3′ end of the primer overlaps with the 5′ end of the template by 24 nucleotides. The 3′ Primer (SEQ ID no. 21) is a synthetic anti-sense-strand oligonucleotide (55-mer) encoding amino acids 43-60. The primer overlaps with the template by 21 nucleotides. The N-template (SEQ ID no. 19) is PCR-amplified using the 5′ and 3′ primer set (SEQ ID no. 20 & 21) using standard techniques and procedures. The C-terminal half is constructed as follows: a C-template (SEQ ID no. 22) is a synthetic sense-strand oligonucleotide (126-mer) encoding amino acids 70-111 of the VH region (SEQ ID no. 18). The template is PCR-amplified by two primers: The 5′ Primer (SEQ ID no. 23) is a synthetic sense-strand oligonucleotide (61-mer) encoding amino acids 57-76 of the VH region. The 3′ end of the primer overlaps with the 5′ end of the template by 21 nucleotides. The 3′ Primer (SEQ ID no. 24) is a synthetic antisense-strand oligonucleotide (59-mer) encoding amino acids 105-123 of the VH region. The primer and the template overlap by 21 nucleotides. The C-template (SEQ ID no. 22) is PCR-amplified using the 5′ and 3′ primer set (SEQ ID no. 23 & 24) using standard techniques and procedures. For the construction of the FR-patched 1F5 VH domain, the N-template (SEQ ID no. 19, 114-mer), C-template (SEQ ID no. 22, 126-mer), and their respective 5′- and 3′ primers (SEQ ID no. 20 & 21 for N-template, and SEQ ID no. 23 & 24 for C-template), are synthesized on an automated Applied Biosystem 380B DNA synthesizer. The oligonucleotides are desalted by passing through a CHROMOSPIN-10™ column (Clonetech). The oligonucleotides are adjusted to a final concentration of 20 μM. One μl of template oligonucleotides at various dilutions (10×, 100×, 1000× and 10000×, etc.) are mixed with 5 μl of their corresponding flanking primers in the presence of 10 μl of 10×PCR Buffer (500 mM KCl, 100 mM Tris.HCl buffer, pH 8.3, 15 mM MgCl 2 ) and 5 units of AMPLITAQ™ DNA polymerase (Perkin Elmer). This reaction mixture is adjusted to a final volume of 100 μl and subjected to 30 cycles of PCR reaction consisting of denaturation at 94° C. for 1 minute, annealing at 50° C. for 1.5 minutes, and polymerization at 72° C. for 1 minute. The PCR reaction mixtures are analyzed under 2% agarose gel electrophoresis. The highest template dilution that gives rise to sufficiently abundant product of the right size will be chosen for further processing. Double-stranded PCR-amplified products for the N- and C-templates are gel-purified, restriction-digested with KpnI site. The N- and C-double stranded DNA are ligated at the SpeI site, and the ligated products are subjected to another round of PCR amplification using the 5′ primer for the N-template (SEQ ID no. 19) and the 3′ primer for the C-template (SEQ ID no. 22). The PCR product with a size of ˜350 is directly cloned into the TA cloning vector (Invitrogen). The sequence of the cloned fragment is confirmed by Sanger's method (Sanger et al. op. cit.) to be identical to the designed VH sequence. The confirmed sequence is used to replace the VH sequence of a heavy chain expression vector containing an IgH promoter, an Ig enhancer, a human IgG1 constant region genomic sequence, and a selectable marker, gpt. The final heavy chain expression vector is designated as hp1F5pSMh. To construct the FR-patched light chain variable region sequence (SEQ ID no. 25), the full length VL variable region sequence is divided into two halves. The N-terminal and C-terminal halves are assembled separately by PCR and joined together via the BspEI site. The N-terminal half is constructed as follows: a N-template (SEQ ID no. 27) is a synthetic sense-strand oligonucleotide (129-mer) encoding amino acids 9-51 of the VL region (SEQ ID no. 26). The template is PCR-amplified by two primers: The 5′ Primer (SEQ ID no. 28) is a synthetic sense-strand oligonucleotide (45-mer) encoding amino acids 1-15 of the VH region. The 3′ end of the primer overlaps with the 5′ end of the template by 21 nucleotides. The 3′ Primer (SEQ ID no. 29) is a synthetic anti-sense-strand oligonucleotide (40-mer) encoding amino acids 45-57. The primer overlaps with the template by 21 nucleotides. The N-template (SEQ ID no. 27) is PCR-amplified using the 5′ and 3′ primer set (SEQ ID no. 28 & 29) using standard techniques and procedures. The C-terminal half is constructed as follows: a C-template (SEQ ID no. 30) is a synthetic sense-strand oligonucleotide (120-mer) encoding amino acids 61-100 of the VH region (SEQ ID no. 26). The template is PCR-amplified by two primers: The 5′ Primer (SEQ ID no. 31) is a synthetic sense-strand oligonucleotide (43-mer) encoding amino acids 54-67 of the VH region. The 3′ end of the primer overlaps with the 5′ end of the template by 21 nucleotides. The 3′ Primer (SEQ ID no. 32) is a synthetic antisense-strand oligonucleotide (42-mer) encoding amino acids 94-107 of the VH region. The primer and the template overlap by 21 nucleotides. The C-template (SEQ ID no. 30) is PCR-amplified using the 5′ and 3′ primer set (SEQ ID no. 31 & 32) using standard techniques and procedures. For the construction of the FR-patched 1F5 VL domain, the N-template (SEQ ID no. 27, 129-mer), C-template (SEQ ID no. 30, 120-mer), and their respective 5′- and 3′ primers (SEQ ID no. 28 & 29 for N-template, and SEQ ID no. 31 & 32 for C-template), are synthesized on an automated Applied Biosystem 380B DNA synthesizer. The oligonucleotides are desalted by passing through a CHROMOSPIN-10™ column (Clonetech). The oligonucleotides are adjusted to a final concentration of 20 μM. One μl of template oligonucleotides at various dilutions (10×, 100×, 1000× and 10000×, etc.) are mixed with 5 μl of their corresponding flanking primers in the presence of 10 μl of 10×PCR Buffer (500 mM KCl, 100 mM Tris.HCl buffer, pH 8.3, 15 mM MgCl 2 ) and 5 units of AMPLITAQ™ DNA polymerase (Perkin Elmer). This reaction mixture is adjusted to a final volume of 100 μl and subjected to 30 cycles of PCR reaction consisting of denaturation at 94° C. for 1 minute, annealing at 50° C. for 1.5 minutes, and polymerization at 72° C. for 1 minute. The PCR reaction mixtures are analyzed under 2% agarose gel electrophoresis. The highest template dilution that gives rise to sufficiently abundant product of the right size will be chosen for further processing. Double-stranded PCR-amplified products for the N- and C-templates are gel-purified, restriction-digested with SpeI site. The N- and C-double stranded DNA are ligated at the BspEI site, and amplified using the 5′ primer for the N-template (SEQ ID no. 12) and the 3′ primer for the C-template (SEQ ID no. 16). The PCR product with a size of ˜320 is directly cloned into the TA cloning vector (Invitrogen). The sequence of the cloned fragment is confirmed by Sanger's method (Sanger et al., op. cit.) to be identical to the designed VL sequence. The confirmed sequence is used to replace the VL sequence of a light chain expression vector containing an IgH promoter, an Ig enhancer, a human kappa constant region genomic sequence, and a selectable marker, hyg. The final light chain expression vector is designated as hp1F5pSMk.

Framework (FR)-patching is a novel approach to modify immunoglobulin for reducing potential immunogenicity without significant alterations in specificity and affinity. Unlike previous described methods of humanization, which graft CDRs from a donor onto the frameworks of a single acceptor immunoglobulin, we patch segments of framework (FR 1 , FR 2 , FR 3 , and FR 4 ), or FRs, to replace the corresponding FRs of the parent immunoglobulin. Free assortment of these FRs from different immunoglobulins and from different species can be mixed and matched into forming the final immunoglobulin chain. A set of criteria in the choice of these FRs to minimize or eliminate the need to reintroduce framework amino acids from the parent immunoglobulin for patching is described. The approach gives greater flexibility in the choice of framework sequences, minimizes the need to include parent framework amino acids, and, most importantly, reduces the chances of creating new T- and B-cell epitopes in the resultant immunoglobulin.

CROSS REFERENCE TO RELATED-APPLICATION This application claims priority to prior U.S. provisional application No. 60/263,327 (filed Jan. 22, 2001) and U.S. provisional application No. 60/278,634 (filed Mar. 26, 2001). BACKGROUND OF THE INVENTION Field of the Invention The present invention generally relates to the field of MEMS (micro-electromechanical systems) sensors and more specifically to a wireless MEMS capacitive sensor for implantation into the body of a patient to measure one or more physiologic parameters. A number of different biologic parameters are strong candidates for continuous monitoring. These parameters include, but are not limited to blood pressure, blood flow, intracranial pressure, intraocular pressure, glucose levels, etc. Wired sensors, if used have certain inherent limitations because of the passage of wires (or other communication “tethers”) through the cutaneous layer. Some limitations include the risks of physical injury and infection to the patient. Another risk is damage to the device if the wires (the communication link) experience excessive pulling forces and separate from the device itself. Wireless sensors are therefore highly desirable for biologic applications. A number of proposed schemes for wireless communication rely on magnetic coupling between an inductor coil associated with the implanted device and a separate, external “readout” coil. For example, one method of wireless communication (well-known to those knowledgeable in the art) is that of the LC (inductor-capacitor) tank resonator. In such a device, a series-parallel connection of a capacitor and inductor has a specific resonant frequency, expressed as 1/√{square root over (LC)}, which can be detected from the impedance of the circuit. If one element of the inductor-capacitor pair varies with some physical parameter (e.g. pressure), while the other element remains at a known value, the physical parameter may be determined from the resonant frequency. For example, if the capacitance corresponds to a capacitive pressure sensor, the capacitance may be back-calculated from the resonant frequency and the sensed pressure may then be deduced from the capacitance by means of a calibrated pressure-capacitance transfer function. The impedance of an LC tank resonator may be measured directly or it may also be determined indirectly from the impedance of a separate readout coil that is magnetically coupled to the internal coil. The latter case is most useful for biologic applications since the sensing device may be subcutaneously implanted, while the readout coil may be located external to the patient, but in a location that allows magnetic coupling between the implanted sensing device and readout coil. It is possible for the readout coil (or coils) to simultaneously excite the resonator of the implanted device and sense the reflected back impedance. Consequently, this architecture has the substantial advantage of requiring no internal power source, which greatly improves its prospects for long-term implantation (e.g. decades to a human lifetime). Such devices have been proposed in various forms for many applications. Chubbuck (U.S. Pat. No. 4,026,276), Bullara (U.S. Pat. No. 4,127,110), and Dunphy (U.S. Pat. No. 3,958,558) disclose various devices initially intended for hydrocephalus applications (but also amenable to others) that use LC resonant circuits. The '276, '110, and '558 patents, although feasible, do not take advantage of recent advances in silicon (or similar) microfabrication technologies. Kensey (U.S. Pat. No. 6,015,386) discloses an implantable device for measuring blood pressure in a vessel of the wrist. This device must be “assembled” around the vessel being monitored such that it fully encompasses the vessel, which may not be feasible in many cases. In another application, Frenkel (U.S. Pat. No. 5,005,577) describes an implantable lens for monitoring intraocular pressure. Such a device would be advantageous for monitoring elevated eye pressures (as is usually the case for glaucoma patients); however, the requirement that the eye's crystalline lens be replaced will likely limit the general acceptance of this device. In addition to the aforementioned applications that specify LC resonant circuits, other applications would also benefit greatly from such wireless sensing. Han, et al. (U.S. Pat. No. 6,268,161) describe a wireless implantable glucose (or other chemical) sensor that employs a pressure sensor as an intermediate transducer (in conjunction with a hydrogel) from the chemical into the electrical domain. The treatment of cardiovascular diseases such as Chronic Heart Failure (CHF) can be greatly improved through continuous and/or intermittent monitoring of various pressures and/or flows in the heart and associated vasculature. Porat (U.S. Pat. No. 6,277,078), Eigler (U.S. Pat. No. 6,328,699), and Carney (U.S. Pat. No. 5,368,040) each teach different modes of monitoring heart performance using wireless implantable sensors. In every case, however, what is described is a general scheme of monitoring the heart. The existence of a method to construct a sensor with sufficient size, long-term fidelity, stability, telemetry range, and biocompatibility is noticeably absent in each case, being instead simply assumed. Eigler, et al., come closest to describing a specific device structure although they disregard the baseline and sensitivity drift issues that must be addressed in a long-term implant. Applications for wireless sensors located in a stent (e.g., U.S. Pat. No. 6,053,873 by Govari) have also been taught, although little acknowledgement is made of the difficulty in fabricating a pressure sensor with telemetry means sufficiently small to incorporate into a stent. Closed-loop drug delivery systems, such as that of Feingold (U.S. Pat. No. 4,871,351) have likewise been taught. As with others, Feingold overlooks the difficulty in fabricating sensors that meet the performance requirements needed for long-term implantation. In nearly all of the aforementioned cases, the disclosed devices require a complex electromechanical assembly with many dissimilar materials, which will result in significant temperature- and aging-induced drift over time. Such assemblies may also be too large for many desirable applications, including intraocular pressure monitoring and/or pediatric applications. Finally, complex assembly processes will make such devices prohibitively expensive to manufacture for widespread use. As an alternative to conventionally fabricated devices, microfabricated sensors have also been proposed. One such device is taught by Darrow (U.S. Pat. No. 6,201,980). Others are reported in the literature (see, e.g. Park, et al., Jpn. J. Appl. Phys., 37 (1998), pp. 7124-7128; Puers, et al., J. Micromech. Microeng. 10 (2000), pp. 124-129; Harpster et al., Proc. 14 th IEEE Int'l. Conf. Microelectromech. Sys. (2001), pp. 553-557). Past efforts to develop wireless sensors have separately located the sensor and inductor and have been limited to implant-readout separation distances of 1-2 cm at most, rendering them impractical for implantation much deeper than immediately below the cutaneous layer. This eliminates from consideration wireless sensing applications, such as heart ventricle pressure monitoring or intracranial pressure monitoring, that inherently require separation distances in the range of 5-10 cm. In the present state-of-the-art, several factors have contributed to this limitation on the separation distance including 1) signal attenuation due to intervening tissue, 2) suboptimal design for magnetic coupling efficiency; and 3) high internal energy losses in the implanted device. In view of the above and other limitations on the prior art, it is apparent that there exists a need for an improved wireless MEMS sensor system capable of overcoming the limitations of the prior art and optimized for signal fidelity, transmission distance and manufacturability. It is therefore an object of the present invention is to provide a wireless MEMS sensor system in which the sensing device is adapted for implantation within the body of patient. A further object of this invention is to provide a wireless MEMS sensor system in which the separation distance between the sensing device and the readout device is greater than 2 cm, thereby allowing for deeper implantation of the sensing device within the body of a patient. Still another object of the present invention is to provide a wireless MEMS sensor system in which the sensing device utilizes an integrated inductor, an inductor microfabricated with the sensor itself. It is also an object of this invention to provide a wireless MEMS sensor system in which the sensing device is batteryless. A further object of the present invention is to provide a wireless MEMS sensor system. BRIEF SUMMARY OF THE INVENTION In overcoming the limitations of the prior art and achieving the above objects, the present invention provides for a wireless MEMS sensor for implantation into the body of a patient and which permits implantation at depths greater than 2 cm while still readily allowing for reading of the signals from the implanted portion by an external readout device. In achieving the above, the present invention provides a MEMS sensor system having an implantable unit and a non-implantable unit. The implantable unit is microfabricated utilizing common microfabricating techniques to provide a monolithic device, a device where all components are located on the same chip. The implanted device includes a substrate on which is formed a capacitive sensor. The fixed electrode of the capacitive sensor may formed on the substrate itself, while the moveable electrode of the capacitive sensor is formed as part of a highly doped silicon layer on top of the substrate. Being highly doped, the silicon layer itself operates as the conductive path for the moveable electrode. A separate conductive path is provided on the substrate for the fixed electrode. In addition to the capacitive sensor, the implanted sensing device includes an integrally formed inductor. The integral inductor includes a magnetic core having at least one plate and a coil defining a plurality of turns about the core. One end of the coil is coupled to the conductive lead connected with the fixed electrode while the other end of the coil is electrically coupled to the highly doped silicon layer, thereby utilizing the silicon layer as the conductive path to the moveable electrode. In order to optimize the operation of the inductor and to permit greater implantation depths, a novel construction is additionally provided for the magnetic core. In general, the optimized magnetic core utilizes a pair of plates formed on opposing sides of the substrate and interconnected by a post extending through the substrate. The windings of the coil, in this instance, are provided about the post. The external readout device of the present system also includes a coil and various suitable associated components, as well known in the field, to enable a determination of the pressure or other physiologic parameter being sensed by the implanted sensing device. The external readout device may similarly be utilized to power the implanted sensing device and as such the implanted sensing device is wireless. Integrally formed on the implanted device and microfabricated therewith, may be additionally be active circuitry for use in conjunction with capacitive sensor. Locating this circuitry as near as possible to the capacitive sensor minimizes noise and other factors which could lead to a degradation in the received signal and the sensed measured physiologic parameter. As such, the active circuitry may be integrally microfabricated in the highly doped silicon layer mentioned above. Further object and advantages of the present invention will become apparent to those skilled in the art from a review of the drawings in connection with the following description and dependent claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic illustration of a wireless MEMS sensor system according the principles of the present invention; FIG. 2 is a graphical illustration of impedance magnitude and phase angle near resonance, as sensed through a readout coil; FIG. 3 is a cross-sectional representation of a sensing device embodying the principles of the present invention. FIGS. 4A and 4B are schematic illustrations of the magnetic field distribution with FIG. 4A illustrating the magnetic field distribution of prior art devices and with FIG. 4B illustrating the magnetic field distribution for a sensing device having a magnetic core embodying the principles of the present invention; FIG. 5 is an enlarged cross-sectional view of the diaphragm portion of FIG. 3 operating in what is herein referred to as a “proximity” mode; FIG. 6 is a cross-sectional view similar to that seen in FIG. 5 illustrating, however, the diaphragm operating in what is herein referred to as a “touch” mode; FIG. 7 is a capacitance versus pressure curve in the proximity and touch modes of operation; FIG. 8 is a top plane view of a second embodiment of the main electrode in the capacitive sensor portion of the implanted sensing device according to the principles of the present invention; FIG. 9 is a diagrammatic illustration of one scheme for providing electrically isolated paths for the connections and electrodes of the capacitive sensor portion; FIG. 10 is a diagrammatic illustration of another scheme for electrically isolating the conductive paths for the connections and contacts of the capacitive sensor portion; FIG. 11 is a cross-sectional view, generally similar to that seen in FIG. 3 , further incorporating active circuitry into the sensing device; FIG. 12 is a block diagram illustrating one possible circuit implementation of the active circuitry when incorporated into the sensing device of the present wireless MEMS sensing system; FIG. 13 illustrates one method of mounting, within the body of a patient, a sensing device embodying the principles of the presents invention; FIG. 14 illustrates a second embodiment by which a sensing device embodying the principles of the present invention may be secured to tissues within the body of a patient FIGS. 15 and 16 are diagrammatic illustrations of different embodiments for locating a sensing device according to the principles of the present invention, within a vessel in the body of a patient; FIG. 17 illustrates a sensing device, according to the principles of the present invention, encapsulated in a material yielding a pellet-like profile for implantation into the tissues in the body of a patient; FIG. 18 illustrates a sensing device according to the principles of the present invention being located within the electrode tip of an implantable stimulation lead, such as that used for cardiac pacing; FIG. 19 illustrates a plurality of sensing devices according to the present invention located within a catheter and utilized to calculate various physiologic parameters within a vessel within the body of a patient; FIG. 20 is a schematic illustration of multiple sensors being used to measure performance of a component in the body or a device mounted within the body of a patient; FIG. 21 illustrates a sensing device according to the principles of the present invention being utilized to measure pressure externally through a vessel wall; FIG. 22 illustrates a portion of a further embodiment of the present invention in which the pressure sensing features of the sensing device have been augmented over or replaced with a structure allowing a parameter other than pressure to be sensed; FIG. 23 is schematic perspective view, with portions enlarged, illustrating an alternative embodiment for sensing according to the principles of the present invention; and FIG. 24 is an embodiment generally similar to that seen in FIG. 23 for sensing according to the principles of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In order to provide for battery-less, wireless physiologic parameter sensing over significant distances greater than 2 cm (e.g. 10 cm), the present invention provides a wireless MEMS sensing system, generally designated at 10 and seen schematically in FIG. 1 . The system 10 includes a microfabricated implantable sensing device 12 , optimized for coupling with an external readout device 14 . The sensing device 12 is provided with an integrated inductor 16 that is conductive to the integration of transducers and/or other components necessary to construct the wireless sensing system 10 . As an example, the preferred embodiment integrates a capacitive pressure sensor 18 into a common substrate 20 with the integrated inductor 16 . A second inductor 24 , in the readout device 14 , couples magnetically 26 with the integrated inductor 16 of the sensing device 12 . The readout device 14 is constructed according to techniques well known in the industry and in the sensing field in general. As such, the readout device 14 is not illustrated or described in great detail. It is noted, however, that the readout device 14 may be included, in addition to its inductor 24 , signal conditioning, control and analysis circuitry and software, display and other hardware and may be a stand alone unit or may be connected to a personal computer (PC) or other computer controlled device. The magnetic coupling 26 seen in FIG. 1 allows the impedance of the LC tank circuit 22 to be sensed by the readout device 14 . The typical impedance magnitude 28 and phase angle 30 near resonance 32 , as sensed through the readout coil 14 , is seen in FIG. 2 . Real-time measurement and analysis of this impedance and changes therein allows the sensed pressure to be determined as previously mentioned. Referring now to FIG. 3 , a cross section of a preferred embodiment of the sensing device 12 is illustrated therein. The sensing device 12 includes a main substrate 34 (preferably 7740 Pyrex glass) formed and located within recessed regions of the substrate 34 are those structures forming the integrated inductor 16 . The integrated inductor 16 is seen to include a magnetic core 33 defined by a top plate 36 , a bottom plate 38 and a post 40 connecting the top plate 36 to the bottom plate 38 and being continuous through the substrate 34 . The plates 36 and 38 and the post 40 are preferably constructed of the same material, a ferromagnetic material and are monolithic. The integrated conductor 16 additionally includes a coil 42 , preferably composed of copper or other high-conductivity material, successive turns of which surround the post 40 of the magnetic core 33 . In FIG. 3 , the coil 42 is seen as being recessed into the top plate 36 . The coil 42 may additionally be planar or layered and preferably wraps as tightly as possible about the post 40 . If the material of the coil 42 has a high electrical resistance relative to the material of the core 33 , (as in a copper coil and NiZn ferrite core system) the core 33 , and specifically the top plate 36 may be directly deposited on top of the coil 42 without need for a intermediate insulating layer. If the electrical resistance of the coil material relative to the coil material is not high, an intermediate insulating layer must be included between the successive turns of the coil 42 and the core 33 . Top and bottom cap layers 44 and 46 respectively, are provided over upper and lower faces 48 and 50 of the substrate 20 and over the top and bottom plates 36 and 38 of the magnetic core 33 . To accommodate any portions of the magnetic core 33 that extend significantly above or below the upper and lower faces 48 and 50 of the substrate 20 , the cap layers 44 and 46 may be provided with recesses 52 and 54 , respectively. Preferably, the cap layers 44 and 46 are of monocrystalline silicon. Other preferred materials include polycrystalline silicon, epitaxially deposited silicon, ceramics, glass, plastics, or other materials that can be bonded to lower substrate and/or are suitable for fabrication of the sensor diaphragm. In lieu of a monolithic cap layer, several sub-pieces may be fabricated at separate process steps, together forming a complete cap layer after processing is finished. The coupling effectiveness of the integrated inductor 16 is a function of the magnetic flux enclosed by the windings of the coil 42 ; therefore the coupling is greatest if the structure of the integrated inductor 16 maximizes the flux encompassed by all of the winding loops. FIG. 4A shows schematically the magnetic field distribution 56 in a known inductor structure having a single core layer 58 and associated windings 60 . Schematically shown in FIG. 4 b is the magnetic field distribution 62 for an inductor structure 16 ′ having upper and lower plates 36 ′ and 38 ′, connected by a post 40 ′ about which windings of a coil 42 ′ are located, as generally seen in the present invention. The design of the present invention optimizes the inductor geometry for maximum field coupling. Placing the plates 36 and 38 on opposite sides of the substrate 20 , as in FIG. 3 , increases the plate-to-plate spacing. The increased plate spacing creates a localized path of least resistance for the free-space magnetic field of an external readout coil, causing the magnetic field to preferentially pass through the post 40 of the integrated inductor's magnetic core 33 . This increases device effectiveness since the coupling efficiency between the sensor and a readout unit increases with the total magnetic flux encompassed by the windings of the inductor. A greater coupling efficiency increases the maximum separation distance between the sensor and a readout unit. The materials used to form the integrated inductor 16 should be chosen and/or processed to maximize the above mentioned effect and to minimize drift in the inductance value across time, temperature, package stress, and other potentially uncontrolled parameters. A high-permeability material such as NiZn ferrite is used to maximize this effect on the magnetic field and to minimize drift. Other preferred materials include nickel, ferrite, permalloy, or similar ferrite composites. To the right of the integrated inductor 16 seen in FIG. 3 is the capacitive pressure sensor 18 . The capacitive pressure sensor 18 may be constructed in many forms commonly know to those familiar with the art. In the illustrated embodiment, the upper cap layer 44 is formed to define a diaphragm 64 . The diaphragm 64 constitutes and may also be referred to as the moveable electrode of the pressure sensor 18 . The fixed electrode 66 of the pressure sensor 18 is defined by a conductive layer formed on the upper face 48 of the substrate 20 , in a position immediately below the moveable electrode or diaphragm 64 . If desired, a conductive layer may additionally be located on the underside of the moveable electrode 64 . To prevent shorting between the upper electrode 64 (as defined by either the diaphragm itself or the diaphragm and the conductive layer 68 ) and the lower electrode 66 , one or both of the electrodes 64 and 66 may be provided with a thin dielectric layer (preferably less than 1000 Å) deposited thereon. To improve performance of the capacitive pressure sensor 18 , as seen in FIG. 8 , one or more secondary electrodes designated at 70 may be located about the fixed electrode 66 near the projected edge of the diaphragm 64 where pressure induced deflection of the diaphragm 64 is minimal. The secondary electrodes 70 experience all of the capacitance-effecting phenomena seen by the main electrode 66 , with the exception of any pressure-induced phenomena. The secondary electrodes 70 , as such, operate as reference electrodes and by subtracting the secondary electrodes' capacitive measurement from the capacitive measurement of the main electrode 66 , most or all non-pressure-induced capacitance changes (signal drift) may be filtered out. Examples as sources of signal drift, that may be filtered out by this method, include thermally induced physical changes and parasitics resulting from an environment with changing dielectric constant, such as insertion of the sensor into tissue. In a preferred embodiment, the secondary (or reference) electrodes 70 would require an additional coil, similar to construction of the previously mentioned coil 42 to form a separate LC tank circuit. It is noted, that both coils may, however, share the same core post 40 . Under normal operation, pressure applied to the exterior or top surface of the capacitive pressure sensor 18 causes the diaphragm 64 (or at least the center portions thereof) to deflect downward toward the fixed electrode 66 . Because of the change in distance between the fixed electrode 66 and the moveable electrode 64 , a corresponding change will occur in the capacitance between the two electrodes. The applied pressure is therefore translated into a capacitance. With this in mind, it is seen that the capacitance pressure sensor 18 may be operated in either of two modes. A first mode, hereinafter referred to as the “proximity” mode, is generally seen in FIG. 5 . In this mode of operation, the starting gap between the fixed electrode 66 and the moveable electrode 64 , as well as the material and physical parameters for the diaphragm 64 itself, are chosen such that the fixed electrode 66 and the moveable electrode 64 will be spaced apart from one another over the entire operating pressure range of the sensor 18 . For the standard equation of parallel plate capacitance, C=∈A/d, the plate separation d will vary with the applied pressure, while the plate area A and the permittivity ∈ remain constant. In the touch mode of operation, generally seen in FIG. 6 , the geometry (e.g., initial gap spacing between the fixed electrode 66 and the moveable electrode 64 ) as well as the material and physical parameters of the diaphragm 64 itself, are chosen such that the fixed electrode 66 and the moveable electrode 64 will progressively touch each other over the operating pressure range of the sensor 18 . Accordingly, the area 72 of the fixed electrode 66 and the moveable electrode 64 in contact with each other will vary with the applied pressure. In the touch mode of operation, the dominant capacitance is the capacitance of the regions of the fixed electrode 66 and the moveable electrode 64 in contact with one another (if the dielectric coating 74 is thin compared to the total gap thickness, thereby yielding a relatively small effective plate separation distance d). In the capacitance equation mentioned above, plate separation d and permittivity ∈ will remain constant (at approximately that of the dielectric thickness) while the plate contact area A varies with the applied pressure. In the graph of FIG. 7 , capacitance-pressure relationship in the proximity and touch modes, respectively designated at 76 and 78 , are seen. From a practical standpoint, the operational mode may be chosen based upon sensitivity, linearity, and dynamic range requirements. The touch mode typically yields higher sensitivity with a more linear output, but involves mechanical contact between surfaces and therefore requires a careful choice of the materials to avoid wear induced changes in performance of the pressure sensor 18 . To permit the innermost turn of the coil 42 to be electrically connected to the moveable electrode 66 , a post 80 (formed integral with the substrate 20 ) extends upward through the top plate 36 and a conductive trace 82 runs up the side of the post 80 . The trace 82 begins at the innermost turn of the coil 42 and proceeds to a point where the trace 82 makes electrical contact with the upper cap layer 44 . Preferably of monocrystalline silicon and highly doped to be conductive, the upper cap layer 44 serves as the electrical connection between the trace 82 and moveable electrode 64 . If the upper cap layer 44 is not conductive, an additional conductive trace along the upper cap layer 44 to the moveable electrode 64 will be utilized. The outermost turn of the coil 42 is connected by an electrical trace 84 . Where the upper cap layer 44 is conductive, a dielectric layer 86 insulates the trace 84 from the upper cap layer 44 . Alternatively, a p-n junction structure (as further described below) could be used. It is noted that the inner and outer turns of the coil 42 may be alternatively connected respectively to the fixed electrode 66 and the moveable electrode 64 , thereby reversing the polarity of the LC tank circuit 22 if desired. Additionally, the particular paths between the coil 42 and the electrodes 66 and 64 may also be varied (e.g., such that both are included on the substrate 20 ) as best suited by the fabrication process. In all cases, the resistance of the electrical path through the traces 82 , 84 and the upper cap layer 44 (if used) should be minimized. The upper and lower cap layers 44 and 46 are bonded to the substrate 20 preferably via a hermetic sealing process. Alternatively, a post-bond coating of the entire sensing device 12 may be used to establish hermeticity. In either situation, steps are taken to minimize the residual gas pressure within the sensing device 12 after a hermetic seal is established. Once the initial hermetic seal is achieved, gas may be trapped in the interior of the sensing device 12 due to continued outgassing of the interior surfaces and/or the bonded regions. Gas pressure of the residual gas will increase within the interior chamber 90 of the pressure sensor 18 as the diaphragm 64 deflects during normal operation. This residual gas may effect the overall sensitivity of the pressure sensor 18 by effectively increasing the spring constant of the diaphragm 64 . Additionally, the residual gas will expand and/or contract with changes in the temperature of the sensing device 12 itself, causing signal drift. To compensate for the various negative effects of any residual gas, the pressure sensor 18 is provided with a displacement cavity 88 . This displacement cavity 88 is generally seen in FIG. 3 and is in communication either directly or through a small connecting channel with the interior chamber 90 of the pressure sensor 18 , defined between the diaphragm 64 and the fixed electrode 66 . The displacement cavity 88 is sized such that the total internal sensor volume, the combined volume of the displacement cavity 88 and the interior chamber 90 , varies minimally with deflection of the diaphragm 64 over its operational range of displacement. By minimizing the overall change in volume with deflection of the diaphragm 64 , the effect of the residual gasses are minimized and substantially eliminated. In the preferred embodiment, the volume of the displacement cavity 88 is approximately ten times greater than the volume of the chamber 90 . To further reduce temperature induced drift and to increase the sensitivity of the device 12 , lower pressures within the internal volume 90 should be used. In addition to the preferred embodiment, other configurations for the sensing device 12 are possible. Depending on the relative sizes of the diaphragm 64 and coil 42 , the diaphragm 64 may be located within, above, or below the turns of the coil 42 , as well as off to one end or side of the device 12 as seen in FIG. 3 . The post 40 and/or one of the plates 36 or 38 of the magnetic core 33 , may be omitted to simplify fabricating. However, this would be to the detriment of performance. Alternate lead transfer schemes may be used instead of the disclosed traces 82 and 84 that connect the coil 42 to the sensor 18 . More or fewer wafer layers may be used to adapt manufacturing processing to available technologies. For example, the entire magnetic core 33 could be formed on the top side of the substrate 20 , thereby eliminating the need for lower cap layer 46 . Multiple coil layers could also be implemented to increase the coil turn count. Finally, the overall shape of the device 10 may be square, round, oval, or another shape. To isolate the internal volume of the pressure sensor 18 from the internal volume of the integrated inductor 16 , a hermetic lead transfer can be provided as a substitute for the dielectric layer 86 . A hermetic lead transfer would eliminate outgassing from the inductor coil 42 and magnetic core 33 as a source of drift for the pressure sensor 18 , thereby improving long-term stability. The hermetic lead transfer may be accomplished by any of several means that provide a sealed and electrically isolated conductive path. One example, of a mechanism for achieving a sealed and electrically isolated conductive path is through the use of a p-n junction structure 92 in the sensor 18 ′. This is illustrated in FIG. 9 . The p-n junction structure 92 (with p-material forming the diaphragm) forms an electrically isolated path in a silicon layer and provides for electrical contact between a fixed electrode 66 ′ and a lead trace 94 but not from the fixed electrode 66 ′ to the diaphragm 66 ′. In another alternative construction, a separate polysilicon layer 96 forms a conductive path to a fixed electrode 66 ″. The conductive layer 96 is insulated, by a separate insulating layer 98 , from the doped silicon rim 100 of the sensor 18 ″. An alternative embodiment of the present sensing device, designated as 12 ″, includes active circuitry for immediate processing of the data including logging, error correction, encoding, analysis, multiplexing of multiple sensor inputs, etc. Since the sensing device 12 ″ of this embodiment, seen in FIG. 11 , includes numerous structures which are the same or identical to the structures seen in the embodiment illustrated in FIG. 3 , like structures are accordingly provided with like designations and are not repetitively discussed. Reference should therefore be accordingly made to the preceding sections of this description where those structures are discussed in connection with FIG. 3 . The block diagram of FIG. 12 illustrates one possible circuit implementation for the active circuitry 102 seen in FIG. 11 . In the illustrated configuration, the integrated inductor 16 serves as an antenna for RF telemetry with the external readout device 14 . Using RF modulation schemes well know to those skilled in the art, the RF magnetic field 26 transmitted from the device 14 provides both data communication and necessary power to the circuitry 102 . The received energy across inductor 16 is rectified and stored temporarily in an onboard capacitor or power supply designated at block 104 . The input decoder 103 may receive digital data pertaining to short or long term memory or real time clock signals, and may transfer this information to the control logic 107 . The front end conditioning circuitry 109 converts an analog sensor signal into a form that is encoded and amplified by the output driver 105 . The integrated inductor 16 then serves to transmit the RF signal back to the external readout device 14 , where the information can be processed, stored, or displayed. The many variations for circuit implementations of the rectifier of 104 , modulation and coding schemes encompassing blocks 103 and 105 , analog circuitry 109 and needed control logic 103 will be appreciated. A key issue for sensing physiologic parameters in medical applications is that the sensor must be biocompatible. Biocompatibility involves two issues: the effect of the sensor on the body (toxicity), and the effect of the body on the sensor (corrosion rate). While the fabrication of the substrate 20 of Pyrex glass, as described in connection with FIG. 3 , would be advantageous since Pyrex is highly corrosion resistant, additional measures must be taken to include the corrosion resistance of the silicon and other components of the sensing device 12 . One method of improving those structures of the sensing device 12 formed of silicon, such as the upper and lower cap layers 44 and 46 , is to fabricate those structures of heavily boron-doped silicon. Heavily boron-doped silicon is believed to be largely corrosion resistant and/or harmless to tissues in biologic environments. Another method by which corrosion resistance of the implanted device 12 may be improved is through coating of the device 12 with titanium, iridium, Parylene (a biocompatible polymer), or various other common and/or proprietary thick and thin films. Such a coated device provides two levels of corrosion resistance: and underlying stable surface and a separate, stable coating (which may also be selectively bioactive or bioinert). Provided with these two levels of corrosion resistance, even if the outer coating contains pinholes, cracks, or other discontinuities, the device 12 retains a level of protection. A number of different, and at times application-specific, schemes can be envisioned for long-term use of the sensing device 12 of the present invention. In general, it is necessary to anchor the device 12 so that migration of the device 12 does not occur within the patient. A dislodged device 12 may migrate away from the physiologic parameter intended to be sensed, thereby rendering the device 12 useless for its intended purpose and requiring implantation of another device 12 . A variety of such anchoring schemes is discussed below. Referring now to FIG. 14 , a screw (or stud) 104 is attached to the lower cap layer 46 of the sensing device 12 . Preferably, the screw 104 is attached to the lower cap layer 46 with biocompatible epoxy or a similar method. The screw 104 is then embedded into tissue 106 of the patient and the device 12 retained in place. Preferred materials for the screw 104 include stainless steel and titanium. Another scheme for securing the sensing device 12 within a patient is seen in FIG. 14 . As seen therein, the sensing device 12 has secured to the lower cap layer 46 a sheet of mesh 108 . The mesh 108 becomes encapsulated by tissue of the patient over time, thus anchoring the sensing device 12 . Sutures 110 may be used to hold the sensing device 12 in place until encapsulation occurs. Preferred materials for the mesh 108 include loosely woven, biocompatible cloth and the mesh 108 may range in size from 1 to 20 mm. An endoluminal attachment scheme is illustrated within FIG. 15 . In this application, sensing device 12 is attached to stent-like spring cage 112 . As such, the sensing device 12 may be non-surgically injected into a blood vessel 114 or other body cavity containing fluid flow. After ejection from the insertion apparatus (not shown), the spring cage 112 expands and lodges the sensing device 12 at the sensing location, while allowing blood (or other fluid) to continue flowing past the sensing device 12 . To expand outward, the spring cage 12 is formed so that the arms 115 thereof are resiliently biased outward. Preferred materials for the arms 115 include stainless steel or titanium. The arms 115 may also be in wire or other forms. Another endoluminal attachment scheme is shown in FIG. 16 . In this embodiment, the sensing device 12 is anchored in place within vessel 114 by a set of radially outwardly expandable spring arms 116 . The spring arms 116 may be provided with depth-limited anchoring tips 118 on their ends to further secure the sensing device 12 . The arms 116 may be in wire, ribbon or other form and are biased outwardly to cause engagement of the anchoring tips 118 with the wall of the vessel 114 . Preferred materials for the arms 116 and for the anchoring tips 118 include stainless steel or titanium. In FIG. 17 , the sensing device 12 is encapsulated in a biocompatible material such as poly(methyl methacrylate), yielding a pellet-like profile designated at 120 . A recess 122 formed in the pellet 120 allows access to the movable element 64 . In addition to providing an alternate form factor that may be less mechanically irritating to tissue 124 both during and after implantation, such an embodiment may better allow the sensing device 12 to be incorporated into the body of a medical device, such as an extrusion, injection-molded part, soft rubber, or other material, that otherwise would poorly anchor to a rectangular or other geometrically shaped sensing device 12 . Obviously, encapsulation could be used to give the sensing device other profiles or form factors as well. From the above, it can be seen that many applications exist for the system 10 of the present invention. Some illustrative examples of such applications are described hereafter. One application of the described technology, depicted in FIG. 18 , locates the sensing device 12 in an electrode tip 126 of an implantable stimulation lead 128 , such as a stimulation lead used for cardiac pacing. In such an arrangement, the sensing device 12 could be used with the read-out device 14 for monitoring arterial, atrial, ventricular, and/or other blood pressures. In the application seen in FIG. 19 , three sensing devices 12 are being used to calculate a diameter 130 of a flow path 132 defined by walls 134 . In addition to the diameter 130 , mass and/or volumetric blood or other fluid flow rates through the flow path 132 may be calculated. The sensing devices 12 are located in a variable diameter catheter 136 or similar geometric construction conductive to taking such measurements. Computational fluid dynamics (CFD) models and calculations utilizing the distances between the sensing devices 12 (L 1 and L 2 ) and pressure changes ΔP 1 and ΔP 2 therebetween, can be used to derive the desired parameters from suitably precise pressure data. Cardiac monitoring applications can particularly benefit from the present system 10 in its various embodiments. One possibility is to locate the sensing devices 12 (either by means of a multiple-sensor catheter or individually placed sensor devices 12 (or placed as a tethered pair)) at appropriate locations around a natural or artificial heart valve or other biologic valve, to monitor the pressure on either side of, and/or the flow through, the valve. The same setup may also be used to monitor pressure along a vascular stent 137 , as shown in FIG. 20 . Sensing devices 12 may be placed at one or more locations 138 - 142 along the length of the stent. Referring now to FIG. 21 , a sensing device 12 is located such that pressure is measured externally through a vessel wall 144 , such as the wall of a blood vessel. The sensing device 12 is placed in intimate contact with the wall 144 through use of a variety of means, including adhesive clips 146 (of a biocompatible material), tissue growth or other methods. The sensing device 12 is oriented so that the moveable element 64 is adjacent the vessel wall 144 and measures pressure transduced through the vessel wall 144 . A calibration factor in active circuitry may be used to adjust the measured value to an actual value so as to account for the effects of sensing the pressure through the vessel wall 144 . As an alternative to the foregoing embodiments, the pressure sensor 18 of the sensing device 12 may be augmented and/or replaced with a structure or sensor 18 ′ that allows a parameter other than pressure to be sensed. For clarity, in FIG. 22 only the sensor 18 ′ portion of the sensing device 12 is shown, the nonillustrated elements being as previously discussed. In the sensor 18 ′, a chemical-sensitive substance 148 is placed in a confinement cavity 149 and contact with and exterior surface of sensor diaphragm 150 . Osmotic expansion of the substance 148 , in response to the concentration of a target chemical, generates a pressure on the diaphragm 150 and allowing the concentration of the chemical to be monitored. For convenience, only the substrate 20 is illustrated, the fixed electrode and associated structures be omitted. This sensor 18 ′ may optionally include cap structure 152 to restrict the expansion of the chemical sensitive substance 148 to the center of the diaphragm 150 to maximize deflection of the diaphragm 150 . A micromachined mesh, grid, or semipermeable membrane 154 , also optional and either integral to the cap or attached separately thereto, may be included to prevent the chemical sensitive substance 148 from escaping (or bulging out of) the confinement cavity 149 , and/or to prevent foreign materials from entering the cavity 149 . The mesh 154 could also exist on the molecular level, being formed of a material such as a cross-linked polymer. In another alternative parameter sensing embodiment, a material with high thermal coefficient of expansion is placed between moveable and fixed electrodes in a structure otherwise constructed similar to a capacitive sensor structure, thereby forming a temperature sensor. FIG. 23 illustrates an alternative capacitive sensor 156 on the substrate 20 , additional structures are omitted for clarity. In this sensor 156 , the capacitance changes due to a varying dielectric constant within the capacitive gap defined between electrodes 158 and 160 . The gap is filled with sensing substance 162 chosen such that its dielectric constant changes in response to the particular physiologic stimulus being evaluated. FIG. 24 depicts an alternate implementation of the above embodiment, with the electrodes 158 ′ and 160 ′ and the sensing substance 162 being stacked vertically on the substrate 20 , as opposed to the lateral orientation in FIG. 23 . The pressure, temperature or other data sensing technology, in its various forms, may be incorporated into an open or closed-loop therapeutic system for the treatment of medical conditions which require or benefit from regular, subcutaneous monitoring of pressures or other parameters. The system may be used, for example, to control the administration of drugs. One particular application of this would be to control hyper- or hypotension. In the preferred embodiment, pressure data from the sensor, alone or in conjunction with other real-time or preexisting data, is used to adjust drug or other therapy for hypo- or hypertensive patient. Therapy is provided by means of a control module worn by, or implanted within, the patient (similar to e.g., an insulin pump for diabetics). The module may alert the user to take action, directly administer a drug intravenously, and/or initiate other invasive or non-invasive responses. Furthermore, relevant information (including, but not limited to, measure physiologic parameters, treatment regimens, data histories, drug reservoir levels) can further be transmitted from the control module to other locations via cellular phone, wireless infrared communication protocols or other communication methods and mechanisms. Other applications of the implantable wireless sensing device of this invention include, without limitation, the following: 1) Monitoring congestive heart failure patients such as left ventricle pressure monitoring, left atrium pressure monitoring and pulmonary artery pressure monitoring; 2) other hemodynamics parameters including blood pressure, blood flow velocity, blood flow volume and blood temperature; 3) diabetic applications including glucose level monitoring; 4) urinary applications such as bladder pressure and urinary tract pressure measuring; and 5) other blood parameters including O 2 saturation, pH, CO 2 saturation, temperature, bicarbonate, glucose, creatine, hematocirt, potassium, sodium, chloride; and 6) cardiac parameters including (previously discussed) valve pressure gradients and stent pressure gradients. In addition to single sensor, an array of different sensors may be fabricated or assembled on one sensing device to enhance artifact removal and/or selectivity/differentiation between signals. A discussion of such a construction best details this construction. Local pressure or pH variations can add spurious signals to a pressure- or pH-based glucose sensor. To compensate for these spurious signals, adjacent pH or pressure reference sensors may be implemented to measure these environmental parameters. External sensors may also be used to compensate for factors such as atmospheric pressure. A combination of sensor arrays, fuzzy logic, look-up tables, and/or other signal-processing technologies could all be used to effect such compensation. The foregoing disclosure is the best mode devised by the inventor for practicing the invention. It is apparent, however, that several variations in accordance with the present invention may be conceivable to one of ordinary skill in the relevant art. Inasmuch as the foregoing disclosure is intended to enable such person to practice the instant invention, it should not be construed to be limited thereby, but should be construed to include such aforementioned variations, and should be limited only by the spirit and scope of the following claims.

The present invention relates to an implantable microfabricated sensor device and system for measuring a physiologic parameter of interest within a patient. The implantable device is micro electromechanical system (MEMS) device and includes a substrate having an integrated inductor and at least one sensor formed thereon. A plurality of conductive paths electrically connect the integrated inductor with the sensor. Cooperatively, the integrated inductor, sensor and conductive paths defining an LC tank resonator.

CROSS REFERENCES TO RELATED APPLICATIONS [0001] The present application is a nonprovisional patent application claiming benefit under 35 U.S.C. § 119(e) from U.S. Provisional Application Ser. No. 60/515,248, filed on Oct. 28, 2003, the entire contents of which are hereby expressly incorporated by reference into this disclosure as if set forth fully herein. BACKGROUND OF THE INVENTION [0002] I. Field of the Invention [0003] The present invention relates generally to inducing ischemia and, more particularly, to a method of inducing ischemia via the introduction of a flowable thermopolymer into a target vessel or structure which, after injection, will cool and solidify to obstruct or occlude the vessel or structure. This method of inducing ischemia is particularly suited for the treatment of cancer, by cutting off blood supply to a tumor to facilitate its removal, as well as removing organs as method of treatment or for transplant and/or draining and subsequent reduction and isolation of an organ for removal or for an organ to maintain its contents for removal. [0004] II. Discussion of the Prior Art [0005] Cancer is a disease that claims the lives of millions of people worldwide. Although there are treatments for the disease, to date there is no cure. Most treatment options are incredibly unpleasant for the patient, and none of them can predict successful recovery with any degree of certainty. Furthermore, many treatment options have debilitating side effects that can affect the lives of cancer patients and their families for the rest of their lives. [0006] All organs, limbs, and tumors rely on a nutrient supply to sustain life and maintain functionality. The greater the metabolic activity of a structure, the more nutrients are required to remain viable. Active or highly aggressive tumors require a rich blood supply in order for the tumor to proliferate. [0007] Much of the contemporary treatment of cancer addresses the cellular production or blood supply. Presently the most-utilized treatments for cancer include surgery, radiation, and chemotherapy. In addition, many alternative or experimental treatments are also available, including immunotherapy, hyperthermia, radio frequency ablation, hormonal therapy, angiogenesis inhibitors, photodynamic therapy, and vaccine therapy. [0008] Each of the primary cancer treatments is highly invasive to the human body, but each in a different way. Removal of tumors via surgery is the most physically invasive technique, yet it potentially carries the lowest degree of damage from side effects. In this treatment, the tumor is physically removed from the body through mechanical processes. Surgical removal can be effective for small tumors, but often it is not possible to extract the entire tumor, and the end result is that cancer remains in the patient. Even if the entire tumor can be removed, doctors must also remove significant portions of healthy tissue and lymph nodes along with the tumor, causing damage to the body. [0009] Radiation therapy, or radiotherapy, is a treatment method in which high-energy rays are used to treat the cancer cells. Radiation is often used in conjunction with surgical treatment, either pre-surgery to shrink the tumor to allow for easier removal, or post-surgery to remove any remaining cancer cells from the tissue. Radiotherapy does have serious, though mostly temporary, side effects. For instance, patients may experience fatigue, hair loss, skin discoloration, and a decrease in infection-fighting white blood cells. [0010] The third conventional method of treating cancer is chemotherapy, in which anticancer drugs are administered in a number of ways, including intravenously through a catheter, intrathecally (into the cerebral spinal fluid) through a needle placed in the spine, or by a heavy dosage of pills. The chemicals once introduced are intended to kill the cancer cells. However, chemotherapy also has side effects that are very similar to, if not more severe than, radiotherapy. For example, patients may experience fatigue, hair loss, nausea, vomiting, and general painful discomfort. More serious side effects include permanent infertility and cessation of the menstrual cycle in women. Unlike radiation, chemotherapy is systemic in nature and therefore exposes the entire body to chemicals, increasing the danger of side effects. [0011] In order to increase the effectiveness and decrease the discomfort associated with the conventional treatments discussed above, many alternative and experimental treatments have emerged in recent years. One such treatment is immunotherapy, in which the body's immune response is increased in order to fight disease or protect from the harmful side effects of other treatments. Some types of immunotherapy include herbal remedies, monoclonal antibodies, interferons, interleukin-2, and colony stimulating factors. Another type of immunotherapy is the use of cancer vaccines. Ordinarily vaccines are used as preventative treatment, administered prior to contraction of a disease in order to prepare the immune system to rapidly fight the disease. However, cancer vaccines are therapeutic in nature: instead of preparing the body to fight future cancer, they aid the body's immune system in fighting existing cancer. Immunotherapy as a primary treatment for cancer itself if ineffective at best, and as a result it is used primarily a means to combat side effects of more conventional treatments. [0012] Another method of treating cancer is hyperthermia, or heating the malignancy to its lethal capacity, heat-killing the tumor. The idea is that since cancer cells have a higher temperature than normal healthy cells, they will reach the lethal temperature for cells faster than the surrounding tissue. However, to date the conventional methods of heating are inadequate because they primarily use external sources of heat and thus cannot reach deep-rooted tumors without creating a toxic temperature gradient within the healthy tissue surrounding the cancer. [0013] An experimental derivative of the hyperthermia treatment currently in development is Intracellular Hyperthermia Therapy (ICHT). The idea behind ICHT is that if the cancer cells could be heated from the inside, then the damage to surrounding tissue from hyperthermia would be minimized. The suggested method is to introduce an “uncoupling agent” into the bloodstream, which would then infiltrate cells and boost their metabolism on the order of four-fold. Cancer cells, with a much higher metabolism, would be pushed beyond their lethal limit, while normal cells would in theory be unaffected. However, the problem with this treatment is that it still has some effect on normal cells. Specifically, the effect of increased metabolism on normal cells is unknown, and may turn out to be harmful. [0014] Another relatively new cancer treatment is radio frequency ablation (RFA), in which RF energy is deposited directly into the tumor by a probe. The energy heats the cells beyond their fatal temperature, destroying them. Although still experimental in nature and primarily used for treating liver cancer, this treatment is not without problems. First, the treatment can be extremely painful for the patient, and various forms of sedation are recommended, ranging from conscious sedation to general anesthesia. Secondly, in order to increase the likelihood of success, a zone of normal cells surrounding the tumor must also be killed. Thirdly, tumors located near major arteries cannot be killed completely since the arteries will siphon some of the heat away from the tumor. [0015] Hormone therapy is an alternative treatment in which cancer cells are starved of the hormones that they need to grow. This can be accomplished either through the administration of hormone-suppressing drugs or surgery to remove a hormone-producing organ. In addition to side effects that are similar to chemotherapy, hormone therapy is only effective against certain types of cancers. [0016] The use of angiogenesis inhibitors is currently under investigation. The idea behind this type of treatment is to arrest the formation of new blood vessels that provide nutrient-rich blood to the tumors. If such formation can be stopped, then the cancer cells will essentially die from malnutrition. However, the primary drawback to this treatment is that it is still highly experimental, and the effectiveness in fighting cancer is not yet known. [0017] Yet another type of alternative cancer treatment is photodynamic therapy (also called PDT, phototherapy, photochemotherapy, or photoradiation therapy). PDT is based on the use of photosensitizing agents that can kill one-celled organisms when exposed to a certain type of light. In this treatment, a photosensitizing agent is introduced into the bloodstream and absorbed by cells all over the body, including the target tumor. Since the agent will remain in cancer cells longer than in healthy cells, treatment is delayed for a period of time after introduction of the agent. The tumor is then treated with a laser, activating the photosensitizing agent and causing the production of an active form of oxygen, which will kill the cells. However, many problems are associated with this treatment. First, there is the aforementioned timing problem, and more specifically picking the right time to be most effective. Secondly, the patient's eyes and skin remain ultra-sensitive to light for at least a period of six weeks. Finally, since the lasers used cannot pass through more than three centimeters of tissue, PDT is not effective against deeper seeded tumors. [0018] In addition to the specific problems with each treatment discussed above, the central disadvantage to many of these cancer treatments is that it is difficult to isolate the tumors and apply the treatment method only to the target area. As a result, many healthy cells are destroyed along with the tumor. If the treatment is systemic in nature, this can cause a multiplicity of problems all over the body. Similarly, localized treatments can damage significant portions of the body surrounding the tumor. [0019] Furthermore, treatments involving introduction of foreign elements not accepted by the body—such as chemicals, radiation, or excessive heat—can cause uncomfortable, painful, or even debilitating side effects that may be more than temporary in nature. [0020] The present invention is directed at overcoming, or at least improving upon, the disadvantages of the prior art. SUMMARY OF THE INVENTION [0021] The present invention accomplishes the above-identified problems by providing a method of treating cancer using a thermopolymer composition to block arterioles feeding the tumor and induce ischemia, thereby killing the cancer cells. Prior to injection, the thermopolymer material is heated to a temperature sufficient to create a flowable form, whereby it may then be injected into the body. After injection into the arterioles, the material will cool to body temperature and solidify, creating an artificial barrier. [0022] According to one broad aspect of the present invention, this method of treating cancer comprises a nonreactive thermopolymer composition capable of injection in flowable form and an injection apparatus. It is contemplated that the injection apparatus may itself be able to heat the thermopolymer to flowable form. [0023] The thermopolymer composition contains the thermopolymer matrix and a dispersion compound. The thermopolymer matrix may include any number of suitable materials capable of being heated to flowable form and injected into an artery, filling the artery and solidifying upon cooling to body temperature in order to form a barrier. The thermopolymer must not react negatively with the body. By way of example only, the thermopolymer matrix may include bone wax, paraffin, gutta percha, balata, polyisoprene and/or any mixture of bone wax, paraffin, gutta percha, balata and/or polyisoprene. [0024] The dispersion compound may include any number of compositions having suitable mechanical, chemical, radiopacity, anti-microbial and/or anti-inflammatory characteristics. By way of example only, the dispersion compound may include, but is not necessarily limited to, titanium, crystalline particles, gold (in any form) and/or and combination of titanium, crystalline particles, and/or gold. [0025] The injection device may include any number of mechanisms capable of injecting molten thermopolymer into the body. By way of example only, the injection device may include an injection gun or simple syringe. In a preferred embodiment, the injection gun would be capable of heating the thermopolymer to the desired temperature in order to facilitate dispersion in a molten form. The preferred injection gun would also be able to maintain the temperature of the thermopolymer composition so as to maintain molten consistency throughout application. The preferred embodiment would also contain a specialized injection needle to facilitate optimal dispersion of the thermopolymer compound. In an alternative embodiment, the thermopolymer composition would be heated using an independent device such as a hot pot, open flame, or microwave, and then transferred to a syringe for injection. BRIEF DESCRIPTION OF THE DRAWINGS [0026] Many advantages of the present invention will be apparent to those skilled in the art with a reading of this specification in conjunction with the attached drawings, wherein like reference numerals are applied to like elements and wherein: [0027] FIG. 1 is a flow chart of a method of treating cancer according to an exemplary embodiment of present invention; [0028] FIG. 2 illustrates the in vivo mechanics of the method of the present invention; [0029] FIG. 3 illustrates an exemplary embodiment of an injection gun suitable for use in injecting a thermopolymer according to the present invention; [0030] FIG. 4 illustrates a cannula for use in an exemplary embodiment of an intravascular injection system for use in injecting a thermopolymer according to the present invention; [0031] FIGS. 5-7 illustrate an enlarged view of the distal end of a cannula for use in an exemplary embodiment of an intravascular injection system for use in injecting a thermopolymer according to the present invention; and [0032] FIG. 8 illustrates an exemplary embodiment of an endoscopic delivery system for use in injecting a thermopolymer according to the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENT [0033] Illustrative embodiments of the invention are described below. In the interest of clarity, not all features of an actual implementation are described in this specification. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decision must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The method of inducing ischemia according to the present invention will be discussed in detail below with respect to its exemplary utility in treating cancer. However, it will be appreciated by those skilled in the art (and is within the scope of the present invention) that the methodology of the present invention may also find use in removing organs as method of treatment or for transplant and/or draining and subsequent reduction and isolation of an organ for removal or for an organ to maintain its contents for removal. The method of inducing ischemia disclosed herein boasts a variety of inventive features and components that warrant patent protection, both individually and in combination. [0034] FIG. 1 is a flowchart illustrating the major steps of a method 10 of treating cancer according to an exemplary embodiment of the present invention. The first step 12 is to locate and diagnose the malignant tumor. This may be accomplished in any number of suitable fashions (currently existing or later developed), including but not limited to the use of Magnetic Resonance Imaging (MRI), X-ray imaging, ultrasound, and/or physical inspection. The second step 14 is to locate each arteriole supplying blood to the tumor. This may be accomplished in any number of suitable fashions (currently existing or later developed), including but not limited to the use of MRI, X-ray imaging, ultrasound, and/or physical inspection. The next step 16 is to inject a flowable thermopolymer into the arterioles leading to cells in and around the tumor. This can be accomplished in any number of suitable fashions (currently existing or later developed), including but not limited to needle injection, intravascular delivery (e.g. catheter based), and/or endoscopic devices. After the thermopolymer cools and solidifies 18 , it will act as a dam to block the arteriole and close off the blood supply to the tumor. In time 20 , the tumor will in effect suffocate and die. At this point 22 , the dead cell mass may be surgically removed if desired. [0035] FIG. 2 is a schematic illustrating the thermopolymer injection step. In this diagram 30 one can see that the nutrient-rich blood flows from the arteries through arterioles to capillaries that feed cells. Preventing the blood from flowing through the arterioles will divert nutrients from the tumor, and the cells will starve to death. To achieve this, the thermopolymer 32 is injected through an injection needle 34 such that it enters the arterioles leading to cells in and around the tumor. Upon cooling, the thermopolymer 32 will form internal dams within the arterioles that will block the arterioles and divert the blood flow from the tumor. [0036] FIG. 3 illustrates an exemplary embodiment of an injection gun 50 suitable for use in inserting a thermopolymer 32 according to the present invention. Specifically, injection of thermopolymer 32 through cannula 82 by injection gun 50 is shown. Injection gun 50 has a body 52 with a removable plunger 54 adapted to receive a cylindrical plug of the thermopolymer material 32 . A heater 56 may be provided to heat thermopolymer material 32 and a heater control unit 58 having an adjustable temperature control knob 60 may be provided with a temperature readout at 62 . Electrical leads 64 extend to heater 56 . An injection needle 34 extends from body 52 and has a ceramic sheath 66 about a portion of the proximal end of needle 34 . Cannula 82 may be attached to distal end of needle 34 to facilitate injection into the body. Injection needle 34 may be composed of any number of suitable materials, including but not limited to silver, aluminum, or stainless steel. A hand-operated trigger 68 may be activated for forcing thermopolymer material 32 from the end of needle 34 into cannula 82 upon heating of the thermopolymer material to a predetermined temperature. To assist trigger 68 in exerting an axial force against the plug of thermopolymer 32 in gun 50 , a foot operated hydraulic pump 70 may be provided to supply fluid through lines 72 , 74 to hydraulic cylinder 76 . A pressure readout is provided at 78 . A suitable piston 80 may exert an axial force against the thermopolymer material 32 . A hydraulic system is effective in providing an axial injection force that may be easily regulated and controlled by personnel performing the procedure. [0037] FIGS. 4-7 illustrate an exemplary embodiment of an intravascular injection system for use in inserting a thermopolymer according to the present invention. FIG. 4 shows the main body and distal end 84 of cannula 82 . Located at distal end 84 of cannula 82 is the distal opening of inner lumen 88 . FIG. 5 represents an enlarged side prospective view of distal end 84 of cannula 82 . Inner lumen 88 contains retractable plunger 94 , shown in the closed position. Inner lumen 88 extends in a generally central manner along the length of cannula 82 and is attached to the distal end of injection needle 34 of injection gun 50 of FIG. 3 to permit flowage of thermopolymer 32 . Surrounding inner lumen 88 is catheter body 86 . Catheter body 86 may be comprised of any material capable of providing a solid yet flexible and insular housing for inner lumen 88 , including but not limited to rubber, plastic, latex, or silicon. Guide wire 90 extends the length of cannula 82 through guide wire lumen 92 . Guide wire lumen 92 is generally a smaller tube than inner lumen 88 , and is located in a generally superior orientation to inner lumen 88 within catheter body 86 . [0038] FIG. 6 illustrates the distal end 84 of cannula 82 with retractable plunger 94 in the open position. Retraction of plunger 94 allows for flowage of thermopolymer 32 into the targeted arteriole. FIG. 7 is a frontal view of the distal end 84 of cannula 82 , illustrating the general orientation of the components. Inner lumen 88 is oriented in a generally central location of cannula 82 . Retractable plunger 94 is located in the interior of inner lumen 88 . Heating element 96 may surround inner lumen 88 in order to facilitate heating (or prevent premature cooling) of thermopolymer 32 . Heating element 96 may comprise any number of suitable elements for heating, including but not limited to ceramics, coils, and the like. Catheter body 86 surrounds inner lumen 88 and, if present, heating element 96 . Guide wire 90 is located inside guide wire lumen 92 , which extends through catheter body 86 and is generally located in a superior position to inner lumen 88 and heating element 96 (if present). [0039] Guide wire 90 can be inserted into the body by any of a number of well-known methods, such as the Seldinger technique. Once guide wire 90 is placed, cannula 82 is advanced by introducing the proximal end of guide wire 90 into guide wire lumen 92 located at distal end 84 of cannula 82 . Cannula 82 is then passed along guide wire 90 until the desired location is reached within the body. Once cannula 82 is properly inserted, trigger 68 of insertion gun 50 is activated, forcing heated thermopolymer 32 through needle 34 , into cannula 82 , and eventually into the proper arteriole. [0040] FIG. 8 illustrates an exemplary embodiment of an endoscopic delivery system for use in injecting a thermopolymer according to the present invention. Once a malignant tumor is located in the patient (shown here in the torso, but could be anywhere), the method 10 of treating cancer may be utilized. A trocar 98 , or any other device commonly used by those skilled in the art to insert intravenous cannulae, may be used to facilitate insertion of cannula 82 into the proper arteriole. Once cannula 82 is properly inserted, trigger 68 of insertion gun 50 is activated, forcing heated thermopolymer 32 through needle 34 , into cannula 82 , and eventually into the proper arteriole. Once thermopolymer 32 has been inserted, only a short time is needed to allow for solidification and consequential blockage of the tumor feeding arteriole. [0041] While the present invention has been shown and described in terms of preferred embodiments thereof, it should be understood that this invention is not limited to any particular embodiment, and that changes and modifications may be made without departing from the true spirit and scope of the invention as defined in the appended claims. By way of example only, the method of inducing ischemia according to the present invention may also find use in removing organs as method of treatment or for transplant. This may be accomplished via oblation or occluding the blood flow, which facilitates the removal of the target organ by restricting blood flow within the organ prior to removal and hence blood loss during removal. In addition, the method of inducing ischemia of the present invention may also find use in maintaining the contents of the target organ during removal, such as by occluding the egress portal ( ) of the target organ via injecting a thermopolymer according to the present invention (as described above with respect to blood flow obstruction).

The present invention relates generally to inducing ischemia and, more particularly, to a method of inducing ischemia via the introduction of a flowable thermopolymer into a target vessel or structure which, after injection, will cool and solidify to obstruct or occlude the vessel or structure. This method of inducing ischemia is particularly suited for the treatment of cancer, by cutting off blood supply to a tumor to facilitate its removal, as well as removing organs as method of treatment or for transplant and/or draining and subsequent reduction and isolation of an organ for removal or for an organ to maintain its contents for removal.

CROSS REFERENCE TO RELATED PATENT APPLICATION This application is a continuation-in-part of U.S. patent application Ser. No. 11/370,045 filed on Mar. 8, 2006. FIELD OF THE INVENTION This invention relates generally to a nursing device, and more particularly to a nursing bottle for infants with a cleft lip and/or cleft palate. BACKGROUND OF THE INVENTION Cleft lips and cleft palates are common birth defects and require special attention during the initial six months of a child's life. To be more specific, there are three types of cleft lip, i.e., unilateral incomplete, unilateral complete and bilateral complete. There are also three types of cleft palates, namely the soft palate only, the unilateral complete, and the bilateral complete. However, each of the cleft lip and/or cleft palate malformations involves leakage of air from the mouth through the nose, which causes an infant to be unable to suck, causing regurgitation of fluids through the nose and difficulty in swallowing and breathing. For a period of about six months until the infant has matured enough for corrective surgery, the infant must be fed. Feeding is not only the most immediate problem encountered in the daily care of an infant with a cleft lip and/or cleft palate, but it is one of the more difficult to solve and the most necessary for the survival of the child. A U.S. Pat. No. 4,856,663 of Epp discloses a nursing device for infants with a cleft lip or cleft palate. As disclosed, the device comprises a solid duckbill shaped shield with an incorporated nipple on its underside, together with means for interconnecting the nipple and a baby bottle or breast. The shield acts to seal the cleft palate, while keeping the nipple from collapsing into the cleft palate and cleft lip to allow an infant to suck liquids from a bottle or the breast. A French Patent No. 2,622,102 A1 of Michel Grateau discloses a control device with feedback for artificial feeding systems for force-feeding of infants. The device, which is fitted into a nursing bottle, allows a caregiver to control the feeding device. A more recent U.S. Pat. No. 6,033,367 of Goldfield discloses a smart bottle and system for neonatal nursing. The system for diagnosing or monitoring sucking/swallowing/breathing of an impaired neonate includes a processor for receiving a signal from a breath sensor. The system develops an output for intraoral tactical or flow control feedback. In a feeding or monitoring embodiment the processor applies a signal to control a liquid feeding valve, which supplies nutrients through a feeding nipple. In another embodiment, adapted for manual feeding, the processor displays a waveform indicative of the breath or airflow sensor output, and a manually operated pressure bulb is provided to allow a nurse to apply arrhythmic muscular pressure stimulus via a feeding or surrogate nipple in a manner visually synchronized with the displayed breath activity. Notwithstanding the above, it is presently believed that there is a need for and a commercial potential for an improved feeding device in accordance with the present invention. There should be a demand for such devices because the devices pump measured amounts of milk in pre-selected periods of time to overcome the difficulties in feeding children with cleft lips and cleft palates. Further, the devices in accordance with the invention include a nipple so that a baby can develop an ability to suck and at the same time to exercise and massage the muscles of the face. In some cases, a baby cannot cope with swallowing because of the defect in the palate. However, with the devices in accordance with the present invention, a nurse or mother can pump measured amounts of nutrient so that the child obtains enough nutrients in enough time without adversely affecting their general condition. The devices in accordance with the present invention are also applicable for pre-natal infants, i.e., those born before 32 weeks. The suction reflex in such infants may not be fully developed and the child may choke on nutrient from an ordinary bottle. Such choking may lead to infection. Further, the use of the present invention may allow the infant to leave the hospital at an earlier time since the mother will be able to feed the child at home. Another advantage of the device is that it has a nipple that helps in developing a child's ability to suck. Further, children with special needs that have a problem with swallowing may also benefit from the use of the devices in accordance with the invention. Still further, the devices avoid a problem associated with spilling relatively large amounts of milk during feeding. Also, such devices can be used to feed fluid foods to elderly people who are having feeding problems. SUMMARY OF THE INVENTION In essence, the present invention contemplates a nursing device or baby's bottle for feeding infants with a cleft lip or cleft palate. The nursing device includes an upper portion including a bottle for containing a supply of nutrients and/or water with an opening at one end thereof. The upper portion also includes a nipple and means for maintaining the nipple in sealing engagement with the top of the bottle. In a preferred embodiment of the invention, the top of the bottle includes a threaded neck portion around the opening and is adapted to receive a conventional cap thereon. The cap includes a central opening adapted to receive a nipple therein and internal threads for engaging the external threads on the bottle. Thus, tightening the cap squeezes a flange on the outer portion of the nipple between the top of the bottle and the underside of the cap to form a liquid tight seal. A pump is disposed in the bottle below the surface of the liquid nutrient or water and preferably near or on the bottom of the bottle. Tubular means, such as a flexible hose or semi-rigid or rigid conduit, connects an output of the pump with a forward portion of the nipple for delivering pre-selected amounts of nutrients or water through the nipple and into an infant's mouth. A lower portion of the device includes a housing and a motor disposed in the housing for rotating the pump through a magnetic coupling. An important feature of the present invention resides in means, such as a timer, for regulating the amount of nutrient or water pumped in a given period of time. The timer may also include means for regulating the cycle. Other embodiments comprise an attachment that secures removably to the threaded neck of a conventional nursing bottle or the like. The attachment has a base that threads onto the neck of the bottle, and a substantially sealed housing that contains an electric motor and controls and electrical storage battery power for the motor. One embodiment includes the motor driven pump within the housing. The pump preferably is a peristaltic pump having a rotary device that travels along the outer surface of a length of flexible tube to compress the tube progressively and force liquid through the tube. Thus, the only liquid path through the housing comprises an unbroken length of flexible tubing extending through the floor of the housing and through the pump to the nipple extending from the top of the housing to minimize the possibility of leakage within the housing. Another embodiment places the pump below the floor of the housing. The pump has a magnetic rotor that is driven by a magnetic drive from the motor in order to preclude the need for a passage through the floor for a driveshaft. Again, the only liquid path through the housing comprises a tube extending from the pump through the floor of the housing and out the top of the housing to the nipple extending therefrom. The top of the housing is configured for the threaded attachment of a conventional nursing bottle cap thereto. The cap serves to capture the base flange of a nursing bottle nipple between the top of the housing and the inwardly disposed flange of the cap. Single or double nipples having the output end of the tube extending therethrough may be provided with any of the embodiments disclosed herein. The nursing bottle is preferably conventional, and may have a neck disposed coaxially with the bottle or aligned at some angle to the bottle. The invention will now be described in connection with the following drawings wherein like reference numerals have been used to define like parts. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevational view of a prior art nursing bottle for children with cleft lips and/or cleft palates. FIG. 2 is a cross-sectional view of a nursing bottle in accordance with the present invention. FIG. 3 is a schematic illustration of a programmable timer for use in the present invention. FIG. 4 is a cross-sectional view of a nursing bottle with a feed regulating nipple according to a second embodiment of the invention. FIG. 5 is an environmental perspective view of a third embodiment of a nursing device according to the present invention, comprising a nursing bottle and attachment being used to feed an infant. FIG. 6 is a partial side elevation view in section of the nursing device of FIG. 5 , showing attachment of a metered liquid dispensing device having a feed regulating nipple to a conventional nursing. FIG. 7 is a partial side elevation view in section of a fourth embodiment of a nursing device according to the present invention, showing a metered liquid dispensing device having a feed regulating nipple attached to a nursing bottle having an angularly displaced. FIG. 8 is a partial perspective view of the nursing device of FIG. 6 , showing an exemplary external control array. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A prior art baby bottle for feeding children with a cleft lip and/or a cleft palate is shown in FIG. 1 . As shown, a conventional baby's bottle 2 includes an elongated container 4 having an open end with an external thread (not shown) formed thereon. A conventional cap 6 has an opening therein and an internal threaded portion and a nipple 8 extends therethrough as attached to the top of the bottle in a conventional manner. However, the nipple 8 includes a substantially solid thin shield 10 of latex rubber or the like. The shield 10 is designed and constructed to prevent the nipple from collapsing into a cleft palate. A nursing bottle 20 in accordance with the present invention includes an upper section 22 having an elongated bottle 24 , which is shaped like a conventional baby's bottle and made of glass or suitable plastic material. Like conventional bottles, the elongated bottles are preferably clear or translucent so that a caregiver can monitor the amount of nutrient being dispensed. The bottle 24 also includes an opening 25 in an upper portion thereof, and a threaded neck 26 surrounds the opening 25 . The threaded neck 26 is constructed and dimensioned to receive a threaded cap 28 with a nipple 30 extending through an opening in the cap 28 in a conventional manner. As in a conventional baby's bottle, the nipple 30 includes a peripheral flange at a base thereof. This flange is compressed between a top of the cap 28 and top of the neck 26 . Unlike a conventional baby's bottle, the nursing device 20 includes an elongated tubular member 34 , which passes through the nipple from a forward opening for delivering liquid, such as milk or water, to an infant. The tubular member may be flexible, semi-flexible or relatively rigid and of a suitable plastic material and is connected to a small submersible rotary pump for delivering pre-selected amounts of liquid to an infant. A small rotatable submersible pump 36 , the output of which is connected to the tube 34 , is disposed in the bottom of the bottle 24 . The pump 36 is connected to a motor 38 through a magnetic coupling 40 (shown schematically). The motor 38 is disposed in a lower section 42 of the device. The lower section 42 includes a plastic housing 44 , which is attached to the bottom of the bottle 24 in any conventional manner. A programmable timer 46 of conventional design regulates the motor 38 in order to provide a selected volume of liquid to an infant and may be programmed to provide small amounts of liquid with intermittent pauses to provide a more natural feeding. A battery 48 is disposed in the lower section 42 for powering the motor 38 and includes means 50 for connecting the batteries to an external charger 52 , which is connected to a source of electricity in a conventional manner. The programmable timer 46 is shown schematically in FIG. 3 and typically includes a microprocessor to control the programming, which is well within the ability of a person of ordinary skill in the art. The timer 46 is also of conventional design and regulates the volume of liquid pumped and the length of pauses between pumping for each feeding cycle. The volume of liquid may be adjusted by a knob 51 and the timing for a pause by a knob 53 . An LED display 55 may also be provided as an indication of volume. For example, the height or amplitude may be shown on the display, or the pause may be indicated by ½ wavelength. A further embodiment of the invention, which is similar to the first embodiment, is illustrated in FIG. 4 . The difference is that the nipple 30 shown in FIG. 2 is replaced with a nipple 60 having a soft rubber shield 62 for covering the defect of the baby's mouth to thereby prevent leakage of milk due to a cleft lip or cleft palate. In the embodiments of FIGS. 2-4 , the tube 34 can be integral with the opening in the feed regulating nipple 30 , or a can be a separate member detachably mounted thereto. The tube 34 facilitates delivery of the nutritious liquid in a controlled manner that will not tax an infant's ability to provide the necessary suction and/or seal, especially infants suffering from cleft lip or cleft palate. This regulation of liquid delivery occurs because only a certain amount of liquid can pass through the tube for any given amount of pressure. Unlike conventional nipples used in infant bottles, any suction or biting of the conventional nipple causes a relative torrent or large amount of liquid to be dispensed. This frequently leads to waste and soiling of the infant's clothes and face due to the infant's inability to swallow such quantities at once. The nipple 30 has a circular flange and a hollow liquid delivery protrusion extending from the flange, an orifice defined in the tip end of the protrusion, and the tube 34 extending from the orifice so that the only milk that can be dispensed through the orifice must pass through the tube 34 . In contrast to conventional nipples, the tube 34 regulates and controls the stream of milk through the orifice by forcing the liquid to be indirectly delivered through the tube 34 , rather than directly through the nipple opening or orifice in conventional nipples, and the quantity being delivered thereby is much smaller and manageable for consumption by infants. The liquid is pumped by the pump 36 described above. However, the nipple 30 can be used to deliver liquid via manual means, e.g., squeezing the bottle or through the efforts of the feeding infant. In this instance, the length of the tube 34 can be shortened so that the intake opening of the tube 34 lies near the top of the bottle during use, since any infant bottle would normally be tilted up during use and the intake opening should be disposed near the bottom of the accumulated liquid inside the bottle at that angle. FIGS. 5 through 8 of the drawings illustrate two additional embodiments of the nursing device having a metered liquid dispensing device. The metered liquid dispensing device has a bottle attachment housing having the motor, pump, and controls enclosed in or mounted on the housing, which is removably threaded in place atop the bottle by means of the conventional externally threaded neck of the bottle. The primary difference between the two embodiments of FIGS. 5-8 is the location of the pump. One embodiment has the pump located within the housing, and the other embodiment has the pump located below the housing and extending into the upper volume of the bottle to which the housing is attached. FIG. 6 provides a detailed side elevation view in section of an embodiment of a nursing device having a metered liquid dispensing device 110 that has all of the components of the dispensing device 110 contained within or mounted on a bottle attachment housing 112 . Each of the various components within the housing 112 , which is illustrated schematically in FIG. 6 , is conventionally available. The bottle attachment housing 112 has an internally threaded bottle attachment base 114 . A floor 116 extends across the housing 112 immediately above the threaded base 114 . The threaded base 114 is adapted for attachment to the externally threaded neck of a standard baby bottle, e.g., the bottle B 1 of FIGS. 5 , 6 , and 8 , or alternatively, to the angled neck of the bottle 132 shown in FIG. 7 . The bottles B 1 and B 2 , or other bottle having an externally threaded neck, may be formed of transparent or translucent glass or plastic material to enable the caregiver to check the contents of the bottle visually. The opposite upper end of the housing 112 has an externally threaded nipple attachment top 118 having a cover 120 spanning the upper end of the top 118 at the upper limit of the threads. The externally threaded nipple attachment top 118 of the housing 112 is of the same diameter and thread pitch as a conventional baby bottle, e.g., the bottle B 1 . Thus, it is adapted to accept an internally threaded nipple collar or cap C conventionally used to capture the flange of the nipple N thereunder to secure it to the neck of the bottle B 1 . The bottle attachment housing 112 defines a substantially sealed interior volume 122 (with the exception of two small passages for the feeding tube, and additional lateral passages for access to controls for the device) for the containment of the operative components of the metering device 110 . The interior 122 of the housing 112 contains a liquid pump 124 that communicates with the interior volume V 1 of the bottle 131 by means of a liquid flow inlet passage 126 formed through the floor 116 of the housing 112 . The pump 124 is preferably a conventional peristaltic pump, i.e., a continuous liquid delivery line or tube 128 is sealed at or through the inlet passage 126 and extends through the pump 124 and through a delivery line or tube outlet passage 130 through the cover 120 of the housing 112 to extend through the perforated tip or orifice of the nipple N. The pump 124 includes one or more rollers therein that travel along a portion of the flexible tube or line 128 disposed within the liquid pump 124 housing, progressively compressing the wall of the tube 128 to convey liquid therethrough. However, other types of pumps may be used in the metering device 110 , if desired. The liquid pump 124 is selectively driven by an electric motor 132 that receives its power from a power supply 134 , comprising a preferably rechargeable electrical storage cell or battery pack disposed within the housing 112 . A recharging port 136 may be provided through the wall of the housing 112 . A control system 138 communicates electrically with the motor 132 and/or power supply 134 to control the power delivered to the motor 132 by the power supply 134 , thereby controlling the speed, operating time, pause time, and/or other factors relating to the operation of the liquid pump 124 and its delivery of liquid from the bottle B 1 . Input to the control system 138 is provided by one or more external control passages 140 disposed through the sidewall of the housing 112 . FIG. 8 provides a perspective view of the metered liquid dispensing device 110 of FIG. 6 , illustrating an exemplary configuration of its external controls and display. The natural sucking action of a normal infant results in a series of liquid pulses entering the mouth of the infant. The pause between pulses provides time for the infant to swallow. However, an infant with a cleft lip or palate is incapable of producing the suction required to draw the liquid from the bottle without assistance. Accordingly, the present nursing device in its various embodiments provides a pump to deliver positive liquid flow from the nipple of the bottle in a series of intermittent pulses simulating the natural sucking reflex of an infant and giving the infant time to swallow after each pulse. The controls for the metering device 110 include a volume control 142 that allows the caregiver to adjust the rate of flow or volume of each pulse of liquid delivered, and a pause tinier control 144 to adjust the time between each pulse of liquid. A display 146 is provided to enable the caregiver to visually determine the magnitude of each pulse of liquid, the duration of the pulses, and the time interval between pulses. The controls 142 and 144 and the display 146 are conventional, such controls and display being well known in the art of microcomputerized pump controls. FIG. 7 of the drawings provides a side elevation view in section of an alternative embodiment of the metered liquid dispensing device, designated as metering device 210 . The metering device 110 comprises a bottle attachment housing 212 having a configuration similar to the bottle attachment housing 112 illustrated in detail in FIG. 6 , i.e., having an internally threaded bottle attachment base 214 that has a floor 216 extending across the housing 212 immediately above the threaded base 214 adapted for attachment to the conventional externally threaded neck of a standard baby bottle, e.g., the angled neck of the bottle B 2 shown in FIG. 7 , or alternatively, to the straight neck of the bottle B 1 , illustrated in FIGS. 5 , 6 , and 8 . The opposite upper end of the bottle attachment housing 212 has an externally threaded nipple attachment top 218 having a cover 220 spanning the upper end of the top 218 at the upper limit of the threads. The externally threaded nipple attachment top 218 of the housing 212 is of the same diameter and thread pitch as a conventional baby bottle, e.g., the bottle B 2 in order to accept a conventional internally threaded nipple attachment collar or cap C to capture the flange of the nipple thereunder and secure the nipple to the neck of the bottle B 2 . However, the embodiment illustrated in FIG. 7 includes an inner nipple IN having a nipple flange NF captured between the nipple attachment cap C (or more precisely, beneath the overlying shield flange SF that is, in turn, captured beneath the cap C) and the underlying nipple attachment top 218 (and the outer portion of the cover 220 formed integrally with the top 218 ). The metering device 210 also includes an outer shield S over the inner nipple IN. The shield S has a shield flange SF captured between the overlying nipple attachment cap C and the nipple attachment top 218 and cover 220 , or more precisely between the cap C and the underlying inner nipple flange IF. The shield S serves to prevent the collapse of the relatively soft inner nipple N. The shield S also serves as a temporary reservoir where discreet amounts of liquid can accumulate for subsequent consumption by the infant. The shield S also has an orifice defined in its tip end for delivery of milk or other liquids from the baby bottle to the infant. The bottle attachment housing 212 defines a substantially sealed interior volume 222 (with the exception of two small passages for the feeding tube, and additional lateral passages for access to controls for the device) for the containment and mounting of the operative components of the device 210 . The metered liquid dispensing device 210 differs from the metering device 110 in that the liquid pump 224 is disposed external to the housing 212 and below the floor 216 , so that the pump 224 is within the interior volume V 2 of the bottle B 2 when the metering device 210 is installed thereon. The pump 224 is preferably a peristaltic pump, as described further above in the discussion of the metering device 110 of FIG. 6 . A passage 226 is provided through the floor 216 of the housing 212 , and a liquid delivery line or tube 228 extends from the pump 224 through the passage 226 in the floor 216 , through the interior of the housing 212 and through the delivery line tube outlet passage 230 in the cover 220 of the housing 212 . The delivery line or tube 228 extends at least through the perforated tip of the inner nipple IN, and terminates in the space between the inner nipple IN and the outer shield S in the metering device 210 of FIG. 7 . However, the delivery line 228 may be extended to the perforated tip of the shield S, if desired. The pump 224 is selectively driven by an electric motor 232 that is disposed within the interior volume 222 of the housing 212 , i.e., on the opposite side of the floor 216 from the pump 224 . No passage for a driveshaft between the motor 232 and the pump 224 is provided, in order to minimize the number of passages and corresponding potential leaks through the floor 216 . Rather, a magnetic drive 225 is provided between the motor 232 and the pump 224 . The drive utilizes a magnet with a rotating polarity driven by the motor 232 . A corresponding magnet or ferromagnetic component at the pump 224 is driven by the rotation of the drive magnet. Such magnetic drives are conventional, and are well known in the field of small motor drive systems. The motor 232 receives its power from a power supply 234 , comprising a preferably rechargeable electrical storage cell or battery pack disposed within the housing 212 . A recharging port 236 may be provided through the wall of the housing 212 . A control system 238 communicates electrically with the motor 232 and/or power supply 234 to control the power delivered to the motor 232 by the power supply 234 , thereby controlling the speed, operating time, pause time, and/or other factors relating to the operation of the liquid pump 224 and its delivery of liquid from the bottle B 2 . Input to the control system 238 is provided by one or more external control passages 240 disposed through the sidewall of the housing 212 . The external appearance of the control system of the metered liquid dispensing device 210 may be substantially similar to the control system illustrated in FIGS. 5 and 8 . It will be seen that many of the various components of the various embodiments illustrated in FIGS. 5 through 8 are interchangeable with one another, e.g., the metered liquid dispensing device embodiment 110 may be installed upon either bottle type B 1 or B 2 , or other suitable bottle configuration as desired. Moreover, the inner nipple IN and shield S may be used in the nursing device of FIG. 6 , if desired. The external appearance of the metered liquid dispensing device in the embodiments of FIGS. 5 through 8 is unobtrusive, thus enabling the caregiver of an infant requiring such a device to use the device without attracting undue attention. This provides much greater comfort and peace of mind to the caregiver, and further encourages the caregiver to enter social situations and expose the infant thereto without concern that the action of bottle feeding the infant will be seen as other than a normal or usual procedure. While the invention has been described in connection with its preferred embodiments, it should be recognized that changes and modifications may be made herein without departing from the scope of the appended claims.

A nursing device for feeding infants with a cleft lip and/or cleft palate includes a nipple body and a tube operatively attached at one end to a pump for pumping liquid and operatively attached at the other end to the nipple body. The tube passively regulates the amount of liquid being pumped, ensuring that the infant can feed with minimal mess from the infirmities of cleft lip and/or cleft palate. The nipple body includes an outer flange and a cap for sealing engagement with the top of a nursing bottle. A shield can be used to cover the nipple body, which serves to protect and form a temporary reservoir for the liquid dispensed through the nipple body.

TECHNICAL FIELD The present invention relates to food products and to their methods of preparation. More particularly, the present invention relates to improved oat and oat flour products and to their heat treatment methods of preparation. BACKGROUND OF THE INVENTION Oat based cereal products for human consumption primarily include grain flakes and oat flour although other specialty oat based or oat derived products are also known. Grain flakes of various sizes are used for oatmeal, granola products, and as topical additives for various products, especially for breads. The processing of oat groats for forming into oat flakes is substantially different than for the preparation of a whole grain oat flour. In prior oat flour production, dehulled oats or oat groats are steamed for enzyme inactivation and then milled to form a shelf stable whole grain oat flour. The oat flour can be subsequently processed to form cooked cereal doughs which in turn are fabricated into R-T-E cereals of various types including flakes, biscuits, and importantly, puffed R-T-E cereals. The puffed R-T-E cereals can be of the popular ring shape or fabricated into other shapes, such as alphabet letters or animal shapes. By "whole grain oat flour" is meant herein an oat flour including its oil component obtained from dehulled oat groats. Processing for the provision of puffed whole grain oat based R-T-E cereals from cooked cereal doughs is particularly complex due to the multiplicity of problems of providing a whole grain R-T-E cereal in general, a puffed whole grain R-T-E cereal, and/or an oat based R-T-E cereal in particular, whether flaked or puffed. For example, one particular problem is that whole grain oat based cooked cereal doughs are notoriously difficult to puff possibly due to the high levels of fat and soluble gums, e.g., beta glucan. A second particular problem is that whole grain oat based R-T-E cereal products experience particularly severe stability problems due to the fat content. For these reasons, some puffed oat based R-T-E cereal products are prepared from defatted oat flour or are merely whole oat flour containing (i.e., have high levels of added starch or other cereal materials). Because of the difficulties of producing a puffed whole oat piece from cooked cereal dough pellets, gun puffing is used since gun puffing is the most vigorous form of cereal pellet puffing. A general problem in providing a puffed R-T-E cereal resides in the provision of an R-T-E cereal having the desirable "cooked grain" flavor. Many cereals can be cooked to gelatinize the starch component in a relatively short period of time. However, the imparting to the cooked cereal dough of a "nutty" or cooked grain flavor requires extended cook times. Traditional batch or semi-continuous cereal cookers can provide the requisite lengthy residence or long cook times to develop the desired "cooked grain" flavor feature. Unfortunately, however, traditional cookers used in the manufacture of whole grain based puffed R-T-E cereal products are very expensive. Thus, it would be highly desirable to be able to either increase the output of such cereal cookers by reducing the required cook time needed to produce a desired level of cooked cereal flavor or to increase the desirable cooked flavor for a given cook time in such traditional long cook time cereal cookers. Moreover, cooker extruders, whether single screw or double screw are increasingly popular, especially in the production of directly expanded R-T-E cereal products. However, since the residence time in the cooker extruder is so short, (e.g., 0.5 to eight minutes) the cooked cereal dough produced often is characterized as having an "uncooked" or "green" flavor rather than the desirable "cooked" or "nutty" flavor. Adding flavor additives to rectify the flavor deficiency is both expensive and marginally effective. Of course, the residence time in the cooker extruder can be increased modestly to further develop desirable flavor. However, the increase in the residence time in the cooker extruder also increases the amount of work imparted to the cooked cereal dough. As the cooked cereal dough is worked more, the texture is adversely affected leading to a pasty finished product having an undesirable eating texture. In direct expansion, the finished puffed products are produced directly from the cooker extruder thereby eliminating such conventional intermediate steps as dough tempering, pellet forming, pellet drying, and gun puffing of the pellets. By avoiding these intermediate steps, the cost of producing the finished R-T-E cereal is dramatically reduced. Due to the difficulty in developing cooked grain flavors in whole oat based R-T-E cereal doughs, cooker extruders have not been used for the preparation of direct expanded puffed whole grain oat R-T-E cereals. Surprisingly, in the present invention it has been found that by extending the steaming step and by adding a particular selected heat treatment of the oat groats prior to milling into a flour, that an improved high flavor, and partially cooked oat flour product can be prepared. Utilization of this high flavor, partially cooked oat flour can be used in conventional cereal processing with shorter cook times to produce finished R-T-E puffed whole grain oat cereal products having a desirable "nutty" cooked cereal flavor. By utilization of such an improved oat flour, increases in cereal processing outputs of up to 10% or more can be obtained without a loss in desirable end product flavor quality. More surprisingly, the improved whole grain oat flour can also be used in short cook time cooker extruders to produce whole oat grain based puffed R-T-E cereals of desirable texture and flavor properties. Even more surprisingly, directly expanded puffed whole grain oat based R-T-E cereals can be prepared which nonetheless exhibit high levels of cooked grain flavor. SUMMARY OF THE INVENTION In its primary method aspect, the present invention resides in methods for providing an improved conditioned whole oat flour having improved flavor and degree of cook. The present methods involve A) steaming oat groats; B) heat treating the steamed oat groats to obtain a conditioned oat groat; and C) milling the conditioned oat groat to form a whole grain oat flour. The flour has a ratio of the HPLC syringic acid peak to ferulic acid peak of ≧2.5:1, and a Farinograph cook time value of about five to 25 minutes. In its primary product aspect, the present invention resides in improved conditioned whole grain oat flours suitable for use in the preparation of whole grain oat based R-T-E cereal products. The whole grain oat flour is essentially characterized in part by a Farinograph cook time value ranging from about five to 25 minutes. The oat flour additionally is essentially characterized by a ratio of the HPLC syringic acid peak to ferulic acid peak of about ≧2.5:1. The present invention further provides methods for making an improved R-T-E cereal employing the present improved oat flour. These methods additionally comprise the steps of D) adding the flour with water and minor R-T-E cereal ingredients; E) cooking to form a cooked cereal dough; and F) forming the cooked cereal dough into a finished R-T-E cereal. In additional product aspects, the present invention provides improved conditioned oat groats for use in milling operations to produce an improved whole grain oat flour for use in the production of R-T-E cereals. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a block flow diagram of the present invention illustrating the preferred embodiment of the present invention including several variations thereof. Certain optional variations are indicated by dashed lines. DETAILED DESCRIPTION OF THE INVENTION The present invention provides improved conditioned oat groats, improved whole grain oat flour and methods for their preparation as well as methods for the preparation of R-T-E cereals made from such improved oat products. Each of the method steps as well as product use are described in detail below. Throughout the specification and claims, percentages are by weight and temperatures in degree Fahrenheit unless otherwise indicated. Referring now to the drawing, there is shown the preferred embodiment of the present process for preparing an improved whole grain oat flour generally designated by reference numeral 10. The methods 10 essentially comprise a first step of A) exposing dehulled oats or oat groats, whether whole or sectioned pieces, to steam, such as in conditioner 16, for sufficient times to deactivate their enzyme activity to provide a steamed enzyme inactivated or "conditioned" oat groat 17. The oat groats 12 starting material generally will have an initial moisture content ranging from about 8 to 10%. The steam injection conditioning step is designed primarily to inactivate the enzymes including lipase, lipoxigenase, peroxidase, amylase, and protease. The conditioned oat groats will have a negative peroxidase activity as measured by AAAC test method 963.27 (American Association of Cereal Chemists, 15th Ed., 1990). The steamed oat groats have a moisture content increased to about 16 to 25% by virtue of moisture absorption from the steaming exposure step. Generally, the step involves heating for about 10 to 15 minutes using steam at about 5 to 20 psig (120 to 150 KPa). Thereafter, the present methods essentially comprise the step of B) dry heating the steamed oat groats 17 such as by indirect steam contact to 185° to 230° F. (85° to 110° C.) in an appropriate vessel such as in toaster 18 for about 70 to 110 minutes to provide a conditioned and toasted oat groat 20. By virtue of the extended heat treatment, the oat groat moisture content is reduced to about 9 to 14%. The steamed, enzyme deactivated oat groats 17 are heated to lessen the energy requirements for cooked dough development and to develop a cooked flavor in the groats. Sufficient cooking is indicated by a Farinograph cook time value of about five to 25 minutes. For those flours to be used in cooker extruders such as a twin screw extruder better results in terms of reductions in needed duration of subsequent cook times is obtained when the Farinograph cook time value ranges from about five to eight minutes, while for extended cook time cookers, better results are obtained when the Farinograph cook time ranges from about 14 to 20 minutes. A Farinograph measurement is a standard test method by the American Association of Cereal Chemists: AACC test method 54-21. The present cook or development time is a modification of the AACC test except that 1) the oat flour herein is used in substitution for wheat flour, and 2) the start point is developed at 95° C. rather than room temperature. Generally, a Farinograph is used to measure the torque required to mix oat flour dough at heated temperature. The time needed to develop maximum torque indicates the level of energy input required to form a cohesive dough. A shorter dough development or cook time in the Farinograph is indicative of a higher level of steam pretreatment. In preferred embodiments (not depicted), the dry heating or toasting step includes a first substep of 1) venting the steam to form steamed and vented oat groats. The venting reduces the moisture content to about 15 to 20%. Thereafter, the dry heating step can include a second substep of dry heating the steamed and vented oat groats to form the steamed and toasted oat groats. The step can be practiced employing indirect steam or other dry heating technique. The dry heating technique is continued to yield the finished conditioned oat groat having a moisture content of about 9 to 14%. The skilled artisan will appreciate that the process can be practiced employing multiple vessels or a single vessel (e.g., gravity fed) having multiple sections or chambers. Dry heating as used herein means heating only in the presence of any moisture which may be inherently present in the flour as a result of the prior steaming step but not in the presence of any additional or added moisture nor in the presence of a humid atmosphere, i.e., ≧40% relative humidity. The finished steamed and toasted oat groats 20 result in a cooked cereal flavor in the resulting flour. The oat groats are further essentially characterized by a ratio of specific phenolic acids of about ≧2.5, preferably ≧3. One analytical method utilized to act as a marker for this flavor development is the HPLC (high performance liquid chromatography) area ratio of specific phenolic acids of ≧2.5. Specifically, the numerator is HPLC area for the syringic acid peak combined, and the denominator is ferulic acid peak area determined by HPLC retention times. The numerator area corresponds to concentration asnd has to this point been observed to range from about 10 to 35 ppm and the denominator will range from about 4 to 7 ppm. The syringic acid peak (including its associated phenolic ester having an HPLC elution time of 0.7 minutes differential) has been observed to be positively correlated with increased heat treatment of the oat groats while the ferulic acid level remains fairly level. Thus, increased heat treatment or toasting results in greater flavor development and in a greater amount of phenolic ester and a larger ratio value. The dry heating will continue to gelatinize the starch, but the primary function of the heating process is to toast the oat groat to generate a distinct toasted flavor. The toasted flavor in the oat flour will impart desirable flavor to the extruded cereal products. To ensure proper toasting, the moisture content and heated temperature of the oat groats, as well as the heating time play important factors. In general, the moisture content of the oat groats entering the heating zone (after venting) should be in the range of 15 to 20%. The heating temperature of the oat groats should be in the range of 185° to 230° F. The heating time is in the range of 70 to 110 minutes. As indicated in FIG. 1, the present invention further provides an improved intermediate product, namely, improved oat groats 20. The improved oat groats 20 are useful as an intermediate material that can be further processed by subsequent milling to form the present improved oat flour. While some plant production facilities are integrated to provide both steam treatment of oat groats and milling to produce oat flours, some production facilities are designed to perform either the steam treatment or the milling steps. The present methods additionally comprise the step of thereafter C) milling 22 the steamed and toasted oat groats 20 to form the present improved oat flour 24. In the R-T-E cereal preparation aspect of the present invention, the present methods additionally can comprise the step of D) combining the improved oat flour 24 with water 27 and minor amounts of other ingredients 29, (e.g., salt(s), sugar, starch) and E) cooking in a cooker 26 to form a cooked whole grain oat cereal dough 28. The cooked cereal dough 28 will have a moisture content of about 12 to 35%. Broadly, the present methods further comprise the step of F) forming the cooked cereal dough 28 into a finished R-T-E cereal. As depicted in FIG. 1, a variety of embodiments and variations within embodiments of various substeps can be used to practice the broad steps. For example, in one preferred embodiment, conventional extended cook time cereal cookers are employed to prepare the cooked cereal dough 28. In this embodiment, cook times can range from about 30 to 70 minutes at 200° to 230° F. (93° to 110° C.) representing a 5 to 15% reduction in cook times compared to conventional processing. Notwithstanding the reduced cook times, the oat based cooked cereal doughs 28 are characterized by the desired cooked flavor characteristic of an extended cooked cereal dough. In this preferred embodiment, step F can comprise the substep of 1) forming the dough 28 into pellets in a pellet former 30. In one variation the pellets can be thereafter 2) dried to a moisture content of about 8 to 14% in a pellet dryer 32 and then 3) puffed 36 (e.g., gun puffed) to form puffed whole grain puffed pieces 43. The puffed cereal pieces 43 can also be 4) toasted in toaster 40 to further develop a toasted oat flavor to form toasted oat puff pieces 45. In another variation of this embodiment, the dried pellets are optionally tempered in temper bins 34 or equivalently on temper belts and then flaked, such as with flaking rolls 38 to form wet oat flakes 45 having a moisture content of about 12 to 18% and then toasted in toaster 40 to tenderize and partially expand the flakes to form toasted oat flakes 47. In another embodiment, the oat flour 24 is combined with minor amounts of the other R-T-E cereal ingredients 29 and water 27 and cooked in a short time cooker extruder 26, whether a single screw or twin screw extruder, for about 0.5 to eight minutes and mechanically worked to form the cooked cereal dough 28. In preferred embodiments, the present whole grain oat flour comprises 80%> of the dough (dry weight basis). The dough can optionally include a variety of starches or other farinaceous materials. In one variation of this embodiment, the cooked cereal dough 28 is similarly processed as described above to produce either an oat flaked product 47 or a puffed oat product 43, including a toasted puffed oat product 45. The cooked dough 28 can be fed to a pellet former 30 or the cooker extruder 26 can be equipped with a pellet forming die head to form pellets 31 which are fed directly to the pellet dryer. In another variation, the cooked cereal dough 28 is extruded under conditions of temperature and pressure and through appropriately shaped and sized dies so as to cause an immediate expansion or puffing of the cooked cereal dough upon extruding to ambient conditions or "directly expanded." The directly expanded puffed oat cooked cereal dough is then face cut to form individual pieces 49. The puffed pieces can be any suitable size and shape such as letters or as ring shaped pieces. The individual puffed cereal pieces 49 can optionally be toasted to impart a desirable further developed toasted oat flavor to the puffed pieces 48 whether by radiant heating, hot air and/or high intensity microwave heating. It is a surprising advantage that the present oat flours can be used to produce by direct expansion high whole oat flour (i.e., 80%>, dry weight basis) puffed cooked cereal dough pieces 49 having a high toasted grain flavor. Thereafter, the oat puffed pieces or flakes, whether dried or toasted to 2 to 6% moisture, can be directly packaged 56 for sale to consumers. It has been previously known that oat material containing cooked cereal doughs can be directly expanded. However, the doughs in prior known methods suffered from one or more deficiencies including using oat flour ingredients that are defatted, or high levels of starch, or lack of cooked grain flavor, or had an undesirable texture due to overworking the cereal dough in the cooker extruder. In another variation, the oat pieces, whether puffed 45 or flaked 47 and/or toasted, can be presweetened by topically adding a sugar syrup sweetener composition 42. In this embodiment, the cereal pieces or cereal base, (45, 47) can be charged to an enrober 48 and the sugar syrup 42 heated in heater 46 is topically applied thereto. The enrobing tumbling action is continued for a few minutes to evenly coat the cereal base (45, 47). If desired, various particulates such as nut pieces, fruit bit pieces, bran, or other topical additives (not shown) can be added to the enrober 48. A vitamin solution 44 optionally can also be added to the cereal base such as by adding to enrober 48 such as by in line admixing with the heated sugar syrup 42 or by separately spraying in the enrober 48. The coated cereal base 49 whether puffed, flaked, shredded, biscuit, shredded biscuit, cut dough sheet pieces, or other forms is then dried in dryer 50 to a final moisture content of about 2 to 5% to remove the added moisture associated with the sugar syrup 44 to form a presweetened finished R-T-E cereal 53. The finished cereal 53 is then conventionally packaged 56 for distribution and sale to customers. The oat flour development time (or "Cook Times") values are measured using the following equipment and procedures. A dough made of oat flour and water is developed and cooked at 95° C. in a Brabender Do-corder (Brabender Do-corder Zype PL-V340 or equivalent equipped with a type 2-16-000 mixer/measuring head blade speed ratio/drive-to-driven:3.2) with sigma type blades (type SB). The Do-corder is colloquially referred to by cereal chemists as a Farinograph. The changes in the oat dough theological properties that occur during the analysis reflect the relative energy required to form a cohesive dough with the particular oat flour sample recorded on the Do-corder chart provide a functionality finger-print. DESCRIPTION OF TYPICAL TEST A 60 gram oat flour sample is transferred to the measuring head/mixing bowl. The bowl temperature is 95° C. and the two paddles inside the bowl are rotating, with the test speed set at 100 rpm. A block, with a port for the addition of water, is placed in the opening of the mixing bowl to prevent the evaporative loss of the moisture in the flour. The chart pen recording the resistance on the rotating paddles as a function of test time is set to the baseline (0 Consistency Units). The flour is given 150 seconds to heat. At the end of the 150 seconds, 25 milliliters of water is added through the port in the mixing bowl block. As an oat dough begins to form, the chart pen raises off the baseline to a height of 400 to 600 Consistency Units. An initial mixing peak viscosity is obtained within one minute of the addition of the water. After reaching a peak, the viscosity gradually declines for the next three to 15 minutes and reaches a minimum of 250 to 350 Consistency Units (The Trough Viscosity). At this point the dough viscosity begins to increase. At eight to 25 minutes into the analysis, the viscosity will peak at 380 to 420 Consistency Units and begin to decline. The test is concluded at this point. The Farinograph plot from the chart recorder will show two peaks. The first peak is the mixing peak and the second peak is the development peak. The Cook Time or development time as used herein is defined as the time point at which the increasing dough consistency portion of the development peak first reaches the dough consistency plateau value, or more simplistically, when the second viscosity increase ceases. The cook time decreases with increased degree of pretreatment. (Less than 15 minutes, higher level of pretreatment; 15 to 22 minutes, moderate level of pretreatment; greater than 22 minutes, low level of pretreatment). Test Parameters 1. Test Speed is 100 pm. 2. Sensitivity Selection is 1:5. 3. Zero Suppression is set to 0. 4. The oil bath controlling the measuring head mixing bowl temperature is set to 95° C. The temperature of the bowl as measured by a thermometer will be 94.5° to 95° C. 5. The sample size is 60 grams of oat flour and 25 mls of distilled water assuming an oat flour moisture of 12% WB. The sample size for an oat flour with a known moisture can be obtained from the attached chart. Procedure 1. Obtain at least 130 grams of the oat flour sample. Determine a moisture content using a certified secondary moisture method. 2. Using the attached chart, weigh out the appropriate mass of the oat flour sample (+0.05 to 0.1 grams to compensate for flour which will adhere to weigh boat). 3. Set the chart on the Do-corder to a 17 minute mark on the x axis of the graph. At this point ensure that the instrument is set to the appropriate test parameters and mixing bowl is securely in place and has reached 94.5° C. 4. Begin the transfer of the oat flour to the bowl. The transfer should be complete within one minute. (The chart will be at the 18 minute mark.) Using the zero adjustment, establish a baseline of 0 Consistency Units at this point. 5. Add the appropriate amount of water. The water addition should be complete within 30 seconds. 6. The dough viscosity will initially peak near the 0 minute mark on the chart recorder. The viscosity will then gradually decline, and then increase to reach a second peak somewhere between eight to 30 minutes after the 0 minute mark. The test can be terminated three minutes after this second peak is obtained. 7. Trough Viscosity: Find the lowest viscosity obtained after the initial mixing peak and before the second peak. Read the Consistency Units value from the center of the line on the chart. Peak Viscosity Find the highest viscosity obtained during the second peak. Read the Consistency Units value from the center of the line on the chart. Cook Time Draw a straight line through the center of the line on the chart through the peak viscosity and value obtained 30 seconds after the peak viscosity. The Cook Time is defined as the earliest point in time at which the drawn line intersects the center of the chart recorder line. EXAMPLE 1 Conditioned oat groats and a whole grain oat flour of the present invention were obtained by the following method. Oat groats were loaded on the top of the conditioner 16 at a rate of 150 lb/min. Steam (15 psig, 180 KPa) was injected into the conditioner at a rate of 1400 lb/min at a point about 4-5 ft below the top of the conditioner 16. The resident time of the steam injection was about 13 minutes. The oat groats 12 traveled downward by gravity. Following steaming, the steamed groats were heated by radiator type of steamed heater 18. The temperature of the groats reached about 215° F. The heating time was about 42 minutes. After the heating, the excess steam was vented through the side ports. The groats received continuous heating treatment for an additional 80 to 85 minutes. Typically, the oat groat temperature through the heating sections was in the range of 185° to 220° F. After heating, the grains were cooled to room temperature and tempered overnight. Oat flour was produced by grinding the conditioned oat groats following standard oat flour milling practice to obtain a whole grain oat flour. Several analytical tests were performed to measure the quality. The results were: ______________________________________peroxidase activity negativeFarinograph cook time: 16 minutessoluble phenolic ratio: 3______________________________________ The methanol soluble phenolic ratio of the syringic acid peak in the numerator and ferulic acid peak in the denominator was determined by high performance liquid chromatography (HPLC) as follows. A 5.00 g sample of oat flour is weighed into a centrifuge tube, and 25 ml of HPLC grade methanol is added. The sample is homogenized for specifically 30 seconds with an homogenizer at a rate of 25 to 30, e.g., using an Ultra Turrex™ homogenizer. Each sample is cooled in the refrigerator for a minimum of 15 minutes, and then centrifuged at full speed (3500 rpm) on an IEC HN-SII centrifuge for five minutes. The methanol is poured off into a round bottom flask and evaporated under reduced pressure at 25° to 30° C. until an oily residue remains. The residue is dissolved in 1 mL of HPLC grade methanol, and analyzed by HPLC. HPLC conditions are as follows: ______________________________________Parameter Value______________________________________Wavelength 280 nmSampling Rate 2 points/second (minimum)AUFS 100Filter Time Constant 1.0 secHigh Pressure Limit 2800 psi-3000 psiHelium Sparge Rate 25 mL/min (minimum)Initial Flow Rate 1.00 mL/min______________________________________ Analysis of phenolic compounds by HPLC requires the use of a gradient pumping system. The gradient profile for this analysis is shown in Table 3. Curve 6 listed in this table corresponds to a linear gradient. A 10 μL aliquot is injected onto a C18 reverse phase column (Waters Nova Pack, 4 μm, 3.9×150 mm), and the gradient listed below is utilized. ______________________________________Time Flow Rate % B % C (2.5% Acetic(min) (mL/min) Curve (Methanol) Acid in Water)______________________________________Initial 1.00 -- 0 10030 1.00 6 50 5030-31 1.00 6 50 5031-40 1.00 6 0 100______________________________________ There are several peaks that elute during the phenolic HPLC run of the oat flour extract. One peak has a retention or elution time corresponding to syringic acid (15 minutes) and this phenolic ester was observed to increase with increased heat treatment. The other peak has a retention time (21 min) corresponding to that of ferulic acid and this compound remains fairly consistent in the amount eluting. The ferulic peak is used as a natural internal standard. The peak area ratio of syringic acid peak (including the associated phenolic ester) to ferulic indicates heat treatment level of oat groats. EXAMPLE 2 An oat flour of the present invention was produced similarly as in Example 1. However, some modifications of the conditioning process were made. The feed rate of the groat was reduced to 150 lb/min. The steam injection rate was reduced to 1200 lb/min. The analytical results for the oat flour were: ______________________________________peroxidase activity: negativeFarinograph cook time: 18 minutessoluble phenolic ratio: 3.2______________________________________ EXAMPLE 3 The oat flour was produced similarly as in Example 1 with some modifications on the conditioning process. The heating temperature of the oat groats was reduced to 165° F. The resulting oat flour had the following characteristics. ______________________________________peroxidase activity: negativeFarinograph cook time: 22 minutessoluble phenolic ratio: 2.2______________________________________ The oat flour was judged to be unacceptable flour because both Farinograph cook time and phenolic ratio were outside the desirable ranges for flavor and cook time or development time.

Improved conditioned whole grain oat flours are provided for the improved production of whole grain Ready-To-Eat breakfast cereals, especially puffed. Whole oat groats are steamed for greater times, dry toasted for extended times and milled to provide the present conditioned oat flour. The oat flours have minimal peroxidase activity and a ratio of the HPLC syringic acid peak to ferulic acid peak, of about ≧2.5 which ratio is characteristic of a toasted flavor attribute. The conditioned oat flour has a Farinograph cook or development time value of about five to 25 minutes indicating partial gelatinization or partial precooking. Employment of the specially conditioned oat flour allows for the production of cooked whole grain oat based cereal doughs having improved desired cooked cereal flavors in traditional extended cook time cereal cookers in reduced times thereby increasing production rates. Also, employment of the present oat flours allows for the production of puffed whole grain oat R-T-E cereals from short residence time cooker extruders which nonetheless have a cooked cereal grain flavor including even by direct expansion.

FIELD OF THE INVENTION The present invention relates to a support for the abdomen. The support of the present invention is especially useful for supporting the distended abdomen during the later months of pregnancy, and will be described with a special reference to this application. However, the support of the present invention also is useful for abdominal support in cases where the abdomen is distended for other reasons e.g., obesity or muscle damage. BACKGROUND OF THE INVENTION A distended abdomen, typical of the later months of pregnancy, distorts a woman's posture, putting a strain on her back and upon her abdominal muscles. In the case of pregnancy, the weight of the fetus adds to the problem:- women in their third trimester of pregnancy typically suffer from strained backs and abdominal muscles, together with varicose veins caused by the abnormal pressure on the vascular system. These problems often cause fatigue, and in many cases cause considerable discomfort and even pain. Over the last 120 years, a number of abdominal supports have been proposed. For example, U.S. Pat. No. 284,831 dated Sep. 11, 1883 discloses a simple sling type of support, with a broad band passing under and over the lower part of the abdomen, supported from shoulder straps. However, the design incorporates very little adjustment:-the only adjustment is the length of each shoulder strap, at a point along the length of the strap above the front of the abdomen. This type of adjustment offers little scope for the very wide range of body sizes and shapes which need to be accommodated, so that a range of different sizes of support would have to be manufactured. Further, the adjustment is such that it tends to pull the abdominal sling upwards over the abdomen:-this does not give optimum support to the abdomen. U.S. Pat. No. 3,273,563 dated Sep. 20, 1966 discloses a design very similar to that of No. U.S. Pat. No. 284,831, but with the addition of a belt around the wearer's back, presumably to improve support. However, the straps are adjusted in a very similar position to that disclosed in U.S. Pat. No. 284,831, with much the same disadvantages. U.S. Pat. No. 4,005,715 dated Feb. 1, 1977 also discloses a design generally similar to U.S. Pat. No. 284,831 but with the only adjustment located under each armpit. In fact, the design offers minimal adjustment and appears to rely almost entirely on the elasticity of the material used for providing adequate support. A number of prior proposals show abdominal supports incorporated into garments:—U.S. Pat. No. 3,621,849 dated Nov. 23, 1971, U.S. Pat. No. 4,789,372 dated Dec. 6, 1988, U.S. Pat. No. 4,835,795 dated Jun. 6, 1989, U.S. Pat. No. 4,746,318 dated May 24, 1988, U.S. Pat. No. 4,822,317 dated Apr. 18, 1989, U.S. Pat. No. 4,952,192 dated Aug. 28, 1990 and U.S. Pat. No. 5,928,059 dated Jul. 27, 1999. In all these patents, a support is incorporated into a girdle (often including a bra) or panty or even incorporated into a bodysuit. The more comprehensive the support, the more complex the adjustments required to make it fit comfortably, and the hotter it is to wear. Since a woman's body generates a great deal of surplus heat during the later months of pregnancy, a support which makes the wearer even hotter is unlikely to prove an advantage, no matter how much support it offers. Further, the garment type of support in most cases would need to be made in a very large range of sizes, to fit all body sizes and types; this very greatly increases the cost of the support. OBJECT OF THE INVENTION It is an object of the present invention to provide an abdominal support which is not incorporated into a garment and which is effective in transferring part of the abdominal load to the wearer's shoulders whilst offering a wide range of adjustment to suit the wearer's particular size and shape. A further object of the present invention is to provide an abdominal support which lifts and cradles the abdominal bulge rather than compressing it, as if the bulge were being supported and lifted by the wearer's own hands. A further object is to provide an abdominal support which can be easily and comfortably adjusted by the wearer in use. DISCLOSURE OF INVENTION The present invention provides an abdominal support not incorporated in a garment, said support including a pair of shoulder and back straps, each of which is designed to pass over one of the wearer's shoulders, cross over the wearer's upper back, and connect to the other shoulder and back strap at the wearer's side; a sling support secured to each shoulder and back strap at or adjacent to the wearer's side; and a supporting sling arranged so as to extend from one sling support to the other, passing beneath the wearer's abdomen in use, said sling incorporating length adjustment means. Said sling length adjustment means may comprise forming the sling as two overlapping portions provided with complementary fasteners, preferably hook and loop fasteners. Alternatively, said sling length adjustment means is constituted by arranging each end of the sling to pass through the adjacent sling support and be doubled back on itself, each end of the sling being releasably securable to the remainder of the sling, preferably by hook and loop fasteners. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT By way of example only, a preferred embodiment of the present invention is described in detail with reference to the accompanying drawings, in which:- FIG. 1 is a front view of a person wearing the support of the present invention; FIG. 2 is a side view of the person of FIG. 1 ; FIG. 2 a is a plan view of part of FIG. 2 on an enlarged scale; and FIG. 3 is a rear view of the person of FIG. 1 . Referring to the drawings, a support 2 in accordance with the present invention comprises first and second shoulder straps 3 , 4 , each of which is secured at one end to a corresponding back strap 5 , 6 and at the other end to a fitting 7 , 8 . The free end of each back strap also is secured to the corresponding fitting 7 , 8 . Thus, the shoulder straps 3 , 4 , back straps 5 , 6 and fitting 7 , 8 together form an upper body harness which provides a pair of shoulder straps each of which passes over the wearer's shoulder, across the wearer's upper back, and is secured to the corresponding fitting a short distance below and in front of the wearer's arm on the opposite side to the corresponding shoulder. Each shoulder strap 3 , 4 is wide and padded, to spread the load and to avoid any cutting in. Each shoulder strap 3 , 4 optionally may be adjustable in length, by incorporating a known type of adjusting buckle 3 a , 4 a . Each back strap 5 , 6 preferably is made of wide elastic material and may be formed as two separate straps or (as shown) as a combined v-shaped strap. Each fitting 7 , 8 provides an anchorage for the respective end of the shoulder and back straps, and also for the remainder of the support, as hereinafter described. Each fitting 7 , 8 is a rectangular buckle as shown in detail in FIG. 2 a . At each side of the wearer, one end of the back strap 5 , 6 is secured to one of the long sides a of the respective fitting 8 , 7 , and the end of the shoulder strap 4 , 3 is secured to a short side b of the fitting 8 , 7 . The straps are secured to the buckle simply by looping the ends of the straps around the buckle and sewing the end to the remainder of the strap. The lower part of the support comprises a sling 9 in the form of a wide band of suitable material (e.g. cotton fabric) which is of sufficient length to extend from one side of the wearer's abdomen, around the other long side c of the first fitting 7 , underneath the lower abdomen of the wearer, around the other long side of the other fitting 8 , and down the other side of the wearer's abdomen. Each fitting 7 , 8 simply needs to provide a secure anchorage for supporting the sling 9 , through which the sling can slide and turn back on itself. The center portion of the sling 9 carries a length of hook and loop fastener 10 on its outer surface, as indicated in broken lines in FIG. 1 . The ends of the sling each carry a complementary strip of hook and loop fastener on their underside (not visible). Each end of the sling also carries a mitten or pocket 11 , 12 which provides space for the insertion of two or more of the wearer's fingers, as shown in FIG. 1 . Alternatively, the mitten or pocket could be formed as a loop. The above described support is used as follows:- first, the wearer puts on the upper body harness and, if necessary, adjusts the length of the shoulder straps 3 , 4 so that each fitting 7 , 8 hangs at the side of the wearer, at a level somewhere between the wearer's bust and waist. The sling 9 is loosely adjusted under the wearer's lower abdomen, so that it lies comfortably underneath the abdominal bulge. The wearer then inserts one hand into each mitten 11 , 12 and moves her hands into the position shown in FIG. 1 (i.e. as though supporting the abdominal bulge with her hands) whilst gently pulling on the ends of the sling 9 until the sling gives comfortable but firm support to the abdominal bulge. When the sling is comfortably adjusted, the wearer simply presses the section of hook and loop fastener at the end of each sling under the complementary section of hook and loop fastener 10 on the outer surface of the sling, thus securing the sling at the required length. The wearer then removes her hands from the mittens. An alternative design for the sling 9 is shown in FIG. 1 only:—In this case, the ends of the sling 9 carrying the mittens 11 , 12 are omitted, and the portions of the sling which pass through the fittings 7 , 8 are permanently secured to those fittings. The center portion of the sling 9 is formed as two pieces, each carrying a complementary section of hook and loop fastener. The length of the sling is adjusted by the wearer by adjusting the degree of overlap of the two portions of the sling 9 ; the end of one overlapping portion is indicated by broken lines 9 a. If the wearer requires extra back support, a back waist belt 13 may be fastened between the fittings 7 and 8 , across the back of the wearer, as shown in broken lines in FIG. 3 . The belt 13 may be made of a single elastic section or two or more sections adjustable in length by means of hook and loop fasteners. The above described support can be quickly and easily put on or removed or adjusted to give a firmer or less firm support. It will be appreciated that the support transfers much of the weight of the abdominal bulge directly to the shoulders and upper back; this weight is well spread due to the wide shoulder straps and wide, elastic back straps. The crossover design of the back straps prevents the shoulder straps from slipping off the shoulder. Since the sling is supported only from the sides, it cradles and lifts the abdominal bulge rather than trying to compress it:—this is very much more comfortable for the wearer. Further, because the upper body harness contacts only the shoulders and upper back, the wearer's chest is not constricted in any way. The support can easily be adjusted to suit a range of body sizes and types.

An abdominal support which includes a pair of shoulder and back straps, each of which passes over one of the wearers shoulders, crosses over the wearer's upper back, and connects to the other shoulder and back strap at the wearer's side; a sling support is secured to each shoulder and back strap at or adjacent the wearers side and a support sling extends from one sling support to the other, passing beneath the wearer's abdomen in use; the sling incorporates length adjusters.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of co-pending U.S. patent application Ser. No. 10/395,031, filed Mar. 21, 2003, now U.S. Pat. No. ______, which is a continuation of International Application PCT/NL01/00697, filed Sep. 21, 2001, designating the United States, published in English Mar. 28, 2002, as WO 02/024906 A1 and subsequently published with corrections Jan. 23, 2003, as WO 02/024906 C2, the contents of the entirety of each of which are hereby incorporated herein by this reference. TECHNICAL FIELD [0002] The invention relates to the field of gene therapy. BACKGROUND [0003] Given the rapid advances of human genome research, professionals and the public expect that the near future will bring us, in addition to understanding of disease mechanisms and refined and reliable diagnostics, therapies for many devastating genetic diseases. [0004] While it is hoped that for some (e.g., metabolic) diseases, the improved insights will bring easily administrable small-molecule therapies, it is likely that in most cases one or another form of gene therapy will ultimately be required, i.e., the correction, addition or replacement of the defective gene product. [0005] In the past few years, research and development in this field have highlighted several technical difficulties which need to be overcome, e.g., related to the large size of many genes involved in genetic disease (limiting the choice of suitable systems to administer the therapeutic gene), the accessibility of the tissue in which the therapeutic gene should function (requiring the design of specific targeting techniques, either physically, by restricted injection, or biologically, by developing systems with tissue-specific affinities) and the safety to the patient of the administration system. These problems are to some extent interrelated, and it can be generally concluded that the smaller the therapeutic agent is, the easier it will become to develop efficient, targetable and safe administration systems. BRIEF SUMMARY OF THE INVENTION [0006] The present invention addresses this problem by inducing so-called exon-skipping in cells. Exon-skipping results in mature mRNA that does not contain the skipped exon and thus, when the exon codes for amino acids, can lead to the expression of an altered product. Technology for exon-skipping is currently directed toward the use of so-called “Anti-sense Oligonucleotides” (AONs). [0007] Much of this work is done in the mdx mouse model for Duchenne muscular dystrophy (DMD). The mdx mouse, which carries a nonsense mutation in exon 23 of the dystrophin gene, has been used as an animal model of Duchenne muscular dystrophy. Despite the mdx mutation, which should preclude the synthesis of a functional dystrophin protein, rare, naturally occurring dystrophin-positive fibers have been observed in mdx muscle tissue. These dystrophin-positive fibers are thought to have arisen from an apparently naturally occurring exon-skipping mechanism, either due to somatic mutations or through alternative splicing. [0008] AONs directed to, respectively, the 3′ and 5′ splice sites of introns 22 and 23 in dystrophin pre-mRNA have been shown to interfere with factors normally involved in removal of intron 23 so that exon 23 was also removed from the mRNA (Wilton, 1999). In a similar study, Dunckley et al. (1998) showed that exon skipping using AONs directed to3′ and 5′ splice sites can have unexpected results. They observed skipping of not only exon 23 but also of exons 24-29, thus resulting in an mRNA containing an exon 22-exon 30 junction. [0009] The underlying mechanism for the appearance of the unexpected 22-30 splicing variant is not known. It could be due to the fact that splice sites contain consensus sequences leading to promiscuous hybridization of the oligos used to direct the exon skipping. Hybridization of the oligos to other splice sites than the sites of the exon to be skipped of course could easily interfere with the accuracy of the splicing process. On the other hand, the accuracy could be lacking due to the fact that two oligos (for the 5′ and the 3′ splice site) need to be used. Pre-mRNA containing one but not the other oligo could be prone to unexpected splicing variants. [0010] To overcome these and other problems, the present invention provides a method for directing splicing of a pre-mRNA in a system capable of performing a splicing operation comprising contacting the pre-mRNA in the system with an agent capable of specifically inhibiting an exon inclusion signal of at least one exon in the pre-mRNA, the method further comprising allowing splicing of the pre-mRNA. Interfering with an exon inclusion signal (EIS) has the advantage that such elements are located within the exon. By providing an antisense oligo for the interior of the exon to be skipped, it is possible to interfere with the exon inclusion signal, thereby effectively masking the exon from the splicing apparatus. The failure of the splicing apparatus to recognize the exon to be skipped thus leads to exclusion of the exon from the final mRNA. [0011] The present invention does not interfere directly with the enzymatic process of the splicing machinery (the joining of the exons). It is thought that this allows the method to be more robust and reliable. It is thought that an EIS is a particular structure of an exon that allows splice acceptor and donor to assume a particular spatial conformation. In this concept, it is the particular spatial conformation that enables the splicing machinery to recognize the exon. However, the invention is certainly not limited to this model. [0012] It has been found that agents capable of binding to an exon can inhibit an EIS. Agents may specifically contact the exon at any point and still be able to specifically inhibit the EIS. The mRNA may be useful in itself. For instance, production of an undesired protein can be at least in part reduced by inhibiting inclusion of a required exon into the mRNA. A preferred method of the invention further comprises allowing translation of mRNA produced from splicing of the pre-mRNA. Preferably, the mRNA encodes a functional protein. In a preferred embodiment, the protein comprises two or more domains, wherein at least one of the domains is encoded by the mRNA as a result of skipping of at least part of an exon in the pre-mRNA. [0013] Exon skipping will typically, though not necessarily, be of relevance for proteins in the wild-type configuration, having at least two functional domains that each performs a function, wherein the domains are generated from distinct parts of the primary amino acid sequence. Examples are, for instance, transcription factors. Typically, these factors comprise a DNA binding domain and a domain that interacts with other proteins in the cell. Skipping of an exon that encodes a part of the primary amino acid sequence that lies between these two domains can lead to a shorter protein that comprises the same function, at least in part. Thus, detrimental mutations in this intermediary region (for instance, frame-shift or stop mutations) can be at least in part repaired by inducing exon skipping to allow synthesis of the shorter (partly) functional protein. [0014] Using a method of the invention, it is also possible to induce partial skipping of the exon. In this embodiment, the contacting results in activation of a cryptic splice site in a contacted exon. This embodiment broadens the potential for manipulation of the pre-mRNA leading to a functional protein. Preferably, the system comprises a cell. Preferably, the cell is cultured in vitro or in the organism in vivo. Typically, though not necessarily, the organism comprises a human or a mouse. [0015] In a preferred embodiment, the invention provides a method for at least in part decreasing the production of an aberrant protein in a cell, the cell comprising pre-mRNA comprising exons coding for the protein, the method comprising providing the cell with an agent capable of specifically inhibiting an exon inclusion signal of at least one of the exons, the method further comprising allowing translation of mRNA produced from splicing of the pre-mRNA. [0016] Any agent capable of specifically inhibiting an exon exclusion signal can be used for the present invention. Preferably, the agent comprises a nucleic acid or a functional equivalent thereof Preferably, but not necessarily, the nucleic acid is in single-stranded form. Peptide nucleic acid and other molecules comprising the same nucleic acid binding characteristics in kind, but not necessarily in amount, are suitable equivalents. Nucleic acid or an equivalent may comprise modifications to provide additional functionality. For instance, 2′-O-methyl oligoribonucleotides can be used. These ribonucleotides are more resistant to RNAse action than conventional oligonucleotides. [0017] In a preferred embodiment of the invention, the exon inclusion signal is interfered with by an antisense nucleic acid directed to an exon recognition sequence (ERS). These sequences are relatively purine-rich and can be distinguished by scrutinizing the sequence information of the exon to be skipped (Tanaka et al., 1994, Mol. Cell. Biol. 14, p. 1347-1354). Exon recognition sequences are thought to aid inclusion into mRNA of so-called weak exons (Achsel et al., 1996, J. Biochem. 120, p. 53-60). These weak exons comprise, for instance, 5′ and or 3′ splice sites that are less efficiently recognized by the splicing machinery. In the present invention, it has been found that exon skipping can also be induced in so-called strong exons, i.e., exons which are normally efficiently recognized by the splicing machinery of the cell. From any given sequence, it is (almost) always possible to predict whether the sequence comprises putative exons and to determine whether these exons are strong or weak. Several algorithms for determining the strength of an exon exist. A useful algorithm can be found on the NetGene2 splice site prediction server (Brunak, et al., 1991, J. Mol. Biol. 220, p. 49-65). Exon skipping by a means of the invention can be induced in (almost) every exon, independent of whether the exon is a weak exon or a strong exon and also independent of whether the exon comprises an ERS. In a preferred embodiment, an exon that is targeted for skipping is a strong exon. In another preferred embodiment, an exon targeted for skipping does not comprise an ERS. [0018] Methods of the invention can be used in many ways. In one embodiment, a method of the invention is used to at least in part decrease the production of an aberrant protein. Such proteins can, for instance, be onco-proteins or viral proteins. In many tumors, not only the presence of an onco-protein but also its relative level of expression has been associated with the phenotype of the tumor cell. Similarly, not only the presence of viral proteins but also the amount of viral protein in a cell determines the virulence of a particular virus. Moreover, for efficient multiplication and spread of a virus, the timing of expression in the life cycle and the balance in the amount of certain viral proteins in a cell determines whether viruses are efficiently or inefficiently produced. Using a method of the invention, it is possible to lower the amount of aberrant protein in a cell such that, for instance, a tumor cell becomes less tumorigenic (metastatic) and/or a virus-infected cell produces less virus. [0019] In a preferred embodiment, a method of the invention is used to modify the aberrant protein into a functional protein. In one embodiment, the functional protein is capable of performing a function of a protein normally present in a cell but absent in the cells to be treated. Very often, even partial restoration of function results in significantly improved performance of the cell thus treated. Due to the better performance, such cells can also have a selective advantage over unmodified cells, thus aiding the efficacy of the treatment. [0020] This aspect of the invention is particularly suited for the restoration of expression of defective genes. This is achieved by causing the specific skipping of targeted exons, thus bypassing or correcting deleterious mutations (typically stop-mutations or frame-shifting point mutations, single- or multi-exon deletions or insertions leading to translation termination). [0021] Compared to gene-introduction strategies, this novel form of splice-modulation gene therapy requires the administration of much smaller therapeutic reagents, typically, but not limited to, 14-40 nucleotides. In a preferred embodiment, molecules of 14-25 nucleotides are used since these molecules are easier to produce and enter the cell more effectively. The methods of the invention allow much more flexibility in the subsequent design of effective and safe administration systems. An important additional advantage of this aspect of the invention is that it restores (at least some of) the activity of the endogenous gene, which still possesses most or all of its gene-regulatory circuitry, thus ensuring proper expression levels and the synthesis of tissue-specific isoforms. [0022] This aspect of the invention can in principle be applied to any genetic disease or genetic predisposition to disease in which targeted skipping of specific exons would restore the translational reading frame when this has been disrupted by the original mutation, provided that translation of an internally slightly shorter protein is still fully or partly functional. Preferred embodiments for which this application can be of therapeutic value are: predisposition to second hit mutations in tumor suppressor genes, e.g., those involved in breast cancer, colon cancer, tuberous sclerosis, neurofibromatosis etc., where (partial) restoration of activity would preclude the manifestation of nullosomy by second hit mutations and thus would protect against tumorigenesis. Another preferred embodiment involves the (partial) restoration of defective gene products which have a direct disease causing effect, e.g., hemophilia A (clotting factor VIII deficiency), some forms of congenital hypothyroidism (due to thyroglobulin synthesis deficiency) and Duchenne muscular dystrophy (DMD), in which frame-shifting deletions, duplications and stop mutations in the X-linked dystrophin gene cause severe, progressive muscle degradation. DMD is typically lethal in late adolescence or early adulthood, while non-frame-shifting deletions or duplications in the same gene cause the much milder Becker muscular dystrophy (BMD), compatible with a life expectancy between 35-40 years to normal. In the embodiment as applied to DMD, the present invention enables exon skipping to extend an existing deletion (or alter the mRNA product of an existing duplication) by as many adjacent exons as required to restore the reading frame and generate an internally slightly shortened, but still functional, protein. Based on the much milder clinical symptoms of BMD patients with the equivalent of this induced deletion, the disease in the DMD patients would have a much milder course after AON-therapy. [0023] Many different mutations in the dystrophin gene can lead to a dysfunctional protein. (For a comprehensive inventory see www.dmd.nl, the internationally accepted database for DMD and related disorders.) The precise exon to be skipped to generate a functional dystrophin protein varies from mutation to mutation. Table 1 comprises a non-limiting list of exons that can be skipped and lists for the mentioned exons some of the more frequently occurring dystrophin gene mutations that have been observed in humans and that can be treated with a method of the invention. Skipping of the mentioned exon leads to a mutant dystrophin protein comprising at least the functionality of a Becker mutant. Thus, in one embodiment, the invention provides a method of the invention wherein the exon inclusion signal is present in exon numbers 2, 8, 19, 29, 43, 44, 45, 46, 50, 51, 52 or 53 of the human dystrophin gene. The occurrence of certain deletion/insertion variations is more frequent than others. In the present invention, it was found that by inducing skipping of exon 46 with a means or a method of the invention, approximately 7% of DMD-deletion containing patients can be treated, resulting in the patients to comprise dystrophin-positive muscle fibers. By inducing skipping of exon 51, approximately 15% of DMD-deletion containing patients can be treated with a means or method of the invention. Such treatment will result in the patient having at least some dystrophin-positive fibers. Thus, with either skipping of exon 46 or 51 using a method of the invention, approximately 22% of the patients containing a deletion in the dystrophin gene can be treated. Thus, in a preferred embodiment of the invention, the exon exclusion signal is present in exon 46 or exon 51. In a particularly preferred embodiment, the agent comprises a nucleic acid sequence according to hAON#4, hAON#6, hAON#8, hAON#9, hAON#11 and/or one or more of hAON#21-30 or a functional part, derivative and/or analogue of the hAON. A functional part, derivative and/or analogue of the hAON comprises the same exon skipping activity in kind, but not necessarily in amount, in a method of the invention. [0000] TABLE 1 Therapeutic for Exon to be DMD-deletions Frequency in skipped (exons) www.dmd.nl (%) 2 3-7 2 8 3-7 4 4-7 5-7 6-7 43 44 5 44-47 44 35-43 8 45 45-54 45 18-44 13 46-47 44 46-48 46-49 46-51 46-53 46 45 7 50 51 5 51-55 51 50 15 45-50 48-50 49-50 52 52-63 52 51 3 53 53-55 53 45-52 9 48-52 49-52 50-52 52 [0024] It can be advantageous to induce exon skipping of more than one exon in the pre-mRNA. For instance, considering the wide variety of mutations and the fixed nature of exon lengths and amino acid sequence flanking such mutations, the situation can occur that for restoration of function more than one exon needs to be skipped. A preferred but non-limiting example of such a case in the DMD deletion database is a 46-50 deletion. Patients comprising a 46-50 deletion do not produce functional dystrophin. However, an at least partially functional dystrophin can be generated by inducing skipping of both exon 45 and exon 51. Another preferred but non-limiting example is patients comprising a duplication of exon 2. By providing one agent capable of inhibiting an EIS of exon 2, it is possible to partly skip either one or both exons 2, thereby regenerating the wild-type protein next to the truncated or double exon 2 skipped protein. Another preferred but non-limiting example is the skipping of exons 45 through 50. This generates an in-frame Becker-like variant. This Becker-like variant can be generated to cure any mutation localized in exons 45, 46, 47, 48, 49, and/or 50 or combinations thereof. In one aspect, the invention therefore provides a method of the invention further comprising providing the cell with another agent capable of inhibiting an exon inclusion signal in another exon of the pre-mRNA. Of course, it is completely within the scope of the invention to use two or more agents for the induction of exon skipping in pre-mRNA of two or more different genes. [0025] In another aspect, the invention provides a method for selecting the suitable agents for splice-therapy and their validation as specific exon-skipping agents in pilot experiments. A method is provided for determining whether an agent is capable of specifically inhibiting an exon inclusion signal of an exon, comprising providing a cell having a pre-mRNA containing the exon with the agent, culturing the cell to allow the formation of an mRNA from the pre-mRNA and determining whether the exon is absent the mRNA. In a preferred embodiment, the agent comprises a nucleic acid or a functional equivalent thereof, the nucleic acid comprising complementarity to a part of the exon. Agents capable of inducing specific exon skipping can be identified with a method of the invention. It is possible to include a prescreen for agents by first identifying whether the agent is capable of binding with a relatively high affinity to an exon containing nucleic acid, preferably RNA. To this end, a method for determining whether an agent is capable of specifically inhibiting an exon inclusion signal of an exon is provided, further comprising first determining in vitro the relative binding affinity of the nucleic acid or functional equivalent thereof to an RNA molecule comprising the exon. [0026] In yet another aspect, an agent is provided that is obtainable by a method of the invention. In a preferred embodiment, the agent comprises a nucleic acid or a functional equivalent thereof Preferably the agent, when used to induce exon skipping in a cell, is capable of at least in part reducing the amount of aberrant protein in the cell. More preferably, the exon skipping results in an mRNA encoding a protein that is capable of performing a function in the cell. In a particularly preferred embodiment, the pre-mRNA is derived from a dystrophin gene. Preferably, the functional protein comprises a mutant or normal dystrophin protein. Preferably, the mutant dystrophin protein comprises at least the functionality of a dystrophin protein in a Becker patient. In a particularly preferred embodiment, the agent comprises the nucleic acid sequence of hAON#4, hAON#6, hAON#8, hAON#9, hAON#11 and/or one or more of hAON#21-30 or a functional part, derivative and/or analogue of the hAON. A functional part, derivative and/or analogue of the hAON comprises the same exon skipping activity in kind, but not necessarily in amount, in a method of the invention. [0027] The art describes many ways to deliver agents to cells. Particularly, nucleic acid delivery methods have been widely developed. The artisan is well capable of determining whether a method of delivery is suitable for performing the present invention. In a non-limiting example, the method includes the packaging of an agent of the invention into liposomes, the liposomes being provided to cells comprising a target pre-mRNA. Liposomes are particularly suited for delivery of nucleic acid to cells. Antisense molecules capable of inducing exon skipping can be produced in a cell upon delivery of nucleic acid containing a transcription unit to produce antisense RNA. Non-limiting examples of suitable transcription units are small nuclear RNA (SNRP) or tRNA transcription units. The invention, therefore, further provides a nucleic acid delivery vehicle comprising a nucleic acid or functional equivalent thereof of the invention capable of inhibiting an exon inclusion signal. In one embodiment, the delivery vehicle is capable of expressing the nucleic acid of the invention. Of course, in case, for instance, single-stranded viruses are used as a vehicle, it is entirely within the scope of the invention when such a virus comprises only the antisense sequence of an agent of the invention. In another embodiment of single strand viruses, AONs of the invention are encoded by small nuclear RNA or tRNA transcription units on viral nucleic encapsulated by the virus as vehicle. A preferred single-stranded virus is adeno-associated virus. [0028] In yet another embodiment, the invention provides the use of a nucleic acid or a nucleic acid delivery vehicle of the invention for the preparation of a medicament. In a preferred embodiment, the medicament is used for the treatment of an inherited disease. More preferably, the medicament is used for the treatment of Duchenne Muscular Dystrophy. BRIEF DESCRIPTION OF THE DRAWINGS [0029] FIG. 1 . Deletion of exon 45 is one of the most frequent DMD-mutations. Due to this deletion, exon 44 is spliced to exon 46, the translational reading frame is interrupted, and a stop codon is created in exon 46 leading to a dystrophin deficiency. Our aim is to artificially induce the skipping of an additional exon, exon 46, in order to reestablish the reading frame and restore the synthesis of a slightly shorter, but largely functional, dystrophin protein as found in the much milder affected Becker muscular dystrophy patients affected by a deletion of both exons 45 and 46. [0030] FIG. 2 . Exon 46 contains a purine-rich region that is hypothesized to have a potential role in the regulation of its splicing in the pre-mRNA. A series of overlapping 2′O-methyl phosphorothioate antisense oligoribonucleotides (AONs) was designed directed at this purine-rich region in mouse dystrophin exon 46. The AONs differ both in length and sequence. The chemical modifications render the AONs resistant to endonucleases and RNaseH inside the muscle cells. To determine the transfection efficiency in our in vitro studies, the AONs contained a 5′ fluorescein group which allowed identification of AON-positive cells. [0031] FIG. 3 . To determine the binding affinity of the different AONs to the target exon 46 RNA, we performed gel mobility shift assays. In this figure, the five mAONs (mAON#4, 6, 8, 9, and 11) with highest affinity for the target RNA are shown. Upon binding of the AONs to the RNA, a complex is formed that exhibits a retarded gel mobility as can be determined by the band shift. The binding of the AONs to the target was sequence-specific. A random mAON, i.e. not specific for exon 46, did not generate a band shift. [0032] FIGS. 4A and 4B . The mouse- and human-specific AONs which showed the highest binding affinity in the gel mobility shift assays were transfected into mouse and human myotube cultures. [0033] FIG. 4A . RT-PCR analysis showed a truncated product, of which the size corresponded to exon 45 directly spliced to exon 47, in the mouse cell cultures upon transfection with the different mAONs#4, 6, 9, and 11. No exon 46 skipping was detected following transfection with a random AON. [0034] FIG. 4B . RT-PCR analysis in the human muscle cell cultures derived from one unaffected individual (C) and two unrelated DMD patients (P1 and P2) revealed truncated products upon transfection with hAON#4 and hAON#8. In the control, this product corresponded to exon 45 spliced to exon 47, while in the patients, the fragment size corresponded to exon 44 spliced to exon 47. No exon 46 skipping was detected in the non-transfected cell cultures or following transfection with a random hAON. Highest exon 46 skipping efficiencies were obtained with hAON#8. [0035] FIG. 5 . Sequence data from the RT-PCR products obtained from patient DL279.1 (corresponding to P1 in FIG. 4 ), which confirmed the deletion of exon 45 in this patient (upper panel), and the additional skipping of exon 46 following transfection with hAON#8 (lower panel). The skipping of exon 46 was specific, and exon 44 was exactly spliced to exon 47, which reestablishes the translational reading frame. [0036] FIG. 6 . Immunohistochemical analysis of the muscle cell culture from patient DL279.1 upon transfection with hAON#8. Cells were subject to two different dystrophin antibodies raised against different regions of the protein, located proximally (ManDys-1, ex. 31-32) and distally (Dys-2, ex. 77-79) from the targeted exon 46. The lower panel shows the absence of a dystrophin protein in the myotubes, whereas the hAON#8-induced skipping of exon 46 clearly restored the synthesis of a dystrophin protein as detected by both antibodies (upper panel). [0037] FIG. 7A . RT-PCR analysis of RNA isolated from human control muscle cell cultures treated with hAON#23, #24, #27, #28, or #29. An additional aberrant splicing product was obtained in cells treated with hAON#28 and #29. Sequence analysis revealed the utilization of an in-frame cryptic splice site within exon 51 that is used at a low frequency upon AON treatment. The product generated included a partial exon 51, which also had a restored reading frame, thereby confirming further the therapeutic value. [0038] FIG. 7B . A truncated product, with a size corresponding to exon 50 spliced to exon 52, was detected in cells treated with hAON#23 and #28. Sequence analysis of these products confirmed the precise skipping of exon 51. [0039] FIG. 8A . Gel mobility shift assays were performed to determine the binding affinity of the different h29AON#'s for the exon 29 target RNA. When compared to non-hybridized RNA (none), h29AON#1, #2, #4, #6, #9, #10, and #11 generated complexes with lower gel mobilities, indicating their binding to the RNA. A random AON derived from dystrophin exon 19 did not generate a complex. [0040] FIG. 8B . RT-PCR analysis of RNA isolated from human control muscle cell cultures treated with h29AON#1, #2, #4, #6, #9, #10, or #11 revealed a truncated product of which the size corresponded to exon 28 spliced to exon 30. These results indicate that exon 29 can specifically be skipped using AONs directed to sequences either within (h29AON#1, #2, #4, or #6) or outside (h29AON#9, #10, or #11) the hypothesized ERS in exon 29. An additional aberrant splicing product was observed that resulted from skipping of both exon 28 and exon 29 (confirmed by sequence data not shown). Although this product was also present in non-treated cells, suggesting that this alternative skipping event may occur naturally, it was enhanced by the AON-treatment. AON 19, derived from dystrophin exon 19, did not induce exon 29 skipping. [0041] FIG. 8C . The specific skipping of exon 29 was confirmed by sequence data from the truncated RT-PCR fragments. Shown here is the sequence obtained from the exon 29 skipping product in cells treated with h29AON#1. [0042] FIG. 9A . RT-PCR analysis of RNA isolated from mouse gastrocnemius muscles two days post-injection of 5, 10, or 20 ng of either mAON#4, #6, or #11. Truncated products, with a size corresponding to exon 45 spliced to exon 47, were detected in all treated muscles. The samples -RT, -RNA, AD-1, and AD-2 were analyzed as negative controls for the RT-PCR reactions. [0043] FIG. 9B . Sequence analysis of the truncated products generated by mAON#4 and #6 (and #11, not shown) confirmed the precise skipping of exon 46. DETAILED DESCRIPTION OF THE INVENTION EXAMPLES Example 1 [0044] Since exon 45 is one of the most frequently deleted exons in DMD, we initially aimed at inducing the specific skipping of exon 46 ( FIG. 1 ). This would produce the shorter, largely functional dystrophin found in BMD patients carrying a deletion of exons 45 and 46. The system was initially set up for modulation of dystrophin pre-mRNA splicing of the mouse dystrophin gene. We later aimed for the human dystrophin gene with the intention to restore the translational reading frame and dystrophin synthesis in muscle cells from DMD patients affected by a deletion of exon 45. [0000] Design of mAONs and hAONs [0045] A series of mouse- and human-specific AONs (mAONs and hAONs) was designed, directed at an internal part of exon 46 that contains a stretch of purine-rich sequences and is hypothesized to have a putative regulatory role in the splicing process of exon 46 ( FIG. 2 ). For the initial screening of the AONs in the gel mobility shift assays (see below), we used non-modified DNA-oligonucleotides (synthesized by EuroGentec, Belgium). For the actual transfection experiments in muscle cells, we used 2′-O-methyl-phosphorothioate oligoribonucleotides (also synthesized by EuroGentec, Belgium). These modified RNA oligonucleotides are known to be resistant to endonucleases and RNaseH, and to bind to RNA with high affinity. The sequences of those AONs that were eventually effective and applied in muscle cells in vitro are shown below. The corresponding mouse and human-specific AONs are highly homologous but not completely identical. [0046] The listing below refers to the deoxy-form used for testing, in the finally used 2-O-methyl ribonucleotides all T's should be read as U's. [0000] mAON#2: (SEQ ID NO: 1) 5′ GCAATGTTATCTGCTT mAON#3: (SEQ ID NO: 2) 5′ GTTATCTGCTTCTTCC mAON#4: (SEQ ID NO: 3) 5′ CTGCTTCTTCCAGCC mAON#5: (SEQ ID NO: 4) 5′ TCTGCTTCTTCCAGC mAON#6: (SEQ ID NO: 5) 5′ GTTATCTGCTTCTTCCAGCC mAON#7: (SEQ ID NO: 6) 5′ CTTTTAGCTGCTGCTC mAON#8: (SEQ ID NO: 7) 5′ GTTGTTCTTTTAGCTGCTGC mAON#9: (SEQ ID NO: 8) 5′ TTAGCTGCTGCTCAT mAON#10: (SEQ ID NO: 9) 5′ TTTAGCTGCTGCTCATCTCC mAON#11: (SEQ ID NO: 10) 5′ CTGCTGCTCATCTCC hAON#4: (SEQ ID NO: 11) 5′ CTGCTTCCTCCAACC hAON#6: (SEQ ID NO: 12) 5′ GTTATCTGCTTCCTCCAACC hAON#8: (SEQ ID NO: 13) 5′ GCTTTTCTTTTAGTTGCTGC hAON#9: (SEQ ID NO: 14) 5′ TTAGTTGCTGCTCTT hAON#11: (SEQ ID NO: 15) 5′ TTGCTGCTCTTTTCC Gel Mobility Shift Assays [0047] The efficacy of the AONs is determined by their binding affinity for the target sequence. Notwithstanding recent improvements in computer simulation programs for the prediction of RNA-folding, it is difficult to speculate which of the designed AONs would be capable of binding the target sequence with a relatively high affinity. Therefore, we performed gel mobility shift assays (according to protocols described by Bruice et al., 1997). The exon 46 target RNA fragment was generated by in vitro T7-transcription from a PCR fragment (amplified from either murine or human muscle mRNA using a sense primer that contains the T7 promoter sequence) in the presence of 32P-CTP. The binding affinity of the individual AONs (0.5 pmol) for the target transcript fragments was determined by hybridization at 37° C. for 30 minutes and subsequent polyacrylamide (8%) gel electrophoresis. We performed these assays for the screening of both the mouse and human-specific AONs ( FIG. 3 ). At least 5 different mouse-specific AONs (mAON#4, 6, 8, 9 and 11) and four corresponding human-specific AONs (hAON#4, 6, 8, and 9) generated a mobility shift, demonstrating their binding affinity for the target RNA. [0000] Transfection into Muscle Cell Cultures [0048] The exon 46-specific AONs which showed the highest target binding affinity in gel mobility shift assays were selected for analysis of their efficacy in inducing the skipping in muscle cells in vitro. In all transfection experiments, we included a non-specific AON as a negative control for the specific skipping of exon 46. As mentioned, the system was first set up in mouse muscle cells. We used both proliferating myoblasts and post-mitotic myotube cultures (expressing higher levels of dystrophin) derived from the mouse muscle cell line C2C12. For the subsequent experiments in human-derived muscle cell cultures, we used primary muscle cell cultures isolated from muscle biopsies from one unaffected individual and two unrelated DMD patients carrying a deletion of exon 45. These heterogeneous cultures contained approximately 20-40% myogenic cells. The different AONs (at a concentration of 1 μM) were transfected into the cells using the cationic polymer PEI (MBI Fermentas) at a ratio-equivalent of 3. The AONs transfected in these experiments contained a 5′ fluorescein group which allowed us to determine the transfection efficiencies by counting the number of fluorescent nuclei. Typically, more than 60% of cells showed specific nuclear uptake of the AONs. To facilitate RT-PCR analysis, RNA was isolated 24 hours post-transfection using RNAzol B (CamPro Scientific, The Netherlands). RT-PCR and Sequence Analysis [0049] RNA was reverse transcribed using C. therm. polymerase (Roche) and an exon 48-specific reverse primer. To facilitate the detection of skipping of dystrophin exon 46, the cDNA was amplified by two rounds of PCR, including a nested amplification using primers in exons 44 and 47 (for the human system), or exons 45 and 47 (for the mouse system). In the mouse myoblast and myotube cell cultures, we detected a truncated product of which the size corresponded to exon 45 directly spliced to exon 47 ( FIG. 4 ). Subsequent sequence analysis confirmed the specific skipping of exon 46 from these mouse dystrophin transcripts. The efficiency of exon skipping was different for the individual AONs, with mAON#4 and #11 showing the highest efficiencies. Following these promising results, we focused on inducing a similar modulation of dystrophin splicing in the human-derived muscle cell cultures. Accordingly, we detected a truncated product in the control muscle cells, corresponding to exon 45 spliced to exon 47. Interestingly, in the patient-derived muscle cells, a shorter fragment was detected, which consisted of exon 44 spliced to exon 47. The specific skipping of exon 46 from the human dystrophin transcripts was confirmed by sequence data. This splicing modulation of both the mouse and human dystrophin transcript was neither observed in non-transfected cell cultures nor in cultures transfected with a non-specific AON. Immunohistochemical Analysis [0050] We intended to induce the skipping of exon 46 in muscle cells from patients carrying an exon 45 deletion in order to restore the translation and synthesis of a dystrophin protein. To detect a dystrophin product upon transfection with hAON#8, the two patient-derived muscle cell cultures were subject to immunocytochemistry using two different dystrophin monoclonal antibodies (Mandys-1 and Dys-2) raised against domains of the dystrophin protein located proximal and distal of the targeted region respectively. Fluorescent analysis revealed restoration of dystrophin synthesis in both patient-derived cell cultures ( FIG. 5 ). Approximately at least 80% of the fibers stained positive for dystrophin in the treated samples. [0051] Our results show, for the first time, the restoration of dystrophin synthesis from the endogenous DMD gene in muscle cells from DMD patients. This is a proof of principle of the feasibility of targeted modulation of dystrophin pre-mRNA splicing for therapeutic purposes. Targeted Skipping of Exon 51 Simultaneous Skipping of Dystrophin Exons [0052] The targeted skipping of exon 51. We demonstrated the feasibility of AON-mediated modulation of dystrophin exon 46 splicing, in mouse and human muscle cells in vitro. These findings warranted further studies to evaluate AONs as therapeutic agents for DMD. Since most DMD-causing deletions are clustered in two mutation hot spots, the targeted skipping of one particular exon can restore the reading frame in series of patients with different mutations (see Table 1). Exon 51 is an interesting target exon. The skipping of this exon is therapeutically applicable in patients carrying deletions spanning exon 50, exons 45-50, exons 48-50, exons 49-50, exon 52, and exons 52-63, which includes a total of 15% of patients from our Leiden database. [0053] We designed a series of ten human-specific AONs (hAON#21-30, see below) directed at different purine-rich regions within dystrophin exon 51. These purine-rich stretches suggested the presence of a putative exon splicing regulatory element that we aimed to block in order to induce the elimination of that exon during the splicing process. All experiments were performed according to protocols as described for the skipping of exon 46 (see above). Gel mobility shift assays were performed to identify those hAONs with high binding affinity for the target RNA. We selected the five hAONs that showed the highest affinity. These hAONs were transfected into human control muscle cell cultures in order to test the feasibility of skipping exon 51 in vitro. RNA was isolated 24 hours post-transfection, and cDNA was generated using an exon 53- or 65-specific reverse primer. PCR-amplification of the targeted region was performed using different primer combinations flanking exon 51. The RT-PCR and sequence analysis revealed that we were able to induce the specific skipping of exon 51 from the human dystrophin transcript. We subsequently transfected two hAONs (#23 and #29) shown to be capable of inducing skipping of the exon into six different muscle cell cultures derived from DMD-patients carrying one of the mutations mentioned above. The skipping of exon 51 in these cultures was confirmed by RT-PCR and sequence analysis ( FIG. 7 ). More importantly, immunohistochemical analysis, using multiple antibodies raised against different parts of the dystrophin protein, showed in all cases that, due to the skipping of exon 51, the synthesis of a dystrophin protein was restored. [0054] Exon 51-specific hAONs: [0000] hAON#21: (SEQ ID NO: 16) 5′ CCACAGGTTGTGTCACCAG hAON#22: (SEQ ID NO: 17) 5′ TTTCCTTAGTAACCACAGGTT hAON#23: (SEQ ID NO: 18) 5′ TGGCATTTCTAGTTTGG hAON#24: (SEQ ID NO: 19) 5′ CCAGAGCAGGTACCTCCAACATC hAON#25: (SEQ ID NO: 20) 5′ GGTAAGTTCTGTCCAAGCCC hAON#26: (SEQ ID NO: 21) 5′ TCACCCTCTGTGATTTTAT hAON#27: (SEQ ID NO: 22) 5′ CCCTCTGTGATTTT hAON#28: (SEQ ID NO: 23) 5′ TCACCCACCATCACCCT hAON#29: (SEQ ID NO: 24) 5′ TGATATCCTCAAGGTCACCC hAON#30: (SEQ ID NO: 25) 5′ CTGCTTGATGATCATCTCGTT Simultaneous Skipping of Multiple Dystrophin Exons [0055] The skipping of one additional exon, such as exon 46 or exon 51, restores the reading frame for a considerable number of different DMD mutations. The range of mutations for which this strategy is applicable can be enlarged by the simultaneous skipping of more than one exon. For instance, in DMD patients with a deletion of exon 46 to exon 50, only the skipping of both the deletion-flanking exons 45 and 51 enables the reestablishment of the translational reading frame. ERS-Independent Exon Skipping [0056] A mutation in exon 29 leads to the skipping of this exon in two Becker muscular dystrophy patients (Ginjaar at al., 2000, EJHG, vol. 8, p. 793-796). We studied the feasibility of directing the skipping of exon 29 through targeting the site of mutation by AONs. The mutation is located in a purine-rich stretch that could be associated with ERS activity. We designed a series of AONs (see below) directed to sequences both within (h29AON#1 to h29AON#6) and outside (h29AON#7 to h29AON#11) the hypothesized ERS. Gel mobility shift assays were performed (as described) to identify those AONs with highest affinity for the target RNA ( FIG. 8 ). Subsequently, h29AON#1, #2, #4, #6, #9, #10, and #11 were transfected into human control myotube cultures using the PEI transfection reagent. RNA was isolated 24 hrs post-transfection, and cDNA was generated using an exon 31-specific reverse primer. PCR-amplification of the targeted region was performed using different primer combinations flanking exon 29. This RT-PCR and subsequent sequence analysis ( FIGS. 8B and 8C ) revealed that we were able to induce the skipping of exon 29 from the human dystrophin transcript. However, the AONs that facilitated this skipping were directed to sequences both within and outside the hypothesized ERS (h29AON#1, #2, #4, #6, #9, and #11). These results suggest that skipping of exon 29 occurs independent of whether or not exon 29 contains an ERS and that, therefore, the binding of the AONs to exon 29 more likely inactivated an exon inclusion signal rather than an ERS. This proof of ERS-independent exon skipping may extend the overall applicability of this therapy to exons without ERS's. [0000] h29AON#1: (SEQ ID NO: 26) 5′ TATCCTCTGAATGTCGCATC h29AON#2: (SEQ ID NO: 27) 5′ GGTTATCCTCTGAATGTCGC h29AON#3: (SEQ ID NO: 28) 5′ TCTGTTAGGGTCTGTGCC h29AON#4: (SEQ ID NO: 29) 5′ CCATCTGTTAGGGTCTGTG h29AON#5: (SEQ ID NO: 30) 5′ GTCTGTGCCAATATGCG h29AON#6: (SEQ ID NO: 31) 5′ TCTGTGCCAATATGCGAATC h29AON#7: (SEQ ID NO: 32) 5′ TGTCTCAAGTTCCTC h29AON#8: (SEQ ID NO: 33) 5′ GAATTAAATGTCTCAAGTTC h29AON#9: (SEQ ID NO: 34) 5′ TTAAATGTCTCAAGTTCC h29AON#10: (SEQ ID NO: 35) 5′ GTAGTTCCCTCCAACG h29A0N#11: (SEQ ID NO: 36) 5′ CATGTAGTTCCCTCC AON-induced exon 46 skipping in vivo in murine muscle tissue. [0057] Following the promising results in cultured muscle cells, we tested the different mouse dystrophin exon 46-specific AONs in vivo by injecting them, linked to polyethylenimine (PEI), into the gastrocnemius muscles of control mice. With mAON#4, #6, and #11, previously shown to be effective in mouse muscle cells in vitro, we were able to induce the skipping of exon 46 in muscle tissue in vivo as determined by both RT-PCR and sequence analysis ( FIG. 9 ). The in vivo exon 46 skipping was dose-dependent with highest efficiencies (up to 10%) following injection of 20 μg per muscle per day for two subsequent days. REFERENCES [0058] Achsel et al., 1996, J. Biochem. 120, pp. 53-60. [0059] Bruice T. W. and Lima, W. F., 1997, Biochemistry 36(16): pp. 5004-5019. [0060] Brunak at al., 1991, J. Mol. Biol. 220, pp. 49-65. [0061] Dunckley, M. G. et al., 1998, Human molecular genetics 7, pp. 1083-1090. [0062] Ginjaar et al., 2000, EJHG, vol. 8, pp. 793-796. [0063] Mann et al., 2001, PNAS vol. 98, pp. 42-47. [0064] Tanaka et al., 1994 Mol. Cell. Biol. 14, pp. 1347-1354. [0065] Wilton, S. D., et al., 1999, Neuromuscular disorders 9, pp. 330-338. [0066] Details and background on Duchenne Muscular Dystrophy and related diseases can be found on website http://www.dmd.nl

The present invention provides a method for at least in part decreasing the production of an aberrant protein in a cell, the cell comprising pre-mRNA comprising exons coding for the protein, by inducing so-call exon skipping in the cell. Exon-skipping results in mature mRNA that does not contain the skipped exon, which leads to an altered product of the exon codes for amino acids. Exon skipping is performed by providing a cell with an agent capable of specifically inhibiting an exon inclusion signal, for instance, an exon recognition sequence, of the exon. The exon inclusion signal can be interfered with by a nucleic acid comprising complementarity to a part of the exon. The nucleic acid, which is also herewith provided, can be used for the preparation of a medicament, for instance, for the treatment of an inherited disease.

CROSS-REFERENCE TO RELATED APPLICATION(S) [0001] This application is based upon and claims the benefit of priority from U.S. Patent Application Ser. No. 60/799,511, filed May 10, 2006, the entire disclosure of which is incorporated herein by reference. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH [0002] The research leading to the present invention was supported, at least in part, by National Institute of Health—National Cancer Institute, Grant number R33 214033. Thus, the U.S. government may have certain rights in the invention. FIELD OF THE INVENTION [0003] The present invention relates to processes, arrangements and systems which obtain information associated with an anatomical structure or a sample using optical microscopy, and more particularly to such methods, systems and arrangements that provide optical frequency domain imaging of the anatomical structure/sample (e.g., at least one portion of an eye). BACKGROUND INFORMATION [0004] Optical frequency domain imaging (“OFDI”), which may also be known as swept source optical coherence tomography (“OCT”), is a technique associated with OCT concepts that generally uses a wavelength-swept light source to probe the amplitude and phase of back scattering light from tissue. Exemplary OFDI techniques and systems are described in International Application No. PCT/US04/029148. Method and system to determine polarization properties of tissue is described in International Application No. PCT/US05/039374. The OFDI technique can offer intrinsic signal-to-noise ratio (“SNR”) advantage over the time-domain techniques because the interference signal can be effectively integrated through a Fourier transform. With the recently developed rapidly tunable lasers in the 1300-nm range, the OFDI technique has enabled significant improvements in, e.g., imaging speed, sensitivity, and ranging depth over the conventional time-domain OCT systems. For example, such OFDI procedures/techniques can be used for imaging skin, coronary artery, esophagus, and anterior eye segments. [0005] While retinal imaging is an established clinical use of the OCT techniques, this application has not been implemented using the OFDI procedures because the optical absorption in the human eye at 1300 nm may be too large. The standard spectral range of the conventional ophthalmic OCT techniques has been between 800 nm and 900 nm where the humors in the eye are transparent and broadband super-luminescent-diode (“SLD”) light sources are readily available. It has been has suggested that the 1040-nm spectral range can be a viable alternative operating window for a retinal imaging, and can potentially offer a deeper penetration into the choroidal layers below the highly absorbing and scattering retinal pigment epithelium. The spectral domain (“SD”) OCT systems, also known as Fourier domain OCT systems, that use broadband light sources at 800 nm and arrayed spectrometers have been provided to facilitate a three-dimensional retinal imaging in vivo with a superior image acquisition speed and a sensitivity to conventional time-domain OCT techniques. [0006] As compared to the SD-OCT techniques, the OFDI procedures offer several advantages, such as an immunity to motion-induced signal fading, simple polarization-sensitive or diversity scheme, and long ranging depth. However, a clinical-viable OFDI system for imaging posterior eye segments has previously been unavailable, primarily due to the lack of a wide-tuning rapidly-swept light source in a low water absorption window. Indeed, despite the widespread use of the conventional OCT for retinal disease diagnostics, imaging posterior eye segment with OFDI has not been possible. [0007] Accordingly, there is a need to overcome the deficiencies as described herein above. OBJECTS AND SUMMARY OF EXEMPLARY EMBODIMENTS [0008] To address and/or overcome the above-described problems and/or deficiencies, exemplary embodiments of systems, arrangements and processes can be provided that are capable of, e.g., utilizing the OFDI techniques to image at least one portion of the eye. [0009] Thus, an exemplary embodiment of OFDI technique, system and process according to the present invention for imaging at least one portion of an eye can be provided. For example, a high-performance swept laser at 1050 nm and an ophthalmic OFDI system can be used that offers a high A-line rate of 19 kHz, sensitivity of >92 dB over a depth range of 2.5 mm with an optical exposure level of 550 μW, and a deep penetration into the choroid. Using the exemplary systems, techniques and arrangements according to the present invention, it is possible to perform comprehensive human retina, optic disk, and choroid imaging in vivo. This can enable a display of a choroidal vasculature in vivo, without exogenous fluorescence contrasts, and may be beneficial for evaluating choroidal as well as retinal diseases. According to another exemplary embodiment of the present invention, an OFDI system can be utilized which uses a swept laser in the 815-870 nm range, which can be used in clinical ophthalmic imaging and molecular contrast-based imaging. [0010] Thus, according to one exemplary embodiment of the present invention, a method, apparatus and software arrangement can be provided for obtaining information associated with an anatomical structure or a sample using optical microscopy. For example, a radiation can be provided which includes at least one first electro-magnetic radiation directed to be provided to an anatomical sample and at least one second electro-magnetic radiation directed to a reference. A wavelength of the radiation can vary over time, and the wavelength is shorter than approximately 1150 nm. An interference can be detected between at least one third radiation associated with the first radiation and at least one fourth radiation associated with the second radiation. At least one image corresponding to at least one portion of the sample can be generated using data associated with the interference. [0011] For example, a period of a variation of the wavelength of the first electro-magnetic radiation can be shorter than 1 millisecond. The anatomical sample can include at least one section of the posterior segment of an eye. The section can include a retina, a choroid, an optic nerve and/or a fovea. The wavelength may be shorter than approximately 950 nm. The wavelength can also vary by at least 10 nm over a period of a variation of the wavelength of the first electromagnetic radiation. At least one fourth arrangement can also be provided which is capable of scanning the first electromagnetic radiation laterally across the anatomical sample. The image may be associated with the anatomical structure of the sample and/or a blood and/or a lymphatic flow in the sample. [0012] In one exemplary variant, the third arrangement may be capable of (i) obtaining at least one signal associated with at least one phase of at least one frequency component of the interference signal over less than an entire sweep of the wavelength, and (ii) comparing the at least one phase to at least one particular information. The particular information can be associated with a further signal obtained from a sweep of the wavelength that is different from the sweep of the wavelength of the signal. The particular information may be a constant, and/or can be associated with at least one phase of at least one further frequency component of the interference signal over less than an entire sweep of the wavelength. The frequency components may be different from one another. [0013] In another exemplary variant, the third arrangement may be capable of generating a two-dimensional fundus-type reflectivity profile of the anatomic sample and/or a two-dimensional fundus-type image of the anatomic sample based the signal. Another arrangement may be provided which is capable of receiving the first or second electromagnetic radiations, and providing at least one fifth electromagnetic radiation associated with the first electromagnetic radiation and/or the second electromagnetic radiation The second arrangement may be further capable of detecting a further interference signal between the fifth radiation and the fourth radiation. The second arrangement may be further capable of obtaining at least one reference signal associated with a further phase of at least one first frequency component of the further interference signal over less than an entire sweep of the wavelength. The particular information may be the further phase. [0014] According to another exemplary embodiment of the present invention, at least one source arrangement can be provided which is configured to provide an electro-magnetic radiation which has a wavelength that varies over time. A period of a variation of the wavelength of the one first electromagnetic radiation can be shorter than 1 millisecond, and the wavelength is shorter than approximately 1150 nm. A control arrangement which is capable of modulating at least one of an optical gain or an optical loss in the at least one source arrangement over time can be provided. The optical gain may be facilitated by a semiconductor material. Another arrangement can be provided which is configured to effect a gain and/or a loss as a function of the wavelength. The wavelength may vary by at least 10 nm over the period and/or may be shorter than approximately 950 nm. [0015] In yet another exemplary embodiment of the present invention, a method, apparatus and software arrangement can be provided. For example, first data can be received for a three-dimensional image of at least one portion of a sample. The first data may be associated with an optical interferometric signal generated from signals obtained from the sample and a reference. A region that is less than an entire portion of the first data can be converted to second data to generate a two-dimensional image which is associated with the portion of the sample. The region can be automatically selected based on at least one characteristic of the sample The entire portion may be associated with an internal structure within the sample (e.g., an anatomical structure). For example, the region may be at least one portion of a retina and/or a choroid. The two-dimensional image may be associated with an integrated reflectivity profile of the region and/or at least one of a blood or a lymphatic vessel network. The region can be automatically selected by determining at least one location of at least one section of the region based a reflectivity in the region. [0016] According to a further exemplary embodiment of the present invention, is possible to cause a radiation to be provided which includes at least one first electro-magnetic radiation directed to a sample and at least one second electromagnetic radiation directed to a reference. A wavelength of the radiation varies over time. An interference signal can be detected between at least one third radiation associated with the first radiation and at least one fourth radiation associated with the second radiation. At least one signal associated with at least one phase of at least one frequency component of the interference signal can be obtained over less than an entire sweep of the wavelength. The phase may be compared to at least one particular information. [0017] In one exemplary variant, the first electromagnetic radiation may be scanned laterally across the sample, which may include at least one section of a posterior segment of an eye. The section can include a retina, a choroid, an optic nerve and/or a fovea. The interference signal may be associated with an integral fraction of the entire sweep of the wavelength. The fraction of the sweep may be a half or a quarter of the sweep. The signal may be associated with a flow velocity and/or an anatomical structure in the sample. The particular information may be associated with a further signal obtained from a sweep of the wavelength that is different from the sweep of the wavelength of the signal. The particular information may be a constant and/or may be associated with at least one phase of at least one further frequency component of the interference signal over less than an entire sweep of the wavelength. The frequency components may be different from one another. [0018] These and other objects, features and advantages of the present invention will become apparent upon reading the following detailed description of embodiments of the invention, when taken in conjunction with the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS [0019] Further objects, features and advantages of the invention will become apparent from the following detailed description taken in conjunction with the accompanying figures showing illustrative embodiments of the invention, in which: [0020] FIG. 1( a ) is a block diagram of an exemplary embodiment of a wavelength-swept laser system according to the present invention; [0021] FIG. 1( b ) is a block diagram of an exemplary embodiment of an interferometric system according to the present invention; [0022] FIG. 2( a ) is a graph illustrating measured output characteristics of a peak-hold output spectrum and an optical absorption in water for a particular propagation distance corresponding to a roundtrip in typical human vitreous; [0023] FIG. 2( b ) is a graph illustrating measured output characteristics of a time-domain output trace; [0024] FIG. 3 is a graph illustrating point spread functions measured at various path length differences; [0025] FIG. 4 is an exemplary image of retina and choroid obtained from a healthy volunteer using the exemplary embodiment of the system, process and arrangement according to the present invention; [0026] FIG. 5( a ) is a first exemplary OFDI image at fovea and optic nerve head of a patient A produced by an exemplary system at one location; [0027] FIG. 5( b ) is a second exemplary OFDI image at the fovea and the optic nerve head of the patient A produced by another exemplary system at such location; [0028] FIG. 5( c ) is a first exemplary SD-OCT image at the fovea and the optic nerve head of the patient A as a similar location produced by an exemplary system according to the present invention; [0029] FIG. 5( d ) is a second exemplary SD-OCT image at the fovea and the optic nerve head of the patient A as the location of FIG. 5( c ) produced by an exemplary system according to the present invention; [0030] FIG. 5( e ) is a third exemplary OFDI image obtained from a patient B produced by another exemplary system according to the present invention; [0031] FIG. 5( f ) is a fourth exemplary OFDI image obtained from the patient B produced by a further exemplary system according to the present invention; [0032] FIG. 6A is an exemplary two-dimensional reflectance image of the retinal and choroidal vasculature extracted from the three-dimensional OFDI data set associated with the image of FIG. 4 obtained by a conventional full-range integration method; [0033] FIG. 6B is an exemplary fundus-type reflectivity image obtained using an exemplary embodiment of an axial-sectioning integration technique; [0034] FIG. 6C is an exemplary retinal reflectivity image showing a shadow of a blood vasculature; [0035] FIG. 6C is an exemplary reflectivity image obtained from an upper part of the choroids; [0036] FIG. 6E is an exemplary image of an exemplary reflectivity image integrated from a center of the choroid showing a choroidal vasculature; [0037] FIG. 7( a ) is a schematic diagram of an exemplary embodiment of the wavelength-swept laser arrangement according to the present invention; [0038] FIG. 7( b ) is a graph of a peak-hold output spectrum of the signals generated using the exemplary embodiment of FIG. 7( a ); [0039] FIG. 7( c ) is a graph of a oscilloscope trace generated using the exemplary embodiment of FIG. 7( a ); [0040] FIG. 8( a ) is a graph of a sensitivity measured as a function of a reference power; [0041] FIG. 8( b ) is a graph of a sensitivity measured as a function of a depth; [0042] FIG. 9 is an exemplary OFDI image of a Xenopus laevis tadpole in vivo acquired using another exemplary embodiment of the system, arrangement and process according to the present invention; [0043] FIG. 10( a ) is a graph of an exemplary output of a shaped spectra without a gain/loss modulation generated as a function of wavelength using another exemplary embodiment of the system, arrangement and process according to the present invention; [0044] FIG. 10( b ) is a graph of an exemplary output of the shaped spectra with the gain/loss modulation generated as a function of wavelength using an exemplary embodiment of the system, arrangement and process according to the present invention; [0045] FIG. 11 is a flow diagram of a conventional method to obtain Doppler OFDI signals; [0046] FIG. 12 is a flow diagram of an exemplary embodiment of a process to obtain Doppler OFDI signals by processing a portion of an interference fringe according to the present invention; [0047] FIG. 13( a ) is an exemplary single image of the retina which includes the fovea and optic disk obtained from a healthy volunteer consecutively acquired at a large number of frames; and [0048] FIG. 13( b ) is an exemplary integrated lindus image of the retina generated from multiple cross-sectional images covering an area by integrating the intensity in each depth profile. [0049] Throughout the figures, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components or portions of the illustrated embodiments. Moreover, while the subject invention will now be described in detail with reference to the figures, it is done so in connection with the illustrative embodiments. It is intended that changes and modifications can be made to the described embodiments without departing from the true scope and spirit of the subject invention as defined by the appended claims. DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS First Exemplary Embodiment of Laser Source System [0050] FIG. 1( a ) depicts an exemplary embodiment of a laser source system (e.g., which can include a 1050 nm swept laser source) provided in a linear cavity configuration according to the present invention. As shown in this figure, a gain medium 10 can be provided, such as a bi-directional semiconductor optical amplifier (QPhotonics, Inc., QSOA-1050) which may be driven at an injection current level of 400 mA. One port of the amplifier can be coupled to a wavelength-scanning filter 20 that may comprise a diffraction grating 30 (1200 lines/mm), a telescope consisting of two lenses 40 , 42 with respective focal lengths of 100 and 50 mm, and a polygon mirror scanner 50 (e.g., Lincoln Lasers, Inc., 40 facets). The design bandwidth and free spectral range of the filter can be approximately 0.1 nm and 61 nm, respectively. The amplifier's other port can be spliced to connect to a loop mirror which may include a 50/50 coupler 60 . A Sagnac loop 70 can also act as an output coupler. [0051] The reflectivity and output coupling ratio can be complementary, and may be optimized by adjusting a polarization controller 80 to tune the amount of the birefringence-induced non-reciprocity in the loop. The linear-cavity configuration can also be used instead of or together with conventional ring cavity designs, since low-loss low-cost circulators and isolators may not be readily available at 1050 nm. Sweep repetition rates of up to 36 kHz may be achieved with 100% duty cycle, which may represent a significant improvement over previously demonstrated swept lasers in the 1050 nm region that offered tuning rates of <1 kHz. In an OFDI system according to one exemplary embodiment of the present invention, the laser can be operated at a wavelength sweep rate of about 18.8 kHz, thus producing a polarized output with an average output power of 2.7 mW. Exemplary Embodiment of Imaging System [0052] FIG. 1( b ) depicts an exemplary embodiment of an optical frequency domain imaging (OFDI) system according to the present invention. For example, it is possible to use a swept laser can be used as a light source 100 . This exemplary system further comprises a fiber-optic interferometer 110 , a beam scanner 120 , a detector 130 and a computer 140 . A sample arm 150 (e.g., 30% port) can be connected to a two-axis galvanometer scanner apparatus 120 which may be designed for a retinal imaging. A focal beam size can be approximately 10 μm in tissue (e.g., index=1.38). The optical power level at an entrance pupil of an eye 160 can be measured to be about 550 μW, which is well below the 1.9-mW maximum exposure level at λ=1050 nm according to the ANSI laser safety standards. A reference arm 170 (e.g., 70% port) can utilize a transmission-type variable delay line 180 and a 10% tap coupler 182 to generate sampling trigger signals for acquiring data. [0053] As shown in FIG. 1( b ), a neutral density (ND) attenuator 184 may be used to obtain an optimal reference-arm power. Light returning from the sample can be combined with the reference light at a 50/50 coupler 190 . Resulting interference signals can be measured using an InGaAs dual-balanced detector 140 (e.g., New Focus, Inc., 1811 ). A signal provided by the balanced detector 140 can be further amplified (e.g., by 10 dB), low-pass filtered, and digitized at 10 MS/s using, e.g., a 12-bit data acquisition board (National Instruments, Inc., PCI-6115). For example, when sampling a 512 samples during each A-line scan, the imaging depth range determined by the spectral sampling interval can be about 2.44 mm in air. Exemplary Laser Output Characteristics [0054] FIG. 2( a ) depicts an exemplary output spectrum measured using an optical spectrum analyzer in peak-hold mode (with resolution=0.1 nm). The exemplary output spectrum spanned from 1019 to 1081 nm over a range of 62 nm determined by the free spectral range of the filter. The spectral range coincided with a local transparent window of the eye. The roundtrip optical absorption in human vitreous and aqueous humors can be estimated to be between about 2 dB and 5 dB based on known absorption characteristics of water (as shown in FIG. 2( a )). Using a variable-delay Michelson interferometer, it is possible to measure the coherence length of the laser output, defined as the roundtrip delay resulting in 50% visibility, to be approximately 4.4 mm in air. From this value, it is possible to determine an instantaneous line width of laser output to be 0.11 nm. In FIG. 2( a ), a peak-hold output spectrum 200 and an optical absorption curve 205 are provided in water for a 42-mm propagation distance corresponding to a roundtrip in a typical human vitreous. [0055] FIG. 2( b ) shows a graph of a time domain exemplary oscilloscope output trace 210 of a laser output indicating 100% tuning duty cycle at 18.8 kHz (single shot, 5-MHz detection bandwidth). The y-axis of the trace graph of FIG. 2( b ) represents an instantaneous optical power. The total power of amplified spontaneous emission (ASE) in the output, measured by blocking the intracavity beam in the polygon filter, is shown as about 1.1 mW. Since ASE is significantly suppressed during lasing, it is expected that the ASE level in the laser output may be negligible. The laser output exhibited significant intensity fluctuations (˜10% pp) due to an etalon effect originating from relatively large facet reflections at the SOA chip with a thickness equivalent to 2.5 mm in air. In the exemplary embodiment of the imaging system, the etalon effect can cause ghost images (−30 dB) by optical aliasing. Exemplary Sensitivity and Resolution of Imaging System [0056] An exemplary embodiment of the OFDI system and exemplary optimized operating parameters can be provided to maximize the SNR using a partial reflector (neutral density filter and metal mirror) as a sample. An exemplary preferable reference arm power for maximal SNR may be 2.6 μW at each detection port. This relatively low value can be attributed to the relatively large intensity noise of the laser that may not be completely suppressed in the dual balanced detection. Exemplary data processing according to an exemplary embodiment of the present invention can include reference subtraction, envelope apodization or windowing, interpolation to correct for nonlinear k-space tuning, and dispersion correction. For example, subtracting the reference from the interference signals can eliminate image artifacts due to a non-uniform spectral envelope of the laser source. Apodizing the interference fringes by imposing a appropriate windowing technique can decrease the sidebands of point spread functions and improve image contrast. [0057] This exemplary embodiment of the process according to the present invention may come at a resolution loss and SNR (due to a reduced integration time). It is possible to use a Gaussian window to yield a desirable compromise in contrast and resolution (e.g., at 1050-nm). Since the detector signal may not be sampled in constant time intervals, whereas the tuning curve of our laser was not linear in k-space, interpolating the interference signal may be preferable to reduce or avoid image blurring. Upon completing the exemplary interpolation, the signal may be further corrected for the chromatic dispersion in the interferometer as well as in the sample, e.g., by multiplying a predetermined phase function. [0058] FIG. 3 shows exemplary A-line profiles and/or point spread functions 220 measured at various path length differences of the interferometer. For this measurement, we used a neutral density attenuator (73 dB) and gold-coated mirror in the sample arm, and the path length was varied by moving the reference mirror. The maximum SNR is 25 dB that corresponds to a maximum sensitivity of 98 dB. The theoretical shot-noise limit of sensitivity is calculated to be 109 dB; the 11-dB deficiency in sensitivity of our system seems reasonable, considering that the residual laser intensity noise, imperfect polarization alignment between the sample and reference light, and Gaussian windowing, among many other practical details, contributed to SNR loss. For example, to facilitate the exemplary SNR analysis, each exemplary curve plotted was obtained by an average over 500 consecutive scans at a constant depth, and a simple numerical subtraction was performed to make the noise floor flat. Ghost artifacts marked as asterisks 230 were caused by the etalon effect in the laser source are shown in this figure. [0059] As indicated in FIG. 3 , the sensitivity was decreased to 92 dB as the path length increased to a depth of 2.4 mm, due to the finite coherence length of the laser output. As compared to the conventional time-domain systems that use a broadband source at 1040 nm, the exemplary embodiment of the system according to the present invention provides a higher sensitivity, e.g., at a 100-fold faster image acquisition speed and one sixth of sample arm power. The high sensitivity and depth range of the exemplary embodiment of the system according to the present invention compare favorably with exemplary SD-OCT systems that use broadband sources in the 800-900 nm spectral range. Due to the absorption by water in the eye, the actual SNR for the human retina is likely 3-4 dB lower than the values measured with the mirror sample. Based on the source spectrum (as shown in FIG. 2( a )) and the Gaussian window function used, the theoretical axial resolution can be determined to be about 13 μm in air; the measured values may be 14-16 μm, increasing with the depth. Errors in interpolation and dispersion compensation due to higher order terms may account for the discrepancy. Exemplary Video-rate Imaging of Retina, Optic Disk, and Choroid in Vivo [0060] Exemplary OFDI imaging was conducted on two healthy volunteers (A: 36-year-old Asian male, B: 41-year-old Caucasian male) using the exemplary embodiments of the system, process and arrangement according to the present invention. The exemplary OFDI system acquired 18,800 A-lines continuously over 10-20 seconds as the focused sample beam was scanned over an area of 6 mm (horizontal) by 5.2 mm (vertical) across the macular region in the retina. FIG. 4 shows a sequence 250 of images of the fovea and optic disk of the sample recorded from volunteer A at a frame rate of 18.8 Hz in 10.6 seconds. Each image frame was constructed from 1,000 A-line scans with an inverse grayscale table mapping to the reflectivity range over 47 dB, with each frame spanning over 6.0 mm (horizontal) and 1.8 mm (depth) in tissue. For example, 200 frames were acquired in 10.6 seconds to screen a tissue area with a vertical span of 5.2 mm. The anatomical layers in the retina are visualized and correlate well with previously published OCT images and histological findings. [0061] FIG. 5A depicts an expanded exemplary image of fovea extracted from the three-dimensional data set using the exemplary embodiments of the system, process and arrangement according to the present invention. The exemplary OFDI image of FIG. 5A indicates a deep penetration into the choroid nearly up to the interface with the sclera, visualizing densely-packed choroidal capillaries and vessels. [0062] To assess the penetration of the exemplary embodiments of the system, process and arrangement according to the present invention, the two volunteers A and B can be three-dimensionally imaged using both the OFDI system and the SD-OCT system previously developed for video-rate retinal imaging. The SD-OCT system employed a super luminescent diode with a center wavelength of 840 nm and a 3-dB spectral bandwidth of 50 nm, offering an axial resolution of 8-9 nm in air. At an A-line rate of 29 kHz and a sample arm power level of 600 μW, the SD-OCT system offered a peak sensitivity of 98 dB at zero delay that decreased to 82 dB at the maximum ranging depth of 2.2 mm in air. [0063] FIGS. 5A-5F illustrate side-by-side comparisons of the OFDI and SD-OCT images near the foveae and optic disks of the two volunteers A and B. For example, FIGS. 5A and 5C shows OFDI images at fovea and optic nerve head from the volunteer A. FIGS. 5B and 5D illustrate SD-OCT images from the same person at similar tissue locations. FIGS. 5E and 5F provide the OFDI and SD-OCT images, respectively, obtained from volunteer B. For example, as shown, the OFDI images exhibit considerably deeper penetration in tissue than the SD-OCT images in most if not in all data sets. Such large penetration depth may stem from both the high system sensitivity and long source wavelength. Despite the relatively large axial resolution of ˜11 μm in tissue, the OFDI system can visualize the anatomical layered structure in the retina (as shown in FIG. 5A ), RNFL, retinal nerve fiber layer, IPL, inner plexiform layer, INL; inner nuclear layer, OPL; outer plexiform layer, ONL; outer nuclear layer, IPRL; interface between the inner and outer segments of the photoreceptor layer, RPE; retinal pigmented epithelium, and C; choriocapillaris and choroid. [0064] As shown in these figures, the OFDI images exhibit considerably deeper penetration into the choroid compared to the SD-OCT images, whereas the higher axial resolution in the SD-OCT images provide better contrast between retinal layers. The lower absorption and scattering in RPE at 1050 nm than 840 nm may account for the apparently superior penetration of the OFDI system to the SD-OCT system with a comparable sensitivity. Visualization of Retinal/Choroidal Vasculature with OFDI Techniques/Systems [0065] With the three-dimensional tomographic data of the eye's posterior segment, the pixel values along the entire depth axis can be integrated to produce a two-dimensional fundus-type reflectivity image. FIG. 6A shows an exemplary integrated reflectivity image generated from the entire OFDI image sequence shown in FIG. 4 , with the image being two-dimensional reflectance image (5.3×5.2 mm 2 ) obtained with the conventional full-range integration method. The exemplary image shows the exemplary optical nerve head, fovea, retinal vessels, and an outline of the deep choroidal vasculature. However, the depth information is not indicated. To address this deficiency of the image generated by a conventional method, it is possible to integrate only selective regions according to using the exemplary embodiment of the system, process and arrangement of the present invention. [0066] For example, according to one exemplary embodiment of the present invention, in order to visualize the retinal vasculature with a maximum contrast, it is possible to integrate the reflectivity in the range between IPRL and RPE 260 , 270 as shown in FIG. 6B . This figure shows an Illustration of an exemplary embodiment of a axial-sectioning integration technique for producing fundus-type reflectivity images. The shadow or loss of signal created by the retinal vessels above can appear most distinctly. Integrating over the entire retina including the vessel often results in a lower contrast in the vasculature because retinal blood vessels produce large signals by strong scattering. Automatic image processing conveniently allowed for automatic segmentations of the IPRL and RPE layers 260 , 270 . [0067] FIG. 6C depicts an exemplary reflectivity image (shadow) of a blood vasculature (3.8×5.2 mm 2 ) of the retina vessels . Using the thin integration region below the RPE, it is also possible to obtain fundus-type reflectivity images of the choriocapillary layer containing abundant small blood vessels and pigment cells obtained from an upper part of the choroid, as shown in FIG. 6D . To obtain an image of the complete choroidal region, it is possible to utilize an integration range indicated by references 280 and 290 of FIG. 6B . The choroidal vasculature is shown in the exemplary resulting reflectivity image of FIG. 6E which is an exemplary reflectivity image integrated from the center of the choroid revealing the choroidal vasculature. Reflectivity images with similar qualities can be obtained from volunteer B. Exemplary Implementation of Exemplary Embodiments of Invention [0068] Experimental results show that the images generated using the exemplary OFDI techniques at 1050 nm can provide a comprehensive imaging of the human retina and choroid with high resolution and contrast. However, the exemplary embodiment of the OFDI system according to the exemplary embodiments of the present invention may provide an order-of-magnitude higher image acquisition speed than with the use of the conventional time-domain OCT systems, and avails the choroid images with an enhanced contrast in comparison to the SD-OCT system at 840 nm. The enhanced penetration makes it possible to obtain depth-sectioned reflectivity images of the choroid capillary and vascular networks. Fundus camera or scanning laser ophthalmoscope have been conventionally used to view vasculatures. However, such methods may require fluoresce in or indocyanine green angiography to have access to the choroid except for patients with significantly low level of pigmentations. [0069] The exemplary OFDI system according to the present invention includes a wavelength-swept laser produced using, e.g., a commercial SOA and custom-built intracavity scanning filter, such laser's output power, tuning speed and range may yield a sensitivity of about 98 dB, A-line rate of 19 kHz, and resolution of 10 μm in tissue. Increasing the saturation power and gain of SOA and reducing the extended-cavity loss can possibly further improve the sensitivity and resolution (tuning range). For example, the power exposure level of the exemplary embodiment of the system according to the present invention can be only 550 μW, whereas the maximum ANSI limit at 1050 nm is likely to be 1.9 mW. Exemplary Embodiment of Swept Laser Source [0070] FIG. 7( a ) shows another exemplary embodiment of a swept laser source arrangement according to the present invention, e.g., in the 815-870 nm spectral range. The swept laser source arrangement can include a fiber-optic unidirectional ring cavity 300 with a free-space isolator 310 . The gain medium 320 may be a commercially-available semiconductor optical amplifier (e.g., SOA-372-850-SM, Superlum Diodes Ltd.). An intracavity spectral filter 330 can be provided which may comprise a diffractive grating (e.g., 830 grooves/mm) 332 , two achromatic lenses 334 , 336 in the 4f configuration, and a 72-facet polygon mirror 340 (Lincoln lasers, Inc.). The polygon can be rotated at about 600 revolutions per second to produce unidirectional sweeps from short to long wavelengths at a repetition rate of 43.2 kHz. [0071] The free-space collimated beam in the cavity may have a size of about 1 mm FWHM (full width at half maximum). The beam incident angle to the grating normal can be 67 deg. The focal lengths of the two lenses 334 , 336 in the telescope can be 75 (f 1 ) and 40 (f 2 ) mm, respectively. It is possible to predict a free-spectral range of 55 nm and FWHM filter bandwidth of 0.17 nm. The laser output can be obtained via a 70% port of a fiber-optic coupler 350 . Two polarization controllers 360 , 362 can be used to maximize the output power and tuning range. [0072] For example, it is possible to measure the spectral and temporal characteristics of the laser output at a sweep rate of about 43.2 kHz. The SOA may be driven with an injection current of about 110 mA. FIG. 7( b ) shows an exemplary output spectrum 380 , 385 measured with an exemplary optical spectrum analyzer in a peak-hold mode at a resolution bandwidth of 0.1 nm. The total tuning range is 55 nm from 815 to 870 nm with a FWHM bandwidth of 38 nm. A stability of the output power is provided in the single-shot oscilloscope trace 390 as shown in FIG. 7( c ) provided at a about 43.2 kHz sweep rate and 7 mW averaged power. The peak power variation across tuning cycles may be less than 1%. The instantaneous laser emission can contain multiple longitudinal modes. [0073] An exemplary measurement of the coherence length (as shown in FIG. 3( b )) can indicate that the FWHM line width may be approximately 0.17 nm corresponding to the filter bandwidth. The intensity noise characteristic of the laser output may further be characterized by using an electrical spectrum analyzer (e.g., Model, Agilent) and low-gain Silicon detector. The measured relative intensity noise can range from about −125 dB/Hz to −135 dB/Hz decreasing with the frequency in the frequency range of about 2 MHz to 10 MHz. The noise peaks due to longitudinal mode beating can appear at 91 MHz. The time-average output power may be about 6.9 mW. [0074] The large output coupling ratio of the exemplary embodiment of the laser source arrangement, e.g., about 70%, can ensure that the peak power at the SOA does not exceed about 20 mW, e.g., the specified optical damage threshold of the SOA. When this condition is not satisfied, a sudden catastrophic or slowly progressing damage may occur at the output facet of SOA chip. Increasing the optical damage threshold of the 800-nm SOA chips, e.g., by new chip designs, can improve the tuning range as well as the long-term reliability. The output may contain a broadband amplified spontaneous emission that can occupy ˜8% (about 0.56 mW) of the total average power. Exemplary Imaging System [0075] An exemplary embodiment of the OFDI system according to the present invention can be provided using the exemplary wavelength-swept laser arrangement. The configuration of the exemplary system can be similar to the system shown in FIG. 1( b ). The laser output can be split into two paths in an interferometer by a 30/70 coupler. In one path (e.g., 30% port, termed “sample arm”) may illuminate a biological sample via a two-axis galvanometer scanner (e.g., Model, Cambridge Technologies). The other path, “reference arm,” generally provides a reference beam. The signal beam returning from the sample by backscattering is combined with the reference beam at, e.g., a 50/50 coupler, thus producing interference. [0076] The interference signal may be detected with a dual-balanced silicon receiver (e.g., DC-80 MHz, 1807-FS, New Focus). The receiver output is low-pass filtered (35 MHz) and digitized at a sampling rate of 100 MS/s with a 14-bit data acquisition board (e.g., DAQ, NI-5122, National Instruments). A small portion (10%) of the reference beam can be tapped and detected through a grating filter to provide triggers to the DAQ board. During each wavelength sweep or A-line scan, a large number, e.g., 2048 samples can be acquired. The sampled data may initially be stored in an on-board memory or on another storage device. [0077] Upon collecting a desired number of A-line scans, the data set may be transferred to a host personal computer, either to the memory/storage arrangement for on-line processing and/or display or to the hard disk for post processing. When only a single frame is acquired at a time, the exemplary system is capable of processing and displaying the image frame in real time at a frame refresh rate of about 5 Hz. For larger data sets, an exemplary 256 MB on-board memory provides for acquisition of up to 65,536 A-line scans consecutively for about 1.3 sec. This corresponds to about 128 image frames, each consisting of 512 A-lines. Post data processing techniques can include reference subtraction, apodization, interpolation into a linear k-space, and dispersion compensation prior to Fourier transforms. [0078] To characterize and optimize the exemplary embodiment of the system, process and arrangement according to the present invention, it is possible to use an axial point spread function (or A-line) by using a partial mirror as the sample (−50 dB reflectivity). FIG. 8( a ) shows a graph 400 of the sensitivity of the exemplary system measured as a function of the reference optical power. The reference power can be varied by using a variable neutral density (ND) filter in the reference arm. Throughout this measurement, for example, the path length difference between the sample and reference arms may be about 0.6 mm, and the optical power returning from the attenuated sample mirror can be 3.3 nW at each port of the 50/50 coupler. The sensitivity values may be determined by adding the sample attenuation (e.g., about 50 dB) to the measured signal-to-noise ratios (SNR). The reference power can be measured at one of the ports of the 50/50 coupler, corresponding to the time-average reference power at each photodiode. At reference powers between about 30 μW and 200 μW, a maximum sensitivity of ˜96 dB may be obtained. [0079] The sensitivity in the unit of decibel may be expressed as: S dB =S 0 −10 log 10 (1+a/P r +P r /b)−Δ, where S 0 denotes the shot-noise limited sensitivity, P r is the reference power level, a and b correspond to the reference power levels at which the thermal and intensity noise, respectively, become equal to that of the shot noise in magnitude, and Δ can be a fitting parameter associated with other factors contributing to the loss of sensitivity. Taking into account amplified spontaneous emission, S 0 may be about 107 dB. For example, a=17 μW from the detector noise level (e.g., 3.3 pA/√Hz) and conversion efficiency (e.g., 1 A/W). Based on the relative intensity noise of the laser (e.g., −130 dB/Hz) and an 18-dB common-noise suppression efficiency of the balanced receiver, b=280 μW. For example, the best fit to the experimental data 410 of FIG. 8( b ) can be obtained with Δ=8 dB. FIG. 8( b ) shows a graph of the sensitivity 420 measured as a function of depth. This exemplary value may be largely attributed to the simplified model assuming a flat reference spectrum, a polarization mismatch between the sample and the reference light, and the apodization step in data processing, each possibly contributing to a loss of sensitivity by a couple of dB's. [0080] Due to a finite coherence length of the laser source, the sensitivity can decrease as the interferometric delay increases. It is possible to measure axial point spread functions at various depth locations of the sample mirror by changing the delay in the reference arm while maintaining the reference power at about 100 μW per photodiode, as shown in the graph of FIG. 8( b ). For example, each axial profile can be calibrated by measuring the noise floor obtained by blocking the sample arm, and then matching the noise floor to a 50 dB level. In this manner, the modest frequency or depth dependence (2 dB) of the noise floor can be reduced or eliminated. Thus, the sensitivity can drop by about 6 dB at a depth of about 1.9 mm. From a Gaussian fit (dashed line), the instantaneous laser line width may be about 0.17 nm. The FWHM of the axial profile, or the axial resolution in air, can be about 8 μm in the depth from zero to B mm. This corresponds to an axial resolution of ˜6 μm in tissue imaging (e.g., refractive index, n≈1.35). [0081] As an example, to confirm and demonstrate the capabilities of the exemplary embodiment of the system, process and arrangement according to the present invention for high-speed high-resolution biological imaging, images of Xenopus laevis tadpoles may be obtained in vivo by scanning the sample beam (B-mode scan). The sample beam can have a confocal parameter of about 250 μm and a FWHM beam size of approximately 7 μm at the focus in air (n=1). The optical power on the sample may be about 2.4 mW. During the imaging procedure, the tadpole (stage 46 ) can be under anesthesia in a water bath by a drop of about 0.02% 3-aminobenzoic acid ethyl ester (MS-222). [0082] FIG. 9 shows a sequence of images 450 obtained as the beam is scanned in one dimension repeatedly over the ventricle in the heart. The image sequence was acquired at a frame rate of 84.4 Hz (512 A-lines per frame) in the duration of 1.2 s, but is displayed at a reduced rate of 24 frames per second. Each frame, cropped from the original (500×1024 pixels), has 400×200 pixels and spans a dimension of 3.3 mm (horizontal) by 1.1 mm (depth, n=1.35). The motion of the ventricle including trabeculae can be seen. The ability to image the beating heart with high spatial and temporal resolution may be useful for investigating normal and abnormal cardiac developments in vivo. Combined with contrast agents such ICG and gold nano particles developed in the 800-nm region, the exemplary embodiment of the OFDI system, process and arrangement according to the present invention can enable high-speed functional or molecular imaging. Exemplary Laser Current Modulation [0083] An exemplary preferred light source arrangement for OFDI imaging generally has a flat output spectrum. To obtain such desired spectral profile, it is possible to modulate the gain or loss of a gain medium or a filter inside or outside a laser cavity. The filter may be a broadband variable attenuator, and its transmission may be controlled synchronously with laser tuning. The exemplary filter may be a passive spectral filter with a desired transmission spectrum. The gain medium can preferably be a semiconductor optical amplifier, and its gain may be varied by modulating the injection current to the amplifier synchronously with filter tuning. FIGS. 10( a ) and 10 ( b ) illustrate graphs of exemplary output tuning traces 480 , 490 without and with the use of an exemplary embodiment of a modulation method according to the present invention, respectively. This exemplary method can also be effective to maximize or at least increase the output power and tuning range for a given optical damage threshold of the semiconductor gain chip. Exemplary Flow Measurement [0084] The ability to detect and quantify the blood flow in the eye retina and choroid can have impacts in several clinical applications such as for an evaluation of age-related macular degeneration. Several methods of extracting the flow information from the phase of the OFDI signals are known in the art. These exemplary conventional methods, however, require a significant beam overlap between two consecutive A-line scans- over sampling, thus causing undesirable compromise between the phase accuracy and image acquisition speed. Using the exemplary embodiment of the system, process and arrangement according to the present invention, instead of comparing the phase values of two A-line scans, it is possible to extract multiple phase values corresponding to different time points or wavelengths within a single A-line and compare the values with reference phase values. This exemplary procedure provides for a measurement of the flow velocity at multiple time points during a single A-line scan, permitting a faster beam scan and image acquisition speed. Such procedure can be used at decreased phase or velocity measurement accuracy, which is likely to be acceptable in many applications. [0085] FIG. 11 illustrates a flow diagram of a conventional method to extract the phase and velocity information from an entire dataset obtained during each wavelength scan. As shown in FIG. 10 , A-line scans, k-th through (k+1)-th are provided. In step 510 , DFT from each of such scans is received, and utilized in the formulas A k (z) iφk(z) and A k (z)e iφk+1(z) , respectively. Then, using the determined results in step 510 , the following determination is made in step 520 : Δ(z)=φ k+1 (z)−φ k (z). Then, in step 530 , a phase image is overlayed to an intensity image if A(z) is larger than a particular threshold. Here, A m (z) denotes the signal amplitude associated with the sample reflectance at a depth z at the m-th A-line scan, φ m (Z) denotes the signal phase associated with a depth z at the m-th A-line scan, and Δ(z) represents a difference between the phases. [0086] FIG. 12 illustrates a flow diagram of the exemplary embodiment of the process according to the present invention which can be used to obtain the phase and flow information by processing a half of the interference fringe data. For example, similarly to the conventional method shown in FIG. 11 , A-line scans, k-th through (k+1)-th are provided. Then, in step 560 , DFT from each of such scans is received, and utilized in the following formulas, respectively: A 1 (z)e iφ1(z)−φr,1(z) , A 2 (z)e iφ2(z)−φr,2(z) , etc. Using the results obtained from step 560 , the following determination is made in step 570 : Δ(z)=φ 1 (z)−φ 2 (z)+φ r,1 (z)−φ r,2 (Z). Here, A 1 (z) and A 2 (z) denote the signal amplitudes obtained from the two different portions of the interference signal acquired in each A-line scan, φ 1 (z) and φ 2 (z) denote the signal phases obtained from the two different portions of the interference signal, and φ r,1 (z) and φ r,2 (z) denote reference phases that may be constants, phases obtained from an auxiliary interferometric signal, or phases associated with a different depth. By subtracting the reference phases from the signal phases, phase noise associated with sampling timing fluctuations and motion artifacts can be greatly reduced. Further, in step 580 , a phase image is overlayed to an intensity image if A(z) is larger than a particular threshold. This exemplary process can also be applicable to beam-scanning phase microscopy. [0087] FIGS. 13( a ) and 13 ( b ) show exemplary images image of the retina obtained from a healthy volunteer. For example, FIG. 13( a ) illustrates a single exemplary image from a large number of frames consecutively acquired using the exemplary embodiment of the system, process and arrangement according to the present invention. The image frame consists of about 1000 axial lines, and the exemplary image shows the fovea and optic disk of the patient. FIG. 13( b ) shows an exemplary Integrated fundus image produced from multiple cross-sectional images covering an area by integrating the intensity in each depth profile to represent a single point in the fundus image using the exemplary embodiment of the system, process and arrangement according to the present invention. [0088] As shown in these figures, the retinal OFDI imaging was performed at 800-900 nm in vivo on a 41-year-old Caucasian male subject. The exemplary embodiment of the OFDI system, process and arrangement according to the present invention acquired 23 k A-lines continuously over 1-2 seconds as the focused sample beam was scanned over an area including the macular and optic nerve head region in the retina. Each image frame was constructed from 1,000 A-line scans with an inverse grayscale table mapping to the reflectivity range. The anatomical layers in the retina are clearly visualized and correlate well with previously published OCT images and histological findings. [0089] The foregoing merely illustrates the principles of the invention. Various modifications and alterations to the described embodiments will be apparent to those skilled in the art in view of the teachings herein. Indeed, the arrangements, systems and methods according to the exemplary embodiments of the present invention can be used with any OCT system, OFDI system, SD-OCT system or other imaging systems, and for example with those described in International Patent Application PCT/US2004/029148, filed Sep. 8, 2004, U.S. patent application Ser. No. 11/266,779, filed Nov. 2, 2005, and U.S. patent application Ser. No. 10/501,276, filed Jul. 9, 2004, the disclosures of which are incorporated by reference herein in their entireties. It will thus be appreciated that those skilled in the art will be able to devise numerous systems, arrangements and methods which, although not explicitly shown or described herein, embody the principles of the invention and are thus within the spirit and scope of the present invention. In addition, to the extent that the prior art knowledge has not been explicitly incorporated by reference herein above, it is explicitly being incorporated herein in its entirety. All publications referenced herein above are incorporated herein by reference in their entireties.

Apparatus, arrangement and method are provided for obtaining information associated with an anatomical structure or a sample using optical microscopy. For example, a radiation can be provided which includes at least one first electromagnetic radiation directed to be provided to an anatomical sample and at least one second electro-magnetic radiation directed to a reference. A wavelength of the radiation can vary over time, and the wavelength is shorter than approximately 1150 nm. An interference can be detected between at least one third radiation associated with the first radiation and at least one fourth radiation associated with the second radiation. At least one image corresponding to at least one portion of the sample can be generated using data associated with the interference. In addition, at least one source arrangement can be provided which is configured to provide an electromagnetic radiation which has a wavelength that varies over time. A period of a variation of the wavelength of the first electromagnetic radiation can be shorter than 1 millisecond, and the wavelength is shorter than approximately 1150 nm.

CROSS-REFERENCE TO RELATED APPLICATION This is a continuation in part of application Ser. No. 849,950, filed Apr. 8, 1986 for "Electrosurgical Conductive Gas Stream Technique of Achieving Improved Eschar for Coagulation", now U.S. Pat. No. 4,781,785, which is assigned to the assignee hereof. The disclosure of this previous application is incorporated herein by this reference. BACKGROUND OF THE INVENTION A concern regarding radio frequency (RF) leakage current is present in any electrosurgical unit (ESU). RF leakage current refers to the small, but nevertheless sometimes significant, current which flows into the surrounding environment from the active electrode and the conductor which supplies the active electrode, when the surgeon has activated or "keyed" the ESU prior to bringing the active electrode into operative arcing distance from the tissue of the patient. There is a concern that the RF leakage current will flow to the surgeon and to those in the operating room, exposing the surgeon and others to risk of injury. Based on these concerns, and on safety regulations, the maximum allowable amount of RF leakage current which can flow from an ESU must be controlled and limited. The RF leakage current is at its maximum during open-circuit, full-power operating conditions. When the ESU is keyed, but no arcs travel from the active electrode to the tissue, relatively high peak-to-peak voltages of full power cause the RF leakage current to more readily disperse into the surroundings. As soon as the active electrode is brought into operative distance from the tissue, and arcs are conducted to the tissue, the circuit is closed, the output voltage drops under this "loaded" condition, and the RF leakage current is no longer of a major concern because most or all of the power is delivered to the tissue. As soon as the conductive pathways are established to the tissue, RD leakage current is minimized due to the considerably lower impedance path of the ionized pathways in the gas jet to the tissue. The same concern with RF leakage current also occurs after the active electrode is pulled away an inoperative distance from the tissue, but the ESU remains keyed. Beam-type ESUs have special power requirements which other types of ESUs do not have. A beam-type ESU is one which delivers electrical energy, usually arcs, in ionized conductive pathways established in a continuously flowing jet of a predetermined gas. U.S. Pat. No. 4,781,175 (Ser. No. 849,950) discloses a beam-type ESU. In a beam-type ESU, the gas flowing past the active electrode must be maintained in an ionized state. The ionized state allows the arcs to be reliably initiated from the active electrode through the gas jet to the tissue, when the pencil-like device which delivers the gas jet and contains the active electrode is brought into an operative distance with the tissue. Without maintaining a state of sufficient ionization, arcs will not initiate when the surgeon desires, or the initiation will not be as reliable and predictable as is desired. Maintaining the ionization state in beam-type ESUs can be difficult, because the continuous flow of gas past the electrode requires electrical energy to be continually delivered in substantial magnitudes to prevent the ionized state from extinguishing. In a conventional ESU, gas is not constantly flowing past the active electrode. Furthermore, many conventional ESUs require actual physical contact or near physical contact of the active electrode with the tissue in order to initiate the arcs. Physical contact of the active electrode to the tissue is not desirable or possible in beam-type ESUs. Therefore, the constant state of ionization in the gas jet flowing from the active electrode must not only be maintained, but it must be maintained to a degree which allows the predictable initiation of arcs in the conductive pathways established by the ionization, once the active electrode is brought into operative proximity with the tissue. It has been determined that an effective technique of maintaining an ionized state of ionized conductive pathways in a gas is to apply relatively high peak-to-peak voltage to the gas. However, maintaining the ionization state in the gas jet of a beam-type ESU by applying a relatively high peak-to-peak voltage has the detrimental effect of increasing the RF leakage current. Thus, the requirement to maintain an effective ionized state in the gas jet sufficient to reliably initiate arcs to the tissue when desired, and the requirement to limit the amount of RF leakage current, are both significant but contradictory considerations in beam-type ESUs. SUMMARY OF THE INVENTION The present invention offers the capability of sustaining and effectively ionized state of ionized conductive pathways in a gas jet of a beam-type ESU, to reliably and predictably initiate the conduction of arcs in the ionized conductive pathways when the surgeon so desires, but while doing so, limiting the RF leakage current to an acceptable level. In accordance with the major aspects of the present invention, an electrosurgical generator means of the beam-type ESU generates bursts of radio frequency electrical energy at a predetermined repetition rate and applies those bursts to the gas jet. In an inactive operational state, when it is desired to maintain the ionized state in the gas jet without initiating or conducting arcs of electrical energy to the tissue, the generator means generates target bursts of RF electrical energy. In an active operational state when it is desired to transfer arcs in the ionized conductive pathways to the tissue, the generator means generates active bursts of RF electrical energy. The improved features of the present invention relates to changing the predetermined repetition rate of the target bursts to a value substantially less than the predetermined repetition rate of the active bursts; and during a sequence of generating a plurality of target bursts, substantially increasing the energy content of a predetermined plurality of less than all of the target bursts occurring in each sequence. The target bursts of increased energy during each sequence, known as booster target bursts, are relatively few, for example, less than ten percent. The peak-to-peak voltage of these booster target bursts is substantially higher than the voltage of the normal target bursts. The booster target bursts ten to create the ionized conductive pathways, while the normal target bursts tend to sustain the ionized conductive pathways between the application of the booster target bursts. By repeating the sequences of target bursts in the manner provided, the ionized state is effectively maintained within the gas jet. By reducing the repetition rate at which the target bursts are generated during the inactive state, the amount of RF leakage current is maintained within acceptable limits because the amount of energy delivered to the gas jet during a predetermined time period is reduced. Thus, the present invention limits the RF leakage current to an acceptable level while maintaining an effective ionized state in the gas jet to initiate arcs of electrical energy to the tissue when desired. Because the reduced repetition rate of the target bursts may be sufficiently low to cause muscle stimulation, the generator means also includes improved means for sensing a condition indicative of the occurrence of arc initiation to the tissue during the inactive state, and thereupon operatively changing the repetition rate from the lower inactive rate to the higher active rate upon sensing such a condition. As soon as arc initiation occurs, preferably upon occurrence of the first arc to the tissue in the inactive state, the generator means immediately begins supplying their higher active repetition rate to avoid significant muscle stimulation. In this manner, the generator means automatically and rapidly transitions from the inactive state to the active state. Similarly, an effective means for terminating the delivery of RF bursts in the active rate is achieved by sensing the absence of at least one arc in the ionized conductive pathway to the tissue in the active state. Preferably, a predetermined plurality of absences of arcs are sensed before transitioning from the active state to the inactive state. The number of arc absences which occur before transitioning occurs is preferably related to the amount of power delivered during the active state. With a higher amount of active power delivered, a fewer number of arc absences must occur in the conductive pathway before transitioning from the higher active repetition rate to the lower inactive repetition rate. Conversely, with lower amount of active power delivered in the active state, more arc absences are required before the generators means transitions from the higher active repetition rate to the lower inactive repetition state. Because the gas jet is in a highly ionized state immediately after switching from the active to the inactive state, and because the application of the booster target pulses immediately after transitioning from the active to the inactive state might result in undesired arcing in the inactive state, the generator means includes means for temporarily delivering only normal target bursts for a predetermined time period after transitioning from the active to the inactive states. During this predetermined time period no booster target bursts are delivered. If the surgeon desires to immediately recommence the active state, a sufficient amount of ionization exists as a residual from the active bursts and the normal target bursts so that arc initiation can immediately and reliably occur. However, if the surgeon ceases active operation for more than the predetermined time period, for example three seconds, the booster target pulses will again commence in the sequences, to establish a sufficiently ionized state to readily support arc initiation. Other significant advantages and improvements are available from the present invention. A more complete explanation of the details of the present invention is found in the following detailed description, taken in conjunction with the accompanying drawings. The actual scope of the present invention is defined by the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a generalized illustration of a beam-type electrosurgical unit (ESU) embodying the present invention, illustrating an electrosurgical generator means (ESG), a gas delivery apparatus, a handpiece or pencil, and a segment of patient tissue. FIG. 2 is a generalized block diagram of the ESG and gas delivery apparatus shown in FIG. 1. FIG. 3 is a generalized block diagram of the RF logic and arc sense circuit illustrated in FIG. 2. FIG. 4 is a generalized schematic diagram of the resonant output circuit shown in FIG. 2. FIG. 5 is a generalized schematic and logic diagram of the repetition rate generator and the pulse generator shown in FIG. 3. FIGS. 6A, 6B, 6C, 6D, 6E, 6F and 6G are waveform diagrams illustrating the operation of the circuit elements shown in FIG. 5. FIG. 7 is a generalized schematic and logic diagram of the arc sensing circuit and the arc sense logic shown in FIG. 3. FIGS. 8A, 8B, 8C, 8D, 8E and 8F are waveform diagrams illustrating the operation of the circuit elements shown in FIG. 7 and the resonant output circuit shown in FIG. 4. FIG. 9 is a generalized schematic and logic diagram of the booster generator shown in FIG. 3. FIG. 10 is a generalized schematic and logic diagram of the pulse width reference circuit, the ramp generator, and the RF drive pulse generator shown in FIG. 3. DETAILED DESCRIPTION A beam-type electrosurgical unit (ESU) which embodies the present invention is illustrated generally in FIG. 1 and is referenced 40. The ESU 40 includes three major components, a pencil or handpiece 42 which is manipulated by the surgeon, gas delivery apparatus 44 and an electrosurgical generator means (ESG) 46. A flexible cord 48 connects the gas delivery apparatus 44 and the ESG 46 to the pencil 42. The gas delivery apparatus delivers a predetermined gas through a plurality of individual passageways or lumens 50 in the cord 48 to the pencil 42. The gas issues from a nozzle 52 of the pencil 42 in a directed or substantially laminar flow stream jet 54. The ESG 46 supplies electrical energy over a conductor 56 of the cord 48 to the pencil. The conductor 56 is electrically connected in the pencil to a needle-like electrode 58 which extends into the nozzle 52. The electrical energy supplied by the ESG 46 is of a predetermined characteristic, as discussed in greater detail below, which is sufficient to ionize the gas flowing through the nozzle 52 and to create ionized conductive pathways in the jet 54. The gas delivery apparatus 44, the cord 48 and the pencil 52 are one example of means for conducting a predetermined gas in a jet. The ESG 46, the cord 48 and the electrode 58 are one example of means for transferring electrical energy in ionized conductive pathways in the gas jet. In an active state or mode of operation of the ESU 40, electrical energy is transferred in the ionized conductive pathways in the jet 54 in the form of arcs 60. The arcs 60 travel within the jet 54 until they reach tissue 62 of the patient at the electrosurgical site. The electrical energy which is transferred into the tissue 62 creates a predetermined electrosurgical effect, usually an eschar. Details of the improved eschar available from a beam-type ESG are more particularly described in the aforementioned U.S. Pat. No. 4,781,175. The electrical energy travels through the tissue 62 to the return electrode or patient plate 70 which contacts the tissue 62. The patient plate 70 is connected by the return electrical conductor 72 to the ESG 46. A complete electrical circuit is thus established for conducting current from the ESG 46, to the electrode 58 in pencil 42, through the jet 54, to and through the tissue 62, to the patient plate 70, through the return conductor 72 and back to the ESG 46. In an active state or mode of operation of the ESU 40, an ionized state of ionized conductive pathways is maintained in the gas jet 54 issuing from the nozzle 52 but no electrical arcs are conducted in the inactive state. The ionized conductive paths create a corona or glow discharge within the jet, and the glow discharge or corona is capable of initiating arc conduction when the surgeon moves the nozzle 52 into operative proximity with the tissue 62. At this operative proximity, the ionized conductive pathways to the tissue 62 establish enough of a closed circuit through the tissue 62, a patient plate 70 and a return conductor 72, that arcs 60 commence or initiate in the jet 54. When the surgeon activates or "keys" the ESU 40 for the delivery of the active level of the electrosurgical power to the tissue, it is important that the ionized state of ionized conductive pathways within the gas jet is established. When the nozzle 52 is brought into operative proximity with the tissue 62, the ionized conductive pathways will commence conducting arcs. Upon occurrence of these arcs, the ESG 46 will automatically switch or transition from the inactive state to the active state and commence delivering an active level of power to the tissue to achieve the predetermined electrosurgical effect. Without maintaining an ionization state in the gas jet in the inoperative state, it is impossible or extremely difficult to repeatedly and reliably initiate arcs 60 in the gas jet 54 to transition to the active state. In order to achieve the electrosurgical effect, the surgeon must activate or "key" the ESG. The inactive state then occurs wherein the ionized state of ionized conductive pathways in the gas jet is created, followed by the delivery of at least one arc to the tissue while in this inactive state due to the surgeon moving the pencil into an operative distance from the tissue, followed by an automatic transition to the active state where the full request amount of electrosurgical power is delivered to the gas jet and conducted to the tissue. Details of an exemplary gas delivery apparatus 44 are described in the above mentioned U.S. Pat. No. 4,781,175. Details of two types of handpieces or pencils 42 and cords 48 and associated equipment are disclosed in United States patent Ser. No. 849,950 and in the U.S. patent application Ser. No. 224,485, for Electrosurgical Conductive Gas Stream Equipment, filed July 26, 1988. Additional details regarding the ESG 46 are also disclosed in U.S. Pat. Ser. No. 849,950. The major elements of an ESG 46 incorporating the present invention are illustrated in FIG. 2. A control switch 80 supplies signals to a front panel control and mode logic microprocessor circuit 82. The switch 80 controls the circuit 82 to signal the gas delivery apparatus 44 to initiate the delivery of the gas to the pencil. The switch 80 also controls the circuit 82 to signal a power supply 84 and a RF logic and arc sense circuit 86 to initiate the application of electrical energy to the gas jet. The front panel control and mode logic microprocessor circuit 82 includes a microprocessor and various control devices, such as switches and potentiometers, which establish the selected flow rate of the gas delivered from the pencil, the source of gas to be delivered (when more than one predetermined type of gas is available), and a variety of other electrical control and operating signals, as is more fully disclosed in U.S. Pat. Ser. No. 849,950. The signals which are supplied to the RF logic and arc sense circuit 86 include a system clock signal at 88 which is derived from a microprocessor of the circuit 82, mode control and jam input count signals supplied over a data path 90 from the microprocessor to control the operation of the ESG in accordance with the type of procedure selected by the surgeon (fulguration being the primary mode relevant to this invention), an active power level analog signal at 92 which relates to the amount of electrical power selected by the surgeon for application to the tissue, and an RF enable signal at 94 which enables the RF logic and arc sense circuit 86 to function in the manner described below when electrical energy is delivered. Gas- and electrical-related alarm conditions are also detected by the circuit 82, and the RF enable signal at 94 prevents the delivery of radio frequency electrical energy to the pencil until all of the proper operating conditions have been satisfied. A convention followed throughout this description is that the signal and the conductor upon which that signal appears will both be referenced by the same reference numeral. The power supply 84 is activated by signals from the circuit 82. The power supply 84 receives electrical energy from conventional AC power source 96 and rectifies the AC power to DC power. When activated, the power supply 84 delivers a predetermined substantially constant voltage levels of DC power to a resonant output circuit 100. The power supply 84 is conventional. The RF logic and arc sense circuit 86 delivers drive pulse signals 102 and 104 to the RF drive 98. The drive pulse signal 102 initiates a conduction switching signal 106 from the RF drive 98, and the drive pulse signal 104 initiates an extinguishing switching signal 108 from the RF drive 98. The switching signals 106 and 108 switch energy from the power supply 84 to the resonant output circuit 100. The conduction switching signal 106 starts the flow of charging current from the power supply 84 to the resonant output circuit 100. The extinguishing switching signal 108 terminates the flow of charging current to the resonant output circuit 100. The amount of energy transferred from the power supply 84 to the output circuit 100 is determined by the time width between the drive pulse signals 102 and 104 which respectively control the switching signals 106 and 108, because the output voltage of the power supply 84 is constant. The resonant output circuit 100 commences resonating at its natural frequency (RF) after the switching signal 108 extinguishes the flow of charging current from the power supply 84. The RF drive 98 energizes the resonant output circuit 100 at a predetermined repetition rate established by the drive signals 102 and 104, and the resonant output circuit 100 discharges at its resonant frequency by conducting electrical energy to the tissue at the surgical site. For a constant output impedance, the peak-to-peak output voltage of the resonant output circuit varies in direct relation to the width of the 17 charging current pulse created by the switching signals 106 and 108 which are created by the drive pulse signals 102 and 104, respectively. Details regarding the RF drive 98 and resonant output circuit 100 are disclosed more completely in U.S. Pat. No. 4,429,694 and Ser. No. 849,950. The RF logic and arc sense circuit 86 receives a control signal 110 from the resonant output circuit 100. The control signal 110 relates to the condition of power delivery to the patient tissue, and is employed primarily to detect the presence of arcs in the ionized conductive pathways in the gas jet to the tissue. The control signal 110 is employed by the RF logic and arc sense circuit 86 to change the repetition rate of drive signals 102 and 104 to a higher active repetition rate when electrosurgery is being performed and to a lower inactive repetition rate when the ionized state in the gas jet is to be maintained, so as to readily initiate the conduction of arcs in a reliable transition to the active state when desired. When the pencil is not within a predetermined operative distance from the tissue, the inactive state of electrical power delivery exists. During the inactive state target bursts of RF energy are delivered to the gas jet to initiate and sustain ionization. The target bursts are of two levels: booster target bursts and normal target bursts. The booster target bursts are of higher energy content and occur much less frequently than the normal target bursts. The circuit 86 controls the energy content of the booster target bursts. When the pencil is moved into sufficiently-close operative proximity to the tissue, an arc will travel in the ionized conductive pathway to the tissue. The control signal 110 from the resonant output circuit 100 indicates the presence of arcs. The circuit 86 immediately transitions from the inactive state to the active state and increases the repetition rate of the signals 102 and 104 from the inactive rate to the active rate when arcs are sensed in the inactive state. After the pencil is removed to an inoperative distance from the tissue, the control signal 110 indicates the absence of arcs in the ionized conductive pathways to the tissue. The RF drive and arc sense circuit 86 reduces the repetition rate from the higher arc sense circuit 86 reduces the repetition rate predetermined number of repetitions occur when the absence of arcs is indicated. Further details of the RF logic and arc sense circuit 86 are illustrated in FIG. 3. The system clock signal 88 is applied to an RF logic clock 112 which delivers clock signals 114 to a repetition rate generator 116 and to a pulse generator 118. Signals from the data path 90 are also applied to the repetition rate generator 116 and pulse generator 118. The signals from the data path 90 are derived from the microprocessor of the circuit 82 (FIG. 2) and are employed by the repetition rate generator 116 to establish the repetition rates for the active and inactive states or modes of operation pertinent to this invention. A repetition (rep) signal is applied at 170 from the repetition rate generator 116 to the pulse generator 118. The rep signal 170 establishes the repetition rate at which the pulse generator 118 supplies pulse signals 122. The width of each pulse signal 122 is established by the signals supplied by the microprocessor on the data path 90 to the pulse generator 118. The control signal 110 from the resonant output circuit 100 (FIG. 2) is supplied to an arc sensing circuit 124. The arc sensing circuit 124 supplies a signal 126 to an arc sense logic circuit 128. The signal 126 indicates the presence or absence of arcs being delivered by the resonant output circuit 100 (FIG. 2) to the tissue. Another input signal to the arc sense logic circuit 128 is the active power level signal 92. Upon the signal 126 indicating the absence or presence of a predetermined number of arcs, as influenced by the level of the active power signal at 92, the arc sense logic 128 changes the logic level of an active/target signal 130. The active/target signal 130 is applied to the repetition rate generator 116, to a booster generator 132 and to a pulse width reference circuit 136. The active/target signal 130 controls the repetition rate generator 116 to change the repetition rate between a higher active repetition and a lower inactive repetition rate in the target state. The booster generator 132 responds to the active/target signal 130 by generating a booster signal 134 to periodically increase the energy content of a selected number of target bursts, called booster target bursts. The active/target signal 130, the booster signal 134 and the active power level signal 92 are applied to a pulse width reference circuit 136. The pulse width reference circuit 136 responds to each of the three input signals 92, 130 and 134 by supplying a width control signal 138. A ramp generator 140 receives the pulse signal 122 and the width control signal 138, and generates a modulated width pulse signal 142. The pulse signal 122 controls the onset of the modulated width pulse signal 142, and the width control signal 138 controls and modulates the width of the pulse signal 142. An RF drive pulse generator 144 responds to the pulse signal 122 and the modulated width pulse signal 142 to create the drive pulse signals 102 and 104. Further details regarding the nature and operation of each of the elements shown in FIG. 3 are described below. Details of the resonant output circuit 100 are shown in FIG. 4. Four high current switches 146 are electrically connected in series. The application of the conduction switching signal 106 causes all four high current switches 146 to become simultaneously conductive. The high voltage at terminals 148 and 150 from the power supply 84 (FIG. 2) charges a resonant LC or "tank" circuit 152 during the time the high current switches 146 are conductive. A capacitor 154 is part of the tank circuit 152 as well as an output transformer 156, having a primary winding 158 and a secondary winding 160. The primary winding 158 is thus charged with high current electrical energy from conductors 148 and 150 when the high current switches 146 are simultaneously conductive. When the high current switches 146 are extinguished or become nonconductive by the application of the extinguishing switching signal 108, the tank circuit 152 commences oscillating at its natural RF frequency. The natural frequency is primarily established by the effective inductance value of the primary winding 158 and the value of the capacitor 154. An unloaded natural frequency of approximately 500-600 KHz has proved satisfactory. Electrical energy is transferred from the tank circuit 152 to the secondary winding 160 of the output transformer 156 and through isolating capacitors 164 to the pencil 42 and tissue 62 (FIG. 1). The impedance created within the pencil, the impedance experienced by the arcs in the ionized pathways of the gas jet, and the impedance or resistance of the tissue causes a damping effect on the electrical energy in the tank circuit 152, establishing a ring down cycle of RF oscillations. Under loaded conditions, inherent reactances in the tissue and energy delivery paths modify the unloaded frequency of the high frequency surgical signal compared to the natural frequency of the resonant circuit. Each ring-down cycle of RF oscillations is established by one charging current pulse to the tank circuit 152. This ring-down cycle of RD oscillations is referred to as a "burst" of RF energy. The peak-to-peak voltage of each burst varies in direct relation to the amount or time width of the charging current pulse delivered to the tank circuit 152, for a set output impedance. The replenish the energy in the resonant circuit 152 after each burst or ring down cycle, the high current switches 146 are switched on and off during each repetition. These repetitions occur at a predetermined repetition rate, which is considerably less than the natural frequency of the tank circuit 152. The time during which the switches 146 are on controls the amount of energy delivered to the tank circuit 152 and also the amount of energy delivered during each burst. The resonant output circuit is thus one example of means for converting the charging pulses into RF energy bursts. A sensing transformer 162 is also connected in series in the resonant circuit 152. The sensing transformer 162 derives the control signal 110. The control signal 110 represents the electrical signals in the tank circuit 152, and those conditions are representative of the arcing condition in the gas jet. Details regarding the repetition rate generator 116 and the pulse generator 118 are shown in FIGS. 5 and 6A through 6G. The primary component of the repetition rate generator 116 is a presettable synchronous down counter 166. A similar down counter 168 is also the major component of the pulse generator 118. The down counters 166 and 168 are conventional items, such as those marketed under the designation CD40103B. The clock signals 114 from the RF logic clock 112 (FIG. 3) are applied to the clock inputs of both down counters 166 and 168. The clock signal 114 is illustrated in FIG. 6A. Signals from the data path 90 are applied to some of the jam input terminals of the down counter 166, and the target/active signal at 130 is applied to at least one other jam input terminal. Signals from the data path 90 are also applied to the jam input terminals of the down counter 168. The predetermined count value of each presettable down counter is set by the signals at the jam inputs. A clock signal has the effect of decrementing the set count upon each positive transition of the clock input signal. The count which is set by the jam input signals may be established in one circumstance by the application of a low level logic signal to the synchronous preset enable (SPE) input terminal of the down counter. The down counter 166 is the preferred form of means for establishing the repetition rate and for changing the repetition rate at which the drive pulse signals 102 and 104 (FIG. 2) are delivered to cause charging of the tank circuit 152 of the resonant output circuit 100 (FIG. 4). During the active state when an active level of power is delivered to the tissue, the active/target signal 130 is at a high level. The other signals from the data path 90 in conjunction with the high active/target signal 130, define a digital input signal which defines the jam input count to the down counter 166. The clock signals 114 decrement the down counter 166 until the count established by the jam input signals is reached, at which time the output signal 170 goes low. The signal at 170 is shown in FIG. 6B. The low signal at 170 is applied to the SPE input terminals of both down counters 166 and 168. Upon the next positive edge of a clock signal at 114, the down counters 166 and 168 are again loaded or jammed according to the counts applied at their jam input terminals. The signal 170 establishes the length of each repetition interval in terms of the number of clock signals 114 which define each repetition. In the active state, the repetition rate intervals are shorter, resulting in a more frequent repetition rate. The preferred repetition interval is approximately 32 microseconds in the active state. In the inactive or target state, the repetition interval is substantially longer, occurring once each preferred time interval of approximately 56 microseconds. A lower repetition rate is thus established in the inactive state. The change in repetition rate is achieved when the active/target signal 130 changes between its high and low logic levels. A high level signal 130 changes the jam input value to shorten the repetition rate, while the low level signal 130 changes the jam input value to lengthen the repetition rate. Although FIG. 6B only illustrates the repetition rate established by the signal 170 for the active state, the inactive or target state would be similar except that the number of clock cycles 114 would be increased substantially between each low level portion of the signal 170. The signal 170 is applied to the pulse generator 118. The count defined by the jam input signals to the counter 168 is set immediately after the signal 170 goes low. A NAND gate 172 receives the signal at 170 at one input terminal, and a signal 174 is applied to the other input terminal from an inverter 176 which is connected to the output terminal of the down counter 168. The signal 174 is illustrated in FIG. 6E. The output signal 180 from the NAND gate 172 is illustrated in FIG. 6C. The signal at 180 and the clock signal 114 are applied to the input terminals of another NAND gate 182 and the output signal 184 from the NAND gate 182 is shown in FIG. 6D. The signal 184 is applied to the clock input terminal of the down counter 168. Upon the occurrence of a signal at 170 which establishes the length of the repetition interval relative to the clock signals 114, and hence the repetition rate, the signal 184 provided by the NAND gates 172 and 182 commences decrementing the down counter 168. The down counter 168 commences counting the number of clock pulses 114 which will establish the width of the signal 174. The down counter 168 thus becomes a preferred form of a means for generating a signal by which the pulse signal 122 will ultimately be derived. The width of the pulse signal 122 is ultimately established by the count set or jammed into the down counter 168. The signal 174 is applied to the D input terminal of a flip-flop 186. The clock signal 114 is applied to the clock input terminal of the flip-flop 186. The output signal 188 from the flip-flop 186 is shown in FIG. 6F. The signals at 174 and 188 are applied to an OR gate 190, and the output signal from the OR gate is the pulse signal 122 which is shown in FIG. 6G. The pulse signal 122 is somewhat less in time width than the signal at 188, because of the manner in which the logic elements shown in FIG. 5 are clocked on the positive edge transitions of the clock signal 114. Details regarding the arc sensing circuit 124 and the arc sense logic 128 are illustrated in FIGS. 7 and 8A through 8F. The control signal 110 from the resonant output circuit 100 (FIGS. 2 and 4) is applied to the arc sensing circuit 124. This control signal 110 is illustrated in FIG. 8A. The control signal 110 is applied through resistors to a Zener diode 192. The Zener diode 192 rectifies the negative half cycles of the control signal 110 while passing the positive half cycles, which are limited by the Zener diode breakdown voltage. The signals passed by the Zener diode 192 are applied to the noninverting input of a comparator 194. A resistive network 196 establishes a threshold level 198 which is applied to the inverting input terminal of the comparator 194. Only those positive half cycles of the control signal 110 which exceed the threshold level 198 create output pulses from the comparator 194. These output pulses are applied to the clock input terminal of a conventional counter 200. Each positive half cycle of the control signal 110 which exceeds the threshold level 198 increments the counter 200. The counter 200 supplies a high level signal 126 after it has counted a number of output pulses from the comparator 194 which correspond to the output terminal from which the signal 126 is derived. When the counter 200 reaches the predetermined output count (which is illustrated as three), the signal 126 goes high, as is shown in FIG. 8C. Thus, the arc sensing circuit 124 supplies the signal 126 only after a predetermined number of positive half cycles of the control signal 110 exceed the threshold level 198. The predetermined number, for example three, is selected to be able to reliably distinguish an absence of arcs, because, as is illustrated in FIG. 8A, the non-arcing condition is represented by a number of oscillations after each charging repetition, while the arcing condition is represented by a highly damped signal which does not oscillate above the threshold level 198 for the required number of times before the signal 126 occurs. Thus, the arc sensing circuit 124 reliably detects arcing and non-arcing conditions from the control signal 110 and supplies the signal 126 when a non-arcing condition is detected. The signal 126 is reset to a low level at the start of each charging repetition by the application of the pulse signal 122 to the reset terminal of the counter 200. The arc sense logic 128 receives the signal 170 from the repetition rate generator 116 (FIG. 5). The signal 170 occurs once during each repetition interval. The signal at 170 is illustrated in FIG. 8B. The signals 170 and 130 are applied to the input terminals of NAND gate 204. The signal 170 is applied to an OR gate 206 and NOR gates 208 and 210. The signal 126 is also applied to OR gate 206. One input signal to NOR gate 208 is derived from the output signal from NOR gate 210. Another input signal to NOR gate 210 is derived from a comparator 212. The comparator 212 receives the active power level signal 92 at its noninverting input, and a threshold level signal 214 at its inverting input. The threshold level signal 214 is established by the resistive network 215. When the active level power signal 92 exceeds the threshold signal 214, the output signal from the comparator 212 is high. For example, when the active power level signal 92 represents a value greater than approximately 85 watts, a high output signal from the comparator 212 is presented to the input terminal of the NOR gate 210. The high output signal from the comparator 212 is used for changing the jam input signals applied to a presettable down counter 216. The down counter 216 is used to established the number of non-arcing repetition intervals which are allowed to occur prior to switching or transitioning from the active state to the inactive state. The active/target signal 130 will be held in a high level indicating an active state until a predetermined number of repetition intervals indicating an absence of arcs being delivered are sensed. Preferably, at power levels greater than approximately 85 watts, as established by the resistive network 215, the active/target signal 130 will transition from the high active level to the low target level in approximately the preferred number of four consecutive repetition intervals when no arcs are sensed. When the active power level is less than 85 watts, the preferred number of consecutive repetition intervals which occur before transitioning to the low level active/target signal (indicating an inactive state) is preferably approximately 128. When the ESU is first keyed, the down counter 216 is jammed to start in the inactive level with a low level signal 130 as is shown in FIG. 8F. The signals 130 and 170 cause the NAND gate 204 to supply an output signal 218 as is shown in FIG. 8D. The signal 218 forms the clock signal to the down counter 216. During the inactive state, the signal 218 remains high and therefore does not decrement the counter 216. The signals 170 and 126 are applied to the OR gate 206, and an output signal 220 (shown in FIG. 8E) is applied to the asynchronous preset enable (APE) terminal of the down counter 216. A low signal at the APE terminal has the effect of asynchronously jamming the input count into the down counter 216. With the application of every signal 170 during the active state when the signal 126 is low, the down counter 216 is repeatedly jammed with its input count established by the output signals from the NOR gates 208 and 210. In the inactive state, when there is a high output signal 202 from the counter 200, this high output signal is coupled through the OR gate 206. The high level signal 220 at the APE input terminal of the down counter 216 prevents it from being repeatedly jammed to its input count. The signals 218 are thus allowed to start decrementing the counter 216. Operation of the arc sensing circuit 124 and the arc sense logic 128 relative to the control signal 110 and the active level power signal 92 proceeds as follows. Upon the first arcing condition in the inactive state shown at point 222 in FIG. 8A, the signal 126 from the counter 200 goes low. The absence of the signal 126 to the OR gate 206 allows the low level transition of signal 170 to create a momentary low signal at the APE input terminal of the down counter 216. The input count set by the jam input signals is thereby set in the down counter 216, and the active/target signal 130 goes high. The high active/target signal 130 allows the signal 218 from the NAND gate 204 to decrement the down counter 216. However, with each consecutive repetition interval when an arc is sensed, the signal at 220 continues to jam the input count to the down counter 216 so that the signals 218 do not effectively decrement the counter 216 because it is repeatedly rejammed. This condition continues throughout the active state while an active level of power is applied to the tissue. As soon as the pencil is pulled back away from the tissue to a predetermined distance where each repetition period results in a non-arcing condition, as is illustrated at points 224 in FIG. 8A, the counter 200 supplies a high level signal 126. The signal 126 causes the OR gate 206 to supply a high output signal 220 to the APE terminal, thereby preventing the resetting of the counter 216. The signal at 218 commences decrementing the counter, and the active/target signal 130 goes to a low level after the counter 216 has been decremented to the value established by the jam input signals from the NOR gates 208 and 210. It is important that the repetition rate is changed from the inactive rate to the active rate immediately upon the detection of the first arc to the tissue. This is established by the signal 126 which, while creating the signal 220 to jam the inputs, causes the active/target signal 130 to immediately assume a high level. By switching immediately upon the first detected arc, the lower repetition rate of the inactive rate will have a minimum muscle stimulation effect. The inactive repetition rate is sufficiently low that it can create muscle stimulation if the change or transition to the higher active rate is not immediately accomplished. Transition from the active state to the inactive state after a predetermined number of non-arcing repetition intervals is important to ensure that the distance at which the arcs in the gas jet extinguishes is different than the distance at which the arcs are initiated. The beam is actually a collection of individual arcs in a uniform bundle. As long as the length of the beam is such that all arcs terminate on tissue, the control signal 110 will remain heavily damped. However, as the beam is made longer with respect to the tissue, occasional arcs in the bundle fail to reach the tissue, with the result that a lightly damped control signals 110 occasionally occurs. Initially, the lightly damped control signal may occur only once in a large number of cycles. However, as the beam is made longer, the ratio of lightly damped to heavily damped responses increases. This reverse situation occurs when activating the beam. As the glow discharge created by the ionized gas jet is brought closer to the tissue, the glow increases until more and more arcs bridge the gap, resulting in more and more heavily damped control signals 110. By immediately switching to the active level of delivered power upon sensing the first arc, and by not switching from the active level to the inactive level until a predetermined number of absences of arcs during sequential repetition intervals are detected, it is assured that the beam will continue in the active state even though the surgeon may unintentionally remove the pencil a short distance out of the operative range while performing the procedure. Switching to the inactive state from the active state only after a predetermined number of repetition rates assures that there will be no fluttering or other instability created by the unintentional fluctuations in position of the pencil, and also assures a more reliable and precise initiation and operation. Details regarding the booster generator 132 are illustrated in FIG. 9. Two presettable down counters 225 and 226 are connected in series. The active/target signal at 130 is applied to an inverter 227. The inverter 227 supplies an output signal to the clear or reset (RST) terminals of the down counters 225 and 226. A low input signal to the RST terminals causes each down counter 225 and 226 to asynchronously be cleared and reset to its maximum count. This occurs after a transition of the active/target signal 130 to the active state, holding the counters 225 and 226 at their maximum count and therefore disabling them during the active state. After a transition of the active/target signal 130 to the inactive state, the counters will have been set for their maximum count instead of the counter normally set at the jam inputs. Since the counter 226 is normally jammed to a counter of 4, the maximum count represents a substantial increase. Resetting the counters thus has the effect of delaying the onset of the booster signal 134, so that the added energy of the booster target pulses will not immediately cause unintentional arcing in the inactive state for a predetermined time after the active state is terminated. This is desirable because the active state has caused a residual amount of ionization which could easily support a distracting and potentially undesirable state of fluttering or intermittent arcing in the inactive state. After the predetermined time period, the residual ionization has dissipated and the fluttering condition is not likely to occur. At this point the booster signals 134 may be delivered. Resetting the counters 225 and 226 is one example of means for temporarily disabling the booster generator. When the ESU is first keyed, the counters 225 and 226 will be jammed to their normal count, as shown in FIG. 9. The counter 225 will commence decrementing based on the pulse signal 122 from the drive pulse generator 118 (FIG. 3). The pulse signals 122 occur once each repetition period, so the down counter 225 is decremented once each repetition period. The signal 174 is applied to a carry-in (CI) input terminal of the down counter 225. A high level signal 174 inhibits the counter 225 from counting. Thus, the application of the pulse signal 122 causes the counter 225 to be decremented only if the CI input terminal of the counter 225 is low, which will occur when the signal 174 from the pulse generator 118 (FIG. 5) goes low. The jam input signals to the counter 225 are set for the maximum counting capability of the counter 225, which is the number 225. Once the counter 225 has been decremented, a low level output signal is supplied to the CI input terminal of the down counter 226, to allow it to commence counting. Down counter 226 decrements by one count, at which point down counter 225 again commences counting downward from its maximum count set by its jam inputs. The procedure continues until four complete cycles of counts from the counter 225 have occurred. The output signal from the down counter 226 is applied through an inverter 230 to a NAND gate 231. The other input signal to the NAND gate 231 is the modulated width pulse signal 142 which occurs at the end of each drive pulse. Thus, at the end of the drive pulse which occurs after 1,020 repetition intervals (counted by down counters 225 and 226) the NAND gate 231 supplies a low signal to the APE input terminal of a presettable down counter 232. The jam inputs to the down counter 232 are established for a count of 48. The low signal at the APE asynchronously forces the count from the jam inputs into the down counter 232. The output signal from the down counter 232, which is the booster signal 134, goes high, and the signals 122 and 134 are logically combined in the NAND gate 234 for decrementing the counter 232. After the counter 232 has counted down from its jam input count, the booster signal 134 goes low. The booster generator 132 thus establishes a number of repetition intervals in a sequence of repetition intervals defined by the counts of the counters 225, 226 and 232. During this sequence, which in the form shown amounts to 1020 repetitions, the booster signal 134 is available to increase the energy content of 48 consecutive repetitions of target bursts. The amount of energy in these 48 target bursts, known as booster target bursts, is increased to maintain the ionization in the gas jet, while the remaining 972 repetitions in each sequence have normal level target bursts. Usually ten percent or less of the target bursts in a sequence should be booster target bursts. Preferably this percentage should be reduced to less than five percent. It has been found satisfactory to increase the energy content of the booster target bursts to three times the energy content of the normal target bursts, when about five percent of the target bursts are booster target bursts. The width of the active level pulses, the booster target pulses and the normal pulses is derived by the pulse width reference circuit 135, the ramp generator 140 and the RF drive pulse generator 144, the details of which are illustrated in FIG. 10. The pulse width reference circuit 136 receives the active power level signal 92 and applies it to a buffer amplifier 236. The output signal from the amplifier 236 is applied as an analog input signal to an analog switch 238. The input control signal to the analog switch 238 is supplied by the active/target level signal 130. With a high level signal 130, the analog switch 238 applies the analog signal from the buffer amplifier 236 as the width control signal 138. When the active/target signal 130 is low, an inverter 240 supplies an input control signal to an analog switch 242. An analog input signal 249 to the analog switch 242 is derived from a resistive network 246. The control signal from the inverter 240 causes the analog switch 242 to supply the voltage level 249 as the width control signal 138. The booster signal 134 forms an input control signal for an analog switch 248. An analog input signal 243 to the analog switch 248 is also derived from the resistive network 246, and the signal 243 is a value greater than the value of the signal 249. Upon the presence of the booster signal 134, the analog switch 248 supplies the signal 243 as the pulse width control signal 138. The output signal from the analog switch 248 is greater in magnitude than that of the output signal from the analog switch 242. Arranged in this manner, it will be seen from the following description that the width or energy content of the booster target pulses is greater than the normal target pulses. The ramp generator 140 includes a transistor circuit 250 which charges a capacitor 242 in a linearly increasing or ramp fashion once the circuit 250 is triggered by a pulse signal 122 from the pulse generator 118 (FIG. 3). The linearly increasing ramp signal is applied to the noninverting input terminal of a comparator 254. The width control signal 138 is applied to the inverting input terminal of the comparator 254. When the ramp signal applied to the noninverting input terminal exceeds the analog level established by the signal 138, the modulated width output signal 142 is delivered by the ramp generator 140. The time width of the signal 142 created by the ramp generator 140 is determined by the analog level of the signal 138. Active pulses have a wider time width, because the output signal from the analog switch 238 will be greater in analog value. The booster target pulse will have a greater value than the normal target pulses, since the analog output signal from the analog switch 248 is greater than that of the analog switch 242. The ramp generator 140 establishes a convenient means for controlling the width of the drive pulses 102 and 104. The RF drive pulse generator 144 includes a flip-flop 256 which is triggered by the pulse signal 122. The flip-flop 256 is reset by the modulated width pulse signal 142. A transistor circuit 258 includes a transistor 260 which is triggered into conduction by the output signal from the flip-flop 256. The output drive pulse signal 104 goes to a low level when transistor 260 commences conducting. When the output signal from the flip-flop 256 cease, transistor 260 becomes nonconductive and transistor 262 becomes conductive. The drive pulse signal 104 goes high, and the drive pulse signal 102 goes low, thus terminating the width of the drive pulse delivered by the RF drive circuit 98 (FIG. 2) to the resonant output circuit 100 (FIG. 2). The various improvements associated with the present invention have been described above. The preferred form of the present invention has been shown and described with a degree of detail. It should be understood, however, that this detailed description has been made by way of preferred example, and that the scope of the present invention is defined by the appended claims.

An electrosurgical generator in an electrosurgical unit (ESU) controls the repetition rate and the energy content of bursts of RF energy delivered to a gas jet supplied by the ESU, in order to maintain RF leakage current within acceptable limits while still achieving a sufficient state of ionization in the gas jet to reliably initiate the conduction of arcs to the tissue. The repetition rate of the RF bursts is substantially reduced in an inactive state when no arcs are delivered. A relatively small number of the RF bursts delivered during the inactive state have an increased or boosted energy content to assure an adequate ionization state in the gas jet.

FIELD OF THE INVENTION [0001] The present invention relates to methods and compositions for inhibiting the activity of skin proteases, especially human kallikrein 7 (KLK7), human kallikrein 5 (KLK5), and human kallikrein 14 (KLK14). More specifically, the invention relates to the use of substituted 3,1-benzoxazin-4-ones being selective inhibitors of human skin kallikreins for the treatment of skin diseases, more specifically for the treatment of inflammatory skin diseases, especially Netherton syndrome. BACKGROUND [0002] KLK7 (hK7, or stratum corneum chymotryptic enzyme (SCCE), Swissprot P49862) is a S1 serine protease of the kallikrein gene family displaying a chymotrypsin like activity. KLK7 is mainly expressed in the skin and appears to play an important role in skin physiology (Egelrud. 1993. Purification and preliminary characterization of stratum corneum chymotryptic enzyme: a proteinase that may be involved in desquamation. J. Invest. Dermatol. 101, 200-204; Skytt et al. 1995. Primary substrate specificity of recombinant human stratum corneum chymotryptic enzyme. Biochem Biophys Res Commun 211, 586-589; Yousef et al. 2000. The KLK 7 ( PRSS 6) gene, encoding for the stratum corneum chymotryptic enzyme is a new member of the human kallikrein gene family—genomic characterization, mapping, tissue expression and hormonal regulation. Gene 254, 119-1281). [0003] KLK7 is involved in the degradation of the intercellular cohesive structure in cornified squamous epithelia in the process of desquamation. The desquamation process is well regulated and delicately balanced with the de novo production of corneocytes to maintain a constant thickness of the stratum corneum. In this regard, KLK7 is reported to be able to cleave the corneodesmosomal proteins comeodesmosin and desmocollin 1 (Simon et al. 2001. Refined characterization of comeodesmosin proteolysis during terminal differentiation of human epidermis and its relationship to desquamation. J. Biol. Chem. 276, 20292-20299; Caubet et al. 2004. Degradation of corneodesmosome proteins by two serine proteases of the kallikrein family, SCTE/KLK 5/ hK 5 and SCCE/KLK 7/ hK 7 . J. Invest. Dermatol. 122, 1235-1244; Brattsand et al. 2005. A proteolytic cascade of kallikreins in the stratum corneum. J. Invest. Dermatol. 124, 198-203. In addition, it has been shown that the two lipid processing enzymes (3-glucocerebrosidase and acidic sphingomyelinase can be degraded by KLK7 (Hachem et al. 2005. Sustained serine proteases activity by prolonged increase in pH leads to degradation of lipid processing enzymes and profound alterations of barrier function and stratum corneum integrity. J. Invest. Dermatol. 125, 510-520). Both lipid processing enzymes are co-secreted with their substrates glucosylceramides and sphingomyelin and process these polar lipid precursors into their more non-polar products e.g. ceramides, which are subsequently incorporated into the extracellular lamellar membranes. The lamellar membrane architecture is critical for a functional skin barrier. Finally, KLK7 has been shown to activate the pro-inflammatory cytokine Pro-interleukin-1β (IL-1(3) (Nylander-Lundqvist & Egelrud. 1997. Formation of active IL -1 β from pro - IL -1β catalyzed by stratum corneum chymotryptic enzyme in vitro. Acta Derm. Venereol. 77, 203-206). [0004] Several studies link an increased activity of KLK7 to inflammatory skin diseases like atopic dermatitis, psoriasis or Netherton syndrome. An increased KLK7 activity might lead to an uncontrolled degradation of corneodesmosomes resulting in a miss-regulated desquamation, an enhanced degradation of lipid processing enzymes resulting in a disturbed lamellar membrane architecture or an uncontrolled (in)activation of the pro-inflammatory cytokine IL-1β. It has previously been demonstrated that this could lead to an impaired skin barrier function and inflammation (WO 2004/108139). [0005] The KLK7 activity is controlled on several levels. Various factors might be responsible for an increased KLK7 activity in inflammatory skin diseases. Firstly, the amount of protease being expressed might be influenced by genetic factors. Such a genetic link, a polymorphism in the 3′-UTR in the KLK7 gene, was recently described (Vasilopoulos et al. 2004. Genetic association between an AACC insertion in the 3 ′UTR of the stratum corneum chymotryptic enzyme gene and atopic dermatitis. J. Invest. Dermatol. 123, 62-66.). The authors hypothesis that the described 4 base pair insertion in the 3′-UTR of the kallikrein 7 gene stabilizes the KLK7 mRNA and results in an overexpression of KLK7. Secondly, since KLK7 is secreted via lamellar bodies to the stratum corneum extracellular space as zymogen and it is not able to autoactivate, it needs to be activated by another protease e.g. KLK5 (Caubet et al. supra). Uncontrolled activity of such an activating enzyme might result in an over activation of KLK7. Thirdly, activated KLK7 can be inhibited by natural inhibitors like LEKTI, ALP or elafin (Schechter et al. 2005. Inhibition of human kallikreins 5 and 7 by the serine protease inhibitor lympho - epithelial Kazal -type inhibitor ( LEKTI ). Biol. Chem. 386, 1173-1184; Franzke et al. 1996. Antileukoprotease inhibits stratum corneum chymohyptic enzyme—Evidence for a regulative function in desquamation. J. Biol. Chem. 271, 21886-21890). The decreased expression or the lack of such inhibitors might result in an enhanced activity of KLK7. [0006] It has been found that mutations in the spink gene, coding for LEKTI, are causative for Netherton syndrome (Descargues et al. 2005. Spink 5 —deficient mice mimic Netherton syndrome through degradation of desmoglein 1 by epidermal protease hyperactivity. Nat. Genet. 37, 56-65) and a single point mutation in the gene is linked to atopic dermatitis (Walley et al. 2001. Gene polymorphism in Netherton and common atopic disease. Nat. Genet. 29, 175-178; Nishio et al. 2003. Association between polymorphisms in the SPINK 5 gene and atopic dermatitis in the Japanese. Genes Immun. 4, 515-517). Finally, another level of controlling the activity of KLK7 is the pH. KLK7 has a neutral to slightly alkaline pH optimum and there is a pH gradient from neutral to acidic from the innermost to the outermost layers in the skin. Environmental factors like soap might result in a pH increase in the outermost layers of the stratum corneum towards the pH optimum of KLK7 thereby increasing the KLK7 activity. [0007] The hypothesis that an increased activity of KLK7 is linked to inflammatory skin diseases is supported by the following studies: Firstly, Netherton syndrome patients show a phenotype dependent increase in serine protease activity, a decrease in corneodesmosomes, a decrease in the lipid processing enzymes β-glucocerebrosidase and acidic sphingomyelinase, and an impaired barrier function (Descargues et al. 2006. Corneodesmosomal cadherins are preferential targets of stratum corneum trypsin - and chymotrypsin - like hyperactivity in Netherton syndrome. J. Invest. Dermatol. 126, 1622-1632; Hachem et al. 2006. Serine protease activity and residual LEKTI expression determine phenotype in Netherton syndrome. J. Invest. Dermatol. 126, 1609-1621.). Secondly, a transgenic mice overexpressing KLK7 shows a skin phenotype similar to that found in patients with atopic dermatitis (Hansson et al. 2002. Epidermal Overexpression of Stratum Corneum Chymotryptic Enzyme in Mice: A Model for Chronic Itchy Dermatitis. J. Invest. Dermatol. 118, 444-449; Ny & Egelrud. 2003. Transgenic mice over - expressing a serine protease in the skin: evidence of interferon gamma - independent MHC II expression by epidermal keratinocytes. Acta Derm. Venereol. 83, 322-327; Ny & Egelrud. 2004. Epidermal hyperproliferation and decreased skin barrier function in mice overexpressing stratum corneum chymotryptic enzyme. Acta Derm. Venereol. 84, 18-22). Thirdly, in the skin of atopic dermatitis and psoriasis patients elevated levels of KLK7 were described (Elcholm & Egelrud. 1999. Stratum corneum chymotryptic enzyme in psoriasis. Arch. Dermatol. Res. 291, 195-200). Therefore, KLK7 is considered to be a target for the treatment of inflammatory skin diseases like atopic dermatitis, psoriasis or Netherton syndrome and there is a need for specific inhibitors thereof. [0008] As patients suffering from Netherton syndrome have a severely impaired skin barrier, also topical administration of therapeutically active compounds will result in systemic exposure of the compounds to the patient. Accordingly, there is a need to identify inhibitors selective for skin proteases which can be used in the treatment of Netherton syndrome without risking systemic effects through unwanted systemic inhibition of proteases. [0009] KLK7, KLK5, and KLK14 are believed to be part of a proteolytic cascade in the stratum corneum layer of human skin (Brattsand et al. 2005. A proteolytic cascade of kallikreins in the stratum corneum. J Invest Dermatol 124, 198-203). [0010] Accordingly, it would be beneficial to identify inhibitors active not only on KLK7, but also on KLK5 and KLK14. [0011] WO 2004/108139 describes certain substituted benzoxazinone and thienoxazinone compounds as inhibitors of KLK7, but fails to report any selectivity data for the described compounds. DESCRIPTION OF THE INVENTION [0012] The present inventors have been able to identify inhibitors being selective for skin protease and have found that the activity of KLK7, KLK5, and KLK14 can be selectively inhibited by compounds according to Formula I, [0000] [0000] wherein R is S—CH 3 or —Cl. [0013] Said compounds exhibit several advantageous properties, such as selectivity for the skin proteases KLK7, KLK5, and KLK14, involved in the pathophysiology of inflammatory skin diseases such as Netherton syndrome, having no or only low inhibitory activity on other proteases. [0014] Accordingly, the present invention provides compounds according to Formula I [0000] [0000] wherein R is —S—CH 3 or —Cl, or a pharmaceutically acceptable salt thereof [0015] The present invention further provides compounds according to Formula I or a pharmaceutical acceptable salt thereof, for use in in medicine. [0016] The compound can be 6-Ethoxy-7-methoxy-2-(2-methylsulfanylphenyl)-3,1 -benzoxazin-4-one, or 2-(2-Chlorophenyl)-6-ethoxy-7-methoxy-3,1 -benzoxazin-4-one [0017] The present invention further provides compounds according to Formula I or a pharmaceutical acceptable salt thereof, for use in the prophylaxis, prevention and/or treatment of a skin disease. [0018] The invention further provides pharmaceutical compositions comprising a compound according to Formula I in admixture with pharmaceutically acceptable adjuvants, diluents and/or carriers. [0019] The invention further provides a pharmaceutical composition according to the invention for use in prophylaxis, prevention and/or treatment of a skin disease. [0020] The invention further relates to the use of a compound according to the Formula I or a pharmaceutically acceptable salt thereof, for the manufacture of a medicament for the treatment of a skin disease. [0021] The present invention further provides a method for the prophylaxis, prevention and/or treatment of a skin disease which comprises the administration of a therapeutically active amount of a compound according to Formula I or a pharmaceutical acceptable salt thereof, to a subject in need of such treatment. [0022] The skin disease may be an inflammatory skin disease. The skin disease can be selected from Netherton syndrome, atopic dermatitis, contact dermatitis, eczema, psoriasis, acne, epidermal hyperkeratosis, acanthosis, epidermal inflammation, dermal inflammation and pruritus. The subject to be treated can be a mammal, such as a human, a dog, a cat, or a horse. [0023] Definitions [0024] As used herein, the term “pharmaceutically acceptable salts” includes acid addition salts and base addition salts. Such salts may be formed by conventional means, for example by reaction of a free acid or a free base form of the compound of the invention with one or more equivalents of an appropriate acid or base, optionally in a solvent, or in a medium in which the salt is insoluble, followed by removal of said solvent, or said medium, using standard techniques (e.g. in vacuo or by freeze-drying). Salts may also be prepared by exchanging a counter-ion of a compound of the invention in the form of a salt with another counter-ion using a suitable ion exchange resin. [0025] In the context of the present specification, the term “treat” also includes “prophylaxis” unless there are specific indications to the contrary. The term “treat” within the context of the present invention further encompasses to administer an effective amount of a compound of the present invention, to mitigate either a pre-existing disease state, acute or chronic, or a recurring condition. This definition also encompasses prophylactic therapies for prevention of recurring condition and continued therapy for chronic disorders. [0026] The compound of the present invention may be administered in the form of a conventional pharmaceutical composition by any route including orally, intramuscularly, subcutaneously, topically, intranasally, intraperitoneally, intrathoracially, intravenously, epidurally, intrathecally, intracerebroventricularly and by injection into the joints. [0027] In one embodiment of the present invention, the route of administration may be topical. [0028] The dosage will depend on the route of administration, the severity of the disease, age and weight of the patient and other factors normally considered by the attending physician, when determining the individual regimen and dosage level at the most appropriate for a particular patient. [0029] For preparing pharmaceutical compositions from the compound of the present invention, inert, pharmaceutically acceptable carriers can be either solid or liquid. Solid form preparations include powders, tablets, dispersable granules, capsules, cachets, and suppositories. [0030] A solid carrier can be one or more substances, which may also act as diluents, flavouring agents, solubilizers, lubricants, suspending agents, binders, or tablet disintegrating agents; it can also be an encapsulating material. [0031] In powders, the carrier is a finely divided solid, which is in mixture with the finely divided compound of the present invention, or the active component. In tablets, the active component is mixed with the carrier having the necessary binding properties in suitable proportions and compacted in the shape and size desired. [0032] For preparing suppository compositions, a low-melting wax such as a mixture of fatty acid glycerides and cocoa butter is first melted and the active ingredient is dispersed therein by, for example, stirring. The molten homogenous mixture is then poured into conveniently sized molds and allowed to cool and solidify. [0033] Suitable carriers are magnesium carbonate, magnesium stearate, talc, lactose, sugar, pectin, dextrin, starch, methyl cellulose, sodium carboxymethyl cellulose, a low-melting wax, cocoa butter, and the like. [0034] The term composition is also intended to include the formulation of the active component with encapsulating material as a carrier providing a capsule in which the active component (with or without other carriers) is surrounded by a carrier which is thus in association with it. Similarly, cachets are included. [0035] Tablets, powders, cachets, and capsules can be used as solid dosage forms suitable for oral administration. [0036] Liquid form compositions include solutions, suspensions, and emulsions. For example, sterile water or propylene glycol solutions of the active compounds may be liquid preparations suitable for parenteral administration. Liquid compositions can also be formulated in solution in aqueous polyethylene glycol solution. [0037] Aqueous solutions for oral administration can be prepared by dissolving the active component in water and adding suitable colorants, flavouring agents, stabilizers, and thickening agents as desired. Aqueous solutions for oral use can be made by dispersing the finely divided active component in water together with a viscous material such as natural synthetic gums, resins, methyl cellulose, sodium carboxymethyl cellulose, and other suspending agents known to the pharmaceutical formulation art. [0038] Depending on the mode of administration, the pharmaceutical composition will according to one embodiment of the present invention include 0.05% to 99% weight (percent by weight), according to an alternative embodiment from 0.10 to 50% weight, of the compound of the present invention, all percentages by weight being based on total composition. [0039] A therapeutically effective amount for the practice of the present invention may be determined, by the use of known criteria including the age, weight and response of the individual patient, and interpreted within the context of the disease which is being treated or which is being prevented, by one of ordinary skills in the art. [0040] The above-mentioned subject-matter for a pharmaceutical composition comprising a compound according to the present invention is applied analogously for a pharmaceutical composition comprising a combination according to the present invention. [0041] It is contemplated that any method or composition described herein can be implemented with respect to any other method or composition described herein. [0042] The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and/or the specification may mean “one,” but it is also consistent with the meaning of “one or more,” “at least one,” and “one or more than one.” [0043] These, and other, embodiments of the invention will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following description, while indicating various embodiments of the invention and numerous specific details thereof, is given by way of illustration and not of limitation. Many substitutions, modifications, additions and/or rearrangements may be made within the scope of the invention without departing from the spirit thereof, and the invention includes all such substitutions, modifications, additions and/or rearrangements. EXAMPLES Example 1 Selectivity of substituted 3,1-benzoxazin-4-ones as inhibitors of human proteases [0044] IC 50 values for a number of substituted 3,1-benzoxazin-4-ones on a panel of human proteases were determined. [0045] KLK7 Assay [0046] Materials: Recombinant human KLK7, Substrate S-2586 (Chromogenics, cat. no. 820894) KLK7 activity was determined at 37° C. in 10 mM Na phosphate pH 7.2, 0.5 M NaCl, with final concentrations of 2.5 μg/ml (100 nM) of KLK7, 1.0 mM substrate, 5% DMSO in the presence of 0 μM, 0.1 μM, 0.5 μM, 1.0 μM and 5 μM of inhibitor, in 96 well plates by measuring absorbance at 405 nm in a plate reader (Spectramax). [0047] KLK5 Assay [0048] Materials: Recombinant human KLK5, Substrate S-2288 (Chromogenics, cat. no. 820852) KLK5 activity was determined at 37° C. in 0.1 M Tris, pH 8.0, 0.15 M NaCl, with final concentrations of 2.5 μg/ml KLK5, 1 mM substrate, 5% DMSO in the presence of 0 μM, 0.1 μM, 1.0 μM and 10 μM of inhibitor, in 96 well plates by measuring absorbance at 405 nm in a plate reader (Spectramax). [0049] KLK14 Assay [0050] Materials: Recombinant human KLK14, Substrate S-2302 (Chromogenics, cat. no. 820340). KLK14 activity was determined at 37° C. in 0.1 mM Tris, pH 8.0, 0.15 M NaCl, with final concentrations of 0.26 μg/ml (9.4 nM) of KLK14, 0.75 mM substrate, 5% DMSO, in the presence of 0 μM, 0.1 μM, 1.0 μM and 10 μM of inhibitor, in 96 well plates by measuring absorbance at 405 nm in a plate reader (Spectramax). [0051] Cathepsin G Assay [0052] Materials: Cathepsin G, 100 mU (VWR, Calbiochem, cat. no. 219373), Substrate Cathepsin G substrate (VWR, Calbiochem, cat. no. 219407) [0053] Cathepsin activity was determined at 37° C. in 10 mM Na phosphate pH 7.2, 0.5 M NaCl, with final concentrations of 1.5 mU/ml (0.75 μg/ml, 32 nM) of Cathepsin G, 0.75 mM substrate, 5% DMSO, in the presence of 0 μM, 0.1 μM, 1.0 μM and 10 μM of inhibitor, in 96 well plates by measuring absorbance at 405 nm in a plate reader (Spectramax). [0054] Chymotrypsin Assay [0055] Materials: Chymotrypsin, bovine, 25 μg (Roche, sequence grade), Substrate S-2586 (Chromogenics, cat. no. 82 08 94) [0056] Chymotrypsin activity was determined at 37° C. in 10 mM Na phosphate pH 7.2, 0.5M NaCl, with final concentrations of 0.2 μg/ml (6,8 nM) of Chymotrypsin, 1 mM substrate, 5% DMSO in the presence of 0 μM, 0.1 μM, 1.0 μM and 10 μM of inhibitor, in 96 well plates by measuring absorbance at 405 nm in a plate reader (Spectramax). [0057] Trypsin Assay [0058] Materials: Trypsin, 100 ug (Roche, sequence grade, Mw 23500), Substrate S-2288 (Chromogenics, cat. no. 820852) [0059] Trypsin activity was determined at 37° C. in 10 mM Na phosphate pH 7.2, 0.5 M NaCl, with final concentrations of 0.8 μg/ml (34 nM) of Trypsin, 1 mM substrate, 5% DMSO in the presence of 0 μM, 0.1 μM, 1.0 μM and 10 μM of inhibitor, in 96 well plates by measuring absorbance at 405 nm in a plate reader (Spectramax). [0060] Thrombin Assay [0061] Materials: Thrombin (Chromogenics, cat. no. 820712), Substrate S-2288 (Chromogenics, cat. no. 82 08 52) [0062] Thrombin activity was determined at 37° C. in 50 mM Tris, pH 8.3, 130 mM NaCl, with final concentrations of 1 pkat/ml (0.03 μg/ml, 88 pM) of thrombin, 0.5 mM substrate, 5% DMSO in the presence of 0 μM, 0.1 μM, 1.0 μM and 10 μM of inhibitor, in 96 well plates by measuring absorbance at 405 nm in a plate reader (Spectramax). [0000] TABLE 1 Selectivity of substituted 3,1-benzoxazin-4-ones - IC 50 (μM) Cathep- Chymo- Compound KLK7 LKL5 KLK14 sin G trypsin Trypsin Thrombin 1 0.048 0.2 0.1 >>10 >>10 >>10 >10 2 0.073 0.5 0.1 >10 >>10 >>10 >10 3 0.116 0.6 0.5 1.1 >>10 >>10 >10 4 0.230 1.0 1.0 2.8 >>10 >>10 >10 5 0.085 0.5 0.3 1.2 >10 >>10 >10 6 0.080 1.0 1.4 0.7 <0.1 >>10 0.6 7 0.090 2.2 2.7 1.9 <0.1 >>10 0.5 8 0.065 1.0 2.3 0.6 <0.1 >>10 >10 9 0.228 1.3 1.5 1.3 0.4 >>10 0.9 10 0.188 1.9 5.2 0.5 0.2 >>10 0.5 11 1.370 >10 >10 >>10 1.0 >>10 >10 12 0.147 1.0 1.1 0.7 0.6 >>10 >>10 13 0.155 0.6 0.8 0.7 <0.1 1.8 3.0 14 0.183 0.6 1.5 0.2 <0.1 1.8 3.0 15 0.105 0.5 0.5 0.5 <0.1 3.7 0.6 16 0.149 1.0 1.3 0.4 <0.1 3.7 0.6 17 0.175 1.0 1.1 0.1 1.2 >>10 >>10 18 0.10  4.5 2.1 1.9 >10 >>10 >10 [0063] As seen in Table 1 only compound 1 (6-ethoxy-7-methoxy-2-(2-methylsulfanylphenyl)-3,1-benzoxazin-4-one) and compound 2 (2-(2-chlorophenyl)-6-ethoxy-7-methoxy-3,1-benzoxazin-4-one) were found to have the desired selectivity, i.e. an ICso below 0.1 μM for KLK7, an ICso below 1 μM for KLK5 and KLK14, and an IC 50; above 10 μM for the other proteases tested. [0064] It should be noted that although several compounds were found to have a strong inhibitory effect on KLK7, as well as KLK5 and KLK14, only compounds 1 and 2, i.e. the compounds according to the invention, could be demonstrated to have a sufficiently low inhibitory activity for other proteases. [0065] Even small changes in the substation pattern of the compounds have a dramatic effect on the selectivity of the compounds. For example, compound 12 being methoxy substituted in position 6, as compared to compound 1 being ethoxy substituted in position 6, shows a more than 10 fold higher inhibitory activity (seen as a 10 fold lower IC 50 ) on Cathepsin G and Chymotrypsin compared to compound 1, making compound 12 unsuitable for use in the treatment of skin diseases. [0066] In summary, the data presented in Table 1 demonstrates that only compounds 1 and 2, i.e. the compounds according to the invention, are sufficiently selective having a high inhibitory activity for the skin proteases KLK7, KLK5, and KLK14, while having a sufficiently low inhibitory activity for other proteases, making them suitable for use in the treatment of skin diseases. Example 2 Synthesis of 6-ethoxy-7-methoxy-2-(2-methylsulfanylphenyl)-3,1-benzoxazin-4-one [0067] Example 3 Synthesis of 2-(2-chlorophenyl)-6-ethoxy-7-methoxy-3 , 1 -benzoxaz in-4-one. [0068] Same as in Example 2 but with use of [0000] in Step 3. [0000]

The present invention relates to methods and compositions for inhibiting the activity of skin proteases, especially human kallikrein 7 (KLK7), human kallikrein 5 (KLK5), and human kallikrein 14 (KLK14). More specifically, the invention relates to the use of substituted 3,1-benzoxazin-4-ones being selective inhibitors of human skin kallikreins for the treatment of skin diseases, more specifically for the treatment of inflammatory skins diseases, especially Netherton syndrome.

FIELD OF THE INVENTION [0001] The present invention relates to the field of electronic cigarette technology, and more particularly, relates to an electronic cigarette case. BACKGROUND OF THE INVENTION [0002] Smoking is bad for health. With the improvement of people's health consciousness, more and more people know the harm of smoking. Smoking not only hurts smokers themselves, but also hurts people around. Nowadays a type of electronic cigarette has been developed, which has a similar shape to an ordinary cigarette. When people smoke, the electronic cigarette may generate smoke that does not include toxic substances such as tar, etc., so the electronic cigarette is healthier than the ordinary cigarette. [0003] The electronic cigarette is equipped with an electronic cigarette case for being placed therein. When smoking, people take out an electronic cigarette from the electronic cigarette case. However, in the existing electronic cigarette case, the body of the electronic cigarette case is generally connected to a box cover of the electronic cigarette case through a shaft, which makes the production process is very time and effort consuming, the assembly process is complicated, and the production cost is high. SUMMARY OF THE INVENTION [0004] The technical problem to be solved in the present invention is to provide an integral forming electronic cigarette case with simple progress and low production costs, aiming at the defects of the complicated assembly process and the high production cost. [0005] The technical solutions of the present invention for solving the technical problem are as follows: [0006] An electronic cigarette case is provided, which comprises a box body, a box cover and a connecting structure connected with the box body and the box cover; the box body, the box cover and the connecting structure are integrally formed. [0007] In the electronic cigarette case of the present invention, the connecting structure comprises a first connecting portion and a second connecting portion; the first connecting portion extends outwardly along an end surface of a sidewall of the box body; the second connecting portion extends outwardly along an end surface of a sidewall of the box cover; and the first connecting portion and the second connecting portion abut against each other. [0008] In the electronic cigarette case of the present invention, the first connecting portion is arranged in the middle area of the end surface of the sidewall of the box body and the second connecting portion is arranged in the middle area of the end surface of the sidewall of the box cover. [0009] In the electronic cigarette case of the present invention, the connecting structure comprises at least two first connecting portions spaced apart and at least two second connecting portions spaced apart; the first connecting portion portions are arranged on the end surface of the sidewall of the box body; and the second connecting portions are arranged on the end surface of the sidewall of the box cover. [0010] In the electronic cigarette case of the present invention, a fold is formed at a junction between the first connecting portion and the second connecting portion; and a thickness of the fold is thinner than that of the rest of the connecting structure. [0011] In the electronic cigarette case of the present invention, shapes of cross sections of the first connecting portion and the second connecting portion are triangular. [0012] In the electronic cigarette case of the present invention, the box body, the box cover and the connecting structure are made of PP plastic or thermoplastic elastomeric materials. [0013] In the electronic cigarette case of the present invention, the electronic cigarette case further comprises a bracket arranged in the box body; a cavity configured for placing electronic cigarettes is defined in the bracket; and the bracket is detachably connected with the box body. [0014] In the electronic cigarette case of the present invention, the bracket comprises an upper connecting portion, a supporting portion and a lower connecting portion, and the cavity is defined in the supporting portion. [0015] In the electronic cigarette case of the present invention, the electronic cigarette case further comprises a seal sleeve and a screw; a through-hole is defined in the bottom of the box body; and the screw passes through the through-hole, the seal sleeve and the lower connecting portion successively and thus fixes the bracket in the body box. [0016] In the electronic cigarette case of the present invention, a protrusion part is arranged on the upper connecting portion; the protrusion part comprises a first protrusion surface, a second protrusion surface and a third protrusion surface; and the second protrusion surface and the third protrusion surface are arranged at two sides of the first protrusion surface respectively. [0017] In the electronic cigarette case of the present invention, the first protrusion surface is arranged on side opposite to the connecting structure between the box body and the box cover. [0018] In the electronic cigarette case of the present invention, the box cover and the bracket are movably buckled together. [0019] In the electronic cigarette case of the present invention, at least a groove is arranged on an outer surface of the second protrusion surface and/or the third protrusion surface; a bulge corresponding to the groove is arranged on an inner wall of the box cover; and the groove and the bulge are buckled together. [0020] In the electronic cigarette case of the present invention, at least a bulge is arranged on an outer surface of the second protrusion surface and/or the third protrusion surface; a groove corresponding to the bulge is arranged on the inner wall of the box cover; and the bulge and the groove are buckled together. [0021] In the electronic cigarette case of the present invention, a first groove and a first bulge alternated with each other are arranged on an outer surface of the second protrusion surface and/or the third protrusion surface; a second bulge and a second groove corresponding to the first groove and the first bulge are arranged on the inner wall of the box cover; and the first groove and the second bulge, and the first bulge and the second groove are buckled together. [0022] When implementing the electronic cigarette case of the present invention, the following advantageous effects can be achieved: since the present invention designs an integrally formed electronic cigarette case with a body box, a body cover and a connecting structure, and since the body box, the body cover and the connecting structure which are integrally formed are made of materials with good flexibility, the electronic cigarette case is foldable, the processing technology is simplified and the production efficiency is increased, thus the production cost is reduced. BRIEF DESCRIPTION OF THE DRAWINGS [0023] The present invention will be further described with reference to the accompanying drawings and embodiments in the following, in the accompanying drawings: [0024] FIG. 1 is a structural schematic view of an electronic cigarette case when it is in a closed state, according to a preferred embodiment of the present invention; [0025] FIG. 2 is a structural schematic view of an electronic cigarette case when it is in an open state, according to a preferred embodiment of the present invention; [0026] FIG. 3 is an explosive structural schematic view of an electronic cigarette case, according to a preferred embodiment of the present invention; [0027] FIG. 4 is a structural schematic view of a bracket of the present invention; [0028] FIG. 5 is a cutaway view of an electronic cigarette case, according to a first embodiment of the present invention; [0029] FIG. 6 is a cutaway view of an electronic cigarette case, according to a second embodiment of the present invention; [0030] FIG. 7 is a cutaway view of an electronic cigarette case, according to a third embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0031] To make the technical feature, objective and effect of the present invention be understood more clearly, now the specific implementation of the present invention is described in detail with reference to the accompanying drawings and embodiments. [0032] As shown in FIGS. 1 to 3 , an electronic cigarette case in accordance with a preferred embodiment of the present invention comprises a box body 10 , a box cover 20 , a bracket 30 , a seal sleeve 40 and a screw 50 . [0033] Wherein one end of the box body 10 has an opening, and the shape of a cross section of the opening is a slope. The box cover 20 is also designed to be a slope matching the shape of the cross section of the open of the box body 10 . A through hole 160 is defined in the bottom of one end of the box body 10 , and the end of the box body 10 is far away from the opening. The box cover 20 is arranged at the end of the box body 10 with the opening. The bracket 30 is arranged within the box body 10 and is detachably connected with the box body 10 . Specifically, the screw 50 successively passes through the through hole 160 in the bottom of the box body 10 and the seal sleeve 40 , and finally the screw 50 is fixed on the bracket 30 , thus the bracket 30 is detachably fixed in the box body 10 to prevent the bracket 30 from shaking or falling. [0034] The electronic cigarette case further comprises a connecting structure 70 for connecting with the box body 10 and the box cover 20 . The box body 10 , the box cover 20 and the connecting structure 70 are integrally formed, and the box cover 20 is retractably covered on the end of the box body 10 with the opening. Specifically, the box body 10 , the box cover 20 and the connecting structure 70 are made of materials with good flexibility, such as plastic materials or thermoplastic elastomeric materials wherein the thermoplastic elastomeric materials can be TPE or TPU. [0035] In the present invention, the body box 10 , the body cover 20 and the connecting structure 70 used to connect with the body box 10 and the body cover 20 are designed to be integrally formed. Since the body box 10 , the body cover 20 and the connecting structure 70 which are integrally formed are made of materials with good flexibility, it makes the electronic cigarette case to be foldable, the processing technology to be simple and the production efficiency to be high, thus the production cost has been greatly reduced. [0036] As shown in FIG. 2 , the connecting structure 70 comprises a first connecting portion 710 and a second connecting portion 720 . The first connecting portion 710 is arranged on the box body 10 , and the second connecting portion 720 is arranged on the box cover 20 . The first connecting portion 710 and the second connecting portion 720 along with the rest part can be injection molded to form an integrally formed electronic cigarette case. The first connecting portion 710 extends outwardly along a sidewall of the box body and the second connecting portion 720 extends outwardly along a sidewall of the box cover 20 , and the first connecting portion 710 and the second connecting portion 720 abut against each other. The first connecting portion 710 extends outwardly along the whole end surface of the sidewall of the box body 10 , namely the length of the first connecting portion 710 is equal to the length of the sidewall of the box body 10 ; similarly, the second connecting portion 720 extends outwardly along the whole end surface of the sidewall of the box cover 20 , namely the length of the second connecting portion 720 is equal to the length of the sidewall of the box cover 20 , thus the first connecting portion 710 and the second connecting portion 720 abut against each other to make the box body 10 and the box cover 20 to be integrally formed. A fold is formed at a junction between the first connecting portion 710 and the second connecting portion 720 , and a thickness of the fold is thinner than that of the rest of the connecting structure 70 . Thus, it is convenient to open the box cover 20 and makes sure that the connecting structure 70 is not easy to be broken. [0037] In another embodiment, the first connecting portion 710 extends outwardly along the middle area of the end surface of the sidewall of the box body 10 , namely the first connecting portion 710 is arranged at the middle area of the end surface of the sidewall of the box body 10 . Similarly, the second connecting portion 720 also extends outwardly along the middle area of the end surface of the sidewall of the box cover 20 , namely the second connecting portion 720 is arranged at the middle area of the end surface of the sidewall of the box cover 20 . The first connecting portion 710 and second connecting portion 720 abut against each other to form an integrally formed electronic cigarette case. [0038] In other embodiments, the connecting structure 70 comprises at least two first connecting portions 710 and at least two second connecting portions 720 . The at least two first connecting portions 710 extend outwardly from the edge region of the sidewall of the box body 10 respectively to form the spaced apart first connecting portion, and the at least two second connecting portions 720 extend outwardly from the edge region of the sidewall of the box cover 20 respectively to form the spaced apart second connecting portion. The corresponding first connecting portion 710 and second connecting portion 720 abut against each other. Specifically there are two first connecting portions 710 and two second connecting portions 720 . There is a gap between the two first connecting portions 710 , and there is a gap between the two second connecting portions 720 . The two first connecting portions 710 are arranged at the edge region of the sidewall of the box body 10 respectively, and the two second connecting portions 720 are arranged at the edge region of the sidewall of the box cover 20 respectively. Finally the first connecting portion 710 and the corresponding second connecting portion 720 abut against each other to form an integrally formed electronic cigarette case. [0039] The lengths that the first connecting portion 710 and the second connecting portion 720 extend outwardly are 0.05 cm to 2.0 cm, namely the lengths that the first connecting portion 710 and the second connecting portion 720 extend outwardly should not he too long or too short, Otherwise, it will be inconvenient to cover the box cover 20 on the box body 10 or the box cover 20 cannot be tightly covered on the box body 10 . Preferably, the lengths that the first connecting portion 710 and the second connecting portion 720 extend outwardly are 0.2 cm. The cross sections of the first connecting portion 710 and the second connecting portion 720 are triangular. Thus, when the electronic cigarette case is open, the first connecting portion 710 and the second connecting portion 720 form a plane together, and at this time shape of cross section of the first connecting portion 710 and the second connecting portion 720 is right triangle. Since shapes of cross sections of the first connecting portion 710 and the second connecting portion 720 are triangular, it not only makes sure that it is not easy for the connecting structure 70 to be broken, but also can save materials. It should he understood that shapes of cross sections of the first connecting portion 710 and the second connecting portion 720 can le other shapes such as curves etc. [0040] As shown in FIG. 4 , the bracket 30 comprises a supporting portion 310 , an upper connecting portion 320 , a lower connecting portion 330 and a protrusion part 340 . Wherein, the upper connecting portion 320 is arranged at one side of the supporting portion 310 and the side is close to the box cover 20 . The supporting portion 310 is arranged between the upper connecting portion 320 and the lower connecting portion 330 . The protrusion part 340 extends upwardly from the upper connecting portion 320 . The upper connecting portion 320 , the supporting portion 310 and the lower connecting, portion 330 are all arranged within the box body 10 . The protrusion part 340 is arranged at one end out of the box body 10 and is close, to the box cover 20 . Thus the screw 50 successively passes through the through-hole 160 in the bottom of the box body 10 , the seal sleeve 40 , and the lower connecting portion 330 so as to fix the bracket 30 and the box body 10 together to prevent the bracket 30 from shaking in the box body 10 . [0041] A cavity used to place electronic cigarettes is formed within the supporting portion 310 . The electronic cigarettes 60 placed in the cavity may be disposable or reusable electronic cigarettes, and it is not limited here. [0042] A shape of a cross section of the upper connecting portion 320 is approximately a trapezoidal slope, and the upper connecting portion 320 comprises a first side 321 , a second side 322 , a third side 323 and a fourth side 324 . The first side 321 , the second side 322 , the third side 323 and the fourth side 324 are successively connected together to form the square hollow upper connecting portion 320 . Specifically, the first side 321 and the third side 323 are parallel to each other, and the second side 322 and the fourth side 324 are parallel to each other. The first side 321 is the side far away from the connecting structure 70 between the box body 10 and the box cover 20 . The height between the first side 321 and the supporting portion 310 is less than the height between the third side 323 and the supporting portion 310 . Advantageously, the height between the first side 321 and the supporting portion 310 is half of the height between the third side 323 and the supporting portion 310 . Namely the height of the first side 321 is half of the height of the third side 323 . The height between the second side 322 and the supporting portion 310 is equal to the height between the fourth side 324 and the supporting portion 310 . Thus the upper connecting portion 320 is made to be a slope with a certain tilt angle. [0043] A shape of the protrusion part 340 is approximately a U-shape, and the protrusion part 340 comprises a first protrusion surface 341 , a second protrusion surface 342 and a third protrusion surface 343 . Two sides of the first protrusion surface 341 are connected with the second protrusion surface 342 and the third protrusion surface 343 respectively. The second protrusion surface 342 and the third protrusion surface 343 are parallel to each other. Specifically, the first protrusion surface 341 is fixed on the first side 321 , the second protrusion surface 342 is fixed on the second side 322 , and the third protrusion surface 343 is fixed on the fourth side 324 . Namely the first protrusion surface 341 extends upwardly from the whole first side 321 , but the second protrusion surface 342 extends upwardly from a part of the second side 322 and the third protrusion surface 343 extends upwardly from a part of the fourth side 324 . [0044] The part of the second protrusion surface 342 fixed at the second side 322 and the part of the third protrusion surface 343 fixed at the fourth side 324 respectively are referred as the two fixed sides of the protrusion part 340 , thus the length of the fixed side of the second protrusion surface 342 fixed at the second side 322 is shorter than the one third of the length of the second side 322 . The length of the fixed side of the third protrusion surface 343 fixed at the fourth side 324 is shorter than the one third of the length of the fourth side 324 . Advantageously, the lengths of the two fixed sides of the protrusion part 340 are equal to each other, and are equal to one fourth of the length of the second side 322 or the fourth side 324 , and thus to approximately form a U-shape protrusion part 340 . [0045] FIG. 5 is a cutaway view of an electronic cigarette case, according to a first embodiment of the present invention. At least a groove 350 is arranged on an outer surface of the second protrusion surface 342 and/or the third protrusion surface 343 . A bulge 210 corresponding to the groove 350 is arranged on an inner wall of the box cover 20 , and thus the groove 350 and the bulge 210 are buckled together. Specifically, a groove 350 is arranged on each of the second protrusion surface 342 and the third protrusion surface 343 and two bulges 210 corresponding to the grooves 350 are arranged on the inner wall of the box cover 20 , and thus the grooves 350 and the bulges 210 are buckled together to fix and seal the box cover 20 and the box body 10 . It should be understood that there may be one or more grooves 350 and bulges 210 , and it is not limited here. However, the number of the groove 350 must he equal to that of the bulge 210 and the groove 350 and the bulge 210 are corresponded to each other. When there are more than one groove 350 and more than one bulge 210 , the grooves 350 may be spaced with the same distance or with different distances and the bulges 210 are spaced corresponding to the grooves 350 . The grooves 350 may be arranged on the second protrusion surface 342 and the third protrusion surface 343 at the same time, and may also only be arranged on one of the second protrusion surface 342 and the third protrusion surface 343 . [0046] FIG. 6 is a cutaway view of an electronic cigarette case, according to a second embodiment of the present invention. At least one groove 360 is arranged on an outer surface of the second protrusion surface 342 and/or the third protrusion surface 343 . A bulge 220 corresponding to the groove 360 is arranged on an inner wall of the box cover 20 , and thus the groove 360 and the bulge 220 are buckled together. Specifically, a groove 360 is respectively arranged on each of the second protrusion surface 342 and the third protrusion surface 343 , and two bulges 220 corresponding to the grooves 360 is arranged on the inner wall of the box cover 20 , and thus the grooves 360 and the bulges 220 are buckled together to fix and seal the box cover 20 and the box body 10 . It should be understood that there may he one or more grooves 360 and bulges 220 , and it is not limited here. However, the number of the groove 360 must be equal to that of bulge 220 and the groove 360 and the bulge 220 are arranged corresponding to each other. When there are more than one groove 360 and more than one bulge 220 , the grooves 360 may be spaced with the same distance or with different distances and the bulges 220 are spaced corresponding to the grooves 360 . The grooves 360 may he arranged on the second protrusion surface 342 and the third protrusion surface 343 at the same time, and may also only he arranged on one of the second protrusion surface 342 and the third protrusion surface 343 . [0047] FIG. 7 is a cutaway view of an electronic cigarette case, according to a third embodiment of the present invention. A groove 370 and a bulge 380 alternated with each other are arranged on an outer surface of the second protrusion surface 342 and/or the third protrusion surface 343 . A bulge 230 and a groove 240 respectively corresponding to the groove 370 and the bulge 380 are arranged on an inner wall of the box cover 20 . The groove 370 and the bulge 230 , and the bulge 380 and the groove 240 are buckled together respectively. Specifically, one groove 370 and one bulge 380 are respectively arranged on the second protrusion surface 342 and the third protrusion surface 343 , and one bulge 230 and one groove 240 are arranged on the inner wall of the box cover 20 , thus when covering the box cover 20 on the box body 10 , the groove 370 and the bulge 230 , and the bulge 380 and the groove 240 are buckled together respectively to seal the electronic cigarette case. It should be understood that more than one groove 370 and more than one bulge 380 may be arranged on the second protrusion surface 342 , and the grooves 370 and the bulges 380 are alternated with each other. Specifically the grooves 370 and the bulges 380 may be spaced with the same distance or with different distances, but the number and the arrangement form of the grooves 370 and the bulges 380 arranged on the third protrusion surface 343 may be the same as or different with those of the second protrusion surface 342 . In other embodiments, the alternated grooves 370 and bulges 380 may be arranged apart both on the second protrusion surface 342 and on the third protrusion surface 343 , and may also be arranged on one of the second protrusion surface 342 and the third protrusion surface 343 . [0048] It should be understood that in other embodiments, the box cover 20 may also be connected with the bracket 30 through other means, such as magnetic attraction etc, as long as the box cover 20 and the box body 10 can be sealed together. [0049] In the present invention, the box body 10 , the box cover 20 and the connecting structure 70 are designed to be integrally formed. Since the integrally formed box body 10 , box cover 20 and connecting structure 70 are made of materials with good flexibility, it makes the electronic cigarette case to be foldable, the processing technology to be simple and the production efficiency to be high, thus the production cost has been reduced. [0050] While the embodiments of the present invention are described with reference to the accompanying drawings above, the present invention is not limited to the above-mentioned specific implementations In fact, the above-mentioned specific implementations are intended to he exemplary not to be limiting. In the inspiration of the present invention, those of ordinary skills in the art can also make many modifications without breaking away from the subject of the present invention and the protection scope of the claims. All these modifications belong to the protection of the present invention.

An electronic cigarette case comprising a cigarette case main body, a case cover, and a connection structure connected to the cigarette case main body and to the case cover is provided. The cigarette case main body, the case cover, and the connection structure are integrally formed. Since the electronic cigarette case comprising the cigarette case main body, the case cover, and the connection structure is designed to be integrally formed, and since the integrally formed cigarette main body, case cover, and connection structure are made of a material with great flexibility, the electronic cigarette case is of good folding endurance, simple processing technology, and high production efficiency, and thus production costs is reduced greatly.

This is a division of application Ser. No. 786,352, filed Apr. 11, 1977. BACKGROUND OF THE INVENTION This invention relates generally to removal of soil and bacteria from hard surface floors; more particularly, it concerns method and apparatus to accomplish such removal, and employing both suction and spray producing means in a novel and highly effective manner. In the past, primary reliance has been placed upon wet mopping to clean hard surfaced floors, as for example in hospitals, stores, and restaurants. Disadvantages with this well known procedure are numerous, and include the inability to remove the film of liquid left on the floor, whereby bacteria in such films are not removed; unsanitary conditions associated with wringing of the mop; and inability to reach floor corner areas. While various expedients have been proposed, none to my knowledge provide the unusually advantageous results and structural combinations of the present invention, which make use of the tool simple, effective and rapid, for cleaning hard surface floors. For example, Canadian Pat. No. 899,574 disclosed a vacuum cleaner floor tool operating to remove soils from surfaces such as carpets; however, no provision was there made for removal of bacteria and wet films on hard surfaced flooring, in the highly advantageous manner as now proposed. SUMMARY OF THE INVENTION It is a major object of the present invention to provide apparatus and method overcoming the deficiencies associated with prior hard floor surface cleaning methods. As will be seen, the invention has particularly advantageous use for cleaning hospital floors and corridors as well as other floor surface areas, and is characterized by elimination of need for mops, wet vacuums and floor scrubbers; it provides increased safety under foot and reduces maintenance work. In addition, it enables savings in water usage of up to 50%, as compared with the mop and bucket method. In its broadest apparatus aspects, the invention comprises; (A) A HEAD ASSEMBLY INCLUDING TWO UPRIGHT, LONGITUDINALLY SPACED, RESILIENTLY FLEXIBLE STRIPS EXTENDING GENERALLY LATERALLY HORIZONTALLY IN PARALLEL RELATION; THE STRIPS PROJECTING DOWNWARDLY TO ENGAGE THE FLOOR SURFACE, (B) MEANS FOR APPLYING SUCTION TO THE SPACE BETWEEN THE STRIPS; (C) THE HEAD ASSEMBLY INCLUDING SUPPORT MEANS TO ENGAGE THE FLOOR WHILE THE HEAD ASSEMBLY IS BODILY DISPLACED LONGITUDINALLY IN ONE DIRECTION WITH THE STRIPS IN SUCH PROXIMITY TO THE FLOOR SURFACE THAT THEIR LOWER EDGE PORTIONS ARE FLEXED IN THE OPPOSITE DIRECTION, WHEREBY THE LEADING STRIP IN SAID ONE DIRECTION PASSES LOOSE SOILS RELATIVELY THEREBENEATH INTO THE SPACE BETWEEN THE STRIPS FOR SUCTION REMOVAL FROM SAID SPACE, AND (d) means for applying cleaning liquid to the floor surface to wet that surface in such spaced relation to the strips that when the head assembly and strips are bodily displaced in the opposite longitudinal direction the lower portions of the strips flex relatively in said one direction and the leading strip in said opposite direction passes applied liquid relatively therebetween into the space between the strips for suction removal from said space. These and other objects and advantages of the invention, as well as the details of an illustrative embodiment, will be more fully understood from the following description and drawings, in which DRAWING DESCRIPTION FIG. 1 is a perspective view of floor cleaning apparatus embodying the invention; FIG. 2 is an enlarged perspective view of the floor cleaning head assembly; FIG. 3 is an enlarged elevational view taken on lines 3--3 of FIG. 2; FIG. 3a is a view like FIG. 3, showing a modification; FIG. 4 is an enlarged elevation view taken in section on lines 4--4 of FIG. 2; FIG. 5 is an enlarged elevation view taken in section on lines 5--5 of FIG. 2; FIG. 5a is an end view taken on line 5a--5a of FIG. 5; FIG. 6 is a bottom plan view taken on lines 6--6 of FIG. 2; FIG. 7 is a schematic showing of the head assembly flexible strips relative to a floor surface under conditions of no suction applied to the head assembly; FIG. 8 is a schematic showing similar to FIG. 7, with suction applied and the head assembly moving in one direction; FIG. 9 is a schematic showing similar to FIG. 7, with suction applied and the head assembly moving in the opposite direction; and FIG. 10 is a schematic showing similar to FIG. 7, with suction applied and the head assembly moved back and forth in scrubbing mode. DETAILED DESCRIPTION In the drawings, a head assembly 10 is shown to include two longitudinally spaced, resiliently flexible strips 11 and 12 extending generally horizontally in parallel relation. The strips are shown in FIG. 4 as projecting downwardly to engage the floor surface 13 at 11b and 12b, and they may consist of rubber or other elastomeric material. The head assembly may also include laterally elongated, downwardly opening structure as defined by walls 14 and 15 and a hollow gooseneck 16 intermediate the laterally opposite ends of the head assembly. An elongated, tubular handle 17 is connected at 18 to the gooseneck, and has S-shape, the upper extent 17a of the handle adapted to be manually grasped to manipulate the head assembly. The head assembly also includes support means, such as wheels 19 at laterally opposite ends of the walls 14 and 15, and closing the open ended chamber defined by such walls. Strips 11 and 12 are sealingly connected to the walls 14 and 15, as via clamp brackets 22 and 123, and fasteners 24 and 25. It will be noted that the strips 11 and 12 project downwardly in FIGS. 4 and 7 beneath the bottom levels 19a of the wheels, whereby in the absence of suction application to the interior 23 of the chamber formed by the head assembly, the strips engage the floor. If the strips are quite flexible, they may bend under the weight of the head assembly, so that the wheels do engage the floor however, the wheels do not project beneath the bottom levels of the strips to prevent their flexing engagement with the floor. For this purpose, the relative levels of the wheels may be upwardly adjusted, as by a nut 26 seen in FIG. 3. The nut is integral with a stem 27 which has threaded engagement at 28 with a bore in the head assembly, whereby the nut moves forwardly or reversely as it is turned. The lower portion of the nut bears against upper leg 29 of a bell crank 30, the latter including a laterally elongated pivot rod 31 and laterally spaced arms 32 which support the wheel axles. Accordingly, as the nut is advanced, the wheels are lowered, and vice versa. Rod 31 is loosely rotatably positioned by a guide sheath 33 attached to the head assembly. Adjustment of the wheels may thus be effected as related to the stiffness of the strips and as related to best cleaning effect, as will be seen. Suction may be applied to the space 23 between the strips 11 and 12, as for example by a blower 86 having its inlet side connected with space 23 via duct 37 and hollow handle 17. See FIG. 8 in this regard. Suction causes the lowermost portions 11b and 12b of the strips 11 and 12 to flex, as the head assembly is displaced downwardly by amount "t" causing wheel 19 to rest on the floor surface. As the head assembly is then moved forwardly in one direction, as for example in the leftward direction of arrow 38, the strip lowermost portions 11b and 12b are flexed in the opposite, i.e. rightward direction. The leading strip 11b in that direction thus passes loose soils and bacteria relatively therebeneath into the space 23 between the strips, for suction removal. Note arrow 39 indicating air-flow beneath the lowermost portion 11b of the strip 11; also, note the lowermost portion of strip 12b scraping the floor surface and preventing air-flow from passing beneath it, into space 23. Some air may also enter space 23 via the small gaps 40 adjacent the wheels. Means is also provided for applying cleaning liquid, as for example germicidal solution, to the floor surface to wet that surface in such spaced relation to the strips that when the head assembly and strips are bodily displaced in the opposite (rightward) longitudinal direction, the lower portions of the strips flex relatively in the one (leftward) direction; also, the leading strip 12b in that opposite direction then passes the applied liquid relatively beneath the strip and into the space 23 for suction removal. Such liquid application means may, with unusual advantage, include at least one spray nozzle, and preferably two nozzles 41 connected to the head assembly and directed to spray liquid downwardly onto surface 13 in spaced relation to the strips 11 and 12. The illustrated nozzles 41 each include a spray orifice 42 (see FIG. 5) directed longitudinally, and a deflection surface 43 facing the orifice to receive impingement of liquid and to deflect same in a fan-shaped spray pattern 44 seen in FIG. 5a. Surface 43 curves downwardly and laterally to cause the spray fan to flare downwardly and laterally, to extents as also shown by broken lines 44a in FIG. 6. Accordingly, the liquid droplets cling to the floor surface and do not appreciably spatter or splash, as is also shown from FIG. 8. Typically, the liquid is delivered to the nozzles as the head assembly moves leftwardly as seen in FIG. 8, leaving a wet swath 45 covering the floor to the right of the head. FIG. 9 shows the head assembly subsequently moving rightwardly in the direction of arrow 46, the liquid 45 relatively entering the space between the strips 11 and 12 via the gap beneath upwardly flexed lowermost portion 12b, and being sucked upwardly. Lowermost portion 11b of strip 11 drags on the floor surface 13 to block escape of any remanent liquid, whereby the latter 45 a at the rightward edge of strip portion 11b may be sucked up as it accumulates. The floor surface 13a at the left of strip 11 is thereby left clean and substantially dry; also it is disinfected if germicidal solution has been used. Referring to FIGS. 1 and 8, germicidal solution may be delivered to the nozzle via a flexible duct or line 60 and pump 61, the latter taking suction via inlet pipe 61a from a reservoir 62 of such liquid in tank 63. A control valve 64 in line 60 regulates the supply of solution to the nozzle. The two nozzles 41 may be supported by a nozzle carrier 65 to which duct 60 is centrally connected, as seen in FIG. 6. The illustrated tubular carrier or manifold extends transversely and is connected to that portion 17b of the handle or wand 17 proximate the head assembly. Valve 64 may be located at the upper end portion 17a of the S-shaped handle, and may include a lever 64a adapted to be finger actuated, as viewed in FIG. 1. Tank 63 is shown as mounted on an ambulatory carrier 66, which has wheels 67 to allow the carrier to be pulled about wherever the apparatus is to be used. A receiver tank on or in the carrier may be formed as by a flaccid bag 68 located within a well 80 on the carrier. The interior 81 of the bag receives discharge 83 from the handle 17 via line 37 and a separator 82. Such discharge may include dry bacteria and soils picked up off a dry hard surface floor, or bacteria in germicidal solution picked up off the floor. The discharged germicidal solution is retained in the bag 68 and it also receives dry bacteria discharged downwardly at 83, to kill same. Dry bacteria that is not trapped in the solution may be sucked toward outlet 84, which is in communication with the suction or inlet side 85 of blower 86. The latter operates continuously and produces suction communication to the head assembly 10, via the enclosed interior zone 87 of the carrier, separator 82, line 37, and handle 17. See also U.S. Pat. No. 3,896,520 in this regard. A sub-micron filter 88 is typically located at or near the inlet to blower 86 to trap airborne bacteria, preventing exhausting thereof to the atmosphere. Referring to FIG. 10, it shows the head assembly including strips 11 and 12 and wheels 19 being moved back and forth, as indicated by arrows 72 and 73, so that the back and forth flexing lowermost portions 11b and 12b of the strips scrub the floor surface 13 wetted by spray from the nozzles. The film of liquid is shown at 45a and 45b at opposite sides of the strips as a result of no suction application during scrubbing. Thereafter, suction may be applied to space 23 to cause pick-up of the liquid film. A suction ON-OFF control 75 may be located at the tank, in association with blower 86. Also, the blower 86 and pump 61 may be integral with or carried by the carrier 66. FIG. 6 shows bottom walls 70 of the head extending transversely and leading into the gooseneck opening 71 at location 70a. Walls 70 are at the level indicated at 70b in FIG. 4. The nozzles 41 have lateral side openings, as seen in FIGS. 7-10, to permit lateral fanning of the spray pattern. The nozzle carrier in FIG. 2 includes bracket elements 74 and 75 encompassing the lower end portion 17b of the handle, bracket portion 75 supporting ducts 65. In FIG. 3a, a swivel joint 90 is shown connected in the wand or handle 17 near the head assembly 10, enabling the operator to keep the head assembly 10 parallel to the floor surface while manipulating the handle to clean under furniture, cabinets, etc., with short legs. The joint 90 may be defined by adjacent flanges 91 and 92 on the end of handle 17 and the end of stub pipe 17a', and a coupling sleeve 93 embracing the two flanges. Seals may be provided, if desired.

Suction and germicidal spray producing apparatus effects rapid removal of soils and bacteria from hard surface floors in both dry and wet states, the removed dry and wet soils and bacteria being isolated and confined; the apparatus includes a head assembly carrying longitudinally spaced, resiliently flexible strips extending in parallel relation to engage the floor surface, the head assembly including support means to engage the floor surface; means is provided for applying suction to the space between the strips; and means is provided for applying cleaning liquid to the floor surface to wet that surface visibly and openly outside the space between the strips, so that the user moving the head assembly back and forth can controllably move the head and strips over the surface to assure suction removal of liquid, soils and bacteria on the floor surface, to be conducted away from the head assembly.

BACKGROUND OF THE INVENTION [0001] 1 Field of the Invention [0002] The present invention concerns a system for non-invasive medical treatment of the type wherein a therapy apparatus (such as a shockwave head in the case of a lithotripsy treatment) is moved on an orbit around a patient table or around a patient on this patient table. [0003] 2 Description of the Prior Art [0004] A body region of the patient to be treated in a system of the above type is arranged in the isocenter of the orbit. The focus of the therapy apparatus (in the case of a shockwave head thus the focus of the ultrasonic waves emanating therefrom) is located in the isocenter or in the body region to be treated. A circular arc, known as a C-arm, is generally used for guidance of the therapy apparatus. In the case of a C-arm that is permanently fixed at a base, this C-arm must exhibit an arc length that is at least as large as the desired movement path of the therapy apparatus. The arc length of the C-arm can be shortened if it is supported so that it can be moved orbitally on the base. A therapy apparatus movably guided on a C-arm has the advantage that it can be positioned on different sides of the body of a patient without the patient having to be repositioned on the patient table. A system of this type is normally designed such that the base and further system parts are arranged on one side of the patient table, so the other side of the patient table can remain essentially free in order to allow unhindered access to the patient (such as for anesthesia purposes). If a therapy apparatus should now be brought into position on this side of the patient table, the therapy apparatus itself is less disruptive than the C-arm because the therapy apparatus is positioned relatively close to the patient. If, for example, a shockwave head is positioned in the 0° position (i.e. in the upper table position given vertical alignment of its shockwave axis) for lithotripsy treatment, the C-arm extends into the space above the patient at least up to this angle position. A treating doctor is thereby severely limited in terms of his or her freedom of movement in the region of the doctor's head. SUMMARY OF THE INVENTION [0005] An object of the present invention is to provide a system for non-invasive medical treatment wherein the aforementioned disadvantage is avoided. [0006] This object is achieved according to the invention by a therapy system having a carrier arm with a fixed end and a free end mounted on the therapy C-arm, the fixed end of the carrier arm being supported on the therapy C-arm between two end positions predetermined by the arc ends such that the carrier arm with its fixed end can move in an orbit. The carrier arm supports the therapy apparatus on its free end. The carrier arm is furthermore supported on the therapy C-arm such that it can rotate around a rotation axis, so it can be aligned at both end positions such that it extends beyond the respective arc end. The rotatable support of the carrier arm on the therapy C-arm ensures that such a projection beyond the arc end can also be produced in a simple manner at the other end position. [0007] The rotation axis of the carrier arm is preferably aligned such that it intersects the focus of the therapy apparatus. It is thereby ensured that, given a rotation of approximately 180 around the rotation axis of the therapy focus, its position is not altered. This position typically lies in the isocenter of a C-arm. The position of the therapy focus is thus altered neither by an orbital movement of the carrier arm nor by a rotation around the rotation axis. [0008] In a further preferred embodiment, the therapy apparatus is arranged such that its focus is located in a plane that runs parallel to and removed from the orbital plane of the therapy C-arm. This makes it possible to remove the effective location of the therapy apparatus from the orbital plane of the therapy C-arm and thereby to achieve even more freedom of movement in the region of the therapy C-arm for a person attending the patient. This embodiment is particularly advantageous when, for imaging accompanying a treatment, an x-ray C-arm is arranged coaxial, coplanar and with axial offset relative to the therapy C-arm, the focus of the therapy apparatus coinciding with the isocenter of the x-ray C-arm. In addition to the increased freedom of movement (already mentioned) for medical personnel, this achieves the advantage that the x-ray C-arm can in practice be moved orbitally without hindrance. In an arrangement of x-ray and therapy C-arms in which the orbital planes of both arcs coincide, the orbital movement capability of the x-ray C-arm is significantly limited, for example because x-ray source or x-ray receiver protrude into the movement path of the therapy C-arm. DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 is a perspective view of a base for a therapeutic treatment system in accordance with the invention, on which a therapy C-arm is supported that carries a therapy apparatus, the C-arm being supported so as to be able to move orbitally around an isocenter. [0010] FIG. 2 is a perspective view of a portion of the system of FIG. 1 . [0011] FIG. 3 is a further perspective view of a further embodiment of a system in accordance with the present invention, wherein an x-ray C-arm is associated with the therapy C-arm. [0012] FIG. 4 shows the system of FIG. 1 , with the therapy apparatus located in a different position. [0013] FIG. 5 shows a portion of the system of FIG. 4 with the therapy apparatus in a treatment position. [0014] FIG. 6 schematically illustrates the therapy C-arm and the x-ray C-arm of the embodiment of FIG. 4 . DESCRIPTION OF THE PREFERRED EMBODIMENTS [0015] The system shown in the Figures has a base 1 on which is fixed a first C-arm that supports a therapy apparatus (for example the shockwave head 2 of a lithotripsy system). The first C-arm (designated in the following as therapy C-arm 3 ) is an annulus segment that can be orbitally moved on an extension arm 4 of the base frame 1 around its middle point or around its isocenter 5 , which is indicated in FIG. 1 by the double arrow 6 . A sled 7 is supported on the therapy C-arm 3 such that it can move orbitally (thus corresponding to double arrow 6 ). A carrier arm 9 is attached with its fixed end 10 on a side 8 of the sled 7 facing the isocenter 5 . The free end 12 of the carrier arm 9 carries the shockwave head 2 . Due to the orbital movement capability of the therapy C-arm 3 and the sled 7 , the shockwave head 2 can be positioned in various angle positions relative to the isocenter 5 or to a patient table 15 . The radial separation of the shockwave head 2 from the isocenter 5 is selected such that the focus 13 of a shockwave cone 14 emitted from the shockwave head 2 lies on a central axis 18 extending through the isocenter 5 . The shockwave head 2 can, for example, be arranged such that the shockwave axis 16 thereof proceeds in the orbital plane 17 spanned by the therapy C-arm 3 . [0016] As can be seen from FIG. 1 and in particular from FIG. 2 , the carrier arm 9 is designed or aligned such that, in its upper end position ( FIG. 2 ), it extends beyond the upper arc end 19 in the arc circumference direction, viewed in the direction of the central axis 18 situated perpendicular to the orbital plane 17 and extending through the isocenter 5 . An unhindered accessible space 20 in the head region of a person attending a patient during the treatment thus exists above the shockwave head 2 . If the carrier arm (likewise seen in the projection of FIG. 2 ) were aligned approximately in the direction of the shockwave axis 16 , thus radially, the therapy C-arm 3 would have to be longer by approximately the arc segment 22 or would have to be orbitally moved further by a corresponding length, whereby it would limit the freedom of movement of an attending person in the space 20 . [0017] So that both the therapy C-arm 3 and the sled 7 of the carrier arm 9 also overhang the lower arc end 19 ′ in the arc circumference direction in the lower end position, the carrier arm 9 is supported on the sled 7 such that it can rotate around a rotation axis 23 . It would now be possible for not only a single rotation axis to be present, but also for the shockwave head 2 also to exhibit a degree of freedom relative to the carrier arm 9 . The purpose of such a movement capability would be to bring the shockwave head 2 back into a position in which its focus 13 again comes to lie on the central axis 18 (for example coincides with the isocenter 5 of the therapy C-arm 3 ) after cycling an orbital movement path. Such multiple movement possibilities or articulation points, however, form error sources with regard to an exact alignment of the shockwave head 2 as a result of tolerances that can never be entirely precluded given parts that are movably connected with one another. In the described exemplary embodiments, the shockwave head 2 is therefore rigidly connected with the carrier arm 9 , which is likewise rigidly fashioned. The rotation of the carrier arm 9 ensues around a single axis, namely the rotation axis 23 . Given a rotation of 1800 around this axis, the carrier arm (like the shockwave head) is located in a mirror-inverted alignment relative to the previous position, with the rotation axis 23 forming the mirror axis. For x-ray-supported observation of, for instance, a lithotripsy treatment, the therapy C-arm can be provided with an x-ray C-arm coaxial therewith, having an x-ray source (not shown) and an x-ray receiver 30 without or with axial offset. In the first case, the orbital planes and the isocenters of both C-arms coincide. The rotation axis 23 of the C-arm 9 proceeds in the common orbital plane of the C-arms and extends through their common isocenter. The shockwave head 2 thus can be aligned such that its shockwave axis 16 proceeds in the common orbital plane. Given a rotation around the rotation axis 23 by 180°, upon transition from one end position into the other the shockwave head 2 again adopts a position in which its shockwave axis 16 runs in the orbital plane 17 of the therapy C-arm 3 . The monitoring with the x-ray system can then ensue “inline” in each angle position, i.e. in the direction of the shockwave axis 16 . In the second case shown in the figures, the x-ray C-arm 24 is arranged with axial separation from the therapy C-arm 3 . Its isocenter 25 , like the isocenter 5 of the therapy C-arm 3 , lies on the central axis 18 . As can be seen from FIG. 3 and FIG. 6 , the carrier arm 9 extends laterally out of the orbital plane 17 . The shockwave head 2 fixed at the free end 12 of the carrier arm 9 is then arranged in the region of the orbital plane 26 of the x-ray C-arm 24 , with its focus 13 located in its isocenter 25 . The shockwave head 2 can be aligned such that its shockwave axis 16 proceeds in the orbital plane 26 of the x-ray C-arm 24 in one angle position per side. However, this alignment changes given a rotation around the rotation axis 23 , meaning that the shockwave axis 16 is tilted out of the orbital plane 26 , but, in accordance with the invention, the common isocenter is retained. [0018] The carrier arm 9 has a first longitudinal segment 27 with a fixed end 10 and a second longitudinal segment 28 with a free end 12 . The longitudinal segment 27 is born on the sled 7 such that it can rotate. The rotation axis 23 (that is identical with the center longitudinal axis 29 of the longitudinal segment 27 ) pierces the orbital plane 17 of the therapy C-arm 3 with its one end and intersects the isocenter 25 of the x-ray C-arm 24 . Given an orbital shift of the sled 7 on the therapy C-arm 3 , the rotation axis 23 sweeps over the plane of a conical segment whose base surface is formed by the orbital plane 17 of the therapy C-arm and whose tip is formed by the isocenter 25 of the x-ray C-arm 24 . The side 8 of the sled 7 from which the longitudinal section 26 projects proceeds at a right angle to the rotation axis 23 . The second longitudinal segment 28 is fixed at an angle on the first longitudinal segment 27 . Its center longitudinal axis 29 thereby forms an acute angle a ( FIG. 2 ) with the rotation axis 23 in the projection on the orbital plane 17 and an acute angle β ( FIG. 6 ) in the projection on a plane spanning from the examination axis 23 and the central axis 18 . When, starting from the upper table position of the FIG. 1-3 , the shockwave head 2 should be moved into an under-table position ( FIG. 4-6 ), perhaps for treatment of a left or right kidney, two symmetrical operations are necessary, namely rotation by up to 180° around the rotation axis 23 and an orbital shift of the sled 7 . Although both movement procedures can proceed simultaneously, they are described in succession for better comprehensibility. Starting from the situation in FIG. 2 , if one initially begins with a rotation of 180° around the rotation axis 23 the shockwave head 2 subsequently, approximately adopts the position shown with dashed lines. As can be seen from FIG. 2 , this corresponds to a rotation around the central axis 18 . The focus 13 persists in the isocenter 25 given the rotation. The shockwave axis 16 thereby sweeps through a conical segment whose tip is the isocenter 25 . Starting from the position shown in the dashed lines, an orbital shift by approximately 50° (angle γ) is necessary if the shockwave head 2 should, for instance, be aligned in the +40° position, and an orbital shift by, for instance, 130° (angle γ′) is necessary for an alignment in the −40° position. In contrast to this, an orbital movement path of the sled 7 (likewise starting from the upper table position) of approximately 240° would be required given an approximately radially-aligned carrier arm extending in the direction of the shockwave axis 16 . A therapy C-arm 3 with an arc length of more than 120° would be necessary for this. In contrast to this, given an inventive embodiment of the carrier arm 9 the therapy C-arm 3 can be shorted by, for instance, a piece corresponding to the arc segment 22 . [0019] Although modifications and changes may be suggested by those skilled in the art, it is the invention of the inventors to embody within the patent warranted heron all changes and modifications as reasonably and properly come within the scope of their contribution to the art.

A non-invasive medical treatment installation has a therapy C-arm mounted on a base, and defining an isocenter. A therapy apparatus having a focus is mounted at the free end of a carrier arm, that has a fixed end attached to the therapy C-arm. The mounting of the fixed end of the carrier arm to the therapy C-arm allows orbital movement of the carrier arm along the therapy C-arm between two final positions respectively delimited by the opposite ends of the C-arm. The carrier arm is mounted to the therapy C-arm to allow rotation of the carrier arm around a rotational axis, so that when the carrier arm is at either of said final positions, it extends beyond the respective end of the C-arm.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 13/349,196 filed on Jan. 12, 2012, which is a divisional of U.S. patent application Ser. No. 12/726,193 filed on Mar. 17, 2010, which is a continuation of U.S. patent application Ser. No. 12/347,696 filed on Dec. 31, 2008. U.S. patent application Ser. No. 12/347,696 is a divisional of U.S. patent application Ser. No. 11/828,002 filed on Jul. 25, 2007, which is a continuation of U.S. patent application Ser. No. 11/434,483, filed on May 15, 2006, which is a continuation of U.S. patent application Ser. No. 10/460,046, filed on Jun. 12, 2003. U.S. patent application Ser. No. 10/460,046 claims priority to U.S. Provisional Patent Application Ser. No. 60/388,514, filed on Jun. 12, 2002. The entire content of each of the priority applications is hereby incorporated by reference. FIELD OF THE INVENTION [0002] The present invention relates to animal enclosures. More particularly, the present pet enclosure includes a collapsible one-piece frame that provides for easy set up of the enclosure as well as portability without the need to keep track of multiple pieces. Advantageously, the enclosure includes a completely removable and washable fabric cover. BACKGROUND OF THE INVENTION [0003] Many pet owners enjoy taking their pet along with them when they travel. For example, when taking an extended road trip, many pet owners like to have their pet's companionship for the trip. Taking the pet along is often preferable to hiring someone to take care of the pet or putting the pet in a kennel. Many pets suffer separation anxiety when their owner is away. The anxiety can cause the pet to chew on furniture, urinate on the carpet, and generally wreak havoc around the house. When the owner returns, the damage causes the owner unnecessary aggravation and repair expense. [0004] Several pet carriers are available that owners can use to conveniently transport their pets. For example, U.S. Pat. Nos. 6,076,485 and 6,155,206 disclose collapsible pet carriers. However, when the owner arrives at his or her destination, often there is no convenient area in which to leave the pet. Pet carriers, such as those described in the above patents, are designed to be small and easy to carry. Consequently, they are generally confining for the pet. They do not have much interior space in which the pet can stretch out. [0005] Leaving the pet in a car is dangerous to the pet. If the temperature outside the car is cold, then the car interior will be cold and the pet may become sick. Conversely, if it is a warm day and the sun is shining, the sun's radiation can cause the interior of the car to reach dangerously hot temperatures. Further, while in the car the pet may suffer from separation anxiety. The pet may then cause the same problems described above. [0006] If the owner is visiting a friend's or relative's home, he or she may sometimes bring the pet into the home. However, many homeowners are sensitive to the problems that pets can cause, such as odors or damage from chewing or scratching. Further, some homeowners are allergic to pet dander, which pets usually leave behind on carpet and/or furniture. Therefore, letting the pet roam free indoors is not always possible. Further, many homes do not have suitable outdoor areas in which the pet may roam. Homes located in heavily populated urban areas often do not have enough outdoor area for the pet to occupy. Homes in more rural areas may not have fencing to contain the pet. The pet could thus wander off and be lost or struck by a car. [0007] A number of portable pet enclosures are available to pet owners. Pet owners can thus bring their pets along with them almost anywhere they go. When the owner arrives at his or her destination, he or she sets up the enclosure, indoors or out, and places the pet inside. The pet is safely contained and cannot wander off. The enclosure is ventilated to prevent the temperature inside from becoming too hot. If the enclosure is placed indoors, the enclosure prevents direct contact between the pet and the surroundings, thus reducing odors or dander that the pet might otherwise leave behind. [0008] U.S. Pat. No. 5,335,618 (the '618 patent) discloses an example of a collapsible animal enclosure. The enclosure has a house unit 10 with spaced side walls 14 and a roof 16 of pliable material, and opposite ends 20 , 22 forming an enclosed area for housing an animal. Each end wall has an opening 24 , 26 for allowing entry to and exit from the enclosure. Support bows 28 extend transversely across the side walls and roof for holding the side walls and roof in an open, spread apart condition. The house unit is convertible between a use configuration in which the opposite ends are spread a maximum distance apart and a collapsed configuration in which the ends are pushed inwardly towards one another, collapsing the pliable material between the ends in an accordion-like manner. Longitudinal spreader bars 32 disposed at either end in pockets 34 at opposite ends of the house unit maintain the house unit in the use configuration. An extended run unit 12 of similar construction to the house unit is releasably securable to one end of the house unit to provide an extended exercise area. [0009] The enclosure of the '618 patent is constructed of multiple pieces that are difficult to keep track of when the enclosure is collapsed. To collapse the house unit, a pet owner removes the spreader bars and floor, and may also remove the support bows. When storing or transporting the enclosure, these separate pieces are cumbersome to carry and are easily lost. [0010] The design of the enclosure of the '618 patent makes accessing the interior of the enclosure difficult. The openings of the enclosure are located on the end walls. Thus, when a pet owner places his or her pet inside the enclosure, he or she must move quickly to seal the opening before the pet runs back out. Also, when a pet owner wants to briefly open the enclosure with his or her pet inside, for example to play with the pet or insert or remove a food or water dish, the pet can easily exit the enclosure by running through the opening. [0011] Another example of a portable pet enclosure is manufactured by Cabana Crate Co. The enclosure comprises a nylon cover stretched about a frame that is substantially in the shape of a rectangular parallelepiped. The frame comprises aluminum tubing that is sewn into the cover. The tubes are sandwiched between layers of the cover material. The front, back and side walls of the cover are mesh, allowing air to circulate through the enclosure. A zipper connects the front wall to the side walls and floor. Unzipping the zipper enables a pet owner to access the interior of the enclosure. [0012] Because the Cabana enclosure opens along its front wall, it provides an easy escape route for the pet whenever the door is open. Also, because the frame tubes are integral with the cover, the cover is not removable from the frame. The cover is thus difficult to clean. It cannot be machine washed, because the frame cannot be placed in a washing machine together with the cover. Further, the area between the layers of cover material, in which the tubes reside, tends to trap dirt, pet hair, pet dander, etc. And if the pet has an “accident” inside the Cabana enclosure, this area traps the pet's waste and leaves the enclosure with an odor that is difficult to remove. [0013] Therefore, a portable pet enclosure from which pets cannot easily escape, that is not constructed of a multitude of pieces that are easy to lose, and that is easy to clean, would be of great benefit to pet owners. SUMMARY OF THE INVENTION [0014] The preferred embodiments of the pet enclosure have several features, no single one of which is solely responsible for their desirable attributes. Without limiting the scope of this pet enclosure as expressed by the claims that follow, its more prominent features will now be discussed briefly. After considering this discussion, and particularly after reading the section entitled “Detailed Description of the Preferred Embodiments,” one will understand how the features of the preferred embodiments provide advantages, which include integration of parts into a one-piece frame, easy transportability, easy washability, and easy access to the enclosure interior without enabling a pet's escape. [0015] A preferred embodiment of the present pet enclosure comprises a rigid support frame and a cover. The frame is constructed of a rigid floor, first and second rigid end trusses, and at least one jointed support member extending between the end trusses. [0016] Another preferred embodiment of the present pet enclosure comprises a support frame for a pet enclosure. The support frame comprises a floor member, a first end truss, a second end truss and at least one support member. The trusses are each constructed of at least one rigid member. The first and second end trusses are preferably hingedly connected to the floor truss. The at least one support member has a first end and a second end. The first end is hingedly connected to the first end truss, and the second end is hingedly connected to the second end truss. [0017] Another preferred embodiment of the present pet enclosure comprises a joint for releasably connecting a first member and a second member. The joint comprises a first connector and a second connector. The first connector is secured to an end of the first member, and the second connector is secured to an end of the second member. Preferably, an elasticized member extends between the ends of the first and second members. A locking sleeve is slidable on the members between a first position in which the sleeve is adjacent a junction of the ends of the first and second members, and a second position in which the sleeve covers the junction. [0018] Another preferred embodiment of the present pet enclosure comprises a rigid frame for a pet enclosure. The frame comprises a bottom truss, end trusses hingedly secured to opposite ends of the bottom truss, and at least one jointed support tube extending between the end trusses. [0019] Another preferred embodiment of the present pet enclosure comprises a method of folding a pet enclosure, wherein the pet enclosure comprises a jointed frame and a cover. The method comprises the steps of bending a jointed frame support member, folding a first frame end truss toward a frame floor member, folding a second frame end truss toward the floor member, and securing a first portion of the cover to a second portion of the cover, thereby resisting unfolding of the enclosure. [0020] Another preferred embodiment of the present pet enclosure comprises a rigid support frame and a cover. The frame is constructed of a rigid roof truss, first and second rigid end trusses, and at least one jointed support member extending between the end trusses. [0021] Any of the above embodiments may further comprise a fabric cover. The cover may be stretchable over the frame, or be supported externally by the frame. The cover is preferably completely removable from the frame so that it is easily machine washed. [0022] Another preferred embodiment of the present pet enclosure comprises a support frame for a pet enclosure. The support frame comprises a floor member defining a floor plane. The floor member includes at least a first pair of lugs that extend away from the floor plane and define a first pivot axis that is spaced from the floor plane. The floor member further includes at least a second pair of lugs that extend away from the floor plane and define a second pivot axis that is spaced from the floor plane. A first truss is pivotably connected to the first pair of lugs at the first pivot axis, and a second truss is pivotably connected to the second pair of lugs at the second pivot axis. The second pivot axis is spaced from the floor plane a greater distance than the first pivot axis. [0023] Another preferred embodiment of the present pet enclosure comprises a support frame for a pet enclosure. The support frame comprises a floor member, a first truss pivotably connected to the floor member at or near a first end thereof, and a second truss pivotably connected to the floor member at or near a second end thereof. The support frame further comprises at least one support member having a first end and a second end, the first end being pivotably connected to the first truss and the second end being pivotably connected to the second truss. The at least one support member comprises a first section and a second section, the first and second sections being separate pieces that are connectable to one another at a free end of each. The first section and the second section are of unequal lengths. [0024] Another preferred embodiment of the present pet enclosure comprises a support frame for a pet enclosure. The support frame comprises a floor member, a first truss pivotably connected to the floor member at or near a first end thereof, and a second truss pivotably connected to the floor member at or near a second end thereof. The support frame further comprises at least one support member having a first end and a second end, the first end being pivotably connected to the first truss and the second end being pivotably connected to the second truss. A locking sleeve is slidable on the at least one support member between a first position and a second position. The at least one support member comprises a first section and a second section, the first and second sections being separate pieces that are connectable to one another at a free end of each. When the locking sleeve occupies the first position the free ends of the first section and the second section may be separated from one another, and when the locking sleeve occupies the second position the free ends of the first and second sections may not be separated from one another. [0025] Another preferred embodiment of the present pet enclosure comprises a support frame for a pet enclosure. The support frame comprises a floor member, a first truss pivotably connected to the floor member at or near a first end thereof, and a second truss pivotably connected to the floor member at or near a second end thereof. The support frame further comprises at least one support member having a first end and a second end, the first end being pivotably connected to the first truss and the second end being pivotably connected to the second truss. A locking sleeve including a first through-hole and a second through-hole is slidable on the at least one support member between a first position and a second position. The support frame further comprises a push-button mechanism associated with the locking sleeve. The push-button mechanism cooperates with the first through-hole and the second through-hole to releasably lock the locking sleeve in the first position and the second position, respectively. [0026] Another preferred embodiment of the present pet enclosure comprises a cover and a support frame. The cover comprises a bottom panel, a top panel opposite the bottom panel, and a plurality of side panels extending between the bottom panel and the top panel to define an interior space of the cover. An aperture is defined in at least one of the top panel and one of the plurality of side panels for accessing the interior space. The support frame is pivotable between a collapsed configuration and an upright configuration and is insertable into the interior space of the cover through the aperture in the collapsed configuration of the support frame. The support frame is also pivotable from the collapsed configuration to the upright configuration while disposed within the interior space of the cover. [0027] A preferred embodiment of a cover for a pet enclosure having a support frame that is pivotable between a collapsed configuration and an upright configuration comprises a bottom panel, a top panel opposite the bottom panel, and at least one side panel extending between the bottom panel and the top panel. The bottom panel, the top panel, and the at least one side panel collectively define an interior space of the cover. The top panel comprises an aperture and a closure for selectively covering and uncovering the aperture to provide access to the interior space through the aperture. The support frame can be inserted into the interior space in the collapsed configuration and pivoted between the collapsed configuration and the upright configuration while being disposed within the interior space. [0028] A preferred method of folding an embodiment of the present pet enclosure that includes a cover and a support frame is also provided. The cover has a plurality of panels defining an interior space and at least one aperture providing access to the interior space, and the support frame is pivotable between a collapsed configuration and an upright configuration. The method comprises inserting the support frame through the aperture in the cover and into the interior space while the support frame is in the collapsed configuration. The method further comprises folding the cover atop of the collapsed support frame such that the cover is configured to be at least one of transported and stored with the collapsed support frame being disposed within the interior space. [0029] Another preferred embodiment of the present pet enclosure comprises a cover and a collapsible support frame. The cover comprises a bottom panel, a top panel opposite the bottom panel, and a plurality of side panels extending between the bottom panel and the top panel to define an interior space of the cover, wherein an aperture is defined in the cover for accessing the interior space. The collapsible support frame is configured for insertion into the interior space of the cover via the aperture, and the support frame comprises a floor arrangement, a first truss hingedly connected to the floor arrangement, and a second truss hingedly connected to the floor arrangement opposite the first truss. The first truss and the second truss are movable relative to one another within the interior space of the cover between a collapsed configuration of the support frame and an uncollapsed configuration of the support frame. [0030] Another preferred embodiment of the present pet enclosure comprises an expandable cover and a collapsible support frame. The expandable cover comprises a roof, a floor opposite the roof, and a plurality of sides connecting the roof to the floor, wherein the plurality of sides includes a first side and a second side opposite the first side. The collapsible support frame comprises a first truss adjacent the first side of the cover, a second truss adjacent the second side of the cover, and a support member extending from the first truss to the second truss. The first truss and the second truss are pivotable relative to the support member toward one another into a collapsed configuration of the support frame and away from one another into an uncollapsed configuration of the support frame. Pivoting the trusses from the collapsed configuration into the uncollapsed configuration rearranges the cover from an unexpanded arrangement of the cover into an expanded arrangement of the cover. The cover in the expanded arrangement defines an interior compartment for housing a pet. [0031] Another preferred embodiment of the present pet enclosure comprises an expandable cover and a collapsible support frame. The expandable cover comprises a roof, a floor opposite the roof, and a plurality of sides connecting the roof to the floor. The plurality of sides includes a first side, a second side opposite the first side, a third side extending from the first side to the second side, and a fourth side extending from the first side to the second side opposite the third side. The collapsible support frame comprises a first truss adjacent the first side, a second truss adjacent the second side, a support member extending from the first truss to the second truss along one of the roof and the floor, and a brace sized to extend from the first truss to the second truss along the other of the roof and the floor. The first truss and the second truss are maintained in a substantially parallel, upright orientation relative to one another when the brace is positioned to extend from the first truss to the second truss such that the support frame assumes an uncollapsed configuration and arranges the cover in an expanded arrangement in which the cover defines an interior compartment for housing a pet. The first truss and the second truss are pivotable toward one another relative to the support member when extension of the brace from the first truss to the second truss is removed such that the support frame assumes a collapsed configuration and rearranges the cover into an unexpanded arrangement in which the cover does not define the interior compartment for housing a pet. [0032] Another preferred embodiment of the present pet enclosure comprises a rigid, rectangular floor panel, a first rigid end truss positioned adjacent a first end of the floor panel, a second rigid end truss positioned adjacent a second end of the floor panel, a rigid support member extending between upper ends of the first and second rigid end trusses, and a fabric cover disposed about the floor panel and the support member. The cover includes a floor panel, a top panel, first and second side panels, and first and second end panel. The floor panel of the cover is constructed of a durable, substantially non-breathable material. At least one of the first and second side panels, and at least one of the first and second end panels includes breathable mesh material portions. The front panel further includes a front recloseable opening, a portion of the front recloseable opening being permanently secured to the cover, and a remaining portion of the front recloseable opening being releasably secured to the cover. [0033] Other objects and features will be in part apparent and in part pointed out hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS [0034] The preferred embodiments of the pet enclosure, illustrating its features, will now be discussed in detail. These embodiments depict the novel and non-obvious pet enclosure shown in the accompanying drawings, which are for illustrative purposes only. These drawings include the following figures, in which like numerals indicate like parts: [0035] FIG. 1 is a front perspective view of a preferred embodiment of the present pet enclosure; [0036] FIG. 2 is a rear perspective view of the pet enclosure of FIG. 1 ; [0037] FIG. 3 is a side elevation view of a preferred embodiment of a frame for the pet enclosure of FIG. 1 , illustrating the locking sleeves in the locked position; [0038] FIG. 4 is a side elevation view of the frame of FIG. 3 , illustrating the locking sleeves in the unlocked position; [0039] FIG. 5 is a side elevation view of the frame of FIG. 3 , illustrating the locking sleeves in the unlocked position and the support tubes bent; [0040] FIG. 6 is a side elevation view of the frame of FIG. 3 , illustrating a first end truss in a folded position; [0041] FIG. 7 is a side elevation view of the frame of FIG. 3 , illustrating the frame in the folded position; [0042] FIG. 8 is an end elevation view of the frame of FIG. 3 ; [0043] FIG. 9 is a cross-sectional end view of the frame of FIG. 3 , taken through the line 9 - 9 ; [0044] FIG. 10 is a detail view of the frame of FIG. 3 , illustrating the joint and locking sleeve in the locked position; [0045] FIG. 11 is a detail view of the frame of FIG. 3 , illustrating the joint and locking sleeve in the unlocked position; [0046] FIG. 12 is a detail view of the frame of FIG. 3 , illustrating the locking sleeve in the unlocked position and the joint in the bent position; [0047] FIG. 13 is a cross-sectional detail view of the frame of FIG. 3 , illustrating the joint and locking sleeve in the locked position; [0048] FIG. 14 is a cross-sectional detail view of the frame of FIG. 3 , illustrating the joint and locking sleeve in the unlocked position; [0049] FIG. 15 is a detail view of the frame of FIG. 3 , illustrating a hinge joining the bottom truss and an end truss; [0050] FIG. 16 is a detail view of the frame of FIG. 3 , illustrating a hinge joining a support tube and an end truss; [0051] FIG. 17 is a perspective view of the frame of FIG. 3 ; [0052] FIG. 18 is a side elevation view of the pet enclosure of FIG. 1 , illustrating the pet enclosure in a folded configuration; and [0053] FIG. 19 is a front perspective view of another preferred embodiment of the present pet enclosure, illustrating an external frame. [0054] Corresponding reference characters indicate corresponding parts throughout the drawings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0055] The present pet enclosure 20 , pictured in FIGS. 1 , 2 and 18 , comprises a fabric cover supported by a rigid frame 24 . In the illustrated embodiment, the enclosure 20 is shaped generally as a six-sided rectangular box, having a top panel 26 , a floor panel 28 , a front panel 30 , a rear panel 32 , and two side panels 34 . Those of skill in the art will appreciate that the enclosure 20 could have any number of sides, and could be a variety of other shapes and sizes. The enclosure 20 is preferably available in a variety of sizes to accommodate pets of different sizes. [0056] The cover 22 is preferably constructed of a lightweight but durable fabric that is resistant to being torn by pet teeth or claws, and can withstand repeated machine washing and drying without wearing out or shrinking. A preferred material is nylon. Those of skill in the art will appreciate that other materials could be used, such as canvas or plastic. Corners of the enclosure 20 preferably include reinforcing patches 36 . Each patch 36 is substantially triangular, with each corner of each triangle residing along a border edge 38 of two contiguous panels 26 , 28 , 30 , 32 , 34 . The patches 36 are preferably constructed of a durable material, such as nylon or leather. The patches 36 not only reinforce the cover 22 and increase its life span, but they also provide a cushion so that the corners of the enclosure 20 are less likely to damage objects that they strike. [0057] The cover 22 preferably includes substantially non-breathable fabric portions 40 and breathable mesh portions 42 that enable air to circulate through the enclosure 20 . In the illustrated embodiment, the floor panel 28 is constructed of only non-breathable fabric 40 , while the remaining panels 26 , 30 , 32 , 34 are constructed of a combination of non-breathable fabric 40 and breathable mesh 42 . Each of these panels 26 , 30 , 32 , includes a central mesh portion 42 surrounded by a fabric border 40 . The side panels 34 may also include a fabric portion 40 running diagonally through the central mesh portion 42 . Those of skill in the art will appreciate that the panels 26 , 28 , 30 , 32 , 34 could comprise a variety of other combinations of fabric and mesh portions. For example, some panels could comprise entirely mesh, or entirely fabric, or the sizes and/or shapes of the mesh and fabric portions could be different. [0058] Opaque shades (not shown) could be provided to selectively cover the mesh portions 42 of each panel. For example, flaps could be sewn or otherwise secured to one or more of the panels 26 , 30 , 32 , 34 . When flat, the flaps could cover the mesh portions 42 , and be secured in place with zippers, snaps, or the like. In this configuration, the flaps would provide privacy to a pet inside the enclosure 20 . The flaps would also prevent sunlight from entering the enclosure 20 , which would keep the pet cooler on hot sunny days. Likewise, the flaps would prevent wind and rain from entering the enclosure 20 , which would keep the pet warmer and drier on cold rainy days. When rolled up or removed, the flaps could be secured adjacent the mesh portions 42 with straps or the like. In this configuration, the flaps would enable air and sunlight to enter the enclosure 20 . [0059] The enclosure 20 may also include a waterproof canopy (not shown). The canopy may comprise a canvas or nylon sheet large enough to stretch over the enclosure 20 . The enclosure 20 may support the canopy directly, or the canopy may be supported with substantially vertical poles, guy wires and stakes. The canopy may be integral with the enclosure 20 , or an independent structure. The canopy provides shelter from rainstorms, keeping the interior of the enclosure 20 dry so that a pet can be left outdoors inside the enclosure 20 even on rainy days. [0060] A first edge 44 of the mesh portion 42 of the top panel 26 is preferably stitched to the fabric portion 40 . The remaining three edges of the mesh portion 42 are releasably secured to the fabric portion 40 with a zipper 46 , which is actuated by one or more zipper pull tabs 47 . The top panel 26 thus includes a recloseable top opening 48 that provides access to the interior of the enclosure 20 . A pet owner can easily place a pet into, or remove a pet from, the enclosure 20 through the top opening 48 . Because the top opening 48 is located in the top panel 26 , a pet within the enclosure 20 cannot easily escape from the enclosure 20 when the top opening 48 is unzipped. Thus, when the pet is within the enclosure 20 , the owner can add or remove items through the top opening 48 , such as food and water dishes, toys or blankets, without having to guard against the pet escaping. The owner can also interact with the pet through the top opening 48 . For example, the owner can pet the animal, brush its fur, etc. [0061] The top panel 26 of the cover 22 preferably includes a retaining strap 50 secured near the first edge 44 of the mesh portion 42 forming the top opening 48 . An end of the strap 50 preferably includes securing means (not shown), such as a button, snap or hook-and-loop fastener. When the mesh portion 42 is unzipped and rolled up, as shown in FIG. 1 , the strap 50 is securable around the rolled up mesh portion 42 . The securing means on the strap 50 is attachable to a mating securing means 106 that is preferably attached to an inside surface of the open mesh portion 42 , or to an inside surface of the cover 22 . [0062] The cover 22 also preferably includes a second recloseable opening 52 in the front panel 30 . Like the top opening 48 , the front opening 52 comprises a mesh portion 42 that is stitched along a first edge 54 to a fabric border portion 40 . The remaining three edges are releasably secureable to the fabric border 40 with a zipper 46 , which is also actuated by one or more zipper pull tabs 47 . The front opening 52 enables a pet owner to allow his or her pet to enter and exit the enclosure 20 without assistance from the owner. For example, if the pet is heavy or otherwise difficult to pick up and place in the enclosure 20 through the top opening 48 , the owner can open the front opening 52 and urge the pet into or out of the enclosure 20 . [0063] The cover preferably includes a security snap clip 116 ( FIG. 1 ). The clip 116 is insertable through holes in the zipper pull tabs 47 , and locks the front opening 52 . The clip 116 is anchored to the cover 22 . If both zipper pull tabs 47 are located near the clip 116 , and the clip 116 is inserted into the pull tab 47 that would be used to unzip the front opening 52 , then that zipper 46 is immobilized and the front opening 52 cannot be opened. The pet inside the enclosure 20 thus cannot unzip the front opening 52 in order to escape from the enclosure 20 . A second clip 116 may be provided adjacent the top opening 48 . [0064] Rather than being anchored to the cover 22 , the clip could be independent of the cover 22 . If the independent clip 116 were inserted through both zipper pull tabs 47 , the top opening 48 or front opening 52 could not be opened, because as one zipper pull tab 47 moves to open the enclosure 20 , the other zipper pull tab follows right behind to reclose the enclosure 20 . Those of skill in the art will appreciate that the enclosure need not include the security snap clip 116 . [0065] In the illustrated embodiment, the exterior surface of the rear panel 32 ( FIG. 2 ) of the cover 22 includes a pocket 55 , a zippered pocket 56 and a mesh pouch 58 . The pockets 55 , 56 and pouch 58 are useful for holding pet accessories, such as food, treats, toys and grooming tools. Those of skill in the art will appreciate that the pockets 55 , 56 and pouch 58 could be located anywhere on the cover 22 , including the interior surface of the cover 22 . Those of skill in the art will further appreciate that the enclosure 20 need not include any pockets or pouches. The cover 22 may also include receptacles (not shown) for containing food and/or water. The receptacles may be located on either the interior or the exterior of the cover 22 , and may comprise, for example, rigid or semi-rigid plastic bowls. Alternatively, the cover 22 may include soft pockets for holding rigid or semi-rigid plastic bowls. [0066] The cover preferably includes tabs 118 ( FIGS. 1 and 2 ) for accepting stakes (not shown). The tabs 118 are attached to the cover floor panel 28 , or adjacent the floor panel 28 . The tabs 118 each include a hole 120 , through which a stake can be driven to firmly secure the enclosure 20 to the ground. Each hole 120 is preferably reinforced with a grommet 121 , which is preferably constructed of any sturdy material such as metal or high-impact plastic. Those of skill in the art will appreciate that the enclosure need not include the tabs 118 . [0067] A rigid frame 24 ( FIGS. 3-17 ) supports the cover 22 . In the illustrated embodiment, the frame 24 is internal to the cover 22 . Those of skill in the art will appreciate that the frame 24 may be external to the cover 22 , as illustrated in FIG. 19 . The frame 24 comprises a substantially rectangular floor truss 60 , two substantially U-shaped end trusses 62 , and jointed support tubes 64 extending between upper edges of the end trusses 62 ( FIG. 17 ). [0068] The word truss, as used herein, is defined as a rigid frame comprised of at least two interconnected members. For example, a truss includes four bars welded to one another to form a rectangular frame. The definition of truss, as used herein, is not exclusive of any manner of attaching the truss members together. The members may be, for example, welded, adhered, riveted, screwed, bolted, nailed, etc, to one another. The members may even be formed integrally with one another. For example, four tubes that are formed as a single piece four-sided frame comprise a truss. The definition of truss, as used herein, is also not exclusive of any material. The truss members may be, for example, metal, plastic, composite, wood, ceramic, etc. [0069] The floor truss 60 and the end trusses 62 are each constructed of rigid bars or tubes 66 ( FIG. 17 ). For ease of reference, the tubes 66 will be referred to herein as tubes, even though they could comprise solid bars, as those of skill in the art will appreciate. [0070] The bars or tubes 66 may be made of any suitable rigid material that is preferably lightweight. Preferred materials include, without limitation, metals such as steel or aluminum, plastics, and composites. The illustrated tubes 66 are of circular cross-section. However, those of skill in the art will appreciate that the tubes could be of any cross-section, such as square or hexagonal. The floor truss 60 may comprise a single tube 66 that is bent at right angles in four places and the ends of the tube 66 connected to one another. Alternatively, the floor truss 60 may comprise four separate tubes 66 connected to one another at their ends to form four corners. Preferably, corners of the trusses 60 , 62 are somewhat rounded to reduce the likelihood of injury to someone bumping into the frame 24 . [0071] Those of skill in the art will appreciate that the frame 24 may be configured differently. For example, if the frame were inverted, the floor truss 60 could be used to support a roof of the enclosure 20 . The jointed support tubes 64 would then extend between lower edges of the end trusses 62 . The floor truss 60 could also include a floor panel (not shown). For example, a flat rectangular panel could be secured to lower, upper or inner surfaces of the tubes 66 comprising the floor truss 60 . The panel could, for example, be made of metal, fiberglass or a composite material, and could be secured to the floor truss 60 by welding or adhesive. Alternatively, the floor truss 60 could be eliminated, and the end trusses 62 could be secured directly to the floor panel. [0072] Four lugs 68 ( FIGS. 3 , 4 , 15 and 16 ) are preferably secured to the floor truss 60 , one lug 68 near each corner of the floor truss 60 . Each lug 68 comprises a substantially rectangular plate that is secured to the floor truss 60 such that a plane defined by each lug 68 is perpendicular to a plane defined by the floor truss 60 . Each lug 68 includes a through-hole (not shown) for receiving a hinge pin 67 ( FIGS. 15 and 16 ). [0073] The end trusses 62 are pivotably attached to the lugs 68 . Each of the end trusses 62 is preferably three-sided and substantially U-shaped. Like the floor truss 60 , the end trusses 62 are constructed of rigid bars or tubes 66 . The bars or tubes 66 may be made of any suitable rigid material that is preferably lightweight. Preferred materials include, without limitation, metals such as steel or aluminum, plastics, and composites. The end trusses 62 may comprise a single tube 66 that is bent in two places. Alternatively, the end trusses 62 may comprise three separate tubes 66 connected to one another at their ends to form a U. [0074] A hinge portion 70 ( FIGS. 15 and 16 ) is inserted within the ends of the tube or tubes 66 forming the open end of the U in each end truss 62 . Each hinge portion 70 is substantially cylindrical. A first end of the hinge portion 70 resides within the end of the tube 62 in a friction fit. The hinge portions 70 may also be attached to the end trusses 62 by alternate means. For example, if the end trusses 62 comprise solid bars, rather than hollow tubes, the hinge portions 70 may be glued, welded or otherwise attached to the bars. Even when the hinge portions 70 are inserted into tubular panels, the hinge portions 70 may also be secured by gluing, welding or the like for a stronger hold. [0075] A length of each hinge portion 70 extends from the end of the tube 66 . This exposed portion 72 includes a longitudinal slit 74 ( FIG. 16 ) that extends through the entire diameter of the hinge portion 70 . A transverse through-hole (not shown) extends through the exposed portion 72 and intersects the space defined by the slit 74 . The slit 74 is configured to accept a lug 68 , such that the through-hole in the hinge-portion 70 aligns with the through-hole in the lug 68 . A hinge pin 67 inserted through both through-holes pivotably secures the hinge portion 70 to the lug 68 . The two hinge portions 70 at either open end of the end trusses 62 , respectively, thus pivotably attach the end trusses 62 to the lugs 68 on the floor truss 60 . [0076] Each support tube 64 comprises a long portion 76 and a short portion 78 ( FIGS. 3 and 4 ). A first end 80 ( FIG. 3 ) of each portion 76 , 78 is pivotably attached to an upper portion 82 of an end truss 62 in a similar manner as the end trusses 62 are pivotably attached to the floor truss 60 . Second ends 84 ( FIG. 4 ) of each portion 76 , 78 are releasably connectable to each other via a joint 86 ( FIGS. 4 , 13 and 14 ). Each joint 86 comprises a female connector 88 having a substantially cylindrical exterior and a substantially cylindrical socket 90 at a first end. Each joint 86 also comprises a male connector 92 having a substantially cylindrical exterior and a substantially cylindrical plug 94 at a first end. An outer diameter of the plug 94 is preferably roughly equal to an inner diameter of the socket 90 . The plug 94 is thus snugly slidable within the socket 90 . [0077] The exterior of the female connector 88 fits snugly within the second end 84 of the support tube long portion 76 . The exterior of the male connector 92 fits snugly within the second end 84 of the support tube short portion 78 . The long portion 76 and short portion 78 are thus connectable to one another by insertion of the plug 94 into the socket 90 . In this configuration, each support tube 64 becomes a one-piece bar that is rigid in compression and maintains the end trusses 62 in their upright positions, as shown in FIGS. 3 and 4 . [0078] A substantially cylindrical passage 96 extends through both the female and male connectors 88 , 92 . An elastic cord 98 ( FIGS. 12 , 13 and 14 ) preferably extends through each passage 96 and is secured at either end to the female and male connectors 88 , 92 , or in the portions 76 , 78 . Tension in the elastic cord 98 urges the female and male connectors 88 , 92 toward one another. Thus, although each support tube 64 comprises two pieces 76 , 78 , the elastic cords 98 assist in aligning and securing the two pieces together. Those of skill in the art will appreciate that the elastic cords 98 need not be provided. However, the elastic cords 98 facilitate quick setup of the enclosure 20 , as described below. The elastic cords 98 also make the frame 24 more manageable by preventing the detached pieces 76 , 78 from flopping around. [0079] Each support tube 64 preferably includes a substantially cylindrical locking sleeve 100 ( FIGS. 10-14 and 17 ). The sleeve 100 is slidable along the support tube 64 from a locked position ( FIGS. 10 , 13 and 17 ) to an unlocked position ( FIGS. 11 , 12 and 14 ). In the locked position, the sleeve 100 covers the joint 86 between the short and long portions 76 , 78 of the support tube 64 and increases the overall rigidity of the support frame 24 . In the unlocked position, the sleeve 100 is slid away from the joint 86 such that the short and long portions 76 , 78 are easily pulled apart from one another and the support tubes 64 bent as shown in FIG. 5 , and in detail in FIG. 12 . Preferably, a length of the cover 22 is substantially equal to a length of the support tubes 64 . Thus, when the cover 22 is stretched over the frame 24 , the cover 22 resists any tendency of the short and long portions 76 , 78 to separate from one another. [0080] The sleeve 100 includes two through-holes 102 ( FIGS. 13 and 14 ), one near each end of the sleeve 100 . The holes 102 lie along a line that is parallel to a longitudinal axis of the sleeve 100 . Near the joint 86 , the long portion 76 of each support tube 64 includes a U-shaped, cantilevered leaf spring 104 with a button 106 near a free end. The button 106 protrudes through a hole 108 in a side wall of the support tube 64 . The button 106 is aligned with the line joining the two holes 102 on the sleeve 100 . Thus, when the sleeve 100 is in the locked position, the button 106 protrudes through one hole 102 in the sleeve 100 . As the sleeve 100 slides along the support tube 64 toward the unlocked position, it maintains the button 106 in a depressed position until it reaches the unlocked position, where the button 106 pops up into the other hole 102 in the sleeve 100 . The button 106 thus releasably locks the sleeve 100 in either the locked or unlocked position. [0081] The enclosure 20 is foldable into the configuration illustrated in FIG. 18 . The front panel 30 is folded approximately ninety-degrees toward the floor panel 28 such that the two panels are substantially parallel. The rear panel 32 is also folded approximately ninety-degrees toward the floor panel 28 , such that it rests atop the front panel 30 , and is substantially parallel to both the floor panel 28 and the front panel 30 . In this configuration, the enclosure 20 comprises a compact flat panel that occupies a fraction of the space that the unfolded enclosure 20 of FIGS. 1 and 2 occupies. The folded enclosure is thus easy to store and easy to transport. [0082] Preferably, the cover 22 includes closure clips 110 ( FIGS. 1 , 2 and 18 ), which comprise releasably lockable male and female connectors. The clips 110 secure the enclosure 20 in the folded configuration as shown in FIG. 18 . The enclosure 20 cover 22 may also include a side handle 112 ( FIG. 2 ) to enable easy carrying of the folded enclosure 20 . Alternatively, the enclosure 20 may include a bag (not shown) into which the folded enclosure 20 may be inserted for easy carrying or storage. Additional handles (not shown) may also be provided to facilitate carrying of the enclosure 20 when the enclosure 20 is in the unfolded configuration as in FIG. 1 . The handles could be conveniently positioned along the upper edges of the cover 22 to enable a pet owner to pick up the enclosure 20 , perhaps with a pet inside, and carry it to a different location. The handles could alternatively be secured directly to the frame 24 , and could protrude through apertures (not shown) in the cover 22 , if the frame 24 is internal. [0083] The procedure for folding the enclosure 20 is illustrated in FIGS. 3-7 . For clarity, the procedure is illustrated with the cover 22 removed from the frame 24 . However, most pet owners will likely prefer to fold the enclosure without first removing the cover 22 , because such removal is unnecessary for storage or transportation of the enclosure 20 . [0084] The pet owner first unzips the top opening 48 and removes the pet and other articles from the enclosure 20 . Next, the pet owner depresses the button 106 and slides both locking sleeves 100 from the locked position ( FIG. 3 ) to the unlocked position ( FIG. 4 ). The owner then pushes downward on the support tubes 64 at or near the joints 86 so that the support tubes 64 bend ( FIG. 5 ). Advantageously, the elastic cords 98 retain the portions 76 , 78 of the support tubes 64 in close proximity. The elastic cords 98 thus guide the support tubes 64 to their desired orientations during folding so that the owner does not have to guide them with his or her hand. [0085] Next, the owner folds downward the end truss 62 that is connected to the short portions 78 of the support tubes 64 ( FIG. 6 ). In the illustrated embodiment, the first-folded end truss 62 corresponds to the front panel 30 ( FIGS. 1 , 2 and 18 ). However, those of skill in the art will appreciate that the orientation of the cover 22 relative to the frame 24 may be reversed such that the end truss 62 corresponds to the rear panel 32 . In such an orientation, the owner would fold the rear panel 32 first. [0086] As the owner folds the first end truss 62 , the short portions 78 pivot about the lugs 68 toward the first end truss 62 . When a plane defined by the first end truss 62 is substantially parallel to the long portions 76 , the short portions 78 begin to pivot in the opposite direction. The short portions 78 continue to pivot in this direction until the plane defined by the first end truss 62 is substantially parallel to a plane defined by the floor truss 60 . In this configuration, shown in FIG. 6 , the short portions 78 are substantially parallel to the plane defined by the first end truss 62 and extend away from the first end truss 62 . [0087] Tucking the cover 22 inside, the owner then folds downward the remaining end truss 62 so that it rests on top of the first-folded end truss 62 ( FIGS. 7 and 18 ). Preferably, the lugs 68 to which the second-folded end truss 62 are attached are somewhat longer than the lugs 68 to which the first-folded end truss 62 are attached. Thus, when the second panel is folded on top of the first, the panels 62 are able to occupy spaced parallel planes. The enclosure 20 is thus able to fold more compactly. To facilitate tighter nesting between the end trusses 62 , the end trusses 62 may have different widths. For example, the end truss 62 that is folded first may be narrower than the end truss 62 that is folded second. The parallel legs of the first-folded end truss 62 would then nest inside the parallel legs of the second-folded end truss 62 . [0088] Preferably, inside surfaces of the cover 22 that abut the frame 24 include straps 114 ( FIG. 2 ). The straps 114 include releasable securing means, such as snaps or hook-and-loop fastener. The straps 114 are wrapped around the tubes 66 of the end trusses 62 to more securely fasten the cover 22 to the frame 24 . Thus, as the owner folds the enclosure 20 , the cover 22 follows the motion of the end trusses 62 . Those of skill in the art will appreciate that the straps 114 need not be provided. [0089] If the cover 22 is external to the frame 24 , the cover 22 preferably includes straps 114 on its outside surfaces, as shown in FIG. 19 . The straps 114 secure the cover 22 to the frame 24 so that the flexible cover 22 does not collapse under its own weight. When the enclosure 20 is folded, the straps 114 also allow the cover 22 , to follow the motion of the end trusses 62 . [0090] To secure the enclosure in the folded configuration shown in FIG. 18 , the owner secures the mating ends of the closure clips 110 together. The owner can thus grasp the handle 112 and carry the enclosure 20 in an upright plane without gravity unfolding the enclosure 20 . [0091] The procedure for unfolding the enclosure 20 comprises, in reverse order, the steps from the folding procedure just described. Again, the elastic cords 98 advantageously guide the support tube portions 76 , 78 to the aligned position of FIG. 5 . The owner thus need not guide them himself or herself, which would add complexity to the unfolding procedure. [0092] Advantageously, the frame 24 of the present enclosure 20 is made up of jointed pieces that are all attached to one another, even when the enclosure 20 is completely folded. The separate portions 76 , 78 of the support tubes 64 are secured to one another with the elastic cord 98 . The frame 24 is thus manipulable as one piece, and is portable as one piece. There are no extra components to keep track of. [0093] As those of skill in the art will appreciate, the elastic cords 98 need not be provided. In an embodiment of the enclosure 20 that does not include the elastic cords 98 , folding would proceed substantially as described above. However, rather than bending the support tubes 64 at or near the joints 86 , the owner would separate the pieces 76 , 78 and allow each one to pivot to an orientation wherein each hung parallel to the end trusses 62 . The owner would then fold the end trusses 62 as described above, securing each piece 76 , 78 under its respective end truss 62 . In addition, each interconnected member of a truss may be secured to the other interconnected member(s) through the use of other hinged arrangements or securement devices. For example, the members may be welded to one another or formed of one integral piece. [0094] The cover 22 of the present enclosure 20 is completely removable from the support frame 24 . To remove the cover 22 , the owner first detaches the cover from the frame 24 by reaching through one of the openings 48 , 52 and unfastening the straps 114 (if straps 114 are provided) from the tubes 66 . The owner then folds the frame 24 by following the procedure described above. However, the owner folds the frame 24 independently of the cover 22 . The owner can then easily remove the compact folded frame 24 from the cover 22 by passing it through one of the openings 48 , 52 . [0095] The cover 22 is thus easily washable, because it can be machine washed when separated from the frame 24 . Also, an owner may easily replace a worn-out cover 22 without having to purchase an entire enclosure 20 . An owner may also purchase additional covers 22 in different colors. The owner may then change the cover 22 as needed to, for example, match a room's decor. Scope of the Invention [0096] The above presents a description of the best mode contemplated for carrying out the present pet enclosure, and of the manner and process of making and using it, in such full, clear, concise and exact terms as to enable any person skilled in the art to which it pertains to make and use this pet enclosure. This pet enclosure is, however, susceptible to modifications and alternate constructions from that discussed above that are fully equivalent. Consequently, this pet enclosure is not limited to the particular embodiments disclosed. On the contrary, this pet enclosure covers all modifications and alternate constructions coming within the spirit and scope of the pet enclosure as generally expressed by the following claims, which particularly point out and distinctly claim the subject matter of the pet enclosure.

A pet enclosure includes an expandable cover and a collapsible support frame. The cover comprises a roof, a floor opposite the roof, and sides connecting the roof to the floor, wherein the sides include a first side and a second side opposite the first side. The support frame comprises a first truss adjacent the first side, a second truss adjacent the second side, and a support member extending from the first truss to the second truss. The first truss and the second truss are pivotable relative to the support member toward one another into a collapsed configuration of the support frame and away from one another into an uncollapsed configuration of the support frame. Pivoting the trusses from the collapsed configuration into the uncollapsed configuration rearranges the cover from an unexpanded arrangement into an expanded arrangement. The cover in the expanded arrangement defines an interior compartment for housing a pet.

RELATED APPLICATIONS [0001] N/A BACKGROUND OF THE INVENTION Field of the Invention [0002] The invention herein resides in the art of sports and, more particularly, to the field of golf. Specifically, the invention relates to a method for playing tournaments including proficient golf and a particular combinations of formats. Discussion of the Background [0003] The sport of golf is viewed and followed by millions all around the world. For proficient golf players, such as professional, and non-professional golf players the athletic ability and the skills demonstrated in their “long” and “short” games which contribute significantly to the enjoyment of the game. Those familiar with the game of golf are aware of a broad range of formats by which the game is played and scored. By way of example, these formats include skins, match play, best ball, points, alternate shot, scramble and the like. Tournaments are often played by predefine teams, mainly well know participants, upon these formats. [0004] In team play rounds or tournaments, a best ball format is often employed. In that format, the field may be broken into teams of several players each, ideally up to 4, and on each hole the lowest or “best” score between the partners is entered for the team. At the end of this best ball round or tournament, the team with the lowest score (aggregate of lowest scores on each hole) is the winner. [0005] One of the problems with best ball play for tournaments, mainly televise tournaments, is the fact that a dominant player on any team can remove any doubt as to the outcome of the round or tournament early in that round or tournament, reducing the suspense or intrigue at the end of the round or tournament, where it is typically desired to be highest. For example in teams including proficient players and non-proficient player the odds are that the lowest score belongs to the proficient player giving no valuable weight and/or participation to the non-proficient players. Moreover, such best ball tournaments often serve to effectively reduce the teams to a one golfer team, again reducing the value of the non-proficient players in a team and the suspense in the rounds or tournament itself. [0006] Therefore, there is a need to provide a scoring method for golf tournaments that gives consideration to all the players including the worst ball on at least certain of the holes of the round or tournament, with the resultant effect of leaving the outcome effectively indeterminate until the last putt is made. [0007] It is most desirable to have a tournament scoring method in golf that considers both the best and worst contributions of team members, that leaves the suspense as to who will win until the last putt, and that is adaptable to implementation in various formats. SUMMARY OF THE INVENTION [0008] In light of the foregoing, it is a first aspect of the invention to provide a method of scoring rounds of golf tournament in which the best and worst contributions from team members are considered in the scoring. [0009] Another aspect of the invention is to stimulate the participation of proficient player in combination with at least three particularly arranged golf formats in order to provide golf viewers with a more intriguing game. [0010] Another aspect of the invention is the selection of team members based on a first day performance. [0011] Another aspect of the invention is the provision of a method of scoring rounds of golf tournament in which the effect of a dominant player on any team is reduced by considering other players performance on various holes. [0012] Another aspect of the invention is to provide a tournament structure including at least 3 golf formats. [0013] Yet a further aspect of the invention is to provide a method of scoring rounds of golf tournament that leaves the outcome of the round or tournament in suspense until the last putt on the last hole. [0014] Still another aspect of the invention is the provision of a method of scoring rounds of golf tournament that is exciting including the full range of performance of team members. [0015] The foregoing and other aspects of the invention that will become apparent as the detailed description proceeds are achieved by a method of scoring a golf tournament between competing teams. BRIEF DESCRIPTION OF THE DRAWINGS [0016] The accompanying drawings which are incorporated herein constitute part of the specifications and illustrate the preferred embodiment of the invention. [0017] FIG. 1 shows a general example flow chart of the first embodiment in accordance with the principles of the present disclosure. [0018] FIG. 2 shows a general example flow chart of how to play the first embodiment in accordance with the principles of the present disclosure of the present disclosure. [0019] FIG. 3 shows a general example flow chart of how to create teams in accordance with the principles of the present disclosure of the present disclosure. DESCRIPTION OF THE PREFERRED EMBODIMENT [0020] The present invention overcomes all the disadvantages mentioned above by providing a new method for a golf tournament. In the context of this description, a tournament may be that typically known to participants and spectators as a multiple day event, more particularly 3 day events, where rounds of golf are played on each day with a particular format. In accordance with the principles of the present disclosure the present game execution consists of 54 holes. [0021] FIG. 1 is directed to show a general example flow chart of the first embodiment, more particularly the tournament 100 in accordance with the principles of the present disclosure, wherein several players 10 - 14 are added to the player list for the tournament 100 . The several players may include proficient players, such as professionals, and non-proficient players such as regular players. Once the players 10 - 14 are registered on the player list 100 teams are created by selecting at least two players from said players' list 100 . The selection of player per team is performed in a blind draw manner M, as shown in FIG. 2 . Therefore players on the list are not ranked based on previous results or experience. The match-ups are based solely on the luck of the draw. Further teams prepare to play a best ball format on the first day D 1 of the tournament. [0022] FIG. 3 is directed to the preferred embodiment of the tournament, wherein a 54 hole tournament is contemplated in which teams of two golfers each are paired against each other. During the first day D 1 of competition (an 18 hole round of golf) a best ball format may be employed. On that day, the best (lowest) score for each hole played that day is the score that is actually entered on behalf of the team. On the second day D 2 of the tournament, a low and aggregate format is employed. A low and aggregate format includes the scores of the two golfers on each hole which are added together and the lowest score is added again to that sum, the result being the score entered for each hole on that day. It will be appreciated that this has the effect of enhancing the value or impact of the best ball or lowest score, while also considering and giving value to the score of the other team player. Further on the third day D 3 of the tournament, a worst ball format is followed. Here, the highest score on each hole by a team member is entered on behalf of the team. This final day of the tournament keeps the outcome of the entire tournament in play until the final putt is made. By performing the current variation of formats the tournament also has a leveling effect against the first day of the tournament in which only the best ball was scored. The team with the lowest score is the winner or tournament champion. [0023] One object of the present invention is to maintain the suspense of the game, therefore the number of holes per day varies. The difference between the number of holes depends on the score difference per day. For example, the preferred embodiment selects the number of holes for the next day based on the following variables: the number of teams, the best and lowest score per hole of the first rank team at the end of the current competition day and the best and lowest score per hole of the last team rank at the end of the current of competition of the tournament. The results of holes to be played are equivalent to the minimum number of holes that permits the minimum difference between the first rank team and the last rank team based on the current day results for the tournament. The tournament format just described ensures that the participation of each team player is considered and counted. The score for both, the best player and the second member, will impact the final score. The invention does, however, contemplate scoring formats that include the combination of best score, a low and aggregate score and the worst score, giving more significance to the worst score on particular holes than the better score. [0024] It will be appreciated by those skilled in the art that any number of formats can be implemented consistent with the foregoing. The teas take the worst score on each hole thereby maintaining the outcome of the tournament in suspense throughout. [0025] Thus it can be seen that the various aspects of the invention have been attained by the method presented above. While in accordance with the patent statutes only the best known and preferred embodiments of the invention have been presented and described in detail, the invention is not limited thereto or thereby. For a true appreciation of the scope and breadth of the invention reference should be made to the following claims. [0026] While the invention has been described as having a preferred design, it is understood that many changes, modifications, variations and other uses and applications of the subject invention will, however, become apparent to those skilled in the art without materially departing from the novel teachings and advantages of this invention after considering this specification together with the accompanying drawings. Accordingly, all such changes, modifications, variations and other uses and applications which do not depart from the spirit and scope of the invention are deemed to be covered by this invention as defined in the following claims and their legal equivalents. In the claims, means-plus-function clauses, if any, are intended to cover the structures described herein as performing the recited function and not only structural equivalents but also equivalent structures. [0027] All of the patents, patent applications, and publications recited herein, and in the Declaration attached hereto, if any, are hereby incorporated by reference as if set forth in their entirety herein. All, or substantially all, the components disclosed in such patents may be used in the embodiments of the present invention, as well as equivalents thereof. The details in the patents, patent applications, and publications incorporated by reference herein may be considered to be incorporable at applicant's option, into the claims during prosecution as further limitations in the claims to patentable distinguish any amended claims from any applied prior art.

The present invention enhances a golf tournament using novel tournament rules that include allowing proficient players to interact with other players, more particularly, professional players to affect the outcome of the tournament. After teams are created the game a best ball is played at the first day, a low and aggregate ball is played on the second day and a worse ball is played on the last day. At the end of the tournament the team with the lowest score wins.

CROSS-REFERENCE TO RELATED APPLICATION This application is a continuation-in-part of U.S. design patent application Ser. No. 29/030,746, entitled Exercise Treadmills, and filed Nov. 7, 1994. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to exercise treadmills and more particularly to such treadmills wherein the plane off the tread belt of the treadmill is variable by means of rearwardly placed slope or incline adjustment mechanism. 2. Description of the Prior Art Exercise treadmills conventionally have tread belt user support surfaces which either have a fixed attitude relative to the support surface on which the treadmill rests user which have mechanism to adjust the incline of the tread belt by means relatively raising or lowering the front or forward end of the treadmill and tread belt. Many examples of such treadmills are known, such as disclosed in Chen U.S. Pat. No. 4,792,134 and Dalebout U.S. Pat. No. 5,062,632, for example. Customarily, also, many treadmills which are inclinable by being raised and lowered at the front end are also provided with a raised deck portion forwardly of the tread belt in which the tread belt drive motor, and sometimes the incline drive motor as well, are housed. One example of this type of arrangement are shown in Chen U.S. Pat. No. 4,792,134, for example, Also of interest in the prior art is Weisz U.S. Pat. No. 5,295,929 which discloses an underwater treadmill for hydrotherapy usage. This treadmill has a tread belt platform which is supported by a roller frame which in turn is supported by vertically extensible pneumatic cylinders or other suitable mechanical devices so that it can be tilted lengthwise. This patent thus may be said to teach the broad proposition of tilting a treadmill tread bed by raising or lowering either the forward or the rearward end of the tread deck. However, this patent does not disclose how this would be done on an exercise treadmill with a fixed forward support and its disclosure is of a special purpose assembly in which a user is partly submerged in a tub for rehabilitative hydrotherapeutic purposes. SUMMARY OF THE INVENTION A treadmill according to the present invention differs from conventional exercise treadmills in that its tread height at the front end of the tread belt is fixed and its incline drive mechanism is situated to act on the rearward end of the treadmill. Being of fixed height and substantially above the floor level, the front end of the treadmill can house the tread belt drive motor entirely below the tread belt plane so that the tread belt can be completely flat end for end and extend completely from one end of the treadmill to the other. To effect such an arrangement, the forward end of the treadmill is supported by a fixed support, and slung under the treadmill frame rearwardly are pivotally movable arms, the angular position of which is variable by means of shortening or lengthening of an extensible, electric motor driven assembly, in one version of the treadmill. In this form, when the extensible incline drive assembly is of maximum length, the arms are moved to a location nested under and between the sides of the treadmill frame, in which position the tread belt has its maximum incline. A modified from of treadmill according to the invention involves control of the position of the pivotally movable incline mechanism arms by means of an extensible gas cylinder and piston rod, the relative length of which is in turn determined by gas flow from one end of the cylinder to the other through valve means manually opened or closed by the user, with change in incline being caused by manual change of position of the user forwardly or rearwardly on the tread belt. This essentially manual control mechanism has the advantage of being quite simple and straightforward for the purpose. On the other hand, the utilization of an electric motor drive for incline adjustment mechanism, as is characteristic of the first form of treadmill incline control discussed, has the advantage that it can be re-programmed. These and other features, advantages and characteristics of inclinable treadmills according to the resent invention will be apparent from the following description and accompanying drawings relating to the referred embodiments thereof. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an isometric view of a treadmill according to the present invention, from an upward and somewhat rearward aspect, showing the first preferred embodiment thereof; FIG. 2 is a top plan view thereof; FIG. 3 is a right side elevational view thereof; FIG. 4 is a left side elevational view thereof; FIG. 5 is a front elevational view thereof; FIG. 6 is a rear elevational view thereof; FIG. 7 is a bottom plan view thereof; FIG. 8 is an exploded isometric view on a smaller scale of various components of the first preferred embodiment, and showing further detail as to such components. FIG. 9 is a top plan view of the second preferred embodiment thereof; FIG. 10 is a right side elevational view thereof; FIG. 11 is a left side elevational view thereof; FIG. 12 is a front elevational view thereof; FIG. 13 is a rear elevational view thereof; and FIG. 14 is a bottom plan view thereof. DESCRIPTION OF THE PREFERRED EMBODIMENTS The first preferred embodiment of the invention as illustrated in FIGS. 1-8 comprises an exercise treadmill with an endless tread belt 10 which courses a front roller 12 (FIG. 8) and a rear roller 14 and with an upper course between the rollers 12, 14 which is supported by a flat tread deck 16. The rollers 12, 14 and tread deck 16 are supported by the treadmill frame which comprises side rails 18, 20 and front and rear cross members 22, 24. As shown in FIGS. 1-8, this treadmill also comprises left and right landing strips 26, 28 along the sides of the tread belt 10, and left and right hand rails 30, 32. Below the side rails 18, 20, near the front thereof, are left and right support brackets 34, 36 which are of fixed form and terminate in their lower extremities in support surface engaging pads 38, 40. Front roller 12, which drives the endless tread belt 10, is in turn driven by electric drive motor 42 (FIG. 8) through drive belt 44. Motor 42 is held on the frame crossbar 22 by motor bracket 46 in the region below the forward portion of the tread belt 10 and between the support brackets 34, 36. Motor cover 48 and support bracket side covers 50, 52 enclose the lower and side portions of the drive motor 42 and drive roller 12 components in a manner so that all parts of the treadmill in the forward region, except the tread belt 10 itself, are in fixed form and stationary during use. This arrangement, unique to the present invention, enables the user engaged surface of the tread belt 10, throughout its length and through the full length of the treadmill, to be completely planar, rather than the treadmill having the conventional raised forward portion which customarily is required to house the belt drive motor, and also the incline drive mechanism, when the treadmill is so equipped. Primarily for aesthetic reasons, the ends of the rear roller 14 are provided with left and right end caps 54, 56. According to the present invention, the first preferred embodiment thereof illustrated in FIGS. 1-8 includes an incline adjustment mechanism comprising rearwardly placed, pivotally movable left and right support arms 60, 62 which are mounted by left and right pins 64, 66 (FIG. 8) to respective side rails 18, 20 and are interconnected by a crossbar 68. Arranged between the fixed crossbar 22 and the pivotally movable crossbar 68 is an electric motor driven, extensible jack 70, which is a mechanism conventional per se, such as disclosed in Dunham U.S. Pat. No. 4,974,831. As will be apparent, the pivotally movable arms 60, 62 are slung under the frame including side rails 18, 20 and the arms 60, 62 are pivotally movable by means of the jack 70. Shortening or lengthening of the jack 70 results in change in incline of the tread belt 10. More specifically, when jack 70 is of maximum length, the arms 60, 62 are moved to a location nested between the frame side rails 18, 20, in which position the tread belt 10 has its maximum incline, i.e. with the forward end maintained in its raised position and with the rear end situated so that the rear of the frame side rails 18, 20 are in engagement with the treadmill support surface. Similarly, with the jack 70 shortened, the tread belt 10 is rendered more horizontal, i.e. less inclined. Further components of the first preferred embodiment shown in FIGS. 1-8, as they appear in the exploded view of FIG. 8, include wheels on the pivotally movable assembly including support arms 60, 62, one of which wheels is indicated at 72, and forward wheels on the forward support brackets 34, 36, one of which is indicated at 74, which facilitate movement of the treadmill when not in use. Also shown in FIG. 8 are alternatively used display panels 76, meter base components 78, tether key, cord and clip 80, left and right foam handle grips 82, 84, left front roller cap 86, right front roller cap 88, handlebar bracket cover 90, handlebar tightening bracket 92, power cable, power plug and circuit breaker 94, speed sensor and wire 96, speed sensor target disc 98, flywheel 100, drive motor bracket pad 102, decals 104, pivot pin 106 for interconnecting jack 70 and front cross member 22, and rubber bumpers 108 on which tread deck 16 rests and which in turn are supported by the side rails 18, 20. FIGS. 9-14 illustrate the second preferred embodiment of the invention. This form of treadmill is like that shown in FIGS. 1-8 except it employs a different incline adjustment mechanism. In FIGS. 9-14 components which are the same as those components shown and discussed with respect to the form of the invention shown in FIGS. 1-8 are given like component numbers and those components which are different are given different numbers. In general, this second form of the invention employs as its incline adjustment mechanism a gas cylinder 120 with a piston rod 124 extensible in length, which gas cylinder 120 and rod 124 are of a type conventional per se, such as disclosed in U.S. Pat. No. 5,192,255, for example. The gas cylinder 120 and rod 124 are interconnected between the pivot arm crossbar 68 and the rear crossbar 24 of the treadmill frame. The latter connection, as shown in FIG. 14, for example, is made through a U-shaped bracket 122 to which the rod 124 is attached and in which is housed a manual valve actuator 126. Valve actuator 126, when in a first control position (the position shown in FIG. 14), operates to maintain closed an internal valve in the cylinder 120 which when closed prevents gas flow from one end of the cylinder 120 to the other and thus maintains the piston rod 124 and the cylinder 120 stationary with the cylinder 120 and its rod 124 of fixed length, with the crossbar 68 and pivot arms 60, 62 in a set position and the treadmill deck and treadbelt 10 in a fixed incline attitude. Said valve actuator 126 has a second position whereby the internal gas valve is opened and the gas contained in the cylinder 120 can flow from one end thereof to the other and consequently permit movement of piston rod 124 and a change in overall length of the piston 120 and its rod 124, which in turn causes corresponding movement of the pivot arms 60. The position of the valve actuator 126 for either maintaining the arms 60, 62 in a fixed position or permitting movement thereof is, in the embodiment of the invention shown in FIGS. 9-14, controlled by relative lengthwise movement of a shielded, flexible control cable 128 which is led from the valve 126 through a portion of the handlebar 30 to a control lever 130 and bracket 132 on the upper portion of handlebar 30° By activation of the control lever 130 on the handlebar 30, the user of the treadmill has available the means by which to permit manual change the incline of the tread belt 10. This is done by moving the lever 130 to open the valve mechanism controlled by the valve actuator 126, whereupon gas in the cylinder 120 is free to be moved to either lengthen or shorten the piston rod 124 relative to the cylinder 120. This is done by the user shifting his or her weight forwardly or rearwardly on the tread belt 10 to the point where the treadmill frame moves pivotally and a desired angle of incline is reached, whereupon the user shifts the control lever 130 and consequently the valve actuator 126 close the internal valve in the cylinder 120 to maintain the then existing length of the piston rod 124 in the cylinder 120 and the then existing incline attitude of the pivot arms 60, 62 and thus the then existing angle of incline of the tread belt 10. As earlier indicated, the change in incline by use of a gas cylinder and the manual change of position of the user on the tread belt is a relatively simple mechanism for the purpose. However, being manual, it does not have the advantage of an electric motor drive such as the electric motor driven incline drive mechanism of the first embodiment, for incline adjustment, which can be pre-programmed to automatically vary the tread belt incline at desired intervals. From the foregoing, these and other adaptations, variations and modifications of the mechanisms and component arrangements shown and discussed will occur to those skilled in the art to which the invention is addressed, within the scope of the following claims.

Exercise treadmills with stationary, forwardly placed supporting surface engaging foot means of fixed form and with rearwardly placed supporting surface engaging support means which are movable relative to the frame of the treadmill to change the angular relation of the frame and the treadmill tread belt relative to the supporting surface. The change in incline of the treadmill tread belt is by either electrical power means involving an extensible jack mechanism or by manually operable means including a gas cylinder with an extensible piston rod movable by gas flow within the cylinder which is in turn controlled by manually operable valve means. When gas can flow within the cylinder, change in incline of the treadmill tread belt is accomplished by the treadmill user moving relatively forwardly or rearwardly on the treadmill belt.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to medical procedures and equipment, and particularly to a pneumatic system for intussusception treatment (the correction of an everted portion of the intestine) that incorporates various pneumatic and computerized components and controls for optimum safety and efficiency. 2. Description of the Related Art Intussusception is a condition in which a portion of the intestine becomes everted, causing one segment of the bowel to invaginate into a neighboring section so that the bowel commonly appears to have overlapping telescoping sections. The condition is somewhat similar to the telescoping of a larger diameter tube over a tube of smaller diameter. While intussusception is not immediately life threatening, it can be an extremely serious and likely fatal condition if it is left untreated for as little as a few days. This is due to the potential reduction in blood supply to a portion of the affected bowel and resulting necrosis of the tissue, possible bowel perforation or bowel obstruction, and other complications. Intussusception is not common in adults, but is frequently seen in children. Accordingly, a number of intussusception treatments have been developed in the past. Earlier developed treatments involved invasive surgery to pull the everted portion of the intestine from the normal portion. Later laparoscopic techniques have been developed to accomplish the same goal. Even more recently, the condition has been treated by pressurizing the interior of the intestine using a relatively slight pressure increase over ambient, e.g., 120 mm of mercury (about 2.32 pounds per square inch), using either hydraulic (salt water) or pneumatic (air or other gas) media. The object is not only to expand the intestine diametrically (this is a side effect), but also to cause the intestine to expand its volume by extending longitudinally in the area of the intussusception, thereby causing the everted portion of the intestine to extend from the normal portion to return to a normal condition. The procedure is frequently called an “air enema,” and is often performed using a sphygmomanometer attached to a Foley catheter. The results are frequently assessed by ultrasonography, by fluoroscopy, or other radiographic technique. The air enema is quicker than a liquid enema, less messy, and safer if the bowel is perforated. However, current apparatus for delivering an air enema is generally ad hoc, has insufficient safety measures, and relies upon subjective judgments to determine when the intussusception has been released due to the difficulty of continuous monitoring by sonographic and radiographic techniques. Thus, a pneumatic system for intussusception treatment solving the aforementioned problems is desired. SUMMARY OF THE INVENTION The pneumatic system for intussusception treatment, i.e., the invagination of a segment of the intestine into an adjacent segment, comprises a supply of pressurized gas (air, carbon dioxide, etc.) connected to a series of filters, valves, regulators, and sensors that are, in turn, connected to a rectal insertion tube to introduce gas at moderate pressure into the intestine of the patient being treated for the condition. The system further includes a computerized control and monitoring subsystem to allow the doctor or medical professional to monitor and adjust the various pressure parameters as desired during the treatment. The system preferably includes a heating system to warm the gas media to normal body temperature, i.e., 37° C. or 98.6° F. The system also preferably includes an exhaust portion to relieve internal intestinal pressure according to the treatment regimen. The exhaust portion of the system preferably includes a filter of activated charcoal or other suitable media to absorb undesirable fecal odors that accompany the exhausted gas. At least the rectal insertion tube and the odor filter may be separable from the remainder of the system for convenient disposal after a single use. The computerized subsystem preferably includes audial and/or visual alarm to alert the doctor or medical professional of conditions other than normal. The pneumatic system may further include a fast acting valve (e.g., solenoid valve, etc.) to produce rapid pressure pulses to produce the desired result if and when such a procedure is deemed desirable by the doctor or medical professional administering the treatment. These and other features of the present invention will become readily apparent upon further review of the following specification and drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic illustration of a pneumatic system for intussusception treatment according to the present invention, showing the various pneumatic and electronic components of the system. FIG. 2 is a chart showing the relationship between gas pressure and internal volume in the intestine during the operation of the pneumatic system for intussusception treatment according to the present invention. FIG. 3 is a graph of the variation of pressure and volume in the intestine when rapid changes in pressure are used to correct the problem, i.e., a “hammering” mode of operation of the pneumatic system for intussusception treatment according to the present invention. Similar reference characters denote corresponding features consistently throughout the attached drawings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The pneumatic system for intussusception treatment provides a non-invasive system for correcting an intussusception disorder, i.e., the invagination of a segment of the intestine into an adjacent segment with accompanying telescoping of the segments. The system is purely pneumatic, and uses no hydraulic fluid. A computerized control and monitoring system is provided with the pneumatic system. FIG. 1 of the drawings is a schematic view of the combined pneumatic system and computerized control system, generally indicated by the reference numeral 10 . The basic system 10 includes a gas supply 12 , e.g., a tank of compressed air, carbon dioxide, or other gas. Gas flow is from this gas supply 12 to the left side of FIG. 1 , through the various components to the patient P to the right side of FIG. 1 . The gas of the gas supply is a non-toxic element, compound, or mixture, and is non-flammable. The gas may be provided under significant pressure, if desired as the system 10 includes one or more pressure regulators therein, as described further below. The gas may be contained in a pressurized tank or other container, or may be provided by a compressor. The gas supply 12 is connected to the inlet end 14 of a gas supply tube 16 via a disconnect fitting 18 (which may be a conventional quick connect pneumatic fitting), permitting the gas supply 12 to be readily connected to and disconnected from the gas supply tube 16 . An inlet filter 20 is preferably installed along the gas supply tube 16 immediately downstream of the inlet end 14 thereof. A first or primary valve 22 , e.g., a solenoid or other suitable shutoff valve, is provided downstream of the inlet filter 20 . The valve 22 is normally closed when the system 10 is not in operation, and opens to allow gas to flow from the gas supply 12 through the supply tube 16 during operation of the system. The valve 22 is controlled by a computerized control system comprising a central processing unit (CPU) 24 and interface 26 (e.g., opto-isolators for interfacing high current devices), shown schematically in FIG. 1 . A pressure sensor 28 is installed in the gas supply tube 16 immediately downstream of the primary shutoff valve 22 . This sensor 28 communicates electronically with the interface 26 , and thus with the CPU 24 . The sensor 28 determines the gas pressure developed in the gas supply line 16 by the gas supply 12 , and signals the CPU 24 accordingly as described above. The gas then flows to an automatic pressure regulator 30 installed inline along the gas supply line or tube 16 downstream from the pressure sensor 28 . The pressure regulator 30 is set to a predetermined output pressure either manually or under electronic control by the CPU 24 , and automatically regulates or modulates the output pressure to the set predetermined output pressure. The regulator 30 reduces the gas pressure in the supply tube 16 to an output of about 120 mm of mercury, or about 2.32 pounds per square inch, above ambient. This pressure is sufficient to produce the desired result in most cases without danger of rupturing the intestine or causing other damage. The components of the system upstream from the pressure regulator 30 may be referred to as the high pressure side of the system 10 , and the components downstream of the pressure regulator 30 may be referred to as the low pressure side of the system 10 . The output pressure of the regulator 30 is monitored by a second pressure sensor 32 downstream of the regulator. This second pressure sensor 32 communicates with the CPU 24 through the interface 26 to confirm that the proper output pressure is being provided from the regulator 30 . In the event that the regulator 30 fails to reduce the pressure sufficiently, or fails in some other manner, the CPU 24 will provide a signal through the interface 26 to close the first shutoff valve 22 (and/or other valves in the system, described further below) and will send an alarm to an audible alarm 34 and/or visual alarm 36 (either or both may be provided with the system 10 ). It is preferred that the gas used in the intussusception treatment be warmed to at least approximately normal body temperature in order to avoid lowering the internal body temperature of the patient and to preclude excessive expansion of the gas due to the body of the patient warming the gas during treatment. Accordingly, a heater 38 is installed along the gas supply tube or line 16 at some point, e.g., downstream of the pressure regulator 30 and pressure sensor 32 . The heater 38 is preferably adjusted or set to warm the gas in the supply tube 16 to a temperature of 37° C. or 98.6° F., i.e., normal human body temperature. The output temperature of the heater 38 is preferably adjustable for other temperatures, if desired. A thermostat or temperature sensor and/or controller 40 , preferably a closed loop control system using a proportional-integral-derivative (PID) controller) is installed in the gas supply tube or line 16 immediately adjacent to the output end or side of the heater 38 . The thermostat or controller 40 communicates with the CPU 24 through the interface 26 , and also controls the heater 38 . The CPU 24 may be set to send an alarm signal to either or both of the alarms 34 and/or 36 in the event that the temperature output of the heater 38 becomes either too high or too low. The gas, now warmed and at appropriate pressure, then flows from the heater 38 and thermostat 40 through a relief valve 42 . This relief valve 42 functions as a redundant, secondary mechanical safety valve in the event that the pressure output from the regulator 30 exceeds the predetermined maximum and the automated shutdown and release systems fail to function for some reason. The relief valve 42 automatically vents all pressure in the gas supply tube 16 to ambient, in the event of excessive pressure, i.e., that the pressure exceeds 120 mm Hg. As this valve 42 is a mechanical device, it does not necessarily communicate electronically with the CPU 24 and/or interface 26 , although it could be connected through the interface 26 and CPU 24 to provide an alarm in the event that it opens. The warmed and pressure-regulated gas then flows from the outlet side of the relief valve 42 to a mass flow controller 44 , which regulates the flow rate of the air or other gas flowing through the supply tube or line 16 . The mass flow controller 44 communicates with and is controlled by the CPU 24 through the interface 26 . The operator of the system adjusts the gas flow through the mass flow controller 44 as desired by means of the computerized control system. The system 10 may include a fast acting valve 46 (e.g., solenoid valve or other suitable valve type) installed in line downstream of the mass flow controller 44 . This fast acting valve 46 communicates with the CPU 24 through the interface 26 and functions to rapidly change the pressure downstream from the valve 46 . The purpose of this function is explained further below. A pressure sensor 48 is installed in the gas supply tube or line 16 downstream from the fast acting valve 46 . The sensor 48 also communicates with the CPU 24 through the interface 26 . Control of the fast acting valve 46 by the CPU 24 is in accordance with pressure signals provided from the sensor 48 . A flow meter 50 is installed downstream of the fast acting valve 46 and the pressure sensor 48 . The flow meter 50 and the pressure sensor 48 provide the operator of the system with real time information (by means of the CPU 24 ) regarding both the pressure and gas volume measured at the patient P side of the system, the information being displayed graphically on the monitor 66 . A rectal insertion tube 54 is releasably connected to the outlet end 52 of the gas supply tube 16 by an appropriate disconnect fitting 56 , which may be similar to the disconnect fitting 18 used to connect the inlet end 14 of the tube 16 to the gas supply 12 . The rectal insertion tube 54 is preferably a disposable unit, i.e., configured for single use, although it may be formed of material providing for sterilization and reuse, if desired. A Tee-fitting 58 is installed in the gas supply tube or line 16 between the flowmeter 50 and the outlet end 52 of the gas supply tube. An exhaust gas tube 60 is releasably attached to the stem of the Tee-fitting 58 , and another shutoff valve 62 is installed along the exhaust gas tube 60 . The shutoff valve 62 is normally closed during operation of the system 10 , in order to maintain the desired pressure and/or flow of gas into the intestine of the patient P by means of the rectal insertion tube 54 . The valve 62 is preferably a pinch-type valve, in which a flexible tube or line extends completely through the valve body and is pinched off by a solenoid or other mechanism for closure. This permits the entire exhaust gas tube 60 that passes through the valve 62 to be disposed of after a single use, if desired. The valve 62 communicates electronically with the CPU 24 through the user interface 26 . The valve 62 opens and closes on demand in accordance with commands sent from the CPU 24 to control 62 , and vary the pressure developed within the system 10 as it is provided to the patient P. The exhaust gas tube 60 allows excessive gas pressure to be vented from the outlet portion of the system 10 , including the mildly pressurized gas that is delivered into the intestine of the patient P. This gas will of course pick up and absorb unpleasant odors that are a normal byproduct of metabolism. Accordingly, an odor filter 64 is installed in line along the exhaust gas tube 60 , downstream of the valve 62 and preferably at or adjacent to the outlet end of the exhaust gas tube. The odor filter 64 is preferably an activated charcoal filter, but may be of any suitable type, so long as it does not significantly restrict the gas flow therethrough when the valve 62 is open. The system 10 is controlled by a human operator through the CPU 24 by means of a visual monitor 66 , keyboard or keypad 68 , and/or computer mouse 70 . The monitor 66 may be a conventional touch screen device, and need not be a full size desktop monitor. A laptop or tablet computer or the like having a suitable monitor may be used. Electrical power for the system and its computerized controls and peripherals is provided by a conventional electrical power supply 72 , e.g., from the power grid or other suitable source. The pneumatic system 10 is operated by initializing power to the computer CPU 24 , which provides power to the various valves, controls, heater, etc. of the system through the interface 26 . The first solenoid valve 22 in the system is normally closed at this point, with no gas flowing through the supply tube or line 16 . The parameters desired (e.g., initial gas flow, maximum pressure, rate of pressure rise, temperature, etc.) are entered into the system by means of the computer 24 and its peripherals. The computer 24 stores these parameters until altered or adjusted by the operator. The system 10 remains in standby mode at this point, i.e., the first solenoid valve 22 remains closed until the system 10 has run its initialization routine and checked the various components for readiness, and until the heater 38 has reached the desired operating temperature. Readiness of the system is indicated on the monitor 66 . At this point, the patient is readied for the procedure (if not previously accomplished), and the rectal insertion tube 54 is inserted into the patient P. The system 10 is then activated and monitored by the operator. The first valve 22 opens at this point, the remaining valves, sensors, controllers, etc. operating in accordance with the programming of the computer 24 and any changes that might be made by the operator during the procedure. The shutoff valve 62 in the exhaust gas tube or line 60 remains closed. The increase in gas pressure within the intestine results in the expansion of the intestine as its internal volume increases. While this causes the diameter of the intestine to increase, it also produces longitudinal pressure along the intestine that results in the release of the intussusception as the intestine expands longitudinally to remove the invaginated section. It will be seen that the volume of the intestine increases proportionally as the internal gas pressure increases, generally in accordance with the graph of FIG. 2 . The volume increase ΔV is initially relatively rapid with the increase in pressure ΔP. The volume increase ΔV eventually decreases with additional pressure increase, since the compliance of the distended intestine decreases. The gas volume is calculated by integrating the flow rate f, as measured by the flow meter 50 , in accordance with the integral V=∫ t0 t1 fdt. The pressure and volume of gas in the intestine is monitored respectively by the pressure sensor 48 and the flowmeter 50 and transmitted to the computer 24 for monitoring by the operator. A sudden increase in compliance, i.e., a sudden increase in flow measured by the flow meter 50 with either no change or a decrease in pressure measured by the pressure sensor 48 , indicates the intussusception has been released. A sudden increase in flow measured by the flow meter 50 accompanied by an increase in pressure measured by the pressure sensor 48 may indicate a leak in the intestine. As these two components 48 and 50 communicate with the computer or CPU 24 , the monitor graphically displays the pressure, the flow rate, and the volume so that the operator may observe such a sudden change in pressure and volume. In addition, the CPU continuously executes a signal processing algorithm to evaluate the instantaneous pressure signals from the pressure sensor 48 and flow readings from the flow meter 50 according to the relationship described in the preceding paragraphs and automatically alerts the operator that the intussusception has been released or that a leak has occurred, either by visual message displayed on the monitor and/or by audio alert. The system 10 enables the operator to perform additional procedures in the event that the intussusception is not released by the introduction of steadily increasing pressure and volume into the intestine. The operator may direct the system 10 to perform what may be called a “hammer” mode, in which the gas pressure and volume are varied rapidly to pulse compressed air into the intestine. This is accomplished by adjusting the mass flow controller 44 to allow maximum flow and alternately opening and closing the fast acting valve 46 and the pinch valve 62 of the system, i.e., when the fast acting valve 46 is opened the pinch valve 62 is closed to apply pressure, with the fast acting valve 46 then closing and the pinch valve 62 opening to relieve the pressure. FIG. 3 of the drawings illustrates a graph showing the rapid variation in both volume (on the lower scale V) and pressure (on the upper scale) over a short span of time. It will be seen that as the pressure increases, as shown by the series of four “sawtooth” pulses P 1 through P 4 along the upper pressure scale P, the volume increases correspondingly, as shown by the series of volume pulses V 1 through V 4 along the lower volume scale V. The intestinal volume drops to a constant level between each expansion, as the pressure drops due to the opening of the fast acting valve 46 . The graph of FIG. 3 indicates that the intestinal volume increases to a maximum level during each of the first three volume pulses or increases V 1 through V 3 . However, the final volume pulse or increase V 4 is somewhat larger than the previous pulses V 1 through V 3 . The only way that this can occur is if the internal volume of the intestine suddenly expands due to the release of the intussusception. Accordingly, the final volume pulse V 4 indicates that the intussusception has been released, and no further pressure pulses (and resulting volume increases) are required. The fast acting valve 46 in the gas supply tube or line 16 may then be closed and the shutoff valve 62 in the exhaust gas tube or line 60 opened to relieve all pressure within the intestine of the patient P. The intestinal gas then flows outward through the exhaust gas tube or line 60 and out the odor filter 64 . The preferably single use, disposable elements of the system 10 , i.e., at least the rectal insertion tube 54 , the exhaust gas tube 60 that passes through the pinch valve 62 , and the odor filter 64 may be disposed of once the procedure has been completed as described above. It will be understood that, in use, the system 10 may be used in a single stage approach, setting the output pressure to 120 mm Hg to see if the intussusception can be released by pneumatic treatment. Alternatively, the system 10 may be used in multiple steps, e.g., beginning by setting the output pressure at 60 mm Hg, releasing the gas from the patient's intestine if the intussusception has not been corrected, then increasing the output pressure in 20 mm Hg steps up to 120 mm Hg, so that the intussusception may be corrected using the least amount of pressure required. If the intussusception cannot be released at 120 mm Hg, even with pulsed compressed air in the hammer mode, then surgical invention may be required. It is to be understood that the present invention is not limited to the embodiments described above, but encompasses any and all embodiments within the scope of the following claims.

The pneumatic system for intussusception treatment, i.e., invagination of a segment of the intestine into an adjacent segment, includes a pressurized gas supply connected to a series of filters, valves, regulators, and sensors connected to a rectal insertion tube to introduce gas at moderate pressure into the intestine of the patient. A computerized control and monitoring subsystem is included. The system preferably includes a heating system to warm the gas as desired. The system also preferably includes an exhaust portion to relieve internal intestinal pressure as required or desired. The exhaust portion of the system preferably includes a filter to absorb undesirable fecal odors that accompany the exhausted gas. At least the rectal insertion tube and the odor filter may be separable from the remainder of the system for convenient disposal. An alarm may be provided to alert the doctor or medical professional of conditions other than normal.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The invention concerns a C-arm apparatus. [0003] 2. Description of the Prior Art [0004] C-arm apparatuses are prevalent today in medical technology. A diagnosis or treatment device is mounted on a C-shaped base body. Due to its shape, the C-arm (and with it the diagnosis or treatment device) can move orbitally around a point of a patient to be examined or treated in order to reach various angle positions between patient and diagnosis or treatment device without having to reposition the patient. [0005] X-ray devices in which an x-ray source is mounted at one end of the C-arm and an x-ray receiver or image intensifier is mounted at the opposite end are prevalent as diagnosis apparatuses. Such an x-ray C-arm exhibits a not-insignificant dead weight. [0006] If it is ensured in a C-arm apparatus that, given orbital travel, the diagnosis or treatment device is aligned on the same point at every angle position, this is known as an isocentric C-arm apparatus. Most notably in x-ray C-arms designed in such a way, in which the central ray of the x-ray system proceeds through the isocenter of the arrangement situated on the orbital axis (rotation axis of the orbital motion), the overall center of gravity of the arrangement naturally lies outside of the isocenter (thus radially removed from the orbital axis) due to the weight ratios. The dead weight of the overall arrangement therefore effects a torque on the C-arm. The center of gravity of the arrangement namely gravitates towards its stable equilibrium position, thus the lowest point below the orbital axis that can be reached via the orbital movement. [0007] Force must thus be applied counter to the intrinsic angular momentum to hold the C-arm in a specific position or given movement. For example, the C-arm must be fixed in a specific position via a suitable braking device at the support device. [0008] However, it is desirable to achieve a weight compensation at the C-arm such that the C-arm is free of force at every travel position, meaning that no torque whatsoever relative to the rotation axis acts on the C-arm. A number of approaches have previously been pursued in order to effect a weight compensation. [0009] A first approach is to place the x-ray source and the image intensifier such that the overall center of gravity of C-arm and x-ray device lies on the rotation axis. Due to the heavy x-ray components, as compensation for the weight of the C-arm these must be further offset towards its ends. The central ray of the x-ray system then no longer proceeds through the isocenter of the arrangement, which requires a continuous re-placement of the patient region or of the entire patient to be treated by movement of the C-arm. [0010] In a second approach the x-ray system is placed such that its central ray passes through the isocenter. Supplementary weights are additionally attached at the C-arm ends in order to again displace the overall center of gravity of the arrangement into the isocenter. However, the heavy supplementary weights significantly increase the total weight of the arrangement and mechanically load the C-arm such that it exhibits an inherent deformation. [0011] A third approach is to act on the C-arm with brakes and an electrical motor drive such that the torque generated by gravity from the center of gravity of the C-arm is compensated by the electrical drive and the brakes. However, it is hereby a disadvantage that the C-arm requires electrical current for movement. Given a power failure a dangerous situation for the patient could occur since, for example, no access space to said patient can be achieved by movement of the C-arm. SUMMARY OF THE INVENTION [0012] An object of the present invention is to provide a C-arm apparatus in which the equilibration is improved. [0013] The object is achieved by a C-arm apparatus, in particular an x-ray C-arm apparatus, with a C-arm that can move around an orbital axis proceeding perpendicular to the C-arm plane. Auxiliary components, in particular an x-ray system including an x-ray source and an image intensifier, are mounted on the C-arm. The overall center of gravity of C-arm and auxiliary components exerts a first torque on the C-arm. The C-arm apparatus includes a compensation device for generation of a second torque that at least partially compensates the first torque. The compensation device includes a counterweight that is displaceably coupled with the C-arm via a gearing arrangement. [0014] Due to the at least partial compensation of the first torque by the second torque, a smaller overall torque generated by gravity acts on the C-arm. Less force is thereby necessary for orbital movement of the C-arm and less retention force via a brake is necessary to secure the C-arm in a specific position. The C-arm is inherently stable (thus weight-compensated) in rotational positions in which first torque and second torque are equal and opposite. For example, a base position can be defined to which the C-arm returns due to gravity as long as no external force is exerted on it, for example with a brake arresting the C-arm is released. If the second torque counteracts the first torque insofar as that the remaining torques are only slight, the C-arm can be effortlessly moved by hand. The contrary torque (second torque) is that generated solely by gravitation acting on the counterweight. No energy feed whatsoever to the C-arm apparatus is thus necessary for the weight compensation. In particular a motor drive for weight compensation at the C-arm is not necessary; the C-arm can thus be moved without power. To increase the operating comfort a motor drive can naturally be provided on the C-arm, such a motor drive, for example, acting on said C-arm in a frictionally-engaged manner but which does not limit the operability of the C-arm given a power failure since it can be brought out of engagement without impairing the movement capability of the C-arm. The compensation device including the counterweight is not mounted on the C-arm itself, which is why the C-arm's own weight is not increased. The masses to be moved given an orbital travel of the C-arm thus remain as small as possible. A wide range of mechanical embodiments in the form of levers, gearings, cable pulls or shafts that allow a transfer or torques are possible for the compensation device or the movement coupling between counterweight and C-arm. [0015] In a preferred embodiment of the invention the counterweight is supported such that it can rotate around a rotation axis so that an angle change at the C-arm effects the same angle change at the counterweight. Due to the orbital path of the overall center of gravity of C-arm and auxiliary components around the orbital axis, the intrinsic angular momentum of the C-arm possesses a torque likewise cosine-dependent on its rotation angle. If the counterweight can likewise rotate around a rotation axis, this thus generates a torque that is likewise cosine-dependent on its rotation angle. If the movement coupling between counterweight and C-arm is not executed in a ratio of 1:1, meaning that an angle change at the C-arm effects the same angle change on the counterweight, the cosine-dependencies of both torques are the same. It can thus be achieved that the second torque exerted on the C-arm is always equal in magnitude to the first in the opposite direction; the C-arm is thus weight compensated in every orbital position, i.e. completely weight compensated. Due to the 1:1 translation no variable lifting arms are necessary for this at the counterweight; the construction is simplified. The C-arm is free of forces at every orbital position. A fixing brake for secure arresting of the C-arm must exert only slight force. A slight friction force (for example in the gearing arrangement) on the C-arm or on the counterweight is sufficient that the C-arm stably remains at each position even without additional braking. [0016] If the counterweight can be moved in the orbital plane (C-arm plane) of the C-arm, a space-saving design of the overall system can be achieved that barely requires an overhang laterally outside of the orbital plane. The mechanical force transfer between the counterweight and C-arm can occur in a simple manner since no angular deflection is required between the movement of the C-arm and that of the counterweight. [0017] In a further embodiment of the invention the C-arm can be moved around an angulation axis intersecting the orbital axis at right angles. Due to its overall center of gravity, a further torque caused by gravity acts on the C-arm relative to the angulation axis via this additional degree of freedom for the C-arm movement and the auxiliary components. This can also be compensated by the compensation device and the counterweight. This causes the C-arm also to be completely weight-compensated with regard to its angulation axis or to return at least in part to a base position with inherent stability, from which base position it can be moved again with a slight displacement force. The angular weight compensation can be achieved by rotation of C-arm and counterweight in the same or opposite direction around the angulation axis. [0018] In addition to the orbital weight compensation, the angular weight compensation is particularly simple to realize when the C-arm is movably supported on a support device that includes the compensation device. If the compensation device is introduced directly onto or into the support device, short paths for force transfer and thus a smaller designed space of the overall system result. Given a design that is rigid relative to the angulation axis, the counterweight is, for example, automatically panned as well when the C-arm is panned. A separate mechanism for the angular weight compensation is still not necessary once. Various degrees, up to the complete weight compensation can be realized by suitable dimensioning of the mass and the movement path of the counterweight or its distances relative to the angular rotation axis and orbital rotation axis. [0019] The support device can include the compensation device with a housing. The compensation device and support device can thus be accommodated in a housing together with the counterweight. A compact C-arm apparatus thus is achieved with a gearing arrangement that is protected from dust, can emit no detritus and allows a simple cleaning and disinfection of the entire C-arm apparatus in a sterile region, for example the treatment room of a hospital. The moving parts of the C-arm are protected from contact via the housing, to the risk of damage to the operating personnel is significantly limited. [0020] The C-arm and counterweight can be coupled via a multi-stage gearwheel gearing arrangement mounted on the support device and including components arranged parallel to the orbital plane. The moment translation between the overall center of gravity and counterweight is 1:1. A gearwheel gearing arrangement is designed mechanically very simple and robust. Via the gearwheels, pinions or other gearing arrangement parts arranged in parallel, a planar design of the gearing arrangement is possible relative to the orbital plane. The 1:1 translation is easily achievable due to the multi-stage nature of the gearwheel gearing arrangement and various increases or decreases of gear ratio, so a degree of freedom with regard to mass and lever arm of the counterweight arises given an at least two-stage gearwheel gearing arrangement. For example, for weight reduction of the overall system the counterweight can thus amount to half of the total mass of C-arm and auxiliary components, but act with a lever arm that is twice as long as the lever arm with which the total mass acts on the orbital axis. The torques also then completely cancel each other. [0021] The gearing arrangement is particularly space-saving the output part of the gearwheel gearing arrangement is an extension arm having an end at which the counterweight is mounted and that exhibits an internal gearing. A nesting of the gearing arrangement and thus the smallest possible design space can be achieved via the internal gearing. Given a level gearing arrangement created by the extension arm, a fine adjustment of the second torque is possible by, for example, a fine adjustment of the length of the extension arm and therewith of the lever arm for the counterweight. The second torque thus can be adjusted such that it is exactly, oppositely equal to the first torque. Should components be exchanged during the lifespan of the C-arm apparatus, the second moment can be adapted to the new weight ratios in the system. [0022] In a further embodiment of the invention, the gearing arrangement and counterweight include a cavity in which is arranged a cable drum for accommodation of a supply cable for the C-arm. The weight compensation and the cabling of the C-arm (thus of all moving parts, connection cables, hoses etc. of the C-arm) are thus inaccessible from the outside. Hooking or twisting of moving parts in the surroundings of the C-arm thus is prevented. The risk of injury by moving parts is minimized for operating personnel. DESCRIPTION OF THE DRAWINGS [0023] FIG. 1 is a side view of an x-ray C-arm with weight compensation in 90° orbital position and 0° angular position. [0024] FIG. 2 is a section through the C-arm from FIG. 1 in the viewing direction of the arrow II. [0025] FIG. 3 is a mass model of the angularly-moved C-arm from FIG. 1 . [0026] FIG. 4 shows the C-arm from FIG. 1 in 0° orbital position in a representation according to FIG. 1 . [0027] FIG. 5 is a mass model of the angularly-moved C-arm from FIG. 4 in a representation according to FIG. 3 . [0028] FIG. 6 shows an alternative embodiment of a support device with a compensation device in a representation according to FIG. 1 . [0029] FIG. 7 is a section through the device from FIG. 6 in the viewing direction of the arrow VII. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0030] FIG. 1 shows an x-ray C-arm apparatus 2 having a C-arm 6 supporting the x-ray system 4 and a support device 8 for the C-arm 6 . The stand of the C-arm apparatus 2 supporting the overall arrangement on an axle 10 is not shown. [0031] The x-ray system 4 has an x-ray source 12 and an x-ray receiver or image intensifier 14 . The central ray 16 of an x-ray cone (not shown) emitted by the x-ray source 12 centrally leaves the x-ray source 12 and centrally strikes the image intensifier 14 . [0032] The C-arm 6 is supported such that it can move orbitally on a roller bearing 18 which is attached in a fixed manner at the support device 8 . The movement direction of the C-arm 6 on the bearing device 8 is represented by the double arrow 20 . Given such a movement C-arm 6 and x-ray system 4 describe orbital movements around an orbital axis 22 perpendicularly piercing the plane of the drawing in FIG. 1 . Orbital axis 22 and central ray 16 intersect in the isocenter 24 . In FIG. 1 the C-arm 6 is situated in the 90° position, meaning that the central ray 16 encompasses an angle 28 of 90° with an angulation axis 26 running horizontally and passing centrally through the bearing axle 10 . Given travel in the direction 20 the C-arm 6 slides along on the rollers 32 of the roller bearing 18 on an orbital contact surface 30 attached to the C-arm 6 . [0033] In addition to the orbital movement of the C-arm 6 relative to the support device 8 , C-arm 6 , bearing device 8 and the axle 10 attached thereon can be panned around the angulation axis 26 in the direction of the arrow 36 in a journal bearing belonging to the stand (not shown) of the C-arm apparatus 2 . In any orbital and angular panning position of the C-arm apparatus 2 , orbital axis 22 and central ray 16 intersect at right angles and penetrate the isocenter 24 (which is stationary) as long as the stand foot of the C-arm 2 is stationary. [0034] The total mass of C-arm 6 and x-ray system 4 at its overall center of gravity 38 is symbolically represented as a virtual total mass 40 with mass M. The force of gravity 42 acting on the total mass 40 effects a torque 46 on the C-arm 6 relative to the orbital axis 22 via the virtual lever arm 44 of the length L extending from the isocenter 24 to the overall center of gravity 38 . The torque 46 in FIG. 1 is T=M·L. If the C-arm 6 is orbitally panned from the position shown in FIG. 1 , the torque cosinusoidally decreases with the corresponding rotation angle since the force of gravity 42 no longer acts at a right angle to the lever arm 44 . [0035] A compensation device 9 is comprised in the support device 8 (see also FIG. 2 in this regard). The compensation device 9 has a gearwheel 48 , two parallel extension arms 50 and a counterweight 52 connecting the extension arms 50 at the ends in a U-shape. The gearwheel 48 has a shaft 54 supported on the housing 56 of the support device 8 , a crown gear 58 centrally attached on the shaft 54 and two pinions 60 attached near the shaft ends. The teeth (situated radially outwards) of the crown gear 58 engage teeth 104 permanently attached on the contact surface 30 . The extension arms 50 with their ends situated opposite the counterweight 52 are fastened on shafts 62 parallel to the shaft 54 and orbital axis 22 , which shafts 62 are supported on the housing 56 such that they can rotate. C-shaped recesses 64 are present near the shafts 62 and concentric to these. The radially outer edges of the recess 64 are provided with inner gearings 66 in which the pinions 60 engage. The counterweight 52 exhibiting the mass 2M is fastened on the free ends of the extension arms 50 . The virtual lever arm 68 of the counterweight 52 amounts to L/2 relative to the shafts 62 , such that via the force of gravity 74 this generates a torque 76 of T=2M·L/2=M·L which is equal in magnitude to the torque acting on the C-arm and exhibits the identical cosine dependency of the rotation angle. [0036] By the movement coupling between teeth 104 , crown gear 58 , pinion 60 , inner teeth 66 and extension arm 50 , an orbital travel of the C-arm 6 in the direction 20 effects an orbital panning of the counterweight 52 around the shaft 62 in the direction of the arrow 69 . The gearing is selected such that an angle change of the angle 28 effects the same (according to amount) angle change of the angle 70 between center longitudinal axis of the extension arms 50 and the perpendicular 72 . Moreover, in FIG. 1 the gearing arrangement (thus the compensation device 9 ) is adjusted such that a 90° position of the angle 28 corresponds to a 90° position of the angle 70 . [0037] Without application of a counterforce, i.e., without the compensation device 9 coupled to the gearing 104 , due to gravity the C-arm 6 would slide downwards in the direction of the arrow 49 into the support device 8 until the angle 28 is 0° and the overall center of gravity 38 finds a stable equilibrium position below the isocenter 24 in the direction of gravity. [0038] Relative to the orbital axis 22 , the compensation device generates the equal and opposite torque on the C-arm 6 . The torque 76 is transferred to the gearwheel 56 via the inner teeth 66 and the pinion 60 and via this gearwheel 56 to the C-arm 6 via the teeth 104 of the contact surface 30 and thus counteracts the torque 46 . In FIG. 1 the dimensions of the gear components are matched to one another such that this translation from torque 76 to torque 46 amounts to one to one. The two torques are equal and opposite and, in fact for each movement angle of the C-arm 6 cancel to zero on the orbital axis 22 . The C-arm 6 is thus completely weight-compensated with regard to the orbital movement 20 and remains free of torque at every rotation position. [0039] All components of the support device 8 and of the compensation device 9 of course have mass. If one excludes the counterweight 52 (strictly speaking together with the likewise movable extension arms 50 which also alter the center of gravity upon movement—for simplicity in the following only the counterweight 52 is discussed) from this consideration, support device 8 and compensation device 9 together have a virtual total mass 78 at the overall center of gravity 80 . Since the support device 8 and compensation device 9 can be moved synchronously with the C-arm 6 around the angulation axis 26 , the total mass 78 effects a torque around the angulation axis 26 , the virtual lever arm 86 being the radial distance of the overall center of gravity 80 from the angulation axis 26 . [0040] FIG. 2 shows the C-arm apparatus 2 from FIG. 1 in the direction of the arrow II in the section at the level of the shaft 62 . The C-arm 6 exhibits an approximately semi-circular hollow section cavity, whereby its wall 100 flattens on the side facing the bearing device 8 and is recessed in a central region 102 . There the wall 100 is directed towards the inside of the C-arm 6 and forms the contact surface 30 on which the rollers 32 borne on the housing 56 run. The teeth 104 in which the teeth of the crown gear 58 engage are centrally affixed on the contact surface 30 . The crown gear 58 is mounted in a fixed manner on the shaft 54 together with the pinions 60 , whereby the shaft 54 is supported at one end in the housing 56 such that it can rotate. The extension arms 50 supporting the counterweight 52 are likewise supported in the housing 56 via the shafts 62 such that they can rotate. The inner gearing 66 on the recess 64 engages both pinions 60 . In the housing 56 a receptacle 106 for rotatable bearing of the bearing axle 10 (not shown in FIG. 2 ) is provided at the end of the bearing device 8 situated opposite the C-arm 8 . [0041] The crown gear 58 runs approximately centrally in the housing 56 , whereby the extension arms 50 and pinions 60 are situated near the inner border of the housing 56 . Free spaces 108 thus arise for acceptance of additional components (not shown) of the C-arm apparatus 2 such as cable guides, drive motors or the like. The mechanically-stable connection between the extension arms 50 is achieved via the counterweight 52 . A cover plate 110 seals the inner chamber of the housing 56 from the receptacle 106 . [0042] FIG. 3 shows the plan view of the mass and lever ratios of the C-arm apparatus 2 from FIG. 1 in the direction of the arrow III. However, the C-arm in the shown 90° orbital position is additionally angularly tilted by approximately 45° relative to the perpendicular 72 in the counter-clockwise direction around the angulation axis 26 . [0043] FIG. 3 is a schematic drawing in which the entire arrangement of the counterweight 52 is shown as a single real component. All other real components of the C-arm 6 and of the x-ray system 4 are represented by their virtual total mass 40 . All real components of the support device 8 and of the compensation device 9 with the exception of the counterweight 52 are represented by their virtual total mass 78 . [0044] Due to the angular tilting orbital axis 22 and central ray 16 are likewise tilted by approximately 45° relative to FIG. 1 . The angulation axis 26 furthermore runs horizontal and perpendicularly penetrates the plane of the drawing in FIG. 2 . Orbital axis 22 , central ray 16 and angulation axis 26 furthermore intersect in the isocenter 24 . [0045] In the orbital 90° position of the C-arm 6 , the total mass 40 with its overall center of gravity 38 lies on the angulation axis 26 and exerts no torque relative to this. Angular torques are generated only by the gravitational forces 84 and 74 acting on the total mass 78 and on the counterweight 52 with the lever arms 86 and 88 with regard to the angulation axis 26 . The lever arm 88 is hereby the radial distance of the center of gravity 53 of the counterweight 52 from the angulation axis 26 (which, due to the 90° position (angle 70 ) of the counterweight here corresponds to the distance of the shaft 62 from the angulation axis 26 ). The lever arm 86 is the radial distance of the overall center of gravity 80 from the angulation axis 26 . [0046] For the following torque consideration, the cosine dependency of the torques on the angulation angle (which here is always the same for all considered values) is omitted for simplicity. [0047] Due to the size of the total mass 78 of M/2 and the lever arm 86 of the length H, the total mass 78 effects a torque T=M/2·H=M·H/2. The lever arm 88 is therefore dimensioned at H/4. The counterweight 52 thus generates a torque T=2M·H/4=M·H/2 and compensates so the torque of the total mass 78 amounts to zero. All torques with regard to the angulation axis 26 are thus compensated and the C-arm apparatus 2 is also weight-compensated with regard to this axis. It remains free of forces at every arbitrary angulation position. [0048] FIG. 4 shows the C-arm apparatus 2 from FIG. 1 with C-arm 6 panned downwards by 90°, thus in the 0° position. The central ray 16 then coincides with the angulation axis 26 so that the angle 28 amounts to 0°. The overall center of gravity 38 is located in the direction of gravity, thus vertically below the isocenter 24 , which is why the C-arm 6 also assumes a stable equilibrium position without contrary torque. The compensation device 8 likewise exerts no torque on the C-arm 6 . The counterweight 52 is namely located in an unstable equilibrium position relative to the shaft 62 , meaning the angle 70 amounts to 180° relative to the perpendicular 72 . The extension arms 50 are thus pivoted upwards by 90° relative to FIG. 1 . [0049] The extension arm 50 is for the most part executed massively and possesses a not-insignificant weight which is likewise to be taken into account as a compensation mass for the weight compensation. Strictly speaking, as already mentioned above the extension arm 50 thus counts towards the total weight 52 given weight considerations. The remaining gearing arrangement parts are designed such that the position of the overall center of gravity 80 does not change in relation to FIG. 1 given their movement since the counterweight 52 (together with the extension arm 50 ) is itself excluded from this consideration. [0050] Given movement of the C-arm 6 from the position according to FIG. 1 into the position according to FIG. 4 , the C-arm 6 performs a 90° pan. Due to the engagement of the gearing 104 in the crown gear 58 , the gearwheel 4 hereby performs approximately one and a half rotations in the direction of the arrow 90 due to the gearing arrangement ratio between the two effective radii of the gearings (radial distance of the gearing 104 from the orbital axis 22 at the diameter of the crown gear 58 ). The pinion 60 passes through the same angle change as the crown gear 58 . Due to the interaction of the pinion 60 with the inner gearing 66 and the gear reduction associated with this (diameter of the pinion 60 at radial distance of the inner gearing 66 from the shaft 62 ), the extension arm 50 passes through the same 90° angle change as the C-arm 6 , meaning that the overall gearing arrangement ratio of the gearing arrangement is 1:1. At arbitrary intermediate positions between FIG. 3 and FIG. 4 , the cosine dependencies of the torques generated by the total mass 40 and the counterweight 52 are therefore equal, which is why the C-arm 6 is weight-compensated at every arbitrary orbital angle position, even beyond those cases shown in Figures. [0051] FIG. 5 shows the C-arm apparatus 2 from FIG. 3 in the 0° orbital position in the direction of the arrow V, but angularly tilted by approximately 60° in the counter-clockwise direction in contrast to FIG. 3 . As in FIG. 3 (with the exception of the counterweight 52 ), again only the virtual total masses 40 and 78 of the arrangement are shown. The total mass 78 with unchanged distance relative to the angulation axis 26 hereby again generates the same torque T=M/2·H=M·H/2 with the omission of the cosine dependencies. Since the center of gravity 28 now no longer lies on the angulation axis 26 , an additional torque with lever arm 92 also arises relative to the angulation axis 26 due to the total mass 40 . The lever arm 92 corresponds to the radial distance of the center of gravity 38 from the angulation axis 26 , which in the shown example corresponds to equal to the lever arm 44 from FIG. 1 . The additional torque T=M·L herewith arises. T=M·H/2+M·L thus acts relative to the angulation axis 26 due to the masses 78 and 40 . [0052] Since the counterweight 52 is now moved on its extension arm 50 , its lever arm now amounts (relative to the angulation axis 26 ) to the sum of the distance 88 of the shaft 62 from the angulation axis 26 and the lever arm 68 , namely the distance of the counterweight 52 from the shaft 62 . The contrary torque due to the counterweight 52 is accordingly T=2M·(H/4+L/2)=M·H/2+M·L, which precisely corresponds to the sum of the other two torques. [0053] Due to the mass and length ratios in the C-arm apparatus 2 , this is thus completely weight-compensated in every orbital and angular position. [0054] FIG. 6 shows an alternative embodiment for the bearing device 8 with compensation device 9 . Instead of the teeth 104 , a toothed belt 112 is directed on the contact surface 30 of the C-arm 6 . This toothed belt 112 is permanently connected with the C-arm 6 at the end of the C-arm 6 that is not visible in FIG. 6 and lies on the contact surface 30 on nearly the entire C-arm length. Only in a region 116 situated between deflection rollers 114 a and 114 b is the toothed belt 112 directed away from the contact surface 30 . It runs from the deflection roller 114 a over a cable drum 118 a and a deflection roller 114 c back to the deflection roller 114 b on the C-arm 6 . The cable drum 118 a comprises a circumferential-side gearing 120 a in which the toothed belt 112 engages. Two pinions 124 are attached near the shaft ends on a shaft 122 passing through the cable drum 118 a and borne on the housing 56 . These pinions 124 respectively engage in the gearing of two crown gears 128 born on a shaft 126 near the shaft ends. Another extension arm 132 that supports a counterweight 130 on its free end is attached at one end to the shaft 126 . [0055] Feed lines (not shown) are wound on the cable drums 118 b , which feed lines lead from the cable drum 118 a along the C-arm 6 to the image intensifier 14 (not visible in FIG. 6 ) and from the cable drum 118 b to the x-ray source 12 (not visible). [0056] Given an orbital travel of the C-arm 6 on the support device 8 in the direction of the arrow 49 , the toothed belt 112 is directed over the roller arrangement described above in the direction of the arrow 134 and hereby displaces the cable drum 118 a into rotation in the direction of the arrow 136 . The cable drum 119 a winds the feed cable approaching from the image intensifier 14 in the direction 49 . The roller 118 a displaces the cable drum 118 into rotation in the direction 138 , which in turn unwinds the feed cable (not shown) and releases it in the direction 49 of the x-ray source 12 . Simultaneously with the cable drum 118 b , the cable drum 118 a displaces the gearwheel 128 into motion in the direction 140 via the pinion 124 . The extension arm 132 and the counterweight 130 are hereby simultaneously panned around the axis 126 . [0057] The dimensioning of the mass and lever ratios is executed corresponding to the embodiment according to FIG. 1 through FIG. 5 . Merely altered values of total mass 78 and position of the center of gravity 80 (and therewith of the lever arm 86 ) of the support device 8 and compensation device 9 would lead to a different measurement for the lever arm 88 , thus to a different placement of the shaft 62 . The gearing arrangement ratio of the individual gear speeds is again tuned such that an angle change given orbital travel of the C-arm 6 effects the same angle change of the counterweight 103 . The moment ratios in FIG. 6 thus correspond to those in FIG. 1 . The mass of the counterweight 52 of 2M is merely split up into two partial masses of M each of the two counterweights 130 . [0058] FIG. 7 shows the arrangement from FIG. 6 in the viewing direction of the arrow VII in the section above the shaft 126 . In contrast to the exemplary embodiment according to FIG. 5 , essentially the cable drums 118 a and 118 b are located in the inside 108 of the bearing device 8 . The pinions 124 connected with the cable drum 118 a are mounted on both sides outside of the bearing device 8 , as well as the gearwheels 128 , extension arms 132 and counterweights 130 . The synchronous movement of the counterweights 130 is ensured via the rigid connection through the axis 126 . A disadvantage of the embodiment according to FIG. 1 through FIG. 5 is that the feed lines (not shown) running in part in the surroundings of the C-arm apparatus 2 interfere and are accident-prone since these easily get caught or twist. Instead of panning outside on the C-arm apparatus 2 , the counterweights 130 in the embodiment according to FIG. 6 and FIG. 7 are significantly less disruptive and can, if applicable, be housed in an additional housing (not shown) entirely surrounding the compensation device 9 , whereby a C-arm apparatus 2 entirely closed from the outside results in turn. [0059] Although modifications and changes may be suggested by those skilled in the art, it is the invention of the inventor to embody within the patent warranted heron all changes and modifications as reasonably and properly come within the scope of his contribution to the art.

An x-ray C-arm device has a C-arm rotatable around an orbital axis proceeding perpendicular to the plane of the C-arm. The C-arm carries an x-ray source and a radiation detector, and the overall center of gravity of the C-arm and the components carried thereby exerts a first torque on the C-arm. A counterbalancing device generates a second torque that at least partially compensates the first torque. The counterbalancing device includes a counterweight that is displaceably coupled to the C-arm by a gearing arrangement.

BACKGROUND OF THE INVENTION The present invention relates generally to a support arrangement for supporting an object above ground level and more particularly to a support arrangement which reduces hazards for motorists when used to support objects along a roadside, e.g., mailboxes, signs, markers, etc. The support arrangement includes an above-ground portion rigidly connected to an in-ground portion by a frangible connector assembly. In applications where the above-ground portion includes a generally horizontally extending portion for supporting an object in a cantilevered manner, the horizontally extending portion is formed as part of a moveable portion connected to a generally vertically extending fixed portion by a rotatable connector assembly. There are problems with positioning any structure close to an edge of a roadway. Suburban and rural areas most often have mail delivered to roadside mailboxes which are supported such that the vehicle from which the mail is delivered can simply stop in front of the mailbox where the driver can reach out, open the mailbox and deliver the mail. Signs for advertising including signs for real estate are typically positioned close to the edge of a roadway to attract the attention of passersby. One problem created by mailboxes and signs is the lack of sufficient clearance for graders to reshape and grade the roads and for snowplows to clear the roadways of snow and ice. A more significant problem is the injury that may occur to passengers and damage to vehicles which hit an object and/or the support for the object when the vehicles deviate from the roadway e.g., when they leave the roadway to avoid hitting children, animals, other vehicles, etc. An important problem for property owners is the damage to a roadside support and object which may result due to the exposure to plows, vehicles, vandals, etc. Owners of mailboxes and signs along a roadside typically are less concerned about the hazard their mailbox and/or sign and the support therefor creates for others and since it is not uncommon for a plow or an errant vehicle to hit a roadside mailbox or sign, owners frequently erect supports which are extremely strong and, accordingly, extremely hazardous. The approach taken by many 14 mailbox and/or sign owners is to space the main vertical support away from the edge of the roadway and include an arm extending horizontally toward the roadway with the mailbox or sign mounted thereon. This approach permits a plow to clear a roadway all the 18 way to the edge and yet have a mailbox positioned where the driver of a mail delivery vehicle can reach out and deliver mail to the mailbox and a sign positioned where it is clearly visible to passersby. In these arrangements the vertical support is frequently constructed in a manner providing inordinate strength and the horizontally extending portion can present hazards to the passengers of the vehicle by penetrating the windshield or side windows of the vehicle in an accident. The problem of penetrating the side windows is a result of constructing the support arrangement such that the horizontally extending arm can rotate 360 degrees around the fixed portion of the support. To date there are no universal standards for support arrangements along rural and suburban roadways. Reports verify that mailboxes and their supports are frequently constructed in a manner which are hazardous upon impact to a vehicle and its passengers and it was noted during the development of the instant invention that many roadside signs present hazards to vehicles and their passengers similar to those created by most mailboxes and their supports. Even though federal standards were set years ago for light posts and sign posts along interstate highways, there are still no federal standards for supports for mailboxes along roadways in urban and rural areas. Each state has authority to mandate support requirements for signs along state highways but in many areas there are no regulations or standards. There is a Task Force for Roadside Safety of the Standing Committee on Highways Subcommittee on Design which has been working on standards for erecting mailboxes on highways and a guide has been published by the American Association of State Highway and Transportation Officials which outlines many of the problems and hazards of existing roadside mailbox supports. Until the instant invention there was no single answer to the question of reducing roadside hazards. Prior inventions have attempted to reduce hazards created by roadside mailboxes for passengers and vehicles using a roadway. An example of a repositionable support is depicted in U.S. Pat. No. 4,915,293. There have also been various approaches to providing a mailbox support which will permit the mailbox to swing out of the way if struck by a plow. Examples of such supports are found in the following U.S. Pat. Nos. 3,870,262; 3,881,650; 4,113,213; 4,130,239; and 4,955,533. An example of a support which permits a sign to swing out of the way and return to its original position is depicted in U.S. Pat. No. 3,229,940. Examples of support arrangements designed to absorb energy and/or break away are depicted in U.S. Pat. No. : 4,286,747; 4,759,161; and 4,852,847. These prior art patents along with others found during a novelty search will be listed on a PTO Form 1449 which will be forwarded in accordance with the duty disclose. Accordingly, it is of major concern that millions of mailboxes and signs along rural roads and suburban streets and highways throughout the United States present roadside hazards to motorists. The effort currently underway by the above noted Task Force is to minimize injuries to occupants of motor vehicles which impact roadside mailboxes by establishing standards for mailbox supports. The instant invention is believed to answer the need and set the standards. There is a market, then, for support arrangements, and particularly for support arrangements which are effective for mailboxes, which are capable of permitting the mailbox to swing out of the way of a vehicle impacting thereon, and which will bend and break when struck by a vehicle such that passengers in the vehicle are not imperiled, especially if such a device is simple in construction and easy to use. SUMMARY OF THE INVENTION It is a primary purpose and principle object of the present invention to provide a support arrangement for an object supported above ground level which is safe, effective, simple to use, economical to manufacture and which will rotate away or bend and break away in a manner such that the object and the support arrangement will not come through the windshield or side windows of the vehicle and thereby cause injury to the occupants. The present invention, broadly stated, involves a support arrangement which has a frangible connector between an in-ground portion and an above-ground portion. The above-ground portion can support any type of object, e.g., mailboxes, birdhouses, road signs, real estate signs, etc., and can include a moveable portion connected to a fixed portion by a rotatable connector assembly when a horizontally extending portion is used as a cantilevered support for the object. The rotatable connector assembly permits the object to swing out of the way when impacted, e.g., out of the way if struck by a vehicle or out of the path of snow thrown by a plow. The frangible connector assembly permits the support arrangement to bend and break in controlled manner such that the object is accelerated out of the path of the vehicle. Accordingly, it is also an object of this invention to provide a support arrangement which includes an above-ground portion rigidly attached to an in-ground portion by a frangible connector assembly. It is a further object of this invention to provide a frangible connector assembly which will concentrate stresses created by an impact on an above-ground portion on an in-ground portion and cause bending and breaking in the area of stress concentration. An additional object of the invention is to provide a support arrangement with an above-ground portion which includes a moveable portion attached to a fixed portion by a rotatable connector assembly. Another object of this invention is to provide a rotatable connector assembly between a movable portion and a fixed portion which controls and limits movement of the movable portion. Yet another object of the invention is to provide an extension for said in-ground portion which utilizes a portion of the same cross-sectional dimensions as the in-ground portion and which creates another frangible connector assembly with stress concentrations on said in-ground portion. A further object of this invention is to provide for stable attachment of a mailbox to a horizontally disposed portion and to provide for the attachment of additional objects such as newspaper tubes and signs. These and other objects and advantages of the present invention will be apparent and understood from the following detailed description when taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a support arrangement according to the present invention supporting a mailbox; FIG. 2 is a cross-section view of the support arrangement depicted in FIG. 1 taken along line II--II in FIG. 12; FIG. 3 is a cross-section view of the support arrangement depicted in FIG. 1 taken along line III--III in FIG. 12; FIG. 4 is a cross-section view of the support arrangement depicted in FIG. 1 taken along line IV--IV in FIG. 12; FIG. 5 is a partial view showing an extension used with the support arrangement depicted in FIG. 1; FIG. 6 is a cross-section view of the support arrangement depicted in FIG. 5 taken along line VI--VI in FIG. 5; FIG. 7 is a partial view of the support arrangement shown in FIG. 12 broken away to show detail; FIG. 8 is a partial view showing a pair of newspaper tubes attached to the horizontally extending portion; FIG. 9 is a view similar to FIG. 8 with a sign suspended from the horizontally extending portion; FIG. 10 is an embodiment of the instant invention showing a generally vertically extending support arrangement; FIG. 11 is a partial view showing a bumper of a vehicle impacting the base pipe of the above-ground portion of the support arrangement; FIG. 12 is a side view of the support arrangement shown in FIG. 1 disposed relative to an edge of a roadway; FIG. 13 is a view similar to FIG. 12 with the moveable portion of the support arrangement rotated about seventy degrees; FIG. 14 is a view similar to FIG. 13 with the moveable portion of the support arrangement rotated about one hundred forty degrees; FIG. 15 is a front view of the support arrangement as depicted in FIG. 12; FIG. 16 is a front view of the support arrangement as depicted in FIG. 13; and FIG. 17 is a front view of the support arrangement as depicted in FIG. 14. DETAILED DESCRIPTION OF THE INVENTION A support arrangement 10 supporting an object 12 at a predetermined height above ground level 14, constructed in accordance with the principles of this invention, is described hereinbelow, with reference to the accompanying drawings, wherein like reference numerals are used throughout the various views to designate the same or similar elements or components. Referring now to FIG. 1, support arrangement 10, depicted supporting a mailbox 12M, includes an above-ground portion 16 connected to an in-ground portion 18 by a frangible connector assembly 20. The above-ground portion 16 includes a moveable portion 22 connected to a fixed portion 24 by a rotatable connector assembly 26. The fixed portion 24 includes a middle pipe 28 connected to a base pipe 30 by a yoke clamp assembly 32 and moveable portion 22 includes a top pipe 34 which in turn includes a horizontally extending portion 36. Wood blocks 38 are attached transversely to the horizontally extending portion 36 and mailbox 12M is attached to wood blocks 38 by threaded fasteners (not shown). As best seen in FIG. 2, lower end 40 of base pipe 30 is generally elliptical in cross-section, for reasons which will be discussed in detail later. In-ground portion 18 includes a ground post 44 with an exposed end 42. Lower end 40 of base pipe 30 is laterally encapsulated by exposed end 42 and cap post 46. Cap post 46 secures base pipe 30 to ground post 44 with at least two bolts 48 cooperating with nuts 50. The frangible connector assembly 20, shown in greater detail in FIG. 2, depicts the manner in which the ground post 44 and cap post 46 laterally encapsulate elliptical lower end 40 of the base pipe 30 and how the elliptical lower end 40 is secured relative to the ground post 44 by bolts 48 extending through aligned apertures in the components and drawn tight by nuts 50. As the nuts 50 are tightened, the laterally extending flanges 51 of the cap post and ground post abut one another and cause a slight deformation of the truncated V-shaped cross-sections of the ground post and cap post until six lines of contact 52 exist between the elliptical lower end 40, the ground post 44, and the cap post 46. The six lines of contact appear as points 52 in this cross sectional view, and position of each point is indicated by a +. The lines of contact 52; are generally parallel to the longitudinal axis of ground post 44 and extend the length of the cap post 46. The fact that there are six lines of contact provides greater stability for the above-ground portion and the manner in which this rigid connection is frangible will be discussed later. The clamping assembly 32, shown in greater detail in FIG. 3, has middle pipe 28 telescopically received within base pipe 30 and secured relative thereto by a pair of yoke clamps 54. Each yoke clamp 54 includes a fixed loop 55, which extends loosely around base pipe 30, a bolt 56, and a nut 58 fixed relative to the fixed loop such that the bolt 56 is radially adjustable. Base pipe 30 includes a pair of diametrically opposed apertures 60 near its upper end which permit bolts 56 to pass therethrough where they can engage and secure middle pipe 28 relative to base pipe 30. This arrangement permits adjustment of the height of the horizontally extending portion 36 above ground level and yet will yield to extreme forces by permitting middle pipe 28 to be withdrawn from base pipe 30 when the forces exerted by bolts 56 of the yoke clamps 54 are overcome. The relationship of the components of the rotatable connector assembly 26 are best seen in FIG. 4. Top pipe 34 is telescoped over the upper end of middle pipe 28 and secured relative thereto by a bolt 62 extending into a slot 64 in middle pipe 28. Slot 64 extends transversely of the middle pipe 28 and is disposed proximate to the end thereof. Bolt 62 is preferably self-tapping and threaded relative to top pipe 34 with sufficient length and is sized to extend into the slot 64 so as to slide and be guided thereby. Slot 64 includes a notch 66 centrally disposed along the length thereof for cooperating with bolt 62 to create a centered at-rest position for the horizontally extending portion 36. It has been found that slot 64 can extend more than 270 degrees around the middle pipe 28 and in practice actually extends 281 degrees. Any weakness created in the upper end of middle pipe 28 is compensated for by the strength of top pipe 34 telescoping thereover. In situations where the ground post 44 needs extra length, extension 68, best seen in FIGS. 5 and 6, which can have the same truncated V-shaped cross-sectional dimension as the ground post 44, is secured to ground post 44 and forms another frangible connection therewith. The need for an extension occurs when there is a steep bank along the edge of the roadway and when included provides additional safety by including a second frangible connection. The frangible connection between the ground post and extension is accomplished by nesting the ground post 44 within the extension 68, or vice versa, and including spacers 76 to fill the void between the bight 72 of the truncated V of ground post 44 and the bight 74 of the truncated V of extension 68 and extending a pair of bolts 82 through aligned apertures in the components and securing the bolts with nuts 84. When the ground post and extension are nested, the sides 78 of the truncated V of the ground post 44 contact the sides 80 of the truncated V of the extension 68 thereby cooperating with the bolts 82 to create a rigid connection which is frangible in the same manner as the frangible connector 20, which will be discussed later. Referring now to FIGS. 7, 8, and 9, stability of the transversely extending wood blocks 38 relative to horizontally extending portion 36 can be improved by creating indentations 86 when punching apertures 88 thereby providing a larger surface area against which the wood block is secured. A bolt 90 and a nut 92 are used to secure each wood block 38 by extending the bolt 90 through aligned apertures in the components and fastening with nut 92. The wood blocks 38 provide an excellent source for the attachment of the mailbox 12M and, when desired, newspaper tubes 12N can be attached to the underside thereof. Newspaper tubes 12N are preferably attached to the wood blocks by threaded fasteners (not shown) and the opening for each newspaper tube is set back from the end of the mailbox 12M, but positioned to extend beyond the distal end of horizontally extending portion 36. The support arrangement 10 can support a sign 12A either by rigidly connecting the sign to the fixed portion 24 or the sign can be fixed to or, as depicted, suspended from horizontally extending portion 36. There may be situations where the support arrangement 10 is used to simply support a sign such as a real estate sign or a sign for commercial advertising, however, it is contemplated that the support arrangement may support a mailbox, newspaper tubes, and an sign at the same time. The embodiment of the support arrangement 10 depicted in FIG. 10 is a vertically extending support and, as shown, can support an object such as a bird feeder 12B or a bird house at the upper end thereof. It is also contemplated that a sign or other object may be supported along the length of the support arrangement as well as at the distal end thereof. An important feature of the instant invention is the frangible connector assembly 20, discussed with regards to FIG. 2, and the manner in which the assembly bends and breaks. It should be noted at the outset of this discussion that it has been found that the frangible connector assembly has been found to bend and break in a predictable manner. However, to break in a predictable manner the ground post needs to be disposed relative to the edge of the roadway such that the truncated V-shape opens toward the roadway. In the event of a vehicle impacting the support arrangement 10, best understood by referring to FIG. 11., i.e., when the bumper 94 of the vehicle strikes the bottom pipe 30, there is a concentration of forces in the area generally indicated as 96. When the support arrangement is impacted, the first occurrence is that the base pipe 30 will begin to bend in the area of its attachment to the exposed end 42 of the ground post 44. As the vehicle continues impacting the support arrangement, and the base pipe 30 continues to bend, there is a concentration of greater forces in the area generally indicated at 96 and the ground post 44 will begin to crack and ultimately will break generally along a line extending through the apertures in the ground post through which bolts 48 extend. Accordingly, as the impact occurs and continues, the object supported by the support arrangement and the support arrangement are accelerated in the direction of the impacting forces prior the breakage of the frangible connection. The progression of events is that the support arrangement will be accelerated in front of the vehicle and bend towards the ground prior to the frangible connector assembly 20 breaking, thereby not posing as a hazard to occupants of the vehicle. When properly installed, it is contemplated that after breaking off, all that will remain is a piece of the ground post extending above ground level which is less than four inches in height and the support arrangement and object will have broken off and thrown out of the path of the vehicle. In the event that the frangible connector assembly 20 should fail to break cleanly, i.e. wherein the bottom pipe 30 and exposed upper end 42 may still be connected but where the bottom pipe 30 has assumed a generally horizontal condition and the vehicle is passing over the connector assembly 20, the vehicle will then impact the object with the bottom side of the vehicle thereby causing the middle pipe 28 to be withdrawn from its telescoped relationship with the bottom pipe 30 by forcibly drawing the middle pipe 28 through the clamp assembly 32. In this latter situation the object and support arrangement are below the level of the windows in the vehicle and present a minimal hazard. It should be noted that when an extension 68 is used, the same area of concentration of forces on the exposed upper end of the ground post will be created with the same result. When an object such as a mailbox is supported along a roadway 98 proximate the edge 100 (see FIG. 12) there is the possibility that only the cantilevered object will be impacted and not the support arrangement. The support arrangement of the instant invention has been designed with this possibility in mind and has features which are intended to minimize damage to the mailbox and any hazard to occupants of a vehicle that hits the mailbox. Accordingly, top pipe 34 preferably includes a bend of about 45 degrees and middle pipe 28 includes a bend of about 45 degrees such that horizontally extending portion 36 is disposed generally horizontally proximate the edge of the roadway. The rotatable connector assembly is positioned such that the notch 66 is at the lowest point of an arc scribed by the slot 64, the slot 64 being disposed in the angled portion of middle pipe 28, thereby creating an at-rest position for the horizontally extending portion 36 with an object 12 mounted thereon, as shown in FIGS. 12 and 15 wherein bolt 62 is resting in notch 66. When the horizontally extending portion and/or the object is impacted, e.g. by snow thrown by a plow, by a plow, or by a vehicle, etc., the moveable portion 22 will rotate in the manner depicted in the progressive FIGS. 12-14 and 15-17. FIGS. 13 and 16 show the horizontally extending portion rotated about 70 degrees and FIGS. 14 and 17 show the horizontally extending portion rotated about 140 degrees. In the preferred form, rotation is limited in each direction to about 140 degrees by bolt 62 engaging the end of slot 64, thereby preventing the object from rotating a full 360 degrees and the possibility that the object could impact the side of the vehicle as it passes by. An additional advantage of this arrangement is that the side profile of the object diminishes as rotation occurs thereby limiting the effect of impact by snow. Subsequent to passage of whatever force is impacting the mailbox, the weight of the horizontally extending portion and the mailbox will automatically return the moveable portion 22 to the at-rest position with the bolt 62 resting in the notch 66. The device disclosed herein can be formed from any number of suitable materials and by any number of different processes. It has been found that galvanized steel tube is preferred for the base pipe, middle pipe, and top pipe and that the ground post is preferably of steel. The proper positioning of a mailbox relative to the edge of a roadway is for the in-ground portion 18 to be set back 46 inches, i.e., (distance a), the bottom of the mailbox should be spaced above the surface of the roadway about 45 inches, i.e., (distance b), and the exposed end 42 of the ground post 44 should extend no more than 4 inches above ground level, i.e., (distance c). While this invention has been described with a certain degree if particularity, it should be understood that other forms of support arrangements are contemplated by the present invention and it is manifest that many changes may be made in the details of construction and in the arrangement of components without departing from the spirit and scope of the disclosure. It is understood that the invention is not limited to the embodiment set forth herein for purposes of exemplification, but is limited only by the scope of the attached claims, including the full range of equivalency to which each element is entitled.

A support arrangement for supporting an object above ground level is designed to reduce hazards for passing motorists. The support arrangement includes an above-ground portion rigidly connected to an in-ground portion by a frangible connector assembly. The above-ground portion can include a generally horizontally extending portion for supporting an object in a cantilevered manner. The horizontally extending portion is formed as part of a moveable portion connected to a generally vertically extending fixed portion by a rotatable connector assembly. The support arrangement is designed to bend and break away in a predetermined manner when impacted and, if it does not break, the rotatable connector is designed to permit the moveable portion to be pulled free and thrown clear of the vehicle. If only the cantilevered object is impacted, the object and moveable portion can rotate out of the path of the impacting force. Once the impacting force has passed, the moveable portion will return to an at-rest position.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This continuation application is based upon, and claims the benefit of priority from prior U.S. patent application Ser. No. 10/347,921, filed on Jan. 22, 2003 which claims the benefit of priority from prior Japanese Patent Application No. 2002-013262, filed January 22, 2002. The entire contents of the above-identified applications are incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention relates to a medical image diagnosis apparatus and a display for a use in a medical image diagnosis apparatus, with a plurality of monitors to display medical images. The present invention further relates to a method of arranging such a plurality of monitors. BACKGROUND OF THE INVENTION [0003] Various kinds of medical diagnoses have been realized nowadays by interpreting medical images obtained from medical diagnosis apparatuses, such as, for example, an X-ray diagnosis apparatus, an X-ray CT (computer tomography) apparatus, an MRI (magnetic resonance imaging) apparatus, a nuclear medical diagnosis apparatus, an ultrasound diagnosis apparatus, and an endoscopic image apparatus. In the event that medical images are obtained from such medical diagnosis apparatuses, the obtained images are usually displayed in one or more monitors provided in the vicinity of the medical diagnosis apparatuses. This is, for example, for the purpose of checking the obtained images and seeing whether the images are correctly obtained or it is necessary to acquire substitute image at the same position again. Further, the obtained images are sometimes used for the image interpretation immediately right at the place in case of emergency, for example. [0004] FIG. 1 is a diagram showing a configuration of an X-ray diagnosis apparatus with a display according to a prior art. The X-ray diagnosis apparatus shown in FIG. 1 is a so-called bi-plane apparatus which allows obtaining images from two directions at the same time. The X-ray diagnosis apparatus includes a first imaging system comprising a first X-ray tube 1 a , a first detector 2 a , and a first holder 3 . The X-ray diagnosis apparatus also includes a second imaging system comprising a second X-ray tube 1 b , a second detector 2 b , and a second holder 4 . Additionally, the apparatus includes a bed table 5 , a bed 6 , a display 7 , a display holder 7 a , a display panel 8 , an operation unit 9 , a first rail 10 a , and a second rail 10 b . [0005] The first imaging system is for obtaining X-ray images from a first direction. The first X-ray tube 1 a generates (or radiates) an X-ray which is exposed to a patient to be examined from the first direction. The X-ray exposed to the patient is transmitted through the patient. The detector 2 a detects the transmitted X-ray. The first holder 3 holds the first X-ray tube 1 a and the first detector 2 a by means of an arm connecting the first X-ray tube 1 a and the first detector 2 a . The first holder 3 further drives or moves a set of the first X-ray tube 1 a and the first detector 2 a in three-dimensional directions. [0006] The second imaging system is for obtaining X-ray images from a second direction. The second X-ray tube 1 b generates (or radiates) an X-ray which is exposed to the patient to be examined from the second direction. The X-ray exposed to the patient is transmitted through the patient. The detector 2 b detects the transmitted X-ray. The second holder 4 holds the second X-ray tube 1 b and the second detector 2 b by means of an arm connecting the second X-ray tube 1 b and the second detector 2 b . The second holder 4 further drives or moves a set of the second X-ray tube 1 b and the second detector 2 b in three-dimensional directions. [0007] The patient lies on the bed table 5 The bed 6 has a driving unit which drives and moves the bed table 5 vertically or horizontally. The display 7 comprises a plurality of monitors. In FIG. 1 , the display 7 has four monitors. There are two monitors in the horizontal direction and also two monitors ill the vertical direction Each monitor can be used to display X-ray images obtained in the X-ray diagnosis apparatus. The display 7 is held by the display holder 7 a . The display panel 8 displays several information related to imaging conditions of the X-ray diagnosis apparatus. [0008] The operation unit 9 is used for determining a position of the bed table 5 by providing designation signals to operate the bed 6 . The first rail 10 a is used for running the second holder 4 . The second rail 10 b is used for running the display holder 7 a . [0009] Conventional monitors used for the display 7 are known to include CRT (cathode ray tube) monitors. Therefore, they occupy a wide space in the vicinity of the X-ray diagnosis apparatus. The display 7 can be moved along the second rail 10 b . However, an examination room where the X-ray diagnosis apparatus is usually placed is not so spacious to move away the display 7 . Keeping the display 7 around the bed table 5 limits an area where a radiological technologist moves around the patient. Further, it was also a big annoyance to a doctor when the doctor must examine the patient with, for example, a catheter. [0010] Under such a circumstance, an image display monitor is being improved and newly developed with a LCD (crystal liquid display). An LCD monitor is much thinner and lighter than the CRT display monitor. Accordingly, the conventional CRT display monitors are challenged to be replaced with the LCD monitors. Such replacement can be very helpful to apply to the above-explained case. The replacement may be a solution to the prior art problem and may allow giving the radiological technologist and the doctor much more space [0011] As shown in FIG. 1 , however, the display 7 has four monitors Even if they are replaced with LCD monitors, it is a fact that this number of monitors still occupies a certain space. In practice, these monitors are moved around the bed table 5 in accordance with the manipulation of the doctor, for example. The doctor usually checks an ongoing manipulation status in the monitors. As he changes his position around the bed table 5 (i.e. around the patient) in accordance with his manipulation, the display 7 (or the monitors) must be changed its position so as to allow the doctor to observe images displayed in the display 7 . [0012] Such position changes are sometimes performed across and over the patient The doctor or his aids must be very careful about moving the display 7 over the patient, but, as a matter of fact, it was not easy to do so due to a size of the display comprising four monitors. Particularly, when there are a plurality of monitors in the vertical direction, it is obviously more difficult. The plurality of monitors in the vertical direction may also be a problem when a person, such as the radiological technologist, the doctor, and the aides, are tall enough to bump his or her head against the display. It disturbs their concentration on their work. BRIEF SUMMARY OF THE INVENTION [0013] According to a first aspect of the present invention, there is provided a medical image diagnosis apparatus, which comprises an image generator configured to generate a medical image, a display, comprising a plurality of monitors, configured to display the medical image, and a mechanism configured to change an arrangement of the plurality of monitors with respect to each of the monitors. [0014] According to a second aspect of the present invention, there is provided a display apparatus for a use in a medical image diagnosis apparatus that generates a medical image. The apparatus comprises a plurality of monitors configured to display the medical image, and a mechanism configured to change an arrangement of the plurality of monitors with respect to each of the monitors. [0015] According to a third aspect of the present invention, there is provided a method of arranging a plurality of monitors which display a medical image in a medical image diagnosis apparatus. The method comprises steps of detecting an operation mode of the medical image diagnosis apparatus, and automatically placing at least one of the plurality of monitors, which is not used in the operation mode detected in the detecting step, behind at least one other of the monitors BRIEF DESCRIPTION OF THE DRAWINGS [0016] A more complete appreciation of embodiments of the present invention and many of its attendant advantages will be readily obtained by reference to the following detailed description considered in connection with the accompanying drawings, in which: [0017] FIG. 1 is a diagram showing a configuration of an X-ray apparatus with a display according to the prior art; [0018] FIG. 2 is a diagram showing a configuration of an X-ray diagnosis apparatus with a display in a bi-plane mode according to an embodiment of the present invention; [0019] FIG. 3 is a diagram showing another configuration of an X-ray diagnosis apparatus with a display in a single-plane mode according to an embodiment of the present invention; [0020] FIG. 4 is a diagram showing a configuration of a display according to an embodiment of the present invention; [0021] FIG. 5 is a diagram showing another configuration of the display according to an embodiment of the present invention; [0022] FIG. 6 is a diagram showing a side aspect of the display and its peripherals with monitors placed at an original position according to an embodiment of the present invention; [0023] FIG. 7 is a diagram showing a side aspect of the display and its peripherals with the monitors placed at a folded position according to an embodiment of the present; [0024] FIG. 8 is a diagram showing side aspects of the display when the upper monitor frame 27 c is folded according to an embodiment of the present invention; [0025] FIG. 9 a diagram showing another side aspect of the display and its peripherals with the monitors placed at an original position according to an embodiment of the present invention; [0026] FIG. 10 is a diagram showing a side aspect of the display 27 and its peripherals with the monitors placed at a slid position according to an embodiment of the present invention; [0027] FIG. 11 is a diagram showing side aspects of the display 27 when the upper monitor frame 27 c slides according to an embodiment of the present invention; [0028] FIG. 12 is a diagram showing an alternative example of the sliding according to an embodiment of the present invention; [0029] FIG. 13 is a diagram showing a first arrangement viewed from a front aspect of a display according to an embodiment of the present invention; [0030] FIG. 14 is a diagram showing a second arrangement viewed from the front aspect of the display according to an embodiment of the present invention; [0031] FIG. 15 is a diagram showing a third arrangement viewed from the front aspect of the display according to an embodiment of an present invention; [0032] FIG. 16 is a diagram showing a fourth arrangement viewed from the front aspect of the display according to an embodiment of the present invention; [0033] FIG. 17 is a diagram showing a fifth arrangement viewed from the front aspect of the display according to an embodiment of the present invention; [0034] FIG. 18 is a diagram showing a sixth arrangement viewed from the front aspect of the display according to an embodiment of the present invention; [0035] FIG. 19 is a diagram showing a seventh arrangement viewed from the front aspect of the display according to an embodiment of the present invention; [0036] FIG. 20 is a diagram showing a eighth arrangement viewed from the front aspect of the display according to an embodiment of the present invention; and [0037] FIG. 21 is a diagram showing still another configuration of an X-ray diagnosis apparatus with a display according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0038] Embodiments of the present invention will be described with reference to the accompanying drawings. The following embodiments of the present invention will be explained with an X-ray diagnosis apparatus as an example of a medical image diagnosis apparatus. [0039] FIG. 2 is a diagram showing a configuration of an X-ray diagnosis apparatus with a display according to an embodiment of the present invention. The X-ray diagnosis apparatus shown in FIG. 2 is a so-called bi-plane apparatus which allows obtaining images from two directions at the same time. The X-ray diagnosis apparatus includes a first imaging system comprising a first X-ray tube 21 a , a first detector 22 a , and a first holder 23 . The X-ray diagnosis apparatus also includes a second imaging system comprising a second X-ray tube 21 b , a second detector 22 b , and a second holder 24 . The X-ray diagnosis apparatus further includes a bed table 25 , a bed 26 , a display 27 , a display holder 27 a , a display panel 28 , an operation unit 29 , a first rail 30 a , a second rail 30 b , a rail sensor 31 , a monitor link mechanism 32 , a position sensor 33 , a controller 34 , a link mechanism driver 35 , and a display supporter driver 36 . [0040] The first imaging system is for obtaining X-ray images from a first direction, such as, for example, a direction from the front to the back of the patient. The first X-ray tube 21 a generates (or radiates) an X-ray which is exposed to the patient to be examined from the first direction. The X-ray exposed to the patient is transmitted through the patient. The detector 22 a detects the transmitted X-ray. The first holder 23 is fixed on the floor and holds the first X-ray tube 2 1 a and the first detector 22 a by means of an arm connecting the first X-ray tube 21 a and the first detector 22 a . The first holder 23 further drives or moves a set of the first X-ray tube 21 a and the first detector 22 a in three-dimensional directions. [0041] The second imaging system is for obtaining X-ray images from a second direction, such as, for example, a direction from the right to the left of the patient. The second X-ray tube 21 b generates (or radiates) an X-ray which is exposed to the patient to be examined from the second direction. The X-ray exposed to the patient is transmitted through the patient. The detector 22 b detects the transmitted X-ray, The second holder 24 is hung from the ceiling and moves along the first rail 30 a . The second holder 24 holds the second X-ray tube 21 b and the second detector 22 b by means of an arm connecting the second X-ray tube 21 b and the second detector 22 b . Further, the second holder 24 also drives or moves a set of the second X-ray tube 21 b and the second detector 22 b in three-dimensional directions. The movement of the second holder 24 along the first rail 30 a may be sensed by the rail sensor 31 , such as a microswitch, at a predetermined position of the first rail 30 a so that it can be determined whether the second imaging system is in a position for its use. [0042] The patient lies on the bed table 25 . The bed 26 has a driving unit which drives and moves the bed table 25 vertically or horizontally. The display 27 comprises a plurality of monitors. [0043] In FIG. 2 , the display 27 has four monitors. Each of the monitors may be an LCD monitor. There are two monitors in the horizontal direction and also two monitors in the vertical direction. For example, two of the monitors may be used for the first imaging system. One of the two monitors may be used for displaying an original image obtained in the first imaging system, and the other one may be used for displaying a processed image resulting from processing the original image or others. These two monitors may be laid in a lower stand of the display 27 . Another two of the monitors may be used for the second imaging system. One of these monitors may be used for displaying an original image obtained in the second imaging system, and the other one may be used for displaying a processed image resulting from processing the original image or others. These other two monitors may be laid in a upper stand of the display 27 . [0044] The two monitors in the lower stand and the two monitors in the upper stand may be linked to each other by the monitor link mechanism 32 . The link mechanism driver 35 drives the monitor link mechanism 32 so as to move the position of the monitors relative to each other. The position sensor 33 may sense a status of the monitor link mechanism 32 . The details of the link mechanism driver 35 and the position sensor 33 will be explained later. The display 27 is held in a rotatable manner by the display holder 27 a and so hung from the ceiling. The display holder 27 a moves along the second rail 30 b . The display 27 is also changed its height from the floor by the display supporter driver 36 . The display supporter driver 36 may control to adjust the height of the display 27 to a height appropriate for the doctor or the like to observe images displayed in the display 27 . [0045] The display panel 28 displays several information related to imaging conditions of the X-ray diagnosis apparatus, such as positions of the first holder 23 , the second holder 24 , and the bed table 25 and X-ray quantities radiating from the first X-ray tube 21 a and from the second X-ray tube 21 b . [0046] The operation unit 29 is used for determining a position of the bed table 25 by providing designation signals to operate the bed 26 . Further, the operation unit 29 may also be used for adjusting a position of the first holder 23 , a position of the second holder 24 , a position of the set of the first X-ray tube 2 la and the first detector 22 a , and a position of the set of the second X-ray tube 2 1 b and the second detector 22 b . [0047] The controller 34 controls each component or unit of the X-ray diagnosis apparatus, which has been described above. [0048] The X-ray diagnosis apparatus with a bi-plane feature may usually be used for, for example, an X-ray fluoroscopy with a contrast agent in an examination of a left ventriculography or a cardiac examination for an infant. Since the bi-plane examination makes it possible to obtain images from two different directions at the same time, it can reduce an amount of the enhancement agent to be used for a patient. [0049] When the X-ray diagnosis apparatus is operated in a bi-plane mode, two monitors in a lower stand may be used to display images obtained in the first imaging system and two monitors in an upper stand may be used to display images obtained in the second imaging system, as mentioned above. When, however, the X-ray diagnosis apparatus is used in a single-plane mode, that is to say, when, for example, only the first imaging system is used to obtain images, it may not be necessary to use all the four monitors in the display 27 . [0050] FIG. 3 is a diagram showing another configuration of an X-ray diagnosis apparatus with a display in the single-plane mode according to an embodiment of the present invention. As shown in FIG. 3 , the second imaging system comprising the second X-ray tube 21 b , the second detector 22 b , and the second holder 24 may be slid back away from the bed table 25 when the X-ray diagnosis apparatus is operated in the single-plane mode. This makes it easier to perform an examination since it provides more space around the bed table 25 . The doctor and the radiological technologist are given more space to move around the bed table 25 . Further, the display 27 is made compact since an examination in the single-plane mode does not require all the four monitors to display images. Here is an example that only two monitors are required in the single-plane mode. In the display 27 , monitors in the upper stand have been moved behind the monitors in the lower stand. This can be accomplished by sliding one monitor behind or in front of another monitor. Likewise, such a re-arrangement can be accomplished by folding one monitor behind or in front of another monitor. In such a circumstance, the doctor or the radiological technologist is given still further more space to move around the bed table 25 . This example of the display 27 will be explained with reference to FIGS. 4 and 5 . [0051] FIG. 4 is a diagram showing a configuration of the display 27 according to an embodiment of the present invention. The display 27 is connected to the display holder 27 a via a supporter 27 d . The display 27 has a lower monitor frame 27 b and an upper monitor frame 27 c . The lower monitor frame 27 b fixes a first monitor 270 a and a second monitor 270 b . The display panel 28 may also he fixed in the lower monitor frame 27 b . The upper monitor frame 27 c fixes a third monitor 270 c and a fourth monitor 270 d . The monitor link mechanism 32 comprises a straight arm 32 a in a form similar to a letter ‘I’, an L arm 32 b in a form similar to a letter ‘L’, and an arm driver 32 c . The arm driver 32 c may be, for example, an air cylinder, a hydraulic cylinder, or an electric power cylinder, so as to be controlled its length An arm driving unit 27 e provided in the display holder 27 a drives the arm driver 32 c . The arm driving unit 27 e may be, for example, an air compressor, a hydraulic pump, or a power source, and be connected to the arm driver 32 c via an air tube, a hydraulic hose, or a power cord. The arm driving unit 27 e may be controlled by the link mechanism driver 35 . [0052] As explained above, for example, when the X-ray diagnosis apparatus is operated in the single-plane mode, the second imaging system is slid away from the bed table 25 to the backward. Such movement of the second imaging system is sensed by the rail sensor 31 and is reported to the controller 34 Responsive to the report from the rail sensor 31 , the controller 34 controls the link mechanism driver 35 so that the link mechanism driver 35 controls the arm driving unit 27 e . The arm driving unit 27 e drives the arm driver 32 c to change its length In accordance with the length of the arm driver 32 c , the straight arm 32 a and the L arm 32 b are moved correspondingly. Accordingly, the upper monitor frame 27 c is moved and placed behind the lower monitor frame 27 b as shown in FIG. 5 . [0053] When the upper monitor frame 27 c is placed behind the lower monitor frame 27 b , the position sensor 33 senses an expanded position or a screw position of the arm driver 32 c and reports such a position to the controller 34 . In addition, when the upper monitor frame 27 c is placed behind the lower monitor frame 27 b , the center of the display 27 is changed its position. In this embodiment, the center of the display 27 is vertically lowered to the floor, compared to the position of before the position change. [0054] The supporter 27 d includes a supporter driver 270 e . As similar to the arm driver 32 c , the supporter driver 270 e may be, for example, an air cylinder, a hydraulic cylinder, or an electric power cylinder, so as to be controlled its length. The supporter driver 270 e is driven by a supporter driving unit 27 f provided in the display holder 27 a . The supporter driving unit 27 f may be, for example, an air compressor, a hydraulic pump, or a servomotor, and be connected to the supporter driver 270 e . The supporter driving unit 27 f may be controlled by the display supporter driver 36 . In the above case, responsive to the report from the position sensor 33 and maybe also from the rail sensor 31 , the controller 34 may also control the display supporter driver 36 so that the display supporter driver 36 controls the supporter driving unit 27 f The supporter driving unit 27 f drives the supporter driver 270 e to change its length. Accordingly, the display 27 may be pulled up towards the ceiling and adjust its position to the height appropriate to observe images displayed in the display 27 . [0055] On the other hand, when the rail sensor 31 senses the second imaging system coming back towards the bed table 25 , the action of the display 27 and its peripherals may obviously be the opposite to the above description. As a result, the upper monitor frame 27 c can be lifted up to its original position, and accordingly the display 27 presents four monitors again. [0056] In addition, the change of arranging the monitors of the display 27 is not limited to whether the X-ray diagnosis apparatus is operated in the bi-plane mode or in the single-plane mode. Sensing any other actions, triggers, or manual changes may be applicable as alternative embodiments of the present invention. [0057] FIG. 6 is a diagram showing a side aspect of the display 27 and its peripherals with the monitors placed at an original position according to an embodiment of the present invention As shown in FIG. 6 , when the upper monitor frame 27 c gets placed behind the lower monitor frame 27 b , the upper monitor frame 27 c is folded towards the lower monitor frame 27 b so that a back 60 of the upper monitor frame 27 c is faced with a back 61 of the lower monitor frame 27 b . Here, the folding is achieved by rotation of the upper monitor frame 27 c around an axis A. Therefore, there is required quite a wide space behind the upper monitor frame 27 c and the lower monitor frame 27 b so as to allow the upper monitor frame 27 c to rotate around the axis A. A preferable height B of the display 27 may be determined to become a border between the upper monitor frame 27 c and the lower monitor frame 27 b . In other words, the center of the display 27 in the vertical direction may be set to the height B. When the center of the display 27 in the vertical direction is set to the height B, the center of the lower monitor frame 27 b in the vertical direction is positioned at the height C. [0058] FIG. 7 is a diagram showing a side aspect of the display 27 and its peripherals with the monitors placed at a folded position according to an embodiment of the present invention As shown in FIG. 7 , when the upper monitor frame 27 c is folded to the lower monitor frame 27 b , the display 27 is controlled to change its height so that the center of the display 27 in the vertical direction still keeps the height B. Here, the center of the display 27 is identical with the center of the lower monitor frame 27 b . Therefore, the display 27 is pulled up a distance (B-C) to keep the preferable height B, by controlling the length of the supporter driver 270 e . When the upper monitor frame 27 c gets returned to its original position, that is, a position on top of the lower monitor frame 27 b , the upper monitor frame 27 c is rotated around the axis A again. [0059] The folding aspects of the upper monitor frame 27 c described with FIGS. 6 and 7 will be clearer in FIG. 8 FIG. 8 is a diagram showing side aspects of the display 27 when the upper monitor frame 27 c is folded according to an embodiment of the present invention. In FIG. 8 , to make it easy to understand the folding, the top end of the upper monitor frame 27 c is marked ‘K’ while the bottom end of the upper monitor frame 27 c is marked ‘L’. Similarly, the top end of the lower monitor frame 27 b is marked ‘M’ while the bottom end of the lower monitor frame 27 b is marked ‘N’. When the folding has been completed, the top end K of the upper monitor frame 27 c faces the bottom end N of the lower monitor frame 27 b Further, the bottom end L of the upper monitor frame 27 c faces the top end M of the lower monitor frame 27 b [0060] Alternatively, the upper monitor frame 27 c of the display 27 may be placed behind the lower monitor frame 27 b of the display 27 in the following manners. [0061] FIG. 9 is a diagram showing another side aspect of the display 27 and its peripherals with the monitors placed at an original position according to an embodiment of the present invention. In FIG. 9 , there is a variable arm 32 d in connection with the L arm 32 b and the arm driver 32 c , instead of the straight arm 32 a The variable arm 32 d varies its length flexibly. When the upper monitor frame 27 c gets placed behind the lower monitor frame 27 b , the upper monitor frame 27 c slides to the backside of the lower monitor frame 27 b so that a front 62 of the upper monitor frame 27 c is faced with the back 61 of the lower monitor frame 27 b . Since the upper monitor frame 27 c slides quite linearly, there is required only a narrow space behind the upper monitor frame 27 c and the lower monitor frame 27 b so that the display 27 and its peripherals can become more compact and so allow the doctor and the radiological technologist a more space around the bed table 25 . The preferable height B of the display 27 may be determined to become a border between the upper monitor frame 27 c and the lower monitor frame 27 b . As similar to FIG. 6 , the center of the display 27 in the vertical direction may be set to the height B. When the center of the display 27 in the vertical direction is set to the height B, the center of the lower monitor frame 27 b in the vertical direction is positioned at the height C. [0062] FIG. 10 is a diagram showing a side aspect of the display 27 and its peripherals with the monitors placed at a slid position according to an embodiment of the present invention. As shown in FIG. 10 , when the upper monitor frame 27 c slides to the backside of the lower monitor frame 27 b , the display 27 is controlled to change its height so that the center of the display 27 in the vertical direction still keeps the height B. Here the center of the display 27 is identical with the center of the lower monitor frame 27 b . Therefore, as similar to FIG. 7 , the display 27 is pulled up a distance (B-C) to keep the preferable height B, by controlling the length of the supporter driver 270 e . When the upper monitor frame 27 c gets returned to its original position, that is, a position on top of the lower monitor frame 27 b , the upper monitor frame 27 c slides back upwards. [0063] The sliding aspects of the upper monitor frame 27 c described with FIGS. 9 and 10 will be clearer in FIG. 11 . FIG. 11 is a diagram showing side aspects of the display 27 when the upper monitor frame 27 c slides according to an embodiment of the present invention. In FIG. 11 , to make it easy to understand the sliding, each end of the upper monitor frame 27 c and the lower monitor frame 27 b is marked the same reference as in FIG. 8 . When the sliding has been completed, the top end K of the upper monitor frame 27 c faces the top end M of the lower monitor frame 27 b . Further, the bottom end L of the upper monitor frame 27 c faces the bottom end N of the lower monitor frame 27 b . [0064] FIG. 12 shows an alternative example of the sliding described in FIGS. 9 to 11 and is a diagram showing another side aspect of the display 27 when the upper monitor frame 27 c slides according to the embodiment of the present invention. The alternative example shown in FIG. 12 is a case that the upper monitor frame 27 c may slide to the front of the lower monitor frame 27 b so that the back 60 of the upper monitor frame 27 c is faced with a front 63 of the lower monitor frame 27 b . To make it easy to understand the sliding, each end of the upper monitor frame 27 c and the lower monitor frame 27 b is marked the same reference as in FIG. 11 . When the sliding has been completed, the top end K of the upper monitor frame 27 c faces the top end M of the lower monitor frame 27 b . Further, the bottom end L of the upper monitor frame 27 c faces the bottom end N of the lower monitor frame 27 b . [0065] According to embodiments of the present invention, the display arrangement can be performed in various ways. In the above description, holding and sliding techniques have been described in terms of viewing the display 27 from its side aspect. Embodiments of the present invention may not be limited to those described above. Further examples of the display arrangement will be described with reference to FIGS. 13 to 20 . FIGS. 13 to 20 show various arrangement forms of the monitors. However, these are only exemplary forms and embodiments of the present invention are not limited to these. Each of the arrangement forms may utilize one or more of the folding and/or the sliding techniques described above. [0066] FIG. 13 is a diagram showing a first arrangement viewed from a front aspect of a display according to an embodiment of the present invention. [0067] As shown in FIG. 13 , the display may comprise four monitors P, Q, R, and S. The monitors P and Q may be placed behind the monitors R and S as described in FIG. 8 or 11 . Similarly, the monitors R and S may be placed in front of the monitors P and Q. In a third way, the monitor P may be placed behind the monitor Q and the monitors P and Q may be placed behind the monitor S by sliding. In a fourth way, the monitor P may be placed in front of the monitor Q and the monitors P and Q may be placed behind the monitor S by folding. In similar manner, there are more possible ways for achieving this arrangement. Accordingly, the monitors R and S are used to display images. [0068] FIG. 14 is a diagram showing a second arrangement viewed from the front aspect of the display according to an embodiment of the present invention. [0069] As shown in FIG. 14 , the display may comprise four monitors P, Q, R, and S. The monitors R and S may be placed behind the monitors P and Q. Similarly, the monitors P and Q may be placed in front of the monitors R and S as described in FIG. 12 . In a third way, the monitor S may be placed behind the monitor R and the monitors R and S may be placed behind the monitor P by sliding. In a fourth way, the monitor S may be placed in front of the monitor R and the monitors R and S may be placed behind the monitor P by folding In similar manner, there are more possible ways for achieving this arrangement. Accordingly, the monitors P and Q are used to display images. [0070] FIG. 15 is a diagram showing a third arrangement viewed from the front aspect of the display according to an embodiment of the present invention. [0071] As shown in FIG. 15 , the display may comprise four monitors P, Q, R, and S. The monitors Q and S may be placed behind the monitors P and R. Alternatively, the monitors P and R may be placed in front of the monitors Q and S. Further, the monitor Q may be placed behind the monitor S and the monitors Q and S may be placed behind the monitor R by sliding. Further still, the monitor Q may be placed in front of the monitor S and the monitors Q and S may be placed behind the monitor R by folding. In similar manner, there are more ways for achieving this arrangement. Accordingly, the monitors P and R are used to display images. [0072] FIG. 16 is a diagram showing a fourth arrangement viewed from the front aspect of the display according to an embodiment of the present invention. [0073] As shown in FIG. 16 , the display may comprise four monitors P, Q, R, and S. The monitors P and R may be placed behind the monitors Q and S. Alternatively, the monitors Q and S may be placed in front of the monitors P and R. Further, the monitor R may be placed behind the monitor P and the monitors P and R may be placed behind the monitor Q by sliding. Further still, the monitor R may be placed in front of the monitor P and the monitors P and R may be placed behind the monitor Q by folding. In similar manner, there are more ways for achieving this arrangement. Accordingly, the monitors Q and S are used to display images. [0074] FIG. 17 is a diagram showing a fifth arrangement viewed from the front aspect of the display according to an embodiment of the present invention. [0075] As shown in FIG. 17 , the display may comprise two monitors P and R. The monitor P may be placed behind the monitor R. It is another way that the monitor R may be placed in front of the monitor P. Accordingly, the monitor R is used to display images. Alternatively, the monitor R may be placed behind the monitor P. It is another way that the monitor P may be placed in front of the monitor R. Accordingly, the monitor P is used to display images. [0076] FIG. 18 is a diagram showing a sixth arrangement viewed from the front aspect of the display according to an embodiment of the present invention. [0077] As shown in FIG. 18 , the display may comprise two monitors P and Q. The monitor Q may be placed behind the monitor P. It is another way that the monitor P may be placed in front of the monitor Q. Accordingly, the monitor P is used to display images. Alternatively, the monitor P may be placed behind the monitor Q. It is another way that the monitor Q may be placed in front of the monitor P. Accordingly, the monitor Q is used to display images. [0078] FIG. 19 is a diagram showing a seventh arrangement viewed from the front aspect of the display according to an embodiment of the present invention. [0079] As shown in FIG. 19 , the display may comprise four monitors P. Q. R, and S. The monitor S may be placed behind the monitor Q. It is another way that the monitor S may be placed behind the monitor R. Accordingly, the monitors P, Q, and R are used to display images. [0080] FIG. 20 is a diagram showing a eighth arrangement viewed from the front aspect of the display according to an embodiment of the present invention. [0081] As shown in FIG. 20 , the display may comprise four monitors P, Q, R, and S. It is the first way that the monitors Q and S may be placed behind the monitors P and R and the monitors R and S may be placed behind the monitors P and Q. It is the second way that the monitors R and S may be placed behind the monitors P and Q and the monitors Q and S may be placed behind the monitors P and R. It is the third way that the monitor S may be placed behind the monitors Q and the monitors Q and S may be placed behind the monitor P, and in addition, the monitor R may be placed behind the monitors P, Q, and S. In similar manner, there are more ways for achieving this arrangement. Accordingly, the monitor P is used to display images. [0082] The arrangement of monitors of the display can be changed in various manners as described above. When the X-ray diagnosis apparatus is operated in the single-plane mode, it may not be necessary to move the second imaging system towards the back. Whether the second imaging system is moved or not, it may not be necessary that the display arrangement always automatically corresponds to the mode of whether bi-plane or single-plane. [0083] Further, the X-ray diagnosis apparatus according to embodiments of the present invention is not limited to the bi-plane apparatus, but may also be applied to an ordinary X-ray diagnosis apparatus with only one imaging system as shown in FIG. 21 . [0084] Still further, the principles of the present invention may also be applied to other medical diagnosis apparatuses, such as, for example, an X-ray CT apparatus, an MRI apparatus, a nuclear medical diagnosis apparatus, an ultrasound diagnosis apparatus, and an endoscopic image apparatus. [0085] For manual operations, by the doctor, the radiological technologist, or the like, of the display arrangement and/or the height of the display 27 , it may be possible to provide the operation unit 29 with one or more buttons or switches for an exclusive use in such manual operations. According to input operations with the buttons or switches in the operation unit 29 , the input information may be sent to the controller 34 . The controller 34 controls the link mechanism driver 35 and the display supporter driver 36 . The link mechanism driver 35 controls the arm driving unit 27 e which drives the arm driver 32 c so as to change the arrangement of the monitors. The display supporter driver 36 controls the supporter driving unit 27 f which drives the supporter driver 270 e so as to change the height of the display 27 . [0086] Alternatively, if the arrangement of monitors and/or the height of the display 27 are changed in manual without any electrical input operations, it may be achieved by reducing or removing load or holding power of the arm driver 32 c and/or the supporter driver 270 e so as to allow the doctor or the like to make the arrangement of the display by himself. However, the weight of the display 27 or monitors may be a problem for such direct manual operations. Therefore, it may be necessary to prepare a fixer, such as fixing screws, to fix the display 27 or monitors to the supporter 27 d or the monitor link mechanism 32 at a desired position. Further, it may also be necessary to prepare a helper, such as gas springs, in the monitor link mechanism 32 for the purpose of helping manual operations of the doctor or the like. [0087] Still furthermore, the mechanism of how to connect the monitors of the display is not limited to those disclosed in the embodiment of the present invention, but can apply any other mechanism including various well-known mechanism thereto. [0088] According to embodiments of the present invention, the arrangement of a plurality of monitors of a display can advantageously be changed. In the arrangement of the monitors, the number of the monitors to be spread out can be reduced by superposing a part of the monitors on the rest of the monitors. Therefore, it may make it possible to reduce a space occupied by the display around the bed table (or a patient) so that a doctor, a radiological technologist, or the like can concentrate on his or her work. This results in improving a quality of his or her manipulation. [0089] The embodiments of the present invention described above are examples described only for making it easier to understand the present invention, and are not described for the limitation of the present invention. Consequently, each component and element disclosed in the embodiments of the present invention may be redesigned or modified to its equivalent within a scope of the present invention. Furthermore, any possible combination of such components and elements may be included in a scope of the present invention as long as an advantage similar to those obtained according to the alcove disclosure in the embodiments of the present invention is obtained.

A medical image diagnosis apparatus, comprises an image generator, a display, and a mechanism. The image generator is configured to generate a medical image. The display comprises a plurality of monitors and is configured to display the medical image. The mechanism is configured to change an arrangement of the plurality of monitors with respect to each of the monitors.

BACKGROUND 1. Technical Field The embodiments herein generally relate to surgical instruments, and, more particularly, to a percutaneous tube used during minimally invasive surgical procedures. 2. Description of the Related Art Traditional surgical procedures for pathologies located within the body can cause significant trauma to the intervening tissues. These procedures often require a long incision, extensive muscle stripping, prolonged retraction of tissues, denervation and devascularization of tissue. These procedures can require operating room time of several hours and several weeks of post-operative recovery time due to the destruction of tissue during the surgical procedure. In some cases, these invasive procedures lead to permanent scarring and pain that can be more severe than the pain leading to the surgical intervention. The development of percutaneous procedures has yielded a major improvement in reducing recovery time and post-operative pain because minimal dissection of tissue, such as muscle tissue, is required. For example, minimally invasive surgical techniques are desirable for spinal and neurosurgical applications because of the need for access to locations within the body and the danger of damage to vital intervening tissues. While developments in minimally invasive surgery are steps in the right direction, there remains a need for further development in minimally invasive surgical instruments and methods. For example, a conventional percutaneous tube employed during minimally invasive surgical procedures often require temporary placement of auxiliary attachments during the procedure to be located in a position that obstructs the view of the surgeon or to be in an unstable position. These shortcomings to convention minimally invasive surgical instruments frequently raise the risk of additional morbidity to a patient undergoing a minimally invasive surgical procedure. SUMMARY In view of the foregoing, an embodiment herein provides a system for performing minimally invasive surgery, the system comprising a percutaneous tube comprising a translucent main body; an external attachment fixture attached to the main body; an access channel longitudinally bored through the main body; an internal attachment channel longitudinally bored through the main body, wherein the internal attachment channel comprises a partially smooth inner surface adjacent to a partially rough inner surface; and an internal attachment, mating with the internal attachment channel. In such a system, the external attachment fixture may mate with an external attachment. Moreover, the external attachment fixture may be offset from the main body of the percutaneous tube by an angle providing unobstructed access to the access channel as the external attachment is coupled to the external attachment fixture. In addition, the main body of the percutaneous tube may comprise an access slot cut through the main body. Additionally, the main body of the percutaneous tube may comprise an upper inner smooth surface and a lower inner rough surface. Furthermore, in such a system, the lower inner rough surface may increase the intensity of light directed into the percutaneous tube compared with the upper inner smooth surface. Moreover, the internal attachment may comprise an internal attachment fixture. In addition, the internal attachment fixture may comprise a clamp-like device. Additionally, the clamp-like device may close in response to a linear pulling force applied to the internal attachment. Furthermore, the clamp-like device may open in response to linear pushing force applied to the internal attachment. Moreover, the internal attachment fixture may comprise at least one of a pin, a screw, and a hook. In addition, the internal attachment may comprise a threaded portion that mates with the internal attachment fixture. Additionally, the internal attachment may comprise a socket-like top portion. Another embodiment herein provides a percutaneous tube apparatus comprising a translucent main body; an external attachment fixture attached to the main body; an access channel longitudinally bored through the main body; and an internal attachment channel longitudinally bored through the main body, wherein the internal attachment channel comprises a partially smooth inner surface adjacent to a partially rough inner surface. With such an apparatus, the main body may comprise a notch and the notch comprises a reflective patch on an interior surface of the notch. Moreover, the external attachment fixture may be adapted to mate with an external attachment. In addition, the external attachment may comprise a light source. Furthermore, the main body of the percutaneous tube may further comprise an upper inner smooth surface and a lower inner rough surface. Additionally, the lower inner rough surface increases the intensity of light directed into the main body compared with the upper inner smooth surface. Another embodiment herein further provides a system for performing minimally invasive surgery, the system comprising a percutaneous tube comprising a translucent main body; an external attachment fixture coupled to a first end of the main body and coupled at an acute angle from the main body; an access slot partially cut longitudinally through the main body, wherein the access slot is longitudinally cut from a second end of the main body to a point on the main body between the second end and the first end, and wherein the second end is positioned opposite to the first end; an access channel longitudinally bored through the main body; an internal attachment channel longitudinally bored through the main body, wherein the internal attachment channel comprises a partially smooth inner surface adjacent to a partially rough inner surface, wherein the partially smooth inner surface begins at the first end and the partially rough inner surface terminates at the second end; and an internal attachment mating with the internal attachment channel, wherein the internal attachment comprises a top portion that comprises a socket and a bottom portion that comprises at least one of a clamp attachment, a pin attachment, and a screw attachment. These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications. BRIEF DESCRIPTION OF THE DRAWINGS The embodiments herein will be better understood from the following detailed description with reference to the drawings, in which: FIG. 1(A) illustrates a schematic diagram of a percutaneous tube assembly according to an embodiment herein; FIG. 1(B) illustrates a schematic diagram of a percutaneous tube according to an embodiment herein; FIG. 2 illustrates a schematic diagram of an internal attachment according to an embodiment herein; FIG. 3(A) illustrates a disassembled view of a percutaneous tube assembly according to an embodiment herein; FIGS. 3(B) and 3(C) illustrate alternate views of a percutaneous tube assembly according to an embodiment herein; FIGS. 4(A) through 4(C) illustrate a schematic diagram of a percutaneous tube assembly with a internal attachment extended according to an embodiment herein; FIGS. 5(A) through 5(C) illustrate a schematic diagram of a percutaneous tube assembly with a internal attachment retracted according to an embodiment herein; FIGS. 6(A) through 6(C) illustrate a schematic diagram of a percutaneous tube according to an embodiment herein; FIGS. 7(A) through 7(C) illustrate a schematic diagram of an internal attachment with a clamp fixture according to an embodiment herein; and FIGS. 8(A) through 8(B) illustrate a schematic diagram of an internal attachment according to an embodiment herein. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS The embodiments herein and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein. As mentioned above, there remains a need for a novel percutaneous tube for use during minimally invasive surgical procedures that allows auxiliary instruments (e.g., internal and external attachments) to be securely coupled to the novel percutaneous tube and provide an unobstructed view of critical areas during surgery. The embodiments herein provide a percutaneous tube assembly with an internal fixation device embedded within the length of the percutaneous tube to allow secured attachment of the fixation device and unobstructed viewing of crucial areas during the minimally invasive surgical procedure. Referring now to the drawings, and more particularly to FIGS. 1(A) through 8(B) , there are shown preferred embodiments of the invention. FIGS. 1(A) and 1(B) illustrate a schematic diagram of a percutaneous tube assembly 1 according to an embodiment herein. As shown, percutaneous tube assembly 1 includes percutaneous tube 10 , which includes a translucent main body 12 , external attachment fixture 14 , access slot 16 , and notch 18 . While not shown in FIG. 1(A) , external attachment fixture 14 is configured to accept external attachments. External attachment fixture 14 is offset by angle 14 a , where angle 14 a is sufficient to prevent external attachments from obscuring the view of a surgeon when attached to external attachment fixture 14 . Access slot 16 provides access to interior anatomical structures of a bodily cavity during a minimally invasive surgical procedure and allows manipulation of surgical implants during the minimally invasive surgery. For example, access slot 16 may be used as a passageway for inserting a rod (not shown) during a minimally invasive surgical procedure for spinal applications. Notch 18 provides a counter-shape to percutaneous tube assembly 1 . For example, notch 18 may prevent percutaneous tube assembly 1 from being blocked by interior anatomical structures of a bodily cavity during a minimally invasive surgical procedure. Percutaneous tube assembly 1 also includes internal attachment 30 . While not shown in FIGS. 1(A) and 1(B) , internal attachment 30 may include a clamp attachment, a pin attachment, a screw attachment, a hook attachment or any other similarly useful attachments that may be used during a minimally invasive surgical procedure. FIG. 2 , with reference to FIGS. 1(A) and 1(B) , FIG. 3(A) , and FIGS. 8(A) and 8(B) , illustrates a perspective view of an internal fixation device 30 according to an embodiment herein. The internal attachment 30 includes main body 32 and clamp attachment 34 . While clamp attachment 34 is shown in FIG. 2(B) coupled to main body 32 , internal attachment 30 is not limited to clamp attachment 34 and may include a pin attachment (e.g., pin attachment 38 , shown in FIG. 3 (A)), a screw attachment (e.g., screw attachment 40 , shown in FIGS. 8 (A) and 8 (B)), a hook attachment or any other device appropriate during minimally invasive surgical procedures. FIG. 3(A) , with reference to FIGS. 1 through 2(B) , illustrates a disassembled view of a percutaneous tube assembly 1 according to an embodiment herein. In addition, FIGS. 3(B) and 3(C) , with reference to FIGS. 1 through 3(A) , illustrate alternate views of a percutaneous tube assembly 1 according to an embodiment herein. Percutaneous tube 10 includes main body 12 , external attachment fixture 14 , access slot 16 , and notch 18 , as shown previously, as well as an access channel 20 , and an internal attachment channel 22 . Both access channel 20 and internal attachment channel 22 are channels bored through main body 12 . In addition, internal attachment 30 is shown with a main body 32 and pin attachment 38 . Main body 32 is configured to loosely mate with internal attachment channel 22 . In FIG. 3(C) , which is an A-A cross-section from FIG. 3(B) , internal attachment channel 22 with main body 32 of internal attachment 30 is shown in percutaneous tube assembly 1 . FIGS. 4(A) through 4(C) , with reference to FIGS. 1(A) through 3(C) , illustrate a schematic diagram of a percutaneous tube assembly 1 with an internal attachment 30 extended according to an embodiment herein. Additionally, FIGS. 5(A) through 5(C) , with reference to FIGS. 1(A) through 4(C) , illustrate a schematic diagram of a percutaneous tube assembly 1 with an internal attachment fixture 30 retracted according to an embodiment herein. As shown previously, percutaneous tube 10 includes internal attachment channel 22 (not shown in FIGS. 4(A) through 5(C) , but shown in FIG. 3(C) ) that accepts internal attachment 30 . As shown in FIGS. 4(A) through 5(C) , internal attachment 30 may include a clamp attachment 34 . While clamp attachment 34 is shown in FIGS. 4(A) through 5(C) , internal attachment 30 is not limited thereto and may include a pin attachment (e.g., pin attachment 38 , shown in FIG. 3(A) ) or a hook attachment. In addition, internal attachment 30 may permit mechanical manipulation of clamp attachment 34 without removal from internal attachment channel 22 . For example, in FIGS. 4(A) through 4(C) , clamp attachment 34 is a clamp-like device with each clamp-like protrusion coupled to a spring-like device and the clamp-liked protrusions are fully extended. In FIGS. 5(A) through 5(C) , however, the clamp-like protrusion of clamp attachment 34 are partially retracted because main body 12 is compressing each clamp-like protrusion causing the spring-like devices to compress and retract clamp attachment 34 . Percutaneous tube assembly 1 may translate from the configuration shown in FIGS. 4(A) through 4(C) to the configuration shown in FIGS. 5(A) through 5(C) when a force (e.g., a pulling force or a pushing force) is applied to a top portion 36 of internal attachment 30 , which translates through internal attachment channel 22 to effectuate the clamping mechanism (e.g., through the spring-like devices coupled to the clamp-like protrusions of clamp attachment 34 ) shown in FIGS. 4(A) through 5(C) . FIGS. 6(A) through 6(C) , with reference to FIGS. 1(A) through 5(C) , illustrate an isolated view of a percutaneous tube 10 according to an embodiment herein. In the views shown, percutaneous tube 10 includes main body 12 , external attachment fixture 14 , angle 14 a , access slot 16 , notch 18 , access channel 20 , internal attachment channel 22 , upper inner smooth surface 24 and lower inner rough surface 26 . While not shown, external attachment fixture 14 is embodied as a universal fixture that accepts a variety of different external attachments. For example, a light source (e.g., a lamp) (not shown) may be attached to external attachment fixture 14 to provide light while percutaneous tube 10 is in use during surgery. In addition, external attachment 14 is offset from main body 12 by angle 14 a to allow an external attachment to be transfixed to external attachment fixture 14 and continue providing unobstructed access to access channel 20 . Percutaneous tube 10 also includes an optional upper inner smooth surface 24 and an optional lower inner rough surface 26 . Generally, light reflected on the smooth surface 24 creates specular reflection such that the reflected light rays are all parallel to each other causing a generally uniform light reflection on the smooth surface 24 . Whereas, light reflected on the rough surface 26 creates diffuse reflection such that the reflected light rays travel in random directions causing an enhanced visibility on the rough surface 26 , which increases illumination towards the notch end 18 of the percutaneous tube 10 , where increased/enhanced light/visibility is desired during surgery. FIGS. 7(A) through 7(C) , with reference to FIGS. 1(A) through 6(C) , illustrate a schematic diagram of an internal attachment 30 with a clamp attachment 34 according to an embodiment herein. In addition, FIGS. 8(A) through 8(B) , with reference to FIGS. 1(A) through 7(C) , illustrate a schematic diagram of an internal attachment 30 with a pin attachment 38 according to an embodiment herein. In the views shown, internal attachment 30 includes main body 32 and either clamp attachment 34 (shown in FIGS. 7 (A) through 7 (C)), pin attachment 36 (shown in FIG. 3(A) ) or a screw attachment 40 (shown in FIGS. 8(A) and 8(B) ). In addition, main body 32 includes a top portion 36 , which is the portion of internal attachment 30 that protrudes above percutaneous tube 10 and permits manipulation during a minimally invasive surgical procedure (e.g., a pulling force or a pushing force may be applied to top portion 36 ). As shown, internal attachment 30 may include a clamp attachment 34 (as shown in FIGS. 7 (A) through 7 (C)), or a screw attachment 40 (as shown in FIGS. 8 (A) and 8 (B)), but may also include a pin attachment (shown in FIG. 3(A) , a hook attachment (not shown) or any other similarly attachment useful during a minimally invasive surgical procedure. While top portion 36 is shown in FIGS. 8(A) through 8(B) as a polygonal socket, top portion 36 is not limited to such a configuration. In addition, as discussed above, top portion 36 may provide mechanical assistance in manipulating internal attachment fixture 32 when internal attachment 30 is secured within internal attachment channel 22 (e.g., as shown in FIG. 3(C) ). The embodiments herein provide a percutaneous tube assembly (e.g., percutaneous tube assembly 1 ) with an internal fixation device (e.g., internal attachment 30 ) embedded within the length of the percutaneous tube (e.g., through internal attachment channel 22 ) to allow secured attachment of the fixation device (e.g. internal attachment 30 ) and unobstructed viewing of crucial areas during the minimally invasive surgical procedure. Since a sturdy and unobstructed access to the surgical location is easily achievable using such a percutaneous tube assembly (e.g., percutaneous tube assembly 1 ), the usage of cannulated implant may be avoided. For example, instead of using a cannulated pedicle screw system, a non-cannulated pedicle screw system would be available during a minimally invasive surgical procedure. The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the appended claims.

A percutaneous tube assembly is provided for performing minimally invasive surgery, the system comprising a percutaneous tube comprising a translucent main body; an external attachment fixture attached to the main body; an access channel longitudinally bored through the main body; an internal attachment channel longitudinally bored through the main body, wherein the internal attachment channel comprises a partially smooth inner surface adjacent to a partially rough inner surface; and an internal attachment, mating with the internal attachment channel.

This application is the National Stage of International Application No. PCT/EP2006/006537, filed Jul. 5, 2006, which is incorporated herein by reference. BACKGROUND OF THE INVENTION The invention pertains to a sock, especially for use in sports activities, with a leg part and a foot part. The foot part has a toe area, a heel area, and a sole area, which is located between the toe and heel areas, the sock being provided with an O-ring bandage. Especially in the case of sports activities, the human foot is usually enclosed by a sock. So that the sock will fit properly on the foot, it is known that O-ring bandages can be provided on socks or stockings (see, for example, U.S. Pat. No. 5,617,745). These, however, are arranged to extend circumferentially and symmetrically, and parallel to the longitudinal center line of the sock. Running and jumping movements exert increased stress on the foot, especially in the area of the ankle. The foot has the natural function of flexing inward to damp such impacts. This function is called pronation. After the outside part of the sole has made contact with the ground, the load shifts somewhat toward the inside, so that the lengthwise arch of the foot can flatten out and thus absorb some of the impact. The human foot, however, can be formed in different ways. Feet can be divided into normal, contracted, inverted, and flat. The normal foot shows a balanced arch. During walking and running, the outside edge of the foot strikes the ground first. Then it rolls inward to absorb and to damp the impact of the foot. This is referred to as “natural pronation”. Contracted and inverted feet do not inflect inward for the most part during the landing phase, and the footprint left behind consists primarily of the forward and rear parts of the foot. This is called “underpronation” or “supination”. The natural ability of the foot to protect against impact is considerably reduced in the case of underpronation. Flat feet, furthermore, have a very low arch and leave behind a footprint consisting of the complete foot. Flat feet flex very strongly toward the inside after the landing phase. This is called overpronation. In addition, the motor apparatus in the area of the foot joints can be stressed by improper alignment of the legs, which can take either the form commonly called bowlegged or that called knock-kneed. Both overpronators and underpronators, as well as people with improper alignment of the legs, suffer from the problem of insufficient natural damping. As a result, severe stress is imposed on the foot. To support the ligaments and tendons of the motor apparatus around the ankle, it is known that bandages can be placed around the foot. A bandage is wrapped horizontally around the lower area of the shin and around the ankle before the sock is pulled over the foot. This wrapping, however, does not offer satisfactory stabilization and support of the motor apparatus around the ankle, and in addition it does not take into account the special forms of stress associated with overpronation and underpronation. The bandage, furthermore, adds considerable bulk under the sock, which decreases the wearing comfort. The invention proposes to provide a remedy to this situation. The invention is based on the task of creating a sock which supports the motion apparatus in the area of the ankle and which is designed specifically to deal with the special stresses which occur in association with overpronation and underpronation and also those associated with misalignment of the legs. According to the invention, this task is accomplished in that at least one O-ring bandage is provided in the area of the ankle, this bandage extending asymmetrically around the circumference of the sock. The invention creates a sock, especially a sock for sports activities, which supports the motion apparatus in the area of the ankle and which deals specifically with the particular stresses associated with overpronation and underpronation and also with those associated with misalignment of the legs. For this reason, the O-ring bandage is located in the area of the ankle in such a way that it can provide a support function appropriate to the type of stress being imposed in the case in question. In an embodiment of the invention, the asymmetric O-ring bandage passes under the ankle on the inside of the foot and above the ankle on the outside of the foot. As a result, the ankle is supported in particular against strong forces acting outward. In another embodiment of the invention, the asymmetric O-ring bandage passes above the ankle on the inside of the foot and under the ankle on the outside of the foot. As a result, the ankle is supported in particular against strong forces acting outward. In an elaboration of the invention, two O-ring bandages are provided. As a result, the support function provided for the ankle is improved even more. The opposing arrangement of the bandages, furthermore, creates a support function acting on both sides of the ankle. In an embodiment of the invention, the sock has at least one wicking channel. The wicking channel is used to optimize the temperature and humidity conditions of the foot by conducting away perspiration. To avoid excessive layers of material, the wicking channel preferably passes through the bandages. Other elaborations and embodiments of the invention are stated in the other subclaims. BRIEF DESCRIPTION OF THE DRAWING Exemplary embodiments of the invention are illustrated in the drawings and are described in detail below: FIG. 1 shows a side view of the outside surface of a foot wearing a sock with an asymmetric O-ring bandage; FIG. 2 shows a view of a pair of socks of the type according to FIG. 1 from the rear; FIG. 3 shows a different design of a sock with an asymmetric O-ring bandage; FIG. 4 shows a view of a pair of socks of the type according to FIG. 3 from the rear; FIG. 5 shows another embodiment of a sock with an asymmetric O-ring bandage; FIG. 6 shows a view of a pair of socks of the type according to FIG. 5 from the rear; FIG. 7 shows another design of a sock with an asymmetric O-ring bandage; and FIG. 8 shows a view of a pair of socks of the type according to FIG. 7 from the rear; DETAILED DESCRIPTION OF THE INVENTION The sock selected as the exemplary embodiment ( FIG. 1 ) consists of a foot part 1 and a leg part 2 . The foot part 1 has a toe area 11 , a heel area 12 , and a sole area 13 located between the toe and heel parts. The areas 11 , 12 , and 13 can be made of reinforced material, as shown in the exemplary embodiment. The use of material combinations such as virgin wool plus elastic fibers is also possible. The leg part 2 is provided with a collar 21 at the end facing away from the foot part 1 . In the ankle area, the sock is provided with an O-ring bandage 22 , which extends asymmetrically around the circumference of the sock. The bandage 22 is made of an elastic and also a wicking fabric. Elastan, Lycra, or other materials of varying degrees of stretchability are preferably used. The O-ring bandage 22 is woven all the way around together with the same fabric as that which forms the sock. In the exemplary embodiment shown here according to FIGS. 1 and 2 , the O-ring bandage 22 is asymmetric; that is, it passes under the ankle, designated “K”, on the outside of the foot and above the ankle on the inside of the foot. In this embodiment, the O-ring bandage 22 supports the ankle and the ligaments arranged around it especially against the effects of forces acting inward on the ankle. Alternatively, the asymmetric O-ring bandage 22 can be designed so that—again in asymmetric fashion—it passes above the ankle on the outside of the foot and below the ankle on the inside of the foot ( FIGS. 3 and 4 ). In this embodiment, it supports the ankle and the ligaments around it especially against the effects of forces acting outward on the ankle. In the case of the pair of socks shown in FIG. 4 , in which the asymmetric O-ring bandage 22 is designed in such a way that it passes above the ankle on the outside of the foot and below the ankle on the inside of the foot, what is obtained when viewed from the rear is the form of a “V”. In contrast, what we see when we look at the pair of socks illustrated in FIG. 2 from the rear is the shape of an “A” because of the different arrangement of the asymmetric O-ring bandages 22 . In the exemplary embodiment shown in FIGS. 5 and 6 , two O-ring bandages 22 are provided in the sock, as a result of which the supporting action is increased even more. An opposing arrangement of the bandages 22 is selected, so that the bandages 22 cross each other in the area of the Achilles tendon and again in the area of the transition between the top of the foot and the shin. When the pair of socks is seen from the rear, we see that this arrangement of the O-ring bandages 22 produces the form of an “X”. As a result of this design, a support function acting on both sides of the ankle is obtained, where the ankle “K” is surrounded by the bandages 22 on both the outside and the inside. In the exemplary embodiment according to FIGS. 7 and 8 , two opposing O-ring bandages 22 are again provided. On the outside of the leg and on the inside of the leg, the bandages 22 , which are a certain distance apart here, are connected to each other by a web 24 . The webs 24 pass across the ankle “K”. The support function is thus improved yet again. In particular, a lateral support function is obtained, which does not hinder the rolling and bending of the foot during running or the like in any way, because the bandages have their narrowest points in the areas where the foot bends—the Achilles tendon and the transition from the top of the foot to the shin. The sock can be provided with a wicking channel (not shown), which proceeds from the collar 21 and extends as far as the sole area 13 and is formed of mesh knit fabric with a wicking function. The wicking channel helps to carry moisture up and away from the sole area. The asymmetric O-ring bandage 22 is located over the wicking channel. A wicking channel of this type can be provided both on the outside of the leg and on the inside of the leg of the sock. Inso far as socks have been mentioned in the description and in the claims, the invention is not limited to these alone; on the contrary, the term “sock” is also meant to include stockings, tights, etc. to which the invention also pertains.

The invention relates to a sock, especially for use in sports, which comprises a foot part ( 1 ) and a leg ( 2 ), said foot part having a toe area ( 11 ) and a heel area ( 12 ) and a sole area ( 13 ) between the toe and the heel area, and which is also provided with an O-ring-type bandage ( 22 ). An O-ring-type bandage ( 22 ) is disposed in the area of the ankle joint and extends asymmetrically on the circumference of the sock.

FIELD OF THE INVENTION The present invention relates to introducing a fluid additive into a relatively more viscous fluid particularly when the fluid is a food composition extrudate. Specifically, in one aspect, the present invention relates to dividing a fluid food extrudate mass flow into a plurality of subflows each traveling through their own corresponding passageway. Each subflow is then cross-sectionally partitioned wherein a fluid additive is dispersed throughout each subflow. BACKGROUND OF THE INVENTION Food products are commonly in some type of fluid form during and/or after processing. Extruders are often used to process various types of food products. Extruders are desirable because they can produce a large amount of a fluid food, which may be a food dough, for example, and more specifically a cooked food cereal dough in a short period of time. Moreover, it is advantageous to divide the fluid food extrudate or other mass food flow into a multiplicity of extrudate subflows by splitting the mass flow and directing these extrudate subflows into and through a plurality of corresponding separate passageways. This enables each extrudate substream to be further manipulated and processed. For example, an additive injection device can then incorporated into each passageway thereby enabling a suitable type and quantity of fluid additive to be introduced into the extrudate subflow. Additives can be introduced to enhance the flavor, color or texture of the final food product. Thus, either a single food product with one or more desired characteristics (i.e., a ready-to-eat cereal of a desired color or with an assortment of differently flavored and/or colored pieces, for example) or a variety of distinct food products (i.e., an array of distinct snack foods derived from the common extrudate mass flow) can be produced by dividing the extrudate mass flow into subflows. However, obtaining a desired degree of mixing or a homogenous mixture after introducing a fluid additive into a relatively viscous fluid food extrudate subflow or other fluid food product is troublesome. Typical food dough extrudates may have a viscosity in the range of from about 200,000 to 1,000,000 centipoise, for example. Upon introduction into a fluid food extrudate, a typically less viscous fluid additive (such as a colorant or flavorant) has a tendency to migrate to the exterior periphery of the extrudate where the additive tends to pool without blending with the food extrudate. This pooling at the extrudate's periphery prevents adequate blending of the additive throughout the extrudate mass by static mixers or other mixers located downstream from the additive injection point leaving undesirable pockets or areas of relatively high additive concentration in the extrudate mass. Dividing a fluid food extrudate mass flow into subflows and subsequently introducing a fluid food additive has inherent shortcomings in addition to pooling or insufficient mixing. Introducing an additive injection device into the cross-sectional flow of the extrudate substream can substantially increase the pressure drop along the length of the passageway where the injection device is present. This increases the overall resistance in the system. When the original extrudate mass flow is divided into a plurality or many subflows, each travelling through a corresponding separate passageway, the additional energy required to drive the highly viscous fluid food extrudate to system's end can be substantial. Moreover, providing an independent additive supply for each additive injection device incorporated within each passageway makes it difficult to obtain a uniform introduction of additive in each of a plurality of extrudate subflow passageways. A need exists to more uniformly introduce the same amount of additive across a plurality of food extrudate subflows travelling through separate passageways. A need also exists to more effectively reduce pooling when additive is introduced. Finally, a need exists for an additive injector device that can be easily and readily cleaned and/or sanitized. SUMMARY OF THE INVENTION To avoid peripheral pooling, fluid additives are introduced by inserting an additive injector into the passageway perpendicular to the longitudinal axis of the fluid food extrudate subflow. This partitions the subflow mass prior to the introduction of the additive. Splitting or partitioning has the advantage of reducing the amount of static mixing required to blend the additive in the passageway which consequently lowers the overall pressure drop of the device. In this configuration, the additive is dispersed in the center of the extrudate mass subflow thereby offsetting the tendency of the additive to migrate and pool on the extrudate's outer periphery. In accordance with one aspect of the present invention, an apparatus for injecting a fluid additive into a viscous fluid food flow stream is provided. The apparatus includes a passageway having an interior and an exterior, including an interior wall, which passageway is suitable to accommodate a fluid food flow, which may be a cooked cereal dough, for example, or other material, through the interior of the passageway. Structure is disposed in the passageway for injecting a fluid additive into the fluid food flow in the passageway. The structure in accordance with the invention for injecting the fluid additive can be streamlined to minimize the pressure drop across the injecting structure. In addition, the injecting device may include structure to preventing fluid injected by the injector from contacting the interior wall of the passageway. Such action prevents unwanted pooling or accumulation of additive fluid at the outer portions of the fluid food stream, which can result in an unacceptable or undesirable product. The fluid additive can be any fluid additive as desired, and may include a colorant, flavor, food supplement or any other desired fluid food additive. In accordance with another aspect of the present invention, the structure for injecting the fluid additive into the relatively viscous fluid food stream includes a fluid additive manifold located within the passageway, which manifold may be mounted within the passageway. The manifold may be contained within an annular body or other shaped body or portion thereof as desired. A plurality of elongated ribs extend from the manifold and extend transversely across at least a portion of the passageway. Each of the ribs may have a downstream surface and a streamlined upstream surface to minimize pressure loss across the injector device. Generally, the manifold will have an internal fluid additive supply channel, with each of the ribs having an internal fluid additive or extending along an axial length of the rib that is in fluid communication with the channel and with the interior of the passageway. Communication between the channel and the interior of the passageway is achieved through a suitably configured aperture located along a central portion of the downstream portion of the rib and spaced transversely from the interior wall of the passageway. The aperture may be configured as an elongated slot. Downstream-extending fins can be located between the interior wall of the passageway and the ends of the aperture or slot aperture. Typically, a pair of such fins will be provided for each elongated slot aperture for preventing fluid injected through the opening or slot and into the viscous fluid food flow within the passageway from contacting the interior wall of the passageway. In this manner, unwanted pooling or accumulation of the fluid additive along the wall of the passageway is prevented. Such pooling or migration to the interior wall of the passageway is undesirable because it is very difficult to properly mix, thereby creating undesirable concentrations of the additive fluid in such areas. In accordance with another aspect of the present invention, the passageways in the fluid injector device are straight and have an exterior line of sight access to permit such passages to be readily cleaned. This is particularly advantageous for various types of food materials that become hardened and have a strong adherence to metal parts, including cooked and dried cereal dough. Preferably, the ratio of the interior diameter of the passageway to fin width is in the range of from about 6 to about 10 and the ratio of the interior diameter of the passageway to the fin length is in the range of from about 3 to about 15. Typically, the ribs have an internal passageway or bore that extends along an axial length of each rib that is relatively large in volume compared with the area of the aperture through which the fluid additive can be injected into the passageway. Such an arrangement facilitates the relatively uniform discharge of fluid throughout the length of the aperture or apertures located in the rib. In accordance with another aspect of the present invention, a system is provided for dispersing a fluid additive into a relatively viscous fluid food flow stream. The system comprises a passageway having an interior and an exterior and including an interior wall. The passageway is suitable to accommodate a fluid food flow through the interior of the passageway. A fluid additive injection device is associated in an operative relation with the interior of the passageway for injecting a fluid additive into a fluid food flow in the passageway. The fluid additive injection device includes a fluid additive manifold, a plurality of elongated ribs extending from the manifold and which extend transversely across at least a portion of the passageway. The manifold has an internal fluid additive supply channel and each of the ribs has an internal fluid additive bore extending along an axial length of the rib in fluid communication with the channel and with the interior of the passageway through a rib aperture preferably located along a central portion of the downstream surface of the rib, face or portion, which aperture is spaced transversely from the interior wall of the passageway. A fluid additive supply source is in fluid communication with the fluid additive manifold. A pump is provided for supplying a constant amount of fluid additive from the supply source to the manifold without utilizing a flow control valve. This can be accomplished in a number of ways, including utilizing piping of equal length and diameter from the pump to each of a plurality of injection devices that may be utilized. Finally, a fluid food mixer is disposed in the passageway downstream of the food additive injection device for mixing the additive to a desired degree. In accordance with the present invention, incomplete mixing is contemplated to provide a swirled or marbled effect or varied concentration of the fluid food additive, which may be a colorant. In accordance with another aspect of the invention, a fluid food flow stream, which may be obtained from the outlet of a food extruder, is directed to the system in accordance with the invention which can include structure for splitting the main flow stream into a plurality of substreams for further processing, including the introduction of a desired fluid additive. In connection with this aspect of the invention, a plurality of passageways can be provided with each passageway having one of the fluid additive injection devices. Structure is provided for supplying an equal amount of the fluid additive to each of the additive injection devices without a flow control valve or other adjustable flow control structure or mechanism. In accordance with another aspect of the invention, the structure for supplying the fluid additive to each of the additive injection devices includes a piping system and a single pump. The piping system is in fluid communication with each of the manifolds of the fluid additive injection devices, including a separate delivery pipe to each manifold, with the piping system being configured so that the flow rate of the fluid additive at a given pump output is the same to each manifold. In accordance with another aspect of the present invention, a plurality of passageways, each containing a fluid additive injection device, is provided, which may be an even number of passageways with a separate pump and piping system supplying a single pair of fluid additive injection devices. In accordance with still another aspect of the present invention, a method of injecting a fluid additive into a relatively viscous fluid food stream traveling in a passageway is provided. The passageway has an interior wall in which the injected fluid additive avoids contact on the interior wall of the passageway. In accordance with the method, a fluid additive injection device is provided and associated in operative relation with the passageway for injecting the fluid additive into the fluid food flow. The injection device can be as previously described and may include a fluid additive manifold, a plurality of elongated ribs extending from the manifold and which extend transversely across at least a portion of the passageway. The manifold may have an internal fluid additive supply channel, with each of the ribs having an internal fluid additive bore that extends along an axial length of the rib in fluid communication with the channel and with the interior of the passageway through a rib aperture located along a central portion of the downstream portion of the rib and spaced transversely from the interior wall of the passageway. In addition, a pair of elongated fins may be associated with each rib and disposed between the interior wall and the end of a rib aperture, which fins extend downstream of their respective rib for preventing fluid injected through the slot from the manifold and into the passageway from contacting or pooling along the interior wall of the passageway. The method further includes passing the relatively viscous fluid food through the passageway and injecting a fluid additive into the fluid additive injection device, through the rib apertures of the injection device and into the viscous fluid food, the fins preventing the fluid additive from contacting or pooling along the wall of the passageway. In addition, the present invention provides for a system and method of introducing a uniform amount of additive across a plurality of subflow passageways. A positive displacement pump capable of generating pressure in excess of each subflow passageway is connected between the additive source and each additive injection cartridge located in the subflow passageways. Tubing or piping between the pump and each subflow passageway may include a suitable restriction or fixed diameter for adjusting the pressure drop between the pump and each additive injection cartridge. For example, a narrow diameter tube diameter could be used to connect the pump to a subflow passageway that is located closer to the pump than another subflow passageway located further from the pump wherein a wider diameter tube or pipe could be used to connect the pump to the longer subflow passageway. Consequently, the additive flow rate into each additive injection cartridge can be uniform without a flow control valve. This ensures that the amount of additive dispersed throughout each extrudate subflow is the same, thereby producing a uniform food product yield from the plurality of subflow passageways. Alternatively, the fluid additive delivery system can consist of a relatively large diameter pipe that supplies the individual injector cartridges. Preferably, any piping that connects the large diameter pipe with the individual injector cartridge is of relatively the same length and diameter. Alternatively, when a uniform additive blend across all extrudate subflows is not desired, one embodiment of the present invention provides for a plurality of pumps wherein the number of pumps is at most one less than the number of subflow passageways. Here, the pressure drop across each additive injection cartridge need not be uniform. With this arrangement, one pump can provide additive to two or more subflow passageways. Thus, different additives may be introduced to different subflow passageways or varying amounts of the same additive may be introduced to different subflow passageways. The present invention further provides for an additive injection cartridge that uniformly disperses additive throughout each corresponding extrudate subflow. The additive injection cartridge may be disk-shaped and partitions the extrudate subflow by means of a plurality of parallel ribs which are positioned perpendicular to the direction of the extrudate subflow in each passageway. In a preferred embodiment, the upstream surface of each rib comes to a point wherein the apex of the point partitions the oncoming subflow. This apex reduces the friction between the ribs and the subflow during partitioning, thereby assisting to reduce the pressure drop across the additive injection cartridge. Another aspect of the invention provides fins on the downstream surface of each rib. These fins are important in restricting the migration or flow of the additive fluid to the exterior of the food stream before the extrudate-additive combination reaches the static mixers. According to a further aspect of the present invention, bores within the ribs extend through the disk with orifices on each end. This allows for easy maintenance and cleaning of the rib interior. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a sectional side view of an apparatus for adding a fluid additive into a viscous fluid food stream in accordance with the invention; FIG. 2 is a sectional plan view of the apparatus of FIG. 1 along line 2 — 2 ; FIG. 3 is a schematic flow diagram for injection of a fluid additive; FIG. 4 is an alternative schematic flow diagram for injection of a fluid additive; FIG. 5 is a perspective view of a fluid additive injector device in accordance with the invention; FIG. 6 is a sectional view of the injector device along line 6 — 6 of FIG. 5; FIG. 7 is a rear elevation view, partly in section, of the injector device of FIG. 5; FIG. 8 is a front elevation view of the injector device of FIG. 5; FIG. 9 is a sectional view of the injector device along line 9 — 9 of FIG. 7; FIG. 10 is a fragmentary sectional view of the injector device along line 10 — 10 of FIG. 8; and FIG. 11 illustrates an alternative embodiment of the portion of the injector device shown in FIG. 10 . DETAILED DESCRIPTION OF THE INVENTION Referring now to the drawings generally, and in particular to FIG. 1, there is illustrated a food processing device 10 in accordance with the present invention. Device 10 is ideally suited for processing cooked cereal dough, which is typically a relatively viscous fluid. Such doughs typically are in the viscosity range of from about 200,000 to about 1,000,000 centipoise. The dough is processed to form a ready to eat (RTE) cereal. Upstream of device 10 is an extruder cooker (not shown) of standard construction. Such devices are well known in the art. The extruder cooker produces a viscous, plastic cooked cereal dough which is fed to food processing device 10 . Food processing device 10 includes an adapter plate 12 for interfacing device 10 with the extruder cooker, an inlet transition plate 14 , a fluid additive, injector cartridge flange 16 , fluid additive injector cartridge 18 , a static mixer assembly 20 , an outlet transition plate 22 , breaker plates 24 and a die plate 26 . A suitable cutter assembly (not shown) can be utilized downstream of die plate 26 to divide the extruded food as it exits die plate 26 into desired lengths which may be subjected to further processing, such as formation into flakes, sheets or puffed pieces. Inlet transition plate 14 provides a constricted diameter for fluid food leaving the extruder cooker at the inlet to food processing device 10 . A constricted diameter increases the pressure in food stream 5 which in this embodiment is split into six food substreams 5 ′, as indicated by arrows A, for ease of processing, in which the streams 5 ′ travel in the direction indicated by arrows B in FIG. 1 . The split into six streams 5 ′ occurs as the fluid food dough travels into fluid additive cartridge flange 16 . Flange 16 includes a center cone section 28 which facilitates the flow of dough into the six separate substreams 5 ′, helping to prevent the formation of any void spaces. Inlet transition plate 14 is secured to adapter plate 12 by means of a suitable fastener, which may be threaded fasteners 30 . Similarly, inlet transition plate 14 , fluid additive cartridge flange 16 , static mixer assembly 20 , transition plate 22 and die plate 26 are also secured together, as illustrated in FIG. 1 by means of suitable fasteners such as threaded fasteners 32 , 34 and 36 . Fluid additive cartridge flange 16 is disc-shaped and includes recesses 38 adapted for mounting fluid additive injector cartridges 18 therein, as shown in FIGS. 1 and 2. A fluid additive supply line 40 is provided for each injector cartridge 18 . Supply lines 40 in flange 16 are preferably straight to readily permit cleaning, which may include cleaning by drilling or boring through any accumulated material or residue in supply lines 40 . Flange 16 defines six passageways 42 in conjunction with injector cartridge 18 and static mixer assembly 20 . Static mixer assembly 20 is composed of an elongated tubular structure 44 in which is disposed static mixer flights 46 , shown schematically in FIG. 1 . Tubular structure 44 is jacketed with jacket 48 to permit heating or cooling as desired with an appropriate fluid through inlet ports 50 and outlet port 52 . A sufficient length of mixer flights 46 are provided to achieve the desired degree of mixing for a particular product, which may range from light mixing to complete mixing. Less than complete mixing can produce a marbled or swirled effect, which can be an appearance (if colorant is utilized as the fluid additive) and/or a concentration gradient. Assembly 20 also includes appropriate mounting flanges 54 and 56 . Mounted at the discharge end 20 ′ of mixer assembly 20 is transition plate 22 , which slightly expands passageways 42 from an upstream to downstream direction. The mixed fluid food with the injected fluid additive then travels through breaker plate 24 which is composed of a plurality of apertures, after which the fluid food travels through die plate 26 for division into individual lengths or ropes, which can then be divided into discrete lengths or pellets, to be processed further as desired, such as by flaking, sheeting or puffed pieces. Referring to FIGS. 5-11, various aspects of fluid additive injector cartridge 18 are illustrated in detail. Cartridge 18 includes a fluid additive manifold 58 which is a straight bore having an external line of sight access 58 ′ to readily permit cleaning such as by boring or drilling, for example. Manifold 58 is aligned with its respective fluid additive supply line 40 in cartridge flange 16 . Such alignment is facilitated by locator pins or dowels 60 in cartridge 18 and complementary holes (not shown) of recess 38 of flange 16 , so that when cartridge 18 is in position as shown in FIG. 1 in flange 16 , pins 60 are contained in the complementary holes of flange 16 . Injector cartridge 18 may have an annular body 62 in which manifold 58 is located. Grooves 64 and 66 extend around the outer periphery of annular body 62 to contain O-rings 68 and thereby provide a fluid-tight seal when mounted in flange 16 as hereinafter described. A plurality of ribs 70 , 72 , 74 and 76 extend from one side of the annular opening to the other as shown in FIGS. 5, and 7 - 9 . Each rib has a longitudinally extending bore 78 , 80 , 82 and 84 , respectively, each of which communicates with manifold 58 and extends through the opposite side of annular body 62 , as shown in FIGS. 5-8. Bores 78 , 80 , 82 and 84 are straight and provide an external line of sight access where bores 78 , 80 , 82 and 84 extend through annular body 62 as shown in FIG. 5 to readily permit cleaning, including by drilling or boring, for example. O-rings 68 provide a fluid-tight seal to prevent any fluid in bores 78 , 80 , 82 and 84 from entering passageway 42 when injector cartridges 18 are installed in cartridge flange 16 . Ribs 70 , 72 , 74 and 76 preferably have an upstream streamlined shape as shown in FIG. 6 so that a viscous fluid food (which may be a cereal dough) readily passes around and past ribs 70 , 72 , 74 and 76 . In this case, the streamlined shape is a wedge shape with the upstream leading edge 70 ′, 72 ′, 74 ′ and 76 ′ of ribs 70 , 72 , 74 and 76 being wedge-shaped having an angle of about 90°. For the illustrated embodiment and recited dimensions, the point of the wedge shape has a radius of curvature that is about 0.060 inches, as indicated by R in FIG. 10 . In addition, ribs 70 , 72 , 74 and 76 have a height H R as shown in FIG. 10 of about 0.313 inches. The downstream side of ribs 70 , 72 , 74 and 76 each have an elongated slot aperture 86 , 88 , 90 and 92 , respectively, that communicate with bores 78 , 80 , 82 and 84 , respectively. The volume of bores 78 , 80 , 82 and 84 is relatively large compared to the area of slot apertures 86 , 88 , 90 and 92 . Each slot aperture 86 , 88 , 90 and 92 is elongated and extends longitudinally of respective rib 70 , 72 , 74 and 76 , and extends along a central portion of the downstream facing side of such ribs. In one embodiment, for an inner diameter annular body 62 of about 3 inches, each of slot apertures 86 , 88 , 90 and 92 is about 0.020 centimeters wide and the diameter of each of bores 78 , 80 , 82 and 84 is about 0.188 inches. Ribs 70 , 72 , 74 and 76 have a spacing therebetween of about 0.219 inches with the maximum spacing between end ribs 70 and 76 and the interior of annular body 62 as indicated by arrows C being about 0.472 inches. Each rib 70 , 72 , 74 and 76 on the downstream side thereof has a pair of fins 94 , 96 , 98 and 100 , respectively, that extend downstream from the ribs and longitudinally of annular body 62 and thus of passageway 42 when mounted in food processing device 10 . Preferably, each end of slot apertures 86 , 88 , 90 and 92 terminates about {fraction (3/32)} inch before each of fins 94 , 96 , 98 and 100 . Fins 94 , 96 , 98 and 100 preferably are slightly curved and thus are concentric to inner diameter curvature 62 ′ of annular body 62 . In the illustrated embodiment of FIGS. 5-10, fins 94 , 96 , 98 and 100 have a width of about 0.375 inches as indicated by arrow D and a height from the tip of rib 72 where aperture 88 is located of about 0.25 inches, indicated by arrow H in FIG. 10 . Fins 94 , 96 , 98 and 100 should have sufficient thickness for the desired structural rigidity for the intended operating environment. In addition, fins 94 , 96 , 98 and 100 are radially inwardly located approximately 0.20 inches from the inner surface of annular body 62 , for annular body 62 having a diameter of about 3 inches. Fins 94 , 96 , 98 and 100 have a rectangular profile as shown in FIG. 10, which is preferred compared to other profile shapes, such as the triangular profile shown in FIG. 11, where like reference numerals represent like elements. The rectangular profile functions more effectively in keeping fluid injected out of bore 80 and slot aperture 88 from reaching the wall of passageway 42 . Preferably, for the illustrated embodiment, the ratio of the interior diameter of passageway 42 (and also interior annular diameter of annular body 62 ) to fin width D is in the range of from about 6 to 10 and the ratio of passageway 42 diameter to fin length H is in the range of from about 8 to about 15, as shown in FIG. 10 . Referring to FIGS. 3 and 4, there is illustrated various fluid additive delivery systems in accordance with the invention. More specifically, a fluid additive delivery system 102 in FIG. 3 includes a pump and pump manifold 104 (shown schematically), piping segments 106 a-f , and six injector cartridges 18 a-f . Pump 104 preferably is a positive displacement pump to reduce the chance that fluid food in passageway 42 would travel into any of injector cartridges 18 a-f . In one embodiment, the length of piping segments 106 a-f are of the same length, geometry and diameter, so that uniform fluid additive flow rates are achieved without the use of any flow control valves or other adjustable flow control devices. Alternatively, for different lengths of piping segments 106 a-f longer segments can be of larger diameter, or shorter segments can be of smaller diameter or otherwise have fixed restrictions 108 a-e therein to provide the same flow rate at a given pump output. Alternatively, different flow rates may be provided by providing for different pressure drops between pump 104 and injectors 18 a-f as desired without an adjustable flow control valve or other adjustable flow controller. Referring to FIG. 4, an alternate fluid additive delivery system is illustrated composed of three pumps and pump manifolds 110 a-c , piping segments 112 a-f and six injector cartridges 18 a-f . Each of pumps 110 a-c supplies a fluid additive to two separate injector cartridges 18 a-f . The additive supplied by each pump may be the same or different as desired. Uniform or different flow rates can be provided as described with respect to FIG. 3 . Referring to FIG. 2, an alternate fluid delivery system is illustrated in which a pump (not shown) supplies the additive fluid under a desired pressure to a relatively large diameter pipe 114 (shown in fragmentary view) which is used to supply each of fluid additive delivery lines 40 . Pipe 114 should preferably have a diameter of at least about two to four or more times the diameter of one of delivery lines 40 . While the invention has been described with respect to certain preferred embodiments, as will be appreciated by those skilled in the art, it is to be understood that the invention is capable of numerous changes, modifications and rearrangements and such changes, modifications and rearrangements are intended to be covered by the following claims.

An apparatus, system and method is provided for injecting a fluid additive into a viscous fluid food flow stream. A fluid additive injector device is utilized to inject the fluid additive which has structure to prevent or minimize the amount of fluid additive that contacts or pools along the periphery of the fluid food flow stream. A fluid additive delivery system is provided to deliver equal amounts of fluid additive to a plurality of fluid additive injectors using a single pump without adjustable flow control apparatus.

BACKGROUND OF THE INVENTION 1. Technical Field The present invention relates generally to a display shelving system. More specifically, the invention relates to a modification to a retail sales display gondola that allows for the replacement of the standard base deck with a free-standing base deck. This modification can be made to numerous different gondola systems manufactured by different manufacturers, but accomplishes the same goal of adding shelf space to the gondola. 2. Description of Related Art Retail display shelving commonly used in grocery stores, department stores, discount stores, and other retail outlets that display items on shelves, are manufactured by numerous companies in a plethora of models and design choices. The units that are typically found in a grocery store to display items for sale, such as bags of salty snacks, are typically referred to in the industry as gondola units. These units are typically self-contained with multiple shelves. A list of some of the manufacturers offering these gondolas includes Lozier, Madix, the Thorco Division of Marmon Group, and Syndic Systems Division of Legget and Platt. Although there are variations amongst the gondola units offered by different manufacturing companies, the basic design is fairly well established and there are many common features shared industry wide. A typical example of a gondola system is illustrated in FIGS. 1A and 1B . The particular gondola system illustrated in these figures is manufactured by Lozier, but is illustrative of many others offered by other manufacturers. FIG. 1A presents an exploded perspective view of the basic components of the prior art while FIG. 1B shows a perspective view of an assembled unit as one would encounter in a retail environment. The core of the prior art gondola is a back panel 102 which is vertically oriented and is held in position by connection to at least one upright 104 , which is also vertically oriented. In the embodiment shown, the connection to the upright 104 is accomplished by at least a bottom rail 108 , a center rail 110 , and a top rail 122 , although more of such horizontal rails 108 , 110 , and 122 can be used for this purpose. The vertical uprights 104 are stabilized by at least one, and typically two, base legs or brackets 106 . One or more shelves 112 can be horizontally positioned in numerous locations relative to the back panel by virtue of connections between the shelf 112 and the uprights 104 . A base deck or shelf 114 is maintained off of the surface upon which the entire unit sits by being supported by the base brackets 106 . A closed base front 116 encloses the space beneath the base deck in conjunction with base deck 114 and base bracket trim 118 , when said base and trim also covers the base brackets 106 . The gondola unit may have other trim components such as the upright and trim 120 that covers the upright 104 . A disadvantage of the gondola system illustrated in FIGS. 1A and 1B is that, since the base deck 114 is elevated off of the flooring to the approximate height of the base leg or bracket 106 , the display space that could be used is limited by the displacement beneath. In certain applications, a modification to the system may be desired that positions the base deck as close as possible, and perhaps even resting on, the flooring. It would be desirable to have a single modification unit that could be used with a variety of gondola systems. Nothing in the prior art addresses the problem associated with maximizing the available retail sales space on a typical gondola. Because retailers have a fixed amount of floor space with which to display retail merchandise, a need exists for a means to maximize the available space. A further need exists for a means to reclaim the retail sales space that is wasted below the bottom shelf of most gondolas. Because retailers typically utilize gondolas from multiple vendors, a further need exists for a means to maximize the retail shelving space that works universally with many different brands of gondolas. The present invention fills these needs and other needs as detailed more fully below. BRIEF SUMMARY OF THE INVENTION The preferred embodiment of the present invention provides a means for reclaiming wasted retail shelving space present in most typical retail display shelving systems (referred to in the industry as “gondolas”). The lower base deck of a typical gondola unit sits several inches above the floor surface. This space beneath the base deck is merely hidden and unutilized. The present invention comprises a free-standing base deck that replaces the fixed base deck, and is positioned entirely within the space that originally held the fixed base deck. This free-standing base deck aligns with the gondola's back panel and base brackets without physical attachments to the gondola. One embodiment of the present invention includes a stretcher device to serve as a means to couple with and maintain proper spacing of the gondola's base brackets, allowing the free-standing base deck to sit directly on the surface of the floor beneath the gondola. One preferred embodiment of the present invention is made of the same or similar materials as the original base deck which it replaces. The preferred embodiment is metal, preferably 18 Ga. cold rolled steel, which affords the free-standing base deck sufficient durability to withstand the abuse of the retail sales environment. All other components are made of similar materials to ensure proper rigidity of the gondola structure as well as proper operation of the entire gondola unit. The invention accordingly comprises the features described more fully below, and the scope of the invention will be indicated in the claims. Further objects of the present invention will become apparent in the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS The novel features characteristic of the invention are set forth in the appended claims. The invention itself, however, as well as a preferred mode of use, further objectives and advantages thereof, will be best understood by reference to the following detailed description of illustrative embodiments when read in conjunction with the accompanying drawings, wherein: FIG. 1A illustrates an exploded perspective view of a prior art design for a typical prior art retail display shelving or “gondola” unit. FIG. 1B illustrates a perspective view of an assembled prior art design for a typical prior art retail display shelving or “gondola” unit as one would encounter in a typical retail sales establishment. FIG. 2A illustrates an exploded perspective view of a first embodiment of the present invention utilizing a “stretcher” in conjunction with a typical gondola unit. FIG. 2B illustrates a cutaway perspective view of an assembled first embodiment of the present invention utilizing a “stretcher” in conjunction with a typical gondola as one would encounter in a retail sales establishment. The cutaway portion shows the interoperability of the various components. FIG. 3A illustrates an exploded perspective view of a second embodiment of the present invention utilizing a “spanner” in conjunction with a typical gondola unit. FIG. 3B illustrates a cutaway perspective view of an assembled second embodiment of the present invention utilizing a “spanner” in conjunction with a typical gondola as one would encounter in a retail sales establishment. The cutaway portion shows the interoperability of the various components. Like reference numerals represent equivalent parts throughout the several drawings. REFERENCE NUMERALS 102 back panel 104 upright 106 base bracket 108 bottom rail 110 center rail 112 shelf 114 base deck 116 base front 118 base bracket trim 120 upright end trim 122 top rail 202 free-standing base deck 204 stretcher 206 leg cap 304 spanner DETAILED DESCRIPTION OF THE INVENTION Referring now to the provided drawings, similar reference numerals represent the equivalent component throughout the several views of the drawings. FIG. 2A shows an exploded perspective view of a first embodiment of the present invention while FIG. 2B shows a cutaway portion of a typical assembled gondola unit modified by the first embodiment of the present invention. FIG. 3A shows an exploded perspective view of a second embodiment of the present invention while FIG. 3B shows the respective cutaway portion of the second embodiment modified by the present invention. The present invention comprises a free-standing base deck 202 (shown in FIGS. 2 and 3 ) that serves as a direct replacement for the original base deck 114 (shown in FIG. 1 ) of the prior art gondola unit. Because the original base deck 114 is normally directly attached to the back panel 102 and both base brackets 106 and possibly the base front 116 , removal of the original base deck 114 and base front 116 requires a spacing device for maintaining the parallel alignment of the base brackets 106 . In the first embodiment as illustrated in FIG. 2 , the spacing device chosen is a stretcher 204 while in FIG. 3 , which shows a second embodiment, a different spacing device known as a spanner 304 is chosen. With respect to FIG. 2 , to maintain proper base bracket 106 alignment, the ends of the stretcher 204 removably attach to the forward most ends of the respective base bracket 106 thus ensuring the base brackets 106 remain fixed in a parallel fashion. The stretcher 204 also restores overall rigidity to the gondola unit that is lost due to the removal of the original base deck 114 and base front 116 , and maintains the overall structural integrity of the gondola with regards to the gondola's load bearing capability. FIG. 3 shows a second embodiment that uses a spanner 304 that serves in the same capacity as the stretcher 204 . The spanner 304 and stretcher 204 (shown in FIG. 2 ) both demonstrate that a different spacing device can be chosen without departing from the inventive concept. It is even possible, on some gondola units, to leave the base front 116 in place. However, removal of the original base deck 114 and installation of the free-standing base deck 202 will result in a lower shelf for the gondola unit having increased vertical space (due to the use of the improvement) but being “walled-in” by the still existing base front 116 . Thus, it may be more aesthetically pleasing to remove the base front 116 and install either a stretcher 204 or a spanner 304 in its place. In FIG. 2 the free-standing base deck 202 takes the place of the original base deck 114 by occupying the space between the back panel 102 , base brackets 106 and stretcher 204 , with no physical attachments to any portion of the gondola. The free-standing base deck 202 thus positionally registers itself between the back panel 102 , base brackets 106 and stretcher 204 . By sitting on the floor beneath the gondola, the free-standing base deck 202 thus reclaims the retail shelving space that is the difference between the height of the original base bracket 114 from the floor and the height of the free-standing base bracket 202 from the floor. In the embodiment shown, the free-standing base deck 202 is approximately 3 inches in height. The original base deck 114 of a representative gondola unit is approximately 6 inches or greater from the top of the base deck to the floor. Thus, the present invention can reclaim as much as 3 inches or more in additional shelving height over the unmodified gondola unit. This additional space translates into increased retail shelving space for display and sales of a greater quantity of retail product per modified gondola. Once the original base deck 114 is removed, portions of the base brackets 106 may become exposed. Consequently, a concealing device for restoring and maintaining the aesthetic qualities of the gondola unit is required. The concealing device chosen in both the first embodiment of FIG. 2 and second embodiment of FIG. 3 is a leg cap 206 . This leg cap 206 replaces the base bracket trim 118 and effectively covers any exposed portions of the base bracket 106 . In the embodiment shown in FIG. 2 , the free-standing base deck 202 and leg caps 206 are constructed from metal, preferably 18 Ga. cold rolled steel. This material is commonly used in the display shelving industry and thus should not require retooling or special machinery to manufacture. It is also durable and relatively inexpensive to use compared to other metals. In addition, this material is easily bent or folded using a metal brake and can also be welded. Thus, the free-standing base deck 202 and leg caps 206 can be manufactured using the same or similar process used to manufacture the other components of a standard gondola unit. Because there is no significant retooling required to manufacture the preferred embodiment of the present invention, manufacturing costs can be kept to a minimum. Alternative materials, such as plastic or fiberglass, can also be used in the construction of the free-standing base deck 202 and leg caps 206 . Material selection can be based on the particular needs of the existing gondola unit. The free-standing base deck 202 can be manufactured to essentially any width/depth/height combination depending on the requirements of the base deck 114 that it is replacing. In the embodiment shown in FIG. 2 , the free-standing base deck 202 measures approximately 46¾ inches in width by approximately 23½ inches in depth by approximately 3 inches in height. It is formed from three pieces of 18 Ga. cold rolled steel; one piece for the base deck top surface and one piece for each of the two sides. One method for manufacturing this embodiment would be to take a single sheet of the preferred material, cut to the preferred dimensions with approximately 4½ inches added to the depth in order to form the front and back edges. The front edge could be formed by bending approximately 1½ inches of the depth dimension downward using a metal brake such that the finished edge forms an angle of approximately 105 degrees with the bottom surface of the base deck material. In a similar fashion, the rear edge of the base deck could be formed by bending approximately 3 inches of the depth dimension downward using a metal brake such that the finished edge forms an angle of 90 degrees with the bottom surface of the base deck material. The dimension of this rear edge establishes the height that the completed free-standing base deck top surface maintains from the floor. The two sides of the base deck can then be formed from pieces of the same preferred material, cut to the profile of the previously formed free-standing base deck with formed front and back edges. These two side pieces can then be welded into place (using any welding process suitable for the material being used) on the respective sides of the free-standing base deck 202 , thus completing its construction. The embodiments shown in FIGS. 2 and 3 each utilize a free-standing base deck 202 with a raised lip on its front edge to provide positive retention of items placed on the top surface. This lip runs the width of the free-standing base deck 202 and has a triangular shaped cross section. It is also possible to use a free-standing base deck 202 without the lip or else with a traditional wire-framed fence as is commonly used in display shelving. To accommodate a traditional wire-framed fence, the free-standing base deck 202 can have suitable perforations in its top surface to accept the fence's mating tabs. The free-standing base deck 202 shown in the provided drawings has perforations in its top surface near the rear edge to illustrate this. With minor modifications, any display shelving product retention means is possible without straying from the inventive concept. The leg cap 206 can be manufactured using the same process and materials as the free-standing base deck, and can be essentially any width/depth/height combination as well. Because the leg cap 206 is meant as a decorative cover to replace the displaced base bracket trim 118 , the width/depth/height combination of any leg cap 206 should be chosen to hide any exposed surfaces of the original gondola base bracket 106 . This is aesthetically necessary because the free-standing base deck 202 exposes the inner surfaces of the original base bracket 106 that were once hidden by the now displaced original base deck 102 . Each leg cap 206 can be manufactured from a single sheet of the same or similar material used for the free-standing base deck 202 by bending the two longest sides downward to form a channel that is sufficiently wide enough to slip over the top of a base bracket 106 . The end of the leg cap 206 that would be opposite the upright 104 could then be closed by welding an appropriate sized rectangular piece of the same or similar material over the opening of the channel. The finished leg cap 206 should be sufficiently wide enough to fit over a base bracket 106 ; sufficiently long enough to cover the length of the base bracket 106 ; and sufficiently tall enough to cover the vertical height of the exposed portions of the base bracket 106 . The stretcher 204 in the preferred embodiment of FIG. 2 is constructed from metal, preferably 16 Ga. cold rolled steel. Likewise, in FIG. 3 , the spanner 304 is constructed of the same material. Heavier materials can be used for the stretcher 204 or spanner 304 because it adds to the structural integrity of the gondola on which it is installed. The stretcher 204 in the first embodiment is comprised of three components formed from three pieces of the chosen material. One component measures approximately 46⅞ inches in length by 1½ inches in width. The piece can be bent on a metal brake such that it forms a “U” shaped channel along the length; the bottom of the channel measuring approximately ¾ inches in width and the two sides of the channel measuring approximately ½ inch in height. Thus, this first piece of the stretcher 204 establishes the width of the space between the two parallel base brackets 106 upon which the stretcher 204 will eventually attach. The other two components that comprise the stretcher 204 are the two upright pieces that provide the physical attachment with the base bracket 106 . These upright pieces can be made from two identical pieces of the same material as the first piece of the stretcher, measuring approximately 4 inches in length by approximately 1⅔ inches in width. The upright pieces in the first embodiment are formed into a “J” shape by bending them along their length such that the bottom and side of the “J” are approximately ½ inches long. To complete the stretcher 204 , the two upright components are attached to the longer center component by welding. Thus, the completed stretcher 204 will provide a positive, physical attachment with each respective base bracket 106 , maintaining the base brackets 106 parallel in order to allow adequate spacing and maintain alignment for the free-standing base deck 202 . In addition, the stretcher 204 allows adequate spacing between itself and the back panel 102 to properly retain the free-standing base deck 202 . The spanner 304 in the second embodiment of FIGS. 3A and 3B is comprised of a single sheet of the same chosen material, which is bent in such a fashion to create the necessary rigidity and removably attachable end pieces to allow it to serve the same spacing device means as the stretcher 204 . The ends of the spanner 304 are essentially “tabs” that are bent inward to create a feature similar to a standard spring clip that allows for the ends to attach to a particular gondola's base brackets 106 . Thus, with minor modifications to the chosen spacing device means it is possible to adapt the spacing device to accommodate essentially any commercial gondola. All of the dimensions provided for the two described embodiments can be easily varied in order to meet the needs of any particular gondola unit. While there are many standard sizes of commercial gondolas, there can be significant variations that would necessitate adjustments to the required dimensions. While specific embodiments of the invention have been disclosed, one of ordinary skill in the art will recognize that one can modify the dimensions and particulars of the embodiments without straying from the inventive concept.

A improved product display adaptable to standard gondola systems. The display increases the retail sales space available by providing for the recovery of unused space traditionally existing below the original base deck of the display. This display comprises a new free-standing base deck to replace the original base deck. The free-standing base deck positionally registers in the space where the original base deck was located. The free-standing base deck rests directly on the floor surface beneath the product display thus reclaiming the unused space beneath the original base deck. The display includes an additional member for maintaining the product display's base brackets parallel to assist in retaining and positionally registering the free-standing base deck, and an additional member for maintaining the aesthetic appearance of the product display's base brackets by covering the exposed portions that were once hidden by the original base deck.

RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Patent Application No. 61/877,391, filed Sep. 13, 2013, the entire contents of which are incorporated herein by reference. BACKGROUND [0002] The present invention relates to flexure mechanism such as, for example, a flexure joint of a surgical tool. Because a flexure joint bends by elastic deformation of a structure, force is required to maintain the position of a flexure joint and to prevent it from returning to its original, non-deformed shape. SUMMARY [0003] Joints that involve elastic deformation of a structure in order to operation (e.g., “flexure joints”) can be used in various applications including, for example, robotic and manually actuated surgical arms, manipulators, flexible scopes, and catheters. The elastic deformation of the structure causes that joints/structure to act like a compressed spring. This spring energy is typically felt by either the user or servo motor as a constant force pushing back against the controls and trying to return the joint/structure to its unbent state. Because of the constant force needed to actuate and hold the continuum joint in a deformed position, flexure joints alone are not practical for use with manual tool. [0004] In one embodiment, the invention provides a mechanical energy balance of a flexure joint. This balance mechanism balances the joint's potential energy such that the user/servo motor no longer needs to resist a constant restoring force. In some embodiments, the flexure joint includes a continuum joint integrated into a dexterous laparoscopic manipulator such as, for example, an elbow joint in a surgical tool. In some embodiments, the energy balance mechanism includes a joint, a control handle, and a spring mechanism. The joint is a flexure joint that elastically stores energy when deformed. The control handle moves above the joint and controls the movement of the joint. The force required to move the control handle is mechanically linked to the joint. The spring mechanism is attached to the control handle and provides energy balance. [0005] In another embodiment, the invention provides a tool including an elastically deformable flexure joint, a control joint, and an energy balance system. The control joint is mechanically linked to the flexure joint such that movement of the control joint causes a corresponding deformation of the flexure joint. The energy balance system provides a spring force to aid movement of the control joint and to overcome an elastic force required to deform the flexure joint. [0006] In yet another embodiment, the invention provides a surgical tool that includes a hollow shaft and an end effector coupled to the distal end of the hollow shaft by an elastically deformable flexure joint. A joint control arm is coupled to the proximal end of the hollow shaft by a control joint. The control joint is mechanically coupled to the flexure joint such that movement of the control joint causes a corresponding deformation of the flexure joint. An energy balance system provides a spring force that aids movement of the control joint and overcomes an elastic force required to deform the flexure joint. [0007] Other aspects of the invention will become apparent by consideration of the detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0008] FIG. 1 is a perspective view of a manually actuated surgical tool including a flexure joint. [0009] FIG. 2 is a cross-sectional view of the flexure joint of the surgical tool of FIG. 1 . [0010] FIG. 3 is a detailed view of the flexure joint of the surgical tool of FIG. 1 in a deformed state. [0011] FIG. 4 is a perspective view of a manually actuated surgical tool including an energy balance mechanism. [0012] FIG. 5 is a graph of forces required to deform the flexure joint of the surgical tool of FIG. 1 and the flexure joint of the surgical tool of FIG. 4 . [0013] FIG. 6 is a perspective view of a surgical tool including an energy balance mechanism that includes a single spring. [0014] FIG. 7 is a perspective view of a surgical tool including an energy balance mechanism with the spring(s) removed to show the details of the gimbal structures. [0015] FIG. 8 is a detailed view of the control joint of the surgical tool of FIG. 7 . [0016] FIG. 9 is a perspective view of a surgical tool including a cam/pulley energy balance mechanism. [0017] FIG. 10 is a perspective view of a surgical tool including a sliding link energy balance mechanism. DETAILED DESCRIPTION [0018] Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. [0019] FIG. 1 illustrates a manually operated laparoscopic manipulator. The surgical tool 100 includes a hollow shaft 101 with a gripper tool 103 positioned at the distal end. An end effector control handle 105 is used to control the orientation and operation of the gripper tool 103 . The control handle 105 can be tilted in two degrees of freedom to control the angle of the gripper 103 (i.e., a “wrist joint”) and the handles of the control handle 105 can be squeezed together to open and close the gripper 103 . [0020] In addition to a mechanical wrist joint incorporated into the gripper structure 103 itself, the tool 100 includes a flexure joint 107 positioned between the gripper 103 and the hollow shaft 101 . The flexure joint 107 as described in further detail below includes a deformable portion of a continuum shaft. The bend and shape of the flexure joint 107 is controlled by moving the flex joint control handle 109 . In particular, the joint control handle 109 is bent relative to the shaft 101 at control joint 111 . Due to the structure of the continuum shaft, the flexure joint 107 bends in response to a bend at the control joint 111 such that the base of the gripper 103 remains substantially parallel with the flex joint control handle 109 . The control joint 111 allows the flex joint control handle 109 to move with two degrees of freedom. Therefore, the flexure joint 107 is also capable of moving with two degrees of freedom. [0021] FIG. 2 further illustrates the details of the continuum shaft that makes up the flexure joint 107 from FIG. 1 . The continuum shaft includes a plurality of discs 201 arranged along the length of the continuum shaft. The continuum shaft runs from the control handle 109 through the hollow shaft 101 and extends to the base of the gripper 103 . Each disc is fixedly joined to the other discs by a backbone that connects to the center of each disc 201 at 203 . A plurality of flexible tubes also extend through each disc at points 205 . However, these secondary tubes are only affixed to the end discs of the continuum shaft. Therefore, they can be pushed and pulled through holes 205 to control the shape of the continuum shaft. Each disc also includes one or more access ports (not pictured) that allow control devices to extend from the end effector control handle 105 to the gripper 103 and to control the operation of the gripper 103 . [0022] When the control joint 111 is bent in a first direction, it pushes the secondary tubes on the right side of the continuum shaft and pulls the secondary tubes on the left side fo the continuum shaft. Because the hollow shaft 101 (of FIG. 1 ) holds the continuum shaft straight, the movement of the control joint 111 and the corresponding pushing and pulling of the secondary tubes causes the flexure joint to bend to the left as shown in Fig [0023] In this example, each secondary tube is a hollow structure formed of a nitonol material. Each secondary tube has a 1.8 mm outer diameter and a 1.4 mm inner diameter. Movement of the control joint 111 causes a circular bend arc at the flexure joint 107 and the secondary tubes exhibit negligible stretching. The disc 201 has a diameter of 6 mm and the length of the flexure joint is 15 mm along the centerline. The difference between bends along the blue axis (in FIG. 2 ) and the red axis is less than 0.01% and the flexure joint experiences almost linear stiffness in bending (˜1% increase from 0 degrees to 45 degrees). The effective torsional spring rate is 0/632 Nm/rad. [0024] FIG. 4 illustrates an example of a manually actuated surgical tool 400 that is similar to the tool 100 illustrated in FIG. 1 . The surgical tool 400 includes a flex joint control handle 401 , a hollow shaft 403 , and a flexure joint 405 positioned at the distal end of the hollow shaft 403 . The flex joint control handle 401 of the surgical tool 400 is only able to move about a single axis and, therefore, one moves with one degree of freedom. Therefore, the flexure joint 405 is also limited to movement with one degree of freedom. The surgical tool 400 also includes a spring 407 coupled to the flex joint control arm 401 and the hollow shaft 403 . As discussed above, deformation of the flexure joint 405 and holding the flexure joint 405 in a deformed position requires constant force on the flex joint control arm 401 . However, the spring 407 counteracts the elasticity of the joint and reduces (or eliminates) the force required to move the joint and hold the joint in a deformed position. [0025] FIG. 5 illustrates the force required to move the flexure joint as a function of the total displacement of the flexure joint. The graph illustrates the difference between the force required to move the uncompensated flexure joint of FIG. 1 compared to the compensated flexure joint of FIG. 4 . As shown in FIG. 5 , the required force increases linearly in the uncompensated system. However, the force required to move the joint in the compensated system remains at (or, in some cases, below) zero. [0026] FIG. 6 illustrates another example of a surgical tool 600 with a compensated flexure joint that provides for movement with two degrees of freedom. The surgical tool 600 includes a hollow shaft 601 with a gripper 603 at the distal end and an end effector control handle 605 at the opposite end. A flexure joint 607 is provided between the gripper 603 and the hollow shaft 601 . A flex joint control arm 609 is coupled to the hollow shaft 601 by a control joint 611 . The energy balance compensation is provided by a spring 613 mounted over the control joint 611 such that the control joint 611 operates inside the spring 613 . The ends of the spring 613 are attached to gimbals 615 , 617 mounted on either end of the control joint 611 . The gimbals 615 , 617 are linearly fixed to the end of the hollow shaft 601 and the flex joint control arm 609 . However, the gimbals 615 , 617 are configured to pivot such that the pull of the spring 613 keeps the gimbals 615 , 617 substantially parallel with each other to prevent bending of the spring as the control joint 611 is actuated. [0027] The spring 613 applies its force along the centerline of the hollow shaft 601 and the flex joint control arm 609 . As with the one degree of freedom example of FIG. 4 , the spring 613 provides force compensation as the control joint 611 is bent to overcome the elasticity of the flexure joint 607 . [0028] FIG. 7 illustrates another example of a compensated surgical tool 700 with the springs removed to further illustrate the detail of the gimbals and the control joint. The surgical tool 700 includes a hollow shaft 701 with a gripper 702 at the distal end and an end effector control handle 705 at the proximal end. A flexure joint 707 is provided between the hollow shaft 701 and the gripper 703 while a flex joint control arm 709 is coupled to the hollow shaft 701 by a control joint 711 . A pair of gimbals 715 , 717 are provided on either side of the control joint 711 . [0029] Although the example of FIG. 6 (discussed above) utilizes a single spring wrapped around the control joint 611 , it is possible to implement an energy balance mechanism with different spring arrangement. For example, the surgical tool 700 is designed to utilize three springs 813 that couple the first gimbal 715 to the second gimbal 717 on either end of the control joint 711 . Although the springs 813 are omitted from the drawing of FIG. 7 , FIG. 8 provides a more detailed view of the control joint and gimbal arrangement including the three springs 813 . [0030] As shown in FIG. 8 , the first gimbal 715 and the second gimbal 717 are each formed of a three piece structure. An inner ring 821 is fixedly attached to the flex joint control arm 709 . A middle ring 823 is coupled to the inner ring 821 at two points to allow the middle ring 823 to pivot relative to the inner ring 821 on a first pivot axis. Similarly, an outer ring 825 is coupled to the middle ring 823 at two points to allow the outer ring 825 to pivot relative to the middle ring 823 on a second pivot axis. The points of connection between the middle ring 823 and the outer ring 825 are positioned such that the second pivot axis is perpendicular to the first pivot axis (i.e., the pivot axis between the middle ring 823 and the inner ring 821 ). The outer ring 825 also includes a series of three spring anchor points 827 positioned at regular intervals around the circumference of the ring. [0031] Although not specifically labeled in FIG. 8 , the first gimbal 715 in this example includes the same three-piece ring structure and a series of three corresponding spring anchor points as the second gimbal 717 . Each spring 813 couples one anchor point 827 of the second gimbal 717 to a corresponding anchor point of the first gimbal 715 . As a result, the springs provide a force that keeps the outer ring of the first gimbal 715 substantially parallel to the outer ring 825 of the second gimbal 717 regardless of the bend angle of the control joint 711 . The three balance springs 813 in this arrangement kinematically act as a single spring to provide force compensation to counter act the elastic force of the deformed flexure joint 707 . As described above, this force provides a counterbalance to the force required to deform the control joint (more specifically, to counterbalance the force required to deform the secondary tubes of the continuum shaft). [0032] As discussed in detail above, the secondary tubes of the continuum shaft are relatively resistant to bending. However, when bending does occur, excessive force can cause the secondary tubes to break. Therefore, the control joint mechanisms of the surgical tool 700 provides a third gimbal structure that maintains a degree of separation between the first gimbal 715 and the second gimbal 717 and prevents the spring force (from springs 813 ) from causing the secondary tubes of the continuum shaft to break. The third gimbal in this example of FIG. 8 is positioned at the center of the control joint 711 . A first pair of spacers 831 is fixedly connected to the stationary inner ring 821 of the second gimbal 717 . The other end of each spacer is pivotally coupled to a central joint gimbal ring 833 . This arrangement allows the central joint gimbal ring to pivot relative to the flex joint control arm 709 . Similarly, a second pair of spacers 835 is fixedly coupled to the inner ring of the first gimbal 715 and pivotally coupled to central joint gimbal ring 833 . The second pair of spacers 835 is positioned such that the pivot axis between the hollow shaft 701 and the central joint gimbal ring 833 is substantially perpendicular to the pivot axis between the flex joint control arm 709 and the central joint gimbal ring 833 . [0033] FIG. 9 illustrates yet another example of a surgical tool 900 with a counterbalance joint to compensate for the force required to deform the continuum shaft at the control joint. The surgical tool 900 includes a hollow shaft 901 and gripper end effector 903 with a flexure joint 907 between them. Like the other examples described above, a flexure joint control arm 909 is moveable relative to the hollow shaft 901 at a control joint and, thereby, causes a corresponding movement of the flexure joint 907 . However, the flexure joint control arm 909 is only pivotable upon a single axis (i.e., left-to-right and right-to-left in FIG. 9 ). [0034] A cam wheel 911 is positioned at the control joint. It is fixedly coupled to the control arm 909 and, therefore, pivots with the control arm 909 relative to the hollow shaft 901 . A cable 913 wraps around the outer surface of the cam 911 with each end coupled to a spring 915 , 917 . The opposite end of each spring 915 , 917 is coupled to an anchor point 919 which is fixedly coupled to the hollow shaft 901 . The cam wheel 911 is shaped and positioned such that one surface 921 has a larger radius than the others. This enlarged radius surface 921 is positioned such that it is facing away from the end effector 903 when the control arm 909 is at a centered position. As a result, the spring force provided by the springs 915 , 917 is the greatest when the control arm 909 is centered and the cam profile works to move the handle away from centered. As the control arm 909 is pivoted, the cam wheel 911 rotates and the effective pulley diameters are changed. Thus, the two springs 915 , 917 are balanced when the control arm 909 is centered. When the control arm 909 is deflected, one cam increases in diameter and thus pulls harder on the lever as compared to the other cam. The cam wheel 911 is sized and the springs 915 , 917 are selected such that the increase in cam diameter overcomes the decrease in spring force as the spring stretch is decreased. [0035] FIG. 10 illustrates still another example of a surgical tool 1000 with a counterbalance joint to compensate for the force required to deform the continuum shaft at the control joint. The surgical tool 1000 includes a hollow shaft 1001 , a gripper end effector (not shown), and a flexure joint (not shown) between the hollow shaft 1001 and the end effector. A flexure joint control arm 1009 is pivotally coupled to the hollows shaft 1001 at a control joint 1011 . A coupling link 1021 is pivotally connected to the hollow shaft 1001 at one end and coupled to a slider 1023 at the other. The slider 1023 allows the end of the coupling link 1021 to move up and down the length of the control arm 1009 as the control arm 1009 is pivoted relative to the hollow shaft 1001 . A spring 1025 is coupled between the coupling link 1021 and another point on the hollow shaft 1011 . [0036] In this example, the spring 1025 is coupled to the hollow shaft 1001 at a point that is further from the control joint 1011 than the point of coupling between the coupling link 1021 and the hollow shaft 1001 . Therefore, the length of the spring 1025 decreases as the control joint 1011 is further deflected. As a result, the force provided by the spring 1025 pulls the control arm 1009 away from center and counter balances the force required to deform the secondary tubes of the continuum shaft. [0037] Thus, the invention provides, among other things, an energy balance mechanism for a flexure joint that counteract the elastic force caused by deformation of the flexure joint. Various features and advantages of the invention are set forth in the following claims.

Systems and method are described for counterbalancing the force required to deform a flexure joint. The system includes an elastically deformable flexure joint, a control joint, and an energy balance system. The control joint is mechanically linked to the flexure joint such that movement of the control joint causes a corresponding deformation of the flexure joint. The energy balance system provides a spring force to aid movement of the control joint and to overcome an elastic force required to deform the flexure joint.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a windsurfer training device, and more particularly to a simple, inexpensive, portable, and safe training aid and step-mast universal joint support for a windsurfer rig, whereby an individual may be taught and can practice, on land and without damage to the mast-step universal joint, the proper manipulation of the rig, and may safely practice the basic and advanced rig manuevers and develop the rig handling skills associated with actual windsurfer board sailing while standing on the ground and before going on the water. The device may also be used as a simple and convenient rigging aid for properly trimming and setting the assembly. A windsurfer comprises a sailboard and a rig which is adapted to be attached to the sailboard. Typically, the rig includes a mast having a mast-step and universal joint, a boom, and a sail. The term "rig" will be used for convenience hereafter from time to time in the description and in the claims and refers to the assembly which is adapted for connection to the sailing board and which typically includes the mast, the mast-step and universal joint, the boom, and the sail. In windsurfer sailing the user stands atop the sailboard and steering and control is accomplished by specific maneuvers of the rig. The user holds the boom, which generally is a forked or "wishbone" boom, and obtains a ride by properly pivoting and otherwise moving the rig. Until such time as the user can master the necessary basic movements of the rig, however, the user will not be able to sail and is bound to fall into the water often. Not only is climbing back onto the board and pulling up the rig time after time not very enjoyable, but it can be exhausting as well It was early recognized that it would be desirable to provide for an "on the land" training aid whereby much of the difficulty encountered by the novice in learning to sail a windsurfer could be avoided and such novice sailor could learn the basic sailing requirements before venturing on the water. 2. DESCRIPTION OF THE PRIOR ART Attempts have been made in the prior art to achieve these desiderata by means of windsurfer simulators. For example, windsurfer simulator training devices are known which attempt to simulate all of the actions of the windsurfer rig and board and other conditions expected to be encountered during actual windsurfer board sailing. It was expected that such devices could hopefully be used to provide a device to teach a novice sailor all of the necessary skills relating to the use of a windsurfer board before actual use of the board on the water. Numerous prior art windsurfer simulators are known, some examples of which are shown in U.S. Pats. Nos. 4,021,934, and 4,449,940. Typically, such simulator devices consist of some type of foundation or base arrangement upon which a sail board, a section of a sailboard, a platform, or the like is secured and arranged for rotation with respect to such foundation or base. The sailboard, or other platform, may also be arranged to pivot or rock and/or otherwise simulate the various board movements to which one is subjected when actually sailing on the water. Such prior art simulator are bulky, costly, and complex and have otherwise not been entirely satisfactory, and have thus had limited practical use by individual sailors. Further, some of such prior art simulator devices have the potential of causing injuries to the user. In U.S. Pat. No. 4,436,513 there is shown a simulator device which attempts to overcome some of the disadvantages and unsafe conditions of the foregoing prior art simulators by employing a lower to the ground platform which is supported by and rotates about a base member. Because of its lower to the ground construction the simulator of U.S. Pat. No. 4,436,513 appears to provide a safer simulator on which to instruct beginners, however, it is still not entirely satisfactory since it is complex, not easily transportable, is not inexpensive, and still employs a platform or deck arranged to be rotatable with respect to a base member. Accordingly, there remains a continuing need for a safe, simple, inexpensive, and truly portable windsurfer training and rigging device. SUMMARY OF THE INVENTION It is an object of this invention to provide an easily portable, safe, effective and inexpensive windsurfer training device which allows the user to learn and practice all of the required and desired rig manuevers while standing on the ground. It is another object of the present invention to provide a portable, safe, simple, and inexpensive device which serves both to provide protection for the expensive universal joint of the mast-step section of a windsurfer rig and an "on the land" training aid to teach the novice sailor the basic maneuvering of the rig, which is a desirable and necessary requirement for the beginner. The device may also be used by the more experienced sailor to develop and improve the more advanced sailing skills. Briefly stated, in accordance with one aspect of the present invention, there is provided a new and improved training aid and support device for a windsurfer rig, which in its most general form comprises a planar deck member having a rig-mast receiving means thereon, means for securing the rig-mast to the deck member, and means depending from the underside of the planar deck member for stably supporting the deck member from and a small distance above a supporting surface, such as the ground. Preferably, the supporting means is arranged in a configuration to provide for at least one acutely-angled vertex and a geometric center near the vertical centerline of the rig-mast receiving means. Preferably, the supporting means is arranged to have a generally trangular configuration. The device further includes means for securing the rig-mast to the planar deck member. In another preferred embodiment the windsurfer rig training aid and support device of this invention comprises a base member in the form of an inverted shallow, triangular receptical defined by a top planar surface and three side rails depending from the top planar surface for supporting the base member from a supporting surface, such as the ground. A rig-mast receiving means is provided at the top planar surface and is arranged and constructed to receive and support the rig-mast near the geometric center of the hollow triangular base member. The device also includes means for securing the rig-mast to the base member. To allow for the broadest range of application from a single model, the rig-mast receiving means can be arranged and constructed so as to be capable of receiving various different sizes, types and styles of masts. In one preferred embodiment the rig-mast receiving means comprises spaced-apart openings of different diameters interconnected by a lateral open slot. That is, the opening has a sort of unsymmetrical dumbell shape. The center of the slot of the dumbell shaped opening is near the geometric center of the triangular base member so that the rig-mast may be disposed in a selected size opening and will be received and supported in such opening and near the geometric center of the triangular base member. Such a dumbell shaped rig-mast receiving means wherein the openings are appropriately sized is capable of receiving and supporting the types of windsurfer masts which are presently most widely used. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the training aid and rig support device in accordance with this invention in use. FIG. 2 is a perspective view of one type of conventional universal joint having a threaded stud means for connecting the universal joint to the sailing board. FIG. 3 is a perspective view of another type of conventional universal joint having the clip-type stud means for connecting the universal joint to the sailing board. FIG. 4 is a perspective view of the windsurfer rig training aid and support device in accordance with one preferred embodiment of the invention. FIG. 5 is a perspective view of another embodiment of the invention illustrating one form of a universal type of rig-mast receiving means. FIG. 6 is a partially sectioned perspective view of the device of FIG. 4. FIG. 7 is an exploded view illustrating another form of universal type of rig-mast receiving means, and FIG. 8 is a perspective view of a windsurfer rig training aid and support device in accordance with another embodiment of the invention employing a planar deck member supported by a plurality of support pads connected to the underside of the deck member and arranged in a triangular configuration. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings, there is shown in FIG. 1 a conventional windsurfer rig 10 connected to the training aid and support device 12 of the present invention. As is well known, a conventional windsurfer rig 10 comprises a mast 11, a boom 14, and a sail 15. At the lower end of the mast 11 there is provided a mast-step 16 which includes a universal joint 18. Two widely used types of conventional universal joints are shown in more detail in FIGS. 2 and 3. As shown, the universal joint 18 terminates in a mounting stud for connecting the universal joint 18 to the sailing board. In FIG. 2 the universal joint 18 terminates in a threaded type of mounting stud 19 which is adapted to be secured to the board by a nut 20. In FIG. 3 the universal joint 18 terminates in a clip-type mounting stud 21 and is adapted to be secured to the board by a sutiable clip (not shown). In FIG. 1 the windsurfer rig 10 is shown secured to the training aid and support device 12 of the present invention so that the windsurfer rig 10 is suitably supported in a manner which prevents damage to the universal joint 18 and allows the user to move the rig through all of the pivoting and other movements desired while the user is standing safely on the ground. In accordance with the present invention, therefore, it is not necessary for the user to stand upon a movable platform with the potential for injury in order to be able to manipulate the windsurfer rig and learn and practice all of the required or desired windsurfer rig movements. Since during actual sailing steering and control of the sailing board is accomplished by the proper pivoting and other movements of the rig, the present invention provides for achieving almost all of the desired benefits in a very simple windsurfer rig training aid and stable rig support device which avoids the deficiencies of prior art simulators, and which is safe, inexpensive, and easily carried by the user with the other usual sailing gear. A preferred embodiment of the windsurfer training aid and rig support device of the present invention is shown in more detail in FIG. 4. As shown, the training aid and rig support device 12 comprises a base member in the form of an inverted, shallow, triangular receptical which is defined by a top planar surface 22 and three side rails 23, 24, and 25. The side rails 23, 24, and 25 depend from the underside of the top planar surface 22 and are adapted to support the base member from a horizontal supporting surface, such as the ground. Each of the side rails 23, 24, and 25 may be provided with a plurality of spaced-apart cut-out slots 28 to limit lateral movement of the planar surface 22. If desired, instead of having a plurality of spaced-apart slots, a single longer slot may be provided in each of the side rails 23, 24, and 25. The top planar surface 22 is provided with a suitable rig-mast receiving means 30 which is arranged and constructed to receive and support the lower end of the rig-mast. Conveniently, the rig-mast receiving means may be a simple opening 31 of an appropriate size adapted to receive the mounting stud of the particular universal joint. Alternatively, as will be described in more detail later, the rig-mast receiving means 30 may be of a "universal type" comprising two spaced-apart openings 36 and 38 interconnected by an open slot 40, a suitable insert means, or any other suitable structure or arrangement for receiving and supporting the rig-mast from the supporting base. The top planar surface 22 is also provided with suitable openings, shown as keyhole shaped openings 32 and 32', disposed on opposite sides of the opening 31. The openings 32 and 32' may be used to secure the ends of a mast arrester means for securing the rig-mast to the base member. Conveniently, such mast arrester means may be a strap or other suitable retaining means, but is preferably a stertchable or elastic type cord ("shock-cord") 33. In operation the elastic cord 33 is streched and wraped around the base of the universal joint 18 and suitable anchor means, such as the knotted ends of the cord 33, are secured by the keyhole openings 32 and 32' as shown more particularly in FIG. 5. As shown in more detail in FIG. 6, the top planar surface 22 may be suitably reinforced. This may be conveniently provided by lateral reinforcing rib supports 34 and 35 which depend from the underside of the planar surface 22. The reinforcing rib 34 is disposed adjacent the rig-mast receiving opening 38 and functions also as a retaining means for the nut 20 when, for example, a threaded type of universal joint is involved. The reinforcing rib 35 may be disposed parallel with the rib 34 and spaced a preselected distance therefrom. To increase the overall rigidity, each of the corners of the triangular base member are also suitably reinforced. The device 12 may be made of metal, wood, or any other suitable material. Preferably, the entire base member 12 is constructed of a rigid plastic, and may be molded in one piece by using well known molding techniques. As previously described, the top planar surface 22 is provided with a suitable rig-mast receiving means 30, which may be any suitable structure, or an opening 31 of an appropriate size adapted to receive the mounting stud of the particular universal joint 18 in a manner which simulates the usual attachment to the sailing board. Alternatively, the top planar surface 22 may be provided with a generalized or "universal type" of rig-mast receiving means. That is, a rig-mast receiving means which is adapted or adaptable to receive various sizes or types of universal joint mounting studs. One form of such universal type of mast receiving means is in the form of the unsymmertical dumbell shaped opening shown in FIGS. 4 and 6. Another form of universal type of rig-mast receiving means is shown in FIG. 7 and includes an adaptor insert, wherein the large mast receiving opening 36 is adapted to receive an insert 44 which has a smaller opening to receive a smaller diameter rig-mast mounting stud. This allows for the selective use of a plurality of inserts 44, each adapted to be received within the larger opening 36 and each such insert having an opening of a desired smaller diameter so as to receive rig-mast mounting studs of different sizes. Yet another form of universal rig-mast supporting means in the form of a double-dumbell opening is shown in FIG. 8 and will be described in more detail in connection with that Figure. Although there has been no standard size of universal joint mounting agreed upon by the various manufactures of universal joints for windsurfer rig-masts, we have found that the majority of the mounting studs in present use fall within a reasonable range of diameters. In order to be capable of receiving these various types, sizes, and styles of universal joints, the rig-mast receiving means 30 may be provided in the form of an opening having an unsymmetrical dumbell shape, as shown in FIGS. 4 and 6. The universal type of rig-mast receiving means 30 shown in FIGS. 4 and 6 has spaced-apart openings 36 and 38 of different diameters interconnected by an open slot 40. The center of the open slot 40 is arranged to be at, or near, the geometric center of the triangular base member so that regardless of which of the openings 36 or 38 the rig-mast 10 is disposed in, it will be mounted and supported near the geometric center of the triangular base member. As shown, the opening 36 is of a larger diameter than the opening 38 and is adapted for receiving the larger sizes of widely used clip-type universal joint mounting studs. The smaller opening 38 is adapted for receiving the smaller diameter, threaded-type of universal joint mounting studs. The interconnecting slot 40 allows for easy connection of the universal joint mounting stud to the appropriate size opening in the top planar surface 22. For example, the universal joint mounting stud may be initially positioned into the larger opening 36 and if the opening 36 is of the appropriate size, the stud can then be secured into that opening in the top planar surface 22 of the base member. If the universal joint mounting stud means is of the threaded type which is usually the smaller diameter such as shown in FIG. 2, the mounting stud is moved through the slot 40 to the smaller opening 38 and suitably secured to the top planar surface 22 by the nut 20, similar to the manner in which such universal joint mounting stud would be secured to the sail board. As previously described, the lateral reinforcing rib 34 would be disposed adjacent the smaller diameter opening 38 so that it may function as a retainer for the nut 20 which secures the threaded mounting stud to the top planar surface 22. The nut 20 can be tightened against the underside of the planar surface 22 by rotating the step-mast and universal joint assembly in the same manner as such assembly would be tightened to the sail board. If the universal joint mounting stud means is of the clip-type, which is usually of a larger diameter than the threaded type such as shown in FIG. 3, the universal joint mounting stud would be disposed and secured in the larger opening 36 as shown more particularly in FIG. 4. We have found that it is not necessary to use the securing clip normally used to secure the clip-type stud to the sail board, and the universal joint may be secured to the top planar surface 22 by means of the stretchable cord 33, or other suitable restraining means, as previously described. In FIG. 8 there is shown a windsurfer rig training aid and support device in accordance with another embodiment of the invention. As shown, the device 12 comprises a planar deck member 50, and a plurality of supporting pads 52, 54, and 56 which are secured to the undersurface of the deck member 50 for securely and stably supporting the deck member from and a preselected small distance above a supporting surface, such as the ground. The deck member 50 is provided with a suitable rig-mast receiving means 30. In the embodiment illustrated in FIG. 8, the rig-mast receiving means 30 is in the form of a "double-dumbell" opening 58, the centerline of which is near the geometric center of the configuration defined by the arrangement of the supporting pads 52 through 56. The double-dumbell opening 58 provides for a universal-type of rig-mast receiving means and is similar to that described in connection with FIGS. 4 and 6 in that it comprises a large diameter opening 36 with different, smaller diameter openings 38 and 38' at opposite ends thereof. The smaller diameter openings 38 and 38' are connected to the large opening 36 by the open slots 40 and 40' The supporting pads 52, 54, and 56 are arranged in a triangular configuration wherein the centers of the pads define a triangle, preferably an equilateral triangle, as indicated by the broken lines a, b, and c. With the triangular arrangement of the supporting pads so that an acutely-angled vertex can be positioned down-wind, and the disposition of the rig-mast receiving means 30 near the geometric center thereof, the devvice is stably supported from the supporting surface and the force generated by the rig during operation is distributed substantially equally among the supporting pads 52, 54, and 56. The deck member is illustrated as being circular, however, such deck member may have any other convenient configuration so long as the supporting means, such as pads or legs are arranged in a generally triangular configuration and so that in operation one acutely-angled vertex can be positioned down-wind. A device and/or a deck member having a triangular configuration generally corresponding to the arrangement of the supporting pads is preferred as previously described. One particulat windsurfer rig training aid and support device constructed in accordance with the teachings of the present invention was in the form of an equilateral triangle having side rails (23, 24, 25) 37.5 centimeters long by 4 centimeters wide. The foregoing preferred embodiments have been described in detail herein. It will be understood, however, that persons skilled in the art to which the invention pertains, or to which it is most nearly connected, will now be in a position to arrive at various modifications without departing from the true spirit, disclosure, and concept of the invention. For example, instead of using openings to provide the rig-mast receiving means, various different forms of structures may be used. For instance, a mast-step and universal joint assembly, or a universal joint adaptor may be arranged as part of the base member and the rig-mast would then be removably coupled to such mast-step assembly or adaptor. The invention is not to be restricted to a specific shape of deck member or top planar surface so long as there is provided protection for and easy connection of the universal joint to the device, and a suitable base member supporting means arranged to raise the deck member or top planar surface a small distance above the supporting surface, such as the ground, and so that such supporting means stably supports the deck or top planar surface against sliding and resists tilting or other movement from the wind during use. While the foregoing described triangular configurations are preferred, acceptable results can be achieved by a supporting means arranged to stably support the base member from and a selected small distance above a supporting surface, and which supporting means includes at least one acutely-angled vertex which can be disposed down-wind during use of the training aid and support device of the invention. The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown or described. It is recognized that various modifications are possible and will readily occur to those of ordinary skill in the art. The appended claims are intended to cover all such modifications and equivalents as fall within their true spirit and scope.

There is disclosed a new teaching aid and support device for use with a windsurfer rig, which rig usually includes a mast, a boom, a sail, and a universal joint. The teaching aid and support device comprises a stationary base member for supporting the windsurfer rig. The stationary base member is in the form of a shallow, inverted receptacle having a top planar surface and depending side walls which are arranged and constructed so that when the bottom edges of the sidewalls of the base member are placed on the ground the base member is securely and non-rotatably supported from the ground. The top planar surface of the base member has a suitable mast receiver opening whose vertical center line is near the geometrical center of the base member. The device also includes an arrangement for securing the mast to the base member.

This application claims the benefit of U.S. Provisional Application Ser. No. 60/545,137, filed Feb. 18, 2004, which is hereby incorporated by reference in its entirety. FIELD OF THE INVENTION The present invention relates to infant and toddler feeding and storing system. More particularly, the present invention relates to disposable containers and nursing assemblies that can be used for preparing, storing and serving liquid food or perishable beverages such as juice, breast milk and infant formula. BACKGROUND OF THE INVENTION Infants are required to be fed very frequently with a small amount of milk such as breast milk or infant formula, and therefore many clean bottles shall be needed. In order to minimize a chance that a baby can be infected by bacteria, the bottle shall be washed and sterilized with boiling water or steam before it is used. Such activities of washing and sterilizing bottles are extra work for parents who are already tired and do not have enough sleep. Therefore, it is advantage to have a bottle or container that is pre-sterilized before use and can be disposed after use. Preparing, storing, and serving liquid food or perishable beverages in a most convenient way that shall free the parents from washing and sterilizing baby bottles is the main focus of this invention. A disposable baby feeding bottle for babies was described in U.S. Pat. No. 2,599,630 to Hair. In the Hair patent, a nursing assembly incorporating a disposable paper container is disclosed for feeding a baby during the traveling. The container is thrown away after each feeding. Thus, eliminating the need to wash and sterilize an used bottle. Nevertheless, this nursing assembly suffers a number of shortcomings. First, the nipple and the flange portion of the bottle are engaged together to form a seal by the interlocking of upper and lower brackets. When an excess force is applied by the brackets and the flange portion which may have already be softened by the infant formula contained therein, the flange portion of the bottle will be torn, ripped or distorted from a circular shape. When this disengagement or misalignment between the nipple and the flange portion occurred, a leakage will result. Second, when manipulating or holding the nursing assembly at the bottle with an excess force, the flange portion of the bottle can be torn or ripped. Thus, leakage will occur. Third, the nipple in the nursing assembly described in the Hair patent has a tailored design to form a seal with the flange portion of the bottle. This limits the use of the disposable bottle to only the described nursing assembly. A nursing assembly for infant incorporating a disposable cup was described in U.S. Pat. No. 5,758,787 to Sheu. In the Sheu patent, a special collar socket with a skirt portion is required to secure a paper cup to the nursing assembly. The Sheu patent claimed improvements over the Hair patent described above. Nevertheless, in this design, it can be concluded with the following defects and which shall be solved sooner or later. First, the collar socket with a skirt portion is contact with an infant formula when it is used in the nursing assembly. Therefore, it is an extra part that needs to be washed and sterilized before it is used. It defeats a purpose of using a paper cup as container. Second, when manipulating, holding or accidentally step on the nursing assembly by the bottle with an excess force, the cup can be crumbled or ripped. Thus, leakage will occur. A nursing assembly for infant incorporate a disposable plastic container was described in U.S. Pat. No. 3,851,781 to Marco. In the Marco patent, a plastic container which has thin and flexible body portion and thicker and less flexible rim portion is used as a disposable container for a nursing assembly. Similar disposable plastic containers can be found in the market manufactured by Playtex Products, Inc. of Dover, Del. The Playtex bottle consists of a cylindrical holder, in which a plastic liner bag is placed and filled with liquid food. In one variant, the plastic liner top is stretched over the top of the holder. In another variant, the plastic liner bag is provided with a semi-rigid rim around the top of to facilitate installation of the bag in just on hand. In either case, it requires parents to prepare infant formula in a separate container and let that cools down before transferring the formula to the plastic liner bag. Furthermore, these plastic liner bags should not be heated up in a microwave. Therefore, it is not convenient for parents. Therefore, there is a need in the art for a disposable container suitable for preparing, short-term storing and feeding of liquid food such as infant formula directly from a single container to minimize the possibility of contamination of the contents and maximizing the usefulness and convenience of the container for parents. Further, there is a need in the art to make a container which can be disposable and affordable. SUMMARY OF THE INVENTION It is an objective of the present invention to provide an infant nursing assembly that reduces the number of parts necessary to be washed and sterilized after each use. It is another object of the present invention to provide an infant nursing assembly that reduces the amount of clean ups due to use of multiple containers. It is another object of the present invention to provide a disposable container for an infant nursing assembly that does not deform its shape when contacts with boiling water. It is another object of the present invention to provide a disposable container for an infant nursing assembly that does not be soften by a liquid food after storing for several days. It is another objective of the present invention to provide an infant/toddler drinking cup that is disposable after use. The above objectives and advantages of the present invention are provided by an infant nursing assembly comprising a disposable container, a holder and a nipple bracket. The disposable container has an open end and generally made from polymer coated paper-board, plastics or combination thereof. The top of the container is provided with a circular flange about the circumference of the cup, such that the liquid filled cup can be dropped down into a cylindrical holder. The container can be use to prepare infant formula, store the formula inside the container for short-term, and feed the formula to an infant by mounting the formula filled container into the nursing assembly. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 representatively illustrates an exploded view of the components of the nursing assembly of the present invention; FIG. 2 representatively illustrates a plan view of the disposable container of FIG. 1 ; FIG. 3A & B reprehensively illustrate a cross section of the disposable container of FIG. 2 ; FIG. 3C & D representatively illustrate a cross section of an inventive container. FIG. 4 representatively illustrates a top view of the disposable container of FIG. 2 ; FIG. 5A-D representatively illustrate different holders that can be used with the disposable container of FIG. 1 ; FIG. 6 representatively illustrates a conventional nipple; FIG. 7 representatively illustrates a locking ring; FIG. 8 representatively illustrates a one-piece nipple-ring assembly; FIG. 9 representatively illustrates an adapter lid FIG. 10 representative illustrates a cross section of the adapter lid of FIG. 9 ; FIG. 11 representatively illustrates a one-piece nipple-lid assembly; FIG. 12 representative illustrates a cross section of the nipple-lid assembly of FIG. 11 ; FIG. 13 representatively illustrates a lid with a drinking spout; FIG. 14 representatively illustrates a lid with a drinking straw; FIG. 15 representatively illustrates a lid; FIG. 16 representatively illustrates a cross section of the lid of FIG. 15 ; FIG. 17 representative illustrates an exploded view of an infant drinking cup according to the present invention, the infant drinking cup having a holder, a disposable container, a lid with drinking spout and a locking ring; FIG. 18 representative illustrates an a perspective view of an infant drinking cup according to the present invention, the infant drinking cup having a holder, a disposable container, a lid with drinking spout and a locking ring; FIG. 19 representative illustrates an exploded view of an infant drinking cup according to the present invention, the infant drinking cup having a holder, a disposable container, a lid with drinking spout and a locking ring; FIG. 20 representative illustrates an a perspective view of an infant drinking cup according to the present invention, the infant drinking cup having a holder, a disposable container, a lid with drinking spout and a locking ring; FIG. 21 representative illustrates an exploded view of an infant feeding assembly according to the present invention, the infant feeding assembly having a disposable container, a adapter lid, a nipple and a locking ring; FIG. 22 representative illustrates an exploded view of an infant feeding assembly according to the present invention, the infant feeding assembly having a disposable container, an adapter lid, a nipple-ring assembly; FIG. 23 representative illustrates an a perspective view of an infant feeding assembly according to the present invention, the infant feeding assembly having a disposable container, an adapter lid, a nipple-ring assembly. FIG. 24 representative illustrates an exploded view of an infant feeding assembly according to the present invention, the infant feeding assembly having a disposable container, a nipple-lid assembly. DETAILED DESCRIPTION OF THE INVENTION The nursing assembly of the present invention shown in FIG. 1 generally has a holder 10 a disposable container 20 , locking ring 40 and a nipple 30 . For storage, the nursing assembly further has a disposable lid 100 . The disposable container 20 shown in FIG. 2 of the preferred embodiment has a cylindrical shape, having a container body 24 , an opening end 29 , a closed end 26 , a flange 22 and graduated markings 28 . The container 20 has preferably larger opening end and smaller closed end to allow stacking of multiple containers 20 for packaging. The container 20 has preferably graduated markings printed on the outside and/or the inside of the container body 24 . Referring to FIG. 4 , the open end 29 of the disposable container is defined by the flange 22 which preferably circular in shape. The open end 29 is defined by the flange 22 , which is extended outward from the container body 24 and along the entire circumference of the container body 24 . The flange 22 preferably has grooves 21 . In the preferred embodiment, the flange 22 , the container body 24 and the close end 26 are made from the same material. The flange 22 , the container body 24 and the close end 26 need to be rigid enough that the container can support the weight of the liquid food therein and stand on its own without any support. Furthermore, the flange 22 is rigid enough that it can support the weight of the liquid food contain therein when the container is mounted on the holder 10 . The flange 22 , the container body 24 and the close end 26 are made from a rigid material that is compression-resistant in the axial and/or radial direction. A container that comprises a compression-resistant material does not collapse or change substantially its shape or volume during normal feeding by the infant. A compression-resistant container can also withstand boiling water without deforming or distorting the shape of the container. Furthermore, it can withstand liquid food contained therein for three days in a refrigerator without weakening the container body 24 or resulting in liquid leakage. In addition, when placed in a water bath, a compression-resistant container preferably does not collapse, leak, or otherwise loose its rigidity and ability to be used. The container is preferably made from a water-proofed or water-resistant material. The preferable water proofed material is plastic or a polymer coated paperboard (i.e., comprised of a wood or cellulose material), which is coated on both side of the paperboard. The paperboard material can be any effective composition, including, e.g. selected kraft, bleached, news, or white-lined recycled or virgin paperboard. Polymers that can be used, include, e.g., polyethylene, polypropylene, polyester, polyethylene terephthalate, polybutylene terephthalate, derivatives thereof, etc. The thickness of the water-proofed or resistant material can be of any effective size, e.g., preferably from 0.1 to 1.0 mm. More preferably in a range of 0.2 to 0.7 mm. Even more preferably in a range of 0.3 to 0.5 mm. Other water-proofed or water-resistant material can be used as well, such as wax coated paperboard, polystyrene, foamboard, styrofoam, etc, and other laminate combinations. The flange 22 is formed by curling the material outward as shown in FIG. 3A . The curl significantly increases the rigidity of the flange 22 , which will prevent the flange 22 from distorting from a circular shape when an excessive force is applied to the locking ring 40 . FIG. 3B shows an alternative way to form the flange 22 . In this approach, the flange 22 is formed by bonding the water proofed paper-board portion of the flange to a polymeric material for reinforcement. The suitable polymeric materials are, but not limited to, polypropylene, polyethylene, and polystyrene. The locking ring 40 shown in FIG. 7 is used to attach the nipple 30 to the disposable container 20 and the holder 10 . The locking ring 40 has a cylindrical shape, having a body 41 , an opening end 43 and end wall 42 with a nipple opening 45 in it. The interior of the locking ring body 41 has inner threads 48 . The locking ring 40 is preferably made from rigid material such as polypropylene, polycarbonate and polystyrene. Referring to FIG. 5A , holder 10 has a cylindrical shape, having a holder body 11 , a bottom open end 13 , a top open end 15 and a rim 12 . The top open end has external threads 14 . The holder body 11 is preferably long enough to contain the entire disposable container body 24 therein. The rim 12 has an interior circumference that is large enough to receive the disposable container body 24 . However, the interior circumference of the rim 12 should be smaller than the outer circumference of the flange 22 , which allow the flange 22 to sit on top of the rim 12 when the disposable container 20 is inserted onto the holder 10 . The top open end 15 of the holder 10 is defined by the rim 12 which preferably circular in shape. The top open end 15 has external threads 14 , which allow engagement of the top open end 15 with the locking ring 40 . In an alternative embodiment, a reusable bottle 210 can be used as a holder (see FIG. 5B ). The reusable bottle 210 has a cylindrical shape, having a body 211 , a close end 213 , an open end 215 and a rim 212 . The open end has external threads 214 . The reusable bottle body 211 should be long enough to contain the entire disposable container body 24 therein. The rim 212 has an interior circumference that is large enough to receive the disposable container body 24 . However, the interior circumference of the rim 212 should be smaller than the outer circumference of the flange 22 , which allow the flange 22 to sit on top of the rim 212 when the disposable container 20 is inserted onto the reusable bottle 210 . In another alternative embodiment shown in FIG. 5C , holder 310 has a cylindrical shape, having a holder body 311 , a bottom closed end 313 , a top open end 315 and a rim 312 . The top open end has external threads 314 . Preferably, the holder 313 has larger opening end and smaller closed end to fit the disposable container body 24 . The rim 312 has an interior circumference that is large enough to partially receive the disposable container body 24 . In addition, the interior circumference of the closed end 313 is large enough to receive the disposable container closed end 26 . However, the holder body 311 should be shorter than the disposable container body 24 , which allow a gap between the flange 22 and the rim 312 when the disposable container 20 is inserted onto the holder 310 (See FIG. 17 ). In another alternative embodiment shown in FIG. 5D , holder 410 has a cylindrical shape, having a holder body 411 , a bottom open end 413 , a top open end 415 and a rim 412 . The top open end has external threads 414 . Preferably, the holder 413 has larger opening end and smaller closed end to fit into the disposable container body 24 . The rim 412 and the open end 413 have interior circumferences that are large enough to partially receive the disposable container body 24 as shown in FIG. 19 . The holder body 411 should be shorter than the disposable container body 24 , which allow a gap between the flange 22 and the rim 412 when the disposable container 20 is inserted onto the holder 410 (See FIG. 19 ). The holders 10 , 210 , 310 and 410 are preferably made from rigid material such as polypropylene and polycarbonate. The disposable lid 100 shown in FIG. 15 has a cylindrical shape, having an opening end 103 and close end 102 . The opening end 103 has an interior circumference that is large enough to receive the flange 22 . In the preferred embodiment, the body 34 should fit tightly around the flange 22 when the disposable lid 100 is engaged with the disposable container 20 . The disposable lid 100 is preferably made from polymer material such as polyethylene. Referring to FIG. 6 , the nipple 30 has a flange 32 , a mouthpiece 34 and an annular lip 36 . The flange 32 is preferably circular in shape. The annular lip 36 is extended downward from undersurface of the flange 32 and along the entire circumference of the flange 32 . The outer circumference of the flange 32 is slightly smaller than the inner circumference of the locking ring body 41 of the locking ring 40 . The outer circumference of the annular lip 36 is slightly smaller than the inner circumference of the flange 22 of the disposable container 20 . The nipple 30 is preferably made from soft polymer material such as silicone. Referring to FIG. 9 , the adaptor lid 60 has a bottom open end 63 , a top open end 65 , a body 61 , and a rim 62 . The top open end has external threads 64 . Preferably, the adaptor lid 60 has larger bottom open end 63 and smaller open top end 65 . This allows the user to use a larger diameter disposable container with a smaller diameter locking ring (see FIG. 21 ). The adaptor lid 60 also has a locking recess channel 66 , which can form a tight seal when it is engaged onto the flange 22 of the disposable container 20 . The user can use the nursing assembly of the present invention as follows Step 1: for preparing infant formula, the user places a powder infant formula directly into the disposable container 20 . Boiling water is then added to the disposable container 20 . The infant formula/water mixture is stirred thoroughly and allowed to cool down to an appropriate temperature for feeding. The mixture can be cooled down by placing the disposable container 20 inside a water bath. Step 2: the user can prepare infant formula and use it at a later time such as making infant formula early in the evening and use it for late night feedings. In this case, the user can prepare infant formula in the disposable container 20 as described in step 1. The disposable lid 100 is then used to seal the open end 29 of the disposable container 20 before the disposable container 20 is placed in the refrigerator for storage. Step 3: for traveling, the user can prepare infant formula in the disposable container 20 as describe step 1 in advance. The filled disposable container 20 maybe packed in a diaper bag for traveling. In this case to prevent leakage, the user engages the disposable lid 100 onto the flange 22 of the disposable container 20 . The user then inserts the filled disposable container 20 into the holder 310 . The locking ring 40 is then engaged into the holder 310 . The inner threads 48 of the locking ring 40 are then engaged with the external threads 14 of the holder 310 . When the locking ring 40 is tightly engaged with the holder 310 , the disposable lid 100 is pressed tightly against the flange 22 of the disposable container 20 . This prevents the infant formula contain therein from leaking. The engaged nursing assembly can be packed in a diaper bag for traveling. Step 4: feeding at home, the stored infant formula described in step 2 can be use for feeding. The disposable container 20 is first removed from the refrigerator. The disposable cover 30 is then removed from the disposable container 20 and discarded. The user inserts the filled disposable container 20 into the holder 10 , which causes the flange 22 to sit on top of the rim 12 of the holder 310 . The user then engages the nipple 30 with the locking ring 40 so that the flange 32 of the nipple 30 is against the interior of the end wall 42 of the locking ring 40 . The inner threads 48 of the locking ring 40 are then engaged with the external threads 14 of the holder 310 . When the locking ring 40 is tightly engaged with the holder 310 , the flange 32 of the nipple 30 is pressed tightly against the flange 22 of the disposable container 20 . This prevents the infant formula contain therein from leaking. After feeding, the locking ring 40 is disengaged from the holder 310 so that the empty disposable container 20 can be removed and discarded. Step 5: feeding while traveling, the stored infant formula described in step 3 can be use for feeding. The locking ring 40 is first disengaged from the holder 310 so that the disposable lid 100 can be removed. The user then engages the nipple 30 with the locking ring 40 so that the flange 32 of the nipple 30 is against the interior of the end wall 42 of the locking ring 40 . The inner threads 48 of the locking ring 40 are then engaged with the external threads 14 of the holder 310 . When the locking ring 40 is tightly engaged with the holder 310 , the flange 32 of the nipple 30 is pressed tightly against the flange 22 of the disposable container 20 . This prevents the infant formula contain therein from leaking. After feeding, the locking ring 40 is disengaged from the holder 310 so that the empty disposable container 20 can be removed and discarded The nursing assembly provided by the present invention provides convenience, versatility and hygienic. As various changes could be made in the above disposable container 20 without departing from the scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

The present invention provides infant and toddler feeding and liquid food storing systems. Disposable containers and infant feeding assemblies are provided for preparing, storing, and serving a liquid food or other beverage to children or other subjects having special needs. The assembly can comprise a holder, a disposable container that fits into the holder, and a means for delivering the food to the subject, e.g., using a nipple or drinking spout.

RELATED APPLICATIONS [0001] This is a continuation of U.S. application Ser. No. 10/981,380, now U.S. Pat. No. 7,431,587, filed on 4 Nov. 2004, which claims the benefit of provisional patent application Ser. No. 60/592,722 filed 30 Jul. 2004. BACKGROUND OF THE INVENTION [0002] The present invention relates to dental syringe adaptors, and more specifically to disposable dental syringe adaptors capable of providing both air and water and that may be quickly inserted or removed from a dental tool. [0003] Dental syringes are widely used by dentists, dental assistants, dental hygienists and similar personnel. The syringes are generally handheld devices that deliver air and water to a patient's mouth during dental procedures. Examples of such syringes are found in U.S. Pat Nos. 5,378,149 and 4,248,589. The devices generally selectively deliver the air and water at a predetermined pressure. Valves in the dental instrument allow for selective control of the water or air discharge. [0004] Cross contamination is a principal concern with dental syringes and dental procedures, in general. Because it is not desirous to transmit or pass bacteria and/or viruses from one patient to another, syringes, tips, and extension pieces have been developed that are autoclavable. Specifically, these devices are made of stainless steel, which can become quite expensive. Extension members, in particular, are expensive, especially if the extension members are designed for a single style of handpiece, such as an air/water syringe or just a water syringe. A disposable extension member would significantly reduce the costs of dental procedures. [0005] U.S. Pat. No. 5,049,071, discloses a plastic dental syringe that is adaptable to a handheld dental tool. The syringe may be used as an air/water syringe. However, the design of the syringe does not allow adaptation between different styles or types of dental tips. The syringe is designed for a single type of use. Thus, the disclosed syringe may not necessarily be used for different procedures that require different dental tips, and the utility of the syringe is limited. [0006] Furthermore, it is desirous for dental tools and dental tips to adapt easily to each other. Such results may be achieved by using a locking device for syringes and adaptors that quickly and easily join the dental tools to the dental tips. It would be further desirous to develop a disposable extension member for releasably receiving and connecting with syringe tips that provides for expanded use of such locking devices and for quick exchange of dental accessories. SUMMARY OF THE INVENTION [0007] The present invention provides an adaptor assembly for connecting a dental tip to a dental handpiece. More specifically, the present invention provides a disposable extension member for connecting a dental tip to a dental handpiece. The extension member has a first end portion that will be releasably retained within a head portion of the dental handpiece by a chuck assembly. A second end portion has an internally threaded cuplike member that allows the dental tip to be threaded onto the extension member. The extension member is ideal for use with threadable dental tips, such as LUER-LOK® style dental tips. The extension member has a through passageway, which allows fluid to pass from the dental handpiece to the dental tip. The arrangement of the first end portion with the chuck and the second end portion with the cuplike member provides a fluid tight seal for the extension member. [0008] Because the extension member is disposable, the member significantly reduces the costs of dental procedures. Also, time is reduced, since the extension member does not need to be autoclaved, but may be thrown out after use. Furthermore, the extension member can be designed to work with a handpiece that delivers water, air, or both, which will further reduce costs in that several different autoclavable extension members may be replaced with the present invention. [0009] The present invention is also advantageous in that it can be used with a wide variety of adaptor assemblies, which also have novel features that will be described in further detail with following specification and drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0010] FIG. 1 is a perspective view of a dental handpiece used for aspiration of air and/or water and including an adaptor assembly according to the present invention. [0011] FIG. 2 is an exploded view of the adaptor assembly shown in FIG. 1 . [0012] FIG. 3 is a partially cut-away side view taken along line 3 - 3 of FIG. 1 showing operating components of the dental handpiece and in operating connection with the adaptor assembly fabricated according to the present invention. [0013] FIG. 4 is an exploded view of an extension member and a connectable dental tip according to the teachings of the present invention. [0014] FIG. 5 is cut-away perspective view of an end of an adaptor body according to teachings of the present invention. [0015] FIG. 6 is a cut-away perspective view of an end of an alternative embodiment of an extension member according to the present invention. [0016] FIG. 7 is a partially cut-away side view of the dental handpiece shown in FIG. 3 and further showing an alternative adaptor assembly for receiving the extension member. [0017] FIG. 8 is a partially cut-away side view of the dental handpiece shown in FIG. 3 and further showing another alternative adaptor assembly for receiving the extension member. [0018] FIG. 9 is a partially cut-away side view of the dental handpiece shown in FIG. 3 and further showing yet another alternative adaptor assembly for the extension member. [0019] FIG. 10 is a perspective exploded view of an adaptor body as shown in FIG. 4 in arrangement with an alternate dental tip. [0020] FIG. 11 is a perspective exploded view of an adaptor body as shown in FIG. 4 in arrangement with another alternate dental tip. [0021] FIG. 12 is a perspective exploded view of an adaptor body as shown in FIG. 4 in arrangement with a further alternate dental tip. DESCRIPTION OF THE PREFERRED EMBODIMENT [0022] Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention which may be embodied in other specific structures. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims. [0023] FIG. 1 shows a perspective view of a dental handpiece 10 including an adaptor assembly 20 . The adaptor assembly 20 includes a chuck 21 and an elongate extension member 22 . The dental handpiece 10 has a head portion 12 with a reentrant socket 14 (see FIG. 3 ) located within the head portion 12 . The socket 14 is arranged to receive an inwardly extending portion of the chuck 21 and the extension member 22 so that the extension member 22 will be fittingly secured to the dental handpiece 10 . The handpiece 10 has a through passageway 16 (see FIG. 3 ) that is in fluid communication with the extension member 22 . The head portion 12 includes finger valves 18 a and 18 b for control of air and water flow, respectively. While the dental handpiece 10 is arranged to receive both water and air, the present invention will work with handpieces that deliver only water or air, or other possible fluids. As will be evident with reference to the further drawings and description of the application, the extension member 22 may be easily removed from the handpiece 10 when necessary. The extension member 22 preferably comprises an elongated body having a first end portion 24 that interacts with the socket 14 and the chuck 21 , and a second end portion 26 that allows a dental tip or needle 28 to be attached to the extension member 22 . As will be discussed in more detail with respect to FIG. 8 , the extension member 22 is arranged so that a disposable dental tip 28 may be removably attached to the second end portion 26 of the extension member 22 . [0024] FIG. 2 shows an exploded view of the adaptor assembly 20 . The adaptor assembly 20 comprises the chuck 21 and an annular collet 30 . The chuck 21 includes a plurality of circumferentially spaced, externally tapered jaws 34 , which will allow the extension member 22 to be clamped within the chuck 21 . The collet 30 and the jaws 34 are preferably designed of a resilient plastic so that they will grasp the extension member 22 securely and with enough resistance to firmly retain the extension member 22 within the chuck 21 , without damaging the extension member 22 . A first O-ring 36 sits between the chuck 21 and an externally threaded coupling member 38 to provide a fluid sealing connection between the chuck 21 and the threaded section 38 . Any suitable sealing means may be used in place of the first O-ring 36 that allows a fluid tight connection between the externally threaded coupling member 38 and the chuck 21 . The externally threaded coupling member 38 will sit within a second O-ring 40 located within the socket 14 to provide a fluid tight throughbore between the dental tool 10 and the externally threaded coupling member 38 . [0025] FIG. 3 is a partially cut-away view of the socket 14 of the dental handpiece 10 housing the chuck 21 . As previously noted, the chuck 21 is arranged to securely retain the extension member 22 within the socket 14 . The adaptor provides fluid communication from the fluid source through the passageway 16 located within the handpiece 10 to the extension member 22 by way of a throughbore or through passageway 42 located in the threaded externally threaded coupling member 38 . A secondary passageway 17 is also located within the handpiece 10 . The passageway 17 would be utilized if the handpiece 10 is used for delivering a second fluid, such as air. The throughbore 42 is in communication with a passageway 44 located in the extension member 22 . As shown in FIG. 3 , a secondary throughbore 42 a , and a secondary passageway 44 a are in communication as well. The secondary throughbore 42 a and passageway 44 a may be used to deliver an air flow to the dental tip. They are not necessary for the present invention, but show that the extension member 22 may be used and adapted for a dental tool having any number of fluid passageways and arrangements. [0026] Still referring to FIG. 3 , the first end 24 of the extension member 22 is inserted into the chuck 21 until it rests firmly upon an extending edge 46 of the coupling member 38 . Once fully inserted, a threaded section 48 of the collet 30 will be threaded onto the externally threaded coupling member 38 . The collet 30 , which has an internal tapered surface 50 , will compress the tapered jaws 34 of the chuck 21 to thereby firmly retain the extension member 22 . The abutment of the first end 24 of the extension member 22 with the extending edge 46 will form a tight seal, but the first O-ring 36 is preferably used to further maintain the fluid tight seal between the extension member 22 and the chuck 21 . [0027] It should be understood that FIG. 3 is merely exemplary of adaptor arrangements and should not be considered limiting. The disposable extension member 22 is designed to provide a sealing arrangement with different dental handpieces and further allow connection to a dental tip in an efficient manner, and should include similarly arranged designs that will provide a fluid tight arrangement with a disposable extension member. [0028] Referring to FIG. 4 , a cut-away exploded perspective view of the extension member 22 and the dental tip 28 is shown. The second end portion 26 of the extension member 22 includes an adaptive releasable locking member, which includes a cuplike portion 52 having an internally threaded surface 54 comprising a raceway 55 . The cuplike member 52 should be considered to include any structure that will provide an internal threaded surface that will allow mating with the dental tip 28 and should not be limited to the presently shown design. The threaded surface 54 interacts with a pair of diametrically opposed extending tabs or tab portions 56 radially extending from a flange 58 located on the dental tip 28 . The threaded surface 54 and the raceway 55 may be arranged to receive a single tab 56 , but preferably it will receive two tabs 56 . As the dental tip 28 is threaded into the cuplike member 52 , the tabs 56 are compressed against the threaded surface 54 to form a fluid tight fitting between the passageway 44 and the interior of the dental tip 58 (see FIG. 1 ). When the dental tip 28 is threaded into the cuplike member 52 , the taper of the dental tip 28 allows for the passageway 44 to be sealed against the inside of the dental tip 28 without necessarily employing other sealing means. Though not necessary, the passageway 44 is shown extending outwardly of the cuplike member 52 . The depicted design allows for a shallow cuplike member, since there is less needed length when threading the dental tip 28 . The tabs 56 of the dental tip 28 only need to be threaded a few rotations within the raceway 55 to form a fluid tight seal between the passageway 44 and the dental tip 28 . However, the passageway 44 may terminate inwardly of the cuplike member 52 , or possibly flush with cuplike member 52 . The dental tips 28 are generally considered LUER-LOK®-style dental tips. Thus, the present invention provides an efficient, inexpensive device that will allow adaptation between dental handpieces and LUER-LOK®-style dental tips. Provided the dental tip 28 and the extension member 22 are capable of sealing engagement, the design will fall within the scope of the present invention. [0029] FIG. 4 also shows fins 60 extending along the length of the extension member 22 . The fins 60 provide support means for the cuplike member 52 and the extension member 22 . The fins 60 reduce twisting of the extension member 22 and potential snapping of the extension member 22 when the dental tip 28 is inserted and secured within the cuplike member 52 . It should be understood that the support means could take different shapes and forms than the fins 60 shown, provided they reinforce and strengthen the arrangement of the extension member 22 . For instance, the support means could be a solid structure encircling the extension member 22 , rather than separate fins. Likewise, more or fewer fins than shown could be used with the extension member 22 . [0030] FIGS. 5 and 6 show partial perspective views of the first end 24 of different embodiments of the extension member 22 used in the present invention. FIG. 5 shows the extension member 22 having the single passageway 44 , while FIG. 6 shows extension member 22 having the passageway 44 surrounded by a plurality of the secondary passageways 44 a . For instance the secondary passageways 44 a would allow for mating with the secondary passageway 17 of the handpiece 10 (see FIG. 3 ). As previously noted, the extension member 22 is not limited to either embodiment, and may also include other potential passageway designs. Whereas the prior art would require many different extension sections or possibly not allow adaptation between different needle or dental tip arrangements, the present invention allows a single extension member to be used for several different dental devices and tips. Furthermore, because the present invention is disposable, using an adaptor to convert between an air/water syringe an air syringe or water syringe is much more economical for many practitioners. [0031] FIG. 7 is a partially cut-away side view of an alternative adaptor assembly 120 for receiving the extension member 22 . The adaptor assembly 120 comprises a chuck 121 and a threaded coupling member 138 . The chuck 121 comprises a plurality of locking fingers 122 that provide the clamping means needed to retain the extension member 22 . Preferably the locking fingers 122 are circumferentially spaced. The coupling member 138 has an externally threaded surface 140 that mates with the chuck 121 and the locking fingers 122 similarly to the first adaptor assembly 20 and chuck 21 . The coupling member 138 has distal end 142 that tapers outwardly from the interior of the coupling member 138 . The fingers 122 have an inwardly extending ridge 144 that forms a cavity 146 . As the chuck 121 is threaded onto the coupling member 138 , the distal end 142 of the coupling member 138 will mate with the cavity 146 of the chuck 121 . As the chuck 121 is threaded further onto the coupling member 138 , the ridges 144 of the fingers 122 come into contact with the sloped or tapered surface of the distal end 142 . The ridge 144 will slide inwardly, thereby gripping and retaining the extension member 22 . The chuck 121 may be formed out of a resilient material, such as a resilient plastic material, that will allow the chuck 121 to sufficiently grasp the extension member 22 and release it, when necessary. However, other materials may be used to form the chuck 121 , as well. [0032] Still referring to FIG. 7 , a sealing mechanism 148 is located within a corresponding annular groove 150 . The sealing mechanism 148 comprises a circumferential resilient flange to provide further sealing means between the extension member 22 and the coupling member 138 . The sealing mechanism 148 also contributes further retention means for the extension member 22 by frictionally engaging the extension member 22 when the extension member 22 is inserted into the coupling member 138 . An O-ring 154 located between the coupling member 138 and the socket 14 provides further sealing means, as well. The extension member 22 is inserted into the socket 14 until it abuts an internal surface 156 , where it will be in fluid communication with the passageway 16 . The overall arrangement provides a fluid-tight arrangement that securely retains the extension member 22 . [0033] FIG. 8 provides another embodiment of an adaptor assembly 220 . As with the prior embodiments, a coupling member 238 is threaded into the socket 14 . The coupling member comprises a cylindrical housing 240 with a centrally located throughbore 242 for insertion of the extension member 22 . The housing 240 comprises an annular reentrant cavity 243 that surrounds the extension member 22 . The extension member 22 will abut the internal surface 156 , as was described in FIG. 7 with respect to the assembly 120 . Likewise, an O-ring 154 sits between the coupling member 238 and the socket, as shown in FIG. 7 . [0034] Still referring to FIG. 8 , an annular sealing mechanism 244 having a resilient flange 246 that frictionally engages the extension member to provide fluid-tight retention of the extension member 22 is located within the reentrant cavity 243 . A collar 248 is located within the reentrant cavity 243 . The collar 248 is connected to the housing 240 by way of a protrusion 250 that mates with a groove 252 located in the housing 240 . The collar 248 has an internally located channel 254 for receiving and supporting retention means 256 . The retention means 256 preferably comprises a flexible annular disc that surrounds and retains the extension member 22 in frictional engagement. A plunger 258 is retained above the retention means 256 within the reentrant cavity by a lip 260 , which is a portion of the collar 248 . In a normal position, the retention means 256 exerts upward force on the plunger 258 to retain the plunger 258 against the lip 260 . To remove the extension member 22 , the plunger 258 is pressed inwardly toward the head portion 12 , thereby moving the retention means 256 away from the extension member 22 and allowing the extension member 22 to be removed from the throughbore 242 . [0035] FIG. 9 shows another embodiment 320 of an adaptor assembly. The extension member 22 mates with the socket 14 , as was shown in FIGS. 7 and 8 . A coupling member 338 extends within a reentrant chamber 340 located within an annular collet 342 . The collet 342 has a throughbore 344 that surrounds the extension member 22 . The chamber 340 is coaxially and radially spaced from the throughbore 344 . The chamber 340 has an internally threaded portion 346 that is in threading engagement with an internally threaded portion 348 of the coupling member 338 . The coupling member 338 further includes a tapered wall 350 . The tapered wall 350 is engageable with a tapered surface 352 of a rubber compression sleeve 354 . As the collet 342 is threaded onto the coupling member 338 , the compression sleeve 354 is pushed downwardly, which allows the sleeve 354 to slide down the tapered wall 350 . The sleeve 354 also moves inwardly towards the extension member 22 to thereby clamp and retain the extension member 22 . [0036] As FIGS. 7-9 show, the extension member 22 can be used with a variety of adaptor assemblies, which further enhances the utility of the present invention. Further, FIGS. 7-9 include the secondary passageway 17 within the handpiece 10 . If the extension member was arranged as shown in FIG. 6 , any of the shown adaptor assemblies would accommodate a secondary fluid through passageway 17 . Thus, the adaptability and interchangeability of the present invention is further exemplified. [0037] FIGS. 10-12 show exploded views of the second end portion 26 of the extension member 22 and alternative dental tips, 428 ( FIG. 8 ), 528 ( FIG. 9 ), and 628 ( FIG. 10 ). FIGS. 8-10 illustrate that the present invention may be used in conjunction with numerous tip designs. For instance the dental tip 628 has the tabs 56 integral with the flange 58 and not as separate protrusions. Provided the mating portions of the dental tips interact with the threaded portion 54 of the cuplike member 52 to form a fluid tight seal, the present invention is useful for different dental tips. The dental tips 428 , 528 , and 628 are generally considered LUER-LOK®-style dental tips, and, also, dental tips considered to have LUER tapers. Thus, the present invention provides an efficient, inexpensive device that will allow adaptation between dental handpieces and LUER-LOK®-style dental tips or LUER taper style dental tips. [0038] The present invention provides an affordable extension member for various dental tips and designs. Because the extension member is disposable, it is inexpensive to design and, also, limits possible contamination, since it may be discarded after a single use. The extension member may be used with many different dental handpieces having different gripping means and adaptor assemblies, which further increases the utility of the instrument. The adaptor assemblies described in the present invention also contain new and novel concepts that enhance the utility of the present invention. [0039] The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.

A disposable extension member for joining a dental handtool to a disposable, hollow, dental tip. The dental handtool includes a chuck for releasably retaining the extension member. The extension member has at least one fluid-tight passageway extending through its body for fluid flow from the dental handpiece to the dental tip. The extension member includes an adaptive releasable locking member having an internally threaded, cuplike end portion dimensioned for releasable threading engagement with the dental tip. The chuck provides easy and efficient clamping means to secure the extension member within the handtool.

BACKGROUND [0001] 1. Field [0002] The invention relates to polymer processing and more particularly to the formation of polymer products used in a variety of applications. [0003] 2. Background [0004] Polymer constructs with a balance of porosity, strength, flexibility and chemical inertness or biocompatibility are desired in many biomedical and industrial applications. [0005] In medical implant fields, polymers such as Dacron polyester and expanded polytetrafluoroethylene (ePTFE) have been used for medium and large diameter vascular prosthesis. Dacron prosthesis are generally woven or knitted into tubular constructs. The relatively large pore size resulting from knitting and weaving techniques allows blood to pass through these pores, necessitating either pre-clotting these constructs with the patient's blood before implantation, or impregnating the constructs with a biocompatible filler. The porosity of ePTFE can be tailored by adjusting the node and fibril structure, and consequently the porosity and pore size, such that blood is contained within the tubular structure under physiological conditions. Neither Dacron, nor ePTFE tubular constructs has however functioned effectively as small diameter vascular prostheses due to problems of thrombosis and anastomotic hyperplasia. [0006] The flexibility, strength, biostability and ability to adjust porosity has also led to ePTFE being used for tissue augmentation in plastic surgery, in dura mater repair in neurosurgery, and for breathable, moisture-barrier cast liners. [0007] In the medical device industry, angioplasty balloons are typically formed from polyethylene terephthalate, nylon, segmented polyurethanes. To reduce the effective profile of the device for ease of delivery into the vasculature, balloons are folded on to the catheters. Upon inflation in the vasculature, the balloons unfold to assume a cylindrical profile. This unfolding generates non-uniform stresses in lesions during inflation. Furthermore, when stents are mounted on folded balloons, their deployment in the vasculature may be non-uniform due to the unfolding process. There is consequently a need for a balloon that is flexible, yet strong with the ability to be delivered in the vasculature in a small tubular profile without folding. Materials with node and fibril structures, that can be rendered auxetic, i.e., having a negative Poisson's ratio, with appropriate processing are particularly suitable for this application. Poisson's ratio [0008] In the field of local drug delivery, there is a need for chemically inert and biocompatible microporous drug reservoirs for releasing drugs from transdermal patches. Polymers such as ultrahigh molecular weight polyethylene (UHMWPE) may serve this need if they are rendered porous. [0009] In the textile industry, ePTFE barrier layers are used for apparel that needs to be breathable, while preventing moisture from passing through the apparel. The combination of flexibility, lubricity and strength have also led to ePTFE use in dental floss. [0010] UHMWPE is used as a separator membrane for electrochemical cells such as lithium-ion batteries, supercapacitors and fuel cells. For these applications, microporous UHMWPE membranes provide the right balance of porosity, wettability, flexibility and strength. [0011] U.S. Pat. No. 5,643,511 discloses a process for the preparation of microporous UHMWPE by solvent evaporation from a gel-formed film. The films are stretched uniaxially or biaxially either during solvent evaporation or after solvent evaporation, to achieve the desired porosity. The microporous films thus obtained do not have a node and fibril structure. [0012] U.S. Pat. No. 4,655,769 describes a process for preparing microporous UHMWPE by forming a pseudo-gel of UHMWPE sheet in a solvent, extracting the solvent with a more volatile solvent, evaporating the volatile solvent to create a semi-crystalline morphology and stretching the dry sheet. These films do not exhibit a well-defined node and fibril structure. [0013] In regards to the above applications and limitations of current materials, there remains a desire for porous and flexible polymer constructs having high strength, good chemical inertness and biocompatibility, and which can preferably be made to exhibit auxetic behavior. SUMMARY [0014] A method is disclosed. The method includes, in one embodiment, forming a semi-crystalline polymer material into a lamella, and stretching the lamella into a polymer article including a node of folded lamella and a fibril orientation. Such polymer article may be used in a variety of applications including, but not limited to, medical device applications such as in catheter balloons, and various grafts. Other applications include, but are not limited to, use in dental floss, sutures, filters, membranes, drug delivery patches, and clothing. [0015] Ultra high molecular weight polyethylene is one example of a suitable semi-crystalline polymer material. In another embodiment, a method including extruding a pseudo-gel comprising an ultrahigh molecular weight polyethylene material into a lamella, stretching the lamella into a polymer including a node of folded lamella and a fibril orientation, and annealing the polymer at a temperature sufficient to define the node and fibril orientation. [0016] An apparatus is still also disclosed. In one embodiment, the apparatus includes a body portion formed of a dimension suitable for a medical device application and including a semi-crystalline polymer arrayed in a node of folded lamella and a fibril orientation or microstructure. In another embodiment, an apparatus including a body portion comprising an ultra-high molecular weight polyethylene material arrayed in a node of folded lamella and a fibril orientation. BRIEF DESCRIPTION OF THE DRAWINGS [0017] [0017]FIG. 1 shows a schematic top perspective view of a polymer array in a node of folded lamella and fibril orientation. [0018] [0018]FIG. 2 is a flow chart of a process for making a polymer product using a non-volatile first solvent and a low boiling second solvent. [0019] [0019]FIG. 3 is a flow chart of an alternative process for making a polymer product using a non-volatile first solvent and a low boiling second solvent. [0020] [0020]FIG. 4 is a flow chart of a second alternative process for making a polymer product of this invention using a low boiling first solvent. DETAILED DESCRIPTION [0021] [0021]FIG. 1 shows a polymer product formed according to the techniques described herein. The polymer product as shown in FIG. 1 is a portion of a polymer fiber having a “shish kebab” morphology formed from a semi-crystalline polymer crystallized from the melt state under high stress/strain fields. These polymers “row nucleate” with rows parallel to a draw direction (e.g., of an extruder) and a crystallite growth perpendicular to the direction of the draw. Highly anisotropic crystallites with extended chain cores surrounded by chain-folded lamella result. [0022] [0022]FIG. 1 shows polymer structure 10 of node 11 A, 11 B, and 11 C. Each node as described is formed of folded lamella. Between nodes in FIG. 1 are fibril portions 12 A and 12 B formed by, in one example, applying a tensile force to an extruded polymer (e.g., an extruded polymer fiber) in the direction of the draw of an extruder (e.g., stretching). In effect, the tensile force pulls a portion of the polymer from the folded lamella resulting in a folded portion (node 11 A, 11 B, 11 C and a fiber-like portion (fibril portions 12 A, 12 B). [0023] In one embodiment, polymer structure 10 is a semi-crystalline polymer material. Such semi-crystalline polymers include polyalkylene polymers, polyolefin polymers, and polyoxymethylene-acetyl co-polymers. Particular types of polyalkylene polymers include polypropylenes and polyethylenes. Particular preferred polymers are high molecular weight or ultra-high molecular weight polyethylene (UHMWPE). [0024] Suitable semi-crystalline polymers are those polymers that are generally not suitable for melt extrusion due to the viscosity of the polymer inhibiting the melt flow. Suitable polymers, such as polyethylene have molecular weights in the range of about 1 million grams per mole (gms/mole) to about 10 million gms/mole. This corresponds to a weight average chain length of 3.6×10 4 to 3.6×10 5 monomer units or 7×10 4 to 7×10 5 carbons. Polypropylene should have similar backbone carbon chain lengths. UHMWPE polymers are classified by molecular weight determination detailed in American Society for Testing Methods (ASTM) D1601 and D4020. Particularly, suitable polyethylene should have a molecular weight of at least about 500,000 gms/mole, preferably at least about 1,000,000 gms/mole, and more preferably at least about 2,000,000 gms/mole to about 10,000,000 gms/mole. Polymers that are commercially available in powder form that are suitable are GUR 4150 ™, GUR 4120™, GUR 2122™, GUR 2126™ manufactured by Ticona; Mipelon XM 220™ and Mipelon XM 221U™ manufactured by Mitsui; and 1900™, HB312CM™, HB320CM™ manufactured by Montell. Suitable polypropylenes have a molecular weight of at least 500,000 gms/mole, preferably at least about 1,000,000 gms/mole and more preferably at least about 2,000,000 gms/mole to about 10,000,000 gms/mole. [0025] [0025]FIG. 2 describes a process for forming a polymer product having a desired node and fibril morphology. The polymer in this example is UHMWPE. In one embodiment as shown in FIG. 2, porous UHMWPE may be prepared from the starting UHMWPE powder (block 100 ) by forming a slurry in a first non-volatile solvent, such as mineral oil or paraffin oil (such as Hydrobrite 550, Hydrobrite 380, Hydrobrite 1000 manufactured by Witco Corporation) at a temperature below about 140° C., and preferably below about 120° C. and more preferably below about 100° C., but above about 25° C. (block 110 ). The weight percent of the polymer is in the range of about one weight percent (wt %) to about 50 wt % and preferably in the range of about one wt % to about 30 wt % and more preferably in the range of about five wt % to about 20 wt %. It is appreciated that additives may also be added to the slurry. Suitable additives include, but are not limited to, antioxidants such as Irgonox-antioxidants to inhibit oxidation. [0026] The slurry of polymer powder and solvent (and optional additive(s)) is then taken to a temperature above about 140° C. to about 325° C., preferably from about 180° C. to about 275° C. to form a pseudo-gel using a mixing device, such as a stirred vessel or a single screw extruder or a twin-screw extruder or a pipe with static mixers or a ram extruder (block 120 ). A pseudo-gel in this context may be thought of as having gel-like properties, typically without (or with less of) the cross-linking behavior seen in true gels. The pseudo-gel thus formed is then pushed under pressure of about 500 pounds per square inch (psi) to about 10,000 psi through a die to form the desired final shape of the product, such as a fiber, or film, or tape (block 130 ). [0027] The shaped pseudo-gel thus formed is then cooled using a cooling medium such as air or water to a temperature below about 140° C., and preferably below about 100° C., more preferably below about 30° C. and most preferably below about 20° C. (block 140 ). The reduced temperature tends to cause folded chain row-nucleated structures to form in the microstructure. These structures are then stretched at a temperature below about 50° C. and preferably below about 40° C. and more preferably below about 30° C. to induce fibrillation (block 150 ). The stretch ratio is preferably from about 2:1 to about 20:1. The amount of stretching eventually determines the porosity of the polymer article formed. Optionally, the stretching may be done after the extraction of the first non-volatile solvent by a second volatile solvent (block 160 ) and the evaporation of the second volatile solvent (block 170 ). During stretching, the porosity and the orientation of the crystals may be increased due to stretching of the article. Additionally, an optional step of hot stretching (block 180 ) such as on the order of 130° C. to 150° C. may be added to increase porosity or increase mechanical properties by increasing crystalline and amorphous orientation. It is believed that hot stretching will also result in a modification of the folded chain lamellar structure of the crystallites. The result is a shaped UHMWPE porous article (block 190 ). The porosity of the final article is preferably at least about 10% by volume and more preferably at least about 30% by volume. [0028] An alternative embodiment of making an article starting with the UHMWPE powder is shown in FIG. 3. Starting from a UHMWPE powder (block 100 ), the UHMWPE is mixed with a first non-volatile solvent such as mineral oil or paraffin oil to form a pseudo-gel inside a mixing device such as a stirred tank, a single screw extruder, a twin-screw extruder, a pipe with static mixers or a ram extruder, at a temperature greater than about 140° C. to about 325° C., preferably greater than about 180° C. to about 275° C. (block 120 ). The weight percent of the polymer is in the range of about one wt % to about 50 wt % and preferably in the range of about one wt % to about 30 wt % and more preferably in the range of about five wt % to about 20 wt %. [0029] The pseudo-gel is then pushed under pressure of about 500 psi to about 10,000 psi through a shaping die to form the desired shape (block 130 ). Then, the article is cooled using a cooling medium such as air or water to a temperature below about 140° C., and preferably below about 100° C., more preferably below about 30° C. and most preferably below about 20° C. (block 140 ). The cooling tends to cause folded chain row-nucleated structures to form in the microstructure. These structures are then stretched at a temperature below about 50° C. and preferably below about 40° C. and more preferably below about 30° C. to induce fibrillation (block 150 ). The stretch ratio is preferably from about 2:1 to about 20:1. The amount of stretching effects the porosity of the resulting polymer product. Optionally, the stretching may be done after the extraction of the first non-volatile solvent by a second volatile solvent (block 160 ) and the evaporation of the second volatile solvent steps (block 170 ). During solvent extraction, this porosity and the orientation of the crystals may be increased due to stretching of the article. Additionally an optional hot stretching may be added to increase porosity or increase mechanical properties by increasing crystalline and amorphous orientation (block 180 ). It is hypothesized that this step will also change the folded chain lamellar structure of the crystallites. The result is the final product of the invention, which is a shaped UHMWPE porous article 190 . The porosity of the final article is preferably at least about 10% by volume and more preferably at least about 30% by volume. [0030] A third embodiment to make a polymer product of this invention is shown in FIG. 4. In this embodiment, UHMWPE powder (block 100 ) is mixed with a first solvent such as decalin or p-xylene, inside a mixing device such as a stirred mixer, single screw extrude, twin-screw extruder, a pipe with static mixers or a ram extruder to form a pseudo-gel 120 at a temperature greater than about 140° C. (block 120 ). The weight percent of the polymer is in the range of one wt % to 50 wt % and preferably in the range of about one wt % to about 30 wt % and more preferably in the range of about five wt % to about 20 wt %. This pseudo-gel with the first solvent is then pushed through a shaping die under a pressure of about 500 psi to about 10,000 psi to make the desired shape such as a fiber or tape of film (block 130 ). As the shaped pseudo-gel exits the die, the solvent flashes off from the pseudo-gel 135 , leaving only a porous UHMWPE, which is cooled, to a temperature below about 140° C., preferably to a temperature below about 100° C. and more preferably to a temperature below about 30° C. using a cooling medium such as air or water (block 140 ). At this point, folded chain row-nucleated microstructure is formed leading to a porous material. These structures are then stretched at a temperature below about 50° C. and preferably below about 40° C. and more preferably below about 30° C. to induce fibrillation (block 150 ). The stretch ratio is preferably from about 2:1 to about 20:1. The amount of stretching effects the porosity of the resulting polymer product. Additionally, an optional hot stretching may be added to increase porosity or increase mechanical properties by increasing crystalline and amorphous orientation (block 180 ). It is hypothesized that the hot stretching will also change the folded chain lamellar structure of the crystallites. The result is a shaped UHMWPE porous article (block 190 ). The porosity of the final article is preferably at least about 10% by volume and more preferably at least about 30% by volume. [0031] Suitable second solvents used to remove the first non-volatile solvent include hydrocarbons, chlorinated hydrocarbons, cholorofluorinated hydrocarbons and others such as pentane, hexane, heptane, cyclohexane, methylene chloride, trichloroethylene, toluene, carbon tetrachloride, trichlorotrifluoroethylene, diethyl ether and dioxane. Preferred second solvents are those that have atmospheric boiling points below about 90° C., preferably below about 80° C. and more preferably below about 60° C. [0032] The final product has a microstructure as determined by SEM to consist of nodes of about 1 micron to about 100 microns in the largest dimension, which are connected together by means of thin, long polymer fibrils. The internodal distance (IND), which is the distance between the nodes varies from about 10 microns to about 500 microns. In one embodiment the fibrils are oriented in all possible directions, leading to an isotropic structure. In another preferred embodiment, the nodes are about 10 microns to about 25 microns, and the IND is about 25 microns to about 125 microns. In another preferred embodiment, the nodes are about 10 microns to about 25 microns, and the IND is about 200 microns to about 500 microns. The node and fibril microstructure tends to make the polymer exhibit auxetic behavior (i.e., have a negative Poisson's ratio). [0033] In one embodiment the porous UHMWPE product thus formed can be used for medical device application such as catheter balloons, stent grafts, Abdominal Aortic Aneurysm (AAA) grafts, vascular access grafts, pacemaker lead components, guiding catheter liners, Coronary Artery Bypass Grafts (CABG). In addition to these applications, porous UHMWPE can be used in dental floss, sutures, filters, permeable membranes, battery terminal separators, breathable fabrics, ballistic shields, packaging films, and drug delivery patches.

A method including forming a semi-crystalline polymer material into a lamella; and stretching the lamella into a polymer comprising a node of folded lamella and a fibril orientation. A method including extruding a pseudo-gel comprising an ultrahigh molecular weight polyethylene material into a lamella; stretching the lamella into a polymer comprising a node of folded lamella and a fibril orientation; and annealing the polymer at a temperature sufficient to define the node and fibril orientation. An apparatus including a body portion formed of a dimension suitable for a medical device application and comprising a semi-crystalline polymer arrayed in a node of folded lamella and a fibril orientation. An apparatus including a body portion comprising an ultra-high molecular weight polyethylene material arrayed in a node of folded lamella and a fibril orientation.

This application is a continuation of application Ser. No. 08/535,806, filed Sep. 29, 1995, now U.S. Pat. No. 5,722,424. FIELD OF THE INVENTION This invention is a surgical instrument. It specifically relates to a guidewire made of a stainless steel alloy core which is coated with a non-hydrophilic lubricious polymer on the majority of its length located proximally and a hydrophilic polymer located at the majority of the remaining distal length of the guidewire. Preferably, the guidewire has a polymeric tie layer located between the metallic core of the guidewire assembly and the hydrophilic polymeric layer. The metallic core is one of a number of stainless steels so to maintain its torque transmitting and bending stiffness capabilities. Desirably the outside diameter of the guidewire is constant from the distal end to the proximal end. The metallic core may be tapered at appropriate locations along the guidewire assembly. BACKGROUND OF THE INVENTION As costs of medical care increase, the need for more precise and less traumatic medical procedures has increased as well. These procedures result in fewer effects ancillary to those necessary for the specific treatment. Hospital stays may be lessened. Recovery times may be improved. Vascular catheters are used to treat a variety of maladies formerly treated by drastic surgery. For instance, current high performance catheters are used in the treatment of berry aneurysms in the brain, various vascular accidents (such as strokes and contusions), percutaneous transcatheter angioplasty (PTCA), and the like. Although various different catheter designs may be used in attaining selected treatment sites, many catheters used for the delivery of therapeutic materials such as drugs and vasooclusive devices are over-the-wire catheters. Other catheters used in the vascular system may be of a design which is flow-directed. A few flow-directed catheters are designed to use a simple distal end which is quite floppy and able to be carried along by the flow of blood through the body. Other flow-directed devices utilize small balloons at their distal end which act as "drag anchors" in pulling that distal end through the vascular path. Flow-directed catheters have the advantage of quickly approaching a site through the vasculature if the site is in a high blood flow region. If the selected site is not in the highest velocity courseway, there is little or no chance that the catheter will reach the desired site. Over-the-wire catheters are especially useful in treating or diagnosing regions of the body which are difficult to reach because of their location, e.g., at the end of distal and complicated routes through the vasculature. This is so since, unlike catheters typically used in the region of the heart, vascular catheters for remote vasculature do not have sufficient strength, stiffness, and ability to transmit torque to allow movement of the catheter by itself to the selected remote site. Consequently, guidewires are used to provide column strength and torsional strength to the overall catheter/guidewire assembly so that these fine vascular catheters can be tracked over the guidewire and steered through pertinent vessels. See, for instance, the disclosure in U.S. Pat. No. 4,884,579 to Engelson. In general, the method of using a guidewire with a highly flexible catheter is as follows: a torqueable guidewire having a distal, bent end is guided by alternately rotating and advancing the wire in the vascular pathway to the target site. The distal bend allows the attending physician the choice (with the aid of fluoroscopy) to select a route through bends and "Y's" in the vasculature to the target site. As the guidewire is moved along the selected route, the catheter is typically advanced along the guidewire in increments. It is critical that the catheter be able to track the guidewire along the route in which the guidewire has been placed. That is to say that the catheter must not be so stiff at its distal end (for a selected guidewire) that the catheter pulls the guidewire from its previously selected route. Additionally the guidewire must be flexible enough to be able to follow the chosen route. Furthermore, both the guidewire and the catheter must be of sufficient resilience that they not easily kink when a difficult or tight region of vasculature is encountered. The guidewire must ideally have the ability to transmit torque along its length in a controllable fashion--that is to say that a selected wire rotation at the wire's proximal end produces a corresponding rotation at the distal end--so to allow the physician to steer the guidewire as needed. The need to penetrate farther into the vasculature of extremely soft organs such as the brain and liver provide great demands on the physical description of and material selection for guidewires. If the wire is too thin along its entire length, it is often difficult to transmit torque in a controlled manner along that wire length. Further, the wire may buckle with axial movement due to low column strength. One solution to many of these problems has been through appropriate choice of material for the guidewire. One such choice of materials is of alloys containing nickel and titanium and which has been treated in a specific fashion to result in a class generally known as nitinols. Typical of such guidewires are those shown in Bates, U.S. Pat. No. 5,129,890 and to Cook, U.S. Pat. No. 5,213,111. Some improvements to such device is using nickel titanium alloys may be found in U.S. Pat. No. 5,409,015 to Palermo. These alloys are especially suitable for accessing deep into vasculature within soft tissue in that for properly chosen alloys, the guidewires have the ability to undergo major bending without any plastic deformation. Although nitinol guidewires are very suitable for deep access into the vasculature, an offset in performance is typically attained because the alloy itself is quite resilient and stores significant mechanical energy. Said another way: a nitinol guidewire that is flexible enough to enter deep tortuous pathways may be difficult to use: a.) the user may not be able controllably to twist or torque the tip of the guidewire into an appropriate position, and b.) the excessive flexibility doesn't permit tracking of the catheter since the stiffer catheter may pull the guidewire from its preselected route. This usability parameter is one which is typically attributable to the size and material found in the more proximal portions of the guidewire. Increasing the size of the proximal portion of the guidewire raises the lateral stiffness of the guidewire. Increasing the diameter of a nitinol guidewire to a point where the torqueability is improved sometimes will result in a guidewire having a diameter which is too large for easy physical manipulation. Another tack taken in improving manipulation and insertability of guidewires has been that of coating the wires with various lubricating materials. An early lubricating material has been high molecular weight silicon-derived oils or near-greases. Other more substantial (and permanent) coverings such as polytetrafluorethylene (TEFLON) and various hydrophilic coatings have also been suggested as coatings for these guidewires. Lubricious coatings on guidewires provide a number of benefits. Proper selection of coatings lowers the resistance to axial movement of the guidewire within the catheter. Similarly, the coatings may be used to lower the resistance of the guidewire within the catheter as it is turned or torqued. Slippery coatings on the guidewire lessen the chance that the catheter will kink as it is moved axially along the guidewire. U.S. Pat. No. 5,129,890 to Bates, et. al was mentioned in passing above. This patent describes a guidewire having a shaped-memory material. The guidewire's central core has an elongated coil attached distally. A thin polymer sleeve, preferably of polyurethane, is positioned adjacent the core wire. The polymer sleeve provides a base for a hydrophilic polymer coating which is placed on the outer periphery of the underlying polymer sleeve. An alternate embodiment of the guidewire is a one in which the proximal portion of the inner polymer sleeve is not coated with a hydrophilic covering. Another variation is shown in U.S. Pat. No. 4,884,579 to Engelson. Engelson teaches a guidewire having a distal section which allows greater purchase with the vessel walls through which it is placed; that is to say the distal portion is a higher friction portion of the guidewire than is the portion just proximal of the higher friction section. The somewhat more proximal section is covered with a material which renders that section more lubricious. Suitable coating materials include TEFLON, polyurethane, or materials which form the support for hydrophilic polymers. U.S. Pat. No. 5,213,111, to Cook, shows a composite guidewire made up of a thin stainless steel wire radially surrounded by a shape-memory alloy, such as a nickel-titanium alloy. The guidewire assembly is said to be coated with a polymer layer and 70%-80% of the distal-most portion of the wire can be coated with a hydrophilic polymer to increase lubricity. U.S. Pat. No. 5,228,453 to Sepetka, shows a guidewire made up of a flexible, torqueable proximal wire section, a more flexible intermediate section with a flexible polymeric tube covering, and a most flexible distal end section. A helical ribbon coil is wrapped about the intermediate core segment between the wire core and the polymer tube covering to increase radio-opacity and to improve torque transmission while retaining flexibility. U.S. Pat. No. 5,259,393 to Corso, Jr. et. al, describes a guidewire having controlled radio-capacity at the guidewire's distal tip. A single spring mounted on the guidewire has a tightly coiled region and a second more loosely coiled and less radio-opaque region. The loosely coiled region may be coated with a polymer to avoid roughness due to the presence of the coil. U.S. Pat. No. 5,333,620 to Moutafis, et. al, describes a guidewire having a metal wire core and a high performance plastic sleeve extruded over that core. A high performance plastic is said to be one which has a flexural modulus of at least 150 ksi and an elongation (at yield) of at least two percent (2%). The preferred high performance plastic is a polysulfone. Other suitable high performance plastics are said to include polyimide, polyetheretherketone (PEEK), polyaryleneketone, polyphenylene sulfide, polyarylene sulfide, polyamideimide, polyetherimide, polyimidesulfone, polyarylsulfone, polyarylethersulfone, and certain polyesters. The coextruded compliant jacket is then said to be completely coated with lubricious material which preferably is hydrophilic. The preferred lubricious materials include complexes of polyurethane and polyvinylpyrrolidone. U.S. Pat. No. 5,372,144 to Mortier, et. al, describes a guidewire having a sleeve element exterior to a guidewire core. The sleeve element apparently is a polymeric material of high elasticity and low flexural modulus such as polyurethane. None of these documents show a high torque capability guidewire comprising stainless steel and a composite covering of sprayed polytetrafluoroethylene proximally and a hydrophilic covering distally. SUMMARY OF THE INVENTION This invention is a guidewire assembly of relatively constant diameter. It is comprised of a stainless steel core which may be tapered at various locations along the length of the wire assembly. Proximally, the core is coated with sprayed polytetrafluoroethylene or other high performance lubricious polymer. Distally (but adjunct the proximal polymeric covering) may either be a hydrophilic lubricious polymeric composition placed directly on the core wire or attached to the core wire via the use of a tie layer of some sort. Suitable tie layers include polyesters such as polyurethane and polyethyleneterephthalate (PET). A distally placed radiopaque coil may be attached to the distal-most portion of the guidewire. This specific combination of coating and core wire materials enables an outer catheter passing thereover to be highly maneuverable because of its distal response to proximal input and yet may be introduced into a soft organ such as the brain or liver nearly to the extent that a much more compliant nitinol guidewire could be. BRIEF DESCRIPTION OF THE DRAWINGS FIGS. 1 and 2 show side view, partial cutaway drawings of guidewires made according to this invention. DESCRIPTION OF THE INVENTION As noted above, this invention is a stainless steel guidewire having a generally constant diameter and multiple coatings along its length. FIG. 1 shows one variation of the invention. FIG. 1 shows a guidewire (100) made according to the invention which has a more proximal region (102) having a permanent, spray-applied coating (103) of a fluorocarbon polymer, e.g., a polytetrafluoroethylene such as a Teflon, or other thin tough lubricious polymer such as polyarylenes or polysulfones applied directly onto the core wire (104) and a more-distal region (106) adjacent to the more-proximal region (102). The more-distal region (106) has a composite covering made up of an outer hydrophilic covering (108) and an inner tie layer (110). Finally, the most distal section of the guidewire (100) comprises a radio-opaque coil (112) which surrounds at least a portion of the core wire (104). The radio-opaque coil (112) lends a measure of directabliity and shapeability to the guidewire assembly (100) in addition to providing an easily viewable terminus to the guidewire (100) when viewed with the aid of a fluoroscope. The radio-opaque coil (112) may be used with a ribbon (114) which variously may help with formation of the tip during the surgical procedure and with protection from the eventuality of the coil (112) separating from the tip. The guidewire (100) typically has a total length typically between about 50 and 300 centimeters. The proximal section (102) preferably has a uniform outer diameter (along its length) of about 0.010 to 0.025 inches, preferably 0.010 to 0.018 inches. The relatively more flexible distal section (106) extends for 3 to 45 centimeters or more of the distal end of the guidewire (100). One or more of the more distal section (106) and the more proximal (102) section may contain portions which are progressively smaller in diameter than the more proximal sections. The junctions may be a step (typically not desired) or a taper-such as is shown in the Figures at, e.g., at (116) and (118). Alternatively, the progression from larger diameter to smaller diameter in the core wire (104) may be via one or more long tapered sections. The fine wire coil (112) may be radiopaque and made from materials including but not limited to platinum and its alloys. Because this catheter is designed to have high torque transmission capabilities, the core wire (104) should have a diameter in its proximal section of between 9 and 18 mils generally between the proximal end (120) and the beginning of the first taper or joint (116). The material making up the core wire (104) may be 303, 304, 304V, or 316 stainless steel. The overall thickness of the coating (103) on this section (102) should be no greater than about 1.0 mil and preferably is between 0.1 mils and 0.5 mils. The coating (103) on the more proximal portion (102) is adjacent the coatings (108) and (110) on the more distal section (106). The material of the more proximal coating (103) is different than the materials in the coating layers (108) and (110). As noted above, the most desirable way on providing a polytetrafluoroethylene coating of minimal thickness on the inventive guidewire is by spray coating. Application of other protective polymers, such as the noted parylene coatings, may be by other methodology. There are a variety of "parylene" polymers (e.g., polyxyxylene) based on para-xylylene. These polymers are typically placed onto a substrate by vapor phase polymerization of the monomer. Parylene N coatings are produced by vaporization of a di(P-xylylene) dimer, pyrollization, and condensation of the vapor to produce a polymer that is maintained at a comparatively lower temperature. In addition to parylene-N, parylene-C is derived from di(monochloro-P-xylylene) and parylene-D is derived from di(dichloro-P-xylylene). There are a variety of known ways to apply parylene to substrates. Their use in surgical devices has been shown, for instance, in U.S. Pat. No. 5,380,320 (to J. R. Morris), in U.S. Pat. No. 5,174,295 (to Christian et al.), in U.S. Pat. No. 5,067,491 (to Taylor et al.) and the like, the entirety of which are incorporated by reference. This combination of more-proximal section material, core wire diameter, and coating material (along with its method of application) provides a guidewire which, when constructed with the combination of materials in the more proximal section as is discussed below, results in enhanced ease of use. As shown in FIG. 1, the guidewire core (104) is covered in the more distal section (106) with hydrophilic polymers including those made from monomers such as ethylene oxide and its higher homologs; 2-vinyl pyridine; N-vinylpyrrolidone; polyethylene glycol acrylates such as mono-alkoxy polyethylene glycol mono(meth) acrylates, including mono-methoxy triethylene glycol mono (meth) acrylate, mono-methoxy tetraethylene glycol mono (meth) acrylate, polyethylene glycol mono (meth) acrylate; other hydrophilic acrylates such as 2-hydroxyethylmethacrylate, glycerylmethacrylate; acrylic acid and its salts; acrylamide and-acrylonitrile; acrylamidomethylpropane sulfonic acid and its salts cellulose, cellulose derivatives such as methyl cellulose ethyl cellulose, carboxymethyl cellulose, cyanoethyl cellulose, cellulose acetate, polysaccharides such as amylose, pectin, amylopectin, alginic acid, and cross-linked heparin; maleic anhydride; aldehydes. These monomers may be formed into homopolymers or block or random copolymers. The use of oligomers of these monomers in coating the guidewire for further polymerization is also an alternative. Preferred precursors include ethylene oxide; 2-vinyl pyridine; N-vinylpyrrolidone and acrylic acid and its salts; acrylamide and acrylonitrile polymerized (with or without substantial crosslinking) into homopolymers, or into random or block copolymers. Additionally, hydrophobic monomers may be included in the coating polymeric material in an amount up to about 30% by weight of the resulting copolymer so long as the hydrophilic nature of the resulting copolymer is not substantially compromised. Suitable monomers include ethylene, propylene, styrene, styrene derivatives, alkylmethacrylates, vinylchloride, vinylidenechloride, methacrylonitrile, and vinyl acetate. Preferred are ethylene, propylene, styrene, and styrene derivatives. The polymeric coating may be cross-linked using various techniques, e.g., by light such as ultraviolet light, heat, or ionizing radiation, or by peroxides or azo compounds such as acetyl peroxide, cumyl peroxide, propionyl peroxide, benzoyl peroxide, or the like. A polyfunctional monomer such as divinylbenzene, ethylene glycol dimethacrylate, trimethylolpropane, pentaerythritol di- (or tri- or tetra-) methacrylate, diethylene glycol, or polyethylene glycol dimethacrylate, and similar multifunctional monomers capable of linking the monomers and polymers discussed above. Polymers or oligomers applied using the procedure described below are activated or functionalized with photoactive or radiation-active groups to permit reaction of the polymers or oligomers with the underlying polymeric surface, the "tie layer", when such tie layer is used. In FIG. 1, the tie layer (110) is found beneath the hydrophilic layer (108). Suitable activation groups include benzophenone, thioxanthone, and the like; acetophenone and its derivatives specified as: ##STR1## where R 1 is H, R 2 is OH, R 3 is Ph; or R 1 is H, R 2 is an alkoxy group including --OCH 3 , --OC 2 H 3 , R 3 is Ph; or R 1 =R 2 =an alkoxy group, R 3 is Ph; or R 1 =R 2 =an alkoxy group, R 3 is H; or R 1 =R 2 =Cl, R 3 is H or Cl. Other known activators are suitable. The polymeric hydrophilic coating (108) may then be linked with the substrate using known and appropriate techniques selected on the basis of the chosen activators, e.g., by ultraviolet light, heat, or ionizing radiation. Crosslinking with the listed polymers or oligomers may be accomplished by use of peroxides or azo compounds such as acetyl peroxide, cumyl peroxide, propionyl peroxide, benzoyl peroxide, or the like. A polyfunctional monomer such as divinylbenzene, ethylene glycol dimethacrylate, trimethylolpropane, pentaerythritol di- (or tri- or tetra-) methacrylate, diethylene glycol, or polyethylene glycol dimethacrylate, and similar multifunctional monomers capable of linking the polymers and oligomers discussed above is also appropriate for this invention. The polymeric hydrophilic coating (108) may be applied to the guidewire by any of a variety of methods, e.g., by spraying a solution or suspension of the polymers or of oligomers of the monomers onto the guidewire core or by dipping it into the solution or suspension. Initiators may be included in the solution or applied in a separate step. The guidewire may be sequentially or simultaneously dried to remove solvent after application of the polymer or oligomer to the guidewire and crosslinked. The solution or suspension should be very dilute since only a very thin layer of polymer is to be applied. The amount of oligomer or polymer in such a solvent should be between 0.25% and 5.0% (wt), preferably is 0.5 to 2.0% (wt). Such a mixture is excellent for thin and complete coverage of the resulting polymer. Preferred solvents for this procedure when using the preferred polymers and procedure are water, low molecular weight alcohols, and ethers, especially methanol, propanol, isopropanol, ethanol, and their mixtures. Other water miscible solvents, e.g., tetrahydrofuran, methylene dichloride, methylethylketone, dimethylacetate, ethyl acetate, etc., are suitable for the listed polymers and must be chosen according to the characteristics of the polymer; they should be polar because of the hydrophilic nature of the polymers and oligomers but, because of the reactivity of the terminal groups of those materials, known quenching effects caused by oxygen, hydroxyl groups and the like must be recognized by the user of this process when choosing polymers and solvent systems. Particularly preferred as an outer hydrophilic coating (108) for the guidewire core (104) discussed herein are physical mixtures of homo-oligomers of at least one of polyethylene oxide; poly 2-vinyl pyridine; polyvinylpyrrolidone, polyacrylic acid, polyacrylamide, and polyacrylonitrile. The catheter bodies or substrates are preferably sprayed or dipped, dried, and irradiated to produce a polymerized and crosslinked polymeric skin of the noted oligomers. The lubricious hydrophilic coating (108) is preferably produced using generally simultaneous solvent removal and crosslinking operations. The coating is applied at a rate allowing "sheeting" of the solution, e.g., formation of a visibly smooth layer without "runs". In a dipping operation for use with most polymeric substrates including those noted below, the optimum coating rates are found at a linear removal rate between 0.25 and 2.0 inches/sec, preferably 0.5 and 1.0 inches/sec. The solvent evaporation operations may be conducted using a heating chamber suitable for maintaining the surface at a temperature between 25° C. and the glass transition temperature (T g ) of the underlying tie layer or layers. Preferred temperatures are 50° C. to 125° C. Most preferred for the noted and preferred solvent systems is the range of 75° to 110° C. Ultraviolet light sources may be used to crosslink the polymer precursors onto the substrate tie layer. Movement through an irradiation chamber having an ultraviolet light source at 90-375 nm (preferably 300-350 nm) having an irradiation density of 50-300 mW/cm 2 (preferably 150-250 mW/cm 2 ) for a period of three to seven seconds is desired. Passage of a guidewire core through the chamber at a rate of 0.25 to 2.0 inches/second (0.5 to 1.0 inches/second) in a chamber having three to nine inches length is suitable. When using ionizing radiation, a radiation density of 1 to 100 kRads/cm 2 (preferably 20 to 50 kRads/cm 2 ) may be applied to the solution or suspension on the polymeric substrate. Exceptional durability of the resulting coating is produced by repetition of the dipping/solvent removal/irradiation steps up to five times. Preferred are two to four repetitions. A tie layer (110) is shown in FIG. 1. A tie layer acts as a coating between the outer polymeric surface (108) and the guidewire core (104) to enhance the overall adhesion of that outer polymeric surface (108) to the core. Of course, the tie layer materials must be able to tolerate the various other solvents, cleaners, sterilization procedures, etc. to which the guidewire and its components are placed during other production steps. Choice of materials for such tie layers is determined through their functionality. Specifically, the materials are chosen for their affinity or tenacity to the outer polymeric lubricious or hydrophilic coating. Clearly, the tie layer material must be flexible and strong. The material may be extrudable and perhaps formable into shrinkable tubing for mounting onto the guidewire through heating. The material may be placed onto the core wire using an exterior temporary heat shrink wrap tubing which is then removed. We have found that various polyamides (e.g., NYLON's), polyethylene, polystyrene, polyurethane, and polyesters, e.g., preferably polyethylene terephthalate (PET) make excellent tie layers. These tubing materials may be also formulated to include radio-opaque materials such as barium sulfate, bismuth trioxide, bismuth carbonate, tungsten, tantalum or the like. As noted above, one readily achievable manner of applying a tie layer is by heat-shrinking the tubing onto the guidewire core (104). The guidewire core (104) is simply inserted into a tubing of suitable size--often with a small amount of a "caulking" at either end to seal the tubing from incursion of fluids or unsterile materials from beneath the tubing. The tubing is cut to length and heated until it is sufficiently small in size. The resulting tubing tie layer desirably is between about 0.25 and 1.5 mils in thickness. The thinner layers in the range are typically produced from polyurethane or PET. The layer of lubricious polymer (110) is then placed on the outer surface of the shrunk tubing. FIG. 2 shows another variation of the invention in which the catheter assembly (130) uses a single layer (132) of hydrophilic polymer on the exterior of the more distal region (134). The procedure for preparing or pretreating the inventive guidewire (130) prior to receiving a subsequent coating of a lubricious, biocompatible, and hydrophilic polymer is via the use of a plasma stream to deposit a hydrocarbon or fluorocarbon residue. The procedure is as follows: the guidewire core is placed in a plasma chamber and cleaned with an oxygen plasma etch. The guidewire core is then exposed to a hydrocarbon plasma to deposit a plasma-polymerized tie layer on the guidewire core to complete the pretreatment. The hydrocarbon plasma may comprise a lower molecular weight (or gaseous) alkanes such as methane, ethane, propane, isobutane, butane or the like; lower molecular weight alkenes such as ethene, propene, isobutene, butene or the like or; gaseous fluorocarbons such as tetrafluoromethane, trichlorofluoromqthane, dichlorodifluoromethane, trifluorochloromethane, tetrafluoroethylene, trichlorofluoroethylene, dichlorodifluoroethylene, trifluorochloroethylene and other such materials. Mixtures of these materials are also acceptable. The tie layer apparently provides C--C bonds for subsequent covalent bonding to the outer hydrophilic polymer coating. Preferred flow rates for the hydrocarbon into the plasma chamber are in the range of 500 c.c./min. to 2000 c.c./min. and the residence time of the guidewire in the chamber is in the range of 1-20 minutes, depending on the chosen hydrocarbon and the plasma chamber operating parameters. Power settings for the plasma chamber are preferably in the range of 200 W to 1500 W. A tie layer of plasma-produced hydrocarbon residue having a thickness on the order of 10 Å thick is disposed between core and coating. This process typically produces layers of hydrocarbon residue less than about 1000 Å in thickness, and more typically less than about 100 Å. Tie layer effectively bonds the outer layer to the guidewire core while adding very little additional bulk to the guidewire. The pretreated guidewire may then be coated by a hydrophilic polymer using a procedure such as described above. For example, the pretreated guidewire may be dipped in a solution of a photoactive hydrophilic polymer system, i.e., a latently photoreactive binder group covalently bonded to a hydrophilic polymer. After drying, the coated guidewire is cured by exposing it to UV light. The UV light activates the latently reactive group in the photoactive polymer system to form covalent bonds with crosslinked C--C bonds in the hydrocarbon residue tie layer. The dipping and curing steps are preferably repeated often enough, typically twice, to achieve the appropriate thickness of the hydrophilic coating layer. The exterior surface of the guidewire is preferably a biocompatible coating of a polyacrylamide/polyvinylpyrrolidone mixture bonded to a photoactive binding agent. The preferred coating is made from a mixture of Bio-Metric Systems PA03 and PV05 (or PVO1) binding systems according to the Examples below. The photoactive hydrophilic polymer system of this preferred embodiment is a mixture of Bio-Metric Systems PA03 polyacrylamide/binder system and Bio-Metric Systems PV05 polyvinylpyrrolidone system. The polyacrylamide system provides lubricity; and the polyvinylpyrrolidone system provides both lubricity and binding for durability. The exact proportions of the two systems may be varied to suit the application. As an alternative, however, the hydrophilic biocompatible coating may be polyacrylamide alone, polyvinylpyrrolidone alone, polyethylene oxide, or any suitable coating known in the art. In addition, a coating of heparin, albumin or other proteins may deposited over the hydrophilic coating in a manner known in the art to provide additional biocompatibility features both in the FIG. 1 and FIG. 2 variations. The guidewire or other device may be cleaned by using an argon plasma etch in place of the oxygen plasma etch. The thickness of the plasma-polymerized tie layer may also vary without departing from the scope of this invention. The following example is further illustrative of the articles and methods of this invention. The invention is not limited to these examples. Although preferred embodiments of the present invention have been described, it should be understood that various changes, adaptations,.and modifications may be made therein without departing from the spirit of the invention and the scope of the claims which follow.

This is a surgical instrument. It is a guidewire made of a stainless steel alloy core which is coated with a non-hydrophilic lubricious polymer on the majority of its length located proximally and a hydrophilic polymer located at the majority of the remaining distal length of the guidewire. Preferably, the guidewire has a polymeric tie layer located between the metallic core of the guidewire assembly and the hydrophilic polymeric layer. The metallic core is one of a number of stainless steels so to preserve its torque transmitting capabilities. Desirably the outside diameter of the guidewire is constant from the distal end to the proximal end. The metallic core may be tapered at appropriate locations along the guidewire assembly.

This application is a continuation of application Ser. No. 07/850,545, filed Mar. 13, 1992 now abandoned. FIELD OF THE INVENTION The present invention concerns a method for the treatment of higher mammals having or being at substantial risk of developing osteoporosis in cortical bone, the treatment comprising the administration of insulin-like growth factor I (IGF-I). Hence, the invention is directed to the fields of bone growth and degeneration, to IGF-I, and to compositions thereof for use as pharmaceuticals. BACKGROUND OF THE INVENTION Osteoporosis encompasses a broad range of clinical syndromes having varying etiologies. In postmenopausal women, for example, two distinct types of osteoporsis have been identified. Type I osteoporosis occurs mainly in the early postmenopausal period from about age 50-65. It is characterized by excessive resorption, primarily in trabecular bone. Vertebral fractures are common. If given prior to significant bone loss, treatment which decreases or prevents bone resorption (such as with estrogen or calcitonin) is considered effective therapy. Type II osteoporosis (a.k.a. senile osteoporosis) occurs essentially in all aging women and, to a lesser extent, in men. It is characterized by proportionate loss of cortical bone as well as trabecular bone. Here decreased bone formation plays a major role, if not a more important role than increased bone resorption. Fractures of the hip are characteristic of this type of osteoporosis. Currently approved therapeutic agents for osteoporosis are antiresorptives. As such, while they may prevent further loss in patients with Type I osteoporosis, they are not as effective in reversing osteoporosis of either Type I or Type II or in halting Type II osteoporsis. See The American Journal of Medicine, Vol. 91 (Suppl 5B) 37S-41S; The American Journal of Medicine, Vol. 91 (Suppl 5B) 10S-13S; and The American Journal of Medicine, Vol. 91 (Suppl 5B) 23S-28S. In addition, the most widely accepted preventive agent for osteoporosis currently in use is estrogen therapy, which is not really an acceptable therapeutic agent for women with a history of or at risk for breast or endometrial cancers (estrogen dependent tumors) or for men with osteoporosis. Insulin-like Growth Factor I (IGF-I) is a 70 amino acid peptide belonging to a family of compounds under the class name somatomedins and retains some structural and biologically similarities to insulin. The somatemedins' activity lie on a spectrum from hypoglycemic effects similar to insulin to growth promoting effects which are exemplified by growth hormone. IGF-I predominately induces growth and cell proliferation. IGF-I has also been demonstrated to specifically bind to receptors on rat osteoblast-like bone cells (Bennett et al, Endocrin. 115(4):1577-1583, 1984). IGF-I is routinely fabricated in the liver and released for binding to carrier proteins in the plasma (Schwander et al, Endocrin. 113(1):297-305, 1983), which bound form is inactive. In addition, there is a biofeedback regulating loop involving the somatomedins and growth hormone such that higher somatomedin concentrations inhibit growth hormone release which results in lesser production of endogenous IGF-I. IGF-I infused into rats has been shown to result in markedly greater increases in body weight gain compared to controls, with increases in tibial epiphyseal width and thymidine incorporation into costal cartilage (Nature 107: 16-24, 1984) and directly stimulate osteoblasts to result in a greater number of functional osteoblasts. IGF-I is also mentioned as the vehicle through which growth hormone's effects on bone is mediated in Simpson, Growth Factors Which Affect Bone, Physiol. 235, TIBS, December 12, 1984. Nevertheless, it is important to note that the foregoing pre-clinical studies were conducted with fetal or newborn rat cells. It is highly likely that such “young” cells are more responsive to IGF-I (as well as other influences) than older cells, especially those in the elderly with established osteoporosis or those with drug induced or environmentally induced defects leading to reduced bone density. Furthermore, in J. Bone and Mineral Res., Vol 6, Suppl 1, Abstr. 549, p. S-221, August 1991, the authors report that IGF-I has virtually no effect on cortical bone of oovariectomized rats. OBJECTS OF THE INVENTION Accordingly, an object of the present invention is to provide a method of treatment of osteoporosis in higher mammals exhibiting decreased cortical bone mineral density and preventing osteoporosis due to cortical bone mineral density reduction in such mammals clinically prone to such cortical bone density reductions. Another object of the invention is to provide pharmaceutical compositions useful in achieving the foregoing object. SUMMARY OF THE INVENTION Surprisingly, these and other objects of the invention have been achieved with the finding that IGF-I is useful in the treatment of osteoporosis in higher mammals exhibiting decreased cortical bone mineral density and those exposed to drugs or environmental conditions which tend to result in cortical bone mineral density reduction and potentially to a cortical bone osteoporotic condition. DETAILED DESCRIPTION OF THE INVENTION The present invention concerns osteoporosis treatment and prevention, which osteoporosis is associated with decreased cortical bone mineral density in mammals generally, but is especially suited for the treatment and prevention of such osteoporosis in humans. For the present invention purposes, mammals includes all mammals within the taxonomic orders of Primates, Carnivora, Perissodactyla and Artiodactyla. This includes, without limitation, Old World monkeys, New World monkeys, great apes, humans, cats, dogs, horses, pigs, cattle, sheep, and goats. Preferably mammals are selected from the taxonmic orders of Primates, Carnivora, Perissodactyla, and Artiodactyla, more preferably Primates, cats, dogs, sheep, goats, horses, pigs and cattle, still more preferably Primates, most preferably humans. IGF-I is a naturally occuring protein that can be obtained from a number of sources. Preferably, IGF-I from the same species (or its synthetic twin) as the species being treated therewith is employed, but IGF-I from one species may be used to treat another species if the immune response elicited is slight or non-existent. In addition, fragments and analogs of IGF-I having IGF-I activity, particularly IGF-I anti-osteoporosis activity, are also suitably employed in the invention. As used within the context of the present invention IGF-I includes such fragments and analogs unless the text clearly states otherwise. Where weights of IGF-I are presented, that weight of IGF-I or an approximately equipotent weight of such analogs and fragments are intended absent clear direction to the contrary. Where no type of IGF-I is indicated, reference is to human-IGF-I (meaning the structure, not the species source), unless the reasonable reading of the text requires otherwise. IGF-I analogs and fragments of IGF-I or its analogs are commonly known in the art as can be seen from Proc. Natl. Acad. Sci. USA, Vol 83, pp. 4904-4907, July 1986; Biochemical and Biophysical Research Communications, Vol 149, No. 2, pp. 398-404, Dec. 16, 1987; Biochemical and Biophysical Research Communications, Vol. 149, No. 2, pp. 672-679, Dec. 16, 1987; Endocrinology, Vol. 123, No. 1, pp. 373-381; The Journal of Biological Chemistry, Vol. 263, No. 13, pp. 6233-6239, May 5, 1988; and Biochemical and Biophysical Research Communications, Vol. 165, No. 2, pp. 766-771, Dec. 15, 1989. IGF-I can be synthetically produced, chemically or by recombinant techniques, as well as extracted from tissues. Recombinant manufacture is preferred. One such recombinant technique is disclosed in EP 123,228, incorporated herein by reference. An effective amount of IGF-I for the present invention is an amount sufficient to slow, stop, or reverse the cortical bone mineral density reduction rate in a patient exhibiting cortical bone mineral density reduction. Throughout the specification where values are given for non-cortical bone tissue they are for purposes of exemplifying the osteoporotic state generally. In the normal healthy 20-25 year old human population, bone mineral density in the spine (using dual photon densitometry) typically is in the range of 0.85 to 1.9 g/cm 3 , usually 0.9 to 1.85 g/cm 3 , and most 1.0 to 1.8 g/cm 3 ; and in the mid radius and distal radius it is typically 0.7-1.4 g/cm 3 , usually 0.75-1.3 g/cm 3 , and most often 0.8-1.2 g/cm 3 . Exemplary non-limiting normal ranges are shown in the Figures along with osteoporosis distributions. Norms using other techniques will be apparent from the literature and general experience therewith as experience with such techniques grow. Of course, it is to be remembered that different sub-populations have different norms in bone mineral density. For example, caucasian women typically differ in this parameter from caucasion men as well as from black women, oriental women, and women of other racial types. It is also important to remember that the present invention is directed to treating those with bone mineral which is (a) totally below either the normal bone mineral density range for the population generally or for the patient sub-population or (b) below 1.0 g/cm 3 or (c) below the fracture threshold (approximately 2 standard deviations below the mean bone mass for the population at age 35). The fracture threshold for the spine, for example, is defined as the bone mineral density value below which 90% of all patients with one or more compression fractures of the spine are found. (See Mayo Clin. Proc., December 1985, Vol 60, p. 829-830). In addition, anyone who demonstrated a statistically significant reduction in bone density over a previous measurement, regardless of where that patient is in the typical ranges above, is a patient to whom the present invention treatment is directed. Statistical significance in this context will vary with the technique employed to measure bone mineral density, as well as with the sensitivity of the instruments used. However, with instrumentation and techniques generally available in 1988, a 1 or 2% change in bone mineral density from the earliest measurement to the most recent is not considered statistically significant. Still as techniques and equipment improve, persons of ordinary skill in the field of bone mineral density measurement will revise downward the maximum percent change which is not considered statistically significant. Current bone mineral density measurement techniques include dual energy radiography, quantitative computerized tomography, single photon densitometry, and dual photon densitometry. These techniques will be well known to those of ordinary skill in the art; however, descriptions thereof can be found in: Mayo Clin. Proc., December 1985, Vol. 60, p. 827-835; Orthopedic Clinics of North America, Vol. 16, No. 3, July 1985, p. 557-568; Hologic QDR™-1000 Product Literature; Annals of Internal Medicine, 1984, 100:908-911; and Clinical Physiol 4:343, 1984. Notwithstanding the lack of statistical significance of a particular result, any bone mineral density reduction should be followed for further reductions, which cumulatively may be significant. Usually, an effective amount of IGF-I, when given parentally (intravenously, subcutaneously, intramuscularly, etc.) is between 2.5 μg/Kg/day up to about 180 μg/Kg/day, preferably about 5μg/Kg/day up to about 150 μg/Kg/day, more preferably 10 μg/Kg/day up to about 120 μg/Kg/day, even more preferably 10 μg/Kg/day up to about 100 μg/Kg/day, still more preferably about 10 μg/Kg/day up to about 90 μg/Kg/day. When given continuously, such effective amount may be given in two or three doses spread over time such as by IV drip or subcutaneous injection(s) with the total daily dose being spread across a portion or the entire administration period. Typical continuous dosing is in the range of 2.5 μg/Kg/hour up lto about 50 μg/Kg/hour, preferably about 5 μg/Kg/hour up to about 25 μg/Kg/hour, although wider ranges of “continuous” administration amounts will be apparent to those of ordinary skill in the art. When given by subcutaneous injection, it is most preferably administered from 2 times/wk up to 3 times a day, preferably 3 times a week up to once or twice daily. Particularly suitable doses are 10, 15, 30, and 60 μg/Kg/day. The specific dosage for a particular patient, of course, has to be adjusted to the degree of response, route of administration, the individual weight and general condition of the patient to be treated, and is finally dependent upon the judgment of the treating physician. In general, the pharmaceutical preparations for use in the present invention comprise an effective amount of IGF-I or an active fragment or analog or fragment of an analog thereof together with a pharmaceutically and parentally acceptable carrier or adjuvant. Compositions having an approximately 6 day supply typically contain from about 0.1 mg to 15 mg, preferably 1 mg to 13 mg, more preferably about 3 mg to about 10 mg, most preferably 5 mg to 10 mg of IGF-I. The liquid carriers are typically sterile water, approximately physiologic saline, about 0.1 M acetic acid, approximately 5% aqueous dextrose, etc; preferably sterile water, physiologic saline, or 5% aqueous dextrose. The carriers and adjuvants may be solid or liquid and may be organic or inorganic. The active compound and the compositions of the invention are preferably used in the form of preparations or infusions for parenteral (subcutaneous, intramuscular, or intravenous) administration. Such solutions are preferably isotonic aqueous solutions or suspensions which can be prepared before use, for example by reconstituting a lyophilized preparation of the active agent. The pharmaceutical preparations may be sterilized and/or contain adjuvants, for example preservatives, antiinfectives, stabilizers wetting agents, emulsifiers, solubilizers, tonicity regulating agents, and/or buffers. Other adjuvants will of course be apparent to those of ordinary skill in the art. Other dosage forms and routes of administration for use in the present invention include aerosols and sprays for lung inhalation or as a nasal spray, transdermal patch administration, and buccal administration. The present pharmaceutical preparations, which, if desired, may contain further pharmacologically active or otherwise pharmaceutically valuable substances, especially bone antiresorptives such as estrogen, calcitonin, and bisphosphonates, particularly 3-aminopropyl-1hydroxy-1, 1-bisphosphonate, are prepared from their constituent parts by techniques known in the art, for example lyophilization, dissolution, reconstitution, and suspension techniques, among others known to those of ordinary skill. They typically contain from about 0.1% to about 100% of active ingredient, but especially in the case of a solution from about 1% to about 20% and especially in the case of a lyophilizate up to 100% of active ingredient. DESCRIPTION OF THE DRAWINGS FIG. 1 . Bone mineral density (BMD in spine ( 1 A); (L1-4; measured with use of dual-photon absorptiometry)), midradius ( 1 B), and distal radius ( 1 C) (measured with use of single-photon absorptiometry) in 76 women with osteoporosis in comparison with age- and sex-adjusted normal range (105 women). Shaded areas represent 5th and 95th percentile range of normals. Patients with osteoporosis are indicated by the dots. Note incomplete separation of the two populations. Spinal measurements result in the best distinction of patients with osteoporosis from normal subjects because this disease primarily affects trabecular bone of the spine. FIG. 2 . Fracture threshold for spinal bone mineral (horizontal line) superimposed on normal range (shaded area) and values for 76 patients with osteoporosis (dots), as depicted in FIG. 1 . With progressing age, values of increasing numbers of normal subjects are below the fracture threshold. Fracture threshold is approximately two standard deviations below mean bone mass at 35 years of age. FIGS. 1 and 2 are taken from Mayo Clin. Proc., Vol. 60, December 1985, mentioned above, and are based on data from Riggs B L, Wahner H W, Dunn W L, Mazess R B, Offord K P, Melton L J III: Differential changes in bone mineral density of the appendicular and axial skeleton with aging: relationship to spinal osteoporosis, J. Clin. Invest. 67:328-335, 1981. FIG. 3. A. Normal male values for vertebral cancellous mineral content by QCT, using cubic regression with 95% confidence intervals. The cubic regression gives only a slightly better fit to the data for men than does a linear regression (p<0.15). B. Normal female values for vertebral cancellous mineral content by QCT, using cubic regression with 95% confidence intervals (p<0.05). An accelerated loss is observed after menopause. FIG. 4. A and B. The accuracy of single-energy QCT is shown for vertebral specimens (preserved in sodium azide) from 11 patients (10 men and 1 woman), ages 40-90 years. FIG. 5 . Values for men with idiopathic osteoporosis and spinal fractures are plotted (black dots) against the normal male curve (cubic regression with 95% confidence intervals). A fracture threshold at approximately 11 mg/cm 3 is observed. FIG. 6 . Idiopathic osteoporotic male values showing larger decrement from normal for vertebral mineral QCT than for mean peripheral cortical mineral by radiogrammetry and photon absorptiometry. FIGS. 3-6 are taken from Orthopedic Clinics of North America, Vol 16 No 3, July 1985, mentioned above. Having fully described the instant invention, the following Examples are presented to more clearly set forth the invention without imposing any limits on the scope of the invention as set out in the claims. EXAMPLES Examples 1-3 Dry Ampules of IGF-I Sterile, filtered 1% (w/v) aqueous solution of IGF-I is added, in the amount indicated to the respective dry ampules set forth below. The solution is then lyophilized to result in the dry ampules for reconstitution. The ampules are reconstituted with the indicated amount of sterile water, physiologic saline, 0.1 M acetic acid, or 5% aqueous dextrose to result in a reconstituted solution having the total volume as shown below. Each vial is sufficient for a 6 day course of treatment for the intended patient. Ex 1 Ex 2 Ex 3 ampule size 5 ml 8 ml 50 ml IGF-I fill volume 1 ml 5 ml 30 ml reconstitution volume 1 ml 5 ml 30 ml Example 4 6 beagles per group are used to demonstrate the ability of IGF-I to improve cortical bone density after loss of ovarian function. One group is given a sham operation to serve as a control. 4 other groups are oophorectomized. Of these 4, one group is treated with IGF-I immediately, one is given IGF-I after bone growth function has been reduced, one is treated with estrogen and one is followed without treatment. Each group is followed for a period of 12 months and bone mineral density (BMD) of the vertibral (trabecular) and femoral (cortical) bones are measured. The results, reported as average changes per group over the 8 month period are reported in Table I below. TABLE I % CHANGE IN BMD % CHANGE IN BMD TREATMENT (12 MONTHS-0 TIME) (12 MONTHS-0 TIME) GROUP CORTICAL BONE TRABECULAR BONE Sham Operation 4.0% 6.2% Oophorectomized 0.4% −1.4% only Oophorect. + imm. 10.1% 12.3% IGF-I Oophorect. + estrog. 4 months treatment after 8 months delay 1.9% 8.8% Oophorect. + IGP-I 4 months treatment after 8 months delay 9.6% 9.0% Not only did the treatment with IGF-I both prophylactically and therapeutically completely wipe out any loss in cortical bone growth associated with oophorectomy, it pushed cortical bone growth beyond the levels which were achieved by the sham operated controls by more than twice those values and beyond that acheived by estrogen by more than 4.5 times.

A method for the treatment or prevention of osteoporosis in higher mammals is disclosed, the method comprising administering Insulin-like Growth Factor I (IGF-I) in an effective amount thereof to said mammal, said mammal being in need of said treatment or prevention. Compositions for pharmaceutical use in the above method are also described.

CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims the benefit of the U.S. provisional application Ser. No. 61/831,520, filed on Jun. 5, 2013, the disclosure of which is expressly incorporated by reference herein in its entirety. BACKGROUND OF THE INVENTION 1. Field of the invention The present invention relates to electronic device holders and more particularly pertains to a new apparatus and method for supporting and operating an electronic device upon a user's forearm for safeguarding the phone and providing immediate and convenient functional access to the phone. 2. Description of the Prior Art The use of electronic device holders is known in the prior art. More specifically, electronic device holders heretofore devised and utilized are known to consist basically of familiar, expected and obvious structural configurations, notwithstanding the myriad of designs encompassed by the crowded prior art which have been developed for the fulfillment of countless objectives and requirements. The prior art includes a wrist-device which comprising a first module such as a personal computer and a second module consisting of a mobile telephone or a wireless telephone terminal which are coupled by means of elements in a bracelet configuration for holding the device to the forearm of the user, and wherein windows are provided in said modules for the passage of electronic connection buses between said modules. Another prior art includes a generally rectangular holder base and a holder configured to secure the mobile device therein. The holder may be removably attachable to the holder base. Another prior art includes an arm harness with a control panel for operating multiple electronic devices contained by the arm harness. In addition, another prior art includes a cell phone holder headband which enables the phone to stay in a normal talking position without having to hold it there with one hand. The cell phone is fit into an elastic band that is looped through a plastic plate. The plate is fitted to a swivel joint that is connected to one end of the headband. Yet, another prior art includes a releasable holder for a portable communication device including a base clip adapted to secure to a carrier such as a belt and an article clip adapted to secure to the portable communication device The base clip includes a channel having a bottom and side walls extending between open opposite ends with overlying flanges on both side walls spaced a selected distance from the channel bottom, and a locking tab extending into an opening in the channel bottom, a biasing member biasing the locking tab into the channel bottom opening. While these devices fulfill their respective, particular objectives and requirements, the aforementioned patents do not disclose a new apparatus and method for supporting and operating an electronic device upon a user's forearm. SUMMARY OF THE INVENTION The general purpose of the present invention, which will be described subsequently in greater detail, is to provide a new apparatus and method for supporting and operating an electronic device upon a user's forearm which has many of the advantages of the electronic device holders mentioned heretofore and many novel features that result in a new apparatus and method for supporting and operating an electronic device upon a user's forearm which is not anticipated, rendered obvious, suggested, or even implied by any of the prior art electronic device holders, either alone or in any combination thereof. The present invention includes an arm mount assembly including an curved arm mount being adapted to fit upon a user's forearm region and also having a cushion member, and also including a swivel assembly having a support member being disposed upon the top side of the curved arm mount, and also having a swivel joint being rotatable upon the support member, and further including an electronic device holder being mounted upon the swivel joint for rotation therewith. None of the prior art includes the combination of the elements of the present invention. There has thus been outlined, rather broadly, the more important features of the apparatus and method for supporting and operating an electronic device upon a user's forearm in order that the detailed description thereof that follows may be better understood, and in order that the present contribution to the art may be better appreciated. There are additional features of the invention that will be described hereinafter and which will from the subject matter of the claims appended hereto. In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. It is an object of the present invention to provide a new apparatus and method for supporting and operating an electronic device upon a user's forearm which has many of the advantages of the electronic device holders mentioned heretofore and many novel features that result in a new apparatus and method for supporting and operating an electronic device upon a user's forearm which is not anticipated, rendered obvious, suggested, or even implied by any of the prior art electronic device holders, either alone or in any combination thereof Still another object of the present invention is to provide a new apparatus and method for supporting and operating an electronic device upon a user's forearm for safeguarding the phone and providing immediate and convenient functional access to the phone. Still yet another object of the present invention is to provide a new apparatus and method for supporting and operating an electronic device upon a user's forearm that allows the user to position the phone upon one's arm to facilitate the use thereof. Even still another object of the present invention is to provide a new apparatus and method for supporting and operating an electronic device upon a user's forearm that is easy to attach to and detach from the user's arm and is positioned to not be an obstructive hindrance. These together with other objects of the invention, along with the various features of novelty which characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be made to the accompanying drawings and descriptive matter in which there are illustrated preferred embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein: FIG. 1 is a partially exploded perspective view of a new apparatus and method for supporting and operating an electronic device upon a user's forearm according to the present invention. FIG. 2 is a perspective view of the present invention in use. FIG. 3 is another perspective view of the present invention in use with a partial cutaway showing the connector assembly. FIG. 4 is a partially explode perspective view of a second embodiment of the present invention. FIG. 5 is a side cross sectional view of the second embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION With reference now to the drawings, and in particular to FIGS. 1 through 5 thereof, a new apparatus and method for supporting and operating an electronic device upon a user's forearm embodying the principles and concepts of the present invention and generally designated by the reference numeral 10 will be described. As best illustrated in FIGS. 1 through 5 , the apparatus and method for supporting and operating an electronic device upon a user's forearm 10 generally comprises an arm mount assembly 38 including a curved arm mount 11 made of a rigid material such as plastic and being laterally curved and adapted to fit upon a forearm 35 of a user. The curved arm mount 11 has a bottom side 12 and a top side 13 and also rounded corners. A cushion member 14 may be affixed with adhesive to the bottom side 12 of the curved arm mount 11 and has a dimension that substantially covers the entire bottom side 12 with the cushion member 14 being moisture permeable. A pair of fastening members 15 , 18 or straps or elastic bands are used to secure the curved arm mount 11 to the user's forearm 35 , and the fastening members 15 , 18 may include first ends 16 , 19 which are securely and conventionally attached to the top side 13 of the curved arm mount 11 near a side edge and at opposed ends of the curved arm mount 11 , and may also include second ends 17 , 20 which are fastenable with hook and loop fasteners to the respective fastening members 15 , 18 to secure the curved arm mount 11 upon the user's forearm 35 . As shown in FIG. 1 , the uppercuts for supporting and operating an electronic device upon a user's forearm 10 also comprises a connector assembly 39 including a support member 21 securely and conventionally attached centrally to the top side 13 of the curved arm mount 11 , and also including a swivel joint 22 being rotatable upon and about the support member 21 . The swivel joint 22 may be freely rotatable upon the support member 21 or the swivel joint 22 may be lockable at selected rotatable positions. The swivel joint 22 and the support member 21 may have a ratcheted assembly such as mateable dimples 23 or slots and nodes 24 conventionally spaced about the circumference of the swivel joint 22 and the support member 21 . The support member 21 may be a disk or a boss having a side wall 21 A with the nodes 24 conventionally attached to and spacedly arranged in a row about an outer side of the side wall 21 A. The swivel joint 22 may be a cap having a top wall 22 A and a side wall 22 B depending from the top wall 22 A with the dimples 23 or slots being disposed in an inner side of the side wall 22 B and spacedly arranged in a row about the side wall 22 B. The swivel joint 22 may also include an annular lip 22 C integral to a bottom edge of the side wall 22 B and being engageable to the support member 21 for retaining the swivel joint 22 to the support member 22 . The spaces between the dimples 23 or slots and the spaces between the nodes 24 are substantially equivalent so that each node 24 will be removably received and engaged in a respective dimple 23 or slot. As illustrated in FIGS. 1-3 , an electronic device holder 25 is securely and conventionally attached to the swivel joint 22 for rotation therewith. The electronic device holder 25 has a back wall 26 , sides 27 , 28 , a bottom end 29 , an open front 31 , an open top end 30 , and also flanges 32 - 34 or tabs being integral to the sides 27 , 28 and to the bottom end 29 with the flanges 32 - 34 or tabs being spaced from the back wall 26 and extending inwardly from the sides 27 , 28 and the bottom end 29 . The back wall 26 of the electronic device holder 25 is securely and conventionally attached to the swivel joint 22 . The electronic device holder 25 has a dimension which is similar to that of the curved arm mount 11 and is adapted to engageably receive an electronic device 37 preferably an iPhone5 through the open top end 30 between the flanges 32 - 34 or tabs and the back wall 26 of the electronic device holder 25 to securely retain the phone 37 to the electronic device holder 25 . As shown in FIGS. 2 , 4 & 5 , a second embodiment of the connector assembly 39 includes the support member 21 having a bottom wall 40 conventionally attached to the topside 13 of the curved arm mount 11 and having a front edge 41 , a convexly curved back edge 42 , and side edges 43 , 44 with a rail 45 conventionally attached to a top of the bottom wall 40 and extending along the curved back 42 and side edges 43 and also with a lip 46 integral to a top of the tail 45 and extending inwardly thus forming a groove 47 between the lip 46 and the bottom wall 40 . The lip 46 also has lugs 48 , 49 integral to and at the ends of the rail 45 at the front edge 41 of the bottom wall 40 . The lugs 48 , 49 project inwardly of the support member 21 . In addition, the support member 21 has ribs 50 , 51 centrally disposed in the top of the bottom wall 40 and longitudinally aligned and spaced from the back edge 42 to the front edge 41 of the bottom wail 40 . A biased and depressible ramp 53 is conventionally secured upon the top side 13 of the arm mount 11 forward of and adjacent to the support member 21 and has a back edge 54 biasedly extending higher than the front edge 41 of the support member 21 , but when depressed, the back edge 54 of the biased ramp 53 aligns with the front edge 41 of the support member 21 . The biased ramp 53 may be made of rigid material and may be a leaf spring. The swivel joint 22 of the second embodiment includes a truncated cylindrical member 55 having a thickness and also having back 56 , front 57 and side edges 58 , 59 . The front and back edges 56 , 57 are convexly curved and the opposed side edges 58 , 59 are truncated. The truncated cylindrical member 55 is conventionally attached to a bottom side of the electronic device holder 25 . The swivel joint 22 further includes a connector member 60 being disc-shaped and made of rigid material and having a planar bottom side 62 and a planar top side 61 and also having a circumferential tapered front edge portion 63 with the taper being from the top side 61 to the bottom side 62 and has a circumferential vertically straight back edge portion 64 which is perpendicular to the planar top side 61 and to the planar bottom side 62 of the connector member 60 . The top side 61 of the connector member 60 is conventionally attached to a bottom side of the truncated cylindrical member 55 and is removably received in the support member 21 . Elongate notches 65 , 66 may be centrally disposed in the bottom side 62 of the connector member 60 with the elongate notches 65 , 66 being longitudinally aligned with one another and spaced from the back edge portion 64 to the front edge portion 63 and is arranged to match the ribs 50 , 51 to effectively retain the connector member 60 in and upon the support member 21 with the longitudinal axis of the electronic device holder being parallel to the longitudinal axis of the curved arm mount 11 . In use as shown in FIGS. 2 & 3 , the user can rotate the electronic device including the phone 37 to be viewed in a portrait or a landscape position as desired by the user bending one's arm at the elbow so that the longitudinal axis of the electronic device holder 25 as measured from the bottom end 29 to the open top end 30 is angled relative to the longitudinal axis of the curved arm mount 11 as measured lengthwise of the curved arm mount 11 In addition, when not using the electronic device or phone 37 , the sure can rotate the electronic device or phone 37 so that the longitudinal axis of the electronic device holder 25 is parallel to the longitudinal axis of the curved arm mount 11 . As to the second embodiment, the electronic device holder 25 and the phone 37 can still be rotated as desired and can also be completely removed from the arm mount 11 . To secure the electronic device holder 25 to the arm mount 11 , the user can slide the connector member 60 upon and depressing the biased ramp 53 and into the support member 21 at the front edge 41 of the support member 21 with either the tapered front edge portion 63 of the connector member 60 or the vertically straight back edge 64 facing the support member 21 as the user slides the connector member 60 into the support member 21 . Once the connector member 60 is fully received within the support member 21 , the biased ramp 53 biases upwardly above the front edge 41 of the support member 21 with the vertically straight back edge 64 of the connector member 60 being engageable with the biased ramp 53 to prevent the removal of the connector member 60 . The lugs 48 , 49 also prevent the removal of the connector member 60 from the support member 21 should the user rotate the electronic device holder 25 more or less than 180 degrees with either of the truncated side edges 58 , 58 of the truncated cylindrical member 55 facing or being parallel to the front edge 41 of the support member 21 . To remove the electronic device holder 25 from the arm mount 11 , the user rotates the electronic device holder 25 so that the tapered front edge portion 63 faces the back edge 54 of the biased ramp 53 and the user then slides the connector member 60 out of the support member 21 with the tapered front edge portion 63 of the connector member 60 depressing the biased ramp 53 . As to a further discussion of the manner of usage and operation of the present invention , the same should be apparent from the above description. Accordingly, no further discussion relating to the manner of usage and operation will be provided. With respect to the above description then, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention. Therefore, the foregoing is considered as illustrative only of the principles of the apparatus and method for supporting and operating an electronic device upon a user's forearm. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

An apparatus and method for supporting and operating an electronic device upon a user's forearm for safeguarding the phone and providing immediate and convenient functional access to the phone. The apparatus and method for supporting and operating an electronic device upon a user's forearm includes an arm mount assembly including a curved arm mount being adapted to fit upon a user's forearm region, and also having a cushion member being attached to the arm mount, the arm mount assembly also including fastening members for fastening the arm mount to the user's forearm; a connector assembly in communication with the arm mount; and an electronic device holder rotatably supported by the connector assembly.

This application is a continuation-in-part of co-pending application, Ser. No. 579,158 now U.S. Pat. No. 4,600,014. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an improved biopsy instrument and more particularly to a medical instrument that permits a clean margin core of tissue to be obtained with the physician using one hand to control the instrument. 2. Description of the Prior Art In performing procedures for obtaining tissue samples, there have existed problems in obtaining diagnostic material adequate for definitive interpretation by a qualified pathologist. Using the case of obtaining samples of tissue for the diagnosis of malignancies of the prostate gland as an example, it is known to utilize cytologic studies based on a fine needle aspiration biopsy. For example, a device for this purpose is disclosed in U.S. Pat. No. 3,595,217 to Rheinfrank. A hollow biopsy needle is passed through a guide tube attached to the operator's finger which is placed on the prostate gland. The needle penetrates the gland and a syringe attached to the needle withdraws a tissue sample. Unfortunately, the use of an aspirating needle to obtain samples from the prostatic tissue has not, in general, produced satisfactory diagnostic material and this approach has been largely abandoned in the United States. Consequently, a preferred approach is to obtain a core sample. Many physicians utilize a biopsy needle available from Travenol Laboratories, Inc. of Deerfield, Ill. and described in U.S. Pat. No. 3,477,423 to Griffith. The Travenol TRU-CUT R biopsy needle comprises a hollow tubular cutting cannula having a sharpened distal end attached to a plastic handle. A coaxial solid stylet telescopes within the cannula and is attached to a knob at its proximal end. The distal end of the stylet is sharpened and includes a transverse slot or specimen notch adjacent to the sharpened end. In the prostatic sample example, the physician positions the stylet of the Travenol needle to project slightly from the cannula. The index finger of one hand is placed along the cannula with the tip in contact with the stylet distal end and the handle is held in the palm. Approaching the prostate gland transrectally, the gland is explored with the finger tip to locate a nodule or suspicious area. After locating a point for a sample, the needle is cased forward into the nodule. Once in place, the stylet is plunged to the desired depth. The physician must then remove his hand and finger, grasp the stylet knob in one hand, and push the cannula handle forward with the other hand. Theoretically, the cutting end moves along the stylet and severs a sample of tissue projecting into the transverse slot in the tip of the stylet. The entire needle is then withdrawn from the gland and the sample removed from the stylet. In practice, the manipulation of the cannula during this latter step is quite difficult since the tip of the stylet is embedded in the soft and pliable prostatic tissue several inches from the handle. The stylet knob gives very little steady support to the needle assembly and the stylet tip, due to its smaller diameter, penetrates the tissue somewhat easier than the tubular cannula cutting edge. On occasions, when attempting to push the cannula into the tissue, the entire needle moves forward, puncturing the bladder or uretha. It is also common to attempt to move the cannula forward only to have the stylet back out of the tissue. When this occurs, the physician must remove the needle, reposition the stylet, and try again. Since the procedure involves puncturing of the colon wall, each attempt increases the risk of infection. Most physicians limit such attempts to two or three passes. Even with a successful insertion of the cannula, the instability of the Travenol needle often results in a limiting core sample. Similar problems exist in obtaining biopsies of other organs. Other biopsy devices are known. For example, Russian Pat. No. 400,319 teaches a needle having an adjustable depth device and obtains a sample by suction. Drer, European Pat. No. 10,321 discloses a one-handed instrument suitable for taking a biopsy of yieldable tissue using a spring driven cannula. Baumgartner in U.S. Pat. No. 4,396,021 describes a biopsy instrument designed to be inserted into a standard cystoscopic instrument and must be guided visually. In my co-pending application, Ser. No. 579,158 entitled "Transrectal Biopsy Device", I disclose an improved instrument of the Griffith-type which permits the physician to guide the needle to the exact point required for a sample by means of a guide tube and to thereafter maintain that hand and finger in place during the remainder of the sampling procedure, eliminating the problems in using the Griffith-type needle noted above. In that invention, the operator can accurately and safely perform the sampling procedure. However, the unit requires the use of one hand to hold the needle in position and the other hand to operate the stylet and cannula for obtaining a sample of tissue. It is desirable that the sampling procedure be accomplished using the same hand holding the instrument in place. Thus, the other hand of the physician is free to steady the patient during the critical sampling period. Thus, there is a long-felt and unfilled need for a biopsy needle which can be guided to the required point of the prostate gland by the physician's finger, a sampling stylet inserted, and a cutting cannula plunged forward without removal of the finger and which would permit the entire procedure to be completed using one hand. SUMMARY OF THE INVENTION The present invention is a further improvement in a biopsy sampling instrument which is especially suited for transcrectal prostate biopsies, although the device is also applicable to many other biopsy procedures. Through the use of a novel spring loading and releasing structure, the physician can perform the entire procedure with one hand. The spring loading arrangement eliminates approaching the patient with a cocked instrument and the attendant risk of premature release which could cause injury. A rapid cutting of the sample core resulting from spring loading of the cannula produces cleaner margins of the sample than obtainable with known prior art instruments. A housing is provided which is adapted to be held in the palm of the operators hand. The housing includes a forward guide tube having a spring loaded cannula telescoped therethrough. A stylet assembly is telescoped within the cannula and includes a hub which extends from the rear of the housing. The stylet projects slightly from the cannula and guide tube, and includes a sampling notch at its distal end. An arming slide is movable in the housing by means of a thumb tab projecting from the top of the housing. When the arming slide is moved fully forward, the stylet is fully extended from the cannula and guide tube and the cannula spring is cooked. A release trigger is provided near the forward end of the housing which is depressed to release the spring loaded cannula for slicing tissue in the stylet sampling notch. To use the instrument, the physician holds it in the palm of the hand with the index finger at the tip of the guide tube. The tip of the stylet is thereby guided to the point at which a sample is to be obtained. The physician then moves the arming slide fully forward with the thumb, causing the stylet tip to penetrate the tissue such that tissue expands into the notch. The movement also cocks the cannula spring. The operator then depresses the release trigger causing the sharpened cannula to snap forward, cleanly slicing the tissue in the stylet notch. The instrument is then withdrawn from the tissue and the sample is removed. It is therefore a principal object of the invention to provide an improved biopsy instrument in which the physician can guide the tip of a sampling stylet to a desired location using the index finger, advance a sampling stylet and cock a spring loaded cannula, and thereafter operate a trigger to slice a tissue sample with such procedure being performed with the use of one hand. It is another object of the invention to provide an improved biopsy instrument for one-handed operation having a spring loaded cannula to insure a biopsy tissue sample having very clean margins. It is yet another object of the invention to provide an improved biopsy instrument in which the index finger of the physician is maintained in contact with the point of sampling during the entire sampling procedure. These and other objects and advantages of the invention will become apparent when read in conjunction with the drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded view of the improved biopsy needle of the invention; FIG. 2 is a partially cut away side view of the device in the condition for approaching a site for a biopsy; FIG. 3 is the device of FIG. 2 in which the stylet portion has been advanced and the cannula portion has been cocked; FIG. 4 is the device of FIG. 3 in which the trigger has been actuated and the cannula extended by means of a spring to effect a sampling of tissue; FIGS. 5, 6, and 7 show the manner of accomplishing the operations of the device shown in FIGS. 2 through 4 with the operator using one hand; FIG. 8 is a partial view of the proximal end of the device showing the arming slide thereof in a locked position; and FIG. 9 shows the arming slide of FIG. 8 withdrawn for retracting the cannula. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The biopsy device of the invention is preferably implemented as a one-use disposable instrument. Referring to FIG. 1, an exploded view of a disposable implementation of the invention is shown. An elongated lower housing 10 is provided preferably formed from a suitable hard plastic. Housing 10 has a guide tube 12 rigidly attached to its distal end. Guide tube 12 is preferably formed from stainless steel and is a thin, tubular element having a sharpened distal end 11. Housing 10 includes an embossed finger grip area 27 near the distal end of housing 10. Housing 10 includes a pair of notches 16 for mounting a release spring 14 as described below. A pair of arming slide locking tabs 17 is provided at the proximal end of housing 10. A cannula assembly 20 is shown having a cannula hub 21 with a cannula 24 rigidly connected thereto. Cannula 24 is preferably formed of stainless steel and includes a sharpened distal end 23. A cannula spring is engaged to the rear of cannula hub 21. As indicated by the dashed lines, cannula 23, upon assembly, is inserted through guide tube 12 and is extendable therefrom. Release spring 14 is preferably formed from a resilient plastic and includes a pair of spring arms 25, a pair of rectangular mounting studs 15, a release trigger 19 and a hub stop 13. As indicated by the dashed lines, mounting studs 15, have their rectangular portions inserted into notches 16 in lower housing 10, holding the ends thereof rigid. As will now be understood, pressure on release trigger 19 will, due to the resilience of spring arms 25, permit the trigger 19 to be pushed downward a short distance. As will be described in more detail hereinafter, hub stop 13 acts as a stop to cannula hub 21 during a sequence of operation in which cannula spring 22 is thereby held in a compressed state. Stylet assembly 30 is shown having a stylet hub 32 from which stylet 34 projects. Stylet 34 includes a sampling notch 31 in its distal end. Stylet hub 32 includes a detent tab 33 and a stylet push bar 36. As indicated by the dashed lines, the distal end of stylet 34 is inserted through cannula spring 32, cannula hub 21 and cannula 24, and is extendable from distal end 23 of cannula 24. As will be later shown, stylet hub 32 extends from the proximal end of lower housing 10 and may be moved forward by stylet push bar 36 until detent tab 33 engages detent 38 of detent flap 35. Arming slide 40 includes a grip portion 42 and a release trigger lock 48 at the distal end thereof, and a pair of cannula release grips 46 at the proximal end thereof. A slide bar 43 is disposed between cannula release grips 46 and grip 42, and has a pair of cannula spring blocks 44 depending from the central portion thereof. A guide bar 41 is provided along the top surface of slide bar 43. Cannula release grips 46 extend from spring arms 45 and have a stylet push tab 49 depending therefrom and a pair of locking grooves 47. As indicated by the dashed lines, cannula spring blocks 44 engage the proximal end of cannula spring 22 when the parts are assembled in lower housing 10. When arming slide 43 is assembled in lower housing 10, as will be shown in more detail hereinafter, locking grooves 47 will engage cannula locking tabs 17 in a certain aspect of operation of the instrument. After assembly of the various elements in lower housing 10 as described, upper housing 10 is attached to the top surfaces of lower housing 50 with release trigger 19 and grip 42 of arming slide 40 extending through opening 52 therein and guide bar 41 engaging arming slide guide slot 51. The assembly of the elements shown in FIG. 1 is more clearly seen from FIGS. 2-4. In FIG. 2, a view of lower housing 10 partially cut away is provided to disclose the various working elements. The instrument is shown in the condition ready for performance of a biopsy procedure. As will be understood with reference to FIG. 1 and the drawings of FIGS. 2-4, the instrument includes a guide tube 12 having a sharpened end 11 with cannula 24 disposed within guide tube 12 and telescoping with respect thereto. Cannula 24 includes a cutting end 23. Stylet 34 is telescoped within cannula 24, and includes cutting end 37 and sampling notch 31. Stylet 34 is slidable within cannula 24 and cannula 24 is slidable within fixed guide tube 12. Cannula 24 is attached to cannula hub 21 while stylet 34 is attached at its proximal end to stylet hub 32. It will be noted from FIG. 2 that a plastic detent flap 35 is molded into the lower portion of the proximal end of lower housing 10 and, provides a pair of detents 37 and 38. Due to the resilience of the material from which housing 10 is formed, detent flap 35 acts as a spring. In FIG. 2, stylet hub 32 has been withdrawn from housing 10 until detent bar 33 of the stylet hub 32 engages detent 37. This results in stylet 34 being withdrawn as far as possible into cannula 24. The cutting end 37 of stylet 34 extends slightly from cannula 24 and, as will be discussed below, permits the point to be pushed into the tissue during a biopsy procedure. When stylet hub 32 is fully withdrawn from housing 10, arming slide 40 is also fully withdrawn. Arming slide 40 is free to slide along the top surface of stylet hub 32 within guide slot 51 and along the upper surface of cannula hub 21. When arming slide 40 is moved forward, contacting stylet push tab 49 compressing spring 22 as discussed below. A guide block 28 is molded in the bottom surface of lower housing 10 to provide support to cannula hub 21 when in the position of FIG. 2. When arming slide 40 is in the full rearward position as in FIG. 2, spring 22 is fully extended in a first rearward position with the rear portion of spring 22 contacting spring blocks 44 of arming slide 40. When the physician approaches the tissue to be sampled with the instrument in the condition shown in FIG. 2, spring 22 is relaxed and the tip of stylet 34 is projecting slightly from cannula 24. The physician will locate the desired point on the tissue and will penetrate the tissue with the cutting tip 37 of stylet 34. At this point, it is required to insert the stylet to the desired depth in the tissue and this is accomplished by moving arming slide 40 forward as indicated in FIG. 3 by arrow A. Slide 40 may be moved forward by pressure on grip 42 in the direction of arrow A. This causes cannula release grips 46 to move forward until locking grooves 47 engage locking tabs 17 in lower housing 10. At the same time, cannula spring blocks 44 compress cannula spring 22 with cannula hub 21 bearing against hub stop 13 of release spring 14. When locking grooves 47 engage locking tab 17, spring 22 and cannula 24 are then in the cocked position. As previously mentioned, moving arming slide 40 forward also extends stylet 37 since tab 49 of cannula release grip 46 contacts stylet push bar 36 thereby moving stylet 34 forward to the position shown by arrow A'. At this point in the procedure, the stylet has penetrated the tissue to the point that the sharpened end of cannula 24 is bearing on the tissue and tissue is then present within sampling notch 31. It is now necessary to advance cannula 24 to slice the tissue projecting into sample notch 31. As indicated in FIG. 4, release trigger 19 is pressed downward as indicated by arrow B. Due to the springiness of spring arms 25, hub stop 13 is moved downward releasing cannula hub 21. Compressed spring 22 snaps cannula hub 21 forward forcing cannula 24 beyond the sampling notch 31 and cleanly slicing the tissue by means of its sharpened end 23. It will be noted that spring 22 is now in the relaxed state in a second forward position. At this point in the procedure, stylet 30 and cannula 20 are both in their maximum forward position. The physician then withdraws the instrument having the desired sample captivated between cannula 24 and notch 31. It will be noted that guide tube 12 has a sharpened end 11. This permits the physician to insert the entire assembly of the guide tube 12, cannula 20 and stylet 30 into tissue when in the unoperated condition of FIG. 2 to be able to reach an area of suspicion which may not be near the surface. Having now explained the operation of the instrument, the above-described procedure using one hand will be illustrated with reference to FIGS. 5-7. While the instrument of the invention is particularly well adapted to transrectal prostate biopsies, there are many other types of biopsies for which one-handed operation is advantageous. For example, it is often necessary for the physician to isolate a suspicious lump or nodule with the fingers with one hand and then produce the desired sampling procedure with the other hand. In the prior art, it is common to require an assistant to perform the isolation function while the physician is utilizing both hands to extract the sample. In such cases, the physician does not have personal control of the procedure. Typical examples of this problem are when biopsies of testicles and breasts are to be performed. In FIG. 5, the procedure for using the instrument to approach the area to be sampled is shown. Assuming right hand operation, the instrument is gripped in the hand 60 approximately as shown with the index finger 62 placed against the distal end of guide tube 12. For example, when doing a transrectal prostate biopsy, the index finger 52 would be used to locate the suspicious area of the prostate gland and the end of guide tube 12 directed to this point. The physician then pushes the tip of stylet 34 into the tissue until the end of cannula 24 touches the tissue. This completes the first step of the procedure. As will be noted, this portion of the procedure is performed with one hand. In FIG. 6, the second step is illustrated. The physician moves thumb 64 to rest on grip 42 of arming slide 40 as shown. The thumb is then moved forward as indicated by arrow A until cannula release grips 46 are flush with the proximal end of housing 50, such that locking grooves 47 engage locking tab 17 in housing 50 as best seen in FIG. 8. As illustrated in FIG. 3 above, this cocks cannula spring 22 and advances stylet 30 as indicated by arrow A', completing the second step in the procedure. The third step is illustrated in FIG. 7 in which the physician moves the thumb from grip 42 to release trigger 19 and pushes downward thereon as indicated by arrow B. This action releases spring 22, causing cannula 24 to snap forward as indicated at arrow B'. This action completes step 3 permitting the physician to then withdraw the instrument from the tissue. Referring to FIG. 8, to remove the specimen obtained which is in the sampling notch at this point, the operator will squeeze cannula release grips 46a and 46b in the directions of arrows C causing spring arms 45 to move together. As will be also noted from FIG. 8, stylet hub 32 is in the forward position indicating that stylet 34 is fully extended. When cannula release grips 46a and 46b are squeezed together, locking grooves 47 are released from locking tabs 17 and the arming slide 40 may be moved rearwardly, as shown in FIG. 9, withdrawing cannula 24 into guide tube 12 and exposing sampling notch 31, thereby permitting removal of the specimen. The instrument is discarded after removal of the sample. The biopsy instrument of the invention is specially adapted for one-hand operation. However, it will be apparent that the novel design is advantageous for two-hand use. The physician may approach the tissue to be sampled as shown in FIG. 5. The stylet 30 may be moved forward into the tissue by using the free hand to push on stylet push bar 36 affording the operator full and precise control of penetration. The cannula 20 may then be cocked by pushing the cannula release grips 46 forward with the free hand. The cannula is then advanced by operating trigger 19. The specific construction of the biopsy instrument shown in the drawings and the above description is for exemplary purposes only. Various modifications in the design of the housing, the spring load cannula, and the triggering element may be made without departing from the spirit and scope of the invention. Although it is preferred that the instrument be disposable, in which case many of the elements may be molded from plastic, it is apparent that the entire instrument may be constructed of metal such as stainless steel to permit sterilization after use and subsequent reuse.

An improved instrument for obtaining tissue samples for biopsies is adapted to permit accurate samples to be taken with one-hand. The instrument includes a housing which fits into the palm of the physician's hand and has a guide tube projecting from the forward end which the physician guides to a point from which a sample is required. A spring-loaded cannula is telescoped within the guide tube and a notched sampling stylet is telescoped within the cannula. The tips of the cannula and stylet project slightly from the distal end of the guide tube. An arming slide is provided which is moved forward by the physician's thumb, advancing the stylet into the tissue and cocking the spring-loaded cannula. The physician's thumb then operates a spring release trigger causing the cannula to snap forward, cutting the tissue sample in the stylet notch. The instrument is then withdrawn from the tissue.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a divisional application of U.S. patent application Ser. No. 08/856,916, filed May 15, 1997, currently pending, the entire disclosure of which is hereby incorporated by reference. BACKGROUND OF THE INVENTION [0002] The present invention relates to implantable spinal fixation systems for the surgical treatment of spinal disorders. More particularly, this invention relates to a transverse rod connector clip for connecting cylindrical rods to each other. [0003] For years doctors attempted to restore stability to the spine by fusion (arthrodesis) of the problem area. This treatment yielded marginal results due to the inherently flexible spinal column. Over the past ten years spinal implant systems have been developed to add stability to the spine to enhance the arthrodesis rates. Such systems often include spinal instrumentation having connective structures such as a pair of plates and/or rods which are placed on opposite sides of the portion of the spinal column which is intended to be fused. These spinal systems consist of screws and hooks for segmental attachment to the spine and longitudinal rods connected to screws or hooks. These components provide the necessary stability both in tension and compression yet yield minimal torsional control. [0004] It has been found that when a pair of spinal rods are fastened in parallel on either side of the spinous process, the assembly can be significantly strengthened by using at least one additional rod to horizontally bridge the pair of spinal rods. A cross brace assembly is disclosed in U.S. Pat. No, 5,084,049. Devices such as these commonly consist of a threaded rod for providing the desired lateral support. The threaded rod is fastened to each of the spinal rods by clamps located on each end of the threaded rod. However, this configuration is bulky and can cause irritation of the patient's back muscles and other tissue which might rub against the device. A cross brace assembly that fits closer to the spine, preferably in the same general plane as the vertical spinal rods, would reduce the complications associated with bulkier devices. [0005] Most existing transverse connectors consist of rods, plates, and bars linked to the longitudinal rods by coupling mechanisms with set screws, nuts, or a combination of each. These connectors require several components and instruments to build the constructs. Each additional component or instrument required to assemble the connectors adds to the “fiddle factor” of the surgical technique. Examples of these transverse connectors include Tranverse Link Device (DLT) and Crosslink manufactured by Sofamor Danek, Trans-Connector manufactured by Synthes, and Modular Cross Connector and Transverse Rod Connector (TRC) manufactured by AcroMed. [0006] Telescopic rod to rod couplers for use in a spinal implant systems have also been described. Prior to the locking member being engaged, the telescoping sections may be easily slid past their extremes and out of engagement with one another. While this is a convenient method of connecting and disconnecting the coupler sections, it can be inconvenient during surgery if the sections accidentally disengage. U.S. Pat. No. 5,275,600 describes a telescopic rod to rod coupler in which the telescopic rod sections are assembled together using a 180 degree twisting motion. This is designed to minimize the risk of the rod sections accidentally disconnecting during the implant procedure. [0007] Presently available spinal fixation systems frequently require careful alignment of the hardware used to connect the components of the spinal instrumentation with each other. A need has thus arisen for improved rod connectors to transversely connect spinal rods without requiring additional manipulation of the spinal instrumentation and to minimize the use of pedicle screws while at the same time reducing requirements to assemble small pieces of hardware during the surgical procedure. SUMMARY OF THE INVENTION [0008] According to one or more aspects of the present invention, a spinal fixation system includes: a first clip body having a pair of opposed spaced apart arcuate rod engaging hooks depending from a first side thereof for engaging a first elongated spinal rod, and a transverse connector extending laterally from a second side thereof; a second clip body having a pair of opposed spaced apart arcuate rod engaging hooks depending from a first side thereof for engaging a second elongated spinal rod, and a transverse connector extending laterally from a second side thereof; and a fastener for securing the transverse connector of the first elongated clip body and the transverse connector of the second elongated clip body to one another. [0009] According to one or more further aspects of the present invention, a spinal fixation system includes: a first clip body having a first pair of opposed spaced apart arcuate engaging hooks depending from a first side thereof for engaging a first elongated spinal rod, and a second pair of opposed spaced apart arcuate engaging hooks depending from a second side thereof for engaging an elongated transverse connector; and a second clip body having a first pair of opposed spaced apart arcuate engaging hooks depending from a first side thereof for engaging a second elongated spinal rod, and a second pair of opposed spaced apart arcuate engaging hooks depending from a second side thereof for engaging the elongated transverse connector. [0010] According to one or more further aspects of the present invention, a spinal fixation system includes: an elongated spinal rod; a transverse member; and a connector having a pair of opposed spaced apart arcuate rod engaging hooks for receiving and engaging the elongated spinal rod, the connector securing the elongated spinal rod and the transverse member in a transverse orientation in which the elongated spinal rod are substantially coplanar. [0011] The transverse connector clips of the present invention can be used to transversely connect spinal rods without requiring additional manipulation of the spinal instrumentation. Because the clips of the present invention do not require any additional locking mechanism, they reduce the assembly of small pieces of hardware during the surgical procedure. BRIEF DESCRIPTION OF THE DRAWINGS [0012] [0012]FIG. 1 is a top perspective view of one embodiment of a transverse connector clip of the present invention; [0013] [0013]FIG. 2 is a perspective view of one embodiment of the transverse connector clip of the present invention with a short, laterally extending bar; [0014] [0014]FIG. 3 is a top perspective view of another embodiment of a transverse connector clip of the present invention with a laterally extending bar having a plurality of vertical teeth; [0015] [0015]FIG. 4 is a bottom perspective view of the invention clip of FIG. 3; [0016] [0016]FIG. 5 is a perspective view of a pair of the connecting transverse connector clips of FIG. 3; [0017] [0017]FIG. 6 is a perspective view of the clip of FIG. 2 securing the transverse connector clips of FIG. 5; [0018] [0018]FIG. 7 is a schematic view of the present invention connected to spinal rods implanted in a human spine and illustrating the method of assembly; [0019] [0019]FIG. 8 is a top perspective view an another embodiment of the present invention; [0020] [0020]FIG. 9 is a bottom perspective view of the invention of FIG. 8; [0021] [0021]FIG. 10 is perspective view of the invention of FIG. 8 illustrating the connecting mechanism of the connector clip; [0022] [0022]FIG. 11 is a perspective view of the invention of FIG. 8 connected to the ends of an T-bar; [0023] [0023]FIG. 12 is a perspective view of an another embodiment of the present invention illustrating the method of assembly of two connector clips having laterally extending tapered bars connected together with a tapered sleeve; [0024] [0024]FIG. 13 is a perspective view of the invention of FIG. 12 illustrating a range of lateral adjustment between the two clips; [0025] [0025]FIG. 14 is a schematic view of the invention of FIG. 13 connected to spinal rods implanted in a human spine and illustrating the method of assembly; [0026] [0026]FIG. 15 is a perspective view of another embodiment of the present invention illustrating the method of assembly; and [0027] [0027]FIG. 16 is a perspective view of the assembled invention of FIG. 15. DETAILED DESCRIPTION OF INVENTION [0028] The present invention is directed to a transverse connector clip 10 and assemblies used in spinal fixation systems. Spinal fixation systems typically include spinal instrumentation having connective structures such as a pair of plates and/or rods which are placed on opposite sides of the spinal column near vertebrae that are intended to be fused. These spinal systems consist of screws and hooks for segmental attachment to the spine and longitudinal rods connected to screws or hooks. These components provide the necessary stability both in tension and compression yet yield minimal torsional control. In addition, it has been found that when a pair of spinal rods are fastened in parallel on either side of the spinous process, the assembly can be significantly strengthened by using at least one additional rod to horizontally bridge the pair of spinal rods. [0029] The transverse connector clips 10 of the present invention consist of a component with a means to clip the device on a spinal or cylindrical rod 11 and a component with a means to link two rod connectors together laterally. Transverse connector clip 10 concept consists of a clip body 12 with a first side 14 and a second side 16 (FIG. 1). On first side 14 are two, mirror image hemi-cylindrical shells 18 and 20 . These two, mirror image hemi-cylindrical shells 18 and 20 have an inner surface 24 that defines a rod bore 26 through which the cylindrical rod 11 can extend. Rod bore 26 has an inner diameter 22 that is designed to be slightly smaller than the outer diameter of the cylindrical rod 11 it will receive. Top surface 28 of the hemi-cylindrical shells 18 and 20 defines an outer diameter 30 . [0030] It should be noted that the two, mirror image hemi-cylindrical shells 18 and 20 can be connected to the first side 14 of clip body 12 as shown in clip 10 A of FIG. 2 or in mirror image relationship as shown in clip 10 A of FIG. 6. [0031] Clip body 12 is placed on the cylindrical rod 11 at 90 degrees and turned so that the hemi-cylindrical shells 18 and 20 spread around the rod 11 . The deflection of the hemi-cylindrical shells 18 and 20 and the inner diameter of the shells 22 allow the clip 10 to securely clamp on the rod 11 . [0032] The second side of the clip body 12 can include, but is not limited to, a short hemi-cylinder rod (Clip 10 A, FIG. 2), a laterally extending hemi-cylinder rod with a plurality of vertical teeth (Clip 10 B, FIGS. 3 - 4 ), a second pair of mirror image hemi-cylindrical shells (Clip 10 C, FIGS. 8 - 9 ), a laterally extending rod tapering from a proximal cylindrical shape to a distal hemi-cylinder shape (Clip 10 D, FIG. 12), or an outwardly extending U-shaped receptacle designed to receive a semi-cylindrical or cylindrical rod and a locking cap device (Clip 10 E, FIGS. 15 - 16 ). Each of these embodiments will be described below. [0033] One embodiment of the transverse connector clip 10 A is shown in FIG. 2. Here, the clip body 12 consists of a first side 14 as previously described (FIG. 1) and a second side 16 that comprises a preferably short laterally extending hemi-cylinder rod 40 , however, any shaped rod could be utilized. The short hemi-cylinder rod 40 integral to the second side 16 of clip body 12 is shaped to facilitate installation of clip 10 A by a user. A user can use the short rod 40 to manually engage and disengage the clip body 12 from a cylindrical rod 11 of two rods joined together in a spinal fixation system. Clip 1 GA can be used to connect transverse connector clips having laterally extending hemi-cylinder rods 10 B (FIG. 6). One advantage of the inventive connector clip 10 A over prior art connectors is that clip 10 A is a single piece connector, thereby reducing the amount of assembly of the spinal fixation system required by prior art connectors during surgery. [0034] Another embodiment of the present invention is the transverse connector clip 10 B (FIG. 3). Here, the clip body 12 consists of a first side 14 as previously described (FIG. 1) and a second side 16 that includes a laterally extending hemi-cylinder rod 50 having a first side 52 , a second side 54 , and a longitudinal axis LA1-LA1. However, other shapes can be utilized for the laterally extending hemi-cylinder rod 50 . The first side 52 contains a plurality of vertically placed teeth 56 extending along the longitudinal axis LA1-LA1. FIG. 4 shows a perspective view of the second side 54 of connector clip 10 B. [0035] Clip 10 B is designed to be interlocked to a second clip 1 GB (FIG. 5). The first sides 52 of the hemi-cylinder rods 50 are connected to each other via the plurality of vertical teeth 56 extending along the longitudinal axes LA1-LA1 of the hemi-cylinder rods 50 . The clips 10 B can transversely connect two longitudinal rods 11 placed at varying distances from each other with the plurality of teeth 56 accommodating the variable distance. This variable distance is indicated by the lateral motion arrows LM1-LM1 (FIG. 5). This ability of the clips 10 B provides a significant advantage during surgery where many such adjustments are necessary to fine tune the alignment of the assembly in the patient. [0036] The connection between clips 10 B can be maintained by using transverse connector clip 10 A (FIG. 6). When the first sides 52 of the hemi-cylinder rods 50 are engaged by the interlocking of the plurality of vertical teeth 56 , the second sides 54 form a cylindrical rod having a diameter that is slightly larger than the inner diameter 22 defined by the inner surface 24 of the hemi-cylindrical shells 18 and 20 of clip 10 A. Thus, the hemi-cylindrical shells 18 and 20 of clip 10 A can snap onto the connected hemi-cylinder rods 50 of clips 10 B as if the connected hemi-cylinder rods 50 were a single cylindrical rod 11 . [0037] While FIG. 6 illustrates a transverse connector clip 10 A of the present invention connecting the laterally extended hemi-cylinder rods 50 of clips 10 B, it should be understood that any connecting device known to one skilled in the art can be used to connect the hemi-cylinder rods 50 . The advantage of using the transverse connector clip 10 A of the present invention, however, is that it consists of a single piece which facilitates surgery by reducing the number of pieces that need to be assembled. [0038] The spinal rod assembly using transverse connector clips 10 A and 10 B of the present invention connects to longitudinal rods 11 that are connected to a human vertebrae 91 as schematically shown in FIG. 7. Two cylindrical rods 11 are each connected to a transverse connector clip 10 B through the mirror image hemi-cylindrical shells 18 and 20 . The laterally extending hemi-cylinder rods 50 of clips 10 B are connected to each other by the interlocking of the plurality of vertical teeth 56 . This connection is maintained by clip 10 A. [0039] Clip 10 C (FIGS. 8 - 9 ) is an alternate embodiment of the transverse clip connector 10 having a clip body 12 with a first side 14 and a second side 16 . The first side 14 is as previously described (FIG. 1). The second side 16 of the clip body 12 comprises a second set of mirror image hemi-cylindrical shells 60 and 62 . Like the hemi-cylindrical shells 18 and 20 on the first side 14 of clip body 12 , hemi-cylindrical shells 60 and 62 can be placed on the second side 16 of the clip body 12 as shown (FIG. 8) or in mirror image relationship (not shown). [0040] The second set of hemi-cylindrical shells 60 and 62 have an outer surface 64 and an inner surface 68 . The inner surface 68 defines a rod bore 70 through which a cylindrical rod 88 can extend. Rod bore 70 has a diameter 72 that is slightly smaller than the diameter of the rod 88 it is designed to receive. [0041] Clip 10 C is designed to simultaneously connect two longitudinal rods 11 and a transverse rod 88 together. The cylindrical rods 11 connect to the first side 14 of the clip body 12 as previously described. Cylindrical rod 88 connects to the second side 16 of clip body 12 in a similar fashion. Namely, clip body 12 is placed on a cylindrical rod 88 at 90 degrees and turned so that the hemi-cylindrical shells 60 and 62 spread around the rod 88 . The deflection of the hemi-cylindrical shells 60 and 62 and the inner diameter 72 allow the clip body 12 of clip 10 C to securely clamp on the rod 88 . [0042] One advantage of having the second side 16 of the inventive clip body 12 comprising a second pair of hemi-cylindrical shells 60 and 62 is that it allows attachment of this second pair of shells 60 and 62 to various other rod types used in spinal surgery such as T-bar 80 (FIG. 10) and an I-bar (not shown). A T-bar 80 and an I-bar can horizontally bridge a pair of cylindrical rods 11 (FIG. 11) significantly strengthening the spinal fixation system. [0043] T-bars 80 have a longitudinal body 82 , a first end 84 and a second end 86 . The first end 84 of T-bar body 82 has a cylindrical-shaped bar 88 perpendicularly connected to the T-bar body 82 (FIG. 10). This bar 88 can be connected to the second pair of hemi-cylindrical shells 60 and 62 of invention clip 10 C as described above. [0044] Two inventive clips 10 C can be used to connect two cylindrical rods 11 via two T-bars 80 (FIG. 11). In this example, two clips 10 C are each connected to bars 88 on the first ends 84 of two separate T-bar bodies 82 . The second ends 86 of each T-bar body 82 is then connected to each other via a tapered locking sleeve 90 or by any means known to those of skill in the art. The relative placement of one cylindrical rod 11 to the other can be adjusted by adjusting the T-bar connection as indicated by circular motion arrows CM1-CM1 and CM2-CM2. In this way, the inventive clips 10 C can facilitate the creation of the desired transverse bridge between two cylindrical rods 11 using a minimum number of pieces. [0045] While the embodiment shown here (FIG. 11) shows invention clips 10 C connected to two different T-bars 80 , it should be understood that two clips 10 C can also be connected to the opposite ends of a single I-bar (not shown). An I-bar has a longitudinal body and a first and second end. The first end has a first rod-shaped bar positioned perpendicular to the I-bar body. The second end has a second cylindrical-shaped bar positioned perpendicular to the I-bar body. The first pair of hemi-cylindrical shells 18 and 20 of clip 10 C is connected to a first cylindrical rod 11 while the second pair of hemi-cylindrical shells 60 and 62 is connected to the first bar on the first end of the I-bar body. A second invention clip 10 C is connected to a second cylindrical rod 11 through hemi-cylindrical shells 18 and 20 and then to the second bar on the second end of the I-bar body via hemi-cylindrical shells 60 and 62 . In this way, the I-bar provides a horizontal bridge between two cylindrical rods by connection via the invention clips 10 C. [0046] In another embodiment of the inventive clip 10 , the first side of the clip body 12 is as previously described, while the second side of the clip body 12 comprises a laterally extending rod 100 having a first side 102 , a second side 104 , a longitudinal axis LA1-LA1, and a proximal 106 and distal 108 end (Clip 10 D, FIG. 12 ). The proximal end 106 is cylindrical in shape and tapers to a hemi-cylindrical shape at the distal end 108 . [0047] Clip 10 D is designed to connect to another clip 10 D (FIGS. 12 - 14 ) via the laterally extending tapering rods 100 . The laterally extending tapered rods 100 are connected to each other by mating the first sides 102 together. This connection can be maintained with any of the devices known to those of skill in the art including, but not limited to, a tapered locking sleeve 90 . This tapered locking sleeve 90 consists of an inner 92 and outer 94 sleeve portion. Inner sleeve portion 92 has an inner surface 96 and outer surface 98 ; and outer sleeve portion 94 has an inner surface 110 and outer surface 112 . The outer surface 98 of the inner portion 92 has a diameter 114 slightly smaller than a diameter 116 of the inner surface 110 of the outer sleeve 94 so as to allow the inner sleeve portion 92 to be placed concentrically inside the outer sleeve 94 in order to lock the inner sleeve portion 92 and outer sleeve portion 94 together. [0048] To assemble clips 10 D, the outer sleeve portion 94 is positioned on a laterally extending hemi-cylinder bar 100 of a first connector clip 10 D and the inner sleeve portion 92 is positioned on a laterally extending hemi-cylinder bar 100 of a second connector clip 10 D (FIGS. 12 - 14 ). The first sides 102 of the laterally extending hemi-cylinder bars 100 of the first and second clips 10 D are mated and held in locking engagement by the tapered sleeve 90 . [0049] The distance between the two connector clips 10 D can be laterally adjusted by moving the laterally extending tapered rods 100 as indicated by the arrows LM2-LM2 in FIG. 13. When the first sides 14 of each clip body 12 of clips 10 D are connected to two different cylindrical rods 11 via the hemi-cylindrical shells 18 and 20 on the first side 14 of the clip body 12 (FIG. 14 ), lateral adjustment of the tapered rods 100 laterally adjusts the relative position of the cylindrical rods 11 to which the connector clips 10 D are connected. This provides the user with some flexibility in adjusting the alignment of the cylindrical rods 11 in a spinal fixation apparatus during surgery. [0050] A spinal rod assembly using connector clips 10 D and a tapered locking sleeve 90 connects to longitudinal rods 11 that are connected to a human vertebrae 91 as schematically shown in FIG. 14. Two cylindrical rods 11 are each connected to a clip 10 D through the mirror image hemi-cylindrical shells 18 and 20 . The laterally extending tapered bars 100 of clips 10 D are held together with a tapered locking sleeve 90 . The assembly of the tapered locking sleeve 90 is also shown. [0051] Several means of clamping the various types of laterally extending rods from the second side 16 of the invention clip body 12 have been described above including another transverse clip of the present inventive clip 10 A (FIG. 6) and a tapered sleeve 90 (FIGS. 12 - 14 ). However, it should be understood that laterally extending hemi-cylinder rods can be connected by any other connecting means known to one skilled in the art. [0052] In yet another embodiment of the inventive transverse connector clip 10 , the first side 14 of the clip body 12 is as previously described, while the second side 16 of the clip body 12 comprises an outwardly extending rod holding portion 120 and a locking mechanism 130 . The rod holding portion has a longitudinal axis positioned perpendicular to the longitudinal axis LA1-LA1 of the first side 14 of the clip body 12 . The locking mechanism 130 is configured to engage with the rod holding portion 120 in order to locking the longitudinal rod into the rod holding portion 120 . The rod holding portion can be in the shape of a solid holding portion having a through bore for receiving a hemi-cylindrical or cylindrical rod and the locking mechanism can be of any locking mechanism known to one skilled in the art, such as tapered locking caps, set screws or locking nuts. In one embodiment, the holding portion is a U-shaped holding portion 120 having a longitudinal axis LA3-LA3 positioned perpendicular to the longitudinal axis LA1-LA1 of the first side 14 of connector clip 10 E (FIGS. 14 - 15 ). The U-shaped holding portion 120 has an upper portion 122 and a lower portion 124 . The lower portion 124 is configured to receive a flat side 126 of a hemi-cylindrical rod 128 . Alternatively (not shown), the lower portion 124 of the U-shaped portion 120 can be configured to receive a cylindrical rod 11 . A locking mechanism for the U-shaped portion 120 can include a locking cap 130 with an upper 132 and lower side 134 configured to slide into and mate with the upper portion 122 of U-shaped portion 120 . Upper side 132 of locking cap 130 has a tapered portion 136 that engages and mates with a tapered portion 138 in the upper portion 122 of the U-shaped portion 120 . The lower side 134 of the locking cap 130 is configured to accommodate an arcuate side 140 of the hemi-cylindrical rod 128 . [0053] The advantage of the inventive clip 10 E, when used in combination with the locking cap 10 G, the hemi-cylinder support bar 128 , and cylindrical rod 11 (FIGS. 15 - 16 ) is that connecting clip 10 E is a single piece that connects two rods together, thus reducing the requirement of the prior art connectors to assemble small pieces of hardware during the surgical procedure. [0054] It should be understood that in keeping with spinal surgery techniques, a plurality of cylindrical rods 11 can be used, each with a plurality of attachment devices affixed thereto, with the present attachment devices transversely connecting either two rods 11 together or connecting portions of rods together in other alignments. [0055] The foregoing disclosure and description of the invention are illustrative and explanatory thereof, and various changes in the details of the illustrated apparatus and construction and method of operation may be made without departing from the spirit of the invention.

A spinal fixation system includes a first clip body having a pair of opposed spaced apart arcuate rod engaging hooks depending from a first side thereof for engaging a first elongated spinal rod, and a transverse connector extending laterally from a second side thereof; a second clip body having a pair of opposed spaced apart arcuate rod engaging hooks depending from a first side thereof for engaging a second elongated spinal rod, and a transverse connector extending laterally from a second side thereof; and a fastener for securing the transverse connector of the first elongated clip body and the transverse connector of the second elongated clip body to one another.

PRIORITY CLAIM [0001] This application claims the priority benefit of U.S. provisional application No. 61/209,755 filed on Mar. 11, 2009, the contents of which are hereby incorporated by reference. FIELD OF INVENTION [0002] This invention relates to syringe injection systems and methods of recovery of fluids from syringe injection systems. BACKGROUND OF THE INVENTION [0003] It is often desirable to treat large numbers of individuals or animals with a substance, such as a medication or other material, with speed, efficiency, accuracy, and accurate maintenance of records. As an example, the livestock industry requires routine vaccinating, medicating and/or treating of cattle or livestock. Failure to properly treat the animals can result in significant losses to the rancher or feedlot owner or other party responsible for the livestock. Typically, the livestock is segregated into groups according to general size and weight. It is common upon arrival at the processing station for cattle to be vaccinated for viral respiratory disease, implanted with a growth stimulant, and treated for internal and external parasites. In high stress situations, antibiotics are sometimes administered simultaneously with vaccinations. [0004] To assist in vaccination large numbers of animals, able syringe injections systems have been developed that allow a syringe to be filled by a pump from a fill bottle, where the dose loaded into the syringe can be effectively controlled and varied as needed to tailor the injections by animal weight. Such a syringe system does not require the cumbersome filling of the syringe from a separate fluid container, allows for repeated injections, using precisely predetermined but differing dosages, and are capable of operating in a wide range of environments. One such syringe system is shown in U.S. Pat. No. 7,056,307, hereby incorporated by reference As shown in FIG. 1 , a syringe system will include a fill or reservoir bottle 2 , a syringe 10 , a highly accurate reversible motor 4 and pump 4 combination, and various fluid lines between the components. The system unit pump 4 is a valveless, substantially viscosity-independent pump. The pump 4 used in the system is manufactured by Fluid Metering, Inc. (“FMI”) of Syosset, N.Y., Models STH and STQ. To the extent necessary to understand the features and construction of the pump 4 manufactured by FMI, Applicant hereby incorporates by reference U.S. Pat. Nos. 5,279,210; 5,246,354; 5,044,889; 5,020,980; 5,015,157; and 4,941,809. A complete FMI pump cycle includes a ½ cycle of gather fluid from the reservoir lines, and a second ½ cycle of pumping the gathered fluid out the fluid line 6 (that is, the pump is not continuously pumping fluids as would, for instance, and impeller type pump). However, instead of use of a reversible motor/pump, two pumps may be used, (one pumping to the syringe, one pumping from the syringe), and a switch employed to select the desired pump. [0005] Animal medicine injection dispensing systems used expensive medications which are wasted when the remaining amount left in the line is not used for medicating. Often, the fluid bottle is removed from the system, and materials remaining in the fluid lines and syringe are wasted, disposed of by dispensing the materials out through the dispensing tip, or in some cases, dispense back into the bottle for later use. This is poor practice, as the dispensing tip could be contaminated and returning materials through the tip could contaminate the remaining volume in the bottle. A system is needed to easily recover fluids in a syringe system without the possibility of contamination. SUMMARY OF THE INVENTION [0006] The fluid recovery system includes two fluid paths, a first path that preferably terminates in a check valve or other one way valve, though it could open to directly to the atmosphere, and a second part that terminates into the syringe, such as at a syringe valve body. The system also includes a switch that allows the fluid line from the pump to be switched between the two paths. BRIEF DESCRIPTION OF THE DRAWINGS [0007] FIG. 1 is a block diagram of representation of a basic syringe system. [0008] FIG. 2 is one embodiment of a syringe that may be used in the syringe system. [0009] FIG. 3 a is a cross section side view of a plunger embodiment of the fluid recovery system in direct path mode. [0010] FIG. 3 b is a cross section side view of a plunger embodiment of the fluid recovery system in vent path mode. [0011] FIG. 4 a is a detail cross section side view of a first plunger embodiment of the fluid recovery system in direct path mode. [0012] FIG. 4 b is a detail cross section side view of a first plunger embodiment of the fluid recovery system in vent path mode. [0013] FIG. 5 a is a cross section side view of a second plunger embodiment of the fluid recovery system in direct path mode. [0014] FIG. 5 b is a cross section side view of a second plunger embodiment of the fluid recovery system in vent path mode. [0015] FIG. 6 a is a detail cross section side view of a rotatable embodiment of the fluid recovery system in direct path mode. [0016] FIG. 6 b is a detail cross section side view of a rotatable embodiment of the fluid recovery system in vent path mode. [0017] FIG. 7 a is a cross section side view of a rotatable embodiment of the fluid recovery system in direct path mode. [0018] FIG. 7 b is a cross section side view of a rotatable embodiment of the fluid recovery system in vent path mode. DETAILED DESCRIPTION OF THE INVENTION [0019] The invention will be described within a syringe system, where a syringed is filled by operation of a reversible pump, such as described in U.S. Pat. No. 7,056,307 or 6,989,000, both of which are incorporated by reference. A basic system is shown in FIG. 1 . As shown in FIG. 1 , a syringe system will include a fill or reservoir bottle 2 , a pump 4 and motor 5 , various fluid lines between the components and a syringe 100 shown in FIG. 2 . Fluid is pumped from the reservoir bottle 2 to the syringe 100 (shown in FIG. 2 ) and enters the syringe at a syringe inlet 111 which controls the flow of fluids within the syringe 100 . [0020] A schematic of one syringe embodiment is shown in FIG. 2 . As shown, the syringe 100 is a includes a syringe body 110 having a front grip 120 and rear grip 130 , with one of the grips movable with respect to the other (here the rear grip 130 is movable with respect to an integral front grip 120 ). The two gripped syringe is preferred, but not required (e.g., the plunger could be separately operated). The syringe 100 includes a dispensing tip 115 to which a needle may be attached. The syringe body 110 includes a hollow barrel chamber 109 with a shaft plunger 140 slidable in the interior of barrel chamber 109 . By squeezing the two grips, the shaft plunger 140 is forced into the barrel chamber 109 to discharge fluids stored in the barrel chamber 109 through the dispensing tip 107 , and ultimately, to an injection needle (not shown) attached to the dispensing tip 107 . Most pump finable syringes include a valve body 160 having internal valves to control fluid movement within the syringe 100 , such as the valve bodies depicted in U.S. Pat. No. 6,989,000. For purposes of the fluid recovery system, there are not preferred syringe valve systems. Fluids enter the syringe through the syringe inlet 111 , here shown as being on the valve body 160 . [0021] To this base syringe injection system is added a fluid recovery system 20 . In the embodiment shown in FIG. 2 , the recovery system is located at the input of the fluid line 6 to the syringe 100 (that is, at the syringe inlet). As shown, the recovery system is shown attached to a syringe valve body 160 , however, the fluid recovery system 20 could be placed anywhere on the fluid line 6 . It is preferred to attach the recovery system directly to the syringe 100 , to provide for the efficient recovery of fluids, later described. In the embodiment shown in FIGS. 3 a & 3 b , the system includes a path body 21 and a fluid switch 22 . Path body 21 is a block (such as inert plastic, stainless, aluminum) having two channels or fluid paths therethrough: a direct path 30 , and a vent path 40 . Both paths have an inlet 41 and 31 respectfully, and outlets 42 and 32 respectfully. Vent path 40 contains in a check valve 45 or other means to removably seal vent path (such as an insertable plug, threaded cover, etc). As shown, the check valve 45 is positioned near the vent path outlet 42 . Vent path may simply open to the atmosphere, but this is not preferred. An air filter 47 may also be positioned in the vent path 40 , or at the vent path outlet 42 . Also a cap or cover is preferably used to cover the terminal end of the vent path when not in use. [0022] As shown in FIGS. 4 a & 4 b , fluid switch 22 is a housing 23 having a slidable plunger 24 positioned therein. Fluid line 6 is coupled to the switch housing 23 (such as with a quick connect joint) at connect 27 . Two hollow tubes or channels are fixedly positioned on the plunger 24 : a direct switch channel 25 and a vent switch channel 26 , each having inlets and outlets (the paths may be channels drilled through the plunger, or tubes attached to the plunger) By sliding the plunger 24 between a first position (shown in FIGS. 3 a & 4 a ) to a second position (shown in FIGS. 3 b & 4 b ), the operator can choose to connect either the direct switch channel 25 , or vent switch channel 26 , to the fluid line 6 . [0023] In the plunger position shown in FIG. 3 a , the switch position fluidly connects direct switch channel 25 between fluid line 6 and direct path 30 , while blocking the vent path inlet 41 . In this position, the direct path outlet 32 is sealingly aligned with the syringe inlet 11 (here shown on the valve body 160 ), and direct path inlet is sealingly aligned with direct switch channel 25 . In the plunger position shown in FIG. 3 b , vent switch channel 26 is fluidly connected between fluid line 6 and the vent path 40 , while the direct path inlet 31 is blocked, thereby connecting fluid line 6 , through the vent path 40 and check valve 45 (if so equipped), to the atmosphere. [0024] In a second embodiment shown in FIGS. 5 a & 5 b , the recovery system is located at the input of the fluid line 6 to the syringe 100 (that is, at the syringe inlet). As shown, the recovery system is shown attached to a syringe valve body 160 . This embodiment uses a type of fluid switch 22 that is a rotatable fluid switch. One embodiment of a rotatable fluid switch is shown in FIGS. 5 a & 5 b . In this embodiment, the switch body 22 is rotatably attached within the path body 21 . Rotation may be in a vertical plane (e.g. in a plane parallel to the plane containing syringe handles), or a horizontal plane (e.g. in a plane perpendicular to the plane containing syringe handles) or even an intermediary plane. If rotation occurs in a vertical plane, as shown in FIGS. 5 a, 5 b , 6 a and 6 b , it is preferred that the lower surface of the path body 21 and the upper surface of the fluid switch housing 22 be curved to accommodate a seal between the two bodies (see detail of FIG. 5 a ). [0025] Within the rotatable fluid switch housing 22 is a single fluid path or fluid channel 52 . The fluid switch housing 22 is rotatable between two positions, a first position connecting the single path outlet 51 to the direct path inlet 31 (see FIG. 5 a ), and a second position, connecting the single path outlet 51 to the vent path inlet 41 (see FIG. 5 b ). The fluid line 6 remains connected to the single path inlet 53 , and hence moves with the rotation of the fluid switch housing 22 . [0026] If rotation occurs in a horizontal plane, as shown in FIGS. 7 a & 7 b , a rotatable disk 49 , rotating around a pivot point 48 , is rotatable between two positions, a first position connecting a single disk fluid channel outlet 46 to the direct path inlet 31 (see FIG. 7 a ), and a second position, connecting the single disk fluid channel outlet 46 to the vent path inlet 41 (see FIG. 7 b ). The fluid line 6 remains connected to the single disk fluid channel outlet 46 , and hence moves with the rotation of the rotatable disk 49 . [0027] Other embodiments of a plunger type switch are may also be utilized. For instance, the plunger may carry a single tube 50 , where the tube inlet remains connected to the fluid line 6 , and the tube outlet is movable by operation of the plunger between the vent path 40 and direct path 30 . In this configuration, that portion of the tube 50 near the tube inlet must bend or flex between the two positions, and for this reason, is not preferred—the flexing or bending of the tube 50 creates a potential fracture point in the flexible tube. An alternative arrangement using a single channel 50 in the switch housing that avoids the need for flexing can be achieved by allowing the switch housing 22 to be slidable with respect to the path body 21 . In this embodiment (not shown), the input fluid line 6 remains connected to the inlet of the channel 50 , and the switch housing 22 acts as a plunger, slidable between a first position (connecting the single path 50 outlet to the vent path inlet 41 and blocking the direct path inlet), and a second position (connecting the single path 50 outlet to the direct path inlet 31 , and blocking the vent path inlet). Fluid Recovery Operation [0028] The fluid recovery system thus has two operator selected operating positions: a first fill position, fluidly connecting the fluid line 6 , through the recovery system (direct path), to the inlet of the syringe, and a second recovery position that fluidly connects the fluid line 6 , through the recovery system (vent path), to a vent and the atmosphere. When the fill position is selected, the pump 4 and motor 5 should be placed in the normal mode, pumping fluids from the reservoir bottle 2 through the pump 4 to the flow control system, and then to the syringe. When the recovery position is selected, the motor 5 pump 4 should be in reverse mode, pumping fluids from the fluid line 6 , through the pump 4 , back to an up-righted reservoir bottle 2 a . In the recovery position, the fluid line 6 is connected to the atmosphere via the vent path 40 in the fluid recovery system, so no back pressure will be created when pumping from the syringe. [0029] In all full fluid line recovery operations, it is preferred that reservoir bottle 2 a be up-righted (See FIG. 1 b ) to prevent the build up of pressure in the reservoir bottle 2 a , which could result in fluid being pushed out the bottle vent. Additionally, shown in the fluid line to the reservoir bottle 2 is a bubble detector 105 , such as a Lifeguard ultrasonic air bubble detector from MOOG, Inc. of Stuttgart, Germany). [0030] During partial fluid line recovery operations, which can occur during the syringe fill operation, fluid is extracted from the reservoir bottle 2 by the motor 5 pump 4 , as the fluid level goes down, air will be pulled into the fluid line where the bubble detector 105 can be tied to a motor control to send a command to shut off the motor and prompt the operator (to replace the empty bottle with a replacement bottle) when bubbles are detected in the fluid line. After a fluid bottle is replaced the motor can be controlled to run in reverse to push the air out of the line between the sensor and the reservoir bottle 2 , then back to forward to pull liquid into the line replacing the air, this will insure that there will be no air in the fluid line that could end up in the syringe, causing the incorrect volume to be dispensed.

With the use of a selectable fluid path assembly, the recovery and cleaning of the liquid path line is possible. Selecting the primary use path permits a syringe assembly to be filled with fluid in a positive pressure supplied fluid system. When the secondary fluid path is selected, the fluid in the line can be reversed and with negative pressure pulled back through the line up to the pump motor and moved back into the bottle. With air following the liquid a bubble can be detected and stop the fluid reversal. With the use of a selectable fluid path assembly, the prevention of contamination of the remaining liquid in the bottle can be prevent through proper use of the fluid recovery system.

CLAIM OF PRIORITY This application claims the priority of U.S. Ser. No. 61/427,813 filed on Dec. 29, 2010, the contents of which are fully incorporated herein by reference. FIELD OF THE INVENTION The invention relates to a device for a unique surrogate experience utilizing artificial intelligence and polymeric materials which enable surrogate exchange and/or interaction with the biology of the user. Medical utility and benefits are also discussed. BACKGROUND OF THE INVENTION The present invention relates to a device providing a unique surrogate experience utilizing artificial intelligence and polymeric materials which enable surrogate exchange and/or interaction with the biology of the user, and its medical utility and benefit. The invention has many uses for the user including providing a virtual sexual experience of the user, assisting in the treatment of underlying medical urological conditions, improving poor sexual function associated with disease or in diagnosing male infertility. Such known medical conditions which may be treated or diagnosed utilizing this invention include, but are not limited to: erectile dysfunction, premature ejaculation, hypogonadism and male infertility. Some literature suggests that increasing ejaculation frequency may have a negative corollary with subsequent development of prostate cancer. Erectile dysfunction (ED) is prevalent in men aged 40 to 70 years and increases with age. Population studies estimate that 10 to 20 million men suffer ED, and 30 million men suffer at least partial ED. In years past, impotence was frequently attributed to psychological causes (psychogenic ED), but today, at least 80% of ED is likely due to physiologic causes such as vascular (decreased arterial blood flow or venous insufficiency), neurologic (nerve injury following surgery or neurologic diseases), or endocrine (hormone) abnormalities. In the past, men have been inclined to suffer ED without seeking medical evaluation or treatment. Today, due to the increase in public awareness and the advent of several treatment options, men with ED are more likely to seek treatment that offers opportunity to regain sexual function and restitution of an important quality of life activity. Premature ejaculation (ejaculation occurring sooner than the male or his partner would want) occurs in up to one third of adult men. Men may be reluctant to seek evaluation or treatment for this problem and consequently they and their partner may suffer frustration and anxiety which detracts from their sexual experience and their quality of life. In some men, premature ejaculation may be associated with erectile dysfunction. Primary premature ejaculation indicates that the condition has been present from the onset of sexual activity. Secondary premature ejaculation denotes the onset after some period of satisfactory sexual activity without ejaculatory problems. Hypogonadism is defined as little or no secretion of sex gland hormones. In men, this is essentially a failure of the testes to secrete the male hormone testosterone that is responsible for male development including sexual maturation at the time of puberty and becoming fertile due to sperm production in the testes. Primary hypogonadism indicates that the male has never produced enough testosterone to provide normal blood levels. This might be due to genetic abnormalities such as Klinefelter's syndrome. Besides genetic causes, other factors that contribute to secondary hypogonadism include tumors, surgery, radiation exposure, infections, trauma/bleeding, nutritional deficiencies, or iron excess (iron deposits in the liver known as hemochromatosis). Testosterone production in the testes depends upon the production of Leutinizing Hormone (LH) which is secreted from the pituitary gland. When testosterone blood levels are low, LH secretion increases leading to increased testosterone production. When serum levels of testosterone reach normal levels, LH production decreases. Approximately 15% of couples have difficulty conceiving, and in these instances, male subfertility is the primary factor in 30% and a secondary factor in 20%. Therefore, the male is a contributing factor in 50% of infertility cases. Fertility evaluation is traditionally recommended for couples who fail to conceive after one year of unprotected intercourse. Evaluation of the male partner should be performed first because initial exam and testing is non-invasive and less expensive than the fertility evaluation of the female partner. The evaluation of the male partner begins with a thorough history to identify risk factors such as previous chemotherapy or radiation exposure, steroid, alcohol or other drug use, and injuries that could contribute to sub fertility. A physical exam seeks to identify anatomic abnormalities such as varicocele or an abnormal vas deferens. Basic laboratory testing that includes two semen analyses and blood tests for hormone abnormalities completes the initial exam. Some or all of these conditions may be treated with the device of this invention, especially with the guidance of medical care and/or therapy, thereby avoiding side effects of oral medication such as Viagra®, Levitra® and Cialis®, avoiding invasive surgery such as penile implants and insertion of medication into the urethra or injection into the penis glands. WO/2002/087478 relates a male sexual aid having the general shape of a condom, but which is loose fitting and which has a tail for insertion between the buttocks of the user in order to retain the device in place. It lacks the virtual experience provided by the device of this invention. United States Patent Application 20060041014 relates to the use of neutral endopeptidase inhibitors (NEPi) and a combination of NEPi and phosphodiesterase type 5 (PDE5) inhibitor for the treatment of male sexual dysfunction, in particular erectile dysfunction. Medications such as this have untoward side effects. U.S. Pat. No. 6,991,600 is a male sexual aid that is made of soft and elastomeric material such as rubber, silicone rubber, or latex. The device is composed of a hollow tube and two rings arranged on two lateral sides thereof. The hollow tube (tubular cone body) has only one opening for accommodating a micro-vibrator or LED capsule. The device does not interface with the electronic devices, as do the devices of this invention. U.S. Pat. No. 6,793,620 relates to a prosthesis for male sexual aid comprising a semi-rigid sleeve of thermoplastic material and two straps of elastomeric material. The sleeve has a cutout along its whole length and is shaped outside in three portions: a head, a shaft, and a base. International Patent Application Publication WO/2008/067487 describes a hand-held or hand-attached computer control device and associated system that is utilized to control graphical objects in a computer-driven display in which the motion, type of behavior, and attributes of the graphical object are controlled through movement and resulting accelerations of the control device. A mouse and computer are required to use the device. United States Patent Application 20090234182 relates to a system comprising segmented sexual aid tools comprising a plurality of interchangeable components, all of which fit together so that a user may customize the shape, girth and length of the sexual aid tool. The system further comprises monetization and internet sales in e-commerce of sexual aid tools utilizing custom orders and rapid fabrication of such interchangeable components. Production of tools may be computer driven. SUMMARY OF THE INVENTION The invention is a device to stimulate a penis and to electronically detect sensory waves from the penis of a user via an electromusculography system (EMG). The device has a polymeric sleeve formed to fit on the head and the shaft of the penis, a power source, and a detector. A plurality of electrodes are mounted on the polymeric sleeve, wherein each electrode has a plurality of elastic flexible fingers, each having a free end portion with a conductive tip at the end of each finger, with the conductive tip making contact with the head of the penis to collect electrical signals from the penis, and a conductive moiety to conduct electrical signals from the conductive tip to the detector. The present invention allows a user to stimulate his penis, and if so desired, to collect data that may be used to aid in overcoming a variety of medical conditions. The device may be programmed to aid a user to follow a set pattern so that he trains his body and thus achieves his desired health goals. It is an object of the invention to provide stimulation to a user's penis. It is an object of the invention to receive feedback from a user's penis in order to improve performance. It is an object of the invention to use data obtained during stimulation of the penis to train the user's body. It is an object of the invention to use data obtained from brain waves to achieve physical objectives. It is an object of the invention to provide target wave patterns for the user to follow to achieve his physical objectives. It is an object of the invention to treat or diagnose a urinary tract infection. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side view of the invention. FIG. 2 is a side cut-away view of the invention. FIG. 3 is a side sectional view of the invention. FIG. 4 is side cut-away view of the invention in use. FIG. 5 is an exploded view of a section of the invention. FIG. 6 is a side cut-away view of an alternate embodiment of the invention. FIG. 7 is a representation of data that may be collected using the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 is a side view of the invention. FIG. 1 shows the electromusculography system (EMG) 100 and the polymeric sleeve 110 , power source 120 , detector 180 , and data collection device/controller 190 . The polymeric sleeve has been formed to fit on the head and the shaft of a penis. The polymeric sleeve is made of an elastic material that can be adapted to stretch and fit any penis. The polymeric sleeve may be made of or include portions of any material, including but not limited to, elastomeric gels, elastomers, rubbers, plastics, thermoplastic elastomers, metals, wood and paper, skin, fluids, or any other material or combination of materials. A preferred material for the polymeric sleeve is an elastomeric gel formed by mixtures of 5%-9% by weight of block copolymer and 90%-95% by weight of plasticizing oil. Any block copolymer may be used; the preferred block copolymer is a mixture of styrene ethylene butylene styrene (SEBS) block copolymer and styrene ethylene propylene styrene (SEPS) block copolymer. Any plasticizing oil may be used; the preferred plasticizing oils are mineral oil, synthetic oil, petrolatum naphthenic oil, synthetic polybutene, and synthetic polypropylene. The power source may be any power source that supplies electrical current, including but not limited to, a battery, a connection to a wall outlet, or other. The power source may power the device through a switch on the device; there may be multiple switches so that one part of the device may be used while the other parts are not used. The detector may be any detector that detects electrical signals, including but not limited to, an electrometer, a current sensor, a voltage detector, a galvanometer, a Hall Effect Sensor or any other detector that will detect and measure the signal generated by the EMG device. The detector may employ amplifiers and other methods to increase the signal strength to make it easier to measure. FIG. 2 is a side cut-away view of the invention. FIG. 2 shows the electromusculography system (EMG) 100 , polymeric sleeve 110 , polymeric sleeve inner surface 115 , power source 120 , non-conductive elastic flexible finger 130 , finger free-end portion 140 , finger conductive tip 150 , electrode 160 , conductive moiety 170 , detector 180 , data collection device/controller 190 , the polymeric sleeve wall thickness 200 , and flexible elements 210 . The polymeric sleeve 110 fits over a user's penis. A user puts it on, then the device is started. The power source 120 provides power to vibrate the flexible elements 210 in the wall of the polymeric sleeve 110 , thereby stimulating the penis. The finger conductive tip 150 contacts the penis and collects electrical signals which are transmitted through the electrode 160 to the detector 180 . The data is then transmitted to the data collection device/controller 190 . Conductive fluid may be applied to the penis to facilitate collection of the electrical signals. Although the device is shown with two electrodes, each having three non-conductive elastic flexible fingers 130 , with their corresponding finger free-end portions 140 and finger conductive tips 150 , there may be any number of electrodes and any number of non-conductive elastic flexible fingers with their corresponding components. The conductive tips conduct electricity from the penis head to the electrodes, which then send the electrical signal to the detector. The finger free-end portions are the part of the conductive elastic flexible fingers that may move around as necessary to comfortably contact the penis head. The other ends of the conductive elastic flexible fingers are anchored to the electrodes. The conductive moiety facilitates transferring the signal from the electrodes to the detector; it may contain amplifiers or other electronics. The polymeric sleeve inner surface 115 is smooth, non-pointed, and non-abrasive to the penis shaft and the penis head. It may be lubricated or dry when the device is in use. The device may be started and controlled using a controller such as a switch or dial on the power source, or it may be started and controlled by the user or from a remote location using a data collection device/controller 190 . The controller may be integral or separate from the data collection device, and they may be operated separately. The data collection device/controller may be wired or wireless. Data from the data collection device may be used to provide feedback to the controller, which may then be adjusted to achieve the desired result. The data collection device may be any device that can collect data, such as but not limited to, a computer, a mobile phone, or a tablet. This device may also control the electromusculography system (EMG), or the control device could be a separate and different type of device, including but not limited to, a switch or control knob. There may be feedback such that a biofeedback loop is created, with data collected being used to control the device and thus the user's behavior, which feeds back again to collected data. These data may be used to develop an algorithm that can be used to evaluate a user's performance compared to others, and may become a training tool for enhancement. FIG. 3 is a side sectional view of the invention. FIG. 3 shows the polymeric sleeve 110 , the power source 120 , and the flexible elements 210 . The flexible elements may be any shape or size, but are preferably round and approximately 2-5 mm in diameter. They may be made of any material, including but not limited to, plastic, rubber, metal, or any filled material, including but not limited to, plastic, rubber or metal filled with water or other fluid. The flexible elements can be heated or cooled using the power source and the controller, and they may be made to expand or contract. The frequency and intensity of vibration of the flexible elements may also be controlled. This may be desirable to adjust the level of stimulation when a user is trying to train himself to achieve a desired result, for instance, to prevent premature ejaculation. He may initiate his session using a high intensity of vibration and warm flexible elements, for instance, then lower the intensity and temperature of the flexible elements to prevent ejaculation, increasing one or both after a set time period or in response to some other criteria. He may also contract the flexible elements so the sensation is lessened, thus preventing ejaculation. He may cycle through this or any combination of routines a number of times until he trains his body to respond in the desired way. Alternately, the polymeric sleeve itself may be heated or cooled, and expanded or contracted, either in conjunction with the flexible elements or on its own. The user may control the characteristics of the flexible elements himself, or he may have someone else, such as a doctor, controlling them. The doctor may adjust the flexible elements based on the feedback from the electrodes and detector that is fed to the data collection device/controller, or there may be set programs that cycle the flexible elements through a set of characteristics. FIG. 4 is side cut-away view of the invention in use. FIG. 4 shows the electromusculography system (EMG) 100 , polymeric sleeve 110 , power source 120 , non-conductive elastic flexible finger 130 , finger free-end portion 140 , finger conductive tip 150 , electrode 160 , conductive moiety 170 , detector 180 , data collection device/controller 190 , polymeric sleeve wall thickness 200 , penis head 220 , and penis shaft 230 . The penis head 220 contacts the finger free-end portion 140 and the finger conductive tip 150 at the end of the non-conductive elastic flexible finger 130 . The flexibility of the non-conductive elastic flexible finger 130 allows the penis head 220 to contact the conductive tip 150 from any close position without causing negative sensation to the penis head 220 . The electrical signals are collected and transmitted as described with FIG. 2 . Signals may be also be collected from the penis shaft 230 by placing the non-conductive elastic flexible fingers 130 with conductive tips 150 at other positions in the polymeric sleeve 110 . Although shown not touching the closed end of the polymeric sleeve, the penis head may be anywhere in that area, including flush against the closed end of the polymeric sleeve. Since the polymeric sleeve is made from an elastomeric material that can stretch, it may form itself to make optimum contact with the penis. The non-conductive elastic flexible fingers may be longer than shown in the figure, and may extend farther into the polymeric sleeve 110 . In an alternate embodiment, the polymeric sleeve itself may be conductive, such that the non-conductive elastic flexible finger 130 , finger free-end portion 140 , and finger conductive tip 150 are not necessary. In this case, the signal from the polymeric sleeve may be sent directly to an electrode or to a detector through either wired or wireless methods. The inner surface of the polymeric sleeve may contain a conductive moiety, either along the entire length or at specific data collection points. The electrical signal from this moiety would then be passed to the outside of the polymeric sleeve where it is collected and detected, or it would be detected wirelessly from the inner surface of the polymeric sleeve. The device may be used as shown with the non-conductive elastic flexible finger, finger free-end portion, finger conductive tip, electrode, detector, conductive moiety, detector, and the data collection device/controller, or none, any or all of these components. For instance, if just used for stimulation, a user may use none of the components. Or, the user may use just the controller with the data collection portion turned off. FIG. 5 is an exploded view of a section of the invention. FIG. 5 shows the electrodes 160 in an electrode holder 165 . This may be desirable to keep the electrodes in a certain position for instance, if they aren't collecting electrical signals as expected, they may need to be somewhat immobilized in an electrode holder to facilitate data collection. FIG. 6 is a side cut-away view of an alternate embodiment of the invention. FIG. 6 shows the polymeric attachment 240 on a user's head 250 . FIG. 6 also shows the non-conductive elastic flexible finger 130 , finger free-end portion 140 , finger conductive tip 150 , electrode 160 , conductive moiety 170 , detector 180 , and data collection device/controller 190 . In this case, the electronically detected sensory waves are coming from the head muscles or brain of the user, depending on how the device is configured. EMG waves may be collected using the device in this configuration, or they may be collected using a separate device and may be used in conjunction with the data from this device. The flexible elements shown in the polymeric sleeve may be present or absent in this embodiment, and, if present, may have different characteristics. The polymeric sleeve of the previous figures may be used in conjunction with this embodiment; the data collected from both embodiments may be used to help a user to train his body and mind to work together to achieve the desired result. It may be placed anywhere on the user's head, or placed as shown in the figure. The polymeric attachment 240 may be formed or stretchable so that it can fit any part of the user's body; for instance, it may be desirable to measure fist clenching, and the polymer attachment could be placed on the user's hand. This could also be used with data from any other part of the body, either for diagnostic or training purposes. FIG. 7 is a representation of data that may be collected using the invention. FIG. 7 shows a graph of time vs. muscle activity. The device is activated at time zero; in the case of this invention, the flexible elements in the polymeric sleeve would be made to stimulate the penis by vibrating, and heating up, and/or expanding. At time 1.0 seconds, the muscle activity, measured as microvolts, indicates that the user is about to ejaculate, which is premature. In order to delay ejaculation, the flexible elements could be controlled to vibrate less intensely or not at all, could cool down and/or contract. This would remove or reduce the stimulation to the penis, such that ejaculation doesn't occur at that time. The stimulation could be re-introduced after muscle activity has decreased, for instance at 2.0 seconds; this cycle could be repeated as many times as desired until the user is ready to ejaculate. In this instance, the user ejaculates at 4.0 seconds, as measured by the device. The device could be used to provide a method of conditioning and building stamina in an individual. For instance, a data set of target patterns for responses, such as a set of brain waves and corresponding muscle waves, could be used to train an individual. The penis could be stimulated as described above, then data collection device/controller could be used to provide target wave patterns for responses. The data collection device/controller could receive data from multiple detectors, for instance one associated with a polymeric attachment on the head and one associated with the polymeric sleeve on the penis. The data from both the brain waves and muscle waves could be measured, and as stimulation is provided, targeted responses could be measured and feedback provided (such as reducing stimulation to the penis) to assist the individual in meeting targets (such as delay of premature ejaculation). This could result in prolonged erection times, larger amounts of sperm delivery, and an increase in sexual stamina in the user. The device could also be devised such that the controller is directed by the user's concentration levels. For instance, the intensity of vibrations of the flexible elements may be modified by the user's concentration levels. This may be achieved by causing an increased level of concentration to result in the creation of greater alpha waves; lowered levels of concentration would result in lesser alpha waves. The alpha waves could influence the intensity of vibrations of the flexible elements. Thus, using a combination of brain and muscle measurements, a user could train his body to respond in desired ways. The elastomeric gels of the invention may be prepared by methods known in the art. For example, as formulas disclosed in U.S. Pat. Nos. 4,369,284, 4,618,213, 5,153,254, 5,262,468, 5,334,649, 5,336,708, 5,466,232, 5,806,523, 5,807,360 and 5,782,818 which are incorporated herein by reference in their entirety. Preferred elastomeric gels are formed by mixtures of 5% to 9% by weight of block copolymer and 90% to 95% by weight of plasticizing oil, and trace amounts of adjunctive agents, such as pigments and fillers. The preferred composition of the polymeric sleeve and polymeric attachment is 99.5% to 98% elastomeric gel compound. The oils may be therapeutic, and may be added separately from the polymeric sleeve composition. For instance, the composition of the polymeric sleeve may not contain certain desired oils due to thermal restrictions. In this case, the oil could be added separately, through a port or other method into the interior of the polymeric sleeve. The release of the oils into the interior of the polymeric sleeve may be triggered by certain EMG responses or may be controlled by the controller, either in conjunction with the data collection portion of the device or by the controller portion alone. Any method may be used to make the polymeric attachment or the polymeric sleeve; the preferred method is molding or extruding the material to yield the desired forms. To such elastomeric gels, active agents may be added prior to extrusion to the preferred shape or placement into a mold or feeding through an extrusion machine. A preferred embodiment is a method of treating or diagnosing a urological condition present in a user by utilizing a device disclosed herein. The urological condition may be selected from one or more: erectile dysfunction, premature ejaculation, hypogonadism, male infertility, prostate cancer and Peyronie's disease (curvature of the penis). The invention contemplates advanced IP Chip design for utilization with the device, for example, including but not limited to, a brain chip or external skin chip, for example an EEG or EMG chip. In addition, software development tools and cryogenics may be utilized as part of the invention. The above-mentioned patents, applications, test methods, and publications are hereby incorporated by reference in their entirety. Many variations of the present invention will suggest themselves to those skilled in the art in light of the above detailed description. All such obvious variations are within the fully intended scope of the appended claims.

A device that provides a unique surrogate experience by utilizing artificial intelligence and polymeric materials which enables surrogate exchange and/or interaction with the biology of the user. The device may be fit on to the penis of a user to provide stimulation and via sensory wave feedback from an electromusculography system (EMG) have the stimulation varied accordingly. The stimulation may include vibrations, heating, cooling, expanding, or contracting of the device as necessary.

CROSS REFRERNCE TO RELATED APPLICATIONS This patent application is related to U.S. patent application Ser. Nos. 09/579,916 and 09/580,229, both filed May 26, 2000 now U.S. Pat. No. 6,440,130 and U.S. Pat. No. 6,443,952 and both now pending, which are continuation and divisional applications, respectively of U.S. patent application Ser. No. 08/901,890, filed Jul. 29, 1997, now U.S. Pat. No. 6,096,037 issued Aug. 1, 2000, which is a continuation of U.S. Ser. No. 08/896,398, filed Jul. 18, 1997, now abandoned. This patent application incorporates the entire disclosure of each patent application herein by reference to the extent they are consistent. BACKGROUND OF THE INVENTION This invention relates to medical instruments, and more particularly to electrosurgical devices, and methods of manipulating tissue as, for example, by cutting the tissue. DESCRIPTION OF THE RELATED ART High-frequency alternating current was used to cut and coagulate human tissue as early as 1911. Current generators and electrode tipped instruments then progressed such that electrosurgical instruments and current generators are available in a multitude of configurations for both open procedures and endoscopic procedures, with microprocessor-controlled currents typically on the order of 500 KHz. Radiofrequency (RF) catheter ablation of brain lesions began in the 1960s, and RF ablation of heart tissue to control supraventricular tachyarrhythmias began in the 1980s. Thus, electrical energy, including but not limited to RF energy, is a known tool for a variety of effects on human tissue, including cutting, coagulating, and ablative necrosis, with and as a part of electrically conductive forceps. Bipolar and monopolar currents are both used with electrosurgical forceps. With monopolar current, a grounding pad is placed under the patient. A recent example of an electrically energized electrosurgical device is disclosed in U.S. Pat. No. 5,403,312 issued on Apr. 4, 1995 to Yates et al., and the disclosure is incorporated by reference. SUMMARY OF THE INVENTION An object of the present invention is to provide an electrosurgery tissue sealing medical device which may and also may not be a forceps. Another object of the present invention is to provide an electrosurgery tissue sealing device such as a forceps that seals tissue by a unique flow of an electrolytic fluid or solution to the manipulating portions of the device in combination with energization of the solution with electrical energy. The effect of the solution and energy may be enhanced with pressure. The solution is brought into contact with and infuses the tissue. The solution may include saline as well as other non-toxic and toxic electrolytic solutions, and may be energized with RF electrical energy. The body of the device itself may or not be energized. The solution provides at least in part the beneficial functions and effects of the instrument. As preferred, pressure on the tissue is applied, and most preferably the effect of pressure is optimized, as by applying pressure across the tissue to be effected that is substantially uniform. Another object of the invention is to provide an electrosurgery medical device as described, and methods of sealing tissue, in which tissues are sealed against flow of fluids including air. With the invention, for example, lung tissue is aerostatically and hemostatically sealed, with the tissue adjacent the sealed tissue retaining blood and air. Another object of the invention is to provide an electrosurgery medical device that may take the form of open surgery forceps of a variety of specific forms, or endoscopic forceps, also of a variety of forms. A further object of the invention is to provide an electrosurgery medical device as described, in which the electrolytic solution by which the instrument functions is infused from the device onto and/or into the tissue along the operative portions of the device. With and without applied pressure, the solution coagulates and additionally seals tissue, as a result of being energized by RF energy, and also envelopes the operative portions of the device in solution all during manipulation of tissue, substantially completely preventing adherence between the instrument and tissue, substantially without flushing action. In a principal aspect, then, the invention takes the form of an enhanced solution-assisted electrosurgery medical device comprising, in combination, co-operating device jaws including jaw portions for manipulating tissue, and a plurality of solution infusion openings defined and spaced along each of the jaw portions, for receiving solution and infusing solution onto and into the tissue along said jaw portions. While the device is contemplated with and without grooves, as preferred, the device further comprises at least one, and most preferably, many, longitudinal grooves along at least one and most preferably, both, of the jaw portions. Also most preferably, the solution infusion openings are located on the inside faces of the jaw portions, adjacent to and most preferably in the groove or grooves. The solution exiting the openings separates substantially all the operative surfaces of the device from tissue, substantially completely preventing adherence between the operative surfaces and tissue. The solution also aids in coagulation Coagulation aside, the invention causes hemostasis, aerostasis, and more generally, “omnistasis” of substantially any and all liquids and gases found in tissue being treated, such as lymphatic fluids and methane, as well as blood and air. These broader effects are understood to result from such actions as shrinkage of vascalature with and without coagulation, and without desiccation and carbonization. Also as preferred, the operative portions of the device may take the form of a circular, semicircular or other regular and irregular geometric shape, to contain and/or isolate tissue to be affected and perhaps resected. As an example, with an enclosed geometric shape such as a circle, tissue surrounding lesions and/or tumors of the lung may be aerostatically and hemostatically sealed, resulting in an isolation of the lesions and/or tumors for resection. Lung function is retained. For adaption to unique tissue geometries, the operative portions of the device may be malleable, to be manipulated to substantially any needed contour. For procedures including resection, the device may include an advanceable and retractable blade, or additional functional structures and features. These and other objects, advantages and features of the invention will become more apparent upon a reading of the detailed description of preferred embodiments of the invention, which follows, and reference to the drawing which accompanies this description. BRIEF DESCRIPTION OF THE DRAWING The accompanying drawing includes a variety of figures. Like numbers refer to like parts throughout the drawing. In the drawing: FIG. 1 is a schematic diagram of the key elements of an electrical circuit according to the invention; FIG. 2 is a perspective view of an endoscopic forceps according to the invention; FIG. 3 is a detail view of a portion of the forceps of FIG. 2; and FIG. 4 is a perspective view of a modification of the embodiment of FIG. 2; FIG. 5 is a second modification, of the embodiment of FIG. 4, shown partially broken away; FIG. 6 is a perspective view of an open surgery forceps according to the invention; FIG. 7 is a detail view of a portion of the forceps of FIG. 6, partially broken away; FIG. 8 is a schematic view of preferred saline supply equipment for the invention; FIG. 9 is a perspective view of a portion of the jaws of an alternative device; FIG. 10 is a perspective view similar to FIG. 9 of another alternative device; FIG. 11 is a cross-sectional view along line 11 — 11 of FIG. 9; and FIG. 12 is a perspective view of yet another alternative device. DESCRIPTION OF THE PREFERRED EMBODIMENTS Electrosurgery uses electrical energy to heat tissue and cause a variety of effects such as cutting, coagulation and ablative necrosis. The heat arises as the energy dissipates in the resistance of the tissue. The effect is dependent on both temperature and time. Lower temperatures for longer times often yield the same effect as higher temperatures for shorter times. Normal body temperature is approximately 37° C. No significant long-term effect is caused by temperatures in the range of 37° C. to 40° C. In the range of 41° C. to 44° C., cell damage is reversible for exposure times less than several hours. In the range of 45° C. to 49° C., cell damage becomes irreversible at increasingly short intervals. The following table states expected effects at higher temperatures: Temperature (° C.) Effect 50-69 Irreversible cell damage - ablation necrosis.  70 Threshold temperature for shrinkage of tissue. (Some collagen hydrogen bonds break at 60-68; those with cross-linkages break at 75-80) 70-99 Range of coagulation. Hemostasis due to shrinkage of blood vessels. 100 Water boils. 100-200 Desiccation as fluid is vaporized Dependent on the length of time during which heat is applied, carbonization may occur, and at higher temperatures, occurs quickly. This table is not intended as a statement of scientifically precise ranges above and below which no similar effects will be found, and instead, is intended as a statement of generally accepted values which provide approximations of the ranges of the stated effects. Limitation of the appended claims in accordance with this and the further details of this description is intended to the extent such details are incorporated in the claims, and not otherwise. As a consequence of the foregoing effects, preferred “soft” coagulation occurs at temperatures slightly above 70° C. Heat denatures and shrinks tissues and blood vessels, thereby leading, as desired, to control of bleeding. Cells are generally not ruptured. “Soft” coagulation is generally assured with voltages below 200 peak Volts. Sparks are avoided. “Forced” coagulation can be accomplished with bursts of electrical energy. Electric arcs are generated. Deeper coagulation is achieved, at the cost of some carbonization and an occasional cutting effect. Spray coagulation is also possible. Tissue cutting occurs by desiccation, when the concentration of electrical energy, also referred to here as energy density, is acute, and the temperature of tissue is raised above 100° C. For both coagulation and cutting by electrical energy, a sine wave waveform is employed, with a frequency of about 500 kHz. For cutting, increasing voltage to as much as 600 peak. Volts leads to higher spark intensity which results in deeper cuts. Frequencies above 300,000 Hz avoid stimulating nerve and muscle cells, and generally assure that the effect on tissue is substantially purely thermal. In contrast with the RF energy tissue-cutting electrosurgery tools of the past, significant purposes of the present invention are to provide a mechanism of avoiding desiccation of tissue at the electrode/tissue interface and to achieve sealing of tissues. By “sealing,” the effects of hemostasis, or arresting of bleeding, “aerostasis,” or arresting of the passage of air; and closure of tissues such as blood vessels against larger-scale passage of blood, among other effects, are intended. More specifically, the effect of sealing at the cellular level is a primary focus, as is sealing at the vascular level. Referring to FIG. 1, key elements of a preferred electrical circuit according to the invention include an electrosurgical unit 10 , a switch 12 , and electrodes 14 , 16 . An effect is created on tissue 18 of a body 20 . One electrode such as electrode 14 acts as a positive or active electrode, while the other such as electrode 16 acts as a negative or return electrode. Current flows directly from one electrode to the other primarily through only the tissue, as shown by arrows 22 , 24 , 26 , 28 , 29 . No pad is needed under the patient. This is a bipolar configuration Referring to FIG. 2, a forceps 30 according to the invention is an endoscopic forceps, and includes manual handles 32 , 34 , an elongated shaft 36 , and jaws 38 , 40 . The handles 32 , 34 pivot together and apart and through a suitable mechanism (not shown; present in the incorporated prior art) control the jaws 38 , 40 to also pivot together and apart about a pivot connection 42 . Referring to FIG. 3, each jaw 38 , 40 is formed in two parts, hinged together. The jaw 38 includes a link portion 44 connected directly to the forceps shaft 36 , and the jaw 40 includes a link portion 46 also connected directly to the forceps shaft 36 . A jaw portion 48 hingedly fastened to the jaw link portion 44 completes the jaw 38 , a jaw portion 50 hingedly fastened to the jaw link portion 46 completes the jaw 40 As stated in the background of the invention, a wide variety of alternatives to the structure described and shown in FIG. 2 are possible. Prominent examples from those incorporated include the structures of U.S. Pat. No. 5,403,312 (Yates et al.) issued Apr. 4, 1995, U.S. Pat. No. 5,395,312 (Desai) issued Mar. 7, 1995; and U.S. Pat. No. 5,318,589 (Lichtman et al.) issued Jun. 7, 1994. Still referring to FIG. 3, a solution supply tube 52 supplies electrolytic solution to an electrode strip 47 along the jaw portion 48 , as will be described. A solution supply tube 54 supplies electrolytic solution to a similar strip 49 along the jaw portion 50 . A wire 56 electrically connects to the solution supply tube 52 ; a wire 58 , electrically connects to the solution supply tube 54 . All the supplies 52 , 54 , 56 , 58 , both solution and electrical, extend from the proximal or manual handle end of the shaft 36 , and connect to solution and electrical sources. Referring to FIG. 4, and in a second form of a jaw, designated 140 , a jaw portion 150 similar to jaw portion 50 in FIG. 3, includes a longitudinal dimension in the direction of arrow 160 . A plurality of longitudinal grooves 162 are spaced side-by-side across the inner face 164 of the jaw portion 150 . The grooves 162 extend the full longitudinal length of the jaw portion 150 . The same is true of a mirror image jaw portion, not shown. Both jaw portions are incorporated in a structure as in FIG. 3, and could be placed in substitution for jaw portions 48 , 50 in FIG. 3 Grooves, not shown, also preferably extend along the corresponding jaw portions 48 , 50 of FIGS. 2-3. Orientations of the grooves other than longitudinal are considered possible, within the limit of construction and arrangement to substantially retain solution along the operative jaw portions. Bodily tissues to be manipulated have a natural surface roughness. This roughness significantly reduces the area of contact between the forceps jaws and manipulated tissues. Air gaps are created between conventional smooth-surfaced jaws and tissues. If the jaws were energized when dry, electrical resistance in the tissues would be increased, and the current density and tissue temperature would be extremely high. In practice, tissue surfaces are sometimes wet in spots, and yet tissue wetness is not controlled, such that electrical power is to be set on the assumption the inner jaw surfaces are dry. This assumption is necessary to minimize unwanted arcing, charring and smoke. In contrast, in a forceps according to the invention, whether the jaw portions are grooved or smooth, whether the grooves are longitudinal or otherwise oriented, the jaw portions are uniquely formed of a material such as hollow stainless steel needle tubing such that solution infusion openings 166 may be and are formed in the jaw inner faces such as the inner face 164 , as in FIG. 4 . Further, the solution supplies 52 , 54 shown by example in FIG. 3 may and do open into the openings 166 , to supply solution to the openings 166 . As most preferred, the openings 166 are laser drilled, and have a diameter in a range centered around four thousandths (0.004) of an inch, and most preferably in a range from two to six thousandths (0.002-0.006) inches. The purpose of the openings 166 is to infuse solution onto and/or into the tissue adjacent to and otherwise in contact with the forceps jaw portions inner surfaces. It is understood the openings are appropriately as small in diameter as described above to assure more even flow among the openings than would otherwise occur. Further, the openings need not be so closely spaced as to mimic the surface roughness as tissues. Microporous surfaces are possibly acceptable, while they are also not necessary. Infusion of fluid through the jaws is to be maintained in a continuous flow during and throughout the application of RF energy in order for the desired tissue effect to be achieved. With the described structure and similar structures and methods within the scope of the invention, numerous advantages are obtained. Deeper and quicker coagulation is possible. The conductive solution infused onto and into the tissues maintains relatively consistent maximal electrical contact areas, substantially preventing hot spots and allowing higher power than soft coagulation. Little to no arcing, cutting smoke or char is formed. Jaw and tissue surface temperatures are lower than otherwise, resulting in significantly less adhesion of tissue to jaw surfaces, and substantially no desiccation. One mode of coagulation may be used in the place of the three modes soft, forced, and spray. Coagulation is possible of even the most challenging oozing tissues such as lung, liver and spleen tissues. Coagulation is more precise, where other coagulation modes sometimes spark to the sides and produce coagulation where not desired. Also, and importantly, electrosurgical cutting by desiccation may be avoided, and tissue sealing achieved. As desired, tissue sealing may occur alone, or be accompanied with mechanical cutting, as by a retractable and advancable blade as in U.S. Pat. No. 5,458,598, and as with blade 1210 in FIG. 12, or otherwise. The tissue sealing itself is understood to occur by flow of electrolytic solution to the manipulating portions of the forceps in combination with energization of the solution with electrical energy, and when included, in combination with pressure on, or compression of, the tissue. Compression of tissue is understood to deform tissues into conditions of sealing of tissues and especially vascalature. Compression of tissue followed by application of solution and energy is understood to permanently maintain compressed deformation of tissue, when present, and to shrink tissue and cause proteins to fix in place. Additional understanding of others is provided in the Yates et al. patent referenced above. The body of the forceps itself may or not be energized. As most preferred, the solution primarily provides the beneficial functions and effects of the instrument. The effectiveness and extent of the tissue sealing is a function primarily of the type of tissue being manipulated, the quantity of electrolytic solution supplied to the tissue, and the power of the electrical energy supplied to the solution. Tissues not previously considered to be suitable for manipulation, as by cutting, are rendered suitable for manipulation by being sealed against flow of fluids, including bodily fluids and air. With the invention, for example, lung tissue may be cut after sealing, with the tissue adjacent the sealed tissue retaining blood and air. Examples of the principal parameters of specific uses of the invention are provided in the following table. It is understood that the combined consequences of the parameters are that energy density in the tissue to be treated is in a range to effect sealing of the tissue. However, in general, a power output of 7 to 150 watts is preferred. Fluid Quantity Power Tissue Effect 2 cc's per minute 20 watts for 30 1 cm diameter hemostasis per electrode seconds vessel through the vessel 2 cc's per minute 30 watts for 45 lung tissue hemostasis and per electrode seconds aerostasis 4 cc's per minute 40 watts for 90 2 cm thickness hemostasis per electrode seconds liver tissue In the examples for which the table is provided, the electrolytic solution is saline. In the first example, the device in use was a device as in FIG. 2, with electrodes of 16 gauge tubing, 1 cm long. The tool in use in the second and third examples was a forceps as in FIG. 6, with jaw portions 348 , 350 , to be described, 4 mm wide and 2.8 cm long. No desiccation was observed at the tissue/electrode interface. The device of FIG. 2 is preferred for vessel closure. A wide variety of the currently installed electrosurgical generators could and will provide proper waveforms and power levels for driving the described forceps. The waveforms need only be sine waves at about 500 kHz, and the power need only be about 30 or more watts. As example of available generators, Valleylab generators are acceptable and widely available The electrolytic solution supplied to the forceps need only be saline, although a variety of non-toxic and toxic electrolytic solutions are possible. Toxic fluids may be desirable when excising undesired tissues, to prevent seeding during excision. Use of a pressure bulb is possible, as shown in FIG. 8. A flexible reservoir such as an intravenous (IV) bag 410 is surrounded with a more rigid rubber bulb 412 that is pressurized with air through an attached squeeze-bulb 414 . The reservoir is filled with solution through an injection port 416 . An outflow line 418 has a filter 420 and a capillary tube flow restrictor 422 to meter flow. A clamp or valve 424 and connector 426 are also provided. A typical flow rate is one to two (1-2) cc/min at a maximum pressure of approximately sixteen pounds per square inch (16 psi)(52 mmHg). An example of opening diameters, numbers, and flow rate is as follows: opening diameter, 0.16 mm, number of openings, 13 per cm; and flow rate, 2 cc's per minute. A long slit has also been used and found acceptable. In this embodiment, flow rates of 0.01 to 50 cc/min are preferred It is understood that highly significant to the invention is the spacing of a plurality of solution openings along the jaw inner surfaces. Single openings as in Ohta et al., that effectively pour fluid adjacent one portion of forceps, are generally not considered suitable or effective. Openings along outer surfaces of the jaws, opposite inner surfaces, are also generally not considered suitable or effective. Referring to FIGS. 4 and 5, the configurations of the most preferred solution openings are disclosed. Referring to FIG. 5, in a jaw 240 , longitudinally spaced openings 166 are rotated from those shown in FIG. 4, in a jaw portion 250 , to turn the openings away from most direct contact with tissues, and more carefully eliminate any unintended plugging of the openings. Electrical insulators 268 in the form of elongated strips extend alongside the tubes which include the openings 166 . Referring to FIG. 6, open surgical forceps 330 include jaws 338 , 340 with jaw portions 348 , 350 . As with jaw portion 350 in FIG. 7, the jaw portions 348 , 350 include spaced solution infusion openings 166 in the central longitudinal groove of a plurality of grooves 162 . A central channel 370 of both jaw portions 348 , 350 , as shown relative to jaw portion 350 in FIG. 7, supplies solution to the openings 166 from solution supplies 52 , 54 . As with the endoscopic forceps of FIGS. 2-5, the open surgical forceps 330 benefits from the unique enhancement of electrosurgical functions through the infusion of electrolytic solutions onto and into tissues through the spaced, laser drilled, solution infusion openings in the grooves 162 . Referring to FIGS. 9 and 10, open surgical devices 430 and 530 also include jaws 438 , 440 and 538 , 540 , respectively. The jaw portions of these devices are curved, and in the case of device 430 , circular, to adapt the invention to specialized surgical situations of tissue manipulation, such as those in which fluid flow is to be terminated all around a tissue to be isolated and resected or excised. An example of such a tissue is a lesion or tumor of lung tissue. In endoscopic or open surgery, such lesions or tumors may be encircled and/or isolated, surrounding tissue sealed, and the lesions or tumors thereafter resected. Preferably, a one centimeter margin is resected about any lesion or tumor, with the lesion or tumor. As shown, the devices 430 , 530 are formed of substantially square cross-section tubing, best shown in the cross-sectional drawing of FIG. 11 . As most preferred, the tubing incorporates a central, depressed, cross-sectionally rectangular, and elongated groove 462 and equilaterally spaced, cross-sectionally triangular, parallel, and elongated outer grooves 464 , 465 . Laser drilled openings 466 , similar to openings 166 described above, are located in and spaced along the central groove 462 . Alternate cross-sectional shapes of tubing may be employed, as exemplified in FIG. 12 . Flatter operative, e.g, inner faces of tubing are preferred within limits of constructing and arranging the operative faces to facilitate firm grasping and holding of tissue. Non-operative surfaces, being less of concern, may adapt to a variety of contours for a variety of alternate reasons. Further, malleable tubing may be employed, to permit the surgeon to shape the operative portions of the invented devices to specific physiological situations. The infusion of conductive solutions, referred to here also as electrolytic solutions, simultaneously with the application of RF energy to tissues is discussed in further detail in U.S. Pat. No. 5,431,649 entitled. “Method and Apparatus for R-F Ablation,” in the name of Peter M. J. Mulier aid Michael F. Hoey; in U.S. Pat. No. 5,609,151, entitled. “Method and Apparatus for R-F Ablation,” in the name of Peter M. J. Mulier. The foregoing patents are commonly assigned to the assignee of the present invention, and are incorporated by reference here. The preferred embodiments, and the processes of making and using them, are now considered to be described in such full, clear, concise and exact terms as to enable a person of skill in the art to make and use the same. Those skilled in the art will recognize that the preferred embodiments may be altered and modified without departing from the true spirit and scope of the invention as defined in the appended claims. For example, if the invented device is incorporated in forceps, the forceps may be varied in a range from excision and cutting biopsy forceps, to endoscopic forceps, dissecting forceps, and traumatic, atraumatic and flexible endoscopic grasping forceps. The jaws may close into fall and tight contact with each other, or close into spaced relationship to each other, to accommodate tissue for purposes other than cutting. As expressed above, parallel spaced relationship is considered most preferably for uniformity of application of pressure across tissue to be affected. A variety of features such as jaw serrations, single acting and double acting jaws, closing springs, ratchet locks, fingertip rotation rings, color coding and smoke aspiration may or may not be included with the features described in detail. Devices according to the invention may be constructed and arranged to grasp, hold, fix, cut, dissect expose, remove, extract, retrieve, and otherwise manipulate and treat organs, tissue, tissue masses, and objects. Endoscopic forceps according to the invention may be designed to be used through a trocar. Bipolar and monopolar currents may both be used. With monopolar current, grounding pads may be placed under patients. The described grooves may be eliminated in favor of alternative grooves. For purposes of the appended claims, the term “manipulate” includes the described functions of grasping, holding, fixing, cutting, dissecting, exposing, removing, extracting, retrieving, coagulating, ablating and otherwise manipulating or similarly treating organs, tissues, tissue masses, and objects. Also for purposes of the appended claims, the term “tissue” includes organs, tissues, tissue masses, and objects. Further for purposes of the appended claims, the term “electrical energy sufficient to affect tissue” includes electrical energy sufficient to raise tissue temperature to cause non-reversible effect on tissue as described above. To particularly point out and distinctly claim the subject matter regarded as invention, the following claims conclude this specification.

An electrosurgery medical device is enhanced with unique solution-assistance, and comprises, in combination, co-operating device jaws including jaw portions for manipulating tissue, and a pluraluty of solution infusion openings defined and spaced along each pf the jaw portions, for receiving electrolytic solution and infusing the solution onto and into tissue to be manipulated, along said jaw portions. As preferred, the device further comprises at least one, and most preferably, many, longitudinal groove(s) along at least one and most preferably, both, of the jaw portions, with the solution infusion openings located in the groove or grooves. The solution is energized with RF energy amd contributes to the functions and beneficial effects of the instrument. The solution exits the openings in the grooves at sufficient flow rates to separate substantially all the operative surfaces of the device from tissue, thereby substantially completely preventing adherence between the operative surfaces and tissue. The solution is further energized to a range of energy densities such that tissues to be affected are sealed against flow of blood, lymphatic fluids, air, and other bodily fluids and gases.

FIELD OF THE INVENTION This invention relates to a carry-on case and has specific but not limited application to a durable lightweight carry-on case having an improved built-in wheel and handle assembly for portable travel convenience. BACKGROUND OF THE INVENTION The conventional carry-on case is typically a hand-carried travel case. Such cases are usually carried by a handle. It is generally necessary that this type of case be carried throughout an airport from places of departure to airplanes, from airplanes to airplanes, and from airplanes to places of arrival. For such cases there is provided a wheeled frame which is separately carried in addition to the carry-on case. The frame serves as a cart onto which the case can be strapped for transport. There are also cases that include incorporated handles and wheels so that the cases can be pulled by the handles, thereby permitting them to be towed about and transported throughout the airport. A problem with these prior art carry-on cases exists in that it is impractical, if not impossible, to use these cases as a support upon which to stack additional pieces of luggage without special devices or attachment hooks. The present invention overcomes the above stated deficiencies of the prior art. Summary of the Invention The carry-on case of this invention serves to alleviate the problem and inconvenience of transporting cumbersome luggage cases. This case contains a storable built-in handle which can function as a luggage travel cart by which the case can be pulled. This case can also be used to carry additional pieces of luggage stacked on top of the case, thereby permitting such pieces of luggage to be transported at one time. It is therefore an object of this invention to provide for a novel carry-on case. Another object of this invention is to provide for a case with wheels and a built-in handle functioning as a travel cart. Another object of this invention is to provide for a case with wheels and a built-in collapsible handle that can be used to carry stacked luggage. Other objects of the invention will become apparent upon a reading of the following description taken with the accompanying drawings. Brief Description of the Drawings FIG. 1 is a perspective view of the carry-on case of this invention having a built-in travel cart with the handle raised and extended positions and tilted about its wheels. FIG. 2 is a perspective view of the carry-on case of this invention which shows the case in a tilted position about its wheels with the handle in its extended and lowered positions. FIG. 3 is an elevational view of the carry-on case with the lid in an open position and with the handle in its lowered and collapsed positions. FIG. 4 is an elevational view of the carry-on case with the lid in a closed position and with the handle in its lowered and collapsed positions. FIG. 5 is a sectional view seen along line 5--5 of FIG. 2. FIG. 6 is a fragmentary sectional view with positions removed to illustrate the securing and locking features of the handle. FIG. 7 is a fragmentary sectional view seen along line 7--7 of FIG. 6. FIG. 8 is a fragmentary sectional view of the handle shown in its raised and collapsed positions. DESCRIPTION OF THE PREFERRED EMBODIMENT Case 10 is illustrated in FIGS. 1-6 and includes a base 12 and a lid 14 both of which are connected and held together by rear hinges 25. Case 10 also includes two wheels 30 and a handle 40 that is releasably extendable, collapsible, lowerable and raisable. Base 12 of case 10 includes a bottom wall 17, two end walls 13, a rear wall and a front wall 19. Front wall 19 carries locks 16. Lid 14 is shiftable about hinges 25 from an open position as shown in FIG. 3 to a closed position as illustrated in FIGS. 1-2. When in its open position, lid 14 is supported and held open by a hinged lid holder 18. Lid 14 also includes a top wall 20, two end walls 15, a rear wall 27 and a front wall 21. Front wall 21 includes latches 23 which interlock with locks 16 to secure lid 14 in a closed position over base 12. Wheels 30 are positioned on opposite sides of base 12 in indentations 31 formed in each wall 11 and 19. Wheels 30 are journalled upon an axle member 32 which extends along the bottom wall 17 of base 12. Axle member 32 extends through each wheel at its center with the wheels being retained upon the axle member by press-fitted retainer cups 34. Axle member 32 is secured to base 12 by extending through wheel plates 36. Wheel plates 36 are secured to base walls 11 and 19 within indentations 31 by fasteners 35. Handle 40 of case 10 is releasably extendable, collapsible, lowerable and raisable as shown in FIGS. 1-6. Handle 40 includes two parallel side rails. Each side rail includes an outer telescopic member 43 and an inner telescopic member 45. Outer telescopic members 43 are joined at corresponding ends by a cross brace 50 and at their opposite corresponding ends by a pivot rod 44. Pivot rod 44 as shown in FIGS. 3-4 is retained in a transverse channel 49 formed in lid 14 by hold down plates 46 which are attached to lid 14 by rivets or other suitable fastening means. Pivot rod 44 is rotatable about its axis within channel 49 to permit handle 40 to be moved from the lowered position shown in FIG. 4 to a raised position when the lid 14 is closed as shown in FIGS. 1-2. When in its raised position, the handle preferably abuts outturned flange 37 of each plate 36 in an over-center orientation. A spring biased pin 38 extends into an opening 39 at the pivoted end of each outer telescopic member 43 to secure the handle in its raised position. To lower handle 40, the inner telescopic members 45 are first collapsed to cause bevelled end 41 of each inner telescopic member 45 to engage the protruding pin 38 and cam the pin sufficiently out of opening 39 in the outer telescopic member 43 to allow pivotal movement of the handle. A hand grip 48 is connected to inner telescopic members 45 of handle 40 at their free ends. The inner telescopic members 45 are shiftable relative to the outer telescopic members 43 to allow handle 40 to assume the collapsed position seen in FIGS. 3 and 4 and the extended position seen in FIGS. 1 and 2. The extension of the handle is accomplished by pulling out on hand grip 48. Handle 40 is selectively secured in its collapsed position or extended position by means of a locking system which is housed in and carried by cross brace 50. This locking system includes two lock rods 58 which are oppositely extending and are axially aligned. Lock rods 58 are retained within cross brace 50 and protrude through guide holes 57 formed in the inside of outer telescopic members 43 and aligned lock holes 59 in the inner telescopic members 45. Each of the lock rods 58 can be retracted out of the lock holes 59 to permit the inner telescopic members 45 to shift relative to the outer telescopic members 43. This feature permits either extension or retraction of handle 40. Lock rods 58 are normally urged outwardly to a protruding position relative to lock holes 59 by a helical spring 60. Each end of helical spring 60 extends about an inner end of a lock rod 58, abutted compressively against a transverse grip pin 62. Each grip pin 62 is press-fitted through a lock rod 58. The grip pins 62 extend outwardly through the cross brace 50 to an exposed position that is adjacent to hand grip 48 when the handle 40 is in its collapsed position. Shifting or squeezing together the exposed ends of grip pins 62 compresses helical spring 60 and draws lock rods 58 together to cause the outer ends of lock rods 58 to be withdrawn from lock holes 59 of the inner telescopic members 45, freeing handle 40 and permitting it to be extended. To secure handle 40 in its extended position, the inner telescopic members 45 have formed at their opposite ends a second set of lock holes 61. As the inner telescopic members 45 are shifted and releasably extended, the lock rods 58 align with the lock holes 61 in inner telescopic members 45 to permit each of the lock rods 58 to be again urged by helical spring 60 into the inner lock holes to secure the handle 40 in its extended position as is shown in FIGS. 1-2. Again, to release and collapse handle 40, the case user need only squeeze together with one hand transverse grip pins 62. This causes the lock rods 58 to be withdrawn from the lock holes 61 and allows the inner telescopic members 45 to be pushed into outer telescopic members 43 until rods 58 enter lock holes 59. In its lowered and collapsed position as shown in FIGS. 3-4, it is necessary to secure handle 40 to case 10. This is accomplished by another locking system including two lock pins 52 which are retained by cross brace 50 and which include head parts 51 and shank parts 53. The head parts 51 extend outwardly from the cross brace 50 and rest against cross brace 50 next to hand grip 48. Each shank part 53 protrudes interiorally through openings in cross brace 50. A head part 51 located exteriorly of the cross brace is threaded onto one end of the shank part. The opposite end of the shank part protrudes outwardly from brace 50. A helical spring 54 extends about each lock pin shank part 53 and is compressed between brace 50 and a shoulder 63 on the shank part so as to urge the lock pin shank part toward a strike plate 56 attached to lid end wall 15 with head part 51 abutting the brace. The protruding end of each shank 53 is forced by spring 54 into a lock hole 55 in strike plate 56 to secure the handle in its lowered position. To release handle 40 from its lowered position in order to allow the handle to pivot away from case 10 into its raised position, the user need only grasp the head parts 51 of lock pins 52 and pull. This causes the helical springs 54 to be compressed with the shanks 53 being withdrawn from the lock holes 55 in the strike plates 56. When handle 40 is moved into its extended and raised position shown in FIG. 1, luggage composed of from 4 to 5 suitcases can be stacked upon the closed lid 14 and can rest against raised and extended handle 40. FIG. 2 illustrates a second towable orientation in which handle 40 is extended in its lowered position. In this position the case 10 can be pivoted upwards to permit towing. FIGS. 3-5 illustrate case 10 with handle 40 in its lowered and collapsed positions with handle 40 being usable as a grip to carry the case. Sufficient spacing is provided between grip 48 and brace 50 to allow the grip to be grasped by the hand of the user. It is understood that the above description does not limit the invention to those details, which may be modified within the scope of the following claims.

An improved carry-on case having a built-in travel cart capable of being towed by itself or with several pieces of luggage. The handle of the cart can be retracted for convenient storage.

CROSS-REFERENCE TO RELATED APPLICATION This is a continuation-in-part of U.S. application Ser. No. 08/955,606, filed Oct. 22, 1997, now abandoned which in turn claims priority to U.S. Provisional application No. 60/029,587, filed Oct. 23, 1996. FIELD OF THE INVENTION This invention relates to systems and methods for noninvasively measuring hemodynamic access, access recirculation and blood flow measurements during hemodialysis. More particularly, the present invention relates to noninvasive spectrophotometric systems and methods for quantitatively measuring the shunt (access) recirculation, the access blood flow rate, the dialysis machine blood flow rate and the volumes of priming fluids required by the hemodialysis tubing lines. INTRODUCTION Modern medical practice utilizes a number of procedures and indicators to assess a patient's condition especially in the dialysis setting. Hemodialysis is a process wherein an artificial kidney is required to function in the place of the patient's normal kidney in order to remove certain biologic waste products. When the human kidney no longer functions correctly removing waste products such as urea, potassium, and even excess water, blood must be removed from the patient via blood tubing lines and filtered through an artificial kidney or dialyzer. In this process blood is passed through the dialyzer, cleansed, then returned to the normal circulatory system of the patient. Access to the patient's circulatory system is achieved through the use of a surgically implanted shunt or fistula. This "access site" is typically located in the arm, leg, or neck of the patient. Typically needles are placed into this "access" in such a way as to facilitate the easy removal of blood on the "arterial" or upstream side of the dialyzer and typically return the purified blood downstream of the first needle placement on the "venous" side. Unfortunately, in many cases the fistula, or shunt, will clot or "stenos" over time. This results in decreased blood flow through the access which ultimately necessitates either angioplasty or a surgical replacement of the shunt. As the shunt ceases or "clots off" part of the purified dialyzed blood is forced to flow back into the arterial withdrawal site and, hence, recirculates only to be dialyzed again; this is termed "access recirculation". As this recirculation of purified blood continues, the rest of the patient's circulating blood is not adequately cleansed and, hence, an inadequate delivery of the dialysis dosage is provided to the patient. Therefore, because of the possibility of inadequate dialysis dosage due to this direct recirculation of purified blood back to the withdrawal site, various techniques and methods have been designed to determine: 1) The degree or percentage of access recirculation; 2) The actual blood flow rate in the shunt per se; and 3) The dialyzer blood flow rate itself. Medical professionals desire to know these three parameters not merely qualitatively, but quantitatively in order to determine the presence and degree of clotting or stenosis. These parameters are desired to predict when the access is beginning to fail and to determine the need for access revision by surgery. Blood flow, Q, measured by the so-called Ficke dilutional techniques, has been described by A. C. Guyton, Textbook of Medical Physiology, Sixth Edition, pg. 287, 1981, wherein Q equals the volume of the injected diluent divided by the mean concentration of the diluent times the duration of the passage of the diluent through the vessel. A dilution curve is obtained by continuously monitoring changes in a given physical parameter of the blood over the time period of the injection. The change in the concentration of either the diluent (or the media) is measured over time. Hester, R. L. et al., American Journal of Kidney Disease 20:6, 1992, pp. 598-602, have shown that when the dialyzer blood lines are reversed, enhanced blood recirculation occurs. Krivitski, in European patent application number WO9608305A1, indicates that blood line reversal (causing forced recirculation) allows for the determination of the actual blood flow in the shunt. One method of measuring access blood flow utilizes color coded duplex sonography. However, this technique is expensive. It involves highly trained professionals and the measurements suffer from operator error. The limitations due to variations in the blood vessel diameter and even the Doppler flow angle complicate this measurement. Another method involves injection of a saline solution intravenously and recording optical detecting the change in the intensity of light passed through a conduit at a point upstream from the injection point (U.S. Pat. No. 5,312,550). Another technique involves injecting saline boluses into the arterial and venous dialyzer tubing lines and measuring the change of ultrasound velocity (U.S. Pat. No. 5,453.576). This technique is sensitive to changes in temperature, plasma protein levels, and other intrinsic factors that change the density of the blood. Of more significance, however, is that the measurements of the absolute ultrasound velocity changes are influenced not only by the intrinsic blood factors, but also by the unknown mechanical properties of the tubing line per se. In order to compensate for those intrinsic and extrinsic physical problems an additional calibration injection of saline is generally required in the opposite tubing line, whether arterial or venous, thereby producing relative changes in the degree of dilution that occurs due to the saline bolus. Hence, the unknown ultrasound characteristics of the tubing line and other physical, dimensional characteristics can be minimized. The present standard measurement for access recirculation requires three blood urea nitrogen samples from the patient while on dialysis. However, in addition to the blood samples required from the patient, nursing time, laboratory costs, and appropriate blood flow rates must be maintained during the actual sampling procedure to assure correct urea nitrogen measurements. Thus, there remains a need for systems and methods for noninvasively and quantitatively determining a patient's hemodynamic access blood flow and blood recirculation parameters. OBJECTS OF THE INVENTION Thus, it is an object of the present invention to provide a system and method for noninvasive access hemodynamic monitoring that requires minimal nursing time and no discreet blood sampling. It is another object of the present invention to provide a system and method for the display of both immediate and continuous-visual information regarding the saline dilutional hemodynamic access data. It is yet another object of the present invention to provide repeatable and reliable systems and methods for the noninvasive determination of the hemodynamic access flow properties under varying conditions including: different ultrafiltration rates, patient postures, tubing types and dimensions, and even different dialyzer membranes and dialysis delivery systems. Another object of the present invention is to provide a means and method of quantitatively determining the volumetric blood flow rate actually passing through the dialyzer, Q i . Another object of the present invention is to present the dilutional concentration-time curves to the operator by visual, real-time display means. Still another object of the present invention is to provide a system and method which can provide immediate and quantitative determination of the actual volume of fluid necessary to prime the dialyzer circuit. It is likewise another object of the present invention to provide a system and method for determining the access blood flow and access recirculation that does not require the injection of saline. For example, by changing the ultrafiltration rate. (UFR) or dialyzer blood flow rate. It is another object of the present invention to provide a system and method for measuring dialyzer blood flow parameters. These and other objects and advantages of the invention will become more fully apparent from the description in the claims which follow or may be learned by the practice of the invention. SUMMARY OF THE INVENTION In one aspect of the present invention, access recirculation in a shunt is determined quantitatively by a method in which a standard solution, such as a saline solution, is injected into the patient's bloodstream at a point upstream of the shunt. At a point in the access line, a photometric measurement is conducted of the change in hematocrit (ΔH) with respect to time. Electronic circuitry receives signals from the detector and compares the integrated area of ΔH with respect to time of the standard solution initially flowing through the access and of the recirculated solution and provides a nearly instantaneous display of the amount of access recirculation. In another aspect of the present invention, the access recirculation and/or access blood flow are quantitatively determined without injecting a solution into the bloodstream. In this aspect the extent of access recirculation and/or access blood flow is determined quantitatively by a method in which the dialyzer blood flow rate or the ultrafiltration rate (UFR) is changed and the corresponding change in concentration of a blood constituent is measured. In this technique, the concentration of a blood constituent is measured as a function of dialyzer blood flow rate or UFR and electronic circuitry converts these measurements into quantitative determinations of access recirculation and/or access blood flow that can be displayed nearly instantaneously. In a preferred embodiment the measured blood constituent is red blood cells. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a typical dialysis tubing connection circuit. FIG. 2 illustrates a plot of %Δ Hematocrit (or %Δ blood volume (BV)) versus Time following an injection of 10 ml saline into the bloodstream at a location upstream of the shunt. FIG. 3 shows a single injection dilutional curve when access recirculation is present, note the second area (curve 2) following the larger first area (curve 1). FIG. 4 shows a single injection dilutional curve with the arterial and venous tubing lines reversed causing forced (or reversed) recirculation. FIG. 5 diagrammatically represents the dialysis circuit in terms of mass flow, in normal arterial, venous line orientation. FIG. 6 diagrammatically represents the dialysis circuit in terms of mass flow with arterial and venous lines reversed. DETAILED DESCRIPTION OF THE INVENTION In a preferred embodiment, measurements are conducted using the apparatus described in U.S. Pat. Nos. 5,456,253 and 5,372,136, which are incorporated herein as if reproduced in full below. Both of these patents form part of the present disclosure. Thus, in a preferred embodiment, hematocrit is measured through blood in a flow through cuvette located in the access line. In a preferred embodiment, the apparatus and signal manipulations described in U.S. Pat. No. 5,372,136 are used to measure hematocrit. The numbered components are the same as FIG. 1 in U.S. Pat. No. 5,456,253. In hemodialysis, blood is taken out of a patient 200 by an intake catheter means, one example of which is shown in FIG. 1 as an input catheter 122. Input catheter 122 is intravenously inserted into patient 200 at a site 180 and is used for defining a blood passageway upstream of a blood filter used to filter the impurities out of the blood. The blood filter is also called a dialyzer 130. The unclean blood flows from an artery in patient 200 to a pump means, an example of which is pump 140. From pump 140, the blood flows to dialyzer 130. Dialyzer 130 has an input port 230 and an output port 240. The pump 140 performs the function of moving the unclean blood from patient 200 into input port 230, through dialyzer 130, and out of dialyzer 130 at output port 240. Specifically, unclean blood in input catheter 122 is transported to input port 230 of dialyzer 130. After passing through and being cleansed by dialyzer 130, the blood may receive further processing, such as heparin drip, in hemodialysis related component 300. The now clean blood is returned to patient 200 after the dialyzing process by means of an output catheter means, an example of which is output catheter 124. Output catheter 124, which is also intravenously inserted into patient 200 at site 180, defines a blood passageway which is downstream from dialyzer 130, taking the blood output by dialyzer 130 back to patient 200. As mentioned, the hemodialysis process uses a blood filter or dialyzer 130 to clean the blood of patient 200. As blood passes through dialyzer 130, it travels in straw-like tubes (not shown) within dialyzer 130 which serve as membrane passageways for the unclean blood. The straw-like tubes remove poisons and excess fluids through a process of diffusion. An example of excess fluid in unclean blood is water and an example of poisons in unclean blood are blood urea nitrogen (BUN) and potassium. The excess fluids and poisons through an ultrafiltration process are removed by a clean dialysate liquid fluid, which is a solution of chemicals and water. Clean dialysate enters dialyzer 130 at an input tube 210 from a combined controller and tank 170. The dialysate surrounds the straw-like tubes in dialyzer 130 as the dialysate flows down through dialyzer 130. The clean dialysate picks up the excess fluids and poisons passing through the straw-like tubes, by diffusion, and then returns the excess fluids and poisons with the dialysate out of dialyzer 130 via an output tube 220, thus cleansing the blood. Dialysate exiting at output tube 220 after cleansing the blood may be discarded. In some, unclean blood flows from an artery in patient 200 to pump 140 and then to dialyzer 130. Unclean blood flows into dialyzer 130 from input catheter 122 and clean blood flows out of dialyzer 130 via output catheter 124 back to patient 200. Installed at either end of dialyzer 130 is a spectrophotometry means for defining a blood flow path, for emitting radiation into the blood in the flow path, and for detecting radiation passing through both the blood and the flow path. The spectrophotometry means includes a cuvette means for defining the blood flow path, and an emitter/detector means for emitting and detecting radiation. Within the emitter/detector means is both an emission means for directing radiation and a detector means for detecting radiation. In a prior art embodiment as shown in FIG. 1, an example of the emitter/detector means is depicted by the emitter/detector apparatus 100. An example of the emission means is indicated by a photoemitter 102. Emitter/detector apparatus 100 also has a detection means, an example of which is depicted as a photodetector 104. An example of the cuvette means is shown in FIG. 1 as cuvette 10. Emitter/detector apparatus 100 enables the detection by photodetector 104 of the portion of radiation which is directed by photoemitter 102 to cuvette 10 and passes through both the blood therein and cuvette 10. As shown in FIG. 1, a cuvette 10 is installed at either end of dialyzer 130. Each cuvette 10 has a photoemitter 102 and a photodetector 104 thereon. In the preferred embodiment of the system, photoemitter 102 and photodetector 104 are shown as being held together by a spring loaded C-Clamp type in emitter/detector photo apparatus 100. The emitter/detector means is electrically connected to a calculation means. In a preferred embodiment of the system, an example of the calculator means is depicted in FIG. 1 as computer 150 which is electrically connected to photoemitter 102 and photodetector 104 on emitter/detector apparatus 100 by means of cable 120 or 128. Intake catheter 122 takes blood to cuvette 10 situated before input port 230 of dialyzer 130. Emitter/detector apparatus 100 at input port 230 of dialyzer 130 subjects the blood therein to radiation wavelengths of electromagnetic radiation for the purposes of analysis, via spectrophotometry, so that the concentration of a desired biological constituent can be derived. Each photodetector 104, at both input port 230 and output port 240 of the dialyzer 130, communicates the detected radiation via cable 120 or 128 to computer 150. Computer 150 calculates both before dialysis (via cable 120) and after dialysis (via cable 128) concentrations of the sought-after or desired biologic constituent. Computer 150 then displays, respectively, at a first display 152 and a second display 154, the derived concentration of the biological constituent in either analogue or digital representations. The calculation means, shown here by example as computer 150, preferably has the multiple capability of simultaneous real-time computation and display of several blood parameters of interest. 1. Single Injection Dilutional Technique In the first aspect, approximately 10 mls of saline is injected over five seconds into the arterial line. The measuring disposable blood chamber 10 is immediately downstream (in the arterial line) from the injection point 15, see FIG. 1. A change in hematocrit (ΔH) instantly occurs due to the dilution of the whole blood by the saline. Then, by appropriately measuring and computing the area under the dilution curve, see FIG. 2, (the Ficke principle), the dialyzer blood flow (Q i ), access recirculation (AR), and access blood flow (Q a ) are determined in the following manner. Q.sub.1 =V/K∫(%ΔH)dt (1) where: Q i =Dialyzer blood flow rate, in ml/min K=a measurement unit conversion factor, determined empirically to convert percent change hematocrit units to area and minute units. ∫(%ΔH)dt=area under the hematocrit dilution curve (1) in FIG. 3. V=Volume of saline injected (typically 10 ml) If access recirculation (AR) is present, FIG. 3 is obtained. In order to determine AR the following equation is used: AR=(∫(%ΔH).sub.2 dt/∫(%ΔH).sub.1 dt)·100(2) where: AR=% Access Recirculation, when ultrafiltration is off ∫(%ΔH) 2 dt=area under curve 2, the "measuring area" ∫(%ΔH) 1 dt=area under curve 1, the "calibration area" The area under the dilution curve 1, the "calibration area", represents 100% of the 10 ml saline bolus passing through the chamber and diluting the blood in the path of the optical detector. The area under dilution curve 2, the "measuring area", represents the amount of saline which "recirculated" from the venous line into the shunt (or access) and "back again" to the arterial line and hence, passing the optical detector a second time. The areas under the dilution curves are measured during specific time intervals in the following way. With reference to FIG. 3, the injection of saline solution takes place at time 0 seconds. The slope of the resulting line 51 remains essentially flat until about 19 seconds, where there is a dramatic increase in the slope of line 51. It is at this point that the system starts to measure the area under curve 1. The system continues to measure the area under curve 1 until the slope of line 51 changes from a negative slope to a zero slope or a positive slope which occurs at about 41 seconds. It is at that point in time that the measurement of curve 1 stops and the measurement of the area of curve 2 begins. The measurement of curve 2 continues until a time is reached where the slope of line 51 changes from a negative to a zero, which in FIG. 3 occurs at about 78 seconds. It is at this point in time that the measurement of the area of curve 2 stops. Knowing Q i (in ml/min) and the time interval (T) between dilution curves 1 and 2 of FIG. 3, the priming dialyzer circuit volume (PDCV) can be calculated with the following: PDCV=Q.sub.i T(1/60) (3) Finally, to calculate the access blood flow, the arterial line is reversed with the venous line and placed "downstream" of the venous line in the shunt. A 10 ml saline bolus (given over 5 seconds) is then injected, into the arterial line, as usual, resulting in the dilution curves seen in FIG. 4. As in the determination of access recirculation, the reversed access recirculation (RAR) is computed from the following formula: RAR=∫(%ΔH).sub.2 dt/∫(%ΔH).sub.1 dt (4) and, as in equation 2, ultrafiltration is off. Once RAR is determined, then the access blood flow, Q a , is calculated from: Q.sub.a =Q.sub.i (RAR.sup.-1 -1) (5) Hence, with a single injection of saline into the arterial line, immediately upstream from the measuring disposable blood chamber, the calibration area (curve 1) and the measuring area (curve 2) are obtained, see FIGS. 3 and 4. A reference, or the calibration area, is already incorporated within the single injected saline bolus, without the need for dual sensors, or a customary second saline injection; where one injection is for reference measurements and the second injection is the measuring injection. The single saline injection technique utilizing a single detector is a major enhancement and has many advantages. For example, in other methods typically two detectors must be "tuned" exactly the same. In a double injection technique, two separate injections must be the exact same volume each time and given at the same rate of injection, otherwise the calibration areas and the measuring areas will be different, giving erroneous results. The equation mentioned above requires accurate measurement of the area under the hematocrit dilution curve, ∫(%ΔH)dt. The most common error in that measurement comes from the variations in the rate of injection of the saline bolus (typically 10 ml over 5 seconds). The actual rate of saline injection can be calculated from time base parameters seen in the arterial injection. The resulting variation (or perturbation), Q i , caused by these injection-induced transients is compensated for as seen in equations 5a and 5b (from equation 1): Q.sub.i (corrected)=V/[K(Area.sub.m -Area.sub.p)] (5a) where: Area m =Area measured under the hematocrit dilution curve Area p =Area of push rate of the saline injection ##EQU1## where: Q i (raw)=raw blood flow rate based on area m span=time interval from the start of the saline injection to the end of the injection, in seconds. The injection rate-induced transients can thusly be compensated for resulting in more accurate blood flow, access recirculation and access blood flow measurements. 2. The Second Aspect, the Δ Hematocrit Technique Referencing FIG. 5, the following mathematics allows determination of access recirculation via the Δ Hematocrit technique, wherein the following mass (m) and blood flow rate (Q) balance obtains: m.sub.a +m.sub.r =m.sub.i (6) and Q.sub.a +Q.sub.r =Q.sub.i (7) so: Q.sub.a H.sub.a +Q.sub.r H.sub.o =Q.sub.i H.sub.i (8) (where Q.sub.o=Q.sub.i =UFR) since: Q.sub.i H.sub.i =Q.sub.o H.sub.o (9) =(Q.sub.i -UFR)H.sub.o and H.sub.o =(Q.sub.i /(Q.sub.i -UFR))H.sub.i (10) But since: R=Q r /Q i , dividing equation 8 by Q i obtaining: H.sub.i /H.sub.a =(1-R)[1-R(Q.sub.i /(Q.sub.i -UFR))].sup.-1(11) Therefore to determine access recirculation (AR) by the Δ Hematocrit method the following obtains: AR=100.sup.• (H.sub.i -H.sub.a)[(Q.sub.i /(Q.sub.i -UFR))H.sub.i -H.sub.a ].sup.-1 (12) From Equation 12 note that by either changing the dialyzer blood flow rate, Q i , or by changing the ultrafiltration rate (UFR) a change in the hematocrit is created; hence, the direct measurement of access recirculation is determined. To determine the access blood flow, Q a , by the Δ Hematocrit method refer to FIG. 6, which shows the arterial and venous lines reversed. Since there must be a hematocrit balance around the tubing/dialyzer circuit the following applies: Q.sub.a H.sub.a +Q.sub.o H.sub.o =H.sub.i (Q.sub.a +Q.sub.o)(13) but, Q.sub.i H.sub.i =Q.sub.o H.sub.o, (and Q.sub.o =Q.sub.i -UFR)(14) so, Q.sub.a H.sub.a +Q.sub.i H.sub.i =H.sub.i (Q.sub.a +Q.sub.i -UFR)(15) and H.sub.i /H.sub.a =Q.sub.a (Q.sub.a -UFR) (16) Therefore: Q.sub.a =H.sub.i (UFR)/(H.sub.i -H.sub.a) (17) From Equation 17, Q a , by the Δ Hematocrit technique, is independent of the dialyzer blood flow rate, Q i . Therefore, by merely changing the ultrafiltration rate (UFR), access blood flow is directly computed, when the measurement of H i occurs in the immediately removed portion of the mixed blood (input to the dialyzer). By way of example, the value of Q a is determined in the following manner. Assume that UFR=0 milliliters/minute or ml/min. According to equation (17), Q a would equal 0 ml/min. Also with UFR=0 ml/min, the access hematocrit H a is measured to be 30.0. This becomes the baseline value for H a . When the UFR is increased, as for example, to 30 ml/min, the value of the hematocrit in the arterial line, H i , measured after a short period of time, (3 or 4 minutes) is about 31.0. Therefore, according to equation 17, Q a =31(30)/(31-30)=930 ml/min. However, when the measurement of hematocrit occurs in the delivered portion of the mixed blood (output of the dialyzer) the following equations obtain, equation 15 becomes: ##EQU2## resulting in: ##EQU3## Substituting from (14) yields: ##EQU4## Again when UFR=0 ml/min, hematocrit=H a , and when UFR=30 ml/min, hematocrit=H o . Note also that if the input, H i , and output H o , are known then: ##EQU5## Without the injection of saline, but by measuring the ΔH on the delivered portion of mixed blood (output of the dialyzer) by merely changing either the UFR or the Q i to known values, the access blood flow is easily and accurately calculated. Likewise, if the input (pre dialyzer) and output (post dialyzer) hematocrits are measured then either the Q i or UFR can be accurately calculated as well. Utilizing the instantaneous hematocrit monitor, the above Δ Hematocrit method will measure AR and Q a immediately and directly. Using the Δ Hematocrit method with a blood volume monitor (a relative measure of hematocrit) to measure AR and Q a will yield immediate and direct results. However, because of the relative measure of hematocrit, the results will not be accurate. It should be emphasized again that while U.S. Pat. No. 5,372,136 shows the measurement of absolute hematocrit, this technique and method described in the second aspect of the invention is intended to incorporate the relative measure of hematocrit (ΔBV), as well as the usage of single wavelength optical, conductimetric or ultrasonic methods of BV measurements. Therefore, the method of simply changing Qi or UFR in order to measure AR or simply changing UFR to measure the Q a are important new and unique concepts. U.S. Pat. No. 5,372,136 clearly defines the operational means whereby the instantaneous and continuous measurement of hematocrit is obtained and used in connection with the disposable blood chamber mentioned above. Although the foregoing discussion relates to noninvasive analysis of hemodynamic access flow information, it will be appreciated that the above mentioned circuitry and algorithms may be adapted for analysis of other rheologic parameters. The present invention may be embodied in other specific forms without departing from its intent or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive.

Access recirculation in a shunt is determined quantitatively by a method in which a standard solution, such as a saline, is injected into a patient's bloodstream upstream of the shunt. At a point in the access line, a photometric measurement is conducted of the change in hematocrit (ΔH) with respect to time. Electronic circuitry receives signals from the detector and compares the integrated area of ΔH with respect to time of the standard solution initially flowing through the access and of the recirculated solution and provides display of access recirculation. In another aspect, access recirculation and access blood flow are quantitatively determined without injecting a solution into the bloodstream. In this aspect the extent of access recirculation and/or access blood flow is determined quantitatively by a method in which the dialyzer blood flow rate or the ultrafiltration rate (UFR) is changed and the corresponding change in concentration of a blood constituent is measured. In this technique, the concentration of a blood constituent is measured as a function of dialyzer blood flow rate or UFR and electronic circuitry converts these measurements into quantitative determinations of access recirculation and/or access blood flow that can be displayed.